Disclosed are a system, methods and computer-readable medium products that provide safety constraints for an insulin-delivery management program. Various examples provide safety constraints for a control algorithm-based drug delivery system that provides automatic delivery of a drug based on sensor input. Glucose measurement values may be received at regular time intervals from a sensor. A processor may predict future glucose values based on prior glucose measurement values. The safety constraints assist in safe operation of the drug delivery system during various operational scenarios. In some examples, predicted future glucose values may be used to implement safety constraints that mitigate under-delivery or over-delivery of the drug while not overly burdening the user of the drug delivery system and without sacrificing performance of the drug delivery system. Other safety constraints are also disclosed.

A drug delivery device may include an Inertial Measurement Unit (IMU) is provided. The IMU may include an accelerometer, a magnetometer, or a gyroscope. Motion parameters may be detected when the drug delivery device is shipped, being prepared for activation for use, or during use. The IMU may provide data indicative of a rapid deceleration, such as when a package containing the drug delivery device is dropped, or some other physical event experienced by the drug delivery device. The drug delivery device may also include internal or external pressure sensors or a blood glucose sensor that may coordinate with the IMU to provide additional feedback regarding the status of the device or user. A controller of the drug delivery device may generate a response depending on the particular parameters being monitored or may change device operational parameters as a result of detected system events.

Fluid delivery devices with passive or pressure-based control valves are described. For example, a fluid delivery device may include a fluid path, a pressure source fluidically coupled to a fluid source storing a fluid, and a pressure-based control valve arranged in the fluid path and configured to move in an opening direction in response to a fluid delivery pressure applied by the pressure source in an upstream portion of the fluid path against the pressure-based control valve, in which the pressure control valve is in an open configuration responsive to the fluid delivery pressure being equal to or greater than a cracking pressure. In some embodiments, the pressure-based control valve may be or may include a bourdon tube. Other embodiments are described.

Medical devices, systems and methods are provided. One method involves obtaining fabrication process measurement data for a plurality of instances of a sensing element, obtaining reference output measurement data from the plurality of instances in response to a reference stimulus, determining a predictive model for a measurement output of the sensing element as a function of fabrication process measurement variables based on the relationship between the fabrication process measurement data and the reference output measurement data, generating a simulated output measurement distribution across a range of the fabrication process measurement variables using the predictive model, identifying performance thresholds for the measurement output based on the simulated output measurement distribution, obtaining output measurement data from the instance of the sensing element in response to the reference stimulus, and verifying the output measurement data satisfies the performance threshold prior to calibrating a subsequent instance of the sensing element.

A system for providing the collection of advanced, improved, and novel new components and elements in a single package to simplify assembly and use of the infusion set by the user, including one or more of an exemplary pushbutton-type inserter, squeeze-type inserter, contact-type inserter, skin pinching-type inserter, folding retraction-type inserter, and/or multistage-type inserter (700) having at least one reusable stage, an exemplary set (350) having an adhesion means with two or more user-selectable degrees of adhesion strength, a self-sealing tube connection means, a lens feature to view a site beneath the set, exemplary tube management and connection elements (450), insulin supply (475), adhesion concealment means (500), finger loops on the inserter and site preparation wipes or sprays (550) which can be provided as part of the inserter. The system can further include an exemplary package (12) which can hold a number of sets that can be easily released and retrieved from the tray by an inserter, an exemplary insertion needle handle and shroud, an exemplary squeeze-type latch between an upper portion and a lower portion of the set, and/or a tool removable upper portion of the set.

Disclosed are methods and medical device systems for automated delivery of therapies for pain and determination of need for and safety of treatment. In one embodiment, such a medical device system may comprise a sensor configured to sense at least one body signal from a patient; and a medical device configured to receive a first sensed body signal from the sensor; determine a patient pain index based at least in part on said first sensed body signal; determine whether said patient pain index is above at least a first pain index threshold; determine a safety index based at least in part on a second sensed body signal; select a pain treatment regimen based on at least one of said safety index and or a determination that said pain index is above said first pain index threshold; and deliver said pain treatment regimen.

Various exemplary liquid drug pumps with a flexible drug reservoir are provided. In general, a pump includes a flexible reservoir configured to contain a liquid drug therein for delivery to a patient wearing the pump. The reservoir is configured to be filled with the drug from a drug storage container, which can either be external to the pump or disposed within the pump.

A device is disclosed that is configured as a fully autonomous and integrated wearable apparatus for diabetes management. The device comprise a self-pressurized reservoir for storing the medication for subsequent delivery to a patient, a needle for delivering the medication to the patient subcutaneously, a first MEMS device configured as a microvalve in a fluid path between the self-pressurized reservoir and needle for controlling flowrate of medication through the needle as the self-pressurized reservoir discharges, a second MEMS device configured as a micropump configured to increase flowrate of the medication in the fluid path to ensure a constant flowrate in the fluid path as the self-pressurized discharges independent of orientation of the device, a flow sensor configured to measure flowrate in the fluid path for controlling microvalve and micropump, and control circuitry connected to the microvalve, micropump and flow sensor for controlling operation of the micropump and microvalve.

Devices, systems, and techniques for controlling delivery of therapy for diabetes are described. In one example, a system includes a wearable device configured to generate user activity data associated with an arm of a user; and one or more processors configured to: identify at least one gesture indicative of utilization of an injection device for preparation of an insulin injection based on the user activity data; based on the at least one identified gesture, generate information indicative of at least one of an amount or type of insulin dosage in the insulin injection by the injection device; compare the generated information to a criteria of a proper insulin injection; and output information indicative of whether the criteria is satisfied based on the comparison.

The present invention relates to a movement disorder monitor with high sensitivity, and a method of measuring the severity of a subject's movement disorder. The present invention additionally relates to a drug delivery system for dosing a subject in response to the increased severity of a subject's symptoms. The present invention provides for a system and method, which can accurately and repeatably quantify symptoms of movements disorders, accurately quantifies symptoms utilizing both kinetic information and/or electromyography (EMG) data, that can be worn continuously to provide continuous information to be analyzed as needed by the clinician, that can provide analysis in real-time, that allows for home monitoring of symptoms in subject's with these movement disorders to capture the complex fluctuation patterns of the disease over the course of days, weeks or months, that maximizes subject safety, and that provides substantially real-time remote access to data by the clinician or physician.