Abstract: An improved pump, reservoir and reservoir piston are provided for controlled delivery of fluids. A motor is operably coupled to a drive member, such as a drive screw, which is adapted to advance a plunger slide in response to operation of the motor. The plunger slide is removably coupled to the piston. A method, system, and an article of manufacture for automatically detecting an occlusion in a medication infusion pump is provided. The electrical current to an infusion pump is measured. Based on a series of measurements of one or more variables, the infusion pump detects whether there is an occlusion in the system.

Abstract: An infusion device for continuous infusion of medication is disclosed, in which infusion is controlled over two separate fluid communications. The infusion is in each fluid communication controlled by restricting means and valve means, and one of the fluid communications further contains a holding device for bolus rate of infusion. The device comprises a flow regulating device comprising a passage defined by at least a first element and a second element, wherein at least one of the first and second element is a primary deformable element adapted to be elastically deformed so as to change the cross sectional area of the passage. Furthermore the device comprises a container for storage and supply of a medication in fluid form, said container comprising a first and a second chamber being arranged relatively to each other so that when volume of the first chamber increases the volume of the second chamber decreases.

Abstract: An injection device for injecting medication to a patient, comprising a surface (5) having a through hole (3) for passage of a needle, is characterised by further comprising a capacitive proximity sensor (12, 13, 30) for detecting proximity or contact of human skin to/with said surface (5).

Abstract: Described herein are syringe devices, systems and methods. In general, the syringe may include a first chamber and a cartridge movable within the first chamber. The cartridge may include a cartridge chamber and a valve in fluid communication with the cartridge chamber and the first chamber and having an open configuration and a closed configuration. The valve may allow movement of a liquid out of the cartridge chamber while in a open configuration. The cartridge may also include a second end, movable within the cartridge chamber, and a locking mechanism having a locked configuration and an unlocked configuration, the locking mechanism preventing movement of the second end within the cartridge chamber while in the locked configuration.

Abstract: Methods, systems, and devices are described for setting a dose of medicine and injecting the medicine. In one aspect, a method to dispense a medicine includes inserting a cartridge containing a medicine into a cartridge holder coupled to a housing of a medicine injection device, positioning a spine component of the device to make contact with the cartridge in the cartridge holder, selecting a dose of the medicine for injection, in which the selecting includes rotating an injection component of the device to a setting corresponding to the selected dose, and linearly advancing the injection component to rotate a drive gear coupled to the injection component to drive the spine component so as to push the end of the cartridge to dispense the medicine in the amount of the selected dose.

Abstract: A production method for a pre-filled syringe includes holding a syringe assembly; reducing a pressure in the outer barrel of the syringe assembly to a set pressure; while the pressure in the outer barrel of the syringe assembly is at the set pressure, sealing the proximal end opening of the outer barrel with the gasket by disposing the gasket at a sealing position; and pushing the gasket toward the barrel tip with a sliding motion through the outer barrel to move the gasket from the sealing position to an insertion position, and the insertion position being a position at which a distal end surface of the gasket is spaced from the drug solution. After the gasket is moved to the insertion position, a pressure in a space between the drug solution and the distal end surface of the gasket is approximately equal to the atmospheric pressure.

Abstract: A drug delivery device is provided comprising a cartridge holder comprising at least one guide track, and a body comprising at least one interaction member adapted and arranged to mechanically cooperate with the at least one guide track.

Abstract: A liquid administration device includes an inner structure that includes a cylindrical body that has a bottom part in a distal portion thereof and an opening portion in a proximal portion thereof, a needle tube that is mounted in the distal portion of the cylindrical body and has a sharp needle tip at a distal end and a proximal end of which is communicatable with an inside of the cylindrical body, and a gasket that is located in the cylindrical body; an operation member that includes a plunger, the operation member being configured to perform a pressing operation in which the plunger is moved relative to the cylindrical body in a distal direction while being pressed; an engagement portion that includes: a first engagement portion and a second engagement portion.

