Patient interface

Abstract

A cushion module for a patient interface for delivering positive pressure respiratory therapy to a user. The cushion module has a seal for forming a seal around the mouth and nostrils of the user, and has a housing connected to the seal. The housing and the seal form a cavity configured to receive a flow of pressurized gas. The sealing piece is provided with at least one opening, and the at least one opening is used for communicating the pressurized gas with the user; an inlet through which the pressurized gas is received into the cavity; an outlet through which gas is discharged from the gasket module; and an exhaust conduit configured to extract gas from the user's nostrils through at least one exhaust conduit inlet and direct it to the outlet of the cushion module.

Description

Technical Field

[0001] This invention relates to a patient interface for delivering respiratory therapy to a patient. Specifically, this invention relates to a non-invasive patient interface for delivering pressurized breathing gases to a patient. Background Technology

[0002] Currently, one treatment option for respiratory diseases such as chest wall restrictive disorders, acute respiratory failure, advanced neuromuscular diseases, and chronic obstructive pulmonary disease (COPD—including emphysema, refractory asthma, and chronic bronchitis) is noninvasive ventilation (NIV) therapy. Some evidence suggests that NIV therapy may help assist breathing after intubation, including reducing the risk of reintubation. NIV therapy applies positive airway pressure to the lungs throughout the inspiratory and expiratory cycles. This can improve the flow of breathing gases into and out of the lungs.

[0003] However, one side effect of the positive pressure applied in current NIV treatment is that the applied therapeutic pressure can be uncomfortable for patients, making them less willing to undergo treatment. A subsequent effect of positive pressure is the need to securely fasten the patient interface to the patient to form a seal sufficient to minimize leakage, thereby ensuring pressure is maintained in both the patient interface and the respiratory system. Securely attaching the patient interface to the patient's face can lead to pressure sores, especially for patients who are semi-conscious or comatose and therefore unable to provide feedback on any pain caused by the pressure applied to their skin by the patient interface.

[0004] For at least the reasons mentioned above, NIV therapy presents two significant challenges: adherence (the degree to which patients are willing to accept the therapy) and pressure sores resulting from contact between the patient interface and the patient's skin. In addition to these challenges, another challenge for patients with obstructive respiratory disease or acute respiratory failure is flushing exhaled carbon dioxide from their anatomical dead space. Specifically, the end of the expiratory cycle is characterized by a decrease in airway pressure. This means that carbon dioxide-rich breathing gas remains in the patient's throat, nose, and mouth, and is inhaled into the lungs at the start of the next inspiratory cycle. Therefore, replacing the carbon dioxide-rich breathing gas in these areas with fresh breathing gas helps patients achieve improved breathing by increasing ventilation efficiency; this fresh breathing gas has a lower carbon dioxide content (and a higher oxygen content) compared to the carbon dioxide-rich gas.

[0005] It is believed that improving ventilation efficiency can reduce therapeutic pressure, which may reduce pressure ulcers and improve patient compliance. Alternatively, this can improve ventilation and patient outcomes at the same therapeutic pressure, while shortening the time required to receive NIV therapy.

[0006] There is a need to provide a patient interface that improves patient comfort and reduces pressure ulcers by enhancing patient ventilation.

[0007] A patient interface that facilitates flushing of anatomical dead space is also needed. Summary of the Invention

[0008] A patient interface for delivering respiratory therapy to a patient will now be described through a set of embodiments. However, it should be understood that further aspects can be defined by combining features of two or more embodiments described herein.

[0009] In a first aspect, a pad module for a patient interface for delivering positive pressure breathing therapy to a user may include: A seal that forms a seal around the user's mouth and nostrils; A housing connected to the seal, the housing and the seal forming a cavity configured to receive a pressurized gas flow; At least one opening in the seal is used to communicate the pressurized gas with the user; The pressurized gas is received into the cavity through the inlet; The gas exits from the gasket module through the outlet; and An exhaust duct is configured to draw gas from the user's nostril through at least one exhaust duct inlet and direct it to the outlet of the pad module.

[0010] In a second aspect, a pad module for a patient interface for delivering positive pressure breathing therapy to a user may include: A seal that forms a seal around the user's mouth and nostrils; A housing connected to the seal, the housing and the seal forming a cavity configured to receive a pressurized gas flow; At least one opening in the seal is used to communicate the pressurized gas with the user; An inlet, used to receive pressurized gas into the cavity; An outlet, used to discharge gas from the gasket module; and An exhaust duct is located within the cavity and has at least one exhaust duct inlet through which gas is received into the exhaust duct, and the exhaust duct extends from the at least one exhaust duct inlet to the outlet of the gasket module.

[0011] When the patient interface is fitted to the user, each exhaust duct inlet may be configured to be located in one or more of the user's nostrils, or below and adjacent to the user's upper lip.

[0012] The cross-sectional area of ​​the at least one exhaust duct inlet may be smaller than the cross-sectional area of ​​the inlet, such that the gas entering the exhaust duct is accelerated as it flows from the cavity into the exhaust duct.

[0013] The exhaust duct and the at least one exhaust duct inlet may be configured to accelerate the gas as it flows from the cavity into the exhaust duct and to bring ambient gas into the exhaust duct.

[0014] When the at least one exhaust duct inlet is located in or below the user’s nostril and near the user’s upper lip, bringing ambient air into the exhaust duct may draw in breathing air from the user’s nostril.

[0015] The at least one opening of the seal may include a first opening covering the user's mouth and a second opening covering the user's nostrils.

[0016] The exhaust duct may be configured to direct exhaled air from the user’s mouth and / or nostrils, and / or excess air from the cavity, to the outlet.

[0017] The exhaust duct can be configured to exhaust the exhaled gas from the user's mouth and / or nostrils and / or the excess gas from the cavity from the liner module.

[0018] The exhaust duct can be adjustablely mounted to the housing, allowing for adjustment of its orientation and / or position relative to the seal.

[0019] The exhaust duct may include a body that is flexible to allow adjustment of the orientation and / or position relative to the seal.

[0020] The exhaust duct can be a closed passage extending from the at least one exhaust duct inlet to the outlet.

[0021] The exhaust duct can be configured to prevent gas from flowing into the cavity except through the at least one exhaust duct inlet, and to prevent gas from flowing out of the cavity.

[0022] The exhaust duct can be surrounded by this cavity.

[0023] The exhaust duct can be a separate structure from the seal.

[0024] The exhaust duct may include at least one insert, and the at least one exhaust duct inlet may be located at the free end of the at least one insert.

[0025] The at least one insertion post may be configured to extend into the user's nostril or into the corresponding nostril.

[0026] The at least one insert may be a sealing insert, which is configured to form a seal with the user’s nostril or the corresponding nostril.

[0027] The at least one insert may be formed of an elastomeric material.

[0028] The elastomer material can be silicone resin.

[0029] The at least one exhaust duct inlet may include a first exhaust duct inlet and a second exhaust duct inlet. When the patient interface is fitted to the user, the first exhaust duct inlet is configured to be located inside a first nostril in the user's nostril, or located below the first nostril in the user's nostril and adjacent to the user's upper lip. The second exhaust duct inlet is configured to be located inside a second nostril in the user's nostril, or located below the second nostril in the user's nostril and adjacent to the user's upper lip.

[0030] The at least one insert may include a first insert and a second insert, the first exhaust duct inlet being located at the free end of the first insert, and the second exhaust duct inlet being located at the free end of the second insert.

[0031] When the patient interface is fitted to the user, the first post may be configured to extend into the user's first nostril, and the second post may be configured to extend into the user's second nostril.

[0032] The exhaust duct may include a manifold from which the first post and the second post extend.

[0033] At least a portion of the exhaust duct may be flexible to allow adjustment of the positions of the first and second inserts.

[0034] The first exhaust duct inlet and the second exhaust duct inlet may have different cross-sectional areas.

[0035] The ratio of the cross-sectional area of ​​the first exhaust duct inlet to the cross-sectional area of ​​the second exhaust duct inlet can be between 1:1.1 and 1:4.

[0036] The ratio of the cross-sectional area of ​​the first exhaust duct inlet to the cross-sectional area of ​​the second exhaust duct inlet can be 1:3.

[0037] At least a portion of the exhaust duct can be incorporated into a nasal interface, the nasal interface including a flushing duct having at least one flushing duct inlet and at least one flushing duct outlet, the at least one flushing duct inlet being within the cavity, and the at least one flushing duct outlet being located at or adjacent to at least one of the first exhaust duct inlet or the second exhaust duct inlet.

[0038] The nose connector may be located within the cavity. The nose connector may be a structure separate from the seal. The nose connector may be a structure separate from the housing. The nose connector may be able to connect to the seal, the housing, or both the seal and the housing.

[0039] Each of the first and second posts can be a sealing post configured to form a seal with a corresponding nostril in the user's nostril.

[0040] The flushing conduit may have a first flushing conduit outlet and a second flushing conduit outlet, the first flushing conduit outlet being located at or near the first exhaust conduit inlet, and the second flushing conduit outlet being located at or near the second exhaust conduit inlet.

[0041] The flushing conduit can be configured to guide gas from the cavity into one or the corresponding nostril of the user.

[0042] The flushing conduit may be configured to accelerate the flow of gas from the at least one flushing conduit inlet to the first flushing conduit outlet and the second flushing conduit outlet, and to direct the accelerated gas into the corresponding nostril of the user.

[0043] The first and second inserts may be formed of an elastomeric material.

[0044] The elastomer material can be silicone resin.

[0045] The outlet of the gasket module is in fluid communication with the filter, so that gas leaving the gasket module through the outlet will pass through the filter.

[0046] The filter can be located outside the liner module.

[0047] The filter can be attached to the gasket module.

[0048] The outlet of the gasket module may include a deflector vent.

[0049] The outlet of the liner module can be configured to connect to or be in fluid communication with the exhalation tube.

[0050] The deflector vent may include multiple holes.

[0051] The gasket module can be configured to receive only the pressurized gas flow through the inlet and discharge only through the outlet.

[0052] The gasket module may include a supplemental deflection vent that is in fluid communication with the cavity.

[0053] The supplemental deflection vent can be configured to have a flow rate that is less than the flow rate through the outlet of the gasket module when in use.

[0054] The supplemental deflection vent can be configured to have a flow resistance during use that is greater than the flow resistance through the outlet of the gasket module.

[0055] The supplemental deflection vent may include at least one hole having a cross-sectional area, and the cross-sectional area of ​​the at least one hole is smaller than the cross-sectional area of ​​the outlet of the gasket module.

[0056] The housing may include a plastic material. This plastic material may be polycarbonate.

[0057] The seal may include an elastomeric material. The elastomeric material may be silicone.

[0058] The seal and the housing can be mechanically connected.

[0059] The housing may include the inlet of the liner module.

[0060] The housing may include the outlet of the padding module.

[0061] The seal may include the outlet of the gasket module.

[0062] The seal may include the gasket module inlet.

[0063] The seal can be a full-face nose seal that is configured to form a seal at the user's bridge of the nose during use.

[0064] The seal can be a full-face subnasal seal that is configured not to form a seal at the user's bridge of the nose during use.

[0065] The seal can be a full-face seal, which is configured to form a seal around the user's mouth, nose and eyes when in use.

[0066] The seal may be a helmet-type seal, which is configured to form a seal at the user's neck during use.

[0067] A patient interface may include a padding module according to any of the foregoing aspects, and the patient interface may also include a frame configured to attach to the padding module, the frame including a plurality of headgear connectors configured to connect to a headgear for holding the patient interface on a user's face during use.

[0068] The patient interface may also include a catheter connector configured to connect to the inlet of the liner module, the catheter connector including an anti-asphyxiation valve and a pressure port, and the catheter connector also configured to be removably attached to a respiratory therapy catheter.

[0069] The catheter connector can be configured to connect to a single-limb breathing circuit.

[0070] The catheter connector can be configured to connect to a dual-limb breathing circuit.

[0071] The catheter connector can be configured to connect to the bilimb breathing circuit via a Y-shaped element.

[0072] In a third aspect, a patient interface for delivering positive pressure ventilation therapy to a user may include: (a) a liner module defining a first cavity configured to be pressurized, the liner module including: an inlet configured to receive a flow of pressurized gas into the cavity; an opening configured to cover the user's mouth and nostrils to communicate the pressurized gas with the user; and an outlet configured to discharge gas to the outside of the liner module; (b) An exhaust duct located within the first cavity, the exhaust duct extending from the outlet of the liner module to at least one exhaust duct inlet, wherein, when the patient interface is fitted to the user, the at least one exhaust duct inlet is configured to be positioned within one of the user's nostrils or a first nostril of a corresponding nostril. The exhaust duct includes at least one post configured to form a seal with the user’s nostril or the first nostril in the corresponding nostril, and the exhaust duct inlet is located at the free end of the at least one post.

[0073] In the fourth aspect, a patient interface for delivering positive pressure breathing therapy to a user may include: (a) A pad module defining a first chamber configured to be pressurized, the pad module including: an inlet configured to receive a flow of pressurized gas into the chamber; an opening configured to cover the mouth and nostrils of the user to communicate pressurized gas with the user; and an outlet configured to discharge gas to the outside of the pad module. (b) An exhaust duct located within the first cavity, the exhaust duct extending from the outlet of the liner module to a first exhaust duct inlet and a second exhaust duct inlet, wherein when the patient interface is fitted to the user, the first exhaust duct inlet is configured to be positioned within a first nostril in the user's nostril, and the second exhaust duct inlet is configured to be positioned within a second nostril in the user's nostril.

[0074] In a fifth aspect, a padding module for a patient interface for delivering positive pressure breathing therapy to a user may include: (a) a cavity for delivering breathing gases to the user's mouth and nostrils; and (b) An exhaust duct for conveying exhaled air from the user's mouth and / or nostrils and / or excess breathing air from the cavity to the outside of the liner module. The exhaust duct is configured to accelerate the breathing gas as it flows from the cavity into the exhaust duct.

[0075] In a sixth aspect, a non-invasive patient interface configured to form a seal around the patient's mouth and nostrils may include: (a) An outer wall defining an internal cavity including a first chamber and a second chamber, the first chamber having an oral cavity opening for communication of gas with the mouth, and the second chamber having a nasal cavity opening for communication of gas with the nostrils; and (b) a partition wall separating the first chamber from the second chamber; and (c) One or more flow deflectors that allow gas to flow from the first chamber into the second chamber, and the flow deflectors are configured to direct the gas flow into the nostril; and The outer wall is configured to extend above the patient's nasal bridge.

[0076] In a seventh aspect, a non-invasive patient interface configured to form a seal around the patient's mouth and nostrils may include: (a) An outer wall defining an internal cavity of the patient interface, the outer wall having a patient contact surface including an oral cavity opening communicating with the mouth and a nasal cavity opening communicating with the nostrils; and (b) a partition wall that divides the internal cavity into a first chamber having the oral cavity opening and a second chamber having the nasal cavity opening; and (c) One or more flow deflectors extending from the partition wall, the flow deflectors allowing gas to flow from the first chamber into the second chamber, and the flow deflectors being configured to direct the gas flow into the nostril; and The flow guide is separated by a spacer element, which maintains the spacing between the flow guides; and The patient contact surface is attached to the patient's nasal bridge.

[0077] In the eighth aspect, a non-invasive patient interface configured to form a seal around the patient's mouth and nostrils may include: (a) An outer wall defining an internal cavity of the patient interface, the outer wall having an oral cavity opening communicating gas with the mouth and a nasal cavity opening communicating gas with the nostrils; (b) a partition wall that divides the internal cavity into a first chamber having the oral cavity opening and a second chamber having the nasal cavity opening; and The partition wall includes one or more spaced-apart guides that allow gas to flow from the first chamber into the second chamber, and the spaced-apart guides are configured to direct the gas flow into the nostril; and The outer wall is attached to the patient's nasal bridge.

[0078] In the ninth aspect, a patient interface for delivering positive pressure breathing therapy to a user may include: A gasket module including a seal and a housing, the seal and housing together defining a cavity configured to receive a pressurized gas flow; The seal is configured to form a seal with the user's mouth and nostrils, and the seal includes at least one opening for communicating the pressurized gas with the user's mouth and nostrils. The pressurized gas is received into the cavity through the gasket module inlet; Gas is discharged from the cavity through the gasket module outlet; and A partition wall insert, configured to be inserted into the cavity of the liner module, includes a partition wall and one or more flow deflectors. When the partition wall insert is inserted into the cavity of the liner module: The partition wall traverses the cavity and intersects with the at least one sealing opening to divide the cavity into a first chamber and a second chamber. The first chamber includes an oral cavity opening for communicating the pressurized gas with the user's mouth, and the second chamber includes a nasal cavity opening for communicating the pressurized gas with the user's nostrils. The one or more flow deflectors allow gas to flow from the first chamber into the second chamber through the partition wall.

[0079] The inlet of the gasket module allows the pressurized gas to be delivered to the first chamber.

[0080] The gasket module outlet allows gas to be discharged from the second chamber.

[0081] The partition wall may include an outer periphery that contacts the housing and / or the seal to adequately seal the first chamber and the second chamber around the outer periphery.

[0082] The partition wall may include an outer periphery whose shape is designed to substantially match the internal geometry of the housing and / or the seal to restrict the flow of gas around the outer periphery between the first chamber and the second chamber.

[0083] The outer periphery of the partition wall may be configured to be spaced apart from the housing and / or the seal to allow a predetermined amount of gas to flow between the outer periphery and the housing and / or the seal.

[0084] The outer periphery of the partition wall may be bonded, adhered to, or mechanically attached to the housing and / or the seal.

[0085] The partition wall insert may include a connector configured to be removably connected to the housing to secure the partition wall insert within the cavity of the liner module.

[0086] The connector of the partition wall insert may include a sleeve configured for connection with the sleeve of the housing.

[0087] The one or more flow diverters may include a first flow diverter, the first flow diverter including a first flow diverter inlet in fluid communication with the first chamber and a first flow diverter outlet in fluid communication with the second chamber.

[0088] When the patient interface is worn by a user, the first duct outlet can be configured to be positioned close to and / or pointing toward the user's nostril.

[0089] The one or more flow deflectors may further include a second flow deflector, the second flow deflector including a second flow deflector in fluid communication with the first chamber and a second flow deflector outlet in fluid communication with the second chamber.

[0090] When the patient interface is worn by a user, the first and second flow outlets can each be configured to be positioned near and / or pointing toward the corresponding nostril in the user's nostril.

[0091] The shapes of the first flow guide and the second flow guide may be designed to be different from each other in at least one aspect.

[0092] The first flow guide outlet and the second flow guide outlet may have unequal cross-sectional areas.

[0093] The partition wall may include a rigid part and an elastomeric part.

[0094] The connector can be attached to the rigid portion, and the one or more flow guides can extend from the elastomeric portion.

[0095] The elastomer portion may include a deformable region, which includes a thin region located between a first thickened region and a second thickened region.

[0096] This deformation zone allows the partition wall to deform in a controlled manner within the thin area in response to the forces applied to it during use.

[0097] The seal can be a full-face nose seal that is configured to contact the user's bridge of the nose.

[0098] The seal can be a full-face subnasal seal that is configured not to contact the user's bridge of the nose.

[0099] In a tenth aspect, a patient interface for delivering positive pressure breathing therapy to a user may include: A gasket module including a seal and a housing, the seal and housing together defining a cavity configured to receive a pressurized gas flow; The seal is configured to form a seal with the user's mouth and nostrils, and the seal includes a nasal opening for communicating the pressurized gas with the user's nostrils and an oral opening for communicating the pressurized gas with the user's mouth. The pressurized gas is received into the cavity through the gasket module inlet; Gas is discharged from the cavity through the gasket module outlet; and A partition wall insert, configured to be inserted into the cavity of the liner module, includes a partition wall and one or more flow deflectors. When the partition wall insert is inserted into the cavity of the liner module: The partition wall traverses the cavity and divides it into a first chamber including the oral cavity opening and a second chamber including the nasal cavity opening; and The one or more flow deflectors allow gas to flow from the first chamber into the second chamber through the partition wall.

[0100] The inlet of the gasket module allows the pressurized gas to be delivered to the first chamber.

[0101] The gasket module outlet allows gas to be discharged from the second chamber.

[0102] The partition wall may include an outer periphery that contacts the housing and / or the seal to adequately seal the first chamber and the second chamber around the outer periphery.

[0103] The partition wall may include an outer periphery whose shape is designed to substantially match the internal geometry of the housing and / or the seal to restrict the flow of gas around the outer periphery between the first chamber and the second chamber.

[0104] The outer periphery of the partition wall may be configured to be spaced apart from the housing and / or the seal to allow a predetermined amount of gas to flow between the outer periphery and the housing and / or the seal.

[0105] The outer periphery of the partition wall may be bonded, adhered to, or mechanically attached to the housing and / or the seal.

[0106] The partition wall insert may include a connector configured to be removably connected to the housing to secure the partition wall insert within the cavity of the liner module.

[0107] The connector of the partition wall insert may include a sleeve configured for connection with the sleeve of the housing.

[0108] The one or more flow diverters may include a first flow diverter, the first flow diverter including a first flow diverter inlet in fluid communication with the first chamber and a first flow diverter outlet in fluid communication with the second chamber.

[0109] When the patient interface is worn by a user, the first duct outlet can be configured to be positioned close to and / or pointing toward the user's nostril.

[0110] The one or more flow deflectors may further include a second flow deflector, the second flow deflector including a second flow deflector in fluid communication with the first chamber and a second flow deflector outlet in fluid communication with the second chamber.

[0111] When the patient interface is worn by a user, the first and second flow outlets can each be configured to be positioned near and / or pointing toward the corresponding nostril in the user's nostril.

[0112] The shapes of the first flow guide and the second flow guide may be designed to be different from each other in at least one aspect.

[0113] The first flow guide outlet and the second flow guide outlet may have unequal cross-sectional areas.

[0114] The partition wall may include a rigid part and an elastomeric part.

[0115] The connector can be attached to the rigid portion, and the one or more flow guides can extend from the elastomeric portion.

[0116] The elastomer portion may include a deformable region, which includes a thin region located between a first thickened region and a second thickened region.

[0117] This deformation zone allows the partition wall to deform in a controlled manner within the thin area in response to the forces applied to it during use.

[0118] The seal can be a full-face nose seal that is configured to contact the user's bridge of the nose.

[0119] The seal can be a full-face subnasal seal that is configured not to contact the user's bridge of the nose.

[0120] In the eleventh aspect, a patient interface for delivering positive pressure breathing therapy to a user includes: A gasket module including a seal and a housing, the seal and housing together defining a cavity configured to receive a pressurized gas flow; The seal is configured to form a seal with the user's mouth and nostrils, and the seal includes a nasal opening for communicating the pressurized gas with the user's nostrils and an oral opening for communicating the pressurized gas with the user's mouth. The pressurized gas is received into the cavity through the gasket module inlet; Gas is discharged from the cavity through the gasket module outlet; and A partition wall divides the cavity into a first chamber having the oral cavity opening and a second chamber having the nasal cavity opening. The partition wall includes a flow guide hole configured to receive a flow guide insert, and The flow guide insert includes one or more flow guides that, when received within the flow guide orifice, allow gas to flow from the first chamber into the second chamber.

[0121] The inlet of the gasket module allows the pressurized gas to be delivered to the first chamber.

[0122] The gasket module outlet allows gas to be discharged from the second chamber.

[0123] The flow guide hole can be configured to removably receive the flow guide insert.

[0124] The flow guide insert may include a flow channel around its periphery, the flow channel being configured to receive the edge of the flow guide orifice to removably attach the flow guide insert to the partition wall.

[0125] The flow guide insert may include an elastomeric material.

[0126] The one or more flow diverters may include a first flow diverter, the first flow diverter including a first flow diverter inlet in fluid communication with the first chamber and a first flow diverter outlet in fluid communication with the second chamber.

[0127] When the patient interface is worn by a user, the first duct outlet can be configured to be positioned close to and / or pointing toward the user's nostril.

[0128] The one or more flow deflectors may further include a second flow deflector, the second flow deflector including a second flow deflector in fluid communication with the first chamber and a second flow deflector outlet in fluid communication with the second chamber.

[0129] When the patient interface is worn by a user, the first and second flow outlets can each be configured to be positioned near and / or pointing toward the corresponding nostril in the user's nostril.

[0130] The shapes of the first flow guide and the second flow guide may be designed to be different from each other in at least one aspect.

[0131] The first flow guide outlet and the second flow guide outlet may have unequal cross-sectional areas.

[0132] The ratio of the cross-sectional area of ​​the first flow guide outlet to the cross-sectional area of ​​the second flow guide outlet is in the range of 1:1.1 to 1:4.

[0133] The flow guide insert may include one or more flow guide holes extending through the flow guide insert.

[0134] The partition wall may include an elastomeric portion.

[0135] The elastomer portion may include a deformable region, which includes a thin region located between a first thickened region and a second thickened region.

[0136] This deformation zone allows the partition wall to deform in a controlled manner within the thin area in response to the forces applied to it during use.

[0137] The seal can be a full-face nose seal that is configured to contact the user's bridge of the nose.

