Patient Interface System

Abstract

A patient interface for respiratory therapy includes an interface body and a housing that receives the interface body. The patient interface also includes a fixation member having a pair of support pads, each of which is configured to engage a user's face. In some configurations, the interface body can be a cannula body or a mask body. In some configurations, the housing can receive different interface bodies, and the interface bodies are interchangeable.

Description

Technical Field

[0001] The present disclosure generally relates to components for medical systems that convey gas to and / or from a patient. In one particular aspect, the present disclosure relates to a patient interface that forms part of a respiratory system.

Background Art

[0002] In assisted respiration, breathing gas is supplied to a patient through a patient interface via one or more flexible breathing tubes. The patient interface can be a nasal cannula, nasal mask, full face or oro-nasal mask, endotracheal tube, or other known type of interface. The gas exhaled by the patient flows through a similar breathing tube to other equipment (valves, ventilators, pressure devices, etc.) or is discharged around the patient.

[0003] In medical applications such as assisted respiration, the gas inhaled by the patient is preferably delivered at a temperature close to body temperature (usually 33°C to 37°C) and at a high relative humidity (generally nearly saturated). In other medical applications such as a continuous positive airway pressure (CPAP) system or a positive pressure ventilation system that provides positive pressure breathing gas to patients suffering from obstructive sleep apnea (OSA), the breathing gas may be heated and / or humidified to various levels to improve the user's comfort, or may be supplied without heating or humidification.

[0004] In this specification, when referring to patent specifications, other external documents or other information sources, this is generally for the purpose of providing a context for considering the features of the present disclosure. Unless otherwise stated, such references to external documents should not be construed in any jurisdiction as admitting that such documents or such information sources are prior art or form part of the common general knowledge in the technical field.

[0005] Further aspects and advantages of the present disclosure will become apparent from the following description given by way of example only.

Summary of the Invention

[0006] It is advantageous to provide a gas delivery therapy system equipped with a replaceable patient interface such as a nasal cannula, nasal mask, or oro-nasal mask. Such alternative or improved systems can further contribute to improved compliance and flexibility in gas delivery therapy. [Means for solving the problem]

[0007] One aspect of the present disclosure includes a patient interface assembly comprising a first interface body, a second interface body, and a housing configured to be detachably coupled to the first interface body or the second interface body. The first interface body and the second interface body are interchangeable such that in a first configuration the first interface body is coupled to the housing, and in a second configuration the second interface body is coupled to the housing.

[0008] In some configurations, the first interface body is the cannula body.

[0009] In some configurations, the cannula body includes one or more nasal prongs.

[0010] In some configurations, one or more prongs are configured to be inserted into the user's nostrils and form a seal.

[0011] In some configurations, the second interface body is the mask body.

[0012] In some configurations, the second interface body is a nasal mask.

[0013] In some configurations, the second interface body is a mouth-nasal mask.

[0014] In some configurations, the mask has a user contact surface configured to define a breathing chamber and to make contact with the user's face and surround at least the user's nostrils.

[0015] In some configurations, the housing includes an upper edge and a lower edge.

[0016] In some configurations, the upper and lower edges of the housing are symmetrical.

[0017] In some configurations, the edges of the housing are curved inward relative to the housing.

[0018] In some configurations, each of the first interface body and the second interface body includes a manifold, which is configured to be at least partially supported by the housing when the first interface body or the second interface body is detachably coupled to the housing.

[0019] In some configurations, the manifold includes a housing coupling portion configured to be received within the housing when the first interface body or the second interface body is detachably coupled to the housing.

[0020] In some configurations, the manifold includes a raised portion adjacent to the housing coupling portion, which is configured to prevent the manifold from rotating around the housing when the first interface body or the second interface body is detachably coupled to the housing.

[0021] In some configurations, the housing and / or manifold includes a feedback mechanism that provides visual or audible feedback when the first interface body or the second interface body is detachably coupled to the housing.

[0022] In some configurations, the patient interface assembly further includes one or more interface tubes.

[0023] In some configurations, the housing includes one or more tube engagement receptacles configured to receive an interface tube.

[0024] In some configurations, the patient interface assembly further includes a fixed member configured to be attached to the housing.

[0025] In some configurations, the first interface body can include a mask or nasal prong of a first size, the second interface body includes a mask or nasal prong of a second size, and the first size is different from the second size.

[0026] One aspect of the present disclosure includes a patient interface including an interface body, a housing, one or more interface tubes, a first fixing member, and a second fixing member extending vertically to provide vertical stability to the patient interface.

[0027] In some configurations, the interface body is configured to engage the patient's face and form a seal.

[0028] In some configurations, the interface body is a mask body or a cannula body.

[0029] In some configurations, the one or more tubes are configured to be coupled to the housing.

[0030] In some configurations, the one or more tubes are formed integrally with the housing as a single piece.

[0031] In some configurations, each of the one or more tubes includes an overmolded grip.

[0032] In some configurations, the first fixing member includes a central portion, a pair of support pads, and a pair of bridging portions. Each of the support pads is configured to engage with a fixing mechanism on both sides of the central portion. Each of the bridging portions connects the central portion to each of the support pads.

[0033] In some configurations, the first fixing member further comprises a patch assembly coupled to each of the support pads to secure the support pads to the user.

[0034] In some configurations, the second fixing member is coupled to the housing.

[0035] In some configurations, the second fixing member is configured to engage with the user's forehead.

[0036] In some configurations, the second fixing member is made of fabric material.

[0037] In some configurations, the second fixing member further comprises a patch assembly for securing the second fixing member to the user.

[0038] In some configurations, the interface body has a Shore hardness of 20A to 100A.

[0039] In some configurations, each of the one or more interface tubes is tapered towards one end.

[0040] One aspect of the present disclosure includes a patient interface comprising an interface body. The interface body comprises one or more prongs extending from a base region of the interface body and one or more openings that allow the flow of respiratory gas into and out of the interface body. One or more prongs are configured to bend in the base region while maintaining a seal with the user's nostrils.

[0041] In some configurations, the interface body includes a right prong and a left prong.

[0042] In some configurations, the thickness of one or more prongs varies along the length of one or more prongs.

[0043] In some configurations, the thickness of one or more prongs remains constant along the length of one or more prongs.

[0044] In some configurations, the base region has a smaller thickness than the rest of the interface body.

[0045] In some configurations, the base region has a surface that is recessed relative to the adjacent region of the interface body.

[0046] In some configurations, the base region has a concave surface around one or more prongs.

[0047] In some configurations, the base region has a concave surface extending around the two prongs.

[0048] In some configurations, one or more prongs are configured to bend forward and backward.

[0049] In some configurations, one or more prongs are configured to curve to the right and to the left.

[0050] In some configurations, one or more prongs are configured to curve to the right and to the left.

[0051] In some configurations, one or more prongs have a circular cross-section adjacent to the apex of the prong.

[0052] In some configurations, one or more prongs are configured to bend along their length while maintaining their diameter and cross-sectional shape.

[0053] In some configurations, one or more prongs are configured to bend while maintaining their flow resistance (RTF).

[0054] One aspect of the present disclosure includes a respiratory system comprising a gas source, an inspiratory conduit fluidly connected to the gas source, and a patient interface. The patient interface comprises an interface body, a housing, one or more interface tubes, and a first fixing member.

[0055] In some configurations, the respiratory system further includes an expiratory conduit configured to receive gas from the patient interface.

[0056] In some configurations, the respiratory system further includes a bubbler device.

[0057] In some configurations, the breathing system also includes a humidifier.

[0058] In some configurations, the housing is configured to accommodate each of several interface bodies, such that the interface bodies are interchangeable.

[0059] In some configurations, the interface body is either the mask body or the cannula body.

[0060] In some configurations, one or more interface tubes are configured to be coupled to the housing.

[0061] In some configurations, one of the interface tubes is configured to connect to the intake conduit.

[0062] In some configurations, one or more interface tubes are formed as a single component with the housing.

[0063] In some configurations, each of one or more tubes features an overmolded grip.

[0064] In some configurations, the first fixing member comprises a central portion, a pair of support pads, and a pair of bridging portions. Each of the support pads is configured to engage with the user's face on either side of the central portion. Each of the bridging portions connects the central portion to each of the support pads.

[0065] In some configurations, the first fixing member further comprises a patch assembly coupled to each of the support pads to secure the support pads to the user.

[0066] In some configurations, the patient interface further includes a second fixing member coupled to the housing.

[0067] In some configurations, the second fixing member is configured to engage with the user's forehead.

[0068] In some configurations, the second fixing member is made of fabric material.

[0069] In some configurations, the second fixing member further comprises a patch assembly for securing the second fixing member to the user.

[0070] In some configurations, the breathing system further includes a headgear or bonnet.

[0071] One aspect of the present disclosure is a fixation member for a patient interface of a respiratory system, comprising a flexible barb that is detachably coupled to a housing of the patient interface.

[0072] In some configurations, the configuration has one or more tabs.

[0073] In some configurations, the housing includes an opening, and one or more tabs are configured to hook onto the housing at the opening.

[0074] In some configurations, the hook includes a notch. The notch is designed to help the hook collapse.

[0075] In some configurations, the latch includes an extended top portion configured to prevent the latch from being excessively inserted into the opening of the housing.

[0076] In some configurations, the mounting is overmolded onto the fixing member.

[0077] One aspect of the present disclosure is a fixation member for a patient interface of a respiratory system, comprising a support pad for fixation to a patch assembly over a patient, wherein the support pad is hinged relative to the rest of the fixation member.

[0078] In some configurations, the support pad is flexible.

[0079] In some configurations, the fixing member further includes a hinge between the support pad and a portion of the fixing member.

[0080] In some configurations, the support pads are overmolded onto the fixing members.

[0081] In some configurations, the hinge is a 180-degree hinge.

[0082] One aspect of the present disclosure includes a fixation member for a patient interface of a respiratory system, comprising a first flexible portion connectable to a patient interface component, a second flexible portion connectable to the patient's forehead, and a third rigid portion extending between the first and second portions.

[0083] In some configurations, the first flexible part is a cap.

[0084] In some configurations, the second flexible portion is a support pad.

[0085] In some configurations, the first and / or second flexible portion is overmolded onto the third rigid portion.

[0086] In some configurations, the second flexible part moves in a hinge-like manner relative to the third rigid part.

[0087] In some configurations, the fixing member can be detachably connected to the patient interface housing.

[0088] In some configurations, the component is either the housing or the interface body.

[0089] One aspect of the present disclosure is an interface body comprising a manifold including a front side configured to contact a patient and a rear side opposite to the front side, wherein the manifold includes a raised portion of a housing coupling portion positioned between the rear side of the manifold and the front side of the manifold, wherein the manifold has a width extending along the lumen of the manifold and a transverse axis extending along the width, the raised portion being inclined with respect to the transverse axis, and the inclined raised portion of the housing coupling portion being configured to improve the assembly and alignment of the interface body when the interface body is detachably coupled to a housing via the manifold. The patient interface assembly includes a housing comprising a front side facing the patient and a rear side opposite to the front side, wherein the housing has a width extending from a first tube engagement portion at one end of the housing to a second tube engagement portion at the opposite end of the housing and a transverse axis extending along the width, and the housing includes an interface body receiving portion between the side of the housing and the rear side of the housing, the interface body receiving portion being inclined with respect to the transverse axis, and the inclined interface body receiving portion being configured to improve assembly and alignment when a manifold is detachably coupled to the housing and supported by the housing.

[0090] In some configurations, the raised portion of the manifold has a first width on the front side of the manifold that is larger than the second width on the rear side of the manifold.

[0091] In some configurations, the raised portion of the manifold has a first width on the front side of the manifold that is smaller than the second width on the rear side of the manifold.

[0092] In some configurations, the sloping protrusion at the manifold housing connection extends from the rear of the manifold at a 120-degree angle.

[0093] In some configurations, the sloping protrusion at the manifold housing joint extends at a 60-degree angle from the rear of the manifold.

[0094] In some configurations, the sloping protrusion at the manifold housing joint extends from the rear of the manifold at an angle of 30 to 170 degrees.

[0095] In some configurations, the patient interface assembly further includes an engagement surface in which a raised portion of the housing coupling and an interface body receiving portion contact each other, wherein a portion of the manifold's raised portion on the engagement surface is relatively higher than the engagement surface of the housing.

[0096] In some configurations, the manifold has portions on both sides of the manifold that are configured to extend into the housing, and the portions extending into the housing have ridged portions configured to be sealed within the housing.

[0097] In some configurations, the ridges are annular ridges.

[0098] In some configurations, the ridged portion is configured to seal against the inner surface of the housing.

[0099] In some configurations, the manifold has a first distance between the front of the engagement surface and the annular ridge, and a second distance between the rear of the engagement surface and the annular ridge, the second distance being greater than the first distance.

[0100] In some configurations, the front of the manifold has a first wall thickness, and the rear of the manifold has a second wall thickness, with the first wall thickness being greater than the second wall thickness.

[0101] One aspect of the present disclosure includes a housing that is detachably coupled to a manifold of an interface body, the housing comprising a side projection and a central projection, the side projection comprising a mechanism for coupling a first fixing member to the housing, and the central projection comprising one or more mechanisms for coupling a second fixing member to the housing.

[0102] In some configurations, the housing is a rigid housing.

[0103] In some configurations, one or more mechanisms for connecting the second fixing member to the housing are one or more openings.

[0104] In some configurations, the second fixing member is detachably coupled to the housing.

[0105] In some configurations, one or more openings are provided with lips configured to hook onto complementary fitting portions of a second fixing member.

[0106] In some configurations, the mechanism of the lateral projection includes an enlarged head and stem for a press-fit connection.

[0107] In some configurations, the first fixing member is detachably coupled to the housing.

[0108] In some configurations, the patient interface assembly includes additional tubing, which is integrated with the housing.

[0109] In some configurations, the patient interface assembly further includes tubing, which is detachably coupled to the housing.

[0110] One aspect of the present disclosure is a fixation member for a patient interface of a respiratory system, comprising: a central portion; a pair of support pads, each of which is configured to engage with the user's face on both sides of the central portion; and a pair of bridging portions, each of which connects the central portion and each of the support pads, wherein the bridging portions include a notch for receiving a housing, and the bridging portions include a thickened portion surrounding the notch.

[0111] In some configurations, the fixing member comprises a patch assembly coupled to each of the support pads to secure the support pads to the user.

[0112] In some configurations, the fixing member further includes an opening configured to detachably connect to a projection on the housing, and the first fixing member is press-fitted onto the projection on the housing.

[0113] In some configurations, the fixing member further includes a recess on its rear side, which is configured to correspond to a central projection on the housing when the fixing member is coupled to the housing.

[0114] One aspect of the present disclosure is a patient interface assembly for a respiratory system, comprising an interface body, a housing to which the interface body is detachably coupled, and a mechanism for restricting the rotation of the interface body relative to the housing.

[0115] In some configurations, the interface body includes a manifold, and the mechanism includes a shoulder portion at the rear of the manifold.

[0116] In some configurations, the shoulder portion abuts against the housing to restrict rotation.

[0117] In some configurations, the mechanism includes a key mechanism in the manifold and housing.

[0118] In some configurations, the interface body includes the cannula body.

[0119] In some configurations, the interface body includes the mask body.

[0120] In some configurations, the housing includes one or more tube engagement receiving portions configured to receive interface tubes.

[0121] One aspect of the present disclosure is a patient interface assembly for a respiratory system, comprising a housing; an inspiratory conduit having a first end and a second end, the first end configured to connect to the housing and deliver an incoming gas flow, and the second end having a locking finger; and an expiratory conduit having a first end and a second end, the first end configured to connect to the housing and receive an expiratory gas flow, and the second end having a locking finger.

[0122] In some configurations, the locking finger at the second end of the expiratory conduit is configured to connect to a downstream component.

[0123] In some configurations, the downstream components include a bubbling device.

[0124] In some configurations, the locking finger at the second end of the intake conduit is configured to connect to an upstream component.

[0125] In some configurations, the upstream components include the flow source.

[0126] In some configurations, the locking fingers extend away from the connector, and they are spaced apart and narrow along their length in the direction away from the connector.

[0127] In some configurations, the locking finger includes a locking recess formed on at least the outer surface of each locking finger, the locking recess being configured to lock with a portion of the gas delivery tube connector, and the locking finger is configured to interact with the recess of the gas delivery tube connector to align the connector with the gas delivery tube connector.

[0128] One aspect of the present disclosure is a patient interface assembly for a respiratory system, comprising an interface body and a housing, wherein at least a portion of the outer surface of the housing and / or the interface body includes a low-friction surface coating or finish.

[0129] In some configurations, the interface body includes the cannula body.

[0130] In some configurations, the interface body includes the mask body.

[0131] In some configurations, the low-friction surface coating or finish is achieved by a parylene coating or by a blasting process such as bead blasting.

[0132] In some configurations, the interface body includes a rear side containing the patient contact surface and a front side opposite the rear side, the rear side having a low-friction surface coating or finish.

[0133] In some configurations, the interface body is detachable from the housing, and the interface body includes a manifold having a low-friction surface coating or finish that engages with the housing.

[0134] One aspect of the present disclosure is a method for manufacturing a patient interface assembly for a respiratory system, comprising the steps of manufacturing an interface body and coating the outer surface of the interface body with a low-friction surface coating or finish.

[0135] In some configurations, the interface body includes the cannula body.

[0136] In some configurations, the interface body includes the mask body.

[0137] In some configurations, the interface unit is detachable from the housing.

[0138] In some configurations, virtually the entire outer surface of the interface itself is coated.

[0139] In some configurations, a portion of the interface body is coated, and the interface body includes the patient-facing rear side and the front side opposite the rear side, with the coated portion being the rear portion of the manifold of the interface body.

[0140] In some configurations, a portion of the interface body is coated, and the interface body includes the patient-facing rear side and the front side opposite the rear side, with the coated portion being the front part of the manifold of the interface body.

[0141] One aspect of the present disclosure is a manifold comprising a front side configured to contact a patient and a rear side opposite to the front side, wherein the manifold comprises a raised portion of a housing coupling portion positioned between the rear side of the manifold and the front side of the manifold, the manifold having a width extending along the lumen of the manifold and a transverse axis extending along the width, the raised portion being inclined with respect to the transverse axis, and the inclined raised portion of the housing coupling portion being configured to improve the assembly and alignment of the interface body when the interface body is detachably coupled to the housing via the manifold, and a mechanism for restricting the rotation of the interface body relative to the housing, wherein the housing comprises a front side facing a patient and a rear side opposite to the front side, the housing having a width extending from a first tube engagement portion at one end of the housing to a second tube engagement portion at the opposite end of the housing and a transverse axis extending along the width, and the housing comprises an interface body receiving portion between the front side of the housing and the rear side of the housing, The interface body is inclined with respect to the horizontal axis, and the inclined interface body receiving portion is configured to improve assembly and alignment when the manifold is detachably coupled to the housing and supported by the housing. The interface body comprises a first fixing member, which has a central portion, a pair of support pads, each of which is configured to engage with the user's face on both sides of the central portion, and a pair of bridging portions, each of which connects the central portion and each of the support pads. However, a first fixing member including a notch for receiving the housing, the bridging portion including a thickened portion surrounding the notch, a second fixing member comprising a first flexible portion connectable to a patient interface component, a second flexible portion connectable to the patient's forehead, and a third rigid portion extending between the first and second portions, an inspiratory conduit having a first end and a second end, the first end configured to connect to the housing and deliver the incoming gas flow, and the second end having a locking finger,The patient interface assembly includes an exhalation conduit configured to connect to a housing and receive the flow of exhaled gas, with a second end having a locking finger.

[0142] In some configurations, the interface body includes the cannula body.

[0143] In some configurations, the interface body includes the mask body.

[0144] In some configurations, the inspiratory and expiratory ducts are integrated with the housing.

[0145] In some configurations, the first and second fixing members can be connected to the housing.

[0146] In some configurations, the second fixing member can be connected to the patient's patch assembly or headgear.

[0147] In one configuration, the second fixing member is detachably connected to the housing.

[0148] In some configurations, the interface unit is detachably coupled to the housing.

[0149] One aspect of the present disclosure includes a patient interface assembly comprising an interface body and a housing configured to be detachably coupled to the interface body, wherein the housing has one or more tube engagement portions at lateral inlet points at both ends of the housing, the tube engagement portions being configured to receive interface tubes.

[0150] In some configurations, the interface body includes the cannula body.

[0151] In some configurations, the interface body includes the mask body.

[0152] One aspect of the present disclosure includes a patient interface assembly comprising a first interface body, a second interface body, and a housing configured to be detachably coupled to the first interface body or the second interface body, wherein the housing has one or more tube engagement portions at a lateral inlet point of the housing, and the tube engagement portions are configured to receive interface tubes, wherein the first interface body and the second interface body are interchangeable such that in a first configuration the first interface body is coupled to the housing, and in a second configuration the second interface body is coupled to the housing.

[0153] One aspect of the present disclosure includes a mask having a breathing chamber and a user contact surface configured to contact the user's face and surround at least the user's nostrils, and an interface body comprising a manifold in fluid communication with the breathing chamber, the manifold having a first opening on a first side of the manifold and a second opening on a second side of the manifold, the first and second openings enabling gas flow into and from the breathing chamber.

[0154] In some configurations, the first and second openings can be configured to communicate with interface tubes configured to deliver the flow of gas entering and exiting the first and second sides of the mask and manifold.

[0155] One aspect of the present invention includes an interface body comprising a mask, the mask having a user contact surface configured to define a breathing chamber and to contact the user's face and surround at least the user's nostrils, the mask comprising a mask seal, at least a portion of which comprises a stiffness reduction region, the stiffness reduction region being positioned between a first relatively stiff region and a second relatively stiff region, the first and second relatively stiff regions having a stiffness greater than that of the stiffness reduction region, and the stiffness reduction region buckles in a first direction as the first relatively stiff region moves toward the second relatively stiff region, as the first relatively stiff region continues to move toward the second relatively stiff region.

[0156] In some configurations, the first relatively rigid region may include a structural support portion that extends at least partially around the mask.

[0157] In some configurations, the second relatively rigid region may be the front part of the mask.

[0158] One aspect of the present disclosure includes a patient interface assembly comprising: an interface body including a housing coupling portion, wherein the housing coupling portion includes a first side facing a patient and a second side opposite to the patient, and the housing coupling portion has a shape defined between the first side and the second side of the housing coupling portion; and a housing including an interface body receiving portion, wherein the interface body receiving portion has a shape complementary to the shape of the housing coupling portion of the interface body, and the housing is configured to be detachably coupled to the interface body.

[0159] In some configurations, the shape of the housing joint includes a trapezoidal shape.

[0160] In some configurations, the housing connection portion of the interface body includes the wider base of the trapezoid, adjacent to the front portion of the housing.

[0161] In some configurations, the housing connection portion of the interface body includes the wider base of the trapezoidal shape, adjacent to the rear portion of the housing.

[0162] One aspect of the present disclosure includes an interface body comprising one or more prongs extending from a base region and one or more openings that allow the flow of respiratory gas into and out of the prongs, wherein one or more prongs are configured to bend in the base region while maintaining a seal with the user's nostrils.

[0163] In some configurations, one or more prongs may have a thickness that varies along the length of the one or more prongs.

[0164] In some configurations, one or more prongs may have a constant thickness along the length of the one or more prongs.

[0165] One aspect of the present disclosure includes an interface body, which may comprise one or more prongs extending from a base region of the interface body, and one or more openings that allow the flow of breathing gas into and out of the interface body, wherein one or more prongs are configured to bend in the base region while maintaining a seal with the user's nostrils.

