Abstract: An analyte, system, strip and method are described. In one example, an analyte test strip is provided that includes a substrate, electrically conductive material and an isolated portion of the electrically conductive material. The substrate has a generally planar surface that extends from a first end to a second end. The electrically conductive material is disposed on the generally planar surface to define a plurality of electrodes spaced apart from each other. The isolated portion of the electrically conductive material is disposed between at least two electrodes so that the isolated portion is not in electrical communication with the plurality of electrodes.

Abstract: Electrochemical test strips and methods for their use in the detection of an analyte in a physiological sample are provided. The subject test strips have a reaction zone defined by opposing metal electrodes separated by a thin spacer layer. The metal surface of at least one of the electrodes is modified by a homogenous surface modification layer made up of linear self-assembling molecules having a first sulfhydryl end group and a second sulfonate end group separated by a short chain alkyl linking group, where 2-mercaptoethane sulfonic acid or a salt thereof is preferred in certain embodiments. The subject electrochemical test strips find application in the detection of a wide variety of analytes, and are particularly suited for use the detection of glucose.

Abstract: System, circuits, and methods to reduce or eliminate uncompensated voltage drop between an electrode of an electrochemical cell usable for analyte measurement. In one example, a system is provided that includes a test strip, a reference voltage circuit, an operational amplifier connected to the reference voltage circuit to provide a predetermined fraction of a reference voltage substantially equal to the test voltage applied to the first line, the operational amplifier having an output configured for one of a connected or disconnected state to the first line, and a processing circuit connected to the output of the operational amplifier and the first line such that, during a disconnected state between the output and the first line, the processing circuit remains in connection with the first line.

Abstract: The present invention relates to electrochemical cells including a first working electrode 32, a first counter electrode 34, a second working electrode 36, and a second counter electrode 38, wherein the electrodes are spaced such that reaction products from the first counter electrode 34 arrive at the first working electrode 32, and reaction products from the first and second counter electrodes 34, 38 do not reach the second working electrode 36. Also provided is a method of using such electrochemical cells for determining the concentration of a reduced or oxidized form of a redox species with greater accuracy than can be obtained using an electrochemical cell having a single working and counter electrode.

Abstract: The present invention relates, in general, to lancing elements for use in drawing bodily fluids out of a patient and, more particularly, to an improved lancing element including first and second elements positioned relative to each other such that an incision formed by the first element is held open by the second element and bodily fluids are pulled up the lancing element by surface tension on the first and second lancing elements.

Abstract: A system and method of processing a test current for an analyte measurement in a fluid using a test strip and a test meter are disclosed. The method comprises sampling the test current at a pre-determined sampling rate to acquire a plurality of A/D conversions. The method also comprises filtering out at least a highest magnitude A/D conversion and a lowest magnitude A/D conversion leaving a plurality of accepted A/D conversions. Further, the method comprises calculating an average or a summation of the plurality of accepted A/D conversions and converting the average or the summation into a glucose concentration.

Abstract: An electrochemical glucose sensor comprising a base substrate, a conductive layer disposed on said base substrate, where said conductive layer comprises a reference electrode and at least two working electrodes; an insulation layer disposed on a part of said conductive layer, a reagent layer disposed on said working electrodes and on at least a part of said reference electrode, an adhesive layer disposed on a portion of said reagent layer and conductive layer wherein said adhesive layer substantially defines an area of said reference electrode which can be wetted by a liquid sample and said insulation layer substantially defines an area of said working electrodes which can be wetted by a liquid sample.

Abstract: A biosensor for use in determining a concentration of a component in an aqueous liquid sample is provided including: an electrochemical cell having a first electrically resistive substrate having a thin layer of electrically conductive material, a second electrically resistive substrate having a thin layer of electrically conductive material, the substrates being disposed with the electrically conductive materials facing each other and being separated by a sheet including an aperture, the wall of which aperture defines a cell wall and a sample introduction aperture whereby the aqueous liquid sample may be introduced into the cell; and a measuring circuit.

Abstract: The present invention relates to electrochemical cells including a first working electrode 32, a first counter electrode 34, a second working electrode 36, and a second counter electrode 38, wherein the electrodes are spaced such that reaction products from the first counter electrode 34 arrive at the first working electrode 32, and reaction products from the first and second counter electrodes 34, 38 do not reach the second working electrode 36. Also provided is a method of using such electrochemical cells for determining the concentration of a reduced or oxidized form of a redox species with greater accuracy than can be obtained using an electrochemical cell having a single working and counter electrode.

