Tracheostomy protector

Abstract

The utility model discloses a tracheostoma protector. A tracheostomy guard (10, 30, 40, 50) for a patient interface is provided. The tracheostomy guard (10, 30, 40, 50) comprises a first portion (11) arranged to be connected, in use, to a patient interface, and a second portion (12) attached to the first portion and configured, in use, to be in fluid communication with the patient interface. The second portion (12) comprises at least one first member (121) and / or a second member (122) forming at least one orifice in fluid communication with the ambient environment, wherein the orifice (13) has a size that varies in use in response to a force applied to at least a portion of the second portion. An assembly (100) comprising a tracheostoma guard, a valve unit, a valve member and a kit of parts is also provided.

Description

[0001] This application is a divisional application of a patent application with application number 2022222595279, application date August 26, 2022, and invention name “Tracheostomy guard and related components”. Technical Field

[0002] The present disclosure relates generally to respiratory assistance systems. More specifically, the present disclosure relates to accessories and / or patient interfaces for providing respiratory therapy to a patient. Background Art

[0003] A tracheostomy is an opening surgically formed into a patient's trachea to provide an airway and remove secretions from the lungs. Breathing gases may be provided to the patient from a gas source via a patient interface, such as a tracheostomy interface. The tracheostomy interface may be connected to a port formed in the tracheostomy to facilitate ventilation.

[0004] The tracheal coupling (e.g. in the form of a connector for a tracheal interface) can be used with a device such as Figure 1a The tracheal coupler provides a passage for the interface connection between a high flow gas supply of breathing gas (such as oxygen) and a patient (such as a patient with a tracheostomy or intubation). The tracheal coupler can take the form of a connector that is connected to a tracheal insert / interface in or on a patient with a tracheostomy or intubation. In one example, the tracheal interface can be attached to a patient with a tracheostomy / intubation.

[0005] A tracheostomy brace may be coupled to the tracheal interface to prevent the patient interface from being blocked, for example, by the patient's chin, bedding, or clothing. The tracheostomy brace includes an opening to allow air exchange therein.

[0006] During tracheal ventilation, patient secretions may be discharged from the patient interface. The secretions may be directed to a caregiver, for example, through an opening in the tracheostomy protector or directly from the interface. The secretions may suddenly exit the opening with sufficient force to reach a caregiver located near the patient. The tracheostomy protector may facilitate removal of secretions therefrom while deflecting the secretions so that they are not directed to the caregiver.

[0007] The provision of high flow therapy can be used to flush the airway and reduce dead space, and generate positive end-expiratory pressure (PEEP), improved humidity to promote mucociliary transport in the lungs. In some use cases, high flow therapy can also provide dynamic positive pressure. However, conventional tracheostomy protectors may not be suitable for such high airflow environments. Therefore, an improved tracheostomy protector for high flow tracheostomy would be advantageous. Utility Model Content

[0008] The present disclosure relates to a tracheostomy brace (hereinafter also referred to as a "tracheal brace") for use with a tracheostomy interface (hereinafter also referred to as a "tracheal interface" or a "patient interface").

[0009] In a first aspect, there may be provided a tracheostomy brace for a patient interface comprising: a first portion arranged to be connected to a patient interface in fluid communication with the first portion in use; a second portion in fluid communication with the first portion and comprising at least one first member and / or second member forming at least one orifice in fluid communication with an ambient environment, wherein the orifice has a size that changes in use in response to a force applied to at least a portion of the second portion.

[0010] In some embodiments, at least one first member is arranged to bi-directionally deflect or bi-directionally move relative to the second member in response to an applied force.

[0011] In some embodiments, the size of the orifice relates to the cross-sectional size of the orifice.

[0012] In some embodiments, the applied force is correlated to a gas flow rate of the gas in the tracheostomy appliance.

[0013] In some embodiments, the gas flow rate involves 20 l / min to 150 l / min or 20 l / min to 80 l / min for adult patients, and a high flow rate of 1 l / min to 30 l / min for neonatal or pediatric patients.

[0014] In some embodiments, the variable size of the aperture is configured to allow saliva to be released therethrough in response to an applied force, in use.

[0015] In some embodiments, the force applied to the second portion in use is at least partly due to the weight of saliva present in the second portion.

[0016] In some embodiments, the variable size of the orifice is configured to achieve a set minimum positive end-expiratory pressure (PEEP) in use.

[0017] In some embodiments, the minimum PEEP is set to be selected from the following range: 1 cmH2O-7 cmH2O.

[0018] In some embodiments, at least one first member and / or second member are relatively arranged to form at least one variable-sized aperture.

[0019] In some embodiments, the first member has a first material or structural feature and the second member has a second material or structural feature, wherein the first material or structural feature and the second material or structural feature are selected to allow the size of the variable-size orifice to change in response to an applied force.

[0020] In some embodiments, the first material or structural feature and the second material or structural feature relate to at least one of: stiffness, hardness, flexibility, elastic modulus, section moment of inertia, length, width, and / or thickness.

[0021] In some embodiments, the first material or structural feature relates to the thickness of the first component, and / or the second material or structural feature relates to the thickness of the second component.

[0022] In some embodiments, at least one of the first member or the second member is made of a polymer, an elastomer, a thermoplastic polymer, or an elastomer or a thermosetting polymer.

[0023] In some embodiments, the second portion is releasably attached to the first portion.

[0024] In some embodiments, the second portion is sealingly attached to the first portion.

[0025] In some embodiments, at least a portion of the second portion is integral with the first portion.

[0026] In some embodiments, the applied force is related to an internal pressure of the second portion.

[0027] In some embodiments, the first and second portions together form a cavity which, in use, is in fluid communication with the surrounding environment only via the variable-sized orifice.

[0028] In some embodiments, the orifice achieves its smallest size in the resting state of the tracheostomy device.

[0029] In some embodiments, at least one of the first member or the second member comprises a flap or a panel.

[0030] In some embodiments, the first material or structural feature and / or the second material or structural feature is selected to achieve reversible deformation or deflection or bending or flexing of the first member and / or the second member based on an applied force.

[0031] In some embodiments, the size of the aperture changes based on the reversible deformation.

[0032] In some embodiments, the second portion is configured to be in fluid communication with the patient interface in use.

[0033] In a second aspect, there may be provided a tracheostomy brace for a patient interface, comprising: a first portion arranged to be attached to a patient interface in fluid communication with the first portion in use; and a second portion in fluid communication with the first portion. The second portion comprises at least one first member having a first material or structural feature and a second member having a second material or structural feature, wherein the first material or structural feature is different from the second material or structural feature and is selected to allow reversible deformation or deflection or bending or flexing of the first member in response to a force applied to at least a portion of the second portion in use.

[0034] In some embodiments, at least one first member and / or second member are relatively arranged to form at least one aperture in fluid communication with the surrounding environment, wherein the aperture has an effective size that is variable in use in response to an applied force acting on the first member.

[0035] In some embodiments, at least one first member is arranged to deflect or move relative to the second member in response to an applied force.

[0036] In some embodiments, the size of the orifice relates to the cross-sectional size of the orifice.

[0037] In some embodiments, the applied force is correlated to the flow rate of gas in the tracheostomy appliance.

[0038] In some embodiments, the gas flow rate involves 20 l / min to 150 l / min or 20 l / min to 80 l / min for adult patients, and a high flow rate of 1 l / min to 30 l / min for neonatal or pediatric patients.

[0039] In some embodiments, the variable size of the aperture is configured to allow saliva to be released therethrough in response to an applied force, in use.

[0040] In some embodiments, the force applied to the second portion in use is at least partly due to the weight of saliva present in the second portion.

[0041] In some embodiments, the variable size of the orifice is configured to achieve a set minimum positive end-expiratory pressure (PEEP) in use.

[0042] In some embodiments, the minimum PEEP is set to be selected from the following range: 1 cmH2O-7 cmH2O.

[0043] In some embodiments, the first material or structural feature and the second material or structural feature relate to at least one of: stiffness, hardness, flexibility, elastic modulus, section moment of inertia, length, width, and / or thickness.

[0044] In some embodiments, the first material or structural feature relates to the thickness of the first component, and / or the second material or structural feature relates to the thickness of the second component.

[0045] In some embodiments, at least one of the first member or the second member is made of a polymer, an elastomer, a thermoplastic polymer, or an elastomer or a thermosetting polymer.

[0046] In some embodiments, the second portion is releasably attached to the first portion.

[0047] In some embodiments, the second portion is sealingly attached to the first portion.

[0048] In some embodiments, at least a portion of the second portion is integral with the first portion.

[0049] In some embodiments, the applied force is related to an internal pressure of the second portion.

[0050] In some embodiments, the first and second portions together form a cavity which, in use, is in fluid communication with the surrounding environment only via the variable-sized orifice.

[0051] In some embodiments, the orifice achieves its smallest size in the resting state of the tracheostomy device.

[0052] In some embodiments, the first member or the second member comprises a flap or a panel.

[0053] In some embodiments, the aperture size changes based on the reversible deformation.

[0054] In a third aspect, a tracheostomy brace for a patient interface may be provided, comprising: a first portion having an end arranged to be releasably attached to the patient interface, the first portion comprising an alignment feature having an outer shape or boundary for aligning with a corresponding alignment feature of the patient interface when connected to the tracheostomy brace, and an attachment member arranged to: mate with the corresponding attachment member of the patient interface when the first portion is attached to the patient interface, and to disconnect from the corresponding attachment member of the patient interface when a directional force is applied to the first portion.