[0138] The seal can be a full-face subnasal seal that is configured not to contact the user's bridge of the nose.

[0139] The sequential references to the aspects disclosed above (e.g., first, second, third) are used solely to distinguish the aspects. These sequential references should not be interpreted as an order of importance of the aspects.

[0140] Although various features have been disclosed above with respect to one or more aspects, it should be understood that one or more features of one aspect may be combined with other aspects to form additional embodiments. Therefore, the disclosure of features in the foregoing statements should not be construed as meaning that the application of these features is limited to the aspects disclosed therein. Attached Figure Description

[0141] The patient interface disclosed above is described in detail below with reference to embodiments used only as examples and the accompanying drawings, wherein: Figure 1 This is a perspective view of the patient interface according to the first embodiment.

[0142] Figure 2 yes Figure 1 A breakdown perspective of the patient interface.

[0143] Figure 3 yes Figure 1 A decomposed side view of the patient interface.

[0144] Figure 4 yes Figure 1 The front view of the patient interface.

[0145] Figure 5 yes Figure 1 A side view of the patient interface.

[0146] Figure 6 yes Figure 1 The rear view of the patient interface.

[0147] Figure 7 yes Figure 1 A top view of the patient interface.

[0148] Figure 8 yes Figure 1 A bottom view of the patient interface.

[0149] Figure 9 yes Figure 1 The patient interface follows, for example Figure 4 The cross-sectional side view of line AA' shown.

[0150] Figure 10 This is a perspective view of the patient interface according to the second embodiment.

[0151] Figure 11 yes Figure 10 A breakdown perspective of the patient interface.

[0152] Figure 12 yes Figure 10 A decomposed side view of the patient interface.

[0153] Figure 13 yes Figure 10 The front view of the patient interface.

[0154] Figure 14 yes Figure 10 A side view of the patient interface.

[0155] Figure 15 yes Figure 10 The rear view of the patient interface.

[0156] Figure 16 yes Figure 10 A top view of the patient interface.

[0157] Figure 17 yes Figure 10 A bottom view of the patient interface.

[0158] Figure 18 yes Figure 10 The patient interface follows, for example Figure 13 The cross-sectional side view of line BB' shown.

[0159] Figure 19 yes Figure 10 The patient interface follows, for example Figure 13 The cross-sectional perspective view of line BB' shown.

[0160] Figure 20 yes Figure 10 The patient interface follows, for example Figure 13 Another cross-sectional perspective view of line BB' shown.

[0161] Figure 21 yes Figure 10 The patient interface follows, for example Figure 13 The top view of the cross section of line CC' shown.

[0162] Figure 22 yes Figure 10 A perspective view of the exhaust duct of the patient interface.

[0163] Figure 23 yes Figure 10 The patient interface follows, for example Figure 13 The schematic cross-sectional side view of line BB' shown shows the patient interface being fitted onto the patient when the patient's mouth is open.

[0164] Figure 24 yes Figure 10 The patient interface follows, for example Figure 13 The schematic cross-sectional side view of line BB' shown shows the patient interface being fitted onto the patient when the patient's mouth is closed.

[0165] Figure 25 This is a perspective view of the patient interface according to the third embodiment.

[0166] Figure 26 yes Figure 25 A breakdown perspective of the patient interface.

[0167] Figure 27 yes Figure 25 A decomposed side view of the patient interface.

[0168] Figure 28 yes Figure 25 The front view of the patient interface.

[0169] Figure 29 yes Figure 25 A side view of the patient interface.

[0170] Figure 30 yes Figure 25 The rear view of the patient interface.

[0171] Figure 31 yes Figure 25 A top view of the patient interface.

[0172] Figure 32 yes Figure 25 A bottom view of the patient interface.

[0173] Figure 33 yes Figure 25 The patient interface follows, for example Figure 30 The cross-sectional side view of line DD' shown.

[0174] Figure 34 yes Figure 25 The patient interface follows, for example Figure 30 The cross-sectional perspective view of line DD' shown.

[0175] Figure 35 yes Figure 25 The patient interface follows, for example Figure 30 The cross-sectional side view of line EE' shown.

[0176] Figure 36 yes Figure 25 The patient interface follows, for example Figure 30 The cross-sectional perspective view of line EE' shown.

[0177] Figure 37 yes Figure 25 A perspective view of the exhaust duct of the patient interface.

[0178] Figure 38 yes Figure 37 Rear view of the exhaust duct.

[0179] Figure 39 yes Figure 37 The exhaust duct runs along, as Figure 38 The cross-sectional side view of line FF' shown.

[0180] Figure 40 yes Figure 37 The exhaust duct runs along, as Figure 38 The cross-sectional side view of line GG' shown.

[0181] Figure 41 yes Figure 25 The patient interface follows, for example Figure 30 The schematic cross-sectional side view of line EE' shown shows the patient interface being fitted onto the patient when the patient's mouth is open.

[0182] Figure 42 yes Figure 25 The patient interface follows, for example Figure 30 The schematic cross-sectional side view of line EE' shown shows the patient interface being fitted onto the patient when the patient's mouth is closed.

[0183] Figure 43 This is a perspective view of the patient interface according to the fourth embodiment.

[0184] Figure 44 yes Figure 43 The front view of the patient interface.

[0185] Figure 45 yes Figure 43 A side view of the patient interface.

[0186] Figure 46 yes Figure 43 The rear view of the patient interface.

[0187] Figure 47 yes Figure 43 A top view of the patient interface.

[0188] Figure 48 yes Figure 43 A bottom view of the patient interface.

[0189] Figure 49 yes Figure 43 The patient interface follows, for example Figure 44 The cross-sectional side view of line HH' shown.

[0190] Figure 50 yes Figure 43 The patient interface follows, for example Figure 44 The cross-sectional perspective view of line HH' shown.

[0191] Figure 51 yes Figure 43 The patient interface follows, for example Figure 44 A cross-sectional perspective view of line II' shown.

[0192] Figure 52 yes Figure 43 The patient interface follows, for example Figure 44 A top view of the cross section of line II' shown.

[0193] Figure 53 yes Figure 43 The patient interface follows, for example Figure 44 The schematic cross-sectional side view of line HH' shown shows the patient interface being fitted onto the patient when the patient's mouth is open.

[0194] Figure 54 yes Figure 43 The patient interface follows, for example Figure 44 The schematic cross-sectional side view of line HH' shown shows the patient interface being fitted onto the patient when the patient's mouth is closed.

[0195] Figure 55 This is a perspective view of the patient interface according to the fifth embodiment.

[0196] Figure 56 yes Figure 55 A perspective view of the padding module of the patient interface.

[0197] Figure 57 yes Figure 55 Front view of the patient interface padding module.

[0198] Figure 58 yes Figure 55 Side view of the padding module of the patient interface.

[0199] Figure 59 yes Figure 55 Rear view of the patient interface padding module.

[0200] Figure 60 yes Figure 55 Side view of the padding module of the patient interface.

[0201] Figure 61 yes Figure 55 The patient interface padding module is along, as shown in the image. Figure 57 The cross-sectional side view of line JJ' shown.

[0202] Figure 62 yes Figure 55 The patient interface padding module is along, as shown in the image. Figure 57 The cross-sectional perspective view of line JJ' shown.

[0203] Figure 63 yes Figure 55 The patient interface padding module is along, as shown in the image. Figure 57 The cross-sectional perspective view of line JJ' shown.

[0204] Figure 64 yes Figure 55 A perspective view of the partition wall component of the patient interface.

[0205] Figure 65 yes Figure 64 Side view of the partition wall component.

[0206] Figure 66 yes Figure 64 The rear view of the partition wall component.

[0207] Figure 67 The partition wall assembly is along such Figure 66 The cross-sectional side view of line KK' shown.

[0208] Figure 68 yes Figure 64 Top view of the partition wall component.

[0209] Figure 69 This is a perspective view of the patient interface according to the sixth embodiment.

[0210] Figure 70 yes Figure 69 A perspective view of the padding module of the patient interface.

[0211] Figure 71 yes Figure 69 A top view of the padding module of the patient interface.

[0212] Figure 72 yes Figure 69 Rear view of the patient interface padding module.

[0213] Figure 73 The padding module is along such Figure 71 The cross-sectional side view of line LL' shown.

[0214] Figure 74 Is it like this? Figure 72 The cross-sectional perspective view of the pad module MM' shown.

[0215] Figure 75 yes Figure 69 A perspective view of the partition wall component of the patient interface.

[0216] Figure 76 yes Figure 75 The rear view of the partition wall component.

[0217] Figure 77 yes Figure 75 Side view of the partition wall component.

[0218] Figure 78 The partition wall assembly is along such Figure 76 The cross-sectional side view of line NN' shown.

[0219] Figure 79 This is a perspective view of the patient interface according to the seventh embodiment.

[0220] Figure 80 yes Figure 79 A perspective view of the padding module of the patient interface.

[0221] Figure 81 yes Figure 79 Front view of the patient interface padding module.

[0222] Figure 82 yes Figure 79 Rear view of the patient interface padding module.

[0223] Figure 83 The padding module is along such Figure 82 The cross-sectional side view of line OO' shown.

[0224] Figure 84 The padding module is along such Figure 82 The cross-sectional perspective view of line OO' shown.

[0225] Figure 85 The padding module is along such Figure 82 The cross-sectional perspective view of line OO' shown shows the flow guide insert removed.

[0226] Figure 86 The padding module is along such Figure 82 The cross-sectional perspective view of line PP' shown.

[0227] Figure 87 The padding module is along such Figure 82The cross-sectional perspective view of line PP' shown shows the flow guide insert removed.

[0228] Figure 88 yes Figure 79 A perspective view of the patient interface flow guide insert.

[0229] Figure 89 yes Figure 88 Top view of the flow guide insert.

[0230] Figure 90 yes Figure 79 A perspective view of the alternative drainage device insert for the patient interface.

[0231] Figure 91 yes Figure 90 Top view of the flow guide insert.

[0232] Figure 92 yes Figure 79 A perspective view of another alternative duct insert for the patient interface.

[0233] Figure 93 yes Figure 92 Top view of the flow guide insert. Detailed Implementation

[0234] Embodiments will now be described in the following text, which includes reference numerals corresponding to the features illustrated in the accompanying drawings. Where possible, related reference numerals have been used to identify the same or substantially similar features in different embodiments. However, to maintain clarity of the drawings, not all reference numerals are included in every drawing.

[0235] The following will refer to Figures 1 to 9 The embodiments of the general form of the patient interface shown are described in detail to illustrate various aspects of the patient interface disclosed above. The embodiments described below are variations of this general form. However, it should be understood that the scope of the aspects should not be limited by reference to this general form or the specific embodiments described below; rather, the aspects should be construed as also relating to other forms of patient interfaces that also deliver pressurized breathing gas to the patient, including full-face patient interfaces that do not contact the bridge of the nose (naso-oropharyngeal mask), full-face masks, helmet interfaces, and nasal masks that, where appropriate, form a seal with the patient's nasal cavity.

[0236] As used throughout this specification, the term "breathing gas" is understood to mean the gas used during human breathing or human ventilation. As used throughout this specification, the term "inhaled breathing gas" is understood to mean the breathing gas inhaled during the inspiratory phase of the respiratory cycle. This term, in its scope, includes ambient air or air conditioned for the treatment of a patient (e.g., with higher humidity and / or oxygen content compared to ambient air). As used throughout this specification, the term "exhaled breathing gas" is understood to mean the breathing gas exhaled from the patient's lungs and airways during the expiratory phase of the respiratory cycle. Therefore, it includes breathing gases from the lungs as well as gases that occupy the anatomical dead space of the patient at the end of the expiratory phase of the respiratory cycle.

[0237] General form Considering Figures 1 to 9 The typical form includes a patient interface 1000, which comprises a padding module 1010, a frame 1400, and a catheter connector 1300. The catheter connector 1300 includes structural components for connecting the padding module 1010 to a pressurized breathing gas source, such as a ventilator, humidifier, flow generator, or wall source. In this embodiment, the patient interface 1000 is in the form of a full-face mask, wherein the padding module 1010 includes a resilient seal 1100 and a housing 1200. The resilient seal 1100 and the housing 1200 together form the padding module 1010, which has an internal cavity 1012 configured to be pressurized.

[0238] The housing 1200 is formed of a substantially rigid plastic material to provide structural support for the seal 1100. Additionally, the housing 1200 provides interfaces for connecting the seal 1100 to the frame 1400 and / or the conduit connector 1300.

[0239] In an alternative configuration, the housing 1200 may be formed of an elastomeric material, textile, or foam sufficient to provide the rigidity required to structurally support the seal 1100. The housing may also be formed of any of the aforementioned materials and reinforced with a secondary material of greater rigidity to provide the necessary structural support for the seal 1100.

[0240] The housing 1200 includes a sleeve 1230, which is sized and shaped to connect with the frame 1400. The connection between the housing 1200 and the frame 1400 is described in further detail below. The sleeve 1230 defines an inlet 1220 through which breathing gas can be transferred from the conduit connector 1300 to the cavity 1012 of the padding module 1010.

[0241] Breathing gas can be delivered from the catheter connector 1300 to the cavity 1012 of the pad module 1010 via either: an inspiratory catheter of a single-limb NIV circuit configured to deliver fresh pressurized breathing gas from a gas source to the catheter connector 1300; or a Y-shaped element of a dual-limb NIV circuit configured to deliver fresh pressurized breathing gas from a gas source along the inspiratory catheter to the catheter connector 1300, and to return at least some of excess breathing gas or exhaled breathing gas from within the pad module 1010 to the gas source via the expiratory catheter through the catheter connector 1300. It is conceivable that when the Y-shaped element of the dual-limb circuit is connected to the catheter connector, the patient interface disclosed herein will maintain an outlet on the housing 1200 through which at least some of the exhaled breathing gas and excess breathing gas will be discharged from within the pad module 1010 to the outside of the pad module 1010.

[0242] The sleeve 1230 includes a critical molding structure 1232. The frame 1400 interacts with the critical molding structure 1232 to ensure proper alignment of the frame 1400 and the housing 1200 during connection. It should be understood that these critical molding structures 1232 can be replaced by any other suitable structure to ensure proper alignment of the frame 1400 and the housing 1200, or can be omitted entirely.

[0243] The housing 1200 includes a series of tabs 1240 projecting outward around its periphery. The outer ends of the tabs 1240 are connected to flanges 1245 that continuously extend through all the tabs 1240, thereby forming a series of discrete overmolded windows 1250 between the tabs 1240 and the flanges 1245. The seal 1100 is integrally formed with the housing 1200 by overmolding an elastic material onto the housing 1200 to fill the series of windows 1250. Thus, the tabs 1240 and flanges 1245 are embedded in the elastic material and mechanically interlocked with the seal 1100. Therefore, the seal 1100 and the housing 1200 form an integral gasket module 1010 structure.

[0244] The housing 1200 includes an outlet 1210 through which exhaled breathing gas and excess breathing gas can be discharged from the anatomical dead space of the padding module 1010 and / or the patient's airway to the outside of the padding module 1010. In a general form, the outlet 1210 includes a biased ventilation port 1215, which includes a plurality of holes penetrating the housing 1200. Thus, exhaled breathing gas and excess breathing gas can be discharged from within the padding module 1010 to the outside of the padding module 1010 or to the atmosphere through the biased ventilation port 1215.

[0245] In an alternative configuration, outlet 1210 and offset ventilation port 1215 may be different structures located at positions spaced apart from each other. In a further alternative configuration, patient interface 1000 may also include supplemental offset ventilation port 1216.

[0246] In another alternative configuration, the outlet 1210 of the pad module 1010 may be configured to connect to or be in fluid communication with an expiratory conduit of the breathing circuit. Such an expiratory conduit can be used for bilimb NIV therapy. In this configuration, exhaled and excess respiratory gases can be expelled from the pad module 1010 and / or from the patient's anatomical dead space and delivered to a location remote from the patient interface 1000, where they can be filtered or received by a ventilator, flow generator, or other gas source supplying fresh respiratory gases to the pad module 1010. In this configuration, the outlet 1210 is configured as an expiratory conduit connector for connection to or in fluid communication with an expiratory conduit connector.

[0247] The seal 1100 is formed of a soft, elastic material, such as silicone or other suitable elastomer. The seal 1100 includes a sealing opening 1110. When fitted to a patient, the sealing opening 1110 surrounds the patient's mouth and nose. The patient contact surface 1120 of the seal 1100 forms a seal around the patient's mouth and nose. The seal formed by the patient contact surface 1120 is sufficient to contain at least substantially the pressurized gas within the cavity 1012. Some pressurized gas leakage may occur, but such leakage is relatively small, allowing the pressurized gas supplied to the patient to be maintained at a level sufficient for NIV therapy delivery. Therefore, high-pressure breathing gas can be delivered from the cavity 1012 of the liner module 1010 to the patient's mouth and / or nostrils through the sealing opening 1110.

[0248] Although this embodiment of the pad module 1010 includes a single sealed opening 1110, it should be understood that other configurations may include an oral opening for delivering pressurized breathing gas to the patient's mouth and a nasal opening for delivering pressurized breathing gas to the patient's nose. Alternatively, the pad module may include more than one oral opening. Alternatively, the pad module may include more than one nasal opening. In yet another alternative, the pad module may include multiple oral openings and multiple nasal openings.

[0249] As mentioned above, it should be understood that, in an alternative embodiment, the seal 1100 may be a full-face subnasal seal including an oral opening and at least one nasal opening. In this configuration, the oral opening of the seal 1100 is defined by a portion of the patient contact surface 1120 surrounding the patient's mouth, and at least one nasal opening is defined by a portion of the patient contact surface 1120 surrounding the patient's nostril, and this portion is configured to support the base and sides of the patient's nose without extending above or contacting the bridge of the nose. Thus, the patient contact surface 1120 of the seal 1100 forms a seal around the patient's mouth and nostrils without contacting the patient's bridge of the nose. Therefore, high-pressure breathing gas can be delivered from the cavity 1012 of the liner module 1010 to the patient's mouth and nostrils through the oral opening and at least one nasal opening.

[0250] The subnasal full-face seal 1100 may include a single nasal opening, two nasal openings, or more than two nasal openings. In a configuration including a single nasal opening, the single nasal opening is configured to surround two nostrils in the patient's nostrils during use. In a configuration including two nasal openings, each of the two nasal openings is configured to surround a corresponding nostril in the patient's nostrils during use.

[0251] In another embodiment, the seal 1100 may be a full-face seal 1100, in which, when fitted onto a patient, the sealing opening 1110 surrounds the patient's mouth, nose, and eyes. In this embodiment, the patient contact surface 1120 of the seal 1100 forms a seal around the patient's mouth, nose, and eyes. Therefore, high-pressure breathing gas can be delivered from the cavity 1012 of the pad module 1010 to the patient's mouth and / or nostrils through the sealing opening 1110.

[0252] In another embodiment, the seal 1100 may be a helmet-type seal 1100, in which, when fitted onto a patient, the sealing opening 1110 surrounds and seals the patient's neck, and the patient's head is located within the cavity 1012 of the padding module 1010 during use. Therefore, high-pressure breathing gas can be delivered directly from the cavity 1012 of the padding module 1010 to the patient's mouth and / or nostrils.

[0253] The catheter connector 1300 of the patient interface 1000 includes a hollow connector body 1320 defining an inner lumen having a ball connector 1322 at a first end 1324, a swivel connector 1350 at a second end 1326, and an anti-asphyxiation valve (AA valve) 1330 located between the first and second ends. The connector body 1320, the swivel connector 1350, and the ball connector 1322 form a flow path for breathing gas to flow from the catheter of the breathing circuit into the liner module 1010.

[0254] The ball connector 1322 includes a convex ball segment configured to be received within a corresponding concave ball segment of the socket 1402 of the frame 1400 to form a ball-and-socket joint that allows three-degree rotation between the frame 1400 and the catheter connector 1300. The swivel connector 1350 is configured to connect to a catheter of a breathing gas source to supply pressurized breathing gas to the pad module 1010. The swivel connector 1350 is capable of single-degree rotation, also referred to as rotation. Together with the ball connector 1322, the swivel connector 1350 serves to disengage forces applied by the catheter from the patient interface 1000.

[0255] The connector body 1320 includes a bend between a first end 1324 and a second end 1326, such that the gas flow through the conduit connector 1300 undergoes a directional change from the first end 1324 to the second end 1326. In other words, the longitudinal axes of the first end 1324 and the second end 1326 of the connector body 1320 are set at an inclined angle.

[0256] Those skilled in the art will understand that, in alternative embodiments, the connector body 1320 may not have a bend between the first end 1324 and the second end 1326, so that the flow path through the connector body 1320 is substantially straight or linear.

[0257] In an alternative embodiment, the catheter connector 1300 may include a ball connector 1322 (replacing the swivel connector 1350) at each end of the connector body, a swivel connector 1350 (replacing the ball connector 1322) at each end of the connector body, or a single swivel connector 1350 or a single ball connector at one of the first end 1324 or the second end 1326 of the connector body 1320. Alternatively, the catheter connector 1300 may completely omit the ball connector 1322 and the swivel connector 1350 to form a fixed connector body 1320 between the liner module 1010 and the catheter.

[0258] The second end 1326 of the catheter connector 1320 also includes a structure configured to cooperate with the anti-asphyxiation valve 1330 to allow ambient air to flow into the patient interface in the event of a failure of the breathing gas source or blockage of the catheter used to deliver gas from the gas source to the patient interface 1010. More specifically, the second end 1326 includes an opening 1327. A main post 1328 is disposed adjacent to the opening 1327 and supports a panel 1329 spaced apart from the opening 1327. The spacing between the panel and the opening 1327 creates a gap through which ambient air can enter the opening.

[0259] The anti-suffocation valve 1330 includes a valve seat 1331 and a valve seal 1336. The valve seat 1331 includes a sealing surface 1332 against which the valve seal 1336 seals the anti-suffocation valve 1330. The valve seat 1331 also includes a sleeve 1333 having a radially outwardly projecting flange 1334. The flange 1334 is located at the end of the sleeve 1333. The valve seat 1331 also includes a connector 1335 for coupling with the valve seal 1336.

[0260] Valve seal 1336 includes a flap 1337 that is switchable between an open position and a closed position. In the open position, the conduit connector 1300 allows breathing gas from a gas source to flow through; in the closed position, the conduit connector 1300 blocks the flow of breathing gas from a gas source. In the open position, ambient air is prevented from entering the interior of the conduit connector 1300; and in the closed position, ambient air is allowed to enter the interior of the conduit connector 1300. In the illustrated embodiment, flap 1337 is formed of a flexible material. Flange 1337 is coupled to lug 1338 via hinge 1339. Hinge 1338 includes a flexible material segment with reduced wall thickness. Lug 1338 is configured to facilitate positioning valve seal 1336 within the end of a second end 1326 of connector body 1320. Additionally, lug 1338 includes a recess 1340 adapted to receive insertion tube 1335. The fitting of the insertion tube 1335 within the groove 1340 correctly oriented the valve seal 1336 onto the valve seat 1331.

[0261] When supplied from a source, pressurized breathing gas flows through the catheter connector 1300 and into the padding module 1010. The high pressure of the breathing gas causes the vane 1337 to swing about the hinge 1339 to cover the opening 1327 in the second end 1326 of the connector body 1320. This represents the "open position" described above, as the vane 1337 prevents ambient air from entering the catheter connector 1300 through the opening 1327. If the breathing gas source fails or the catheter connected to the source becomes blocked, the anti-asphyxiation valve 1330 closes because the air pressure inside the catheter connector 1300 is equal to the air pressure outside the catheter connector 1300, causing the vane 1337 to switch to the "closed position" as described above due to the inherent elasticity in the flexible material forming the hinge 1339. In the closed position, the opening 1327 is exposed inside the catheter connector 1300, allowing the patient's natural breathing cycle to draw air into the catheter connector 1300 and the padding module 1010 through the opening 1327.

[0262] Valve seat 1331 includes a radially projecting step configured to couple with conduit connector 1300. Specifically, the step is configured to engage within a second end 1326 of connector body 1320. This coupling may include a snap-fit ​​connection or may include permanent fixation, such as welding or adhesive bonding.

[0263] Valve seat 1331 is coupled to a rotary connector 1350, which is configured to connect to a conduit from a breathing gas source. Rotary connector 1350 includes a radially inwardly projecting shoulder 1352 that engages with a step on valve seat 1331 to attach valve seat 1331 to rotary connector 1350. This connection is a snap-fit ​​connection. The snap-fit ​​connection can be removable or a one-time connection. However, in other embodiments, the connection may include permanent fixation, such as welding or adhesive bonding.

[0264] Frame 1400 includes a central body portion 1401 that includes one or more flow channels for delivering breathing gas from a gas source to the pad module 1010 and thus to the patient via the catheter connector 1300. Frame 1400 includes one or more upper headgear connectors 1410 and one or more lower headgear connectors 1420, configured to cooperate with a headgear 1900 (such as elastic bands) to fit the patient interface 1000 onto the patient. The one or more upper headgear connectors 1410 are configured to cooperate with corresponding one or more upper bands of the headgear 1900, while the one or more lower headgear connectors are configured to cooperate with corresponding one or more lower bands of the headgear 1900. When pressurized breathing gas is delivered to the patient through the patient interface 1000, the headgear 1900 operates by pulling the patient interface 1000 into contact with the patient's face to form a substantially airtight seal.

