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LifeScan, Inc.

LifeScan, Inc. Patent applications
Patent application numberTitlePublished
20120130646ANALYTE TESTING METHOD AND SYSTEM WITH HIGH AND LOW ANALYTE TRENDS NOTIFICATION - Described herein are systems and methods to utilize factual information based on stored analyte data to allow greater insight into a chronic disease of a user, such as, for example a diabetic patient.05-24-2012
20120067741APPARATUS AND PROCESS FOR IMPROVED MEASUREMENTS OF A MONITORING DEVICE - Methods and devices for improving measurements of test meter, and in particular for detecting a presence of an electrochemical sensor or strip in the test meter and a start time of an electrochemical reaction, are provided. In one exemplary embodiment of an electrochemical system includes an electrochemical sensor , a test meter, and a circuit. The circuit is configured to form an electrical connection with the electrochemical sensor such that the circuit can detect three distinct voltage ranges. The voltage ranges can be indicative of an absence of the electrochemical sensor, a presence of the sensor that is devoid of a sample, and a presence of the sensor with a sample. Test meters, methods for detecting when a sample starts to fill an electrochemical sensor for establishing when a reaction starts, and circuits for use with electrochemical strips, are also provided.03-22-2012
20110313395DRUG DELIVERY MANAGEMENT SYSTEMS AND METHODS - Various embodiments of a “smart” drug delivery pen are provided which include a drug delivery pen having an inertial sensor or accelerometer. A system is also provided that includes the smart drug pen in conjunction with a data management unit(s) DMU. Various exemplary methods for use of the pens and systems are also described and illustrated.12-22-2011
20110313350DRUG DELIVERY SYSTEM - Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reusage of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module.12-22-2011
20110198367SENSOR DISPENSER DEVICE AND METHOD OF USE - Disclosed herein are electrochemical sensor dispensing methods and apparatus. The sensors dispensers can include an elongate body having a proximal end and a distal, the elongate body including a proximally positioned dispensing surface with an opening for dispensing a sensor. A storage chamber having a series of connected sensors is positioned distally and can feed a proximally positioned sensor feeder mechanism. The feeder mechanism includes an elongate member having a first end and second end, the second end adapted to pivot between a sensor engaging position and a sensor feeding position.08-18-2011
20110190607METHODS AND SYSTEMS TO CORRECT FOR HEMATOCRIT EFFECTS - Described and illustrated herein are exemplary methods of operating an analyte measurement system having a meter and a test strip. Such methods may be exemplarily achieved by determining a first glucose concentration by measuring a first reflectance at about a first wavelength at a testing surface of the pad; measuring a second reflectance at about a second wavelength; formulating at least one equation to correct the first glucose concentration for temperature or hematocrit effects using the second reflectance at about the second wavelength; determining a second glucose concentration using the first glucose concentration, the second reflectance at about a second wavelength; and displaying the second glucose concentration that is corrected for temperature and hematocrit effects.08-04-2011
20110184752DIABETES MANAGEMENT UNIT, METHOD, AND SYSTEM - A system and method are shown and described for outputting a customized health data report with minimal usage of a user interface.07-28-2011
20110184653ANALYTE TESTING METHOD AND SYSTEM - Various methods and systems to manage diabetes using data relating to testing compliance, bolus dosing, or cannula usage are described and illustrated.07-28-2011
20110184343DRUG DELIVERY WITH EVENT NOTIFICATION - Devices, systems and methods are provided for drug delivery and the monitoring thereof.07-28-2011
20110174616METHODS FOR MEASURING PHYSIOLOGICAL FLUIDS - Electrochemical measurement techniques for measuring the concentration of an analyte in a physiological fluid sample are described. More particularly, the present invention relates to techniques for distinguishing a signal caused by an extraneous event from a desired information providing signal such as one indicative of a measurement error.07-21-2011
20110155589Systems, Devices, and Methods for Improving Accuracy of Biosensors Using Fill Time - Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, the method includes detecting a presence of a sample in an electrochemical sensor including two electrodes. A fill time of the sample is determined with the two electrodes and a correction factor is calculated in view of at least the fill time. The method also includes reacting an analyte that causes a physical transformation of the analyte between the two electrodes. A concentration of the analyte can then be determined in view of the correction factor with the same two electrodes. Systems and devices that take advantage of the fill time to make analyte concentration determinations are also provided.06-30-2011