[0055] In some embodiments, the alignment feature relates to an outer shape or border of the first portion.

[0056] In some embodiments, the alignment feature relates to the outer shape or border of the oblong or tongue-like extension of the first portion.

[0057] In some embodiments, the attachment member includes an attachment release lip.

[0058] In some embodiments, the attachment member is formed by a smooth tubular inner surface of the first portion, wherein the smooth tubular inner surface is arranged to mate with a corresponding smooth outer surface of the patient interface.

[0059] In some embodiments, the attachment member is arranged to mate with a corresponding attachment member of the patient interface by means of a friction fit.

[0060] In some embodiments, the attachment member comprises a protrusion configured to mate with a corresponding recess of the patient interface.

[0061] In some embodiments, the attachment member includes a recess configured to mate with a corresponding protrusion of the patient interface.

[0062] In some embodiments, the attachment member is configured to sealingly attach to a corresponding attachment member of the patient interface.

[0063] In a fourth aspect, there may be provided an assembly for providing a high flow tracheostomy, comprising a tracheostomy brace as disclosed herein, and at least one of: a tracheostomy patient interface for connection to the tracheostomy brace, a conduit or tube arranged for connection to a gas source at a first end thereof and to the tracheostomy patient interface at a second end thereof, and a supply of the gas source for supplying a gas flow to the patient interface via the conduit in use.

[0064] In some embodiments, the gas source includes a blower and a humidifier.

[0065] In some embodiments, the conduit or tube is a breathable tube that allows excess water vapor to migrate from the tube to the atmosphere.

[0066] In some embodiments, the tracheostomy interface comprises a breathable tube.

[0067] In a fifth aspect, a tracheostomy interface assembly for providing a high-flow tracheostomy may be provided, comprising a tracheostomy brace as disclosed herein, and a tracheostomy interface (20) comprising: a first end for connection to the airway of a patient; a port for connection to a gas source for supplying a gas flow to the patient via the first end; and a second end for connection to a first portion of the tracheostomy brace.

[0068] In some embodiments, the tracheostomy brace may be releasably attached to the second end of the tracheostomy interface via the first portion.

[0069] In a sixth aspect, there may be provided a tracheostomy brace for a patient interface, the tracheostomy brace comprising: a first portion arranged to be connected to the patient interface in use; a second portion attached to the first portion and configured to be in fluid communication with the patient interface in use; the second portion forming at least one orifice in fluid communication with the surrounding environment, wherein the orifice has an effective size that changes in use in response to a force applied to at least a portion of the second portion.

[0070] In some embodiments, the at least a portion of the second portion includes a region of the second portion proximate the orifice, the region being configured to elastically deform such that an effective size of the orifice changes in response to a force applied to the region.

[0071] In some embodiments, the region is elastically deformable in a bi-directional manner.

[0072] In some embodiments, the region is biased towards a rest position in which the effective size of the aperture is at its minimum.

[0073] In some embodiments, the regions are configured such that the increase in effective size occurs in a controlled and gradual manner in order to maintain a desired pressure and prevent forceful discharge of saliva.

[0074] In some embodiments, the regions are configured such that, when starting from (the) rest position, the effective size of the orifice increases as the absolute value of the applied force increases.

[0075] In some embodiments, the second portion includes at least one first member and / or second member; and the at least one first member and / or second member forms the at least one aperture.

[0076] In some embodiments, the at least one first member and / or second member of the second portion resiliently moves in response to a force applied to the at least a portion of the second portion, thereby providing the at least one aperture with a variable effective size.

[0077] In some embodiments, the at least one first member and / or the second member of the second portion is resiliently movable in a bidirectional manner.

[0078] In some embodiments, the at least one first member is arranged to deflect or move relative to the at least one second member in response to an applied force.

[0079] In some embodiments, the effective size of the orifice is related to the cross-sectional size of the orifice.

[0080] In some embodiments, the applied force is correlated to a gas flow rate of the gas in the tracheostomy appliance.

[0081] In some embodiments, the gas flow rate involves 20 l / min to 150 l / min or 20 l / min to 80 l / min for adult patients, and a high flow rate of 1 l / min to 30 l / min for neonatal or pediatric patients.

[0082] In some embodiments, the variable effective size of the orifice is configured to allow saliva to be released through the orifice in response to an applied force, in use.

[0083] In some embodiments, the applied force is due at least in part to the weight of saliva present in the second portion.

[0084] In some embodiments, the variable size of the orifice is configured to achieve a set minimum positive end-expiratory pressure (PEEP) in use.

[0085] In some embodiments, the minimum PEEP is set to be selected from the following range: 1 cmH2O-7 cmH2O.

[0086] In some embodiments, at least one first member and / or second member are relatively arranged to form at least one variable-sized aperture.

[0087] In some embodiments, the first member has a first material or structural feature and the second member has a second material or structural feature, wherein the first material or structural feature and the second material or structural feature are selected to allow the size of the variable-size orifice to change in response to an applied force.

[0088] In some embodiments, the first material or structural feature and the second material or structural feature relate to at least one of: stiffness, hardness, flexibility, elastic modulus, section moment of inertia, length, width, and / or thickness.

[0089] In some embodiments, the first material or structural feature relates to the thickness of the first component, and / or the second material or structural feature relates to the thickness of the second component.

[0090] In some embodiments, the first member and / or the second member are made of a polymer, an elastomer, a thermoplastic polymer, or an elastomer or a thermosetting polymer.

[0091] In some embodiments, the second portion is releasably attached to the first portion.

[0092] In some embodiments, the second portion is sealingly attached to the first portion.

[0093] In some embodiments, at least a portion of the second portion is integral with the first portion.

[0094] In some embodiments, the applied force is related to an internal pressure within the second portion.

[0095] In some embodiments, the applied force is associated with a difference between the internal pressure and an ambient pressure external to the second portion.

[0096] In some embodiments, the second portion forms a cavity which, in use, is in fluid communication with the surrounding environment only via the at least one variable-sized orifice.

[0097] In some embodiments, the orifice achieves its minimum effective size in the resting state of the tracheostomy device.

[0098] In some embodiments, the first member and / or the second member comprises a flap or a panel.

[0099] In some embodiments, the first material or structural feature and / or the second material or structural feature are selected to achieve reversible deformation of the first member and / or the second member based on an applied force.

[0100] In some embodiments, the effective size of the orifice changes based on the reversible deformation.

[0101] In some embodiments, the attachment member is configured to sealingly attach to a corresponding attachment member of the patient interface.

[0102] In a seventh aspect, there may be provided a valve unit for use with a tracheostomy brace, comprising: a hollow body having: a first port for connection to a corresponding port of the tracheostomy brace and a second port in fluid communication with the surrounding environment, at least one first member and a second member forming at least one orifice, wherein the orifice has an effective size that changes in use in response to a force applied to the first member and / or the second member.

[0103] In some embodiments, the aperture of the valve member is configured to coincide, in use, with an aperture on the second portion of the tracheostomy guard when the valve member is substantially mated with the second portion.

[0104] In an eighth aspect, there may be provided a valve component for use with a tracheostomy brace for a patient interface, the tracheostomy brace comprising: a first portion which is connected to the patient interface in use; and a second portion which is attached to the first portion and is configured to be in fluid communication with the patient interface in use, the valve component being configured to substantially mate with the second portion and to provide at least one orifice in fluid communication with a surrounding environment, wherein the orifice has an effective size that is variable in use in response to an applied force.

[0105] In some embodiments, the aperture of the valve member is configured to coincide, in use, with an aperture of the second portion of the tracheostomy appliance when the valve member is substantially mated with the second portion.

[0106] In a ninth aspect, a kit of parts may be provided, comprising: a tracheostomy brace as disclosed herein and at least one of: a tracheostomy patient interface for connection to the tracheostomy brace; a conduit or tube arranged to be connected to a gas source at a first end thereof and to be connected to the tracheostomy patient interface at a second end thereof; and a gas source for supplying a gas flow to the patient interface via the conduit or tube in use.

[0107] In some embodiments, the kit comprises a tracheal tube coupled or coupleable to the tracheostomy patient interface.

[0108] In some embodiments, the kit includes a connector for connecting the endotracheal tube to a tracheostomy patient interface.

[0109] In some embodiments, the kit is configured to provide a tracheostomy interface assembly for providing high flow therapy.

[0110] In a tenth aspect, a kit of parts may be provided, comprising: a tracheostomy guard; and a valve unit disclosed herein or a valve component disclosed herein for use with the tracheostomy guard and at least one of: a tracheostomy patient interface connected to the tracheostomy guard; a conduit or tube arranged to be connected to a gas source at a first end thereof and to the tracheostomy patient interface at a second end thereof; and a gas source for supplying a gas flow to the patient interface via the conduit or tube in use.

[0111] In some embodiments, the kit comprises a tracheal tube coupled or coupleable to the tracheostomy patient interface.

[0112] In some embodiments, the kit includes a connector for connecting the endotracheal tube to a tracheostomy patient interface.

