Abstract: The present disclosure relates to a facial mask system having an internal intermediate maxilla support structure for providing increased support and decreased occurrence of points having increased pressure concentration on a user's face, where the maxilla support system provides a comfortable, uniform sealing force around the breathing passages of a user.

Abstract: A cushion (44) for a patient interface device (26) that has an inverted geometry. In particular, the cushion includes a support portion (56) having a first edge (60) and a second edge (62) located opposite the first edge, and a sealing flap (58) extending in a cantilevered fashion inwardly from an inner edge of the second edge of the support portion and toward the longitudinal axis (59) of the cushion.

Abstract: A breathing mask which is convenient for enteral nutrition using a nasogastric feeding tube when the mask is in use may be provided. The breathing mask may include at least one nasogastric tube port. The port may allow a nasogastric tube to pass through the mask without substantially affecting the seal or pressure of the mask while accommodating enteral feeding. In addition, the breathing mask may incarnate the human-centered design to reduce discomfort in patients and is favorable for therapy and rehabilitation.

Abstract: An apparatus for administering a respirable gas to an individual includes a body receivable against a facial area for enclosing a respiratory organ, a vacuum hose, and a scavenger valve. The body is cup shaped, and includes a first side and a second side. An inhalation member extends from the first side of the body. An exhalation member extends from the second side of the body. The vacuum hose is for coupling a vacuum source to the exhalation member. The scavenger valve is coupled to the vacuum hose. The inhalation member is for administering respirable gas into the body, the exhalation member is for exhausting exhaust gas from the body into the vacuum hose, and the scavenger valve is for exhausting exhaust gas therethrough from the vacuum hose to an atmosphere.

Abstract: A patient interface device uses a pressure flap which extends inwardly from an outer edge of a mask of the device. The pressure flap is for contacting the skin of the patient to provide a seal or partial seal between the mask volume and the ambient surroundings. The pressure flap includes a cavity area which is exposed to a reduced pressure compared to the mask volume. This assists in keeping the pressure flap pressed against the patient's skin, and thereby maintain a large contact area. This in turn gives a reduction in local high pressure areas.

Abstract: A subnasal sealing cushion for a patient interface device includes a cushion member having a front side and a rear side, the rear side being structured to face a face of the user responsive to the patient interface device being donned, the cushion member including: a support portion having an outer wall and a support structure coupled to the outer wall and extending longitudinally along a first direction extending from the front side to the rear side, and a sealing flap portion coupled a nasal shelf portion, the nasal shelf portion defining a nasal orifice and being structured to contact a bottom of a nose of the user to create a seal therewith responsive to the patient interface device being donned by the user, wherein the support structure is positioned under and spaced from a bottom of the nasal shelf portion.

Abstract: A respiratory inlet having a mask end and a fitting end is provided. The respiratory inlet also includes a cavity and an exterior mating surface. The exterior mating surface is disposed proximate the fitting end, and is configured to matingly accept a first type of air supply fitting. The first type of air supply fitting is configured as a female fitting, and the respiratory inlet is configured to operate in a first mode when the female fitting is mated to the exterior mating surface. The cavity includes an opening oriented toward the fitting end, and an interior mating surface configured to matingly accept a second type of air supply fitting. The second type of air supply fitting is configured as a male fitting, and the respiratory inlet is configured to operate in a second mode when the male fitting is mated to the interior mating surface.

Abstract: A positive pressure ventilation (PPV) appliance module includes an adapter that couples to a port on an NIV mask and an appliance for performing a respiratory care procedure. The adapter is configured to form a PPV seal with the port of the PPV mask and also form a PPV seal with the appliance. The PPV appliance module allows clinicians to perform procedures through the NIV mask without disrupting the therapeutic pressure.

Abstract: A breathing assistance apparatus is designed for use with delivery of respiratory gases to a patient. The breathing assistance apparatus includes a patient interface, having a body section adapted to cover the nose, or nose and mouth of a patient and a sealing interface. The sealing interface includes at least an outer sealing member. The outer sealing member (201) is adapted to attach to the body section in a sealing manner and has a substantially thin section (203) in at least its nasal bridge region. The thin section is substantially thinner than the rest of the outer sealing member.