20110155585Systems, Devices, and Methods for Improving Accuracy of Biosensors Using Fill Time - Methods for determining a concentration of an analyte in a sample, and the devices and systems used in conjunction with the same, are provided herein. In one exemplary embodiment of a method for determining a concentration of an analyte in a sample, a sample including an analyte is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and a fill time of the sample into the device is calculated. A concentration of the analyte in view of fill time can then be determined. Systems and devices that take advantage of the fill time to make analyte concentration determinations are also provided.06-30-2011
20110155584Systems, Devices, and Methods for Measuring Whole Blood Hematocrit Based on Initial Fill Velocity - Methods for determining the hematocrit of a blood sample, and devices and systems used in conjunction with the same. The hematocrit value can be determined on its own, and further, it can be further used to determine a concentration of an analyte in a sample. In one exemplary embodiment of a method for determining the hematocrit value in a blood sample, a volume of blood is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and an initial fill velocity of the sample into the device is calculated. The hematocrit of the blood, as well as a concentration of an analyte in view of the initial fill velocity can then be determined. Systems and devices that take advantage of the use of an initial fill velocity to determine hematocrit levels and make analyte concentration determinations are also provided.06-30-2011
20110073493Adhesive Composition for Use in an Immunosensor - An adhesive composition for use in devices and methods for measuring a presence or a concentration of a particular component, such as an antigen, in a sample, such as blood, are provided. In one exemplary embodiment of an adhesive composition, the composition includes an adhesive, water, a poloxamer, and an anticoagulant. The adhesive can include particular properties, such as being hydrophilic, pressure-sensitive, heat-activated, and/or water soluble. The adhesive is particularly useful because it can help improve the flow of sample a device. For example, when the device is an immunosensor, the adhesive can help prevent the blood from clotting in chambers of the immunosensor. This results in a more efficient and accurate determination of the concentration of the sample. Methods of making the composition and device in which the composition can be used are provided, as are methods of using the same.03-31-2011
20110011752SYSTEMS AND METHODS FOR DISCRIMINATING CONTORL SOLUTION FROM A PHYSIOLOGICAL SAMPLE - Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.01-20-2011
20100332445ANALYTE TESTING METHOD AND SYSTEM - A system and method of detecting a flagged glucose concentration pattern with the use of medians having a common type of flag collected over discrete time periods so that whenever significant differences between the medians arise, the user or a caretaker of a diabetic user is notified.12-30-2010
20100326846METHOD FOR DETERMINING AN ANALYTE IN A BODILY FLUID SAMPLE USING AN ANALYTE TEST STRIP WITH COMBINATION ELECTRODE CONTACT AND METER IDENTIFICATION FEATURE - A method for determining an analyte in a bodily fluid sample includes inserting the analyte test strip into a test meter. The insertion is such that an electrical connector pin of the test meter travels along an electrical contact pad of the analyte test strip, and across a meter identification feature disposed on the electrical contact pad, during the insertion. Moreover, during the insertion, a signal processing module of the test meter measures an electrical characteristic via the electrical connector pin as the electrical connector pin travels along the electrical contact pad and across the meter identification feature. The method also includes identifying the analyte test strip, using the signal processing module, based on the electrical characteristic measured as the analyte test strip is inserted into the test meter and, thereafter, applying the bodily fluid sample to the analyte test strip upon notification by the test meter that the identification indicates that such applying is appropriate. The method then includes determining an analyte in the bodily fluid sample using the test meter only if the identification indicates that such determining is appropriate. The electrical contact pad of the analyte test strip employed in the method has a predetermined contact electrical characteristic value and the meter identification feature of the analyte test strip has a predetermined identification feature electrical characteristic value that is dissimilar from the predetermined contact electrical characteristic, thus providing for identification of the analyte test strip by the test meter.12-30-2010
