Patient Interface

Abstract

A patient interface is disclosed that may have a first body that rests on a first portion of a patient's face, a second body that rests on a second portion of the patient's face, and a bridge that links the first and second bodies. The patient interface may have an attachment structure that couples with a complementary fixing structure positioned on the patient's face to secure the patient interface to the face. The fixing structure may include an adhesive for affixing the fixing structure, and thus the attached patient interface, to the face. The fixing structure may have an edge that is shaped to reduce the tendency of the fixing structure to move away from the face when the patient interface is removed from the face.

Description

Technical Field

[0001] The present disclosure relates generally to respiratory therapy. More specifically, the present disclosure relates to a patient interface for providing respiratory therapy. Background Art

[0002] Patients with respiratory diseases, such as chronic obstructive pulmonary disease (COPD) may have difficulty in breathing effectively. This difficulty may be the result of a variety of reasons, including lung tissue weakness, small airway dysfunction, excessive accumulation of sputum, infection, hereditary disorders, or heart failure. In the case of respiratory diseases, it is useful to provide patients with a therapy that can improve patient ventilation. A respiratory therapy system can be used to provide high flow therapy to patients, and the respiratory therapy system includes a gas source, a patient interface that can be used to transfer gas to the patient's airway, and a conduit extending between the gas source and the patient interface. The patient interface is typically not sealed. Gas can be heated and humidified before being delivered to the patient.

[0003] Obstructive sleep apnea (OSA) is a sleep disorder in which the muscles that normally keep the airway open collapse, thereby temporarily sealing the airway. The sleep pattern of OSA patients is characterized by a sequence of repeated snoring, dyspnea, hypopnea, waking up and then returning to sleep. Respiratory therapy with continuous positive airway pressure (CPAP) can be used to fix the airway and reduce or eliminate the occurrence of OSA. A respiratory therapy system can be used to provide CPAP therapy to a patient, and the respiratory therapy system includes a gas source, a patient interface that can be used to transfer gas to the patient's airway, and a conduit extending between the gas source and the patient interface. The patient interface is typically sealed. The gas can be heated and humidified before being delivered to the patient. Summary of the invention

[0004] The patient interface for respiratory therapy system can include nasal cannula, nasal mask, mouth mask, oronasal mask, full face mask, nasal pillow mask, or endotracheal tube. When the patient interface is worn on the patient, the gas is guided through the nasal delivery element (e.g., the tubular tip of the nasal cannula, which rests in the patient's nostrils) of the patient interface to reach the patient's airway. In some cases, it is useful to attach the patient interface to the patient's face. One option is to position a viscous pad on the patient's face, and the viscous pad has a mechanical fastener on the side of the viscous pad that faces away from the patient's face. The mechanical fastener is connected to the complementary fastener attached to the patient interface. However, according to multiple factors including the shape of the viscous pad, the separation of the mechanical fastener and the complementary fastener may cause the viscous pad to be undesirably detached from the patient's face. In seeking a solution to the above difficulties, or a system or device that provides a useful alternative.

[0005] According to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure is adapted to cooperate with a patient interface so as to fix the patient interface on the face of a patient. The fixing structure includes a first edge, which is adapted to face toward the patient's nose or mouth when in use. The fixing structure includes a second edge, which is adapted to face away from the patient's nose or mouth when in use. The first edge is substantially flat or straight. The width of the first edge and the second edge are substantially the same.

[0006] The first edge and the second edge may be of the same shape and size. The fixed structure may include a substantially flat or straight third edge extending between the first edge and the second edge. The fixed structure may include a substantially flat or straight third edge and a fourth edge extending between the first edge and the second edge. The second edge may be substantially rounded. The fixed structure may include a perimeter having a substantially triangular shape. The fixed structure may include a perimeter having a substantially curved shape.

[0007] The fixing structure may include a first fastener adapted to interface with a complementary second fastener of the attachment structure of the patient interface. The first fastener may be fixed or affixed to a first surface of the fixing structure facing away from the patient's face when in use. The first fastener may substantially cover the entire first surface of the fixing structure.

[0008] The fixing structure may include an opposite third edge and a fourth edge extending between the first edge and the second edge. The first fastener may extend between the first edge and the second edge substantially along the entire first surface of the fixing structure and only partially extend between the opposite third edge and the fourth edge.

[0009] The first fastener may extend from the first edge to a position between the first edge and the second edge along the length of the fixed structure. The fixed structure may include an opposing third edge and a fourth edge extending between the first edge and the second edge. The first fastener may extend from the first edge to a position between the first edge and the second edge along the length of the fixed structure. The first fastener may extend from the third edge to a position between the third edge and the fourth edge along the width of the fixed structure.

[0010] The first fastener may include a hook fastener adapted to interface with a complementary loop fastener of the attachment structure of the patient interface. The hook fastener may include a plurality of hooks extending outwardly from the side of the fixed structure facing away from the patient's face. The hooks may extend toward a first edge and / or a second edge of the fixed structure.

[0011] The hooks may be generally parallel to the first and second edges and generally perpendicular to the third and fourth edges when the third edge is substantially flat.

[0012] The securing structure may have a substantially uniform thickness.

[0013] The fixing structure may be composed of a hydrocolloid-based adhesive. The fixing structure may be composed of a silicone-based adhesive.

[0014] The fixing structure may be adapted to facilitate attachment of the fixing structure to the patient's face. For example, the patient-facing region of the fixing structure may be comprised of a material that, in use, substantially maintains a constant level of adhesion to the skin after being applied to the skin for at least a predetermined period of time.

[0015] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure is adapted to cooperate with a patient interface so as to fix the patient interface on the patient's face. The fixing structure includes a body having a patient-facing area adapted to be affixed to the patient's face. The fixing structure includes a first fastener affixed to the body. The first fastener is adapted to interface with a complementary second fastener of an attachment structure of the patient interface. The body is composed of a hydrocolloid-based adhesive or a silicone-based adhesive.

[0016] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure is adapted to cooperate with a patient interface so as to fix the patient interface on the patient's face. The fixing structure includes a first edge, which is adapted to face the patient's nose or mouth when in use. The fixing structure includes a second edge, which is adapted to face away from the patient's nose or mouth when in use. The fixing structure includes a hook fastener, which is adapted to be connected to the complementary loop fastener interface of the attachment structure of the patient interface. The hook fastener extends at least partially between the first edge and the second edge. The hook fastener includes a plurality of hooks extending toward the first edge and / or the second edge of the fixing structure.

[0017] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure is adapted to cooperate with a patient interface so as to fix the patient interface on the face of a patient. The fixing structure includes a first edge, which is adapted to face toward the patient's nose or mouth when in use. The fixing structure includes a second edge, which is adapted to face away from the patient's nose or mouth when in use. The fixing structure includes a third edge extending between the first edge and the second edge. The third edge includes a concave curve.

[0018] The fixing structure may include a fourth edge extending between the first edge and the second edge. The fourth edge may include a concave curve shaped to match the shape of the area under the eye of the patient. The third edge and the fourth edge may be opposite.

[0019] The fixed structure may include a first fastener adapted to interface with a complementary second fastener of the attachment structure of the patient interface. The first fastener may be fixed to the side of the fixed structure facing away from the patient. The midpoint of the first fastener may deviate from a first centerline or middle central portion between a first edge and a second edge of the fixed structure. The first fastener may be positioned so that it is closer to the first edge than to the second edge. The midpoint of the first fastener may be located on a second centerline or middle central portion between a third edge and a fourth edge of the fixed structure.

[0020] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure is adapted to cooperate with a patient interface so as to fix the patient interface on the face of the patient. The fixing structure includes a first edge, which is adapted to face the patient's nose or mouth when in use. The fixing structure includes a second edge, which is adapted to face away from the patient's nose or mouth when in use. The fixing structure includes a third edge extending between the first edge and the second edge. The third edge extends further from the centerline or center portion of the fixing structure at a portion of the third edge close to the first edge and the second edge than at a portion of the third edge far from the first edge and the second edge.

[0021] The portion of the third edge that is proximate to the second edge may extend further from a centerline or central portion of the fixed structure than the portion of the third edge that is proximate to the first edge.

[0022] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure is adapted to cooperate with a patient interface so as to fix the patient interface on the face of a patient. The fixing structure includes a body adapted to be attached to the face of a patient. The body is at least partially composed of a material with low water absorption.

[0023] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure is adapted to cooperate with a patient interface so as to fix the patient interface on the face of a patient. The fixing structure includes a body adapted to be attached to the face of a patient. The body is at least partially composed of a material having a low Young's modulus.

[0024] The body may have a thickness that allows the body to flex in response to movement of the patient's face. The body may have a thickness between 0.05 and 5.0 mm. The thickness of the first fastener may be less than the thickness of the body. The thickness of the first fastener may be at least one quarter of the thickness of the body.

[0025] The body may include a silicone-based adhesive that conforms to the shape of the patient's skin when in use.The body may include a hydrocolloid-based adhesive.

