Abstract: A mask for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilator support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. The pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator. The pilot may also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein.

Abstract: A respiratory assistance device is disclosed. There is a variable speed blower with an output, and a patient ventilation interface configured for fitment on a patient respiratory passageway. A gas passage conduit couples the output of the blower to the patient ventilation interface. A pilot line from the gas passage conduit is coupled to a piloted exhalation valve of the patient ventilation interface. A pressure sensor measures a mask pressure in the patient ventilation interface, and a blower speed sensor measures a speed of the blower. A pressure controller in communication with the pressure sensor and the blower speed sensor detects a patient inspiratory phase and a patient expiratory phase from at least one of the measured speed of the blower and a set speed of the blower. The pressure controller adjusts an operating speed of the blower and actuates the piloted exhalation valve based upon the measured mask pressure.

Abstract: A forehead support for a respiratory mask includes a forehead support arm structured to extend from a frame and a forehead support pad provided to the arm. The forehead support pad includes upper headgear connectors adapted to engage upper headgear straps and a flexible region. The upper headgear connectors are constructed of a first material and the flexible region is constructed of a second material that is more flexible than the first material to allow adjustment of the distance of the forehead support pad from the patient's forehead in use.

Abstract: A flow generator for generating a flow of pressurized breathable gas includes a cylindrical housing and a motor supported in the housing. The motor has a shaft having a first end and a second end opposite the first end. The shaft is generally coincident with an axis of the motor. A first impeller is attached to the first end of the shaft and a second impeller is attached to the second end of the shaft. A stator directs an air flow from the first impeller back towards the motor axis. The housing includes an inlet adjacent the first end of the shaft having an inlet axis generally coincident with the motor axis and at least one outlet between the first and second impellers. The at least one outlet has an outlet axis generally tangential to the motor axis.

Abstract: Systems and methods are provided for humidifying ventilation gas. Systems and methods may include a nasal interface apparatus for receiving ventilation gas from gas delivery tubing and for humidifying ventilation gas. The nasal interface apparatus may have one or more channels within the nasal interface to deliver gas from a gas delivery circuit to a patient's nose; one or more structures in fluid communication with the one or more channels to direct ventilation gas to the patient's nose; and a hygroscopic material within the nasal interface in the flow path of the ventilation gas.

Abstract: A mask for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilator support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. The pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator. The pilot may also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein.

Abstract: A cushion assembly for use with a respiratory mask includes a bladder filled with the combination of a gel having a first indentation hardness and a gel having a second indentation hardness.

Abstract: Headgear for a respiratory mask assembly includes at least one strap. The at least one strap includes one or more bladders filled with a gel.

Abstract: A mask system includes a frame (20) adapted to attach headgear, a sealing arrangement (40) releasably connectable to the frame, and an elbow (70) provided to the sealing arrangement and adapted to be connected to an air delivery tube that delivers breathable gas to the patient. The sealing arrangement defines a breathing chamber and is adapted to form a seal with the patient's face. The sealing arrangement includes structure (50) to establish a positive connection with the frame and with the elbow.

Abstract: A respiratory mask includes a frame and a flexible structure provided to the frame and adapted to engage a patient's face. The flexible structure includes a chamber filled with a first gel and a second gel that is relatively harder than the first gel. A ratio of height of the first gel to the second gel in a lip region is in the range of about 0.25 to about 0.6.

Abstract: A respiratory mask includes a mask frame, a forehead support provided to the mask frame and including a forehead member, and headgear including at least one strap adapted to connect to the forehead member. The forehead member includes one or more holes configured and positioned to allow at least one strap to form a strap loop that loops around at least a portion of the forehead member and arrange one or more layers of the strap loop between the headgear member and the patient's forehead in use.

Abstract: A nasal cushion for a mask system includes a side wall defining a breathing chamber, an undercushion extending from the side wall, and a membrane that at least partially covers the undercushion. The membrane is adapted to seal along the nasal bridge, sides of nose, corners of nose, and upper lip of the patient's face in use. The undercushion is only provided along the side of nose, corner of nose, and upper lip regions of the cushion. The undercushion includes a flap or extending portion in each side of nose region that is wider than the other regions thereof and adapted to engage and provide a force into the sides of the patient's nose in use.

