Abstract: A control circuit for controlling a supply of power to an external electronics module for controlling an implanted device of the user, the control circuit electrically coupled to a switching circuit for controlling an electrical connection between an external power source, a battery, and an external electronics module, the control circuit further electrically coupled to a sensor for sensing at least one from the group consisting of a voltage and a current received from the external power source, the control circuit being configured to control the switching circuit to electrically disconnect the external electronics module from the external power source and electrically connect the external electronics module to the battery in response to a sensed fluctuation of at least one from the group consisting of voltage and current and electrically connect the external electronics module to the external power source and electrically disconnect the external electronics module from the battery when the fluctuation is not

Abstract: A detachable module for optionally recharging sorbent materials, including zirconium phosphate, with an optional bypass and conduits for a sorbent cartridge. The sorbent cartridge can have one or more modules contained therein having connectors connecting each of the modules. One or more of the modules can be reusable and the sorbent materials therein recharged.

Abstract: A portable hemodialysis system is provided including a disposable cartridge and a reused dialysis machine. The disposable cartridge includes a dialysate flow path and a blood flow path which flow in opposite directions through a dialyzer. The disposable cartridge further includes a filter for removing waste products from the dialysate as well as one or more flow sensors for measuring the flow of dialysate in the dialysate flow path. The preferred flow sensor includes a rotatable spoked wheel in the dialysate flow path which is rotated by the flow of dialysate. The spoked wheel includes one or more magnets which are rotated with the rotation of the spoked wheel. The flow sensor further includes a magnetic field sensor in the reused dialysis machine which is connected to a processor for monitoring the rotation of the spoked wheel to determine flow of fluid in the dialysate flow path.

Abstract: The invention relates to a handle for a medical device (10) which has a dual function: gripping (12) the medical device and holding a functional component of a medical system against the medical device, preferably a dialysis filter (4).

Abstract: A hemodialysis device is described herein. An exemplary hemodialysis device includes an import tube, a dialysis tube, and an export tube. The dialysis tube includes an inner dialysis tube, a dialysis membrane and an outer dialysis tube. The inner dialysis tube is within the dialysis membrane, which is within the outer dialysis tube. An inlet and an outlet of the inner tube are disposed at a first end of the outer dialysis tube. The inlet of the inner dialysis tube is coupled to the import tube and the outlet of the inner dialysis tube is coupled to the export tube. The dialysis tube is inserted into an artery of a patient, and thereby performs hemodialysis within the body. Since the hemodialysis in performed within the artery instead of drawing blood out of the body, the hemodialysis device will minimally affect blood pressure, which is more economic and safe.

Abstract: A line holder assembly may include a molded nest coupled to an anchor pad or base having a flat bottom with sufficient surface area in contact with a table or other surface to secure the line holder assembly in place during use. The nest is designed to extend around a cart or table edge and having tabs to accept a line holder for holding and organizing lines and which may be disposed in a vertical position. The anchor base may be made of or otherwise include a flexible, rubber-like material, such as silicone, and thereby use the material's natural stickiness to provide fixation to the table or cart. The line holder assembly may be beneficially used in connection with a home dialysis machine, such as a peritoneal dialysis (PD) cycler, in which lines and connectors are desirably organized and anchored during a dialysis treatment.

Abstract: Systems and methods for purification and concentration of autologous alpha-2 macroglobulin (A2M) from whole blood and or recombinant A2M are provided. Also provided are methods of treating wounds with A2M. Methods for utilizing A2M in combination with other treatments (e.g., platelets and other growth factors) are provided in addition to combinations with exogenous drugs or carriers. Also provided is a method of producing recombinant A2M wild type or variants thereof where the bait region was modified to enhance the inhibition characteristics of A2M and/or to prolong the half-life of the protein for treating wounds.

Abstract: An apparatus for treating a medical fluid is provided which includes a treatment machine having a coupling surface, with a cassette made of a hard part having liquid-conducting passages which are covered by a flexible film being able to be coupled to the coupling surface of the treatment machine. A corresponding medical cassette is also provided. An air-free coupling of the flexible film of the cassette to the treatment machine is ensured in that air can be sucked out areally along a plane between the flexible film and the coupling surface during the coupling process and/or with a coupled cassette. A method for coupling the cassette and a method for checking the leaktightness of the cassette via the vacuum control of the air suction is also provided.

