Patient Interface

Abstract

This is a cushion module for a patient interface to deliver positive airway pressure therapy to a user. The cushion module has a seal for forming a seal around the user's mouth and nostrils, and a housing connected to the seal. The housing and seal form a cavity configured to receive a flow of pressurized gas. The seal has at least one opening for communicating the pressurized gas with the user, an inlet into which the pressurized gas is received into the cavity, an outlet from which the gas is discharged from the cushion module, and an exhaust conduit configured to draw the gas through at least one exhaust conduit inlet from the user's nostrils and guide it to the outlet of the cushion module.

Description

Detailed Description of the Invention

[0001] [Technical Field] The present invention relates to a patient interface for delivering respiratory therapy to a patient. In particular, the present invention relates to a non-invasive patient interface for delivering pressurized breathing gas to a patient. [Background Art]

[0002] One current treatment for respiratory diseases such as chest restrictive diseases, acute respiratory failure, progressive neuromuscular diseases, chronic obstructive pulmonary disease (COPD including emphysema, refractory asthma, and chronic bronchitis) is non-invasive ventilation (NIV) therapy. There is some evidence suggesting that NIV therapy can be useful in assisting post-intubation breathing, including reducing the likelihood of re-intubation. NIV therapy applies airway positive pressure to the lungs through the inhalation and exhalation cycles. This improves the flow of breathing gas into and out of the lungs.

[0003] However, one side effect of the positive pressure applied in current NIV treatment is that the applied treatment pressure can discomfort the patient and thus reduce the willingness to receive treatment. A subsequent effect of the positive pressure is that the patient interface needs to be firmly fixed to the patient for a seal sufficient to minimize leakage, thereby ensuring that the pressure is maintained in both the patient interface and the respiratory system. Such a firm application of the patient interface to the patient's face can cause pressure ulcers, especially for patients who are semi-conscious or unconscious and thus cannot provide feedback regarding any pain caused by the pressure of the patient interface on their skin.

[0004] For at least the reasons mentioned above, NIV therapy presents two major challenges: compliance (the degree to which the patient is willing to submit to the therapy) and pressure ulcers that develop due to contact between the patient interface and the patient's skin. In addition to these challenges, a further challenge for patients with obstructive respiratory disease or acute respiratory failure is flushing out exhaled carbon dioxide from their anatomical dead space. Specifically, the end of an exhalation cycle is characterized by a decrease in pressure in the patient's airways. This means that the carbon dioxide-loaded breathing gas remains in the patient's throat, nose, and mouth and is drawn back into the lungs at the start of the next inhalation cycle. Therefore, by replacing the carbon dioxide-loaded breathing gas in these areas with fresh breathing gas containing lower levels of carbon dioxide (and higher levels of oxygen) than the carbon dioxide-loaded breathing gas, we help the patient achieve improved breathing through improved ventilatory efficiency.

[0005] This improved ventilation efficiency could potentially allow for reduced treatment pressure, leading to a decrease in pressure ulcers and improved patient compliance. Alternatively, it could provide improved ventilation at the same treatment pressure, resulting in improved patient outcomes and shorter time spent in NIV treatment.

[0006] It is desirable to provide a patient interface that reduces pressure ulcers by improving patient comfort and ventilation.

[0007] It is also desirable to provide a patient interface that assists in flushing anatomical dead space. [Overview of the prefecture]

[0008] Next, an embodiment of a patient interface for delivering respiratory therapy to a patient will be described here by a set of embodiments. However, it will be understood that further embodiments can be defined by combining two or more features of the embodiments.

[0009] In the first embodiment, a cushion module for a patient interface for delivering positive airway pressure therapy to a user is, A seal for forming a sealing area around the user's mouth and nostrils, A housing connected to a seal, forming a cavity configured to receive a flow of pressurized gas, At least one opening in the seal for communicating pressurized gas with the user, An inlet into which pressurized gas is received into the cavity, The outlet from which the gas is discharged from the cushion module, The system may include an exhaust conduit configured to draw gas from the user's nostrils through at least one exhaust conduit inlet and guide it to the outlet of a cushion module.

[0010] In a second embodiment, a cushion module for a patient interface for delivering positive airway pressure therapy to a user is: A seal for forming a sealing area around the user's mouth and nostrils, A housing connected to a seal, forming a cavity configured to receive a flow of pressurized gas, At least one opening in the seal for communicating pressurized gas with the user, An inlet for receiving pressurized gas into the cavity, An outlet for releasing gas from the cushion module, An exhaust conduit located within a cavity, the exhaust conduit having at least one exhaust conduit inlet, through which gas is received into the exhaust conduit, and the exhaust conduit extends from at least one exhaust conduit inlet to the outlet of a cushion module.

[0011] Each exhaust conduit inlet may be configured to be located inside one or each of the user's nostrils when the patient interface is worn by the user, or to be located below one or each of the user's nostrils, adjacent to the user's upper lip.

[0012] The cross-sectional area of ​​at least one exhaust conduit inlet may be smaller than the cross-sectional area of ​​the inlet in order to accelerate the gas entering the exhaust conduit as it flows from the cavity into the exhaust conduit.

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

[0014] The intake of ambient gas into the exhaust conduit may occur when at least one exhaust conduit inlet is located within one or each of the user's nostrils, or below one or each of the user's nostrils, adjacent to the user's upper lip.

[0015] At least one opening in the seal may include a first opening surrounding the user's mouth and a second opening surrounding the user's nostrils.

[0016] The exhaust conduit may be configured to guide exhaled gas from the user's mouth and / or nostrils, or excess gas from the cavity, or both, to the outlet.

[0017] The exhaust conduit may be configured to discharge exhaled gas from the user's mouth and / or nostrils, or excess gas from the cavity, or both from the cushion module.

[0018] The exhaust conduit may be adjustablely mounted to the housing so that its orientation and / or position relative to the seal can be adjusted.

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

[0020] The exhaust conduit may be a sealed passage extending from at least one exhaust conduit inlet to an outlet.

[0021] The exhaust duct can be configured to prevent the entry of gas from the cavity and the exit of gas from the cavity, except via at least one exhaust duct inlet.

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

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

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

[0025] At least one prong can be configured to extend into one or each of the user's nostrils.

[0026] At least one prong can be a sealing prong configured to form a seal with one or each of the user's nostrils.

[0027] At least one prong can be formed of an elastomeric material.

[0028] The elastomeric material can be silicone.

[0029] At least one exhaust duct inlet can include a first exhaust duct inlet configured to be disposed within the first nostril of the user's nostrils or adjacent to the user's upper lip below the first nostril of the user's nostrils when the patient interface is worn by the user, and a second exhaust duct inlet configured to be disposed within the second nostril of the user's nostrils or adjacent to the user's upper lip below the second nostril of the user's nostrils when the patient interface is worn by the user.

[0030] At least one prong may include a first prong and a second prong, the first exhaust conduit inlet being located at the free end of the first prong and the second exhaust conduit inlet being located at the free end of the second prong.

[0031] When the patient interface is worn by the user, the first prongs may be configured to extend into the user's first nostrils, and the second prongs may be configured to extend into the user's second nostrils.

[0032] The exhaust conduit may further include a manifold, with first and second prongs extending from the manifold.

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

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

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

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

[0037] At least a portion of the exhaust conduit may be incorporated into a nasal interface that includes a flushing conduit having at least one flushing conduit inlet in the cavity and at least one flushing conduit outlet located in or adjacent to at least one of the first or second exhaust conduit inlets.

[0038] The nasal interface may be located within the cavity. The nasal interface may be a separate structure from the seal. The nasal interface may be a separate structure from the housing. The nasal interface may be connectable to the seal, the housing, or both the seal and the housing.

[0039] Each of the first and second prongs may be a sealing prong configured to form a seal with each of the user's nostrils.

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

[0041] The flushing conduit may be configured to direct gas from within the cavity to one or each of the user's nostrils.

[0042] The flushing conduit may be configured to accelerate gas from at least one flushing conduit inlet toward a first flushing conduit outlet and a second flushing conduit outlet, and to direct the accelerated gas toward one of the user's nostrils.

[0043] The first and second prongs may be formed from an elastomer material.

[0044] The elastomer material can be silicone.

[0045] The cushion module outlet can be in fluid communication with the filter so that the gas exiting the cushion module through the outlet passes through the filter.

[0046] The filter may be located outside the cushion module.

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

[0048] The cushion module outlet may include a bias flow vent.

[0049] The cushion module outlet may be connected to the exhalation conduit or configured to communicate with it via fluid.

[0050] A bias flow vent may include multiple openings.

[0051] The cushion module can be configured to accept only the flow of pressurized gas through the inlet and exhaust only gas through the outlet.

[0052] The cushion module further includes an auxiliary bias flow vent, which may be in fluid communication with the cavity.

[0053] The auxiliary bias flow vent may be configured to have a flow rate lower than the flow rate passing through the cushion module outlet during use.

[0054] The auxiliary bias flow vent may be configured to have a flow resistance greater than the flow resistance through the cushion module outlet during use.

[0055] The auxiliary bias flow vent may include at least one opening, the at least one opening having a cross-sectional area, the cross-sectional area of ​​the at least one opening being smaller than the cross-sectional area of ​​the cushion module outlet.

[0056] The housing may contain plastic material. The plastic material may be polycarbonate.

[0057] The seal may contain an elastomer material. The elastomer material may be silicone.

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

[0059] The housing may include a cushion module entrance.

[0060] The housing may include a cushion module outlet.

[0061] The seal may include the cushion module outlet.

[0062] The seal may include the entrance to the cushion module.

[0063] The seal may be a full-surface supranasal seal configured to form a seal on the user's nasal bridge during use.

[0064] The seal may be a full subnasal seal configured not to form a seal on the user's nasal bridge during use.

[0065] The seal may be a full-surface seal configured to form a seal around the user's mouth, nose, and eyes during use.

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

[0067] The patient interface may include a cushion module as described in any one of the preceding embodiments, and the patient interface may further include a frame configured to be attached to the cushion module, the frame including a plurality of headgear connectors configured to be connected to a headgear to hold the patient interface on the user's face during use.

[0068] The patient interface may further include a conduit connector configured to connect to the inlet of a cushion module, the conduit connector including an asphyxiation prevention valve and a pressure port, and further configured to be detachably attached to a respiratory therapy conduit.

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

[0070] The conduit connector may be configured to connect to the biliary respiratory circuit.

[0071] The conduit connector may be configured to connect to the biliary breathing circuit via a Y-piece.

[0072] In a third aspect, a patient interface for delivering positive pressure ventilation therapy to a user includes (a) a cushion module defining a first cavity configured to be pressurized, the cushion module comprising: an inlet configured to receive a flow of pressurized gas into the cavity; an opening configured to surround the user's mouth and nostrils to communicate the pressurized gas with the user; and an outlet configured to discharge the gas to the outside of the cushion module; (b) an exhaust conduit located within a first cavity, the exhaust conduit extending from the outlet of the cushion module to at least one exhaust conduit inlet, the at least one exhaust conduit inlet configured to be located within one of the user's nostrils or each of a first nostril when the patient interface is worn by the user, The exhaust conduit includes at least one prong configured to form a seal with one of the user's nostrils or each of a first nostril, and at least one exhaust conduit inlet is located at the free end of at least one prong.

[0073] In the fourth aspect, the patient interface for delivering positive airway pressure therapy to the user is: (a) A cushion module defining a first cavity configured to be pressurized, the cushion module including an inlet configured to receive a flow of pressurized gas into the cavity, an opening configured to surround the user's mouth and nostrils to communicate the pressurized gas with the user, and an outlet configured to discharge the gas to the outside of the cushion module, (b) an exhaust conduit located within a first cavity, which, when the patient interface is worn by a user, extends from the outlet of the cushion module to a first exhaust conduit inlet and a second exhaust conduit inlet, the first exhaust conduit inlet being configured to be located within a first nostril of the user's nostrils, and the second exhaust conduit inlet being configured to be located within a second nostril of the user's nostrils.

[0074] In the fifth aspect, a cushion module for a patient interface for delivering positive airway pressure therapy to a user is: (a) Cavities for communicating breathing gases with the user's mouth and nostrils, (b) an exhaust conduit for communicating exhaled gas from the user's mouth and / or nostrils, or excess respiratory gas from within the cavity, or both, to the outside of the cushion module, The exhaust conduit is configured to accelerate the breathing gas as it flows from the cavity into the conduit.

[0075] In the sixth aspect, a non-invasive patient interface configured to seal around the patient's mouth and nostrils is, (a) an outer wall defining an internal volume, including a first chamber having a mouth opening for communicating gas to the mouth and a second chamber having a nasal opening for communicating gas to the nostrils, (b) A partition separating the first chamber from the second chamber, (c) one or more flow guides configured to allow gas to flow from a first chamber into a second chamber and to direct the gas flow into the nostrils, The outer wall is designed to extend over the patient's nasal bridge.

[0076] In the seventh aspect, a non-invasive patient interface configured to seal around the patient's mouth and nostrils is, (a) An outer wall defining the internal volume of a patient interface, the outer wall having a patient contact surface including an oral opening for communicating gas to the mouth and a nasal opening for communicating gas to the nostrils, (b) A partition separating the internal volume into a first chamber having a mouth opening and a second chamber having a nasal opening, (c) One or more flow guides extending from a partition, one or more flow guides configured to allow gas to flow from a first chamber into a second chamber and to direct the gas flow into the nostrils, may include The flow guides are separated by spacing elements that maintain the distance between them. The patient contact surface engages with the patient's nasal bridge.

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

[0078] In the ninth aspect, the patient interface for delivering positive airway pressure therapy to the user is: A cushion module including a seal and housing that together define a cavity configured to receive a flow of pressurized gas, The seal is configured to form a seal with the user's mouth and nostrils and includes a cushion module with at least one opening for communicating pressurized gas with the user's mouth and nostrils. The cushion module inlet where pressurized gas is received into the cavity, The cushion module outlet from which the gas is discharged from the cavity, It may include a partition insert configured to be inserted into the cavity of a cushion module, and comprising a partition wall and one or more flow guides, When the partition insert is inserted into the cavity of the cushion module, The partition extends across the cavity and intersects with at least one sealing opening, separating the cavity into a first chamber including a mouth opening for communicating pressurized gas with the user's mouth, and a second chamber including a nasal opening for communicating pressurized gas with the user's nostrils. One or more flow guides allow gas to flow from the first chamber through the partition to the second chamber.

[0079] The cushion module inlet can deliver pressurized gas into the first chamber.

[0080] The cushion module outlet can discharge the gas from the second chamber.

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

[0082] The partition wall may include an outer periphery that substantially matches the internal geometry of the housing and / or seal and restricts the flow of gas between the first chamber and the second chamber around the outer periphery.

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

[0084] The outer perimeter of the bulkhead can be bonded, glued, or mechanically attached to the housing and / or seal.

[0085] The bulkhead insert may include a connector configured to be removably connected to the housing in order to secure the bulkhead insert within the cavity of the cushion module.

[0086] The bulkhead insert connector may include a sleeve configured to connect to the housing sleeve.

[0087] One or more flow guides may include a first flow guide that has a first flow guide inlet that is in fluid communication with a first chamber and a first flow guide outlet that is in fluid communication with a second chamber.

[0088] The first flow guide outlet may be positioned near and / or directed toward the user's nostrils when the patient interface is worn by the user.

[0089] One or more flow guides may further include a second flow guide, which includes a second flow guide inlet that is in fluid communication with the first chamber and a second flow guide outlet that is in fluid communication with the second chamber.

[0090] The first and second flow guide outlets may be configured to be positioned near and / or directed toward one of each of the user's nostrils when the patient interface is worn by the user.

[0091] The first and second flow guides may have different shapes from each other in at least one way.

[0092] The outlets of the first and second guides may include unequal cross-sectional areas.

[0093] The partition wall may include a rigid portion and an elastomer portion.

[0094] The connector may be attached to the rigid part, and one or more conduits may extend from the elastomer part.

[0095] The elastomer portion may include a deformation region, which includes a thin-walled region located between a first thick-walled region and a second thick-walled region.

[0096] The deformation region can allow for controlled deformation of the partition wall within the thin-walled region in response to forces applied to the partition wall during use.

[0097] The seal may be a full-surface supranasal seal configured to come into contact with the user's nasal bridge.

[0098] The seal may be a full-surface subnasal seal configured not to come into contact with the user's nasal bridge.

[0099] In the tenth aspect, the patient interface for delivering positive airway pressure therapy to the user is: A cushion module including a seal and housing that together define a cavity configured to receive a flow of pressurized gas, The seal is configured to form a seal with the user's mouth and nostrils, and includes a cushion module with a nasal opening that communicates pressurized gas with the user's nostrils and a mouth opening that communicates pressurized gas with the user's mouth. The cushion module inlet where pressurized gas is received into the cavity, The cushion module outlet from which the gas is discharged from the cavity, It may include a partition insert configured to be inserted into the cavity of a cushion module, and comprising a partition wall and one or more flow guides, When the partition insert is inserted into the cavity of the cushion module, The partition extends across the cavity, separating it into a first chamber containing the oral opening and a second chamber containing the nasal opening. One or more flow guides allow gas to flow from the first chamber through the partition to the second chamber.

[0100] The cushion module inlet can deliver pressurized gas into the first chamber.

[0101] The cushion module outlet can discharge the gas from the second chamber.

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

[0103] The partition wall may include an outer periphery that substantially matches the internal geometry of the housing and / or seal and restricts the flow of gas between the first chamber and the second chamber around the outer periphery.

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

[0105] The outer perimeter of the bulkhead can be bonded, glued, or mechanically attached to the housing and / or seal.

[0106] The bulkhead insert may include a connector configured to be removably connected to the housing in order to secure the bulkhead insert within the cavity of the cushion module.

[0107] The bulkhead insert connector may include a sleeve configured to connect to the housing sleeve.

[0108] One or more flow guides may include a first flow guide that has a first flow guide inlet that is in fluid communication with a first chamber and a first flow guide outlet that is in fluid communication with a second chamber.

[0109] The first flow guide outlet may be positioned near and / or directed toward the user's nostrils when the patient interface is worn by the user.

[0110] One or more flow guides may further include a second flow guide, which includes a second flow guide inlet that is in fluid communication with the first chamber and a second flow guide outlet that is in fluid communication with the second chamber.

[0111] The first and second flow guide outlets may be configured to be positioned near and / or directed toward one of each of the user's nostrils when the patient interface is worn by the user.

[0112] The first and second flow guides may have different shapes from each other in at least one way.

[0113] The outlets of the first and second guides may include unequal cross-sectional areas.

[0114] The partition wall may include a rigid portion and an elastomer portion.

[0115] The connector may be attached to the rigid part, and one or more conduits may extend from the elastomer part.

[0116] The elastomer portion may include a deformation region, which includes a thin-walled region located between a first thick-walled region and a second thick-walled region.

[0117] The deformation region can allow for controlled deformation of the partition wall within the thin-walled region in response to forces applied to the partition wall during use.

[0118] The seal may be a full-surface supranasal seal configured to come into contact with the user's nasal bridge.

[0119] The seal may be a full-surface subnasal seal configured not to come into contact with the user's nasal bridge.

[0120] In the eleventh aspect, the patient interface for delivering positive airway pressure therapy to the user is: A cushion module including a seal and housing that together define a cavity configured to receive a flow of pressurized gas, The seal is configured to form a seal with the user's mouth and nostrils, and includes a cushion module with a nasal opening that communicates pressurized gas with the user's nostrils and a mouth opening that communicates pressurized gas with the user's mouth. The cushion module inlet where pressurized gas is received into the cavity, The cushion module outlet from which the gas is discharged from the cavity, The cavity includes a partition separating it into a first chamber having a mouth opening and a second chamber having a nasal opening, The partition wall includes a flow guide opening configured to receive a flow guide insert, The flow guide insert includes one or more flow guides that allow gas to flow from the first chamber into the second chamber when the flow guide insert is received into the flow guide opening.

[0121] The cushion module inlet can deliver pressurized gas into the first chamber.

[0122] The cushion module outlet can discharge the gas from the second chamber.

[0123] The flow guide opening may be configured to removably receive a flow guide insert.

[0124] The flow guide insert may include a channel around the flow guide insert that is configured to receive the rim of the flow guide opening and to removably mount the flow guide insert to the bulkhead.

[0125] The flow guide insert may contain an elastomer material.

[0126] One or more flow guides may include a first flow guide that has a first flow guide inlet that is in fluid communication with a first chamber and a first flow guide outlet that is in fluid communication with a second chamber.

[0127] The first flow guide outlet may be positioned near and / or directed toward the user's nostrils when the patient interface is worn by the user.

[0128] One or more flow guides may further include a second flow guide, which includes a second flow guide inlet that is in fluid communication with the first chamber and a second flow guide outlet that is in fluid communication with the second chamber.

[0129] The first and second flow guide outlets may be configured to be positioned near and / or directed toward one of each of the user's nostrils when the patient interface is worn by the user.

[0130] The first and second flow guides may have different shapes from each other in at least one way.

[0131] The outlets of the first and second guides may include unequal cross-sectional areas.

[0132] The ratio of the cross-sectional area of ​​the outlet of the first guide to the cross-sectional area of ​​the outlet of the second guide can be within the range of 1:1.1 to 1:4.

[0133] A flow guide insert may include one or more flow guide openings extending through the flow guide insert.

[0134] The partition may include an elastomer portion.

[0135] The elastomer portion may include a deformation region, which includes a thin-walled region located between a first thick-walled region and a second thick-walled region.

[0136] The deformation region can allow for controlled deformation of the partition wall within the thin-walled region in response to forces applied to the partition wall during use.

[0137] The seal may be a full-surface supranasal seal configured to come into contact with the user's nasal bridge.

[0138] The seal may be a full-surface subnasal seal configured not to come into contact with the user's nasal bridge.

[0139] The sequential references to the embodiments disclosed above (e.g., First, Second, Third) serve only to distinguish the embodiments from one another. The sequential references should not be interpreted as an order of importance of the embodiments.

[0140] Although various features have been disclosed above in relation to one or more embodiments, it will be understood that one or more features from one embodiment can be combined with those from other embodiments to realize additional embodiments. Therefore, the disclosure of features in the foregoing description should not be interpreted as meaning that the features are limited to their application in the embodiments in which they are disclosed. [Brief explanation of the drawing]

[0141] The embodiments of the patient interface disclosed above will be described in detail below with reference to the illustrative embodiments and the attached drawings.

