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Biosensor


Title: Biosensor.
Abstract: The present invention relates to a biosensor. The biosensor includes a support substrate, an electrically conductive coating positioned on the support substrate, the coating being formed to define electrodes and a code pattern, wherein there is sufficient contrast between the conductive coating and the substrate such that the code pattern is discernible, and a cover cooperating with the support substrate to define a channel. At least a portion of the electrodes are positioned in the channel. ...




USPTO Applicaton #: #20100219071 - Class: 20440301 (USPTO) - 09/02/10 - Class 204 
Inventors: Raghbir S. Bhullar, Henning Groll, John T. Austera, Douglas P. Walling, Timothy I. Ranney, James L. Pauley, Jr.

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The Patent Description & Claims data below is from USPTO Patent Application 20100219071, Biosensor.

FIELD OF THE INVENTION

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The present invention relates to a biosensor, more particularly to an electrochemical biosensor with a code pattern thereon.

BACKGROUND AND

SUMMARY

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OF THE INVENTION

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. It is also known to include a code on a test strip that identifies the manufacturing batch of the strip. See WO 99/22236.

According to one aspect of the present invention a biosensor is provided. The biosensor comprises a support substrate, an electrically conductive coating positioned on the support substrate, the coating being formed to define electrodes and a code pattern, wherein there is sufficient contrast between the conductive coating and the substrate such that the code pattern is discernible, and at least one reagent positioned on at least one electrode.

According to another aspect of the present invention a biosensor is provided. The biosensor comprises a support substrate, an electrically conductive coating positioned on the support substrate, the coating being formed to define electrodes and a code pattern, wherein there is sufficient contrast between the conductive coating and the substrate such that the code pattern is discernible, and a cover cooperating with the support substrate to define a channel. At least a portion of the electrodes are positioned in the channel.

In addition, a method of forming a biosensor is provided in accordance with the present invention. The method comprises the steps of providing a substrate coated with a electrically conductive material, ablating the electrically conductive material to form electrodes and a code pattern, wherein there is sufficient contrast between the conductive coating and the substrate such that the code pattern is discernible, and applying a reagent to at least one of the electrodes.

Still further, in accordance with the present invention a biosensor is provided. The biosensor comprises a support substrate and an electrically conductive coating positioned on the support substrate. The coating is formed to define electrodes and means for identifying the biosensor, wherein there is sufficient contrast between the conductive coating and the substrate such that the identifying means is discernible.

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.

BRIEF DESCRIPTION OF THE DRAWINGS

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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, showing the biosensor formed to include a code pattern formed thereon.

FIG. 2 is an exploded assembly view of the biosensor of FIG. 1, showing the biosensor including an electrode array positioned at one end, a spacer substrate including a notch, and a cover formed to extend over a portion of the notch.

FIG. 3 is a view taken along lines 3-3 of FIG. 1.

FIG. 4 is a view taken along lines 4-4 of FIG. 1.

FIG. 5 is an enlarged top view of an alternative code pattern formed on a biosensor in accordance with the present invention.

FIG. 6 is an enlarged top view of an alternative code pattern formed on a biosensor in accordance with the present invention.

DETAILED DESCRIPTION

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OF THE INVENTION

The present invention relates to a biosensor and a method for manufacturing a biosensor that has a specific code pattern. This code pattern is beneficially formed from the same electrically conductive material and in the same manner as the electrodes of the biosensor, which reduces steps in the manufacturing process. Laser ablation is preferably used in forming the code pattern while generating the electrode pattern. The code pattern can be read in a number of ways, non-limiting examples of which include optically or electrically depending on the structures formed onto the biosensor. The structures could show contrast in their optical reflectivity, their electrical conductivity, or their resistance respectively. The structures could also be high reflectivity areas surrounded by low reflectivity areas or vice versa, or areas of high electrical conductivity surrounded by areas of low conductivity. Aspects of the invention are presented in FIGS. 1-6, which are not drawn to scale and wherein like components in the several views are numbered alike.

FIGS. 1-4 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 substrate 12 that is disrupted to define electrodes 14, 16, a spacer substrate 18 positioned on substrate 12, and a cover substrate 20 positioned on the spacer substrate 18. Biosensor 10 is preferably rectangular in shape. It is appreciated however, that biosensor 10 can assume any number of shapes in accordance with this disclosure, Biosensor 10 is preferably produced from rolls of material however, it is understood that biosensor 10 can be constructed from individual sheets in accordance with this disclosure. Thus, the selection of materials for the construction of biosensor 10 necessitates the use of materials that are sufficiently flexible for roll processing, but which are still rigid enough to give a useful stiffness to finished biosensor 10.