20100326824ANALYTE TEST STRIP WITH COMBINATION ELECTRODE CONTACT AND METER IDENTIFICATION FEATURE - An analyte test strip (e.g., an electrochemical-based analyte test strip for determining glucose in a bodily fluid sample) for use with a test meter includes a first insulating layer and a electrically conductive layer disposed on the first insulating layer. The electrically conductive layer includes at least one electrode portion and at least one electrical contact pad configured for an electrical connector pin of a test meter to travel therealong during insertion of the analyte test strip into the test meter. In addition, the electrical contact pad is in electrical communication with the electrode portion. The analyte test strip also includes at least one meter identification feature (such as stripes of visually transparent material) disposed on the electrical contact pad such that the electrical connector pin of the test meter travels across the meter identification feature during insertion of the analyte test strip into the test meter. The analyte test strip further includes a second insulating layer disposed above the first insulating layer and a patterned spacer layer positioned between the first insulating layer and the electrically conductive layer that defines a sample-receiving chamber therein. The electrical contact pad of the analyte test strip has a predetermined contact electrical characteristic value and the meter identification feature has a predetermined identification feature electrical characteristic value that is dissimilar from the predetermined contact electrical characteristic.12-30-2010
20100300897FLEXIBLE INDWELLING ELECTROCHEMICAL-BASED BIOSENSOR AND RELATED METHODS - A flexible indwelling electrochemical-based biosensor includes an elongated framework and an integrated electrochemical-based biosensor. The elongated framework is formed of an electrically conductive flexible material (e.g., a Nitinol) with a body portion, a sharp head, a distal end and a proximal end. The integrated electrochemical-based biosensor (such as an electrochemical-based glucose sensor) is integrated with the elongated framework in that the biosensor has a sensing element that is disposed over the body portion or sharp head of the elongated framework and a portion of the elongated framework is configured as an electrode component that electrically cooperates with the sensing element. The electrode component can, for example, be configured to electrically cooperate as a working electrode, counter electrode, reference electrode or combined reference/counter electrode of the sensing element. Moreover, the sharp head is disposed at the distal end of the elongated framework and the sharp head, the electrode component and at least the sensing element of the biosensor are configured for insertion into a target site (for example, a subcutaneous target site).12-02-2010
20100270178Method And Apparatus For Rapid Electrochemical Analysis - Methods and apparatus for electrochemically determining an analyte concentration value in a physiological sample are disclosed. The methods include using a test strip in which two time-current transients are measured by a meter electrically connected to an electrochemical test strip. Integrative current values are derived from the time-current transients and used in the calculation of analyte concentration.10-28-2010
20100192369Electrochemical Cell - A method of manufacture of an electrochemical cell is provided. In one exemplary embodiment, at least one non-metal working electrode is provided, at least one counter electrode or counter/reference electrode is provided such that it is not co-planer with respect to the working electrode, and a spacer is provided interposed between the working and counter or counter/referenced electrode. In one embodiment the counter or counter/reference electrode can be separated from the working electrode by a distance of from about 20 microns to about 200 microns. Alternatively, the cell can have an effective volume of less than 1.5 microliters. A method of manufacture of an electrochemical apparatus is also provided. The method can include providing both a hollow electrochemical cell for measuring a concentration of glucose in a blood sample and a mechanism configured to determine a concentration of a redox mediator from, at least in part, a measured current of the cell. Other methods of manufacture of electrochemical apparatuses and electrochemical cells are also provided.08-05-2010
20100168661DRUG DELIVERY WITH EVENT NOTIFICATION - Devices, systems and methods are provided for drug delivery and the monitoring thereof.07-01-2010
20100084288Electrochemical Cell - A method for determining the concentration of a reduced or oxidized form of a redox species is provided. In one exemplary embodiment, an electrochemical apparatus is provided in which the apparatus includes a hollow electrochemical cell for measuring a concentration of glucose in a blood sample, a current of the cell is measured, and a concentration of a redox mediator is determined, at least in part from, a measured current of the cell. The hollow electrochemical cell can include at least one non-metal working electrode, at least one counter electrode or counter/reference electrode, and a spacer interposed between the working electrode and the counter or counter/reference electrode. In one embodiment the working electrode and the counter or counter/reference electrode are not co-planer and are separated by a distance of from about 20 microns to about 200 microns. In another embodiment the working electrode and the counter or counter/reference electrode are not co-planer and the cell has an effective cell volume of less than 1.5 microliters.04-08-2010
