Abstract: An implantable medical device configured to monitor fluid in proximity to an implantable medical device for an inadvertent introduction of infusate into a pocket of tissue surrounding the implantable medical device during a refill procedure, the implantable medical device including a refillable infusate delivery system, the refillable infusate delivery system including a reservoir in fluid communication with an access port, and a conductivity sensor configured to monitor fluid in proximity to the conductivity sensor for an introduction of infusate into a pocket of tissue surrounding the implantable medical device, wherein the conductivity sensor comprises a pair of electrodes positioned on an external surface of the implantable medical device.

Abstract: Techniques disclosed herein relate to nutritional content determination based on gesture detection data. In some embodiments, the techniques involve obtaining gesture detection data corresponding to consumption of a food item or a drink; determining, based on the gesture detection data, nutritional content of the food item or the drink; and causing delivery of insulin in accordance with the nutritional content of the food item or the drink.

Abstract: The invention relates to an applicator system comprising a microneedle array and to the use thereof for the intradermal delivery of active ingredients, and in particular of medicinal drugs, wherein this microneedle array is suitable for penetrating the skin of humans or animals and includes at least one active ingredient for wound healing.

Abstract: A system for monitoring at least presence of a bioanalyte. The system comprises: a substrate having a skin contact surface, a microneedle outwardly protruding from the skin contact surface, a sensing complex positioned in the microneedle, and a circuit attached to the substrate. The sensing complex can comprise a nanostructure modified by a functional moiety covalently attached thereto, and an affinity moiety effective to react specifically with the bioanalyte to produce a reaction product. The circuit can apply voltage to the nanostructure and monitor changes in an electrical property of the nanostructure responsively to reaction between the reaction product and the functional moiety.

Abstract: Systems and methods are provided for signaling a condition of an infusion assembly. An example system may comprise an elastomeric pump that includes a chamber for receipt of a volume of fluid, an outer layer configured to expand and contract as the chamber receives and dispenses the fluid, and a passive indicator provided on the outer layer for signaling a change in the volume of the fluid in the chamber. The example system further may comprise an image capture device configured to capture an image of the pump, and a processing system configured to process the image to signal the condition of the infusion assembly to a user of the system. An example method may comprise capturing the image of the pump; processing the image; and displaying information to the user of the pump to communicate a condition of the pump to the user. Various elastomeric pumps for infusion assemblies also are provided.

Abstract: The invention provides a delayed release dosage form and a bolus configured for administration to an animal, wherein the dosage form and the bolus is configured to release a hydrophobic substance to the animal over a period of time. Preferably the hydrophobic substance is a haloform. Also provided is the use of the delayed release dosage form or bolus of the invention to reduce methane production in a ruminant animal. Also provided is the method of manufacturing a bolus of the invention.

Abstract: A system with container volume tracking includes a pump receiving a line connected to a tracked container, an air sensor to detect air in the line, and a controller coupled to pump and sensor. The controller is configured to monitor pump operation, and determine a volume removed from the container based thereon. If the volume removed is less than a first percentage of a target volume and there is air, continue operation after an air purge. If the volume removed is more than the first percentage and less than a second percentage and if there is air, prompt the user for an input, and continue operation after an air purge if a first input is received or end operation if a second input is received. If the volume removed is more than the second percentage and if there is air, end operation.

Abstract: The present invention relates to a microneedle system (MNS for short) for the intradermal application of a hepatitis vaccine, namely the antigen HBsAg.

Abstract: A system and method is provided for detecting fluid low-volume and occlusion in a device using force sensing resistor (FSR) sensor. One or more force sensing resistors are positioned in communication with a fluid channel at one or more of a pump intake and pump outlet to detect pressure in the fluid channel. The pressure is detected through communication with the force sensing resistor and indicates an irregular system condition including but not limited to, fluid low-volume level and occlusion. Also provided are a fluid flow sensor (e.g., FSR or MEMS sensor) disposed relative to an embedded fluid channel in the base of a wearable medicine delivery pump.

