Abstract: A headgear assembly for a mask system includes a two-dimensional first headgear section and a two-dimensional second headgear section, wherein the two-dimensional first and second headgear sections are attached to one another to form a three-dimensional anatomically-shaped headgear assembly.

Abstract: The present invention relates to a patient interface device and system for delivering continuous airway pressure to a patient (14). The patient interface system comprises a patient interface (12) and at least one bone anchor (24, 26) fixed to the patient (14). The patient interface (12) is attached to the patient (14) by connection to the at least one bone anchor (24, 26). This is realized by coupling elements (32, 34) as part of the patient interface device.

Abstract: A mask for patient ventilation comprises a frame portion, a front portion, a retention strap, and a gas delivery orifice. The frame portion is for surrounding a respiratory opening of a patient. The front portion is coupled with the frame portion and covers the respiratory opening region. The retention strap is for maintaining positive pressure between the frame portion and the patient. The gas delivery orifice is coupled with the frame portion and configured such that the gas delivery orifice is lateral to the front portion.

Abstract: Ergonomic protective air filtration devices and methods for manufacturing the same are disclosed herein. An ergonomic protective air filtration device includes a stack of at least two layers of an air permeable material, the stack forming a body, a periphery, and a back; a plurality of intersecting three-dimensional V-shaped pleats extending from the periphery and into the stack of layers, so the back of the device defines a breathing chamber adapted to cover a mouth and a nose of the wearer; and a retaining means engaging the body of the device to secure the device to a face of the wearer and to create the breathing chamber. The ergonomic protective air filtration device provides protection against contaminated droplets, fluid splashes, solid particulates, pathogenic microorganisms, or aerosoled air pollutions.

Abstract: A continuous positive airway pressure (“CPAP”) mask is provided. The CPAP mask includes a mask support that includes a cavity provided within the mask support. The CPAP mask further includes a mask cushion that is received within the cavity. The mask cushion and the mask support each include an opening. Air can pass from an air delivery tube through the openings and into the mask cushion. The mask cushion can be placed around a patient's breathing orifice to deliver the air to the patient. The CPAP mask further includes a forehead support that is spaced apart form the mask support. A neck portion attaches the forehead support to the mask support. The neck portion is flexible and is molded to both the mask support and the forehead support. The flexible neck portion allows the mask support to move with respect to the forehead support.

Abstract: A respirator mask device includes a frame unit, a mask shell connected pivotally to the frame unit, a mask cushion secured to the mask shell, an adjusting unit operable for adjusting relative position between an upper end of the mask shell and the frame unit, two connecting pieces disposed respectively on left and right sides of a lower end of the frame unit and connected pivotally to the mask shell, two first engaging members disposed respectively on the left and right sides of the lower end of the extension frame, and a head strip unit. The head strap unit includes a strap body, and two second engaging members disposed on the strap body and connected respectively and removably to the first engaging members.

Abstract: A respiration assist mask having an input gas feed tube, a ventilation interface, a facial interface and nasal inserts. The gas feed tube can connect to the ventilation interface and form a seal. The ventilation interface may be joined with the facial interface to form a seal between the ventilation interface and the facial interface, as well as between the facial interface and the face of a user. Additionally, nasal inserts may be inserted into a portion of the facial interface and form a seal between the inserts and the facial interface.

Abstract: The invention relates to a respiratory mask comprising a mask body and an articulated connection piece that can be connected to a respiratory tube. On the mask body, at least one exhalation gap is located in the vicinity of a connection that holds the articulated connection piece. Preferably, the exhalation gap terminates in an umbrella-shaped outflow channel that runs away from the patient. Preferably, at least two components of the respiratory mask are interconnected without play.

Abstract: A method of relieving pain resulting from breathing in a patient with fractured ribs, wherein the pain interrupts the sleeping of the patient. A positive airway pressure machine is attached to the nose or nose and mouth of the patient. The patient turns the machine on to produce a positive airway pressure in the airways of the lungs and adjusts the positive airway pressure to a level where the patient feels that the pain is reduced or eliminated. The method allows a patient with fractured ribs to sleep comfortably without the pain associated with breathing in and out, and without interruption of sleep. The method also promotes the healing and recovery of the fractured ribs.

