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: Provided are systems, devices and methods for ventilating patients. For example, provided are ventilation masks. The described ventilation masks can be used in ventilation procedures of patients.

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 includes a frame including a breathable gas port, wherein the frame defines an inner chamber to receive at least one of a wearer's nasal region and mouth, and a cushion including a flange connected to the frame, an inner rim defining an opening to the inner chamber of the frame, and a sealing portion disposed between the flange and the inner rim to contact the wearer's face. The sealing portion includes a nasal seal section to span a wearer's face above the wearer's nares, side seal sections extending from each side of the nasal seal section on both sides of the wearer's mouth, and a chin seal section that extends between the side seal sections, wherein the chin seal section is upwardly curved in an arch to follow the chin's bony contour.

Abstract: A face mask that may be used for bag-mask ventilation, during the induction of general anesthesia for example, and allows for two-handed or ambidextrous use. The face mask includes a dome connected to a deformable rim, which forms an enclosed air space when the rim is pressed against a patient's face. The dome has a connection port and a contoured outer surface adjacent the connection port. The contoured outer surface includes contour features such as a pair of crossed composite recesses which may each receive a different one of a user's thumbs. The connection port is aligned with the patient's mouth when the mask is in use and an adapter may be included that attaches to the connection port and provides a ventilation port as well as an intubation port that is aligned with the mouth.

Abstract: Disclosed is ventilator mask comprising an upper part of an elastic material and a mask body, wherein the upper part of the mask is joined with the mask body of the ventilator mask by a mask connection region, wherein a wall of the upper part of the mask bounds at least in certain regions of the wall a cavity which is filled with a filler at least in certain regions of the cavity and the cavity is formed at least in certain regions of the cavity along the periphery of the upper part of the mask.

Abstract: A ventilation mask comprises a corrugated flexible seal, and a plurality of ridges disposed along the corrugated flexible seal. The corrugated flexible seal is configured for establishing a fluid seal between the ventilation mask and a patient, and for allowing facial movements of the patient while maintaining the fluid seal. The plurality of ridges disposed along the corrugated flexible seal is configured for physical contact with the patient.

Abstract: A respiratory mask, a mould for a respiratory mask, as well as to a method for producing a respiratory mask are disclosed, in which manufacturability and usability of respiratory masks are improved. A respiratory mask is disclosed for administering a breathable gas to a patient, the respiratory mask comprising a first component formed from a flexible material and a second component formed from a material that is more rigid than the flexible material, wherein the first component is formed onto the second component by an overmoulding process.

Abstract: A patient interface device that includes a support member sized and configured to span at least a portion of a patient's face while remaining below the patient's eyes responsive to the patient interface device being donned by such a patient and a sealing assembly operatively coupled to the support member such that the support member is moveable relative to the support member. The support member defines a gas carrying conduit adapted to carry a flow of gas to the sealing assembly. The support member is a single-piece unitary member and includes a conduit coupling portion adapted to be coupled to a patient circuit.

Abstract: A mask system for delivering breathable gas to a patient includes a common frame provided without built-in or integral headgear attachment points and at least first and second headgear connectors adapted to be provided to the frame. Each of the at least first and second headgear connectors are adapted to attach headgear straps of headgear. The at least first and second headgear connectors are different from one another in at least one aspect.

Abstract: A breathing mask (1) for aircraft crewmember or passenger comprises a rigid portion (3) to be fit against the face of an user, said rigid portion comprising elements to bring a breathable gas to the user. The breathing mask further comprises an extensible harness (4) having end portions (5) connected to said rigid portion and including an inflatable element (6) connected to a source (7) of pressurized gas through a manually operable valve which delivers the pressurized gas to the inflatable element for extending the harness when actuated, and which reduces the pressure in said inflatable element to retract the harness and to cause the rigid portion to engage the face of the user when released. The source of pressurized gas is an autonomous container (7) supported by the rigid portion and containing the pressurized gas.