Abstract: The present invention relates to a piston for a cartridge for a drug delivery device comprising: at least one annular sealing surface to radially abut against an inner side wall of a cartridge, a distal surface to confine a drug receiving volume of the cartridge, a thrust receiving surface adapted to receive a thrust exerting plunger of a drug delivery device for displacing the piston in a proximal direction relative to the side wall, wherein the thrust receiving surface comprises numerous centering elements protruding from the thrust receiving surface towards the plunger and wherein the centering elements comprise an outer shape and geometry that matches with a corresponding receptacle of the plunger, and wherein the centering elements are arranged and aligned on the circumference of an imaginary annular or circular structure.

Abstract: The invention relates to a medicament delivery device (100) having a a drive mechanism arranged to drive a plunger rod (12). A release button (4) is movable between an active and an inactive state, wherein the release button (4) in the active state allows the actuator (3) to move axially towards a proximal end position and wherein the release button (4) in the inactive state allows the actuator (3) can move axially towards the proximal end position or towards the distal end position.

Abstract: A resettable dosing mechanism comprises a dose button and a dial grip operatively coupled to the dose button. A spindle acts on a bung of a cartridge and a driver is operatively coupled between the dose button and the spindle. During an injection of the dose, the dose button moves in an axial direction to cause the spindle to administer the dose. During resetting of the dose setting mechanism, the spindle is retracted back into the dose setting mechanism. An advantageous resetting mechanism is described.

Abstract: A syringe for mixing and ejecting an active pharmaceutical ingredient is disclosed. The syringe is designed in such a manner that it is ensured that substantially all of the mixed drug is ejected, and in such a manner that an active pharmaceutical ingredient can be lyophilized directly into the syringe. The syringe comprises a syringe body, a first plunger arranged movably inside the syringe body and a second plunger arranged movably inside the first plunger. In one aspect the second plunger comprises a first plunger part and a second plunger part, and the first and second plunger parts are adapted to cooperate to collapse the cavity of the first plunger. In a second aspect the cavity of the first plunger has a first diameter at a distal end and a second diameter at a proximal end, the first diameter being smaller than the second diameter.

Abstract: A drug administration instrument including a syringe including: a tubular surrounding periphery portion forming a drug chamber configured to store a drug; a discharge part disposed at a first axial end of the surrounding periphery portion; and a flange portion disposed at a second axial end of the surrounding periphery portion; and a sheath member having a tubular shape, surrounding an outer circumference of the surrounding periphery portion of the syringe, and holding the syringe. The sheath member includes a fitting part configured to support at least one of the surrounding periphery portion and the discharge part of the syringe.

Abstract: An injector includes a hollow needle; a main body unit including a needle holding portion that holds the needle; and a protection device configured to cover the needle before and after puncturing a puncture target with the needle. The protection device includes: an inner member attached to the needle holding portion and being freely rotatable around an outer periphery of the needle holding portion; and an outer member configured to (i) cover an outer side of the needle and the inner member before puncturing, (ii) expose the needle by moving toward a proximal end side relative to the main body unit at a time of puncturing, and (iii) cover a distal end of the needle by moving toward a distal end side relative to the main body unit after puncturing.

Abstract: According to various embodiments, a method and system to obtain access to a blood vessel underneath a skin layer that may preserve lifespan of the blood vessel and reduce executional skill variability may be provided. The method includes placing a guiding portion between the blood vessel and the skin layer; and configuring the guiding portion to receive and guide a needle to reach the same location of the blood vessel repeatedly and consistently; and forming a resultant scarred track between the blood vessel and the skin layer as the guiding portion is resorbed over time. The system includes a vascular access device configurable to first possess strength to penetrate through a tissue layer, subsequently possess flexibility to conform to the surrounding tissue beneath the tissue layer; and a guiding portion which may be resorbable, wherein the inlet includes a larger diameter compared to the outlet.

