Modular patient interface including a joint coupling mouth and nasal cushions
A patient interface kit to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to a patients airways including at least the entrance of a patients nares while the patient is sleeping. The patient interface comprising: a nasal cushion having a nasal cushion opening; a mouth cushion having a mouth cushion opening, the mouth cushion including a flexible joint, positioned above the mouth opening, to selectively connect the nasal cushion to the mouth cushion; and a positioning and stabilizing structure to provide a force to hold the nasal and/or mouth seal-forming structures in a therapeutically effective position on a patient's head, the positioning an stabilizing structure including a nasal headgear including upper straps or conduits and a mouth headgear including lower straps, the mouth headgear being selectively connected to the nasal headgear.
1 . A patient interface kit to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least the entrance of a patient's nares while the patient is sleeping, to ameliorate sleep disordered breathing, the patient interface comprising:
a nasal cushion forming at least part of a nasal cushion plenum chamber pressurizable to a therapeutic pressure, wherein the nasal cushion comprises a nasal seal-forming structure configured to form a seal with a region of a patient's face surrounding the entrance to the patient's nares, the nasal cushion having a nasal cushion opening;
a mouth cushion forming at least part of a mouth cushion plenum chamber pressurizable to the therapeutic pressure, wherein the mouth cushion comprises a mouth seal-forming structure configured to form a seal with a region of a patient's face surrounding the entrance to a patient's mouth, the mouth cushion having a mouth cushion opening, the mouth cushion including a flexible joint, extending from another opening in the mouth cushion positioned above the mouth cushion opening, to selectively connect the nasal cushion to the mouth cushion; and
a positioning and stabilizing structure configured to provide a force to hold the nasal seal-forming structure and/or the mouth seal-forming structure in a therapeutically effective position on a patient's head, the positioning an stabilizing structure including a nasal headgear including upper straps or upper conduits and a mouth headgear including lower straps, the mouth headgear being selectively connected to the nasal headgear,
wherein each of the nasal cushion opening and the mouth cushion opening is configured to receive a vent insert with one or more gas washout vents, and in the alternative, a tube connector configured to connect to an air delivery tube, the nasal cushion opening and the mouth cushion opening having the same size,
wherein the nasal cushion opening is additionally and alternatively configured to receive a nasal cushion end of the flexible joint,
wherein the patient interface kit is configured to allow the patient to select a nasal cushion therapy mode or a combined nasal cushion and mouth cushion therapy mode,
the nasal cushion therapy mode including a nasal assembly having the nasal cushion and the nasal headgear and not the mouth cushion or the mouth headgear, the nasal cushion including the vent insert and/or the tube connection received in the nasal cushion opening,
the combined nasal cushion and mouth cushion therapy mode including an oro-nasal assembly including the nasal cushion and the mouth cushion being connected by inserting the nasal cushion end of the flexible joint into the nasal cushion opening, the nasal headgear connected to nasal connectors of the nasal cushion, the mouth headgear connected to mouth connectors of the mouth cushion, the mouth headgear being detachably connected to the nasal headgear, the mouth cushion including the vent insert or the tube connector received in the mouth cushion opening.
2 . The patient interface kit of claim 1 , wherein the nasal headgear includes the upper conduits to deliver flow of breathable gas to the nasal cushion.
3 . The patient interface kit of claim 1 , wherein, in the nasal cushion therapy mode, the nasal cushion opening includes the vent insert, and wherein in the nasal cushion and mouth cushion therapy mode the mouth cushion opening includes the vent insert.
4 . The patient interface kit of claim 1 , wherein the nasal headgear includes the upper straps to connect with the nasal cushion.
5 . The patient interface kit of claim 1 , wherein, in the nasal cushion therapy mode, the nasal cushion opening includes the tube connector, and wherein in the nasal cushion and mouth cushion therapy mode, the mouth cushion opening includes the tube connector.
6 . The patient interface kit of claim 1 , wherein the nasal cushion includes ports to receive pressurized gas, the nasal cushion including plugs to close the ports, the plugs including connectors to connect to the upper straps.
7 . The patient interface kit of claim 1 , wherein the tube connector includes at least one vent hole for gas washout.
8 . The patient interface kit of claim 1 , wherein the flexible joint comprises a concertina section having at least one fold.
9 . The patient interface kit of claim 8 , wherein the concertina allows the mouth cushion to move relative to the nasal cushion in an axial direction, as well as a curved direction to accommodate the patient's supramenton angle.
10 . The patient interface kit of claim 1 , wherein the flexible joint and/or the mouth cushion are configured to move towards the patient's supramenton due to a spring bias of the flexible joint and/or introduction of the flow of breathable gas through the mouth cushion and/or the flexible joint.
