Abstract: A respiratory mask body having a nose region including a seal and a support extension is provided. In an exemplary embodiment, the mask body has a nose region including a support extension which extends in a direction away from the seal and is configured to contact a user's nose at a position beyond the seal.

Abstract: A nasal assembly for delivering breathable gas to a patient includes a frame having an integrally formed first connector portion. A nozzle assembly includes a gusset or base portion and a pair of nozzles. At least one inlet conduit is structured to deliver breathable gas into the frame and nozzle assembly for breathing by the patient. A pair of second connector portions are removably and rotatably connected to respective first connector portions of the frame and are in communication with respective inlet conduits, e.g., directly or via angle connectors. A headgear assembly is removably connected to the pair of second connector portions and/or the angle connectors so as to maintain the frame and the nozzle assembly in a desired adjusted position on the patient's face.

Abstract: A disposable mask made from bioplastic resins includes a biodegradable resin selected from the group consisting of polylactic acid (PLA), cellulose based PH, polycaprolate (PCL), polybutyleneadipatetetephathalate (PBT), polyhydroxyalkanoate (PHA), green polyethylene (GPE), green polyethylene terephthalate (GPET), Poly3-hydoxybutrate-3-hydroxyhexxanate (PHBH), poly-D-lactide (PDLA), and poly-L-lactide (PLLA); a plasticizer intermixed with the resin to provide a generally homogenous bioplastic; and a medical mask that includes a shell substantially made of the bioplastic and a biodegradable cushion attached to an edge of the shell.

Abstract: A mask system including a frame module and a cushion module provided to the frame module and adapted to form a seal with the patient's face. The cushion module includes a main body defining a breathing chamber and adapted to interface with the frame module and a cushion adapted to form a seal with the patient's face. The main body and the cushion are comolded with one another.

Abstract: A mask system for delivering air to a user includes a suspension mechanism to allow relative movement between a face-contacting cushion and a mask shell. The suspension mechanism also provides a predetermined force to the cushion that is a function of mask pressure, displacement of the cushion or both.

Abstract: A mask assembly includes a mask with an inflatable bladder. The internal pressure of the inflatable bladder can be set to be higher than the delivered therapeutic pressure. The pressure offset may be constant, or it may vary over the range of therapeutic pressures. Thus, the force necessary to maintain a contact seal between the mask and the patient can be reduced, thereby providing a system that is more comfortable to the patient, which increases patient compliance.

Abstract: A cushion for a patient interface that delivers breathable gas to a patient includes a base wall structured to be connected to a frame, an underlying support cushion extending away from the base wall towards the patient's face in use, and a membrane provided to substantially cover at least a portion of the underlying cushion. The membrane is adapted to form a continuous seal on the patient's face. The underlying cushion has a spring-like connection with the base wall. The underlying cushion and/or base wall define a spring constant that varies along a length of the seal.

Abstract: A respirator includes a mask having a body extending between a front edge and a rear edge, and a face seal extending inward from the body. The face seal has a first wall extending from the body and a second wall intersecting with the first wall at a sealing land. The sealing land is configured to contact a user's face to form a continuous circumferential seal. The face seal is folded over such that the first wall and the second wall both extend away from the sealing land in a common direction. Optionally, the face seal may be U-shaped.

Abstract: An interfacing structure is arranged to cooperate with a frame to contact with the skin of a patient. The interfacing structure includes a clip portion joined to a cushioning component. The frame is more rigid than the clip portion and the clip portion is more rigid than the cushioning component.

Abstract: A full-face cushion for a patient interface that delivers breathable gas to a patient includes a frame connector adapted to engage the cushion with a mask frame. A clip is provided to maintain the cushion to the frame. The clip includes clip portions that connect to the frame with a snap-fit.

Abstract: A mask system including a frame module and a cushion module provided to the frame module and adapted to form a seal with the patient's face. The cushion module includes a main body defining a breathing chamber and adapted to interface with the frame module and a cushion adapted to form a seal with the patient's face. The main body and the cushion are comolded with one another.

Abstract: A full-face mask assembly includes a frame, a cushion provided to the frame, the cushion adapted to form a seal around the patent's nose and mouth and a skeleton frame to maintain the cushion to the frame, the skeleton frame including at least one of an upper support member adapted to support a forehead support, lower headgear clip receptacles adapted to be engaged with clips provided to straps of a headgear assembly, and an annular elbow connection seal adapted to engage an inlet conduit.

Abstract: A sealing interface forms part of an apparatus for supplying a flow of respiratory gases to a user. The sealing interface comprises a foam or gel inner cushion and a thin resilient rubber outer sheath. A face side of the inner cushion resiliently supports the outer sheath. The inner cushion has a toothed profile formed on the face side of the inner cushion. The toothed profile consists of at least one tooth having an apex on the perimeter of the inner cushion. The apex is positioned between two valleys in the perimeter of the inner cushion. In use the apex of each tooth of the toothed profile is in supporting contact with the outer sheath.

