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 comprising 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: The present invention relates to a mask bead for a patient interface, comprising a nose bridge region, at least one side region, a base region, a mask bead attachment, and a bearing region on the patient. The bearing region extends from the side regions and the base region and also the nose bridge region to an opening and is designed as a sealing lip which frames the central opening which serves at least for the introduction of the nose of the patient. The mask bead is formed from at least one elastic material and comprises at least one support structure in the mask bead, which support structure is designed to in part face the bearing region and to in part face the mask bead attachment.

Abstract: This invention relates to headgear and a patient interface, or components of a headgear or patient interface, such as a nasal cannula. In one embodiment is a size adjustable headstrap to be provided as a headgear or a part thereof, in another is a portion of a headstrap or component for association therewith in which the portion or component facilitates improved location of the strap upon a user's face, in another embodiment is a system for encapsulating or covering a connector from contact with a user's face or facial skin, in another embodiment is a face mount part or body for a patient interface of a particular configuration, and in yet a further embodiment is a gases flow manifold for delivering of gases to a patient interface of a particular configuration for improved patient comfort.

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 guide framework for positioning an ultrasonic transducer which emits a focused ultrasound to a target point in carrying out surgery to apply ultrasonic stimulation to a subject's brain, includes a body in a shape of a mask that is laid on the subject's face, and a positioning hole formed through an inner surface and an outer surface of the mask body, the positioning hole into which the ultrasonic transducer is inserted, wherein the inner surface of the mask body is formed to conform a facial contour of the subject, and when the guide framework is laid on the subject's face and the ultrasonic transducer is disposed at the positioning hole, the position of the target point is naturally disposed at a preset stimulation site of the brain. An ultrasonic stimulation device includes an ultrasonic transducer and the guide framework for positioning the ultrasonic transducer.

Abstract: A full-face mask assembly includes a frame and a cushion provided to the frame. The cushion is adapted to form a seal around the patient's nose and mouth. A flexible lip is provided to an interior wall of the cushion. The flexible lip is adapted to engage the frame to provide a seal in use.

Abstract: A shroud for a mask system includes a retaining portion structured to retain a frame, a pair of upper headgear connectors each including an elongated arm and a slot at the free end of the arm adapted to receive a headgear strap, and a pair of lower headgear connectors each adapted to attach to a headgear strap. The retaining portion, the upper headgear connectors, and the lower headgear connectors are integrally formed as a one piece structure.

Abstract: A patient interface system for delivering a flow of breathable gas to a user includes a patient interface structure configured to sealingly engage the face of the user. The patient interface system further includes an elbow and connector assembly adapted to receive gases from a flow generator and deliver the gases to the patient interface structure. The elbow and connector assembly includes a ring attached to the patient interface, a sleeve, and an elbow. The ring includes an inner flange, an outer flange separated from the inner flange by a channel, and a plurality of vent slots extending through the inner flange, across the channel, and through the outer flange. The sleeve is configured so that inserting the sleeve into the ring forms a plurality of vent paths for the venting of exhalation gases from an interior of the patient interface to an exterior of the patient interface through the vent slots.

Abstract: A wearable inhalation delivery device comprising a wearable member that is securable to a wearer's head; and an inhalation delivery device carried by the wearable member and configured to deliver fluid to the wearer's air passages upon inhalation.

Abstract: A respiratory mask system includes a headgear that, in use, secures the respiratory mask system to a patient's head. The headgear includes a pair of forehead straps that are coupled together by a forehead coupler to form a closed loop. The forehead coupler is removably connected to a frame of the respiratory mask such that the forehead straps remain in a closed loop. The pair of forehead straps can also be coupled together by positioning a male strap portion within an aperture of a female strap portion. The male strap portion has a free end that is configured to be received into the aperture. The male strap portion includes a plurality of notches that engage the aperture of the female strap portion and provide incremental adjustment. The free ends of the male and female strap portions have fasteners configured to engage the surface of the other strap portion.

