Abstract: This invention relates to automatic insulin delivery systems and methods of administering insulin. Preferably the systems and methods comprise a predictive feedforward control.

Abstract: Systems, and methods relate to a medical device receiving a treatment parameter operating point within a first operating region defined by a first set of operating points for which automatic incremental adjustment of a parameter in the current operation is permitted. In an illustrative example, incremental adjustment may use artificial intelligence based on patient feedback and sensor measurement of outcomes. Some exemplary devices may receive a request to alter the current treatment parameter operating point to a second treatment parameter operating point outside the first operating region and in a second operating region in a known safe operation zone, bounded by a known unsafe zone unavailable to the user. In the second operating region, some examples may restrict the step size of incremental adjustments requested by the user. Data may be collected for cloud-based analysis, for example, to facilitate discovery of more effective treatment protocols.

Abstract: Methods, systems, and computer readable media for physiology parameter-invariant meal detection are disclosed. According to one system, the system includes at least one processor and a meal detection module implemented using the at least one processor. The meal detection module is configured to receive insulin intake information and blood glucose level information for a user, to detect a meal event using a physiology parameter-invariant meal detection algorithm, and after detecting the meal event, to perform at least one control action associated with insulin management.

Abstract: A liquid medicine administration device for administration of a liquid medicine includes a liquid delivery unit; a control unit configured to control the liquid delivery unit; an activity detection unit; a storage unit configured to store data indicating an amount of the liquid medicine that has already been delivered into the living body; and a calculation unit configured to calculate a residual amount of the liquid medicine in the living body on the basis of (i) the data indicating the amount of the liquid medicine that has already been delivered by the liquid delivery unit into the living body, and (ii) the activity detected by the activity detection unit, and calculate a scheduled delivery amount of the liquid medicine to be administered into the living body on the basis of the residual amount of the liquid medicine.

Abstract: A treatment system configured to treat a condition using a first fluid, the treatment system including a first reservoir configured to store a first fluid, a cannula insertion mechanism configured to insert a cannula into a user, the cannula in fluid communication with the first reservoir, a first rotatable shaft member configured to pull a first plunger disposed within the first reservoir and coupled to the first rotatable shaft member by a first flexible member, and a drive mechanism having a first expandable member configured to move from a first position to a second position to rotate the first rotatable shaft member to deliver the first fluid to the user through the cannula.

Abstract: An autoinjector system for injecting a fluid medicament into a patient includes a re-usable autoinjector, and a disposable cassette loaded with a hypodermic syringe pre-filled with a fluid medicament. The autoinjector includes a first motor for injecting a needle of the hypodermic syringe into the patient and a second motor for expelling the fluid medicament from the syringe.

Abstract: Described herein are assisted syringes. The syringes provide a higher force to the plunger tip than the extrusion force applied to the plunger. The assisted syringes can be used to inject or extrude viscous materials.

Abstract: A medicament delivery device (10) comprising a syringe (12) having a barrel with an open end, and an axially moveable stopper (18) received in the barrel separating a first chamber axially forwards of the stopper from a second chamber axially rearwards of the stopper. The medicament delivery device further including an expandable drive housing (24) arranged to receive a propellant from a propellant source (36) for providing a vapour pressure, the expandable drive housing having a narrow channel in fluid communication with the second chamber. The expandable drive housing is expandable upon receiving propellant from the propellant source and, upon expansion, causes forward axial movement of the syringe.

Abstract: The invention relates to a needleless injection device or a device for the needleless injection of a substance into a tissue or body, with which device a substance, in particular an active substance, can be injected by means of high pressure. A device according to the invention comprises a chamber (11) containing a pyrotechnic material, wherein the chamber has a fixed double membrane (13, 15) at a discharge opening, wherein the skin-side membrane (15) of the double membrane (13, 15) is provided with a substance application (25). A successful injection lies in the fact that sufficient substance is introduced into the body through the tissue barrier or body barrier, in particular such as the skin.