Abstract: A fully integrated small size implantable sensing device is described, which can include a sensor and an electronic circuit to interface with the sensor and communicate with an external device. Various fabrication methods for the sensing device are described, including provision of wells, created using same fabrication technology as the electronic circuit, to contain electrodes of the sensor and corresponding functionalization chemicals. Such implantable sensing device can be used for a variety of electrochemical measuring applications within a living body as well as actuation by injecting a current into the living body.

Abstract: This invention relates to gels that undergo either oscillatory stepwise expansion or oscillatory expansion and contraction. An oscillatory reaction occurs within the gel, changing the conditions of the gel, and causing the gel to expand and optionally contract. The gels may be used for oscillatory release of a chemical agent.

Abstract: A method for adjusting a bolus amount of insulin for a meal event using a control unit having a processing unit and a touch screen display as well as a medical control device and a medical system configured to perform the method. Additionally, the present disclosure relates to a computer program or computer program product that, when executed, performs the method. A carbohydrate-based bolus amount of insulin can be delivered in a first bolus and a second bolus. A movable slider displayed on the touch screen display can be used to adjust the relative amounts of the first and second boli.

Abstract: A server computer processes infusion pump data for presentation on an operator interface. The computer includes a network circuit configured to provide communications over a network and a processing circuit. The processing circuit receives infusion pump history data from a plurality of infusion pumps, including an indication that a user inputted to an infusion pump a parameter which was outside of a prestored limit, an indication that a user was notified that the parameter was outside the prestored limit, an indication that the infusion pump parameter was returned to within the prestored limit, and an indication that the user started infusion on the pump at the parameter within the prestored limit. Display data indicating reprogram and override events is generated for display on an operator interface.

Abstract: A drug delivery device (1), comprising a delivery unit (2) in the form of a disposable single use part and a base unit (4) in the form of a reusable part for coupling to the delivery unit (2), the delivery unit comprising a liquid flow system for pumping liquid from a drug vial or cartridge (3) received in the drug delivery device to an outlet of the device for transcutaneous administration of a liquid drug, the base unit including at least a power source and an electronic control system, the delivery unit and base units comprising a releasable locking mechanism including a locking shoulder (30) on the delivery unit that engages a complementary locking shoulder (34) on the base unit. The locking mechanism comprising an unlocking actuator that may be actuated to release the locking shoulder (30) from the complementary locking shoulder (34).

Abstract: A device and a method for delivering a flowable ingestible medicament into the gastrointestinal tract of a user. The device includes a vibrating ingestible capsule attached to a medicament delivery compartment. The medicament delivery compartment includes a housing including a portal, a medicament reservoir, a reservoir biasing mechanism applying pressure to the reservoir, a resilient conduit extending from the reservoir to the portal, and a valve including a weight and a spring adapted, when closed, to bias the weight against the conduit so as to block flow therethrough, and, when open, to remove the weight from the conduit to allow fluid to flow through the conduit. When the vibrating agitator is in the vibration mode of operation, vibrations exerted thereby are applied to the valve biasing mechanism and periodically transition the valve between the closed operative orientation and the open operative orientation.

Abstract: A system for delivery of a volume of infusible fluid. The system includes a controller configured to calculate a trajectory for delivering infusible fluid, the trajectory comprising at least one volume of fluid, and determine a schedule for delivering the at least one volume of fluid according to the trajectory, wherein the schedule comprising an interval and a volume of infusible fluid for delivery. The system also includes a volume sensor assembly for determining the at least one volume of fluid delivered, wherein the controller recalculates the trajectory based on the volume of fluid delivered.

Abstract: A system for electronic patient care includes a hub. The hub is configured to monitor a patient-care device. The sandbox may be configured to control access to at least one of a hardware resource and a software resource. The hub is further configured to identify the patient-care device and execute an application to monitor the patient-care device. The hub executes the application within the sandbox component such that the application accesses the at least one of the hardware resource and the software resource through the sandbox component. The hub may be further configured to control the patient-care device. The hub may be further configured to receive an identification from the patient-care device and download the application from a server associated with the identification. The hub may be further configured to receive an identification from the patient-care device and update the application from a server associated with the identification.

