Abstract: A closed-loop control for a medical therapeutic system is disclosed that includes one or more processes or components for/in the medical therapeutic system, a controller configured to determine whether one or more operations of the process(es) or component(s) are within a corresponding safety envelope, and one or more sensors. The process(es)/component(s) are configured to deliver a controlled amount of a substance, energy or force to a patient. The sensor(s) are configured to measure or determine a value of a measurable parameter of the process(es)/component(s) and/or effected by the operation(s), and provide the value(s) of the measurable parameter(s) to the controller. The controller determines whether each of the operation(s) are within the corresponding safety envelope according to a corresponding function that mathematically describes the operation. The safety envelope corresponds to known safe values of the measurable parameter, or an unmeasured parameter based on the measurable parameter.

Abstract: Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user's insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user's blood glucose characteristics, the user's insulin load information, or the like.

Abstract: A medical liquid injection device includes a base body, a needle assembly mounted on the base body, a reservoir fluidly connected to the needle assembly and having a plunger therein, a driving unit that linearly moves the plunger, and an encoder unit disposed at an end of the driving unit to measure rotation of the driving unit.

Abstract: Disclosed herein are techniques related to glucose level management without carbohydrate counting. The techniques may involve obtaining contextual information for a meal, predicting amounts of glucose to be absorbed into a bloodstream of the patient over a duration of time due to consumption of the meal based on the contextual information for the meal, determining one or more amounts of insulin to counteract effects of the predicted amounts of glucose, and affecting insulin therapy based on outputting information indicative of the determined one or more amounts of insulin.

Abstract: The exemplary embodiments provide medicament delivery devices that use cost functions in their control systems to determine medicament dosages. The cost function may have a medicament cost component and a performance cost component. The exemplary embodiments may use cost functions having medicament cost components that scale asymmetrically for different ranges of inputs (i.e., different candidate medicament dosages). The variance in scaling for different input ranges provides added flexibility to tailor the medicament cost component to the user and thus provide better management of medicament delivery to the user and better conformance to a performance target. The exemplary embodiments may use a cost function that has a medicament cost component (such as an insulin cost component) of zero for candidate dosages for a range of candidate dosages (e.g., below a reference dosage).

Abstract: A needleless injector is provided. The needleless injector includes a loading lever having a working arm part having a lever shaft, a towing member inserted inside the cylinder housing, a link having one end portion pin-coupled to the working arm part and the other end portion pin-coupled to the towing member, an inner cylinder inserted inside the cylinder housing, a spring inserted into the inner cylinder, an actuating head inserted into the inner cylinder in front of the spring and having a catching protrusion configured to be inserted into the slit, and a trigger means having a stopper head part configured to be able to be inserted into the slit of the inner cylinder and detached from the slit. Accordingly, the needleless injector can achieve a reduction in size and thickness by having a simple structure even with a lever for reloading integrally formed therein.

Abstract: Systems and methods for detecting an implanted medical device, such as a vascular access port. The implanted medical device may include at least one passive RFID tag that has disposed thereon information about the implanted medical device. The at least one passive RFID tag is designed to be interrogated by a detector associated with an external device, such as an infusion set with an access needle. The interrogating signal induces a return signal from the at least one passive RFID tags. The strength of the return signal may be dependent on the distance and orientation of the tag relative to the detector. The system may be designed to interpret different signal strengths from different RFID tags to guide the needle to a correct insertion position, thereby accessing a port that cannot be readily detected visually or by palpation.

Abstract: A system, apparatus and method for a tightly sealed, low moisture vapor transmission, low relative humidity headspace atmosphere aseptic vaccine delivery with low particulate generation. The system can include a housing, desiccant and a biasing member designed to quickly and efficiently deliver medicament to a patient.

Abstract: Machine learning in an artificial pancreas is described. An artificial pancreas system may include a wearable glucose monitoring device, an insulin delivery system, and a computing device. Broadly speaking, the wearable glucose monitoring device provides glucose measurements of a person continuously. The artificial pancreas algorithm, which may be implemented at the computing device, determines doses of insulin to deliver to the person based on a variety of aspects for the purpose of maintaining the person's glucose within a target range, as indicated by those glucose measurements. The insulin delivery system then delivers those determined doses to the person. As the artificial pancreas algorithm determines insulin doses for the person over time and effectiveness of the insulin doses to maintain the person's glucose level in the target range is observed, an underlying model of the artificial pancreas algorithm may be updated to better determine insulin doses.

Abstract: The invention relates to a metallic, nanoporous canister used to encapsulate cellular and/or biotherapeutic agents. The device is biocompatible and functions to wholly isolate a therapeutically active agent and/or cells therein. Their implantation, and survival in vivo, permits the local or systemic diffusion of their encapsulated cellular and/or biomolecular and therapeutics factors with the potential to promote repair of damaged or degenerated tissues in mammalian hosts, primarily humans.