Abstract: A free-jet dosing system for administering a fluid into or under the skin having a micropump and a nozzle arranged on the outlet side. The micropump has an inlet and an outlet and is configured to transport a fluid from the inlet to the outlet and to generate a blocking pressure of at least 20 bar at the outlet. The nozzle is configured to output the fluid output at the outlet as a free jet at a fluid pressure so that the fluid of the free jet may be injected into the skin.

Abstract: A syringe packaging system that includes a tube and a cap for enclosing a pre-filled syringe is disclosed. The tube includes a tube cut flange and the cap includes a cut skirt. With a syringe barrel contained within the tube, a syringe barrel cut flange is aligned with the tube cut flange. With the pre-filled syringe enclosed within the tube and the cap, the cut skirt of the cap surrounds the syringe barrel cut flange. In one embodiment, a film is securable to a portion of the tube and a portion of the cap to connect the tube and the cap with the pre-filled syringe enclosed within the cap and the tube.

Abstract: A drug delivery system for injecting a medicament includes a housing, a container configured to receive a medicament including a stopper configured to move within the container and a closure, a needle in fluid communication with the container, a spacer configured to be engaged with the stopper, a first plunger, a first spring configured to bias the first plunger in an axial direction, second plunger disposed about the first plunger, a second spring configured to bias the second plunger in an axial direction. The first plunger is configured to move the spacer and the container relative to the housing via the first spring to establish fluid communication between the container and the patient needle, and the second plunger is configured to move the spacer and the stopper relative to the container via the second spring.

Abstract: The present invention concerns a syringe assembly comprising a hollow tubular syringe body, having a proximal end and a distal end, a plunger rod, axially movable in the syringe body between an initial position and a final position. The assembly also includes a support transversally stiff for supporting the plunger rod, the support having a distal end and a proximal end respectively transversally fixed to the syringe body and to the plunger rod, the proximal end of the support being movable with respect to the syringe body.

Abstract: A medicament delivery device includes a body having a proximal end and a distal end, in turn comprising a distal housing part, and a medicament container holder, adapted to receive a medicament container; a dose setting drum for setting a dose when rotated in a first direction and for delivering a dose when rotated in a second direction, and a drive drum sleeve selectively operably connectable to a piston plunger for delivering a dose.

Abstract: An injection system, including an injector having a dispensing mechanism configured to dispense a medicament, and a ready-to-use indicator. The ready-to-use indicator includes a controller configured to interact with the ready-to-use indicator and an audio and/or visual indicator, a temperature sensor, and a temperature analog having similar thermodynamic properties of the medicament. The temperature sensor is configured to detect a temperature of the temperature analog which represents the dynamic temperature of medicament as the medicament is heated or cooled. The temperature sensor is configured to communicate the detected temperature to the controller and to alert the controller when a preset temperature is reached. The ready-to-use indicator is configured to alert a user when the preset temperature is reached, signifying the medicament is thermally ready to be delivered by the dispensing mechanism. The audio and/or visual indicator is configured to display indicate one or more notifications to the user.

Abstract: A spring assisted drug delivery device comprising: a housing; a piston rod having a longitudinal axis, a distal end and a proximal end that is axially movable in a distal direction relative to the housing, a mid-body fixed inside of the housing and coupled to the piston rod in such a manner that the piston rod is axially movable in a distal direction relative to the mid-body, and wherein a preloaded spring is operatively coupled to the piston rod in such a manner that the spring is released and the stored force in the spring supports driving the piston rod in the distal direction during a dose administration step.

Abstract: The present disclosure relates to a safety mechanism (5) for a push-off cap of a medicament delivery device. The safety mechanism (5) includes a cap (9) and an actuator assembly (11). The cap (9) has a through-opening (9b) and is configured to be mounted to the proximal end of a medicament delivery device. The actuator assembly (11) is configured to be received by the cap (9), and extend proximally from the cap (9). The actuator assembly (11) is linearly displaceable relative to the cap (9), from a first position in which the actuator assembly (11), to a second position in which the actuator assembly (11) is displaced in the distal direction and received further by the cap relative to the first position. The actuator assembly (11) includes a guide structure configured to guide linear displacement of the actuator assembly (11) relative to the cap (9), a proximal top member (11c) and a lock structure (11d).