[0265] In the illustrated embodiment, one or more upper headgear connectors 1410 include a nominal midplane located on the frame 1400 (generally along) Figure 4 The first upper headgear connector slot 1412 (represented by line AA' in the diagram) is located on the first side of the frame 1400, and the second upper headgear connector slot 1414 is located on the second side of the frame 1400, on the nominal midplane. Each slot is configured to receive a corresponding upper strap of the headgear 1900. The strap may be permanently or removably received within the slot, such as by inserting the strap through the slot, looping it back around itself, and securing it in place via a hook-and-loop connection. In an alternative embodiment, slots 1412, 1414 may be replaced by any suitable structure for permanently or removably cooperating with the upper headgear strap. Suitable connection structures may include connectors for releasably receiving the corresponding strap via a mechanical, magnetic, or adhesive connection.

[0266] In the illustrated embodiment, one or more lower headband connectors 1420 include a first lower headband connector 1422 located on a first side of the nominal midplane of the frame 1400 and a second lower headband connector 1424 located on a second side of the nominal midplane of the frame 1400. Each headband connector 1420 is configured to receive a corresponding lower band of the headband. Each lower headband connector 1422, 1424 includes a rod configured to removably receive a clip of the corresponding lower headband via a mechanical connection such as a hook-and-pin connection. In an alternative embodiment, the connector may be replaced by any suitable structure for permanently or removably cooperating with the lower headband and / or the clip of the lower headband, such as the connection method described above with respect to the upper band and one or more upper headband connectors 1410. Specifically, a suitable connection structure may include one or more lower headband connectors 1420 on the frame 1400 for releasably receiving a clip of the corresponding lower band via a mechanical, magnetic, or adhesive connection.

[0267] Although the illustrated embodiments include a frame 1400, the headgear connectors 1410, 1420 may be alternatively integrated with or connected to the housing 1200. In this case, the frame 1400 is not necessary and may be omitted from such configurations, while the housing 1200 integrates these features. Therefore, it should be understood that all features described herein with respect to the frame 1400 may be alternatively incorporated into the housing 1200.

[0268] The frame 1400 also includes a connector sleeve 1430 comprising one or more arcuate fingers 1432. In the illustrated embodiment, the connector sleeve 1430 includes four arcuate fingers 1432. The connector sleeve 1430 has an inner wall 1434 including a ball socket 1402 configured to receive a ball connector 1322 of the conduit connector 1300. The outer wall of the connector sleeve 1436 is shaped to fit within the sleeve 1230 of the housing 1200. The arcuate fingers 1432 are shaped and spaced to form a complementary fit with critical molding structures 1232. Alignment of the critical molding structures 1232 between the fingers 1432 ensures proper alignment when the frame and housing 1200 are assembled together.

[0269] It should be understood that, as mentioned above, the connector sleeve 1430 of the frame 1400 can receive the conduit connector 1300 in a fixed manner without requiring the ball socket 1402. In such embodiments, the conduit connector 1300 will be permanently directly or indirectly connected to the connector sleeve 1430, or integrally formed with the connector sleeve.

[0270] Each arcuate finger 1432 has an arcuate flange portion 1433 at its end, which engages with a radially inwardly projecting lip 1231 of the sleeve 1230. The snap-fit ​​engagement holds the frame 1400 to the housing 1200. The snap-fit ​​engagement can be releasable or it can be a permanent engagement between the frame 1400 and the housing 1200.

[0271] Alternatively, the arcuate fingers 1432 of the frame 1400 and / or the radially inwardly projecting lip 1231 of the housing may be omitted. Instead, the frame 1400 may be attached to the housing 1200 by any conventional means, such as using adhesives or welding. For example, the frame 1400 may be permanently attached to the housing 1200 by ultrasonically welding the housing 1200 and the frame 1400 together.

[0272] As foreshadowed above, the general form of the patient interface 1000 can vary. One such variation of this general form, and applicable to the embodiments described below, is that the housing 1200 and frame 1400 are integrally formed. In other words, the patient interface 1000 may include an integral structure that performs the same function as the housing 1200 and frame 1400. Although the housing 1200 and frame 1400 are described as separate components of the patient interface 1000, this description should be understood to include the option of integrally formed components that function in the same manner as the housing 1200 and frame 1400.

[0273] Further considering variations of the general form of the patient interface 1000, and another variation applicable to the embodiments described below, is that the housing 1200 and the seal 1100 are integrally formed of the same material. In other words, the patient interface 1000 may comprise a single-material, integral structure performing the same function as both the housing 1200 and the seal 1100. In such embodiments, the housing 1200 may be formed of the same material as the seal 1100, such as an elastomeric material like silicone. It is conceivable that in variations requiring additional rigidity in the integral elastomeric housing 1200 and seal 1100, the thickness and / or hardness of the elastomeric material may vary in localized areas to provide such rigidity. Different hardnesses can be achieved using any suitable known manufacturing technique, such as two-color injection molding or overmolding.

[0274] Considering Figures 10 to 24 The diagram illustrates a second embodiment of a patient interface 2000. Patient interface 2000 is a variation of the general form of patient interface 1000 and, unless otherwise stated, includes all the components and functions of patient interface 1000. More specifically, patient interface 2000 includes at least the frame 1400 of patient interface 1000, a catheter connector 1300, and a seal 1100. Patient interface 2000 has a housing 2200 that is slightly different from the housing 1200 of patient interface 1000. Housing 2200 is configured for connection to an exhaust conduit 2500. This difference in housing 2200 will be described below; otherwise, it should be understood that housing 2200 includes all the features and functions of housing 1200.

[0275] Furthermore, due to the modification of housing 2200, the reference numerals for the gasket module 2010 formed by housing 2200 and seal 1100 and the cavity 2012 defined by gasket module 2010 have been updated. However, it should be understood that the description of gasket module 1010 and cavity 1012 also applies to gasket module 2010 and cavity 2012, and all features and functions will be included therein. Features of housing 2200 that are identical to those of housing 1200 are indicated by the same reference numerals, but the first digit is “2” instead of “1”.

[0276] As described above, patient interface 2000 differs significantly from patient interface 1000 in that it also includes an exhaust conduit 2500. The exhaust conduit 2500 is located within the cavity 2012 of the pad module 2010. The exhaust conduit 2500 includes an exhaust conduit inlet 2510 at a first end of the exhaust conduit 2500. The exhaust conduit 2500 also includes an exhaust conduit outlet 2505 at a second end of the exhaust conduit 2500. The exhaust conduit 2500 defines an exhaust flow passage 2501 extending between the exhaust conduit inlet 2510 and the exhaust conduit outlet 2505. The exhaust conduit outlet 2505 is configured to be in fluid communication with the outlet 2210 of the pad module 2010. Therefore, the exhaust conduit inlet 2510 is in fluid communication with the outlet 2210 of the pad module 2010 through the exhaust flow passage 2501.

[0277] The exhaust duct 2500 includes a body 2560, a manifold 2550 connected to the body 2560, and one or more inserts 2530 extending from the manifold 2550. These may be separate components permanently or removably connected to each other, or they may be parts of an integral exhaust duct 2500. Each of the body 2560, the manifold 2550, and the one or more inserts 2530 defines a portion of an exhaust flow passage 2501 through the exhaust duct 2500.

[0278] For example, refer to Figure 18 The patient interface 2000 and therefore the exhaust conduit 2500 are shown in a cross-sectional side view. The body 2560 includes a base 2566 located at a first end. The base 2566 is configured to connect to the inner surface of the housing 2200. The base 2566 is connected to the housing 2200 at a location surrounding the outlet 2210. This connection can be removable or permanent and can be achieved by any suitable means, such as welding, overmolding, mechanical connection, magnetic connection, or adhesive connection.

[0279] In one embodiment, the connection between the base 2566 and the housing 2200 is a mechanical connection, wherein the connection includes a plurality of mating features formed on the base 2566 and the housing 2200, respectively. The mating features on the base 2566 and the housing 2200 engage with each other in a complementary and interlocking manner. The mating features may include, but are not limited to, grooves, ridges, cones, hooks, slots, pins, channels, or any combination thereof. The plurality of mating features may engage with each other in a removable and repeatable manner or in a permanent manner (such as a one-time engagement).

[0280] In one example of these multiple mating features, the base 2566 may include a male connector, and the housing 2200 may include a female connector configured to removably receive the male connector of the base 2566. This connection between the base 2566 and the housing 2200 forms a seal that is substantially airtight under the expected gas pressures experienced by the gasket module 2200 during use. The connection between the male connector of the base 2566 and the female connector of the housing 2200 may be a snap-fit ​​connection. Alternatively, the housing 2200 may include a male connector, and the base 2566 may include a female connector configured to receive the male connector of the housing 2200. This alternative connection between the female connector of the base 2566 and the male connector of the housing 2200 may also be a snap-fit ​​connection. It is also conceivable that the connection between the respective male and female connectors may be a permanent, one-time connection, rather than a removable connection.

[0281] In another embodiment, the connection between the base 2566 and the housing 2200 may be a tapered connection, wherein the housing 2200 includes a male tapered connector with a tapered outer surface and a female tapered connector with a tapered inner surface, the female tapered connector being configured to removably receive the tapered outer surface of the male tapered connector of the base 2566. This tapered connection between the base 2566 and the housing 2200 forms a seal that is substantially airtight under the expected gas pressures experienced by the gasket module 2010 during use. Alternatively, the housing 2200 may include a male tapered connector, while the base 2566 includes a female tapered connector configured to receive the male tapered connector of the housing 2200.

[0282] In another embodiment, the connection between the base 2566 and the housing 2200 can be a welded connection. In this embodiment, the base 2566 is ultrasonically welded to the housing 2200 to form a permanent connection.

[0283] In another embodiment, the connection between the base 2566 and the housing 2200 can be an adhesive connection. In this embodiment, the base 2566 is adhered to the housing 2200 to form a permanent connection.

[0284] In another embodiment, the base 2566 may be omitted. In this embodiment, the main body 2560 or a portion thereof may be integrally formed with the outer shell 2200. Therefore, this integral formation does not require an additional connection between the main body 2560 and the outer shell 2200. This integral formation can be achieved, for example, by molding the outer shell 2200 and the main body 2560 in a one-piece molding process, or by molding the main body 2560 onto the outer shell 2200 through a two-color molding process or an overmolding process to form an integral structure.

[0285] It should be understood that in the illustrated embodiment, since the outlet 2210 of the gasket module 2010 is located on the housing 2200, the body 2560 (and specifically the base 2566) is connected to the housing 2200. However, in an alternative embodiment where the outlet 2210 is located on the seal 1100 or on the integrated frame-housing gasket module 2010, the body 2560 and specifically the base 2566 may be connected to any one or more components including the outlet 2210 at a location surrounding the outlet 2210. In other words, regardless of the location of the outlet 2210, the body 2560 is intended to be connected at a location surrounding the outlet 2210.

[0286] The body 2560 extends between the housing 2200 and the manifold 2550. In the illustrated embodiment, the body 2560 takes the form of a tubular structure having a base 2566 at a first end, a manifold connector 2564 at a second end, and a central portion 2562 extending between the base 2566 and the manifold connector 2564. The body 2560 allows a gas flow passage to be formed between the first and second ends. As previously mentioned, the body 2560 defines a portion of the exhaust flow passage 2501 of the exhaust duct 2500. The body 2560 in the illustrated embodiment can be described as a hollow duct, vent, or pipe.

[0287] In an alternative embodiment, a portion 2565 of the body 2560 may be flexible. This flexibility allows the portion to be repeatedly deformed without structural failure. The portion 2565 allows the exhaust conduit 2500 to be adjustable. That is, the orientation and / or position of the exhaust conduit 2500, or specifically, the manifold 2550 of the exhaust conduit 2500, relative to the seal 1100. The portion 2565 allows adjustment of the orientation and / or position of one or more inserts 2530. The flexible portion 2565 may be located within the central portion 2562 of the body 2560. Alternatively, substantially the entire central portion 2562 may be flexible, allowing it to be repeatedly deformed without structural failure. To achieve the desired flexibility, the body 2560 may be constructed of, for example, but not limited to, a plastic material, an elastomeric material, a metallic material, or a combination of one or more of these (such as an elastomeric conduit including metal reinforcing wires or embedded metal wires).

[0288] Those skilled in the art will understand that, in alternative embodiments, the size and / or location of the manifold 2550 and one or more posts 2530 may render the body 2560 redundant. In such embodiments, the manifold 2550 may be connected to or extend directly from the housing 2200. In this case, any of the features and / or functions of the body 2560 described above may be incorporated into the housing 2200, the manifold 2550, or both.

[0289] In the illustrated embodiment, manifold 2550 is connected to and / or extends from body 2560, and one or more pins 2530 are connected to and / or extend from manifold 2550. Manifold 2550 includes manifold outlet 2552, which is configured to connect to manifold connector 2564 of body 2560, such that manifold outlet 2552 and body 2560 are in fluid communication.

[0290] Manifold 2550 can be removably or permanently connected to body 2560. Such a connection can be made by any conventional method, such as mechanical fasteners, adhesives, welding, two-color molding, overmolding, or tapered connections. For example, manifold connector 2564 and manifold outlet 2552 can be connected by ultrasonic welding, a permanent or removable snap-fit ​​connection, or by applying an adhesive to the mating surfaces of the two components. Manifold 2550 can also be overmolded onto body 2560, wherein body 2560 is formed by a first molding process and then placed in a mold, wherein manifold 2550 is formed by overmolding manifold 2550 onto body 2560, thereby forming a permanent connection. Alternatively, body 2560 and manifold 2550 can be formed separately and then joined by an overmolding process, wherein material is overmolded over both components to form a permanent connection between manifold 2550 and body 2560.

[0291] A portion or all of the manifold 2550 may be integrally formed with the body 2560 as a single component. In such embodiments, it should be understood that the body 2560 and the manifold 2550 can be understood as parts of an integral structure comprising both the body 2560 and the manifold 2550. Therefore, the manifold connector 2564 and the manifold outlet 2552 may be omitted if not required, or they may be considered as transition sections between the body 2560 and the manifold 2550 of the integral structure. Features and / or functions of the body 2560 and the manifold 2550 otherwise disclosed are retained in this integral structure.

[0292] Manifold 2550 forms part of exhaust flow passage 2501. Manifold 2550 is primarily configured to receive gas from one or more inserts 2530 and deliver that gas to body 2560, where the gas is ultimately delivered to outlet 2210 of housing 2200. From there, gas flows through outlet 2210 to the outside of liner module 2010. In this embodiment, outlet 2210 is a biased vent 2215. In other embodiments, outlet 2210 may be configured to connect to an expiratory conduit.

[0293] In the illustrated embodiment, manifold 2550 also includes a facial contact portion 2554. The facial contact portion 2554 is configured to contact one or more of the patient's upper lip, philtrum, or nostrils. Such a connection can help support or position one or more posts 2530 in a desired location. The facial contact portion 2554 comprises a relatively soft material that can help avoid or minimize patient discomfort. For example, the facial contact portion 2554 may comprise an elastomeric material, such as silicone or rubber. In the illustrated embodiment, manifold 2550 is a dual-material structure. In this embodiment, manifold 2550 includes a rigid plastic portion comprising a manifold outlet 2552, and an elastomeric portion comprising the facial contact portion 2554. Alternatively, the entire manifold 2550 may comprise an elastomeric material. Further alternatively, substantially the entire manifold 2550 may comprise an elastomeric material, with only a minimal number of rigid components providing support when necessary. In such embodiments, essentially the entire manifold 2550 may comprise an elastomeric material, with only the manifold outlet 2552 being formed of a rigid material.

[0294] In an alternative embodiment, the face contact portion 2554 may not be configured to contact the patient's face during use, but may still be formed of an elastomeric material and alternatively configured to avoid discomfort in the event of any accidental contact between the manifold 2550 and the patient's face.

[0295] In the illustrated embodiment, at least a portion of the facial contact portion 2554 of the manifold 2550 is recessed when viewed in the proximal-distal direction to conform to the shape of the patient's upper lip or philtrum.

[0296] One or more inserts 2530 extend from manifold 2550 to exhaust duct inlet 2510. In the illustrated embodiment, exhaust duct 2500 includes a first insert 2532 and a second insert 2540, the first insert 2532 extending from manifold 2550 to a first free end 2532 including a first exhaust duct inlet 2515, and the second insert 2540 extending from manifold 2550 to a second free end 2542 including a second exhaust duct inlet 2520.

[0297] In the illustrated embodiment, the first post 2532 and the second post 2540 are non-sealed nasal posts. The non-sealed nasal posts are not configured to form a seal with the corresponding nostril of the patient during use. In other words, the cross-sectional areas of the first post 2532 and the second post 2540 at their respective free ends 2532, 2542 are both designed to be smaller than the cross-sectional area of ​​the intended patient's nostril. This is intended to allow gas to flow into and out of the patient's nostril through a gap defined between the outer surfaces of the first post 2532 and the second post 2540 and the inner surface of the user's nostril.

[0298] In an alternative embodiment, the exhaust duct 2500 may include only a single post 2532, and therefore only a single exhaust duct inlet 2515. In this configuration, the first post 2532 extends from the manifold 2550 to a first free end 2532, which includes the first exhaust duct inlet 2515.

[0299] In embodiments comprising only a single insertion post, the first insertion post 2532 may be a non-sealed nasal insertion post or a sealed nasal insertion post. In embodiments where the first insertion post 2532 is a sealed insertion post, the first insertion post 2532 is configured to engage with the inner surface or edge of the corresponding nostril in the patient's nostril and form a seal. In embodiments where the first insertion post 2532 is a non-sealed insertion post, as discussed above, the cross-sectional area of ​​the first insertion post 2532 is designed to be smaller than the cross-sectional area of ​​the intended patient's nostril, such that no seal is formed between the first insertion post 2532 and the inner surface of the corresponding nostril in the patient.

[0300] The cross-sectional area of ​​the exhaust duct inlet 2510 includes a first exhaust duct inlet 2515 and a second exhaust duct inlet 2520 (where applicable). This cross-sectional area of ​​the exhaust duct inlet 2510 is configured to be smaller than the cross-sectional area of ​​the inlet 2220 of the housing 2200. In the illustrated embodiment, all gas entering the gasket module 2010 enters through inlet 2220, and substantially all gas leaving the gasket module 2010 exits through outlet 2210, except in cases of accidental leakage. The exhaust duct 2500 is in sealed fluid communication with the outlet 2210 of the housing 2200, thus the reduced cross-sectional area of ​​the exhaust duct inlet 2510 compared to the inlet 2220 of the housing 2200 creates a flow restriction, which accelerates the gas flow into the exhaust duct 2500 as pressurized gas flows into the gasket module 2010 through inlet 2220 and then into the exhaust duct 2500 to exit the gasket module 2010. The reduction in cross-sectional area in the flow path creates a pressure drop, which accelerates the gas flow into the exhaust duct 2500. The following paragraphs explain the importance of this gas acceleration.

[0301] In the illustrated embodiment, the flow restriction mentioned above is formed by the exhaust duct inlet 2510, whose cross-sectional area is smaller than that of the inlet 2220 of the housing 2200. However, it is conceivable that the flow restriction may be applied elsewhere in the exhaust duct 2500, or more specifically, elsewhere in one or more inserts 2530, manifolds 2550, or bodies 2560.

[0302] In the illustrated embodiment of the patient interface 2000, the ratio of the cross-sectional area of ​​the first exhaust duct inlet 2515 to the cross-sectional area of ​​the second exhaust duct inlet 2520 is 1:1. That is, the cross-sectional areas of the two exhaust duct inlets 2515 and 2520 are equal. However, in another embodiment, the cross-sectional area of ​​the first exhaust duct inlet 2515 may not be equal to the cross-sectional area of ​​the second exhaust duct inlet 2520. The ratio of the cross-sectional area of ​​the first exhaust duct inlet 2515 to the cross-sectional area of ​​the second exhaust duct inlet 2520 may be in the range of 1:1.1 to 1:4. In one embodiment, the ratio of the cross-sectional area of ​​the first exhaust duct inlet 2515 to the cross-sectional area of ​​the second exhaust duct inlet 2520 is 1:3.

[0303] As a complement or alternative to different exhaust duct inlet cross-sectional areas, the shape and / or size of the first insert 2532 and the second insert 2540 may differ in at least one aspect (such as insert diameter, length, or shape). Such embodiments with different shapes and / or sizes of the first insert 2532 and the second insert 2540 can be described as having asymmetrical first insert 2532 and second insert 2540.

[0304] In the illustrated embodiment, the exhaust duct 2500 is configured to prevent gas from flowing from the cavity 2012 of the gasket module 2010 into the exhaust flow passage 2501, rather than through the exhaust duct inlet 2510, and to prevent gas from flowing out of the exhaust flow passage 2501 into the cavity 2012. The exhaust duct 2501 is a closed passage extending from the exhaust duct inlet 2510 to the exhaust duct outlet 2505.

[0305] In the preceding paragraphs, the exhaust duct 2500 has been described with respect to the sub-components of body 2560, manifold 2550, and one or more inserts 2530. However, in an alternative embodiment, the exhaust duct 2500 may include a body 2560 integrally formed with housing 2200 as a single rigid component, while one or more inserts 2530 may be made of an elastomeric or flexible material and connected to the integral housing 2200 and the exhaust duct body 2560. For example, the body 2560 of the exhaust duct 2500 may be integrally formed with housing 2200. The integrally formed body 2560 and housing 2200 may include a rigid plastic material. One or more inserts 2530 may be individually formed of an elastomeric material and then connected to the integrally formed housing 2200 and the body 2560 of the exhaust duct 2500.

[0306] In the illustrated embodiment, the exhaust conduit 2500 is permanently or removably attached to the housing 2200 and does not directly contact the seal 1100. In other words, the exhaust conduit 2500 is a separate structure from the seal 1100. Furthermore, the exhaust conduit 2500 is surrounded by the cavity 2012 of the liner module 2010. It is believed that this may be advantageous for improving patient comfort by reducing interference or interaction with the soft seal 1100, which is configured to contact the patient's face. However, it should be understood that in alternative configurations, the exhaust conduit 2500 may contact or connect to the seal 1100 at one or more locations without significantly affecting patient comfort. For example, the exhaust conduit 2500 may be attached to a portion of the seal 1100 remote from the patient contact surface 1120.

[0307] The exhaust duct 2500 can be designed to be retrofitted to existing patient interfaces. This allows the exhaust duct to be sold separately from the rest of the patient interface 2000. In such cases, the exhaust duct 2500 is located within the cavity 1012 of the existing patient interface, and the exhaust duct outlet 2505 is in fluid communication with the outlet or bias vent of the existing patient interface. Thus, existing patient interfaces can be fitted with the exhaust duct 2500 to improve the performance of these existing patient interfaces.

[0308] For illustrative purposes, see reference. Figure 23 and Figure 24 The patient interface 2000 is shown in cross-section along line B-B' as an anatomical model (also shown in cross-section) assembled to the patient. Figure 23 In the illustration, the patient interface 2000 is depicted as being fitted onto the patient with their mouth open. Figure 24 In this illustration, the patient interface 2000 is shown fitted onto a patient with their mouth closed. Arrows indicate the direction of gas flow into the pad module 2010 through inlet 2220 and out of the pad module 2010 through outlet 2210, at which point the pad module is fitted onto the patient and the patient is not breathing. The relative size of the arrows should not be interpreted as an indication of gas flow rate or velocity. It should be understood that additional gas flow paths are formed during respiration, in addition to those described above. However, for illustrative purposes, it is assumed that the general operation of the patient interface 2000 can be adequately described while neglecting respiration, as the effect of the patient interface 2000 is considered most significant at the end of the expiratory cycle (which can be figuratively compared to a situation where there is no breathing).

[0309] When the patient interface 2000 is fitted onto the patient, the exhaust duct 2500 is positioned such that the exhaust duct inlet 2510 is located within one or more of the patient's nostrils, or below one or more of the patient's nostrils and adjacent to the patient's upper lip, or immediately adjacent to one or more of the patient's nostrils. In other words, the exhaust duct inlet 2510 is located within, adjacent to, or close to one or more of the patient's nostrils.

[0310] More specifically, in embodiments including a first exhaust duct inlet 2515 and a second exhaust duct inlet 2520, the first exhaust duct inlet 2515 is configured to be located inside a first nostril in the patient's nostril, or located below the first nostril in the patient's nostril and adjacent to the patient's upper lip, or located immediately adjacent to the first nostril in the patient's nostril, while the second exhaust duct inlet 2520 is configured to be located inside a second nostril in the patient's nostril, or located below the second nostril in the patient's nostril and adjacent to the patient's upper lip, or located immediately adjacent to the second nostril in the patient's nostril.

[0311] In embodiments including a single exhaust duct inlet 2515, the first exhaust duct inlet 2515 is configured to be located inside a first nostril in the patient's nostril, or located below the first nostril in the patient's nostril and adjacent to the upper part of the patient's lips, or located immediately adjacent to the first nostril in the patient's nostril.

