Abstract: A simple, disposable sensing device for sensing an analyte is housed in a single case. The sensing device can transmit sensor data to monitoring device(s). The sensing device includes: a case having a lower major wall adapted to be mounted against a patient's skin, and an upper opposing major wall; a sensor extending from the case and having a distal end sensitive to the analyte to produce an electrical signal, and a proximal end within the case having electrical contacts; a printed circuit board assembly within the case supported by one of the major walls to receive the electrical signal via the electrical contacts; and an elastomeric pad disposed in the case and biased by the other major wall to urge the proximal end of the sensor into contact with the printed circuit board assembly and maintain an electrical connection between the electrical contacts and the printed circuit board assembly.

Abstract: A medical sensor device includes a sensor assembly including an underside surface for attachment against a patient's skin, a sensor portion to detect a characteristic of the patient, and sensor assembly contacts which in operation carry signals representing the detected characteristic. The device also includes a transmitter assembly removably engageable with the sensor assembly and including circuitry to take the signals from the sensor assembly contacts and to transmit readings of the detected characteristic to external equipment. The device also includes mechanical interface components on the sensor assembly and the transmitter assembly which allow the transmitter assembly to be brought into abutment with the sensor assembly at a first angular position via relative axial movement between them, and then allow a relative rotation of the assemblies with respect to one another towards a second angular position and presents axial separation of the assemblies in the second angular position.

Abstract: Processor-implemented methods of controlling an insulin infusion device for a user are provided here. A first method obtains a current insulin on board (IOB) value that estimates active insulin in the user, and compensates a calculated insulin infusion rate in response to the obtained IOB value. A second method supervises the operation of a glucose sensor by obtaining and processing insulin-delivered data and glucose sensor data for the user. An alert is generated if the second method determines that a current glucose sensor value has deviated from a predicted sensor glucose value by at least a threshold amount.

Abstract: Ambulatory infusion pumps, medicament reservoirs, and plungers, including both dynamic and static seals, plus related components, as well as component combinations and related methods.

Abstract: A method and/or system may be provided for determining a suggested change in a recommended therapy for a patient based, at least in part, on sensor measurements, and generating an alert to an attendant in a hospital environment upon detection of the suggested change. A method and/or system may also be provided to automatically determine a maximum interval to alert an attendant following receipt of a measurement at an operator interface. A method and/or system may also be provided to blood-glucose sensor calibration.

Abstract: Disclosed is a medical device component for delivering medication fluid to a patient. The medical device component includes a fluid infusion device to regulate delivery of medication fluid, a body-mountable base unit, and a top cover assembly that is removably couplable to the base unit and to the fluid infusion device. The base unit includes a cannula to deliver medication fluid under the control of the fluid infusion device, and a physiological analyte sensor to measure a physiological characteristic. The base unit also includes an electronics assembly electrically connected to sensor leads to obtain measurements in the analog domain, to convert measurements into digital sensor data, and to communicate conditioned digital sensor data to the fluid infusion device. The top cover assembly is configured to provide both fluid and electrical connections for the base unit, by way of an infusion tube having sensor conductors integrated therein or otherwise associated therewith.

Abstract: Subject matter disclosed herein relates to a method and/or system for tailoring insulin therapies to physiological characteristics of a patient. In particular, observations of a blood glucose concentration of a patient responsive to a meal profile and an insulin profile may be used for estimating one or more physiological parameters.

Abstract: An insertion device may include a device housing configured to be operatively engaged with and disengaged from a base, and engageable with an actuation device, the device housing having a carrier body supporting a piercing member. The carrier body moveable by a carrier body of the actuation device at least between a retracted position and an advanced position. The device housing having a section for supporting a portion of the carrier body of the device housing, the section moveable relative to the carrier body of the device housing to provide sufficient clearance to allow the carrier body of the device housing to be moved by the carrier body of the actuation device.

Abstract: The invention is directed to a competitive glucose binding affinity assay comprising a glucose receptor (typically mannan binding lectin) labeled with an assay fluorophore and a modified glucose analog (typically dextran) labeled with a reference fluorophore. In certain embodiments, the glucose analog is dextran and is coupled to both a reference fluorophore and a quencher dye (e.g. hexamethoxy crystalviolet-1). Optionally the reference fluorophore is blue shifted relative to the assay fluorophore.

Abstract: A computer-implemented system and related method of reporting glucose information for a user of a diabetes management device are presented here. An embodiment of the method obtains input data for the user of the diabetes management device, and identifies a tracked glycemic response event. One or more recommended glycemic control parameters are calculated based on an analysis of the obtained input data. The glycemic control parameters are calculated to extend a time period during which the user remains within a target glucose range following the tracked glycemic response event. The method continues by generating an output message that includes at least some of the recommended glycemic control parameters, and delivering the generated output message to a user device operated by the user of the diabetes management device.