Abstract: A system, method, and computer program product are disclosed for a flow rate algorithm that utilizes changes in fluid pressure over a set time interval to calculate a true flow rate compared to a programmed flow rate, determine any over-delivery or un-der-delivery in the amount of fluid delivered over the set time interval, compensate for any determined over-delivery or under-delivery in the fluid flow rate over a subsequent set time interval, and repeat the flow rate algorithm for a series of subsequent set time intervals over the duration of a fluid injection procedure.

Abstract: An apparatus for perfusing an organ or tissue includes a perfusion circuit for perfusing the organ or tissue; a controller configured to control the apparatus; and a detector configured to detect an optional component of the apparatus, and provide a signal to the controller indicative of the presence of the optional component, wherein the controller is configured to control the perfusion circuit in a first mode when the optional component is detected and to control the perfusion circuit in a second mode when the optional component is not detected.

Abstract: The present disclosure relates to a delivery device capable of delivering compositions. In some embodiments, the delivery device may deliver compositions to the gastrointestinal tract. In some embodiments, the compositions contain active drug substances. In some embodiments, the active drug substances are low permeable active drug substances.

Abstract: A fill port for filling a liquid medicament into a reservoir located inside a drug delivery device includes insert fixed in a passage of a wall of the drug delivery device, and a pierceable fill port sealing is sandwiched between the insert and both the housing of the drug delivery device and the reservoir to provide a fluid-tight sealing between the reservoir and the housing.

Abstract: A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

Abstract: A sensor (220) for a body monitoring system (1), having analyte-measuring microneedles (210) that extend parallel to a main direction (Z) from a substrate (242) and define a working plane (Pt), wherein the sensor (220) has at least one conductivity electrode (600) with a metallic track (602), the end of the metallic track extending along the main direction (Z) to a position strictly between the substrate (242) and the working plane (Pt).

Abstract: A system includes one or more processors and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of obtaining a first target value for a glucose level of a patient, modifying a glucose setpoint from a second target value to the first target value, and regulating the glucose level of the patient to the modified glucose setpoint based on controlling insulin delivery by an insulin infusion device.

Abstract: An annuloplasty device is disclosed comprising first and second support rings being configured to be arranged as a coil in a first configuration around an axial direction, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, a stiffening unit, wherein at least part of the first and second support rings comprises an interior channel configured to receive the stiffening unit, wherein insertion of the stiffening unit into the interior channel increases the stiffness of the first and/or second support rings. A method of repairing a defective heart valve is also disclosed.

Abstract: A hydraulic system includes a hydraulic gear pump with a first gear having a plurality of first gear teeth and a second gear having a plurality of second gear teeth. The hydraulic system also includes a control valve and a control circuit. The control circuit controls the pump to adjust at least one of a flow in the hydraulic system to a flow set point or a pressure in the hydraulic system to a pressure set point, and concurrently establishes an opening of the control valve to adjust at least one of the flow to the flow set point or the pressure to the pressure set point. The control circuit establishes a position of a first tooth relative to a position of a second tooth to seal a fluid path from the outlet of the hydraulic gear pump to the inlet of the hydraulic gear pump.

Abstract: Aspects provide fluid responsive actuators and methods of using fluid responsive actuators capable of generating a power-to-volume ratio sufficient to inject a drug from a syringe within an injection period from about 1 to about 60 seconds after exposure of the fluid responsive elements to a fluid. The fluid responsive actuators can be used to inject viscous drugs to a patient.

Abstract: The present disclosure provides methods of stabilizing surgical screws comprising the intraoperative mixing of reactive putties to yield a homogenous putty composition (HPC) into which the screw is inserted, wherein the HPC comprises a polyurethane or polyurethane urea copolymer, one or more particulate materials, and one or more additive materials.