Abstract: A patient interface device includes an elastomeric contacting portion that is structured to directly engage the skin of the user. The contacting portion has an engineered surface that includes a plurality of non-random, predesigned surface features designed to reduce friction and improve user comfort. In one implementation, the pitch between each immediately adjacent pair of the surface features is less than or equal to a predetermined maximum pitch value, and the height of each of the surface features is less than or equal to a predetermined maximum height value.

Abstract: A hollow structure for a face mask includes an inner wall, an outer wall spaced from the inner wall to define a hollow area between the inner wall and the outer wall, and a bottom wall that couples the inner wall to the outer wall. A first portion and a second portion together define a closable opening into the hollow area. The second portion is coupled to the outer wall by a bi-stable membrane that allows the second portion to move between (1) a first, opened position in which the second portion is spaced from the first portion to allow access to the hollow area through the opening, and (2) a second, closed position in which the second position abuts the first portion to close the opening.

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 breathing mask arrangement includes a mask frame, a sealing structure provided to the mask frame and adapted to form a seal with a patient's face, and a forehead support device movably mounted to the mask frame for adjustable movement with respect to the mask frame. The sealing structure is movably mounted to the mask frame for adjustable movement with respect to the mask frame, and the adjustable movement of the sealing structure is independent of the adjustable movement of the forehead support device.

Abstract: A respiratory interface device is provided that includes a mask (10) and a brace (40) assembly. The mask has a faceplate (12) and a cushion (15), and the brace assembly has a brace body (42) and a lever assembly (44). The brace body is coupled to the mask faceplate, and the lever assembly has at least one lever arm (70) and at least one actuator assembly (72) for each lever arm. The at least one lever arm has a body (76) and a pivot assembly (90). The lever arm body is pivotally coupled to the brace body at the pivot assembly. The lever arm body is structured to move between two positions, a first position, where the lever arm body does not effectively engage a portion of the mask, and a second position, wherein the lever arm body effectively engages a portion of the mask.

Abstract: A non-invasive ventilation patient interface comprises a fresh gas entry port, an exhaust gas entry port, and a facial skin interface. Fresh gas entry port is configured for coupling with a fresh gas supply. The exhaust gas vent port is configured for allowing expulsion of exhaust gas from the patient interface. The facial skin interface is configured for eliminating fluid from within the patient interface and for eliminating fluid from facial skin which is covered by the patient interface.

Abstract: Described herein is a mask for delivery of gas, such as oxygen, to a patient and useable in a naso-gastric intubation procedure without disruption of the seal between the mask and the patient's face. The body of the mask includes a fenestration or opening through which the naso-gastric tube may be inserted. The fenestration is preferably shaped to support the tube in a manner that is comfortable for the patient and that eliminates or minimizes the amount of gas lost to the atmosphere outside the mask. In at least some embodiments, the fenestration is closed when a tube is not inserted therethrough so that the mask may be used normally without loss of the gas through the fenestration.

Abstract: A method of adjusting the fit of a patient interface device having a nasal cushion rotatably coupled to frame member includes providing resistance to rotation of the nasal cushion assembly in a first direction toward a face of a patient using a rotational resistance mechanism provided between the nasal cushion and the frame member, and responsive to a force being applied to the nasal cushion by a nose of the patient, allowing the nasal cushion to rotate relative to the frame member in the first direction against the resistance to a tilted position, wherein in the tilted position the rotational resistance mechanism biases the cushion assembly in favor of rotation in a second direction opposite the first direction.

Abstract: A cushion assembly (16) for use in a patient interface device (10) includes a cushion member having a sealing flap (24) adapted to sealing engage a user's face about at least one of an oral orifice or nasal orifices of the user. The cushion member defines a cavity (30) therein accessible via an opening generally defined by the sealing flap. The cushion assembly further includes a stabilizing member (16b) having a first end and an opposite second end, the first end and the second end being selectively coupled to the sealing flap such that the stabilizing member spans across at least a portion of the opening.

Abstract: A chin strap includes a chin cup, side straps, and rear straps. The chin strap is used to urge the patient's jaw upwards and substantially close the patient's mouth while pressurized breathable gas is delivered to the patient's nose by the mask system.

Abstract: A full-face cushion comprises a substantially triangularly shaped frame from which extends a membrane. The frame has a scalloped edge by which the cushion is affixed to a mask body to form a full-face mask. The membrane has an aperture into which the wearer's nose is received. The member is spaced away from the rim of the frame, and its outer surface is of substantially the same shape as the rim. 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. The shape of the seal forming portion is particularly suited to effectively seal the difficult region of the facial contour that is the crease between the sides of the nose and the face.