Abstract: Improved systems and methods for extracorporeal blood temperature control and patient temperature control, e.g., for induced hypothermia and optional normothermia, may include or otherwise employ a heat exchanger for cooling/warming of a fluid, a thermal exchange module having fluidly isolated first and second volumes, and a fluid pump for circulating the fluid through the heat exchanger and the first volume of the thermal exchange module. A blood pump may be provided for the flow of blood through the second volume of the thermal exchange module, and a first controller may be provided for providing output signals for use in operation of the heat exchanger to selectively control thermal exchange between the fluid circulated through the first volume of the thermal exchange module and the blood flowed through the second volume of the thermal exchange module, thereby providing for selective cooling/warming of the blood.

Abstract: According to some embodiments, a system may treat blood outside the body of a patient. The system may include at least one toxin removal system configured to process blood from at least two places on the patient's body at a rate, for example, of at least 0.5 liters per minute. The system may be configured to raise the pH level of the patient's blood by introducing a fluid at rate of at least 9 liters per hour.

Abstract: A method for collecting and washing shed blood includes providing a blood salvage reservoir and a blood salvage system. The user may connect a vacuum inlet port on the reservoir to a vacuum outlet port on the salvage system, connect an inlet port on the reservoir to a patient, and connect a vacuum source to a vacuum connection port on the salvage system. The method may then (1) draw a vacuum on the reservoir to draw shed blood into the reservoir, (2) disconnect the reservoir from the surgical field and salvage system, and (3) connect a second reservoir. The first blood salvage reservoir may then be connected to an automated blood processing system, and the collected blood may be introducing into the automated blood processing system and washed. The blood processing system may then return a portion of the washed blood to the patient.

Abstract: A centrifuge bowl for separating whole blood into blood components includes a rotatable body, and inlet, and a plurality of vibration reduction members. The rotatable body has a body portion and a neck portion. The body portion defines an interior for receiving whole blood, and the body is rotatable to separate the whole blood into a plurality of blood components. The inlet is in fluid communication with the interior of the rotatable body, and is configured to introduce the whole blood into the rotatable body. The plurality of vibration reduction members are spaced about the neck portion, and are configured to reduce vibration of the centrifuge bowl as the bowl is rotated.

Abstract: A medical fluid injector device capable of injecting a patient with a mixed medical fluid and simply setting injection conditions for the mixed medical fluid. A medical fluid injector includes an injector head injecting a diluted contrast medium into a patient and a controller unit. The controller unit receives an input relating to an injection rate of the diluted medical fluid, receives an input relating to a mixture ratio by an operator, calculates an injection rate of a contrast medium based on the mixture ratio, and calculates an injection rate of physiological saline based on the mixture ratio. The injector head injects the contrast medium and the physiological saline at the calculated injection rate of the contrast medium and the calculated injection rate of the physiological saline, respectively.

Abstract: Infusion devices, systems, and methods can detect a presence or absence of an infusion cartridge in an infusion pump. Embodiments may include a loading sequence, recording loading pulse width modulation (PWM) commands applied to an infusion pump motor during the loading sequence, setting a value of threshold PWM commands based on the commands applied during the loading sequence and comparing values of operational PWM commands applied during pumping operations to the value of the threshold PWM commands. If the value of the operational PWM commands drops below the threshold by a predetermined amount, a missing infusion cartridge warning may be generated.

Abstract: Embodiments are directed to infusion devices, systems, and methods to detect a capacity of a collapsible fluid reservoir of an infusion cartridge and/or a volume of a fluid disposed in the collapsible fluid reservoir or some other parameters of the infusion cartridge, and setting corresponding therapeutic parameters of an infusion device. Embodiments may include, obtaining data on the volume of fluid in the collapsible fluid reservoir, analyzing the obtained data to determine the setting of therapeutic parameters, and setting one or more therapeutic parameters of an infusion device.

Abstract: A pump device (10) operable with a syringe (11) having a barrel (12) and a plunger (13). The pump device (10) is operable to cause relative movement between the syringe plunger (13) and the syringe barrel (12) for discharging fluid from the syringe (11). The pump device (10) comprises a portion (31) adapted to engage the syringe barrel (12), and a drive mechanism for moving the syringe plunger (13) relative to the syringe barrel (12) to discharge fluid from the syringe (11). The drive mechanism comprises an actuator (45) adapted to engage the syringe plunger (13) and a power mechanism (61) for moving the actuator (45) to effect movement of the syringe plunger (13) relative to the syringe barrel (12). The pump device (10) thus provides a syringe driving means. There is also provided an infusion system comprising a syringe driving means, the syringe driving means comprising the pump device (10).