[0026] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure cooperates with a patient interface to fix the patient interface to the patient's face. The fixing structure includes a body that is affixed to the patient's face when in use. The body includes a first fastener that is coupled to a complementary second fastener of the attachment structure of the patient interface. The body includes an adhesive that is affixed to the skin of the patient's face when in use. When the adhesive is applied to the skin, the adhesive substantially immediately reaches maximum adhesion to the skin.

[0027] When the adhesive is applied to the skin, the adhesive may flow into the voids of the skin substantially immediately. The adhesive may be a silicone-based adhesive. The adhesive may require less force to remove than a hydrocolloid-based adhesive applied to the skin of the patient's face.

[0028] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure is disclosed. The fixing structure cooperates with a patient interface to fix the patient interface to the face of the patient. The fixing structure includes a first edge that faces toward the patient's nose or mouth when in use. The fixing structure includes a second edge that faces away from the patient's nose or mouth when in use. The fixing structure includes a plurality of slots that facilitate the flexibility of the fixing structure.

[0029] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a patient interface system is disclosed. The patient interface system includes a patient interface, the patient interface including an attachment structure fixed to a patient-facing portion of the patient interface. The attachment structure is coupled to a fixing structure fixed to the face when in use so as to secure the patient interface to the face. The fixing structure may be the same or similar to any fixing structure described above or elsewhere in the description with reference to the accompanying drawings.

[0030] The patient interface may include a first body adapted to rest on a first portion of the patient's face, a second body configured to rest on a second portion of the patient's face, and a bridge linking the first body and the second body.

[0031] The attachment structure may be fixed to a patient-facing region of the first body and / or the second body.

[0032] The patient interface may include a nasal cannula, a nasal mask, a mouth mask, an oronasal mask, a full-face mask, an unsealed oronasal interface, a nasal pillow mask, an endotracheal tube, or other such respiratory interface.

[0033] Additionally, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a securing structure for securing a patient interface to a patient's face includes: a first edge; a second edge opposite the first edge, such that when used on the patient's face, the second edge is further from the patient's nose or mouth than the first edge; and opposite third and fourth edges extending between the first and second edges. The portion of the third edge closer to the first and second edges extends further from a centerline or center portion of the securing structure than the portion of the third edge farther from the first and second edges.

[0034] The portion of the third edge that is closer to the second edge may extend further from a centerline or center portion of the fixation structure than the portion of the third edge that is closer to the first edge. The third edge may include a concave curve. The fourth edge may include a concave curve shaped to match the shape of the under-eye area of ​​the patient.

[0035] The fixing structure may include a first side extending between the first edge and the second edge. The first side may face away from the patient's face and face the patient interface when in use. The first side may include a first fastener that may be attached to a complementary fastener of the attachment structure of the patient interface. The first fastener may be positioned closer to the first edge than to the second edge. The midpoint of the first fastener may be offset from a centerline or a middle central portion between the first edge and the second edge. The midpoint of the first fastener may be located on a centerline or a middle central portion between the third edge and the fourth edge.

[0036] At least a portion of the first side not covered by the first fastener may include a gripping or support area. The first fastener may extend from the first edge to a position between the first edge and the second edge along the length of the first side. The length of the first fastener between the first edge and the second edge may be less than the length of the first side between the first edge and the second edge. The ratio of the length of the first fastener to the length of the first side may be between 0.2 and 0.9.

[0037] The first fastener may extend substantially all between the first and second edges and only partially between the third and fourth edges, and the first fastener may extend from the third edge to a position between the third and fourth edges along the width of the first side. The first fastener may extend from the first edge to a position between the first and second edges along the length of the first side, and the first fastener may extend from the third edge to a position between the third and fourth edges along the width of the first side.

[0038] The first fastener may include a hook fastener that is removably attachable to a complementary loop fastener of the attachment structure of the patient interface. The hook fastener may include a plurality of hooks extending outwardly from the first side. At least some of the plurality of hooks may extend toward the first edge and / or the second edge. At least some of the plurality of hooks may be generally parallel to the first edge and the second edge, and generally perpendicular to the third edge and the fourth edge.

[0039] The first fastener may include a plurality of slots that facilitate flexibility of the first fastener. At least some of the plurality of slots may extend to at least one of the first edge, the second edge, the third edge, or the fourth edge. At least some of the plurality of slots may be arranged in rows of slots that extend alternately to the third edge and the fourth edge. Each of the rows of slots may include a plurality of slots having a semicircular or crescent shape that faces in a direction opposite to the semicircular or crescent shape of the slots in an adjacent row and at least partially deviates from the third edge or the fourth edge.

[0040] At least some of the plurality of slots may extend toward the third edge and the fourth edge. At least some of the plurality of slots closer to the first edge and the second edge may be shorter than at least some of the plurality of slots farther from the first edge and the second edge. At least some of the plurality of slots may not extend across a centerline or a central portion in the middle between the third edge and the fourth edge.

[0041] At least one of the plurality of slots may have a serpentine shape.Two of the plurality of slots may have a serpentine shape, one of the serpentine slots may extend toward the first edge, and the other of the serpentine slots may extend toward the second edge.

[0042] At least some of the plurality of slots may have a zigzag shape.

[0043] The fixing structure may include a second side extending between the first edge and the second edge. The second side may face the patient's face and away from the patient interface when in use. The second side may include a second fastener that can be attached to the patient's face. The second fastener may include an adhesive that can be removably attached to the patient's face. The adhesive may be a hydrocolloid-based adhesive. The adhesive may be a silicone-based adhesive. The adhesive may include a material that, when in use, substantially maintains a constant level of adhesion to the patient's face for at least a predetermined period of time after being applied to the face. The adhesive may include a material that substantially conforms to the shape of the patient's face when in use.

[0044] The fixing structure may include a material with low water absorption. The fixing structure may include a material with a low Young's modulus. The fixing structure may have a substantially uniform thickness. The fixing structure may have a thickness that allows the fixing structure to flex in response to movement of the patient's face. The fixing structure may have a thickness between 0.05 mm and 5 mm.

[0045] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a fixing structure for fixing a patient interface to a patient's face includes: a first edge; a second edge opposite the first edge, so that when used on the patient's face, the second edge is farther from the patient's nose or mouth than the first edge; a first side extending between the first edge and the second edge, the first side facing away from the patient's face and toward the patient interface; and a second side opposite the first side. The first side includes a first fastener that can be attached to a complementary fastener of an attachment structure of the patient interface. The second side includes a second fastener that can be attached to the patient's face. The first edge is substantially straight. The widths of the first edge and the second edge are substantially the same.

[0046] The shape and size of the first edge and the second edge may be substantially the same. The second edge may be substantially rounded. The fixed structure may include a perimeter having a substantially triangular shape. The fixed structure may include a substantially curved perimeter. The fixed structure may include a substantially straight third edge extending between the first edge and the second edge. The fixed structure may include an opposite substantially straight third edge and a fourth edge extending between the first edge and the second edge.

[0047] In addition, according to certain features, aspects, and advantages of one or more embodiments disclosed herein, a patient interface system includes a fixing structure according to any of the previously disclosed embodiments; and a patient interface, the patient interface including one or more attachment structures facing the patient's face when in use. Each of the one or more attachment structures includes a fastener that can be attached to a complementary fastener of the fixing structure.

[0048] The patient interface may include a first body adapted to rest on a first portion of the face. The patient interface may include a second body adapted to rest on a second portion of the face. The patient interface may include a bridging portion linking the first body and the second body. One or both of the first body and the second body may each include one of these attachment structures. One or both of the first body and the second body may each include a first edge and a second edge opposite to the first edge. When used on the patient's face, the second edge may be farther from the patient's nose or mouth than the first edge. The second edge may include a split structure so that the patient interface is easily removed from the patient's face. The patient interface may include a nasal cannula, a nasal mask, a mouth mask, an oronasal mask, a full face mask, an unsealed oronasal mask, a nasal pillow mask, or an endotracheal tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Specific embodiments and modifications thereto will become apparent to those skilled in the art from the detailed description herein with reference to the following drawings.

[0050] Figure 1 A respiratory therapy system is shown.

[0051] Figure 2 A front view of the patient interface is shown.

[0052] Figure 3 Shows Figure 2 Rear view of the patient interface shown in .

[0053] Figure 4 Shows Figure 2 A side perspective view of the patient interface shown in FIG.

[0054] Figure 5A A top view of the patient-facing area of ​​the fixation structure is shown.

[0055] Figure 5B A top view of the region of the fixing structure facing the interface is shown.

[0056] Figure 5C A top view of the region of the fixing structure facing the interface is shown.

[0057] Fig. 6A The fixation structure is shown worn on a patient.

[0058] Figure 6B The fixation structure is shown worn on a patient.

[0059] Fig. 7A A top view of the region of the fixing structure facing the interface is shown.

[0060] Figure 7B A top view of the region of the fixing structure facing the interface is shown.

[0061] Figure 7C A top view of the region of the fixing structure facing the interface is shown.

[0062] Fig.7D A top view of the region of the fixing structure facing the interface is shown.

[0063] Fig. 7E A top view of the region of the fixing structure facing the interface is shown.

[0064] Figure 7F A top view of the region of the fixing structure facing the interface is shown.

[0065] Figure 7G A top view of the region of the fixing structure facing the interface is shown.