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 respiratory mask assembly for delivering breathable gas to a patient includes a frame and a headgear assembly removably attachable to the frame. The headgear assembly includes a pair of side portions and a rear portion that interconnects the pair of side portions. The pair of side portions includes at least one strap. The rear portion has at least one strap constructed of at least two layers of material. One of the layers of material has a more rigid construction than the other of the layers of material to resist compression of the at least one strap of the rear portion in a first direction which resists movement of the at least one strap of the pair of side straps in the first direction.

Abstract: A cushion for a patient interface includes two or more bladders arranged in concentric relation. Each of the bladders includes a face-contacting portion adapted to engage the patient's face, and each of the bladders is adapted to be pressurized independently from one another. At least one of the bladders is an active bladder that is pressurized to at least a sealing pressure to form a continuous seal with the patient's face in use.

Abstract: The present invention relates to the surface structure of a plastic material and particularly of silicone surfaces. More particularly, the present invention relates to the surface structure of the surfaces of a breathing mask assembly or a patient interface to be used for supplying breathing gas to a patient. Such patient interface for providing respiratory gas to a patient comprises a contact surface for contacting a patient's skin, wherein at least a part of said contact surface is a structured surface.

Abstract: A forehead pad for a breathing mask includes a substantially dimensionally stable first wall element and an elastomer second wall element coupled to the first wall element. The second wall element has a contact zone adapted to contact a surface of a user in use. The first and second wall elements define a filling-material-receiving chamber adapted to receive a filling material.

Abstract: The present invention provides a symmetrical face mask suitable for use with one hand that allows an operator to provide a reliable seal with the patient's face with his/her hand and arm in an anatomically favorable position for application of a user's physical strength. In general, a user may reach at an acute angle to the plane of their chest and engage the invention mask with their hand in a manner the user may shake another person's hand, i.e., with a distal portion of their radius and ulna arranged essentially vertically so that side to side motion of the hand translates to forward and rearward motion of a mask shell while a user reserves full bi-directional rotational capability of their arm for forward or rearward rotation compression of the mask shell while, at the same time, reserving full and lever-efficient, bi-directional pushing and pulling range of a user's arm for greater pressure of the mask shell to a right or left side of a user's fleshy cheek.

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 kit for fitting a patient interface device (10) to the naris of a patient. The patient interface device employs a replaceable nasal pillow (46). The kit comprises a plurality of nasal pillows each having a characteristic that varies from one of the plurality of nasal pillows to another of the plurality of nasal pillows. Each of the nasal pillows comprises a base portion (62), a casing (65) and a fill material (66). The base portion is structured to be disposed on a portion of the patient interface device. The casing is coupled to the base in a manner which defines a sealed cavity therein. The casing includes an outer portion (65) structured to sealingly engage a naris of a patient and an inner portion (67). The fill material is disposed in the sealed cavity defined by the casing and the base.

Abstract: Disclosed is an artificial respiration device that includes a tubular element, which forms a main channel having an upstream part at the proximal end of the tubular element and a downstream part at the distal end of the tubular element. Auxiliary channels open into the main channel and deflecting means are located internal to the main channel. The deflecting means are configured to deflect jets of respiratory gas injected into the main ckannel through the auxiliary channels so as to converge the gas at a point of convergence inside the main channel. The tubular element also includes at least one lateral safety orifice that extends through a lateral wall of the tubular element at a location sustantially opposite the point of convergence, and which is configured to communicate air from outside the tubular element to the downstream part of the main channel.