20100078324ELECTROCHEMICAL CELL - A hollow electrochemical cell is provided. In one exemplary embodiment, a hollow electrochemical cell includes two sets of electrodes and an opening for admitting an analyte to the cell. At least one of the two sets of electrodes can be in fluid communication with the opening. Further, a first set of electrodes can include a working electrode spaced from a counter or counter/reference electrode by less than 500 μm. In one embodiment the working and counter or counter/reference electrodes are not co-planer. In another embodiment the working and counter or counter/reference electrodes are of substantially corresponding area. In yet another embodiment the working and counter or counter/reference electrodes are spaced from 100 to 200 μm apart. The first set of electrodes and the second set of electrodes can be spaced apart by greater than about 500 μm. Other embodiments of a hollow electrochemical cell are also provided, as are several embodiments of a glucose sensor.04-01-2010
20100016700ANALYTE MEASUREMENT AND MANAGEMENT DEVICE AND ASSOCIATED METHODS - Various embodiments of a diabetes management system are provided. One exemplary system may include an analyte measurement device and a therapeutic agent delivery device. The measurement device includes a measurement unit, display, and first wireless module. The therapeutic agent delivery device has a delivery device housing, delivery mechanism disposed in the housing that delivers a dosage of the agent to the user upon actuation by the user or health care provider, and a second wireless module. The second module, automatically, without prompting from a user or any active input or action by the user, transmits a signal to the first wireless module indicative of: (a) type of therapeutic agent delivered; and (b) amount of therapeutic agent delivered to the user; or (c) type of therapeutic agent device from which the therapeutic agent was administered. Also described are diabetes management devices and methods.01-21-2010
20090301899SYSTEM AND METHOD FOR MEASURING AN ANALYTE IN A SAMPLE - Methods for calculating an analyte concentration of a sample are provided. In one exemplary embodiment the method includes steps that are directed toward accounting for inaccuracies that occur as a result of temperature variations in a sample, a meter, or the surrounding environment. In another exemplary embodiment the method includes steps that are directed toward determining whether an adequate sample is provided in a meter because insufficient samples can result in inaccuracies. The methods that are provided can be incorporated into a variety of mechanisms, but they are primarily directed toward glucose meters for blood samples and toward meters for controls solutions.12-10-2009
20090247982Medical Device Mechanical Pump - A medical device pump with a housing with a compartment for removably receiving a cartridge containing a therapeutic agent, a conduit configured to operatively provide a fluid flow path for therapeutic agent to exit from the cartridge, a user activated delivery button, a trigger mechanism, and a mechanical pump mechanism. The trigger mechanism, user activated delivery button and mechanical pump mechanism of the medical device pump are configured such that the trigger mechanism is activated by a user fully activating the user activated delivery button. Moreover, such full activation generates mechanical power employed by, and sufficient for, the mechanical pump mechanism to pump a predetermined volume of therapeutic agent from the cartridge and through the fluid flow path.10-01-2009
20090240127METHODS OF DETERMINING PRE OR POST MEAL TIME SLOTS OR INTERVALS IN DIABETES MANAGEMENT - A diabetes management system or process is provided herein that may be used to analyze and recognize patterns for a large number of blood glucose concentration measurements and other physiological parameters related to the glycemia of a patient. In particular, a method of monitoring glycemia in a patient may include storing a patient's data on a suitable device, such as, for example, a blood glucose meter. The patient's data may include blood glucose concentration measurements. The diabetes management system or process may be installed on, but is not limited to, a personal computer, an insulin pen, an insulin pump, or a glucose meter. The diabetes management system or process may identify a plurality of pattern types from the data including a testing/dosing pattern, a hypoglycemic pattern, a hyperglycemic pattern, a blood glucose variability pattern, and a comparative pattern. After identifying a particular pattern with the data management system or process, a warning message may be displayed on a screen of a personal computer or a glucose meter. Other messages can also be provided to ensure compliance of any prescribed diabetes regiments or to guide the patient in managing the patient's diabetes.09-24-2009
20090184004SYSTEM AND METHOD FOR MEASURING AN ANALYTE IN A SAMPLE - Methods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration in view of an extreme level of hematocrit found within the sample. In other embodiments, methods are provided for identifying various system errors and/or defects. For example, such errors can include partial-fill or double-fill situations, high track resistance, and/or sample leakage. Systems are also provided for determining a corrected analyte concentration and/or detecting some system error.07-23-2009