[0066] Fig. 8A A top view of the region of the fixing structure facing the interface is shown.

[0067] Figure 8B A section along line AA is shown of a region of the fixing structure facing the interface.

[0068] Fig. 9A A top view of the region of the fixing structure facing the interface is shown.

[0069] Fig. 9B A section along line BB is shown of a region of the fixing structure facing the interface.

[0070] Fig. 10A A diagram of the fixation structure on the skin layer is shown.

[0071] Fig. 10B A diagram of the fixation structure on the skin layer is shown.

[0072] Figures 11A-12H A top view of the region of the fixing structure facing the interface is shown.

[0073] Fig.13A A top view of the region of the fixing structure facing the interface is shown.

[0074] Fig. 13B Shows Fig.13A A cross section of the fixing structure along line CC.

[0075] Fig.14 A top view of a region of another fixing structure facing the interface is shown.

[0076] Fig.15 A top view of a region of another fixing structure facing the interface is shown. DETAILED DESCRIPTION

[0077] Figure 1An exemplary respiratory therapy system 100 is shown. A patient 1 is receiving heated and humidified gas through a patient interface 200, which is connected to a humidified gas transport path or inspiratory conduit 3, which in turn is connected to a humidifier 8 (including a humidification chamber 5), which is supplied with gas from a blower 15 or other suitable gas supply. The gas can be supplied from a source external to and / or separate from the respiratory therapy system 100, or from a source internal to and / or integral with the respiratory therapy system 100. A headgear 20 is provided to support and hold the patient interface 200 on the patient's face. The inspiratory conduit 3 is connected to an outlet 4 of a humidification chamber 5 containing a volume of water 6. The humidification chamber 5 is preferably formed of a plastic material and can have a highly thermally conductive base (e.g., an aluminum base) that is in direct contact with a heater plate 7 of the humidifier 8. The heater 8 is provided with a control mechanism or electronic controller 9 which may comprise a microprocessor based controller executing computer software commands stored in an associated memory. Gas flowing through the inspiratory conduit 3 is delivered to the patient's airway through the patient interface 200 .

[0078] The controller 9 receives input from, for example, an input device (e.g., a dial 10) by which a user (e.g., a nurse or other care provider) can, for example, set a predetermined desired value (preset value) of the humidity or temperature of the gas supplied to the patient. In response to the user inputting the set humidity or temperature value through the dial 10 and other possible inputs (e.g., an internal sensor sensing the gas flow or temperature), or parameters calculated by the controller 9, the controller 9 determines when (or to what extent) to energize the heater plate 7 to heat the metered quantity of water 6 in the humidification chamber 5. When the metered quantity of water 6 in the humidification chamber 5 is heated, water vapor begins to fill the volume above the water surface of the chamber and flows out of the outlet 4 of the humidification chamber 5 along with the gas (e.g., air) provided by the gas supply device or blower 15 and flowing through the inlet 16 into the humidification chamber 5. It should be noted that it is possible to obtain a relationship between the humidity of the gas in the humidification chamber 5 and the temperature of the heater plate 7. Therefore, the temperature of the heater plate 7 can be used in an algorithm or a lookup table to determine the humidity of the gas.

[0079] The blower 15 may be equipped with a variable speed pump or fan 2 that draws air or other gas through a blower inlet 17. The speed of the variable speed pump or fan 2 may be controlled by a further control device or electronic controller 18 (or alternatively, the functions of the controller 18 may be performed by the controller 9) in response to input from the controller 9 and predetermined desired values ​​(preset values) of pressure and / or fan speed set by the user via one or more input devices (e.g., dials 19) .

[0080] A heating element 11 may be provided within the conduit 3 to help prevent condensation of the humidified gas within the conduit 3. Such condensation is due to the temperature of the walls of the conduit 3 being close to the ambient temperature (being the temperature of the surrounding atmosphere), which is generally lower than the temperature of the humidified gas within the conduit 3. The heating element 11 effectively makes up for the energy lost by the gas during transmission through the conduit 3 due to conduction and convection. Thus, the heating element 11 ensures that the delivered gas is at an optimal temperature and humidity.

[0081] In the illustrated configuration, the patient interface 200 includes a nasal cannula. In some alternative configurations, the patient interface 200 may include a sealed or non-sealed interface. For example, the patient interface 200 may include a nasal mask, a mouth mask, an oronasal mask, a full face mask, a nasal cannula, an unsealed oronasal interface, a nasal pillow mask, an endotracheal tube, a combination of the above, or some other gas delivery system or device. In other such patient interfaces, certain features, aspects, and advantages of the illustrated nasal cannula are contemplated.

[0082] See also Figures 2 to 4 , a patient interface 200 is shown. The patient interface 200 can generally be shaped or configured so that it substantially matches the contour of the face. The patient interface 200 includes a first nasal delivery element 202A and a second nasal delivery element 202B that fit the patient's nostrils. The displayed nasal delivery elements 202A, 202B are substantially tubular and guide the gas passing through the patient interface 200 to the patient. The nasal delivery elements 202A, 202B can be shaped and angled so that they generally extend inwardly toward the patient's nasal septum when in use. The nasal delivery elements 202A, 202B terminate at tips 202A', 202B'. When in use, the tips 202A', 202B' point to the back of the patient's head. It should be understood that in some configurations, the nasal delivery elements 202A, 202B can have different shapes. For example, although in the illustrated configuration, the general cross-section of the nasal delivery elements 202A, 202B is substantially circular, in some configurations, the cross-section of the nasal delivery elements 202A, 202B can be substantially elliptical, substantially square, or substantially rectangular. In some configurations, the cross-section of the nasal delivery elements 202A, 202B can vary along the length of the nasal delivery elements 202A, 202B. In some configurations, the first nasal delivery element 202A and the second nasal delivery element 202B can have different features. For example, the first nasal delivery element 202A can be smaller than or shorter than the second nasal delivery element 202B. In some configurations, only one nasal delivery element can be used. In some configurations, more than two (e.g., three or four) nasal delivery elements can be used.

[0083] The first and second nasal delivery elements 202A, 202B may extend from the first and second bodies 206A, 206B of the patient interface 200. The first and second bodies 206A, 206B include gas delivery lumens 210A, 210B that receive gas from gas inlets 208A, 208B of the first and second bodies 206A, 206B and direct the gas to the first and second nasal delivery elements 202A, 202B. The gas inlets 208A, 208B are coupled to a pair of gas delivery conduits 218A, 218B (see FIG. Figure 1 ). In the illustrated configuration, the gas delivery conduits 218A, 218B are integrally formed with or inseparably connected to the gas inlets 208A, 208B. Furthermore, the gas delivery conduits 218A, 218B are integrally formed with or inseparably connected to the gas conduit connector 222. The gas conduit connector 222 is releasably coupled to the complementary connector 118, which is coupled to the gas conduit 110 (see FIG. Figure 1 , described elsewhere in this disclosure as being in ventilatory communication with the inspiratory conduit 3). Other configurations are contemplated. For example, in some configurations, the first nasal delivery element 202A and the second nasal delivery element 202B can receive gas from a single gas delivery lumen positioned in one of the first body 206A or the second body 206B. In turn, the single gas delivery lumen can receive gas from a single gas delivery conduit.

[0084] In some configurations, the one or more gas inlets 208A, 208B can be directly coupled to the gas conduit 110 (or indirectly coupled via the complementary connector 118 and / or the gas conduit connector 222). In some such configurations, the first body 206A and / or the second body 206B can be integrally formed with the gas conduit 110, or can be in the form of a single continuous component therewith. In some configurations, one or more of the gas delivery conduits 218A, 218B can be removably coupled to one or more of the gas inlets 208A, 208B. In some configurations, one or more of the gas delivery conduits 218A, 218B can be removably coupled to the gas conduit connector 222.

[0085] The first body 206A and the second body 206B of the patient interface 200 are adapted to rest on the face of the patient. In the configuration shown, the first body 206A and the second body 206B are adapted to rest on the cheeks of the patient's face. In order to fix the first body 206A and the second body 206B in place on the patient's face, the patient-facing areas of the first body 206A and the second body 206B are equipped with attachment structures 216A, 216B. In a non-limiting example, the attachment structures 216A, 216B are adapted to maintain the patient interface 200 in desired alignment with the face so that the nasal delivery elements 202A, 202B can be comfortably and non-sealedly positioned in the nostrils.

[0086] Attachment structures 216A, 216B are connected or attached to the fixed structure pasted on the face when in use. In some configurations, attachment structures 216A, 216B and fixed structures can be configured so that they complement each other. For example, attachment structures 216A, 216B may include 'loop' portions (e.g., made of fabric or plastic), which are pasted or otherwise fastened to the first body 206A and the second body 206B on the patient-facing area, and these fixed structures can be pasted or otherwise fixed to the face and can include 'hook' pads. Attachment structures 216A, 216B and fixed structures are connected or attached to each other via, for example, 'hook and loop' style connections. Other configurations are contemplated. In some configurations, attachment structures 216A, 216B can be directly connected to the face by using adhesive pads or other structures. In some configurations, a single attachment structure can be used, or more than two (e.g., three or four) attachment structures can be used.