Abstract: A respiratory mask system includes a headgear that, in use, secures the respiratory mask system to a patient's head. The headgear includes a pair of forehead straps that are coupled together by a forehead coupler to form a closed loop. The forehead coupler is removably connected to a frame of the respiratory mask such that the forehead straps remain in a closed loop. The pair of forehead straps can also be coupled together by positioning a male strap portion within an aperture of a female strap portion. The male strap portion has a free end that is configured to be received into the aperture. The male strap portion includes a plurality of notches that engage the aperture of the female strap portion and provide incremental adjustment. The free ends of the male and female strap portions have fasteners configured to engage the surface of the other strap portion.

Abstract: Various embodiments of a breathing tube retainer and a respirator that utilizes the breathing tube retainer are disclosed. In one or more embodiments, the breathing tube retainer can include a mask attachment portion configured to connect the retainer to a face mask of a respirator, and a tube attachment portion including an arm that connects the tube attachment portion to the mask attachment portion. The tube attachment portion can further include a tube receiver configured to receive a breathing tube of the respirator.

Abstract: The present invention relates to an improved mask apparatus for veterinary applications. The mask may be used for dogs in particular. Most prior art masks are conical. This leads to problems in comfort and effectiveness. The present mask has a cross sectional profile and an opening shaped similar to an animal's muzzle. It has a flat top and a flat bottom, slightly wider than the top, and rounded sides. It also extends backwardly from the top of the opening to the bottom of the opening, so as to comfortably cover the commissure of the animal's lips.

Abstract: A patient interface to provide breathable gas to a patient, comprising: a plenum chamber assembly, comprising: a nasal plenum chamber at least partly defining an upper gas chamber; an oral plenum chamber at least partly defining a lower gas chamber; and a decoupling structure at least partly connecting the nasal plenum chamber and the oral plenum chamber and at least party defining a flow path; a top plate including at least one connection feature configured to releasably retain a first portion of a positioning and stabilising structure; and a faceplate configured to releasably retain a second portion of a positioning and stabilising structure.

Abstract: A customized mask is manufactured by the process of: generating surface geometry data of a face of a patient, the surface geometry data corresponding to and representing a surface geometry of the face of the patient; generating original cushion geometry data using the surface geometry data; generating modified cushion geometry data using the original cushion geometry data; producing a rigid support member using the modified cushion geometry data such that it is shaped according to the modified cushion geometry data, the support member being made of a unitary material; and coupling a sealing flap to the support member, the sealing flap being structured to engage the face of the patient.

Abstract: A cushion pad for a mask worn by a patient, comprising a first side to contact skin of the patient, and a second side, opposite the first side, to contact or face the mask. The pad has a main body portion having a central portion shaped to cover a portion of the patient's nose extending from above the nose tip to the nasal bridge region without obstructing the patient's line of sight, and lateral side portions to extend downward and terminate along the sides of the nose or on the patient's cheeks. The main body is made of a breathable material, e.g., foam. The pad may include adhesive and/or an attached portion, e.g., a ring, to couple the pad to the patient and/or portion of the mask.

Abstract: An apparatus and methods for air filtration are disclosed. The apparatus includes a body and first and second replaceable filters. The body of the apparatus further contains an air-exchange assembly and a filter receiver attached to the air exchange assembly. The air-exchange assembly contains an exhaust tube with an open end and a closed end, two wings on opposite sides of the exhaust tube, and an intake check valve and an exhaust check valve inside the exhaust tube. The first replaceable filter surrounds the filter receiver; and the second replaceable filter is inside the filter receiver. Several apertures and the check valves are strategically disposed in the exhaust tube to achieve optimal air filtration and avoid contamination of a user's exhaust.

Abstract: This invention offers a fully protective cowl neck garment with various fasteners designed to attach additional protective gear, such as gloves and shoe coverings. Additionally, a temperature sensor shield is located on the hat and protective mask. This allows the clients or patients the ability to see and to monitor the temperature of their caregivers. The caregiver's temperature is visible on the hat, as well as the face mask. This makes the caregivers accountable to their clients or patients, as well as their colleagues and coworkers. This invention eliminates the worry of contact with infectious diseases or dangerous liquids, by utilizing elastic manual ties and hook-and-loop fasteners to ensure the garment is secured fully on a user's body. Overall, this invention ensures medical professionals, firemen, emergency medical personnel, government workers, and so forth, are protected fully from contagious and infectious diseases, liquids, and so forth.