11 . The patient interface kit of claim 1 , wherein the flexible joint has a neutral position and a curved position oriented towards the patient's supramenton, and wherein the flexible joint resists movement from the neutral position to a position away from the patient's face.
12 . The patient interface kit of claim 1 , wherein the nasal cushion end is configured to direct or receive the flow of pressurized breathable gas into or from the nasal plenum chamber in a direction that is substantially parallel to the patient's Frankfurt horizontal.
13 . The patient interface kit of claim 1 , wherein the flexible joint is attached to the mouth cushion at a position that is above a horizontal medial plane of the mouth cushion.
14 . The patient interface kit of claim 1 , wherein the nasal cushion includes a pair of upper headgear connectors, the mouth cushion includes a pair of lower headgear connectors, the nasal headgear is configured to connect to the upper headgear connectors, and the mouth headgear is configured to connect to the lower headgear connectors.
15 . The patient interface kit of claim 14 , wherein each of the lower headgear connectors includes a magnetic connection element.
16 . The patient interface kit of claim 1 , wherein the lower headgear connectors each include a pair of arms having a wish-bone shape, each of the lower headgear connectors having an upper arm and a lower arm connected to a front face of the mouth cushion, the upper arm being spaced from the lower arm.
17 . The patient interface kit of claim 16 , wherein the upper arm and the lower arm distribute support forces, respectively, to a mid-zone and a lower zone of the mouth cushion.
18 . The patient interface kit of claim 16 , wherein each of the pair of arms is flexible and has a U-shape.
19 . The patient interface kit of claim 18 , wherein the U-shape is similar in size and/or shape to lateral side portions of the mouth cushion.
20 . The patient interface kit of claim 16 , wherein each of the pair of arms is made of silicone or a material that is more rigid than silicone.
21 . The patient interface kit of claim 16 , wherein each of the pair of arms is connected to the front face of the mouth cushion made of silicone.
22 . The patient interface kit of claim 16 , wherein each of the arms is attached to the front face of the mouth cushion at a position that is spaced inwards from a lateral edge of the mouth cushion.
23 . The patient interface kit of claim 16 , wherein each of the arms is dimensioned and configured to straddle opposite sides of the patient's cheilion, thus applying forces against corners of the patient's mouth when worn by the patient and supported by the positioning and stabilizing structure.
24 . The patient interface kit of claim 16 , wherein each of the arms is movable or flexible to lie flush against the front face of the mouth cushion.
25 . The patient interface kit of claim 16 , wherein the arms apply a force to the front face of the mouth cushion due to tension applied to the lower straps coupled to the arms, to anchor the mouth cushion into corners surrounding the patient's mouth.
26 . The patient interface kit of claim 1 , wherein the mouth cushion and/or the nasal cushion includes a textile sealing surface mounted on a silicone body.
27 . The patient interface kit of claim 1 , wherein the mouth cushion includes a front face, a sealing lip and a wall connecting the front face and the sealing lip, all made of silicone, wherein the wall and/or the sealing lip at a superior part of the corner-of-mouth portions of the mouth cushion is more rigid than an inferior part of the corner-of-mouth portions of the mouth cushion.
28 . The patient interface kit of claim 1 , wherein the mouth cushion has a depth configured so as not to extend beyond the nasal cushion and/or the pronasale of the patient's nose.
29 . The patient interface kit of claim 1 , wherein the mouth seal-forming structure includes an upper lip membrane configured to allow the mouth cushion to expand upwards when the patient's jaw opens.
30 . The patient interface kit of claim 29 , wherein the upper lip membrane includes a central portion that is curved inwardly towards the mouth cushion plenum chamber.
31 . The patient interface kit of claim 30 , wherein the upper lip membrane includes a central portion that is substantially linear or curved outwardly away from the mouth cushion plenum chamber.
32 . The patient interface kit of claim 1 , wherein the mouth seal-forming structure includes a lower lip membrane configured to allow the mouth cushion to expand downwards when the patient's jaw opens.
33 . The patient interface kit of claim 1 , wherein the mouth cushion is configured to expand due to flow of pressurized gas to hold upper portion and/or lower portion of the mouth cushion outwards from lateral sides of the mouth cushion.
34 . The patient interface kit of claim 1 , wherein the flexible joint includes an anti-asphyxia valve.
35 . The patient interface kit of claim 1 , wherein the mouth cushion is made of a first type of material and the nasal cushion is made of a second type of material different from the first type of material.