Abstract: An insertion mechanism having a vented fluid pathway includes an insertion biasing member 210, a hub 212, a needle 214, a retraction biasing member 216, and a manifold 240 having a septum 230 and a cannula 234, wherein the annular space between the septum 230 and the cannula 234 defines a manifold header 242. The manifold and fluid conduit are ventable through the membrane prior to or just after needle 214 and cannula 234 are inserted into the user. Such insertion is caused by the insertion biasing member(s) 210, after which only the needle 214 or another occlusion element is retracted. Such retraction may open a fluid pathway from the manifold header 242 to the body through the cannula 234 and/or needle 214. A drug delivery pump 10 includes such an insertion mechanism 200 having a vented fluid pathway. The drug delivery pump 10 may contain the insertion mechanism 200 having a vented fluid pathway in either an internally i or an externally tethered configuration.

Abstract: The invention provides an injector comprising a body and a container. The body has an injection opening and including a drive mechanism which can be actuated to move the container within the body and inject medication from the container through the injection opening. The container comprises an outlet and includes an injection needle releasably coupled thereto. The injection needle comprises a hub and a needle. The hub extends along a first axis between a connecting end and a needle end. The connection end comprises connection means for connecting to the container and the needle connecting to the hub at a needle end. The needle extends from the hub along the first axis to an injection end. The injection needle comprises a channel extending from the connection end of the hub to the injection end of the needle. The hub comprises at least one reference shoulder extending radially from the hub and directed towards the injection end.

Abstract: The invention refers to an injection device comprising a delivery mechanism for injection of a medicament, preferably through a needle, and an end of dose mechanism comprising a feedback element, wherein the end of dose mechanism is operable to be activated at a position at which the delivery mechanism reaches the end of the dose and the end of dose mechanism is further operable to force the feedback element to move into a feedback direction which is opposite or parallel to the activation direction of a release button and/or into the longitudinal direction, wherein the activation direction is preferably a longitudinal direction of the device.

Abstract: An apparatus includes a label configured to be coupled to a medicament delivery device. The label includes a first surface and a second surface. The first surface is configured to be coupled to an outer surface of the medicament delivery device. The second surface includes a textual indicia. The label further includes an electronic circuit system configured to output an electronic signal.

Abstract: This disclosure relates to an apparatus useful for the delivery of aerosols, such as those containing drugs, to the lungs or other locations in the body. The disclosure also relates to methods of administering an aerosol to the lungs or other locations in the body of a patient.

Abstract: A method for filling a plurality of microdepressions in a major surface of a web with finely divided powder in which the web is fed continuously to and through a powder filling stage including a driven roller. A method of manufacturing an elongate carrier with microdepressions containing finely divided powder comprising steps filling a plurality of microdepressions in a major surface of a web as described, removing from upper surface of the web excess powder not filled within the microdepressions and remaining on areas of the surface between the depressions, and optionally slitting and/or cutting the web in width and/or length.

Abstract: An improved dry-powder inhalation device having a casing having an air inlet located at a first terminus; a powder delivery port located at a second terminus, which is positioned distal to the air inlet; and an elongated support panel located within an interior of the casing and being fitted within the casing so as to partially rotate therein about a single axis. The support panel has at least one compartment containing dry-powder located proximally to the second terminus, and the casing has a plurality of needle-like structures located proximal to the delivery port and arranged above the dry-powder compartment. The compartment with a dry-powder includes a blister structure encasing the dry-powder, whereby airflow through the device causes the elongated support panel to partially rotate repeatedly within the casing, thereby striking the plurality of needle-like structures and releasing the dry-powder in the airflow.

Abstract: A dry-powder inhalation device including a casing having at least one push button located on an external portion thereof, the push button including at least one pin structure, an air inlet located at a first terminus of the casing; a powder delivery port located at a second terminus of the casing and is positioned distal to the air inlet; and an elongated support panel located within an interior of the casing and being fitted within the casing so as to partially rotate therein about a single axis. The support panel has at least one compartment containing dry-powder located proximal to the first terminus, and the at least one pin structure is located proximal to the air inlet and arranged above the dry-powder compartment.