Abstract: A non-invasive ventilation patient interface comprises a fresh gas entry port, a frame, and a zygomatic facial interface. The fresh gas entry port is configured for coupling with a fresh gas supply. The frame is configured for coupling with a head strap system, wherein the head strap system is configured for supplying a securing force to secure the patient interface in a position over a respiratory opening of a patient. The zygomatic facial interface is coupled with the frame and configured for spreading the securing force away from a nasal bridge of the patient and onto left and right zygomatic arch regions of the patient.

Abstract: A patient interface device (8) includes a cushion member (16) structured to engage a face of a patient when the patient interface device is donned by a patient, and a frame assembly (14), wherein the cushion member is coupled to the frame assembly. The frame assembly including a main frame member (18) having a plurality of pocket members (32) provided therein, and a plurality of peg members (20) coupled to the main frame member, wherein each peg member includes an arm member (42) that is received and held within a respective one of the pocket members at a user selectable position, and where in movement of the peg members relative to the main frame member adjusts a size and/or shape of the patient interface device.

Abstract: A patient interface device (8) includes a cushion assembly (100) that is customizable to compensate for anatomical variances from patient-to-patient and, therefore, provides an effective seal with the patient's face. The cushion assembly includes a cushion member (102) having a first side structured to engage the patient's face, and a second side disposed opposite the first side, a plurality of plate members (108, 110, 112, 114, 116), and an adjustment mechanism (120, 122, 124). The adjustment mechanism is structured to adjust the position of the plate members, thereby changing the shape of the cushion member to gener ally conform to the patient's face.

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: A mask system has a shroud module with headgear connectors adapted to removably attach to respective headgear straps of headgear; and a cushion module, including a frame defining a breathing chamber; and a cushion to form a seal with the patient's face in a nasal bridge region, a cheek region and a lower lip/chin region of the patient's face. The cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion, and a nasal bridge portion of the cushion includes one or more folds to provide in use a higher level of adaptability or flexibility to the nasal bridge region of the cushion module relative to another region of the cushion module. The shroud module and the cushion module are configured to be removably coupleable to one another.

Abstract: A ventilation mask for sealing on a face of a patient comprises a nasal passage opener configured for facilitating in opening the nasal passage of the patient. The nasal passage opener is disposed over a nasal valve of the patient when the ventilation mask is sealed on the face of the patient.

Abstract: According to the present device, system, and method, the respiratory assistance mask comprising a hollow body bounding an internal chamber provided with a respiratory gas inlet and outlet, and a bearing member is remarkable in that it also comprises: a flexible membrane inserted on said bearing member and being able to be interposed between said bearing member and the face of said patient; and a multi-perforated internal skirt inserted, thru one of its two contours, on said bearing member and surrounded, at least partially, by said flexible membrane, the free contour of said skirt extending in direction of said internal chamber.

Abstract: A cushion arrangement for a patient interface (for communicating with the nose or the nose and mouth of a patient) comprises a cushion and a shaping structure in contact with the cushion. The shaping the comprises a thermo-shrink material, and the local dimension of themo-shrink material determines a level of local compression or expansion of the cushion. The shaping structure enables the cushion to be customised for the end user.

Abstract: In a method for adjusting a ventilation mask, a ventilative state is measured of a ventilation mask that is placed over a respiratory opening of a patient. A sealing portion of the ventilation mask is for establishing a fluid seal between the ventilation mask and the patient. The sealing portion comprises a plurality of bladders. An unintentional leak of the fluid seal is determined based on a measured change of the ventilative state. A bladder of the plurality of bladders is adjusted to seal the unintentional leak.

Abstract: A cushion assembly for use in a patient interface device includes a first end portion adapted to engage a user's face; a second end portion opposite the first end portion, the second end portion being adapted to be coupled to a mask shell; a cushion portion having a wall portion extending between the first end portion and the second end portion, the wall portion including a stiffened portion; and a dampening portion including a dampening material disposed about the second end portion and adapted to be disposed between the stiffened portion and the mask shell.

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: A patient interface device (8) includes a patient sealing assembly (12) structured to engage a face of the patient when the patient interface device is donned by a patient. The patient sealing assembly has a bottom region (36), a top region (38) opposite the bottom region, and a side region (40, 42) extending from the bottom region to the top region, wherein one or more orifices (48a, 48b) are provided in the side region, the one or more orifices each extending from an interior of the patient sealing assembly to an exterior of the patient sealing assembly and being structured to allow a liquid that condenses within the patient sealing assembly to drain from the patient sealing assembly.

Abstract: A cushioning component for use with a mask is constructed of foam material. A patient contacting surface, that is adapted to contact a patient, in use, has a rounded cross sectional profile and a base surface opposed to the patient contacting surface.