[0113] In some embodiments, the kit is configured to provide a tracheostomy interface assembly for providing high flow therapy. BRIEF DESCRIPTION OF THE DRAWINGS

[0114] Several embodiments will now be described by way of example with reference to the following drawings, in which:

[0115] Figure 1a A breathing assistance system of the prior art is shown;

[0116] Figure 1b A perspective view showing a prior art tracheostomy connector and associated breathing tube connected to a patient's tracheostomy;

[0117] Figure 1c An example of a respiratory support apparatus is shown in diagrammatic form;

[0118] Figure 1d A perspective view of an example of a respiratory support apparatus is shown;

[0119] Figures 2 to 5 shows a corresponding perspective view of a tracheostomy guard according to a first embodiment;

[0120] Figure 6 Show Figures 2 to 5 Bottom view of the tracheostomy device;

[0121] Figure 7 Show Figure 6 Enlarged cross section of tracheostomy device;

[0122] Figure 8 Show Figures 2 to 7 A front view of a tracheostomy protector;

[0123] Fig. 9 Show Figures 2 to 8 Rear view of the tracheostomy device;

[0124] Fig.10a A cross-sectional view showing the tracheostomy protector of the first embodiment in a static state;

[0125] Fig.10b When a portion of a tracheostomy device is subjected to a first applied force and / or internal pressure Fig.10a A cross-sectional view of a tracheostomy device;

[0126] Fig.10c Show Fig.10a and Fig.10b A cross-sectional view of a tracheostomy device when a portion of the tracheostomy device is subjected to a second applied force and / or internal pressure;

[0127] Fig.11 Show Figures 2 to 9 A cross-sectional stereoscopic view of a tracheostomy device;

[0128] Fig.12 Show Figures 2 to 9 Another cross-sectional perspective view of the tracheostomy protector;

[0129] Fig.13 and Fig.14 shows a corresponding perspective view of a patient interface according to the prior art;

[0130] Figure 15 to Figure 17a Shows the connection to Figure 13 to Figure 14 Patient interface Figures 2 to 12 The corresponding stereogram of the tracheostomy device;

[0131] Fig.17b Show Figures 2 to 12 The tracheostomy protector is Figure 13 to Figure 14 A stereoscopic view of the patient interface when it is disconnected;

[0132] Fig.18 and Fig.19 shows a corresponding perspective view of a tracheostomy guard according to a second embodiment;

[0133] Figure 20 to Figure 21 The tracheostomy protector of the second embodiment is shown connected to Fig.13 and Fig.14 corresponding stereogram of the patient interface;

[0134] Fig. 22 The tracheostomy protector of the second embodiment is shown connected to Fig.13 and Fig.14 Bottom view of the patient interface;

[0135] Figure 23 to Figure 26 shows a corresponding perspective view of a tracheostomy guard according to a third embodiment;

[0136] Fig. 27 The tracheostomy protector of the third embodiment is shown connected to Figure 13 to Figure 14 Stereoscopic view of the patient interface;

[0137] Fig.28 The tracheostomy protector of the third embodiment is shown connected to Figure 13 to Figure 14 The main view of the patient interface;

[0138] Fig.29 The tracheostomy protector of the third embodiment is shown connected to Figure 13 to Figure 14 Rear view of the patient interface;

[0139] Fig.30 The tracheostomy protector of the third embodiment is shown connected to Figure 13 to Figure 14 Rear cross-sectional view of the patient interface;

[0140] Figure 31 to Figure 34 shows a corresponding perspective view and bottom view of a tracheostomy protector according to a fourth embodiment;

[0141] Fig.35 The tracheostomy protector of the fourth embodiment is shown connected to Figure 13 to Figure 14 Stereoscopic view of the patient interface;

[0142] Fig.36 The tracheostomy protector of the fourth embodiment is shown connected to Figure 13 to Figure 14 The main view of the patient interface;

[0143] Fig.37The tracheostomy protector of the fourth embodiment is shown connected to Figure 13 to Figure 14 Rear view of the patient interface;

[0144] Figures 38 to 41 10 respectively show a corresponding perspective view and a bottom view of a tracheostomy protector according to a fifth embodiment;

[0145] Fig.42 The tracheostomy protector of the fifth embodiment is shown connected to Figure 13 to Figure 14 Stereoscopic view of the patient interface;

[0146] Fig.43 The tracheostomy protector of the fifth embodiment is shown connected to Figure 13 to Figure 14 Front view of the patient interface;

[0147] Fig.44 The tracheostomy protector of the fifth embodiment is shown connected to Figure 13 to Figure 14 rear view of the patient interface; and

[0148] Fig.45 A perspective view of an assembly comprising a tracheostomy brace, a tube and a patient interface of a first embodiment is shown. DETAILED DESCRIPTION

[0149] Figure 1a A prior art respiratory support system is shown in which a tracheal coupler, such as the tracheostomy brace disclosed herein, may be incorporated. The exterior of a tracheostomy tube 72 extends out of the neck of a patient 71. A male connector 73 extends from the tracheostomy tube 72. A tracheal connector 74 includes a patient end 75 connected to the male connector 73 of the tracheostomy tube. The tracheal connector 74 includes an outlet end 76 and an inlet tube 77. The inlet tube is connected to a cuff 78 of a breathing tube 80. The breathing tube 80 includes a flexible conduit 79 for supplying breathing gases to the patient. At least a portion 80a of the breathing tube 80, such as a portion 80a of the breathing tube 80 proximal to the patient, is provided. Figure 1b As indicated, a breathable tube made of a breathable material may be provided. A nozzle 81 at the other end of the breathing tube 80 is connected to an outlet connector of a gas flow source. The gas flow source may be a flow generator 83, typically forming part of a respiratory support device arranged to provide a flow of breathing gas to a patient.

[0150] The outlet end 76 of the connector 74 may be arranged to be connected to a conventional tracheostomy guard. Such a conventional tracheostomy guard is arranged to allow fluid at the outlet end 76 to exit the tracheostomy guard through a fixed-sized orifice during airflow therapy, or at least to allow a clinician to aspirate fluid through a fixed-sized orifice. Since high-flow therapy is performed over a relatively wide range of flow rates (see below), it may be difficult to maintain PEEP within appropriate limits over the entire range of flow rates used for high-flow therapy using a conventional tracheostomy guard. In addition, conventional tracheostomy guards may also be prone to clogging when used during high-flow therapy.

[0151] The flow generator 83 may optionally include a humidification system / humidifier including a humidification chamber 84. The flow generator 83 may include an outlet connector 82 configured to be connected to the nozzle 81. The breathing gas can be delivered to the user at an optimal temperature and humidity (37°C, 44mg / L humidity) or near the optimal temperature and humidity when the gas is delivered. Simulating the conditions of healthy adult lungs (37°C, 44mg / L humidity) can help users with respiratory diseases that affect secretion maintain healthy mucociliary function. It is advantageous to use a humidification system / humidifier when providing tracheal therapy because the upper airway is bypassed. In addition, the humidified airflow makes high flow therapy more comfortable and tolerable for the patient.

[0152] The flow generator 83 typically includes a blower that receives air from an air inlet 85 and optionally oxygen from an oxygen supply line 86. The user interface may include a display screen 87 and user controls 88. The user controls may be in the form of buttons located on the housing of the flow generator or combined with the display screen as a touch screen on the flow generator. An example flow generator used in this application is the Fisher & Paykel Healthcare AIRVO 2 TM or AIRVO 3.

[0153] The flow generator 83 includes a flow sensor and feedback control means which monitors the delivered flow rate and varies the blower speed to maintain the output flow of the generator at a level set by the user controls.

[0154] Figure 1c An example of a respiratory support device 90 is shown. The respiratory support device 90 may include a housing 200 (e.g., as a single housing) containing one or more of a flow generator 91, which in some configurations is in the form of a motor / impeller device (e.g., a blower), a humidifier 92 pneumatically connected to the flow generator 91, a controller 93, and a user interface 94 (including, for example, a display and input devices such as buttons, a touch screen, etc.).

[0155] Figure 1dAlso shown is a respiratory support device 90 including a housing 200, illustrating that the components of the respiratory support device 90 (e.g., including a humidifier 92 pneumatically connected to a fluid generator 91) are integrated into a common housing. This provides a compact device that can be easily moved around or carried to provide mobility. In addition, the components of the respiratory support device 90 (e.g., the fluid generator 91 and the humidifier 92) combined in the same housing allow for a simpler setup (i.e., the chamber 300 is located in the housing).

[0156] In some configurations, the respiratory support device 90 may not include a fluid generator 91. In this case, the respiratory support device 90 does not generate an airflow, but is configured to be connected to an external fluid generator and configured to humidify the airflow from the external fluid generator. For example, the respiratory support device 90 can be used as a stand-alone humidifier to humidify the gas flowing through the humidifier. The fluid generator can be a wall air supply device (e.g., regulated by a flow meter or a rotor flow meter) or a ventilator or other separate fluid generator, which can be configured to provide high flow therapy (e.g., NIV, CPAP, BCPAP, etc.). The humidifier can include a battery connected to the humidifier to provide power (as a battery power source) when the main power supply is not available. In some configurations, the battery can be detachably connected to the device and is rechargeable. The humidifier is pneumatically connected to the fluid generator via a conduit, and a separate conduit is connected to the humidifier to deliver the humidified gas from the humidifier to the patient.

[0157] In some examples, the breathing tube 96 is coupled at one end to a gas outlet 97 in the housing 200 of the respiratory support device 90. The breathing tube 96 is coupled at the other end to a patient interface, which for present purposes is provided by a tracheostomy interface and / or a tracheal coupler (e.g., a tracheostomy brace as disclosed herein). As further explained in detail below, it should be understood that the combination of the tracheostomy interface and the tracheal coupler can be non-sealing (i.e., include leaks) in order to produce / provide a flushing effect (further explained below) and reduce the risk of barotrauma.