[0312] refer to Figure 23 The patient interface 2000 is fitted to the patient with their mouth open and not breathing, and pressurized gas is delivered to the patient interface 2000 via the conduit connector 1300. The pressurized gas flow enters the liner module 2010 through inlet 2220. Excess pressurized gas from within the liner module 2010 and / or from the patient's airway then flows into the exhaust conduit 2500 through exhaust conduit inlet 2510. The gas then travels along the exhaust flow channel 2501 and exits the liner module 2010 through outlet 2210. Due to the intended positioning of the exhaust conduit inlet 2510 relative to the patient's nostrils (including the positioning of either or both of the first exhaust conduit inlet 2515 and the second exhaust conduit inlet 2520), a first effective flow path and a second effective flow path are formed for gas to enter the exhaust conduit 2500 through the exhaust conduit inlet 2510.

[0313] The first effective flow path extends from within the liner module 2010 through the patient's mouth into their oral cavity, through the patient's throat into the patient's nasal cavity, and: (1) extends to the exhaust duct inlet 2510 when the exhaust duct inlet 2510 is located within one or more of the patient's nostrils; or (2) extends out of one or more of the patient's nostrils and to the exhaust duct inlet 2510 when the exhaust duct inlet 2510 is located adjacent to one or more of the patient's nostrils, or located below one or more of the patient's nostrils and adjacent to the patient's upper lip, or located immediately adjacent to one or more of the patient's nostrils. In all cases, the gas flow entering the patient's oral cavity and exiting through the nasal cavity is considered to result in flushing of at least a portion of the anatomical dead space of the patient's oral cavity, throat, and nasal cavity.

[0314] The second effective flow path extends from within the liner module 2010 and: (1) extends through one or more of the patient's nostrils to the patient's nasal cavity, wherein the gas flow is decelerated and / or the direction of the gas flow is changed such that the gas flow can enter the exhaust duct inlet 2510 when the exhaust duct inlet 2510 is positioned within one or more of the patient's nostrils; or (2) extends through the space defined between the patient's supralipal and / or external nasal cavity and the exhaust duct 2500 to the exhaust duct inlet 2510, provided that the exhaust duct inlet 2510 is positioned immediately adjacent to one or more of the patient's nostrils, or positioned below one or more of the patient's nostrils and adjacent to the patient's supralipal. In the first instance, the gas flow flowing into the nasal cavity and subsequently into the exhaust duct inlet 2510 is believed to cause flushing of at least a portion of the anatomical dead space of the patient's nasal cavity. In the second instance, due to the limited cross-sectional area of ​​the flow path, directing the gas flow between the patient's supralipal and / or external nasal cavity and the exhaust duct 2500 will accelerate the gas flow. It is believed that this acceleration will likely cause at least some of the gas flow to enter the patient's nasal cavity through one or more nostrils, then decelerate and / or change direction and exit the nasal cavity through one or more nostrils, subsequently entering the exhaust duct inlet 2510. It is believed that this portion of the gas flow entering the nasal cavity will cause flushing of a portion of the anatomical dead space within the patient's nasal cavity.

[0315] refer to Figure 24The patient interface 2000 is fitted to the patient with their mouth closed and no breathing, and pressurized gas is delivered to the patient interface 2000 via the conduit connector 1300. The pressurized gas flow enters the pad module 2010 through inlet 2220. Excess pressurized gas from within the pad module 2010 and / or from the patient's airway then flows into the exhaust conduit 2500 through exhaust conduit inlet 2510. The gas then travels along the exhaust flow channel 2501 and exits the pad module 2010 through outlet 2210. However, because the patient's mouth is closed, only a second effective flow path is formed. The second flow path is discussed in detail in the paragraph immediately preceding this one.

[0316] Since the gas flow through both the first and second effective flow paths is believed to induce anatomical dead space flushing to some extent, the patient interface 2000 is believed to provide significant benefits beyond conventional non-invasive ventilation masks. In NIV therapy, it is advantageous to provide pressure support and simultaneously flush the dead space while the patient's mouth is open or closed. Additionally, in embodiments where the exhaust conduit 2500 is a removable exhaust conduit, it is conceivable that the patient interface 2000 with the exhaust conduit 2500 removed could be used to provide standard NIV therapy (if such effects are desired). For example, it is conceivable that the patient may only require anatomical dead space flushing during discrete time periods throughout the day. This allows the patient interface 2000 to be used alternately for several time periods with the exhaust conduit 2500 in place and with the exhaust conduit 2500 removed.

[0317] In an alternative embodiment of the exhaust conduit 2500, which includes a single post 2532 acting as a sealing post, it should be understood that the second effective flow path will differ from that described in the paragraph immediately preceding this one. In such an embodiment, the second effective flow path extends from within the liner module 2010, through the patient's first nostril to the nasal cavity located on the first side of the nasal septum, and then exits the patient's nasal cavity located on the second side of the nasal septum through an exhaust conduit inlet 2510 positioned within the patient's second nostril. In other words, gas enters the nasal cavity through the first nostril from the liner module 2010 and exits the nasal cavity through the exhaust conduit inlet 2510 located within the second nostril. In this case, it is believed that the unidirectional gas flow through the patient's nasal cavity will cause flushing of the anatomical dead space of the patient's nasal cavity.

[0318] In the preceding paragraphs, the expected benefits of anatomical dead space flushing of the patient as a patient interface 2000 have been discussed. The patient's anatomical dead space consists of the total volume of the patient's airway segments responsible for guiding air to the alveoli and respiratory bronchioles, but not participating in the gas exchange process itself. Therefore, the anatomical dead space is the total volume of the airway from the patient's nose or mouth to the terminal bronchioles (including the oral cavity, nasal cavity, and pharynx, also known as the larynx).

[0319] During a patient's breathing, air with a lower CO2 content is inhaled into the lungs, and air with a higher CO2 content is exhaled. At the end of the expiratory cycle, some of the exhaled air with a higher CO2 content remains in the patient's anatomical dead space. This air with a higher CO2 content is then inhaled or rebreathed in the next respiratory cycle. Rebreathing this air with a higher CO2 content reduces the efficiency of gas exchange occurring within the patient's lungs.

[0320] Dead space flushing replaces at least a portion of the exhaled, CO2-rich air present in the patient's anatomical dead space with fresh, low-CO2 air, so that in the next inspiratory cycle, the reduced amount of exhaled, CO2-rich air is inhaled or rebreathed. Rebreathing the reduced CO2-rich air increases the efficiency of gas exchange occurring in the patient's lungs.

[0321] As mentioned in the preceding paragraphs, the cross-sectional area of ​​the exhaust duct inlet 2510 is configured to be smaller than that of the inlet 2220 of the housing 2200. This smaller cross-sectional area of ​​the exhaust duct inlet 2510 creates a flow restriction, resulting in a pressure drop when pressurized gas is supplied to the padding module 2010 of the patient interface 2000 during use, thus accelerating the gas flow into the exhaust duct 2500. It is believed that this accelerated gas flow into the exhaust duct 2500 may also cause ambient gas to be drawn into the exhaust duct 2500.

[0322] When the exhaust duct inlet 2510 is positioned within or adjacent to one of the patient's nostrils, or below the nostrils and near the upper lip, the introduction of gas into the exhaust duct 2500 at the location surrounding the exhaust duct inlet 2510 may facilitate flushing of the patient's anatomical dead space. When the gas flow is accelerated into the exhaust duct inlet 2510, gases with higher CO2 content present in the patient's anatomical dead space may be introduced into the exhaust duct inlet 2510 due to the combination of gas flow acceleration and / or local pressure drop. This is believed to provide anatomical dead space flushing as an alternative to or supplement to the description above regarding effective flow paths formed during use.

[0323] refer to Figures 25 to 42 The diagram illustrates a third embodiment of a patient interface 3000. The patient interface 3000 is a variation of the general form of the patient interface 1000 and, unless otherwise stated, includes all the components and functions of the patient interface 1000. More specifically, the patient interface 3000 includes at least the frame 1400, headgear 1900, catheter connector 1300, and seal 1100 of the patient interface 1000. The housing 3200 of the patient interface 3000 differs slightly from the housing 1200 of the patient interface 1000 in that the former is configured to connect to the nasal interface 3600. This difference in the housing 3200 will be described below; otherwise, it should be understood that the housing 3200 includes all the features and functions of the housing 1200. Features of the housing 3200 that are identical to those of the housing 1200 are indicated by the same reference numerals, but the first digit is “3” instead of “1”.

[0324] Furthermore, due to the modification of the housing 3200, the reference numerals for the gasket module 3010 formed by the housing 3200 and the seal 1100, and the cavity 3012 defined by the gasket module 3010, have been updated. However, it should be understood that the description of the gasket module 1010 and the cavity 1012 also applies to the gasket module 3010 and the cavity 3012, and all features and functions will be included therein. Features of the gasket module 3010 that are identical to those of the gasket module 1010 are indicated by the same reference numerals, but the first digit is “3” instead of “1”.

[0325] Patient interface 3000 is also a variant of patient interface 2000 and includes an exhaust conduit 3500 that functions in substantially the same manner and contains all the features of exhaust conduit 2500, unless otherwise stated. However, patient interface 3000 differs from patient interface 2000 in that the exhaust conduit 3500 is integrated into nasal interface 3600. Nasal interface 3600 includes exhaust conduit 3500 and flushing conduit 3610. Nasal interface 3600 is permanently or removably connected to housing 3200 and does not directly contact seal 1100. In other words, nasal interface 3600 is a separate structure from seal 1100. Nasal interface 3600 is surrounded by cavity 3012 of liner module 3010.

[0326] An exhaust duct 3500 is located within the cavity 3012 of the gasket module 3010 and includes an exhaust duct inlet 3510 at a first end of the exhaust duct 3500 and an exhaust duct outlet 3505 at a second end of the exhaust duct 3500. The exhaust duct 3500 defines an exhaust flow passage 3501 extending between the exhaust duct inlet 3510 and the exhaust duct outlet 3505. The exhaust duct outlet 3505 is configured to be in fluid communication with the outlet 3210 of the gasket module 3010. Therefore, the exhaust duct inlet 3510 is in fluid communication with the outlet 3210 of the gasket module 3010 through the exhaust flow passage 3501.

[0327] A flushing conduit 3610 is located within the cavity 3012 of the liner module 3010 and includes a flushing conduit inlet 3612 at a first end of the flushing conduit 3610 and a flushing conduit outlet 3613 at a second end of the flushing conduit 3610. The flushing conduit 3610 defines a flushing flow channel 3611 extending between the flushing conduit inlet 3612 and the flushing conduit outlet 3613. The flushing conduit inlet 3612 is configured to be in fluid communication with the cavity 3012 of the liner module 3010. Therefore, the flushing conduit outlet 3610 is in fluid communication with the cavity of the liner module 3010 through the flushing flow channel 3611.

[0328] In the illustrated embodiment, the flushing conduit outlet 3613 includes a first flushing conduit outlet 3614 and a second flushing conduit outlet 3615. In the illustrated embodiment, the flushing flow passage 3611 thus extends from the flushing conduit inlet 3612 to both the first flushing conduit outlet 3614 and the second flushing conduit outlet 3615. In an alternative embodiment, the flushing conduit outlet 3613 may include only the first flushing conduit outlet 3614.

[0329] The flushing duct outlet 3613 is configured to be located near or adjacent to the exhaust duct inlet 3510, such that the exhaust duct inlet 3510 and the flushing duct outlet 2613 are located at the first end of the nasal interface 3600, the exhaust duct outlet 2505 is located at the second end of the nasal interface 3600, and the flushing duct inlet 3612 is located between the first end and the second end of the nasal interface 3600.

[0330] In the illustrated embodiment, the flushing conduit inlet 3612 is located in the manifold 3550 adjacent to or near the manifold outlet 3552, such that a rigid or semi-rigid portion of the manifold 3550 can partially or completely surround the manifold outlet 3552 and the flushing conduit inlet 3612. This relatively small rigid or semi-rigid portion of the manifold 3550 can advantageously provide structural integrity for both the manifold outlet 3552 and the flushing conduit inlet 3612 without providing undesirable rigidity to the rest of the manifold 3550, which may comprise a soft elastomeric material.

[0331] Alternatively, the flushing conduit inlet 3612 may be located in the manifold 3550 at a different location than the manifold outlet 3552. If located at a different location than the manifold outlet 3552, the flushing conduit inlet 3612 may be surrounded or completely surrounded by an additional rigid or semi-rigid portion of the manifold 3550, which is separate from the portion that partially or completely surrounds the manifold outlet 3552.

[0332] In a further alternative embodiment, the flushing conduit inlet 3612 may be located within the body 3560 or within one or more posts 2530. It is envisioned that the flushing conduit inlet 3612 should be in fluid communication with the cavity 3012 of the liner module 3010, but it may be located at any suitable location on the nasal interface 3600 where such fluid communication can be achieved. Positioning the flushing inlet 3612 within the body 3560 or within a portion of the manifold 3550 near a rigid or semi-rigid structure provides structural integrity to the flushing inlet 3612, preventing or minimizing undesirable blockage or deformation during use.

[0333] The nose interface 3600 includes a body 3560, a manifold 3550 connected to the body 3560, and one or more posts 3530 extending from the manifold 3550. These may be separate components that are permanently or removably connected to each other, or they may be parts of an integral nose interface 3600.

[0334] Each of the body 3560, manifold 3550 and one or more inserts 3530 defines a portion of an exhaust flow passage 3501 through the exhaust duct 3500.

[0335] One or more of the insert 3530, manifold 3550, and body 3560 define a portion of the flush flow passage 3611 through the flush conduit 3600. In the illustrated embodiment, one or more inserts 3530 and manifold 3550 each define a portion of the flush flow passage 3611.

[0336] For example, refer to Figure 35The patient interface 3000 and therefore the nasal interface 3600 are shown in a cross-sectional side view. The body 3560 of the nasal interface 3600 is configured to connect to the pad module 3010. A first end of the nasal interface 3600 connects to the inner surface of the pad module 3010 at a location surrounding the outlet 3210. In the illustrated embodiment, since the outlet 3210 is located on the housing 3200, the body 3560 connects to the housing 3200 at a location surrounding the outlet 3210. The body 3560 includes a base 3566 located at the first end, and the base 3566 is configured to connect to the housing 3200 at a location surrounding the outlet 3210. This connection can be removable or permanent and can be achieved by any suitable means, such as welded connection, overmolded connection, mechanical connection, magnetic connection, or adhesive connection.

[0337] In one configuration, the base 3566 and the housing 3200 are mechanically connected. This connection includes a plurality of mating features formed on the base 3566 and the housing 3200, respectively. The mating features engage with each other in a complementary and interlocking manner. The mating features may include, but are not limited to, grooves, ridges, cones, hooks, slots, pins, channels, or any combination thereof. The plurality of mating features may engage with each other in a removable and repeatable manner or in a permanent manner (such as a one-time engagement).

[0338] In one example of these multiple mating features, the base 3566 may include a male connector, and the housing 3200 may include a female connector configured to removably receive the male connector of the base 3566. This connection between the base 3566 and the housing 3200 forms a seal that is substantially airtight under the expected gas pressures experienced by the gasket module 2200 during use. The connection between the male connector of the base 3566 and the female connector of the housing 3200 may be a snap-fit ​​connection. Alternatively, the housing 3200 may include a male connector, and the base 3566 may include a female connector configured to receive the male connector of the housing 3200. This alternative connection between the female connector of the base 3566 and the male connector of the housing 3200 may be a snap-fit ​​connection. It is also conceivable that the connection between the respective male and female connectors may be a permanent, one-time connection, such as a one-time snap-fit ​​connection, rather than a removable connection.

[0339] In another embodiment, the connection between the base 3566 and the housing 3200 may be a tapered connection. In this embodiment, the housing 3200 includes a male tapered connector with a tapered outer surface, and the housing 3200 includes a female tapered connector with a tapered inner surface, the female tapered connector being configured to removably receive the tapered outer surface of the male tapered connector of the base 3566. This tapered connection between the base 3566 and the housing 3200 forms a seal that is substantially airtight under the expected gas pressures experienced by the gasket module 2010 during use. Alternatively, the housing 3200 may include a male tapered connector, while the base 3566 includes a female tapered connector configured to receive the male tapered connector of the housing 3200.

[0340] In another embodiment, the connection between the base 3566 and the housing 3200 can be a welded connection, wherein the base 3566 is ultrasonically welded to the housing 3200 to form a permanent connection.

[0341] In another embodiment, the base 3566 may be omitted. The main body 3560, or a portion thereof, may be integrally formed with the outer casing 3200. Therefore, this integral formation eliminates the need for an additional connection between the main body 3560 and the outer casing 3200. This integral formation can be achieved, for example, by molding the outer casing 3200 and the main body 3560 in a single molding process, or by molding the main body 3560 onto the outer casing 3200 using a two-color molding process or an overmolding process to form an integral structure.

[0342] It should be understood that in the illustrated embodiment, since the outlet 3210 of the gasket module 3010 is located on the housing 3200, the body 3560 (and specifically the base 3566) is connected to the housing 3200. However, in an alternative embodiment where the outlet 3210 is located on the seal 1100 or on the integrated frame-housing gasket module 3010, the body 3560 and specifically the base 3566 may be connected to any one or more components including the outlet 3210 at a location surrounding the outlet 3210. In other words, regardless of the location of the outlet 2210, the body 3560 is intended to be connected at a location surrounding the outlet 3210.

[0343] A body 3560 extends between a housing 3200 and a manifold 3550. In the illustrated embodiment, the body 3560 takes the form of a hollow structure with a variable cross-section, having a base 3566 at a first end, a manifold connector 3564 at a second end, and a central portion 3562 extending between the base 3566 and the manifold connector 3564. The body 3560 allows a gas flow passage to be formed between the first and second ends and, as previously mentioned, defines a portion of an exhaust flow passage 3501 for an exhaust duct 3500. The body 3560 in the illustrated embodiment can be described as a hollow duct, vent, channel, or pipe.

[0344] In an alternative embodiment, a portion 3565 of the body 3560 may be flexible. This flexibility allows the portion 3565 to be repeatedly deformed without structural failure. The portion 3565 allows the nose inlet 3600 to be adjustable. That is, the orientation and / or position of the nose inlet 3600 relative to the seal 1100 of the manifold 3550. This portion allows adjustment of the orientation and / or position of one or more posts 3530. The flexible portion 3565 may be located within the central portion 3562 of the body 3560. Alternatively, substantially the entire central portion 3562 may be flexible, allowing it to be repeatedly deformed without structural failure. To achieve the desired flexibility, the body 3560 may be constructed of, for example, but not limited to, a plastic material, an elastomeric material, a metallic material, or a combination of one or more of these (such as an elastomeric conduit including metal reinforcing wires or embedded metal wires).

[0345] Those skilled in the art will understand that, in alternative embodiments, the size and / or location of the manifold 3550 and one or more posts 3530 may render the body 3560 redundant. In such embodiments, the manifold 3550 may be connected to or extend directly from the housing 3200. In this case, any of the features and / or functions of the body 3560 described above may be incorporated into the housing 3200, the manifold 3550, or both.

[0346] In the illustrated embodiment, manifold 3550 is connected to and / or extends from body 3560, and one or more posts 3530 are connected to and / or extend from manifold 3550. Manifold 3550 includes manifold outlet 3552 configured to connect to manifold connector 3564 of body 3560, such that manifold outlet 3552 and body 3560 are in fluid communication. Additionally, manifold 3550 includes flushing conduit inlet 3612 in fluid communication with cavity 3012 of liner module 3010.

[0347] Manifold 3550 can be removably or permanently connected to body 3560. This connection can be made by any conventional method, such as mechanical fasteners, adhesives, welding, two-color molding, overmolding, or tapered connections. For example, manifold connector 3564 and manifold outlet 3552 can be connected by ultrasonic welding, a permanent or removable snap-fit ​​connection, or by applying an adhesive to the mating surfaces of the two components. Manifold 3550 can also be overmolded onto body 3560, wherein body 3560 is formed by a first molding process and then placed in a mold, wherein manifold 3550 is subsequently formed by overmolding manifold 3550 onto body 3560, thereby forming a permanent connection. Alternatively, body 3560 and manifold 3550 can be formed separately and then joined by an overmolding process. For example, material can be overmolded over both components to form a permanent connection between manifold 3550 and body 3560.

[0348] A portion or all of the manifold 3550 may be integrally formed with the body 3560. In such embodiments, it should be understood that the body 3560 and the manifold 3550 can be understood as parts of an integral structure comprising both the body 3560 and the manifold 3550. Therefore, the manifold connector 3564 of the body 3560 and the manifold outlet 3552 of the manifold 3550 may be omitted if not required, or they may be considered as transition portions between the body 3560 and the manifold 3550 of the integral structure. Features and / or functions of the body 3560 and the manifold 3550 otherwise disclosed will be incorporated into this integral structure.

[0349] In the illustrated embodiment, manifold 3550 defines a portion of exhaust flow passage 3501 of exhaust conduit 3500 and a portion of flush flow passage 3611 of flush conduit 3610. Manifold 3550 is configured to receive gas from one or more inserts 3530 and deliver gas to body 3560 via manifold outlet 3552. Gas is ultimately delivered to outlet 3210 of housing 3200 and to the exterior of liner module 3010. This can be done via biased vent 3215 or an outlet configured to connect to an exhalation conduit. Manifold 3550 is additionally configured to receive gas from cavity 3012 of liner module 3010 into manifold 3550 via flush conduit inlet 3612 and deliver it to one or more inserts 3530.

[0350] Manifold 3550 includes a manifold partition wall 3553 that defines a manifold exhaust chamber 3554 and a manifold flushing chamber 3555. The manifold exhaust chamber 3554 defines a portion of an exhaust flow passage 3501. The manifold flushing chamber 3555 defines a portion of a flushing flow passage 3611.

[0351] Therefore, manifold 3550 is configured to receive gas from one or more inserts 3530 and deliver the gas from manifold outlet 3552 to body 3560 via manifold exhaust chamber 3554. Manifold 3550 is also configured to receive gas from cavity 3012 of gasket module 3010 and deliver the gas to manifold flushing chamber 3555 via flushing conduit inlet 3612, and deliver the gas to one or more inserts 3530.

[0352] In the illustrated embodiment, the manifold exhaust chamber 3554 and the manifold flushing chamber 3555 are formed by a manifold partition wall 3553 that branches the internal cavities of the manifold 3550. However, it should be understood that the formation of these two cavities can be achieved without the manifold partition wall 3553. For example, in an alternative embodiment, the manifold 3550 includes separate manifold exhaust chambers 3554 and separate manifold flushing chambers 3555 that do not share any walls and / or are not defined by each other's boundaries. In other words, the manifold 3550 may include a body comprising the manifold exhaust chamber 3554 and the manifold flushing chamber 3555, each of these cavities being formed separately from each other. In yet another alternative embodiment, the manifold 3550 may include a first body comprising the manifold exhaust chamber 3554 and the second body comprising the manifold flushing chamber 3555.

[0353] In the illustrated embodiment, the manifold 3550 also includes a facial contact portion 3556 configured to contact one or more of the patient's upper lip, philtrum, bridge of the nose, or nostrils. Such contact helps to support or position one or more posts 3530 in a desired location. The facial contact portion 3556 comprises a relatively soft material. This may help to avoid or minimize patient discomfort. For example, the facial contact portion 3556 may comprise an elastomeric material, such as silicone or rubber.

[0354] In the illustrated embodiment, the manifold 3550 has a dual-material construction comprising a rigid plastic portion and an elastomer portion, the rigid plastic portion comprising at least a portion of each of the manifold outlet 3552 and the flushing conduit inlet 3612, and the elastomer portion comprising a face contact portion 3556.

[0355] Alternatively, the entire manifold 3550 may comprise an elastomeric material. Further alternatively, the majority of the manifold 3550 may comprise an elastomeric material, with only a minimal rigid portion providing support where necessary. In such embodiments, the majority of the manifold 3550 may comprise an elastically deformable elastomeric material, with only the manifold outlet 3552 formed of a rigid plastic material, or only the manifold outlet 3552 and the flushing conduit inlet 3612 formed of a rigid plastic material.

[0356] In an alternative embodiment, the face contact portion 3556 may not be configured to contact the patient's face during use, but may still be formed of an elastomeric material and alternatively configured to avoid discomfort in the event of any accidental contact between the manifold 3550 and the patient's face.

[0357] In the illustrated embodiment, at least a portion of the facial contact portion 3556 of the manifold 3550 is recessed when viewed in the proximal-distal direction to conform to the shape of the patient's upper lip, philtrum, and / or nostrils.

[0358] One or more insertion posts 3530 extend from manifold 3550 to exhaust duct inlet 3510 and flushing duct outlet 3613. In the illustrated embodiment, nasal interface 3600 includes a first insertion post 3531 and a second insertion post 3540. The first insertion post 3531 extends from manifold 3550 to a first free end 3532. The first free end 3532 includes a first exhaust duct inlet 3515 and a first flushing duct outlet 3614. The second insertion post 3540 extends from manifold 3550 to a second free end 3542. The second free end 3542 includes a second exhaust duct inlet 3520 and a second flushing duct outlet 3615.

