Abstract: An infusion set is disclosed that includes an inserter including an inserter housing having at least one flexible arm for holding an infusion set in a single axial position prior to insertion of at least a portion of a cannula of the infusion set, the inserter housing having a surface for contacting the patient's skin. The inserter also includes a movable plunger disposed within the inserter housing for releasing the infusion set from the inserter housing, impacting the infusion set, and imparting momentum to the infusion set to insert the cannula into the patient's skin. The inserter additionally includes a biasing element biasing the plunger toward the activated position.

Abstract: An infusion device. The infusion device includes a top portion comprising an introduction needle, and a bottom portion comprising a cannula, the top portion removably attached to the bottom portion, wherein the introduction needle is used to insert the cannula, and wherein after insertion, the top portion is removed from the bottom portion.

Abstract: A priming system including a resilient chamber having flexible walls and a first check valve in a first fluid pathway between the resilient chamber and a fluid reservoir such that a fluid flows through the first check valve only in a direction from the fluid reservoir toward the resilient chamber and the fluid returns to the fluid reservoir through a second fluid pathway between the resilient chamber and the fluid reservoir upon compression of the walls of the resilient chamber.

Abstract: A valve for a tubing kit used provides a resilient element naturally moving to a closed state to reduce opportunity for inadvertent leakage of medicine and to reduce effort required by healthcare personnel to seal the fluid line. In one embodiment the resilient element is a spring serving to compress the walls of IV tube in the closure and in a second embodiment the resilient element is an elastomeric member that is deformed to provide an opening to allow passage of fluid through the fluid line.

Abstract: A model-based control scheme consisting of either a proportional-integral-derivative (IMC-PID) controller or a model predictive controller (MPC), with an insulin feedback (IFB) scheme personalized based on a priori subject characteristics and comprising a lower order control-relevant model to obtain PID or MPC controller for artificial pancreas (AP) applications.

Abstract: Systems and methods for delivering a medication to a person experiencing an emergency medical event without requiring intervention or action on the part of the person. A device encases a reservoir of medication and a delivery mechanism. Sensors in the housing sense a physical attribute of the person and circuitry monitors information collected by the sensors to determine if the person is experiencing a severe medical condition or event based on the information. An input device on or in the housing, such as a button, may be used or activated by the person if the detected condition or event is a false positive to cancel further action. If the system does not include the button or if the user does not press it in time, the system activates the delivery device and injects the medication into the person.

Abstract: The present disclosure describes embodiments of a patient monitoring system and methods that include the measure and display of hemoglobin statistics. In an embodiment, total hemoglobin trending is displayed over a period of time. Statistics can include frequency domain analysis, which may be unique for each patient monitored. The total hemoglobin trending and/or statistics can further be used to help control the treatment of a patient, such as being used to control IV administration.

Abstract: Described is an autoinjector comprising of a case, a motor adapted to rotate a drive gear, and a curvi-linear plunger adapted to mate with the drive gear. The plunger includes a distal end with a resilient flange, which in a non-deflected state, abuts a proximal collar of a syringe, and, in a deflected state, advances through the proximal collar and engages a stopper in the syringe.

Abstract: An auto-injector for administering a dose of a liquid medicament includes an elongate case arranged to be held by a user, a tubular chassis telescopable in the case and biased against the case so as to protrude from the case, a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, and a trigger button which is initially abutted against the case thus preventing actuation. The chassis is arranged to translate into the case against the bias when pressed against an injection site. The trigger button is initially coupled to the chassis such that the trigger button emerges from the case when the chassis is being pressed against the injection site to allow actuation by being translated towards the case for starting an injection cycle.

Abstract: A disposable injector comprising a housing, a spring-loaded piston-actuating plunger arranged in the housing and able to be released by a trigger unit. A cylinder-piston unit comprising a cylinder and a piston that is positioned at a distance from the piston-actuating plunger. A closed layer made on an elastically-deformable material surrounds the piston-actuating plunger in at least some sections and projects beyond same in the trigger direction, resulting in a disposable injector that will not alarm a patient during use thereof.