[0166] Throughout the drawings, reference numbers may be reused to indicate the overall correspondence between reference elements. The drawings are provided to illustrate the embodiments described herein and are not intended to limit the scope of this disclosure. [Brief explanation of the drawing]

[0167] [Figure 1] An example of a system that can use a patient interface embodiment is shown. [Figure 2] An example of a system that can use a patient interface embodiment is shown. [Figure 3] These are front, top, and side perspective views of the patient interface. [Figure 4] Figure 3 shows front, top, and side perspective views of the patient interface. [Figure 5] These are front, top, and side perspective views of the patient interface. [Figure 6] Figure 5 shows front, top, and side perspective views of the patient interface. [Figure 7] These are front, top, and side perspective views of the housing. [Figure 8] Figure 7 is a front view of the housing. [Figure 9] Figure 7 is a rear view of the housing. [Figure 10] These are front, top, and side perspective views of the nasal interface. [Figure 11] Figure 10 is a front view of the nasal interface. [Figure 12A] Figure 10 is a top view of the nasal interface. [Figure 12B] Figure 10 is a rear view of the nasal interface. [Figure 13A] This is a representation of the nasal prongs on the cannula itself. [Figure 13B] This is a representation of the nasal prongs on the cannula itself. [Figure 13C] This is a representation of the nasal prongs on the cannula itself. [Figure 13D] This is a representation of the nasal prongs on the cannula itself. [Figure 13E] The diagram shows the nasal prongs of the cannula body. [Figure 13F] The diagram shows the nasal prongs of the cannula body. [Figure 13G] The diagram shows the nasal prongs of the cannula body. [Figure 13H] The diagram shows the nasal prongs of the cannula body. [Figure 13I] The diagram shows the nasal prongs of the cannula body. [Figure 14A] Figure 10 is a schematic diagram of the nasal interface showing the thickness analysis. [Figure 14B] This is a schematic drawing of the nose interface showing the thickness analysis. [Figure 14C] This is a cross-sectional view of the nasal prongs of the cannula body. [Figure 15] These are rear, top, and side perspective views of the patient interface. [Figure 16] These are front, top, and side perspective views of the patient interface. [Figure 17] Figure 16 is a front view of the patient interface. [Figure 18] Figure 16 is a top view of the patient interface. [Figure 19] Figure 16 is a rear view of the patient interface. [Figure 20] Figure 16 is a schematic diagram of the patient interface. [Figure 21] Figure 16 is a schematic diagram of the patient interface. [Figure 22A] These are front, top, and side perspective views of the nasal interface. [Figure 22B] Figure 22A shows the rear, top, and side perspective views of the nasal interface. [Figure 23] Figure 22A is a schematic diagram of the nasal interface. [Figure 24A] These are rear, top, and side perspective views of the nasal interface. [Figure 24B] This is a cross-sectional view of the nasal interface. [Figure 24C] This is a side cross-section of the nasal interface. [Figure 24D] This is a schematic diagram of the upper cross-section of the nasal interface. [Figure 24E] This is a schematic diagram of a lateral cross-section of the nasal interface. [Figure 25] These are front, top, and side perspective views of the patient interface. [Figure 26] Figure 25 is a top view of the patient interface. [Figure 27] These are front, top, and side perspective views of the fixing member. [Figure 28] Figure 27 is a front view of the fixing member. [Figure 29] These are front, top, and side views of the fixing member and housing. [Figure 30] Figure 29 is a rear view of the fixing member and housing. [Figure 31] This is a schematic drawing of the fixing member. [Figure 32] This is a schematic drawing of the fixing member. [Figure 33] These are front, top, and side views of the fixing member. [Figure 34] Figure 33 is a front view of the fixing member. [Figure 35] Figure 33 is a rear view of the fixing member. [Figure 36] These are front, top, and side perspective views of the patient interface assembly. [Figure 37] This is a top view of the housing. [Figure 38] This is a top perspective view of the interface housing. [Figure 39A] This is a front perspective view of the fixing member. [Figure 39B] This is a rear perspective view of the fixing member. [Figure 39C] This is a top view of the fixing member. [Figure 40] This is a front perspective view of the fixing member. [Figure 41] This is a front perspective view of the fixing member. [Figure 42] This is a front perspective view of the fixing member. [Figure 43A] This is a front view of the fixing member and housing. [Figure 43B] This is a top view of the housing. [Figure 44] These are front and side perspective views of the fixing member. [Figure 45] This is a diagram of the fixing member. [Figure 46A] These are front and side perspective views and rear and side perspective views of the fixing member. [Figure 46B] These are front and side perspective views and rear and side perspective views of the fixing member. [Figure 47]This is a front and side perspective view of the fixing member and housing. [Figure 48A] This is a rear view of the cannula itself. [Figure 48B] This is a front view of the mask itself. [Figure 48C] This is a schematic front view of the mask body. [Figure 48D] This is a schematic diagram of the mask body, showing the front and side perspective views. [Figure 48E] This is a schematic top view of the mask body. [Figure 49] This is a top view of the nasal interface and housing. [Figure 50] This is a partial top view of the nasal interface and housing. [Figure 51A] This is a partial top view of the nasal interface and housing. [Figure 52A] This is a top view of the nasal interface and housing. [Figure 52B] Figure 52A is a rear view of the nose interface and housing. [Figure 53A] This is a top view of the nasal interface and housing. [Figure 53B] Figure 53A is a partial top view of the nasal interface and housing. [Figure 53C] Figure 53A is a partial top view of the nasal interface and housing. [Figure 53D] Figure 53A is a partial top view of the nasal interface and housing. [Figure 54] This is a side cross-sectional view of the interface body. [Figure 55] This is a side cross-sectional view of the interface body. [Figure 56A] This is a diagram of the interface unit and housing. [Figure 56B] This is a diagram of the interface unit and housing. [Figure 56C] This is a diagram of the interface unit and housing. [Figure 56D] This is a diagram of the interface unit and housing. [Figure 56E] This is a diagram of the interface assembly, including the interface body, housing, and tubing. [Figure 56F] Interface assembly: interface body, housing [Figure 57] This is a front perspective view of the interface tube and connector. [Modes for carrying out the invention]

[0168] Hereinafter, embodiments of the system, components, and assembly and manufacturing methods will be described with reference to the accompanying drawings, where similar figures refer to similar or identical elements. Several embodiments, examples, and examples are disclosed below, but those skilled in the art will understand that the invention described herein extends beyond the specifically disclosed embodiments, examples, and examples and may include other uses of the invention and obvious variations and equivalents thereof. The terms used in the description presented herein are not intended to be construed in any restrictive or limiting manner, solely because they are used in conjunction with the detailed description of some specific embodiments of the invention. In addition, embodiments of the invention may include several novel features, and no single feature alone constitutes its desired attributes, nor is it essential for carrying out the invention described herein.

[0169] In the following description, some terms may be used for reference purposes only and are therefore not intended to be limiting. For example, terms such as “top” and “bottom” refer to the direction in the referenced drawing or the direction relative to the orientation of the device when the user is using it in an upright position. Terms such as “front,” “back,” “left,” “right,” “rear,” and “side” describe the orientation and / or location of a part of a component or element within a consistent but arbitrary reference frame or relative to the orientation of the device when the user is using it in an upright position, as becomes clear by referring to the text and related drawings describing the component or element under consideration.

[0170] Respiratory system Figure 1 shows an example respiratory system 1000 in which an embodiment of the patient interface 3000 can be used. In the illustrated configuration, the patient interface 3000 receives an inspiratory gas flow via an inspiratory conduit 201a. The expiratory gas flow can be directed from the interface 3000 through an expiratory conduit 201b to a resistance device, which is a bubbler device 70 in the illustrated configuration. An optional humidifier system 30 is provided to humidify the inspiratory gas flow. The humidifier system 30 typically includes a chamber located on a heater base, to which a gas flow source from, for example, a hospital or other source 300 is supplied. The humidified inspiratory gas flow is delivered to the patient's airway by the inspiratory conduit 201a and the patient interface 3000. Excess gas and expiratory gas are exhausted from the patient interface 3000 by the expiratory conduit 201b. The resistance device 70 provides resistance to the exhaled gas flow from the system 1000 to the atmosphere, thereby providing a desired peak end-expiratory pressure (PEEP). Those skilled in the art will understand that such a system may include additional and / or interchangeable components as known in the art. In some embodiments, the patient interface 3000 includes a nasal cannula. In other embodiments, the patient interface 3000 includes a mask. For example, the patient interface 3000 may include a nasal mask, an orb-nasal mask, an orb mask, or a full-face mask. In some embodiments, the resistance device and / or humidifier are incorporated into the supply source 300. Figure 1 shows a water-based resistance device, but those skilled in the art will understand that the resistance device may be any other mechanical or electrical resistance device as known in the art.

[0171] Referring here to Figure 2, another example of a respiratory system including a bubbler device and a humidifier is shown. It shows a humidified positive end-expiratory pressure (PEEP) system in which a patient 119 receives humidified and pressurized gas through a patient interface 3000 connected to an inspiratory or inhalation conduit 201a. However, it should be understood that this disclosure is not limited to the delivery of PEEP gas and is applicable to other types of gas delivery systems, which may not necessarily involve humidification. The inspiratory conduit 201a is connected to an outlet 112 of a humidification chamber 110 containing a certain amount of water 115. The inspiratory conduit 201a may house heating means or heater wires 120 that heat the walls of the conduit to ensure a constant humidity profile along the conduit and thus reduce condensation of the humidified gas within the conduit. When a certain amount of water 115 in the humidification chamber 110 is heated, steam begins to fill the chamber volume above the water level and is expelled from the humidification chamber 110 outlet 112 along with the flow of gas (e.g., air) supplied from a gas supply means or blower 118 that enters the chamber 110 through the inlet 116. The humidified gas proceeds through the inspiratory conduit 201a to the interface 3000 worn by the patient 119. The excess gas then flows through the exhalation or discharge conduit 201b to the pressure regulator 40.

[0172] In some embodiments, the pressure regulator 40 takes the form of discharging the exhaled gas flow into a chamber 204 containing a water column 138. The gas flowing through the exhaled conduit 201b is discharged into the water body 138 through a short conduit 136 extending from the exhaled conduit 201b into the chamber 204. This results in a bubbling effect, thereby causing the gas to eventually exit the chamber 204 through an outlet port, which can also be used to initially fill the chamber 204 with water. The outlet port includes a shield to prevent the discharge of liquid aerosols resulting from vigorous bubbling on the water surface. It will be understood that the short conduit 136 can similarly be incorporated into the end of the exhaled conduit 201b.

[0173] Patient Interface Assembly Figures 3 to 6 show embodiments of the patient interface 3000. As shown in Figures 3 to 6, the patient interface 3000 includes an interface body that can form a seal with the user's face and allow gas flow from and to the user, and the interface body can be coupled to a housing 3400. In some embodiments, the housing 3400 may be a frame that can receive a portion of the interface body. In some embodiments, the interface body is a cannula body 3200a that can fit with the housing 3400 to form a nasal cannula 3200, as shown in Figures 3 to 4. The cannula body 3200a can form a seal with the nostrils of the user's nose. In some embodiments, the interface body is a mask body, such as the mask body 3200b shown in Figures 5 and 6. The mask body 3200b has a mask or mask cushion that can form a seal with the user's face. The illustrated embodiments of the patient interface 3000 also include a first fixing member 3600, one or more interface tubes 3800 and a second fixing member 3900.

[0174] In some embodiments, the housing 3400 can be detachably coupled to the cannula body 3200a, the mask body 3200b, or any other type of interface body. The housing 3400 can be detachably coupled to the interface body using a mechanism, for example, described in more detail herein, so that the user or clinician can swap between different types of interface bodies (e.g., between the cannula body 3200a and the mask body 3200b) and / or between interface bodies of different sizes. This can help to better fit while reusing the same housing without disassembling or removing the entire patient interface 3000 during treatment. For example, while the first fixing member 3600, the interface tube 3800 and / or the forehead support member 3900 are coupled to the housing 3400, the interface body can be coupled to and / or detached from the housing. In some cases, for example, it may be necessary to alternate between the mask body and the cannula body during treatment to reduce or prevent skin irritation or damage. The interface body can be replaced while the housing 3400 remains connected to the headgear, bonnet, chin strap, or the user's face. Furthermore, the detachable connection between the interface body and the housing 3400 may be advantageous for cleaning and maintenance. In some embodiments, the kit for treating a patient includes one or more cannula bodies and / or one or more mask bodies compatible with the housing 3400, so that the user or clinician can select and use the appropriate interface body. In some embodiments, the kit includes cannula bodies and / or mask bodies of different sizes. Different sizes of mask bodies and / or cannula bodies may be indicated by different colors or by other means such as letters and / or symbols. Letters and / or symbols may be molded, laser-marked, printed, or otherwise displayed on the mask bodies and / or cannula bodies.

[0175] In some embodiments, the housing 3400 can be permanently coupled to a cannula body 3200a, a mask body 3200b, or any other type of interface body. The user or clinician may swap between different types of interface bodies (e.g., between cannula body 3200a and mask body 3200b) or between interface bodies of different sizes for better mating by replacing the assembly including the housing and interface body. For example, the interface body and housing 3400 can be coupled to and / or detached from the interface tube 3800. In some embodiments, a kit for treating a patient includes one or more cannula bodies and / or one or more mask bodies attached to the housing 3400, so that the user or clinician can select and use the appropriate interface body attached to the housing 3400.

[0176] The first fixing member 3600 can fix or support the patient interface 3000 to the user. The first fixing member 3600 can be coupled to the housing 3400 and can facilitate the fixation of the interface body to the user's face, thereby helping the interface body form and maintain a seal with the user's face. In some embodiments, the first fixing member 3600 includes means for attaching and fixing the patient interface 3000 to the patient's face by a headgear, chin strap, patient interface patch or skin patch on the patient's face, or by any other suitable mechanism. For example, the first fixing member 3600 may include hook and loop material or adhesive on the side facing the user, as described in more detail herein. Even when the first fixing member 3600 is coupled to the housing 3400 in the illustrated embodiments, the patient interface 3000 can be used without the first fixing member 3600. For example, the housing 3400 may be fixed to the user's face, for example, directly to the cheek, or by other fixing means such as a headgear or chin strap. As shown in Figures 3 to 6, the first fixing member 3600 can extend horizontally or substantially horizontally. However, the first fixing member 3600 can be positioned in any suitable orientation.

[0177] The patient interface 3000 may further include other fastening means in addition to, or instead of, the first fastening member 3600. For example, in the illustrated embodiment, the patient interface 3000 includes a second fastening member 3900. In some embodiments, the patient interface 3000 includes both the first fastening member 3600 and the second fastening member 3900. In some embodiments, the patient interface includes one of the first fastening member 3600 and the second fastening member 3900. As shown in Figures 3 to 6, the second fastening member 3900 may extend vertically or substantially vertically. However, the second fastening member 3900 may be positioned in any suitable orientation.

[0178] The patient interface 3000 may further include one or more interface tubes 3800. In some embodiments, the walls of the interface tubes may be made of a material that can allow water vapor to pass through the walls of the interface tubes. In some embodiments, one or more interface tubes 3800 are at least partially insulated. The interface tubes 3800 can be coupled at one end to a housing 3400 and at the other end, for example via tubes 201a and 201b, to a CPAP therapy delivery device, allowing gas from and to the user to flow through the housing 3400 and the interface body. Each of the interface tubes 3800 may include a connector 3860 for connecting to respiratory components such as tubes 201a and 201b. The connectors 3860 can be overmolded onto the tubes 3800. The connectors 3860 may be made of silicone or elastomer material, or may include such materials. The connectors 3860 may have a rigidity similar to or greater than that of the interface tubes 3800. The connector 3860 is provided in a more rigid geometric form relative to the tube 3800 and may be made of the same material as the components of the interface tube 3800, such as the bead of the interface tube 3800, or may include such material. In some embodiments, the connector 3860 includes one or more ports for monitoring gas properties such as pressure. In some embodiments, the patient interface 3000 may include one or more sensors for monitoring gas properties such as pressure at one or more ports or at any other preferred location. The connector 3860 may be suitable for receiving a clip, which can be used to clip onto a bed sheet or clothing to provide further fastening of the patient interface 3000 and the tube 3800. In some embodiments, each of the interface tubes 3800 further includes a grip 3850. The grip 3850 can be overmolded directly or indirectly onto the tube 3800, for example, on both the tube 3800 and the connector 3860.In some embodiments, the tube 3800 may be attached with adhesive or screwed onto the connector 3860 or other area of ​​the grip 3850. A clinician or user can hold the grip 3850 and connect or plug the connector 3860 to respiratory components such as tubes 201a and 201b. In some embodiments, one or more components of the interface tube 3800 may be rotatable relative to other components of the interface tube 3800. For example, the grip 3850 may be rotatable relative to the connector 3860 so that twisting or movement caused by holding the grip 3850 is not transmitted through the rest of the tube 3800 to the housing 3400 and the interface body.

[0179] In some embodiments, the tubes 3800 can be detachably coupled to the housing 3400. In some embodiments, one or more of the interface tubes 3800 are permanently attached to the housing 3400. For example, one or more of the interface tubes 3800 may be overmolded directly or indirectly onto the housing 3400 to form a single integrated part. In some embodiments, the tubes 3800 may be attached with adhesive or screwed to the housing 3400. In some embodiments, the tubes 3800 can rotate or pivot relative to the housing 3400 such that twisting or movement of the tubes 3800 is not transmitted to the housing 3400 and the interface body. In some embodiments, the interface tubes 3800 have a diameter and / or thickness that varies along their length. For example, each of the interface tubes 3800 may be tapered toward one end. In some embodiments, the interface tubes 3800 have a constant diameter and / or thickness along their length. In some embodiments, the interface tube 3800 may have a circular, semicircular, or D-shaped cross-section. When a semicircular or D-shaped cross-section is used, the flat side of the interface tube 3800 can face the patient.

[0180] housing Figures 7 to 9 show one embodiment of the housing 3400. In the illustrated embodiment, the housing 3400 has a front portion 3430 and a rear portion 3450. The rear portion 3450 can be oriented to face the user's face when the patient interface 3000 is applied to the user's face, and the front portion 3430 can be oriented away from the user's face when the patient interface 3000 is applied to the user's face.

[0181] In the illustrated embodiments, the front portion 3430 includes one or more mounting elements. These mounting elements may extend outward from the front portion 3430. In the embodiments shown in Figures 7 to 9, the one or more mounting elements may include a central projection 3440 and a front extension 3420. In some embodiments, such as those shown in Figures 7 to 9, the one or more mounting elements include a central projection 3440 together with a pair of front extensions 3420. Each of the pair of front extensions 3420 may be positioned laterally on either side of the central projection 3440. In other embodiments, the one or more mounting elements may include any arrangement of projections or extensions. For example, a single mounting element may be used.

[0182] In some embodiments, as shown in Figure 7, the front extension 3420 can be raised in a forward direction. The front extension 3420 can form a ridged portion 3422. The ridged portion 3422 can at least partially define the channel 3424. In some embodiments, the first fixing member 3600 can be positioned around the front extension 3420 and fixed in the channel 3424 so that the first fixing member 3600 can be detachably coupled to the housing 3400 when the patient interface 3000 is assembled.

[0183] The central projection and the front extension can be used to secure one or more fastening members to the housing 3400. The central projection and the front extension can be shaped to receive complementary portions of the fastening members. As shown in Figures 7 to 9, in some embodiments, the central projection 3440 may include an enlarged head 3442 and a stem 3444. In other embodiments, such as those shown in Figures 37 and 38, the central projection 4440 may have an opening to receive a fastening member, as described herein with reference to Figures 37 and 38.

[0184] As shown in Figures 7 to 9, the central projection 3440 can receive and hold one or more components having holes that fit into the enlarged head 3442, for example, by a push-fit. For example, a second fixing member 3900 can be detachably coupled to the housing 3400 at the central projection 3440. In some embodiments, the central projection 3440 is positioned between the front extensions 3420, either in the center or substantially in the center of the front portion 3430.

[0185] In some embodiments, the front extension 3420 can be positioned on both sides of the central projection 3440, as shown in Figures 7 to 9. The front extension may have a shape to receive complementary fasteners. As shown in Figures 7 to 9, the front extension 3420 may be recessed around the central projection 3440 so that the central projection 3440 can have a greater height to receive thicker components such as the second fastener 3900 without excessively protruding from the housing 3400. In some embodiments, the front extension 3420 may not be recessed around the central projection 3440. In other embodiments, as shown in Figures 37 and 38, the front projection 4420 may be circular to receive fasteners as described herein with reference to Figures 37 to 38.

[0186] In the illustrated embodiment, the rear portion 3450 of the housing 3400 includes an interface body receiving portion 3480 for receiving an interface body such as a cannula body 3200a or a mask body 3200b. The inner surface of the housing 3400 is exposed in the interface body receiving portion 3480. The interface body receiving portion 3480 and the inner surface of the housing 3400 can be shaped and / or sized to match the shape and / or size of the interface body and to allow for the removal and replacement of the interface body relative to the housing 3400. For example, the inner surface of the housing 3400 may have a cylindrical shape that can receive and fit the cylindrical portion of the interface body.

[0187] The housing 3400 may further include one or more tube engagement portions 3460 that receive one or more interface tubes, such as one or more interface tubes 3800. The tube engagement portions 3460 may be sized and / or shaped to match the shape and / or size of the interface tubes so that the interface tubes can be coupled to the tube engagement portions 3460 without leakage. The tube engagement portions 3460 may be positioned so that the housing 3400 can receive gas from the interface tubes through the tube engagement portions 3460 and allow the gas to flow into the interface body coupled to the interface body receiving portion 3480.

[0188] The housing 3400 further includes an upper edge 3470 and a lower edge 3490 opposite to the upper edge 3470. In some embodiments, the upper edge 3470 and the lower edge 3490 are symmetrical so that the housing 3400 can be oriented in either direction when the user or clinician assembles the interface 3000. As shown in Figures 8 and 9, the upper edge 3470 and / or the lower edge 3490 may have an inwardly curved contour. The inwardly curved contour of the upper edge 3470 and / or the lower edge 3490 allows the user's mouth to be exposed, even when the user is wearing the patient interface 3000, for the user's comfort. If the user is an infant, a pacifier can be used, or the user can be breastfed during treatment. Furthermore, an oral gastric tube can be introduced to the patient, and the user's mouth can be easily cleaned.

[0189] In some embodiments, the housing 3400 is constructed from a material having greater rigidity than the interface bodies, such as the cannula body 3200a and the mask body 3200b, so that the housing 3400 can provide structural stability to the patient interface 3000. For example, the housing 3400 can be constructed from a material having a Young's modulus of 0.1 GPa to 7 GPa, 0.5 GPa to 7 GPa, 0.5 GPa to 6 GPa, 0.8 GPa to 6 GPa, 1 GPa to 6 GPa, 1.8 GPa to 6 GPa, 2 GPa to 5 GPa, or 3 GPa to 5 GPa. The thickness of the housing 3400 may then be modified to achieve the desired rigidity of each region of the housing 3400. The housing 3400 can be constructed from a thermoplastic elastomer such as polycarbonate, thermoplastic polyurethane (TPU), polyamide, or nylon. The pre-extension 3420 forms a raised portion having a greater thickness as described herein, so as to contribute to the rigidity of the housing 3400. The size and / or thickness of the front extension 3420 can be adjusted to control the rigidity of the housing 3400.

[0190] Interface body As described herein, the patient interface 3000 includes an interface body that can form a seal with the user's face and allow gas flow from and to the user. The interface body can be coupled to a housing 3400. In some embodiments, the interface body is a cannula body 3200a that can form a nasal cannula that can mate with the housing 3400 and form a seal with the user's nostrils. In other embodiments, the interface body is a mask body such as a mask body 3200b.