Abstract: An infusion set component of a fluid infusion device and/or a fluid infusion port component for delivery of fluid to a patient is compatible with a cooperating fluid channel module. The fluid channel module includes a body section having coupling features to mate with a base of the component. The fluid channel module also includes an interior fluid flow channel formed within the body section to receive fluid from the fluid infusion device and/or from a syringe or pen delivery device. The fluid channel module also includes a conduit having a first end in fluid communication with the interior fluid flow channel, and having a second end to deliver the fluid to the patient.

Abstract: A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

Abstract: Medical devices and methods and apparatuses for identifying fluids in a conduit of a device are provided. An exemplary apparatus for identifying an infusate in a conduit of an infusion device includes a transmitter element for transmitting a beam of energy for interaction with the infusate. Further, the apparatus includes a receiver element for receiving a signal from the beam of energy after interaction with the infusate. Also, the apparatus includes an identifier element coupled to the receiver element for analyzing the signal to identify the infusate. The transmitter element and receiver element may form a spectroscopy device and may transmit and receive a beam of infrared light or near infrared light.

Abstract: Methods and devices are provided for reducing a diabetic patient's foreign body immune response, including infusion site-loss and/or occlusion. Such foreign body responses are associated with the treatment of the diabetic patient where the treatment requires subcutaneous implantation of a foreign body, such as a cannula or catheter. In certain embodiments of the invention, a response-inhibiting agent is administered to a patient at the site of cannula/catheter insertion, thereby facilitating delivery of insulin to the diabetic patient and mitigating site-loss and/or occlusion over a period of time.

Abstract: Electrochemical Impedance Spectroscopy (EIS) is used in conjunction with continuous glucose monitors and continuous glucose monitoring (CGM) to enable in-vivo sensor calibration, gross (sensor) failure analysis, and intelligent sensor diagnostics and fault detection. An equivalent circuit model is defined, and circuit elements are used to characterize sensor behavior.

Abstract: This disclosure generally relates to medical devices that include a transmitter assembly positioned on top of a sensor assembly. A sensor assembly includes a sensor base having a bottom surface and a top surface having an interface. The interface accommodates a sensor stack that includes at least one sensor head having electrical contact pads connected to an elastomeric connector. The sensor assembly further includes a mounting base having a first side that attaches to the bottom surface of the sensor base, and a second side that adheres to a patient's skin. A transmitter assembly includes a transmitter shell and a transmitter cap having an interface that engages with the sensor base. Also, the transmitter assembly includes electrical contacts disposed on the transmitter cap that connect with the electrical contact pad(s) of the sensor assembly.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary infusion device includes a motor operable to deliver fluid to a body of a user, a first control module to enable input power for the motor and provide a dosage command for operating the motor, and a second control module coupled to the first control module to receive the dosage command and operate the motor using at least a portion of the input power based at least in part on the dosage command. One of the first control module and the second control module detects an anomalous condition, and in response, disables the input power to the motor, stores diagnostic information for the anomalous condition in its internal memory, and automatically resets thereafter.

Abstract: A monitor system to monitor a characteristic of a user is disclosed. A monitor system includes a sensor producing signals indicative of glucose characteristics within the user. The sensor has a connector with a plurality of contacts, at least two contacts being shorted by a fuse trace. The monitor system further includes an electronics package with a package housing. The package housing contains a battery, a package port interfaced with the connector to receive signals from the sensor, and a package processor to process the signals from the sensor. Further included in the monitor system is a fuse system controlled by the package processor that includes a fuse timer, wherein the fuse trace is destroyed after the fuse timer reaches a threshold value.

Abstract: An adhesive patch arrangement for a sensor includes a flexible patch, a sensor-affixing feature located in a sensor mounting region of the component-facing side of the flexible patch, the sensor-affixing feature securing the sensor to the flexible patch, and a device-affixing feature located in a device mounting region of the component-facing side of the flexible patch. The device-affixing feature secures a device to the flexible patch. The sensor mounting and device mounting regions are distinct and separate regions. The arrangement also includes a removable reinforcement liner adhered to, and covering, the device-affixing feature, and shaped to define a cutout area that partially surrounds the sensor-affixing feature. The arrangement also includes a removable backing liner adhered to, and covering, the adhesive skin-facing side of the flexible adhesive patch.

Abstract: Disclosed are a system and method for determining a metric and/or indicator of a reliability of a blood glucose sensor in providing glucose measurements. In one aspect, the metric and/or indicator may be computed based, at least in part, on an observed trend associated with signals generated by the blood glucose sensor.