Abstract: A safety needle device is disclosed having a hub, needle cannula, housing, tether, retractable sleeve, locking member and spring element. The tether is movably disposed in the housing, the tether having a slot with an enlarged first guide path and a narrowed second guide path extending distally from the enlarged first guide path. The retractable sleeve is configured to move from an initial position to partially expose a distal tip of the needle cannula, a retracted position to fully exposes the needle cannula, and an extended position to fully cover the distal tip of the needle cannula. The proximal movement of one or more protrusions on the retractable sleeve, rotates the tether to move the at least one or more protrusions from the enlarged first guide path of the tether to the narrowed second guide path of the tether, this rotation activating the device.

Abstract: A safety needle device is disclosed having a hub, needle cannula, housing, tether, retractable sleeve, locking member and spring element. The tether is movably disposed in the housing, the tether having a slot with an enlarged first guide path and a narrowed second guide path extending distally from the enlarged first guide path. The retractable sleeve is configured to move from an initial position to partially expose a distal tip of the needle cannula, a retracted position to fully exposes the needle cannula, and an extended position to fully cover the distal tip of the needle cannula. The proximal movement of one or more protrusions on the retractable sleeve, rotates the tether to move the at least one or more protrusions from the enlarged first guide path of the tether to the narrowed second guide path of the tether, this rotation activating the device.

Abstract: An infusion pump system is disclosed. The system includes at least one infusion pump, a companion device, the companion device in wireless communication with the infusion pump, and a user interface on the companion device, the user interface adapted to receive textual input.

Abstract: The present invention relates to a recording unit arranged to be connected to a medicament delivery device, which recording unit comprises a generally elongated housing (10; 90) having dimensions so as to enclose at least a distal part of the medicament delivery device (50), the recording unit comprising a recording mechanism (60; 120) provided with an electronic circuit (64; 134) and arranged at a distal end inside said housing, said electronic circuit comprising an activation element (40; 108) operably arranged to activate said electronic circuit (64; 134) when said medicament delivery device is inserted in said housing, said electronic circuit (64; 134) comprising sensor elements (80; 140) capable of sensing status changes of said medicament delivery device during use.

Abstract: An apparatus for generating aerosol comprises a capillary tube comprising at least one bend, fluid inlets, and an outlet along the bend. The capillary tube is heated to a temperature sufficient to volatilize fluid in the capillary tube, such that the volatilized fluid discharges from the outlet to form an aerosol.

Abstract: A composite wick is provided for use in a micro-vaporizer having a fluid reservoir and a heating element. The composite wick comprises a wick body positionable so that its upstream surface is in fluid communication with the fluid reservoir and the downstream surface is disposed in opposition to a surface of the heating element. The wick body comprises at least one base wick structure having a plurality of tortuous passages that collectively provide a capillary effect to draw fluid from the reservoir and transport it toward the downstream surface. The wick body further comprises an active material positioned within the wick body so that vaporizable fluid drawn through the wick body contacts and interacts with the active material. The active material is selected to impart a desired characteristic to the vaporizable fluid.

Abstract: A dose indicator or dose counter is disclosed which includes an indexable first display unit indexable about a first display axis, an indexable second display unit indexable about a second display axis, the second display axis being transverse to the first display axis, and a chassis comprising a chassis frame, a displacement portion comprising a drive means to engage the first display unit, and at least one hinge means directly or indirectly connecting the displacement portion and chassis frame. The drive means is preferably configured to index the dose indicator. The dose indicator/counter has a small number of components yet is effective, reliable and compact.

Abstract: A spacer chamber for an inhaler includes a housing chamber, a mouthpiece arranged on a side of the housing chamber, and a connecting means arranged on the housing chamber opposite to the mouthpiece to connect the inhaler. A lever means is held on the housing chamber which is movable to two positions and has an active surface that is arranged in such a manner that the active surface can act on an activation element of the inhaler in any one of the positions, if the inhaler is connected to the connecting means. The lever means includes a lever element and a lever carrier for carrying the lever element, which is fastened to the housing chamber.