[0142] [Figure 1] This is a perspective view of the patient interface according to the first embodiment. [Figure 2] Figure 1 is an exploded perspective view of the patient interface. [Figure 3] Figure 1 is an exploded side view of the patient interface. [Figure 4] Figure 1 is a front view of the patient interface. [Figure 5] Figure 1 is a side view of the patient interface. [Figure 6] Figure 1 is a rear view of the patient interface. [Figure 7] Figure 1 is a top view of the patient interface. [Figure 8] Figure 1 is a bottom view of the patient interface. [Figure 9] Figure 4 is a cross-sectional side view of the patient interface in Figure 1 along line AA'. [Figure 10] This is a perspective view of the patient interface according to the second embodiment. [Figure 11] Figure 10 is an exploded perspective view of the patient interface. [Figure 12] Figure 10 is an exploded side view of the patient interface. [Figure 13] Figure 10 is a front view of the patient interface. [Figure 14] Figure 10 is a side view of the patient interface. [Figure 15] Figure 10 is a rear view of the patient interface. [Figure 16] Figure 10 is a top view of the patient interface. [Figure 17]Figure 10 is a bottom view of the patient interface. [Figure 18] Figure 13 is a cross-sectional side view of the patient interface in Figure 10 along line BB'. [Figure 19] Figure 13 is a cross-sectional perspective view of the patient interface in Figure 10 along line BB', as shown in Figure 13. [Figure 20] Figure 13 is a further cross-sectional perspective view of the patient interface in Figure 10 along line BB', as shown in Figure 13. [Figure 21] Figure 13 is a cross-sectional top view of the patient interface in Figure 10 along line CC', as shown in Figure 13. [Figure 22] Figure 10 is a perspective view of the exhaust conduit of the patient interface. [Figure 23] This is a schematic cross-sectional side view of the patient interface of Figure 10 along line BB', as shown in Figure 13, worn on the patient while the patient's mouth is open. [Figure 24] This is a schematic cross-sectional side view of the patient interface of Figure 10 along line BB', as shown in Figure 13, worn by the patient while the patient's mouth is closed. [Figure 25] This is a perspective view of the patient interface according to the third embodiment. [Figure 26] Figure 25 is an exploded perspective view of the patient interface. [Figure 27] Figure 25 is an exploded side view of the patient interface. [Figure 28] Figure 25 is a front view of the patient interface. [Figure 29] Figure 25 is a side view of the patient interface. [Figure 30] Figure 25 is a rear view of the patient interface. [Figure 31] Figure 25 is a top view of the patient interface. [Figure 32] Figure 25 is a bottom view of the patient interface. [Figure 33]Figure 30 is a cross-sectional side view of the patient interface shown in Figure 25 along line DD'. [Figure 34] Figure 30 is a cross-sectional perspective view of the patient interface shown in Figure 25 along line DD'. [Figure 35] Figure 30 is a cross-sectional side view of the patient interface shown in Figure 25 along line EE'. [Figure 36] Figure 30 is a cross-sectional perspective view of the patient interface shown in Figure 25 along line EE'. [Figure 37] Figure 25 is a perspective view of the exhaust conduit of the patient interface. [Figure 38] Figure 37 is a rear view of the patient interface. [Figure 39] Figure 38 is a cross-sectional side view of the exhaust conduit shown in Figure 37 along line FF'. [Figure 40] Figure 38 is a cross-sectional side view of the exhaust conduit shown in Figure 37 along line GG'. [Figure 41] This is a schematic cross-sectional side view of the patient interface shown in Figure 25 along line EE', as shown in Figure 30, worn on the patient while the patient's mouth is open. [Figure 42] This is a schematic cross-sectional side view of the patient interface shown in Figure 25 along line EE', as shown in Figure 30, worn by the patient while the patient's mouth is closed. [Figure 43] This is a perspective view of the patient interface according to the fourth embodiment. [Figure 44] Figure 43 is a front view of the patient interface. [Figure 45] Figure 43 is a side view of the patient interface. [Figure 46] Figure 43 is a rear view of the patient interface. [Figure 47] Figure 43 is a top view of the patient interface. [Figure 48] Figure 43 is a bottom view of the patient interface. [Figure 49]Figure 44 is a cross-sectional side view of the patient interface shown in Figure 43 along line HH'. [Figure 50] Figure 44 is a cross-sectional perspective view of the patient interface shown in Figure 43 along line HH'. [Figure 51] Figure 44 is a cross-sectional perspective view of the patient interface shown in Figure 43 along line II'. [Figure 52] Figure 44 is a cross-sectional top view of the patient interface shown in Figure 43 along line II'. [Figure 53] This is a schematic cross-sectional side view of the patient interface shown in Figure 43 along line HH', as shown in Figure 44, which was worn on the patient while the patient's mouth was open. [Figure 54] This is a schematic cross-sectional side view of the patient interface shown in Figure 43 along line HH', as shown in Figure 44, worn by the patient while the patient's mouth is closed. [Figure 55] This is a perspective view of the patient interface according to the fifth embodiment. [Figure 56] Figure 55 is a perspective view of the patient interface cushion module. [Figure 57] Figure 55 is a front view of the patient interface cushion module. [Figure 58] Figure 55 is a side view of the patient interface cushion module. [Figure 59] Figure 55 is a rear view of the patient interface cushion module. [Figure 60] Figure 55 is a side view of the patient interface cushion module. [Figure 61] Figure 57 is a cross-sectional side view of the patient interface cushion module shown in Figure 55 along line JJ'. [Figure 62] Figure 57 is a cross-sectional perspective view of the cushion module of the patient interface shown in Figure 55 along line JJ'. [Figure 63]Figure 57 is a cross-sectional perspective view of the cushion module of the patient interface shown in Figure 55 along line JJ'. [Figure 64] Figure 55 is a perspective view of the patient interface partition assembly. [Figure 65] Figure 64 is a side view of the bulkhead assembly. [Figure 66] Figure 64 is a rear view of the bulkhead assembly. [Figure 67] Figure 66 is a cross-sectional side view of the bulkhead assembly along line KK'. [Figure 68] Figure 64 is a top view of the bulkhead assembly. [Figure 69] This is a perspective view of the patient interface according to the sixth embodiment. [Figure 70] Figure 69 is a perspective view of the patient interface cushion module. [Figure 71] Figure 69 is a top view of the patient interface cushion module. [Figure 72] Figure 69 is a rear view of the patient interface cushion module. [Figure 73] Figure 71 is a cross-sectional side view of a cushion module along line LL'. [Figure 74] Figure 72 is a cross-sectional perspective view of the cushion module along line MM'. [Figure 75] Figure 69 is a perspective view of the patient interface partition assembly. [Figure 76] Figure 75 is a rear view of the bulkhead assembly. [Figure 77] Figure 75 is a side view of the bulkhead assembly. [Figure 78] Figure 76 is a cross-sectional side view of the partition wall assembly along line NN'. [Figure 79] This is a perspective view of the patient interface according to the seventh embodiment. [Figure 80] Figure 79 is a perspective view of the patient interface cushion module. [Figure 81] Figure 79 is a front view of the patient interface cushion module. [Figure 82] Figure 79 is a rear view of the patient interface cushion module. [Figure 83] Figure 82 is a cross-sectional side view of a cushion module along line OO'. [Figure 84] Figure 82 is a cross-sectional perspective view of a cushion module along line OO'. [Figure 85] Figure 82 is a cross-sectional perspective view of a cushion module with a guide insert removed along line OO'. [Figure 86] Figure 82 is a cross-sectional perspective view of the cushion module along line PP'. [Figure 87] Figure 82 is a cross-sectional perspective view of a cushion module with the guide insert removed along line PP'. [Figure 88] Figure 79 is a perspective view of the flow guide insert in the patient interface. [Figure 89] Figure 88 is a top view of the flow guide insert. [Figure 90] Figure 79 is a perspective view of an alternative flow guide insert for the patient interface. [Figure 91] Figure 90 is a top view of the flow guide insert. [Figure 92] Figure 79 is a perspective view of a further alternative flow guide insert for the patient interface. [Figure 93] Figure 92 is a top view of the flow guide insert. [Modes for carrying out the invention]

[0143] Embodiments are described below in the following text, including reference numerals corresponding to features shown in the accompanying drawings. Where possible, relevant reference numerals are used to identify the same or substantially similar features in different embodiments. However, not all reference numerals are included in each drawing in order to maintain clarity.

[0144] The embodiments of the patient interface disclosed above will be described in detail below with reference to the general embodiments of the patient interface shown in Figures 1-9. The embodiments described hereafter are variations of the general embodiment. However, it will be understood that the scope of embodiments should not be limited by reference to the general embodiment or the specific embodiments described below, but rather that embodiments should be interpreted as relating to other forms of patient interfaces that also deliver pressurized respiratory gases to the patient, including full-face patient interfaces that do not contact the bridge of the nose (over a nasal-mouth-nasal mask), full-face masks, helmet interfaces, and nasal masks that seal the patient's nasal cavity where appropriate.

[0145] As used throughout this specification, the terms “respiratory gas” or “respiratory gasses” are interpreted to mean the gases used in human respiration or human ventilation. As used throughout this specification, the term “inspiratory respiratory gas” is interpreted to mean the respiratory gases inhaled during the inspiratory phase of the respiratory cycle. This term includes, within its scope, ambient air, or air that has been adjusted to treat a patient, such as having a higher humidity or oxygen level compared to the ambient air, or both. As used throughout this specification, the term “expiratory respiratory gas” is interpreted to mean the respiratory gases exhaled from a patient’s lungs and airways during the expiratory phase of the respiratory cycle. Thus, it includes respiratory gases from the lungs and gases that occupy the patient’s anatomical dead space at the end of the expiratory phase of the respiratory cycle. General form

[0146] Referring to Figures 1-9, a typical configuration includes a patient interface 1000 comprising a cushion module 1010, a frame 1400, and a conduit connector 1300. The conduit connector 1300 includes structural components for connecting the cushion module 1010 to a source of pressurized breathing gas, such as a ventilator, humidifier, flow generator, or wall supply source. In this embodiment, the patient interface 1000 is in the form of a full-face mask in which the cushion module 1010 comprises an elastic seal 1100 and a housing 1200. Collectively, the elastic seal 1100 and housing 1200 form the cushion module 1010 having an internal cavity 1012 configured to be pressurized.

[0147] The housing 1200 is formed of a substantially rigid plastic material to provide structural support to the seal 1100. Additionally, the housing 1200 provides an interface for connecting the seal 1100 to the frame 1400 and / or the conduit connector 1300.

[0148] In an alternative configuration, the housing 1200 may be formed from an elastomer, fabric, or foam sufficient to provide the rigidity necessary to structurally support the seal 1100. It may also be formed from one of the aforementioned materials and reinforced with a secondary, more rigid material to provide the necessary structural support for the seal 1100.

[0149] The housing 1200 includes a sleeve 1230 of a size and shape suitable for connecting to 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 communicated from the conduit connector 1300 to the cavity 1012 of the cushion module 1010.

[0150] The respiratory gas is communicated from the conduit connector 1300 to the cavity 1012 of the cushion module 1010 via the inspiratory conduit of a single-limb NIV circuit, which is configured to deliver fresh, pressurized respiratory gas from a gas source to the conduit connector 1300, or via a Y-shaped component of a bilimb NIV circuit, which is configured to deliver fresh, pressurized respiratory gas from a gas source along the inspiratory conduit to the conduit connector 1300 and return at least a portion of the excess or exhaled respiratory gas from within the cushion module 1010 through the conduit connector 1300 to the gas source along the exhalation conduit. While the Y-shaped component of the bilimb circuit is connected to the conduit connector, the patient interface disclosed herein is assumed to maintain an outlet on the housing 1200 from which at least a portion of the exhaled and excess respiratory gas is discharged from within the cushion module 1010 to the outside of the cushion module 1010.

[0151] The sleeve 1230 includes a key-forming portion 1232. The frame 1400 interacts with the key-forming portion 1232 to ensure their correct alignment when the frame 1400 and the housing 1200 are connected. It will be understood that these key-forming portions 1232 can be replaced with any other suitable structure to ensure the precise alignment of the frame 1400 and the housing 1200, or they can be omitted entirely.

[0152] The housing 1200 includes a series of tabs 1240 projecting outward around its outer circumference. The outer ends of the tabs 1240 are connected to a bead 1245 that extends continuously across all the tabs 1240, thereby forming a series of discontinuous overmolded windows 1250 between the tabs 1240 and the bead 1245. The seal 1100 is formed integrally 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 the bead 1245 are embedded in the elastic material and mechanically interlocked with the seal 1100. Thus, the seal 1100 and the housing 1200 form an integrated cushion module 1010 structure.

[0153] The housing 1200 includes an outlet 1210 from which exhaled and excess respiratory gases can be discharged from the cushion module 1010 and / or from the anatomical dead space of the patient's airway to the outside of the cushion module 1010. In a typical configuration, the outlet 1210 includes a bias vent 1215 with multiple openings extending through the housing 1200. Thus, exhaled and excess respiratory gases can be discharged from within the cushion module 1010 through the bias vent 1215 to the outside of the cushion module 1010 or to the atmosphere.

[0154] In an alternative configuration, the outlet 1210 and the bias vent 1215 may be separate structures located spaced apart from each other. In a further alternative configuration, the patient interface 1000 may also include an auxiliary bias vent 1216.

[0155] In a further alternative configuration, the outlet 1210 of the cushion module 1010 may be in the form of an outlet configured to connect to or fluidize the expiratory conduit of the breathing circuit. Such an expiratory conduit may be used in biliary NIV therapy. In this configuration, exhaled and excess respiratory gases can be discharged from the cushion module 1010 and / or the patient's anatomical dead space and transported from the patient interface 1000, where the exhaled and excess respiratory gases may be filtered or received by a ventilator, flow generator, or other gas source supplying fresh respiratory gas to the cushion module 1010. In such a configuration, the outlet 1210 may be an expiratory conduit connector configured for connection to or fluidize the expiratory conduit.

[0156] The seal 1100 is formed of a soft, elastic material such as silicone or other suitable elastomer. The seal 1100 includes a seal opening 1110. When worn by a patient, the seal opening 1110 surrounds the patient's mouth and nose. The patient contact surface 1120 of the seal 1100 forms a seal portion centered on 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 leakage of the pressurized gas may occur, but such leakage is relatively small so that the supply of pressurized gas to the patient is maintained at a level sufficient to deliver NIV treatment. Thus, the high-pressure breathing gas can be delivered from the cavity 1012 of the cushion module 1010 to the patient's mouth and / or nostrils through the seal opening 1110.

[0157] While this embodiment of the cushion module 1010 includes a single sealing opening 1110, it will 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 cushion module may include two or more oral openings. Alternatively, the cushion module may include two or more nasal openings. In further alternatives, the cushion module may include multiple oral openings and multiple nasal openings.

[0158] As described above, in an alternative embodiment, it will be understood that the seal 1100 may be a full 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 nostrils and is configured to support the base and sides of the patient's nose without extending over or contacting the nasal bridge. Thus, the patient contact surface 1120 of the seal 1100 forms a seal centered on the patient's mouth and nostrils without contacting the patient's nasal bridge. Thus, high-pressure breathing gases can be delivered from the cavity 1012 of the cushion module 1010 to the patient's mouth and nostrils through the oral opening and at least one nasal opening.

[0159] The full subnasal seal 1100 may include a single nasal opening, two nasal openings, or three or more nasal openings. In a configuration with a single nasal opening, the single nasal opening is configured to surround both of the patient's nostrils during use. In a configuration with two nasal openings, each of the two nasal openings is configured to surround one of each of the patient's nostrils during use.

[0160] In a further embodiment, the seal 1100 may be a full-surface seal 1100 in which the seal opening 1110 surrounds the patient's mouth, nose, and eyes when worn by the patient. In this embodiment, the patient contact surface 1120 of the seal 1100 forms a seal centered on the patient's mouth, nose, and eyes. Thus, high-pressure respiratory gases can be delivered from the cavity 1012 of the cushion module 1010 to the patient's mouth and / or nostrils through the seal opening 1110.

[0161] In a further embodiment, the seal 1100 may be a helmet-type seal 1100 such that, when worn by a patient during use, the seal opening 1110 surrounds and seals the patient's neck, positioning the patient's head within the cavity 1012 of the cushion module 1010. Thus, high-pressure breathing gases can be delivered directly from the cavity 1012 of the cushion module 1010 to the patient's mouth and / or nostrils.

[0162] The conduit connector 1300 of the patient interface 1000 includes a hollow connector body 1320 defining a lumen with a ball connector 1322 at a first end 1324, a swivel connector 1350 at a second end 1326, and an asphyxiation prevention 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 passage for respiratory gas from the conduit of the breathing circuit into the cushion module 1010.

[0163] The ball connector 1322 includes a convex spherical segment configured to receive into a corresponding concave spherical segment of the ball socket 1402 of the frame 1400, forming a ball joint that allows for 3 degrees of rotational movement between the frame 1400 and the conduit connector 1300. The swivel connector 1350 is configured to connect to the conduit of the respiratory gas supply source in order to supply pressurized respiratory gas to the cushion module 1010. The swivel connector 1350 can rotate with a single degree of freedom, also known as swiveling. Together, the swivel connector 1350 and the ball connector 1322 function to isolate the force applied by the conduit from the patient interface 1000.

[0164] The connector body 1320 includes a bend between the first end 1324 and the second end 1326 such that the gas flow through the conduit connector 1300 undergoes a change in direction 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 oblique angle.

[0165] Those skilled in the art will understand that, in an alternative embodiment, the connector body 1320 may be provided without a bend between the first end 1324 and the second end 1326, such that the flow path through the connector body 1320 is substantially straight or linear.

[0166] In an alternative embodiment, the conduit 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, and a single swivel connector 1350 or a single ball connector at one of the first end 1324 or second end 1326 of the connector body 1320. Alternatively, the conduit connector 1300 may completely omit the ball connector 1322 and the swivel connector 1350 to form a fixed connector body 1320 between the cushion module 1010 and the conduit.

[0167] The second end 1326 of the conduit connector 1320 further includes a structure configured to work with the asphyxiation prevention valve 1330 to allow ambient air into the patient interface in the event of a failure of the breathing gas supply source or an obstruction of the conduit for transporting gas from the gas source to the patient interface 1010. More specifically, the second end 1326 includes an opening 1327. A spine 1328 is positioned adjacent to the opening 1327 and supports a panel 1329 spaced apart from the opening 1327. The spacing of the panel from the opening 1327 forms a gap into which ambient air can access the opening.

[0168] The choking prevention valve 1330 includes a valve seat 1331 and a valve seal 1336. The valve seat 1331 includes a sealing surface 1332 on which the valve seal 1336 seals the choking prevention valve 1330. The valve seat 1331 further includes a sleeve 1333 having a bead 1334 projecting radially outward. The bead 1334 is located at the end of the sleeve 1333. The valve seat 1331 further includes a spigot 1335 for coupling with the valve seal 1336.

[0169] The valve seal 1336 includes a flap 1337 that can transition between an open position, in which the conduit connector 1300 is open to the flow of breathing gas from the gas source, and a closed position, in which the conduit connector 1300 is closed to the flow of breathing gas from the gas source. In the open position, ambient air access to the inside of the conduit connector 1300 is prevented, and in the closed position, ambient air access to the inside of the conduit connector 1300 is permitted. In the illustrated embodiment, the flap 1337 is formed of a flexible material. The flap 1337 is joined to a lug 1338 by a hinge 1339. The hinge 1338 includes a portion of flexible material with reduced wall thickness. The lug 1338 is configured to assist in positioning the valve seal 1336 within the end of the second end 1326 of the connector body 1320. Additionally, the lug 1338 includes a recess 1340 that is adapted to receive a spigot 1335. The fitting of the spigot 1335 within the recess 1340 correctly orients the valve seal 1336 on the valve seat 1331.

[0170] When pressurized breathing gas is supplied from the source, it flows through the conduit connector 1300 into the cushion module 1010. The high pressure of the breathing gas causes the flap 1337 to swing around the hinge 1339, covering the opening 1327 of the second end 1326 of the connector body 1320. This represents the “open position” described above, where the flap 1337 prevents ambient air from entering the conduit connector 1300 through the opening 1327. If the breathing gas source fails or the conduit connected to the source becomes blocked, the suffocation prevention valve 1330 closes because the air pressure inside the conduit connector 1300 is equal to the air pressure outside the conduit connector 1300, and this causes the flap 1337 to move to the “closed position” described above due to the inherent restorative force of the flexible material forming the hinge 1339. In the closed position, the opening 1327 is exposed inside the conduit connector 1300 so that the patient's natural breathing cycle draws air through the opening 1327 into the conduit connector 1300 and the cushion module 1010.

[0171] The valve seat 1331 includes a radially projecting step configured to connect with the conduit connector 1300. In particular, the step is configured to mate into the second end 1326 of the connector body 1320. The connection may include a snap-fit ​​connection or a permanent fixation such as welding or adhesive fastening.

[0172] The valve seat 1331 is coupled to a swivel connector 1350, which is configured to connect to a conduit from a breathing gas source. The swivel connector 1350 includes a shoulder portion 1352 projecting radially inward, the shoulder portion 1352 being able to cooperate with a stepped portion of the valve seat 1331 to connect the valve seat 1331 to the swivel connector 1350. The connection is a snap-fit ​​connection. The snap-fit ​​connection may be removable or a one-time connection. However, in other embodiments, the connection may include permanent fixation, such as welding or adhesive fastening.

[0173] The frame 1400 includes a central body portion 1401 which includes one or more channels for transporting respiratory gas from a gas source to a cushion module 1010 via a conduit connector 1300, and thus to the patient. The frame 1400 includes one or more upper headgear connectors 1410 and one or more lower headgear connectors 1420 which are configured to work with a headgear 1900 (such as elastic straps) to wear the patient interface 1000 on the patient. One or more upper headgear connectors 1410 are configured to work with one or more upper straps of each of the headgear 1900, while one or more lower headgear connectors are configured to work with one or more lower straps of each of the headgear 1900. The headgear 1900 operates by pressing the patient interface 1000 against the patient's face to form a substantially airtight seal when high-pressure respiratory gas is delivered to the patient via the patient interface 1000.

[0174] In the illustrated embodiment, one or more upper headgear connectors 1410 include a first upper headgear connector slot 1412 on a first side of the theoretical central plane of the frame 1400 (substantially shown along line AA' in Figure 4) and a second upper headgear connector slot 1414 on a second side of the theoretical central plane of the frame 1400. Each slot is configured to receive an individual upper strap of the headgear 1900. The strap may be received in the slot permanently or removablely by, for example, being inserted through the slot, looped back to itself, and secured in place by a hook-and-loop connection. In an alternative embodiment, slots 1412, 1414 may be replaced with any suitable structure for permanently or removablely cooperating with the upper headgear strap. Preferred connection structures may include connectors for releasably receiving clips of individual straps via mechanical, magnetic, or adhesive connections.