[0191] Cannula body Figures 10 to 12B show one embodiment of the cannula body 3200a. In other embodiments, the cannula body described herein may have similar features to those described with reference to Figures 10 to 12B. For example, embodiments of the cannula body described with reference to Figures 21, 48A, 49, 52A and 52B, 53A and 55 may include the features described herein with respect to the cannula body 3200a and nasal prongs. As shown in Figures 10 to 12B, the cannula body 3200a may have at least one nasal prong 3220, such as a pair of prongs 3220. The prong 3220 may extend from the rear portion 3243 of the manifold 3240 facing the patient. The nasal prong 3220 can form a seal with the nostrils of the user's nose, allowing gas flow from and to the user. The nasal prong 3220 of the patient interface illustrated and described herein is shaped to seal within the patient's nostrils. In some embodiments, the nasal prongs are shaped to seal within the nostrils of an infant. However, it should be understood that the prongs may be suitable for any patient population having similar nostril shapes, and that the prongs can be provided in different absolute sizes for different patient populations. The prongs 3220 can be shaped and formed to minimize tissue compression and kinking of one or more of the prongs 3220 during insertion into the patient's nostrils.

[0192] In the illustrated embodiment, the manifold 3240 can be coupled to a tube engagement portion 3460 of the housing 3400 to receive an interface tube and defines one or more openings 3246, such as a pair of openings 3246 that can allow gas flow from and to the patient through the manifold 3240 and the nasal prongs 3220. The openings 3246 can be in fluid communication with each other through the manifold 3240. The manifold 3240 can be sealed except for the lumen of the openings 3246 and the nasal prongs 3220. The openings 3246 can be positioned on the side of the manifold 3240. As shown in Figures 10 to 12B, the manifold 3240 may have two openings 3246, and the openings 3246 may be on both sides of the manifold 3240. By positioning the opening 3246 on the side of the manifold, when the manifold 3240 is coupled to the tube engagement portion 3460 of the housing 3400, lateral flow of fluid into and out of the manifold 3240 through the opening 3246 becomes possible.

[0193] Prongs of the cannula body The cannula body 3200a may include nasal prongs having orientation and / or shape that can assist in gas flow and delivery of gas to the patient. For example, Figures 13A to 13D show the shape of one embodiment of the prong 105, which is similar to or may be the same as the nasal prongs on the cannula body as described herein, such as nasal prongs 3220 and 4220.

[0194] As shown in Figures 13A and 13B, the prong 105 can be tapered inward from the gas inlet 106 to the gas outlet 108, or between the gas inlet 106 and the gas outlet 108. The cross-sectional area of ​​the gas inlet 106 can be larger than that of the gas outlet 108. The cross-sectional area of ​​the prong can be gradually reduced from the inlet 106 to the outlet 108, or between the inlet 106 and the outlet 108. This prong tapering can contribute to the sealing function of the prong 105. When the prong 105 is pushed into the patient's nostril, the tapering, which widens towards the inlet 106, allows it to seal at any point along its length. The tapering can aid in the insertion of the prong 105, in contrast to a prong with a constant cross-sectional area or a prong that widens towards the outlet.

[0195] The lumen of the nasal prong 105 may have an internal cross-section that varies along the length of the nasal prong 105. For example, as shown and described with reference to Figures 13A to 13D, the internal cross-section of the prong may vary in shape and / or diameter along its length.

[0196] As described in more detail herein, the nasal prongs 105 can be shaped to substantially align the flow of respiratory gas through the gas outlet with the user's upper airway.

[0197] The nasal prongs 105 can be shaped to extend generally upward and backward within the user's nostrils, and the nasal prongs 105 have a curvature that includes at least two inflection points, for example, as shown in Figures 13A to 13D and described herein.

[0198] The prongs 105 extend from the cannula body or manifold toward the user's nasal septum, curving upward and backward around the corners of the user's nostrils to enter the user's nostrils. Each prong 105 extends along a generally inclined posterior trajectory and can pass through two mediolateral inflection points. This shape can help direct the gas outlet 108 toward the user's upper airway passage.

[0199] At least one prong 105 may have a trajectory that conforms to or is similar in shape to the anatomical shape of the user's nostril. In the first part (or stage) of the prong 105, the trajectory may advance horizontally toward the midline of the face. In the second part (or stage) of the prong 105, the trajectory may curve upward and enter the nostril toward the top of the head. In the third part (or stage) of the prong 105, the trajectory may turn backward and enter the head, generally following the anatomical curvature of the nostril. In the fourth part (or stage) of the prong 105, the trajectory may tilt horizontally toward the center of the interface assembly so as to align the exit 108 with the user's upper airway.

[0200] The prong 105 may have a cross-section that changes along the central orbit, as described above. For example, the cross-section may be generally circular at the base of the orbit and generally circular, oval, or elliptical towards the end of the orbit or the prong 105.

[0201] The cross-sectional diameter can generally be reduced along the track from the first section (or stage) to the end of the fourth section (or stage).

[0202] The prong shapes shown in Figures 48A, 49, 52A, 52B, and 53, along with Figures 10 to 12B described herein, can be substantially as shown in Figures 13A to 13D, where the curves represent the trajectory of the prongs, and the ellipses 1135 primarily represent the orientation of the lumen within each prong in a particular trajectory (also showing the lumen shape of one possible cross-section). In some embodiments, the ellipses 1135 can be circular or substantially circular. Each prong can generally follow a curved trajectory that follows the anatomical shape / curvature / contour of the user's nostril. The prongs 105 can be molded or shaped to substantially follow the anatomical shape and curvature of the user's nostril.

[0203] The prongs 105 can be pre-molded or pre-formed according to the anatomical shape of the nostrils. In some embodiments, the prongs 105 may include at least one thinned wall section that can be adapted to limit pressure on the patient's nasal septum. In other embodiments, the thickness of the prong wall may be uniform throughout.

[0204] From the base 1415, each prong 105 can curve generally upward or superiorly toward the user's crown (away from the transverse plane) relative to the user's upper lip, and generally backward or posteriorly (towards the user's coronal plane). Between ellipses 1131 and 1133 (second stage), the lumen of the prong 105 can transition from a generally medial-lateral orientation along the user's upper lip to a predominantly inclined posterior orientation. This configuration allows the gas flow to be directed toward the upper portion of the user's occipital region. The lumen of the prong 105 may be slightly reduced during this stage. The lumen may become more elliptical, thereby utilizing the available space within the nostrils.

[0205] In the third stage (between ellipse 1133 and ellipse 1134), the prong 105 may continue along an inclined posterior trajectory toward the upper part of the occipital region of the user's head (away from the transverse plane toward the coronal plane). There may be a smooth reduction in the rate of inclination in the upper component of the prong trajectory 1420, which may cause the lumen to move away from the transverse plane. During this stage, the prong 105 may have very little or minimal convergence (or medial-lateral component) toward the sagittal plane. The prong lumen may further reduce during this stage and become increasingly elliptical.

[0206] In the final stage (between ellipse 1134 and ellipse 1135), prong 105 can continue along an inclined backward trajectory with some inward-outward convergence toward the sagittal plane. The inward-outward convergence of prong 105 can begin at the illustrated trajectory inflection point 107a at the start of (or slightly before) the fourth stage adjacent to ellipse 1134.

[0207] The second inflection point 107b may be adjacent to the final ellipse 1135. The second inflection point reduces the convergence of the prong 105 and can orient the prong exit 1411 generally backward (towards the coronal plane) with a small medial-lateral component toward the sagittal plane (as represented by the orientation of the final ellipse 1135 in Figure 13A).

[0208] The inclination of the prong trajectories 1420 can continue to decrease during the fourth stage until each trajectory 1420 becomes substantially parallel to the cross-section at the prong outlet 1411 (represented by the ellipse 1135). By adjusting the medial-lateral and superior-inferior aspects of the prong trajectories 1420 adjacent to the final ellipse 1135, the prong outlet 1411 can be positioned in general alignment with the upper airway passage. This can help reduce soft tissue irritation caused by the escaping respiratory gases.

[0209] The prong lumen may be elliptical at outlet 1411. The principal elliptical axis can generally be located within the cross-section. The prong lumen may be circular or substantially circular at outlet 1411. Outlet 1411 can direct the breathing gas upward or superiorly (away from the cross-section) toward the top of the user's head, and backward or posteriorly (towards the user's coronal plane).

[0210] In alternative embodiments, the cross-section of the lumen may be triangular or quadrilateral.

[0211] As shown in Figures 13C and 13D, the nasal prong may have a sealing region 1109 that is longer than the sealing region 109 of the embodiments described above with reference to Figures 13A and 13B. The longer sealing region 1109 allows the total length of the nasal prong in this embodiment to be longer than the total length of the prong in the embodiments described above. This may have the additional advantage of reducing the likelihood of the prong protruding from the patient's nostril or otherwise becoming dislodged. Referring to the curve representing the trajectory of the prong, as well as the ellipses in Figures 13C and 13D, the prong sealing region 1109 is located between ellipses 1134a and 1135. The prong sealing region 1109 may include a tapered region. The cross-section of the outer surface of the prong 105 near the gas inlet 106 may be larger than the cross-section of the outer surface of the prong 105 near the gas outlet 108.

[0212] In the illustrated exemplary embodiment, the prong sealing region 1109 is tapered, for example, from about 5 mm to about 4 mm. The prong measurements (5 mm and 4 mm) refer to the equivalent diameter of the oval. The equivalent diameter may be the diameter calculated from the circumference of the prong (circular and oval prongs may have the same equivalent diameter), or it may be the maximum width dimension of the prong (circular and oval prongs may have different equivalent diameters). The tapered sealing region 1109 allows the patient interface 1101 to be used for patients with nostril sizes of about 4 mm to about 5 mm. For example, if the patient's nostril size is 4.5 mm, the prong 1105 can be inserted into the nostril so that a section of the sealing region 1109 with a diameter of 4.5 mm seals with the patient's nostril.

[0213] The prong sealing area 1109 may have different dimensions and / or different amounts of taper. The length range of the sealing area may be about 1 mm to about 10 mm. The length of the sealing area may be about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. The diameter of the sealing area may be about 2 mm to about 10 mm. The diameter of the sealing area may be about 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.

[0214] The taper ratio from the widest part to the narrowest part can be approximately 1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1, 1.6:1, 1.7:1, 1.8:1, 1.9:1, or 2:1.

[0215] For example, the prong sealing region may be tapered from 10 mm to 9 mm, 9 mm to 8 mm, 8 mm to 7 mm, 7 mm to 6 mm, 6 mm to 5 mm, 5 mm to 4 mm, or 4 mm to 3 mm, for example from 3 mm to 2 mm. The taper may be steeper, for example, the prong sealing region may be tapered from 10 mm to 8 mm, 9 mm to 7 mm, 8 mm to 6 mm, 7 mm to 5 mm, 6 mm to 4 mm, 5 mm to 3 mm, or 4 mm to 2 mm. The taper does not have to be very steep; for example, the prong sealing region may be tapered from 10 mm to 9.5 mm, from 9.5 mm to 9 mm, from 9 mm to 8.5 mm, from 8.5 mm to 8 mm, from 8 mm to 7.5 mm, from 7.5 mm to 7 mm, from 7 mm to 6.5 mm, from 6.5 mm to 6 mm, from 6 mm to 5.5 mm, from 5.5 mm to 5 mm, from 5 mm to 4.5 mm, from 4.5 mm to 4 mm, or from 4 mm to 3.5 mm, from 3.5 mm to 3 mm, from 3 mm to 2.5 mm, or from 2.5 mm to 2 mm.

[0216] Patient interfaces 101 and 1101 of different sizes can be provided, and for this purpose, different dimensions of the prong sealing area can be utilized.

[0217] The outlet of the prong lumen may be substantially circular. In some embodiments, the outlet of the prong lumen may be substantially elliptical. Those skilled in the art will understand that any preferred shape of outlet can be used.

[0218] The nasal prong lumen may flare out at or near the lumen outlet. Examples of nasal prong lumen having a flared portion at the outlet or an alternative outlet shape are shown in Figures 13E and 13H. As shown in Figure 13E, the end of the prong 305 adjacent to the prong outlet 308 may be shaped to reduce the flow resistance of the prong 305. For example, the prong 305 may be cut horizontally or obliquely. This can reduce the flow resistance in the prong 305. Furthermore or alternatively, when the prong 305 is viewed from above the interface 300 in the same or similar view as in Figure 13F, the prong outlet 308 may have a substantially U-shape, as shown in Figure 13G. These features can provide lower resistance to flow during use and / or help prevent accidental sealing of the prong outlet 308, which could lead the user or clinician to mistakenly believe that CPAP therapy is being delivered to the user. In some embodiments, the nasal prong may have a thickness that varies circumferentially.

[0219] Base of the nasal prong The cannula body may have a base region at and / or adjacent to the base of the nasal prongs. The base region may form the portion of the cannula body where the base of the nasal prongs merges with the manifold. The base region may be configured to allow movement of the manifold and / or housing while maintaining the nasal prongs within the patient's nostrils. The base region may also provide comfort and adaptability to the patient while ensuring that a flow path is maintained between the manifold and the nasal prongs.

[0220] In some embodiments, the base region allows the nasal prongs to bend in different directions without impairing the gas flow path from the manifold to the prong outlet. For example, the base region allows the prongs to move relative to the housing / manifold without kinking. The base region can function to decouple the position of the prongs or each prong from the position of the manifold / housing. In this way, the housing / manifold can move from forces applied to the interface, for example, by pulling the tube, facial movements, and / or gripping the interface, while holding the prongs in place within the nasal cavity. The base region can also provide a spring mechanism that can act to assist in compensating for external forces applied to or experienced by the interface. The spring mechanism can also allow movement of the housing / manifold while assisting the prongs to remain in their operating position within the nostril, i.e., sealed position. Optionally, the base region may include grooves, recesses, channels, or any other mechanism between the prongs to provide adequate clearance in the nasal septum.

[0221] This portion of the cannula body may be an alternating arrangement of the base of the prongs or adjacent materials, and / or a predetermined shape of the base of the prongs. For example, the base region may be a groove, a recess or concave region, thinning of the nasal prong wall, the base or peripheral region of the manifold, the shape of the nasal prongs and / or manifold, and / or any other feature that can provide elasticity or adaptability. Embodiments of the base region described herein may be used with any embodiment of the cannula body and / or nasal prongs described herein.

[0222] In some embodiments, the manifold 3240 may have a base region which may be a recessed or concave area below and / or adjacent to the base of the prongs 3220. For example, in the embodiments illustrated in Figures 10 to 12B, the manifold 3240 includes one or more grooves 3222 located below the prongs 3220. One or more grooves 3222 can support the prongs 3220 with respect to the peripheral portion of the manifold 3240. The grooves 3222, as shown in Figures 10 to 12B, may extend substantially around the base of each prong 3220, or at least partially around the base of each prong 3220. The grooves 3222 can help the prongs 3220 pivot and move around or relative to the peripheral portion of the manifold 3240. The ability of the prongs 3220 to pivot at or adjacent to their bases allows for more effective fitting and sealing of the prongs 3220 within the patient's nostrils without impairing gas flow. The ability of the prongs 3220 to bend or move relative to the manifold 3240 allows for the position or orientation of the prongs 3220 to be separated from the position of the manifold / housing. In other words, the housing / manifold can move while the prongs 3220 remain in the sealing position within the nasal cavity.

[0223] The grooves 3222 allow one size of prong to fit a wider range of nostril sizes. The grooves 3222 around each prong 3220 allow the prong 3220 to move back and forth or bend when the prong 3220 is inserted and fitted into the patient's nostril. This movement can adapt to variations in the size of the patient's face and pharynx. The grooves 3222 can also allow lateral movement to adapt to variations in nasal septum size and / or to help accommodate movement of the interface 3000 caused, for example, by the movement of the user's cheek. The recessed or concave areas such as the grooves 3222 can further increase the effective length of the prong 3222 so that the prong 3222 has greater adjustability.

[0224] The manifold 3240 can have varying thicknesses in different areas. For example, as shown in Figure 14A, at least a portion of the groove 3222 may be thinner than the prongs 3220 and the rest of the manifold 3240 (the thinner areas of the prong material are shown with darker shading in Figures 14A and 14B). The groove 3222 can facilitate the movement of the prongs 3220 so as to help maintain a seal with the patient's nostrils. The groove 3222 also helps ensure that the prongs 3220 collapse into the manifold 3240 by the groove 3222 folding, bending, or curving, rather than one or more of the prongs kinking, thereby maintaining the diameter and cross-sectional shape of the prongs 3220 and / or maintaining the flow resistance (RTF) of the prongs 3220.

[0225] As shown in Figure 14A, the manifold 3240 may further include a thickened region 3249 adjacent to the groove 3222, indicated by the brighter shaded area adjacent to the groove 3222. When the prongs 3220 are positioned in the user's nasal cavity, the groove 3222, with its relatively thin walls, can allow the prongs 3220 to move or bend preferentially into the manifold 3240. In other words, when the prongs 3220 are inserted into the nostril, at least a portion of the relatively thin walls of the groove 3222 can bend or flex inward into the manifold 3240. While in the bent or flexed position, the groove 3222 can exert an upward force on the user's nostril to maintain the sealing position. On the other hand, the thickened region 3249 prevents the manifold 3240 from collapsing in the area surrounding the groove 3222, thereby maintaining the structural integrity of the cannula body 3200a. In the illustrated embodiment, the grooves 3222 are formed separately around each prong 3220, spaced apart from one another.

[0226] In some embodiments, the groove or recessed area at the base of the prong 3220 may be continuous. Figure 14B shows a cannula body 3200a having a recessed area 3223 that extends continuously around the bases of both prongs 3220. Similarly, along with the groove 3222, as shown in Figure 14B, the recessed area 3223 may have a reduced thickness relative to the prongs 3220 and the rest of the manifold 3240. The recessed area 3223 can provide the prongs 3220 with greater flexibility than the groove 3222 because there is no rigid portion between the prongs 3220 that exists between the grooves 3222. Furthermore, the recessed area 3223 may have a larger gap from the nasal septum so that the cannula body 3200a is less likely to obstruct and / or damage the nasal septum. The recessed area 3223 can also make it easier to clean the cannula body 3200a because there is relatively little cavity or space. A groove or recessed area may partially or completely enclose the base of the prong. For example, a groove or recessed area may be present on one or both sides of each prong to allow adjustment of the nasal septum width. A groove or recessed area 3222 at the base of the prong 3220 may allow spring-like movement at the base of the prong to decouple the movement of the nasal prong from the movement of the housing and / or manifold and to hold the nasal prong in the correct sealed position within the nostril.

[0227] In some embodiments, the base region includes a relatively thin region of material at and / or adjacent to the base of the nasal prong. In some embodiments, grooves or recessed regions may be absent. The relatively thin region of material may surround or partially surround the base of each nasal prong. The relatively thin region of material may be formed partially or entirely at the base of the nasal prong.

[0228] The nasal prong may have a wall thickness that varies from the base of the prong 309 to the outlet 308. As shown in Figure 14C, the wall at the base of the prong 309 may have a first thickness t1 as it extends from the manifold. The wall of the prong may have a second thickness t2 as it extends toward the outlet. The first thickness t1 may be thinner than the second thickness t2. The first thickness t1 may be thinner than the material of the manifold surrounding the base of the prong 309. The thinner wall cross section t1 at the base of the prong 309 compared to the prong 309 and the rest of the manifold allows for prong movement and patient adaptability of the nasal prong. The relatively thin wall at the base of the prong allows for achieving the same benefits as described with respect to grooves or recessed areas, but without the presence of grooves.

[0229] The cannula body 3200a can be constructed from a single material or a combination of materials. The cannula body 3200a can be constructed from a material having a Shore hardness between 20A and 100A. For example, the cannula body 3200a can have a Shore hardness of 20A to 90A, 40A to 100A, 40A to 90A, 50A to 80A, or 60A to 70A. The cannula body 3200a can be constructed from a silicone material. As described herein, the thickness ratio of this material may later be modified to achieve the desired hardness of each region of the cannula body 3200a, such as the prongs 3220, grooves 3222, and recessed areas 3223. The grooves 3222 and recessed areas 3223 can have thicknesses of 0.1mm to 1.5mm, 0.2mm to 1.5mm, 0.2mm to 1.3mm, 0.3mm to 1.3mm, 0.5mm to 1.2mm, or 0.5mm to 1.0mm. The walls of the prongs 3220 and thickened areas 3249 can have greater thicknesses than the grooves 3222 and recessed areas 3223. For example, the walls of the prongs 3220 and thickened areas 3249 can have thicknesses in the range of 0.3mm to 2.0mm, 0.5mm to 2.0mm, 0.6mm to 2.0mm, 0.3mm to 1.8mm, 0.5mm to 1.8mm, 0.6mm to 1.8mm, 0.7mm to 1.8mm, 0.6mm to 1.5mm, or 0.7mm to 1.5mm.

[0230] The prongs 3220 extend from the manifold 3240 and can be shaped and formed to minimize tissue compression and kinking during insertion into the user's nostrils. As shown in Figure 10, each of the nasal prongs 3220 has a gas outlet 3224 configured to direct the flow of gas toward the user's nostrils. Each of the nasal prongs 3220 further includes an outer surface 3225. At least a portion of the outer surface 3225 is a sealing surface 3226. The sealing surface 3226 is configured to seal the user's nostrils. In one embodiment, the sealing surface 3226 is configured to seal with the nasal valve of the user's nose. The sealing surface 3226 may be configured to seal at or adjacent to the entrance of the user's nostrils. In another embodiment, the sealing surface 3226 is configured to seal between the entrance of the nostril and the nasal valve.

[0231] In some embodiments, the prongs 3220 have a cross-section of a constant or substantially constant shape along their length. For example, each of the prongs 3220 may have a circular or oval cross-sectional shape along its length. If the prongs 3220 have a constant cross-section along the region at the distal end of the prongs 3220 (i.e., the end adjacent to the exit), it can compensate for slight movement in and out of the nasal cavity, which can help maintain a seal. In some embodiments, the prongs 3220 may have a variety of shapes along their length. For example, the prong 3200 may have a circular cross-section in the portion closer to the base, while the prong 3200 may have an oval cross-section in the portion closer to the apex of the prong. The variety of cross-sections in the portion of the prong may be similar to the various shapes described herein with reference to Figures 13A-13D.

[0232] Figure 15 shows a cannula body 3200a having a base region 3228 that can provide a spring action or mechanism at the base of the prong 3220. The base region 3228 can help isolate the movement of the housing and / or manifold from the movement of the nasal prong. The base region 3228 can allow the prong 3220 to bend around the base region 3228 while avoiding kinking of the prong 3220. The prong 3220 can bend while maintaining its position within the nostril. For example, the base region 3228 can provide spring-like motion at the base of the prong 3220 and / or in the region surrounding the base of the prong 3220. The base region 3228 can apply a spring load to the prong to absorb some interface movement while maintaining the prong 3220 in place within the nostril. For example, the base region can initially be in a neutral / relaxed position (i.e., the natural state of the cannula body) without any force being applied to any part of it. When inserted into the nostril, the action of pushing the prongs into place (and sealing) can cause the base region 3228 to bend or flex downward within the manifold. The prong position within the nasal cavity can remain constant, especially when the prongs are in a sealed position. During use, if the housing and / or manifold is pulled downward and / or away from the face (e.g., by pulling the tube), the base region 3228 can move toward the neutral position. The base region 3228 may still have enough elasticity to maintain the prong position within the nostril. For example, the spring load from the base region 3228 can absorb interface movements such as cheek movements, patient movements, or headgear movements. The base region 3228 can assist the movement of its or each prong 3220 from right to left.

[0233] The base region 3228 can serve to accommodate various septal spacings. The base region 3228 allows one or both of the prongs 3220 to bend back and forth to adapt to different facial shapes. The base region 3228 may alternatively or additionally provide an upward push into the nostril to maintain a certain seal.