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 cushion tension assembly for a respiratory interface device is provided. Cushion tension assembly includes an adjustment assembly and a number of tension members. Each tension member is operatively coupled to the adjustment assembly and is operatively coupled to the cushion body. In this configuration, the adjustment assembly is structured to move cushion body between a first configuration in which the cushion body provides a generally continuous seal, and a second configuration in which the cushion body provides a more complete seal.

Abstract: Systems and methods are disclosed for delivering medication to a patient. One such system has an aerosol generator for aerosolizing medication. The generator is located outside the airway of a patient. A chamber is provided for receiving aerosolized medication from the generator. The system has a carrier gas supply tube for delivering carrier gas to the chamber, and an aerosol delivery tube for receiving the aerosolized medication and the carrier gas from the chamber. The aerosol delivery tube delivers the aerosolized medication to the patient. A distal end of the aerosol delivery tube is positioned inside the airway of the patient in order to discharge the aerosolized medication within the patient's airway.

Abstract: A patient interface that is comfortable for a user to wear is disclosed. The patient interface includes a forehead rest and cushion. In particular the cushion includes a deformable resilient member that when compressed creates a uniformly and gradually increasing force while evenly distributing the pressure on the forehead of the patient.

Abstract: An electronic apparatus (1) including a display generation unit (110) configured to generate a display area (210) in a user interface, the display area being configured to display a 3-D model of a patient's face and a 3-D model of a patient interface device fitted to the 3-D model of the patient's face; and an interaction map unit (160) configured to generate an interaction map tool (260) in the user interface and to calculate an interaction map between the patient's face and the patient interface device indicating levels of an interaction characteristic between the patient's face and the patient interface device, wherein the interaction map tool is operable to toggle display of the interaction map in the user interface.

Abstract: An artificial airway including an airway tube having proximal and distal ends and a mask mounted at the distal end of the airway tube characterized in that the airway tube includes a curved portion adjacent to its distal end and a straight portion extending from the curved portion to the proximal end of the airway tube and the curved portion is more rigid than the straight portion.

Abstract: A patient interface device includes a cushion member having a main body portion having a surface structured to engage a face of a patient. A frame member is coupled to the cushion member, and a fluid coupling conduit is coupled to the frame member. An engagement member is coupled to the cushion member; and a rotatable cam wheel is disposed between the frame member and the engagement member. Rotation of the cam wheel changes a position of the main body portion relative to the frame member. The cushion member includes a flexible portion adjacent the main body portion, and the cam wheel is rotatable about the flexible portion, such that rotation of the cam wheel about the flexible portion causes the flexible portion to deflect thereby moving the cushion member relative to the frame member.

Abstract: An elbow connector (10,20) for use with a patient interface device (2) includes a coupling portion (11,21) structured to be inserted into an opening in the patient interface device to couple the elbow connector with the patient interface device. The coupling portion includes an upper coupling portion (11a) and a lower coupling portion (11b). The elbow connector also includes a rear surface (13). Applying pressure to the rear surface causes the upper coupling portion to move towards the lower coupling portion.

Abstract: A respiration mask includes an upper portion connectible to a source of gas, a lower portion connected to the upper portion, facilitating a seal between the upper portion and a person's face, and a deformation element incorporated into the lower portion to establish a plurality of sealing barriers between the lower portion and the person's face. The upper portion is made from a first material with a modulus of elasticity between 150 ksi and 200,000 ksi. The deformation element is made from a second material exhibiting a hardness below one of 40 Shore A or 80 Shore OO and tear a resistance greater than 5 lbf/in.

Abstract: Masks for various uses and methods for manufacture thereof, including masks for use in continuous positive air pressure (CPAP) therapies. An example includes a mask having a first, relatively softer material for contact with the face of the user, and a second, relatively harder or more structural material used away from the face of the user, with a gradient therebetween. The mask can be produced by additive manufacturing to avoid a discernible boundary between the first and second materials.

Abstract: Masks for various uses and methods for manufacture thereof, including masks for use in continuous positive air pressure (CPAP) therapies. An example includes a mask having a first, relatively softer material for contact with the face of the user, and a second, relatively harder or more structural material used away from the face of the user, with a gradient therebetween. The mask can be produced by additive manufacturing to avoid a discernible boundary between the first and second materials. The mask may include a foam element, which can be removable for replacement in some examples, for contacting the patient's skin.