Abstract: A needleless syringe comprises an enclosing unit for an injection objective substance, a pressurizing unit for the injection objective substance, a discharge unit having a flow passage for allowing the injection objective substance to flow therethrough so that the injection objective substance is discharged from an open end of the flow passage to an injection target area, the open end being formed so that an area thereof is smaller than a flow passage area of the enclosing unit, and a minute pore unit including a minute pore having a flow passage area smaller than the area of the open end of the discharge unit and which is arranged on an outer side of the open end so that the injection objective substance discharged from the open end passes through the minute pore and arrives at a side of the injection target area.

Abstract: An apparatus for injectate delivery includes a cartridge, a linear actuator, a rotary motor mechanically coupled the actuator, and a controller coupled to the motor. The controller controls a linear motion of the actuator by controlling an electrical input supplied to the motor in a first interval during which the motor is stationary with the linear actuator engaged with the cartridge to displace an injectate in the cartridge, a second interval following the first interval during which the controller accelerates the motor from stationary to a first speed selected to create a jet of the injectate from the cartridge with a velocity sufficient to pierce human tissue to a subcutaneous depth, a third interval during which the controller maintains the motor at or above the first speed, and a fourth interval during which the controller decelerates the motor to a second speed to deliver the injectate at the subcutaneous depth.

Abstract: A dispensing device (1) for dispensing a fluid, preferably an injection syringe. The device comprises a main body (2) which has a longitudinal axis (A) and has a receiving space (3) for receiving the fluid, and a connection channel (4) communicates with the receiving space. The connection channel opens on a valve face (5) of the main body. The device comprises a movable flow control element (6) arranged on the main body. The flow control element has one or more flow channels (7) which open on a valve face (8) of the flow control element. The connection channel of the main body and the flow channels of the flow control element are fluidically connected to each other by relative movement of main body and flow control element. A sealing element (10) is arranged between the valve face of the main body and the valve face of the flow control element.

Abstract: The invention relates to a driving device for an injection device for administration of a liquid drug. The driving device has inter alia a rotary member, rotation of which relative to the housing causes a pretensioned spring to move a propulsion member in the dispensing direction, and a coupling which is closed and is opened by pressing of an actuating member, the opened coupling enabling the rotation of the rotary member in a first direction of rotation, and the actuating member being coupled to the rotary member such that pressing of the actuating member causes the rotary member to rotate already when the coupling is still closed.

Abstract: An injection device includes a housing, a dosing member held so as to be rotatable and fixed in the housing and an injection sleeve held so as to be rotationally fixed in relation to the housing and displaceable therein. A latching unit of the injection device is configured to act between two components thereof which, during setting of an amount of injection fluid to be dispensed, move relative to one another. A set amount of injection fluid is unequivocally assigned to each relative position of the two components.

Abstract: The disclosure provides a supplemental device configured for removable attachment to a medicament injection device. The supplemental device includes a display, a processor arrangement, at least one memory, and an image-capturing component. The processor arrangement is configured to cause the supplemental device to: (i) use the image capturing component to capture successive images of a medicament dosage indicated by a medicament dispensing device, (ii) successively display the captured images on the display, (iii) perform optical character recognition on captured images to identify medicament dosage indicated by the medicament dispensing device when the images were captured, (iv) and make a non-transient record of delivered dosage information in the at least one memory based at least in part on the identified medicament dosage.

Abstract: A medication injection device includes a plunger head having an elastomer housing that fits within a barrel. The plunger head includes an ultrasonic transducer that sends and receives ultrasonic signals in the form of ultrasonic waves, an antenna, a microcontroller that interfaces with the ultrasonic transducer and the antenna, and a power source that powers the microcontroller and the ultrasonic transducer. The ultrasonic transducer, the antenna, the microcontroller, and the power source may be at least partially encapsulated in the elastomer housing. The microcontroller may be programmed to measure echo times of the ultrasonic waves, compare consecutive echo times, and apply a compensation factor. The microcontroller may also be programmed to calculate a volume of medication dispensed from the barrel.

Abstract: An apparatus includes a syringe housing and a plunger slidably received within the syringe housing. A plunger magnet is secured to the plunger. A potentiometer housing is fixed to the syringe housing and includes a potentiometer disposed therein. A wiper magnet is also disposed within the potentiometer housing. Movement of the plunger magnet causes a corresponding movement of the wiper magnet.