Abstract: A metering device for dispensing medication fluid includes: a spindle unit, a drive unit for rotationally driving the spindle unit, and a reservoir for the medication fluid. The reservoir has a wall, which defines a cross-sectional area of the reservoir, and a plunger located in the reservoir. The rotational driving of the spindle unit causes a translational motion of the plunger, and therefore displaces medication fluid. Because the product of the cross-sectional area of the reservoir in the unit mm2 and the spindle pitch in the unit mm/degree is less than 0.13 mm3/degree and the medication fluid is a liquid insulin having a concentration in a range of U20 to U100, a metering system can be formed that is suitable specifically for the CSII therapy of children and youth, where high discharge accuracy is important for good therapy control.

Abstract: A wearable infusion pump assembly includes a reservoir for receiving an infusible fluid, and an external infusion set configured to deliver the infusible fluid to a user. A fluid delivery system is configured to deliver the infusible fluid from the reservoir to the external infusion set. The fluid delivery system includes a volume sensor assembly, and a pump assembly for extracting a quantity of infusible fluid from the reservoir and providing the quantity of infusible fluid to the volume sensor assembly. The volume sensor assembly is configured to determine the volume of at least a portion of the quantity of fluid. The fluid delivery system further includes at least one optical sensor assembly configured to sense the movement of the pump assembly, a first valve assembly configured to selectively isolate the pump assembly from the reservoir, and a second valve assembly configured to selectively isolate the volume sensor assembly from the external infusion set.

Abstract: A device for delivering medicament into skin of a patient, the device having a housing, which includes a reservoir for housing the medicament, a first internal region that is sealed from fluid ingress and includes one or more components, and a second internal region that is not sealed from fluid ingress and includes one or more components. The housing also has a barrier that separates the first internal region and the second internal region, a delivery cannula that delivers the medicament into the skin of the patient, and a base including a bottom surface for orienting toward the skin of the patient. The bottom surface of the base has one or more fluid channels disposed therein and at least one of the fluid channels is in fluid communication with the delivery cannula.

Abstract: A system and method for physiological monitoring and regulation of a drug infusion device. The system includes an internal compact unit that is implantable in a patient having a pulmonary disorder, the internal unit encasing a power supply, a fluid reservoir, a motor pump, a digital control unit, and a radio frequency transmitter. An infusion catheter is connected to the fluid reservoir and motor pump for automatically infusing a drug into a right ventricle of the patient during a diastole phase of a cardiac cycle. The system includes an external unit for monitoring and storing a plurality of physiological parameters of the patient and for making adjustments to a drug infusion rate.

Abstract: The invention relates to an insertion device comprising —a penetrating member (50) connected to transformation means (52), —a moving part (38) comprising guiding means (39) which guiding means (39) restrict the movement of the transformation means (52) and guide the penetrating member (50) from a first to a second position in a first direction, i.e. the direction of insertion, towards the injection site, and —a stationary housing (30) comprising guiding means (32) which guiding means (32) restrict the movement of the moving part (38). The guiding means (32) guide the moving part (38) in a second direction which is linear and different from the first direction i.e. the direction of insertion.

Abstract: A securement device assembly, including an adhesive layer having a top surface and a bottom surface, wherein said adhesive layer includes at least two apertures, a non-adhesive substrate secured to said bottom surface of said adhesive layer to form an integral unit, and a plurality of perforations within said integral unit.

Abstract: A system and method that identifies delayed infusion programs at an infusion pump or with a first computer and an infusion pump. The first computer receives an infusion auto-program from a remote source, transmits the infusion auto-program to the infusion pump, and sends a stale auto-program to the infusion pump. The infusion pump receives a manual infusion program, saves and executes the manual infusion program, and compares the stale auto-program to the manual infusion program to identify potential matches between the stale auto-program and the manual infusion program. The infusion pump evaluates the potential matches and determines if the potential matches are within a predefined tolerance, continues to execute the at least one manual infusion program on the infusion pump if the potential matches are within the predefmed tolerance, and remotely saves differences in the manual infusion program and the at stale auto-program in a remote server for later analysis.