Abstract: A transdermal drug delivery device includes a reservoir, a transdermal membrane, a piston, a control rod, a spring, and a rotational cam. The reservoir is configured to hold a formulation. The transdermal membrane is configured to allow the formulation from the reservoir to pass therethrough. The piston is configured to move into the reservoir. The control rod is attached to the piston and includes a plurality of teeth thereon. The spring is configured to apply force to the control rod in the direction of the reservoir. The rotational cam has a first camming surface and a second camming surface that are configured to engage with the plurality of teeth. The rotational cam, when rotated, is configured to disengage the first camming surface from a first tooth of the plurality of teeth, thereby allowing the spring to advance the piston into the reservoir to expel the formulation onto the transdermal membrane.

Abstract: The present invention relates to new compositions for sclerotherapy. In particular, the invention relates to the use of light activated biocompatible glues and catheter for the application of said glue. The catheter of the present invention comprises a light source for the glue activation.

Abstract: An implantable device for monitoring physiological changes in a patient is provided. The device can include a vessel adapted to being implanted within a patient's body; a chamber having a cell layer and capable of being secured to the vessel; a light source for shining light onto the cell layer; and a reader for detecting and/or decoding signals from the cell layer to monitor physiological changes in the patient. The device is capable of engaging in a two-way communication with a second device through transmission of one or more electromagnetic signals through at least a portion of the patient's body.

Abstract: Disclosed is a portable device for processing continuous monitoring data. The portable device includes a data interface that receives a stream of continuous monitoring data from a body-worn sensor. The data is indicative of an analyte in a bodily fluid. The portable device also includes a storage device that can store the continuous monitoring data. The control processes the continuous monitoring data and is switchable between first and second modes of operation during a sensor session of the body-worn sensor. In the first mode of operation, the control is configured to provide video data indicative of the continuous monitoring data for outputting by a display. In the second mode of operation the control is configured to store the continuous monitoring data in the storage device and to block the continuous monitoring data from being displayed on the display. A related method, system and computer program product are also disclosed.

Abstract: A medical liquid infusion apparatus includes: a housing provided such that an interior thereof is at least partially open at a first time point and is sealed at a second time point later than the first time point; a needle assembly located in the housing and provided such that at least a portion thereof is discharged to an outside of the housing at a third time point later than the second time point by a user's operation; a reservoir that is sealed in the housing after the second time point, receives a medical liquid, and is fluidly connected to the needle assembly; a driving module that is sealed in the housing after the second time point, interposed between the needle assembly and the reservoir, and generates a driving force for discharging the medical liquid after the third time point; a battery module sealed in the housing after the second time point; and a control module that is sealed in the housing after the second time point, and electrically connected to a transmission module and the battery module a

Abstract: A wirelessly powered inflatable medical implant system includes a medical provider software application, a patient external controller and a MR-Conditional, nonferrous pump in reservoir implant. The medical provider software application programs the patient external controller for the patient to transmit wireless power and control signals to circuitry in a pump in reservoir implant. In response, the pump in reservoir implant, containing a fluid reservoir and pump package submerged therein, transfers fluid from the reservoir through tubing, and into one or more inflatable medical implants. Submerging the pump package within the reservoir simplifies surgery in males and pump placement in females and provides pump package heatsinking to limit implant overheating.

Abstract: An apparatus comprising a pump configured to deliver insulin, a processor, and a user interface including a color display. Color on the display can be used to bring a user's attention to a change in status of the device or a detected change in status of the patient.

Abstract: Provided is a wearable, self-contained drug infusion or medical device capable of communicating with a host controller or other external devices via a personal area network (PAN). The medical device utilizes a PAN transceiver for communication with other devices in contact with a user's body, such as a physiological sensor or host controller, by propagating a current across the user's body via capacitive coupling. The wearable nature of the medical device and the low power requirements of the PAN communication system enable the medical device to utilize alternative energy harvesting techniques for powering the device. The medical device preferably utilizes thermal, kinetic and other energy harvesting techniques for capturing energy from the user and the environment during normal use of the medical device. A system power distribution unit is provided for managing the harvested energy and selectively supplying power to the medical device during system operation.