[0175] In the illustrated embodiment, one or more lower headgear connectors 1420 include a first lower headgear connector 1422 on a first side surface of the theoretical central plane of the frame 1400 and a second lower headgear connector 1424 on a second side surface of the theoretical central plane of the frame 1400. Each headgear connector 1420 is configured to receive individual lower straps of the headgear. Each lower headgear connector 1422, 1424 includes a bar configured to removably receive clips of individual lower headgear straps via mechanical connections such as hook and post connections. In an alternative embodiment, the connectors may be replaced with any suitable structure for permanently or removably cooperating with the lower headgear straps and / or clips of the lower headgear straps, such as the connection method described above in relation to the upper straps and one or more upper headgear connectors 1410. Specifically, a preferred connection structure may include one or more lower headgear connectors 1420 on the frame 1400 to removably receive clips of individual lower straps via mechanical, magnetic, or adhesive connections.

[0176] The illustrated embodiment includes a frame 1400, but the headgear connectors 1410, 1420 may be integrated with or connected to the housing 1200 in an alternative configuration. In the above case, the frame 1400 is not necessary and can be omitted from such a configuration, but the housing 1200 integrates these features. It will be understood that all features described herein with respect to the frame 1400 can be alternatively incorporated into the housing 1200.

[0177] The frame 1400 further includes a connector sleeve 1430 which includes one or more arched fingers 1432. In the illustrated embodiment, the connector sleeve 1430 includes four arched fingers 1432. The connector sleeve 1430 has an inner wall 1434 which includes 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 into the sleeve 1230 of the housing 1200. The arched fingers 1432 are shaped and spaced apart to form a complementary mating with keying portions 1232. The alignment of the keying portions 1232 between the fingers 1432 ensures that the frame and the housing 1200 are properly aligned when they are mated together.

[0178] As described above, it will be understood that the connector sleeve 1430 of the frame 1400 may securely receive the conduit connector 1300 without requiring the ball socket 1402. In such embodiments, the conduit connector 1300 is permanently connected directly or indirectly, or is formed integrally with the connector sleeve 1430.

[0179] Each arched finger 1432 has an end with an arched flange portion 1433 that forms a snap fit with a lip 1231 projecting radially inward from the sleeve 1230. The snap fit holds the frame 1400 to the housing 1200. The snap fit may be releasable or may be a permanent mating between the frame 1400 and the housing 1200.

[0180] Alternatively, the arched 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 connected to the housing 1200 by any conventional means such as adhesive or welding. For example, the frame 1400 may be permanently connected to the housing 1200 by ultrasonic welding the housing 1200 and the frame 1400 together as a single unit.

[0181] As described above, the general form of the patient interface 1000 can be modified. One such modification of the general form, 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, the description should be read as including the option of an integrally formed component that functions in the same way as both the housing 1200 and frame 1400.

[0182] Further considering variations of the general form of the patient interface 1000, another variation of the general form applicable to the embodiments described below is that the housing 1200 and seal 1100 are integrally formed from the same material. In other words, the patient interface 1000 may include an integral structure of a single material that performs the same function as both the housing 1200 and seal 1100. In such embodiments, the housing 1200 can be formed from the same material as the seal 1100, for example, an elastomer material such as silicone. In variations where additional rigidity is required for the integral elastomer housing 1200 and seal 1100, the thickness and / or hardness of the elastomer material is intended to vary in local areas to provide such rigidity. The varying hardnesses can be achieved by any suitable known manufacturing technique, such as two-shot injection molding or overmolding.

[0183] Referring to Figures 10-24, a second embodiment of the patient interface 2000 is shown. The patient interface 2000 is a variation of the general form of the patient interface 1000 and incorporates all components and functions of the patient interface 1000 unless otherwise specified. More specifically, the patient interface 2000 incorporates at least the frame 1400, conduit connector 1300, and seal 1100 of the patient interface 1000. The patient interface 2000 has a housing 2200 that is slightly different from the housing 1200 of the patient interface 1000. The housing 2200 is configured to connect to the exhaust conduit 2500. This difference in the housing 2200 is described below, and separately, it should be understood that the housing 2200 includes all the features and functions of the housing 1200.

[0184] Furthermore, due to the changes in housing 2200, the reference numbers for cushion module 2010 formed by housing 2200 and seal 1100, and for cavity 2012 defined by cushion module 2010, have been updated. However, it should be understood that the descriptions of cushion module 1010 and cavity 1012 are equally applicable to cushion module 2010 and cavity 2012, and all features and functions should be incorporated. Features of housing 2200 that are the same as those of housing 1200 are indicated by the same reference number, but the leading number is "2" instead of "1".

[0185] As described above, the patient interface 2000 differs from the patient interface 1000 primarily in that it further includes an exhaust conduit 2500. The exhaust conduit 2500 is located within the cavity 2012 of the cushion module 2010. The exhaust conduit 2500 includes an exhaust conduit inlet 2510 located at a first end of the exhaust conduit 2500. The exhaust conduit 2500 also includes an exhaust conduit outlet 2505 located at a second end of the exhaust conduit 2500. The exhaust conduit 2500 defines an exhaust flow path 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 cushion module 2010. As a result, the exhaust conduit inlet 2510 is in fluid communication with the outlet 2210 of the cushion module 2010 via the exhaust flow path 2501.

[0186] The exhaust conduit 2500 includes a body 2560, a manifold 2550 connected to the body 2560, and one or more prongs 2530 extending from the manifold 2550. These may be separate components permanently or detachably connected to one another, or they may be part of an integrated exhaust conduit 2500. Each of the body 2560, the manifold 2550, and the one or more prongs 2530 defines a portion of the exhaust passage 2501 through the exhaust conduit 2500.

[0187] For example, referring to Figure 18, the patient interface 2000, and consequently the exhaust conduit 2500, are shown in a cross-sectional side view. The body 2560 includes a base 2566 at a first end. The base 2566 is configured to connect to the inner surface of the housing 2200. The base 2566 connects to the housing 2200 at a position surrounding the outlet 2210. The connection may be removable or permanent and may be achieved by any preferred means such as welded connection, overmolded connection, mechanical connection, magnetic connection, or adhesive connection.

[0188] In one embodiment, the connection between the base 2566 and the housing 2200 is a mechanical connection, and 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, tapers, 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.

[0189] In one example of 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 creates a seal that is substantially airtight at the intended gas pressure to which the cushion module 2010 is exposed for 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, while the base 2566 includes 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 individual male and female connectors may be a permanent, one-time connection instead of a removable connection.

[0190] 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 having a tapered outer surface, and the housing 2200 includes a female tapered connector having a tapered inner surface 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 creates a seal that is substantially airtight at the intended gas pressure to which the cushion module 2010 is exposed for use. Alternatively, the housing 2200 may include a male tapered connector, and the base 2566 includes a female tapered connector configured to receive the male tapered connector of the housing 2200.

[0191] In another embodiment, the connection between the base 2566 and the housing 2200 may be a welded connection. In this embodiment, the base 2566 is ultrasonically welded to the housing 2200 to form a permanent connection.

[0192] In another embodiment, the connection between the base 2566 and the housing 2200 may be an adhesive connection. In this embodiment, the base 2566 is bonded to the housing 2200 to form a permanent connection.

[0193] In another embodiment, the base 2566 may be omitted. In this embodiment, the body 2560 or a portion of the body 2560 may be integrally formed with the housing 2200. Thus, the integral formation does not require additional connecting means between the body 2560 and the housing 2200. This integral formation can be achieved, for example, by molding the housing 2200 and the body 2560 in a single molding process, or by forming the body 2560 on the housing 2200 in a two-shot or overmolding process to form an integrated structure.

[0194] In the illustrated embodiment, it should be understood that the body 2560, specifically the base 2566, is connected to the housing 2200 as a result of the outlet 2210 of the cushion module 2010 being located in the housing 2200. However, in an alternative embodiment where the outlet 2210 is located on the seal 1100 or on the integrated frame housing cushion module 2010, the body 2560, specifically the base 2566, may then be connected to any component including the outlet 2210 at a position surrounding the outlet 2210. In other words, the body 2560 is intended to be connected at a position surrounding the outlet 2210, regardless of the outlet 2210's location.

[0195] The body 2560 extends between the housing 2200 and the manifold 2550. In the illustrated embodiment, the body 2560 is in 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 enables a gas flow path between the first end and the second end. As previously stated, the body 2560 defines a portion of the exhaust flow path 2501 of the exhaust conduit 2500. In the illustrated embodiment, the body 2560 can be described as a hollow conduit, duct, or pipe.

[0196] In an alternative embodiment, a portion 2565 of the body 2560 may be flexible. Such flexibility allows it to be repeatedly deformed without causing structural damage. The portion 2565 makes it possible to adjust the exhaust conduit 2500, namely the orientation and / or position of the exhaust conduit 2500 relative to the seal 1100, or more specifically, the orientation and / or position of the exhaust conduit 2500 in the manifold 2550. The portion 2565 makes it possible to adjust the orientation and / or position of one or more prongs 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 to allow for repeated deformation without causing structural damage. To achieve the desired flexibility, the body 2560 may be composed of one or more combinations of materials, such as plastic material, elastomer material, metallic material, or elastomer conduits containing metal-reinforced wire or embedded metal wire.

[0197] Those skilled in the art will understand that in alternative embodiments, the size and / or position of the manifold 2550 and one or more prongs 2530 may render the body 2560 redundant. In such embodiments, the manifold 2550 may connect to the housing 2200 or extend directly from the housing 2200. In this situation, any of the above-described features and / or functions of the body 2560 can be incorporated into either the housing 2200, the manifold 2550, or both.

[0198] In the illustrated embodiment, the manifold 2550 connects to and / or extends from the body 2560, and one or more prongs 2530 connect to and / or extend from the manifold 2550. The manifold 2550 includes a manifold outlet 2552, which is configured to connect to a manifold connector 2564 of the body 2560 so that the manifold outlet 2552 and the body 2560 are in fluid communication.

[0199] The manifold 2550 may be detachably or permanently connected to the body 2560. Such connections may be made via any conventional means such as mechanical fasteners, adhesives, welding, two-shot molding, overmolding, or tapered connections. For example, the manifold connector 2564 and the manifold outlet 2552 may be connected via ultrasonic welding, permanent or detachable snap-fit ​​connections, or adhesives applied to the mating surfaces of the two components. The manifold 2550 may also be overmolded onto the body 2560, where the body 2560 is formed in a first molding process and then placed in a molding tool where the manifold 2550 is overmolded onto the body 2560 to form a permanent connection. Alternatively, the body 2560 and the manifold 2550 may be formed separately and then joined by an overmolding process, where the material is overmolded onto both components to form a permanent connection between the manifold 2550 and the body 2560.

[0200] Part or all of the manifold 2550 may be formed integrally with the body 2560 as a single component. In such embodiments, it will be understood that the body 2560 and the manifold 2550 may be understood as part of an integrated structure that includes both the body 2560 and the manifold 2550. Thus, the manifold connector 2564 and the manifold outlet 2552 may be omitted if they are not required or if they are considered a transitional portion between the body 2560 and the manifold 2550 of the integrated structure. Features and / or functions separately disclosed with respect to the body 2560 and the manifold 2550 are retained in this integrated structure.

[0201] The manifold 2550 forms part of the exhaust passage 2501. The manifold 2550 is primarily configured to receive gas from one or more prongs 2530 and deliver the gas to the body 2560, where the gas is ultimately delivered to the outlet 2210 of the housing 2200. From there, the gas flows out of the cushion module 2010 through the outlet 2210. In this embodiment, the outlet 2210 is a bias vent 2215. In other embodiments, the outlet 2210 may be configured to connect to an exhalation conduit.

[0202] In the illustrated embodiment, the manifold 2550 further includes a face contact portion 2554. The face contact portion 2554 is configured to contact one or more of the patient's upper lip, philtrum, or nostrils. Such a connection may support or assist in positioning one or more prongs 2530 in a desired position. The face contact portion 2554 includes a relatively soft material which may help avoid or minimize discomfort to the patient. For example, the face contact portion 2554 may include an elastomer material such as silicone or rubber. In the illustrated embodiment, the manifold 2550 has a dual-material structure. In this embodiment, the manifold 2550 includes a rigid plastic portion including a manifold outlet 2552 and an elastomer portion including the face contact portion 2554. Alternatively, the entire manifold 2550 may include an elastomer material. Further alternatively, substantially the entire manifold 2550 may include an elastomer material, providing support where only minimal rigid components are needed. In such embodiments, the manifold 2550 may consist substantially of an elastomer material, with only the manifold outlet 2552 being formed of a rigid material.

[0203] In an alternative embodiment, the face contact portion 2554 does not have to be configured to come into contact with the patient's face during use, but may still be formed of an elastomer material and instead be configured to avoid any discomfort that would result from any unintended contact between the manifold 2550 and the patient's face.

[0204] In the illustrated embodiment, at least a portion of the face contact portion 2554 of the manifold 2550 is concave when viewed in the proximal-distal direction to conform to the shape of the patient's upper lip or philtrum.

[0205] One or more prongs 2530 extend from the manifold 2550 to the exhaust conduit inlet 2510. In the illustrated embodiment, the exhaust conduit 2500 includes a first prong 2532 and a second prong 2540, the first prong 2532 extending from the manifold 2550 to a first free end 2532, the first free end including a first exhaust conduit inlet 2515, and the second prong 2540 extending from the manifold 2550 to a second free end 2542, the second free end including a second exhaust conduit inlet 2520.

[0206] In the illustrated embodiment, the first prong 2532 and the second prong 2540 are non-sealing nasal prongs. Non-sealing nasal prongs are not configured to form a seal with each of the patient's nostrils during use. In other words, the cross-sectional areas of the first prong 2532 and the second prong 2540, at their individual free ends 2532, 2542, are both designed to be less than the cross-sectional area of ​​the intended patient nostril. Gas is intended to be able to enter and exit the patient's nostril through the gap defined between the outer surfaces of the first and second prongs 2532, 2540 and the inner surfaces of the user's nostril.

[0207] In an alternative embodiment, the exhaust conduit 2500 may include only a single prong 2532 and therefore only a single exhaust conduit inlet 2515. In this configuration, the first prong 2532 extends from the manifold 2550 to a first free end 2532, the first free end including a first exhaust conduit inlet 2515.

[0208] In embodiments comprising only a single prong, the first prong 2532 may be either an unsealing nasal prong or a sealing nasal prong. In embodiments where the first prong 2532 is a sealing prong, the first prong 2532 is configured to engage with the inner surface or rim of an individual nostril among the patient's nostrils and form a seal with it. As described above, in embodiments where the first prong 2532 is an unsealing prong, the first prong 2532 is designed to have a cross-sectional area less than the intended cross-sectional area of ​​the patient's nostril so that no seal is formed between the first prong 2532 and the inner surface of an individual patient nostril.

[0209] The exhaust conduit inlet 2510 has a cross-sectional area that includes a first exhaust conduit inlet 2515 and, where applicable, a second exhaust conduit inlet 2520. This cross-sectional area of ​​the exhaust conduit inlet 2510 is configured to be less than the cross-sectional area of ​​the inlet 2220 of the housing 2200. In the illustrated embodiment, all gas entering the cushion module 2010 enters through the inlet 2220, and substantially all gas leaving the cushion module 2010, except for unintended leaks, exits through the outlet 2210. The exhaust conduit 2500 is in sealed fluid communication with the outlet 2210 of the housing 2200, and therefore the reduced cross-sectional area of ​​the exhaust conduit inlet 2510 compared to the inlet 2220 of the housing 2200 creates a flow restriction that accelerates the gas flow into the exhaust conduit 2500 when a pressurized gas flow flows into the cushion module 2010 through the inlet 2220 and then into the exhaust conduit 2500 to exit the cushion module 2010. The reduced cross-sectional area of ​​the flow path creates a pressure drop that accelerates the gas flow entering the exhaust conduit 2500. The importance of this gas acceleration will be explained in the following paragraphs.

[0210] In the illustrated embodiment, the flow restriction described in the above paragraph is caused by the exhaust conduit inlet 2510 having a cross-sectional area less than the cross-sectional area of ​​the inlet 2220 of the housing 2200. However, it is assumed that this flow restriction may be located elsewhere in the exhaust conduit 2500, or more specifically, elsewhere in one or more prongs 2530, manifold 2550, or body 2560.

[0211] In the illustrated embodiment of the patient interface 2000, the ratio of the cross-sectional areas of the first exhaust conduit inlet 2515 to the second exhaust conduit inlet 2520 is 1:1. That is, the cross-sectional areas of both exhaust conduit inlets 2515 and 2520 are equal. However, in an alternative embodiment, the cross-sectional area of ​​the first exhaust conduit inlet 2515 does not have to be equal to the cross-sectional area of ​​the second exhaust conduit inlet 2520. The ratio of the cross-sectional area of ​​the first exhaust conduit inlet 2515 to the cross-sectional area of ​​the second exhaust conduit inlet 2520 can 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 conduit inlet 2515 to the cross-sectional area of ​​the second exhaust conduit inlet 2520 is 1:3.

[0212] In addition to having different exhaust conduit inlet cross-sectional areas, or instead, the first prong 2532 and the second prong 2540 may differ in shape and / or size in at least one aspect, for example, in the diameter, length, or shape of the prongs. Such embodiments in which the first prong 2532 and the second prong 2540 have different shapes and / or sizes may be described as having asymmetrical first and second prongs 2532, 2540.

[0213] In the illustrated embodiment, the exhaust conduit 2500 is configured to prevent gas from entering the exhaust passage 2501 from the cavity 2012 of the cushion module 2010, except through the exhaust conduit inlet 2510, and to prevent gas from exiting the exhaust passage 2501 to the cavity 2012. The exhaust conduit 2501 is an enclosed, sealed passage extending from the exhaust conduit inlet 2510 to the exhaust conduit outlet 2505.

[0214] In the previous paragraph, the exhaust conduit 2500 was described in terms of its subcomponents: a body 2560, a manifold 2550, and one or more prongs 2530. However, in an alternative embodiment, the exhaust conduit 2500 may include a body 2560 formed integrally with the housing 2200 as a single rigid component, while one or more prongs 2530 may be constructed from an elastomer or flexible material and connected to the integrated housing 2200 and exhaust conduit body 2560. For example, the body 2560 of the exhaust conduit 2500 may be formed integrally with the housing 2200. The integrally formed body 2560 and housing 2200 may include a rigid plastic material. One or more prongs 2530 may be separately formed from an elastomer material and then connected to the integrally formed housing 2200 and the body 2560 of the exhaust conduit 2500.

[0215] In the illustrated embodiment, the exhaust conduit 2500 is permanently or removablely connected 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 cushion module 2010. This is thought to be beneficial in improving patient comfort by reducing interference or interaction with the flexible seal 1100, which is configured to come into contact with 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 connected to a portion of the seal 1100 away from the patient contact surface 1120.

[0216] The exhaust conduit 2500 can be designed to be retrofitted to an existing patient interface. This enables the exhaust conduit to be sold separately from the rest of the patient interface 2000. In such a situation, the exhaust conduit 2500 is positioned within the cavity 1012 of the existing patient interface, and the exhaust conduit outlet 2505 is in fluid communication with the outlet or bias vent of the existing patient interface. By doing so, the exhaust conduit 2500 can be fitted to the existing patient interface to improve the performance of these existing patient interfaces.

[0217] Referring to FIGS. 23 and 24, for illustrative purposes, the patient interface 2000 is shown in a cross-section along line B-B' adapted to a patient anatomical model (also shown in cross-section). In FIG. 23, the patient interface 2000 is shown worn on the patient with the patient's mouth open. In FIG. 24, the patient interface 2000 is shown worn on the patient with the patient's mouth closed. The arrows indicate the direction of the gas flow that enters the cushion module 2010 through the inlet 2220 and exits the cushion module 2010 through the outlet 2210 while being worn on the patient without respiration occurring. The relative size of the arrows should not be interpreted as an indication of gas flow rate or gas velocity. During respiration, additional gas flow paths are formed, and it will be understood that this is described beyond that. However, for the purpose of explanation, since the effect of the patient interface 2000 is considered to be most prominent at the end of the exhalation cycle which can realistically be exemplified in a situation where no respiration is taking place, it is considered that the general operation of the patient interface 2000 can be appropriately explained while ignoring respiration.

[0218] When the patient interface 2000 is worn by a patient, the exhaust conduit 2500 is arranged such that the exhaust conduit inlet 2510 is disposed within one or each of the patient's nostrils, or at a position adjacent to and below one or each of the patient's nostrils and adjacent to the patient's upper lip, or at a position directly adjacent to one or each of the patient's nostrils. In other words, the exhaust conduit inlet 2510 is located within, adjacent to, or proximate to one or each of the patient's nostrils.

[0219] More specifically, in an embodiment including a first exhaust conduit inlet 2515 and a second exhaust conduit inlet 2520, the first exhaust conduit inlet 2515 is configured to be disposed within the first nostril of the patient's nostrils, or at a position adjacent to and below the first nostril of the patient's nostrils and adjacent to the patient's upper lip, or at a position directly adjacent to the first nostril of the patient's nostrils, while the second exhaust conduit inlet 2520 is configured to be disposed within the second nostril of the patient's nostrils, or at a position adjacent to and below the second nostril of the patient's nostrils and adjacent to the patient's upper lip, or at a position directly adjacent to the second nostril of the patient's nostrils.

[0220] In an embodiment including a single exhaust conduit inlet 2515, the first exhaust conduit inlet 2515 is configured to be disposed within the first nostril of the patient's nostrils, or at a position adjacent to and below the first nostril of the patient's nostrils and adjacent to the patient's upper lip, or at a position directly adjacent to the first nostril of the patient's nostrils.

[0221] Referring to Figure 23, the patient interface 2000 is worn on the patient with their mouth open and no breathing occurring, and pressurized gas is delivered to the patient interface 2000 via the conduit connector 1300. The flow of pressurized gas enters the cushion module 2010 via the inlet 2220, and any excess pressurized gas from within the cushion module 2010 and / or from within the patient's airway then flows into the exhaust conduit 2500 via the exhaust conduit inlet 2510, and the gas then moves along the exhaust flow path 2501 through the outlet 2210 of the cushion module 2010 and exits the cushion module 2010. The intended placement of the exhaust conduit inlet 2510 relative to the patient's nostril(s) as described above (including the placement of either or both of the first exhaust conduit inlet 2515 and the second exhaust conduit inlet 2520) forms a first and second critical flow path for the gas to enter the exhaust conduit 2500 via the exhaust conduit inlet 2510.