Abstract: An assembly for a drug delivery device, comprising a housing having a proximal end and a distal end, a piston rod and an indicator. The piston rod is adapted to be displaced distally with respect to the housing away from a proximal start position and towards a distal end position for delivering a drug. The indicator is adapted for indicating at least two different operation conditions of the assembly, the indicator being moveable with respect to the housing from a first indication position for a first condition of the assembly into a second indication position for a second condition of the assembly. The piston rod and the indicator are configured to mechanically interact for converting movement of the piston rod into movement of the indicator. A first detent is provided which is configured to releasably secure the indicator in the first indication position such that movement into the second indication position is allowed.

Abstract: Apparatus is described for administering a substance to a subject. A vial contains the substance and a stopper is disposed within the vial and is slidably coupled to the vial. A first threaded element is (a) rotatable with respect to the vial and (b) substantially immobile proximally with respect to the vial during rotation of the first threaded element. A second threaded element is threadedly coupled to the first threaded element. At least a distal end of the second threaded element is substantially non-rotatable with respect to the vial, and the distal end of the second threaded element defines a coupling portion that couples the second threaded element to the stopper. The first threaded element, by rotating, linearly advances the stopper and at least the distal end of the second threaded element toward a distal end of the vial. Other embodiments are also described.

Abstract: A needle assembly includes: a needle comprising a hollow needle tube, a needle tip at a distal end of the hollow needle tube, and a cutting face disposed adjacent to the needle tip; and a needle hub that includes a tip and a base end, and holds the needle at the needle tip. The needle hub includes a needle tip side end face from which the needle tip projects. An outer diameter of the needle is within a range of 0.15 mm to 0.20 mm, inclusive. A projection needle length extending from the needle tip side end face to the needle tip is within a range of 0.50 mm to 1.25 mm, inclusive. A needle body length extending from the needle tip side end face to a proximal end of the cutting face in within a range of 0.10 mm to 0.70 mm, inclusive.

Abstract: A syringe for injecting a drug solution into an upper layer of skin includes an injection needle having a needle hole communicating from a needle tip to a needle proximal end, the injection needle having a blade face at the needle tip; and a needle hub having a distal end portion and a proximal end portion, the needle hub holding the injection needle at the distal end portion. The needle hub has a needle tip side end face, and the needle tip protrudes from the needle tip side end face. A protruding needle length of the needle tip from the needle tip side end face is 1.15 mm±0.1 mm, and a blade face length of the blade face along an axis of the injection needle is 0.60 mm±0.15 mm.

Abstract: A system for priming an infusion pump is disclosed. The system includes a priming cap including a septum and configured to matably connect with a male part comprising a needle and attached to a length of tubing for fluid, wherein when matably connected with the male part, the priming cap occludes the tubing.

Abstract: A device and method for dispensing a liquid with a gas includes an instrument having a cannula and a low-pressure tip. The low-pressure tip includes a tip housing that at least partially defines a high pressure chamber. A distal wall of the tip housing includes an aperture in fluid communication with the high pressure chamber. The low-pressure tip also includes a tube and a gas flow channel. The tube fluidly communicates liquid at a relatively low pressure from the cannula through the first aperture. The gas flow channel fluidly communicates gas from the cannula at a relatively high pressure and to the high pressure chamber for discharge from the aperture. The tube and aperture are adapted to dispense the liquid and the gas in order to create a low pressure zone distal of the tube to dispense droplets of the liquid.

Abstract: The invention relates to an inhalation device for powdered drugs to be received by a patient by an inhalation-caused air stream, comprising at least one powder reservoir, metering means for repeatedly metering a powder dose from the reservoir, a transportation mechanism for moving said metering means from a filling position for receiving a powder dose into an emptying position for releasing said powder dose into a powder channel, at least one activating device for manual operation by the patient, said activating device being operatively connected to said transportation mechanism such that upon operation a single powder dose is being metered, said activating device comprising a dosage key (5) acting on said transportation mechanism when pressed by the patient. The inhalation device further comprises an advancing mechanism for advancing a counter means each time the inhalation device has been activated by the patient so that a powder dose has been released into the powder channel.