[0359] The exhaust duct inlet 3510 includes both a first exhaust duct inlet 3515 and a second exhaust duct inlet 3520. The flushing duct outlet 3613 includes both a first flushing duct outlet 3614 and a second flushing duct outlet 3615.

[0360] In the illustrated embodiment, the first insert 3531 is branched by a first insert partition wall 3534 to form a first insert exhaust chamber 3536 and a first insert flushing chamber 3538. The second insert 3540 is branched by a second insert partition wall 3536 to form a second insert exhaust chamber 3546 and a second insert flushing chamber 3548.

[0361] Forming separate exhaust chambers and flushing chambers within each of one or more inserts 3530 allows each of the exhaust flow passages 3501 and flushing flow passages 3611 to pass through portions of the first insert 3531 and the second insert 3540, respectively, to be separated from each other.

[0362] In the illustrated embodiment, each of the first insert partition wall 3534 and the second insert partition wall 3536 is configured to be connected to, abut against, connect to, or be continuous with the manifold partition wall 3553. This allows for the continuous separation of portions of the exhaust flow passage 3501 and the flushing flow passage 3611 defined by the manifold 3550 and one or more inserts 3530.

[0363] Therefore, the first insert 3531 is configured to receive gas through the first exhaust duct inlet 3515 and deliver the gas to the manifold exhaust chamber 3554 through the first insert exhaust chamber 3536. The first insert 3531 is also configured to receive gas from the manifold flush chamber 3555 and deliver the gas from the first flush duct outlet 3614 through the first insert flush chamber 3538.

[0364] Similarly, the second insert 3540 is configured to receive gas through the second exhaust duct inlet 3520 and deliver the gas to the manifold exhaust chamber 3554 through the second insert exhaust chamber 3546. The second insert 3540 is also configured to receive gas from the manifold flush chamber 3555 and deliver the gas from the second flush duct outlet 3615 through the second insert flush chamber 3548.

[0365] In an alternative embodiment, the first insert partition wall 3534 and the second insert partition wall 3546 may be omitted. In this embodiment, portions of the respective exhaust flow passages 3510 and flushing flow passages 3611 penetrating the first insert 3531 and the second insert 3540 may be separated by any suitable structure that prevents gas flow mixing between the two passages.

[0366] In the illustrated embodiment, the first insert partition wall 3534 and the second insert partition wall 3546 respectively form a first insert exhaust cavity 3536, a first insert flushing cavity 3538, a second insert exhaust cavity 3546, and a second insert flushing cavity 3548. However, it should be understood that the formation of these cavities can be achieved without the partition wall for each of these inserts. For example, in an alternative embodiment, the first insert 3531 may include different first insert exhaust cavities 3536 and different first insert flushing cavities 3538, and the second insert 3540 may include different second insert exhaust cavities 3546 and different second insert flushing cavities 3548, none of these cavities being defined by the boundaries of each other. In other words, the first insert 3531 may include a body comprising a first insert exhaust chamber 3536 and a first insert flushing chamber 3538, each of which is formed separately from each other, and the second insert 3540 may include a body comprising a second insert exhaust chamber 3546 and a second insert flushing chamber 3548, each of which is formed separately from each other.

[0367] In another alternative embodiment, the first insert 3531 may include a first body and a second body, the first body including a first insert exhaust chamber 3536 and the second body including a first insert flushing chamber 3538, and the second insert 3540 may include a third body and a fourth body, the third body including the second insert exhaust chamber 3546 and the fourth body including the second insert exhaust chamber 3548.

[0368] In the illustrated embodiment, the first insertion post 3531 and the second insertion post 3540 are sealing nasal insertion posts. The sealing nasal insertion posts are configured to form a seal with the corresponding nostril in the patient's nostril during use. Each of the first insertion post 3531 and the second insertion post 3540 includes an outer surface configured to form a seal with the inner surface or edge of the corresponding nostril in the patient's nostril. Alternatively or additionally, the outer surface of each of the first insertion post 3530 and the second insertion post 3540 may form a seal with the outer surface of the corresponding nostril in the patient's nostril.

[0369] In an alternative embodiment, the first post 3531 and the second post 3540 may be non-sealed nasal posts. Non-sealed nasal posts are not configured to form a seal with the corresponding nostril in the patient's nostril during use. In other words, the cross-sectional area of ​​the first post 3531 and the second post 3540 at their respective free ends 3532, 3542 is designed to be smaller than the cross-sectional area of ​​the inlet of the corresponding nostril in the intended patient's nostril.

[0370] In an alternative embodiment, the nasal interface 3600 may include only a single post 3530, and therefore only a single vent inlet 3515 and a single flushing outlet 3615. In this configuration, a first post 3531 extends from a manifold 3550 to a first free end 3532, the first free end 3532 including the first vent inlet 3515 and the first flushing outlet 3615. The first post 3531 is bifurcated by a first post partition wall 3536 and includes a first post vent chamber 3536 and a first post flushing chamber 3538. The first post vent chamber 3536 is in fluid communication with the first vent inlet 3515, and the first post flushing chamber 3538 is in fluid communication with the first flushing outlet 3615. The first post 3531 includes an outer surface configured to form a seal with the inner surface of the corresponding nostril in the patient's nostril and / or with the outer surface of the corresponding nostril in the patient's nostril. It should be understood that the above description is not intended to be limiting, and any features and functions described in the specification related to the first plug 3530 can be incorporated into a configuration that includes only a single plug nose interface 3600.

[0371] It should be understood that while the illustrated embodiments include a nasal interface 3600 comprising an exhaust conduit 3500 and an irrigation conduit 3610 as a combined component, in an alternative embodiment, the patient interface 3000 may include separate exhaust conduits 3500 and irrigation conduits 3610. In this embodiment, each of the exhaust conduits 3500 and irrigation conduits 3610 may include separate posts such that the two posts are positioned within or near / adjacent to one or both nostrils of a patient. In such a configuration, all features and functions of the first post 3531 and / or the second post 3540 related to the exhaust conduit 3500 may be incorporated into the first exhaust conduit post and / or the second exhaust conduit post. Similarly, all features and functions of the first post 3531 and / or the second post 3540 related to the irrigation conduit 3610 may be incorporated into the first irrigation conduit post and / or the second irrigation conduit post.

[0372] As previously mentioned, the nose interface 3600 may be permanently attached to the housing 3200, or may be removably attached to the housing 3200, for example, via a removable connection between the body 3560 and the housing 3200 as described above. Alternatively, portions of the nose interface 3600 may be integrally formed with the housing 3200, and the remaining portions of the nose interface 3600 may be removably or permanently attached to the integrally formed portions of the nose interface 3600.

[0373] In embodiments where the nose interface 3600 is integrally formed with the housing 3200, portions of the nose interface 3600 may be overmolded onto the housing 3200, co-molded with the housing, or integrally formed with the housing. Specifically, the body 3560 may be integrally formed with the housing 3200, and the remaining portions of the nose interface 3600 may be permanently or removably connected to the body 3560.

[0374] Alternatively, a large portion of the nose inlet 3600 may be integrally formed with the housing 3200, while the first post 3531 and / or the second post 3540 may be made of a different material than the housing 3200 and connected to the rest of the nose inlet 3600 in a secondary process. For example, the body 3560 and the manifold 3550 may be integrally formed with the housing 3200 by molding as integral components, and the first post 3531 and / or the second post 3540 may be formed from an elastomeric material by a separate molding process and then connected to the rest of the nose inlet 3600.

[0375] Alternatively, the body 3560 and manifold 3550 of the nasal inlet 3600 may be integrally formed with the housing 3200. Such integral forming may involve injection molding using a plastic material. The first post 3531 and / or the second post 3540 may then be overmolded into the integrally formed housing 3200, body 3560, and manifold 3550 components using an elastomeric material. In one example, the plastic material is polycarbonate, and the elastomeric material is silicone.

[0376] The nasal interface 3600 can be sold separately from the rest of the patient interface 3000. This allows the nasal interface 3600 to be retrofitted to existing patient interfaces. In this case, the nasal interface 3600 is located within the cavity of the existing patient interface, and the exhaust duct outlet 3505 is in fluid communication with the outlet or bias vent of the existing patient interface. Thus, existing patient interfaces can be fitted with the nasal interface 3600 to improve the performance of these existing patient interfaces.

[0377] The cross-sectional area of ​​the exhaust duct inlet 3510 includes a first exhaust duct inlet 3515 and a second exhaust duct inlet 3520 (where applicable). This cross-sectional area of ​​the exhaust duct inlet 3510 is configured to be smaller than the cross-sectional area of ​​the inlet 3220 of the housing 3200. In the illustrated embodiment, all gas entering the gasket module 3010 enters through the inlet 3220, and, except for accidental leaks, substantially all gas leaving the gasket module 3010 exits through the outlet 3210. The exhaust duct 3500 is in sealed fluid communication with the outlet 3210 of the housing 3200. The reduced cross-sectional area of ​​the exhaust duct inlet 3510 compared to the inlet 3220 of the housing 3200 creates a flow restriction, which accelerates the gas flow into the exhaust duct 3500 as pressurized gas flows into the gasket module 3010 through the inlet 3220 and then into the exhaust duct 3500 to exit the gasket module 3010. The reduction in cross-sectional area in the flow path creates a pressure drop, which accelerates the gas flow into the exhaust duct 3500. The following paragraphs explain the importance of this gas acceleration.

[0378] In the illustrated embodiment, the flow restriction mentioned above is formed by the exhaust duct inlet 3510, whose cross-sectional area is smaller than that of the inlet 3220 of the housing 3200. However, this flow restriction may be applied elsewhere in the exhaust duct 3500, or more specifically, elsewhere in one or more inserts 3530, manifolds 3550, or bodies 3560. For example, a flow restrictor may be located within the exhaust flow passage 3501 near or adjacent to the exhaust duct inlet 3510 to accelerate the gas as it flows into the exhaust duct 3500.

[0379] In the illustrated embodiment of the patient interface 3000, the ratio of the cross-sectional area of ​​the first exhaust duct inlet 3515 to the cross-sectional area of ​​the second exhaust duct inlet 3520 is 1:1, meaning that the cross-sectional areas of the two exhaust duct inlets are equal. However, in an alternative embodiment, the cross-sectional area of ​​the first exhaust duct inlet 3515 may not be equal to the cross-sectional area of ​​the second exhaust duct inlet 3520. The ratio of the cross-sectional area of ​​the first exhaust duct inlet 3515 to the cross-sectional area of ​​the second exhaust duct inlet 3520 may range from 1:1.1 to 1:4. In one configuration, the ratio of the cross-sectional area of ​​the first exhaust duct inlet 3515 to the cross-sectional area of ​​the second exhaust duct inlet 3520 is 1:3.

[0380] As a complement or alternative to different exhaust duct inlet cross-sectional areas, the shape and / or size of the first insert 3531 and the second insert 3540 may differ in at least one aspect (such as insert diameter, length, or shape). Such embodiments with different shapes and / or sizes of the first insert 3531 and the second insert 3540 can be described as having asymmetrical first insert 3531 and second insert 3540.

[0381] The cross-sectional area of ​​the flushing conduit outlet 3613 includes a first flushing conduit outlet 3614 and a second flushing conduit outlet 3615 (where applicable). In the illustrated embodiment, the total cross-sectional area of ​​the flushing conduit outlet 3613 is configured to be smaller than the cross-sectional area of ​​the flushing conduit inlet 3612.

[0382] Compared to the cross-sectional area of ​​the flushing conduit inlet 3612, the cross-sectional area of ​​the flushing conduit outlet 3613 is smaller, which creates a flow restriction at the flushing conduit outlet 3613. This flow restriction causes the gas flow to accelerate out of the flushing conduit outlet 3613 as pressurized gas flows through the flushing flow channel 3611. Therefore, in use, the gas flow exits the flushing conduit outlet 3613 at a higher velocity than the gas flow entering the flushing conduit inlet 3612 from within the cavity 3012 of the liner module 3010. The following paragraphs explain the importance of this gas acceleration.

[0383] In an alternative embodiment, it should be understood that the necessary flow restriction can be created at or near the flushing conduit outlet 3613 in ways other than the cross-sectional area of ​​the flushing conduit outlet 3613. For example, a flow restrictor may be located within the flushing flow channel 3611 near or adjacent to the flushing conduit outlet 3613 to accelerate the gas flow through the flushing conduit 3610.

[0384] Additionally or alternatively, the cross-sectional area of ​​the flushing flow passage 3611 of the flushing conduit 3610 may gradually taper or decrease from the flushing conduit inlet 3612 to the flushing conduit outlet 3613. In conjunction with or instead of reducing the cross-sectional area of ​​the flushing conduit outlet 3613 relative to the flushing conduit inlet 3612, this gradual taper of the flushing flow passage 3611 will accelerate the gas flow through the flushing conduit 3610.

[0385] In the illustrated embodiment of the patient interface 3000, the ratio of the cross-sectional area of ​​the first flushing catheter outlet 3614 to the cross-sectional area of ​​the second flushing catheter outlet 3615 is 1:1, meaning that the cross-sectional areas of the two flushing catheter outlets are equal. However, in an alternative embodiment, the cross-sectional area of ​​the first flushing catheter outlet 3614 may not be equal to the cross-sectional area of ​​the second flushing catheter outlet 3615. The ratio of the cross-sectional area of ​​the first flushing catheter outlet 3614 to the cross-sectional area of ​​the second flushing catheter outlet 3615 may range from 1:1.1 to 1:4. In one configuration, the ratio of the cross-sectional area of ​​the first flushing catheter outlet 3614 to the cross-sectional area of ​​the second flushing catheter outlet 3615 is 1:3.

[0386] In the illustrated embodiment, the nose interface 3600 is permanently or removably attached to the housing 3200. That is, the nose interface 3600 does not directly contact the seal 1100. In other words, the nose interface 3600 is a separate structure from the seal 1100. Furthermore, the nose interface 3600 is surrounded by the cavity 3012 of the padding module 3010. It is believed that this may be advantageous in improving patient comfort by reducing interference or interaction with the soft seal 1100 configured to contact the patient's face. However, it should be understood that in alternative embodiments, the nose interface 3600 may contact or connect to the seal 1100 at one or more locations without significantly affecting patient comfort. For example, the nose interface 3600 may connect to a portion of the seal 1100 remote from the patient contact surface 1120.

[0387] For illustrative purposes, see reference. Figure 41 and Figure 42 The patient interface 3000 is shown in cross-section along line E-E' as it is assembled onto the anatomical model of the patient (also shown in cross-section). Figure 41 In the illustration, the patient interface 3000 is depicted as being fitted onto the patient with their mouth open. Figure 42In this illustration, the patient interface 3000 is shown fitted onto a patient with their mouth closed. Arrows indicate the direction of gas flow into the pad module 3010 through inlet 3220 and out of the pad module 3010 through outlet 3210, at which point the pad module is fitted onto the patient and the patient is not breathing. The relative size of the arrows should not be interpreted as an indication of gas flow rate or velocity. It should be understood that additional gas flow paths are formed during respiration, in addition to those described above. However, for illustrative purposes, it is assumed that the general operation of the patient interface 3000 can be adequately described while ignoring respiration, as the effect of the patient interface 3000 is considered most significant at the end of the expiratory cycle (which can be figuratively compared to a situation without breathing).

[0388] When the patient interface 3000 is fitted onto a patient, the nasal interface 3600 is positioned such that the exhaust duct inlet 3510 and the flushing duct outlet 3613 are located within one or more of the patient's nostrils, or below one or more of the patient's nostrils and adjacent to the patient's upper lip, or immediately adjacent to one or more of the patient's nostrils. In other words, the exhaust duct inlet 3510 and the flushing duct outlet 3613 are located within one or more of the patient's nostrils, adjacent to or close to one or more of the patient's nostrils.

[0389] More specifically, in embodiments including a first exhaust duct inlet 3515, a second exhaust duct inlet 3520, a first flushing duct outlet 3614, and a second flushing duct outlet 3615, the first exhaust duct inlet 3515 and the first flushing duct outlet 3614 are configured to be positioned inside the first nostril of the patient's nostril, or positioned below the first nostril of the patient's nostril and adjacent to the upper part of the patient's lips, or positioned immediately adjacent to the first nostril of the patient's nostril. The second exhaust duct inlet 3520 and the second flushing duct outlet 3615 are configured to be positioned inside the second nostril of the patient's nostril, or positioned below the second nostril of the patient's nostril and adjacent to the upper part of the patient's lips, or positioned immediately adjacent to the second nostril of the patient's nostril.

[0390] In embodiments including a single exhaust duct inlet 3515 and a single flushing duct outlet 3614, the first exhaust duct inlet 3515 and the first flushing duct outlet 3614 are configured to be located inside a first nostril in the patient's nostril, or located below the first nostril in the patient's nostril and adjacent to the upper part of the patient's lips, or located immediately adjacent to the first nostril in the patient's nostril.

[0391] refer to Figure 41 The patient interface 3000 is fitted onto the patient with their mouth open and not breathing, and pressurized gas is delivered to the patient interface 3000 via the conduit connector 1300. The pressurized gas flow enters the liner module 3010 through inlet 3220. Excess pressurized gas from within the liner module 3010 and / or from the patient's airway then flows into the exhaust conduit 3500 through exhaust conduit inlet 3510, and the gas then travels along the exhaust flow channel 3501 and exits the liner module 3010 through outlet 3210. Due to the intended positioning of the exhaust conduit inlet 3510 relative to the patient's nostrils (including the positioning of either or both of the first exhaust conduit inlet 3515 and the second exhaust conduit inlet 3520), a first effective flow path and a second effective flow path are formed for gas to enter the exhaust conduit 3500 through the exhaust conduit inlet 3510.

[0392] The first effective flow path extends from within the liner module 3010 through the patient's mouth into their oral cavity, through the patient's throat into the patient's nasal cavity, and: (1) extends to the exhaust duct inlet 3510 when the exhaust duct inlet 3510 is located within one or more of the patient's nostrils; or (2) extends out of one or more of the patient's nostrils and to the exhaust duct inlet 3510 when the exhaust duct inlet 3510 is located adjacent to one or more of the patient's nostrils, or located below one or more of the patient's nostrils and adjacent to the patient's upper lip, or located immediately adjacent to one or more of the patient's nostrils. In all cases, the gas flow entering the patient's oral cavity and exiting through the nasal cavity is considered to result in flushing of at least a portion of the anatomical dead space of the patient's oral cavity, throat, and nasal cavity.

[0393] The second effective flow path extends from within the padding module 3010 through the flushing conduit inlet 3612 along the flushing flow channel 3611 to the flushing conduit outlet 3613, at which the gas flow is accelerated and: (1) flows into the patient's nasal cavity, wherein the gas flow is decelerated and / or the direction of the gas flow is changed such that the gas flow can enter the exhaust conduit inlet 3510 when the exhaust conduit inlet 3510 is positioned within one or more of the patient's nostrils; or (2) flows through one or more of the patient's nostrils and into the patient's nasal cavity, wherein the gas flow is decelerated and / or the direction of the gas flow is changed such that the gas flow exits one or more of the patient's nostrils and can enter the exhaust conduit inlet 3510, provided that the exhaust conduit inlet 3510 is positioned adjacent to one or more of the patient's nostrils, or positioned below one or more of the patient's nostrils and adjacent to the patient's upper lip, or positioned immediately adjacent to one or more of the patient's nostrils.

[0394] In the first instance, it is believed that accelerating the gas flow out of the flushing conduit 3610 and into the patient's nasal cavity before entering the exhaust conduit inlet 3510 will cause flushing of at least a portion of the anatomical dead space of the patient's nasal cavity. In the second instance, it is believed that accelerating the gas flow out of the flushing conduit 3610 will cause at least some of the gas flow to enter the patient's nasal cavity through one or more nostrils, then decelerate and / or change direction and exit the nasal cavity through one or more nostrils, and enter the exhaust conduit inlet 3510. It is believed that this portion of the gas flow entering the nasal cavity via the accelerated gas flow will cause flushing of a portion of the anatomical dead space of the patient's nasal cavity. In other words, it is believed that in both instances, at least partially through the second effective flow path formed by the flushing conduit 3610 and thereby accelerating the gas flow into the patient's nasal cavity will cause flushing of at least a portion of the anatomical dead space of the patient's nasal cavity and / or throat.

[0395] refer to Figure 42 The patient interface 3000 is fitted onto the patient with their mouth closed and no breathing, and pressurized gas is delivered to the patient interface 3000 via the conduit connector 1300. The pressurized gas flow enters the liner module 3010 through inlet 3220. Excess pressurized gas from within the liner module 3010 and / or from the patient's airway then flows into the exhaust conduit 3500 through exhaust conduit inlet 3510, and the gas then travels along the exhaust flow channel 3501 and exits the liner module 3010 through outlet 3210. However, because the patient's mouth is closed, only a second effective flow path is formed. The second flow path is discussed in detail in the paragraph immediately preceding this one.

[0396] In the illustrated embodiment of the patient interface 3000, since the gas flow through both the first and second effective flow paths is believed to induce anatomical dead space flushing to some extent, the patient interface 3000 is believed to provide significant benefits beyond conventional non-invasive ventilation masks. In NIV therapy, it is advantageous to provide pressure support and simultaneously flush the dead space while the patient's mouth is open or closed. Additionally, in embodiments where the nasal interface 3600 is a removable nasal interface, it is conceivable that the patient interface 3000 with the nasal interface 3600 removed could be used to provide standard NIV therapy (if such effects are desired). For example, it is conceivable that the patient may only require anatomical dead space flushing during discrete time periods throughout the day. This allows the patient interface 3000 to be used alternately for several time periods with the nasal interface 3600 in place and removed.

[0397] In the preceding paragraphs, the expected benefits of anatomical dead space flushing of the patient as a patient interface 3000 have been discussed. The patient's anatomical dead space consists of the total volume of the patient's airway segments responsible for guiding air to the alveoli and respiratory bronchioles, but not participating in the gas exchange process itself. Therefore, the anatomical dead space is the total volume of the airway from the patient's nose or mouth to the terminal bronchioles (including the oral cavity, nasal cavity, and pharynx (also known as the larynx)).

[0398] During a patient's breathing, air with a lower CO2 content is inhaled into the lungs, and air with a higher CO2 content is exhaled. At the end of the expiratory cycle, some of the exhaled air with a higher CO2 content remains in the patient's anatomical dead space. This air with a higher CO2 content is then inhaled or rebreathed in the next respiratory cycle. Rebreathing this air with a higher CO2 content reduces the efficiency of gas exchange occurring within the patient's lungs.

[0399] Dead space flushing replaces at least a portion of the exhaled, CO2-rich air present in the patient's anatomical dead space with fresh, low-CO2 air, so that in the next inspiratory cycle, the reduced amount of exhaled, CO2-rich air is inhaled or rebreathed. Rebreathing the reduced CO2-rich air increases the efficiency of gas exchange occurring in the patient's lungs.

[0400] As mentioned in the preceding paragraphs, the cross-sectional area of ​​the exhaust duct inlet 3510 is configured to be smaller than that of the inlet 3220 of the housing 3200. This smaller cross-sectional area of ​​the exhaust duct inlet 3510 creates a flow restriction, resulting in a pressure drop when pressurized gas is supplied to the padding module 3010 of the patient interface 3000 during use. This causes the gas flow to accelerate into the exhaust duct 3500. It is believed that this accelerated gas flow into the exhaust duct 3500 may also lead to the introduction of ambient gas into the exhaust duct 3500.

[0401] When the exhaust duct inlet 3510 is positioned within or adjacent to one of the patient's nostrils, or below the nostrils and near the patient's upper lip, the introduction of gas into the exhaust duct 3500 at the location surrounding the exhaust duct inlet 3510 may facilitate flushing of the patient's anatomical dead space. When the gas flow is accelerated into the exhaust duct inlet 3510, due to the combination of gas flow acceleration and / or local pressure drop, gases with higher CO2 content present in the patient's anatomical dead space may be introduced into the exhaust duct inlet 3510. It is believed that the introduction of gases with higher CO2 content can provide anatomical dead space flushing as an alternative to or supplement to the anatomical dead space flushing described above regarding the effective flow path formed during use.

[0402] refer to Figures 43 to 54 The diagram illustrates a fourth embodiment of a patient interface 4000. The patient interface 4000 is a variation of the general form of the patient interface 1000 and, unless otherwise stated, includes all the components and functions of the patient interface 1000. More specifically, the patient interface 4000 includes at least the frame 1400, headgear 1900, and catheter connector 1300 of the patient interface 1000. Due to the inclusion of a partition wall 4700, the housing 4200 and seal 4100 of the patient interface 4000, and therefore the padding module 4010, differ from the housing 1200, seal 1100, and padding module 1010 of the patient interface 1000. The differences between the housing 4200, seal 4100, and padding module 4010 will be described below; otherwise, it should be understood that the housing 4200, seal 4100, and padding module 4010 respectively include all the features and functions of the housing 1200, seal 1100, and padding module 1010. Features of housing 4200, seal 4100 and gasket module 4010 that are identical to those of housing 1200, seal 1100 and gasket module 1010 are indicated by the same reference numerals, but the first digit is “4” instead of “1”.