[0222] The first important flow path is from within the cushion module 2010 through the patient's mouth into the patient's oral cavity, through the patient's throat, into the patient's nasal cavity, (1) to the exhaust conduit inlet 2510 if the exhaust conduit inlet 2510 is located in the patient's nostril(s), or (2) exiting from one or more of the patient's nostrils and extending to the exhaust conduit inlet 2510 if the exhaust conduit inlet 2510 is located adjacent to one or more of the patient's nostrils, or below one or more of the patient's nostrils, adjacent to the patient's upper lip, or directly adjacent to one or more of the patient's nostrils. In all situations, this gas flow entering the patient's oral cavity and exiting through the nasal cavity is thought to cause anatomical dead space flushing of at least part of the patient's oral cavity, throat, and nasal cavity.

[0223] A second important flow path extends from within the cushion module 2010 into the patient's nasal cavity through one or more of the patient's nostrils, where the gas flow is decelerated and / or its direction is changed, allowing the gas flow to enter the exhaust conduit inlet 2510 if the exhaust conduit inlet 2510 is located within one or more of the patient's nostrils, or (2) through the space defined between the patient's upper lip and / or external nostrils and the exhaust conduit 2500, where the exhaust conduit inlet 2510 is located directly adjacent to 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. In the first situation, the gas flow into the nasal cavity and then into the exhaust conduit inlet 2510 is thought to cause anatomical dead space flushing of at least a portion of the patient's nasal cavity. In the second situation, the gas flow guided between the patient's upper lip and / or external nostrils and the exhaust conduit 2500 causes acceleration of the gas flow due to the limited cross-sectional area of ​​the flow path. This acceleration is likely to cause at least some gas flow to enter the patient's nasal cavity through one or more nostrils before deceleration and / or a change of direction, exit the nasal cavity through one or more nostrils, and then enter the exhaust conduit inlet 2510. This portion of the gas flow entering the nasal cavity is thought to result in some anatomical dead space flushing of the patient's nasal cavity.

[0224] Referring to Figure 24, the patient interface 2000 is worn on the patient with their mouth closed and no breathing occurring, and pressurized gas is delivered to the patient interface 2000 via the conduit connector 1300. The flow of pressurized gas enters the cushion module 2010 via the inlet 2220, and any excess pressurized gas from within the cushion module 2010 and / or from within the patient's airway then flows into the exhaust conduit 2500 via the exhaust conduit inlet 2510, and the gas then moves along the exhaust flow path 2501 through the outlet 2210 of the cushion module 2010 and exits the cushion module 2010. However, because the patient's mouth is closed, only a second important flow path is formed. The second flow path will be described in detail in the preceding paragraph.

[0225] Since the gas flow through both the first and second critical pathways is thought to induce some degree of anatomical dead space flushing, the patient interface 2000 is considered to offer significant advantages over conventional non-invasive ventilation masks. The ability to provide pressure support and simultaneous dead space flushing with the patient's mouth open or closed is advantageous in NIV therapy. Additionally, in embodiments where the exhaust conduit 2500 is removable, it is envisioned that the patient interface 2000 with the exhaust conduit 2500 removed can be used to provide standard NIV therapy when such an outcome is desired. For example, it is envisioned that a patient may only require anatomical dead space flushing during a discontinuous period of one day. This would allow the patient interface 2000 to be used over alternating periods with the exhaust conduit 2500 in place and with the exhaust conduit 2500 removed.

[0226] In alternative embodiments of the exhaust conduit 2500, which includes a single prong 2532 that is a sealed prong, it should be understood that the second critical flow path will differ from that described in the previous paragraph. In such embodiments, the second critical flow path extends from within the cushion module 2010, through the patient's first nostril, into the patient's nasal cavity on the first side of the septum, and then exits the patient's nasal cavity on the second side of the septum by entering the exhaust conduit inlet 2510 located within the patient's second nostril. In other words, gas enters the nasal cavity from the cushion module 2010 through the first nostril and exits the nasal cavity through the exhaust conduit inlet 2510 located within the second nostril. In this situation, the unidirectional gas flow through the patient's nasal cavity is thought to cause anatomical dead space flushing of the patient's nasal cavity.

[0227] In the previous paragraph, dead space flushing of the patient's anatomical dead space was discussed as an intended benefit of the Patient Interface 2000. The patient's anatomical dead space consists of the total volume of the patient's airway segments that are responsive to directing air into the alveoli and respiratory bronchioles but do not participate in the gas exchange process itself. Thus, the anatomical dead space is the total volume of the patient's leading airways from the nose or mouth to the terminal bronchioles, including the oral cavity, nasal cavity, and pharynx (also called the throat).

[0228] During a patient's respiration, air with a lower CO2 content is inhaled into the lungs, while air with a higher CO2 content is exhaled. At the end of the exhaled 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 during the next respiratory cycle. This rebreathing of high-CO2 content air causes a decrease in the efficiency of gas exchange occurring in the patient's lungs.

[0229] The dead space flushing process replaces at least a portion of the exhaled, higher CO2-content air present in the patient's anatomical dead space with fresh, lower CO2-content air, thereby reducing the amount of exhaled, higher CO2-content air that is inhaled or rebreathed during subsequent inhalation cycles. This reduction in the rebreathing of higher CO2-content air improves the efficiency of gas exchange occurring within the patient's lungs.

[0230] As stated in the previous paragraph, the exhaust conduit inlet 2510 has a cross-sectional area configured to be less than the cross-sectional area of ​​the inlet 2220 of the housing 2200. When pressurized gas is supplied to the cushion module 2010 of the patient interface 2000 during use, the smaller cross-sectional area of ​​the exhaust conduit inlet 2510 compared to the inlet 2220 of the housing 2200 creates a flow restriction that causes a pressure drop and therefore an acceleration of the gas flow into the exhaust conduit 2500. This acceleration of the gas flow into the exhaust conduit 2500 is also thought to cause the intake of ambient gas into the exhaust conduit 2500.

[0231] The intake of gas into the exhaust conduit 2500 at a position surrounding the exhaust conduit inlet 2510 may be advantageous for flushing the patient's anatomical dead space if the exhaust conduit inlet 2510 is located within one or each of the patient's nostrils, or directly adjacent to the patient's nostrils, or below the patient's nostrils and adjacent to the patient's upper lip. When the gas flow is accelerated into the exhaust conduit inlet 2510, gas with a higher CO2 content present in the patient's anatomical dead space may be taken into the exhaust conduit inlet 2510 due to the combination of gas flow acceleration and / or local pressure drop. This is thought to provide anatomical dead space flushing in place of, or in addition to, the anatomical dead space flushing described above in relation to the important flow paths formed during use.

[0232] Referring to Figures 25-42, a third embodiment of the patient interface 3000 is shown. The patient interface 3000 is a modification of the general form of the patient interface 1000 and incorporates all components and functions of the patient interface 1000 unless otherwise specified. More specifically, the patient interface 3000 incorporates at least the frame 1400, headgear 1900, conduit 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 it is configured to connect to the nasal interface 3600. This difference in the housing 3200 is described below, and separately, 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 the same as those of the housing 1200 are indicated by the same reference numbers, but the leading number is "3" instead of "1".

[0233] Furthermore, due to the changes in housing 3200, the reference number for cushion module 3010 formed by housing 3200 and seal 1100, and the cavity 3012 defined by cushion module 3010, have been updated. However, it should be understood that the descriptions of cushion module 1010 and cavity 1012 are equally applicable to cushion module 3010 and cavity 3012, and all features and functions should be incorporated. Features of cushion module 3010 that are the same as those of cushion module 1010 are indicated by the same reference number, but the leading number is "3" instead of "1".

[0234] Patient interface 3000 is also a variation of patient interface 2000 and, unless otherwise specified, functions substantially the same and includes an exhaust conduit 3500 that incorporates all the features of the exhaust conduit 2500. However, patient interface 3000 differs from patient interface 2000 in that the exhaust conduit 3500 is incorporated into the nasal interface 3600. The nasal interface 3600 includes both the exhaust conduit 3500 and the flushing conduit 3610. The nasal interface 3600 is permanently or removablely connected to the housing 3200 and does not directly contact the seal 1100. In other words, the nasal interface 3600 is a separate structure from the seal 1100. The nasal interface 3600 is surrounded by the cavity 3012 of the cushion module 3010.

[0235] The exhaust conduit 3500 is located within the cavity 3012 of the cushion module 3010 and includes an exhaust conduit inlet 3510 located at a first end of the exhaust conduit 3500 and an exhaust conduit outlet 3505 located at a second end of the exhaust conduit 3500. The exhaust conduit 3500 defines an exhaust flow path 3501 extending between the exhaust conduit inlet 3510 and the exhaust conduit outlet 3505. The exhaust conduit outlet 3505 is configured to be in fluid communication with the outlet 3210 of the cushion module 3010. As a result, the exhaust conduit inlet 3510 is in fluid communication with the outlet 3210 of the cushion module 3010 via the exhaust flow path 3501.

[0236] The flushing conduit 3610 is located within the cavity 3012 of the cushion module 3010 and includes a flushing conduit inlet 3612 located at a first end of the flushing conduit 3610 and a flushing conduit outlet 3613 located at a second end of the flushing conduit 3610. The flushing conduit 3610 defines a flushing 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 cushion module 3010. As a result, the flushing conduit outlet 3610 is in fluid communication with the cavity of the cushion module 3010 via the flushing channel 3611.

[0237] 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 channel 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.

[0238] The flushing conduit outlet 3613 is configured to be located near or adjacent to the exhaust conduit inlet 3510, such that the exhaust conduit inlet 3510 and the flushing conduit outlet 2613 are located at the first end of the nasal interface 3600, the exhaust conduit outlet 2505 is located at the second end of the nasal interface 3600, and the flushing conduit inlet 3612 is located between the first and second ends of the nasal interface 3600.

[0239] In the illustrated embodiment, the flushing conduit inlet 3612 is located within the manifold 3550 adjacent to or near the manifold outlet 3552 such that the rigid or semi-rigid portion of the manifold 3550 can partially or completely surround both the manifold outlet 3552 and the flushing conduit inlet 3612. This relatively small rigid or semi-rigid portion of the manifold 3550 can beneficially provide structural integrity to both the manifold outlet 3552 and the flushing conduit inlet 3612 without providing unwanted rigidity to the remaining portion of the manifold 3550, which may separately include a soft elastomeric material.

[0240] Alternatively, the flushing conduit inlet 3612 can be located on the manifold 3550 at a location separate from the manifold outlet 3552. When located at a location separate from the manifold outlet 3552, the flushing conduit inlet 3612 can be partially surrounded or completely surrounded by an additional rigid or semi-rigid portion of the manifold 3550 that is separate from the portion that partially or completely surrounds the manifold outlet 3552.

[0241] In a further alternative embodiment, the flushing conduit inlet 3612 can be located within the body 3560 or within one or more of the prongs 2530. The flushing conduit inlet 3612 is expected to be in fluid communication with the cavity 3012 of the cushion module 3010, but can be located at any suitable location on the nose interface 3600 that allows for this fluid communication. By locating the flushing inlet 3612 within the body 3560 or within a portion of the manifold 3550 near a rigid or semi-rigid structure, structural integrity is provided to the flushing inlet 3612, which can prevent or minimize unwanted blockage or deformation during use.

[0242] The nasal interface 3600 includes a body 3560, a manifold 3550 connected to the body 3560, and one or more prongs 3530 extending from the manifold 3550. These may be separate components permanently or detachably connected to one another, or they may be part of an integrated nasal interface 3600.

[0243] Each of the main body 3560, the manifold 3550, and one or more prongs 3530 defines a portion of the exhaust passage 3501 through the exhaust conduit 3500.

[0244] One or more of the prongs 3530, manifolds 3550, and bodies 3560 define a portion of the flushing passage 3611 through the flushing conduit 3600. In the illustrated embodiment, one or more prongs 3530 and manifolds 3550 each define a portion of the flushing passage 3611.

[0245] For example, referring to Figure 35, the patient interface 3000, and consequently 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 a cushion module 3010. The first end of the nasal interface 3600 connects to the inner surface of the cushion module 3010 in a position surrounding the outlet 3210. In the illustrated embodiment, the body 3560 connects to the housing 3200 in a position surrounding the outlet 3210 when the outlet 3210 is located on the housing 3200. The body 3560 includes a base 3566 at the first end, and the base 3566 is configured to connect to the housing 3200 in a position surrounding the outlet 3210. The connection may be removable or permanent and may be achieved by any preferred means such as welded connection, overmolded connection, mechanical connection, magnetic connection, or adhesive connection.

[0246] In one configuration, the base 3566 and the housing 3200 are mechanically connected. The 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, tapers, 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.

[0247] In one example of 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 creates a seal that is substantially airtight at the intended gas pressure to which the cushion module 2010 is exposed for 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, while the base 3566 includes 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 individual male and female connectors may be a permanent, one-time connection, such as a one-time snap-fit, instead of a removable connection.

[0248] 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 having a tapered outer surface, and the housing 3200 includes a female tapered connector having a tapered inner surface 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 creates a seal that is substantially airtight at the intended gas pressure to which the cushion module 2010 is exposed for use. Alternatively, the housing 3200 may include a male tapered connector, and the base 3566 includes a female tapered connector configured to receive the male tapered connector of the housing 3200.

[0249] In another embodiment, the connection between the base 3566 and the housing 3200 may be a welded connection, where the base 3566 is ultrasonically welded to the housing 3200 to form a permanent connection.

[0250] In another embodiment, the base 3566 may be omitted. The body 3560 or a portion of the body 3560 may be formed integrally with the housing 3200. Thus, integral formation does not require additional connecting means between the body 3560 and the housing 3200. This integral formation can be achieved, for example, by molding the housing 3200 and the body 3560 in a single molding process, or by forming the body 3560 on the housing 3200 in a two-shot or overmolding process to form an integrated structure.

[0251] In the illustrated embodiment, it should be understood that the body 3560, specifically the base 3566, is connected to the housing 3200 as a result of the outlet 3210 of the cushion module 3010 being located in the housing 3200. However, in an alternative embodiment where the outlet 3210 is located on the seal 1100 or on the integrated frame housing cushion module 3010, the body 3560, specifically the base 3566, may then be connected to any component including the outlet 3210 at a position surrounding the outlet 3210. In other words, the body 3560 is intended to be connected at a position surrounding the outlet 3210, regardless of the position of the outlet 2210.

[0252] The body 3560 extends between the housing 3200 and the manifold 3550. In the illustrated embodiment, the body 3560 is a hollow structure having various cross-sections, with 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 enables a gas passage between the first and second ends and defines a portion of the exhaust passage 3501 of the exhaust conduit 3500, as described above. The body 3560 in the illustrated embodiment can be described as a hollow conduit, duct, passage, or pipe.

[0253] In an alternative embodiment, a portion 3565 of the body 3560 may be flexible. Such flexibility allows the portion 3565 to be repeatedly deformed without causing structural damage. The portion 3565 makes it possible to adjust the nasal interface 3600, namely the orientation and / or position of the nasal interface 3600 relative to the seal 1100 of the manifold 3550. The portion makes it possible to adjust the orientation and / or position of one or more prongs 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 to allow for repeated deformation without causing structural damage. To achieve the desired flexibility, the body 3560 may be composed of one or more combinations of materials, such as plastic, elastomer, metal, or elastomer conduits containing metal-reinforced wires or embedded metal wires.

[0254] Those skilled in the art will understand that in alternative embodiments, the size and / or position of the manifold 3550 and one or more prongs 3530 may render the body 3560 redundant. In such embodiments, the manifold 3550 may connect to the housing 3200 or extend directly from the housing 3200. In this situation, any of the above-described features and / or functions of the body 3560 can be incorporated into either the housing 3200, the manifold 3550, or both.

[0255] In the illustrated embodiment, the manifold 3550 connects to and / or extends from the body 3560, and one or more prongs 3530 connect to and / or extend from the manifold 3550. The manifold 3550 includes a manifold outlet 3552, which is configured to connect to a manifold connector 3564 of the body 3560 so that the manifold outlet 3552 and the body 3560 are in fluid communication. The manifold 3550 further includes a flushing conduit inlet 3612 that is in fluid communication with the cavity 3012 of the cushion module 3010.

[0256] The manifold 3550 may be detachably or permanently connected to the body 3560. The connection may be made via any conventional means such as mechanical fasteners, adhesives, welding, two-shot molding, overmolding, or tapered connections. For example, the manifold connector 3564 and the manifold outlet 3552 may be connected via ultrasonic welding, permanent or detachable snap-fit ​​connections, or adhesives applied to the mating surfaces of the two components. The manifold 3550 may also be overmolded onto the body 3560, where the body 3560 is formed in a first molding process and then placed in a molding tool where the manifold 3550 is then overmolded onto the body 3560 to form a permanent connection. Alternatively, the body 3560 and the manifold 3550 may be formed separately and then joined by an overmolding process. For example, material may be overmolded onto both components to form a permanent connection between the manifold 3550 and the body 3560.

[0257] Part or all of the manifold 3550 may be formed integrally with the body 3560. In such embodiments, it will be understood that the body 3560 and the manifold 3550 may be understood as part of an integrated structure that includes both the body 3560 and the manifold 3550. Accordingly, the manifold connector 3564 of the body 3560 and the manifold outlet 3552 of the manifold 3550 may be omitted if they are not required or if they are considered a transitional portion between the body 3560 and the manifold 3550 of the integrated structure. Features and / or functions separately disclosed with respect to the body 3560 and the manifold 3550 are incorporated into this integrated structure.

[0258] In the illustrated embodiment, the manifold 3550 defines a portion of both the exhaust passage 3501 of the exhaust conduit 3500 and the flushing passage 3611 of the flushing conduit 3610. The manifold 3550 is configured to receive gas from one or more prongs 3530 and deliver the gas to the body 3560 through the manifold outlet 3552. The gas is ultimately delivered to the outlet 3210 of the housing 3200 and to the outside of the cushion module 3010. This can be done via either the bias vent 3215 or an outlet configured to connect to the exhalation conduit. The manifold 3550 is further configured to receive gas into the manifold 3550 from the cavity 3012 of the cushion module 3010 through the flushing conduit inlet 3612 and deliver it to one or more prongs 3530.

[0259] The manifold 3550 includes a manifold partition 3553 that defines a manifold exhaust cavity 3554 and a manifold flushing cavity 3555. The manifold exhaust cavity 3554 defines a portion of the exhaust passage 3501. The manifold flushing cavity 3555 defines a portion of the flushing passage 3611.

[0260] Therefore, the manifold 3550 is configured to receive gas from one or more prongs 3530 and transfer the gas through the manifold exhaust cavity 3554 to the manifold outlet 3552 into the body 3560. The manifold 3550 is also configured to receive gas from the cavity 3012 of the cushion module 3010 and transfer the gas through the flushing conduit inlet 3612 to the manifold flushing cavity 3555 and deliver it to one or more prongs 3530.

[0261] In the illustrated embodiment, the manifold exhaust cavity 3554 and the manifold flushing cavity 3555 are formed by a manifold partition 3553 that branches off the internal cavity of the manifold 3550. However, it will be understood that the formation of these two cavities can be achieved without the manifold partition 3553. For example, in an alternative embodiment, the manifold 3550 includes separate manifold exhaust cavities 3554 and separate manifold flushing cavities 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 containing the manifold exhaust cavity 3554 and the manifold flushing cavity 3555, with each cavity being formed separately from each other. In a further alternative embodiment, the manifold 3550 may include a first body containing the manifold exhaust cavity 3554 and a second body containing the manifold flushing cavity 3555.

[0262] In the illustrated embodiment, the manifold 3550 further includes a facial contact portion 3556 configured to contact one or more of the patient's upper lip, philtrum, nasal bridge, or nostrils. Such a connection assists in supporting or positioning one or more prongs 3530 in a desired position. The facial contact portion 3556 comprises a relatively soft material, which may help avoid or minimize discomfort to the patient. For example, the facial contact portion 3556 may comprise an elastomer material such as silicone or rubber.

[0263] In the illustrated embodiment, the manifold 3550 has a dual-material structure comprising a rigid plastic portion including at least a portion of the manifold outlet 3552 and the flushing conduit inlet 3612, and an elastomer portion including the face contact portion 3556.

[0264] Alternatively, the entire manifold 3550 may consist of an elastomer material. Further alternatively, the majority of the manifold 3550 may consist of an elastomer material having only a minimal amount of rigid portion that provides support as needed. In such embodiments, the majority of the manifold 3550 may consist of an elastically deformable elastomer material, with either the manifold outlet 3552 being formed of a rigid plastic material, or the manifold outlet 3552 and the flushing conduit inlet 3612 being formed of a rigid plastic material.

[0265] In an alternative embodiment, the face contact portion 3556 does not have to be configured to come into contact with the patient's face during use, but may still be formed of an elastomer material and instead be configured to avoid any discomfort that would result from any unintended contact between the manifold 3550 and the patient's face.

[0266] In the illustrated embodiment, at least a portion of the face contact portion 3556 of the manifold 3550 is concave when viewed in the proximal-distal direction to conform to the shape of the patient's upper lip, philtrum, and / or nostrils.

[0267] One or more prongs 3530 extend from the manifold 3550 to the exhaust conduit inlet 3510 and the flushing conduit outlet 3613. In the illustrated embodiment, the nose interface 3600 includes a first prong 3531 and a second prong 3540. The first prong 3531 extends from the manifold 3550 to a first free end 3532. The first free end 3532 includes a first discharge conduit inlet 3515 and a first flushing conduit outlet 3614. The second prong 3540 extends from the manifold 3550 to a second free end 3542. The second free end 3542 includes a second discharge conduit inlet 3520 and a second flushing conduit outlet 3615.

[0268] The exhaust conduit inlet 3510 includes both the first exhaust conduit inlet 3515 and the second exhaust conduit inlet 3520. The flushing conduit outlet 3613 includes both the first flushing conduit outlet 3614 and the second flushing conduit outlet 3615.

[0269] In the illustrated embodiment, the first prong 3531 is branched by the first prong partition 3534 to form the first prong exhaust cavity 3536 and the first prong flushing cavity 3538. The second prong 3540 is branched by the second prong partition 3536 to form the second prong exhaust cavity 3546 and the second prong flushing cavity 3548.

[0270] By forming separate exhaust cavities and flushing cavities within each of the one or more prongs 3530, it is possible to separate portions of the exhaust passages 3501 and flushing passages 3611, which extend through the first prong 3531 and the second prong 3540, respectively.

[0271] In the illustrated embodiment, each of the first prong partition 3534 and the second prong partition 3536 is configured to connect to, abut against, join to, or be continuous with the manifold partition 3553. This allows for the continuous separation of a portion of the exhaust passage 3501 and flushing passage 3611 defined by the manifold 3550 and one or more prongs 3530.