[0087] In some configurations, the attachment structures 216A, 216B may include features other than the 'loop' portion. For example, the attachment structures 216A, 216B may include a 'hook' portion that is coupled to or attached to a complementary 'loop' portion on the fixed structure. As another example, the attachment structures 216A, 216B may include snap-fit ​​features or other mechanical interlocking features that are coupled to or attached to features on the fixed structure. In some configurations, the patient interface 200 may also include a headgear that is adapted to be used to retain the patient interface 200 on the face in a desired orientation or alignment state. The headgear may include, for example, one or more straps configured to extend around the patient's head, buckles for adjusting the tightness of the straps by modifying the effective length of the straps, hoods, headscarves, hats, helmets, and / or one or more other features.

[0088] The bridge 204 connects the first body 206A and the second body 206B. The bridge 204 is an extension of the first body 206A and / or the second body 206B. In some embodiments, the bridge 204 does not include a gas lumen. The bridge 204 is used to help keep the nasal delivery elements 202A and 202B in a desired orientation relative to each other. Other configurations are contemplated. For example, in some configurations, the bridge 204 can be made of a material different from the first body 206A and the second body 206B. Alternatively, the bridge 204 can be made of the same material as the first body 206A and the second body 206B. In some configurations, the bridge 204 can be opened, for example, via a gas lumen that fluidly connects the nasal delivery elements 202A and 202B to provide gas transport between the first body 206A and the second body 206B. In some such configurations, only one of the bodies 206A, 206B includes a gas lumen and / or a gas inlet. In some configurations, the bridge 204 extends between a first connection point on the first body 206A and a second connection point on the second body 206B.

[0089] See Figure 3 , the width of the first body 206A and the second body 206B gradually decreases as they extend toward the nasal delivery elements 202A, 202B and the bridge 204. The attachment structures 216A, 216B are positioned on relatively wide portions of the first body 206A and the second body 206B, at or near the outer edges of the first body 206A and the second body 206B, so as to improve the stability of the patient interface 200 on the face when the attachment structures 216A, 216B are used with the fixing structure. For example, the attachment structures 216A, 216B can be positioned at or near the distal portions of the first body 206A and the second body 206B relative to the nasal delivery elements 202A, 202B. The attachment structures 216A, 216B can substantially cover the patient-facing areas of the first body 206A and the second body 206B. The attachment structures 216A, 216B can at least partially cover the patient-facing areas of the first body 206A and the second body 206B. The attachment structures 216A, 216B may be positioned within at least partially recessed areas of the first and second bodies 206A, 206B.

[0090] Further references Figure 2 and 4, the outer edges of the first body 206A and the second body 206B may include split structures 212A, 212B. Split structures 212A, 212B are positioned on the non-patient-facing areas of the bodies 206A, 206B. Split structures 212A, 212B are spaced apart from gas inlets 208A, 208B. In the configuration shown, split structures 212A, 212B are tabs that include inner regions whose thickness is reduced relative to adjacent portions of the bodies 206A, 206B. Outside the inner regions of these tabs and toward the outer edges of the bodies 206A, 206B, these tabs also include outer regions of normal thickness or thickness increased relative to the same adjacent portions of the bodies 206A, 206B. These outer regions can be grasped and pulled by a patient or another person (e.g., a health care professional, such as but not limited to a nurse or physician). When pulled, these outer areas can rotate around these inner areas, and sufficient force can be applied to the patient interface 200 to separate the attachment structures 216A, 216B from the fixed structures present on the face. Therefore, the split structures 212A, 212B can be used to more easily separate the patient interface 200 from the face. Other configurations are contemplated. For example, in some configurations, one of the split structures 212A, 212B can be positioned on one of the first body 206A or the second body 206B of the patient interface 200. In some configurations, the patient interface 200 may include more than two (e.g., three or four) split structures. In some configurations, the split structures 212A, 212B can be positioned on other parts of the body 206A, 206B, or on other parts of the patient interface 200. In some configurations, the split structures 212A, 212B may include structures other than tabs. For example, the split structures 212A, 212B may include flat extensions of the first body 206A and / or the second body 206B that may be pulled or otherwise manipulated to separate the patient interface 200 from the face.

[0091] Figure 5A A patient-facing region 301 of the fixation structure 300 is shown, and Figure 5B An interface-facing region 301' of the fixing structure 300 is shown. The patient-facing region 301 is removably coupled to or adhered to the patient's face. The interface-facing region 301' of the fixing structure 300 is attached to the patient interface 200 to removably couple the patient interface 200 to the patient's face. The fixing structure 300 is removably coupled to the attachment structures 216A, 216B, as described elsewhere in this disclosure. Figures 2 to 4 as described.

[0092] In the configuration shown, the fixed structure 300 includes a body 302. The body 302 has a uniform thickness substantially. In other configurations, the body 302 has a variable thickness along the length L and / or width W of the body 302. The body 302 includes a first edge 304, which is adapted to face the patient's nose or mouth when in use. In the configuration shown, the first edge 304 is substantially rounded and the width is gradually reduced to form an extension or button-shaped portion of the body 302. The body 302 also includes a second edge 306 (being the lateral edge relative to the patient's face), and is therefore adapted to turn away from the patient's nose or mouth when in use. In the configuration shown, the second edge 306 is substantially rounded and the width is slightly gradually reduced. The third edge 308A and the fourth edge 308B of the opposite curvature extend between the first edge 304 and the second edge 306 of the body 302.

[0093] The interface-facing region 301' of the fixing structure 300 includes a fixing element 310' facing the interface. The fixing element 310' facing the interface engages the attachment structures 216A, 216B to fix the patient interface 200 to the patient's face when in use. In the illustrated configuration, the fixing element 310' facing the interface is a hook pad that is removably coupled to a loop pad of one of the attachment structures 216A, 216B (e.g., a hook-and-loop style connection). The hook pad can be coupled to the fixing structure 300 in a variety of ways, including, but not limited to, using an adhesive, ultrasonic welding, high frequency welding, suturing, or chemical bonding. In other configurations, the interface-facing fixing element 310' may include other structures or elements adapted to be connected to or attached to the attachment structures 216A, 216B, including but not limited to: a lock that can be connected to a complementary latch of the attachment structures 216A, 216B; or a latch that can be connected to or attached to a complementary hook of the attachment structures 216A, 216B; a complementary adhesive; a pin; a clasp; or other mechanical fasteners.

[0094] The patient-facing area 301 is composed of a material that can be removably coupled to the patient's face. In the illustrated configuration, the material is an adhesive material, such as a hydrocolloid-based adhesive material, a zinc oxide-based adhesive material, or a hydrogel-based material.

[0095] Figure 5CShown is an exemplary embodiment of a fixed structure 300 and a fixed element 310' facing an interface. In the configuration shown, the fixed element 310' facing an interface is a hook pad with a serpentine shape. The serpentine shape defines a gap 312 between adjacent masses of the fixed element 310' facing an interface. The gap 312 improves the flexibility of the fixed element 310' facing an interface, especially when the fixed structure 300 is placed to twist around an axis substantially parallel to the first edge 304 and / or the second edge 306. The gap 312 can include an incision, a slot, a perforation, or a thin area formed in the fixed element 310' facing an interface. The fixed element 310' facing an interface can be configured to exhibit the increased flexibility under twisting around an axis substantially parallel to the first edge 304 and / or the second edge 306 by changing the material configuration. For example, in some configurations, the interface-facing fixation element 310' can be comprised of a mechanically anisotropic material that exhibits increased flexibility when twisted about an axis substantially parallel to the first edge 304 and / or the second edge 306. In some configurations, the interface-facing fixation element 310' can be comprised of a plurality of variable flexibility materials. The plurality of materials can be layered along the length of the interface-facing fixation element 310'.

[0096] Figures 11A-11D The use of different patterns of the interface-facing fixation element 310', such as slots, is shown. The interface-facing fixation element 310' has a substantially oval shape, but in other configurations, the interface-facing fixation element 310' can have other shapes, including but not limited to: rectangular, square, trapezoidal, triangular, or pentagonal. As shown in FIG. Figure 5C As described, the interface-facing fixing element 310' may include slots or other features that improve the flexibility of the interface-facing fixing element 310'. Different patterns of slots may be used to impart flexibility to the interface-facing fixing element 310'. In some embodiments, the slots extend to at least one edge of the interface-facing fixing element 310'. In some embodiments, the slots do not extend to the edge of the interface-facing fixing element 310'.

[0097] Fig.11A An embodiment is shown comprising an interface facing fixation element 310' having a pattern of successive slots extending in an arcuate shape towards the longitudinal edges of the interface facing fixation element 310'. The length of the slots increases towards the centre of the interface facing fixation element 310'.

[0098] Fig. 11BAn example of an interface facing fixing element 310' is shown, which includes a pattern having multiple pairs of slots in a first region of the interface facing fixing element 310' and an odd number of slots in a second region of the interface facing fixing element 310'. The slot pairs in the first region of the interface facing fixing element 310' extend substantially inwardly from the third edge 308A and the fourth edge 308B of the interface facing fixing element 310', and their lengths increase toward the center of the interface facing fixing element 310'. The odd number of slots in the second region of the interface facing fixing element 310' increases in length toward the center of the interface facing fixing element 310'.