Abstract: A mouth cushion (20) for a mask system includes a side wall (50), an undercushion (52) extending away from the side wall (50), and a membrane (54) provided to substantially surround the undercushion (52) and adapted to form a continuous seal around an exterior of a patient's mouth in use. The side wall (50) includes spaced-apart prong support structures (60) that provide annular recesses (62) adapted to support respective nasal prongs (30). Each prong support structure (60) includes an alignment indicator (70) to aid correct assembly of the respective nasal prong (30).

Abstract: A foam cushion assembly for a patient interface, the foam cushion assembly being adapted to couple with a patient interface frame, the cushion assembly comprising a substantially above the nose seal portion and a mouth seal portion, wherein the cushion assembly comprises a foam cushion arranged to form with the frame a common plenum chamber for sealing about the nose and mouth.

Abstract: A patient interface which is comfortable for the user to wear can include at least in part a moisture permeable or breathable area in the body of the patient interface. The patient interface can be a strapless mask that is molded to fit the contours of a user's face and maximize the mask-to-skin seal. An adhesive material is bonded to the mask cushion and is stamped in place to form substantially the same shape as the cushion such that it fits the facial contours of the user.

Abstract: A mask system for providing respiratory therapy to the airways of a patient includes a frame, a sealing arrangement adapted to form a seal with the patient's nose and/or mouth, an elbow, and headgear to maintain the mask system in position on the patient's face. The frame has a main body and a forehead support extending from a top end of the main body. The forehead support includes an upper headgear connector, and the main body includes a lower headgear connector. The sealing arrangement is structured to interface with the frame. The sealing arrangement comprises a cushion having a face-contacting side and a non face-contacting side.

Abstract: A support frame for releasably attaching a facemask to a goggle including at least one vent and its method of use are described. In one non-limiting embodiment, the support frame includes a nose bridge and two legs extending from the nose bridge. The nose bridge and the two legs are adapted and arranged to releasably attach the facemask to a bottom surface of the goggles. The nose bridge and two legs are arranged such that the at least one vent is unobstructed when the facemask is attached to the goggles by the support frame.

Abstract: Patient interface components and/or associated head gear and adjustment systems improve sealing and/or patient comfort and/or ease of use. The interface includes an inflating or ballooning seal. The headgear assembly can be connected to the interface with an elastic component and an inelastic component. The elastic component enabling a course fitting of the interface to the patient and the inelastic component enabling a final fitting of the interface to the patient.

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

Abstract: A pivotable frame assembly (60) for a patient interface device (8) is provided. The patient interface device includes a mask (10) and a support assembly (40). The support assembly includes a first support member (52), a first strap (42A) and a second strap (42B), the first strap coupled at two locations to the first support member. The second strap is structured to be temporarily coupled to a mask first, temporary support assembly coupling (18). The pivotable frame assembly includes a frame member (62), a hinge assembly (64) and a support assembly strap coupling (66). The hinge assembly pivotally coupled the frame assembly and the mask. In this configuration, when the mask is coupled to the hinge assembly second component (82), the mask may move between a first position, wherein the mask is pivoted away from the user's face, and a second position, wherein the mask is sealed against the user's face.

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 seal device or gasket assembly usable with respiration or ventilation mask systems and that is preferably at least one of adhesive or deformable. The gasket is disposed between the mask and the wearer and reduces the escape of respiration gases between the perimeter edge interface of the mask with the anatomy of the wearer and limits exposure of the epidermis located within the perimeter of the mask and between the mask and the wearer to the respiration gas flows. The mask system is particularly useful for improving communication of the respiration gases for those wearers having facial hair, abnormal dontia, and/or other abnormal facial features.

Abstract: A cushion (26) for a patient interface device includes a support wall portion having a first edge and an opposite second edge, and a sealing flap (40) extending in a cantilevered fashion inwardly from the second edge and toward a longitudinal axis of the cushion such that when the patient interface device is donned a portion of the face of the user will engage the top outer surface of the sealing flap to form a seal. The sealing flap includes a corrugated portion (56), wherein the corrugated portion commences at a distal edge of the sealing flap and extends toward a proximal edge of the sealing flap along at least a portion of a width of the sealing flap. The corrugated portion includes a series of alternating furrows and ridges.