20090139300AUTO-CALIBRATING METERING SYSTEM AND METHOD OF USE - A method of auto-calibrating a meter is provided herein. The method can include disposing a sensor within a sensor dispenser associated with a tag element wherein the tag element is configured to store a plurality of sensor-specific information as well as communicate the information to a meter. Next, the method can include placing the sensor dispenser into communication with a meter which is configured to receive and retain a sensor from the sensor dispenser, and also configured to receive the sensor-specific information from the tag element thereby allowing the meter to perform an auto-calibration procedure which is at least partially dependent upon the sensor-specific information. Similarly, a system for auto-calibrating a meter is also provided herein. Additionally, various embodiments of a meter and various embodiments a sensor dispenser are also provided herein.06-04-2009
20090112185Integrated Conduit Insertion Medical Device - A medical device includes a medical device flexible conduit that has an elongated Nitinol strip with a distal end, a proximal end, a longitudinal axis running from the distal end to the proximal end, a sharp head extending from the distal end, and a channel etched therein. Moreover, the channel is dispositioned along the longitudinal axis. The medical device flexible conduit also has a flexible tube at least partially jacketing the elongated Nitinol strip between the distal end and the proximal end, with the channel and the flexible tube defining a conduit. The medical device also includes an insertion mechanism configured to insert a portion of the flexible conduit, including the sharp head, into a user's target site such that the conduit provides fluid communication to the target site.04-30-2009
20090112180Method for Inserting a Medical Device Flexible Conduit into a User's Target Site - A method for inserting a medical device flexible conduit into a user's target site includes adhering a medical device to a user with the medical device including a medical device flexible conduit and an insertion mechanism. Moreover, the medical device flexible conduit has an elongated Nitinol strip with a distal end, a proximal end, a longitudinal axis running from the distal end to the proximal end, a sharp head extending from the distal end, and a channel etched therein. In addition, the channel is dispositioned along the longitudinal axis. The medical device flexible conduit also includes a flexible tube at least partially jacketing the elongated Nitinol strip between the distal end and the proximal end, the channel and flexible tube defining a conduit. The insertion mechanism is configured to insert a portion of the flexible conduit including the sharp head into a user's target site such that the conduit provides fluid communication to the target site. The method also includes inserting the medical device flexible conduit into the user's target site.04-30-2009
20090112155Micro Diaphragm Pump - The invention relates to micropumps for infusing fluids. More specifically, the present disclosure describes and illustrates a micropump design that may be useful for infusing insulin into a diabetic patient. The disclosed design employs a pump chamber that has a diaphragm and a plurality of check valves that are configured to avoid leakage from the reservoir through the pump engine and into an infusion device and, also, to ensure the complete, accurate evacuation of the pump chamber.04-30-2009
20090084687SYSTEMS AND METHODS OF DISCRIMINATING CONTROL SOLUTION FROM A PHYSIOLOGICAL SAMPLE - Methods for distinguishing between an aqueous non-blood sample (e.g., a control solution) and a blood sample are provided herein. In one aspect, the method includes using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or an aqueous non-blood sample based on at least two characteristics (e.g., amount of interferent present and reaction kinetics). The method can also include calculating a discrimination criteria based upon at least two characteristics. Various aspects of a system for distinguishing between a blood sample and an aqueous non-blood sample are also provided herein.04-02-2009
20090057146ANALYTE TEST STRIP WITH IMPROVED REAGENT DEPOSITION - 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.03-05-2009
20090027040OPEN CIRCUIT DELAY DEVICES, SYSTEMS, AND METHODS FOR ANALYTE MEASUREMENT - 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. In another example, a method of measuring an electrochemical reaction of an electrochemical cell is provided that includes applying a test voltage to the first electrode and connecting the second electrode to ground; uncoupling the first electrode from the output of the circuit while allowing electrical communication from the first electrode to the processor; and coupling the first electrode to the output to measure a test current generated in the electrochemical cell without an uncompensated voltage drop.01-29-2009
20090020438ELECTROCHEMICAL CELL - The present invention relates to electrochemical cells including a first working electrode 01-22-2009
20080214919SYSTEM AND METHOD FOR IMPLEMENTATION OF GLYCEMIC CONTROL PROTOCOLS - 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. Additionally, methods of implementing such glucose control protocols are also provided herein.09-04-2008
20080208026SYSTEMS AND METHODS FOR DETECTING HYPOGLYCEMIC EVENTS HAVING A REDUCED INCIDENCE OF FALSE ALARMS - 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.08-28-2008

Patent applications by LifeScan, Inc.