[0099] Fig. 11C An example is shown comprising an interface facing fixation element 310' having a pattern of slots extending alternately from opposite lateral edges of the interface facing fixation element 310'. The length of the slots increases towards the center of the interface facing fixation element 310'.

[0100] Fig.11D An example is shown comprising an interface facing fixation element 310' having a pattern of consecutive straight slots, the lengths of which increase towards the center of the interface facing fixation element 310'.

[0101] Figures 12A-12H Various slot patterns are shown for use in embodiments of an interface-facing fixation element 310' having a substantially triangular shape, or a shape similar to a Reuleaux triangle with rounded edges, or Figure 7G 'guitar plectrum'-like shape shown in . However, it should be understood that such slot patterns can be similarly applied to fixing elements having other shapes. In some embodiments, the slots extend to at least one edge of the fixing element 310' facing the interface. In some embodiments, the slots do not extend to the edge of the fixing element 310' facing the interface.

[0102] Fig. 12AAn example of a fixing element 310' facing an interface is shown, which includes a pattern of a pair of slots extending from opposite ends of the fixing element 310' facing the interface. As shown, these slots can extend along a portion of the width W and length L of the fixing element 310' facing the interface. In some embodiments, each of the slots has a serpentine shape. These slots can have straight slots that define each turn or change of direction of the serpentine slot. As shown, one or each of these serpentine slots can include a plurality of substantially parallel transverse sections linked by longitudinal sections. These longitudinal sections can extend along the edge of the fixing element 310' facing the interface and can extend in a radially outward direction, and / or can extend toward the center of the fixing element 310' facing the interface. In some configurations, these longitudinal sections are substantially angularly deviated from the transverse direction (e.g., the longitudinal axis of the fixing element 310' facing the interface). As shown, some configurations have a single non-serpentine slot positioned between the pair of slots. The single slot may extend at least partially between the third edge 308A and the fourth edge 308B.

[0103] Fig. 12B An example of an interface-facing fixation element 310' is shown that includes a pattern of a single slot having a serpentine shape, with straight edges defining each turn or change in direction of the serpentine slot.

[0104] Fig. 12C An example of an interface-facing fixation element 310' is shown comprising a pattern of alternating columns of semicircular slots. Each column comprises a plurality of semicircular slots whose shape faces in the opposite direction of the column on the other side and is at least partially offset therefrom.

[0105] Fig.12D An example of an interface facing fixation element 310' is shown that includes a pattern of slots extending inwardly from the third edge 308A and the fourth edge 308B of the interface facing fixation element 310' toward the center of the interface facing fixation element 310'. The slots shown may not extend across the entire interface facing fixation element 310'.

[0106] Fig.12E Shows that including similar Fig. 12C However, in the illustrated interface-facing fixing element 310', the rows of semicircular slots are aligned so that they are closer than Fig. 12C The rows shown are closer together. In an embodiment, the slots may overlap.

[0107] Fig.12FAn example of an interface-facing fixation element 310' is shown comprising a pattern of slots comprising 'stair step' or zigzag shapes.

[0108] Figure 12G An example is shown comprising an interface facing fixation element 310' having a pattern of consecutive straight slots, the lengths of which increase towards the centre of the interface facing fixation element 310'. The slots are substantially parallel to the second edge 306 of the interface facing fixation element 310'.

[0109] Fig.12H Shows that including similar Figure 12G However, in the illustrated interface facing fixing element 310', the centermost slot is straight and substantially parallel to the second edge 306 of the interface facing fixing element 310', while the other slots are bent inwardly toward the centermost slot.

[0110] Although the illustrated embodiment of the fixing structure 300 is useful for assisting in retaining the patient interface 200 on the patient's face, in some cases, the force applied to the fixing structure 300 may cause the fixing structure 300 to be inadvertently lifted from the patient's face, which may cause inconvenience to the patient and / or the medical professional tending to the patient. This may occur because a portion of the force applied to remove the patient interface 200 from the fixing structure 300 may be transferred to the fixing structure 300. For example, the force may be applied in a direction perpendicular to the patient's cheek. In order to reduce the possibility of inadvertently removing the fixing structure 300 from the patient's cheek, for example after removing the patient interface 200, the adhesion force of the fixing structure 300 to the patient's cheek is greater than the adhesion force of the fixing structure 300 to the patient interface 200. In order to remove the fixing structure 300 from the patient's face, a removal force that overcomes the adhesion force between the patient's face and the fixing structure 300 may be applied. Alternatively, a removal mechanism (e.g., applying a removal agent, such as water) can reduce the adhesion force between the patient's face and the fixing structure 300. Other removers are also contemplated.

[0111] Fig. 6A The fixing structure 300 is shown, wherein the area 301 facing the patient is fixed to the patient's face. In other words, the area 301 facing the patient is facing the patient's face. Fig. 6A. As shown, the first edge 304 of the fixing structure 300 faces the patient's nose N, philtrum P, and / or mouth M. The interface-facing fixing element 310' is adapted to be connected to or attached to the attachment structure 216A of the first body 206A of the patient interface 200. In some configurations, when properly aligned with the interface-facing fixing element 310', the body 206A, 206B and / or bridge 204 of the patient interface 200 can be placed above the patient's mouth M and straddle the philtrum P.

[0112] In some cases, it may be desirable to disassemble the patient interface 200 positioned on the patient's face by attaching to the fixed structure 300 while the fixed structure 300 is maintained on the patient's face. For example, this may be desirable when cleaning and / or replacing the patient interface 200, or fixing a tube (including but not limited to a nasogastric tube or a nasal tube) to the face. However, it has been found that insufficient fixation strength of the fixed structure 300 to the patient's face will cause a portion of the fixed structure 300 to be easily lifted from the face. For example, the fixed structure 300 may be lifted from the patient's face in response to a lifting force (e.g., a force substantially perpendicular to the fixed structure 300) applied to the fixed element 310' facing the interface. In some configurations, a lifting force may be applied to the fixed structure 300 when the patient interface 200 is removed from the fixed structure 300. The fixation strength between the fixed structure 300 and the patient's face may depend on the adhesive or adhesive material of the fixed element 310 facing the patient, for example, the region 301 facing the patient. In some cases, the entire patient-facing fixation element 310 and thus the fixation structure 300 may be removed from the face. In some embodiments, when a lifting force is applied to the interface-facing fixation element 310', the lifting force may be transmitted to the patient-facing fixation element 310 (facing the face). Figure 6B ). Figure 6B As illustrated, such force transfer may cause the first edge 304 of the securing structure 300 or other portion of the body 302 of the securing structure to be lifted from the face.

[0113] It has been discovered that the shape of one or more portions of the securing structure 300 may be a factor that affects the ability to prevent the securing structure 300 from being lifted off the face, for example, when removing the patient interface 200. Figures 5A to 6B In the embodiment of the fixing structure 300 shown in FIG. 1 , the tapered first edge 304 is used to concentrate the pressure generated by the lifting force applied to the fixing structure 300, thereby making it easier to lift from the face. In embodiments, the shape of the fixing structure 300 can be selected to determine the pressure distribution profile when the fixing structure 300 is removed from the face.

[0114] Figures 7A to 7ENon-limiting examples of embodiments of a fixing structure 300 and a fixing element 310' facing an interface are shown. The body 302 of the different embodiments of the fixing structure 300 shown includes an embodiment of a substantially flat or straight first edge 304, rather than a first edge that tapers or narrows in width, as described in conjunction with some of the embodiments above. The flat or straight first edge 304 allows the pressure generated by the lifting force to be distributed along the length of the first edge 304. In an embodiment, the corners of the fixing structure 300 are substantially rounded. In an embodiment, the corners of the fixing element 310' facing the interface are substantially rounded.

[0115] Fig. 7A An exemplary embodiment of a fixing structure 300 is shown, wherein the second edge 306 is rounded. The third edge 308A and the fourth edge 308B are at least partially rounded. The fixing element 310' facing the interface extends substantially along the entire interface-facing region 301' of the body 302 in a direction defined between the third edge 308A and the fourth edge 308B. The fixing element 310' facing the interface extends partially along the interface-facing region 301' of the body 302 in a direction defined between the first edge 304 and the second edge 306. Therefore, a portion of the second edge 306 may not be closely adjacent to the fixing element 310' facing the interface.

[0116] Figure 7B An exemplary embodiment of a fixed structure 300 is shown, wherein the second edge 306 is substantially flat or straight. The third edge 308A and the fourth edge 308B are substantially rounded. The fixed element 310' facing the interface substantially covers the entire interface-facing area 301' of the body 302. Alternatively, the fixed element 310' facing the interface can cover at least a portion of the area 301' facing the interface. The area 301' facing the interface can provide a border or edge around the fixed element 310' facing the interface. A user (e.g., a nurse or other healthcare provider) can grasp the edge of the fixed structure 300 in order to remove the fixed structure 300 from the patient's face. The size of the fixed element 310' facing the interface can be configured relative to the size of the fixed structure 300 so that, during the process of removing the patient interface 200, the force applied to the fixed structure 300 does not cause the fixed structure 300 to be removed from the patient's face.