Abstract: A respiratory mask includes a mask body and an adjusting unit. The mask body has a frame portion, a flexible portion extending from the frame portion, and a forehead pad. The flexible portion has a mask-connecting end that is adjacent to the frame portion, and a pad-connecting end that is distal from the frame portion and connected to the forehead pad. The adjusting unit has a hardness greater than that of the flexible portion, and is removably coupled to the flexible portion for adjusting a curvature of the flexible portion and a distance between the forehead pad and the frame portion.

Abstract: A patient interface device (8) includes a cushion assembly (16) including a nasal cushion member (20), and a frame assembly (14) having frame member (48) having a first arm (54A) and a second arm (54B). The cushion assembly is rotatably coupled to the first and second arm such that the cushion assembly rotates with respect to the frame assembly about an axis extending through the first arm and the second arm. In addition, the frame assembly includes a drive mechanism (50) received and held by the frame member, the drive mechanism being operatively coupled to the cushion assembly such that actuation of the drive mechanism changes a tilt angle of the cushion assembly relative to the frame assembly.

Abstract: A mask system for treating sleep disordered breathing, comprising headgear, a shell/cushion including a channel adjacent a front aperture, a frame, an elbow including at least one undercut on a proximal end, a retaining ring including a rear flange adapted to be retainably insertable in the channel of the shell/cushion, and a front flange adapted to retainably engage with the at least one undercut of the elbow.

Abstract: A respirator 10 that includes a harness 14 and a mask body 12 that is air permeable. The mask body 12 has a sinus region 40 and a primary filtering region 44 and comprises at least one nonwoven fibrous webs, which web includes a layer of filter media. The sinus region 40 of the mask body 12 exhibits a resistance to airflow that is greater than the primary filtering region 44. This resistance to airflow is achieved through an alteration of the intrinsic structure of the plurality of nonwoven fibrous layers in the sinus region 40 without adding additional material to the mask body. The alteration of the intrinsic structure assists in preventing eyewear fogging.

Abstract: A mask for supplying gas under pressure to the nasal airway of an infant human includes a manifold for supplying air to an aperture in the mask. A shaped membrane structure formed from a thin walled membrane defines an enclosure for receiving at least the nares of an infant human nose and a generally trapezoidal aperture adapted to fit around the nasal area of the infant human. Part of the membrane around the aperture is sufficiently flexible to mold to the shape of the infant human's nasal area or is contoured to generally match the contours around that nasal area while the membrane structure itself has sufficient rigidity to support the weight of the backing plate without collapsing. The provision of a generally trapezoidal rather than the generally triangular apertures for fitting around the nares provides a substantially improved fit when the mask is used with infants.

Abstract: A patient interface device (8) for delivering a flow of breathing gas to an airway of a patient is provided that includes a patient contacting component (9, 90) having a patient contacting surface structured to engage the face of the patient when the patient interface device is donned by the patient, the patient contacting surface also including a plurality of ribs (40, 52, 62, 72, 82, 96) extending therefrom. The patient contacting component may be, without limitation, a mask having a mask cushion, a forehead support having a forehead cushion, a cheek pad or a chin pad.

Abstract: The present invention 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 comfort 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 mask for delivery of respiratory therapy to a patient may include one or more of the following improvements: rigidizer provided to headgear strap, locking clip/clip receptacle headgear connection, keyed headgear buckles, lotion dispenser on frame, rotatable prongs to adjust orientation, alignment indicators provided to prong, cushion and/or frame, chin flap with bellows arrangement, vent holes positioned away from gas entry port, and vent holes to direct washout gas at an angle.

Abstract: Headgear for use with a respiratory mask is described. The headgear comprises a continuous and substantially curved elongate member extending in use below a user's nose and at least two headgear straps capable of attachment to the ends of the elongate member. A mask attachment on the elongate member is disposed to sit below or on one of said user's nose, mouth, upper lip and an inlet to the mask. The attachment is capable of receiving the mask.

Abstract: A patient interface device (2, 60, 160, 204) includes a cushion (8, 66, 210), a frame (10, 68, 162, 206) having a faceplate portion. The cushion is coupled to the frame. The faceplate portion has a main orifice and holes adjacent the main orifice. The device further includes a coupling conduit (6, 64, 164, 212) having an inlet end, an outlet end coupled to the inlet end, and a hood member having openings provided on an outer periphery thereof. The inlet end is structured to receive a flow of breathing gas. The outlet end is coupled to the main orifice to deliver the flow of breathing gas to the main conduit. The hood member surrounds the outlet end and is disposed over the holes such that exhalation gasses will through the holes and be captured by the hood member and directed through the openings.

