Abstract: An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Abstract: Infusion devices, systems, and related operating methods are provided. A method of detecting an occlusion in a fluid path involves a control module of an infusion device operating a driver module to provide energy to an actuation arrangement to achieve a commanded actuation state, wherein the actuation arrangement is coupled to a plunger configured to deliver fluid via the fluid path, obtaining a measured actuation state of the actuation arrangement via a sensing arrangement, and detecting an occlusion condition based on a relationship between the commanded actuation state and the measured actuation state.

Abstract: A medicine injection pen includes a rotatable drive member and a rotary encoder associated with the drive member. The rotary encoder is configured to determine an amount of liquid medicine dispensed based on a rotational orientation of the drive member.

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 patient involves obtaining, by a control system associated with the infusion device, measurement values indicative of a condition of the patient provided by a sensing device, identifying an event pattern based at least in part on the measurement values for the condition and historical data associated with the patient, generating a notification indicative of the event pattern in response to identifying the event pattern, and adjusting operation of the infusion device to deliver the fluid to the patient in a manner that is influenced by the event pattern in response to receiving user input confirming the event pattern.

Abstract: Disclosed is a method of controlling operation of a medical device that regulates delivery of a fluid medication to a user. The method obtains a current sensor-generated value that is indicative of a physiological characteristic of the user, and is produced in response to operation of a continuous analyte sensor device. The method continues by: calculating a sensor quality metric that indicates reliability and trustworthiness of the current sensor-generated value; adjusting, in response to the calculated sensor quality metric, therapy actions of the medical device to configure a quality-specific operating mode of the medical device; managing generation of user alerts at the medical device in response to the calculated sensor quality metric; and regulating delivery of the fluid medication from the medical device, in accordance with the current sensor-generated value and the quality-specific operating mode of the medical device.

Abstract: A system for a physiological characteristic sensor deployed with a sensor inserter includes an adhesive skin patch coupled to the physiological characteristic sensor. The adhesive patch is to couple the physiological characteristic sensor to an anatomy. The system also includes a gravity resistance system coupled to the adhesive patch and to be coupled to the sensor inserter. The gravity resistance system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological characteristic sensor and is removable from the adhesive patch by the sensor inserter upon deployment of the physiological characteristic sensor.

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 patient involves obtaining, by a control system associated with the infusion device, an input meal indication, obtaining historical data for the patient associated with the input meal indication, determining an estimated carbohydrate amount corresponding to the input meal indication based at least in part on the historical data, determining a bolus dosage of the insulin based at least in part on the estimated carbohydrate amount, and operating an actuation arrangement of the infusion device to deliver the bolus dosage of the insulin to the patient.

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 patient involves obtaining, by a control system associated with the infusion device, user input indicating an activity by the patient, obtaining historical data for the patient corresponding to the activity, determining a probable patient response corresponding to the activity based at least in part on the historical data for the patient, determining an adjustment for delivering the fluid by the infusion device based at least in part on the probable patient response, and operating the infusion device to deliver the fluid to the patient in accordance with the adjustment.

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 computer-implemented therapy management system is operated to collect patient data associated with medical device users. Treatment of the users is managed by healthcare professionals (HCPs), which include a customer HCP and a plurality of non-customer HCPs. The system receives a first set of attributes for a first individual patient or a first group of patients under care of the customer HCP, and a second set of attributes for a second individual patient or a second group of patients. The system identifies a first set of patient records associated with the customer HCP that satisfy the received first attributes, and a second set of patient records that satisfy the received second attributes, and compares patient outcomes from the first set of records against patient outcomes from the second set of records. A comparative therapy report is generated and communicated to a client device associated with the customer HCP.

Abstract: Disclosed herein are techniques related to insulin delivery recommendations based on nutritional information. In some embodiments, the techniques may involve obtaining user input indicative of quantitative information for a food item. The techniques may further involve determining, based on the user input, nutritional information for the food item. Additionally, the techniques may involve generating, based on the nutritional information, an insulin delivery recommendation.