Abstract: A spacer device for use with a metered dose inhaler (MDI). The spacer device comprises an aerosol chamber for holding the aerosolized medication sprayed from the MDI. According to one particular design, the aerosol chamber has a forward shell, a rear shell, and an extendable barrel in between. The extendable barrel comprises a flexible plastic sheath that is supported by a coiled wire spring. The spacer device further comprises a mounting bracket to hold the MDI. The mounting bracket holds the MDI such that the spray outlet of the MDI is mated with the aerosol chamber. Also, the assembly is configured such that the aerosol chamber is aligned substantially parallel to the actuator boot of the MDI. During use, the aerosol chamber is folded downward away from the MDI. The aerosol chamber is then extended outward to increase its volume.

Abstract: A breath actuated metered dose inhaler may include a canister fire system configured to fire a medicament containing canister in response to patient inhalation. The canister fire system may include a pneumatic force holding unit and having a rest configuration in which a metering valve of the canister is in a refill configuration; a prepared configuration in which a canister actuation force is retained by the pneumatic force holding unit and the canister fire system is actuatable by patient inhalation induced airflow; and a fire configuration in which the metering valve is in a dose delivery position. When in the prepared configuration, the force retained by the so pneumatic force holding unit may be reduced by less than about 6% over a period of 5 minutes, preferably less than about 3% over a period of 5 minutes.

Abstract: A respiratory apparatus includes components to protect operations of the apparatus. For example, in some versions, the apparatus may include a power supply, a motor powered by the power supply, and a transient absorption diode circuit between the motor and the power supply. The transient absorption diode circuit may be configured to absorb energy generated by the motor from rotational kinetic energy. Such absorption may serve to protect the components of the apparatus. In some examples, the apparatus may include a fault mitigation integrated circuit (IC). The IC circuit may be included in the respiratory apparatus to detect one or more faults based on physical and system parameters of the apparatus. The fault mitigation integrated circuit may generate a signal to stop the motor based on the detected fault, and may digitally communicate with a processor information about the detected fault.

Abstract: A patient circuit of a ventilation system, such as a non-invasive open ventilation system, wherein the patient circuit comprises a nasal pillows style patient interface that incorporates at least one “Venturi effect” jet pump proximal to the patient. The patient circuit further comprises a pair of uniquely configured 3-way connectors which, in cooperation with several uniquely configured tri-lumen tubing segments, facilitate the cooperative engagement of the patient interface to a ventilator of the ventilation system.

Abstract: A patient interface for sealed delivery of a flow of air to ameliorate sleep disordered breathing may include: a seal-forming structure to form a pneumatic seal with the entrance to the patient's airways; a positioning and stabilising structure to maintain the seal-forming structure in sealing contact with an area surrounding the entrance to the patient's airways; a plenum chamber pressurised at a pressure above ambient pressure in use; a connection port for the delivery of the flow of breathable gas into the patient interface; and a device positioned within a breathing chamber defined, at least in part, by the seal-forming structure and the plenum chamber, wherein the device divides the breathing chamber into a posterior chamber and an anterior chamber, and wherein the device comprises a plurality of apertures such that turbulence of the air in the posterior chamber is less than turbulence in the air in the anterior chamber.

Abstract: A patient interface has a single loop headstrap and a mask for covering at least the nostrils of the user. The single loop headstrap extends from the mask at either end. A short length of supple conduit is coupled to the mask by a swivel or ball joint to allow rotation of the conduit relative to the mask through different angles and orientations.

Abstract: An air delivery conduit for conveying breathable gas from a positive airway pressure device to a patient interface includes a tubular wall structure constructed from a textile material. A reinforcing structure may be provided to the wall structure that is structured to prevent kinking or collapsing of the wall structure. The wall structure may include a warp having a plurality of lengthwise textile warp threads arranged in a circle and a weft having a textile weft thread that is woven through the warp threads.