[0272] Therefore, the first prong 3531 is configured to receive gas through the first exhaust conduit inlet 3515 and move it through the first prong exhaust cavity 3536 into the manifold exhaust cavity 3554. The first prong 3531 is also configured to receive gas from the manifold flushing cavity 3555 and move it through the first prong flushing cavity 3538 to the outside of the first flushing conduit outlet 3614.

[0273] Similarly, the second prong 3540 is configured to receive gas through the second exhaust conduit inlet 3520 and transfer it through the second prong exhaust cavity 3546 into the manifold exhaust cavity 3554. The second prong 3540 is also configured to receive gas from the manifold flushing cavity 3555 and transfer it through the second prong flushing cavity 3548 to the outside of the second flushing conduit outlet 3615.

[0274] In an alternative embodiment, the first prong partition 3534 and the second prong partition 3546 may be omitted. In this embodiment, portions of the separate exhaust passages 3510 and flushing passages 3611 extending through the first prong 3531 and the second prong 3540 may be separated by any suitable structure that stops the mixing of gas flows occurring between the two passages.

[0275] In the illustrated embodiment, the first prong partition 3534 and the second prong partition 3546 form the first prong exhaust cavity 3536, the first prong flushing cavity 3538, the second prong exhaust cavity 3546, and the second prong flushing cavity 3548, respectively. However, it will be understood that the formation of these cavities can be achieved without the partitions of each prong. For example, in an alternative embodiment, the first prong 3531 may include a separate first prong exhaust cavity 3536 and a separate first prong flushing cavity 3538, and the second prong 3540 may include a separate second prong exhaust cavity 3546 and a separate second prong flushing cavity 3548, with none of the cavities defined by each other's boundaries. In other words, the first prong 3531 may include a body containing a first prong exhaust cavity 3536 and a first prong flushing cavity 3538, each of which is formed separately from the others, and the second prong 3540 may include a body containing a second prong exhaust cavity 3546 and a second prong flushing cavity 3548, each of which is formed separately from the others.

[0276] In further alternative embodiments, the first prong 3531 may include a first body containing a first prong exhaust cavity 3536 and a second body containing a first prong flushing cavity 3538, and the second prong 3540 may include a third body containing a second prong exhaust cavity 3546 and a fourth body containing a second prong flushing cavity 3548.

[0277] In the illustrated embodiment, the first prong 3531 and the second prong 3540 are sealing nasal prongs. The sealing nasal prongs are configured to form a seal with individual nostrils among the patient's nostrils during use. Each of the first prong 3531 and the second prong 3540 includes an outer surface configured to form a seal with the inner surface or rim of individual nostrils among the patient's nostrils. Alternatively or additionally, the outer surfaces of each of the first prong 3530 and the second prong 3540 may form a seal with the outer surface of individual nostrils among the patient's nostrils.

[0278] In an alternative embodiment, the first prong 3531 and the second prong 3540 may be non-sealing nasal prongs. Non-sealing nasal prongs are not configured to form a seal with individual nostrils or nasal openings of the patient during use. In other words, the cross-sectional area of ​​the first prong 3531 and the second prong 3540 at their free ends 3532, 3542, respectively, is designed to be less than the cross-sectional area of ​​the entrance to individual nostrils or nasal openings of the intended patient nostrils or nasal openings.

[0279] In an alternative embodiment, the nose interface 3600 may include only a single prong 3530, and therefore only a single exhaust conduit inlet 3515 and a single flushing conduit outlet 3615. In this configuration, a first prong 3531 extends from the manifold 3550 to a first free end 3532, the first free end 3532 including a first exhaust conduit inlet 3515 and a first flushing conduit outlet 3615. The first prong 3531 is branched by a first prong partition 3536, which includes a first prong exhaust cavity 3536 and a first prong flushing cavity 3538. The first prong discharge cavity 3536 is in fluid communication with the first discharge conduit inlet 3515, and the first prong flushing cavity 3538 is in fluid communication with the first flushing conduit outlet 3615. The first prong 3531 includes an outer surface configured to form a seal with the inner surface and / or outer surface of an individual nostril among the patient's nostrils. The above description is not intended to be limiting, and it will be understood that any features and functions described herein with respect to the first prong 3530 can be incorporated into a nasal interface 3600 configuration that includes only a single prong.

[0280] The illustrated embodiment includes a nasal interface 3600 as a combined assembly, which includes an exhaust conduit 3500 and a flushing conduit 3610. However, it should be understood that in alternative embodiments, the patient interface 3000 may include separate exhaust conduits 3500 and flushing conduits 3610. In this embodiment, each of the exhaust conduit 3500 and flushing conduit 3610 may include separate prongs such that two prongs are positioned in, near, or adjacent to one or both of the patient's nostrils. In such a configuration, all the features and functions of the first prong 3531 and / or the second prong 3540 associated with the exhaust conduit 3500 can be incorporated into the first and / or second exhaust conduit prongs. All the features and functions of the first prong 3531 and / or the second prong 3540 associated with the flushing conduit 3610 can be incorporated into the first and / or second flushing conduit prongs.

[0281] As described above, the nasal interface 3600 may be permanently connected to the housing 3200, or it may be detachably connected to the housing 3200 by a detachable connection between the main body 3560 and the housing 3200, for example, as described above. Alternatively, a portion of the nasal interface 3600 may be integrally formed with the housing 3200, and the remaining portion of the nasal interface 3600 may be detachably or permanently connected to the integrally formed portion of the nasal interface 3600.

[0282] In embodiments where the nasal interface 3600 is integrated with the housing 3200, a portion of the nasal interface 3600 may be overmolded, co-molded, or integrally formed with the housing 3200. Specifically, the body 3560 may be integrally formed with the housing 3200, and the remaining portion of the nasal interface 3600 may be permanently or detachably connected to the body 3560.

[0283] Alternatively, the majority of the nasal interface 3600 may be formed integrally with the housing 3200, while the first prongs 3531 and / or the second prongs 3540 may be constructed from a different material, for example, than the housing 3200, and then connected to the rest of the nasal interface 3600 in a second process. For example, the body 3560 and manifold 3550 may be formed integrally with the housing 3200 by molding an integrated component, while the first prongs 3531 and / or the second prongs 3540 may be formed from an elastomer material in a separate molding process and then connected to the rest of the nasal interface 3600.

[0284] Alternatively, the body 3560 and manifold 3550 of the nose interface 3600 may be formed integrally with the housing 3200. Such integral molding may involve injection molding using a plastic material. Then, the first prongs 3531 and / or the second prongs 3540 may be overmolded with an elastomer material onto the integrally formed components of the housing 3200, body 3560, and manifold 3550. In one example, the plastic material is polycarbonate and the elastomer material is silicone.

[0285] The nasal interface 3600 may be sold separately from the rest of the patient interface 3000. This allows the nasal interface 3600 to be retrofitted to an existing patient interface. In such a scenario, the nasal interface 3600 is located within the cavity of the existing patient interface, and the exhaust conduit outlet 3505 is in fluid communication with the outlet or bias vent of the existing patient interface. In this way, the nasal interface 3600 can be fitted to an existing patient interface to improve the performance of these existing patient interfaces.

[0286] The exhaust conduit inlet 3510 has a cross-sectional area that includes a first exhaust conduit inlet 3515 and, where applicable, a second exhaust conduit inlet 3520. This cross-sectional area of ​​the exhaust conduit inlet 3510 is configured to be less than the cross-sectional area of ​​the inlet 3220 of the housing 3200. In the illustrated embodiment, all gas entering the cushion module 3010 enters through the inlet 3220, and substantially all gas leaving the cushion module 3010, except for unintended leaks, exits through the outlet 3210. The exhaust conduit 3500 is in sealed fluid communication with the outlet 3210 of the housing 3200. The reduced cross-sectional area of ​​the exhaust conduit inlet 3510 compared to the inlet 3220 of the housing 3200 creates a flow restriction that accelerates the gas flow into the exhaust conduit 3500 when the pressurized gas flow flows into the cushion module 3010 through the inlet 3220 and then flows into the exhaust conduit 3500 to exit the cushion module 3010. The reduced cross-sectional area of ​​the flow path creates a pressure drop that accelerates the gas flow entering the exhaust conduit 3500. The importance of this gas acceleration will be explained in the following paragraphs.

[0287] In the illustrated embodiment, the flow restriction described in the above paragraph is caused by the exhaust conduit inlet 3510 having a cross-sectional area less than the cross-sectional area of ​​the housing inlet 3220. However, this flow restriction may be located elsewhere in the exhaust conduit 3500, or more specifically, elsewhere in one or more prongs 3530, manifold 3550, or body 3560. For example, a flow restrictor may be located near or adjacent to the exhaust conduit inlet 3510 in the exhaust passage 3501 to accelerate the gas as it flows through the exhaust conduit 3500.

[0288] In the illustrated embodiment of the patient interface 3000, the ratio of the cross-sectional areas of the first exhaust conduit inlet 3515 to the second exhaust conduit inlet 3520 is 1:1, meaning that the cross-sectional areas of both exhaust conduit inlets are equal. However, in alternative embodiments, the cross-sectional area of ​​the first exhaust conduit inlet 3515 does not have to be equal to the cross-sectional area of ​​the second exhaust conduit inlet 3520. The ratio of the cross-sectional area of ​​the first exhaust conduit inlet 3515 to the cross-sectional area of ​​the second exhaust conduit inlet 3520 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 exhaust conduit inlet 3515 to the cross-sectional area of ​​the second exhaust conduit inlet 3520 is 1:3.

[0289] In addition to having different exhaust conduit inlet cross-sectional areas, or instead, the first prong 3531 and the second prong 3540 may differ in shape and / or size in at least one aspect, for example, in the diameter, length, or shape of the prongs. Such embodiments in which the first prong 3531 and the second prong 3540 have different shapes and / or sizes may be described as having asymmetrical first and second prongs 3531, 3540.

[0290] The flushing conduit outlet 3613 has a cross-sectional area that includes a first flushing conduit outlet 3614 and, if applicable, a second flushing conduit outlet 3615. In the illustrated embodiment, the total cross-sectional area of ​​the flushing conduit outlet 3613 is configured to be less than the cross-sectional area of ​​the flushing conduit inlet 3612.

[0291] The reduced cross-sectional area of ​​the flushing conduit outlet 3613 compared to the cross-sectional area of ​​the flushing conduit inlet 3612 creates a flow restriction at the flushing conduit outlet 3613. This flow restriction accelerates the gas flow exiting the flushing conduit outlet 3613 when the pressurized gas flow flows through the flushing channel 3611. Therefore, during use, the gas flow exits the flushing conduit outlet 3613 at a faster rate than the gas flow enters the flushing conduit inlet 3612 from the cavity 3012 of the cushion module 3010. The importance of this acceleration of the gas is explained in the following paragraphs.

[0292] In alternative embodiments, it will be understood that the necessary flow restriction may occur at or near the flushing conduit outlet 3613 by means other than the cross-sectional area of ​​the flushing conduit outlet 3613. For example, a flow limiter may be located near or adjacent to the flushing conduit outlet 3613 in the flushing channel 3611 to accelerate the gas flow through the flushing conduit 3610.

[0293] Additionally or alternatively, the flushing channel 3611 of the flushing conduit 3610 may taper or decrease in cross-sectional area from the flushing conduit inlet 3612 to the flushing conduit outlet 3613. Combined with, or substituting for, the decreasing cross-sectional area of ​​the flushing channel 3611 at the flushing conduit outlet 3613 compared to the flushing conduit inlet 3612, this taper of the flushing channel 3611 accelerates the gas flow through the flushing conduit 3610.

[0294] In the illustrated embodiment of the patient interface 3000, the ratio of the cross-sectional areas of the first flushing conduit outlet 3614 to the second flushing conduit outlet 3615 is 1:1, meaning that the cross-sectional areas of both flushing conduit outlets are equal. However, in alternative embodiments, the cross-sectional area of ​​the first flushing conduit outlet 3614 does not have to be equal to the cross-sectional area of ​​the second flushing conduit outlet 3615. The ratio of the cross-sectional area of ​​the first flushing conduit outlet 3614 to the cross-sectional area of ​​the second flushing conduit outlet 3615 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 flushing conduit outlet 3614 to the cross-sectional area of ​​the second flushing conduit outlet 3615 is 1:3.

[0295] In the illustrated embodiment, the nasal interface 3600 is permanently or removablely connected to the housing 3200. That is, the nasal interface 3600 does not directly contact the seal 1100. In other words, the nasal interface 3600 is a separate structure from the seal 1100. Furthermore, the nasal interface 3600 is surrounded by the cavity 3012 of the cushion module 3010. This is thought to be beneficial in improving patient comfort by reducing interference or interaction with the flexible seal 1100, which is configured to contact the patient's face. However, it should be understood that in alternative embodiments, the nasal interface 3600 may contact or connect to the seal 1100 at one or more locations without significantly affecting patient comfort. For example, the nasal interface 3600 may connect to a portion of the seal 1100 away from the patient contact surface 1120.

[0296] Referring to Figures 41 and 42, for illustrative purposes, the patient interface 3000 is shown in a cross-section along line E-E' adapted to an anatomical model of the patient (also shown in cross-section). In Figure 41, the patient interface 3000 is shown worn on the patient with their mouth open. In Figure 42, the patient interface 3000 is shown worn on the patient with their mouth closed. Arrows indicate the direction of gas flow entering the cushion module 3010 via the inlet 3220 and exiting the cushion module 3010 via the outlet 3210 while worn on the patient without respiration occurring. The relative size of the arrows should not be interpreted as an indicator of gas flow rate or gas velocity. It will be understood that during respiration, additional gas channels are formed and described beyond them. However, for explanatory purposes, it is considered 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 pronounced at the end of the expiratory cycle, which can realistically be likened to a situation where no respiration is occurring.

[0297] When the patient interface 3000 is worn by the patient, the nasal interface 3600 is positioned such that the exhaust conduit inlet 3510 and the flushing conduit outlet 3613 are located within one or each of the patient's nostrils, or below one or each of the patient's nostrils, adjacent to the patient's upper lip, or directly adjacent to one or each of the patient's nostrils. In other words, the exhaust conduit inlet 3510 and the flushing conduit outlet 3613 are located within, adjacent to, or near one or each of the patient's nostrils.

[0298] More specifically, in an embodiment including a first exhaust conduit inlet 3515, a second exhaust conduit inlet 3520, a first flushing conduit outlet 3614, and a second flushing conduit outlet 3615, the first exhaust conduit inlet 3515 and the first flushing conduit outlet 3614 are configured to be located within the first nostril of the patient, or below the first nostril of the patient, adjacent to the patient's upper lip, or directly adjacent to the first nostril of the patient. On the other hand, the second exhaust conduit inlet 3520 and the second flushing conduit outlet 3615 are configured to be located within the second nostril of the patient, or below the second nostril of the patient, adjacent to the patient's upper lip, or directly adjacent to the second nostril of the patient.

[0299] In embodiments including a single exhaust conduit inlet 3515 and a single flushing conduit outlet 3614, the first exhaust conduit inlet 3515 and the first flushing conduit outlet 3614 are configured to be located within a first nostril of the patient, or below a first nostril of the patient, adjacent to the patient's upper lip, or directly adjacent to a first nostril of the patient.

[0300] Referring to Figure 41, the patient interface 3000 is worn on the patient with their mouth open and no breathing occurring, and pressurized gas is delivered to the patient interface 3000 via the conduit connector 1300. The flow of pressurized gas enters the cushion module 3010 via the inlet 3220. Excess pressurized gas from within the cushion module 3010 and / or from within the patient's airway then flows into the exhaust conduit 3500 via the exhaust conduit inlet 3510, and the gas then moves along the exhaust flow path 3501 through the outlet 3210 of the cushion module 3010 and exits the cushion module 3010. The intended placement of the exhaust conduit inlet 3510 relative to the patient's nostril(s) as described above (including the placement of either or both of the first exhaust conduit inlet 3515 and the second exhaust conduit inlet 3520) forms a first critical flow path and a second critical flow path for the gas to enter the exhaust conduit 3500 via the exhaust conduit inlet 3510.

[0301] The first important flow path extends from within the cushion module 3010 through the patient's mouth into the patient's oral cavity, through the patient's throat, into the patient's nasal cavity, (1) to the exhaust conduit inlet 3510 if the exhaust conduit inlet 3510 is located in the patient's nostril(s), or (2) out of one or more of the patient's nostrils and into the exhaust conduit inlet 3510 if the exhaust conduit inlet 3510 is located adjacent to one or more of the patient's nostrils, or below one or more of the patient's nostrils, adjacent to the patient's upper lip, or directly adjacent to one or more of the patient's nostrils. In all situations, this gas flow entering the patient's oral cavity and exiting through the nasal cavity is thought to cause anatomical dead space flushing of at least part of the patient's oral cavity, throat, and nasal cavity.

[0302] A second important flow path extends from within the cushion module 3010 through the flushing conduit inlet 3612 along the flushing flow path 3611 to the outside of the flushing conduit outlet 3613, through which the gas flow is accelerated and flows, into the nasal cavity of the patient, (1) in which the gas flow is decelerated and / or its direction is changed so that the gas flow can enter the exhaust conduit inlet 3510 when the exhaust conduit inlet 3510 is located within one or more nostrils of the patient, or (2) in which the gas flow is decelerated and / or its direction is changed so that the gas flow can exit one or more nostrils of the patient and enter the exhaust conduit inlet 3510 when the exhaust conduit inlet 3510 is located adjacent to one or more nostrils of the patient, or below one or more nostrils of the patient, adjacent to the upper lip of the patient, or directly adjacent to one or more nostrils of the patient, into the nasal cavity of the patient through one or more nostrils of the patient.

[0303] In the first scenario, the acceleration of the gas flow from the flushing conduit 3610 into the patient's nasal cavity before entering the exhaust conduit inlet 3510 is thought to cause anatomical dead space flushing of at least a portion of the patient's nasal cavity. In the second scenario, the acceleration of the gas flow exiting the flushing conduit 3610 is thought to cause at least a portion of the gas flow to enter the patient's nasal cavity through one or more nostrils before decelerating and / or changing direction, and to exit the nasal cavity through one or more nostrils before entering the exhaust conduit inlet 3510. This portion of the accelerated gas flow entering the nasal cavity is thought to cause anatomical dead space flushing of a portion of the patient's nasal cavity. In other words, in both scenarios, the second significant channel formed at least partially through the flushing conduit 3610, and the resulting acceleration of the gas entering the patient's nasal cavity, is thought to cause anatomical dead space flushing of at least a portion of the patient's nasal cavity and / or throat.

[0304] Referring to Figure 42, the patient interface 3000 is worn on the patient with their mouth closed and no breathing occurring, and pressurized gas is delivered to the patient interface 3000 via the conduit connector 1300. The flow of pressurized gas enters the cushion module 3010 via the inlet 3220. Excess pressurized gas from within the cushion module 3010 and / or from within the patient's airway then flows into the exhaust conduit 3500 via the exhaust conduit inlet 3510, and the gas then moves along the exhaust flow path 3501 through the outlet 3210 of the cushion module 3010 and exits the cushion module 3010. However, because the patient's mouth is closed, only a second important flow path is formed. The second flow path will be described in detail in the preceding paragraph.

[0305] In the illustrated embodiment of the patient interface 3000, since the gas flow through both the first and second critical channels is expected to induce some degree of anatomical dead space flushing, the patient interface 3000 is considered to offer significant advantages over conventional non-invasive ventilation masks. The ability to provide pressure support and simultaneous dead space flushing with the patient's mouth open or closed is advantageous in NIV therapy. Additionally, in embodiments where the nasal interface 3600 is removable, it is envisioned that the patient interface 3000 with the nasal interface 3600 removed can be used to provide standard NIV therapy when such an outcome is desired. For example, it is envisioned that a patient may only require anatomical dead space flushing during a discontinuous period of one day. This would allow the patient interface 3000 to be used over alternating periods with the nasal interface 3600 in place and with the nasal interface 3600 removed.

[0306] In the previous paragraph, dead space flushing of the patient's anatomical dead space was discussed as an intended benefit of the patient interface 3000. The patient's anatomical dead space consists of the total volume of the patient's airway segments that are responsive to directing air into the alveoli and respiratory bronchioles but do not participate in the gas exchange process itself. Thus, the anatomical dead space is the total volume of the patient's leading airways from the nose or mouth to the terminal bronchioles, including the oral cavity, nasal cavity, and pharynx (also called the throat).

[0307] During a patient's respiration, air with a lower CO2 content is inhaled into the lungs, while air with a higher CO2 content is exhaled. At the end of the exhaled 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 during the next respiratory cycle. This rebreathing of high-CO2 content air causes a decrease in the efficiency of gas exchange occurring in the patient's lungs.

[0308] The dead space flushing process replaces at least a portion of the exhaled, higher CO2-content air present in the patient's anatomical dead space with fresh, lower CO2-content air, thereby reducing the amount of exhaled, higher CO2-content air that is inhaled or rebreathed during subsequent inhalation cycles. This reduction in the rebreathing of higher CO2-content air improves the efficiency of gas exchange occurring within the patient's lungs.

[0309] As stated in the previous paragraph, the exhaust conduit inlet 3510 has a cross-sectional area configured to be less than the cross-sectional area of ​​the inlet 3220 of the housing 3200. When pressurized gas is supplied to the cushion module 3010 of the patient interface 3000 during use, the smaller cross-sectional area of ​​the exhaust conduit inlet 3510 compared to the inlet 3220 of the housing 3200 creates a flow restriction that causes a pressure drop and therefore an acceleration of the gas flow into the exhaust conduit 3500. This acceleration of the gas flow into the exhaust conduit 3500 may also cause the intake of ambient gas into the exhaust conduit 3500.

[0310] The intake of gas into the exhaust conduit 3500 at a position surrounding the exhaust conduit inlet 3510 may be advantageous for flushing the patient's anatomical dead space if the exhaust conduit inlet 3510 is located within one or each of the patient's nostrils, or directly adjacent to the patient's nostrils, or below the patient's nostrils and adjacent to the patient's upper lip. When the gas flow is accelerated into the exhaust conduit inlet 3510, gas with a higher CO2 content present in the patient's anatomical dead space may be taken into the exhaust conduit inlet 3510 due to the combination of gas flow acceleration and / or local pressure drop. This intake of gas with a higher CO2 content is thought to provide anatomical dead space flushing in place of, or in addition to, the anatomical dead space flushing described above in relation to the important flow paths formed during use.