Abstract: A respiratory mask system is provided, in which while wearing a respiratory mask system, force generated by movement of a user's head and the like to induce laterally slipping a mask cushion may be reduced or absorbed. The respiratory mask system is provided with a mask cushion covering a nose, a nose and a mouth, or a full face. A first frame is connected with the mask cushion to supply respiratory gas under positive pressure. A second frame is connected with a headgear strap, in which the mask cushion is placed on a face side of the first frame and the first frame is placed on a face side of the second frame. The first frame is connected slidably with the second frame along a slide surface.

Abstract: The present inention provides a cost effective customization of user interface devices for use with respiratory ventilation systems, such as face masks that may be used for CPAP therapy. By integrating a user specific customize element (15) into a pre-fabricated user interface device (10), increased confort for a user during use of the interface device (10) is provided. The customized element (15) is adapted to affect the shape of the user interface device making it compliant with at least one user specific body feature, for example, a facial feature of a particular user. The shape of the customized element may be computed from a user specific data set representing an e.g. three-dimensional shape at least one body feature of a user.

Abstract: An application device for a breathing mask arrangement includes a base portion, a holding portion structured to support a mask and pivotally mounted to the base portion for pivotal movement about a first pivot axis, a right arm element pivotally mounted to the base portion for pivotal movement about a second pivot axis, and a left arm element pivotally mounted to the base portion for pivotal movement about a third pivot axis. The right and left arm elements are each provided with a contact portion for bearing against a right and a left forehead zone respectively of a mask user. The holding portion, the right arm element, and left arm element can be pivoted with respect to the base portion about the respective first, second, and third pivot axes.

Abstract: A mask assembly adapted for use with a positive airway pressure device, includes a mask frame, an elbow assembly provided to the frame, a cushion provided to the frame, a forehead support assembly, and a neck to connect the frame to the forehead support assembly, wherein the neck includes a pair of side walls having a streamlined design that is made to look sleek and reduce or minimize obtrusiveness. The pair of side walls may take the form of a single wall or more than two walls. The mask frame may include a recessed port structure including at least one port having access to an interior of the frame which at least in part with the cushion defines a breathing chamber in communication with a nasal passage of the patient in use. The mask frame may also include a channel to receive the cushion. The channel is formed by an outer wall and an inner wall and the channel includes an inner surface having a bead to engage with an outer surface of an edge of the cushion.

Abstract: A mask assembly that includes a mask frame; a frame connector; a forehead support comprising a tube and a forehead cushion support plate, the forehead cushion support plate extending perpendicularly to a longitudinal axis of the tube; and an adjustment knob movably mounted to the frame connector, wherein the tube is movably mounted to the frame connector for linear movement with respect to said frame connector, and further wherein the tube includes at least one split that allows deflection of the tube when inserting the tube into the frame connector.

Abstract: According to one embodiment, a custom medical mask formed for a particular user from a three-dimensional electronic model includes a body formed from a polymerized photopolymer material. An interior surface of the body is configured to seat on the particular user's face and comprises a physical embodiment of a three-dimensional electronic model corresponding to unique facial features of the particular user. According to another embodiment, a method of creating a three-dimensional electronic model for use in forming a custom medical mask for a particular user includes scanning a portion of the particular user's face using an electronic scanning device, generating a three-dimensional electronic model of the portion of the particular user's face based on the scanning, and transmitting the three-dimensional electronic model of the portion of the particular user's face for use in forming the custom medical mask for the particular user from a photopolymer using a stereolithography apparatus.

Abstract: A full-face cushion for a patient interface that delivers breathable gas to a patient includes a frame connector adapted to attach the cushion to a mask frame and an interface provided to the frame connector. The interface is constructed of foam and defines a cushion cavity. The interface includes a foam contact surface adapted to interface or contact with surfaces of the patient's face in use.