Abstract: In accordance with the present invention, there is provided a mask for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilator support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask of the present invention includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. The pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator. The pilot may also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein.

Abstract: The disclosure is directed to various tubing arrangements and an associated Y-connector which may be used to facilitate the operative interface of the mask to a ventilator within a ventilation system. The tubing arrangement may comprise a pair of bi-lumen tubes. One end of each of the bi-lumen tubes is fluidly connected to the mask, with the opposite end being fluidly connected to the Y-connector. The Y-connector is in turn fluidly connected to one end of either a tri-lumen tube or a quad-lumen tube also included in the tubing arrangement, the opposite end of such tri-lumen tube or quad-lumen tube being fluidly connected to the ventilator. The Y-connector is uniquely configured to fluidly connect certain lumens of the tri-lumen tube or the quad-lumen tube to dedicated, corresponding ones of the lumens included in respective ones of the bi-lumen tubes, and to further allow for the selective detachment of the tri-lumen tube or the quad-lumen tube from the bi-lumen tubes.

Abstract: Indicating fit status of a mask in communication with a respiratory assistance device is disclosed. Upon initiating a therapeutic gas delivery from the respiratory assistance device to the mask, one or more measurements from respective one or more sensors of the respiratory assistance device is received. A leakage value from these measurements is derived, and a mask fit index is assigned. This is based at least upon a correlation of the leakage value to a particular sub-range of predetermined leakage values that corresponds to the mask fit index. The particular sub-range of predetermined leakage values is one among a plurality of sub-ranges, which together comprises an overall mask fit range defined at least by an ideal mask fit region, a loose mask fit region, and a tight mask fit region. A mask fit status based upon the assigned mask fit index is output to an indicator interface.

Abstract: A mask for achieving positive pressure mechanical ventilation (inclusive of CPAP, ventilator support, critical care ventilation, emergency applications), and a method for a operating a ventilation system including such mask. The mask includes a piloted exhalation valve that is used to achieve the target pressures/flows to the patient. The pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator. The pilot may also be a preset pressure derived in the mask, a separate pneumatic line from the ventilator, or an electro-mechanical control. The mask of the present invention may further include a heat and moisture exchanger (HME) which is integrated therein.

Abstract: Systems and methods are provided for humidifying ventilation gas. Systems and methods may include a nasal interface apparatus for receiving ventilation gas from gas delivery tubing and for humidifying ventilation gas. The nasal interface apparatus may have one or more channels within the nasal interface to deliver gas from a gas delivery circuit to a patient's nose; one or more structures in fluid communication with the one or more channels to direct ventilation gas to the patient's nose; and a hygroscopic material within the nasal interface in the flow path of the ventilation gas.

Abstract: A ventilation gas cooling apparatus or unit which, in an exemplary embodiment, is configured in a modular form adapted for selective removable engagement to a ventilator. The cooling unit includes a gas inlet port, a gas delivery port, a pressure sensing port, and a thermoelectric cooler. The inlet port is fluidly connectible to a source of therapeutic breathing gas at an external end and is fluidly connectible to an inlet of the ventilator at an internal end. The delivery port is fluidly connectible to a patient circuit at an external end and is fluidly connectable to an outlet of the ventilator at an internal end. The pressure sensing port is fluidly connectible to both a pressure sensing port of the ventilator and to the patient circuit. The cooling unit may further include a cooling fluid system which is operative to circulate either a gas coolant or a liquid coolant along at least a portion of a multi-lumen tube which is integrated into the patient circuit.

Abstract: In accordance with the present invention, there is provided is provided a tubing arrangement and associated connectors, including a delivery adaptor and a Y-connector, which may be used to facilitate the operative interface of a patient interface to a ventilator within a ventilation system. The delivery adaptor is connected between the outlet connector of the flow generator and the main delivery tube (i.e., the quad-lumen tube) in the ventilation system. The delivery adaptor functions to retain the pneumatic isolation of a sense line of the ventilation system from certain other lumens of the quad-lumen tube, and further connects one of the small lumens of the quad-lumen tube to an external oxygen source or an external humidification source. The oxygen or humidification is delivered to such lumen through the adaptor. The oxygen or humidification is then bled into the air stream at the outlet of such lumen which is at the Y-connector.