Abstract: 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.

Abstract: 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.

Abstract: This invention relates to a biosensor and more particularly to an electrochemical biosensor for determining the concentration of an analyte in a carrier. The invention is particularly useful for determining the concentration of glucose in blood and is described herein with reference to that use but it should be understood that the invention is applicable to other analytic determinations.

Abstract: This invention relates to a biosensor and more particularly to an electrochemical biosensor for determining the concentration of an analyte in a carrier. The invention is particularly useful for determining the concentration of glucose in blood and is described herein with reference to that use but it should be understood that the invention is applicable to other analytic determinations.

Abstract: 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.

Abstract: 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.

Abstract: A redox polymer for use in an electrochemical-based sensor includes a hydrophobic polymer backbone (e.g., a hydrophobic poly(methyl methacrylate) polymer backbone) and at least one hydrophilic polymer arm (such as a hydrophilic oligo(N-vinylpyrrolidinone) polymer arm) attached to the hydrophobic polymer backbone. The redox polymer also includes a plurality of redox mediators (e.g., ferrocene-based redox mediators) attached to the at least one hydrophilic polymer arm.

Abstract: 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.

Abstract: Compositions, methods, devices and kits utilizing water-based hydrophilic coating formulations on medical implements. The composition for applying a coating comprises a sulfonated polyester, water, and a surface active agent. Methods for coating a medical implement comprise providing an aqueous dispersion comprising sulfonated polyester and surface active agent, contacting the medical implement with the aqueous dispersion, and drying the medical implement. Methods for acquiring a sample of bodily fluid from a patient comprise coating a needle with a sulfonated polyester, penetrating the needle into the patient, and drawing bodily fluid through the needle.

Abstract: A flexible diagnostic device has a measurement cell that is sandwiched between the conductive surfaces of two conductive-coated insulating layers. At least one of the conductive surfaces is scored with an insulating pattern, so that the flow of a conductive fluid sample into the cell can be monitored.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The present invention provides a device and methods for detecting the presence of an analyte in a sample using an encapsulated sensor. Methods for manufacturing the sensor are also disclosed.

Abstract: 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.