Abstract: Headgear for a respiratory mask includes a strap arrangement comprising front strap portions adapted to be disposed over a patient's cheeks and each having a connector adapted for attachment to an airway interfacing portion, and a cover provided to each front strap portion and structured to at least partially encapsulate the front strap portion. The cover includes side portions adapted to be wrapped around the front strap portion and releasably fastened to one another.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and a headgear assembly which are adapted to being remove ably magnetically coupled to one another at a desired angular orientation therebetween.

Abstract: A patient interface assembly that includes a first conduit, a second conduit, and a patient interface coupled to the first conduit and the second conduit. The first and second conduits each include a first end that is disposed proximate to a top of a head of a user, and a second end that is disposed proximate to an airway of such a user when the patient interface assembly is being worn by the user. The first and second conduits also each include a central portion that extends along the sides of a face between the user's eye and an ear a head strap is coupled between the first and second conduit, and a patient interface is coupled to the second ends of the first and second conduits.

Abstract: A medical device may include a patient interface for use in a breathing assistance system, an electronic device coupled to the patient interface, and one or more electrical conductors at least partially integrated with the patient interface. The patient interface may include a connection end configured for receiving gas communicated by a gas delivery apparatus, and a patient end configured for insertion into or more breathing passageways of a patient. The one or more electrical conductors at least partially integrated with the patient interface may be capable of facilitating communication of electrical signals between the electronic device and the gas delivery apparatus when the patient interface is communicatively coupled to the gas delivery apparatus.

Abstract: A breathing mask has a mask body, a mounting bracket and a universal connecting tube. The mask body has a first universal socket bracket having a first spherical recess. The mounting bracket is mounted on the mask body and has a second universal socket bracket having a second spherical recess. The universal connecting tube is mounted universally pivotally in the mask body and has a ball joint mounted universally rotatably in the first and second spherical recesses. The universally rotating ball joint allows a breathing tube connected to the universal connecting tube to pivot to any orientations and prevents the breathing tube from over bending.

Abstract: A connector arrangement joining a respiratory mask and headgear is adapted for single-handed disengagement by the patient. A first, rigid connector part is formed into the rigid mask frame, with a mating second connector attached to a strap of the headgear. The connectors are held away from the patient's face by the connection to the mask frame.

Abstract: A method for geometrically forming a portion of a headgear to conform to a selected portion of an intended user's head. The method includes determining a triangular region on the portion of the headgear that generally coincides with the selected portion of the intended user's head. The triangular region being defined by a first side, a second side and a third side. The method further includes forming a curved and cupped region in the portion of the headgear by bringing together and coupling the second and third sides of the triangular region.

Abstract: A multi-positional connector for respiratory support systems that enables the attachment and detachment of an accessory device to a respiratory support system in a manner that does not require an interruption in a patient's oxygen supply but does allow the patient to easily. change positions when the accessory device is a nebulizer. The device has four components that are push-fit together and are able to rotate relative to each other.

Abstract: A positive-pressure respiratory mask can be used during medical procedures to provide oxygen to a patient while the instruments and devices used in the procedure remain in place. A flap system that includes a flexible diaphragm is used on the mask to create an airtight seal around the instrument.

Abstract: A mask (10) for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal's airways. The mask (10) includes a mask shell (12) which is, in use, in fluid communication with a gas supply conduit and a gas washout vent assembly (20). The gas washout vent assembly (20) includes at least one gas washout orifice (22) extending from a first side of the vent assembly (20) positioned, in use, adjacent the human or animal's face and a second side positioned, in use, adjacent the atmosphere. The cross-sectional area of the orifice (22) at the first side is larger than the cross-sectional area of the orifice (22) at the second side.