Abstract: A nasal respiratory mask system configured to be placed on a user's face to provide respiratory gas under positive pressure to the user, the nasal respiratory mask system includes: a nasal mask shell configured to cover a user's nose and mouth, the nasal mask shell includes a first valve opening and a second valve opening, wherein the first valve opening is configured to receive a respiratory tube connected to a positive gas pressure source, wherein the second valve opening is configured to enable the entrance of fresh air when the pressure within the nasal mask shell cavity falls below a threshold pressure; and a securing system configured to secure the nasal mask shell to the user's face, wherein the securing system includes at least one horizontal securing strap, wherein the horizontal securing strap extends from a first side face of the nasal mask shell to a second side face of the nasal mask.

Abstract: Apparatus and associated methods relate to fitting a virtual mask to a virtual face by first fitting a chin region of the virtual mask to the virtual face, then determining an virtual mask angle that maintains the fitted chin region while simultaneously fitting a nose-bridge region of the virtual mask to the virtual face, and then calculating a fit-quality metric corresponding to the fitted position. In an illustrative embodiment, the fitted chin region may include the high curvature menton region of the chin. In some examples, a virtual mask may be virtually pressed toward the virtual face using a predetermined force corresponding to a force of a mask securing device of a real mask corresponding to the virtual mask In an exemplary embodiment, the fitting of a virtual mask to a virtual face may advantageously yield a mask's fit quality in a brief amount of time.

Abstract: The present invention relates to a breathing mask for use in a respirator, comprising a receiving cover comprising an engagement portion for engaging a patient's mouth portion and/or nose portion, a connection portion connected to a breathing pipe, and an elastic deformable portion for connecting the engagement portion with the connection portion; a bracket assembly, comprising a forehead support disposed external of the connection portion and a receiving cover fixing frame fixedly disposed external of the engagement portion, and an elastic member for connecting the forehead support with the receiving cover fixing frame from a bottom of the receiving cover. The breathing mask for use in a respirator according to the present invention may achieve automatic adjustment of the forehead support without manual assistant adjustment.

Abstract: A face mask for extended wear by a user including a customized, contoured facial mask portion constructed and configured to cover and matingly contact a corresponding contoured surface area of a human face, preferably formed by 3D printing methods and materials.

Abstract: The present disclosure relates to a human wearable mask includes a skirt for directly contacting a forehead of a human wearer, a patch with sensors on the skirt to obtain and provide temperature data from the forehead of the human wearer.

Abstract: It is discloses a patient interface 3000 comprising a seal forming portion 11, a pad 10, and a cushion 20. The seal forming portion 11 may comprise a base surface 111 and a plurality of fibers 112 fixed to and extending away from said base surface 111 for contacting a patient's skin. The cushion 20 may comprise at least along a portion of the circumference a first structure 22 having an elongate section 24 joined with at least one end section 26 oriented substantially perpendicular or at an angle to the elongate section 24. A first end A of the elongate section 24 may be connected or connectable to a frame member 30. The end section 26 may be provided at an opposing second end B of the elongate section 24. The pad 10 may comprise a resilient foam material layer with the seal forming portion 11. The pad 10 may be adapted to be connected to the cushion 20.

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: An elbow for a respiratory mask includes a mask connection end adapted to connect to the mask and a tube connection end adapted to connect to an air delivery tube that delivers breathable gas to a patient. The mask connection end includes a first region constructed of a more rigid material and a second region constructed of a more flexible material. The second region provides flexibility to one or more portions of the mask connection end to enable engagement and disengagement of the elbow with the mask and/or sealing of the elbow with the mask.

Abstract: A sealing device (20) includes a base (22) adapted to attach at any of a plurality of positions on a patient interface device (8), an arm (26) having a first end coupled to the base (22), and an end portion (24) connected to a second end of the base and adapted to apply pressure to an area of a cushion member (12) of the patient interface (8) device when the base is attached at any of the plurality of positions on the patient interface device.

Abstract: A vent arrangement is provided to a mask to discharge exhaled gas from the mask to atmosphere. The vent arrangement is structured to diffuse the exhaust vent flow to produce less air jetting, thereby increasing the comfort of the patient and their bed partner. The vent may include a first wall, a second wall defining an outer perimeter, and a plurality of gas washout vent holes positioned between the first wall and the second wall, the vent holes having an inner edge positioned within the outer perimeter of the second wall.