Abstract: A hand-held, automated qualitative fit tester (QLFT) for establishing gas mask fit integrity. The automated QLFT may be configured to utilize a pressure source in combination with a cartridge and a nebulizer to generate aerosols having size distributions and concentrations that are substantially the same as OSHA-approved manual units. The QLFT may further include a cartridge that contains the aerosol solution used to test mask integrity. The cartridge may be configured to recapture solution that collects on the interior walls of the nebulizer. The automated QLFT may also be equipped with a microprocessor for executing sequences that are in substantive compliance with 29 CFR 1910.134 and for writing to a data storage device. The automated aspects of the invention can reduce or negate the need for operating personnel to repeatedly and manually actuate a squeeze ball and record results manually, as is required with present OSHA-approved hand-held aerosol generators.

Abstract: This invention is a respiratory mask for delivering pressurized gas with a perimeter that can be custom fitted to the contours of a person's face by active and individual adjustment of multiple shape-changing members in the body of the mask. In different embodiments of this invention, the shape-changing members may be located around the perimeter of the mask and individually adjusted by inflation, other pneumatic means, hydraulic means, electric means, or magnetic means. The resulting mask can conform to the contours of an individual's face, even while they sleep, so that there are no places around the mask that fit too tightly (causing irritation, skin marks, and pain) and no places that fit too loosely (causing air leaks).

Abstract: A mask system includes a frame and a cushion provided to the frame. The frame provides a brace or fulcrum like structure about which the cushion may pivot, bend, and/or flex.

Abstract: A medical device may include a gas delivery apparatus, a patient interface, a connection system, and an electrical circuit. The gas delivery apparatus may be configured to deliver gas to a patient. The patient interface may be configured to interface with the patient to deliver gas communicated by the gas delivery apparatus to the patient. The connection system may be configured to communicate gas from the gas delivery apparatus to the patient interface. The electrical circuit may be configured to communicate electrical signals between the patient interface and the gas delivery apparatus, and may including one or more first electrical conductors at least partially integral with the patient interface and one or more second electrical conductors at least partially integral with the connection system.

Abstract: A mask cushion or a mask assembly therewith provides a comfortable and effective seal for provision of a gas therapy by a respiratory treatment apparatus. The mask cushion (102) may be integrated with or coupled to a mask frame. The mask cushion typically includes an inner cushion component (104). The mask cushion also includes a patient facial-contact side portion with a chamber (108) and a barrier (106) to form the chamber that may be flexible. The chamber may serve as an outer layer with respect to the inner cushion component. The chamber may be partially or completely filled with a gas, fluid or gel. The inner cushion may be formed with a soft flexible material such as an elastomer or foam, etc. The barrier may be a membrane and may also be soft flexible material.

Abstract: A mask system includes a frame, cushion, cushion clip, swivel elbow, headgear and/or headgear clips that are configured for use in a clinical or hospital environment. One or more components of the mask system are configured to promote single patient use, e.g., by providing an age indicator and/or preventing disassembly and/or cleaning, etc.

Abstract: A respiratory mask including a base plate adapted for connection to a gas source and a bladder secured to the base plate to form a generally fluid tight seal with the base plate, and defining at least one internal chamber with the base plate for receiving a fluidizing medium to fill the bladder and form a resilient cushion.

Abstract: A mask system is provided to fit pre-adult patients, or patients having facial features that are very small or child-like, e.g., patients having dimensions in the lower 5%-10% of the population. For example, the headgear and/or cushion are dimensioned to accommodate this range of patients.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a frame and a headgear assembly removably attachable to the frame. The headgear assembly includes a pair of side portions and a rear portion that interconnects the pair of side portions. The pair of side portions includes at least one strap. The rear portion has at least one strap constructed of at least two layers of material. One of the layers of material has a more rigid construction than the other of the layers of material to resist compression of the at least one strap of the rear portion in a first direction which resists movement of the at least one strap of the pair of side straps in the first direction.

Abstract: The present invention is a breathing mask that is fully adjustable so as to enable a comfortable and leak proof seal around a patient's face. The mask includes a frame, a cushion, a hose connector, a strap, connector, a strap, and a headgear. The present invention ensures both comfort and effectiveness by enabling a full adjustment of various components such as the angle of the strap relative to the face mask and the adjustment of the size of the headgear. Furthermore, the present invention also allows for the free rotation of certain elements in order to maintain a sufficient seal without increasing the pressure applied to the patient.