Abstract: An integrated nasal mask is adapted for delivering gas to a patient and comprises a mask body and a pair of elongate nostril-engaging stems. The mask body is generally triangularly shaped and includes a nasal opening sized and configured to substantially envelope a patient's nose. The nasal opening opens to a nasal cavity. The nostril-engaging stems extend outwardly from the nasal cavity. Each one of the stems defines a fluid passageway for delivering gas to the patient's nose and for allowing discharge of exhalation gasses during the exhalation phase of the breathing cycle.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a front surface and a rear surface, opposite the front surface, and adapted in use to face the patient. The frame defines an inner wall and an outer wall extending from the rear surface, the inner and outer walls being spaced to define a channel therebetween. A cushion is removably attachable to the frame such that the cushion and frame are repeatably engagable with and disengagable from one another. The cushion includes a side wall to be inserted into the channel of the frame, the side wall having a first interlocking surface that engages a second interlocking surface provided in the channel when the cushion and frame are engaged with one another. The first and second interlocking surfaces interlock with one another to removably attach the cushion to the frame.

Abstract: Condensation management techniques for a gas flow delivery system. The techniques include providing a radiant barrier associated with patient circuit and/or a patient interface, providing a water trap and/or an absorbent insert in the patient interface device, or a combination of these techniques. The radiant barrier prevents condensation from forming in the patient circuit and/or the patient interface. The water trap and absorbent insert in the patient interface control condensation that reaches or forms in the interior of the patient interface to prevent it from interfering the user of the gas delivery system.

Abstract: A patient interface device includes a support structure, a pivot arm pivotably coupled to the support structure and structured to pivot about an axis, a patient coupling member, such as a mask or a forehead support, coupled to the pivot arm, and a cam wheel rotateably coupled to the support structure and engaging the pivot arm, wherein rotation of the cam wheel relative to the support structure and the pivot arm causes the pivot arm to pivot about the axis and the patient coupling member to move either forward or backward along a path of movement. Also, an alternative patient interface device includes a cam wheel rotatable about a cushion member that changes a position of a main body portion of the cushion member relative to a headgear frame member of the patient interface device.

Abstract: A respiratory face mask is provided suitably sized and configured to engage the nose portion, mouth portion and chin portion of a patient's face. The face mask is characterized by a cup-like shell or receptacle member defining a peripheral flange and a flexible inflatable hollow sealing cushion on the shell member flange. Headstrap fastener projections extending upright on the flange are adapted to accommodate an elastic headstrap that adjustably may be removably slidingly coupled to the projections to hold the mask in place on a patient's face and head.

Abstract: A method for attaching a removable, washout vent insert to a CPAP mask, the CPAP mask comprised of a rigid plastics shell having an inlet tube, the rigid plastics shell having an opening bounded by a rim, the vent insert being made of a material more flexible than the rigid plastic shell, the vent insert having a plurality of orifices, the vent insert, in a cross-sectional view, having a recess located at its periphery, includes: squeezing the vent insert along its longitudinal axis; aligning the vent insert so it is oriented to match the shape of the opening; inserting the vent insert into the opening; and releasing the vent insert once it is within the opening, the vent insert resiliently expanding to engage the rim of the opening.

Abstract: An elbow assembly for use in a respiratory mask, which includes an elbow, an inlet port, an exhaust port, and a baffle separating the inlet port from the exhaust port. A mask assembly includes a cushion comprising at least one gusset and an aperture for connection to the elbow assembly.

Abstract: A filter system includes a housing, a filter medium disposed within the housing and a optical analyte sensor also disposed within the housing in fluid communication with the filter medium. The optical analyte sensor includes a detection medium that changes at least one of its optical characteristics in response to an analyte. The filter system further includes an optical reader having at least one light source and at least one detector. The optical reader is attached to the housing such that at least a portion of light emitted by at least one light source is reflected from the optical analyte sensor and captured by at least one detector.