Abstract: Ambulatory infusion pumps, medicament reservoirs, and medicament sealing assemblies, including a variety of trocar seal assemblies and fill plug seal assemblies, plus related components, as well as component combinations and related methods.

Abstract: Medical devices and methods and apparatuses for identifying fluids in a conduit of a device are provided. An exemplary medical device includes a reservoir for holding a fluid and a conduit for dispensing the fluid from the reservoir. Further, the medical device includes a spectroscopy device for examining the fluid.

Abstract: The invention provides amperometric analyte sensor systems comprising one or more electrodes designed to monitor in vivo levels of 3-hydroxybutyrate (and optionally glucose as well) in order to facilitate the management of diabetic ketoacidosis. The invention further includes dual layer membrane compositions, elements and methods useful with such amperometric analyte sensor systems.

Abstract: Medical devices and related patient management systems and methods are provided. An exemplary system includes a medical device to obtain measurement values for a physiological condition in a body of a patient and a computing device to identify a plurality of event patterns within a plurality of monitoring periods based on the measurement values, prioritize the plurality of event patterns based on one or more prioritization criteria, filter the prioritized list of event patterns based on one or more filtering criteria, and generate a snapshot graphical user interface display. The snapshot graphical user interface display includes a graph overlay region having a graphical representation of the measurement values with respect to a time of day and an event detection region below the graph overlay region, where the event detection region includes pattern guidance displays for event patterns of the filtered prioritized list ordered according to the prioritization.

Abstract: Medical devices and related systems and methods are provided. A method of estimating a physiological condition involves determining a translation model based at least in part on relationships between first measurement data corresponding to instances of a first sensing arrangement and second measurement data corresponding to instances of a second sensing arrangement, obtaining third measurement data associated with the second sensing arrangement, determining simulated measurement data for the first sensing arrangement by applying the translation model to the third measurement data, and determining an estimation model for a physiological condition using the simulated measurement data, wherein the estimation model is applied to subsequent measurement output provided by an instance of the first sensing arrangement to obtain an estimated value for the physiological condition.

Abstract: A method and system are provided for controlling which communication interface is used for communication between devices that are configurable to be part of a wireless body area network (BAN) for a medical device system depending on their respective locations with respect to a first device. Based on a security secret shared between the first device and a second device, a secure communication channel can be established between the first device and the second device when the second device is located in a coverage region of the wireless body area network. A controller can determine, whether a quality of service (QoS) over the secure communication channel is greater than or equal to a first threshold. In response to the controller determining that the QoS is greater than or equal to the first threshold, data can be communicated from the first device via magnetic signals using a first BAN communication interface.

Abstract: Systems, devices and methods are disclosed for a prescription-regulated software application and an associated medical device. In some aspects, a smart medicine-injection device (e.g., smart insulin pen) is configured to be in communication with a patient's companion device (e.g., smartphone) having a software application (prescription app) that serves the patient as a complimentary medical device to the smart medicine-injection device, in which only certain features and functionalities of the prescription app are fully operable based on device pairing with the smart medicine-injection device to unlock medical device capabilities only available to the patient through prescription.

Abstract: A method of controlling an insulin infusion device involves controlling the device to operate in an automatic basal insulin delivery mode, obtaining a blood glucose measurement for the user, and initiating a correction bolus procedure when: the measurement exceeds a correction bolus threshold value; and a maximum basal insulin infusion rate is reached during the automatic basal insulin delivery mode. The correction bolus procedure calculates an initial correction bolus amount, and scales the initial amount to obtain a final correction bolus amount, such that a predicted future blood glucose level resulting from simulated delivery of the final correction bolus amount exceeds a low blood glucose threshold level. The final amount is delivered to the user during operation in the automatic basal insulin delivery mode.

Abstract: Activity monitoring systems and methods are disclosed. Systems include a continuous glucose monitoring device for a user including a glucose sensor for monitoring blood glucose levels of the user during an activity. An activity monitoring device is associated with the user and includes an activity sensor for tracking movement of the user during the activity. A display device is associable with the user during the activity.