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

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: 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: 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: 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: 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.

Abstract: Devices, systems, and methods are provided herein for delivering medication (e.g., insulin) via a wearable pump having a patch-style form factor for adhesion to a user's body. The reusable pump may be coupled to a disposable cap housing a microdosing system for delivering precise, repeatable doses of medication to a cannula configured to deliver medication to a target infusion area beneath the user's outer skin layer. The system further may include an applicator for inserting the cannula into the user's skin and/or applying an adhesive pad to the skin.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to a delivery mechanism having one or more balloons or other expandable devices which are expandable responsive to a condition in the small intestine or other GI lumen to advance the preparation out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A surface coating configured to locally enhance ultraviolet light density of ultraviolet light incident on the surface coating. The surface coating includes a dielectric layer, a conductive layer on the dielectric layer, a series of nano-openings in the dielectric layer and the conductive layer, a series of nano-antennae in the series of nano-openings, and a dielectric gap between the series of nano-antennas and the conductive layer. The conductive layer and the nano-antennae both include a UV plasmonic material.

Abstract: A drug delivery system for injecting a medicament is provided. The system includes a container configured to receive a medicament; a drive assembly which, upon actuation, is configured to expel the medicament from the container; a needle for injecting the medicament to a patient; a fluid path assembly comprising a tube in fluid communication with the container and the needle for conducting fluid from the container to the needle; and a tube crimping arrangement configured to engage the tube to block fluid flow through the tube. The drive assembly causes the tube crimping arrangement to engage the tube after a dose of the medicament has been delivered to the patient through the needle.

Abstract: According to the present invention, there are provided a chamber for transplantation, including a membrane for immunoisolation including a porous membrane at at least part of a boundary between an inside and an outside of the chamber for transplantation, in which the porous membrane contains a polymer and has a layered compact portion where a pore diameter is the smallest within the membrane, a pore diameter continuously increases in a thickness direction from the compact portion toward both one surface A and the other surface B of the porous membrane, a porosity in a vicinity of the surface A is 65% or more, an average pore diameter of the surface A is larger than an average pore diameter of the surface B, and the surface B is disposed on the inside of the chamber for transplantation; and a device for transplantation including the chamber for transplantation enclosing a biological constituent therein.

Abstract: Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject) such as a liquid pharmaceutical agent.

Abstract: A blood glucose control system is configured to modify therapy provided to a subject. The system can cause first therapy to be delivered by the blood glucose control system to a subject during a first therapy period. The first therapy can be delivered based at least in part on a first value of a control parameter used by a control algorithm to generate a dose control signal. The system can determine a first effect corresponding at least in part to the first therapy and autonomously generate a second value of the control parameter. The system can cause second therapy to be delivered by the blood glucose control system to the subject during a second therapy period, wherein the second therapy is delivered based at least in part on the second value of the control parameter.

Abstract: Systems and methods are provided for signaling a condition of an infusion assembly. A 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 fluid, and a passive indicator provided on the outer layer for signaling a change in the volume of fluid in the chamber. The 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. A method may comprise capturing an image of a pump; processing the image; and displaying information to a user of the pump to communicate the condition of the pump to the user. Elastomeric pumps for infusion assemblies also are provided.

Abstract: A blood glucose control system is configured to modify therapy provide to a subject and determine whether the modified therapy results in a statistically significant improvement in glycemic control. The system obtains glycemic control information resulting from delivery of first therapy using a first value of a control parameter and determines a first effect corresponding to the first therapy. The control parameter is set to a second value that differs from the first value. The system obtains glycemic control information resulting from the delivery of the second therapy using the second value of the control parameter and determines a second effect corresponding to the second therapy. The system can perform a comparative assessment and determine whether the second value for the control parameter results in a statistically significant improvement in glycemic control for the subject.

Abstract: Systems and methods for automatically delivering medication to a user. A sensor coupled to a user can collect information regarding the user. A controller can use the collected information to determine an amount of medication to provide the user. The controller can instruct a drug delivery device to dispense the medication to the user. The drug delivery device can be a wearable insulin pump that is directly coupled to the user. The controller can be part of or implemented in a cellphone. A user can be required to provide a confirmation input to allow a determined amount of insulin to be provided to the user based on detected glucose levels of the user. The sensor, controller, and drug delivery device can communicate wirelessly.

