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: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: A method of initializing a sensor with a voltage sequence including a ramped voltage combined with a biphasic voltage pulse. The initialization scheme results in faster in-vitro sensor run-in and stabilization times. In various examples, the in-vitro sensor stabilization time is reduced from 200 minutes to 40-55 minutes (a reduction by a factor of least 5 as compared to a non-initialized sensor). In addition, staircase voltage initialization is implemented adaptively so that the voltage step size and sweep rates are changed depending on the state of the sensor (characterized by ISIG magnitude). As a result, individual sensors can be initialized in a customized manner rather than by using a general hardwired and harsh initialization scheme.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. The reservoir, a base and a cap are connected to form an integrated unit that is capable of being inserted and secured in an infusion pump housing. The cap and the infusion pump are each provided with at least one sensor or at least one detectable feature, arranged to interact with at least one corresponding detectable feature or sensor on the other of the cap and infusion pump device, to detect one or more of the presence, position or other characteristic of the cap when the cap is aligned or coupled with the infusion pump housing. The detectable feature and sensor may be magnetic, RF, mechanical, optical or any combination.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves identifying a condition of the user that is likely to influence a response to the fluid in the body of the user and classifying the condition as a first type of a plurality of types of conditions. After classifying the condition as the first type, the method continues by adjusting control information for operating the infusion device based on the first type and operating the infusion device to deliver the fluid to the user in accordance with the adjusted control information.

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: A system and method for controlling and monitoring a diabetes-management system through the use of a model that predicts or estimates future dynamic states of glucose and insulin from variables such as insulin delivery or exogenous glucose appearance as well as inherent physiological parameters. The model predictive estimator can be used as an insulin bolus advisor to give an apriori estimate of postprandial glucose for a given insulin delivery profile administered with a known meal to optimize insulin delivery; as a supervisor to monitor the operation of the diabetes-management system; and as a model predictive controller to optimize the automated delivery of insulin into a user's body to achieve a desired blood glucose profile or concentration. Open loop, closed-loop, and semi-closed loop embodiments of the invention utilize a mathematical metabolic model that includes a Minimal Model, a Pump Delivery to Plasma Insulin Model, and a Meal Appearance Rate Model.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device capable of delivering fluid to a user involves determining one or more signal characteristics associated with a subset of the measurements corresponding to a monitoring period, determining a reliability metric for the monitoring period based on the one or more signal characteristics, and providing indication of a maintenance condition when the reliability metric violates a threshold.

Abstract: A motor may be configured to drive a drive shaft and an engagement member supported on the drive shaft. A detectable feature comprising a rotary member may be supported on the drive shaft such that movement of the drive shaft by the motor changes a state of the detectable feature. At least one sensor may be arranged to detect the state of the detectable feature. Circuitry may be configured to provide a signal in response to a change in the state of the detectable feature detected by the at least one sensor.

Abstract: Medical devices and related systems and operating methods for communicating data therewith are provided. An exemplary method involves the medical device detecting an interfacing device coupled to the medical device via a physical communications medium, initializing a wireless communications session with the interfacing device in response to detecting the interfacing device, modulating an electrical signal between the interfacing device and the medical device to transmit data from the medical device to the interfacing device via the physical communications medium, and receiving communications, such as acknowledgments of the transmitted data, from the interfacing device via the wireless communications session.

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, and a second control module. The first control module and the second control module are coupled to one another. The first control module enables input power for the motor in accordance with a handshaking sequence of communications between the first control module and the second control module and provides a dosage command to the second control module, with the second control module operating the motor using the input power based on the dosage command in accordance with the handshaking sequence of communications.

Abstract: Apparatus are provided for motor control systems and related medical devices. In one embodiment, a control system includes a motor having a rotor, a modulation module coupled to the motor, and a control module coupled to the motor and the modulation module. The modulation module generates a modulated voltage that is applied to the motor, and the control module adjusts a duty cycle of the modulated voltage to achieve a commanded rotation of the rotor and detects a degradation condition based on the duty cycle.

Abstract: A medical therapy system including liquid detection is disclosed. A medical therapy includes a case with an interior and an exterior. Within the interior of the case is the liquid detection system that includes a first electrode set with a first positive electrode and a first negative electrode. The liquid detection system further includes an impedance measurement circuit coupled to the first electrode set to determine impedance values between the first positive electrode and the first negative electrode. A threshold detector compares impedance values between the first electrode set to a first threshold impedance. A microprocessor is programmed to initiate an alarm when measured impedance from the first electrode set is below the first threshold impedance.

Abstract: An insulin infusion device includes a processor architecture, and a memory element that stores executable instructions to perform a method of controlling delivery of insulin to a user. The method operates the device in a closed-loop mode to deliver insulin, obtains patient-specific parameters for a current time sample, and estimates a plasma insulin value and a blood glucose value for the user based on at least some of the patient-specific parameters. The estimating is also based on a previously estimated plasma insulin value obtained for a previous time sample, and a previously estimated blood glucose value obtained for the previous time sample. A predicted sensor glucose value is generated for the current time sample, and the closed-loop mode or a safe basal mode is selected for controlling operation of the insulin infusion device in accordance with the selected mode.

Abstract: Embodiments of the invention provide compositions useful in analyte sensors as well as methods for making and using such compositions and sensors. In typical embodiments of the invention, the sensor is a glucose sensor comprising an analyte modulating membrane formed from a polymeric reaction mixture formed to include limiting amounts of catalyst and/or polycarbonate compounds so as to provide such membranes with improved material properties such as enhanced thermal and hydrolytic stability.

Abstract: Apparatus are provided for infusion devices and related operating methods. An exemplary device includes a sensing arrangement to provide an output indicative of a characteristic that is influenced by operation of the device, and a control module that is coupled to the sensing arrangement to apply a matched filter corresponding to a condition associated with the operation of the device to the output of the sensing arrangement and detect that condition based on the filtered output. In one example, the device includes a motor coupled to a plunger of a reservoir and operable to displace the plunger, wherein the characteristic is a force opposing displacement of the plunger and the control module detects an occlusion condition in a fluid path from the reservoir based on filtered force measurements.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves obtaining measurement values for a physiological condition influenced by the fluid, autonomously operating the infusion device to deliver the fluid based at least in part on the measurement values, and detecting a nonactionable condition based on the measurement values. In response to detecting the nonactionable condition, delivery of the fluid is limited while maintaining autonomous operation of the infusion device. In one exemplary embodiment, the nonactionable condition is a rescue condition indicative of the user having consumed fast-acting carbohydrates, and thus insulin delivery may be automatically limited in response to detecting the rescue carbohydrate consumption.

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: 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.