[0311] Referring to Figures 43-54, a fourth embodiment of the patient interface 4000 is shown. The patient interface 4000 is a modification of the general form of the patient interface 1000 and incorporates all components and functions of the patient interface 1000 unless otherwise specified. More specifically, the patient interface 4000 incorporates at least the frame 1400, headgear 1900, and conduit connector 1300 of the patient interface 1000. The housing 4200 and seal 4100 of the patient interface 4000, and consequently the cushion module 4010, differ from the housing 1200, seal 1100, and cushion module 1010 of the patient interface 1000 because they include a partition wall 4700. The differences between housing 4200, seal 4100, and cushion module 4010 are described below, but please note separately that housing 4200, seal 4100, and cushion module 4010 include all the features and functions of housing 1200, seal 1100, and cushion module 1010, respectively. The features of housing 4200, seal 4100, and cushion module 4010 that are the same as those of housing 1200, seal 1100, and cushion module 1010 are indicated by the same reference number, but the leading number is "4" instead of "1".

[0312] In the illustrated embodiment, the patient interface 4000 is in the form of a full-face supranasal mask, with the cushion module 4010 comprising a seal 4100 and a housing 4200. The seal 4100 is connected to the housing 4200, and together the seal 4100 and the housing 4200 form the cushion module 4010, which has an outer wall 4011 defining an internal volume 4012. The internal volume 4012 of the cushion module 4010 is configured to be pressurized through an inlet 4220, which allows breathing gases to communicate into the internal volume 4012 from a conduit connector 1300.

[0313] The patient interface 4000 further includes a partition wall 4700 that separates the internal volume 4012 of the cushion module 4010 into a first chamber 4014 and a second chamber 4016. The partition wall 4700 is joined to both the housing 4200 and the seal 4100 to separate the first chamber 4014 from the second chamber 4016.

[0314] The seal 4100 is formed of a soft, elastic material such as silicone or other suitable elastomer and includes a seal opening 4110. When worn by a patient, the seal opening 4110 is configured to surround the patient's mouth and nose. The patient contact surface 4120 of the seal 4100 forms a seal portion centered on 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 leakage of the pressurized gas may occur, but such leakage is relatively small so that the supply of pressurized gas to the patient is maintained at a level sufficient to deliver NIV treatment. Thus, the high-pressure breathing gas can be delivered from the cushion module 4010 to the patient's mouth and / or nostrils through the seal opening 4110.

[0315] As described above, the partition wall 4700 extends across the internal volume 4012 and is a physical barrier that separates the internal volume 4012 into a separate first chamber 4014 and a second chamber 4016. To enable this separation, the partition wall 4700 is bonded to both the housing 4200 and the seal 4100 along a portion of the partition wall 4700's perimeter. In the illustrated embodiment, another portion of the partition wall 4700 branches the seal opening 4110 so that a mouth opening 4114 and a nose opening 4116 are formed.

[0316] The mouth 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 centered on the patient's mouth.

[0317] 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 4700 together form a seal centered on the patient's nose.

[0318] Therefore, high-pressure breathing gas can be delivered from the cushion module 4010 to the patient's mouth through the mouth opening 4414. Furthermore, high-pressure breathing gas can be delivered from the cushion module 4010 to the patient's nose through the nasal opening 4116.

[0319] The housing 4200 includes an inlet 4220 through which pressurized breathing gas can be connected from the conduit connector 1300 to the internal volume 4012 of the cushion module 4010. In an alternative embodiment, it will be understood that the conduit connector 1300 may be omitted. Instead, the pressurized breathing gas can be connected directly from the flow source to the inlet 4220 of the housing 4200. It is also conceivable that the inlet 4220 may instead be located on the seal 4100. In this embodiment, the pressurized breathing gas can be connected to the internal volume 4012 of the cushion module 4010 through the inlet 4220 of the seal 4100.

[0320] The housing 4200 includes an outlet 4210 from which exhaled and excess respiratory gases can be discharged from the cushion module 4010 and / or the patient's airway. In the illustrated embodiment, the outlet 4210 is a bias vent 4215 including multiple openings extending through the housing 4200.

[0321] In an alternative embodiment, the outlet 4210 and the bias vent 4215 may be separate structures located spaced apart from each other. In a further embodiment, the patient interface may also include an auxiliary bias vent 1416.

[0322] In a further alternative embodiment, the outlet 4210 of the cushion module 4010 may be in the form of an opening that is connected to the expiratory conduit of the breathing circuit or configured to be fluid-communicated. In this configuration, exhaled and excess respiratory gases can be discharged from the cushion module 4010 and / or the patient's airway and transferred from the patient interface 4000, where the exhaled and excess respiratory gases can be ventilated to the atmosphere or received by a ventilator, flow generator or other gas source.

[0323] In the illustrated embodiment, the perimeter of the partition wall 4700 is joined to the housing 4200 at a position between the inlet 4220 and the outlet 4210. In this embodiment, the inlet 4220 is located within the first chamber 4014, and the outlet 4210 is located within the second chamber 4016.

[0324] As a result of the perimeter of the bulkhead 4700 joining with the housing 4200 and seal 4100 and branching the seal opening 4410, in the above-mentioned positions, the inlet 4220 and mouth opening 4114 are located within the first chamber 4014, and the outlet 4210 and nose opening 4116 are located within the second chamber 4016.

[0325] In the illustrated embodiment, the housing 4200 and seal 4100 are described as separate components permanently connected to form the cushion module 4010. However, it will be understood that the housing 4200 and seal 4100 can instead be a single component incorporating the features and functions of the housing 4200 and seal 4100. It should be understood that the disclosure relating to the cushion module 4010 including separate housing 4200 and seal 4100 is equally applicable to configurations including a combination of housing 4200 and seal 4100, or to configurations including a single component incorporating the features and functions of housing 4200 and seal 4100.

[0326] The partition wall 4700 further includes one or more flow guides 4730 located on the partition wall 4700. In the illustrated embodiment, one or more flow guides 4730 extend from the partition wall 4700 into the second chamber 4016. A flow path extends through each of the one or more flow guides 4730 and the partition wall 4700. This flow path allows gas to flow from the first chamber 4014 through the one or more flow guides 4730 into the second chamber 4016. In the illustrated embodiment, the flow path extending through the one or more flow guides 4730 and the partition wall 4700 is the only flow path through the partition wall 4700.

[0327] In the illustrated embodiment, one or more flow guides 4730 include a first flow guide 4732 and a second flow guide 4736. The first flow guide 4732 includes a first flow guide inlet 4733 through a partition wall 4700 and extends from the partition wall 4700 to the free end of the first flow guide 4734 located in the second chamber 4016. The free end of the first flow guide 4734 includes a first flow guide outlet 4735. The second flow guide 4736 includes a second flow guide inlet 4737 through the partition wall 4700 and extends from the partition wall 4700 to the free end of the second flow guide 4738 located in the second chamber 4016. The free end of the second flow guide 4738 includes a second flow guide outlet 4739.

[0328] In an alternative embodiment, one or more flow guides 4730 may include only a first flow guide 4732, which includes a first flow guide inlet 4733 through a partition wall 4700 and extends from the partition wall 4700 to the free end of a first flow guide 4734 located in a second chamber 4016. The free end of the first flow guide 4734 includes a first flow guide outlet 4735.

[0329] In the illustrated embodiment, the partition wall 4700 includes a spacing element 4731 extending between the first flow guide 4732 and the second flow guide 4736 and configured to maintain the distance between the flow guides during use. In the illustrated embodiment, the spacing element 4731 is in the form of a rib extending between the first flow guide 4732 and the second flow guide 4736 and connected to them. It will be understood that the partition wall 4700 may provide sufficient rigidity around the positions of the first flow guide 4732 and the second flow guide 4736 so that the spacing element 4731 can be omitted.

[0330] In an alternative embodiment, the first flow guide 4732 and / or the second flow guide 4736 do not have to extend from the partition wall 4700, but can instead be formed within the partition wall 4700. In such a configuration, it is assumed that the first flow guide inlet 4733 and / or the second flow guide inlet 4337 may be located on the surface of the partition wall 4700 in the first chamber 4014, and the first flow guide outlet 4735 and / or the second flow guide outlet 4739 may be located on the surface of the partition wall 4700 in the second chamber 4016. In this embodiment, each of the first flow guide 4732 and / or the second flow guide 4736 includes a flow path through the partition wall 4700.

[0331] In the illustrated embodiment, the partition wall 4700 includes a deformation region 4720 located on the partition wall 4700 between one or more flow guides 4730 and a portion of the outer periphery of the partition wall 4700 that joins to the housing 4200. The deformation region 4700 is a localized area of ​​the thickness reduction of the partition wall 4700 that is configured to deform preferentially 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, thereby minimizing deformation or collapse of one or more flow guides 4730.

[0332] The deformable region 4720 includes a first thick-walled region 4724 and a second thick-walled region 4726 joined by a thin-walled region 4721. The thin-walled region 4721 has a thickness less than both the first thick-walled region 4724 and the second thick-walled region 4726. The deformable region 4720 is configured to deform as the first thick-walled region 4724 moves toward the second thick-walled region 4726 during the process, preferentially deforming the thin-walled region 4721.

[0333] In the illustrated embodiment, the thin-walled region 4721 includes a first thin wall 4722 and a second thin wall 4723. The first thin wall 4722 extends from the first thick-walled region 4724, and the second thin wall 4723 extends from the second thick-walled region 4726, and the first thin wall 4722 and the second thin wall 4723 join to each other so as to form an angle of less than 180 degrees between them. During deformation of the deformation region 4720, as the first thick-walled region 4724 moves toward the second thick-walled region 4726, the angle formed between the first thin wall 4722 and the second thin wall 4723 decreases.

[0334] It will be understood that the purpose of the deformation region 4720 is to absorb undesirable forces applied to the partition wall 4700 and to allow preferential deformation to occur at a given location on the partition wall 4700 in order to minimize deformation or collapse of one or more flow guides 4730. Accordingly, any suitable structure that allows preferential deformation to occur at a given location on the partition wall 4700 may be incorporated into the patient interface 4000, for example, a bellows, fold, pleat, corrugation, concertina, or retractable joint located on the partition wall 4700, at a location on the partition wall 4700 between one or more flow guide sections 4730 and the surrounding position sections of the partition wall 4700 that join to the housing 4200.

[0335] The partition wall 4700 may comprise a single material such as an elastomer or plastic, or multiple materials such as an elastomer and plastic. In the illustrated embodiment, the partition wall comprises a rigid portion 4710 comprising a plastic material and an elastomer portion 4712 comprising an elastomer material. The rigid portion 4710 includes a portion of the partition wall 4700 that joins to the housing 4200, and the elastomer portion 4712 includes a portion that joins to the seal 4100 of the partition wall 4700. Additionally or alternatively, the elastomer portion 4712 comprises a deformable region 4720 and one or more flow guides 4730. In other words, the deformable region 4720 and one or more flow guides 4730 comprise the elastomer material.

[0336] In the illustrated embodiment, the rigid portion 4710 comprises a polycarbonate material, and the elastomer portion 4712 comprises a silicone material. However, in alternative embodiments, it is conceivable that any other suitable plastic and / or elastomer material may be used. Furthermore, in the illustrated embodiment, the rigid portion 4710 and the elastomer portion 4712 are permanently connected, but in alternative embodiments, they may be detachably connected by any suitable connecting means.

[0337] The flow guide outlet 4740 has a cross-sectional area that includes the first flow guide outlet 4735 and, where applicable, the second flow guide outlet 4739. This cross-sectional area of ​​the flow guide outlet 4740 is configured to be less than the cross-sectional area of ​​the inlet 4220 of the housing 4200. In the illustrated embodiment, all gas entering the cushion module 4010 enters through the inlet 4220, and substantially all gas leaving the cushion module 4010, except for unintended leaks, exits through the outlet 4210. The inlet 4220 is located within the first chamber 4014, and the outlet 4210 is located within the second chamber 4016, and the only flow path through the partition 4700 separating the chambers is through one or more flow guides 4730. Therefore, the reduced cross-sectional area of ​​the flow guide outlet 4740 compared to the inlet 4220 of the housing 4200 creates a flow restriction that accelerates the gas flow through one or more flow guides 4730 when the pressurized gas flows through one or more flow guides 4730 into the first chamber 4014 of the cushion module 4010 via the inlet 4220, into the second chamber 4016, and exits the cushion module 4010 via the outlet 4210. The reduced cross-sectional area of ​​the flow path creates a pressure drop that accelerates the gas flow entering the second chamber 4016. The importance of this acceleration of the gas flow will be explained in the following paragraphs.

[0338] In the illustrated embodiment, the flow restriction described in the above paragraph is caused by the flow guide outlet 4740 having a cross-sectional area less than the cross-sectional area of ​​the inlet 4220 of the housing 4200. However, the inventors intend that this flow restriction may be located elsewhere in one or more flow guides 4730.

[0339] In the illustrated embodiment of the patient interface 4000, the ratio of the cross-sectional areas of the first flow guide outlet 4735 to the second flow guide outlet 4739 is 1:1, meaning that the cross-sectional areas of both flow guide outlets are equal. However, in alternative embodiments, the cross-sectional area of ​​the first flow guide outlet 4735 does not have to 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 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 guide outlet 4735 to the cross-sectional area of ​​the second flow guide outlet 4739 is 1:3.

[0340] Additionally, in the illustrated embodiment, the first flow guide 4732 and / or the second flow guide 4736 each include a tapered cross-sectional area from the first flow guide inlet 4733 to the first flow guide outlet 4735, and from the second flow guide inlet 4737 to the second flow guide outlet 4739. This tapered cross-sectional area can improve the acceleration of the gas flow through the first flow guide 4732 and / or the second flow guide 4736.

[0341] In addition to having different flow guide outlet cross-sectional areas, or instead, the first flow guide 4732 and the second flow guide 4736 may differ in shape and / or size in at least one aspect, for example, in the diameter, length, or shape of the flow guide. Such a configuration in which the first flow guide 4732 and the second flow guide 4736 have different shapes and / or sizes may be described as having asymmetrical first and second flow guides 4732, 4736.

[0342] Referring to Figures 53 and 54, for illustrative purposes, the patient interface 4000 is shown in a cross-section along line H-H' adapted to an anatomical model of the patient (also shown in cross-section). In Figure 53, the patient interface 4000 is shown worn on the patient with their mouth open. In Figure 54, the patient interface 4000 is shown worn on the patient with their mouth closed. Arrows indicate the direction of gas flow entering the cushion module 4010 via the inlet 4220 and exiting the cushion module 4010 via the outlet 4210 while worn on the patient without respiration occurring. The relative size of the arrows should not be interpreted as an indicator of gas flow rate or gas velocity. It will be understood that during respiration, additional gas channels are formed and described beyond them. However, for explanatory purposes, it is considered 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 pronounced at the end of the expiratory cycle, which can realistically be likened to a situation where no respiration is occurring.

[0343] When the patient interface 4000 is worn by the patient, one or more flow guides 4730 are positioned such that the flow guide outlet 4740 is adjacent to the patient's upper lip, or directly adjacent to one or each of the patient's nostrils, below one or each of the patient's nostrils. In other words, the flow guide outlet 4740 is positioned adjacent to, below, or in close proximity to, one or each of the patient's nostrils.

[0344] More specifically, in embodiments including a first flow guide outlet 4735 and a second flow guide outlet 4739, the first flow guide outlet 4735 is configured to be located below the first nostril of the patient and adjacent to the patient's upper lip, or directly adjacent to the first nostril of the patient, while the second flow guide outlet 4739 is configured to be located below the second nostril of the patient and adjacent to the patient's upper lip, or directly adjacent to the second nostril of the patient.

[0345] Referring to Figure 53, the patient interface 4000 is worn on the patient with their mouth open and no breathing occurring, and pressurized gas is delivered to the patient interface 4000 via the conduit connector 1300. The flow of pressurized gas enters the first chamber 4014 of the cushion module 4010 via the inlet 4220. The pressurized gas in the first chamber 4014 then flows (1) through one or more conduits 4730 into the second chamber 4016, or (2) through the patient's mouth into the patient's oral cavity, through the patient's throat, into the patient's nasal cavity, or through the patient's nostrils into the second chamber 4016. Then, any excess pressurized gas and / or gas from within the patient's airway flows out of the second chamber 4016 through the outlet 4210 of the cushion module 4010 and exits the cushion module 4010. The partition wall 4700, the first chamber 4014, the second chamber 4016, and one or more flow guides 4730 that enable flow between the first chamber 4014 and the second chamber 4016, thus form the first and second important flow paths from the inlet 4220 of the cushion module 4010 to the outlet 4210 of the cushion module 4010.

[0346] The first important flow path extends from the inlet 4220 of the cushion module, through the first chamber 4014 of the cushion module 4010, through the patient's mouth into the patient's oral cavity, through the patient's throat into the patient's nasal cavity, through one or more of the patient's nostrils into the second chamber 4016, and exits the cushion module 4010 through the outlet 4210. This unidirectional flow of gas entering the patient's oral cavity and exiting through the nasal cavity is thought to cause anatomical dead space flushing of at least a portion of the patient's oral cavity, throat, and nasal cavity.

[0347] A second important flow path extends from the inlet 4220 of the cushion module into the first chamber 4014 through one or more flow guides 4730, where, due to the acceleration of the gas, it is expected that at least some of the gas flow enters the patient's nasal cavity through one or more nostrils before deceleration and / or redirection, exits the nasal cavity through one or more nostrils into the second chamber 4016, and exits the cushion module 4010 through the outlet 4210. It is also expected that some of the gas will flow into the second chamber 4016 through one or more flow guides 4730 without entering the patient's nasal cavity. It is important that the gas flow is guided through one or more flow guides 4730, which are configured to produce acceleration of the gas flow and are positioned below the patient's nostrils, adjacent to the patient's upper lip, or directly adjacent to the patient's nostrils, in order to ensure that at least some of the gas flow enters and exits the patient's nasal cavity through one or more nostrils before deceleration and / or redirection. This portion of the gas flow entering the nasal cavity is thought to cause flushing of some anatomical dead space in the patient's nasal cavity.

[0348] Referring to Figure 54, the patient interface 4000 is worn by the patient with their mouth closed and no breathing occurring, and pressurized gas is delivered to the patient interface 4000 via the conduit connector 1300. The flow of pressurized gas enters the first chamber 4014 of the cushion module 4010 via the inlet 4220, and then the pressurized gas from within the first chamber 4014 flows through one or more conduits 4730 into the second chamber 4016, and then any excess pressurized gas and / or gas from within the patient's airway flows out of the cushion module 4010 through the outlet 4210 of the cushion module 4010 and exits the cushion module 4010. Because the patient's mouth is closed, only a second important flow path is formed. The second important flow path will be described in detail in the preceding paragraph.

[0349] Since gas flow through both the first and second critical pathways is thought to induce some degree of anatomical dead space flushing, the patient interface 4000 is considered to offer significant advantages over conventional non-invasive ventilation masks. The ability to provide pressure support and simultaneous dead space flushing whether the patient's mouth is open or closed is advantageous in NIV therapy.

[0350] In the previous paragraph, dead space flushing of the patient's anatomical dead space was discussed as an intended benefit of the patient interface 4000. The patient's anatomical dead space consists of the total volume of the patient's airway segments that are responsive to directing air into the alveoli and respiratory bronchioles but do not participate in the gas exchange process itself. Thus, the anatomical dead space is the total volume of the patient's leading airways from the nose or mouth to the terminal bronchioles, including the oral cavity, nasal cavity, and pharynx (also called the throat).

[0351] During a patient's respiration, air with a lower CO2 content is inhaled into the lungs, while air with a higher CO2 content is exhaled. At the end of the exhaled 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 during the next respiratory cycle. This rebreathing of high-CO2 content air causes a decrease in the efficiency of gas exchange occurring in the patient's lungs.

[0352] The dead space flushing process replaces at least a portion of the exhaled, higher CO2-content air present in the patient's anatomical dead space with fresh, lower CO2-content air, thereby reducing the amount of exhaled, higher CO2-content air that is inhaled or rebreathed during subsequent inhalation cycles. This reduction in the rebreathing of higher CO2-content air improves the efficiency of gas exchange occurring within the patient's lungs.

[0353] As discussed in the previous paragraph, the flow guide outlet 4740 has a cross-sectional area configured to be less than the cross-sectional area of ​​the inlet 4220 of the housing 4200. The smaller cross-sectional area of ​​the flow guide outlet 4740 compared to the inlet 4220 of the housing 4200 forms a flow limit that causes acceleration of the gas flow. However, it should be understood that in alternative embodiments, the flow limit may be located anywhere within one or more flow guides 4730 to cause this desired acceleration of the gas through one or more flow guides 4730.

[0354] In an alternative embodiment, the outlet 4210 of the cushion module 4010 is configured to have a resistance to flow that is less than the resistance to flow through one or more flow guides 4730. This difference in resistance to flow is configured to create a pressure difference between the first chamber 4014 and the second chamber 4016, the second chamber 4016 being configured to have a lower pressure than the first chamber 4014 during use.

[0355] During use, with the patient's mouth open and pressurized gas being supplied to the first chamber 4014 of the cushion module 4010, it is thought that the flow along the first significant pathway, namely from the first chamber 4014 through the patient's oral cavity, through the throat, into the nasal cavity, out of the nasal cavity through the nostrils, and into the second chamber 4016, can be facilitated by this configured pressure difference.

[0356] The pressure difference described in the above configuration is achieved by forming resistance to the flow through the outlet 4210, but it will be understood that any preferred method for creating a lower pressure in the second chamber 4016 than in the first chamber 4014 may be incorporated into further alternative configurations.

[0357] Referring to Figures 55-68, a fifth embodiment of the patient interface 5000 is shown. The patient interface 5000 is a modification of the patient interface 4000 and incorporates all the components and functions of the patient interface 4000 unless otherwise specified. Features of the patient interface 5000 that are the same as those of the patient interface 4000 are indicated by the same reference numbers, but the first number is "5" instead of "4".

[0358] The patient interface 5000 differs from the patient interface 4000 in that all the features and functions of the partition wall 4700 of the patient interface 4000 are incorporated into the partition wall insert 570 of the patient interface 5000. The partition wall insert 570 is a component manufactured separately from the seal 5100 and housing 5200 and is configured to be permanently or removablely inserted into the cushion module 5010 after manufacturing. In other words, the partition wall insert 570 is not integrally formed with the seal 5100, the housing 5200, or the cushion module 5010 formed by both.

[0359] However, the bulkhead insert 570 and the housing 5200 can be formed separately, and then the bulkhead insert 570 can be connected to the housing 5200 before the seal 5100 is overmolded onto the housing 5200 and / or bulkhead insert 570.