Abstract: An apparatus comprises a body having an opening at a first end of the body. A plunger control grip is slidably coupled to a portion of the body circumference and configured to couple to a syringe plunger. The apparatus further comprises a cover pivotably coupled to the first end of the body, wherein in an open position the cover exposes a cavity configured to receive a syringe. A locking mechanism is pivotally secured to the cover, wherein the locking mechanism is configured to prevent forward movement of the plunger control grip when in a locked position and to enable forward movement of the plunger control grip when in an unlocked position. The unlocked position is activated by external contact with the locking mechanism and forward movement is in the direction toward the first end of the body.

Abstract: An automated wearable device measure physiological signals, and when parameters which cause the wearer to be at risk are measured, the device delivers an antidote for a given medical condition. This prevents overdose or medical conditions from occuring.

Abstract: The invention relates to a needleless injection device, comprising a firing chamber (11) for the needleless injection of a substance (25), having a firing chamber containing a pyrotechnic material and a gel-like medium, with which a substance, in particular an active substance, can be accelerated at high speed and injected in a needleless manner into a tissue or into a body by means of a membrane (15). The invention also relates to a method for producing a needleless injection device of this type containing a firing chamber together with pyrotechnic material and filled with a gel-like medium, and use thereof.

Abstract: An autoinjector includes a main body having a container, the container having a drug therein, a hollow needle coupled to the container through which the drug can be delivered. The autoinjector also has a power source having a liquefied gas therein as a driver, a flow regulator, and at least one outlet through which some of the driver can exit the power pack in a gaseous state. The power source and container are coupled together for operation such that, when an injection is initiated, the flow regulator will control an exit rate of the driver such that the liquefied gas in the power source is maintained at substantially its vapor pressure and the power source will adjustably apply a force to deliver the drug via the hollow needle at a delivery rate that is a constant delivery rate.

Abstract: An auto-injector operable in a single activation step. The auto-injector is automatically armed when removed from its carrying receptacle. The auto-injector may be prefilled with more than one constituent of a beneficial agent, stored in separated compartments, in such an arrangement that the compartments will automatically merge when the auto-injector is removed from its carrying receptacle.

Abstract: A plunger seal for a drug delivery device may have a mobile and an enhanced sealing parked state. Optionally, the cartridge is stored with the plunger seal in the parked state. Optionally, drug discharge occurs with the plunger seal in the mobile state. For example in the parked state there may be increased normal force between the plunger seal and an inner wall of the cartridge. Optionally there is limited deformation of the plunger seal between the parked and mobile states. Optionally the plunger seal is biased to the parked state. Optionally, a distal force switches the plunger seal to the mobile state. For example, the plunger seal may have an inner cavity that is expanded radially by core. A biasing element optionally biases the core wedging it proximally to the parked state. A distal force on the core may push it distally to the mobile state.

Abstract: A drive mechanism for a delivery device comprising a rotator comprising an outer surface and an inner surface, the rotator configured to rotate from a first position to a second position; and a needle cover comprising an inner surface that engages the outer surface of the rotator. An end of injection indication device is positioned at least partially within a plunger rod spring, the end of injection indication device providing a signal to a user of the drive mechanism that an injection has been completed.

Abstract: A medical injection device, including: a medication container having a mov-able piston; a push rod assembly displaceably disposed in the medical injection device, the push rod assembly having a plurality of spaced-apart position setting means disposed along the length thereof, the push rod assembly selectively displacing the movable piston to dispense medicament from the medication container; a spring to bias the push rod assembly to move toward the distal end of the medical injection device; a releasable restraining means configured to releasably restrain the push rod assembly in a locked state against the biasing of the spring, wherein, upon release of the releasable restraining means, the push rod assembly moves under force of the spring toward the distal end of the medical injection device; and an arming means configured to move the push rod assembly toward the proximal end of the medical injection device.

Abstract: An auto-injector for administering a dose of a liquid medicament includes a case and a carrier subassembly with a carrier slidably arranged inside the case. The carrier can contain a syringe with a hollow injection needle, a drive spring and a plunger for forwarding drive spring load to a syringe stopper. The syringe can jointly, axially translate with the carrier. The drive spring acts between the carrier and the plunger. In an initial state, the plunger is locked to the carrier by a ramped engagement to the carrier and is prevented from rotating out of this engagement depending on a longitudinal position of the carrier in the case. The plunger can be released for rotating out of the ramped engagement when the needle reaches nearly a predefined injection depth on translation of the carrier in the proximal direction for advancing the needle beyond a proximal end of the auto-injector.