Abstract: A patient interface device (10, 10?, 62, 62?, 102, 152, 162, 172) is provided that includes a patient sealing assembly (12, 64, 104), such as a mask having a rigid shell and a cushion coupled to the rigid shell, a forehead support (26, 72, 118) coupled to the patient sealing assembly, and a hinge assembly (40, 40?, 84, 84?, 124, 154, 164, 174) provided between a top portion of the patient sealing assembly and the forehead support.

Abstract: A breathing assistance apparatus is designed for use with delivery of respiratory gases to a patient. The breathing assistance apparatus includes a patient interface, having a body section adapted to cover the nose, or nose and mouth of a patient and a sealing interface. The sealing interface includes at least an outer sealing member. The outer sealing member is adapted to attach to the body section in a sealing manner and has a substantially thin section in at least its nasal bridge region. The thin section is substantially thinner than the rest of the outer sealing member.

Abstract: An infant hat with a pacifier retaining strap retains and secures a pacifier nearby an infant's mouth. The device includes a hat and a pair of fastening straps. The hat is a headgear member adapted for wear on a head of an infant. Each of the straps is a durable fabric member affixed to a perimeter side portion of the hat. Each strap has a fastener which allows the free end of strap to be secured to a middle portion of itself to form a loop. In such a manner, both straps loop through a pair of pacifier mouth guard slits while an infant is wearing the hat in order to provide secure retention of the pacifier within or adjacent to the infant's mouth. In an alternate embodiment, the pair of fastening straps attach to a separate retaining ring capable of engaging a rear of the pacifier guard.

Abstract: A patient interface device includes a support member, a sealing assembly attached to the support member, and a pair of contacting members. The contacting members are coupled to the support member on each side of the sealing assembly. The contacting members are each configured and arranged to contact the user over a limited contacting region, which corresponds to a junction of the orbicularis oris facial muscle, the zygomaticus facial muscle, and the risorius facial muscle.

Abstract: A patient interface includes a sealing arrangement adapted to provide an effective seal with the patient's nose, an inlet conduit arrangement adapted to deliver breathable gas to the sealing arrangement, and a cover that substantially encloses the sealing arrangement and/or the inlet conduit arrangement.

Abstract: A breathing mask arrangement includes a mask frame, a sealing device provided to the mask frame, a forehead support device movably mounted to the frame for adjustable movement with respect to the frame, and a rotatable adjustment knob operatively associated with the forehead support device such that rotative movement of the adjustment knob is adapted to cause relative movement between the forehead support device and the frame.

Abstract: A patient interface includes a cushioning structure including at least one hollow chamber filled with first and second discrete and/or layered filling materials and a seal forming structure formed in one piece with the cushioning structure. The seal forming structure includes a thin membrane flap that is structured to provide a seal to the patient's face. The chamber extends only around a portion of the perimeter of the cushioning structure such that the chamber with first and second filling materials is provided in cheek and lip regions of the cushioning structure and a solid silicone portion is provided in a nasal bridge region of the cushioning structure.

Abstract: A patient interface for delivering breathable gas to a patient includes a sealing portion (210) including a nose tip engagement portion (212) adapted to form a seal with the patient's nose tip, an upper lip engagement portion (213) adapted to form a seal with the patient's upper lip and/or base of the patient's nares, and nostril engagement flaps (214) adapted to form a seal with the patient's nares. The nose tip engagement portion (212), the upper lip engagement portion (213), and the nostril engagement flaps (214) are all structured to extend or curve outwardly from a supporting wall defining an air path.

Abstract: A sealing interface includes an inner cushion and an outer sheath. The outer sheath substantially seals against the facial contours of the user. The inner cushion and the outer sheath each have a nasal bridge region, left and right cheek regions and either one of an upper lip region or a chin region. In use these regions are aligned with the corresponding nasal bridge region, left and right cheek regions and either the upper lip region or the chin region of a user. The inner cushion includes a hinged region. The hinged region is adapted to flex substantially independently of the inner cushion cheek regions.