Abstract: A ventilator device delivers ventilatory support to a patient in a back up timed mode when patient respiration is not detected or a spontaneous mode when patient respiration is detected. The timing threshold governing the back-up mode is chosen to deviate from normal expected respiration time for the patient to promote patient initiated ventilation in the spontaneous mode but permit back-up ventilation in the event of apnea. Automated adjustments to the timing threshold during the timed mode are made from the less vigilant timing threshold to a more vigilant threshold at or near a timing of normal expected breathing of the patient. Such adjustments may be made from a minimum to a maximum vigilance timing settings or incrementally there between as a function of time in the timed mode which is preferably the number of delivered machine breaths.

Abstract: A system for oral care of patients ventilated with an ETT tube 120 comprising: a deformable fluid blocking element 200 reversibly mountable around an ETT (for example, side-mountable thereon), the fluid blocking element having: a midsection channel 205 sized to fit snugly and reversibly around the ventilation tube 120 when the fluid blocking element is mounted thereto; and an outer surface configured, when the fluid blocking element is mounted, to fit snugly and reversibly into the back of the mouth of an adult human patient so as to span both lateral left-to-right tonsils and tongue-soft palate dimensions thereof, wherein the fluid blocking element 200 is reversibly inflatable to simultaneously press against the soft pallet and the tongue and/or the fluid blocking element 200 is collapsible and outwardly biased so that when placed in the back of the human mouth, the fluid blocking element expands so as to simultaneously press against the soft pallet and the tongue. Methods and kits are also disclosed herein.

Abstract: A sputum apparatus includes a suction line, a switching unit, a measurement unit, and a control unit. The suction line has a suction inlet which aspirates sputum produced in patient's respiratory tract; and an accommodating part maintained at negative pressure, which accommodates the aspirated sputum. The switching unit is in the suction line, and can switch between first state where the suction inlet communicates with the accommodating part, and second state where the suction inlet is shutoff from the accommodating part. The measurement unit measures the expired air being aspirated into the accommodating part, under the first state. The control unit can switch the switching unit from the second state to the first state during expiration, and keep the first state when the expired air measured by the measurement unit is under predetermined value.

Abstract: There is provided herein, a bite block comprising an insertion channel and an airway channel, wherein the airway channel is adapted to receive exhaled breath and wherein the first insert channel is adapted to pass a medical instrument. There is provided herein, a bite block comprising an oral insert channel, wherein a portion of said channel opens into a cavity adapted to slidably receive an oral prong the oral insert channel is adapted to receive exhaled breath.

Abstract: A patient interface comprises a patient interface element for delivering a gas a patient, and a forehead support. An improved adjustment mechanism is provided for the forehead support.

Abstract: A forehead pad for use in a respiratory mask with a forehead support, which includes a base portion to contact a user's forehead, a support post connected to the base portion, and a head adapted to connect the support post to a forehead support. A pair of forehead pads may be joined with a connector.

Abstract: A patient interface structure for delivery of respiratory therapy to a patient includes a front plate configured to conform to the shape of the patient's face; a mouth cushion defining a breathing chamber and provided to the front plate and configured to seal around the patient's mouth; and a nasal cushion configured to seal the patient's nasal airways. The nasal cushion is supported by the mouth cushion, does not contact a bridge of the patient's nose in use, and extends at least partially into the breathing chamber. A patient interface system includes a patient interface structure and a patient interface structure positioning system configured to position, stabilize and secure the patient interface structure in sealing engagement with the patient's face.

Abstract: A portable, compact closed circuit ventilation device for manual ventilation of a patient undergoing a surgical or medical procedure that requires sedation as well as emergency management of respiratory failure. One example embodiment includes a closed breathing circuit having a manually squeezable bag, a carbon dioxide absorption canister, a plurality of valves, a gas port and a plurality of sensors for measuring Tidal Volume (TV), Peak Airway Pressure (PAP) and End Tidal CO2 (ETCO2). Another example embodiment includes an open breathing circuit having a bag, valves and sensors. A monitor displays the sensor measurements during the respiratory phases. In a spontaneously breathing patient the device may be used to assess the adequacy of patient's respiratory efforts. During manual or assisted ventilation, the monitor assures safe and efficacious ventilation by the closed breathing circuit.