[0117] Figure 7CAn exemplary embodiment of a fixed structure 300 is shown, wherein a first edge 304, a second edge 306, a third edge 308A, and a fourth edge 308B are all substantially flat or straight. In an example, the fixed structure 300 forms a substantially square or substantially rectangular shape. In an alternative example, the corners of the fixed structure 300 are substantially rounded. The fixed element 310' facing the interface substantially covers the entire interface-facing region 301' of the body 302. Alternatively, the fixed element 310' facing the interface covers at least a portion of the region 301' facing the interface. The region 301' facing the interface can provide a border or edge around the fixed element 310' facing the interface. A user (e.g., a nurse or other healthcare provider) can grasp the edge of the fixed structure 300 so that the fixed structure 300 is removed from the patient's face. The size of the fixed element 310' facing the interface can be configured relative to the size of the fixed structure 300 so that, during the process of removing the patient interface 200, the force applied to the fixed structure 300 does not cause the fixed structure 300 to be removed from the patient's face.

[0118] Fig.7D Shown is an exemplary embodiment of a fixed structure 300, wherein the first edge 304, the second edge 306, the third edge 308A and the fourth edge 308B are all substantially flat or straight. The fixed element 310 ' facing the interface covers only a portion of the region 301 ' facing the interface of the body 302. Specifically, the fixed element 310 ' facing the interface extends from the first edge 304 to a certain position between the first edge 304 and the second edge 306 along the length L of the body 302 and extends from the fourth edge 308B to a certain position between the third edge 308A and the fourth edge 308B along the width W of the body 302. As shown in the figure, in some configurations, the body 302 and / or the fixed element 310 ' facing the interface have a generally square perimeter shape. In some configurations, the fixed element 310 ' facing the interface can be substantially symmetrical about the plane extending along the diagonal V. As shown, in some configurations, the diagonal line V extends between the vertex defined by the first edge 304 and the fourth edge 308B and the vertex defined by the second edge 306 and the third edge 308A. The fixed structure 300 can then be rotated 90 degrees to be placed on either cheek of the face. Embodiments of the fixed structure 300 having a substantially symmetrical configuration (e.g., a peripheral shape) can enhance convenience and / or can reduce the number of different parts that a healthcare facility purchases, stocks, and maintains.

[0119] Fig. 7EAn exemplary embodiment of a fixing structure 300 is shown in which the first edge 304, the second edge 306, the third edge 308A, and the fourth edge 308B are all substantially flat or straight. The interface-facing fixing element 310' extends substantially along the entire length of the interface-facing region 301' of the body 302 between the first edge 304 and the second edge 306. The interface-facing fixing element 310' extends only partially along the width of the interface-facing region 301' of the body 302 from the fourth edge 308B to a position somewhere between the third edge 308A and the fourth edge 308B.

[0120] Figure 7F and Figure 7G A non-limiting configuration of the securing structure 300 is shown. Figure 7F An embodiment of a fixing structure 300 having a substantially oval shape is shown, wherein the edges are substantially rounded. The first edge 304 tapers slightly along its length, but the taper is not as Figures 5A to 6B The illustrated securing structure terminates in an extension or knob. The curvature of the first edge 304 is such as to impart an aesthetically pleasing shape while avoiding undesirable concentrated pressure on the first edge 304 when a lifting force is applied to the securing structure 300 .

[0121] Figure 7G An embodiment of a fixation structure 300 having a substantially triangular shape, or a shape similar to a Reuleaux triangle-like shape with rounded edges, or a 'guitar pick'-like shape is shown. This shape is substantially symmetrical and can be positioned on either side of the nose and have the same mechanical features without requiring rotation or reorientation. Similarly, the first edge 304 and the second edge 306 (in this case, either is adapted to face toward the patient's nose and / or mouth when in use) are rounded and slightly tapered, but still avoid undesirable concentrated pressure on the first edge 304 and the second edge 306 when a lifting force is applied to the fixation structure 300.

[0122] Other useful shapes for the fixation structure 300 are contemplated. In some patients, facial deformation (due to, for example, crying or expression of emotion) or improper handling of the fixation structure 300 may cause the fixation structure 300 to move across the eye or eyelid, thereby causing a potential momentary threat or irritation to the patient. In some cases, it is desirable to form the fixation structure 300 so that when a shear force (e.g., a force that pushes the fixation structure 300 toward the eye) is applied to the body 302 of the fixation structure 300, the fixation structure is less likely to be pushed into the patient's eye.

[0123] Fig.13AAn interface-facing view of a non-limiting configuration of a fixing structure 300 is shown. The illustrated embodiment of the fixing structure 300 includes an embodiment of a first edge 304 that faces toward the patient's nose or mouth when in use and an embodiment of a second edge 306 that faces away from the patient's nose or mouth when in use. Opposing third edges 308A and fourth edges 308B extend between the first edge 304 and the second edge 306. As shown, the third edge 308A and the fourth edge 308B can include concave curves (e.g., relative to the longitudinal axis of the fixing structure 300). As shown, in some embodiments, the third edge 308A and the fourth edge 308B include curves that bend in opposite directions or face in opposite directions. The third edge 308A and the fourth edge 308B extend further from the center line or center portion of the body 302 at portions of the third edge 308A and the fourth edge 308B that are close to the first edge 304 and the second edge 306 than at portions of the third edge 308A and the fourth edge 308B that are far from the first edge 304 and the second edge 306 (e.g., central portions of the third edge 308A and the fourth edge 308B). The portions of the third edge 308A and the fourth edge 308B that are close to the second edge 306 extend further from the center line or center portion of the body 302 than portions of the third edge 308A and the fourth edge 308B that are close to the first edge 304. The concave curve of the fourth edge 308B substantially corresponds to the outer shape of an eye or an eyelid (e.g., a lower eyelid). When an upward force is applied to the body 302 of the fixation structure 300, such as shown along the force vector F1, the concave curvature of the fourth edge 308B increases the tendency of the body 302 of the fixation structure 300 to cup or move around the eye area. This can allow the body 302 to cup, for example, the contour of the lower eyelid, and / or can reduce the tendency of the body 302 to move into or onto the eye or eyelid. When the concave curve is present on both the third edge 308A and the fourth edge 308B, the fixation structure 300 can be rotated approximately 180 degrees for use on either side of the face while maintaining the same characteristics.

[0124] As shown, the interface-facing fixing element 310' is located on the interface-facing region 301' of the fixing structure 300 and is therefore facing away from the patient's face. The interface-facing fixing element 310' is offset from the central portion of the body 302. In the configuration shown, the interface-facing fixing element 310' is positioned so that it is closer to the first edge 304 than to the second edge 306. In addition, the length L1 of the interface-facing fixing element 310' is less than or equal to the length L2 of the body 302 of the fixing structure 300, where L2 is defined as the length between the first edge 304 and the second edge 306. In some configurations, the ratio of the lengths L1:L2 can be in the range of 0.2-0.9, or in the range of 0.3-0.8, or in the range of 0.4-0.7, or in the range of 0.5-0.6. If the interface-facing fixing element 310' is offset from the central portion of the body 302 and the lengths L1 and L2 have such a ratio, the portion of the body 302 farthest from the interface-facing fixing element 310' (e.g., the portion of the body 302 closer to the second edge 306) can provide a better gripping area when attaching or detaching the fixing structure 300 to the patient's face.

[0125] In some embodiments, the fixed structure 300 has an increased area that can serve as a support portion. For example, the fixed structure 300 can include tabs or other protrusions, for example, on the first edge 304, the second edge 306, the third edge 308A, and / or the fourth edge 308B. The support portion can enable a user (e.g., a nurse) to engage (e.g., push downward) the support portion by a finger or an instrument. This can assist in disconnecting the fixed structure 300 from a tubing system (e.g., a nasogastric tube or a nasal tube) and / or a patient interface. In some variants, the support portion can assist in removing the tubing system from the patient. In some embodiments, the support portion can help stabilize the fixed structure 300 and / or can reduce the distribution of the fixed structure 300 on the patient's face.

[0126] It should be understood that taking into account Fig.13A. For example, in some configurations, the concave curve may be present on only one of the third edge 308A or the fourth edge 308B, such as the edge that faces the patient's eye or eyelid when in use. In some configurations, instead of having a concave curve, one of the third edge 308A or the fourth edge 308B may extend further from the centerline or center portion of the fixing structure 300 at only the portion of the third edge 308A or the fourth edge 308B that is near one of the first edge 304 and the second edge 306. In some configurations, the portion of the third edge 308A and the fourth edge 308B that is near the second edge 306 may extend a shorter distance or a substantially equal distance from the centerline or center portion of the body 302 than the portion of the third edge 308A and the fourth edge 308B that is near the first edge 304. In some configurations, the concave curve may have a more expanded shape, including but not limited to a crescent shape. In some configurations, the interface-facing fixation element 310' can be present at or near the center of the fixation structure 300, rather than offset therefrom. In some configurations, the interface-facing fixation element 310' can occupy nearly or substantially the entire interface-facing region 301' of the fixation structure 300.