[0403] In the illustrated embodiment, the patient interface 4000 is in the form of a full-face mask over the nose, wherein the padding module 4010 includes a seal 4100 and a housing 4200. The seal 4100 is connected to the housing 4200, and the seal 4100 and the housing 4200 together form the padding module 4010, which has an outer wall 4011 defining an internal cavity 4012. The internal cavity 4012 of the padding module 4010 is configured to be pressurized through an inlet 4220 through which breathing gas can be delivered from the catheter connector 1300 into the internal cavity 4012.

[0404] The patient interface 4000 also includes a partition wall 4700 that divides the internal cavity 4012 of the liner module 4010 into a first chamber 4014 and a second chamber 4016. The partition wall 4700 is connected to the housing 4200 and the seal 4100 to separate the first chamber 4014 from the second chamber 4016.

[0405] The seal 4100 is formed of a soft, elastic material (such as silicone or other suitable elastomer) and includes a sealing opening 4110. When fitted to a patient, the sealing opening 4110 is configured to surround the patient's mouth and nose. The patient contact surface 4120 of the seal 4100 forms a seal around the patient's mouth and nose. The seal formed by the patient contact surface 4120 is sufficient to contain at least substantially the pressurized gas within the cavity 4012. Some pressurized gas leakage may occur, but such leakage is relatively small, allowing the pressurized gas supplied to the patient to be maintained at a level sufficient for delivering NIV therapy. Therefore, high-pressure breathing gas can be delivered from the liner module 4010 to the patient's mouth and / or nostrils through the sealing opening 4110.

[0406] As mentioned above, the partition wall 4700 is a physical barrier that traverses the internal cavity 4012 and divides it into separate first chamber 4014 and second chamber 4016. To achieve this separation, the partition wall 4700 is coupled to the housing 4200 and the seal 4100 along a portion of its periphery. In the illustrated embodiment, another portion of the periphery of the partition wall 4700 branches the sealing opening 4110, thereby forming an oral cavity opening 4114 and a nasal cavity opening 4116.

[0407] The oral cavity opening 4114 is configured to surround the patient's mouth during use. A portion of the patient contact surface 4120 of the seal 4100 and a portion of the periphery of the partition wall 4700 together form a seal around the patient's mouth.

[0408] The nasal opening 4116 is configured to surround the patient's nose during use. A portion of the patient contact surface 4120 of the seal 4100 and a portion of the periphery of the partition wall 4700 together form a seal around the patient's nose.

[0409] Therefore, high-pressure breathing gas can be delivered from the pad module 4010 to the patient's mouth through the oral cavity opening 4414. Additionally, high-pressure breathing gas can be delivered from the pad module 4010 to the patient's nose through the nasal cavity opening 4116.

[0410] The housing 4200 includes an inlet 4220 through which pressurized breathing gas can be transferred from the conduit connector 1300 to the internal cavity 4012 of the padding module 4010. It should be understood that, in an alternative embodiment, the conduit connector 1300 may be omitted. Instead, pressurized breathing gas can be transferred directly from a flow source to the inlet 4220 of the housing 4200. It is also conceivable that the inlet 4220 may alternatively be located on the seal 4100. In this embodiment, pressurized breathing gas can be transferred through the inlet 4220 in the seal 4100 to the internal cavity 4012 of the padding module 4010.

[0411] The housing 4200 includes an outlet 4210 through which exhaled breathing gas and excess breathing gas can be discharged from the padding module 4010 and / or the patient's airway. In the illustrated embodiment, the outlet 4210 is a biased ventilation port 4215, which includes a plurality of holes penetrating the housing 4200.

[0412] In another embodiment, outlet 4210 and offset ventilation port 4215 may be different structures located at positions spaced apart from each other. In a further embodiment, the patient interface may also include supplemental offset ventilation port 1416.

[0413] In yet another embodiment, the outlet 4210 of the pad module 4010 may be an opening configured to connect to or be in fluid communication with the expiratory conduit of the breathing circuit. In this configuration, exhaled and excess breathing gases may be discharged from the pad module 4010 and / or from the patient's airway and delivered from the patient interface 4000, where they may be released into the atmosphere or received by a ventilator, flow generator, or other gas source.

[0414] In the illustrated embodiment, the periphery of the partition wall 4700 is connected to the housing 4200 at a location between the inlet 4220 and the outlet 4210. In this embodiment, the inlet 4220 is located in the first chamber 4014, and the outlet 4210 is located in the second chamber 4016.

[0415] Since the periphery of the partition wall 4700 is connected to the housing 4200 and the seal 4100, and causes the sealing opening 4410 to branch, the inlet 4220 and the oral cavity opening 4114 are located in the first chamber 4014 at the location described above, and the outlet 4210 and the nasal cavity opening 4116 are located in the second chamber 4016.

[0416] In the illustrated embodiment, housing 4200 and seal 4100 are described as separate components permanently joined to form gasket module 4010. However, it should be understood that housing 4200 and seal 4100 can alternatively be single components encompassing the features and functions of housing 4200 and seal 4100. It should be understood that the disclosure relating to gasket module 4010 including different housings 4200 and seals 4100 is equally applicable to configurations including combinations of housings 4200 and seals 4100, or configurations including single components encompassing the features and functions of housings 4200 and seals 4100.

[0417] The partition wall 4700 also includes one or more flow deflectors 4730 located on the partition wall 4700. In the illustrated embodiment, the one or more flow deflectors 4730 extend from the partition wall 4700 into the second chamber 4016. A flow path runs through each of the one or more flow deflectors 4730 and the partition wall 4700. This flow path allows gas to flow from the first chamber 4014 through the one or more flow deflectors 4730 and into the second chamber 4016. In the illustrated embodiment, the flow path running through the one or more flow deflectors 4730 and the partition wall 4700 is the only flow path through the partition wall 4700.

[0418] In the illustrated embodiment, one or more flow deflectors 4730 include a first flow deflector 4732 and a second flow deflector 4736. The first flow deflector 4732 includes a first flow deflector inlet 4733 passing through a partition wall 4700 and extending from the partition wall 4700 to a free end of a first flow deflector 4734 located within a second chamber 4016. The free end of the first flow deflector 4734 includes a first flow deflector outlet 4735. The second flow deflector 4736 includes a second flow deflector inlet 4737 passing through the partition wall 4700 and extending from the partition wall 4700 to a free end of a second flow deflector 4738 located within the second chamber 4016. The free end of the second flow deflector 4738 includes a second flow deflector outlet 4739.

[0419] In an alternative embodiment, one or more flow deflectors 4730 may include only a first flow deflector 4732, which includes a first flow deflector inlet 4733 passing through partition wall 4700 and extending from partition wall 4700 to a free end of a first flow deflector 4734 located within second chamber 4016. The free end of the first flow deflector 4734 includes a first flow deflector outlet 4735.

[0420] In the illustrated embodiment, the partition wall 4700 includes a spacer element 4731 extending between the first flow guide 4732 and the second flow guide 4736, and configured to maintain the spacing between these flow guides in use. In the illustrated embodiment, the spacer element 4731 is in the form of a rib extending between and connecting the first flow guide 4732 and the second flow guide 4736. It should be understood that the partition wall 4700 may provide sufficient rigidity around the locations of the first flow guide 4732 and the second flow guide 4736, such that the spacer element 4731 can be omitted.

[0421] In an alternative embodiment, the first flow deflector 4732 and / or the second flow deflector 4736 may not extend from the partition wall 4700, but may be formed within the partition wall 4700. It is conceivable that in such a configuration, the first flow deflector inlet 4733 and / or the second flow deflector inlet 4337 may be located on the surface of the partition wall 4700 within the first chamber 4014, and the first flow deflector outlet 4735 and / or the second flow deflector outlet 4739 may be located on the surface of the partition wall 4700 within the second chamber 4016. In this embodiment, the first flow deflector 4732 and / or the second flow deflector 4736 each include a flow path through the partition wall 4700.

[0422] In the illustrated embodiment, the partition wall 4700 includes a deformable region 4720 located on the partition wall 4700 between a portion of the coupling housing 4200 and the periphery of the partition wall 4700 of one or more flow deflectors 4730. The deformable region 4700 is a localized area of ​​reduced thickness of the partition wall 4700, configured to preferentially deform in response to forces applied to the partition wall 4700 during use of the patient interface 4000. This preferential deformation is configured to absorb some or all of the unintended forces applied to the partition wall 4700 during use to minimize deformation or collapse of the one or more flow deflectors 4730.

[0423] The deformable region 4720 includes a first thickened region 4724 and a second thickened region 4726 connected by a thin region 4721. The thickness of the thin region 4721 is less than that of both the first thickened region 4724 and the second thickened region 4726. The deformable region 4720 is configured to move from the first thickened region 4724 to the second thickened region 4726 and, in the process, preferentially deform the thin region 4721.

[0424] In the illustrated embodiment, the thin region 4721 includes a first thin wall 4722 and a second thin wall 4723. The first thin wall 4722 extends from the first thickened region 4724, and the second thin wall 4723 extends from the second thickened region 4726, and the first thin wall 4722 and the second thin wall 4723 are connected to each other to form an angle of less than 180 degrees between them. During deformation of the deformable region 4720, as the first thickened region 4724 moves toward the second thickened region 4726, the angle formed between the first thin wall 4722 and the second thin wall 4723 decreases.

[0425] It should be understood that the purpose of the deformation region 4720 is to allow preferential deformation to occur at predetermined locations on the partition wall 4700 in order to absorb undesirable forces applied to the partition wall 4700 and minimize deformation or collapse of one or more flow diverters 4730. Therefore, any suitable structure capable of preferential deformation at predetermined locations on the partition wall 4700 (such as bellows, pleats, folds, corrugations, accordion structures, or retractable joints located in the partition wall 4700, preferably located on the partition wall 4700 between a portion of the connecting housing 4200 and the periphery of the partition wall 4700) can be incorporated into the patient interface 4000.

[0426] The partition wall 4700 may comprise a single material (such as an elastomeric material or a plastic material) or may comprise multiple materials (such as an elastomeric material and a plastic material). In the illustrated embodiment, the partition wall includes a rigid portion 4710 comprising a plastic material and an elastomeric portion 4712 comprising an elastomeric material. The rigid portion 4710 includes the portion of the partition wall 4700 that is coupled to the housing 4200, and the elastomeric portion 4712 includes the portion of the partition wall 4700 that is coupled to the seal 4100. Additionally or alternatively, the elastomeric portion 4712 includes a deformable region 4720 and one or more flow deflectors 4730. In other words, the deformable region 4720 and the one or more flow deflectors 4730 comprise an elastomeric material.

[0427] In the illustrated embodiment, the rigid portion 4710 comprises a polycarbonate material, and the elastomeric portion 4712 comprises a silicone material. However, it is contemplated that in alternative embodiments, any other suitable plastic and / or elastomeric material may be used. Furthermore, in the illustrated embodiment, the rigid portion 4710 and the elastomeric portion 4712 are permanently connected; however, in alternative embodiments, these portions may be removably connected by any suitable connection method.

[0428] The cross-sectional area of ​​the flow guide outlet 4740 includes a first flow guide outlet 4735 and a second flow guide outlet 4739 (where applicable). This cross-sectional area of ​​the flow guide outlet 4740 is configured to be smaller than the cross-sectional area of ​​the inlet 4220 of the housing 4200. In the illustrated embodiment, all gas entering the gasket module 4010 enters through the inlet 4220, and, except for accidental leaks, substantially all gas leaving the gasket module 4010 exits through the outlet 4210. The inlet 4220 is located in the first chamber 4014, the outlet 4210 is located in the second chamber 4016, and the only flow path through the partition walls 4700 separating these chambers passes through one or more flow guides 4730. Therefore, the cross-sectional area of ​​the guide outlet 4740 is reduced compared to the inlet 4220 of the housing 4200. This creates a flow restriction, which accelerates the gas flow through the one or more guides 4730 as pressurized gas flows into the first chamber 4014 of the gasket module 4010 through the inlet 4220, passes through one or more guides 4730, and then flows into the second chamber 4016 to exit the gasket module 4010 through the outlet 4210. The reduced cross-sectional area in the flow path creates a pressure drop, which accelerates the gas flow into the second chamber 4016. The following paragraphs explain the importance of this gas flow acceleration.

[0429] In the illustrated embodiment, the flow restriction mentioned above is formed by a flow deflector outlet 4740 whose cross-sectional area is smaller than that of the inlet 4220 of the housing 4200. However, the inventors envision that this flow restriction could be applied elsewhere in one or more flow deflectors 4730.

[0430] In the illustrated embodiment of the patient interface 4000, the ratio of the cross-sectional area of ​​the first flow guide outlet 4735 to the cross-sectional area of ​​the second flow guide outlet 4739 is 1:1, meaning that the cross-sectional areas of the two flow guide outlets are equal. However, in an alternative embodiment, the cross-sectional area of ​​the first flow guide outlet 4735 may not be equal to the cross-sectional area of ​​the second flow guide outlet 4739. The ratio of the cross-sectional area of ​​the first flow guide outlet 4735 to the cross-sectional area of ​​the second flow guide outlet 4739 may range from 1:1.1 to 1:4. In one configuration, the ratio of the cross-sectional area of ​​the first flow guide outlet 4735 to the cross-sectional area of ​​the second flow guide outlet 4739 is 1:3.

[0431] Additionally, in the illustrated embodiment, the first guide vane 4732 and / or the second guide vane 4736 each include a gradually tapering cross-sectional area from the first guide vane inlet 4733 to the first guide vane outlet 4735 and from the second guide vane inlet 4737 to the second guide vane outlet 4739, respectively. This gradually tapering cross-sectional area can help accelerate the gas flow through the first guide vane 4732 and / or the second guide vane 4736.

[0432] As a complement or alternative to different guide vane outlet cross-sectional areas, the shape and / or size of the first guide vane 4732 and the second guide vane 4736 may differ in at least one aspect (such as guide vane diameter, length, or shape). Such a configuration in which the first guide vane 4732 and the second guide vane 4736 have different shapes and / or sizes can be described as having an asymmetrical first guide vane 4732 and the second guide vane 4736.

[0433] For illustrative purposes, see reference. Figure 53 and Figure 54 The patient interface 4000 is shown in cross-section along line H-H' as it is assembled onto the anatomical model of the patient (also shown in cross-section). Figure 53 In the illustration, the patient interface 4000 is depicted as being fitted onto the patient with their mouth open. Figure 54 In this illustration, the patient interface 4000 is shown fitted onto a patient with their mouth closed. Arrows indicate the direction of gas flow into the pad module 4010 through inlet 4220 and out of the pad module 4010 through outlet 4210, at which point the pad module is fitted onto the patient and the patient is not breathing. The relative size of the arrows should not be interpreted as an indication of gas flow rate or velocity. It should be understood that additional gas flow paths are formed during respiration, in addition to those described above. However, for illustrative purposes, it is assumed that the general operation of the patient interface 4000 can be adequately described while ignoring respiration, as the effect of the patient interface 4000 is considered most significant at the end of the expiratory cycle (which can be figuratively compared to a situation where there is no breathing).

[0434] When the patient interface 4000 is fitted onto a patient, one or more drain outlets 4730 are positioned such that the drain outlet 4740 is located below or adjacent to the patient's upper lip, or immediately adjacent to or adjacent to one or more of the patient's nostrils. In other words, the drain outlet 4740 is located below, adjacent to, or close to one or more of the patient's nostrils.

[0435] More specifically, in the embodiment including a first drain outlet 4735 and a second drain outlet 4739, the first drain outlet 4735 is configured to be positioned below the first nostril in the patient's nostril and adjacent to the patient's upper lip, or positioned immediately adjacent to the first nostril in the patient's nostril, while the second drain outlet 4739 is configured to be positioned below the second nostril in the patient's nostril and adjacent to the patient's upper lip, or positioned immediately adjacent to the second nostril in the patient's nostril.

[0436] refer to Figure 53 The patient interface 4000 is fitted onto the patient with their mouth open and not breathing, and pressurized gas is delivered to the patient interface 4000 via a conduit connector 1300. The pressurized gas flows through inlet 4220 into the first chamber 4014 of the liner module 4010. The pressurized gas in the first chamber 4014 then: (1) flows through one or more diffusers 4730 and into the second chamber 4016; or (2) flows through the patient's mouth into the patient's oral cavity, through the patient's throat into the patient's nasal cavity, out of the patient's nostrils, and into the second chamber 4016. Excess pressurized gas and / or gas from the patient's airway then flows out of the second chamber 4016 through outlet 4210 of the liner module 4010 to discharge from the liner module 4010. The partition wall 4700, the first chamber 4014, the second chamber 4016, and one or more flow deflectors 4730 that allow flow between the first chamber 4014 and the second chamber 4016 thus form the first and second effective flow paths mentioned above from the inlet 4220 of the liner module 4010 to the outlet 4210 of the liner module 4010.

[0437] A first effective flow path extends from the inlet 4220 of the liner module, through the first chamber 4014 of the liner module 4010, into the patient's oral cavity through the mouth, through the patient's throat into the patient's nasal cavity, into a second chamber 4016 through one or more of the patient's nostrils, and out of the liner module 4010 through the outlet 4210. It is believed that this unidirectional gas flow entering the patient's oral cavity and exiting through the nasal cavity will cause flushing of at least a portion of the anatomical dead space in the patient's oral cavity, throat, and nasal cavity.

[0438] A second effective flow path extends from the inlet 4220 of the liner module into the first chamber 4014 via one or more diverters 4730, wherein it is believed that accelerating the gas will likely allow at least some gas flow to enter the patient's nasal cavity through one or more nostrils, then decelerate and / or change direction and exit the nasal cavity through one or more nostrils into the second chamber 4016, and exit the liner module 4010 through the outlet 4210. It is also anticipated that some gas will flow through one or more diverters 4730 and into the second chamber 4016 without entering the patient's nasal cavity. It is believed that guiding the gas flow through one or more diverters 4730 is essential for allowing at least some gas flow to enter the patient's nasal cavity through one or more nostrils and then decelerate and / or change direction and exit the nasal cavity; these diverters are configured to accelerate the gas flow and are configured to be positioned below the patient's nostrils and adjacent to the patient's upper lip, or positioned immediately adjacent to the patient's nostrils. It is believed that this portion of the gas flow entering the nasal cavity will cause flushing of a portion of the anatomical dead space in the patient's nasal cavity.

[0439] refer to Figure 54 The patient interface 4000 is fitted to the patient with their mouth closed and no breathing, and pressurized gas is delivered to the patient interface 4000 via a catheter connector 1300. The pressurized gas flow enters the first chamber 4014 of the liner module 4010 through inlet 4220. The pressurized gas from the first chamber 4014 then flows through one or more diffusers 4730 and into the second chamber 4016. Excess pressurized gas and / or gas from the patient's airway then exits the second chamber 4016 through outlet 4210 of the liner module 4010 to discharge from the liner module 4010. Because the patient's mouth is closed, only a second effective flow path is formed. The second effective flow path is discussed in detail in the paragraph immediately preceding this one.

[0440] Since gas flows through both the first and second effective flow paths are believed to induce anatomical dead space flushing to some extent, the Patient Interface 4000 is believed to offer significant benefits beyond conventional non-invasive ventilation masks. In NIV therapy, the ability to provide pressure support while the patient's mouth is open or closed, while simultaneously flushing the dead space, is advantageous.

[0441] In the preceding paragraphs, the expected benefits of anatomical dead space flushing of the patient as a patient interface 4000 have been discussed. The patient's anatomical dead space consists of the total volume of the patient's airway segments responsible for guiding air to the alveoli and respiratory bronchioles, but not involved in the gas exchange process itself. Therefore, the anatomical dead space is the total volume of the airway from the patient's nose or mouth to the terminal bronchioles (including the oral cavity, nasal cavity, and pharynx, also known as the larynx).

[0442] During a patient's breathing, air with a lower CO2 content is inhaled into the lungs, and air with a higher CO2 content is exhaled. At the end of the expiratory cycle, some of the exhaled air with a higher CO2 content remains in the patient's anatomical dead space. This air with a higher CO2 content is then inhaled or rebreathed in the next respiratory cycle. Rebreathing this air with a higher CO2 content reduces the efficiency of gas exchange occurring within the patient's lungs.

[0443] Dead space flushing replaces at least a portion of the exhaled, CO2-rich air present in the patient's anatomical dead space with fresh, low-CO2 air, so that in the next inspiratory cycle, the reduced amount of exhaled, CO2-rich air is inhaled or rebreathed. Rebreathing the reduced CO2-rich air increases the efficiency of gas exchange occurring in the patient's lungs.

[0444] As discussed in the preceding paragraphs, the cross-sectional area of ​​the flow deflector outlet 4740 is configured to be smaller than the cross-sectional area of ​​the inlet 4220 of the housing 4200. The smaller cross-sectional area of ​​the flow deflector outlet 4740 compared to the inlet 4220 of the housing 4200 creates a flow restriction that accelerates gas flow. However, it should be understood that in alternative embodiments, the flow restriction may be applied anywhere within one or more flow deflectors 4730 to accelerate gas flow through one or more flow deflectors 4730 as desired.

[0445] In an alternative embodiment, the flow resistance at the outlet 4210 of the gasket module 4010 is configured to be lower than the flow resistance through one or more flow deflectors 4730. This difference in flow resistance is configured to create a pressure differential between the first chamber 4014 and the second chamber 4016, wherein the pressure in the second chamber 4016 during use is configured to be lower than that in the first chamber 4014.

[0446] It is believed that during use, when the patient's mouth is open and pressurized gas is supplied to the first chamber 4014 of the liner module 4010, the gas flows along a first effective path, i.e. from the first chamber 4014 through the patient's mouth, through the throat, into the nasal cavity, out of the nasal cavity through the nostrils, and into the second chamber 4016, which can be facilitated by the pressure difference of the structure.

[0447] It should be understood that although the pressure differential described in the above configuration is achieved by constructing flow resistance through outlet 4210, it is conceivable that any suitable method for generating a lower pressure in the second chamber 4016 than in the first chamber 4014 could be incorporated into yet another alternative configuration.

[0448] refer to Figures 55 to 68 The diagram illustrates a fifth embodiment of a patient interface 5000. Patient interface 5000 is a variation of patient interface 4000 and, unless otherwise stated, includes all the components and functions of patient interface 4000. Features of patient interface 5000 that are identical to those of patient interface 4000 are indicated using the same reference numerals, but with the first digit being "5" instead of "4".

[0449] Patient interface 5000 differs from patient interface 4000 in that all features and functions of the partition wall 4700 of patient interface 4000 are integrated into the partition wall insert 570 of patient interface 5000. The partition wall insert 570 is manufactured separately from the seal 5100 and housing 5200 and is configured to be permanently or removably inserted into the liner module 5010 after manufacturing. In other words, the partition wall insert 570 is not integrally formed with the seal 5100, housing 5200, or the liner module 5010 formed by both.

[0450] However, the partition wall insert 570 and the housing 5200 may be formed separately, and the partition wall insert 570 may subsequently be attached to the housing 5200 before the seal 5100 is overmolded to the housing 5200 and / or the partition wall insert 570.

[0451] The partition wall insert 570 includes a partition wall 5700. When the partition wall insert 570 is inserted into the pad module 5010, the partition wall 5700, like the partition wall 4700 of the patient interface 4000, traverses the cavity 5012 of the pad module 5010 and divides it into a first chamber 5014 and a second chamber 5016. The partition wall 5700 intersects with and separates the sealing opening 5110 to form an oral opening 5114 and a nasal opening 5116. The oral opening 5114 enters the first chamber 5014, and the nasal opening 5116 enters the second chamber 5016.

[0452] The partition wall 5700 of the partition wall insert 570 includes an outer periphery 5705, the shape of which is designed to substantially match the internal geometry of the padding module 5010. In the illustrated embodiment, the outer periphery 5705 contacts both the housing 5200 and the seal 5100 to adequately seal the first chamber 5014 and the second chamber 5016. This restricts and / or prevents gas flow between the outer periphery 5705 of the partition wall 5700 and the housing 5200 and / or the seal 5100, between the first chamber 5014 and the second chamber 5016.

[0453] It should be understood that different levels of acceptable gas flow will exist between the outer periphery 5705 of the partition wall 5700 and the housing 5200 and / or seal 5100, from the first chamber 5014 to the second chamber 5016. If low to medium gas flow rates are acceptable, the outer periphery 5705 of the partition wall 5700 may be configured to abut against the housing 5200 and / or seal 5100 within the gasket module 5010 to restrict gas flow between the first chamber 5014 and the second chamber 5016. Alternatively, the outer periphery 5705 may even be spaced apart from the housing 5200 and / or seal 5100 to allow for limited flow between them. If a minimum gas flow rate between the partition wall 5700 and the housing 5200 and / or seal 5100 is acceptable, the outer periphery 5705 may include flanges, lips, gaskets, or other sealing structures to abut against the housing 5200 and / or seal 5100 and form a substantially airtight seal. If it is acceptable that there is substantially no gas flow between the partition wall 5700 and the housing 5200 and / or the seal 5100, the outer periphery 5705 may be adhered, chemically bonded or mechanically connected (such as by means of lip and groove arrangement) to the housing 5200 and / or the seal 5100 to form an airtight seal around the periphery 5705 of the partition wall 5700.