[0234] In some embodiments, the base region 3228 can be a thickness reduction region. The thickness reduction region can enable a spring at the base of the prong. The base region 3228 can be of reduced thickness relative to the prong 3220 and the remainder of the manifold 3240. The thickness reduction region can be used in combination with or as an alternative to other base regions. For example, the base region 3228 can be a bellows region that enables a spring at the base of the prong by providing a bellows-like structure or configuration in the base region. In further embodiments, as described above, the nasal prong can have a groove or recessed region at the base 3220 of the prong that enables a spring-like movement at the base of the prong.

[0235] FIG. 15 shows an embodiment of the base region 3228 at the base of the prong 3220. The prong 3220 can have a constant wall section with a constant thickness that transitions to a base region 3228 around the prong that enables a spring-like movement at the base of the prong. The prong can have a constant wall thickness throughout the prong up to the base region 3228. The constant wall thickness of the prong can help the prong to be less prone to kinking because the base region 3228 can absorb movement and the bending can be localized to the base region 3228.

[0236] In some embodiments, the prong 3220 may have a certain wall section having a certain thickness that transitions toward a base region 3228 around the prong. The base region 3228 may be thinner than the certain wall thickness of the prong 3220. This base region 3228 may also have a substantially constant thickness throughout its entirety. In some embodiments, the thickness of the prong 3220 may be 0.3mm to 2.0mm, 0.5mm to 2.0mm, 0.6mm to 2.0mm, 0.3mm to 1.8mm, 0.5mm to 1.8mm, 0.6mm to 1.8mm, 0.7mm to 1.8mm, 0.6mm to 1.5mm, or 0.7mm to 1.5mm. The thickness of the base region 3228 can be 0.1mm to 1.5mm, 0.2mm to 1.5mm, 0.2mm to 1.3mm, 0.3mm to 1.3mm, 0.5mm to 1.2mm, or 0.5mm to 1.0mm. For example, in one embodiment, the thickness of the prong 3220 can be 0.6mm and the thickness of the base region 3228 can be 0.3mm. In such embodiments, the thickness ratio of the prong 3220 to the base region 3228 can be 1:0.5. The thickness ratio of the prong 3220 to the base region 3228 can be any other ratio that provides a desired transition between them.

[0237] As described herein, the ratio of the thickness of this material may be modified to achieve the desired stiffness of each region of the cannula body 3200a, such as the prongs 3220, base regions 3223 and 3228, and the groove 3222 in the base region (described with reference to Figure 14A). For example, the base region 3228 may have a thickness of 0.1 mm to 1.5 mm, 0.2 mm to 1.5 mm, 0.2 mm to 1.3 mm, 0.3 mm to 1.3 mm, 0.5 mm to 1.2 mm, or 0.5 mm to 1.0 mm. The wall of the prong 3220, which has a certain wall thickness, may have a greater thickness than the base region 3228. For example, the wall of the prong 3220 may have sections where the prong transitions to a region having a certain wall thickness, which may have a thickness of 0.3mm to 2.0mm, 0.5mm to 2.0mm, 0.6mm to 2.0mm, 0.3mm to 1.8mm, 0.5mm to 1.8mm, 0.6mm to 1.8mm, 0.7mm to 1.8mm, 0.6mm to 1.5mm, or 0.7mm to 1.5mm.

[0238] The base region 3228 may be a thin, localized region at the base of the prongs that allows the manifold and / or housing to move relative to the nasal prongs. For example, when movement from the patient or an external force puts pressure on the prongs, the base region 3228 can at least partially absorb the movement and / or force of the prongs. The base region 3228 can respond to or at least partially absorb the movement and / or force of the prongs by bending or flexing inward. In some embodiments, the base region 3228 may have a larger gap from the nasal septum than the groove 3222 so that the cannula body 3200a is less likely to obstruct and / or damage the nasal septum. The base region 3228 also makes it easier to clean the cannula body 3200a because it has relatively few small cavities or spaces.

[0239] Interface body and housing connection Returning to Figures 10 to 12B, the manifold 3240 may include a front portion 3241 opposite to the rear portion 3243. The front portion 3241 may include a housing coupling portion 3244 which can be received by the interface body receiving portion 3480 of the housing 3240. The housing coupling portion 3244 and the rest of the manifold 3240 may be shaped and / or sized such that they are inserted into and received by the housing 3400, forming an airtight seal. For example, the manifold 3240 may include ridges 3248 in each of the openings 3246. The ridges may be annular ridges 3248. The annular ridges 3248 can provide a tight fit with the housing 3400 and form an airtight seal with the housing 3400.

[0240] In the illustrated embodiments, the manifold 3240 includes a raised portion 3242 that defines a raised surface relative to the housing coupling portion 3244 and the rest of the manifold 3240. The raised surface defined by the raised portion 3242 may be discontinuous with the surface of the housing coupling portion 3244. In some embodiments, the raised portion 3242 is formed on both the upper and lower portions of the manifold 3240 such that the housing coupling portion 3244 is surrounded by the raised portion 3242. In some embodiments, the raised portion 3242 may be formed on either the upper or lower portion of the manifold 3240. In some embodiments, the raised portion 3242 can prevent or block rotation of the cannula body 3200a around the housing 3400 when the cannula body 3200a and housing 3400 are assembled, as described in further detail herein. In some embodiments, the manifold 3240 may not include the raised portion 3242 and may have a generally continuous outer surface adjacent to the housing coupling portion 3244. In some embodiments, the manifold 3240 may include bands or reinforcing members to improve the structural integrity of the manifold 3240. For example, the bands or reinforcing members may be formed by a region that is at least partially significantly thicker than the rest of the manifold 3240.

[0241] As discussed herein, the cannula body 3200a can be coupled to the housing 3400 by inserting the housing coupling portion 3244 of the manifold 3240 into the interface body receiving portion 3480. Figures 16 to 19 show one embodiment of the cannula body 3200a assembled with the housing 3400. As shown in Figures 16 and 17, the raised portion 3242 of the cannula body 3200a can be exposed when the cannula body 3200a is coupled to the housing 3400. In the illustrated embodiment, the raised portion 3242 coincides with the upper edge 3470 and / or the lower edge 3490, so that when the cannula body 3200a is assembled with the housing 3400, there is no gap between the raised portion 3242 and the upper edge 3470 and / or the lower edge 3490. In such an embodiment, rotation of the cannula body 3200a around the housing 3400 can be prevented. In some embodiments, the raised portion 3242 and the upper and / or lower edges 3470 and / or 3490 may be shaped such that a certain amount of gap exists between them when assembled, allowing a certain degree of rotation of the cannula body 3200a around the housing 3400. In some embodiments, the manifold 3240 does not include the raised portion 3242 to allow for freer rotation of the cannula body 3200a around the housing 3400 and to allow for greater adjustment. In some embodiments, the raised portion 3242 may have a thickness similar to that of the housing 3400 so that the raised portion 3242 can form a continuous surface with the housing 3400. In some embodiments, the raised portion 3242 may have a thickness greater than or less than that of the housing 3400 so that the raised portion 3242 can protrude from or be recessed into the surface of the housing 3400.

[0242] The raised portion 3242 can also assist in the visual alignment of the manifold 3240 with respect to the housing 3400. For example, a user or clinician can align the raised portion 3242 with the upper edge 3470 and lower edge 3490 of the housing 3400 to assemble the manifold 3240 in the correct position. In some embodiments, the manifold 3240 and / or housing 3400 may include audible and / or tactile indicators to provide feedback when the manifold 3240 and housing 3400 are in the correct position. For example, the manifold 3420 and / or housing 3400 may emit a “click” sound when the manifold 3420 and / or housing 3400 are correctly positioned and properly assembled. In some embodiments, the manifold 3420 and / or housing 3400 may include a visual indicator to indicate when the manifold 3420 and / or housing 3400 are correctly positioned and properly assembled. In some cases, the visual indicator may be a color indicator. Color indicators can be used in conjunction with transparent components of the manifold and / or housing. Examples of color indicators are further described herein with reference to Figures 56A to 56F.

[0243] When the housing 3400 and manifold 3420 are assembled, the housing 3400 can only contact the manifold 3420 and cannot obstruct the prongs 3220. In some embodiments, the recessed area 3223 or groove 3222 can be fully or partially exposed and the movement of the prongs 3220 cannot be obstructed by the housing 3400.

[0244] Figures 20A and 20B illustrate how the manifold 3240 can be held within the housing 3400. As shown in Figures 20A and 20B, the inner surface of the housing 3400 can fit with the manifold 3240, thereby holding the manifold 3240 within the housing 3400. As shown in Figures 20A and 20B, the opening 3246 of the manifold 3240 can be held within the tube engagement portion 3460 of the housing 3400 to receive the interface tube. In some embodiments, annular ridges 3248 in each of the openings 3246 of the manifold 3240 can provide a tight fit with the housing 3400 and form an airtight seal with the inner surface of the housing 3400.

[0245] Mask body Figures 22A and 22B show one embodiment of the mask body 3200b. In the illustrated embodiment, the mask body 3200b includes the same or similar manifold 3240 as the manifold 3240 of the cannula body 3200a. For example, the manifold 3240 includes the raised portion 3242, housing coupling portion 3244, opening 3246, and annular ridge portion 3248 as described in relation to Figures 10 to 13. The manifold 3240 can be coupled to the housing 3400 in substantially the same manner as described in relation to the manifold 3240 of the cannula body 3200a. As described herein, by including the same or similar manifold as the cannula body 3200a, the cannula body 3200a and the mask body 3200b can be interchanged while the housing 3400 remains the same.

[0246] In the illustrated embodiment, the mask body 3200b further includes a mask 3232 or mask cushion extending backward from the manifold 3240. The mask 3232 can be applied to the patient's face. In the illustrated embodiment, the mask 3232 is a nasal mask. The nasal mask can form a nasal seal applied over the patient's nose. The nasal mask can surround the patient's nostrils and form a seal over or around the nose. In some embodiments, the mask 3232 can cover both the patient's nose and mouth.

[0247] The mask 3232 or mask cushion includes a facial contact surface 3234. The facial contact surface 3234 may have an inner periphery 3235 that defines a nose-receiving opening to a mask cavity 3236 that receives the user's nose when in use. In some embodiments, the facial contact surface 3234 is located generally opposite the manifold 3240. When in use, the contact surface 3234 of the mask 3232 may enclose or surround a portion of the user's nose that defines the nostrils. The contact surface 3234 may seal-engage around the user's nose, such as with respect to one or more of the cheek surface and / or the outer side of the user's nose, the upper lip region below the user's nose, and the bridge or tip region of the user's nose.

[0248] The mask 3232 is substantially hollow and may generally be shaped to provide or define a mask cavity 3236. The mask cavity 3236 can receive the gas flow from the manifold 3240. The mask cavity 3236 can be fluidly connected to the manifold 3240 and the opening 3246 so that gas from and to the patient flows through the mask cavity 3236.

[0249] Figure 23 shows a schematic view of the mask body 3200b from the face-contact side, i.e., the posterior side. In some embodiments, a region 3237 ("rolling region") of the mask 3232 can be provided, as indicated by the striped region in Figure 23. The region 3237 can be designed so that at least a portion of the region 3237 rolls on the outer surface of the mask 3232. The rolling region 3237 may extend into the upper and / or lateral portions of the mask 3232. The rolling region 3237 may include, or function with, at least a portion of the face-contact surface 3234. The rolling region 3237 may help to alleviate pressure applied to the user's nose and / or face, such pressure is necessary to provide a sufficient seal for delivery of treatment.

[0250] To facilitate rolling of region 3237, region 3237 may have varying thicknesses or varying stiffnesses. Region 3237 may be formed by a stiffness reduction region and / or may have the same extent as the stiffness reduction region. In some embodiments, the wall thickness of the mask 3232 may be substantially constant throughout the rolling region 3237. In some embodiments, the wall thickness of the mask 3232 may vary between relatively thick and thin regions, or alternate between them. The wall thickness of the mask 3232 may be relatively thicker along with the rest of the mask, thereby providing support for the structure of the mask 3232. However, other arrangements may also be used to induce or promote rolling in the rolling region 3237. An example of a mask seal including a rolling portion is disclosed in International Publication No. 2014 / 062070, which is incorporated herein by reference in its entirety.

[0251] In some embodiments, the lower or base portion 3256 of the mask 3232 may have a region with greater thickness / rigidity, thereby enabling greater structural stability of the mask. For example, the base or a portion thereof may be formed at least in part by a region with significantly increased thickness relative to the reduced rigidity region. This base portion 3256 may have greater thickness relative to the face-contact portion of the mask.

[0252] The base portion 3256 can be formed from the same material as that forming the mask 3232. The area of ​​the base portion having increased thickness can be configured as a thickening band. The base portion 3256 can be positioned in the lower or bottom portion of the mask below the rolling area 3237. When the rolling area is subjected to force and rolls as the mask is applied to the patient's face, the mask can pivot at or around the base portion or the thickening band. In other configurations, the base portion may be a component formed from a material having increased stiffness relative to the silicone or other material forming the mask 3232, or may include such a component. This can help insert the mask 3232 into and remove it from the housing 3400 and maintain a seal during use.

[0253] The mask body 3200b can be made from a single material or from two or more different materials. The mask body 3200b can be made from silicone. The mask body 3200b can be made from a material having a Shore hardness between 15A and 80A. For example, the mask body 3200b may have a Shore hardness of 15A to 80A, 20A to 80A, 30A to 80A, 40A to 70A, or 40A to 60A. As described herein, the thickness ratio of this material may later be changed to achieve the desired hardness of each region of the mask body 3200b.

[0254] In some embodiments, the mask 3232a may be provided in various or alternative shapes or sizes to achieve the desired fit in order to achieve comfort, compliance, and / or effective delivery of treatment. The mask 3232a shown in Figure 24A is similar to the mask 3232 described in relation to Figures 22A to 23, but the mask 3232a may have a different shape. The mask 3232a may have a width measured from the first end 3252 in the first annular ridge 3246 to the second end 3254 in the second annular ridge 3246 (shown in Figure 22A). The mask 3232a may have a transverse axis extending along its width and a longitudinal axis perpendicular to the transverse axis. As shown in Figure 24, the mask 3232a may be longer in the longitudinal direction than the mask 3232 described herein. This shape allows mask 3232a to seal higher above the user's nasal bridge than mask 3232 shown in Figures 22 and 23. This configuration may be more comfortable for the patient. Furthermore, sealing higher above the user's nasal bridge minimizes the risk of obstructing the patient's airway or otherwise affecting the flow of gas into or out of the patient's airway, especially in infant patients. For example, by configuring the mask so that it can seal higher above the user's nasal bridge or the harder part of the nose, as opposed to the softer, fleshier part of the nose near the tip, the risk of obstructing or affecting the flow of gas into or out of the patient's airway can be minimized.

[0255] Mask rolling region When the mask 3232 is attached to the user's face during use, the contact surface 3234 can extend across the user's nasal bridge, across the sides of the nose, and above the upper lip. By supplying positive pressure air, the contact surface 3234 can expand and seal against the user's face. If the seal contact pressure between the contact surface 3234 and the user's face is lower than the pressure of the delivered air, leakage may occur. For the treatment to be delivered properly, the pressure of the mask contact surface 3234 must be higher than the air pressure at the outer periphery of the contact surface 3234 that forms the mask seal.

[0256] The mask 3232a can include a rolling region 3237, as described in connection with FIGS. 22A-23. In some embodiments, the rolling region can roll or bend so that the mask can respond to facial movement or force applied to the mask. For example, the rolling pattern at the sides of the mask and the pivot points at the base of the mask allow the mask to respond to facial movement or force applied to the mask. Thereby, the mask can maintain the integrity of the seal between the mask and the patient. The thickness of the rolling region 3237 is intended to reduce the pressure on the nasal bridge. In some embodiments, the rolling region 3237 is present at the sides of the mask and allows the mask to be compressed into the nasolabial fold to increase contact between the patient and the mask and form a seal around the nose. This can be useful, for example, to accommodate cheek movement. In some embodiments, the rolling region 3227 can allow the mask to form a seal in the wrinkles between the nose and the cheek even when the cheek is compressed. For example, the cheek may be compressed during side lying or lateral placement, such as during use of a chin strap.

[0257] To assist rolling or bending, region 3237 can have varying thicknesses or varying stiffnesses. For example, in the configurations shown in Figures 24B to 24E, region 3237 includes thin / thick / thin configurations. Figures 24B to 24E show a mask body 3200b with a mask 3232b having reduced-thickness, i.e., thin regions 3237b and 3237c, which allow the mask 3232b to roll, bend, or fold. In the illustrated embodiment, the thin region 3237c is configured to roll or bend over the relatively thick or stiff front portion 3238 of the mask 3232b.

[0258] Figures 24B–24E show a mask body 3200b with a mask 3232b having thin areas 3237b and 3237c that allow the mask 3232b to bend or fold. The mask 3232b may have a reduced stiffness area 3237b at the patient contact surface to conform to the patient's face. The mask 3232b may further or alternatively have a reduced stiffness and / or reduced thickness area 3237c at the rolling area (top and sides of the mask) to allow rolling motion with a flattened force-displacement curve. The shading in Figures 24B and 24C shows areas 3237b and 3237c, which are reduced stiffness sections of the mask 3232b. The reduced stiffness may be provided by reducing or thinning the thickness of these areas compared to adjacent or other parts of the mask. Therefore, these regions 3237b and 3237c allow for greater flex and flexibility compared to thicker or stiffer material sections.

[0259] The reduction in stiffness of regions 3237b and 3237c can be created by the thin material forming the sections. Figures 24B and 24C show the patient contact surface of region 3237b and region 3237c. The varying stiffness of the regions can result in hinge or pivot points that can direct the movement of the mask 3232b. In the illustrated embodiments, the hinge or pivot point is located at or adjacent to the base of the mask 3232. When the mask cushion is compressed, such as when the mask 3232 is pressed toward the patient's face during use, region 3237c can roll forward from the pivot or hinge point at or adjacent to the base of the mask 3232. Region 3237c can roll or bend over the relatively thicker or stiffer front portion 3238 of the mask 3232b. Thus, region 3237c can be referred to as the rolling region 3237c. When the mask is used with or without a midline fixing member, the pivot point or hinge point can remain at the base of the mask.

[0260] The mask 3232b may have a rigid structural portion 310 between two regions 3237b and 3237c. The rigid structural portion 310 may be made of a material that is stiffer or thicker than regions 3237b and 3237c. The structural portion 310 may be continuous or uninterrupted around the mask. The structural portion 310 may extend partially around the mask. For example, in the embodiment shown in Figure 24C, the structural portion 310 may extend around the sides and top of the mask. The structural portion 310 may be a band. The band may be located around the sides and top of the mask.

[0261] A stiffer or thicker structural portion 310 or band can gradually transition to the rest of the rolling area. In other words, the structural portion 310 or band can gradually transition to areas 3237b and / or 3237c. This can improve comfort by reducing the likelihood that the band or other such relatively stiff sections may come into contact with the user's skin and / or nasal bridge, which could occur if the thickened section does not gradually transition. In some embodiments, the ease of cleaning can also be improved by gradually transitioning the structural portion 310 to the rest of the rolling area 3237. In some embodiments, the structural portion 310 can gradually transition to the rest of the rolling area 3237.

[0262] In some cases, such as at higher pressures, the structural part 310 can help prevent the mask from expanding. The structural part 310 can also help prevent folds or creases in the thin material sections of areas 3237b and 3237c, which can help maintain area 3237b in a patient-conformed state. In some embodiments, the structural part 310 can make cleaning of the mask 3232b easier.

[0263] Mask 3232b and region 3237c may be designed to roll or bend at the top of the mask, along with the sides of the mask. Rolling at the top is intended to reduce pressure on the bridge of the nose and to better accommodate the broader shape of the patient's face. Rolling at the sides is intended to allow the mask to sink into the cheek folds (nasolabial folds) and achieve sufficient contact to provide a seal. Rolling at the sides allows the mask to oscillate from side to side while maintaining the seal, thus reducing the likelihood of forces from the sides displacing the seal (e.g., moving to an outward position). In some cases, cheek folds may be increased by patient positioning, the use of a chin strap, and / or tension applied to other patient restraint mechanisms or devices.

[0264] The structural part 310 can be fused on the front side, i.e., the patient-facing side, of the mask 3232b so that there are no rigid edges in the area 3237b that contacts the patient buckle. On the opposite side of the structural part 310, i.e., the side not facing the patient, fusion may not be as necessary. However, in some cases, the structural part 310 can be fused on both sides of the structural part 310. The structural part 310 can be positioned to influence the force-displacement profile of the rolling area at the top and / or sides. For example, the force profile may be relatively flat as the thin material of the de-stiffening section rolls until the thickness of the rolling material begins to increase (abruptly or gradually). Subsequently, the increase in the thickness of the rolling material can cause the force-displacement profile to rise. The gradual thinning or gradual de-stiffening of the structural part 310 can be used to cause the rolling area to roll a certain distance before gradually resisting displacement, rather than going from a low force to a high force when the rolling area stops rolling.

[0265] The mask 3232b can roll at its sides and pivot at or adjacent to its base. As shown in Figure 24B, the rolling region 3237c can be positioned around point 312 at the base of the mask 3232b. The material thickness of the wall at the base of the mask 3232b can become thicker or stiffer as it moves away from point 312 toward the rear of the mask. As shown in Figure 24B, the less stiff region 3237c can extend inward and backward from point 312, thereby allowing the mask 3232b to roll at point 312 and move further inward in a hinged manner. This configuration can allow the sides of the mask 3232b to displace or roll more easily when force is applied to the mask 3232b. In some embodiments, the mask may have a rolling region or region 3237c that is continuous around the entire circumference of the mask 3232b. In some embodiments, the mask may have a thickened or rigid base, for example, which can be used to add a structure that prevents the mask from being folded in half laterally.

[0266] To assist in stability, it may be useful to mount interface retainers or stabilizing devices (e.g., headgear) near the pivot point. The base of region 3237c, as shown in Figures 24B and 24C, follows a somewhat triangular shape, but in some embodiments, the rolling region can be more rounded.

[0267] In some embodiments, the hardness reduction section of the material may have a thickness of about 0.5 mm or less. The hardness reduction section of the material may have a thickness of 0.8 mm or less, 0.7 mm or less, 0.6 mm or less, 0.5 mm or less, 0.4 mm or less, or 0.3 mm or less. In some embodiments, the thickness ratio of the structural portion 310 to the hardness reduction section may be about 20:1, 15:1, 10:1, 5:1, 2:1, or 1.5:1.

[0268] The mask 3232b can assist in sealing, and the sealing contact pressure between the facial contact surface 3234 and the patient may be sufficient to prevent leakage. The sealing contact pressure can be applied to the skin at the nasal bone, and the top region 3237b of the mask 3232b can be in contact with the patient's skin.

[0269] Mask 3232a can be used in combination with one or more fixing members that provide stability of the mask on the user. Mask 3232b can be used in combination with a midline fixing member applied to the patient's forehead (for example, the fixing members described with reference to Figures 33-35 and 40-47). This fixing member can compress the rolling area so that the contact pressure can exceed the delivered air pressure when the mask is sealed. Areas 3237b and 3237c can reduce pressure on the bridge of the nose and / or the sides of the nose while still achieving proper sealing and stabilization of mask 3232b.

[0270] The rolling region of mask 3232b can roll both at the top and the sides. Figures 24D and 24E show the movement of mask 3232b when rolling at the sides and top. Figure 24D is a top cross-sectional view of the nasal interface. The top cross-section of the nasal interface shown in Figure 24D shows the lateral roll of mask 3232b moving in the direction of the dashed line and arrow. As shown in Figure 24D, mask 3232b pivots at point 312 when regions 3237b and 3237c are compressed by a force acting on one side of mask 3232b. When the mask pivots, region 3237c bends or rolls over the front surface 3238 of the mask. Figure 24E is a side cross-sectional view of the nasal interface. The side cross-section of the nasal interface shown in Figure 24E shows the top roll of mask 3232b moving in the direction of the dashed line and arrow. As shown in Figure 24E, the mask 3232b moves hinged at its base when region 3237c bends forward or rolls due to a force acting on the front top portion of the mask 3232b, as indicated by the arrow.