Abstract: A vaporizer can include a reservoir for holding oil, a chamber for holding vapor, a feeder for feeding oil from the reservoir to the chamber, and a heater for heating oil. A feeder can be configured to feed oil from the reservoir to the chamber by capillary action. A vaporizer can include a plug sealingly coupled to the reservoir and configured to slide relative to at least a portion of the reservoir. A heater can include at least one of a laser, a resistance heater, a wire, a coil, a wire at least partially disposed in a housing, and a combination thereof. A vaporizer can include a controller and can be configured to heat a heater to a first temperature for a first time period, reduce the temperature of the heater, and maintain the heater at a second temperature for a second time period.

Abstract: A nasal clip and/or dilator which is U-shaped having protruding wider spherical/spheroid holders at each end of the U is designed to be placed such that each spherical holder is in a nostril. The U-shaped clip can press against the columella and each holder against the septum. Inside each holder is a scented piece, such as a plastic ball or cylinder with aromatic compounds there-in which exit from the surface of the respective scented piece. To facilitate the scent escaping from the scented piece and into the nose, each holder has portals such as around the circumference thereof and/or on opposite sides thereof, transverse to the “U” of the holder.

Abstract: A catheter mount is configured to be attached to a respiratory apparatus. The catheter mount includes a plurality of ports in fluid communication with each other. The plurality of ports include an interface poll configured to connect to an interface tube, a conduit port configured to connect to a conduit tube, and at least one suction port configured to allow insertion of a suction catheter. The at least one suction port can be positioned to allow the suction catheter, when inserted, access to both the interface port and conduit port.

Abstract: An add-on device and method for an Endo-Tracheal Tube (ETT), the add-on device including a lengthy body having a major arc-shaped cross section sized and shaped to tightly fit over an ETT, at least one longitudinal cavity passing along the lengthy body, including a distal suction cavity ending with a suction inlet at a distal end of the lengthy body; and a distal suction outlet channel extending from a proximal end of the lengthy body, the channel is a continuous extension of the distal suction cavity and configured to provide suction to the distal suction cavity. The add-on device senses moisture at a distal end of the add-on device, and in case of detection of excessive wetness, provides suction to the distal end of the device through a cavity passing along the device, the suction is provided via a suction outlet channel extending from a proximal end of the device.

Abstract: An oropharyngeal airway for use during diagnostic and surgical procedures, comprising a body with a proximal and a distal end. The distal end is sized for insertion through a protective bite block disposed in a patient's mouth. Both sides of the distal end are tapered to a curved distal edge. A flange is transversely opposed at the proximal end, preventing the proximal end from moving through the protective bite block and into the patient's mouth. An elliptically-arched channel in the shape of a lingual contour extends from the proximal end to the distal end. The channel includes a pair of tapered upstanding walls that guide the passage of a surgical instrument through the space between them. The oropharyngeal airway can be constructed of recyclable or biodegradable materials and is compatible with protective bite blocks of all sizes.

Abstract: The present invention relates generally to an oral device, or mouthpiece, for delivering a fluid to the mouth or oropharynx of a user. In one embodiment, the oral device includes an intraoral portion, an extraoral portion, and an auxiliary support device that serves to stabilize the oral device. In various embodiments, the auxiliary support device may be configured with ear loops, a support band, a support frame and/or a support member. The intraoral portion generally includes at least one outlet port through which the fluid is delivered to the oral cavity or oropharynx. A method of dispensing a fluid using the oral device is also provided.

Abstract: Provided is a gas storing mask which, with a simple configuration, allows a reduction in feeling of discomfort given to a patient. An oxygen delivering mask (1a) includes a first sheet (2) and a second sheet (3), oxygen supplied from outside the oxygen delivering mask (1a) being stored in a gas storing part (4) formed between the first sheet (2) and the second sheet (3).

Abstract: A foam cushion assembly for a patient interface, the foam cushion assembly being adapted to couple with a patient interface frame, the cushion assembly comprising a substantially above the nose seal portion and a mouth seal portion, wherein the cushion assembly comprises a foam cushion arranged to form with the frame a common plenum chamber for sealing about the nose and mouth.