[0158] A tracheostomy coupler (e.g., a tracheostomy brace and associated patient interface disclosed herein) can be used to provide a high flow therapy for spontaneous breathing of the patient. This means that a significant proportion of the air supplied to the connector is ventilated directly to the room and is not breathed by the patient. As will be further explained below, the tracheostomy brace can be connected, for example, to a tracheostomy or tracheal interface, such as Figure 1a or as indicated by connector 74 in 1b. Figure 1aThe flow generator 83 shown in the figure can be used as a gas source for providing a high flow of gas, and in some configurations, other high flow gas sources can be used, such as air supply from a wall outlet or a ventilator. It should be understood that the tracheostomy guard disclosed herein is not limited to use with any particular type of gas source.

[0159] As previously mentioned, a high airflow environment such as in high flow therapy can be used to flush the airway and reduce dead space, produce positive end-expiratory pressure (PEEP), and optionally produce elevated pressure in the patient's airway. Positive end-expiratory pressure (PEEP) can keep the airway and alveoli collapsed at the end of exhalation and reopen the collapsed airway and alveoli. The therapy supply of PEEP can improve gas exchange (reduced intrapulmonary shunt), reduce the resistance to airflow (pulmonary resistance), and make the lungs less stiff (increased lung compliance). Due to high flow gas delivery, the levels of oxygen and carbon dioxide can also be improved, reducing the need for supplemental oxygen and the feeling of shortness of breath. High flow therapy can also improve the humidity in the lungs to improve mucociliary delivery. PEEP can assist the treatment of obstructive pulmonary disease and heart failure, including emphysema, bronchiectasis, chronic bronchitis, cystic fibrosis and pulmonary edema.

[0160] The high flow therapy discussed herein is intended to give its typical common meaning understood by ordinary technicians in the field, which generally refers to a respiratory assistance device that delivers a target flow of humidified respiratory gas via an intentionally unsealed patient interface at a flow rate that is generally intended to meet or exceed the patient's inspiratory flow rate. Typical patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults generally range from (but are not limited to) about 15 liters per minute to about 60 liters per minute or higher. Typical flow rates for pediatric patients (such as newborns, infants and children) generally range from (but are not limited to) about 1 liter / minute / kilogram of patient weight to about 3 liters / minute / kilogram of patient weight or greater. High flow therapy can also optionally include a gas mixture composition, including the administration of supplemental oxygen and / or therapeutic drugs. High flow therapy is commonly referred to as nasal high flow (NHF), humidified high flow nasal cannula ventilation (HHFNC), nasal high flow oxygen therapy (HFNO), high flow therapy (HFT), or tracheal high flow (THF), as well as other common names. It will be appreciated that the present invention relates particularly to the delivery of high flow therapy via a tracheostomy interface or tracheal coupler.

[0161] For example, in some configurations, for an adult patient, 'high flow therapy' can refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for a neonatal, infant, or pediatric patient, 'high flow therapy' may refer to delivering gas to the patient at a flow rate greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. In some configurations, a high flow therapy device with an adult patient, neonatal, infant, or pediatric patient may deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or at a flow rate in any of the sub-ranges outlined above. The delivered gas may include a percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas can be between about 20% and about 100%, or between about 30% and about 100%, or between about 40% and about 100%, or between about 50% and about 100%, or between about 60% and about 100%, or between about 70% and about 100%, or between about 80% and about 100%, or between about 90% and about 100%, or about 100%, or 100%.

[0162] High flow therapy can effectively meet or exceed the patient's inspiratory flow, increase the patient's oxygenation, and / or reduce the work of breathing.

[0163] High flow therapy may be administered to the patient's nostrils and / or orally or via a tracheostomy interface.

[0164] High flow therapy can produce a flushing effect in the airway, so that the high incoming gas flow flushes the anatomical dead space of the airway. This can produce a reservoir of fresh gas that can be used for each and every breath, while reducing the re-breathing of nitrogen and carbon dioxide. High flow therapy can be delivered with a non-sealed patient interface (such as, for example, a tracheostomy interface (which can be connected to a tracheal coupler and / or a tracheostomy protector)). High flow therapy can slow the patient's respiratory rate. High flow therapy can provide expiratory resistance to the patient.

[0165] High flow therapy may be used to treat patients with obstructive lung disease (eg, COPD, bronchiectasis, dyspnea, cystic fibrosis, emphysema) and / or patients with respiratory distress or hypercapnic patients.

[0166] The term "non-sealed patient interface" (i.e., unsealed patient interface) as used herein may refer to an interface that provides a pneumatic link between a patient's airway and a source of airflow (such as from a flow generator 91) that does not completely block the patient's airway. A non-sealed pneumatic link may include less than about 95% blockage of the patient's airway. A non-sealed pneumatic link may include less than about 90% blockage of the patient's airway. A non-sealed pneumatic link may include between about 40% and about 80% blockage of the patient's airway. The airway may include one or both nostrils of the patient and / or their mouth. For a tracheostomy interface, the airway is through the trachea.

[0167] As will be further explained below, the tracheostomy guards disclosed in various embodiments herein are designed for use in such high airflow environments.

[0168] The tracheostomy guard may allow for the generation of a desired PEEP pressure while still having a desired irrigation effect at a high associated flow rate.

[0169] Figures 2 to 10c Different views of a tracheostomy brace (also referred to as a "tracheal brace") 10 according to a first embodiment are shown. The tracheostomy brace 10 comprises a first portion 11 arranged to be connected to a tracheostomy patient interface 20. The patient interface may for example be a tracheostomy interface, see for example Fig.13 and Fig.14As shown, in use, it is fluidly connected to the first part 11. "Fluid communication" means that when the patient interface 20 is connected to the first part 11, the fluid from the patient interface is allowed to enter the tracheostomy device via the first part 11. The tracheostomy device 10 also includes a second part 12 that is fluidly connected to the first part. When the second part 12 is fluidly connected to the first part 11, any fluid in the tracheostomy device can travel between the first part 11 and the second part 12, or vice versa. The second part 12 includes at least one first member 121 and a second member 122 that form or define an orifice 13 that is fluidly connected to the surrounding environment. The orifice 13 has a variable size, which may also be referred to as an effective size hereinafter. The size can change in response to a force applied to at least a portion of the second part during use, as will be further explained below.

[0170] The force applied to at least a portion of the second portion can be related to the internal pressure within the second portion, the pressure difference between the internal pressure of the second portion 12 and the ambient pressure around the second portion, the pressure associated with the flow of fluid or saliva within the second portion, or a physical force applied by a user, operator or clinician on at least a portion of the second portion, as will be further explained below. In addition, the specific design of the first member 121 and the second member 122, the type of force applied, and which portion of the second portion 12 the force is applied to will affect the manner in which the size of the hole changes, as will be further explained below.

[0171] The second part 12 is connected to the first part 11. When the patient interface 20 is connected to the tracheostomy brace 10, in use, the second part 12 is in fluid communication with the patient interface 20. This means that fluid entering the tracheostomy brace 10 via the first part 11 is allowed to freely enter the second part 12. The reverse is also true, whereby fluid in the second part 12 can freely enter the patient interface 20.

[0172] The size of the orifice 13 may also be referred to hereinafter as the effective size. The size or effective size may actually be related to the area of ​​the orifice 13 at a given point in time. The effective size is associated with and / or affects the flow rate that can theoretically pass through the orifice 13 within a given time increment (assuming that the orifice 13 remains at a certain size within the time increment).

[0173] As can be seen from the first embodiment Figures 2 to 10c As can be seen, the second portion 12 may include a first member 121 and a second member 122. However, as will be described below with reference to Figures 23 to 44 To further explain, the second portion 12 may also include one or more first components 121 .

[0174] The first member 121 and the second member 122 may be relatively arranged to form at least one variable-size aperture 13 .

[0175] See Figures 2 to 12 As shown, the variable-size orifice 13 may be formed or defined between a first peripheral end 1211 of the first member 121 and a second peripheral end 1221 of the second member 122. The respective peripheral ends 1211, 1221 may form respective boundary surfaces of the first member 121 and the second member 122.

[0176] The first member 121 may be arranged to deflect or move relative to the second member 122 in response to an applied force. The deflection or relative movement of the first member relative to the second member 122 changes the size of the variable size aperture 13.

[0177] Additionally, in some configurations, at least a portion of the variable-size orifice 13 may be formed between a region of the first portion or the second portion and the corresponding first member and / or second member. Figure 6 If the first member 121 is not directly attached to the second member 122, at least a portion of the variable-size aperture may be defined between an area of ​​the first portion or the second portion and the respective member 121, 122. For example, Figure 6 The leftmost end of the aperture 13 can be said to be defined by the area of ​​the first portion 11 and the respective members 121 , 122 .

[0178] In one embodiment, the first member 121 can be cantilevered from the first portion 11. Figures 2 to 12 , Figures 15 to 30 This configuration is shown.

[0179] Additionally or alternatively, the second member 122 may be cantilevered from the first portion 11 .

[0180] In an alternative embodiment, the first member 121 can be cantilevered from the second member 122. Additionally or alternatively, the second member 122 can be cantilevered from the first member 121.

[0181] In an alternative embodiment, the first member 121 may be attached to the first portion 11 by an articulation arrangement (not shown), such as a living hinge. The size of the variable-size aperture 13 changes in response to the articulated orientation of the first member 121. The first member 121 and the articulation arrangement may be arranged such that in the rest state, the variable-size aperture 13 reaches its minimum size and the first member 121 is biased back toward the rest state.

[0182] Figure 15 to Figure 17b Shows connection to Figure 13 to Figure 14 Patient interface Figures 2 to 12 Stereoscopic image of a tracheostomy device.