Abstract: An auto-injector for administering a dose of a liquid medicament has a tubular chassis telescopable in a tubular case, a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis inside the case, where the carrier adapted to contain a syringe with a hollow injection needle. The injector has a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier. There is also a trigger button arranged distally or laterally in or on the case, a control spring arranged around the carrier, and a needle extension control mechanism for coupling a proximal end of the control spring to either the carrier for advancing it for needle extension or to the chassis for needle retraction depending on the relative axial position of the carrier and the chassis.

Abstract: A sensing system for determining a position of a plunger within a fluid container. The sensing system includes a light source, a light detector and a controller. The light source is configured to emit light into a barrel wall of the fluid container so that the barrel wall serves as a waveguide to guide the light to travel therein in an axial direction. The light detector is positioned to detect reflected light that was emitted by the light source, traveled through the barrel wall serving as the waveguide, and then reflected off a surface of the plunger. The controller is in communication with the light detector to determine an axial position of the plunger surface based on data from the light detector of the detected reflected light.

Abstract: A drive mechanism for a delivery device comprising, a rotator comprising an outer surface and an inner surface, the rotator configured to rotate from a first position to a second position. A needle cover comprising an inner surface that engages the outer surface of the rotation. A rotatable plunger rod comprising an outer surface configured to engage the inner surface of the rotator. When the rotator rotates from the first position to the second position, the rotatable plunger rod is rotated by the rotator and the plunger rod spring is released from a pre-tensioned state to exert a force on the rotatable plunger rod.

Abstract: A dispensing device is disclosed which provides for dispensing multiple doses in amounts determined by a movable collar attached to a plunger shaft.

Abstract: A dispensing device is disclosed which provides for dispensing multiple doses from a cylindrical volume. An actuator button moves a tooth to engage a series of links which move a stopper to dispense the doses.

Abstract: An injection device for delivering a dose of medicament from a syringe includes: a housing including a forward body and rearward body and wherein the forward and rearward body are axially moveably interconnected; a drive mechanism arranged, in use, to be released from an energized position to deliver a dose from the syringe; a latch arranged to hold the drive mechanism in the energized position; and a trigger for releasing the latch; wherein the injection device further includes an interlock arrangement moveable between a locked position in which release of the drive mechanism is prevented and an unlocked position in which the drive mechanism may be released, the interlock arrangement including: an internal blocking formation associated with the rearward body and positioned between the latch and trigger, and wherein in use, forward movement of the rearward body relative to the forward body moves the blocking formation into the unlocked position.

Abstract: Apparatus and method for injecting fluid into a subject includes a fluid injecting portable communication device case. The fluid injecting portable communication device case has a communication device portion. The communication device portion has a device recess that is configured to removably hold at least a portion of a portable communication device therein. A fluid injection portion has at least two fluid injection stations. Each fluid injection station is configured to interact with a fluid injector assembly, a removable trigger block, and a removable needle cover. Each fluid injector assembly includes a trigger, a firing mechanism, a plunger, and a needle.

Abstract: A device for generating a condensation aerosol includes (a) vaporization chamber having an upstream first inlet and a downstream outlet; (b) a heater element in the vaporization chamber between the upstream first inlet and the downstream outlet; (c) an airflow path in fluid communication with the vaporization chamber, wherein the airflow path comprises a second inlet configured to permit a substantially laminar flow of air into the airflow path, wherein the second inlet is downstream of the heater element; and (d) the device having components or apparatus on or in the device for changing air flow in the vaporization chamber. Changing the air flow in the vaporization chamber may be used to change the particle size of a condensation aerosol produced in the vaporization chamber, and/or to change the amount of visible vapor emitted from the device.

Abstract: Some embodiments are directed to a compliance monitor for monitoring patient usage of a dry powder medicament delivery device, including a store of medicament housed within a main body portion, and a base portion which is rotatable with respect to the main body portion. The medicament delivery device also includes a medicament dispensing means for dispensing a dose of medicament into an inhalation chamber, a mouthpiece through which the dose of medicament may be inhaled by a user, and a replaceable cap. The compliance monitor includes a first portion for receiving and/or retaining the base portion of the medicament delivery device, and a second portion for releasably securing the medicament delivery device to the first portion. The arrangement and construction is such that the fitting of the second portion of the compliance monitor to the first portion of the compliance monitor does not include a screw fit.

Abstract: A method of manufacturing a flavor cartridge for a flavor inhalator, the method comprising the steps of filling a predetermined amount of a flavor generating material capable of emitting a flavor component in a frame compressing the flavor generating material in the frame by applying pressure thereto by a pusher and fixing a lid to the frame, wherein the flavor generating material contains a tobacco material obtained by shredding or pulverizing tobacco leaf, and the lid has air permeability.