Abstract: A gas generating system for health use is provided, comprising a hydrogen-oxygen gas generator and an atomized/volatile gas generator. The hydrogen-oxygen gas generator has a first casing. The first casing accommodates an electrolysis device for electrolyzing water in order to produce a gas mixture of hydrogen and oxygen. The atomized/volatile gas generator has a second casing, the second casing accommodates a gas mixing camber coupled to the electrolysis device to receive and combine the gas mixture of hydrogen and oxygen with water vapor, an atomized medicine, a volatile essential oil or any combination thereof in order to produce a healthy gas for a user to inhale.

Abstract: A positive airway pressure (PAP) device for supplying a flow of breathable gas to a patient includes a flow generator configured to pressurize a flow of breathable gas and a humidifier configured to receive and humidify the pressurized flow of breathable gas from the flow generator. The PAP device also includes a power source. The flow generator, humidifier and power source are positioned so that heat generated by at least one of the flow generator and the power source is conveyed to water in the humidifier.

Abstract: A vent valve apparatus (10) for use with a system for supplying breathable gas pressurised above atmospheric pressure to a human or animal. The apparatus (10) includes a gas washout vent (15), a vent valve (18) adapted to progressively restrict the flow area of the washout vent (15), and a pressure sensitive vent valve control means (20,22,23). The control means is adapted to progressively cause the vent valve (18) to restrict the flow area of the gas washout vent (15) in response to increases in the pressure of the gas supply, thereby substantially regulating the volumetric flow of gas and/or CO2 gas through the washout vent (15) over a range of gas supply pressures.

Abstract: A control method includes the steps of: (a) monitoring an electrooculogram signal of a user using an electrooculogram sensor for monitoring the electrooculogram signal of the user; (b) determining whether or not a sleep state of the user is a non-rapid eye movement (non-REM) sleep state, based on the electrooculogram signal monitored in step (a); and (c) performing a control operation to cause an element capable of warming the eye area of the user to warm an eye area of the user when the sleep state of the user is determined not to be the non-REM sleep state in step (b).

Abstract: Provided herein are apparatus and methods of relaxation. In particular, disclosed herein includes a system that provides realtime or near realtime feedback response to a user in order to achieve a relaxation response.

Abstract: A device includes a sleep depth data acquisition unit configured to acquire sleep depth data indicating a sleep depth of a user in a state in which a sound is being emitted. The device also includes a generation unit configured to generate influence data indicating an influence exerted on a variation with time of the sleep depth of the user by the sound based on a variation with time of the sleep depth indicated by the sleep depth data acquired by the sleep depth data acquisition unit and a variation with time of the sleep depth serving as a reference relating to the user.

Abstract: Catheterization employing a cable extending from the catheter to a fixed point of attachment is performed by providing a sensor to detect rotation of the catheter about its longitudinal axis, the rotation causing the cable to form a twist. The cable extends through a cable arranger that operates to remove the twist. A controller receives signals from the sensor and generates control signals to actuate the cable arranger responsively to the signals from the sensor.

Abstract: A pericardial access device includes a first tube, a second tube coupled to the first tube, and a biasing mechanism coupled to the second tube. The pericardial access device is moveable between an expanded configuration and a contracted configuration. The biasing mechanism biases the pericardial access device towards the expanded configuration, and the pericardial access device moves towards the contracted configuration when a force is applied to the second tube.

Abstract: Catheters and methods of making catheters are provided which include a connector with a guide wire channel and an inflation channel, a shaft extending from a proximal end to a distal end and having a guide wire lumen and an inflation lumen, the shaft being connected, at its proximal end, to the connector so that said guidewire lumen and inflation lumen are mechanically and fluidly connected with said guide wire channel and inflation channel respectively. The connection is realized in correspondence to a kink portion. Such catheters may include a protective sheath placed around an external wall of the shaft extending from a first sheath end, axially placed at a first distance from the proximal end of the shaft so as to allow direct contact and fixation between the external wall of the shaft and the internal wall of the kink portion, to a second sheath end.