Abstract: A sealing lip device for a breathing mask includes a receiving opening for receiving at least the nose tip region of a mask wearer, a sealing lip which is formed from an elastomeric material and which surrounds the receiving opening and which is configured to cross the bridge of the nose and which has a contact zone provided for bearing against the face of a mask wearer in use. The sealing lip is elastically and yieldingly arranged in such a way that a first sealing lip zone which in use seals the region of the bridge of the nose has a higher degree of flexibility than a second sealing lip zone which in use is adjacent to at least one of the nostrils and the upper lip of the mask wearer in the application position of the breathing mask. The sealing lip includes a folding bellows structure that suspends the sealing lip in the region of the first zone provided for sealing of the region of the bridge of the nose. The folding bellows structure includes a fold indentation having zones of differing wall thickness.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and at least one locking clip. The frame has a main body and a side frame member provided on each lateral side of the main body, at least one of the side frame members including a locking clip receiver assembly. The at least one locking clip has a main body providing a front portion adapted to be removably coupled with the at least one locking clip receiver assembly and a rear portion adapted to be removably coupled to a headgear assembly. The rear portion includes a cross bar that forms an opening through which a strap of the headgear assembly can pass and be removably coupled with the cross bar, and the front portion includes at least one resiliently flexible spring arm that is flexible within the plane of the main body.

Abstract: A continuous positive airway pressure (“CPAP”) mask is provided. The CPAP mask includes a mask support that includes a cavity provided within the mask support. The CPAP mask further includes a mask cushion that is received within the cavity. The mask cushion and the mask support each include an opening. Air can pass from an air delivery tube through the openings and into the mask cushion. The mask cushion can be placed around a patient's breathing orifice to deliver the air to the patient. The CPAP mask further includes a forehead support that is spaced apart form the mask support. A neck portion attaches the forehead support to the mask support. The neck portion is flexible and is molded to both the mask support and the forehead support. The flexible neck portion allows the mask support to move with respect to the forehead support.

Abstract: A full-face cushion comprises a frame and a membrane. The membrane has an aperture into which the wearer's nose is received. The membrane is spaced away from the frame. Respective notches receive the bridge of the wearer's nose. The wearer's nose and lips are received through the aperture into the chamber within the mask body. The seal forming portion thus contacts both the surface of the wearer's nose and a portion of the wearer's face in the region between the bottom lip and the chin, and around the sides and over the bridge of the nose.

Abstract: A forehead abutting device for use with a respiratory mask without adjustment thereof is provided. The upper end of the respiratory mask extends upward to form a support portion. A forehead cushion component, which has a forehead cushion and is capable of protracting and retracting resiliently and automatically, is disposed at the upper end of the support portion. The forehead cushion component includes a forehead cushion and a pipe portion extending therefrom. The terminal end of the pipe portion abuts against a receiving hole portion disposed at the upper end of the support portion. A resilient element capable of pushing the forehead cushion component outwardly and resiliently is disposed inside the receiving hole portion. The mask is fixed at three points and accurately positioned, fits different forehead contours through the forehead cushion component, imposes less burden on the nasal bridge, and prevents gas leakage.

Abstract: A cushion for a patient interface includes an outer membrane providing a sealing structure adapted to form a seal with the patient's face in use and an underlying membrane generally spaced away from the outer membrane. The underlying membrane provides a support structure for the outer membrane. The outer membrane and the underlying membrane each have an inner edge which defines an aperture to receive the patient's nose in use. The underlying membrane is segmented along its inner edge.

Abstract: A patient interface that reliably and comfortably seals a user's face by providing an oral-nasal mask that includes an integrated nasal interface. The patient interface includes a seal member having an oral cushion portion configured to surround the user's mouth and a nasal interface portion that provides an interface with the user's nose. The seal member, including the oral cushion portion and the nasal interface portion, is a unitary member. Finally, the nasal interface portion remains below the bridge of the nose.

Abstract: Headgear for a respiratory mask includes a strap arrangement including front strap portions adapted to be disposed over a patient's cheeks and having front ends adapted for attachment to an airway interfacing portion, top strap portions connected to respective front strap portions and adapted to be disposed over the top of a patient's head and to connect to each other, and a back strap extending rearwardly from and connecting respective junctions of the front strap portions and top strap portions or regions adjacent these junctions and adapted to locate underneath a patient's occiput. In use with a patient having long hair, the back strap is adapted to extend under the patient's hair and urge upwardly on the patient's hair and against the patient's head beneath the occiput. In use with a patient having short hair, the back strap is adapted to urge against the patient's head beneath the occiput. In an embodiment, front strap portions of the headgear may be provided with a sleeve or cover (e.g.