[0454] The illustrated partition wall insert 570 is configured to insert into the gasket module 5010 and is removably or permanently connected to the housing 5200 via connector 5750. However, it should be understood that, as described above, additional connections may exist between the partition wall insert 570 and the gasket module 5010. For example, a connection may exist between the outer perimeter 5705 and the housing 5200 and / or the seal 5100.

[0455] The partition wall insert 570 includes a connector 5750 configured for complementary connection with the housing 5200. The connection can be removably or permanently made. In the illustrated embodiment, connector 5750 takes the form of sleeve 5755. The sleeve is configured to be removably connected to the outer surface of the sleeve 5230 of the housing 5200. The connection to the housing 5200 can be a removable interference fit or a tapered fit. This outer surface is located within the gasket module 5010, specifically within the first chamber 5014. For example, the connection can be... Figure 63 As seen in the image, the partition wall insert 570 can be removably connected to the patient interface 5000, thereby converting it between a single-chamber patient interface and a dual-chamber patient interface.

[0456] Alternatively, the sleeve 5755 of connector 5750 may be permanently connected to the sleeve 5230 of housing 5200. This can be a one-time connection in which patient interface 5000 can be converted from a single-chamber patient interface to a dual-chamber patient interface, but the partition wall insert 570 cannot be removed afterward. This may be necessary, for example, for patient safety.

[0457] It should be understood that once the partition wall insert 570 is inserted into the liner module 5010 and connected to the housing 5200 and / or the seal 5100, the function of the patient interface 5000 will be substantially the same as that of the patient interface 4000. Therefore, unless otherwise explicitly stated, the intended function of the patient interface 5000 in use will not be described here, but can be obtained from the paragraph above regarding the intended function of the patient interface 4000 in use.

[0458] The partition wall insert 570, being separate from and in some instances removable from the seal 5100 and housing 5200, offers at least two advantages. First, it reduces the molding complexity of the seal 5100 and / or housing 5200, as molding a single-chamber liner module is considered significantly less difficult than molding a dual-chamber liner module. Second, the partition wall insert 570 can be retrofitted into an existing single-chamber patient interface to convert a single-chamber patient interface 1000 into a dual-chamber patient interface 5000. Regarding the latter point, it is anticipated that the partition wall insert 570 can be sold separately to allow for the conversion of existing single-chamber patient interfaces into dual-chamber patient interfaces.

[0459] Now we will combine Figures 64 to 68 The specific structural features of the illustrated embodiment of the partition wall insert 570 are described.

[0460] Figure 64 A perspective view of a partition wall insert 570 is shown. The illustrated partition wall insert 570 includes a partition wall 5700, a connector 5750 attached to the partition wall 5700, and one or more flow deflectors 5730 extending from the partition wall 5700 and defining one or more gas flow paths through the partition wall 5700.

[0461] One or more flow deflectors 5730 include at least a first flow deflector inlet 5733 in fluid communication with a first chamber 5014 and a first flow deflector outlet 5735 in fluid communication with a second chamber 5016 to allow gas flow through partition wall 5700. In the illustrated embodiment, one or more flow deflectors 5730 include a single gas flow path through partition wall 5700.

[0462] In the illustrated embodiment, the partition wall 5700 includes a first flow deflector 5732 and a second flow deflector 5736. The first flow deflector 5732 includes a first flow deflector inlet 5733 in fluid communication with a first chamber 5014 and a first flow deflector outlet 5735 in fluid communication with a second chamber 5016. The second flow deflector 5736 includes a second flow deflector inlet 5737 in fluid communication with the first chamber 5014 and a second flow deflector outlet 5739 in fluid communication with the second chamber 5016.

[0463] In addition, similar to the patient interface 4000, when the patient interface 5000 is worn by a user, the first flow outlet 5735 and / or the second flow outlet 5739 are configured to be positioned near and / or pointing toward the user's nostrils to direct gas flow to the user's nostrils through one or more flow outlets 5730.

[0464] In the illustrated embodiment, the partition wall 5700 includes a rigid portion 5710 and an elastomeric portion 5711. A connector 5750 of the partition wall insert 570 is attached to the rigid portion 5710 and one or more flow deflectors 5730 extending from the elastomeric portion 5711 of the partition wall 5700. In the illustrated embodiment, the elastomeric portion 5711 is connected to the rigid portion 5710 via a flange on the elastomeric portion 5711, the flange being received within a flow channel on the rigid portion 5710. This allows for a removable mechanical connection. However, any suitable connection, such as overmolding, adhesive, chemical bonding, or alternative mechanical connections, can be used.

[0465] It is also conceivable that the partition wall 5700 and its sub-components may be formed entirely of rigid materials, entirely of elastomeric materials, or, as needed, by an alternative combination of both.

[0466] As described above, the illustrated partition wall 5700 includes an outer periphery 5705 that, once inserted into the gasket module 5010, contacts the seal 5100 and the housing 5200 to form a seal. In the illustrated embodiment, the outer periphery 5705 includes a thickened flange that provides an increased contact surface area to form an improved seal with the gasket module 5010. This flange provides the additional benefit of reduced contact pressure and helps distribute force over a larger area. Additionally, a portion of the outer periphery 5705 that bisectes the sealing opening 5110 is intended to contact the patient's upper lip during use; therefore, the flange can form an improved seal at the patient's upper lip and alleviate any discomfort by reducing contact pressure.

[0467] Optionally, but not illustrated, the elastomeric portion 5711 of the partition wall 5700 may include a deformable region 5720, which includes a thin region 5721 located between a first thickened region 5724 and a second thickened region 5726 to allow the partition wall 5700 to deform in a controlled manner within the thin region 5721 in response to forces applied to the partition wall 5700 during use. The terms "thin" and "thickened" refer to the wall thickness of the elastomeric portion 5711. The deformable region 5720 includes all the features and functions of the partition wall 4720 as described above with respect to the patient interface 4000.

[0468] In the illustrated embodiment, the partition wall insert 570 includes a first flow deflector 5732 and a second flow deflector 5736 of the same size and shape. The first flow deflector 5732 and the second flow deflector 5736 respectively incorporate all the features and functions of the first flow deflector 4732 and the second flow deflector 4736 as described above.

[0469] In an alternative embodiment, the first flow deflector 5732 and the second flow deflector 5736 may be asymmetrical, i.e., their shapes may be designed to be different from each other in at least one aspect, and may differ in at least one of, for example, height, width, thickness, inlet opening size, outlet opening size, or cross-sectional shape.

[0470] In some embodiments, the partition wall insert 570 may include one or more holes through the partition wall 5700 that provide intended restriction and pressure differential between the first chamber 5014 and the second chamber 5016. In these embodiments, these holes replace one or more flow guides 5730. Such holes may be aligned with the user's nostrils or may be located elsewhere on the partition wall 5700. However, these holes do not substantially direct gas flow into the patient's nostrils.

[0471] The advantage of having the partition wall insert 570 as a separate component from the liner module 5010 is that a series of partition wall inserts 570 can be provided, each including a different diffuser configuration. For example, these configurations may vary in the number of diffusers, diffuser size, diffuser shape, diffuser location, and / or diffuser material. For instance, these different configurations can be suitable for different purposes, such as different therapies, patients with different nostril sizes, and / or patients with different nasal cavity limitations.

[0472] In one embodiment, a series of partition wall inserts 570 are provided, which are diverters with different flow restrictions. A first partition wall insert 570 may have one or more diverters 5730 with relatively low flow restriction. A second partition wall insert 570 may have one or more diverters 5730 with relatively moderate flow restriction. A third partition wall insert 570 may have one or more diverters 5730 with relatively high flow restriction. The above are merely examples and not limitations. These may be provided individually or as a set. Depending on the patient's anatomy and ventilation requirements, a suitable partition wall insert 570 may be selected to adjust the amount of restriction through the partition wall 5700, thereby adjusting the flushing flow directed through the patient's mouth, around the back of the throat, and out of the nostrils to flush the patient's anatomical dead space at least at the end of the expiratory phase. This flushing mechanism has been described above with respect to the patient interface 4000 and is integrally incorporated herein with respect to the patient interface 5000.

[0473] In another embodiment, a series of partition wall inserts 570 will be provided, these partition wall inserts having an asymmetrical diffuser configuration. In such embodiments, the cross-sectional area of ​​the first diffuser outlet 5735 may not be equal to the cross-sectional area of ​​the second diffuser outlet 5739. One partition wall insert 570 may be provided with a diffuser outlet configured to align with the user's left nostril, which is larger than a diffuser outlet configured to align with the user's right nostril. The second partition wall insert 570 may have an arrangement opposite to this. Furthermore, a third partition wall insert 570 may be provided with only a single diffuser 5732 configured to align with the user's left nostril, and a fourth partition wall insert 570 may be provided with a single diffuser 5732 configured to align with the user's right nostril.

[0474] For unequal or asymmetrical flow deflectors, the ratio of the cross-sectional area of ​​the first flow deflector outlet 5735 to the cross-sectional area of ​​the second flow deflector outlet 5739 can be in the range of 1:1.1 to 1:4. In one configuration, the ratio of the cross-sectional area of ​​the first flow deflector outlet 5735 to the cross-sectional area of ​​the second flow deflector outlet 5739 is 1:3. The first flow deflector inlet 5733 and the second flow deflector inlet 5737 can have equal cross-sectional areas, or they can have different cross-sectional areas in the range of 1:1.1 to 1:4.

[0475] refer to Figures 69 to 78 The diagram illustrates a sixth embodiment of the patient interface 6000. The patient interface 6000 is a variation of the patient interface 6000 and, unless otherwise stated, includes all the components and functions of the patient interface 5000. Features of the patient interface 6000 that are identical to those of the patient interface 5000 are indicated using the same reference numerals, but with the first digit being "6" instead of "5".

[0476] The patient interface 6000 differs from the patient interface 5000 in that the seal 6100 is a full-face subnasal seal, and the partition wall insert 670 does not include the connector 6750. Instead, the partition wall insert 670 is configured to adhere, chemically bond, or mechanically attach to the housing 6200 and / or the seal 6100.

[0477] The seal 6100 is formed of a soft, elastic material, such as silicone or other suitable elastomer. The seal 6100 includes an oral cavity opening 6114 and a nasal cavity opening 6116. When fitted onto a patient, the oral cavity opening 6114 is configured to surround the patient's mouth. A patient contact surface 6120 surrounding the oral cavity opening 6114 forms a seal around the patient's mouth. The nasal cavity opening 6116 is configured to surround the patient's nostrils. A patient contact surface 6120 surrounding the nasal cavity opening 6116 forms a seal around the patient's nostrils. Therefore, high-pressure breathing gas can be delivered from the pad module 6010 to the patient's mouth and nostrils through the oral cavity opening 6114 and nasal cavity opening 6116, respectively.

[0478] Since the seal 6100 is a subnasal seal, which includes a nasal opening 6116 surrounding the user's nostrils but not receiving the user's nose, one or more diverters 6730 are positioned such that gas flowing through one or more diverters 6730 is directed to the nasal opening 6116 and, in some cases, such as when the patient's mouth is closed at the end of exhalation, flows through the nasal opening 6116 and into the patient's nostrils.

[0479] The seal 6100 is configured not to contact the user's bridge of the nose during use, and therefore has a different shape profile than the supranasal seal shown in the previous embodiment. Because the subnasal seal 6100 has a different shape than the seal 1100, the housing 6200 and frame 6400 include different profiles than the housing and frame shown in the previous embodiment. However, it should be understood that the function and features of the housing 6200 and frame 6400 are otherwise substantially identical to the function and features of the housing 1200 and frame 1400 of the general form of the patient interface 1000.

[0480] Furthermore, since the seal 6100 includes a portion of the patient contact surface 6120 that extends between the oral cavity opening 6114 and the nasal cavity opening 6116 and is configured to contact the patient's upper lip during use, the outer periphery 6705 of the partition wall 6700 contacts the seal 6100 and / or the housing 6200 throughout its entire periphery. In other words, the outer periphery 6705 of the partition wall 6700 is not configured to intersect with the opening of the seal 6100.

[0481] As mentioned above, a second difference between patient interface 6000 and patient interface 5000 is that the partition wall insert 670 does not include connector 6750, but is instead configured to be adhesively, chemically, or mechanically attached to housing 6200 and / or seal 6100. Like partition wall insert 570, partition wall insert 670 includes an outer periphery 6705 with a flange having increased thickness. For example, this flange creates an increased surface area on which adhesives or other bonding agents can be applied.

[0482] In the illustrated embodiment, it is anticipated that an adhesive or other chemical agent will be applied to the outer periphery 6705 of the partition wall 6700, and then the partition wall insert 670 will be inserted into the gasket module 6010. The outer periphery 6705 will contact the housing 6200 and the seal 6100 at the corresponding locations, thereby forming a permanent and hermetically sealed connection between the partition wall insert 670 and the gasket module 6010.

[0483] In an alternative embodiment, the outer periphery 6705 may be received within a channel or groove on the housing 6200 and / or the seal 6100 to mechanically attach the partition wall insert 670 to the gasket module 6010.

[0484] Similar to patient interface 5000, once the partition insert 670 is inserted into the liner module 6010 and adhered, bonded, or mechanically attached in place, the function of patient interface 6000 will be essentially identical to that of patient interface 4000, the only difference being that the seal 6100 seals the underside of the patient's nose and does not contact the bridge of the nose. As with patient interface 5000 above, the explanation of the intended function will not be repeated, and can be understood by referring to the published information of patient interface 4000.

[0485] It is also conceivable that a series of partition wall inserts 670 may be provided, each including different flow guide configurations as discussed above with respect to the patient interface 5000. These partition wall inserts may be supplied as a kit with the single-chamber patient interface 6000, and once the desired partition wall insert 670 has been identified, it may be adhered, bonded, or mechanically attached to the liner module 6010 to form a dual-chamber patient interface 6000 with the desired flow guide configuration.

[0486] Finally, a partition wall insert 670 configured to be adhered, bonded, or mechanically attached in place and not including a connector can be used with the supranasal patient interface 5000. Additionally, a partition wall insert 570 including a connector 5750 can be used with the subnasal patient interface 6000.

[0487] refer to Figures 79 to 87 The diagram illustrates a patient interface according to a seventh embodiment. Patient interface 7000 is a variation of patient interface 4000 and, unless otherwise stated, includes all the components and functions of patient interface 4000. Features of patient interface 7000 that are identical to those of patient interface 4000 are indicated using the same reference numerals, but with the first digit being "7" instead of "4".

[0488] Patient interface 7000 differs from patient interface 4000 in that all features and functions of one or more ductors 7730 are integrated into ductor insert 773, and the seal 7100 is a subnasal seal. The function and structure of the full-face subnasal seal and its effect on the shape of frame 1400 and housing 7200 have been described above with respect to seal 6100 and patient interface 6000, and are incorporated into seal 7100 and patient interface 7000 unless otherwise explicitly stated.

[0489] Similar to the liner module 4010, the liner module 7010 includes a partition wall 7700 that divides the cavity 7012 of the liner module 7010 into a first chamber 7014 and a second chamber 7016. The partition wall 7700 is connected to the housing 7200 and / or the seal 7100 around its outer periphery 7705 to separate the first chamber 7014 from the second chamber 7016. The partition wall 7700 is connected to the seal 7100 between the oral cavity opening 7114 and the nasal cavity opening 7116, such that the oral cavity opening 7114 opens to the first chamber 7014 and the nasal cavity opening 7116 opens to the second chamber 7016.

[0490] Aside from the fact that the nasal opening 4116 of patient interface 4000 surrounds the patient's nose and contacts the bridge of the nose, and the nasal opening 7116 of patient interface 7000 surrounds the patient's nostrils but does not contact the bridge of the nose, the intended functions of patient interfaces 4000 and 7000 are essentially the same in use. Therefore, it should be understood that the description of the operation of patient interface 4000 outlined above also applies here to patient interface 7000.

[0491] As mentioned above, the key difference in patient interface 7000 is that all features and functions of one or more diverters 4730 of patient interface 4000 are integrated into a removable diverter insert 773. The diverter insert 773 is a component separate from any of the seal 7100, housing 7200, and partition wall 7700. Partition wall 7700 includes a diverter aperture 7707 configured to removably or permanently receive the diverter insert 773.

[0492] In the illustrated embodiment, the flow guide insert 773 includes a flow channel around the periphery of the insert body 7731, the flow channel being configured to receive the edge of the flow guide aperture 7707 to removably attach the flow guide insert 773 to the partition wall 7700. For example, this connection may be... Figure 84 As seen in the image. In another embodiment, the diffuser insert 773 may be removably or permanently attached to the partition wall by any suitable mechanical connection, adhesive or chemical bond. For example, the diffuser insert 773 may include an external geometry configured to be received in the diffuser bore 7707 by a tapered or interference fit.

[0493] The flow guide insert 773 includes one or more flow guides 7730 extending from the insert body 7731. The one or more flow guides 7730 incorporate all the features and functions of one or more flow guides 4730. Therefore, the descriptions above regarding the features of the patient interface 4000 also apply here to the one or more flow guides 7730.

[0494] In the illustrated embodiment, the diffuser insert body 7731 and one or more diffusers 7730 comprise an elastomeric material and are integrally formed as a single component. The diffuser insert body 7731 is configured to be thicker than the surrounding portion of the partition wall 7700 to provide stability to the one or more diffusers 7730.

[0495] It should be understood that the diffuser insert body 7731 may alternatively be made of a rigid material such as plastic. In such cases, one or more diffusers 7730 may be made of the same rigid material, or may be made of an elastomeric material attached to the rigid diffuser insert body 7731.

[0496] Similar to the patient interface 5000, it is conceivable that the advantage of the nasal guide insert 773 being a component separate from the partition wall 7700 is that it allows for the provision of a series of nasal guide inserts, each comprising a different nasal guide configuration. For example, these configurations may vary in the number of nasal guides, nasal guide size, nasal guide shape, nasal guide location, and / or nasal guide material. For instance, these different configurations may be suitable for different therapies, patients with different nostril sizes, and / or patients with different nasal cavity limitations.

[0497] The preceding section describes a series of partition wall inserts 570 for the patient interface 5000, outlining various possible flow guide configurations that are integrated here as a choice for combination with the patient interface 7000 (as a series of flow guide inserts 773). Furthermore, regarding... Figures 88 to 93 Three exemplary configurations are illustrated.

[0498] Figure 88 A first flow guide insert 773 is shown, comprising a first flow guide 7732 and a second flow guide 7736. When the flow guide insert 773 is attached to the partition wall 7700, the first flow guide 7732 includes a first flow guide inlet 7733 in fluid communication with a first chamber 7014 and a first flow guide outlet 7735 in fluid communication with a second chamber 7016. When the flow guide insert 773 is attached to the partition wall 7700, the second flow guide 7736 includes a second flow guide inlet 7737 in fluid communication with the first chamber 7014 and a second flow guide outlet 7739 in fluid communication with the second chamber 7016.

[0499] The first diffuser 7732 and the second diffuser 7736 are of equal and symmetrical dimensions. Each includes a diffuser outlet smaller than the corresponding diffuser inlet, and the cross-sectional area generally tapers from the diffuser inlet to the diffuser outlet. It is believed that this will direct and / or accelerate the gas flow through the first diffuser 7732 and the second diffuser 7736 toward the nasal opening 7116.

[0500] Figure 90 A second alternative flow guide insert 873 is shown, comprising a single flow guide 8732 that, when attached to the partition wall 7700, includes a first flow guide inlet 8733 in fluid communication with the first chamber 7014 and a first flow guide outlet 8735 in fluid communication with the second chamber 7016. The flow guide insert 873 also includes one or more flow guide holes 8745 extending through the flow guide insert body 8731. It is believed that, in the event of removal of the second flow guide, this additional flow path through the partition wall 7700 via the flow guide insert 873 may be necessary to achieve a desired pressure differential between the first chamber 7014 and the second chamber 7016.

[0501] Figure 92 A third alternative flow guide insert 973 is shown, which includes a first flow guide 9732 and a second flow guide 9734. When the flow guide insert 973 is attached to the partition wall 7700, the first flow guide 9732 includes a first flow guide inlet 9733 in fluid communication with a first chamber 7014 and a first flow guide outlet 9735 in fluid communication with a second chamber 7016. When the flow guide insert 973 is attached to the partition wall 7700, the second flow guide 9736 includes a second flow guide inlet 9735 in fluid communication with the first chamber 7014 and a second flow guide outlet 9739 in fluid communication with the second chamber 7016.

[0502] One or more flow deflectors 9730 are asymmetrical, wherein the ratio of the cross-sectional area of ​​the first flow deflector outlet 9735 to the cross-sectional area of ​​the second flow deflector outlet 9739 is in the range of 1:1.1 to 1:4. In the illustrated configuration, the ratio of the cross-sectional area of ​​the first flow deflector outlet 9735 to the cross-sectional area of ​​the second flow deflector outlet 9739 is 1:3. The first flow deflector inlet 9733 and the second flow deflector inlet 9737 may have equal cross-sectional areas, or they may have different cross-sectional areas in the range of 1:1.1 to 1:4.

[0503] The flow guide insert 973 also includes one or more flow guide holes 9745 extending through the flow guide insert body 9731. It is believed that this additional flow path through the partition wall 9700 may be necessary to achieve the desired pressure differential between the first chamber 7014 and the second chamber 7016 when the cross-sectional area of ​​the second flow guide outlet 9737 is reduced.

[0504] It should be understood that one or more flow guide orifices 8745, 9745 may be implemented in any suitable portion of the partition walls 4700, 5700, or 6700 in any of the patient interfaces 4000, 5000, and 6000, respectively, to achieve a desired pressure differential across the partition walls 4700, 5700, and 6700 between the first chambers 4014, 5014, and 6014 and the second chambers 4016, 5016, and 6016. As specifically described in the description relating to the patient interface 4000, this pressure differential is believed to cause, to some extent, anatomical dead space flushing, which is thought to enter through the oral cavity and exit through the nasal cavity at least during mouth-open breathing.

[0505] In the appended claims and in the foregoing description, unless the context requires otherwise by explicit language or necessary meaning, the term "stud" will be used interchangeably with "pillow." The applicant intends that the described or claimed "sealing stud" be used interchangeably with "nose pillow," "pillow seal," or "pillow."

[0506] Those skilled in the art will understand that many variations and modifications can be made to the preferred embodiments without departing from the spirit and scope of the invention.

[0507] In the appended claims and in the foregoing description, unless the context requires otherwise due to explicit language or necessary meaning, the word “comprising” and its variations are used in an inclusive sense, i.e., to specify the presence of the said feature, but not to exclude the presence or addition of further features in various embodiments of the apparatus and methods disclosed herein.

[0508] In the foregoing description of the preferred embodiments, specific terminology has been used for clarity. However, the invention is not intended to be limited to the specific terminology chosen, and it should be understood that each specific term includes all technical equivalents that operate in a similar manner to achieve similar technical purposes. Terms such as “front” and “back”, “inner” and “outer”, “above”, “below”, “top”, “bottom”, “upper” and “lower”, “lower side” and “top side”, “vertical” and “horizontal” are used as convenient terms to provide a point of reference and should not be construed as limiting terms. When used throughout the specification (including the claims) to refer to the patient interface, these terms refer to an orientation relative to the normal operating orientation, i.e., when the interface is fitted onto the patient and the patient’s head is upright.

[0509] Throughout the specification and claims, terms such as “connected,” “linked,” and “joined” should not be interpreted as requiring two separate components to be joined together. These terms should be interpreted according to the context, including referring to the intersection of integrally formed features. For example, in the fourth embodiment, the partition wall is connected to the outer wall, but in this embodiment they are integrally formed.

[0510] Furthermore, the invention has been described in conjunction with embodiments currently considered to be the most practical and preferred. It should be understood that the invention is not limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Moreover, the various embodiments described above can be implemented in combination with other embodiments; for example, aspects of one embodiment can be combined with aspects of another embodiment to implement yet more embodiments. Furthermore, each individual feature or component of any given component can constitute an additional embodiment.

Claims

1. A pad module for delivering positive pressure ventilation therapy to a user, the pad module comprising: A seal for forming a seal around the user's mouth and nostrils; A housing connected to the seal, the housing and the seal forming a cavity configured to receive a pressurized gas flow; At least one opening in the seal, the at least one opening being used to communicate the pressurized gas with the user; The pressurized gas is received into the cavity through the inlet; The gas is discharged from the gasket module through the outlet. and An exhaust duct, configured to draw gas from the user's nostrils through at least one exhaust duct inlet and direct it to the outlet of the pad module.

2. A pad module for delivering positive pressure ventilation therapy to a user, the pad module comprising: A seal for forming a seal around the user's mouth and nostrils; A housing connected to the seal, the housing and the seal forming a cavity configured to receive a pressurized gas flow; At least one opening in the seal, the at least one opening being used to communicate the pressurized gas with the user; An inlet for receiving pressurized gas into the cavity; An outlet, wherein the outlet is used to discharge gas from the gasket module; and An exhaust duct is located within the cavity and has at least one exhaust duct inlet through which gas is received into the exhaust duct, and the exhaust duct extends from the at least one exhaust duct inlet to the outlet of the gasket module.