Abstract: An oxygen concentrator comprises a product tank that is fluidly coupled to at least one sieve bed, and a product gas accumulator tank that is fluidly coupled to the product tank via a first conduit and to an outlet port via a second conduit, wherein the first conduit and the second conduit are disposed to allow at least a portion of product gas to flow from the product tank to the outlet port.

Abstract: An undermold coupling to couple a hose to a hose fitting includes: a tubular portion to be inserted into a hose interface of the hose fitting; threads formed on an inner surface of the tubular portion to engage a support helix on an end of the hose as a set of threads; and a first grating comprising a first plurality of elongate portions to intermesh with a corresponding second plurality of elongate portions of a second grating of the hose interface, wherein the first plurality of elongate portions extend into a second plurality of slots defined by the second plurality of elongate portions, and the second plurality of elongate portions extend into a first plurality of slots defined by the first plurality of elongate portions.

Abstract: A supplemental oxygen delivery system is described in which Aerosol is delivered into a housing 10, 20, which sits in the circuit from the supplemental oxygen supply and optional humidifier. The supplemental oxygen passes through this chamber 10, 20 in which the aerosol is located, and collects the aerosol transporting it to a patient via a nasal cannula 3 or a face mask 4. An aerosol generator 9 is mounted to the housing 10, 20 and delivers aerosol into an oxygen stream 13 flowing between an inlet 14 and an outlet 15 of the housing 10. The housing 10 also has a removable plug 16 in the base 17 thereof for draining any liquid that accumulates in the housing 10. There is no disruption of oxygen delivery to patients using nasal cannulas who currently have to use a separate face-mask when receiving nebulized medication.

Abstract: Lung tumors are treated in-vitro and in-vivo by an apparatus and method for operating the apparatus wherein the lung being treated is made receptive to ultrasound in order to allow the ultrasound waves to be guided through the healthy lung tissue to the tumor tissue in an optimized manner for the use of FUS therapy.

Abstract: A humidifier for an airway pressure support system, includes a base, a number of side walls extending from the base, and a top wall provided opposite the base, wherein the base, the number of side walls, and the top wall are made from an elastomeric material and at least partially define an internal chamber for receiving and holding a liquid. The humidifier also includes a plurality of support structures provided on or within the humidifier, each support structure extending along at least the number of side walls, wherein the humidifier is structured to collapse from an initial, expanded condition to a collapsed condition when a compressive force is applied to the top wall in the initial, expanded condition and to automatically return to the initial, expanded condition when the force is removed.

Abstract: A pressure support system includes a pressure generating device, an airflow path, and a control system. The control system is structured to determine a first measurement indicative of an amount of water vapor in the airflow path or an amount of condensation in the airflow path and generate a number of control signals structured to control an environmental control device structured to control an environmental parameter in an environment including the pressure support system, wherein the control signals are generated based on at least the first measurement and are configured to cause the environmental control device to adjust the environmental parameter in a manner that will reduce a degree or a likelihood of rainout in the airflow path, and transmit the control signals to the environmental control device so that it may be controlled to reduce the degree or likelihood of rainout.

Abstract: The present invention discloses ventilation apparatus, comprising a casing with a first vent and a second vent, a fixed spacer disposed within the casing, and a movable spacer in operative connection with a power mechanism. Also discloses herein are methods for ventilating a subject, by synchronously providing a positive pressure ventilation and a negative pressure ventilation using the ventilation apparatus described herein.

Abstract: A valve with an internal member is disclosed which allows exhaled carbon dioxide to escape from a breathing circuit when the circuit gas pressure drops below a threshold pressure. The valve operates by occluding one or more ports under a relatively high pressure and opening the one or more ports under a relatively low pressure. The internal member is attached to the body of the valve at two or more locations on the internal member. The internal member moves in a direction perpendicular to the gas flow through the valve.

Abstract: Introduced are methods and systems for an adjustable bed device configured to: gather biological signals associated with multiple users, such as heart rate, breathing rate, or temperature; analyze the gathered human biological signals; and heat or cool a bed based on the analysis.