Abstract: An interface assembly comprises a nasal mask that includes a seal having a rolling portion. The rolling portion of the seal rolls over a portion of a clip that secures the seal to a frame. The frame has a ball and socket connection to a connector. The connector comprises an elbow having integrally formed exhaust holes and a swivel.

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: A nasal cannula assembly includes a breathing gas supply lumen assembly splitting into a first inspiratory gas lumen and a second inspiratory gas lumen. An inspiratory gas nasal end portion is in fluid communication with the first inspiratory gas lumen and a second inspiratory gas lumen. The inspiratory gas nasal end portion has a pair of nasal prongs extending outwardly therefrom. An expiratory gas assembly splits into a first expiratory gas lumen and a second expiratory gas lumen. An expiratory gas nasal end portion is in fluid communication with the first expiratory gas lumen and a second expiratory gas lumen. A passage is disposed across the inspiratory nasal end portion from the pair of nasal prongs. The passage provides fluid communication between the inspiratory nasal end portion and the expiratory nasal end portion.

Abstract: A medical headgear is disclosed having a flexible band having an inner surface and an opposite outer surface. The band includes a non-stretch central portion having a first side and an opposite second side, a first elastic portion connected to the first side, and a second elastic portion connected to the second side.

Abstract: An oxygen mask can include an oxygen supply unit and an attachment unit which is to be attached to a periphery of a nose or a nose and a mouth of a patient. The attachment unit can include an opening which communicates with external air and which is formed at a position to which, when the oxygen mask is attached to the patient, at least one of the nose and the mouth of the patient is opposed.

Abstract: A respiratory treatment device comprising at least one chamber, a chamber inlet configured to receive exhaled air into the at least one chamber, at least one chamber outlet configured to permit exhaled air to exit the at least one chamber, and an exhalation flow path defined between the chamber inlet and the at least one chamber outlet. A restrictor member positioned in the exhalation flow path is moveable between a closed position, where a flow of exhaled air along the exhalation flow path is restricted, and an open position, where the flow of exhaled air along the exhalation flow path is less restricted. A vane in fluid communication with the exhalation flow path is operatively connected to the restrictor member and is configured to reciprocate between a first position and a second position in response to the flow of exhaled air along the exhalation flow path.

Abstract: Provided is a sleep guidance device that serves to control a stimulus imparter for imparting stimuli to a human subject. The sleep guidance device acquires a biorhythm of the human subject; estimates sleep depths of the human subject from the acquired biorhythm of the human subject; and controls the stimulus imparter to impart a stimulus to the human subject in accordance with the acquired biorhythm of the human subject, and from among the sleep depths, a current sleep depth estimated for the human subject.

Abstract: A procedure kit that removably retains components to be used during a medical procedure, such as the insertion of a catheter into a patient, is disclosed. The procedure kit is securable to a surface or structure such that the kit is positioned as desired by the clinician, thus minimizing chances that the kit will fall to the ground or undesirably move. In one embodiment, the procedure kit comprises a body defining a plurality of pockets that are sized to removably receive therein components for use in the medical procedure, an openable flap that covers at least a portion of the pockets; and an adhesive portion included on a portion of the body to enable the procedure kit to be secured to a structure or surface proximate to the patient, such as the sterile drape covering the patient.

Abstract: A medical tube in which an intermediate layer composed of a composition containing (a), (b), and (c1) listed below and a lubricant layer composed of a composition containing (a), (b), and (c2) listed below are sequentially laminated on a surface of an insertion member to be inserted into a living body: (a) 1 to 35 weight % of at least one of aromatic diisocyanate, aliphatic diisocyanate, and alicyclic diisocyanate; (b) 1 to 35 weight % of trifunctional or higher functionality polyol; (c1) 30 to 98 weight % of polyalkylene glycol and/or monomethoxypolyalkylene glycol; and (c2) 30 to 98 weight % of polyalkylene glycol (including polyalkylene glycol larger in weight-average molecular weight than polyalkylene glycol in (c1)) and/or monomethoxypolyalkylene glycol (including monomethoxypolyalkylene glycol larger in weight-average molecular weight than monomethoxypolyalkylene glycol in (c1)), (where each of the glycols in (c1) and (c2) is diol).