Abstract: The present disclosure relates to implantable encapsulation devices for housing a biological moiety or a therapeutic device that contains a biological moiety. Particularly, aspects of the present disclosure are directed to an implantable apparatus that includes a distal end, a proximal end, a manifold including at least one access port positioned either at the distal end or the proximal end, and a plurality of containment tubes affixed to the manifold and in fluid communication with the at least one access port. Additionally, the encapsulation device may contain a flush port and a tube that are fluidly connected to the manifold. The containment tubes may contain therein a biological moiety (e.g., cells) or a therapeutic device (e.g. a cell encapsulation member).

Abstract: A system and a method for filling an on-body injector includes a needle of the prefilled syringe being aligned with a fill port of the on-body injector. The needle may then be inserted into a guide of a needle cover attached to the on-body injector. An adapter attached to the syringe barrel may guide the needle into a center of the bore of the guide and into the fill port of the on-body injector. The needle may be inserted into the fill port and the adapter may be mechanically coupling to the guide. After the adapter is mechanically coupled to the guide, a volume of the drug of the prefilled syringe may be dispensed into a reservoir of the on-body injector. Once the reservoir is filled to a desired amount, the needle may be removed from the fill port by decoupling the adapter from the guide.

Abstract: Systems and methods of use involving sensors having a particle-containing domain are provided for continuous analyte measurement in a host. In some embodiments, a continuous analyte measurement system is configured to be wholly, transcutaneously, intravascularly or extracorporeally implanted.

Abstract: A patch-sized fluid delivery device may include a reusable portion and a disposable portion. The disposable portion may include components that come into contact with the fluid, while the reusable portion may include only components that do not come into contact with the fluid. Redundant systems, such as redundant controllers, power sources, motor actuators, and alarms, may be provided. Alternatively or additionally, certain components can be multi-functional, such a microphones and loudspeakers that may be used for both acoustic volume sensing and for other functions and a coil that may be used as both an inductive coupler for a battery recharger and an antenna for a wireless transceiver. Various types of network interfaces may be provided in order to allow for remote control and monitoring of the device.

Abstract: A digestive organ internal contents sampling capsule for sampling internal contents in a digestive organ includes: a cylindrical container insoluble in a digestive tract for housing the internal contents in the digestive organ; an outer lid enclosing an orifice of the cylindrical container and to dissolve at least partially in the digestive organ; an inner lid arranged in the cylindrical container, and to swell in response to contact with the internal contents in the digestive organ to enclose the orifice of the cylindrical container after the orifice is exposed by dissolving of at least a part of the outer lid; and a marker material to be discharged together with the cylindrical container housing the internal contents in the digestive organ and feces.

Abstract: The present disclosure relates to systems and methods for controlling physiological glucose concentrations in a patient.

Abstract: Described herein are wearable devices and methods for medicament delivery. Example devices can include a housing having an underside adapted to be proximate to a skin surface, and a reservoir disposed in the housing, the reservoir configured to be filled with a medicament to be delivered to the patient. The devices can include a cannula disposed within the housing and coupled to the reservoir, in which the cannula configured to protrude from a port defined by the housing to be positioned in the skin surface. The devices can further include a capacitive sensor configured to detect whether the medicament has leaked from the delivery device, in which the capacitive sensor includes a conductor disposed in a portion of the underside of the housing.

Abstract: Provided are active agent delivery devices configured to deliver an active agent formulation into or through a mucosal layer in a subject. The active agent delivery devices include a power reservoir configured to eject the active agent formulation at a pressure sufficient to deliver the active agent formulation into or through a mucosal layer in a subject. Methods of using the subject active agent delivery devices are also provided.