Abstract: A manually positionable armature system including a flexible semi-rigid housing including an inner wall, a connecter coupled to the housing to connect the housing to a holding structure, a holder coupled to the housing to hold an instrument in place during a procedure, a compressible media disposed within the flexible semi-rigid housing, an adjustable volume member disposed within the compressible media within the flexible semi-rigid housing, the adjustable volume member adjustable between at least a first volume state where the compressible media is less compressed against the inner wall of the housing and the flexible semi-rigid housing is freely positionable and a second volume state where the compressible media is more compacted against the inner wall of the housing, rigidizing and fixing the flexible semi-rigid housing in a desired orientation.

Abstract: A medical guide wire is provided having a wire core made, for example, of MR-invisible material and a sheath that surrounds the wire core at least sectionally and so as to be in touching contact therewith. The sheath can have a multilayer structure which has at least two solid material layers and/or fiber layers which are formed by different, MR-invisible plastics materials. The MR marker has at least one MR marker element which is integrated at least partially into the multilayer structure of the sheath or is surrounded thereby.

Abstract: A catheter system includes an elongate catheter having a lumen extending at least partially therethrough, and a leading catheter end segment, a guidewire positionable within the lumen of the catheter, and fastening structure supported adjacent the leading catheter end segment. The guidewire and the catheter are adapted for relative movement. The fastening structure is dimensioned to selectively engage the guidewire to secure the guidewire with respect to the leading catheter end segment such that movement of the guidewire causes deflection of the leading end segment with respect to the longitudinal axis.

Abstract: A medical system may include a shaft member and a structure physically coupled to the shaft member. A portion of the shaft member may be sized to be delivered through a bodily opening leading to a bodily cavity. The structure may include at least two flexible couplings, each flexible coupling extending transversely from an intermediate portion of a respective one of at least two elongate members of the structure. The flexible coupling extending transversely from the intermediate portion of a first one of the at least two elongate members forms at least a part of a first closed loop arranged to receive a portion of the flexible coupling of a second one of the at least two elongate members therethrough to limit a spacing between the intermediate portions of the first and the second ones of the at least two elongate members.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a push member having a proximal portion with a proximal stiffness, a distal portion with a distal stiffness different from the proximal stiffness, and a transition portion disposed between the proximal portion and the distal portion. The transition portion may provide a smooth transition between the proximal stiffness and the distal stiffness. The push member may have a first outer diameter. A distal tubular member may be attached to the push member. The distal tubular member may have a second outer diameter larger than the first outer diameter.

Abstract: Balloon catheters that include a balloon and an elastomeric sheath, each having a surface with a therapeutic agent disposed thereon, along with methods of making and methods of using the disclosed balloon catheters.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: A system for redistributing interstitial fluid within a mammal is disclosed. The system comprises an implantable accumulation chamber, a confined flow passageway such as a catheter in communication with the accumulation chamber, and a liquid transfer pump for dispensing accumulated interstitial fluid from the accumulation chamber to a predetermined body site via the confined flow passageway.

Abstract: The present invention provides a device for displacing healthy or normal tissue away from radiation exposure during brachytherapy. In one embodiment, the device of the present invention comprises an inflatable component attached to the ring of a tandem and ring brachytherapy applicator. When the tandem and ring applicator is inserted, the balloon is deflated so that patient discomfort is minimized. Once the ring is in the correct position, the balloon is inflated and the rectum is displaced. The balloon remains inflated during any image guidance that is performed and for the duration of the brachytherapy treatment. The balloon is deflated prior to the removal of the ring from the body.

Abstract: Methods and apparatus are disclosed for making and using adjustable epidermal tissue ingrowth cuff and catheter assemblies for transcutaneous placement to provide periodic or continuous external access for medical purposes to an interior body region of a patent who requires such medical treatment over an extended period of time.