A disposable, single-dose delivery device for self-administration by a patient of a predefined amount or dose of drug from a reservoir through an outlet of the reservoir includes a device operation lock to prevent a delivery operation of the delivery device as shipped to the patient, an embedded electronic control unit with a wireless receiver for receiving an unlock command or message, and an electromechanical actuator for mechanically unlocking the device operation lock and enabling delivery device operation by the patient. The control unit is configured to activate the actuator instantaneously and unconditionally upon receipt of the unlock command. The unlocking mechanism of the delivery device is adapted to be activated from remote in response to a confirmative message indicative of additional double check by a Health Care Professional HCP or expert system.

Methods and systems for delaying alarms that include detecting an analyte level using an analyte sensor; and delaying the annunciation of an analyte alarm after the analyte level crosses an analyte threshold, wherein the delay is based on one or both of (1) a magnitude of difference between the analyte level and the analyte threshold and (2) a duration of time in which the analyte level has crossed the analyte threshold.

Methods and systems for delaying alarms that include detecting an analyte level using an analyte sensor; and delaying the annunciation of an analyte alarm after the analyte level crosses an analyte threshold, wherein the delay is based on one or both of (1) a magnitude of difference between the analyte level and the analyte threshold and (2) a duration of time in which the analyte level has crossed the analyte threshold.

Capsule devices, such as devices suitable for swallowing into a lumen of a body lumen, are generally provided. In some embodiments, the capsule device (100) comprises a tissue interfacing component (130) disposed relative to a capsule housing (110,120). The capsule device (100) may comprise a plurality of elongated spike members (182, 130) advanceable relative to the capsule housing (110,120) from a non-advanced first state to an advanced second state, wherein free ends of the elongated spike members (182, 130) engages tissue of a lumen wall of the body lumen. In some embodiments, the capsule device (100) comprises an actuator (155) coupled to the plurality of elongate spike members (182) and an energy source (140) coupled to the actuator (155) for moving the plurality of elongated spike members (182, 130) to the advanced second state. At least one of the plurality of spike members (182, 130) is configured as a deflectable spike member (182) that is deflected laterally as the deflectable spike member is advanced toward the second state so that the plurality of spike members (182, 130) act by spreading or pinching engagement on tissue between the plurality of spike members, thereby anchoring the capsule device (100) relative to the lumen wall.

Medical devices and related guidance systems and methods for interactive patient guidance are provided. An exemplary method of interactively providing guidance facilitating operation of a medical device involves identifying, at a computing device communicatively coupled to the medical device, a user objective associated with the medical device, obtaining, at the computing device from the medical device, user interface status information corresponding to a current state of a user interface of the medical device, and providing, on a display associated with the computing device, guidance information influenced by the user interface status information and the user objective. Subsequently, updated user interface status information for the infusion device responsive to a user input with respect to the infusion device may be provided to the computing device, with the guidance information being dynamically updated in response to the updated status information.

Medical devices and related guidance systems and methods for interactive patient guidance are provided. An exemplary method of interactively providing guidance facilitating operation of a medical device involves identifying, at a computing device communicatively coupled to the medical device, a user objective associated with the medical device, obtaining, at the computing device from the medical device, user interface status information corresponding to a current state of a user interface of the medical device, and providing, on a display associated with the computing device, guidance information influenced by the user interface status information and the user objective. Subsequently, updated user interface status information for the infusion device responsive to a user input with respect to the infusion device may be provided to the computing device, with the guidance information being dynamically updated in response to the updated status information.

An implantable pump system is provided, suitable for use as a left ventricular assist device (LVAD) system, having an implantable pump, a battery, a controller, and a programmer. The implantable pump includes a flexible membrane coupled to an actuator assembly via a skirt that extends toward the inlet of the pump and curves to guide blood toward the outlet. The actuator assembly is magnetically engageable with electromagnetic coils, so that when the electromagnetic coils are energized, the actuator assembly causes wavelike undulations to propagate along the flexible membrane to propel blood from the inlet, across the skirt, and through the outlet of the implantable pump. The controller may be programmed by a programmer to operate at frequencies and duty cycles that mimic physiologic flow rates and pulsatility while operating in an efficient manner that avoids thrombus formation, hemolysis and/or platelet activation.

An implantable drug delivery device and method for delivering a drug to a living body. The device includes a housing having at least one opening, a reservoir within the housing adapted to contain a drug, a temporary seal closing the opening of the housing, and a heating element in thermal contact with the temporary seal. The heating element is adapted to generate heat in response to a magnetic field to melt the temporary seal and release a drug within the reservoir through the opening of the housing.

Embodiments provide devices, preparations and methods for delivering therapeutic agents (TAs) such as clotting factors (CFs, e.g., Factor 8) within the GI tract. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations configured to be contained within the capsule, advanced from the capsule into the IW and/or surrounding tissue (ST) and degrade to release the TA into the bloodstream to produce a therapeutic effect (e.g., improved clotting). The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW or ST (e.g., the peritoneal cavity). Embodiments are particularly useful for delivery of CFs for treatment of clotting disorders (e.g., hemophilia) where such CFs are poorly absorbed and/or degraded within the GI tract.

Systems, methods, and/or apparatuses may be operative to perform a dialysis process that includes a displacer infusion process. The dialysis machine may include at least one processor and a memory coupled to the at least one processor, the memory comprising instructions that, when executed by the processor, may cause the at least one processor to access dialysis information for a dialysis process performed by a dialysis machine, the dialysis information indicating a target substance to be displaced from a binding compound by a displacer, and determine an infusion profile for infusing the displacer into a patient during a displacer infusion process of the dialysis process, the infusion profile determined based on the dialysis information and an infusion constraint. Other embodiments are described.