Abstract: Missed meal bolus reminders or alerts require a user to access the user's pump and/or remote control to clear the reminder/alert even when the user skipped a meal such that no meal bolus was needed. CGM data can be leveraged such that the missed meal bolus alert is only triggered when glucose levels rise in response to consuming the meal within the programmed time window. Therefore, the alert is only provided when a meal is actually consumed and no bolus has been delivered. This further allows the user to be alerted sooner, i.e., as soon as glucose levels rise a predetermined amount or passed a predetermined threshold indicating consumption of a meal as opposed to only at the end of the programmed window.

Abstract: The invention relates to a metallic, nanoporous canister used to encapsulate cellular and/or biotherapeutic agents. The device is biocompatible and functions to wholly isolate a therapeutically active agent and/or cells therein. Their implantation, and survival in vivo, permits the local or systemic diffusion of their encapsulated cellular and/or biomolecular and therapeutics factors with the potential to promote repair of damaged or degenerated tissues in mammalian hosts, primarily humans.

Abstract: A material includes a metallic, nanoporous structure having a plurality of nanopores having a porosity that allows passage of insulin but not IgG. The metallic nanoporous structure includes titanium, 316L stainless steel and may have a textured nano-sericeous surface. A nanoporous bicontinuous structure can be integrated with nanopores.

Abstract: This invention relates to a feedback predictive controller, systems comprising and methods employing the same. Preferably the feedback predictive controller and/or systems comprising the feedback predictive controller are part of an automatic insulin delivery system. The methods described herein can be used to control blood glucose concentration in a patient with diabetes. Preferably, the insulin delivery system is an artificial pancreas.

Abstract: A medical device is configured to monitor, using one or more sensors, an environmental condition of a physical environment proximate to a medical device, and to determine when a value representative of the environmental condition exceeds a threshold for safe operation of the medical device with regard to care of a patient. Responsive to the value exceeding the threshold, an operation mode of the medical device is automatically switched from a first mode currently programmed for the care of the patient to a second mode, the second mode using different parameters than the first mode to control the medical device.

Abstract: A user-mountable electronic device includes a housing, an accelerometer located within the housing, and at least one processor located within the housing. The accelerometer measures acceleration of the user-mountable electronic device and is configured to generate an output in response to detecting acceleration of the user-mountable electronic device that is greater than a minimum acceleration threshold. The at least one processor controls operation of the user-mountable electronic device. The at least one processor is configured to receive the output generated by the accelerometer and, in response thereto, to transition from a dormant or standby state of the user-mountable electronic device to an active state of the user-mountable electronic device.

Abstract: An insulin device configured to control insulin dispensing based on insulin sensitivity. The insulin device includes a processor configured to receive insulin dosing schedule information, psychological stress level data, and body mass index (BMI) data; a sensor configured to generate a blood glucose level measurement. The sensor is calibrated as a function of the psychological stress level data and the BMI data and the processor is configured to monitor and detect changes of the blood glucose level measurement that are determined to have occurred as a function of changes of the psychological stress level data, and identify a time when the BMI data counteracts a detected change in the blood glucose level measurement. The insulin device also includes an insulin dispensing valve controlled by the processor to change the insulin dosing schedule information in accordance with the counteracting BMI data.

Abstract: This document provides devices and methods for the treatment of heart conditions such as valvular stenosis. For example, this document provides devices and methods by which a guide catheter can align itself with a blood flow stream to thereby help direct a guidewire or other elongate device transmitted from the guide catheter through an orifice of a heart valve.

Abstract: Disclosed is a method for fabricating a wearable hydrogel glucose sensor, belonging to the technical field of biomedical sensing, including using polyacrylamide hydrogel as a basic material, preparing a hydrogel film by adding with phenylboronic acid group capable of recognizing glucose molecules, and carrying out grating writing on the hydrogel film in a femtosecond laser direct writing mode to obtain the wearable hydrogel glucose sensor. The hydrogel film combines with glucose and expands linearly, which makes the grating period and effective refractive index change. The quantitative measurement of glucose is realized by detecting the spatial position of diffraction band and the change of diffraction power intensity.

Abstract: An intravenous delivery system may have a liquid source containing a liquid, tubing, and an anti-run-dry membrane positioned such that the liquid, flowing form the liquid source to the tubing, passes through the anti-run-dry membrane. The anti-run-dry membrane may have a plurality of pores through which the liquid flows, and may be formed of a hydrophilic material that resists passage of air through the pores. The intravenous delivery system may further have a bubble point raising component that raises the bubble point of the anti-run-dry membrane. The bubble point raising component may, in some embodiments, be a high surface energy coating or additive.