[0183] The first portion 11 may have a shape suitable for coupling with the patient interface 20. For example, the first portion 11 may have a circular, oval, elliptical, hexagonal, octagonal, or square cross-section. The first portion 11 may include a concave end for matching with a convex end of the patient interface 20, the convex end having a shape corresponding to the shape of the concave end, or vice versa.

[0184] When connected to the patient interface 20, the first portion 11 is arranged to enable fluid to flow between the tracheostomy brace 10 and the patient interface 20. This allows airflow and / or saliva to enter the tracheostomy brace 10 from the patient interface 20 via the first portion 11 and to leave the tracheostomy brace 10 via the variable size orifice 13. The second portion 12 together with the first portion 11 forms a cavity of the tracheostomy brace 10 that is able to retain an amount of saliva trapped in the tracheostomy brace 10. This means that the tracheostomy brace 10 can hold a certain amount of saliva before releasing it to the surrounding environment via the variable size orifice 13.

[0185] It should be understood that, depending on the configuration, the patient interface 20 can be connected to the first portion 11 at different depths or distances. In some configurations, the patient interface 20 can be arranged to be connected to the first portion 11. In alternative configurations, the patient interface 20 can be arranged to be connected above and / or around the first portion. When connected, the patient interface 20 will seal the first portion 11.

[0186] When the patient interface 20 is connected to the first portion 11, the terminal portion of the patient interface can be positioned within the first portion 11 in some configurations. However, in other configurations, the terminal portion of the patient interface 20 can be positioned within the second portion 12. The relative penetration depth of the patient interface 20 into the first portion 11 depends on the specific design of the patient interface 20 as well as the design of the first portion 11. Therefore, fluid exiting or entering the patient interface 20 when connected to the first portion 11 can therefore flow through the cavity formed by the first portion 11, the cavity formed by the second portion 12, or the cavity shared by the first portion 11 and the second portion 12, depending on the actual design.

[0187] The cavity formed by the second portion 12 is designed to retain an amount of saliva captured in the tracheostomy brace 10. Throughout the embodiments disclosed herein, the cavity of the second portion 12 is in fluid communication with the patient interface 20 when connected to the first portion 11 .

[0188] The first member 121 and / or the second member 122 may include one or more flaps or panels. The first member 121 and / or the second member 122 or its flaps or panels may be configured to move in both directions, so as to move or deflect relative to each other inwardly and outwardly in response to a force applied to at least a portion of the second portion 12 during use.

[0189] The first member 121 and / or the second member 122 may be physically arranged such that the size of the variable size aperture 13 is greater than zero during bidirectional movement caused by a force applied to at least a portion of the second portion 12. A size greater than zero means that the variable size aperture is always open, allowing airflow and saliva release therethrough.

[0190] Furthermore, a size greater than zero means that the variable size orifice 13 is always open. It will be appreciated that saliva may be initially retained by the second portion 12 and subsequently released in a delayed / controlled manner when a certain level or amount is reached within the second portion 12.

[0191] The first member 121 and / or the second member 122 may be arranged such that their peripheral ends 1211 , 1221 do not engage each other or other parts of the tracheostomy mask 10 in use in response to a force applied to at least a portion of the second portion.

[0192] By arranging the first member 121 and the second member 122 so that there is a distance between the first member 121 and the second member 122 for all relative positions, respectively, the variable size orifice 13 formed or defined therebetween will remain open, and in use, gas will be allowed to flow through the variable size orifice 13, regardless of the magnitude or degree of the force applied. Because the peripheral end 1211 of the first member 121 and the peripheral end 1221 of the second member 122 do not engage with each other or engage with other parts of the tracheostomy protector 10, the variable size orifice 13 forms a non-blocking passage that allows gas to flow through, regardless of the magnitude of the force applied to at least a portion of the second part. Therefore, the first member 121 and / or the second member 122 are arranged so as not to completely prevent gas from flowing inwardly or outwardly through the tracheostomy protector 10. This is advantageous in terms of patient safety, because in the event that the flow generator stops operating, the patient can breathe through (e.g., directly through) the orifice 13. In addition, the orifice 13 is always kept open, and the first member and / or the second member and / or their respective flaps are bidirectional, further allowing this technical effect.

[0193] Furthermore, as mentioned above, in high flow therapy, a large portion of the air supplied to the connector is exhausted directly to the room without being breathed by the patient, so the orifice should always be open, or able to be opened. However, at the same time, it is desirable to provide PEEP requiring resistance during the expiratory phase. See Figures 2 to 12The disclosed tracheostomy guard 10 can meet these two requirements: the variable-sized orifice 13 biased towards a closed or relatively or substantially closed position can provide resistance to expiratory airflow, thereby facilitating the provision of PEEP, while the design of the orifice 13 can also ensure that a path for escaping air is always open. These two aspects can also have a further synergistic effect, namely, any obstruction of the orifice 13 can immediately cause a pressure increase within the second portion 12, thereby in turn causing the orifice 13 to be pushed open.

[0194] In some embodiments, the first member 121 may be arranged to move or deflect 1 to 3 mm under normal operating conditions, although greater deflections may occur when saliva or secretions are expelled.

[0195] See Figures 2 to 12 As shown, the first member 121 can be shaped to include a partial tubular portion 1212 extending longitudinally from the first portion 11. In addition, the first member 121 can further include a partial hemispherical terminal portion 1213 extending longitudinally from the partial tubular portion 1212 away from the first portion 11. It can be said that the outer peripheral end 1211 of the first member 121 extends along the boundary of the partial tubular portion 1212 and the partial hemispherical terminal portion 1213. Such a shape can provide the first member 121 with desired deformation characteristics.

[0196] By providing the first member 121 with a partial tubular portion 1212 and a partial hemispherical terminal portion 1213, the degree of deflection and movement of the first member 121 can be more easily controlled. This can be achieved by providing the first member 121 with desired deformation characteristics, such as a certain degree of rigidity to prevent premature and / or excessive deflection of the first member 121, and also providing a certain degree of flexibility required to ensure or allow the first member 121 to deflect in a controlled manner in response to an applied force. In addition, this configuration can further reduce or mitigate the effects of aeroelastic flutter of the first member 121.

[0197] By providing the thickness of the first member 121 to be less than the thickness of the second member 122 , in use, the first member 121 will deflect or move to a greater extent than the second member 122 in response to a force applied to at least a portion of the second portion 12 .

[0198] However, other configurations are also within the scope of the present invention. For example, even if they have the same thickness, the desired deflection behavior of the first member 121 relative to the second member can be achieved by their relative proportions (such as, the first member 121 has a "shallower" cross-section than the second member 122). It is even within the scope of the present invention that the first and second members 121, 122 are substantially identical, wherein both are configured and dimensioned to deflect in response to an applied force so as to change the effective size of the orifice 13, wherein when saliva accumulates in or on the first member 121, the deflection of the first member 121 is additionally provided by gravity.

[0199] In addition, the first member 122 is provided with a partial tubular portion and a partial hemispherical terminal portion, which can more easily control the degree of deflection and movement of the first member. Moreover, this shape can reduce or mitigate the impact of aeroelastic flutter of the first member 121.

[0200] Similar to the first member 121, the second member 122 may be formed to include a partial tubular portion 1222 extending longitudinally from the first portion 11. In addition, the second member 122 may also include a partial hemispherical terminal portion 1223 extending longitudinally from the partial tubular portion 1222 away from the first portion 11. The outer peripheral end 1221 of the second member 122 can be said to extend along the boundary of the partial tubular portion 1222 and the partial hemispherical terminal portion 1223.

[0201] The partial tubular portion 1212 of the first member 121 and the partial tubular portion 1222 of the second member 122 may be arranged to form a substantially cylindrical cavity therebetween within the tracheostomy brace 10. The partial hemispherical terminal portion 1213 of the first member 121 and the partial hemispherical terminal portion 1223 of the second member 122 may be arranged to form a substantially hemispherical cavity therebetween within the tracheostomy brace 10.

[0202] Thus, the cavity formed or defined between the first member 121 and the second member 122 may include a substantially cylindrical portion and a terminal hemispherical portion.

[0203] As from Figures 2 to 12 It can be observed that the partially hemispherical terminal portion 1223 of the second member 122 can extend longitudinally beyond the corresponding partially hemispherical terminal portion 1213 of the first member 121. This configuration can be used to deflect or direct gas or saliva toward the variable size orifice 13 formed or defined between the first and second members 121,122.

[0204] Figures 2 to 12The configuration (the second member 122 overlaps and protrudes beyond the first member 121) can also help the orifice 13 to remain open, even in the absence of an applied force, because the first member 121 is smaller than the second member 122, and the gap between them forms the orifice 13. In addition, since the orifice 13 generally faces downward in this configuration, the explosively discharged saliva will tend to be captured and redirected in a controlled manner by the partially hemispherical terminal portion 1223 of the second member 122, rather than immediately and forcefully exiting through the orifice 13. In addition, when the second member 122 is arranged above the first member 121, in the "in use" configuration, gravity can act to assist in releasing the deflected saliva via the partially hemispherical terminal portion 1223 of the second member 122.

[0205] In this embodiment, the first member 121 can be arranged to deflect or deform not only due to gravity and its own weight. For example, the above-mentioned shape of the first member 121 (including the partially hemispherical terminal portion 1213) is designed to deflect or deform not only due to gravity and the weight of the first member 121. To this end, the non-planar arrangement of the first member 121 can be conducive to achieving this effect.