Abstract: A mask is disclosed that has a gas outlet which is quiet and provides for a diffused outlet flow of gases. The outlet is preferably a slot formed between a hollow body and cover over said hollow body. The mask also preferably extends and seals under a user's chin in use.

Abstract: A mask apparatus for a respiratory treatment can permit delivery of breathable gas to a user. In one example, the mask may employ a frame and cushion to form a seal for both mouth and nose. The frame may be adapted for coupling with a respiratory treatment apparatus so as to permit communication of a pressurized gas from the respiratory treatment apparatus. The cushion, which may be foam, may have a substantially under the nose configuration. The mask may have a common plenum chamber for both nose and mouth. The cushion may further define a centrally open lip superior region. The cushion may be adapted to couple with the frame directly or to the frame in conjunction with a cushion support clip. Various features of the cushion may further promote sealing and comfort for the under the nose design.

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 cushion (26) for a patient interface device includes a support wall portion and a sealing flap (40) extending in inwardly from the support wall portion and toward a longitudinal axis of the cushion. The sealing flap has a distal edge (44)which defines an opening (46) in the sealing flap. The opening extends from the nose bridge to the upper lip and is created by two planes (hinged nearer the upper lip) that intersect at a large angle (e.g., 90 degrees to 150 degrees) near the upper lip.

Abstract: A shroud (1020) for a mask system includes a retaining portion structured to retain a frame (1040), a pair of upper headgear connectors (1024) each including an elongated arm (1026) and a slot (1027) at the free end of the arm adapted to receive a headgear strap, and a pair of lower headgear connectors (1025) each adapted to attach to a headgear strap. The retaining portion, the upper headgear connectors, and the lower headgear connectors are integrally formed as a one piece structure.

Abstract: A patient interface that provides a flow of gas to a user. The interface includes a face-contacting layer and a multi-layer structure covered by the face-contacting layer. The responsive structure includes a plurality of actuators for moving the face-contacting layer. The actuators include a first and second groups of actuators, each of which comprises electrodes arranged in one or more layers. The layers are arranged above each other. The electrodes in the first group of actuators are, with respect to a first axis, transverse to the one or more first and second layers, and are arranged spatially offset relative to the electrodes of the second group actuators such that the electrodes of the first group of actuators do not overlap the electrodes of the second group of actuators.

Abstract: Devices and systems provide methods for detecting cardiac signals from head or facial biopotential sensors. In one embodiment, a facial biopotential signal is measured by a set of sensors. A processor derives a cardiac signal from the facial biopotential signal. Optionally, heart rate is detected from the cardiac signal. Heart rate variability may be determined and evaluated by the processor to generate warnings or messages from the evaluation. One or more head or facial biopotential electrodes for measuring the facial biopotential signal may be integrated in or at a contact surface of head support structures such as a headgear support or respiratory treatment mask. In some such embodiments a controller of a respiratory treatment apparatus may serve as a cardiac signal detector by processing the facial biopotential signal from the sensors and may make control adjustments or generate warnings based on an evaluation of detected signals.

Abstract: A breathing assistance apparatus is disclosed, 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. The patient interface comprises a mask body and a seal assembly. The seal assembly includes a flexible seal, and a rigid seal clip, the seal assembly being removably attached to the mask body via the rigid seal clip. The mask body and rigid seal clip are profiled to match the contours of a user's face so that the seal has a substantially constant wall depth.

Abstract: A resistance breathing device includes a face mask having a perimeter and a central aperture extending therethrough, and being adapted to overlay a user's mouth and nose such that the perimeter forms an air-tight seal with the user's face. An outer layer overlays the face mask and includes a pair of straps for affixing the face mask about a user's face. An insert is disposed within the central aperture of the face mask and has at least one inlet aperture extending therethrough. An adjustment element overlays the insert, has an inlet aperture extending therethrough, and is movable between a first position in which a first portion of its inlet aperture overlaps the at least one inlet aperture of the insert and a second position in which a larger second portion of its inlet aperture overlaps the at least one inlet aperture of the insert.

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 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.