Abstract: A patient interface device includes a fluid coupling device, a frame member having a connecting portion defining a first opening, and a cushion member. The cushion member has a main body portion, a coupling portion attached thereto, and an inwardly extending sealing member defining a second opening in the cushion member. The coupling portion is attached to a first side of the connecting portion so that at least a portion of the sealing member extends over the first opening. The fluid coupling device is attached to a second side of the connecting portion so that the outlet end of the fluid coupling device extends through the first opening and a terminal portion of the outlet end engages the sealing member and creates an airflow seal at a joint connection between the fluid coupling conduit and the frame member.

Abstract: A cushion (44) for a patient interface device (26) that has an inverted geometry. In particular, the cushion includes a support portion (56) having a first edge (60) and a second edge (62) located opposite the first edge, and a sealing flap (58) extending in a cantilevered fashion inwardly from an inner edge of the second edge of the support portion and toward the longitudinal axis (59) of the cushion.

Abstract: A mask system for use between a patient and a device to deliver a breathable gas to the patient includes a frame including a channel and a cushion provided to the frame. The cushion includes an end portion that is inserted and retained within the channel. The frame includes a recess that communicates with the channel and a hole that connects the recess to a frame exterior. The hole and recess provide an exit route for air contained within the channel.

Abstract: A patient interface, including a mask assembly and a headgear assembly, provides improved facial sealing and improved ease of use. The mask assembly includes an inflating or ballooning seal. The seal can be secured between two portions of a snap-fit exoskeleton. The headgear assembly connects to the mask assembly with flexible straps during course fitting and with more rigid straps following course fitting. The straps include holes that fit over a tapering post on the mask assembly.

Abstract: A respiratory protection composite facepiece is disclosed and includes a polymeric rigid facepiece body portion having a first surface and a second surface and a silicone sealing facepiece element chemically bonded at least one of the first surface or the second surface. The first and second surfaces can be opposing major surfaces. A second silicone element is chemically bonded to at least one of the first surface or the second surface. Methods of making the same are also disclosed.

Abstract: A device and method of use for depressing the cheeks of a user, to limit significant motion of the cheeks and provide for enhanced inhalation and exhalation. The device may be used to enhance respiration during a variety of activities, and is especially beneficial during the use of positive airway pressure (PAP) type medical. devices The device may include a pad adapted to engage a target area of a user's cheek and to maintain cheek tissue against a bone surface during inhalation and exhalation. The device may also include at least one support element coupled to the pad to maintain the pad at the target area during a therapy session.

Abstract: Disclosed is a device for respiration which comprises at least of one body that delimits an inner chamber from an outer chamber, a region for sealing the device against parts of the face of a patient, fastening elements for positioning the device on the patient's head and a connection for supplying respiratory gas. The device is equipped with an actuator, which when adjusted, changes the distance of at least one part of the device from at least one part of the body of the patient.

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

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a front surface and a rear surface adapted in use to face the patient. A cushion having a side wall is removably attachable to the frame. The cushion has a rim extending away from the side wall, and a membrane provided to substantially surround the rim. An inner edge of the membrane defines an aperture, the aperture having a generally trapezoidal shape.

Abstract: A patient interface is disclosed which is comfortable for the user to wear and includes at least in part a moisture permeable or breathable area in the body of the patient interface. In another embodiment the patient interface is a strapless mask that is moulded to fit the contours of a user's face and maximise the mask-to-skin seal. An adhesive material is bonded to the mask cushion and is stamped in place to form substantially the same shape as the cushion such that it fits the facial contours of the user.

Abstract: A headband device for a respiratory mask includes a strap portion including a multi-layered construction including an inner cover layer, an outer cover layer, and foam padding. The inner cover layer has a face contacting surface adapted to contact a patient's skin in an application position of the headband device. The outer cover layer is adapted to be oriented outwardly from the patient's skin in the application position of the headband device. The inner cover layer and the outer cover layer are coupled to one another via connection points that are laterally spaced from one another when viewed in cross-section, each connection point being spaced outwardly away from the face contacting surface of the inner cover layer so as to position the connection points outwardly away from the patient's skin in the application position of the headband device.