[0271] The side rolls of the mask allow the mask to sink into the nasolabial folds, thereby enabling a proper seal at the sides. The side rolls of the mask can also help accommodate cheek movements.

[0272] Entrance and exit points In some embodiments, the interface body may have lateral inlet and outlet points to the mask chamber or nasal prongs so that the gas flow can enter the interface body from the tubes at each end of the housing. Lateral gas flow into and out of the interface body can result in greater CO2 removal compared to masks or fluid interfaces with inlet and outlet points located in the center or top of the mask. Furthermore, lateral inlet and outlet points for gas flow can reduce dead space outside the flow path within the interface body. In some embodiments, the housing is configured so that the gas can enter and / or exit the interface body substantially along the lateral axis of the housing and / or interface body. In some embodiments, the ends of the housing at or adjacent to the inlet / outlet points may generally curve or extend downward. In such embodiments, the inlet / outlet points can direct the gas laterally into the interface body at an angle offset from the horizontal position.

[0273] Fixing member Figures 25 and 26 show one embodiment of a patient interface 3000 assembled to form a nasal cannula interface. In the illustrated embodiment, the patient interface 3000 includes a cannula body 3200a, a housing 3400, a first fixing member 360, and an interface tube 3800. As shown in Figure 25, the first fixing member 3600 includes a central portion 3610, a support pad 3660, and a bridging portion 3630 extending between the central portion 3610 and the support pad 3660. As shown in Figures 25 and 26, the bridging portion 3630 can be positioned on either side of the central portion 3610. The support pad 3660 can extend laterally outward from the bridging portion 3630. In some embodiments, the first fixing member 3600 may include a single support pad 3660 extending from a single bridging portion 3630. In some embodiments, the first fixing member 3600 may include two or more support pads 3660 extending from the bridging portion 3630 on the outer circumference of the central portion 3610. In some embodiments, the first fixing member 3600 may include a pair of support pads 3660. Each support pad 3660 in the pair may extend from the bridging portion 3630 at both ends of the central portion 3610, as shown in Figures 25 and 26.

[0274] As shown in Figures 25 and 26, the central portion 3610 may have a generally thin contour. The central portion 3610 may have a small thickness that allows it to extend minimally outward from the patient's face. In some embodiments, the central portion 3610 may have a generally planar shape. In some embodiments, the central portion 3610 may have a generally rectangular shape. In some embodiments, the central portion 3610 may be generally curved. In some embodiments, the central portion 3610 may generally curve outward from the patient's face when in use. In some embodiments, the central portion 3610 is permanently or semi-permanently connected to the bridging portion 3630. In some embodiments, the central portion 3610 and the bridging portion 3630 are integrally formed into a single, integral part. In some embodiments, the central portion 3610, the bridging portion 3630 and the support pad 3660 may be integrally formed into a single, integral part. For example, the central portion 3610, the bridging portion 3630, and the support pad 3660 may be molded as a single part from a single material, commolded or overmolded as a single part from different materials, welded (e.g., ultrasonic welding, thermal welding), or attached by any preferred method of forming a single part. If the central portion 3610 and the bridging portion 3630 are formed separately and then assembled or joined, the ease of manufacture can be improved. In some embodiments, the first fixing member 3600 and the second fixing member 3900 can be formed integrally.

[0275] A support pad (e.g., support pad 3660) can rest directly or indirectly on the user's face when the patient interface (e.g., patient interface 3000) is fitted by the user. For example, the support pad 3660 can be fixed directly or indirectly to the user's face by external force, such as by using another suitable support structure, such as adhesive connection, headgear arrangement, hook or loop connection as described above, or any of those described herein. In some arrangements, the support pad 3660 can be connected to a headgear and / or chin strap for securing the interface body. In some embodiments, the support pad 3660 can be connected to one or more face pads or skin patches. The face pad or skin patch may have a patient side and an interface side. The interface side may have a first fastening element. The first fastening element may be removably coupled to or attached to a complementary fastening element on the patient side of the support pad 3660. In some embodiments, the support pad 3660 may include tabs 3666 at each end of the support pad 3660 to assist in positioning and / or removing the support pad 3660 and / or the first fixing member 3600.

[0276] Therefore, the bridging portion connected to the support pad (e.g., bridging portion 3630) may move or flex when the user's face moves. For example, if the part of the user's face on which the support pad rests moves, such external force or movement may be transmitted to the bridging portion 3630, then to the central portion (e.g., central portion 3610), and finally to the housing (e.g., housing 3400) and interface body (e.g., cannula body 3200a, mask body 3200b). In some cases, the bridging portion itself may move or flex when an external force is applied. Therefore, it is desirable that the bridging portion be configured so that the interface body can maintain its seal with the user even when the user's face and / or support pad moves. In some configurations, the deformable configuration of the bridging portion 3630 provides some degree of detachment of the support pad 3660 from the interface body. Preferably, the deformation of the bridging portion 3630 reduces, or in some cases eliminates, the failure of the seal between the interface body and the user's face, at least as a result of the movement of the user's cheeks or external forces applied to the user's face. Furthermore, the deformation of the bridging portion of the fixing member, in combination with the rolling region of the mask, can act to maintain the seal between the interface body and the user's face.

[0277] In some embodiments, the first fixing member 3600 can accommodate the movement of the patient's face at one or more hinge points located further outward from the surface of the patient's face than the location of the support pad 3660. As shown in Figures 25 and 26, the hinge point 3662 may be located on the portion of the first fixing member 3600 where the first fixing member 3600 is connected to the housing 3400. Optionally, the hinge point may be located on the connection point of the bridging portion 3630 with the central portion 3610 of the first fixing member 3600. In some embodiments, such as shown in Figure 39, the bridging portion 3630 can help maintain torsional stability and prevent or minimize movement of the central portion 3610 and the manifold relative to each other.

[0278] In some embodiments, the crosslinked portion 3630, or the entire first fixing member 3600, is made from a flexible material such that the crosslinked portion 3630 is flexible or deformable as described above. In some embodiments, the crosslinked portion 3630 is made from the same material as the central portion 3610 in an assembled or integral structure. In some embodiments, the first fixing member 3600 can be made from one or more elastomer materials such as silicone, rubber, or polyethylene. In some embodiments, the first fixing member 3600 may be made from a single material. In some embodiments, the first fixing member 3600 may be made from two or more materials such that one region of the crosslinked portion 3630 has different flexibility than another region. In some embodiments, at least one region of the crosslinked portion 3630 may be made from a flexible but stretchable material such that the crosslinked portion 3630 is compressible while being stiff enough to resist torsional forces. This can help minimize the transfer of force and / or movement from the patient's cheek to the sealing area. In some embodiments, the first fixing member 3600 may be made of the same material as the interface body (e.g., cannula body 3200a, mask body 3200b) and / or housing 3400.

[0279] The patient-facing side of the support pad 3660 may have fastening elements that allow for direct attachment to the face (e.g., by adhesive) or indirect attachment to a headgear or a patient interface patch or skin patch which may have complementary fastening elements on the side not facing the patient. The user-facing side 3680 of the support pad 3660 may initially be provided without a user interface patch or skin patch. The side 3680 may receive or hold a patient interface patch or skin patch. Such a patient interface patch may be connected to the side 3680 by adhesive or by other suitable connections known in the art (e.g., by hook-and-loop fasteners, ultrasonic welding, and / or by commolding or overmolding). Once the support pad patch is in place, it may be connected to or receive a skin patch. Alternatively, the patient interface patch may be assembled to the side 3680 of the support pad 3660 in the same operation as the face pad is molded. In some embodiments, the user-facing surface 3680 is configured so as not to cause excessive abrasion or discomfort to the patient's face. For example, the user-facing surface 3680 includes loop material for a hook-and-loop mechanism, and the user interface patch or skin patch includes hook material for a hook-and-loop mechanism. In some embodiments, the user-facing surface 3680 engages with a fastening mechanism other than the skin patch, such as a headgear, chin strap, or bonnet.

[0280] In some embodiments, the first fixing member 3600 can be coupled to the housing 3400 by coupling its central portion 3610 to the housing 3400. The first fixing member 3600 may have a mechanism or mounting portion that can be held by the housing 3400. For example, the first fixing member 3600 may include a central opening 3620. The central opening 3620 can be coupled to one or more mounting elements of the housing 3400. For example, the central opening 3620 may be coupled to one or more front extensions 3420 and / or central projections 6440 of the housing 3400. The central opening 3620 may be sized and shaped to receive and hold one or more mounting elements of the housing 3400, such as the front extensions 3420. For example, the central opening 3620 may be sized and shaped to be held in or around the ridged portion 3422. In some embodiments, the first fixing member 3600 may be detachably coupled to the housing 3400. In some embodiments, the first fixing member 3600 may be attached to the housing 3400 with a clip. In some embodiments, the first fixing member 3600 may be permanently attached to the housing 3400. In some embodiments, the first fixing member may not have a central portion 3610 and / or a bridging portion 3630, and may include a support pad 3600 that is detachably or permanently directly attached to the housing 3400 or the interface body.

[0281] In some embodiments, the bridging portion 3630 may include a notch 3640. The notch 3640 may be positioned to allow passage of an interface tube, such as an interface tube 3800 passing through the first fixing member 3600. In some embodiments, the bridging portion 3630, or any other area of ​​the first fixing member 3600, may include a mechanism to further hold the interface tube 3800 and facilitate or assist in managing the interface tube 3800. For example, the bridging portion 3630 may include hook-and-loop fasteners or adhesives in the notch 3640, which can be detachably bonded to the interface tube 3800.

[0282] In some embodiments, the first fixing member 3600 may be made of a fabric material. Figures 27 and 28 show one embodiment of the first fixing member 3600 made of a fabric material. The first fixing member 3600 made of a fabric material may be similar to the first fixing member 3600 described in relation to Figures 25 and 26, except as otherwise provided herein. For example, the first fixing member 3600 may include a central opening 3620 for coupling with the housing 3400. The first fixing member 3600 may include one or more notches 3640 through which the interface tube 3800 can pass. Figures 29 and 30 show the first fixing member 3600 coupled to the housing 3400.

[0283] Figures 31 and 32 show schematic cross-sectional views of the fabric of the first fastening member 3600, illustrating its multilayer structure. The multilayer structure may include one or more mechanical fastener substrates sandwiched between a pair of film layers. In the illustrated embodiment, a continuous loop material 3695 and a nylon loop material 3696 can be sandwiched between two thin outer laminate films 3694, 3697. The laminate films 3694, 3697 can make cleaning and maintenance of the first fastening member 3600 easier. The laminate films 3694, 3697 can help reduce the amount of moisture and other substances that the fabric of the first fastening member 3600 can absorb. In some embodiments, the laminate film 3694 on the patient-facing side may be interrupted in an exposed area 3691 to expose a portion of the continuous loop material 3695. The exposed area 3691 is also shown in Figure 30. The exposed continuous loop material 3695 in the exposed area 3691 can be attached to a corresponding hook material on the user's face, headgear, or chin strap to secure the patient interface 3000. In some embodiments, the continuous loop material 3695 and nylon loop material 3696 may be overmolded with an elastomer layer (e.g., thermoplastic elastomer) instead of being laminated with nylon films 3694, 3697. The nylon films 3694, 3697 can provide rigidity to the first fastening member 3600. The nylon films 3694, 3697 can form a non-stretchable area 3692 that can help stabilize and support the patient interface. In some embodiments, the first fastening member 3600 may include tabs 3693 at both ends of the first fastening member 3600 to help position and / or remove the first fastening member 3600. The tabs 3693 may be positioned adjacent to the exposed portion 3691. In some embodiments, the first fixing member 3600 may further include a foam material 3698, as shown in Figure 32. The foam material 3698 may be located between the continuous loop material 3695 and the nylon loop material 3696. In some embodiments, the first fixing member 3600 may be cut, for example, by die-cutting, from a pre-formed multilayer fabric.In some embodiments, the first fixation member 3600 may include perforated strips so that the first fixation member 3600 can be cut or pulled apart at several locations in order to determine the size of the first fixation member 3600 for the patient.

[0284] Figures 33 to 35 show one embodiment of the second fixing member 3900. In the illustrated embodiment, the second fixing member 3900 includes a connecting portion 3910, a support pad 3980, and a bridging portion 3930 extending between the connecting portion 3910 and the support pad 3980. The support pad 3980 may be a forehead support pad. The second fixing member 3900 can generally extend vertically when the patient interface 3000 is being used on the user's face.

[0285] The coupling portion 3910 can be attached to, or may be mountable to, the housing 3400 in order to connect the second fixing member 3900 to the patient interface 3000. In some embodiments, the coupling portion 3910 includes a hole or recess 3912. The hole or recess 3912 may be configured to receive a central projection 3440 so that the coupling portion 3910 can be attached to the housing 3400. In some embodiments, the coupling portion 3910 and / or the housing 3400 may be configured to prevent rotation of the second fixing member 3900 around the housing 3400. For example, the outer circumference of the coupling portion 3910 may be polyhedroned and embedded between the central projection 3440 and the front extension 3420 so that the front extension 3420 prevents rotation of the coupling portion 3910. In some embodiments, the second fixing member 3900 may be configured to rotate relative to the housing 3400. In some embodiments, the central projection 3400 may be symmetrical, as described herein, so that the housing 3400 may be symmetrical. In some embodiments, the second fixing member 3900 may be coupled to the housing in either an upward or downward direction. In some embodiments, the second fixing member 3900 may be applied in other directions, such as laterally or in any inclined direction.

[0286] In some embodiments, the second fixing member 3900 can be detachably attached to the housing 3400. In some embodiments, the second fixing member 3900 may be permanently attached to the housing 3400. The second fixing member 3900 may be overmolded with the housing 3400 and / or formed as a single unit. In some embodiments, the second fixing member 3900 may be detachably or permanently coupled to an interface body such as the cannula body 3200a and the mask body 3200b. In some embodiments, the second fixing member 3900 may be detachably or permanently coupled to the first fixing member 3600. In some embodiments where the second fixing member 3900 is integrated with the first fixing member 3600, the second fixing member 3900 may include a perforated strip so that it can be cut or separated from the first fixing member 3600. In some embodiments, the first fixing member and / or the second fixing member can be integrated with the patient's headgear.

[0287] The support pad 3980 can be configured to rest directly or indirectly on the user's face. For example, the support pad 3980 can be positioned on or above the forehead when the patient interface 3000 is fitted by the user. For example, the support pad 3980 can be fixed directly or indirectly to the user's forehead by external force, such as by using another suitable support structure, such as adhesive connections, headgear arrangements, hook or loop connections as described above, or any of those described herein. In some arrangements, the support pad 3980 can be connected to headgear and / or a chin strap for securing the interface body.

[0288] In some embodiments, the second fixing member 3980 may be made of a fabric material. The fabric material may be the fabric material described in relation to Figures 31 and 32. In some embodiments, the second fixing member 3980 may be made of a rigid material such as a thermoplastic material or a combination of materials. In some embodiments, the second fixing member 3980 may be made of the same material as the housing, for example, if the second fixing member 3980 is integrally formed with the housing. In some embodiments, the second fixing member 3980 may be made of one or more elastomer materials such as silicone, rubber, or polyethylene. In some embodiments, the second fixing member 3900 may include perforated strips so that the second fixing member 3900 can be cut or separated at several positions in order to determine the size of the second fixing member 3900 for a patient.

[0289] Further examples of patient interface assemblies Figure 36 shows one embodiment of the patient interface assembly 4000. As shown in Figure 36, the patient interface assembly 4000 includes an interface body 4200 that can form a seal with at least a portion of the user's airway and allow gas flow from and to the user, and a housing 4400 that can be coupled to the interface body 4200. In some embodiments, the interface body 4200 is a cannula body such as the cannula body 3200a shown in Figures 3 and 4 and Figures 10 to 21, or a mask body such as the mask body 3200b shown in Figures 5 and 6 and Figures 22 to 24. The cannula body 3200a can form a seal with one or both nostrils of the user's nose. The mask body 3200b can form a seal with the user's nose, mouth, or nose and mouth. In the embodiment shown in Figure 36, the mask body 3200b is a nasal mask. The cannula body 3200a and the mask body 3200b can be interchangeably coupled to the housing. The illustrated embodiment of the patient interface 4000 also includes a first fixing member 4600, one or more interface tubes 4800, and a second fixing member 4900. The components and features described in these embodiments of the patient interface assembly 4000 can be used with any embodiment of the patient interface assembly and components of the patient interface assembly described above.

[0290] In some embodiments, the interface housing includes a transverse axis extending from one tube engagement portion to a second tube engagement portion at the opposite end of the housing. In some embodiments, the interface tube can engage with the housing at the tube engagement portion and can extend laterally outward along the transverse axis from the tube engagement portion, as shown in Figure 36. In other embodiments, the interface tube can engage with the housing at the tube engagement portion and can be biased downward from the transverse axis of the housing or tilted away from the transverse axis. In these embodiments, the first fixing member can be positioned above the tube, as opposed to the tube passing through the first fixing member.

[0291] In some embodiments, the first fixing member 4600 and / or the second fixing member 4900 can be attached to or coupled with the housing 4400. In some embodiments, the first fixing member 4600 and / or the second fixing member 4900 may be integrated with the housing 4400 and / or the interface body. Figures 37 and 38 show a housing 4400 equipped with a mechanism for attaching the first fixing member 4600 and / or the second fixing member 4900. In the embodiments shown in Figures 37 and 38, the attachment mechanism is located on the front side or front portion 4430 of the housing 4400. The attachment mechanism may include one or more attachment elements. One or more attachment elements may be similar to the attachment elements described above, such as those related to the embodiments shown in Figures 7 to 9.

[0292] In some embodiments, the housing 4400 can be formed from a rigid material. The housing 4400 can be detachably coupled to an interface body as described herein. The housing 4400 can be detachably coupled to the manifold of the interface body. In the illustrated embodiments, the front portion 4430 includes one or more mounting elements in the form of one or more projections. The projections may include one or more lateral projections 4420 and a central projection 4440. The lateral projections 4420 may protrude forward. The lateral projections 4420 may extend outward from the front portion 4430. The lateral projections may have an enlarged head 4422 and a stem 4424. The head 4422 may have a larger cross-section than the stem 4424. The lateral projections 4420 may be received by and engaged with one or more complementary or receiving components. For example, the side projections 4420 or each side projection 4420 may be received by, for example, a push-fit, by a hole or recess that fits into the enlarged head 4422, and may engage with such hole or recess. For example, the first fixing member 4600 can be detachably coupled to the housing 4400 at the side projections 4420. The first fixing member 4600 may have one or more holes or recesses configured to receive or engage with the side projections 4420.

[0293] The central projection 4440 may include a mechanism for coupling the second fixing member 4900 to the housing 4400. The central projection 4440 may include an opening 4442. In some embodiments, the second fixing member 4900 can be coupled to the housing 4400 through the opening 4442 of the central projection 4440. In some embodiments, the opening 4442 may have one or more channels 4443 into which the second fixing member 4900 is inserted. In some embodiments, the central projection 4440 may include two channels in the opening 4442, as shown in Figures 37 and 38. In some embodiments, such as shown in Figure 38, the central projection 4440 may include a lip 4446. The lip 4446 may engage with a complementary mating portion of the second fixing member 4900 (not shown), as described in more detail herein. Mechanisms on the housing 4400 help to secure the first fixing member 4600 and / or the second fixing member 4900 to the housing 4400. This allows the fixing members to be positioned for subsequent attachment to the patient via a patient interface patch, a skin patch on the patient's face, adhesive, any other suitable mechanism, or other suitable device such as a headgear, chin strap, or bonnet, in order to stabilize the seal of the mask body or cannula body to the patient. The mechanism on the housing that secures the first fixing member 4600 and / or the second fixing member 4900 to the housing may have a thin contour to minimize the outward extension of the mechanism from the patient's face. This arrangement can minimize the bulk or contour of the patient interface to the patient.

[0294] First fixing member Figures 39A and 39B show a diagram of one embodiment of the first fixing member 4600. As shown in Figures 39A and 39B, the first fixing member 4600 includes a central portion 4610, a support pad 4660, and a bridging portion 4630 extending between the central portion 4610 and the support pad 4660. The first fixing member 4600, comprising the central portion 4610, the support pad 4660, and the bridging portion 4630, is similar to, and can be formed and used in the same manner as the first fixing member 3600, comprising the central portion 3610, the support pad 3660, and the bridging portion 3630, as described in relation to Figures 25 and 26, except as otherwise provided herein. As shown in Figures 39A and 39B, the bridging portion 4630 can be positioned on both sides of the central portion 4610. The support pad 4660 can extend laterally outward from the bridging portion 4630. In some embodiments, the first fixing member 4600 may include a single support pad 4660 extending from a single bridging portion 4630. In some embodiments, the first fixing member 4600 may include two or more support pads 4660 extending from the bridging portion 4630 on the outer circumference of the central portion 4610. In some embodiments, the first fixing member 4600 may include a pair of support pads 4660 extending from the bridging portion 4630 at both ends of the central portion 4610, as shown in Figures 39A and 39B.

[0295] The first fixing member 4600 may include a pair of support pads 4660 configured to rest on or engage with the user's face on both sides of the central portion 4610. In some embodiments, the first fixing member 4600 includes means for attaching and securing the patient interface to the patient's face by a headgear, chin strap, patient interface patch or skin patch on the patient's face, or by any other preferred mechanism.

[0296] In some embodiments, the first fixing member 4600 may include a notch 4640 and two arms 4642 bridging the central portion 4610 and the support pad 4660. The notch 4640 allows the interface tube 4800 to pass between the two arms 4642 and through the notch 4640. The notch 4640 can receive the interface tube 4800 through the notch 4640. The notch 4640 can be fitted onto the interface tube 4800 and secured in place. In some embodiments, the arms 4642 can be positioned around the interface tube 4800 as the tube 4800 extends through the notch 4640. In some embodiments, the arms 4642 can be bent or fitted around the tube 4800. The arms 4642 can be configured to "clasp" the tube 4800 or to be positioned adjacent to the tube 4800. This configuration can help reduce the thickness or bulk of the interface assembly while still allowing the bridging portion 4630 to move or bend freely in a hinged manner. The notch 4640 in the bridging portion 4630 provides a passage for the interface tube 4800 to pass through the notch 4640 and connect to the housing 4400. Optionally, the interface tube 4800 can be integrated with the housing 4400. Optionally, the interface tube 4800 can be detachably coupled to the housing 4400.

[0297] As shown in Figures 39A and 39B, the first fixing member 4600 can be curved at the point where the bridging portion 4630 meets the central portion 4610 (4634). This curve can help accommodate the tubular shape of the tube 4800 and / or housing 4400. Figure 39C is a top view of the first fixing member 4600. The arm 4642 of the bridging portion 4630 may have a first end 4644 that contacts the support pad 4660 and a second end 4646 that contacts the central portion 4610. The arm 4642 may have a transverse axis extending from the first end 4644 to the second end 4646. As shown in the top view in Figure 39C, the arm 4642 of the bridging portion 4630 may widen at the second end 4646. The arm 4642 may taper inward as it extends along the transverse axis toward the first end 4644. However, in some embodiments, the first end 4644 of the bridging portion 4630 connected to the support pad 4660 may have a thickened region 4632. As shown in Figures 39A and 39B, a rigid region of the material may be provided in the thickened region 4632 to provide further support, or the thickened region 4632 may have such a rigid region. Figure 39A shows a front view of the first fixing member 4600. As shown in Figures 39A and 39B, when viewed from the front, the thickened region 4632 of the first end 4644 may be thicker than the second end 4646 of the arm 4642.