Abstract: A system for implementing a wide-range of glycemic control protocols (e.g., Tight Glycemic Control protocols) in an automated, semi-closed or closed loop manner thereby eliminating common sources of system error is provided herein. More specifically, the system can include a blood glucose measuring device in communication with a wide-range of databases and/or interfaces thereby allowing for typically independent steps such as patient testing, result determination, protocol adjustment (suggestions as well as actual calculations of new dosages), meal information, scheduling of future testing in light of test results, and administration of medicine to be performed automatically in a semi-closed or closed loop manner. Furthermore, the system provides for ultimate flexibility by allowing a protocol administrator to continuously add, subtract, and/or modify various steps of the protocol while maintaining the integrity and safety of the system.

Abstract: The present invention is directed to a method of reducing false readings in a hypoglycemic detector that includes establishing a predetermined hypoglycemic threshold, a predetermined critical threshold, a predetermined rate of change in glucose concentration where the predetermined critical threshold is below the predetermined hypoglycemic threshold. A first sampling rate is then calculated based upon said predetermined hypoglycemic threshold, said predetermined critical threshold, and said predetermined rate of change in glucose concentration.

Abstract: The present invention relates to a method and a device for transporting a molecule through a mammalian barrier membrane of at least one layer of cells comprising the steps of: ablating said membrane with a shear device; and utilizing a driving force to move said molecule through said perforated membrane.

Abstract: A fusible conductive ink for use in manufacturing microfluidic analytical systems includes micronised powder containing platinum and carbon, poly(bisphenol A-co-epichlorohydrin)-glycidyl end capped polymer, and a solvent. In addition, the ratio of micronised powder to poly(bisphenol A-co-epichlorohydrin)-glycidyl end capped polymer is in the range of 3:1 to 1:3. The fusible conductive inks can be employed in the manufacturing of microfluidic systems to form electrodes, electrically conductive traces and/or electrically conductive contact pads.

Abstract: The present application is directed to systems and methods associated with infusion pumps, which can optionally utilize an electrokinetic driving mechanism. Infusion pumps, including electrokinetically-driven pumps, are discussed, along with schemes for controlling their operation. As well, systems and methods of detecting malfunctions in infusion pumps are discussed. Any number of malfunctions can be detected including the presence of occlusions and/or leaks. In some instances, a measurement associated with some aspect of electrokinetic phenomena (e.g., an electrode measurement such as voltage or current) is compared with one or more sample values, the comparison allowing an indication of pump malfunction to be determined. A variety of such measurements and comparison techniques are discussed in the present disclosure.

Abstract: A method, system, and computer program product related to the maintenance of optimal control of diabetes, and is directed to predicting patterns of hypoglycemia, hyperglycemia, increased glucose variability, and insufficient or excessive testing for the upcoming period of time, based on blood glucose readings collected by a self-monitoring blood glucose device. The method, system, and computer program product pertain directly to the enhancement of existing home blood glucose monitoring devices, by introducing an intelligent data interpretation component capable of predicting and alerting the user to periods of increased risk for hyperglycemia, hypoglycemia, increased glucose variability, and ineffective testing, and to the enhancement of emerging self-monitoring blood glucose devices by the same features. With these predictions the diabetic can take steps to prevent the adverse consequences associated with hyperglycemia, hypoglycemia, and increased glucose variability.

Abstract: A method for producing a porous flow-through element for use in an electrokinetic infusion pump is provided and generally includes providing a porous membrane that is entirely porous along both its length and width, treating the membrane by selectively inactivating portions of the membrane in a desired pattern to define active regions that allow fluid flow therethrough and inactive regions that do not, and laminating the treated membrane. Various techniques can be used to treat the membrane including, for example, applying a heated embossing die to the membrane, contacting selected portions of the membrane with laser energy, applying a pore-penetrating chemical to the membrane, and cutting and removing selected portions of the membrane. The resulting treated membrane can be laminated between opposed films having one or more perforations therethrough with each perforation being aligned with an active region to define a fluid flow pathway therebetween.