3. The padding module according to claim 1 or 2, wherein each exhaust duct inlet is configured to be located in one or more nostrils of the user, or located below or adjacent to the upper part of the user's lips.

4. The gasket module according to any one of claims 1 to 3, wherein the cross-sectional area of ​​the at least one exhaust duct inlet is smaller than the cross-sectional area of ​​the inlet, such that the gas entering the exhaust duct is accelerated as it flows from the cavity into the exhaust duct.

5. The liner module according to any one of claims 1 to 4, wherein the exhaust duct and the at least one exhaust duct inlet are configured to accelerate the gas as it flows from the cavity into the exhaust duct and to bring ambient gas into the exhaust duct.

6. The padding module according to any one of claims 1 to 5, wherein when the at least one exhaust duct inlet is positioned in the user's nostril or in the corresponding nostril, or positioned below the user's nostril and adjacent to the user's upper lip, bringing ambient gas into the exhaust duct will carry away breathing gas from the user's nostril or the corresponding nostril.

7. The pad module according to any one of claims 1 to 6, wherein the at least one opening of the seal comprises a first opening covering the user's mouth and a second opening covering the user's nostrils.

8. The pad module according to any one of claims 1 to 7, wherein the exhaust conduit is further configured to direct exhaled gas from the user's mouth and / or nostrils and / or excess gas from the cavity to the outlet, and is configured to discharge the exhaled gas from the user's mouth and / or nostrils and / or excess gas from the cavity from the pad module.

9. The gasket module according to any one of claims 1 to 8, wherein the exhaust duct is adjustablely mounted to the housing, enabling adjustment of its orientation and / or position relative to the seal.

10. The gasket module according to any one of claims 1 to 9, wherein the exhaust duct is a closed channel extending from the at least one exhaust duct inlet to the outlet.

11. The gasket module according to any one of claims 1 to 10, wherein the exhaust duct is configured to prevent gas from flowing into the cavity except through the at least one exhaust duct inlet, and to prevent gas from flowing out of the cavity.

12. The gasket module according to any one of claims 1 to 11, wherein the exhaust duct is surrounded by the cavity.

13. The gasket module according to any one of claims 1 to 11, wherein the exhaust duct is a structure separate from the seal.

14. The gasket module according to any one of claims 1 to 12, wherein the exhaust duct comprises at least one insert, and wherein the at least one exhaust duct inlet is located at the free end of the at least one insert.

15. The padding module of claim 14, wherein the at least one insert is configured to extend into one or the corresponding nostril of the user.

16. The padding module of claim 14 or 15, wherein the at least one insert is a sealing insert configured to form a seal with the user’s nostril or the corresponding nostril.

17. The liner module according to any one of claims 14 to 16, wherein the at least one insert is formed of an elastomeric material.

18. The padding module of claim 17, wherein the elastomer material is silicone resin.

19. The padding module of claim 14, wherein the at least one exhaust duct inlet comprises a first exhaust duct inlet and a second exhaust duct inlet, the first exhaust duct inlet being configured to be located within a first nostril of the user's nostril or located below the first nostril of the user's nostril and adjacent to the upper part of the user's lips, and the second exhaust duct inlet being configured to be located within a second nostril of the user's nostril or located below the second nostril of the user's nostril and adjacent to the upper part of the user's lips.

20. The gasket module of claim 19, wherein the at least one insert comprises a first insert and a second insert, the first exhaust duct inlet is located at the free end of the first insert, and the second exhaust duct inlet is located at the free end of the second insert.

21. The padding module of claim 20, wherein the first insert is configured to extend into the user's first nostril, and the second insert is configured to extend into the user's second nostril.

22. The gasket module of claim 20, wherein the exhaust duct further comprises a manifold, and the first post and the second post extend from the manifold.

23. The gasket module of claim 20, wherein at least a portion of the exhaust duct is flexible to allow adjustment of the positions of the first and second inserts.

24. The gasket module according to any one of claims 19 to 24, wherein the first exhaust duct inlet and the second exhaust duct inlet have different cross-sectional areas.

25. The gasket module of claim 24, wherein the ratio of the cross-sectional area of ​​the first exhaust duct inlet to the cross-sectional area of ​​the second exhaust duct inlet is between 1:1.1 and 1:

4.

26. The gasket module of claim 25, wherein the ratio of the cross-sectional area of ​​the first exhaust duct inlet to the cross-sectional area of ​​the second exhaust duct inlet is 1:

3.

27. The pad module of claim 19 or 20, wherein at least a portion of the exhaust conduit is incorporated into the nasal interface, the nasal interface comprising a flushing conduit having at least one flushing conduit inlet and at least one flushing conduit outlet, the at least one flushing conduit inlet being in the cavity, and the at least one flushing conduit outlet being located at or adjacent to at least one of the first exhaust conduit inlet or the second exhaust conduit inlet.

28. The padding module according to claim 27, which is dependent on claim 19, wherein each of the first and second inserts is a sealing insert configured to form a seal with a corresponding nostril in the user's nostril.

29. The liner module according to claim 27 or 28, wherein the flushing conduit has a first flushing conduit outlet and a second flushing conduit outlet, the first flushing conduit outlet being located at or near the first exhaust conduit inlet, and the second flushing conduit outlet being located at or near the second exhaust conduit inlet.

30. The pad module according to any one of claims 27 to 29, wherein the flushing conduit is configured to guide gas from the cavity into one of the user's nostrils or the corresponding nostril.

31. The pad module according to any one of claims 27 to 30, wherein the flushing conduit is configured to accelerate gas flow from the at least one flushing conduit inlet to the first flushing conduit outlet and the second flushing conduit outlet, and to direct the accelerated gas into the respective nostrils of the user.

32. The pad module according to any one of claims 27 to 31, wherein the first post and the second post are formed of an elastomeric material.

33. The padding module of claim 32, wherein the elastomer material is silicone resin.

34. The gasket module according to any of the preceding claims, wherein the outlet of the gasket module is in fluid communication with the filter such that gas exiting the gasket module through the outlet will pass through the filter.

35. The liner module of claim 34, wherein the filter is located outside the liner module.

36. The liner module of claim 34 or 35, wherein the filter is attached to the liner module.

37. The gasket module according to any of the preceding claims, wherein the outlet of the gasket module includes a deflector vent.

38. The liner module according to any of the preceding claims, wherein the outlet of the liner module is configured to be connected to or in fluid communication with the expiratory conduit.

39. The gasket module according to claim 37 or 38, wherein the deflection vent includes a plurality of holes.

40. The gasket module according to any of the preceding claims, wherein the gasket module is configured to receive only the pressurized gas flow through the inlet and discharge gas only through the outlet.

41. The padding module according to any one of claims 1 to 39, wherein the padding module further comprises a supplemental deflection vent, the supplemental deflection vent being in fluid communication with the cavity.

42. The gasket module of claim 40, wherein the supplemental deflection vent is configured to have a flow rate less than the flow rate through the outlet of the gasket module during use.

43. The gasket module of claim 40 or 41, wherein the supplemental deflection vent is configured to have a flow resistance in use that is greater than the flow resistance through the outlet of the gasket module.

44. The gasket module according to any one of claims 40 to 42, wherein the supplemental deflection vent includes at least one hole having a cross-sectional area, and the cross-sectional area of ​​the at least one hole is smaller than the cross-sectional area of ​​the outlet of the gasket module.

45. The gasket module according to any of the preceding claims, wherein the housing comprises a plastic material, and wherein the seal comprises an elastomeric material.

46. ​​The gasket module of claim 44, wherein the plastic material is polycarbonate and the elastomer material is silicone.

47. The gasket module according to any of the preceding claims, wherein the seal and the housing are connected by a mechanical connection.

48. The gasket module according to any of the preceding claims, wherein the housing includes the gasket module inlet.

49. The gasket module according to any of the preceding claims, wherein the housing includes the gasket module outlet.

50. The gasket module according to any one of claims 1 to 47, wherein the seal includes the outlet of the gasket module.

51. The gasket module according to any one of claims 1 to 46, wherein the seal includes the gasket module inlet.

52. The pad module according to any of the preceding claims, wherein the seal is a full-face nasal seal configured to form a seal at the user's bridge of the nose during use.

53. The pad module according to any one of claims 1 to 51, wherein the seal is a full-face subnasal seal, the full-face subnasal seal being configured not to form a seal at the user's bridge of the nose during use.

54. The pad module according to any one of claims 1 to 51, wherein the seal is a full-face seal configured to form a seal around the user's mouth, nose and eyes during use.

55. The padding module according to any one of claims 1 to 51, wherein the seal is a helmet seal configured to form a seal at the user's neck during use.

56. A patient interface comprising a padding module according to any preceding claim, wherein the patient interface further comprises a frame configured to attach to the padding module, the frame including a plurality of headgear connectors configured to connect to a headgear for holding the patient interface on a user's face in use.

57. The patient interface of claim 56, wherein the patient interface further comprises a catheter connector configured to connect to the inlet of the liner module, the catheter connector including an anti-asphyxiation valve and a pressure port, and the catheter connector further configured to be removably attached to a respiratory therapy catheter.

58. The patient interface of claim 57, wherein the catheter connector is configured to connect to a single-limb breathing circuit.

59. The patient interface of claim 57, wherein the catheter connector is configured to connect to a bilimb breathing circuit.

60. The patient interface of claim 59, wherein the catheter connector is configured to connect to the bilimb breathing circuit via a Y-shaped element.

61. A patient interface for delivering positive pressure breathing therapy to a user, the patient interface comprising: (a) A padding module defining a first chamber configured to be pressurized, the padding module comprising: an inlet configured to receive a flow of pressurized gas into the chamber; an opening configured to cover the mouth and nostrils of the user to communicate the pressurized gas with the user; and an outlet configured to discharge gas to the outside of the padding module; (b) An exhaust duct located within the first cavity, the exhaust duct extending from the outlet of the liner module to at least one exhaust duct inlet, the at least one exhaust duct inlet being configured to be positioned within one of the user's nostrils or a first nostril in a corresponding nostril. The exhaust duct includes at least one post configured to form a seal with the user’s nostril or the first nostril in the corresponding nostril, and the exhaust duct inlet is located at the free end of the at least one post.

62. A patient interface for delivering positive pressure breathing therapy to a user, the patient interface comprising: (a) A padding module defining a first chamber configured to be pressurized, the padding module comprising: an inlet configured to receive a flow of pressurized gas into the chamber; an opening configured to cover the mouth and nostrils of the user to communicate pressurized gas with the user; and an outlet configured to discharge gas to the outside of the padding module; (b) An exhaust duct located within the first cavity, the exhaust duct extending from the outlet of the pad module to a first exhaust duct inlet and a second exhaust duct inlet, the first exhaust duct inlet being configured to be positioned within a first nostril in the user's nostril, and the second exhaust duct inlet being configured to be positioned within a second nostril in the user's nostril.

63. A pad module for delivering positive pressure ventilation therapy to a user, the pad module comprising: (a) A cavity for delivering breathing gas to the user's mouth and nostrils; and (b) An exhaust duct for conveying exhaled air from the user's mouth and / or nostrils and / or excess breathing air from the cavity to the outside of the liner module. The exhaust duct is configured to accelerate breathing gas as it flows from the cavity into the exhaust duct.

64. A non-invasive patient interface configured to form a seal around a patient's mouth and nostrils, the patient interface comprising: (a) An outer wall defining an internal cavity, the internal cavity including a first chamber and a second chamber, the first chamber having an oral cavity opening for communicating gas with the mouth, and the second chamber having a nasal cavity opening for communicating gas with the nostrils; and (b) A partition wall that separates the first chamber from the second chamber; and (c) One or more flow deflectors, the one or more flow deflectors enabling gas to flow from the first chamber into the second chamber, and the one or more flow deflectors being configured to direct the gas flow into the nostril; and The outer wall is configured to extend above the patient's nasal bridge.

65. A non-invasive patient interface configured to form a seal around a patient's mouth and nostrils, the patient interface comprising: (a) An outer wall defining an internal cavity of the patient interface, the outer wall having a patient contact surface including an oral cavity opening communicating gas with the mouth and a nasal cavity opening communicating gas with the nostrils; and (b) A partition wall that divides the internal cavity into a first chamber having the oral cavity opening and a second chamber having the nasal cavity opening; and (c) One or more flow deflectors extending from the partition wall, the one or more flow deflectors enabling gas to flow from the first chamber into the second chamber, and the one or more flow deflectors being configured to direct the gas flow into the nostrils; and The flow guides are spaced apart by spacer elements, which maintain the spacing between the flow guides; and The patient contact surface is engaged with the patient's nasal bridge.

66. A non-invasive patient interface configured to form a seal around a patient's mouth and nostrils, the patient interface comprising: (a) An outer wall defining an internal cavity of the patient interface, the outer wall having an oral cavity opening communicating gas with the mouth and a nasal cavity opening communicating gas with the nostrils; (b) a partition wall that divides the internal cavity into a first chamber having the oral cavity opening and a second chamber having the nasal cavity opening; and The partition wall includes one or more spaced-apart deflectors that allow gas to flow from the first chamber into the second chamber, and the spaced-apart deflectors are configured to direct the gas flow into the nostrils. and The outer wall thereunder is joined to the patient's nasal bridge.

67. A patient interface for delivering positive pressure breathing therapy to a user, the patient interface comprising: A gasket module, the gasket module including a seal and a housing, the seal and the housing together defining a cavity configured to receive a pressurized gas flow; The seal is configured to form a seal with the user's mouth and nostrils, and the seal includes at least one opening for communicating the pressurized gas with the user's mouth and nostrils. The pressurized gas is received into the cavity through the gasket module inlet; Gas is discharged from the cavity through the outlet of the gasket module. and A partition wall insert, configured to be inserted into the cavity of the liner module and including a partition wall and one or more flow deflectors. When the partition wall insert is inserted into the cavity of the liner module: The partition wall traverses the cavity and intersects with the at least one sealing opening to divide the cavity into a first chamber and a second chamber. The first chamber includes an oral cavity opening for communicating the pressurized gas with the user's mouth, and the second chamber includes a nasal cavity opening for communicating the pressurized gas with the user's nostrils. The one or more flow deflectors allow gas to flow from the first chamber into the second chamber through the partition wall.

68. The patient interface of claim 67, wherein the liner module inlet delivers the pressurized gas into the first chamber.

69. The patient interface according to claim 67 or 68, wherein the gas outlet of the liner module discharges gas from the second chamber.

70. The patient interface according to any one of claims 67 to 69, wherein the partition wall includes an outer periphery that contacts the housing and / or the seal to adequately seal the first chamber and the second chamber around the outer periphery.

71. The patient interface according to any one of claims 67 to 69, wherein the partition wall includes an outer periphery whose shape is designed to substantially match the internal geometry of the housing and / or the seal to restrict gas flow around the outer periphery between the first chamber and the second chamber.

72. The patient interface of claim 71, wherein the outer periphery of the partition wall is configured to be spaced apart from the housing and / or the seal to allow a predetermined amount of gas to flow between the outer periphery and the housing and / or the seal.

73. The patient interface of claim 70, wherein the outer periphery of the partition wall is bonded, adhered to, or mechanically attached to the housing and / or the seal.

74. The patient interface according to any one of claims 67 to 72, wherein the partition wall insert includes a connector configured for removable connection to the housing to secure the partition wall insert within the cavity of the liner module.

75. The patient interface of claim 74, wherein the connector of the partition wall insert includes a sleeve configured for connection with a sleeve of the housing.

76. The patient interface according to any one of claims 67 to 75, wherein the one or more flow diverters include a first flow diverter, the first flow diverter including a first flow diverter in fluid communication with the first chamber and a first flow diverter outlet in fluid communication with the second chamber.

77. The patient interface of claim 76, wherein when the patient interface is worn by a user, the first duct outlet is configured to be positioned near and / or pointing toward the user's nostrils.

78. The patient interface of claim 76, wherein the one or more flow diverters further comprises a second flow diverter, the second flow diverter comprising a second flow diverter in fluid communication with the first chamber and a second flow diverter outlet in fluid communication with the second chamber.

79. The patient interface of claim 78, wherein when the patient interface is worn by a user, the first flow outlet and the second flow outlet are each configured to be positioned near and / or pointing toward the corresponding nostril in the user's nostril.

80. The patient interface according to claim 78 or 79, wherein the shapes of the first flow guide and the second flow guide are designed to be different from each other in at least one respect.

81. The patient interface according to any one of claims 78 to 80, wherein the first flow outlet and the second flow outlet comprise unequal cross-sectional areas.

82. The patient interface according to any one of claims 67 to 81, wherein the partition wall comprises a rigid portion and an elastomeric portion.

83. The patient interface according to claim 82, which is dependent on claim 74, wherein the connector is attached to the rigid portion and the one or more flow diverters extend from the elastomeric portion.

84. The patient interface according to claim 82 or 83, wherein the elastomer portion includes a deformable region, the deformable region including a thin region located between a first thickened region and a second thickened region.

85. The patient interface of claim 84, wherein the deformable region allows the partition wall to deform in a controlled manner within the thin region in response to a force applied to the partition wall during use.

86. The patient interface according to any one of claims 67 to 85, wherein the seal is a full-face nasal seal configured to contact the bridge of the user's nose.

87. The patient interface according to any one of claims 67 to 85, wherein the seal is a full-face subnasal seal configured not to contact the user's bridge of the nose.

88. A patient interface for delivering positive pressure breathing therapy to a user, the patient interface comprising: A gasket module, the gasket module including a seal and a housing, the seal and the housing together defining a cavity configured to receive a pressurized gas flow; The seal is configured to form a seal with the user's mouth and nostrils, and the seal includes a nasal opening for communicating the pressurized gas with the user's nostrils and an oral opening for communicating the pressurized gas with the user's mouth. The pressurized gas is received into the cavity through the gasket module inlet; Gas is discharged from the cavity through the outlet of the gasket module. and A partition wall insert, configured to be inserted into the cavity of the liner module and including a partition wall and one or more flow deflectors. When the partition wall insert is inserted into the cavity of the liner module: The partition wall traverses the cavity and divides the cavity into a first chamber including the oral cavity opening and a second chamber including the nasal cavity opening; and The one or more flow deflectors allow gas to flow from the first chamber into the second chamber through the partition wall.

89. The patient interface of claim 88, wherein the liner module inlet delivers the pressurized gas into the first chamber.

90. The patient interface according to claim 88 or 89, wherein the gas outlet of the liner module discharges gas from the second chamber.

91. The patient interface according to any one of claims 88 to 90, wherein the partition wall includes an outer periphery that contacts the housing and / or the seal to adequately seal the first chamber and the second chamber around the outer periphery.

92. The patient interface according to any one of claims 88 to 90, wherein the partition wall includes an outer periphery whose shape is designed to substantially match the internal geometry of the housing and / or the seal to restrict gas flow around the outer periphery between the first chamber and the second chamber.

93. The patient interface of claim 92, wherein the outer periphery of the partition wall is configured to be spaced apart from the housing and / or the seal to allow a predetermined amount of gas to flow between the outer periphery and the housing and / or the seal.

94. The patient interface of claim 91, wherein the outer periphery of the partition wall is coupled, adhered or mechanically attached to the housing and / or the seal.

95. The patient interface according to any one of claims 88 to 93, wherein the partition wall insert includes a connector configured for removable connection to the housing to secure the partition wall insert within the cavity of the liner module.

96. The patient interface of claim 95, wherein the connector of the partition wall insert includes a sleeve configured for connection with a sleeve of the housing.

97. The patient interface according to any one of claims 88 to 96, wherein the one or more flow diverters include a first flow diverter, the first flow diverter including a first flow diverter in fluid communication with the first chamber and a first flow diverter outlet in fluid communication with the second chamber.

98. The patient interface of claim 97, wherein when the patient interface is worn by a user, the first duct outlet is configured to be positioned near and / or pointing toward the user's nostrils.

99. The patient interface of claim 97, wherein the one or more flow diverters further comprises a second flow diverter, the second flow diverter comprising a second flow diverter in fluid communication with the first chamber and a second flow diverter outlet in fluid communication with the second chamber.

100. The patient interface of claim 99, wherein when the patient interface is worn by a user, the first flow outlet and the second flow outlet are each configured to be positioned near and / or pointing toward the corresponding nostril in the user's nostril.

101. The patient interface according to claim 99 or 100, wherein the shapes of the first flow guide and the second flow guide are designed to be different from each other in at least one respect.

102. The patient interface according to any one of claims 99 to 101, wherein the first flow outlet and the second flow outlet have unequal cross-sectional areas.

103. The patient interface according to any one of claims 88 to 102, wherein the partition wall comprises a rigid portion and an elastomeric portion.

104. The patient interface according to claim 103, which is dependent on claim 95, wherein the connector is attached to the rigid portion and the one or more flow diverters extend from the elastomeric portion.

105. The patient interface according to claim 103 or 104, wherein the elastomer portion includes a deformable region, the deformable region including a thin region located between a first thickened region and a second thickened region.

106. The patient interface of claim 105, wherein the deformable region allows the partition wall to deform in a controlled manner within the thin region in response to a force applied to the partition wall during use.

107. The patient interface according to any one of claims 88 to 106, wherein the seal is a full-face nasal seal configured to contact the bridge of the user's nose.

108. The patient interface according to any one of claims 88 to 106, wherein the seal is a full-face subnasal seal, the full-face subnasal seal being configured not to contact the user's bridge of the nose.

109. A patient interface for delivering positive pressure breathing therapy to a user, the patient interface comprising: A gasket module, the gasket module including a seal and a housing, the seal and the housing together defining a cavity configured to receive a pressurized gas flow; The seal is configured to form a seal with the user's mouth and nostrils, and the seal includes a nasal opening for communicating the pressurized gas with the user's nostrils and an oral opening for communicating the pressurized gas with the user's mouth. The pressurized gas is received into the cavity through the gasket module inlet; Gas is discharged from the cavity through the outlet of the gasket module. and A partition wall divides the cavity into a first chamber having the oral cavity opening and a second chamber having the nasal cavity opening. The partition wall includes a flow guide hole configured to receive a flow guide insert, and The flow guide insert includes one or more flow guides that, when received within the flow guide orifice, allow gas to flow from the first chamber into the second chamber.

110. The patient interface of claim 109, wherein the liner module inlet delivers the pressurized gas into the first chamber.

111. The patient interface according to claim 109 or 110, wherein the gas outlet of the liner module discharges gas from the second chamber.

112. The patient interface according to any one of claims 108 to 111, wherein the flow guide hole is configured to removably receive the flow guide insert.

113. The patient interface of claim 112, wherein the flow guide insert includes a channel around the periphery of the flow guide insert, the channel being configured to receive the edge of the flow guide orifice to removably attach the flow guide insert to the partition wall.

114. The patient interface according to any one of claims 109 to 113, wherein the flow guide insert comprises an elastomeric material.

115. The patient interface according to any one of claims 109 to 114, wherein the one or more flow diverters include a first flow diverter, the first flow diverter including a first flow diverter in fluid communication with the first chamber and a first flow diverter outlet in fluid communication with the second chamber.

116. The patient interface of claim 115, wherein when the patient interface is worn by a user, the first duct outlet is configured to be positioned near and / or pointing toward the user's nostrils.

117. The patient interface of claim 115, wherein the one or more flow diverters further comprises a second flow diverter, the second flow diverter comprising a second flow diverter in fluid communication with the first chamber and a second flow diverter outlet in fluid communication with the second chamber.

118. The patient interface of claim 117, wherein when the patient interface is worn by a user, the first flow outlet and the second flow outlet are each configured to be positioned near and / or pointing toward the corresponding nostril in the user's nostril.

119. The patient interface according to claim 117 or 118, wherein the shapes of the first flow guide and the second flow guide are designed to be different from each other in at least one respect.

120. The patient interface according to any one of claims 117 to 119, wherein the first flow outlet and the second flow outlet comprise unequal cross-sectional areas.

121. The patient interface of claim 120, wherein the ratio of the cross-sectional area of ​​the first flow guide outlet to the cross-sectional area of ​​the second flow guide outlet is in the range of 1:1.1 to 1:

4.

122. The patient interface according to any one of claims 109 to 121, wherein the flow guide insert includes one or more flow guide holes through the flow guide insert.

123. The patient interface according to any one of claims 109 to 122, wherein the partition wall comprises an elastomeric portion.

124. The patient interface of claim 123, wherein the elastomer portion includes a deformable region, the deformable region including a thin region located between a first thickened region and a second thickened region.

125. The patient interface of claim 124, wherein the deformable region allows the partition wall to deform in a controlled manner within the thin region in response to a force applied to the partition wall during use.

126. The patient interface according to any one of claims 109 to 125, wherein the seal is a full-face nasal seal configured to contact the bridge of the user's nose.

127. The patient interface according to any one of claims 109 to 125, wherein the seal is a full-face subnasal seal configured not to contact the user's bridge of the nose.

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