[0298] In some embodiments, the notch 4640 of the bridging portion 4630 can allow the passage of an interface tube, such as the interface tube 4800 passing through the first fixing member 4600 as shown in Figure 36. In some embodiments, the bridging portion 4630, or any other area of ​​the first fixing member 4600, may include a mechanism to further hold the interface tube 4800 to facilitate management of the interface tube 4800. For example, the bridging portion 4630 may include hook-and-loop fasteners or adhesives in the notch 4640, which can be detachably coupled to the interface tube 4800.

[0299] In the embodiments illustrated in Figures 39A to 39C, the first fixing member 4600 includes an opening 4640 formed through the bridging portion 4630. When the user interface patch is applied to the patient-facing surface of the support pad 4660, the opening 4640 allows the user interface patch to be exposed from the front side opposite to the rear side of the first fixing member 4600. Therefore, if the patient interface patch is connected to the rear side of the support pad 4660 using double-sided adhesive or double-sided hook-and-loop fasteners, such adhesive or hook-and-loop fasteners will be exposed from the rear side, i.e., the front side opposite to the user side. In some configurations, such exposed adhesive or hook-and-loop fasteners passing through the opening 4640 can be used as tube fasteners or to otherwise bundle interface tubes or conduits.

[0300] In some cases, the arms of the bridging portion 4630 may have a recessed area equipped with a hook-and-loop fastener, which can also be used to manage the interface tube or conduit. In some cases, it may be desirable to have some way of holding and managing the interface tube 4800 of the patient interface assembly 4000. In such arrangements, the tube 4800 may have sufficient flexibility to facilitate movement and fixation of the tube by the clinician or user. Being able to move and fix the tube 4800 as required can enable more comfortable positions for the patient, such as a lateral decubitus position.

[0301] In some embodiments, the bridging portion 4630 of the first fixing member 4600 may have a notch or recessed area to receive a tube 4800 as described herein. The notch or recessed area may further include hook or loop material for attachment to the corresponding material on the tube 4800. In some embodiments, there may be one or more notches or recessed areas on the bridging portion 4630 or the support pad 4660. The notch areas may be located at any preferred location along the bridging portion 4630 or the support pad 4660. In some embodiments, there may be a notch or recessed area with a hook or loop on the front side (the side not facing the patient) of each support pad 4660 or bridging portion 4630. In some embodiments, the hook or loop material may be overmolded onto the bridging portion 4630 or the support pad 4660 or attached by adhesive.

[0302] In some embodiments, the rear and patient-facing hook or loop material pieces can be formed as a single piece to form a double-sided hook or loop material that can be overmolded into a notch or opening in the support pad 4660. The use of double-sided hook or loop material may be advantageous because it can be more easily overmolded onto the first fixing member 4600 than separate hook or loop pieces on each side. Furthermore, when a single double-sided hook or loop material piece is used, as opposed to multiple hook or loop material pieces, the support pad 4660 becomes more flexible, thereby conforming more appropriately to the user's face.

[0303] The tube 4800 may have a strip of hooks or loops that are attached to a corresponding material on the patient interface assembly 4000. For example, the strip of hooks or loops may be wrapped around the outside of the tube 4800 or attached to a portion of the tube 4800. In some embodiments, the tube 4800 may include an engaging portion 4840 to which the strip of hooks or loops or any other attachment mechanism may be attached. The engaging portion 4840 may be wrapped around the outside of the tube 4800, molded, or positioned. The tube 4800 can be secured by attaching a piece of loop material to a corresponding hook material on the bridging portion 4630 of the patient interface assembly 4000. Alternatively or further, there may be an overmolded portion on the tube, part of which may include loop material.

[0304] In some embodiments, magnets can be used to hold the conduit or tube 4800 on the patient interface assembly 4000. For example, the magnets may be on the support pad 4660 or the bridging portion 4630, or they may be placed on a piece of material that wraps around the tube 4800 or is overmolded into the tube 4800. The magnets can interact with the corresponding ferromagnetic material on other components to secure the tube 4800 and the patient interface assembly 4000. The tube 4800 can be attached to the first fixing member 4600 using any other suitable detachable coupling mechanism, such as the mechanism described elsewhere in this specification with respect to the attachment of the fixing member and the interface body.

[0305] The first fixing member 4600 may be held by the housing 4400 or have a mechanism for coupling to the housing 4400 in other ways. The first fixing member 4600 may be coupled to the housing 4400 by coupling its central portion 4610 to the housing 4400. The first fixing member 4600 may also be coupled to the housing 4400 by coupling to one or more mounting elements on the housing 4400. For example, the first fixing member 4600 may include an opening 4426 at a mounting element for coupling the first fixing member 4600 to the housing 4400. The opening 4426 may be coupled to the housing 4400 at a lateral projection 4420. In some embodiments, the first fixing member 4600 may be detachably coupled to the housing 4400. The first fixing member 4600 may be held by the housing 4400 or have a mechanism for coupling to the housing 4400. The opening 4426 may be sized and shaped such that it is received and held by the side projection 4420, or engages with the side projection 4420. For example, the opening 4426 may be sized and shaped such that it is held at the stem 4424 of the side projection 4420.

[0306] In some embodiments, the first fixing member 4600 can be made from a soft, flexible material (e.g., TPE / silicone) or any other material described herein for the fixing member. In some embodiments, the first fixing member 4600 may have one or more openings or recesses 4426. The first fixing member 4600 may have two openings or recesses 4426. The openings or recesses 4426 may be located in the central portion of the first fixing member 4600. The openings or recesses 4426 can be pressed against or otherwise engaged with two lateral projections 4420 of the housing 4400 to fix the first fixing member 4600 in place. In some embodiments, the openings 4426 and the lateral projections 4420 can be used to fix the first fixing member 4600 and the housing by a push-fit mechanism. The openings 4426 of the first fixing member 4600 can be pressed against the enlarged heads 4422 of the lateral projections 4420. The inner diameter of the opening 4426 of the first fixing member 4600 can be positioned around the stem 4424 of the side projection 4420 when the first fixing member 4600 is positioned on the housing 4400. The uniform recess of the stem 4424 around the entire circumference of the side projection 4420 prevents the first fixing member 4600 from separating from the housing 4400.

[0307] Figure 39B shows a rear view of the first fixing member 4600. As shown in Figure 39B, the first fixing member 4600 may include a recess 4428 in the rear side 4645 of the central portion 4610. The recess 4428 corresponds to the presence of a central projection 4440 on the housing 4400 and prevents the first fixing member 4600 from increasing the bulk of the interface assembly when it is in place on the housing 4400. Although two side projections are used, the housing 4400 may include only one side projection to fix the first fixing member 4600. In other cases, more than two side projections may be used. For example, the first fixing member 4600 may be fixed using one or more projections on the housing 4400 and corresponding openings on the first fixing member 4600.

[0308] In some embodiments, the first fixing member 4600 can be attached to the housing 4400 via any other mechanism through which the side projection 4420 can receive and hold one or more complementary components or engage with such components in any other way. For example, the side projection 4420 can engage with a hole that fits into the enlarged head of the side projection 4420. In some embodiments, the first fixing member 4600 can be detachably coupled to the housing 4400. In some embodiments, the first fixing member 4600 can be coupled to the housing 4400 using clips. In some embodiments, the first fixing member 4600 may be permanently coupled to the housing 4400. In some embodiments, the first fixing member may not have a central portion 4610 and / or a bridging portion 4630, and may include a support pad 4660 that is detachably or permanently directly coupled to the housing 4400 or the interface body.

[0309] In some embodiments, the crosslinked portion 4630, or the entire first fixing member 4600, is made from a flexible material such that the crosslinked portion 4630 is flexible or deformable, as described above. In some embodiments, the crosslinked portion 4630 is made from the same material as the central portion 4610, in an assembled or integral structure. In some embodiments, the first fixing member 4600 can be made from one or more elastomer materials, such as silicone, rubber, polyethylene, or any other flexible material. In some embodiments, the first fixing member 4600 may be made from a single material. In some embodiments, the first fixing member 4600 may be made from two or more materials such that one region of the crosslinked portion 4630 has different flexibility than another region of the first fixing member 4600. In some embodiments, at least one region of the bridging portion 4630 may be made of a flexible but stretchable material such that the bridging portion 4630 is rigid enough to resist torsional forces and prevent rotation of the central portion relative to the housing, while being able to move or bend in a hinged manner to help minimize the transfer of force and / or movement from the patient's cheek to the sealing area. In some embodiments, the first fixing member 4600 may be made of the same material as the interface body (e.g., cannula body 3200a, mask body 3200b) and / or housing 4400.

[0310] The first fixing member 4600 may have a material thickness that can be defined as the distance from the rear side 4645 of the first fixing member 4600 to the front side 4647 of the first fixing member 4600. The first fixing member 4600 may have different thicknesses in different regions. In some embodiments, the first fixing member 4600 may have a thickened region in the bridging portion 4632 where the material thickness in the bridging portion 4632 is greater than the material thickness in other parts of the first fixing member 4600. For example, the material thickness in the bridging portion 4632 may be greater than the material thickness in one or more of the support pad 4660, other parts of the arms of the bridging portion 4630, and / or the central portion 4610, as described above in relation to Figures 39A-39C. This thickened bridging portion 4632 is located in the arms 4642 surrounding the notch 4640 of the bridging portion 4632 and can improve the torsional stability of that region. Depending on the circumstances, the thickened crosslinked portion 4632 may be located at the first end portion 4644, as shown in Figure 39A.

[0311] The torsional rigidity of the first fixing member 4600 can resist movement and thus breakage of the seal when a force is applied to the interface, for example, by pulling the tube or touching the housing and / or interface body. The torsional rigidity of the first fixing member 4600 can help resist vertical rotation or movement of the interface body seal by minimizing the impact on the seal when a force is applied.

[0312] The portion of the first fixing member 4600 equipped with or connected to the support pad 4660 may be flexible for attaching the first fixing member 4600 to the patient. The bending of the support pad 4660 may also conform to the contour of the patient's face.

[0313] In some embodiments, the first fixing member 4600 may include a perforated area or markings that allow a clinician to cut off a portion of the support pad 4660 to change the size of the support pad 4660, for example, to create a smaller support pad for a smaller patient.

[0314] Second fixing member Figures 40-42 and 44-47 show embodiments of the second fixing member 4900. The second fixing member 4900 may include a mounting portion 4910, a support pad 4980, and a central portion 4920 connecting the mounting portion 4910 to the support pad 4980. The support pad 4980 may be a flexible connecting pad that can rest directly or indirectly on the user's face. For example, the support pad 4980 may be configured to rest on the forehead when the patient interface 4000 is fitted by the user. In some embodiments, the support pad 4980 is made of a flexible material. For example, the support pad 4980 may be fixed directly or indirectly to the user's forehead by external force, such as using a skin patch on the patient's face, or by any suitable mechanism such as adhesive connections, headgear arrangements, hook or loop connections as described above, or any other suitable support structure as described herein. In some arrangements, the support pad 4980 may be connected to headgear and / or a chin strap that secures the interface body.

[0315] The second fixing member 4900 can be attached to the housing 4400 using the mounting portion 4910. The mounting portion 4910 is formed to connect with a corresponding structure on the housing 4400. In some embodiments, the corresponding structure may be located in the central portion of the housing 4400. The central portion of the housing 4400 may have a central projection 4440 as shown in Figures 43A and 43B. The mounting portion 4910 may be formed to connect with an opening 4442 in the central projection 4440 (shown in Figures 43A and 43B). The second fixing member 4900, as described with reference to Figures 40 to 47, is described as connecting to the housing 4400, but the second fixing member 4900 can be used in combination with any of the housing or patient interface assembly components and embodiments described herein.

[0316] In one embodiment, the mounting portion 4910 may be made of a soft, deformable, or flexible material that can be attached to or removed from the housing 4400. This may be desirable, for example, when swapping between different interface bodies. The mounting portion 4910 may be a flexible latch 4912. The flexible latch 4912 may have a pair of tabs 4914 on either side of the latch 4912. The pair of tabs 4914 may be configured to hook into or otherwise engage with an opening 4442 in the housing 4400. The pair of tabs 4914 may be a pair of downwardly projecting tabs 4914. The flexible latch 4912 may include a pair of downwardly projecting tabs 4914, an extended top portion 4918, and a connecting portion 4915 between them. The connecting portion 4915 may include a notch 4916 in the center of the connecting portion 4915. The notch 4916 allows at least a portion of the flexible latch 4912 to be compressed or deformed during insertion and removal. The flexible latch 4912 can be compressed or deformed, and the connecting portion 4915 can move inward toward each other. The compressed flexible latch 4912 can pass through the opening 4442 of the housing 4400. The flexible latch 4912 can then be relaxed, and the connecting portion 4915 returns to its extended resting position as the laterally projecting tab 4914 passes through the opening 4442. After insertion, the pair of downward laterally projecting tabs 4914 can be located on one side of the central projection 4440, as shown in Figure 43A, and the extended top portion 4918 can be on the other side of the central projection 4440.

[0317] The flexible material of the flexible latch 4912 allows for low insertion force and strong separation force unless it is intentionally removed from its mounting location. The flexible latch 4912 can be easily deformed by compression and crushing or by other means to be pushed through and fitted into the opening 4442, and then return to its original shape as it passes through the opening 4442. The central notch 4916 of the flexible latch 4912 facilitates this compression and crushing. Optionally, the mounting portion 4910 can be made from a soft or flexible material; for example, the mounting portion 4910 can be made from TPE or silicone.

[0318] Figure 43A shows the interconnection of one embodiment of the second fixing member 4900 with the housing 4400. The flexible latch 4912 can fit into the opening 4442 (shown in Figure 43B) of the central projection 4440 of the housing 4400. The flexible latch 4912 can fit into the central projection 4440 by each of the laterally projecting tabs 4914 hooking onto the lower edge of the central projection 4440 of the housing 4400, as shown in Figure 43. The flexible latch 4912 can be crushed or otherwise temporarily deformed to fit into the opening 4442. The flexible latch 4912 can be designed to be crushed or deformed to fit into the opening 4442 and does not need to be a press fit. In other embodiments, the flexible latch 4912 can be fitted in a press fit. Figure 43B does not show a central projection with a lip, but in some embodiments, the central projection 4440 may include a lip similar to the lip 4446 shown in Figure 38. In such embodiments, the lip can hook onto a laterally projecting tab 4914 of the second fixing member 4900.

[0319] In some embodiments, the flexible latch 4912 can have a low insertion force and a strong separation force. The flexible latch 4912 can be easily disassembled from the housing 4400. The flexible latch 4912 can be removed by moving or pivoting the second fixing member 4900 to one side or laterally and pulling the second fixing member 4900 and the flexible latch 4912 away from the housing 4400. In some embodiments, the flexible latch 4912 can be removed by crushing it in a manner similar to insertion but in the opposite direction. In some embodiments, the length, size and / or configuration of the protruding tab 4914 can be selected so that when the second fixing member 4900 is moved laterally to a certain extent, the tab 4914 can be folded and the second fixing member 4900 can be removed. In some embodiments, the protruding tab 4914 can have a length of 1.5 mm (approximately 1.5 mm). In some embodiments, the protruding tab 4914 may have a length of 0.5 mm to 10.0 mm, 1.0 to 5.0 mm, 1.0 to 2.5 mm, 1.0 to 2.0 mm, 1.5 to 5.0 mm, 1.5 to 2.5 mm, or 1.5 mm to 2.0 mm.

[0320] The flexible latch 4912 may have an extended top portion 4918 extending outward from the flexible latch 4912. The extended top portion 4918 can prevent the flexible latch 4912 from being excessively inserted into the opening 4442 of the housing 4400. The extended top portion 4918 may extend outward from the connecting portion 4915 of the flexible latch 4912 and may be located above the opening of the housing 4400 as shown in Figure 43. The extended top portion 4918 can prevent the second fixing member 4900 from being excessively inserted into the opening 4442. The width of the housing opening 4442 may be less than the width of the extended top portion 4918 measured from one end of the extended top portion 4918 to the other end of the extended top portion 4918. The width of the housing opening 4442 can be less than the width measured between a pair of tabs 4914, from the tip of one tab 4914 to the tip of the other tab 4914.

[0321] In some cases, the flexible latch 4912 may be beneficial because it can prevent rigid, sharp, or potentially damaging parts from interacting with the patient. Furthermore, the flexible latch 4912 can withstand compressive forces for assembly and can be disassembled without breaking.

[0322] The central portion 4920 may be a rigid central portion that connects the mounting portion 4910 to the support pad 4980. In some embodiments, the mounting portion 4910 may be integrally molded or formed as a single component with the central portion 4910. In other embodiments, the mounting portion 4910 may be molded separately and attached to the central portion 4920. In some embodiments, the mounting portion 4910 may be overmolded onto the central portion 4920 of the second fixing member 4900. In some embodiments, the mounting portion 4910 may be attached to the central portion 4920 by crimping or deforming one or both of its portions to join them together. Furthermore, in some embodiments, the support pad 4980 may also be overmolded. In some embodiments, the support pad 4980 may be flexible. In some embodiments, the support pad 4980 may be rigid. A rigid central portion may have a Shore hardness of 30A to 100D. In some embodiments, the mounting portion 4910 and / or the support pad 4980 may have a Shore hardness of 20A to 80A. In some embodiments, the Shore hardness of the central portion 4920 may be the same as or greater than (or even less than) the Shore hardness of the mounting portion 4910 and / or the support pad 4980.

[0323] Figures 41 and 42 show other embodiments of the interface between the mounting portion 4910 and the central portion 4920. Figures 41 and 42 show the joining of the mounting portion 4910 and the central portion 4920. In some embodiments, the mounting portion 4910 can be overmolded onto the central portion 4920. Figure 41 shows the portion of the central portion 4920 to which the mounting portion 4910 is overmolded. Figure 42 shows the portion resulting from the second fixing member after the mounting portion 4910 has been overmolded onto the central portion 4920. Figure 41 shows a specific structure extending from the central portion 4920 to which the mounting portion is overmolded, but any structure or shape can be used.

[0324] In some embodiments, the central portion 4920 can act in tensile and compressive states. In some embodiments, the central portion 4920 can prevent excessive upward rotation of the interface body and housing 4400, which may apply additional pressure to the nose compared to a flexible second fixing member. In some embodiments, the central portion 4920 can be formed from an optically transparent, i.e., clear material, which can help allow visibility of the patient's face. In some embodiments, the contour of the second fixing member 4900 can be shaped to avoid the interface body, which may give the second fixing member 4900, in particular the central portion 4920, a somewhat slight curvature when in use. However, the central portion 4920 can generally be relatively straight. In some embodiments, the central portion 4920 can be rigid. In other cases, the central portion 4920 can be flexible.

[0325] Figure 44 shows one embodiment of the support pad 4980 and the central portion 4920 of the second fixing member 4900. The support pad 4980 can be connected to the central portion 4920 by a hinged or pivotal connector 4982. In some embodiments, the central portion 4920 can move hingely relative to the mounting portion 4910 due to differences in material hardness and / or thickness, or a hinged connector similar to the hinged connector 4982 can be located between the support pad 4980 and the central portion 4920.

[0326] Pivoting the support pad 4980 relative to the central portion 4920 can help provide the intended vertical stability of the second fixing member 4900 by allowing adjustment of the position of the support pad 4980 on the second fixing member 4900. This adjustment may be important because the support pad 4980 can be connected to the patient, for example, at the patient's forehead, or to different devices (e.g., headgear) that can position the support pad 4980 at different heights from the patient's forehead. Therefore, the second fixing member 4900 can accommodate these different heights (e.g., headgear height) and different forehead angles by having a hinged or pivotable connection portion 4982 of the support pad 4980. Compensation for different heights and / or forehead angles can help minimize the impact on the seal of the interface body with the patient. In some embodiments, the support pad 4980 can be flexible. The support pad 4980 may have means of being attached and secured to the patient's face by any suitable mechanism to a headgear, chin strap, patient interface patch or skin patch on the patient's face, or by other means.

[0327] The second fixing member 4900 may have a hinged connection between the support pad 4980 and the rest of the second fixing member 4900. In some embodiments, the hinged or pivoted connection 4982 may allow for 180-degree pivots, pivots beyond 180 degrees, or any other pivot angle that allows the second fixing member 4900 to be kept over the patient (and the rest of the assembly) while a caregiver or clinician is tending to the patient or removing / moving the assembly, for example, while cleaning the patient's nostrils. For example, the housing 4400 and interface body can be flipped up above the support pad 4980 via the pivot axis or hinge 4982, moving the support pad 4980 out of the way. In this configuration, the housing 4400 and interface body assembly does not need to be completely removed. This may be beneficial because the housing 4400 and interface body assembly can be easily flipped up and pushed down. For example, if a patient begins to experience a decrease in saturation during care and requires further treatment, the mask can be easily pushed down to return it to its proper position.

[0328] In other embodiments, the second fixing member 4900 may not have a pivotable connection. The support pad 4980 may instead be integrated with the second fixing member 4900, as described in relation to Figures 33 to 35. In some embodiments, the support pad 4980 is overmolded onto the central portion 4920.

[0329] Figure 45 shows one embodiment of the second fixing member 4900a. The second fixing member 4900a may have a pivot or hinged portion handle 4984 connected to a support pad (not shown). The second fixing member 4900a may include a mounting portion 4910, a support pad (not shown), and a central portion 4920, similar to the second fixing member 4900 described in relation to Figures 40 to 44, except as otherwise described herein. The mounting portion 4910 may be formed from a rigid material and may have a wide base 4986, a notched contour portion 4972 in the wide base 4986, a gripping finger 4987, and a gripping catch 4988.

[0330] The wide base 4986 can be compressed to bring the gripping fingers 4987 closer together. The notched contour 4972 of the wide base 4986 can contribute to the deformation of the base 4986 when compressed. The gripping catch 4988 can hook onto the central projection 4440 of the housing 4400 and / or the lip of the central projection 4440. The wide base 4986 above the gripping fingers 4987 can be clamped and tightened to compress the mounting portion 4910 and to fit the gripping fingers 4987 into the opening 4442 (or more openings) of the housing 4400. The mounting portion 4910 can provide tactile feedback to the user.

[0331] Similar to the installation of the second fixing member 4900, the second fixing member 4900a can be installed by compression and subsequent extension of the engagement. Once compressed and fitted into the opening, the compressive force is released, and the engagement finger 4987 springs back and catches on the central projection 4440 of the housing 4400, securing it in place.

[0332] A similar mechanism can be used to remove the second fixing member 4900a. The mounting portion 4910 may have a low insertion force but a high removal force. Removal of the mounting portion 4910 may require the user to actively compress the mounting for easy removal. The second fixing member 4900a has a mounting rod 4984, which allows for the connection of a support pad or any other pad or patch that can be attached to a device (such as a headgear or patch) that secures the assembly to a patient, similar to the fixture described in relation to Figure 44. In some embodiments, the mounting rod 4984 may allow for the connection of a skin patch that can help secure the assembly to a patient. In other embodiments, the second fixing member 4900a may not have a pivotable connection, and the support pad may instead be integrated with the second fixing member 4900, as described in relation to Figures 33-35.

[0333] Figures 46A and 46B show one embodiment of the second fixing member 4900b. Figure 46A shows a front view of the second fixing member 4900b. Figure 46B shows a rear view of the second fixing member 4900b. The second fixing member 4900b may include a mounting portion 4910, a support pad (not shown), and a central portion 4920, similar to the second fixing member 4900a described in relation to Figure 45, except as otherwise described herein. The second fixing member 4900b may have a mounting portion 4910 with two gripping fingers 4987 and a tab 4989. When the mounting portion 4910 is pressed through one or more openings 4442 of the central projection 4440 of the housing 4400, the gripping fingers 4987 may move and be compressed together. When received in one or more openings, the tab 4989 of the engaging finger 4987 can hook onto the side of the central projection 4440.