36 . The patient interface kit of claim 1 , wherein the mouth cushion includes a sealing surface made of a first type of material and the nasal cushion includes a sealing surface of a second type of material different from the first type of material.
37 . The patient interface kit of claim 35 , wherein one of the first type of material and the second type of material is silicone and the other one of the first type of material and the second type of material is textile.
38 . The patient interface kit of claim 1 , further comprising a pair of vent connectors including a plurality of holes, the pair of vent connectors configured to couple the nasal headgear to the nasal connectors of the nasal cushion.
39 . A patient interface kit to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least the entrance of a patient's nares while the patient is sleeping, to ameliorate sleep disordered breathing, the patient interface comprising:
a nasal cushion forming at least part of a nasal cushion plenum chamber pressurizable to a therapeutic pressure, wherein the nasal cushion comprises a nasal seal-forming structure configured to form a seal with a region of a patient's face surrounding the entrance to the patient's nares, the nasal cushion having a nasal cushion opening;
a mouth cushion forming at least part of a mouth cushion plenum chamber pressurizable to the therapeutic pressure, wherein the mouth cushion comprises a mouth seal-forming structure configured to form a seal with a region of a patient's face surrounding the entrance to a patient's mouth, the mouth cushion having a mouth cushion opening, the mouth cushion including a flexible joint, extending from another opening in the mouth cushion positioned above the mouth cushion opening, to selectively connect the nasal cushion to the mouth cushion; and
a positioning and stabilizing structure configured to provide a force to hold the nasal seal-forming structure and/or the mouth seal-forming structure in a therapeutically effective position on a patient's head, the positioning an stabilizing structure including a nasal headgear including upper conduits and a mouth headgear including lower straps, the mouth headgear being selectively connected to the nasal headgear,
wherein each of the nasal cushion opening and the mouth cushion opening is configured to receive a vent insert with one or more gas washout vents, and in the alternative, a tube connector configured to connect to an air delivery tube, the nasal cushion opening and the mouth cushion opening having the same size,
wherein the nasal cushion opening is additionally and alternatively configured to receive a nasal cushion end of the flexible joint,
wherein the patient interface kit is configured to allow the patient to select a nasal cushion therapy mode or a combined nasal cushion and mouth cushion therapy mode,
the nasal cushion therapy mode including a nasal assembly having the nasal cushion and the upper conduits and not the mouth cushion, the mouth headgear or the tube connector, the nasal cushion including the vent insert received in the nasal cushion opening,
the combined nasal cushion and mouth cushion therapy mode including an oro-nasal assembly including the nasal cushion and the mouth cushion being connected by inserting the nasal cushion end of the flexible joint into the nasal cushion opening, the upper conduits being connected to hollow nasal connectors of the nasal cushion, the mouth headgear connected to mouth connectors of the mouth cushion, the mouth headgear being detachably connected to the nasal headgear, the mouth cushion including the vent insert received in the mouth cushion opening.
40 . A method of fitting an oro-nasal mask on a patient, the oro-nasal mask configured to deliver a flow of air at a positive pressure with respect to ambient air pressure to the patient's while the patient is sleeping, to ameliorate sleep disordered breathing, the method comprising:
providing a nasal cushion forming at least part of a nasal cushion plenum chamber pressurizable to a therapeutic pressure, wherein the nasal cushion comprises a nasal seal-forming structure configured to form a seal with a region of a patient's face surrounding an entrance to a patient's nares;
providing a mouth cushion forming at least part of a mouth cushion plenum chamber pressurizable to the therapeutic pressure, wherein the mouth cushion comprises a mouth seal-forming structure configured to form a seal with a region of a patient's face surrounding the entrance to a patient's mouth, the mouth cushion having a mouth cushion opening;
connecting the nasal cushion and the mouth cushion with a flexible joint extending from another opening in the mouth cushion positioned above the mouth cushion opening; and
holding the nasal seal-forming structure and the mouth seal-forming structure in a therapeutically effective position on a patient's head by:
placing the nasal cushion under the patient's nose and engaging a superior portion of the patient's upper lip, whilst the mouth cushion is connected to the nasal cushion,
securing the nasal cushion on the patient's head using upper headgear conduits or straps,
adjusting a length and/or position of the upper headgear conduits or straps,
positioning an upper membrane of the mouth cushion on an inferior portion of the patient's upper lip, below the nasal cushion, allowing engagement between the mouth cushion and the nasal cushion,
securing the mouth cushion on the patient's head using lower headgear straps,
adjusting a length and/or position of the lower headgear straps,
wherein the adjustment of the upper headgear conduits or straps is substantially independent of adjustment of the lower headgear straps.