[0360] The septum insert 570 includes a septum 5700. Similar to the septum 4700 of the patient interface 4000, the septum 5700 extends across the cavity 5012 of the cushion module 5010 when the septum insert 570 is inserted into the cushion module 5010, separating it into a first chamber 5014 and a second chamber 5016. The septum 5700 intersects and separates with the seal opening 5110 to form an oral opening 5114 and a nasal opening 5116. The oral opening 5114 is located within the first chamber 5014, and the nasal opening 5116 is located within the second chamber 5016.

[0361] The partition wall 5700 of the partition insert 570 includes a perimeter 5705 whose shape substantially matches the internal geometry of the cushion module 5010. In this embodiment, the outer periphery 5705 contacts both the housing 5200 and the seal 5100 to adequately seal the first chamber 5014 from the second chamber 5016. This restricts and / or stops gas from flowing between the first chamber 5014 and the second chamber 5016 between the outer periphery 5705 of the partition wall 5700 and the housing 5200 and / or seal 5100.

[0362] It should be understood that there are different levels of acceptable gas flow between the first chamber 5014 and the second chamber 5016 between the outer perimeter 5705 of the bulkhead 5700 and the housing 5200 and / or seal 5100. If a moderate to small amount of gas flow is acceptable, the outer perimeter 5705 of the bulkhead 5700 may be configured to abut against the housing 5200 and / or seal 5100 in the cushion module 5010 to restrict the gas flow between the first chamber 5014 and the second chamber 5016. Alternatively, the outer perimeter 5705 may be further spaced away from the housing 5200 and / or seal 5100 to allow a limited amount of flow between them. If a minimum amount of gas flow 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 that abut against the housing 5200 and / or seal 5100 to form a substantially airtight seal. If the gas flow between the partition wall 5700 and the housing 5200 and / or seal 5100 is not substantially acceptable, the outer periphery 5705 may be bonded to the housing 5200 and / or seal 5100 (such as by lip and groove arrangement), chemically bonded, or mechanically connected to form an airtight seal around the outer periphery 5705 of the partition wall 5700.

[0363] The illustrated bulkhead insert 570 is inserted into the cushion module 5010 and configured to be removable or permanently connected to the housing 5200 via the connector 5750. However, as described above, it will be understood that additional connections may exist between the bulkhead insert 570 and the cushion module 5010. For example, a connection may exist between the outer perimeter 5705 and the housing 5200 and / or seal 5100.

[0364] The partition insert 570 includes a connector 5750 configured to connect detachably or permanently to a complementary connection structure of the housing 5200. In the illustrated embodiment, the connector 5750 is in the form of sleeves 5755, 77, 78, 79, 80, 77 configured to connect detachably to the outer surface of sleeve 5230 of the housing 5200. The connection to the housing 5200 may be a detachable interfering mat or a tapered mat. This outer surface is located within the cushion module 5010, specifically within the first chamber 5014. This connection is shown, for example, in Figure 63. Thus, the partition insert 570 is detachably connected to the patient interface 5000, thereby allowing it to be converted between a single-chamber patient interface and a double-chamber patient interface.

[0365] Alternatively, the sleeve 5755 of the connector 5750 may have a permanent connection with the sleeve 5230 of the housing 5200. This may be a one-time connection that allows the patient interface 5000 to be converted from a single-chamber patient interface to a double-chamber patient interface, but after which the partition insert 570 cannot be removed. This may be required, for example, for patient safety.

[0366] Once the partition insert 570 is inserted into the cushion module 5010 and connected to the housing 5200 and / or seal 5100, it will be understood that the patient interface 5000 functions substantially the same as the patient interface 4000. Therefore, a description of how the patient interface 5000 is expected to function in use will not be repeated here, but instead can be taken from the above paragraph regarding the expected function of the patient interface 4000 in use unless otherwise specified.

[0367] The fact that the partition insert 570 is a separate, and possibly removable, component from the seal 5100 and housing 5200 offers at least two advantages. First, the reduction in complexity of molding the seal 5100 and / or housing 5200 when molding a single-chamber cushion module is considered to be no more significantly difficult than that of a double-chamber cushion module. Second, the partition insert 570 can be retrofitted to an existing single-chamber patient interface to convert a single-chamber patient interface 1000 into a double-chamber patient interface 5000. In regard to the latter, it is anticipated that the partition insert 570 can be sold separately to enable the conversion of an existing single-chamber patient interface into a double-chamber patient interface.

[0368] Now, specific structural features of the illustrated embodiment of the partition insert 570 will be described in reference to Figures 64-68.

[0369] Figure 64 shows a perspective view of a partition insert 570. The illustrated partition insert 570 includes a partition 5700, a connector 5750 attached to the partition 5700, and one or more fluid guides 5730 extending from the partition 5700 and defining one or more gas passages through the partition 5700.

[0370] One or more flow guides 5730 include at least a first flow guide inlet 5733 that is in fluid communication with a first chamber 5014 and a first flow guide outlet 5735 that is in fluid communication with a second chamber 5016, in order to allow gas flow through the partition wall 5700. In the illustrated embodiment, one or more flow guides 5730 include one(s) gas passage through the partition wall 5700.

[0371] In the illustrated embodiment, the partition wall 5700 includes a first flow guide 5732 and a second flow guide 5736. The first flow guide 5732 includes a first flow guide inlet 5733 that is in fluid communication with the first chamber 5014 and a first flow guide outlet 5735 that is in fluid communication with the second chamber 5016. The second flow guide 5736 includes a second flow guide inlet 5737 that is in fluid communication with the first chamber 5014 and a second flow guide outlet 5739 that is in fluid communication with the second chamber 5016.

[0372] Furthermore, similar to the patient interface 4000, the first flow guide outlet 5735 and / or the second flow guide outlet 5739 are positioned near the user's nostrils and configured to be directed toward them while the patient interface 5000 is worn by the user and directs the gas flow through one or more flow guides 5730 toward the user's nostrils.

[0373] In the illustrated embodiment, the partition wall 5700 includes a rigid portion 5710 and an elastomer portion 5711. A connector 5750 of the partition wall insert 570 is attached to the rigid portion 5710, and one or more flow guides 5730 extend from the elastomer portion 5711 of the partition wall 5700. In the illustrated embodiment, the elastomer portion 5711 is connected to the rigid portion 5710 via a bead on the elastomer portion 5711 that is received within a channel on the rigid portion 5710. This allows for a removable mechanical connection. However, any preferred connection, such as overmolding, adhesive, chemical bonding, or alternative mechanical connection, can be used.

[0374] The partition wall 5700 and its subcomponents may, as desired, be formed entirely from rigid materials, entirely from elastomer materials, or from alternative combinations thereof.

[0375] As described above, the illustrated partition 5700 includes a periphery 5705 that, when inserted into the cushion module 5010, contacts the seal 5100 and the housing 5200 to form a seal. In the illustrated embodiment, this periphery 5705 includes a thickened flange that provides an increased contact surface area to provide an improved seal with the cushion module 5010. This flange may offer the secondary benefit of helping to reduce contact pressure and distribute the force over a larger area. Additionally, a portion of the periphery 5705 that bisects the seal opening 5110 is expected to contact the patient's upper lip during use, and therefore this flange may provide an improved seal to the patient's upper lip and reduce any discomfort by reducing contact pressure.

[0376] Optionally, although not shown, the elastomer portion 5711 of the partition wall 5700 may include a deformable region 5720, which includes a thin-walled region 5721 located between a first thick-walled region 5724 and a second thick-walled region 5726, to allow for controlled deformation of the partition wall 5700 within this thin-walled region 5721 in response to forces applied to the partition wall 5700 during use. The references to “thin-walled” and “thick-walled” refer to the wall thickness of the elastomer portion 5711. The deformable region 5720 incorporates all the features and functions of the partition wall 4720 as described above with respect to the patient interface 4000.

[0377] In the illustrated embodiment, the partition insert 570 includes a first fluid guide 5732 and a second fluid guide 5736 of equal size and shape. The first fluid guide 5732 and the second fluid guide 5736 each incorporate all the features and functions of the first fluid guide 4732 and the second fluid guide 4736 as described above.

[0378] In an alternative embodiment, the first flow guide 5732 and the second flow guide 5736 may be asymmetrical, that is, they may differ from each other in at least one way, for example, in at least one of the following aspects: height, width, thickness, inlet opening size, outlet opening size, or cross-sectional shape.

[0379] In some embodiments, the partition insert 570 may include one or more openings through the partition 5700 that provide the intended restriction and pressure difference between the first chamber 5014 and the second chamber 5016. In these embodiments, the openings replace one or more flow guides 5730. Such openings may be aligned with the user's nostrils or located elsewhere on the partition 5700. However, the openings do not substantially direct the gas flow toward the patient's nostrils.

[0380] An advantage of the partition insert 570 being a separate component from the cushion module 5010 is that a series of partition inserts 570 can be provided, each containing a different flow guide configuration. The configurations can differ, for example, in terms of the number of flow guides, the size of the flow guides, the shape of the flow guides, the position of the flow guides, and / or the material of the flow guides. These different configurations can be suitable for different purposes, such as different treatments, patients with different nostril sizes, and / or patients with different nasal cavity limitations.

[0381] In one embodiment, the selection of the septum insert 570 provides flow guides with different flow limits. A first septum insert 570 may have one or more flow guides 5730 having relatively low flow limits. A second septum insert 570 may have one or more flow guides 5730 having relatively moderate flow limits. A third septum insert 570 may, but is not limited to, one or more flow guides 5730 having relatively high flow limits. These may be provided individually or as a set. Depending on the patient's anatomical structure and ventilation requirements, an appropriate septum insert 570 can be selected to adjust the amount of restriction through the septum 5700, and therefore, in order, the amount of flushing flow guided through the patient's mouth, around the back of the throat, and out of the nostrils, thereby flushing the patient's anatomical dead space at least at the end of the expiratory phase. This flushing mechanism is described above in relation to the patient interface 4000 and is incorporated herein in its entirety in relation to the patient interface 5000.

[0382] In another embodiment, the selection of partition inserts 570 provides an asymmetrical conduit configuration. In such an embodiment, the cross-sectional area of ​​the first conduit outlet 5735 does not have to be equal to the cross-sectional area of ​​the second conduit outlet 5739. One partition insert 570 may have a conduit outlet configured to align with the user's left nostril, which is larger than the conduit outlet configured to align with the user's right nostril. The second partition insert 570 may have this arrangement reversed. Furthermore, a third partition insert 570 may have only a single conduit 5732 configured to align with the user's left nostril, and a fourth partition insert 570 may have a single conduit 5732 configured to align with the user's right nostril.

[0383] For unequal or asymmetrical flow guides, the ratio of the cross-sectional area of ​​the first flow guide outlet 5735 to the cross-sectional area of ​​the second flow guide 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 guide outlet 5735 to the cross-sectional area of ​​the second flow guide outlet 5739 is 1:3. The first flow guide inlet 5733 and the second flow guide inlet 5737 may have equal cross-sectional areas or different cross-sectional areas in the range of 1:1.1 to 1:4.

[0384] Referring to Figures 69-78, a sixth embodiment of the patient interface 6000 is shown. The patient interface 6000 is a variation of the patient interface 6000 and incorporates all the components and functions of the patient interface 5000 unless otherwise specified. Features of the patient interface 6000 that are the same as those of the patient interface 5000 are indicated by the same reference numbers, but the leading number is "6" instead of "5".

[0385] The patient interface 6000 differs from the patient interface 5000 in that the seal 6100 is a full subnasal seal and the septum insert 670 does not include a connector 6750. Instead, the septum insert 670 is configured to be bonded, chemically bonded, or mechanically attached to the housing 6200 and / or seal 6100.

[0386] The seal 6100 is formed of a soft, elastic material such as silicone or other suitable elastomer. The seal 6100 includes a mouth opening 6114 and a nasal opening 6116. When worn by a patient, the mouth opening 6114 is configured to surround the patient's mouth. The patient contact surface 6120 surrounding the mouth opening 6114 forms a seal centered on the patient's mouth. The nasal opening 6116 is configured to surround the patient's nostrils. The patient contact surface 6120 surrounding the nasal opening 6116 forms a seal centered on the patient's nostrils. Thus, high-pressure breathing gases can be delivered from the cushion module 6010 to the patient's mouth and nostrils, via the mouth opening 6114 and the nasal opening 6116, respectively.

[0387] Since the seal 6100 is a subnasal seal that includes a nasal opening 6116 that surrounds the user's nostrils but does not accept the user's nose, one or more flow guides 6730 are arranged such that the gas flowing through the one or more flow guides 6730 is directed toward the nasal opening 6116 and, in certain circumstances, for example, with the patient's mouth closed at the end of exhalation, flows through the nasal opening 6116 into the patient's nostrils.

[0388] The seal 6100 is configured not to come into contact with the user's nasal bridge during use and therefore has a different shape profile than the supranasal seal shown in the above embodiments. Due to the different shape of the subnasal seal 6100 compared to the seal 1100, the housing 6200 and frame 6400 include different profiles than the housing and frame shown in the above embodiments. However, it will be understood that the function and features of the housing 6200 and frame 6400 are, separately, substantially identical to the function and features of the housing 1200 and frame 1400 of a general form of patient interface 1000.

[0389] Furthermore, since the seal 6100 includes a portion of the patient contact surface 6120 that extends between the mouth opening 6114 and the nasal opening 6116 and is configured to contact the patient's upper lip during use, the outer periphery 6705 of the partition 6700 contacts the seal 6100 and / or the housing 6200 around its entire circumference. In other words, the outer periphery 6705 of the partition 6700 is not configured to intersect with the opening of the seal 6100.

[0390] As described above, the second difference between patient interface 6000 and patient interface 5000 is that partition insert 670 does not include connector 6750, and instead is configured to be bonded, chemically bonded, or mechanically attached to housing 6200 and / or seal 6100. Similar to partition insert 570, partition insert 670 includes an outer perimeter 6705 with an increased-thickness flange. This flange creates an enlarged surface area to which adhesives or other binders can be applied, for example.

[0391] In the illustrated embodiment, an adhesive or other chemical agent is expected to be applied to the outer periphery 6705 of the partition wall 6700, after which the partition wall insert 670 is inserted into the cushion module 6010. The outer periphery 6705 contacts the housing 6200 and seal 6100 at individual locations, forming a permanent and airtight connection between the partition wall insert 670 and the cushion module 6010.

[0392] In an alternative embodiment, the outer circumference 6705 can be received into a channel or groove of the housing 6200 and / or seal 6100 in order to mechanically attach the partition insert 670 to the cushion module 6010.

[0393] Similar to the patient interface 5000, once the partition insert 670 is inserted into the cushion module 6010 and bonded, bonded, or mechanically mounted in place, the patient interface 6000 functions substantially identically to the patient interface 4000, with the only difference being that the seal 6100 seals the underside of the patient's nose and does not contact the nasal bridge. Thus, as with the patient interface 5000 described above, the expected function can be understood by referring to the disclosures of the patient interface 4000 without repeating the description.

[0394] It is also conceivable that a series of partition inserts 670, each containing different flow guide configurations as described above, can be provided in relation to the patient interface 5000. These can be provided in a pack having a single-chamber patient interface 6000, and once the desired partition insert 670 is identified, it can be bonded, coupled, or mechanically mounted within the cushion module 6010 to form a double-chamber patient interface 6000 having the desired flow guide configuration.

[0395] Finally, a septum insert 670 without connectors, configured to be bonded, joined, or mechanically attached in place, may be used with the supranucular patient interface 5000. Additionally, a septum insert 570 including a connector 5750 may be used with the infranasal patient interface 6000.

[0396] Referring to Figures 79-87, a patient interface of the seventh embodiment is shown. Patient interface 7000 is a modification of patient interface 4000 and incorporates all the components and functions of patient interface 4000 unless otherwise specified. Features of patient interface 7000 that are the same as those of patient interface 4000 are indicated by the same reference numbers, but the leading number is "7" instead of "4".

[0397] The patient interface 7000 differs from the patient interface 4000 in that all the features and functions of one or more flow guides 7730 are incorporated into the flow guide insert 773, and the seal 7100 is a subnasal seal. The function and structure of the full subnasal seal, as well as its impact on the shape of the frame 1400 and housing 7200, are described above in relation to the seal 6100 and patient interface 6000 and are incorporated within the seal 7100 and patient interface 7000 unless otherwise explicitly stated.

[0398] Similar to the cushion module 4010, the cushion module 7010 includes a partition wall 7700 that separates the cavity 7012 of the cushion module 7010 into a first chamber 7014 and a second chamber 7016. The partition wall 7700 separates the first chamber 7014 from the second chamber 7016 by bonding to the housing 7200 and / or seal 7100, respectively, around its outer circumference 7705. The partition wall 7700 bonds to the seal 7100 between the mouth opening 7114 and the nasal opening 7116, such that the mouth opening 7114 opens into the first chamber 7014 and the nasal opening 7116 opens into the second chamber 7016.

[0399] Except for the fact that the nasal opening 4116 of patient interface 4000 surrounds the patient's nose and contacts the nasal bridge, and the nasal opening 7116 of patient interface 7000 surrounds the patient's nostrils and does not contact the nasal bridge, the two patient interfaces 4000 and 7000 are expected to function substantially the same in use. Therefore, it will be understood that the description outlined above regarding the operation of patient interface 4000 applies equally to patient interface 7000 in this specification.

[0400] As described above, the main difference of the patient interface 7000 is that all the features and functions of one or more flow guides 4730 from the patient interface 4000 are incorporated into a removable flow guide insert 773. The flow guide insert 773 is a separate component from any of the seal 7100, housing 7200, and partition wall 7700. The partition wall 7700 includes a flow guide opening 7707 configured to accept the flow guide insert 773 either removablely or permanently.

[0401] In the illustrated embodiment, the flow guide insert 773 includes a channel around the insert body 7731 configured to receive the rim of the flow guide opening 7707 and to removably attach the flow guide insert 773 to the partition wall 7700. This connection is seen, for example, in Figure 84. In an alternative embodiment, the flow guide insert 773 can be removably or permanently attached to the partition wall by any suitable mechanical connection, adhesive, or chemical bond. For example, the flow guide insert 773 may include an external geometric shape configured to receive the flow guide opening 7707 in a tapered fit or a tight fit.

[0402] The flow guide insert 773 includes one or more flow guides 7730 extending from the insert body 7731. Each of the one or more flow guides 7730 incorporates all the features and functions of each of the one or more flow guides 4730. Therefore, the above description of those features of the patient interface 4000 is equally applicable to each of the one or more flow guides 7730 as described herein.

[0403] In the illustrated embodiment, the flow guide insert body 7731 and one or more flow guides 7730 comprise an elastomer material and are integrally formed as a single component. The flow guide insert body 7731 is configured to be thicker than the surrounding portion of the partition wall 7700 in order to provide stability to one or more flow guides 7730.

[0404] It should be understood that the flow guide insert body 7731 can, alternatively, be constructed from a rigid material such as plastic. In such a situation, one or more flow guides 7730 may be constructed from the same rigid material, or they may be constructed from an elastomer material that is attached to the rigid flow guide insert body 7731.

[0405] Similar to the patient interface 5000, the advantage of the flow guide insert 773 being a separate component from the partition 7700 is assumed to be the ability to provide a series of flow guide inserts, each containing different flow guide configurations. The configurations can differ, for example, in terms of the number of flow guides, the size of the flow guides, the shape of the flow guides, the position of the flow guides, and / or the material of the flow guides. These different configurations can be suitable, for example, for different treatments, patients with different nostril sizes, and / or different nasal cavity limitations.

[0406] Multiple possible flow guide configurations have been described above with respect to a series of partition inserts 570 of the patient interface 5000, and these flow guide configurations are incorporated herein as an option for combining with the patient interface 7000 as a series of flow guide inserts 773. Furthermore, three exemplary configurations are shown with respect to Figures 88–93.

[0407] Figure 88 shows a first flow guide insert 773, which includes a first flow guide 7732 and a second flow guide 7736. The first flow guide 7732 includes a first flow guide inlet 7733 that is in fluid communication with the first chamber 7014 when the flow guide insert 773 is mounted on the partition wall 7700, and a first flow guide outlet 7735 that is in fluid communication with the second chamber 7016. The second flow guide 7736 includes a second flow guide inlet 7737 that is in fluid communication with the first chamber 7014 when the flow guide insert 773 is mounted on the partition wall 7700, and a second flow guide outlet 7739 that is in fluid communication with the second chamber 7016.

[0408] The first flow guide 7732 and the second flow guide 7736 are equal in size and symmetrical. Each includes a flow guide outlet that is smaller than the corresponding flow guide inlet and whose cross-sectional area generally tapers from the flow guide inlet to the flow guide outlet. The gas flow is intended to be guided and / or accelerated through the first flow guide 7732 and the second flow guide 7736 toward the nose opening 7116.

[0409] Figure 90 shows a second alternative flow guide insert 873, which includes a single flow guide 8732, including a first flow guide inlet 8733 that fluidly communicates with the first chamber 7014 and a first flow guide outlet 8735 that fluidly communicates with the second chamber 7016, when the flow guide insert 873 is mounted on the partition wall 7700. The flow guide insert 873 further includes one or more flow guide openings 8745 extending through the flow guide insert body 8731. Assuming the 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 allow a desired pressure difference between the first chamber 7014 and the second chamber 7016.

[0410] Figure 92 shows a third alternative flow guide insert 973, which includes a first flow guide 9732 and a second flow guide 9734. The first flow guide 9732 includes a first flow guide inlet 9733 that is in fluid communication with the first chamber 7014 when the flow guide insert 973 is mounted on the partition wall 7700, and a first flow guide outlet 9735 that is in fluid communication with the second chamber 7016. The second flow guide 9736 includes a second flow guide inlet 9735 that is in fluid communication with the first chamber 7014 when the flow guide insert 973 is mounted on the partition wall 7700, and a second flow guide outlet 9739 that is in fluid communication with the second chamber 7016.

[0411] One or more flow guides 9730 are asymmetrical such that the ratio of the cross-sectional area of ​​the first flow guide outlet 9735 to the cross-sectional area of ​​the second flow guide 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 guide outlet 9735 to the cross-sectional area of ​​the second flow guide outlet 9739 is 1:3. The first flow guide inlet 9733 and the second flow guide inlet 9737 may have equal cross-sectional areas or different cross-sectional areas in the range of 1:1.1 to 1:4.

[0412] The flow guide insert 973 further includes one or more flow guide openings 9745 extending through the flow guide insert body 9731. Given the reduction in the cross-sectional area of ​​the second flow guide outlet 9737, it is considered that this additional flow path through the partition wall 9700 may be necessary to allow a desired pressure difference between the first chamber 7014 and the second chamber 7016.