[0334] Furthermore, the second fixing member 4900b may have a projection 4985 on the rear side of each engaging finger 4987, which can provide an additional hook that can secure the second fixing member 4900b to the central projection 4440 of the housing, for example, the housing 4400 described in relation to Figures 37 and 38, by hooking onto the lip 4446 (shown in Figure 38).

[0335] Figure 47 shows a further embodiment of the mounting portion 4910 of the second fixing member 4900b. In this embodiment, the mounting portion 4910 includes one or more anterior overhangs 4950. One or more anterior overhangs 4950 may be positioned outward from the front surface of the mounting portion 4910 and may extend from there. A first or lower anterior overhang 4950a may be located at the lowest or distal end of the mounting portion 4910. In the illustrated embodiment, the first anterior overhang 4950a includes an upwardly extending hook portion 4951. The hook portion 4951 may be flexible or elastically deformable so that it can be inserted into a corresponding mounting mechanism on the housing 4400. In the illustrated embodiment, the hook portion 4951 engages with an opening 4442 in the central projection 4440 of the housing 4400.

[0336] A second or upper front overhang portion 4950b may be positioned above the first front overhang portion 4950a of the mounting portion 4910. In the illustrated embodiment, the second overhang portion 4950b includes a projection extending outward from the front surface of the mounting portion 4910. The projection may be configured so as not to pass through the opening 4442. Thus, the second overhang portion 4950b prevents the mounting portion 4910, and therefore the second fixing member 4900, from being excessively inserted into the opening 4442.

[0337] In some embodiments, the housing may have a single opening (shown in Figure 43B) in the central projection on the front side of the housing 4400 that receives both of the engaging fingers 4987, or it may have two openings (as shown in Figures 37 and 38) for each finger 4987.

[0338] The mounting portion 4910 can provide tactile feedback to the user. The tactile feedback of the mounting portion 4910 allows the user to know when the mounting portion 4910 is properly inserted into the housing 4400 or under the first fixing member 4600. Optionally, the mounting portion 4910 can control the angle of the second fixing member 4900 relative to the patient seal assembly.

[0339] In some embodiments, the mounting portion 4910 may be rigid. In some embodiments, the mounting portion 4910 may be made of a flexible material.

[0340] The embodiment of the second fixing member 4900 described in relation to Figures 40 to 47 can be inserted into the housing 4400 by vertical force, by the user pushing down the mounting portion until it is received within the opening of the central projection of the housing 4400. This may be preferable to the second fixing member 3900 described in relation to Figures 33 to 35, as the second fixing member 3900, which attaches to the central projection of the housing 3400 by push-fit, can be attached by applying a force that presses against the patient's face. The above force may cause discomfort to the patient, and therefore, the assembly must be removed first in order to attach this second fixing member 3900.

[0341] Seal between the housing and the interface body The patient interface assembly includes an interface body that can form a seal with at least a portion of the user's airway and allow gas flow from and to the user, and a housing that can be coupled to the interface body. The housing and the interface body can be coupled in various configurations. The mating of these two components can be optimized for the functionality of the patient interface assembly and / or for the caregiver's convenience. The interface body can seal-engage with the housing to allow gas flow from and to the user.

[0342] In some embodiments, the coupling of the interface body to the housing may be a complementary mating as described herein. The coupling of the interface body and the housing allows for the assembly and disassembly of the patient interface, as well as the switching between different interface bodies. The coupling is also configured to help prevent unintended separation of the interface body from the housing. The housing and the interface body can be a complementary mating, which makes incorrect assembly difficult and / or provides a visual indication of incorrect and correct assembly. The interface body may have a manifold 4240 that connects to the internal cavity of the housing 4400 at a tubular engagement portion 4460 of the housing 4400.

[0343] Figure 48A shows one embodiment of the interface body, which is a cannula body 4200a. The cannula body 4200a may have a manifold 4240 and at least one nasal prong 4220, such as a pair of prongs 4220. The prongs 4220 may extend from the rear portion of the manifold 4240 that faces the patient during use. The cannula body 4200a may be the same as the cannula bodies described in relation to Figures 10-13 and 21, except as described herein. The manifold 4240 shown in Figure 21 and Figure 48A may be the same as the manifold described in relation to Figures 10-13, but the manifold 4240 and the annular ridge 4248 are positioned closer to the bottom side of the interface body. For example, this can be done by positioning the manifold and the annular ridge closer to the bottom side of the interface body (as opposed to the centerline or substantially center of the interface body described in relation to Figures 10-13). This alignment can help improve the stability of the patient interface.

[0344] The manifold 4240 may include a housing coupling portion 4244 on the rear side of the manifold 4240. The housing coupling portion 4244 can be received by the interface body receiving portion 4480 of the housing (shown in Figures 37-38). The housing coupling portion 4244 may have a raised portion 4247. The raised portion 4247 may be adjacent to the interface body receiving portion 4480 of the housing 4400 when the manifold 4240 and the housing are coupled. The housing coupling portion 4244 and the rest of the manifold 4240 may be shaped and / or sized such that they are inserted into and received by the housing 4400, forming an airtight seal. For example, the manifold 4240 may include annular ridges 4248 at each of the openings 4246. The annular ridges 4248 can provide a tight fit with the inner surface of the housing 4400 at or adjacent to the opening of the housing 4400, forming an airtight seal with the housing 4400, as shown in Figures 49 to 53D. The annular ridges 4248 of the manifold 4240 are in contact with the inner surface of the housing 4400. All other features of the manifold are spaced apart to reduce frictional forces when assembling the manifold 4240 into the housing 4400. Reduced frictional forces facilitate the assembly of the components and reduce the risk of rotational misalignment between the two components.

[0345] The interface body and housing may have an engagement surface 4889 that contacts the interface body and housing after assembly (as shown in Figure 50). The engagement surface 4889 of the interface body may include a raised portion 4247 of the housing coupling portion 4244, as shown in Figure 49. The raised portion 4247 of the housing coupling portion 4244 may be adjacent to the interface body receiving portion 4480 when the housing 4400 and the interface body are assembled. The engagement surface 4889 may be continuous around the entire perimeter of the raised portion 4247. In other embodiments, the engagement surface 4889 may include only a portion of the raised portion.

[0346] Figures 48B to 48E show the interface body, which is the mask body 4200b. The mask body 4200b is similar to the mask body 3200b described herein, but includes the manifold mechanism described with reference to Figure 48A.

[0347] The manifold 4240 of the cannula body 4200a and the mask body 4200a can define one or more openings 4246, such as a pair of openings 4246 (shown in Figures 48A-48E). The openings 4246 are coupled to tube engagement portions 4460 of the housing 4400 (shown in Figures 37 and 38) to receive interface tubes, allowing gas flow from and to the patient through the manifold 4240 and the interface body. Positioning the openings 4246 at both ends of the housing 4400 can provide lateral inlet points for gas flow into and out of the interface. Lateral inlet points help remove CO2 and can reduce dead space outside the flow path, as described herein with respect to lateral inlet and outlet points of the interface body. Lateral gas flow entering and exiting the interface body, such as the mask cavity of the mask body, can result in greater CO2 removal compared to a mask or fluid interface having inlet and outlet points located in the center or top of the mask. Furthermore, the lateral inlet and outlet points for gas flow can reduce dead space outside the flow path within the interface body.

[0348] The lateral openings 4246 can communicate fluidly with each other via the manifold 4240. The manifold 4240 can be sealed when the cannula body engages with the housing, except for the lumen of the openings 4246 and the nasal prongs 4220, and when it is coupled with the housing. The manifold can be sealed when the mask body engages with the housing, except for the openings of the manifold and the mask cavity, and when it is coupled with the housing.

[0349] As shown in Figure 49, the housing 4400 may have a width w measured from the first tube engagement portion 4460 at the first end of the housing 4400 to the second tube engagement portion 4460 at the second end of the housing 4400. The interface body may extend along or be measurable along the lumen of the manifold 4240 and have a width a measured from the first annular ridge portion 4248 at the first end of the manifold 4240 to the second annular ridge portion 4248 at the second end of the manifold 4240. In some embodiments, it may be beneficial to reduce the contour of the housing and minimize the overall bulk of the interface. In some embodiments, a single housing size and style can be used for all sizes of cannula or mask bodies. This allows a single and constant housing or frame to be used with multiple interface bodies. The interface body may be of different types, such as being able to use both a cannula and a mask body. Such different interface bodies can use different sized masks with different mask bodies and different sized nasal prongs with different cannula bodies. This eliminates waste and allows the interface itself to be easily modified and adapted according to the clinician's requirements.

[0350] Figures 49 and 50 show one embodiment of the housing coupling portion 4244 of the manifold 4240 positioned within the interface body receiving portion 4480 of the housing 3400. Figures 49 to 53 show the housing 4400 as transparent, thereby allowing the manifold 4240 to be seen inside the housing 4400. The housing 4400 and the manifold 4240 may have engaging surfaces 4889 in which the raised portion 4247 of the housing coupling portion 4244 of the manifold 4240 and the interface body receiving portion 4480 of the housing 4400 fit together or abut against each other. The housing 4400 may have a width w that extends from one tube engaging portion 4460 to a second tube engaging portion 4460, or a measurable width w, as shown by the line "w" in Figure 49. The interface body receiving portion 4480 may include an opening. The opening may be an inclined opening 4845, as shown in Figure 43B in one design with the manifold not installed and in Figure 49 in another design with the manifold 4240 positioned within the housing 4400. Embodiments in Figure 43D and Figure 49 have different inclined openings that can mate with manifolds of different shapes of the interface body. The inclined opening 4845 may include a portion of the housing 4400 that can receive the manifold 4240 of the interface body. The inclined opening 3845 may be an angle extending along the opening of the housing, from the front portion 4841 of the housing to the rear portion 4843 of the housing along the top of the housing, as shown in Figure 49. In some embodiments, the housing coupling portion 4244 of the manifold 4240 may have a raised portion 4247 having an inclined surface that is a complementary fit to the inclined opening 4845 of the interface body receiving portion 4480. As shown in Figure 49, the inclined surface of the raised portion 4247 can extend along the top of the manifold at an angle from the front portion 4241 of the manifold 4240 to the rear portion 4243 of the manifold 4240.The complementary mating of the inclined interface body receiving portion 4480 and the inclined raised portion 4247 of the housing coupling portion 4244 can improve assembly and alignment when the manifold 4240 is detachably coupled and received by the housing 4400.

[0351] In some embodiments, the housing coupling portion 4244 of the interface body and the manifold 4240 may have a width measured along the lumen of the manifold 4240, from one end of the raised portion 4247 of the housing coupling portion 4244 to the second end of the raised portion 4247 of the housing coupling portion 4244. As shown in Figure 49, if the raised portion 4247 of the housing coupling portion 4244 is an inclined raised portion 4247, the raised portion 4247 of the housing coupling portion 4244 may have a varying width. For example, the raised portion 4247 of the housing coupling portion 4244 may have a first width b on the front portion 4841 of the manifold 4240 and a second width c on the rear portion 4843 of the manifold 4240. In some cases, as shown in Figure 49, the first width b on the front portion of the manifold 4240 is smaller than the second width c on the rear portion of the manifold 4240. In some cases, the first width b of the front portion of the manifold 4240 is greater than the second width c of the rear portion of the manifold 4240.

[0352] The angle 4847 of the opening 4845 can be balanced with the width w of the housing. The inclined opening 4845 can prevent and block the manifold 4240 from being misoriented within the housing 4400. As shown in Figure 49, the inclined opening may have curved or trapezoidal sides instead of a straight edge. In other embodiments, the inclined opening may have a straight edge. In other embodiments, the inclined opening may have one or more curved edges.

[0353] In some embodiments, the inclined opening 4845 can assist in the alignment and removal of the manifold 4240 from the housing 4400. In some embodiments, a narrow or smaller angle in the inclined opening (e.g., 0-30 degrees, 0-45 degrees, or 0-60 degrees) can prevent incorrect assembly. Smaller angles may necessitate widening the housing, for example, because the position of the prongs on the interface body is fixed. In some embodiments, the inclined opening 4845 and raised portion 4247 of the housing coupling portion 4244 having larger angles (e.g., 30-180 degrees, 45-180 degrees, or 60-180 degrees) can reduce the housing width. However, larger angles may negate the benefit of the angle in preventing or preventing incorrect orientation. In some embodiments, at a 90-degree angle, the angle-assisted orientation may be lost. Therefore, it may be desirable to make the housing 4400 as narrow as possible to improve patient comfort when the patient is lying on their side, as well as to reduce bulk and improve aesthetics. However, the width of the housing 4400 is preferably balanced with an angle that can help prevent the manifold 4240 from being misaligned within the housing 4400. In some embodiments, the raised portion 4247 of the housing coupling portion 4244 may have an inclined opening having a 60-degree angle 4847 measured from the rear portion 4843 of the manifold 4240, as shown in Figure 49. In some embodiments, the inclined raised portion 4247 of the housing coupling portion 4244 may extend from the rear side of the manifold at an angle of 30 to 170 degrees. In some embodiments, the inclined raised portion of the housing coupling portion may extend from the rear side of the manifold at an angle of 60 to 120 degrees. In some embodiments, the inclined raised portion of the housing coupling portion may extend from the rear side of the manifold at an angle of 30 to 90 degrees. In some embodiments, the inclined raised portion of the housing coupling portion may extend from the rear side of the manifold at an angle of 90 to 170 degrees.

[0354] Figure 50 shows a portion of the manifold 4240 coupled to the housing 4400. Figure 50 also shows the housing coupling portion 4244 of the interface body coupled to the interface body receiving portion 4480 of the housing 4400. As shown in Figure 50, the manifold 4240 is positioned off-center from the center of the transverse axis h2 that extends through the center of the lumen of the housing 4400 from the first tube engagement portion 4460 to the second tube engagement portion 4460. This arrangement of the manifold 4240 relative to the housing 4400 allows for a larger manifold bore diameter, which can reduce flow resistance within the housing 4400 and the manifold 4240. This offset arrangement allows for a thicker front portion 4841 of the housing 4400, thereby increasing the rigidity of the housing 4400. The increased thickness of the front portion 4841 of the housing 4400 improves stability and facilitates the assembly and / or disassembly of the interface body with the housing 4400. This configuration also improves the structural integrity of the housing 4400.

[0355] In some embodiments, the manifold 4240 may have a transverse axis h1 extending through the center of the lumen of the manifold 4240. The housing 4400 may have a transverse axis h2 extending through the housing 4400, passing through the centers of the tube engagement portions 4460 on both sides of the housing 4400. In some cases, the transverse axis h1 may be the same as the transverse axis h2. In other embodiments, the transverse axis h1 may be offset or out of center from the transverse axis h2 of the housing 3400. Thus, the annular ridge portion 4248 of the manifold 4240 may be out of center from the transverse axis h2. The annular ridge portion 4248 of the manifold 4240 may be substantially the same size as or smaller than the inner diameter of the housing 4400.

[0356] Figures 51A and 51B show some of other embodiments of the manifold 4240 coupled to the housing 4400. Figure 51B is an enlarged view of the manifold 4240 and the end of the housing 4400 shown in boxes in Figure 51A. The manifold 3240 may include extension portions 4288 extending outward from each opening 4246 of the manifold 4240. Each extension portion 4288 may extend a certain distance beyond the annular ridge portion 4248. The extension portion 4288 may have a diameter smaller than the outer diameter of the annular ridge portion 4248. The extension portion 4288 may have an outer diameter similar to the inner diameter of the interface tube 4800. The extension portion 4288 may be configured to extend from the manifold 4240 into the tube 4800 when in use. The extension portion 4288 may extend into the tube engagement portion 4460 of the housing 4400. In some embodiments, the extension portion 4288 can extend into the interface tube 4800 of the patient interface assembly. The extension portion 4288 can increase the manifold removal force required to remove the manifold from the housing 4400. The extension portion 4288 can reduce the possibility of the annular ridge portion 4248 (e.g., the annular ridge portion including an O-ring) getting caught in the housing 4400 when the user is assembling the two components. When the extension portion 4288 is used, misalignment of the manifold and housing 4400 may become more obvious and pronounced.

[0357] Figures 52A and 52B show one embodiment of a manifold 4240 coupled to a housing 4400, which has a mechanism designed to prevent or limit the rotation of the interface body within the housing. The manifold / housing interface may include a key mechanism 4286. The key mechanism 4286 may include a projection 4287 on the manifold and a recess 4289 on the housing. The projection 4287 and the recess 4289 may have complementary shapes so that the projection 4287 can engage with the recess 4289 in a complementary fit, as shown in Figures 52A and 52B. In some embodiments, the key mechanism 4286 can prevent misalignment between the manifold and the housing 4400. The key mechanism 4286 can prevent rotation between the two sides of the manifold, as shown in Figure 52B. This may be beneficial because rotation of the manifold may affect the shape of the prongs or mask. By limiting or preventing the rotation of the manifold, a more consistent sealing surface can be enabled between the manifold and the housing, thereby improving the assembly's ability to maintain a seal between the two components.

[0358] The key mechanism 4286 is shown on the rear side of the housing 4400 (i.e., the side facing the patient). However, the key mechanism 4286 can be positioned on the front or rear side of the housing 4400, or at any location that allows for complementary mating between a projection and a corresponding recess. Furthermore, although the manifold is shown as having a projection and the housing 4400 is shown as having a recess, a key mechanism can be used in which the projection is on the housing and the recess is on the manifold. The key mechanism shown in Figures 52A and 52B is rectangular in shape, but it can be any shape, such as a square, rectangle, circle, or any part of these shapes, or an irregular shape.

[0359] Figures 53A to 53D show another embodiment of the manifold 4240 coupled to the housing 4400. The raised portion 4247 of the housing coupling portion 4244 of the manifold 4240 may have an inclined surface 4849 which is a complementary fit to the inclined opening 4284 of the interface body receiving portion 4480 of the housing 4400. The inclined opening 4284 and the raised portion 4247 may be the same as the inclined opening described in relation to Figure 49, except as otherwise provided herein. The inclined opening 4384 of the housing may have a larger angle than the inclined opening described in relation to Figure 49 when measured in the same manner. The inclined opening 4284 may have a shape and form that helps to result in a geometric shape that automatically aligns with the housing coupling portion 4244 of the manifold 4240. The inclined opening 4284 as shown in Figures 53A and 53B may be the same as or have the same shape as the inclined opening of the interface body receiving portion 3480 of the housing 4400 shown in Figures 37 and 38. The inclined raised portion 4247 and the inclined interface body receiving portion 4480 of the housing coupling portion 4244 can control the orientation between the manifold and the housing, reducing the possibility of incorrect placement of the manifold within the housing. The inclined ridged portion 4247 and the inclined interface body receiving portion 4480 of the housing coupling portion 4244 can also reduce the possibility of rotational misalignment between the manifold and the housing.

[0360] The inclined protrusion 4247 of the manifold may be substantially trapezoidal in shape when viewed from the top views of the housing 4400 and the manifold 4240, as shown in the top view of Figure 53A. As shown in Figure 53A, the trapezoidal shape of the inclined protrusion 4247 is such that the wider base of the trapezoid is close to the front portion of the housing 4400. In other embodiments, the protrusion of the interface body includes the wider base of the trapezoid close to the rear portion of the housing.

[0361] The housing 4400 may have an inclined interface body receiving portion 4480 having a complementary configuration, as shown in Figures 37, 37 and 53A. As shown in the top view of the interface assembly in Figure 53A, the inclined protrusion 4247 may be trapezoidal when viewed from above. As shown in Figure 53A, when viewed from above, the trapezoidal shape outlined by the inclined protrusion 4247 of the housing coupling portion 4244 and the inclined interface body receiving portion 4480 may have four corners at angles other than 90 degrees.

[0362] As shown in Figure 53A, the inclined raised portion 4247 and the inclined interface body receiving portion 4480 of the housing coupling portion 4244 can have corners 4482 formed by the rear side of the manifold with an angle greater than 90 degrees. The inclined raised portion 4247 and the inclined interface body receiving portion 4480 of the housing coupling portion 4244, as shown in Figure 53A, can have corners 4484 at the front corners 4484 of the manifold's raised portion and the housing's interface body receiving portion with an angle less than 90 degrees. For example, the inclined raised portion 4247 and the inclined interface body receiving portion 4480 of the housing coupling portion 4244, as illustrated in Figure 53A, can have an angle of 120 degrees at the two opposing corners on the rear side of the manifold.

[0363] As shown in Figures 53A and 53B, the angle 4482 of the inclined protrusion 4247 is greater than 90 degrees when measured from the rear of the manifold. The angle shown in the embodiment of the housing 4400 shown in Figure 49 is less than 90 degrees when measured from the rear of the manifold. However, openings of any angle can also be used to allow evaluation of correct mounting and to prevent rotational misalignment of components. In some embodiments, the inclined protrusion 4247 of the housing coupling portion 4244 can extend from the rear of the manifold at an angle of 30 to 170 degrees. In some embodiments, the inclined protrusion of the housing coupling portion can extend from the rear of the manifold at an angle of 60 to 120 degrees. In some embodiments, the inclined protrusion of the housing coupling portion can extend from the rear of the manifold at an angle of 90 to 120 degrees. In some embodiments, the inclined protrusion of the housing coupling portion can extend from the rear of the manifold at an angle of 90 to 170 degrees.

[0364] While inserted into the housing 4400, the manifold 4240 can be folded, bent, flexed, or otherwise manipulated as preferred. For example, during insertion, the manifold 4240 can be folded through the center of the housing 4400 to operate the annular ridge 4248 through the narrowest point of the housing 4400. Once the annular ridge 4248 is concentrically positioned within the housing, the manifold can straighten and return to its stationary shape. During this process, the inclined surface 4849 and the inclined opening 4284 can act to align the manifold 4240 in the correct orientation relative to the housing 4400.

[0365] Figure 53B shows a portion of the manifold 4240 and housing 4400 shown in Figure 53A. The annular ridge portion 4248 of the manifold 4240 can contact the housing 4400. The annular ridge portion 4248 can contact the inner surface of the housing 4400 to provide a gas seal. Other mechanisms on the manifold 4240 can avoid or minimize contact with the housing to reduce frictional forces when assembling the two components. Reduced frictional forces can facilitate user assembly and reduce the risk of rotational misalignment between the two components. In some cases, the annular ridge portion 4248 may have a press fit to prevent leakage.

[0366] Figure 53C shows a portion of the manifold 4240 and housing 4400 shown in Figure 53A. The manifold 4240 and housing 4400 of the interface body may each have an engagement surface 4889 that contacts or otherwise connects when assembled. The side walls of the raised portion 3247 of the housing coupling portion 3244 may form at least a portion of the engagement surface 4889 of the interface body. A portion of the raised portion 4247 on the manifold 4240 may be raised relative to the engagement surface 4889 on the housing 4400. This arrangement results in a portion of the raised portion 4247 of the manifold 4240 remaining in contact with the housing, as shown in Figure 53C. For example, as shown in Figure 53C, the rear raised portion 4247 of the manifold 4240 extends beyond the rear side of the housing 4400 at the engagement surface 4889. This difference in the backward-facing (i.e., patient-facing) spread of these components allows the relatively soft manifold material of the interface body to make contact with the patient's face before or preferentially before the relatively hard or more rigid housing material.