Referring to FIG. 4, the support substrate 12 includes a first surface 22 facing the spacer substrate 18 and a second surface 24. In addition, as shown in FIG. 2, substrate 12 has opposite first and second ends 26, 28 and opposite edges 30, 32 extending between the first and second ends 26, 28. Substrate 12 is generally rectangular in shape, it is appreciated however, that support may be formed in a variety of shapes and sizes in accordance with this disclosure. Substrate 12 is formed of a flexible polymer and preferably from a flexible polymer and preferably from a polymer such as a polyester or polyimide, polyethylene naphthalate (PEN). A non-limiting example of a suitable PEN is 5 mil (125 um) thick KALADEX®, a PEN film commercially available from E.I. DuPont de Nemours, Wilmington, Del., which is coated with gold by ROWO Coating, Henbolzhelm, Germany.

Electrodes 14, 16 are created or isolated from conductor 13 on first surface 22 of substrate 12. Non-limiting examples of a suitable 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. Preferably, electrical conductor 13 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, electrical conductor 13 is gold.

Electrodes 14, 16 are isolated from the rest of the electrical conductor 13 by laser ablation. See FIG. 4. Techniques for forming electrodes on a surface using laser ablation are known. See, for example, U.S. patent application Ser. No. 09/411,940, filed Oct. 4, 1999, and entitled “LASER DEFINED FEATURES FOR PATTERNED LAMINATES AND ELECTRODE”, the disclosure of which is expressly incorporated herein by reference. Preferably, electrodes 14, 16 are created by removing the electrical conductor 13 from an area extending around the electrodes to form a gap of exposed support substrate 12. Therefore, electrodes 14, 16 are isolated from the rest of the electrically-conductive material on substrate 12 by a gap having 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 that electrodes 14, 16 may be created by laser ablation alone on substrate 12. It is appreciated that while laser ablation is the preferred method for forming electrodes 14, 16 given its precision and sensitivity, other techniques such as lamination, screen-printing, or photolithography may be used in accordance with this disclosure.

As shown in FIG. 2, electrodes 14, 16 cooperate with one another to define an electrode array 36. In addition, electrodes 14, 16 each include a contact 34 and a lead 38 extending between the contact 34 and the array 36. It is appreciated that the leads 38 extending from the array 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 a greater than one array may be formed as will be appreciated by one of skill in the art.

Referring again to FIGS. 2 and 3, a recess 35 is formed from the electrical conductor 13 by laser ablation using techniques as described above. Recess is created by removing the electrical conductor 13 to expose the first surface 22 of the support substrate 12 adjacent to the first end 26. It is appreciated that a portion of the first surface 22 may also be removed to form the recess 35 in accordance with this disclosure.

In addition, as shown in FIGS. 1, 2, and 4, the discernible code pattern 40 is formed from the electrical conductor 13 by laser ablation using techniques as described above with reference to electrodes 14, 16. Specifically, the code pattern 40 is created by removing the electrical conductor 13 in a pre-defined pattern to expose the first surface 22 of the support substrate 12. While pattern 40 is illustratively a barcode type pattern, it is appreciated that the pattern 40 can take on any number of shapes and patterns, non-limiting examples of which are shown in FIGS. 5 and 6.

It is also appreciated that the pattern 40 can be provided in a human readable, optical readable, or electrical readable form in accordance with this disclosure. The structures could show contrast in their optical reflectivity, their electrical conductivity, or their resistivity respectively. To aid in contrasting the electrical conductivity of the code pattern 40, the electrical conductor 13 of the pattern 40 may be coated with a second conductive material (not shown) that is different from the electrical conductor 13. Non-limiting examples of the second conductive material include carbon and silver. It is appreciated, however, that a wide variety of materials may be coated on the electrical conductor 13 to change the electrical property of the code pattern 40.

It is also appreciated; electrodes 14, 16 could be formed from layers of electrically conductive materials having different colors, reflectivity, conductance, etc. Thus, the code pattern can be formed by removing a portion of the electrical conductor layers, leaving behind areas of high reflectivity surrounded by low reflectivity areas or vice versa, areas of high electrical conductivity surrounded by areas of low conductivity or vise versa. It is also possible to laser etch a code pattern that has a known resistance and this area can be read electrochemically to identify or recognize the code pattern. Moreover, it is appreciated that the code pattern can be a combination of any of the above readable forms in accordance with the present invention.