Abstract: A method of acclimatizing a user to provide continuous positive airway pressure (CPAP) therapy, including operating a device for treating sleep disordered breathing (SDB) during successive treatment sessions, wherein the device provides continuous positive airway pressure during sleep, includes determining a clinically-derived full therapeutic pressure, applying a sub-therapeutic treatment pressure for the duration of a first session, obtaining responses to a series of pre-programmed patient and/or bed partner feedback questions before the start of a second session, and, based on the responses, either incrementally increasing the treatment pressure for the second session if the responses indicate that the patient is adjusting to therapy, or maintaining the treatment pressure for the second session if the responses do not indicate that the patient is adjusting to therapy.

Abstract: The systems and methods include providing, displaying, and/or utilizing leak estimation during ventilation of a patient with a ventilator. The systems and methods include providing, displaying, and/or utilizing internal leak estimation, total leak estimation, and/or external leak estimation during ventilation of a patient with a ventilator.

Abstract: An introducer for tracheal tube intubation has a proximal section connected to a distal section having an angled bougie tip. The introducer is configurable (i) for use as a bougie in which a tracheal tube is railroaded over the introducer's back end and into a trachea and (ii) for use as a stylet in which a tracheal tube is pre-loaded onto the introducer for insertion into a trachea. In certain embodiments, the introducer has one or more flexible or malleable sections that enable the introducer to bend into different configurations. The flexible/malleable sections have directional bending such that the sections bend in roughly the same plane as the angled bougie tip. This enables an operator always to know the orientation of the bougie tip even after it has been inserted into the trachea. The flexible/malleable sections enable the introducer to be configured with a handle or other type of grip.

Abstract: An interface for positive pressure respiratory therapy includes a mask assembly having a mask seal and a mask shell. The mask assembly is positioned lower than and exposes a bridge of the user's nose. The mask seal includes first and second portions on respective first and second sides of a nasal region that contact opposing sides of the user's nose. The first and second portions each include supports that help maintain a shape of the mask seal. A pair of covers can be supported relative to the mask assembly and adjacent a respective one of the first and second portions of the mask seal. The covers limit expansion of the first and second portions of the mask seal in response to pressurized air within the mask seal. The supports of the first and second portions can transfer load from the mask seal to the covers.

Abstract: A breathing mask includes a relatively rigid shell and an elastomeric sealing lip mounted to the relatively rigid shell. The elastomeric sealing lip has a contact zone configured to bear against the face of the person. The elastomeric sealing lip further includes a nose bridge region, a first nostril region and a second nostril region. The nose bridge region has a first zone of lower load-bearing capability. The first nostril region has a first zone of higher load-bearing capability. The second nostril region has a second zone of higher load-bearing capability. The first zone of lower load-bearing capability has a lower load-bearing capability than the first and second zones of higher load-bearing capability. In addition, the contact zone is configured to pivot about an articulation axis that extends through the first and second nostril regions.

Abstract: An intranasal device having a first cannula for insertion into a first nostril of a user and a second cannula for insertion into a second nostril of a user. Each cannula has an interior surface defining a generally cylindrical lumen. On the exterior surface of each cannula is a first protrusion in the shape of an anteromedial concavity of a nostril of the user and second, separate and distinct protrusion in the shape of a posterolateral concavity of the nostril of the user.

Abstract: The breathing mask with nasal cannula includes a breathing mask having a frontal air inlet port that communicates with an air inlet in a removable mask retainer. The air inlet of the mask retainer is adapted to receive ambient air provided by a non-invasive ventilation (NIV) device. In addition, the mask includes an oxygen pass-through connector tube that is sealed in place in the front of the mask. A nasal cannula is connected to the interior portion of the connector tube and adhesively secured to the patient's nose. The mask and retainer are then secured over the patient's nose and mouth, and an oxygen supply tube is connected to the external end of the pass-through tube of the mask. Airflow is adjusted from the NIV and to oxygen flow is adjusted to the cannula to provide the patient with the required air and oxygen flow for proper blood saturation.

Abstract: A mask assembly for delivering breathable gas to a patient may include a patient interface structured to engage the patient's face and provide a seal, a headgear arrangement to support the patient interface in a desired position on the patient's face, and an audio unit provided to at least one of the patient interface and the headgear arrangement. The audio unit may be operable to selectively generate at least one sound.