[0206] It should be understood that other shapes of the second portion, the first member and the second member are possible, such as Figures 23 to 44 those shapes shown or any other suitable shape.

[0207] Thus, while some tracheostomy guards disclosed herein have a substantially convex hemispherical terminal portion 1213, 1223, it will be appreciated that this may alternatively be substantially planar, or have a concave curvature referenced to a given reference point within the tracheostomy guard.

[0208] The variable size orifice 13 may be formed or defined at least in part by the peripheral end 1211 of the first member 121 and the peripheral end 1221 of the second member 122. Each corresponding peripheral end may thus serve as an orifice boundary or wall. In addition, one or more portions of the first portion 11 or the second portion 12 may serve as an orifice boundary or wall.

[0209] Thus, the first member 121 and the second member 122 may have corresponding shapes, such as shapes that complement each other, that form the variable-sized aperture 13 therebetween.

[0210] The size of the variable size orifice 13 may be related to the cross-sectional size of the orifice 13 .

[0211] Additionally or alternatively, the size of the variable size orifice 13 may be related to an area formed or defined between the peripheral ends 1211 of the first member 121 and / or the peripheral ends 1221 of the second member 122, and / or a portion of the first portion 11 of the boundary wall that optionally forms or defines the orifice 13. This area may be defined as a non-obstructed area or passage that allows gas flow and, optionally, saliva or secretions to be released therethrough.

[0212] refer to Figures 2 to 12 as well as Figure 15 to Figure 17b , the variable size orifice 13 can be said to be in the joint plane (in Figure 2 The joint plane is formed by the longitudinal center axis of the tracheostomy guard 10 (in Figure 2 The middle plane marked as A1 in the figure is offset by a vertical distance. Figure 2 It can be observed that the middle plane A1 extends through the first portion 11 and the second portion 12. Figure 2 , the joint plane can be arranged below such an intermediate plane.

[0213] However, it should be understood that the joint plane can be offset by different vertical distances, which in turn affects the stiffness of the first member 121 and / or the second member 122. A larger offset (i.e., a greater vertical distance from the mid-plane / longitudinal center axis) can result in a more compliant first member 121, while a smaller offset can provide a stiffer first member 121.

[0214] This is because, assuming that the outer dimensions of the second portion are fixed, a larger offset, i.e., a larger vertical distance from the midplane / longitudinal center axis, results in a relatively "shallower" cross-section of the first member 121, which can result in a more compliant first member 121. On the other hand, a smaller offset resulting in a relatively "deeper" cross-section of the first member 121 can provide a stiffer first member 121.

[0215] refer to Figures 2 to 12 , the second portion 12 including the first member 121 and the second member 122 may extend longitudinally away from the first portion 11 with reference to the longitudinal axis of the first portion 11. Figure 2 As can be observed in FIG. 1 , the second portion 12 extends away from the first portion 11 towards the right hand side in this way. This means that both the first member 121 and the second member 122 can extend away from the first portion 11, for example longitudinally. Figures 2 to 6 as well as Figures 10a to 10c As can be observed in FIG. 1 , the second member 122 can extend beyond (eg longitudinally beyond) the first member 121 and given the partially hemispherical peripheral terminal portion 1223 , the second member 122 can thus deflect the gas flow and / or saliva towards the orifice 13 .

[0216] In use, it is advantageous when the second member 122 is arranged above the first member 121 with reference to the intended orientation of the tracheostomy guard 10. In this configuration, the variable-size aperture 13 is in fluid communication with the surrounding environment below the tracheostomy guard 10 in use. As will be further explained below, in this configuration, gravity can assist in deflecting the first member 121 outwardly (i.e., downwardly with reference to the intended orientation of use of the tracheostomy guard) so as to allow improved release of saliva contained in the second portion 12.

[0217] In some embodiments, the first portion 11 is integrally formed with the second portion 12. Thus, a portion of the first member 121 may be integrally formed with the first portion 11, and additionally or alternatively, a portion of the second member 122 may be integrally formed with the first portion 11.

[0218] When integrally formed, the thickness of the first member 121 may be arranged to be different from that of the second member 122. In use, the thinner member will deflect or move more easily in response to a force applied to at least a portion of the second portion 12. Figures 2 to 12 In the embodiment shown, the first member 121 has a thickness that is less than the thickness of the second member 122. This means that, in use, the first member 121 will deflect or move to a greater extent than the second member 122 in response to any given force applied to at least a portion of the second portion 12.

[0219] As will be explained further below, in use, the force applied to at least a portion of the second portion may be caused by a pressure within the second portion 12 .

[0220] Although some of the figures disclosed herein show a tracheostomy brace in a unitary configuration, it should be appreciated that a tracheostomy brace according to some embodiments may alternatively be subdivided into multiple components made of different materials.

[0221] Therefore, it should be understood that the first part 11 and the second part 12 need not be integrally formed. In some embodiments, the second part 12 is releasably attached to the first part 11. The second part 12 may additionally or alternatively be sealingly attached to the first part 11.

[0222] refer to Figures 2 to 12 as well as Figure 15 to Figure 17b In the tracheostomy device 10, in use, the cavity formed or defined by the first part 11 and the second part 12, or alternatively formed by the second part 12 itself, is in fluid communication with the surrounding environment only through the variable-sized orifice 13. Although the first part 11 allows fluid to access the cavity via the patient interface 20, in use, the environment within the patient interface 20 is independent of the environment of the surrounding environment.

[0223] Figures 2 to 12 as well as Figure 15 to Figure 17b The tracheostomy device 10 can be said to have two access points to the cavity therein, one access point formed by the first portion 11 in fluid communication with the patient interface 20 (ie, the non-ambient environment) and one access point formed by the orifice 13 in fluid communication with the ambient environment.

[0224] As will be further explained below, the tracheostomy guard 10 may be provided with more than one variable-sized orifice 13 (see Figures 38 to 44 As shown), each orifice is connected to the surrounding fluid.

[0225] It should also be appreciated that according to some embodiments, one or more constant size (ie, non-variable size) orifices in fluid communication with the surrounding environment may be used in combination with a variable size orifice.

[0226] When undergoing invasive or high flow ventilation, there is a risk that the patient may attempt to remove or adjust the patient interface 20 due to perceived discomfort. Therefore, the at least one variable size orifice 13 of the tracheostomy guard 10 may be positioned and / or shaped to prevent such interference. For example, in use, by arranging the variable size orifice 13 on the bottom or underside of the tracheostomy guard 10 so as to be oriented downward, patient interference may be reduced and excess saliva may be allowed to be removed or drained by gravity. Alternatively or additionally, by arranging the variable size orifice 13 on the top side of the tracheostomy guard 10 (relative to the orientation of the tracheostomy guard 10 in use), patient interference may be reduced.

[0227] The first member 121 may have a first material or structural feature, and the second member 122 may have a second material or structural feature. These first and second materials or structural features are selected to allow the size of the variable size orifice 13 to change in response to an applied force.

[0228] According to some embodiments, the first material or structural feature and the second material or structural feature relate to at least one of the following: stiffness, hardness, flexibility, elastic modulus, section moment of inertia, length, width, and thickness.

[0229] The first material and the second material or structural feature can be provided by the profile and / or cross-section and / or size of the first member 121 and the second member 122, respectively, or in part by the profile and / or cross-section and / or size of the first member 121 and the second member 122. For example, as described above, Figures 2 to 12 In an embodiment, for a given material and a given thickness, a first member 121 having a relatively "shallow" cross-section will deflect more easily than a first member 121 having a relatively "deep" cross-section.

[0230] In some embodiments, the second member 122 can be more rigid than the first member 121. Additionally or alternatively, the second member 122 can be substantially stiff to prevent the expiratory airway from being nearly completely blocked by an external object (e.g., a user's hand) striking the outer surface of the second member 122. Additionally or alternatively, the second member 122 can be substantially stiff to redirect saliva that is advanced from the tracheostomy tube and strikes the inner surface of the second member 122.

[0231] As described above, the first material or structural feature and the second material or structural feature may be related to the thickness or the section moment of inertia of the first member 121 or the second member 122. For example, Figure 10a to Figure 10c It can be observed that the thickness of the first member 121 is less than (i.e., thinner than) the thickness of the second member 122, which in turn allows the first member 121 to be arranged or attached to the first portion 11 in consideration of the manner in which the first member 121 is arranged or attached to the first portion 11. Fig.10a It is shown reversibly deflecting inwardly or outwardly relative to its resting state of the second member 122. Increased thickness may result in increased stiffness and vice versa, so by simply making the second member 122 thicker than the first member 121, in response to any given force applied to at least a portion of the second portion 12 in use, the first member 121 will deflect or move to a greater extent than the second member 122.

[0232] In some embodiments, the tracheostomy guard 10, the first portion 11, the second portion 12, the first member 121 and / or the second member 122 can be made of a polymer, a thermosetting or thermoplastic polymer. In some embodiments, the polymer is an elastomer. In some embodiments, the polymer is a thermoplastic elastomer. It should be understood that one or more components of the tracheostomy guard 10 can be made of different materials.

[0233] In some embodiments, the tracheostomy guard 10 is made of a single material.

[0234] The first material or structural feature and / or the second material or structural feature may be selected to achieve reversible deformation of the first member 121 and / or the second member 122 in use based on a force applied to at least a portion of the second portion 12. The size of the variable-size orifice 13 may change based on or in response to the reversible deformation. The reversible deformation may be referred to as elastic deformation, wherein the associated material returns to its original resting state shape after the associated load of the applied force has been removed.