Abstract: A feedback mechanism for an injection device that is configured to deliver a medicament to a user is described. The feedback mechanism comprises an actuator and a fluid chamber having a restricted outlet. The actuator is adapted to urge fluid from the fluid chamber through the restricted outlet. The feedback mechanism also has an indicator that is adapted to provide feedback to the user after a predetermined volume of fluid has passed from the fluid chamber through the restricted outlet during use of the injection device.

Abstract: According to the present invention, there are provided a chamber for transplantation, as a planar chamber for transplantation which has a structure in which membranes for immunoisolation face each other, and which is capable of stably enclosing a biological constituent, including a membrane for immunoisolation at a boundary between an inside and an outside of the chamber for transplantation, in which the membranes for immunoisolation which face each other have joint portions that are joined to each other, an interior space includes a point at a distance of 10 mm or longer from any position of the joint portion, and the membrane for immunoisolation has flexibility that allows a distance of 1 mm to 13 mm as the following distance: in a case where a portion of 10 mm from a side surface of one short side of a 10 mm×30 mm rectangular test piece of the membrane for immunoisolation is vertically sandwiched between flat plates, and the flat plates are placed horizontally, a distance between a horizontal plane includi

Abstract: Via communications with an association management resource, an operator of a respective fluid delivery system can associate a medical device (fluid pump) with a particular entity such as a patient, location, one or more other medical devices, the caregiver, etc. Thereafter, the operator of the fluid delivery system is able to better manage use of the fluid delivery system based on relevant medical information, which is accessible as a result of creating the association. For example, the association management resource gathers and stores information associated with the entity prior to the operator providing the input associating the fluid delivery system with the entity. After the operator of the fluid delivery system creates the association, the medical information associated with the entity is immediately available to the fluid delivery system and/or corresponding operator of the fluid delivery system.

Abstract: Methods, computer-readable medium, and devices that provide a graphic user interface for operating a medical infusion system are described. An exemplary method includes receiving analyte level information for a user; and providing a graphic user interface on a display element that includes an analyte level chart depicting analyte values and an infusate delivery chart. An exemplary chart depicts graphics showing basal amounts of infusate delivered by the system over time, wherein each graphic is illustrated with a dimension indicating an increased, same, or decreased amount relative to an immediately preceding graphic. Further, the exemplary chart depicts indicators showing bolus amounts delivered by the medical infusion system over time, wherein at least a portion of the bolus indicators is illustrated with a dimension not to scale.

Abstract: According to the invention, an auto-injector for administering a dose of a liquid medicament (M) comprises of a substantially cylindrical housing arranged to contain a pre-filled syringe filled with the medicament (M), a needle shroud slibably arranged with respect to the housing and adapted to rest on the skin of a patient receiving an injection, a releasable drive means arranged within the housing that is capable of, upon release, translating the needle shroud in a proximal direction (P) towards a safe position (PS) and a rotating collar rotatably arranged within the housing. The needle shroud in the safe position (PS) surrounds the injection needle after the injection has been carried out. The rotating collar engages the needle shroud in a manner that forces the rotating collar to rotate within the housing when the needle shroud is translated in the proximal direction (P).

Abstract: An iron-based alloy absorbable and implantable medical device for internal fixation. A substrate includes an iron-based alloy and degradable polymer. The mass ratio of the iron-based alloy to the degradable polymer is between 1:4 and 4:1. The weight-average molecular weight of the degradable polymer is between 150000 to 3000000, and the polydispersity index thereof is between 1 and 6. The device further includes antioxidants. The iron-based alloy is used as a load-bearing framework or reinforcement phase of the device. By adjusting the mass ratio of the iron-based alloy to the degradable polymer and the combination mode thereof, the corrosion rate of the iron-based alloy in the late period of the implantation is accelerated, and the quantity of corrosion products poorly soluble in the iron-based alloy is reduced. Adding antioxidants to the device further reduces the quantity of the corrosion products poorly soluble in the iron-based alloy.