[0413] It should be understood that one or more flow guide openings 8745, 9745 may be implemented in any suitable portion of the partitions 4700, 5700, or 6700 of the patient interfaces 400, 5000, and 6000, respectively, to enable a desired pressure difference across the partitions 4700, 5700, and 6700 from the first chambers 4014, 5014, and 6014 to the second chambers 4016, 5016, and 6016, respectively. As specifically described in the description of the patient interface 4000, this pressure difference is considered to be partially responsive to anatomical dead space flushing, which is thought to exit the nasal cavity through the oral cavity during open-mouth breathing.

[0414] In the following claims and the preceding description, unless the context requires otherwise by express wording or necessary implication, the terms “prong” or “prongs” are used interchangeably with “pillow” or “pillows.” The applicant intends that the “sealing prongs” described or claimed are to be used interchangeably with “nasal pillow,” “pillow seal,” or “pillow.”

[0415] Those skilled in the art will understand that many modifications and alterations can be made to preferred embodiments without departing from the spirit and scope of the present invention.

[0416] In the following claims and prior description, unless the context requires otherwise by express language or necessary implication, the word “comprise” and variations such as “comprises” or “comprising” are used in a comprehensive sense, that is, to specify the presence of the described features, but not to exclude the presence or addition of further features in various embodiments of the apparatus and methods disclosed herein.

[0417] In the above description of preferred embodiments, certain terms are used for clarity. However, it should be understood that the present invention is not intended to be limited to the specific terms thus selected, and that each specific term includes all technical equivalents that operate similarly to achieve similar technical objectives. Terms such as “front” and “back,” “inside” and “outside,” “up,” “down,” “top,” “bottom,” “up” and “down,” “underside” and “upperside,” “vertical” and “horizontal” are used as terms of convenience to provide a point of reference and should not be interpreted as limiting terms. When these terms are used in reference to the patient interface throughout this specification, including the claims, they refer to orientation relative to the normal operating orientation, i.e., when the interface is worn by a patient and the patient’s head is upright.

[0418] Throughout the specification and claims, terms such as “joining,” “linking,” and “connecting” should not be interpreted as requiring two separate components to be linked to one another. These terms should be interpreted in contexts that include the option of meaning the intersection of integrally formed features. For example, the partition wall in the fourth embodiment joins the outer wall, but in that embodiment, it is integrally formed.

[0419] Furthermore, while the present invention has been described in relation to what is currently considered the most practical and preferred embodiment, it should be understood that the present invention is not limited to the disclosed embodiments, but rather is intended to cover a variety of modifications and equivalent configurations that fall within the spirit and scope of the invention. Also, the various embodiments described above may be implemented in conjunction with other embodiments; for example, an aspect of one embodiment may be combined with an aspect of another embodiment to realize yet another embodiment. Furthermore, each independent feature or component of any given assembly may constitute an additional embodiment.

Claims

1. A cushion module for a patient interface for delivering positive airway pressure therapy to a user, A seal for forming a sealing portion around the user's mouth and nostrils, A housing connected to the seal, comprising a housing that forms a cavity configured to receive a flow of pressurized gas, At least one opening in the seal for communicating the pressurized gas with the user, The pressurized gas is received into the cavity at an inlet, An outlet from which the gas is discharged from the cushion module, A cushion module comprising an exhaust conduit configured to draw gas from the user's nostrils through at least one exhaust conduit inlet and guide it to the outlet of the cushion module.

2. A cushion module for a patient interface for delivering positive airway pressure therapy to a user, A seal for forming a sealing portion around the user's mouth and nostrils, A housing connected to the seal, comprising a housing that forms a cavity configured to receive a flow of pressurized gas, At least one opening in the seal for communicating the pressurized gas with the user, An inlet for receiving the pressurized gas into the cavity, An outlet for discharging gas from the cushion module, A cushion module comprising an exhaust conduit located within the cavity, the exhaust conduit having at least one exhaust conduit inlet, through which gas is received into the exhaust conduit, and the exhaust conduit extending from the at least one exhaust conduit inlet to the outlet of the cushion module.

3. The cushion module according to claim 1 or 2, wherein each exhaust conduit inlet is configured to be located within one or each of the user's nostrils, or to be located below one or each of the user's nostrils, adjacent to the user's upper lip.

4. The cushion module according to any one of claims 1 to 3, wherein the cross-sectional area of ​​the at least one exhaust conduit inlet is smaller than the cross-sectional area of ​​the inlet in order to accelerate the gas entering the exhaust conduit as it flows from the cavity into the exhaust conduit.

5. The cushion module according to any one of claims 1 to 4, wherein the exhaust conduit and the at least one exhaust conduit inlet are configured to accelerate the gas as it flows from the cavity into the exhaust conduit and to draw in the surrounding gas.

6. The cushion module according to any one of claims 1 to 5, wherein the intake of ambient gas into the exhaust conduit is such that the at least one exhaust conduit inlet is located within one or each of the user's nostrils, or below one or each of the user's nostrils and adjacent to the user's upper lip, thereby taking in respiratory gas from within one or each of the user's nostrils.

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

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

9. The cushion module according to any one of claims 1 to 8, wherein the exhaust conduit is adjustablely mounted to the housing so that its orientation and / or position relative to the seal can be adjusted.

10. The cushion module according to any one of claims 1 to 9, wherein the exhaust conduit is a sealed passage extending from the at least one exhaust conduit inlet to the outlet.

11. The cushion module according to any one of claims 1 to 10, wherein the exhaust conduit is configured to prevent gas from entering the cavity and to prevent gas from leaving the cavity, in addition to through the at least one exhaust conduit inlet.

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

13. The cushion module according to any one of claims 1 to 11, wherein the exhaust conduit has a structure separate from the seal.

14. The cushion module according to any one of claims 1 to 12, wherein the exhaust conduit includes at least one prong, and the at least one exhaust conduit inlet is located at the free end of the at least one prong.

15. The cushion module according to claim 14, wherein the at least one prong is configured to extend into one or each of the user's nostrils.

16. The cushion module according to claim 14 or 15, wherein the at least one prong is a sealing prong configured to form a seal with one or each of the user's nostrils.

17. The cushion module according to any one of claims 14 to 16, wherein the at least one prong is formed of an elastomer material.

18. The cushion module according to claim 17, wherein the elastomer material is silicone.

19. The cushion module according to claim 14, wherein the at least one exhaust conduit inlet includes a first exhaust conduit inlet configured to be located within a first nostril of the user's nostrils or below the first nostril of the user's nostrils and adjacent to the user's upper lip, and a second exhaust conduit inlet configured to be located within a second nostril of the user's nostrils or below the second nostril of the user's nostrils and adjacent to the user's upper lip.

20. The cushion module according to claim 19, wherein the at least one prong comprises a first prong and a second prong, the first exhaust conduit inlet is located at the free end of the first prong and the second exhaust conduit inlet is located at the free end of the second prong.

21. The cushion module according to claim 20, wherein the first prong is configured to extend into the first nostril of the user, and the second prong is configured to extend into the second nostril of the user.

22. The cushion module according to claim 20, wherein the exhaust conduit further includes a manifold, and the first and second prongs extend from the manifold.

23. The cushion module according to claim 20, wherein at least a portion of the exhaust conduit is flexible to allow adjustment of the positions of the first and second prongs.

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

25. The cushion module according to claim 24, wherein the ratio of the cross-sectional area of ​​the first exhaust conduit inlet to the cross-sectional area of ​​the second exhaust conduit inlet is 1:1.1 to 1:

4.

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

3.

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

28. The cushion module according to claim 27, as dependent on claim 19, wherein each of the first and second prongs is a sealing prong configured to form a seal with each of the user's nostrils.

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

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

31. The cushion module according to any one of claims 27 to 30, wherein the flushing conduit is configured to accelerate gas from the at least one flushing conduit inlet toward the first flushing conduit outlet and the second flushing conduit outlet, and to guide the accelerated gas toward each of the user's nostrils.

32. The cushion module according to any one of claims 27 to 31, wherein the first and second prongs are formed of an elastomer material.

33. The cushion module according to claim 32, wherein the elastomer material is silicone.

34. The cushion module according to any one of the prior claims, wherein the outlet of the cushion module is in fluid communication with the filter such that the gas exiting the cushion module through the outlet passes through the filter.

35. The cushion module according to claim 34, wherein the filter is located outside the cushion module.

36. The cushion module according to claim 34 or 35, wherein the filter is attached to the cushion module.

37. The cushion module outlet includes a bias flow vent, according to any one of the prior claims.

38. The cushion module according to any one of the prior claims, wherein the outlet of the cushion module is configured to be connected to or in fluid communication with an exhalation conduit.

39. The cushion module according to claim 37 or 38, comprising a plurality of openings, wherein the bias flow vent is present.

40. The cushion module according to any one of the prior claims, wherein the cushion module is configured to accept only the flow of the pressurized gas through the inlet and exhaust only the gas through the outlet.

41. The cushion module according to any one of claims 1 to 39, further comprising an auxiliary bias flow vent, the auxiliary bias flow vent being in fluid communication with the cavity.

42. The cushion module according to claim 40, wherein the auxiliary bias flow vent is configured to have a flow rate less than the flow rate passing through the outlet of the cushion module during use.

43. The cushion module according to claim 40 or 41, wherein the auxiliary bias flow vent is configured to have a resistance to a flow greater than the resistance to the flow through the outlet of the cushion module during use.

44. The cushion module according to any one of claims 40 to 42, wherein the auxiliary bias flow vent includes at least one opening, the at least one opening having a cross-sectional area, and the cross-sectional area of ​​the at least one opening is smaller than the cross-sectional area of ​​the cushion module outlet.

45. The cushion module according to any one of the prior claims, wherein the housing comprises a plastic material and the seal comprises an elastomer material.

46. The cushion module according to claim 44, wherein the plastic material is polycarbonate and the elastomer material is silicone.

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

48. The housing includes the cushion module inlet, as described in any one of the prior claims.

49. The housing includes the cushion module outlet according to any one of the prior claims.

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

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

52. The cushion module according to any one of the prior claims, wherein the seal is a full supranuclear seal configured to form a seal on the bridge of the user's nose during use.

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

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

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

56. A patient interface comprising a cushion module as described in any one of the prior claims, the patient interface further comprising a frame configured to be attached to the cushion module, the frame comprising a plurality of headgear connectors configured to be connected to a headgear to hold the patient interface on the user's face during use.

57. The patient interface according to claim 56, further comprising a conduit connector configured to connect to the inlet of the cushion module, the conduit connector comprising an asphyxiation prevention valve and a pressure port, and further configured to be detachably attached to a respiratory therapy conduit.

58. The patient interface according to claim 57, wherein the conduit connector is configured to be connected to a single-limb breathing circuit.

59. The patient interface according to claim 57, wherein the conduit connector is configured to be connected to biliary respiratory circuits.

60. The patient interface according to claim 59, wherein the conduit connector is configured to be connected to the biliary breathing circuit via a Y-shaped component.

61. A patient interface for delivering positive airway pressure therapy to a user, (a) A cushion module defining a first cavity configured to be pressurized, the cushion module including an inlet configured to receive a flow of pressurized gas into the cavity, an opening configured to surround the mouth and nostrils of the user to communicate the pressurized gas with the user, and an outlet configured to discharge the gas to the outside of the cushion module, (b) an exhaust conduit located within the first cavity, the exhaust conduit extending from the outlet of the cushion module to at least one exhaust conduit inlet, the at least one exhaust conduit inlet configured to be located within one of the user's nostrils or each of the first nostrils, The exhaust conduit includes at least one prong configured to form a seal with one or each of the first nostrils of the user, and the at least one exhaust conduit inlet is located at the free end of the at least one prong, the patient interface.

62. A patient interface for delivering positive airway pressure therapy to a user, (a) A cushion module defining a first cavity configured to be pressurized, the cushion module including an inlet configured to receive a flow of pressurized gas into the cavity, an opening configured to surround the mouth and nostrils of the user to communicate the pressurized gas with the user, and an outlet configured to discharge the gas to the outside of the cushion module, (b) A patient interface comprising an exhaust conduit located within the first cavity, the exhaust conduit extending from the outlet of the cushion module to a first exhaust conduit inlet and a second exhaust conduit inlet, wherein the first exhaust conduit inlet is configured to be located within a first nostril of the user's nostrils, and the second exhaust conduit inlet is configured to be located within a second nostril of the user's nostrils.

63. A cushion module for a patient interface for delivering positive airway pressure therapy to a user, (a) A cavity for communicating breathing gas with the user's mouth and nostrils, (b) an exhaust conduit for communicating exhaled gas from the user's mouth and / or nostrils, or excess respiratory gas from within the cavity, or both, to the outside of the cushion module, The exhaust conduit is configured to accelerate breathing gas as it flows from the cavity into the exhaust conduit, and is a cushion module.

64. A non-invasive patient interface configured to seal around the patient's mouth and nostrils, (a) an outer wall defining an internal volume including a first chamber having an opening for communicating gas to the mouth and a second chamber having a nasal opening for communicating gas to the nostrils, (b) A partition wall separating the first chamber from the second chamber, (c) comprising one or more flow guides configured to allow the gas to flow from the first chamber into the second chamber and to guide the gas flow into the nostrils, The aforementioned outer wall is configured to extend over the nasal bridge of the patient, providing a non-invasive patient interface.

65. A non-invasive patient interface configured to seal around the patient's mouth and nostrils, (a) An outer wall defining the internal volume of the patient interface, the outer wall having a patient contact surface including an oral opening for communicating gas with the mouth and a nasal opening for communicating gas with the nostrils, (b) A partition wall that separates the internal volume into a first chamber having the mouth opening and a second chamber having the nose opening, (c) One or more flow guides extending from the partition wall, the one or more flow guides being configured to allow the gas to flow from the first chamber into the second chamber and to guide the gas flow into the nostrils, The flow guides are separated by spacing elements that maintain the distance between the flow guides, The patient contact surface is a non-invasive patient interface that engages with the nasal dorsum of the patient.

66. A non-invasive patient interface configured to seal around the patient's mouth and nostrils, (a) An outer wall defining the internal volume of the patient interface, the outer wall including an oral opening for communicating gas with the mouth, and a nasal opening for communicating gas with the nostrils, (b) A partition wall separating the internal volume into a first chamber having the mouth opening and a second chamber having the nose opening, The partition wall includes one or more spaced flow guides configured to allow the gas to flow from the first chamber into the second chamber and to guide the gas flow into the nostrils, The outer wall is a non-invasive patient interface that engages with the nasal bridge of the patient.

67. A patient interface for delivering positive airway pressure therapy to a user, A cushion module including a seal and housing that together define a cavity configured to receive a flow of pressurized gas, The seal is configured to form a seal with the user's mouth and nostrils and includes at least one opening for communicating the pressurized gas with the user's mouth and nostrils, and comprises a cushion module. The pressurized gas is received into the cavity at the cushion module inlet, The aforementioned gas is discharged from the cavity through a cushion module outlet, The cushion module includes a partition insert configured to be inserted into the cavity, and comprising a partition wall and one or more flow guides, When the partition insert is inserted into the cavity of the cushion module, The partition wall extends across the cavity and intersects with the at least one sealing opening, separating the cavity into a first chamber including a mouth opening that communicates the pressurized gas with the user's mouth and a second chamber including a nasal opening that communicates the pressurized gas with the user's nostrils. The one or more flow guides are patient interfaces that allow the gas to flow from the first chamber through the partition to the second chamber.

68. The patient interface according to claim 67, wherein the cushion module inlet delivers the pressurized gas into the first chamber.

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

70. The patient interface according to any one of claims 67 to 69, wherein the partition wall includes the outer periphery that contacts the housing and / or the seal to adequately seal the first chamber away from 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 which is shaped to restrict the flow of gas between the first chamber and the second chamber around the outer periphery, substantially matching the internal geometry of the housing and / or seal.

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

73. The outer periphery of the partition wall is joined, bonded, or mechanically attached to the housing and / or seal, according to claim 70.

74. The patient interface according to any one of claims 67 to 72, wherein the partition insert includes a connector configured to be removably connected to the housing for securing the partition insert within the cavity of the cushion module.

75. The patient interface according to claim 74, wherein the connector of the partition insert includes a sleeve configured to connect to a sleeve of the housing.

76. The patient interface according to any one of claims 67 to 75, wherein the one or more flow guides include a first flow guide that has fluid communication with the first chamber and a first flow guide outlet that has fluid communication with the second chamber.

77. The patient interface according to claim 76, wherein the first flow guide outlet is configured to be positioned near and / or directed toward the user's nostrils when the patient interface is worn by the user.

78. The patient interface according to claim 76, wherein the one or more flow guides further include a second flow guide that has a second flow guide inlet and a second flow guide outlet that has a second flow guide outlet having fluid communication with the first chamber.

79. The patient interface according to claim 78, wherein the first flow guide outlet and the second flow guide outlet are each configured to be positioned near and / or directed toward one of the user's nostrils when the patient interface is worn by the user.

80. The patient interface according to claim 78 or 79, wherein the first flow guide and the second flow guide are shaped differently from each other in at least one way.

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

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

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

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

85. The patient interface according to claim 84, wherein the deformation region allows for controlled deformation of the partition within the thin-walled region in response to a force applied to the partition during use.

86. The patient interface according to any one of claims 67 to 85, wherein the seal is a full supranuclear 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 subnasal seal configured not to come into contact with the user's nasal bridge.

88. A patient interface for delivering positive airway pressure therapy to a user, A cushion module including a seal and housing that together define a cavity configured to receive a flow of pressurized gas, The seal is configured to form a seal with the user's mouth and nostrils, and includes a cushion module with a nasal opening that communicates the pressurized gas with the user's nostrils and a mouth opening that communicates the pressurized gas with the user's mouth, The pressurized gas is received into the cavity at the cushion module inlet, The aforementioned gas is discharged from the cavity through a cushion module outlet, The cushion module includes a partition insert configured to be inserted into the cavity, and comprising a partition wall and one or more flow guides, When the partition insert is inserted into the cavity of the cushion module, The partition wall extends across the cavity, separating the cavity into a first chamber containing the mouth opening and a second chamber containing the nasal opening. The one or more flow guides are patient interfaces that allow the gas to flow from the first chamber through the partition to the second chamber.

89. The patient interface according to claim 88, wherein the cushion module inlet delivers the pressurized gas into the first chamber.

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

91. The patient interface according to any one of claims 88 to 90, wherein the partition wall includes the outer periphery that contacts the housing and / or the seal to adequately seal the first chamber away from 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 which is shaped to restrict the flow of gas between the first chamber and the second chamber around the outer periphery, substantially matching the internal geometric shape of the housing and / or seal.

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

94. The outer periphery of the partition wall is joined, bonded, or mechanically attached to the housing and / or seal, according to claim 91.

95. The patient interface according to any one of claims 88 to 93, wherein the partition insert includes a connector configured to be removably connected to the housing for securing the partition insert within the cavity of the cushion module.

96. The patient interface according to claim 95, wherein the connector of the partition insert includes a sleeve configured to connect to a sleeve of the housing.

97. The patient interface according to any one of claims 88 to 96, wherein the one or more flow guides include a first flow guide that has fluid communication with the first chamber and a first flow guide outlet that has fluid communication with the second chamber.

98. The patient interface according to claim 97, wherein the first flow guide outlet is configured to be positioned near and / or directed toward the user's nostrils when the patient interface is worn by the user.

99. The patient interface according to claim 97, wherein the one or more flow guides further include a second flow guide that has a second flow guide inlet that has fluid communication with the first chamber and a second flow guide outlet that has fluid communication with the second chamber.

100. The patient interface according to claim 99, wherein the first flow guide outlet and the second flow guide outlet are each configured to be positioned near and / or directed toward one of the user's nostrils when the patient interface is worn by the user.

101. The patient interface according to claim 99 or 100, wherein the first flow guide and the second flow guide are shaped differently from each other in at least one way.

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

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

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

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

106. The patient interface according to claim 105, wherein the deformation region allows for controlled deformation of the partition within the thin-walled region in response to a force applied to the partition during use.

107. The patient interface according to any one of claims 88 to 106, wherein the seal is a full supranuclear 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 subnasal seal configured so as not to come into contact with the user's nasal bridge.

109. A patient interface for delivering positive airway pressure therapy to a user, A cushion module including a seal and housing that together define a cavity configured to receive a flow of pressurized gas, The seal is configured to form a seal with the user's mouth and nostrils, and includes a cushion module with a nasal opening that communicates the pressurized gas with the user's nostrils and a mouth opening that communicates the pressurized gas with the user's mouth, The pressurized gas is received into the cavity at the cushion module inlet, The aforementioned gas is discharged from the cavity through a cushion module outlet, The cavity includes a partition separating it into a first chamber having the mouth opening and a second chamber having the nose opening, The partition wall includes a flow guide opening configured to receive a flow guide insert, The flow guide insert includes one or more flow guides that allow the gas to flow from the first chamber into the second chamber when the flow guide insert is received into the flow guide opening.

110. The patient interface according to claim 109, wherein the cushion module inlet delivers the pressurized gas into the first chamber.

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

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

113. The patient interface according to claim 112, wherein the flow guide insert includes a channel around the flow guide insert, which is configured to receive the rim of the flow guide opening and 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 elastomer material.

115. The patient interface according to any one of claims 109 to 114, wherein the one or more flow guides include a first flow guide that has fluid communication with the first chamber and a first flow guide outlet that has fluid communication with the second chamber.

116. The patient interface according to claim 115, wherein the first flow guide outlet is configured to be positioned near and / or directed toward the user's nostrils when the patient interface is worn by the user.

117. The patient interface according to claim 115, wherein the one or more flow guides further include a second flow guide that has a second flow guide inlet that has fluid communication with the first chamber and a second flow guide outlet that has fluid communication with the second chamber.

118. The patient interface according to claim 117, wherein the first flow guide outlet and the second flow guide outlet are each configured to be positioned near and / or directed toward one of the user's nostrils when the patient interface is worn by the user.

119. The patient interface according to claim 117 or 118, wherein the first flow guide and the second flow guide are shaped differently from each other in at least one way.

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

121. The patient interface according to 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 within 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 openings extending through the flow guide insert.

123. The partition wall includes an elastomer portion, according to any one of claims 109 to 122.

124. The patient interface according to claim 123, wherein the elastomer portion includes a deformable region, and the deformable region includes a thin-walled region located between a first thick-walled region and a second thick-walled region.

125. The patient interface according to claim 124, wherein the deformation region allows for controlled deformation of the partition within the thin-walled region in response to a force applied to the partition during use.

126. The patient interface according to any one of claims 109 to 125, wherein the seal is a full supranuclear 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 subnasal seal configured not to come into contact with the user's nasal bridge.

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