Abstract: A substance delivery device is disclosed. The substance delivery device includes a lever that includes a drive arm that is rotatable about a pivot. The substance delivery device also includes a pump that has a deformable chamber. The deformable chamber is configured to rotate the drive arm about the pivot towards a container so as to deform the container to drive a fluid substance from the container.

Abstract: An implantable containment apparatus for receiving and retaining a biological moiety or a therapeutic device within a tissue bed is disclosed. The device includes a shaping element to maintain the device in a generally toroidal configuration and to return the apparatus to that configuration after deformation. The apparatus can be placed in a host tissue with minimal trauma to the patient. Methods for implanting and using the apparatus are also disclosed.

Abstract: Disclosed is a fluid delivery device including a fluid reservoir and a transcutaneous access tool fluidly coupled to the fluid reservoir, wherein the transcutaneous access tool includes a needle or a trocar. The fluid delivery device may further include a transcutaneous access tool insertion mechanism for deploying the transcutaneous access tool, wherein the insertion mechanism is configured to insert and retract the needle/trocar in a single, uninterrupted motion.

Abstract: Methods and apparatus provide treatment with a first therapeutic agent and a second therapeutic agent for an extended time. The first therapeutic agent may comprise a VEGF inhibitor and the second therapeutic agent may comprise an antiinflammatory, such as a non-steroidal anti-inflammatory, for example a cyclooxygenase inhibitor. One or more of the first therapeutic agent or the second therapeutic agent can be injected into the eye, for example injected into a therapeutic device implanted into the eye to release the injected therapeutic agent for an extended time.

Abstract: A fluid delivery device includes a housing having a bottom surface configured to be coupled to the skin surface. The fluid delivery device includes a cartridge prefilled with a fluid and configured to be inserted into the housing. The cartridge has a septum configured to be generally perpendicular to the bottom surface when the cartridge is inserted in the housing. The fluid delivery device includes a needle assembly that has a needle that includes a fluid coupling end and a delivery end. The fluid coupling end of the needle is fluidly disengaged from the cartridge in an initial position. The delivery end of the needle extends past the plane of the bottom surface and the fluid coupling end of the needle extends through the septum in a deployed position.

Abstract: Implantable gas delivery device and methods, systems, and devices including same. According to one embodiment, the implantable gas delivery device includes a porous core that permits facile transport of gas throughout its open volume. The porous core has sufficiently high tensile strength to withstand pressurization without significant deformation. The porous core is generally planar and is shaped to include a pair of opposing surfaces and a periphery. Diffusion membranes are fixed to the two opposing surfaces of the porous core. A gas supply tube has one end inserted into the porous core and another end connectable to a gas source. The periphery of the porous core is sealed gas-tight, either with a gasket or by sealing the porous core and/or diffusion membranes. The device may be used to deliver a gas to an implanted cell capsule or to native cells or tissues or may be used to expel waste gas.

Abstract: Systems and methods can include wearable, non-invasive ultrasound modalities for treating a variety of medical conditions, including but not limited to peripheral vascular disease. The modality could be therapeutic ultrasound (TUS), and be configured to promote angiogenesis within a patient via stimulation of cavitation and shear stress, among other mechanisms.

Abstract: A syringe pump includes a lead screw, a motor, and a sliding block assembly. The lead screw has threads and the motor is coupled to the lead screw to rotate it. The half-nut housing has a half nut and a barrel cam. The half nut is disposed within the half-nut housing. The half nut has half-nut threads at an end adjacent to the lead screw void. The half nut engages or disengages with the threads of the lead screw. The half nut includes a half-nut cam-follower surface and a half nut slot. The barrel cam is disposed within the half-nut housing and engages with the half-nut cam-follower surface. The barrel cam includes a pin to fit within the half nut slot such that the barrel cam rotates between a first position and a second position to actuate the half nut between the engagement position and the disengagement position, respectively.

Abstract: A method for producing an underpants-type disposable diaper including a stretchable region stretchable at least in one direction in an outer body. The stretchable region is formed by stacking an elastic film between a first sheet layer composed of a nonwoven fabric and a second sheet layer composed of a nonwoven fabric. When the elastic film is stretched in the stretching and contracting direction, the first sheet layer and the second sheet layer are joined via through holes formed in the elastic film at a large number of sheet bond portions arranged at intervals in each of a stretching and contracting direction and a direction orthogonal thereto, and in the sheet bond portions, the first sheet layer and the second sheet layer (20B) are joined at least by a melted and solidified material of the elastic film among the first sheet layer and the second sheet layer.