Abstract: A drainage catheter, comprising an elongate body member, an elongate flexible member and a hub, the hub including a base and a collar, the base an internal passageway and a side lumen and an outer surface including an engagement element and a mating surface portion, and the collar including a side lumen extending from the inner surface to the outer surface and wherein the inner surface of the collar includes a mating surface portion and a counter element, wherein the elongate flexible member extends through the side lumen side lumens, and wherein the hub has an unlocked position where the engagement element and the counter element are not engaged and a locked position where the engagement element and the counter element are engaged, the collar is tightened on the base and the elongate flexible element is clamped between the mating surface portions of the base and the collar.

Abstract: For treating a treatment area in the vasculature, this disclosure relates to a first, pre-dilatation catheter having a first shaft including a first distal portion adapted for positioning at the treatment area and a first proximal portion including a first marking at a first location. A second, dilatation catheter includes a second shaft including a second distal portion adapted for positioning at the treatment area and a second proximal portion including a second marking at a second location substantially matching a first location of the first marking. Related methods are disclosed.

Abstract: The present disclosure provides a medical device (10) comprising a friction member (30, 48) configured to assist in controlling and/or limiting unintentional and/or undesirable movement between two releasably secured components (18, 28) of the medical device. The releasably secured components may be part of a resistance assembly for holding a medical device actuator (20) in a particular position and/or to improve the ease of which the activator moves into one position versus another position.

Abstract: Cannula devices and related methods are provided. In accordance with one embodiment, a cannula ring includes a body portion having a substantially cylindrical member defining an opening therethrough. A plurality of anchor arms coupled with the body portion and configured to be positioned in a first, collapsed state and a second, deployed state, wherein the anchor arms each include a free end that is radially displaced from the body portion while in the second, deployed state relative to their positions while in the first, collapsed state. Suture rings and other associated structures and devices are also described.

Abstract: The present invention relates to a catheter insertion system and method. The system comprises an IV catheter comprising a distal cannula attached to a proximal hollow hub; a forward arm attachably connected to a proximal portion of said IV catheter or element connected thereto, and extending distally therefrom; and a needle configured to pass through and protrude from the cannula.

Abstract: A guidewire that is specifically designed for performing an intracardiac transseptal puncture procedure is described. A piercing head for the guidewire has a conically-shaped section that tapers to a cutting section comprised of three tapered facets extending to a pointed tip. The three facets form three cutting edges that each provide for smooth cutting of body tissue, for example, cutting of the septum wall. The cut tissue does not tend to close or relax as readily as if the tissue had been punctured with a conically-shaped piercing tip, for example, one that has a structure similar to a pencil tip, This helps with subsequently moving a catheter and similar medical device through the pierced body tissue. Consequently, the faceted piercing head leaves an opening having a diameter that is substantially similar to the maximum outer diameter of piercing head.

Abstract: An elongate flexible steerable guidewire for facilitating placement of a medical implement is described having a proximal section, an intermediate section, and a distal steerable section. In embodiments the distal steerable section comprises a plurality of rotatable swivel members, and an elongate directional tip extending distally from the distalmost swivel member. At least one manipulation wire is secured to the swivel members and extends proximally to the proximal section. Axial movement of manipulation wires rotates the swivel members, thereby curving the guidewire and deflecting the directional tip. An actuator or handle may be incorporated with the guidewire. Methods include placing medical implements in target regions. Exemplary applications include guiding and placement of electrical leads in the spine, and placement of angioplasty devices in the vasculature.

Abstract: A dilatation catheter includes a high-pressure balloon component comprising an inner balloon and an outer balloon. An interior of the inner balloon is in fluid communication with a lumen of the catheter for receiving inflation fluid therefrom. The outer balloon defines a separate interior within which the inner balloon is disposed. The outer balloon has a hole in a wall thereof for venting the interior of the outer balloon to ambient environment. Proximal necks of the inner and outer balloons are bonded to an outer shaft of the catheter and distal necks of the inner and outer balloons are bonded to an inner shaft of the catheter. In accordance with embodiments hereof, the interior of the outer balloon is not in fluid communication with the interior of the inner balloon, the lumen of the catheter or any other source of fluid from the catheter.