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: An improved patient interface has a post to which can alternatively be attached a clip or a strap. A strap apparatus includes a clip mounted at an end of a strap, but if the clip is lost the strap can itself be mounted to the post.

Abstract: A respiratory mask has an adjustable forehead support member that is simple and inexpensive to manufacture. The forehead support member may be adjusted by rotating a forehead pad about an off-center bore or by bending an angular adjustment beam. The mask has a mask cushion with an accordionate membrane having at least two hinged portions. The mask may be constructed with a mask frame, the mask cushion, and the forehead support member molded as one piece.

Abstract: A patient interface device (8) includes a frame (14) including a faceplate (18) having an outer surface (18A) and an inner surface (18B), the inner surface having an inward facing portion (74) which is oriented generally perpendicular to a patient's face when disposed on a patient's head. A cushion assembly (16) is coupled to the frame. The cushion assembly includes a support frame (44) including a coupling portion (48) having a bottom surface (48A) and an opposite top surface (48B) and a sealing cushion (46) coupled to the coupling portion of the support frame. The sealing cushion includes a first portion (62) extending from the bottom surface of the coupling portion and a second portion (64) extending from the top surface of the coupling portion, wherein an outward facing portion (72) of the second portion of the sealing cushion sealingly engages the inward facing portion of the frame.

Abstract: The disclosure discloses an eye protection adjunct that provides protection to a person's eyes and resembles a normal pair of eyewear, but contains a hidden facepiece that deploys into a face protection system for the eyes, face, nasal and pharyngeal openings.

Abstract: A patient interface device (8) includes a cushion member (10), a frame member (16), and nasal pillows (18,20). A first side (12) of the cushion member forms a seal with a patient's mouth. The nasal pillows are structured to form a seal with the patient's nares. The nasal pillows are attached to the frame member. The frame is attached to a second side (14) of the cushion member. The frame member includes a connecting portion (228), a first aperture (240), and a second aperture (242). The nasal pillows include a first nasal pillow element (218) and a second nasal pillow element (220). The first nasal pillow element is at least partially removably disposed in the first aperture. The second nasal pillow element is at least partially removably disposed in the second aperture. The connection portion is connected to the second side of the cushion member.

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 patient interface device includes a cushion member having a first side, a second side, and a first outer perimeter. The first side is structured to form a seal with a patient's face for delivering a flow of breathing gas to the patient. A modular hub is attached to the second side of the cushion member. The modular hub includes a receiver and a second outer perimeter. The second outer perimeter of the modular hub is disposed inward of the first outer perimeter of the cushion member when the patient interface device is viewed from a front elevation perspective.

Abstract: An interface for positive pressure therapy includes a mask assembly and a headgear assembly. The mask assembly comprises a mask seal that is adapted to underlie the nose. The mask seal extends up the lateral sides of the nose. The mask seal has a primary seal below the nose and a secondary seal alongside the nose.

Abstract: A cushion (16) for use with a mask (10) in delivering a flow of breathing gas to a user includes a first portion adapted to contact a surface of a user, a second portion adapted to be coupled to a mask shell (18), and a wall portion extending between the first portion and the second portion. The wall portion includes a chamber formed therein, the chamber having one of an electro-rheological fluid or a magneto-rheological fluid disposed therein. The cushion further includes a means (44, 50) for selectively varying the apparent viscosity of the fluid disposed within the chamber.

Abstract: A mask system includes a cushion for a mask that seals at its upper extent in a region of the nose that is generally above the tip of the nose or pronasale, and extends across a portion of the cartilaginous framework, alar or flares of the patient's nose, e.g., not extending over or across the bone nasal bone of the patient's nose.

Abstract: A respiratory mask assembly for delivery of non-invasive positive airway pressure to a user having a rigid mask shell including a plurality of slots; a soft cushion including at least one flexible sealing lip constructed and arranged to extend around an inner periphery of the cushion and to deform to provide a continuous airtight seal between the cushion and the rigid mask shell, the at least one flexible sealing lip being constructed and arranged to return to a relaxed state when the cushion is disassembled from the rigid mask shell, the soft cushion including a retaining portion; and a retaining ring configured to engage with the retaining portion of the cushion, and including a plurality of clips each positioned on respective spring arms to engage with each of the respective plurality of slots of the rigid mask shell to retain the cushion in position with the rigid mask shell.

Abstract: A patient interface device includes a headgear assembly (20) having at least two strap member (22). The strap members (22) each include a flexible body and a bladder assembly (50). In one embodiment, bladder assemblies (50) may be selectively inflated and deflated. In the inflated, or first, filled configuration, headgear assembly (20) defines a three-dimensional shape sized to fit about a patient's head. In the deflated, or second, collapsed configuration, the head gear assembly (20) may be placed in a flat or other compact configuration.