[0367] Figure 53D shows a portion of the manifold 4240 and housing 4400 in an assembled configuration. Disassembly of the manifold 4240 from the housing 4400 can be controlled or optimized at least partially based on the materials and / or construction of the manifold and housing. The disassembly force required to disassemble the components can be controlled at least partially by a distance "x", as shown in Figure 53D, which is the horizontal distance between the outer edge of the annular ridge portion 4248 and the sealing or engagement surface 4889 of the manifold 4240. Disassembly of the manifold 4240 from the housing 4400 can occur when the annular ridge portion 4248 moves beyond the engagement surface 4889 of the housing 4400, releasing the seal of the manifold 4240 from the interface body receiving portion 4480 of the housing. The user can overcome this force to swap between interface bodies, e.g., between masks, between prongs, or between different sizes.

[0368] In some embodiments, if the annular ridge 4248 moves beyond the distance "y" as shown in Figure 53D, the seal between the manifold 4240 and the housing 4400 may be broken, where "y" is the distance between the outer edge of the annular ridge 4248 and the raised portion 4247 of the manifold. If the annular ridge 4248 is at or beyond this point, a clear channel may exist between the housing and the annular ridge 4248, potentially resulting in leakage that is unacceptable for treatment delivery. In some embodiments, the inclined opening may affect both of these dimensions ("x" and "y"), so as to be the full width of the housing.

[0369] Figures 54 and 55 show side cross-sectional views of the interface body. Figure 54 shows a side cross-sectional view of the interface body including the cannula body. Figure 55 shows a side cross-sectional view of the interface body including the mask body. The manifold 4240, cannula body, and mask body are the same as the manifold, cannula body, and mask body described in relation to Figures 10 to 24, except as otherwise provided herein. The manifold 4240 may have an inner diameter of the inner surface 4851 of the manifold wall, an outer diameter of the outer surface 4853 of the manifold wall, and a wall thickness between them. The rear portion 4243 of the manifold 4240, i.e., the portion facing the patient, may have a thinner wall thickness compared to the wall thickness of the front portion 4241 of the manifold 4240. A thinner wall thickness allows for greater flexibility, which may be more comfortable for the patient. The wall thickness of the front portion 4241 of the manifold 4240, which is supported by the housing, may generally be thicker compared to the rest of the manifold 4240. This can be helpful for the user or clinician in assembling and removing the interface body from the housing. For example, when the interface assembly is assembled or the interface body is removed, if force is applied to the side of the interface body, the interface body may fold inward. This folding is at least partially possible because the wall thickness of the rear portion 4243 of the manifold 4240 is thinner than that of the front portion 4241 of the manifold 4240. Relatively thin material can be crushed inward when force is applied to its side or each side of the manifold 4240 during insertion and removal of the interface body.

[0370] Both the mask body and the cannula body of the manifold 4240 have annular ridges 4248 on both sides of the manifold 4240. The annular ridges 4248 may be integrated sealing O-ring portions. These annular ridges 4248 of the manifold 4240 fit into the housing 4400 and seal with the housing 4400 so that each side is also in fluid communication with one of the tubes. The annular ridges 4248 are the intended contact points between the manifold 3240 and the housing 4400. Having a single contact point reduces friction between the manifold 4240 and the housing 4400, thereby allowing the interface body to slide more easily when fitted into the housing and to autoalign more easily. The amount of rotation of each side of the interface body or each annular ridge relative to each other can be controlled by the amount of interference between the components (e.g., the amount of interference between the housing 4400 and the manifold 4240). Because even a small rotation on one side could cause the seal between the housing 4400 and the manifold 4240 to flex, this rotation (and therefore interference) should ideally be minimized. Therefore, it may be important to ensure and verify the proper alignment of the manifold 4240 within the housing 4400. The manifold 4240 may include an automatic alignment mechanism that helps prevent this rotation and maintain each side of the manifold 4240 in the same position within the housing 4400 relative to the other.

[0371] Figures 54 and 55 show a manifold equipped with a mechanism to prevent or at least minimize rotation of the interface body within the housing. In some cases, this mechanism may be a shoulder portion 4628. The shoulder portion 4628 may be any structure having a surface large enough to engage with the bottom edge of the housing opening (not shown) and prevent or reduce rotation. For example, the shoulder portion 4628 may be a thickened portion of the wall of the manifold 4240, as shown in Figures 54 and 55. The shoulder portion 4628 may help to automatically align the manifold 4240 within the housing. As shown in Figures 54 and 55, the shoulder portion 4628 may be a thickened portion at the bottom of the housing mounting portion of the manifold. When assembled, the shoulder portion 4628 may protrude from the housing. In other cases, the shoulder portion may not protrude from the housing and may abut against the surface of the housing opening. The shoulder portion 4628 can catch and abut against the edge of the housing, preventing or limiting the rotation and movement of the interface body relative to the housing. By limiting or preventing the rotation of the manifold, a more consistent sealing surface can be enabled between the manifold and the housing, thereby improving the ability to maintain a seal between the two components. The shoulder portion 4628 may be a thickened portion of the manifold that can help prevent the interface body from being incorrectly inserted into the housing. The shoulder portion 4628 allows for visual assessment of incorrect or correct configuration of the interface body within the housing. The user can visually observe if the manifold is misaligned and correct the alignment of the manifold with the housing.

[0372] As shown in Figure 54, distance "d" represents the width of the shoulder portion 4628, which is wider than the rest of the manifold wall. The thickness "t" of the manifold wall, shown in Figure 54, is thinner than the width of the manifold region including the shoulder portion 4628, distance "d". In some embodiments, the width "d" of the shoulder portion can be 2.5 mm and the thickness "t" of the manifold wall is 1.0 mm. The width "d" of the shoulder portion can be 1.5 mm to 3.5 mm, with a thickness of 1.5 mm to 2.5 mm, 2.5 mm to 3.5 mm, and 2.0 mm to 3.0 mm.

[0373] The width of the shoulder portion 4628 can form a region at the base of the interface body that, when assembled, can act to prevent rotation of the manifold within the housing. In some embodiments, the shoulder portion 4628 extends only along a portion of the manifold. In some embodiments, the shoulder portion 4628 can extend across the width of the manifold from one side to the other. The shoulder portion 4628 can also give the nasal prongs or mask some structure or rigidity that can facilitate the insertion of the device as described above. Furthermore, increasing the thickness of this shoulder portion 4628 can also increase the required removal force, thereby reducing the possibility of accidental disassembly.

[0374] In some embodiments, the surface finish of the housing and interface body or manifold material can aid in the placement of the manifold within the housing, thus improving the fitting of the manifold into the housing. In some embodiments, to achieve this, the surface finish of the housing and manifold or interface body can result in a low-friction or slippery surface. In some embodiments, a low-friction surface of the housing or interface body may be a property of the material forming the housing or interface body, or a part of the housing or interface body. In some embodiments, a low-friction surface can be achieved during the manufacturing process. For example, a material coating can be added to the material of the housing or interface body. For example, to achieve a low-friction surface, a parylene coating can be applied to the outer surface of the housing or interface body. Alternatively, a low-friction surface can be provided by treating the surface with a process such as a blasting process (e.g., bead blasting). The coating or treatment can reduce friction and adhesion to other materials of the housing or interface body, thereby improving the sliding of the interface body into the housing. Furthermore, a low-friction surface can also reduce friction in the part of the interface body that comes into contact with the patient's face, improving comfort. In some embodiments, other components of the patient interface assembly may also have low-friction surfaces or be formed from low-friction materials.

[0375] Figures 56A to 56F show a manifold 5420 coupled to a housing 5400 that uses a visual indicator to show the correct positioning and proper alignment of its components. The visual indicator may be a color indicator or indicator line that shows the correct placement of the components.

[0376] Figures 56A–56D show that a visual indicator may be a colored ring 5604 located on or around the annular ridges of the manifold 5420. The colored ring 5604 can be observed through a transparent or translucent portion of the housing 5400. The user or clinician can observe the position and configuration of the colored ring 5604 through the transparent or translucent portion. In the illustrated embodiment, correct positioning of the component is indicated by observing that the colored ring 5604 is axially aligned with the housing 5400 and forms a circle. Incorrect positioning of the component is indicated, for example, by observing that the colored ring 5604 is deformed or not aligned with the housing 5400.

[0377] The colored rings 5604 can be provided on opposing annular ridges on both sides of the manifold. In some embodiments, the color indicators can be provided on the manifold only, on the housing only, or on both the manifold and the housing.

[0378] Furthermore, or by alternative means, the interface assembly may include a second visual indicator, such as a second color indicator, on the angled corner of either the housing 5400 and / or the manifold 5420. Figures 56C and 56D show the color indicator 5606 on the angled edge of the manifold 5420 and the housing 5400. The color indicator 5606 can provide a visual indication when the angled edges of these two components are properly aligned. When the two components are not properly aligned, the user can see the misalignment of the color indicator on the components.

[0379] Further embodiments of the visual indicator are shown in Figures 56E and 56F. In this embodiment, the visual indicator is provided as a colored or contrasting bar or line 5608. The colored bar 5608 may be located on the surface of the interface body manifold 5420. In the illustrated embodiment, the colored bar 5608 is located on the manifold 5420 on or adjacent to a surface or edge that mats with or abuts against the housing 5400. When the manifold 5240 and housing 5400 are properly aligned, the colored bar 5608 can be observed to have a non-linear form, as shown in Figure 56E. When the components are properly assembled and aligned, the colored bar 5608 can be observed to have a linear or straight form, as shown in Figure 56F.

[0380] In some embodiments, color indicators on the housing and / or manifold can be used as sizing indicators as well as alignment indicators. For example, housings and manifolds can be supplied in various sizes, and different sizes can use different color indicators so that the correct-sized housing can be paired with the correct-sized manifold. This can help users correctly pair the components of the housing and manifold. The color indicators shown with reference to Figures 56A–56F are provided on the ends of the manifold that mate with the housing, or on the angled edges of the manifold and housing, but the color indicators can be provided on any component of the manifold and / or housing, such as any part of the manifold that mate with the housing, to provide a visual indication of correct positioning and alignment. In some embodiments, any part or component of the interface assembly or the whole of a component may be transparent or translucent to allow visibility of the visual alignment indicator. Transparent or translucent materials can make the colored portions of the components visible, for example, transparent or translucent materials can make the colored portions on the annular ridges of the manifold within the housing visible.

[0381] Pipes and connectors One or more interface tubes and connectors of a patient interface assembly enable fluid communication from an external device or gas source to the patient and from the patient to them. Figure 57 shows a tube 4800 and a connector 4820 at the end of the tube. In some embodiments, the walls of the interface tube 4800 may be made of a material that can allow water vapor to pass through the walls of the tube 4800. The connector 4820 may be any type of interlock or mating connector that connects the tube to another device or an additional tube. As shown in Figure 57, the connector may have locking fingers 4822 that connect and secure the tube to another device or an additional tube. Examples of connectors and / or connector assemblies can be found in International Application PCT / NZ2012 / 000142, filed August 10, 2012, entitled "CONDUIT CONNECTOR FOR A PATIENT BREATHING DEVICE", the entire application of which is incorporated herein by reference. In other embodiments, the connector may have a tapered mating that connects to another device or an additional tube.

[0382] The housing can be connected to the tube at the tube engagement portion (shown in Figure 36). In some embodiments, the tube 4800 may include an inspiratory conduit having a first end that connects to the housing and can deliver an incoming gas flow, and a second end with a locking finger 4822. In some embodiments, the tube 4800 may include an expiratory conduit having a first end that connects to the housing and can receive an expiratory gas flow, and a second end with a locking finger 4822. In some embodiments, the tube may include both an inspiratory and an expiratory conduit. Optionally, the locking finger 4822 at the second end may be coupled to a downstream component, such as a bubbler. In some embodiments, the locking finger 4822 at the second end of the inspiratory conduit may be coupled to an upstream component, such as a flow source.

[0383] In some embodiments, the locking fingers 4822 may extend away from the connector 4820. The locking fingers 4822 may be spaced apart and narrow along their length away from the connector. The locking fingers may have locking recesses formed on at least the outer surface of each locking finger. The locking recesses may lock with a portion of the gas delivery tube connector or other connector. The locking fingers may interact with recesses of the gas delivery tube connector or other connector to align the connector 4820 with the gas delivery tube connector or other connector.

[0384] term Unless explicitly required in the context otherwise, throughout this specification and the claims, words such as “comprise,” “comprising,” etc., should be interpreted in an inclusive sense, as opposed to an exclusive or exhaustive sense, i.e., “includes, but not limited to.” In particular, conditional language used herein, such as “can,” “may,” “possibly,” “may,” “may,” “for example,” etc., unless explicitly stated otherwise or understood to have a different meaning in the context in which they are used, is generally intended to suggest that some embodiments include some features, elements, and / or states, but other embodiments do not. Accordingly, such conditional language is generally not intended to suggest, with or without author input, that these features, elements, and / or states are necessarily required for one or more embodiments, or that one or more embodiments necessarily include logic for determination, regardless of whether those features, elements, and / or states are included in or implemented in any particular embodiment.

[0385] The term “multiple” refers to two or more items. Enumerations of quantities, dimensions, sizes, formulations, parameters, shapes, and other features should be interpreted as if preceded by the term “about” or “approximately.” The terms “about” or “approximately” mean that quantities, dimensions, sizes, formulations, parameters, shapes, and other features do not need to be exact, but are approximate and / or may be greater or less, as necessary, to reflect acceptable tolerances, conversion factors, rounding, measurement errors, and other factors known to those skilled in the art. Enumerations of quantities, dimensions, sizes, formulations, parameters, shapes, and other features should also be interpreted as if preceded by the term “substantially.” As used herein, the terms “about,” “approximately,” and “substantially” refer to quantities that are close to the stated quantity, still performing the desired function or achieving the desired result. For example, in some embodiments, as may depend on the context, the terms “approximately,” “about,” and “substantially” may refer to an amount that is within 10% or less of the amount being stated. As used herein, the term “generally” refers to a value, quantity, or characteristic that largely comprises or tends toward a particular value, quantity, or characteristic. For example, as may depend on the context, the term “generally linear” may mean that it deviates from exactly parallel by 15° or less.

[0386] In this specification, numerical data may be expressed or presented in range format. Such range formats are used merely for convenience and clarity, and should therefore be interpreted flexibly to include not only the numerical values ​​explicitly listed as the limits of the range, but also to include all individual numerical values ​​or subranges within that range, as if each numerical value and subrange were explicitly listed. For example, the numerical range "1 to 5" should be interpreted to include not only the explicitly listed values ​​approximately 1 to approximately 5, but also the individual values ​​and subranges within the indicated range. Thus, this numerical range includes individual values ​​such as 2, 3, and 4, and subranges such as "1 to 3," "2 to 4," and "3 to 5." This same principle applies to ranges listing only one numerical value (e.g., "greater than 1"), regardless of the size of the range or the characteristics described.

[0387] For convenience, multiple items may be presented in a common list. However, these lists should be interpreted as if each element of Schilt were individually identified as a distinct and unique element. Therefore, no individual element of such lists should be interpreted as a de facto equivalent of any other element of the same list, solely on the basis of being presented in a common group, unless otherwise indicated. Furthermore, where the terms “and” and “or” are used with a list of items, these terms should be interpreted broadly, meaning that any one or more items on a list can be used alone or in combination with items on other lists. The term “alternatively” refers to a choice of one of two or more alternative forms and is not intended to limit the choice to only the alternative forms on a list or only one of the alternative forms on a list at a time, unless otherwise clearly indicated in the context.

[0388] No reference to prior art in this specification is considered, nor should it be interpreted, to be an indication in any form that such prior art constitutes, or is part of, common general knowledge in any country in the world in the field of focus.

[0389] The present invention can also be broadly said to exist individually or collectively in any two or more of the parts, elements, and features referred to or indicated in the specification of this application, in any combination of such parts, elements, or features.

[0390] Where the foregoing statements refer to a complete body or component having known equivalents, those complete bodies are incorporated herein as if they were individually indicated.

[0391] Those skilled in the art should note that various variations and modifications of the currently preferred embodiments described herein will become apparent. Such variations and modifications can be made without departing from the spirit and scope of the invention and without diminishing its associated advantages. For example, various components can be rearranged as needed. Thus, such variations and modifications are intended to fall within the scope of the invention. Furthermore, not all features, embodiments and advantages are necessarily required to carry out the invention. Thus, the scope of the invention is intended to be defined solely by the following claims. [Explanation of symbols]

[0392] 30 Humidifier Systems 40 Pressure Regulator 70 Resistor Devices 101 Patient Interface 105 Nasal prongs 106 Gas Inlet 107 Orbital inflection point 108 Gas Outlet 109 Sealing area 110 Humidifying Chamber 112 Exit 116 Entrance 118 Gas supply means or blower 119 patients 120 Heating means 136 Conduit 138 water column 201 Tube 204 Chamber 300 Source 305 Prong 308 Prong Exit 310 Rigidized structure part 360 First fixing member 1000 System 1101 Patient Interface 1105 Prong 1109 Prong sealing area 1131, 1133, 1134, 1135 Ellipse 1411 Prong Exit 1415 base 1420 Prong orbit 3000 Patient Interfaces 3200 Mask body 3220 Nasal prongs 3222 Groove 3223 Subsidence Area 3224 Gas outlet 3225 External surface 3226 Sealing surface 3227 Rolling area 3228 Base region around the prong 3232 Masks 3234 Facial contact surface 3235 Inner peripheral edge 3236 Mask Cavity 3237 Rolling area 3238 Front of the mask 3240 Manifold 3241 Front part 3242 Raised area 3243 rear part 3244 Housing joint 3246 Opening 3247 Raised area 3248 Annular ridged section 3249 Thickened area 3252 First end 3254 Second end 3256 Base part 3400 Housing 3420 Front extension 3422 Ridged part 3424 channels 3430 front part 3440 Central protrusion 3442 Enlarged Head 3444 and stem 3450 rear part 3460 Tube engagement portion 3470 Upper edge 3480 Interface main unit receiving section 3490 Lower edge 3600 First fixing member 3610 Central part 3620 Central opening 3630 Crosslinked part 3640 Notch 3660 Support Pad 3662 hinge points 3666 tabs 3680 faces 3691 Exposed area 3692 Inelastic region 3693 tabs 3694 Laminating film 3695 Continuous Loop Material 3696 Nylon Loop Material 3697 Laminating film 3698 Foam Materials 3800 Tube 3845 Slanted opening 3850 Grip 3860 connector 3900 Second fixing member 3910 Joining part 3930 Crosslinked part 3980 Support Pad 4000 Patient Interface Assemblies 4200 Mask body 4220 Nasal prongs 4240 Manifold 4241 Front part 4243 rear part 4244 Housing joint 4246 Opening 4247 Raised area 4248 Annular ridged section 4284 Slanted opening 4286 Key mechanism 4287 Protrusion 4288 Extension 4384 Inclined opening of the housing 4400 Housing 4420 Side protrusion 4422 Head 4424 Stem 4426 Opening 4428 recess 4430 Front part 4440 Central protrusion 4442 Housing opening 4443 channels 4446 Lip 4460 Tube engagement portion 4480 Interface main unit receiving part 4482 Corner 4600 First fixing member 4610 Central part 4628 Shoulder area 4630 Crosslinked part 4632 Thickened area 4640 opening 4642 Arm 4644 First end 4645 rear side 4646 Second end 4647 Front 4660 Support Pad 4800 Tube 4820 connector 4822 Second end lock finger 4840 Engagement part 4841 Front part of the housing 4843 Rear part of the housing 4845 Slanted opening 4849 Slope 4851 The inner surface of the manifold wall 4853 Exterior surface of the manifold wall 4889 Engagement surface of the interface body 4900 Second fixing member 4910 Mounting part 4914 tabs 4915 Connection part 4916 Notch 4918 Extended top section 4920 Central part 4950 parts 4951 Hook part 4972 Notched contour 4980 Support Pad 4982 Hinged or pivoted connection 4984 Mounting Rod 4985 Protrusion 4986 Wide base 4987 Finger 4988 Catch 4989 tabs 5240 Manifold 5400 Housing 5420 Manifold 5604 Colored Ring 5606 Color Indicator 5608 Colored bar 6440 Central protrusion

Claims

1. The first interface unit and The second interface unit, A housing configured to be detachably coupled to the first interface body or the second interface body, A pair of interface tubes, wherein the first interface tube is equipped with an inspiratory conduit and the second interface tube is equipped with an expiratory conduit, A patient interface assembly comprising, The first interface body and the second interface body are interchangeable such that in the first configuration the first interface body is coupled to the housing, and in the second configuration the second interface body is coupled to the housing. A patient interface assembly comprising a first interface body and a second interface body, each comprising a manifold, wherein the material of the manifold is softer than the material of the housing, the manifold is configured to bend when inserted into the interface body receiving portion of the housing, the manifold comprising a housing coupling portion configured to be received within the housing when the first interface body or the second interface body is detachably coupled to the housing, the manifold comprising a first opening and a second opening, each having annular ridged portions that contact the inner surface of the housing and form an airtight seal with the housing, the positioning of the first and second openings defining lateral inlet points for gas flow into and from each of the first and second interface bodies.

2. The patient interface assembly according to claim 1, wherein the first and second openings are in fluid communication with each other via the manifold.

3. The patient interface assembly according to claim 1 or 2, wherein the housing is provided with a pair of tube engagement portions at lateral inlet points on both sides of the housing, and each tube engagement portion is configured to receive one of the pair of interface tubes.

4. The patient interface assembly according to any one of claims 1 to 3, wherein the first and second openings are located on both sides of the manifold.

5. The patient interface assembly according to any one of claims 1 to 4, wherein the first interface body is a cannula body.

6. The patient interface assembly according to any one of claims 1 to 5, wherein the second interface body is a mask body.

7. The patient interface assembly according to any one of claims 1 to 6, wherein each of the first interface body and the second interface body is configured to form a seal with the user's face.

8. The patient interface assembly according to any one of claims 1 to 7, wherein the upper edge of the housing is symmetrical with respect to the lower edge of the housing.

9. The patient interface assembly according to any one of claims 1 to 8, wherein the manifold further comprises a raised portion adjacent to the housing coupling portion, the raised portion being configured to prevent the rotation of the manifold around the housing when the first interface body or the second interface body is detachably coupled to the housing.

10. The patient interface assembly according to any one of claims 1 to 9, wherein the housing coupling portion and the manifold are shaped and / or sized to be inserted into the housing, received by the housing, and to form an airtight seal with the housing.

11. The patient interface assembly according to any one of claims 1 to 10, wherein the housing coupling portion has a trapezoidal shape.

12. The patient interface assembly according to any one of claims 1 to 11, further comprising a fixing member configured to be attached to the housing.

13. The patient interface assembly according to claim 12, wherein the fixing member comprises two lateral arms.

14. The patient interface assembly according to any one of claims 1 to 13, wherein the manifold is provided with a visual indicator for indicating correct positioning and proper alignment with respect to the housing when the first interface body or the second interface body is detachably coupled to the housing.

15. The patient interface assembly according to claim 14, wherein the visual indicator comprises a colored ring positioned on or around the ridged portion of the manifold.

16. The patient interface assembly according to any one of claims 1 to 15, wherein the housing coupling portion is configured such that its entire width is received within the housing.

17. The first interface unit and The second interface unit, A housing configured to be detachably coupled to the first interface body or the second interface body, wherein the housing has a pair of tube engagement portions at the lateral inlet point of the housing, and each of the tube engagement portions is configured to receive an interface tube, In a patient interface assembly equipped with, The first interface body and the second interface body are interchangeable such that in the first configuration the first interface body is coupled to the housing, and in the second configuration the second interface body is coupled to the housing. Each of the first interface body and the second interface body is equipped with a manifold, the material of the manifold is softer than the material of the housing, the manifold is configured to bend when inserted into the interface body receiving portion of the housing, the manifold is equipped with a housing coupling portion configured to be received within the housing when the first interface body or the second interface body is detachably coupled to the housing, and the manifold is equipped with a first opening and a second opening, each having annular ridged portions that contact the inner surface of the housing and form an airtight seal with the housing. Patient interface assembly.

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