[0235] Reversible deformation therefore means that once the applied force causing the deformation is removed, the material in question will return to its resting state. Typically, elastic materials allow reversible deformation.

[0236] In some embodiments, reversible deformation may be associated with a material being deflected or bent or flexed or otherwise deformed from its resting state.

[0237] The material or structural features of the first member 121 may be selected so that the first member 121 is biased toward or toward its resting state, such as Fig.10a As shown, due to the elastic properties of the material. Additionally or alternatively, additional structural features such as ribs or reinforcing features (including increased thickness) can be used to further enhance the behavior or tendency of the first member 121 in use to approach or move back to its resting state when the force applied to at least a portion of the second portion 12 is removed.

[0238] In some embodiments, the first member 121 is sufficiently flexible to allow suction.

[0239] The tracheostomy guard 10 disclosed herein is particularly designed to be suitable for high-flow tracheostomy. In high-flow tracheostomy, the flow rate typically varies between about 1 l / min and 150 l / min, depending on the type of patient. For example, for a neonate or pediatric patient, the high flow rate may typically be in the range of about 1 l / min to about 30 l / min. For most adults, the high flow rate may be in the range of about 20 l / min to about 80 l / min. In addition, compared to the prior art, the tracheostomy guard disclosed with reference to various embodiments herein is provided with a variable-size orifice 13, the size of which changes in a controlled manner in response to a force applied to at least a portion of the second portion 12 under normal operating conditions. This means that even for high-flow applications, the tracheostomy guard 10 allows a favorable high PEEP to be maintained while still allowing the release of secretions and saliva.

[0240] Therefore, according to some embodiments, the variable size of the orifice 13 is configured to allow saliva to be released therethrough in response to an applied force during use. This reduces the risk of clogging or blockage of the patient interface 20. Blockage may adversely lead to barotrauma and / or accumulation of CO2, which may further lead to rebreathing of CO2. The variable size orifice 13 disclosed herein allows a path, such as an escape path for gas exhaled from a patient. To this end, it should be understood that although the fixed size orifice (or PEEP valve device) of the prior art can provide increased PEEP at higher flow rates, this configuration is more susceptible to clogging due to saliva or secretions. The deflection of the reversibly deformable first member 121 and / or second member 122 disclosed herein allows the size of the variable size orifice 13 to be changed, thereby reducing the risk of blockage.

[0241] Furthermore, utilizing the variable size orifice 13, the tracheostomy device 10 according to some embodiments can provide a desired PEEP within a given high gas flow rate range while allowing for the release of saliva or secretions.

[0242] As a non-limiting example, a tracheostomy device according to some embodiments may allow PEEP to be achieved during use:

[0243] 1 to 3 cm H20 at a flow rate of 20 l / min

[0244] 2 to 3.2 cmH20 at a flow rate of 30 l / min,

[0245] 2.5 to 3.6 cm H20 at a flow rate of 40 l / min,

[0246] 3.3 to 4.5 cm H20 at a flow rate of 50 l / min,

[0247] 3.8 to 5.2 cm H20 at a flow rate of 60 l / min, or

[0248] 4.5 to 6 cm H20 at a flow rate of 70 l / min.

[0249] According to some embodiments, the variable size of the orifice 13 is configured to achieve a set minimum positive end-expiratory pressure (PEEP) in use. The set minimum PEEP can be selected from the following range: 1 cm H20 to 7 cm H20. As indicated above, the PEEP achieved depends on the flow rate, and the choice of setting the minimum PEEP is determined by the clinician.

[0250] It will be appreciated that for any given gas flow rate, decreasing the size of the variable size orifice 13 will generally increase PEEP, and vice versa.

[0251] Depending on the degree of applied force experienced by at least a portion of the second portion 12 , in use the relative orientation between the first and second members 121 , 122 will change, causing the size of the aperture 13 formed or defined therebetween to change or vary.

[0252] In use, a force applied to at least a portion of the second part 12, which in turn changes the size of the variable-size orifice 13 by changing the relative orientation of the first member 121 and the second member 122, may be related to, associated with, or at least partially caused by the internal pressure of the second part 12 or the pressure therein.

[0253] The respective configurations, shapes, material characteristics, and / or structural features of the first member 121 and the second member 122 affect how the first member 121 and / or the second member 122 will behave in terms of movement and / or deflection when a force is applied. This in turn affects how the components of the first member 121 and the second member 122 will behave when experiencing an applied force. In addition, the portion to which the force of the second portion is applied (e.g., at least a portion of the first member 121 and / or the second member 122) will affect how the first member 121 and the second member 122 will behave when experiencing an applied force.

[0254] For example, when considering the structural features alone, if both the first member 121 and the second member 122 are made of the same material, and the first member 121 is made thinner than the second member 122, then for a given configuration, when subjected to the same applied force, the first member 121 will tend to move or deflect from its original orientation to a greater extent than the second member 122. This situation can be Figure 10a to Figure 10c It is observed that the first member 121 is made thinner than the second member 122.

[0255] As further explained herein, the configuration and / or shape of the respective components 121 , 122 also influences the behavior of the components 121 , 122 in terms of movement and / or deflection when experiencing an applied force.

[0256] In at least one example, the second member 122 is designed to provide less or substantially less deflection than the first member 121 when subjected to a given applied force. Figures 10a to 10c The second member 122 is designed to provide substantially less deflection than the first member 121 when subjected to an applied force.

[0257] The internal pressure of the second portion 12 may be at least partially related to the internal gas pressure within the cavity formed by the first portion 11 and the second portion 12. Additionally or alternatively, the internal pressure may be at least partially related to the pressure formed by the weight of saliva or secretions acting on the second portion 12 (e.g., the first member 121 thereof) in use. The force applied to at least a portion of the second portion 12 (such as a force applied to the second portion 12 or at least a portion of the second portion 12) may be at least partially related to the weight of saliva or secretions present in the second portion 12 in use.

[0258] The force applied to at least a portion of the second portion 12 in use may also be related to the gas flow rate in the tracheostomy guard 10. For example, when a patient coughs, an increased gas flow rate through the tracheostomy guard 10 will result in an increased force applied to at least a portion of the second portion 12 (e.g., the first member 121 and / or the second member 122 thereof), such that the size of the orifice 13 changes accordingly.

[0259] In use, according to some embodiments, the force applied to at least a portion of the second portion 12 can be referred to as an operating force, which depends on, among other things, the supplied gas flow rate, the patient's breathing cycle, sudden pressure changes due to the patient's coughing, and / or the amount of saliva or secretions present in the tracheostomy guard 10.

[0260] Additionally or alternatively, the force applied to at least a portion of the second portion 12 may further relate to a physical force, such as a force applied by a user (e.g., a clinician) to deform the first member 121 and / or the second member 122 to change the size of the variable-size orifice 13. Alternatively, the physical force may be applied by means of a tool (e.g., a suction catheter) inserted through the orifice 13 during use.

[0261] In some embodiments, the applied force, i.e., the force applied to at least a portion of the second portion, is related to the resultant or net force of all forces acting on the second portion 12 or its associated portion (including its first member 121 and / or second member 122).

[0262] In some embodiments, the size of the variable sized orifice 13 changes when positive and / or negative net forces are applied to the second portion 12 or a portion thereof, including the first member 121 and / or the second member 122 thereof. Thus, the size of the variable sized orifice 13 changes due to the positive and / or negative net forces applied to the second portion 12 or a portion thereof, including the first member 121 and / or the second member 122 thereof. A positive net force is defined herein as a force, such as a force acting on at least a portion of the second portion 12, having a component directed outward from the second portion 12 toward the surroundings. A negative net force is defined herein as a force, such as a force acting on at least a portion of the second portion 12, having a component directed inward from the surroundings or toward the second portion 12. When the net force is zero, the tracheostomy brace 10 can be said to be in its rest state. In other words, the rest state can be defined as a resting or equilibrium state in which all external forces acting on the tracheostomy brace 10 are in equilibrium. For example, the tracheostomy brace 10 may be in its resting state when not connected to the patient interface 20 or when connected to the patient interface 20 but not connected to the flow generator in use, whereby the internal pressure of the second portion 12 is equal to the ambient pressure.

[0263] In some embodiments, the applied net force may also be referred to as or related to the relative pressure difference between the internal pressure acting on the second portion 12 and the external pressure acting on the second portion 12. Thus, when the internal pressure is higher than the external pressure, the applied force may be said to be associated with a positive relative pressure difference, and vice versa, which in turn acts to change the size of the variable size orifice 13.

[0264] The dimensions of the tracheostomy guard 10 may be selected so that it does not obstruct the patient and / or caregiver, but provides an adequate occlusive barrier and / or is capable of deflecting patient secretions so that they do not communicate with the caregiver or are otherwise drained or projected into the environment in an uncontrolled manner.

[0265] In some embodiments, the area of ​​the variable-size orifice 13 in the static state is about 25 to 30 mm. 2 , for example 27mm 2 .

[0266] As previously described, in use, the variable size aperture 13 formed or defined between the first and second members 121, 122 will change size in response to a force applied to at least a portion of the second portion 12. The applied force affects the relative position between the first and second members 121, 122.

[0267] In some embodiments, for example, reference Figures 10a to 10c , the first member 121 may be arranged to move relative to the second member 122 in response to an applied force, thereby changing the size of the variable size orifice 13 .

[0268] Whether the size of the variable-size orifice 13 increases or decreases depends on a change in the force applied to at least a portion of the second portion 12. For example, when the applied force involves and / or includes a positive force, defined as a force having a component directed outward from the second portion (i.e., outward from the second portion) toward the surrounding environment, this will cause the first member 121 and / or the second member 122 to deflect or move outward.