Abstract: A context-sensitive soundscape is generated by receiving a first identifier for identifying a target cognitive state for a user, and a second identifier for identifying a user cohort for the user. A present context is determined for the user. A machine-learning procedure is performed to map the target cognitive state to a set of audio output characteristics based upon the identified user cohort and the determined present context. An audio output is generated to create the context-sensitive soundscape that includes the set of audio output characteristics.

Abstract: An embodiment of the present invention provides for an elongated medical device with a hypotube backbone running through the device, and a spiral lumen spiraled around the backbone along the length of the backbone. The backbone may be formed from a nitinol alloy for increased bendability without compromising axial stiffness. The device may also incorporate a jacket around the hypotube and spiral lumen formed using either melting, molding, bonding, or casting. The spiral lumen may be configured to accommodate a variety of uses, including actuation members (e.g., pull wires), tools, and means for aspiration, irrigation, image capture, and illumination. Additionally, the present invention provides a method for constructing an elongated medical device with a hypotube backbone running through the device, and a spiral lumen spiraled around the backbone along the length of the backbone.

Abstract: Hub assemblies that include a first hub and a second hub can be used to selectively couple and uncouple medical device components to and from each other without rotating the first hub relative to the second hub. Some hub assemblies can include a dilator that includes a dilator hub and an introducer sheath that includes an introducer sheath hub.

Abstract: Certain aspects relate to a handle mechanism that permits control of linear motion of a shaft secured within the handle via two different interfaces for actuating the linear motion. In some aspects, a rotational interface can allow for fine control linear positioning of the shaft, for example by allowing a user to rotate the rotational interface to extend or retract the shaft. In some aspects, a plunging interface can enable a faster linear motion, for example by implementing a biasing mechanism that releases to drive rapid linear motion.

Abstract: In one representative embodiment, a steerable catheter device comprises a shaft comprising a proximal portion, a distal portion, and a pull-wire lumen that extends at least partially through the proximal and distal portions. A pull wire extends through the pull-wire lumen and has a proximal end portion and a distal end portion, wherein the distal end portion of pull wire is fixed to the distal end portion of the shaft. An adjustment mechanism is operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft. An axially non-compressible pull-wire sleeve extends co-axially through the pull-wire lumen and over the pull wire.

Abstract: An endovascular guide catheter includes a guide tube and a handle. The flexible guide tube has a distal end portion configured to deflect via actuation of a pull wire. The handle is coupled to the guide tube and comprises a steering assembly configured to actuate the pull wire to deflect the distal end portion of the guide tube. The steering assembly can comprise a stationary rack, a gear, a reel, and a slider. The gear engages the rack and the reel is coupled to and configured to rotate with the gear. The pull wire is coupled to the reel such that rotation of the reel causes the pull wire to wind or unwind around the reel. The slider is adapted for translation relative to the rack. Translation of the slider translates the reel relative to the rack and rotation of the gear along the rack rotates the reel.

Abstract: Devices, systems, and methods are disclosed that help deliver catheters or other medical devices to locations within a patient's body. The device comprises a transporter catheter having a proximal end and a distal end, at least a first balloon located at the distal end, substantially at a tip of the transporter catheter, and at least a second balloon located between the distal end and the proximal end of the transporter catheter. The first balloon is an orienting balloon and the second balloon is an anchor balloon. The transporter catheter may include a single lumen or more than one lumen. The transporter catheter may include a shaft comprising an inner layer and an outer layer, the inner layer may be made of a material more flexible than the material of the outer layer. The outer layer may also comprise a braided wire assembly, said braided wire assembly being formed by braiding a plurality of flat wires or circular wires. The braided wire assembly may wrap around the inner layer.

Abstract: A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

Abstract: A delivery sheath includes an elastic outer tubular layer and an inner tubular layer having a thick wall portion integrally connected to a thin wall portion. The inner tubular layer can have a compressed or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the compressed condition with the sheath reassuming its smaller profile. The sheath may also include selectively placed longitudinal rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion and collapse, thereby reducing the push force needed to advance the implant through the sheath's lumen.