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: 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: An osmotic food production system designed to produce fruits, vegetables, and freshwater from urine or saltwater. In some embodiments the osmotic food production system also produces oxygen. In some embodiments, the osmotic food production system is portable and capable of transporting on a vehicle capable of space travel. Embodiments of the present invention can be used to address the existing problems of food production, waste disposal/utilization, oxygen generation, and water conservation in an efficient way to allow for prolonged space travel or colonization of distant planets and moons.

Abstract: A wearable infusion port for infusing a fluid includes a first housing that defines an inlet port to receive the fluid, and a second housing coupled to the first housing. The second housing is to be coupled to an anatomy. The wearable infusion port includes a valve assembly fluidly coupled to the inlet port, and the valve assembly is movable from a closed state to an opened state to dispense the fluid. The wearable infusion port includes a cannula assembly extending through the first housing and the second housing, and the cannula assembly includes a cannula fluidly coupled to the valve assembly. The cannula is to be coupled to the anatomy. The wearable infusion port includes a flow sensor fluidly coupled to the inlet port and the cannula. The flow sensor is fluidly coupled upstream from the cannula to observe an amount of fluid received by the cannula.

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: The present disclosure is in the field of gastroretentive dosage forms. A gastroretentive dosage form for extended retention in a stomach is provided.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering therapeutic agents within the GI tract such as neutralizing proteins (NP) particularly antibodies which neutralize interleukins. Many embodiments provide a swallowable device e.g., a capsule for delivering various agents into the intestinal wall (IW). Embodiments also provide agent preparations that are configured to be contained within the capsule, advanced from the capsule into the IW and degrade to release the agent into the bloodstream to produce a therapeutic effect. 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.

Abstract: An elastic film stretchable structure in which an elastic film is stacked between a first sheet layer having air permeability and a second sheet layer having air permeability, the first sheet layer and the second sheet layer are bonded through bonding holes penetrating the elastic film at a number of sheet bonded portions arranged at intervals. A region having the elastic film stretchable structure has a stretchable region that is stretchable in a stretchable direction, and the stretchable region is contracted in the stretchable direction by a contraction force of the elastic film and is extensible in the stretchable direction, and vent holes are formed on the elastic film at sites where the elastic film does not overlap with the sheet bonded portions.

Abstract: The present invention provides a closed loop control method in an artificial pancreas and a system using the method, comprising sensing an activity level of a patient by at least one motion sensor and providing signals to at least one processer; then adjusting a series of related algorithms depending partly on the signals by the processer to provide more accurate and reliable data that is the basis of desirable treatment plans, and sending corresponding instructions by the processer for automatic operations of the artificial pancreas to realize a closed loop control.

Abstract: Embodiments of the present invention are directed to a liquid delivery apparatus. A non-limiting example of the apparatus includes a substrate including a cavity formed in a surface of the substrate. The apparatus can also include a membrane disposed on the surface of the substrate covering an opening of the cavity. The apparatus can also include a hydrophobic layer disposed on the membrane. The apparatus can also include a seal disposed between the membrane and the substrate, wherein the seal surrounds the opening of the cavity. The apparatus can also include an electrode layer coupled to the membrane.

Abstract: This invention relates to an ingestible drug delivery device configured for wireless communication with other ingestible drug delivery devices.

Abstract: An injector has a cartridge door movable between a fully closed position and a fully open position. A power supply is employed to power at least one power-operated component of the injector. A power supply circuit electrically connects the power supply with the at least one power-operated component. An electrically insulated arm is movable from a first state, in which the electrically insulated arm electrically disconnects the power supply from the circuit, to a second state, in which the electrically insulated arm connects the power supply with the circuit to provide power to the at least one power-operated component. The insulated arm is coupled to the cartridge door and initially positioned in the first state thereof in the fully closed position of the cartridge door, whereby movement of the cartridge door out of the fully closed position toward the fully open position moves the arm to the second state thereof.

Abstract: A method of in vivo conditioning of an indwelling sensor to reduce run-in time, (stabilization time) comprising: a) applying a first potential to the sensor and measuring a first current at the first potential; b) applying a second potential to the sensor and measuring a second current at the second potential; c) determining a relationship of the first current measured to the second current measured; repeating a, b, and c until the relationship between the first current measured and the second current measured has stabilized, thereby reducing sensor run-in time.

Abstract: 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.