[0127] Fig. 13B Shows Fig.13A300 along section CC. As shown, the body 302 of the fixing structure 300 has a thickness t1, and the fixing element 310' facing the interface has a thickness t2. It has been recognized that the body 302 needs to have a high flexibility or a low Young's modulus to conform to the shape changes of the face due to, for example, crying or emotional expressions. The thickness t1 of the body 302 can be, for example, in the range of 0.05-0.35 mm, or 0.10-0.30 mm, or 0.15-0.25 mm. In some embodiments, the thickness t1 of the body 302 can be, for example, in the range of 0.05-5.0 mm ± 10%, 0.05-3.0 mm ± 10%, 0.1-1.0 mm ± 10%, 0.178-0.76 mm ± 10%, 0.178-0.381 mm ± 10%, 0.38-0.76 mm ± 10%, or appropriately 0.76 mm ± 10%. In some embodiments, the thickness t1 of the body 302 is equal to or approximately 0.178 mm. In some embodiments, the thickness t1 of the body 302 can be equal to, approximately equal to, or less than the thickness t2 of the fixing element 310 'facing the interface. The body 302 with a relatively small thickness t1 can improve the overall flexibility of the fixing structure 300. In some embodiments, the body 302 includes a material with a low Young's modulus. In some variations, the entire body 302 or substantially the entire body 302 includes a material with a low Young's modulus. In some configurations, increasing the flexibility of the body 302 may cause the patient-facing region 301 of the body 302 to not adhere strongly to the patient's face. Alternatively, increasing the adhesion between the patient-facing region 301 of the body 302 and the patient's face may reduce the flexibility of the body 302. Therefore, it is desirable to optimize the adhesion between the patient-facing region 301 of the body 302 and the patient's face while maintaining flexibility. Different materials have different effects on the flexibility and / or adhesion of the body 302.

[0128] Fig.14 and 15 An interface-facing view of an additional non-limiting embodiment of a securing structure 300 is shown. Fig.14 and 15 Examples may include Fig.13A Any feature of an embodiment of the present invention. For example, as shown in the figure, Fig.14 and 15An embodiment of the fixed structure 300 may include a body 302, a first edge 304, and a second edge 306. The first edge 304 may face toward the patient's nose or mouth when in use, and the second edge 306 may face away from the patient's nose or mouth when in use. Opposite third edge 308A and fourth edge 308B may extend between the first edge 304 and the second edge 306. As shown, the third edge 308A and the fourth edge 308B may include a concave curve (e.g., relative to the longitudinal axis of the fixed structure 300).

[0129] The fixing structure 300 may include a fixing element 310' facing the interface. The fixing element 310' facing the interface is located on a region 301' of the fixing structure 300 facing the interface and thus facing away from the patient's face. The fixing element 310' facing the interface may be offset from the central portion of the body 302. In the illustrated configuration, the fixing element 310' facing the interface is positioned so that it is closer to the first edge 304 than to the second edge 306.

[0130] The fixing element 310' facing the interface may include one or more slots. These slots may be a pattern including alternating slot columns of various shapes. For example, as shown, each column may include arcuate and / or semicircular slots, which are shaped to face in the opposite direction of the column on the other side and at least partially deviate from it. In some embodiments, a portion of these slot columns overlap along the longitudinal direction of the fixing structure 300.

[0131] In some cases, during use, tears, mucus, vomit, liquids, or liquid-solid mixtures may be present around the fixed structure 300. The presence of such materials may reduce the adhesion of the patient-facing region 301 of the fixed structure 300 to the patient. It has been recognized that it is desirable to construct the body 302 of the fixed structure 300 from a material having relatively low water absorption to reduce the loss of adhesion of the patient-facing region 301 to the face due to the presence of liquids or liquid-solid mixtures.

[0132] Fig. 8A An exemplary non-limiting configuration of a fixation structure 300 is shown including an interface facing fixation element 310'. The interface facing fixation element 310' comprises a hook pad that forms a 'hook and loop' style connection with one of the attachment structures 216A, 216B of the patient interface 200. The hook pad comprises a plurality of hooks 314. Figure 8BAn enlarged cross section is shown as viewed from the first edge 304 along dashed line AA. As shown, the hook 314 extends toward the fourth edge 308B of the body 302 of the fixation structure 300. In some configurations, the hook 314 additionally or alternatively extends toward the third edge 308A of the body 302 of the fixation structure 300. In some cases, if the fixation structure 300 is used on the face of a patient (e.g., a toddler or infant), the patient tends to attempt to remove the fixation structure 300 by grasping the first edge 304 or the second edge 306 and pulling the corresponding edge over the length of the fixation structure 300. It has been recognized that the strength of the hook and loop fixation structure is anisotropic with respect to the orientation of the hook 314.

[0133] In some configurations, and as Fig. 9A and Fig. 9B As can be seen, the hooks 314 can be arranged so that they extend toward the second edge 306. Fig. 9B yes Fig. 9A ) In other configurations, the hooks 314 can be arranged so that they extend toward the first edge 304, the second edge 306, or the first edge 304 and the second edge 306. If the hooks 314 are arranged so that they extend toward the first edge 304 and / or the second edge 306, the strength of the hook and loop fastening structure can be such that when a force is applied along an axis substantially parallel to the third edge 308A and / or the fourth edge 308B, the uncoupling is resisted to a greater extent than when a force is applied along an axis substantially parallel to the first edge 304 and / or the second edge 306. Since the loop complementary to the hook 314 will be pushed substantially toward and / or against the length of the hook 314 when such a force is applied, rather than being pushed in a direction substantially perpendicular to the hook 314, the force is more resisted. In some configurations, the hook 314 can extend in multiple directions. In some such configurations, the hook 314 can extend, for example, in a substantially perpendicular direction to mitigate the anisotropy of the hook and loop fastening strength. In some configurations, the angle of the hook 314 can be varied to suit different applications. In some configurations, a combination of different angles can be used to determine the strength of the fixation between the interface-facing fixation element 310' and the patient interface 200. The hook 314 can be positioned at a variety of angles and / or different orientations to aid in the strength of the fixation.

[0134] In an embodiment, the Figure 5C and Figures 11A-12H The combination of at least one of the slot embodiments shown in FIG. 3 and the configuration of the hook 314 is used to maximize the fixation strength and / or flexibility of the interface-facing fixation element 310 ′ to the patient interface 200 .

[0135] Fig. 10AThe fixation structure 300 is shown in use on a skin surface S of a patient's face. The patient-facing area 301 includes a patient-facing fixation element 310, which can be composed of a material that adheres to the skin surface S, such as a hydrocolloid-based adhesive. As shown, at a microscopic level, the skin surface S includes an irregular thickness and includes a plurality of ridges and voids G along the skin surface S. After being applied to the skin surface S, the patient-facing fixation element 310 initially adheres to only a portion of the skin surface S (see Fig. 10A During the time period t, the adhesive fixing element 310 facing the patient flows into the gap G and increases the adhesive force (see Fig. 10A However, it has been recognized that discomfort is experienced when removing the fixing structure 300 from the skin surface S because in some cases the hair and a portion of the stratum corneum of the skin surface S are removed simultaneously. Additionally, in some cases, it is difficult to predict the strength of the adhesive after it has been applied to the skin surface S.

[0136] Fig. 10B The purposes of the embodiment of fixed structure 300 are shown, wherein the fixed element 310 facing the patient is made of silicone-based adhesive. As shown in the figure, at the microscopic level, after being applied on the skin surface, the fixed element 310 facing the patient flows into the gap G quickly and reaches the maximum adhesion with the skin rapidly. Accordingly, the strength of the adhesive becomes more predictable when the adhesive is applied. The viscosity of the adhesive based on silicone is lower than that based on hydrocolloid and needs to be removed than the less force based on hydrocolloid adhesive. Increasing the contact area between adhesive and skin can allow to obtain enough adhesion between them and reduce the removal of a part of the skin surface when removing fixed structure 300. If the fixed element 310 facing the patient is made of silicone-based adhesive, the discomfort of removing or disassembling the fixed structure 300 from the skin can be reduced.

[0137] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprising," "including," and the like should be construed in an open sense (as opposed to a closed or exhaustive sense), that is, in the sense of "including but not limited to."

[0138] Where in the foregoing description, reference has been made to integers or components having known equivalents thereof, such integers or components are herein incorporated as if individually set forth.

[0139] The disclosed methods, apparatuses, and systems may also broadly include the parts, elements, and features mentioned or indicated in the present disclosure, either individually or collectively, and any or all combinations of two or more of the parts, elements, or features. In addition, the present disclosure includes combinations of these different features, aspects, methods, characteristics, features, qualities, attributes, elements, etc. of these different embodiments. For example, any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like associated with one embodiment herein may be used in all other embodiments set forth herein.

[0140] The reference to any prior art in this specification is not, and should not be taken as, an admission or any form of suggestion that this prior art forms part of the common general knowledge in the field in any country in the world.