Abstract: A filtering face-piece respirator 10 that comprises a mask body 12 and a harness 14 that is joined to the mask body 12. The mask body 12 includes a filter layer 30 and a nonwoven fibrous cover web 16. The fibrous cover web 16 is partially occluded and is generally parallel to and spaced from the filter layer 30 such that air passing through the cover web 16 can move freely between the cover web 16 and the filter layer 30 so that it can enter the filter layer 30 at essentially any available point over the filter layer surface 32. The inventive respirator is beneficial in that it can provide very good splash fluid and airborne contaminant protection while also exhibiting an extraordinary low pressure drop across the mask body during breathing.

Abstract: A headgear or headgear segments are manufactured to shape thereby producing little or no waste material. Techniques such as knitting, braiding, crocheting, and 3D printing can be used produce the headgear.

Abstract: A ventilation mask having a cushioned facial interface and an adjustable support structure. The ventilation mask can have a gas delivery port with a gas delivery tube rotatably coupled thereto. The cushioned facial interface may have one or more interior membranes and an extended lower portion. The support structure may have an adjustable slide allowing a wearer to adjust the mask to increase comfort while maintaining a gas-tight seal between the mask and the face of the wearer.

Abstract: A respiratory mask assembly including a frame and a cushion provided to the frame. The cushion including a non-face contacting portion removably attached to the frame and a face-contacting portion adapted to engage a patient's face. The face-contacting portion includes a side wall, a rim extending from the side wall and curving inwardly into a cavity of the cushion, and a membrane substantially surrounding the rim and including an inside surface spaced from an outside surface of the rim. The cushion includes a gusset portion extending radially outwardly from the side wall of the face-contacting portion and a reinforcing ring between the gusset portion and the face-contacting portion. The reinforcing ring is constructed and arranged to act as a stiffening hoop to reduce the tendency of the cushion to expand when under pressure.

Abstract: A patient interface device (e.g., nasal pillows, a nasal mask or a full-face mask) for delivering breathable gas to a patient has a frame with a main body and a side frame member provided on each lateral side of the main body, each side frame member including a first connector portion, and a headgear assembly removably attachable to the frame, the headgear assembly having a second connector portion adapted to be removably coupled with the first connector portion provided on the frame. The first connector portion and the second connector portion are configured for rotationally locking engagement in a plurality of different rotationally locked positions in which the first and second connector portions may not rotate relative to one another, such that the headgear assembly is rotationally adjustable with respect to the frame.

Abstract: In one embodiment, a nasal cannula is shaped to fit within a user's nares, includes at least one prong allowing high flow delivery of humidified gases and creates positive airway pressure in the patient's airway. The prongs have angled ends, such that in use, gases flowing through the prongs are directed to the user's nasal passages. The nasal cannula body is partially swivelling and preferably has a ball joint connector. In another embodiment the nasal cannula may have at least one flared end prong that preferably seals within a patient's nare.

Abstract: In a mask for patient ventilation, a frame portion is included for surrounding a respiratory opening of a patient. A retention strap is coupled with the frame portion for maintaining positive pressure between the frame portion and the respiratory opening of the patient. A removable insert is configured to physically attach and detach from the frame portion without requiring removal of the frame or the retention strap from the patient.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and at least one locking clip. The frame has a main body and a side frame member provided on each lateral side of the main body, at least one of the side frame members including a locking clip receiver assembly. The at least one locking clip has a main body providing a front portion adapted to be removably coupled with the at least one locking clip receiver assembly and a rear portion adapted to be removably coupled to a headgear assembly. The rear portion includes a cross bar that forms an opening through which a strap of the headgear assembly can pass and be removably coupled with the cross bar, and the front portion includes at least one resiliently flexible spring arm that is flexible within the plane of the main body.