Abstract: A patient interface has a single loop headstrap and a mask for covering at least the nostrils of the user. The single loop headstrap extends from the mask at either end. A short length of supple conduit is coupled to the mask by a swivel or ball joint to allow rotation of the conduit relative to the mask through different angles and orientations.

Abstract: A respiratory mask includes a frame including a breathable gas port, wherein the frame defines an inner chamber to receive at least one of a wearer's nasal region and mouth. The mask includes a cushion including a flange connected to the frame, an inner rim defining an opening to the inner chamber of the frame, and a sealing portion disposed between the flange and the inner rim to contact the wearer's face. The sealing portion includes a nasal seal section to span a wearer's face above the wearer's nares, side seal sections extending from each side of the nasal seal section on both sides of the wearer's mouth, and a chin seal section that extends between the side seal sections. The chin seal section is upwardly curved in an arch to follow the chin's bony contour.

Abstract: A respiratory mask is provided having an outer shell coupled to a cushion for the delivery of a gas to a user. The cushion of the respiratory mask has a pleat and varied wall thicknesses about the device in order to provide varying degrees of flexibility and support about the cushion.

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

Abstract: A respiratory interface device includes a respiratory mask that interfaces with a face of a patient. The respiratory mask comprises a body portion that forms an enclosure around a nose of a patient and at least one set of headgear strap flanges. The body portion is substantially entirely manufactured from an elastomeric material. A bellows-like structure is integrally molded in the body portion to create a sealing interface between an inner bottom portion of the mask and the patient's nose.

Abstract: A mask system includes a frame, cushion, cushion clip, swivel elbow, headgear and/or headgear clips that are configured for use in a clinical or hospital environment. One or more components of the mask system are configured to promote single patient use, e.g., by providing an age indicator and/or preventing disassembly and/or cleaning, etc.

Abstract: A respiratory mask provides improved sealing through the use of an intraoral mouthpiece with a large sealing area. A tubular extension, configured at one end to accept standard respiratory fittings, is the conduit for gas delivery to the intraoral mouthpiece. The respiratory mask may also include an intraoral oropharyngeal airway which flexes so that it can be inserted without the need for rotation or use of a tongue blade. The respiratory mask may also include an external shield to enhance sealing and provide a barrier of protection for the healthcare provider. The mask's design allows for a novel handgrip technique that allows a single healthcare provider to ventilate with enhanced sealing.

Abstract: A respiratory mask assembly for delivering breathable gas to a patient includes a mask frame, a mask cushion and a cushion clip to secure the mask cushion and mask frame.

Abstract: A respiratory mask for use with a patient, and that is suited for use with children, includes a flexible cushion arranged to interface with and deliver air to the patient's nose. The cushion has a tube connection portion at one or both sides adjacent the patient's nares, the tube connection portion being arranged to connect to an air delivery tube. This location, plus the very low profile of the mask, allows a patient (e.g. an infant) to sleep on their face more comfortably. A more rigid support structure adjacent the cushion is provided to stabilize the cushion and prevent it from collapsing. Headgear is also provided and arranged for releasable attachment to the support structure.

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 component mounting assembly includes a first respiratory component, a second respiratory component and a mounting clip for mounting the second respiratory component to the first respiratory component. Each of the first and second respiratory components includes at least two spaced apart clip openings. The mounting clip has an intermediate portion and two spaced apart free ends connected to the intermediate portion. The intermediate portion of the mounting clip is received within both of the clip openings of the first respiratory component and the free ends of the mounting clip are received in the clip openings of the second respiratory component for releasably securing the first and second respiratory components together.