[0141] Language of degree used herein, such as the terms "substantially," "about," "generally," and "substantially" as used herein, means a value, amount, or characteristic that is close to a stated value, amount, or characteristic, and still performs a desired function or achieves a desired result. For example, the terms "generally parallel" and "substantially parallel" refer to values, amounts, or characteristics that may deviate from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degrees, or another value, amount, or characteristic.

[0142] Some embodiments have been described in conjunction with the accompanying drawings. These drawings are drawn to scale, but such scale should not be limiting. Dimensions and proportions other than those shown are contemplated and are within the scope of the present disclosure. Distances, angles, shapes, etc. are merely illustrative and do not necessarily have an exact relationship to the actual size and layout of the displayed device. Components may be added, deleted, and / or rearranged.

[0143] Although the present disclosure has been described with respect to specific embodiments, other embodiments apparent to those of ordinary skill in the art are also within the scope of the present disclosure. Therefore, various changes and modifications may be made without departing from the spirit and scope of the present disclosure. For example, various components may be repositioned as desired. In addition, not all of these features, aspects, and advantages are necessary to practice the present disclosure. Therefore, the scope of the present disclosure is intended to be limited only by the following claims.

Claims

1. A fixing structure (300) for fixing a patient interface (200) to a patient's face, the fixing structure (300) comprising: Ontology(302); wherein a first side of the body (302) facing away from the patient's face and toward the patient interface (200) when in use comprises a fixing element (310') which can be attached to a complementary fastener of an attachment structure (216A, 216B) of the patient interface (200); and wherein the fixing element (310') comprises a pattern of slots that facilitates the flexibility of the fixing element (310'); wherein the pattern of the slots comprises a plurality of columns, each column comprises a plurality of slots arranged in the longitudinal direction of the fixing element (310'), and each slot has a semicircular shape; wherein a plurality of slots in any one column are bent in the same direction; wherein the plurality of slots in the first column have a bending direction opposite to that of the plurality of slots in the second column, the second column being adjacent to the first column in the width direction of the fixing element (310'); and The plurality of slots in the first column are positioned alternately with the plurality of slots in the second column in the longitudinal direction.

2. The fixing structure (300) according to claim 1, wherein: The body (302) comprises: a first edge (304); a second edge (306) opposite the first edge (304) such that when used on the patient's face, the second edge (306) is further from the patient's nose or mouth than the first edge (304); an opposing third edge (308A) and a fourth edge (308B) extending between the first edge (304) and the second edge (306), The first side extends between the first edge (304) and the second edge (306).

3. The fixing structure (300) according to claim 2, wherein: At least some of the slots extend toward at least one of the first edge, the second edge, the third edge, or the fourth edge (304, 306, 308A, 308B).

4. The fixing structure (300) according to claim 2, wherein: At least some of the slots are arranged in rows of slots extending alternately to the third and fourth edges.

5. The fixing structure (300) according to any one of claims 1 to 4, wherein: The semicircular slots overlap along the longitudinal direction of the fixing structure (300).

6. The fixing structure (300) according to claim 4, wherein: A portion of the rows of slots overlap in the longitudinal direction of the fixing structure (300).

7. The fixing structure (300) according to claim 4, wherein: Each of the columns of slots includes a plurality of slots having semicircular or crescent shapes that face in an opposite direction to the semicircular or crescent shapes of the slots in an adjacent column and diverge therefrom at least partially toward the third edge or the fourth edge.

8. The fixing structure (300) according to claim 2, wherein: The fixing element is positioned closer to the first edge than to the second edge.

9. The fixing structure (300) according to claim 2, wherein: The midpoint of the fixing element is offset from a center line or a middle portion between the first edge and the second edge.

10. The fixing structure (300) according to claim 2, wherein: The midpoint of the fixing element is located on a center line or a middle central portion between the third edge and the fourth edge.

11. The fixing structure (300) according to any one of claims 1 to 4, wherein: At least a portion of the first side not covered by the fixing element comprises a gripping or supporting area.

12. The fixing structure (300) according to claim 2, wherein: The securing element extends from the first edge to a position between the first edge and the second edge along the length of the first side.

13. The fixing structure (300) according to claim 2, wherein: A length of the fixing element between the first edge and the second edge is smaller than a length of the first side between the first edge and the second edge.

14. The fixing structure (300) according to claim 13, wherein: A ratio of the length of the fixing element to the length of the first side is between 0.2 and 0.

9.

15. The fixing structure (300) according to claim 2, wherein: The securing element extends substantially all between the first edge and the second edge and only partially between the third edge and the fourth edge, and the securing element extends from the third edge to a position between the third edge and the fourth edge along the width of the first side.

16. The fixing structure (300) according to claim 2, wherein: The fixing element extends from the first edge to a position between the first edge and the second edge along the length of the first side, and the fixing element extends from the third edge to a position between the third edge and the fourth edge along the width of the first side.

17. The fixed structure (300) according to any one of claims 2 to 4, wherein: The fixation element comprises a hook fastener removably attachable to a complementary loop fastener of the attachment structure of the patient interface.

18. The fixing structure (300) according to claim 17, wherein: The hook fastener includes a plurality of hooks extending outwardly from the first side.

19. The fixing structure (300) according to claim 18, wherein: At least some of the plurality of hooks extend toward the first edge and / or the second edge.

20. The fixing structure (300) according to claim 18, wherein: At least some of the plurality of hooks are generally parallel to the first edge and the second edge, and generally perpendicular to the third edge and the fourth edge.

21. The fixing structure (300) according to claim 2, wherein: At least some of the slots extend toward the third edge and the fourth edge.

22. The fixing structure (300) according to claim 21, wherein: At least some of the slots, cutouts, perforations, or thinned areas that are closer to the first edge and the second edge are shorter than at least some of the slots that are farther from the first edge and the second edge.

23. The fixing structure (300) according to claim 21, wherein: At least some of the slots do not extend across a centerline or a central portion intermediate between the third edge and the fourth edge.

24. The fixed structure (300) according to any one of claims 2 to 4, wherein: At least one of the slots has a serpentine shape.

25. The fixing structure (300) according to claim 24, wherein: Two of the slots have a serpentine shape, one of the serpentine slots extends toward the first edge, and the other of the serpentine slots extends toward the second edge.

26. The fixed structure (300) according to any one of claims 1 to 4, wherein: At least some of the slots have a zigzag shape.

27. The fixed structure (300) according to any one of claims 1 to 4, wherein: The slots are formed into at least one of the following shapes: serpentine, zigzag, and semicircular.

28. The fixing structure (300) according to claim 2 further includes a second side extending between the first edge and the second edge, the second side facing the patient's face and away from the patient interface when in use, and the second side includes a second fastener that can be attached to the patient's face.

29. The fixed structure (300) according to claim 28, wherein: The second fastener includes an adhesive removably attachable to the patient's face.

30. The fixed structure (300) according to claim 29, wherein: The adhesive is at least one of a hydrocolloid-based adhesive and a silicone-based adhesive.

31. The fixed structure (300) according to claim 29, wherein: The adhesive includes the following materials: The material, in use, maintains a substantially constant level of adhesion to the patient's face for at least a predetermined period of time after being applied to the face.

32. The fixed structure (300) according to claim 29, wherein: The adhesive comprises a material that substantially conforms to the shape of the patient's face when in use.

33. The fixing structure (300) according to any one of claims 1 to 4, comprising a material with low water absorption.

34. The fixing structure (300) according to any one of claims 1 to 4, comprising a material having a low Young's modulus.

35. The fixed structure (300) according to any one of claims 1 to 4, wherein: The securing structure has a substantially uniform thickness.

36. The fixed structure (300) according to any one of claims 1 to 4, wherein: The fixation structure has a thickness that allows the fixation structure to flex in response to movement of the patient's face.

37. The fixed structure (300) according to any one of claims 1 to 4, wherein: The fixing structure has a thickness between 0.05 mm and 5 mm.

38. The fixed structure (300) according to any one of claims 1 to 4, wherein: The fixing element (310') has a substantially oval, square, rectangular, trapezoidal, triangular or pentagonal shape.

39. A fixing structure (300) for fixing a patient interface (200) to a patient's face, the fixing structure (300) comprising: a first edge (304); a second edge (306) opposite the first edge (304) such that when used on the patient's face, the second edge (306) is further from the patient's nose or mouth than the first edge (304); Opposing third edge (308A) and fourth edge (308B) extending between the first edge (304) and the second edge (306); a first side extending between the first edge (304) and the second edge (306), the first side facing away from the patient's face and toward the patient interface (200) when in use, the first side comprising a fixing element (310') attachable to a complementary fastener of an attachment structure (216A, 216B) of the patient interface (200), wherein the fixing element (310') comprises a pattern of slots that facilitates the flexibility of the fixing element (310'); wherein the pattern of the slots comprises a plurality of columns, each column comprises a plurality of slots arranged in the longitudinal direction of the fixing element (310'), and each slot has a semicircular shape; wherein a plurality of slots in any one column are bent in the same direction; wherein the plurality of slots in the first column have a bending direction opposite to that of the plurality of slots in the second column, the second column being adjacent to the first column in the width direction of the fixing element (310'); and The plurality of slots in the first column are positioned alternately with the plurality of slots in the second column in the longitudinal direction.

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