As shown in FIG. 4, the code pattern 40 is isolated from the rest of the electrically conductive material 13 on substrate 12 by gaps 42. Gaps 42 can have a wide variety of widths in accordance with this disclosure depending upon the specific use of the code pattern 40. Non-limiting examples of widths of the gaps include from about 1 μm to about 1000 μm. Alternatively, it is appreciated that the code pattern 40 may be created by laser ablation alone on substrate 12. It is appreciated that while laser ablation is the preferred method for forming the code pattern 40 given its precision and sensitivity, other techniques such as lamination, screen-printing, or photolithography may be used in accordance with this disclosure.

The manufacturer of biosensor 10 may maintain a central database containing a set of code patterns, each of which uniquely identifies an individual biosensor, or batch of biosensors. There may also be associated with each code pattern a set of calibration data for the biosensor 10. It is appreciated that the code patterns may be associated with any number of identification or data sets in accordance with the present invention.

Spacer substrate 18 of biosensor 10 includes an upper surface 44 and a lower surface 46 facing the substrate 12. In addition, the spacer substrate 18 includes opposite first and second ends 48, 50. First end 48 includes a notch 52, which is defined by a border 54. The border illustratively includes three generally linear sides. It is appreciated that the notch can take on a variety of shapes and sizes in accordance with this disclosure. When biosensor 10 is assembled, the border 54 extends about at least a portion of the array 36 so that the array 36 is at least partially exposed in the notch 52.

Spacer substrate 18 is formed of a flexible polymer and preferably from 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 3 mil (75 um) thick white PET film both sides of which are coated with a pressure-sensitive adhesive (Product # ARcare 8877) commercially available from Adhesives Research, Inc. Glen Rock, Pa. It is appreciated that spacer substrate 18 may be constructed of a variety of materials and may be coupled to the substrate 12 and the cover substrate 20 using a wide variety of commercially available adhesives, or by welding (heat or ultrasonic) when large portions of the surface 22 of the electrode support substrate 12 are exposed and not covered by electrical conductor 13.

The cover substrate 20 is coupled to the upper surface 44 of the spacer substrate 18. See FIG. 3. The cover substrate 20 includes opposite first and second ends 56, 58. The cover substrate 20 is coupled to the spacer substrate 18 such that the first end 56 is spaced-apart from the end 48 of the spacer substrate 18 and the second end 58 is spaced-apart from the end 50 of the spacer substrate 18. When biosensor 10 is assembled, cover substrate 20 cooperates with the spacer support 20 and the electrode-support 12 to define a capillary channel 60.

Cover substrate 20 is generally rectangular in shape, it is appreciated, however, that the cover substrate may be formed in a variety of shapes and sizes in accordance with this disclosure. Cover substrate 20 is formed from a flexible polymer and preferably from a polymer such as polyester. A non-limiting example of a suitable polymer is 3.9 mil (99 um) thick 3M hydrophilic polyester film (3M Product #9971), commercially available from 3M Healthcare, St. Paul, Minn.

Referring now to FIGS. 1 and 3, the capillary channel 60 is generally linear in shape and is defined by the cover substrate 20, the electrode support substrate 12, and the border 54 of the spacer substrate 18. When biosensor 10 is assembled, channel 60 extends across the electrode array 36. Cover substrate 20 does not extend across the entire notch 52, therefore, a portion of the notch serves as an air outlet in accordance with this disclosure.

An electrochemical reagent 62 is positioned on the array 36. The reagent 62 provides electrochemical probes for specific analytes. 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 is preferably glucose.

The choice of the specific reagent 62 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 in biosensor 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 Dehydrogenase Ferricyanide and Diaphorase Glucose Glucose-Dehydrogenase Ferricyanide (Quinoprotein) Cholesterol Cholesterol Esterase and


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stats Patent Info
Application #
US 20100219071 A1
Publish Date
09/02/2010
Document #
11158772
File Date
06/22/2005
USPTO Class
20440301
Other USPTO Classes
International Class
01N33/50
Drawings
5


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Chemistry: Electrical And Wave Energy   Apparatus   Electrolytic   Analysis And Testing   Biological Material (e.g., Microbe, Enzyme, Antigen, Etc.) Analyzed, Tested, Or Included In Apparatus  

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