Abstract: A patient interface having a cushion for engagement with the face of a user, a shell having an extension with a forehead support connected to the extension. The forehead support has a hinge so that the forehead support can be deformed to conform to the user's forehead. The patient interface also has a pivotable coupling defined by a body and a coplanar conduit that extends radially from the body. The coupling also has a port that allows access within the cavity formed by the cushion so that the port and coupling may rotate together.

Abstract: A patient interface device that includes a mask shell and a cushion assembly. The cushion assembly includes a seal cushion and a support cushion. The seal cushion contacts a first area of a patient's face to form a seal therewith. The support cushion defines a second area over a face of such a patient when the patient interface device is being worn. The second area overlaps at least a portion of the first area.

Abstract: A mask mounting mechanism for use in connection with a patient interface device having a mask and a mask attachment assembly with at least one strap for retaining the mask in a sealed position on a user's face. The mask mounting mechanism includes a button element extending from the mask, and the button element includes a shaft and a cap having a diameter greater than the diameter of the shaft. A clip element includes a clip element arm and a buckle. A second end of the arm includes an orifice extending therethrough. The buckle is attached to a first end of the clip element arm for engaging the strap of the mask attachment assembly. The clip element is engageable with a button element by engaging the orifice of the clip element arm over the cap and adjacent the shaft of the button element.

Abstract: An infant nasal interface mask for use with a nasal continuous positive airway pressure (nCPAP) system including a mask body and a base. The mask body forms a cavity and is defined by a leading portion, an intermediate shell portion, and a trailing portion. The leading portion terminates in a leading edge forming an aperture open to the cavity and having a generally triangular shape for placement over a patient's nose. The trailing portion includes a bellows segment characterized by an increased flexibility as compared to a flexibility of the intermediate shell portion. The base extends from the trailing portion opposite the leading portion and forms at least one longitudinal passage extending through a thickness of the base and fluidly connected to the cavity. The intermediate shell portion is laterally pivotable relative to the base via the bellows segment.

Abstract: An inflatable face seal (1?;30?) for a respiratory mask, the inflatable face seal comprising an annular air-tight hollow portion (12?;40?) where a cross section through one section of the annular hollow portion (12; 40) comprises a bonded joint (11;41) which joins two overlapping flanges (6,7; 35,36). The two flanges are bonded together such that an inwardly facing surface (10; 39) of a first flange (6;35) of the two overlapping flanges is in contact with an outwardly facing surface (9; 38) of a second flange (7;36) of the two overlapping flanges. In this way, the bond is strong and only exposed to shear stresses when the annular air-tight hollow portion is exposed to increased pressure.

Abstract: The present invention is a generally conical nebulizer, aerosol, filter or inhalant face mask for sealing against the atmosphere a wearer's mouth and nose, the improvement comprising a representation of a face on the outside surface with an exhaust valve located where the mouth would be located. The exhaust valve is adapted to visibly lift outward and up from the outside mask surface to imitate a flapping tongue.

Abstract: A method for producing a filled hollow structure includes producing an open hollow structure of a first material, positioning the open hollow structure on a tool adapted to hold the open hollow structure, filling the open hollow structure with a filler medium, and closing the filled open hollow structure with a second material. A hollow structure may be produced by such method, and a tool may be structured to perform such method.

Abstract: A patient interface device including a cushion assembly having a cushion-in-a-cushion arrangement and a system for supplying a flow of gas to a patient using such an interface device. The patient interface includes a mask shell having a patient side and an outer side opposite the patient side adapted for receiving a supply of gas. A seal cushion contacts a first area of a patient's face to form a seal therewith. A support cushion is disposed outside the seal cushion and includes a first end portion that contacts a second area of a patient's face.

Abstract: A cushion for a patient interface includes two or more bladders arranged in concentric relation. Each of the bladders includes a face-contacting portion adapted to engage the patient's face, and each of the bladders is adapted to be pressurized independently from one another. At least one of the bladders is an active bladder that is pressurized to at least a sealing pressure to form a continuous seal with the patient's face in use.