[0269] Additionally or alternatively, the size of the variable size orifice may also be affected by which part of the second portion the force is applied.

[0270] When the applied force involves and / or includes a negative net force, defined as a force having a component directed inwardly from the surroundings toward the second portion 12 (ie, inwardly from the surroundings), this will cause the first member 121 and / or second member 122 to deflect or move inwardly.

[0271] For all configurations except the static state where the variable sized orifice 13 reaches its minimum size, the size of the variable sized orifice 13 will decrease in response to a negative change in the resultant force, and increase in response to a positive change in the generated force. Therefore, for any given orientation except the static state, when a negative change in the resultant force occurs, the size of the variable sized orifice 13 will decrease. Here, a negative change in the resultant force means a situation where the new resultant force is less than or lower than the original resultant force before the change. In addition, for any given orientation except the static state, when a positive change in the resultant force occurs, the size of the variable sized orifice 13 will increase. Here, a positive change in the resultant force means a situation where the new resultant force is greater than or higher than the original resultant force before the change. In other words, larger and higher in this article means a larger magnitude of the relevant resultant force.

[0272] Under certain conditions (e.g., for symmetrical orifice configurations where negative and positive resultant forces of the same magnitude or absolute value come to the same size, or for asymmetrical orifice configurations where no intersecting resting states exist), if the absolute value (i.e., magnitude) of the resultant force decreases (i.e., becomes smaller), the size of the variable-size orifice 13 can be said to decrease, and if the absolute value (i.e., magnitude) of the resultant force increases (i.e., becomes larger), the size of the variable-size orifice 13 increases. Under these conditions, for any given orientation other than resting state, when the absolute value (magnitude) of the resultant force decreases, the size of the variable-size orifice 13 will decrease. Furthermore, under these conditions, for any given orientation other than resting state, when the absolute value (magnitude) of the resultant force increases, the size of the variable-size orifice 13 will increase.

[0273] Figures 10a to 10c The tracheostomy guard 10 of the first embodiment is shown in respective cross-sectional views when subjected to three different forces applied to at least a portion of the second portion 12. The different applied forces each cause the first member 121 to move relative to the second member 122, thereby changing the size of the variable size orifice 13. Fig.10a The tracheostomy guard 10 is shown in its rest state, ie, wherein the size of the variable-size aperture reaches its minimum size. In this configuration, all net forces acting on at least a portion of the second portion 12 are in equilibrium. Fig.10b FIG. 1 shows a case where a negative resultant force is applied to at least a portion of the second portion 12. Due to the negative change in the resultant force, the first member 121 is moved from Fig.10a Its resting position is shown deflected or displaced inwardly. Fig.10b Configuration may occur, for example, in situations where patient interface 20 is fully or partially obstructed, or gas flow from the gas source is fully or partially obstructed and the patient is unlikely to inhale. Fig.10c1 represents the configuration of the tracheostomy guard 10 when a positive force is applied to at least a portion of the second portion 12 in use. As previously described, the positive force may be caused by the gas flow rate provided to the patient from the gas source via the patient interface 20, the patient's exhalation, the patient's coughing, or by the weight of saliva (not shown) acting on at least a portion of the second portion 12 (e.g., the first member 121 and / or the second member 122).

[0274] If the applied force (eg, the resultant applied force) decreases, then when the tracheostomy guard 10 is already on the negative force side of its resting configuration, i.e., when the first member 121 (eg, Fig.10b shown) and / or the second member 122 ( Fig.10b cannot be observed in the case of Fig.10b When the variable size orifice 13 is deflected or moved inwardly from the resting state (which may be essentially negligible for a particular design), the variable size orifice 13 will increase as the negative force side of the tracheostomy guard 10 configured in the resting state moves further and further away from the resting state.

[0275] When the tracheostomy device is in the negative force side of its rest state configuration, this means that the net force applied to the second portion is defined as negative. In other words, all forces acting inwardly on the second portion or at least a portion thereof are greater than those forces acting outwardly on the second portion. In this configuration, at least one first member will deflect inwardly.

[0276] When the tracheostomy device is in the positive force side of its rest state configuration, this means that the net force applied to the second portion is defined as positive. In other words, all forces acting inwardly on the second portion or at least a portion thereof are less than those forces acting outwardly on the second portion. In this configuration, at least one first member will deflect outwardly.

[0277] When the tracheostomy device is already in its rest state, this means that the resultant force applied to the second portion is defined as zero. In the rest state, all forces acting inwardly on the second portion or at least a portion thereof are balanced with those acting outwardly on the second portion. In this configuration, the at least one first member can neither deflect inwardly nor outwardly.

[0278] Depending on how all forces acting inwardly on the second portion and all forces acting outwardly on the second portion vary over time, this will affect whether the tracheostomy device will reach the negative force side, the positive force side, or the static state.

[0279] For the sake of completeness, it should be noted that an increase in the absolute value of the applied negative net force may be referred to as a "decrease" in the sense of becoming a more negative value. However, in this specification, the term "increase / decrease in absolute value" is used to refer to a change in the magnitude of the force itself; and "positive / negative" is used to refer to the general direction of the force, with "positive" indicating that the force acts in an outward direction relative to the second portion, and "negative" indicating that the force acts in an inward direction relative to the second portion.

[0280] On the other hand, if the applied force (e.g., the resultant applied force) decreases, when the tracheostomy guard 10 is already on the positive force side of its resting configuration, i.e., when the first member 121 and / or the second member 122 is deflected or moved outwardly from the resting state, e.g. Fig.10c In the embodiment, the variable size orifice 13 will become smaller as the applied force to bring the configuration closer to the static state decreases, but after Fig.10a After the resting state shown, as long as the applied force is still decreasing, the variable size orifice 13 will increase as the tracheostomy guard 10 is configured on the negative force side of the resting state and moves further and further away from the resting state, as shown in FIG. Fig.10b shown.

[0281] Alternatively or additionally, if the absolute value of the applied positive force decreases, the variable size orifice 13 will decrease, since a decrease in the absolute value of the applied force will bring the configuration closer to a static state (eg, Fig.10a However, if a negative force (i.e., an inward force) is applied (or continues to be applied) after the tracheostomy guard 10 has reached the resting state, the variable-size orifice 13 will increase as the tracheostomy guard 10 is configured on the negative force side of the resting state and moves further and further away from the resting state, as shown in FIG. Fig.10b shown.

[0282] Depending on the resultant positive or negative applied force acting on at least a portion of the second portion 12, the size of the variable-size orifice may eventually stabilize (i.e., reach a state of equilibrium) and be maintained until the applied force is further changed. In this stable state, the first member 121 and the second member 122 will maintain their respective orientations and deflections.

[0283] If the applied force increases when the tracheostomy guard 10 is already on the positive force side of its resting state configuration (e.g., when subjected to a positive outwardly acting resultant applied force and the positive resultant applied force increases), the variable size orifice will increase as the tracheostomy guard configuration moves further and further away from the resting state from the positive force side of the resting state.

[0284] On the other hand, if the tracheostomy guard 10 is already on the positive force side of its resting state configuration (i.e., subject to a positive (outwardly acting) resultant applied force), and the absolute value of the positive resultant applied force decreases, then the variable size orifice will decrease as the tracheostomy guard configuration moves closer to the resting state.

[0285] On the other hand, if the applied force increases (eg, is subjected to a negative (inwardly acting) resultant applied force) when the tracheostomy guard 10 is already on the negative force side of its resting configuration, such as Fig.10b As shown, and the absolute value of the negative resultant applied force decreases, the variable size orifice will decrease because the increase in applied force causes the configuration to be closer to the static state, as shown in FIG. Fig.10a As shown, however, after passing the resting state, the variable size orifice will increase as the positive force side of the tracheostomy guard configured in the resting state moves further and further away from the resting state, as shown. Fig.10c shown.

[0286] In this way, it can be said that the variable size orifice is reduced because a decrease in the amplitude of the applied force will bring the configuration closer to the static state, e.g. Fig.10a shown.

[0287] On the other hand, if the tracheostomy device 10 is already on the negative force side of its rest configuration (i.e., subjected to a negative (inwardly acting) resultant applied force), such as Fig.10b As shown, and as the absolute value of the negative resultant applied force increases, the variable size orifice will increase because the increase in the magnitude of the applied force will urge the first member 121 further inward and away from the rest state.

[0288] It will be appreciated that the second portion 12 is configured so that the orifice size can be increased in a bidirectional manner; that is, the minimum size of the orifice is when the second portion 12 is in the resting state, and an applied force (whether inward (negative) or outward (positive) direction) causes the orifice size to increase by pushing the first member 121 away from the resting state (whether inward or outward). It will also be appreciated that if the first member, which has been displaced, is returned toward the resting state, and a force is applied or continues to be applied in the other direction, the first member 121 will move past the resting state, thereby increasing the size of the orifice again. Thus, if the tracheostomy brace 10 is on the negative force side of its resting state and the absolute value (magnitude) of the negative resultant applied force decreases, the first member 121 will move toward the resting state until the resultant applied force becomes or passes through zero, at which point the tracheostomy brace reaches its resting state. If a positive resultant applied force is then applied, the first member 121 will move outward away from the resting state.

[0289] As described above, depending on the magnitude of the applied force, such as the resultant applied force, the system can reach an equilibrium state in which the size of the variable-size orifice will stabilize and be maintained until the applied force is further changed. In this stable state, the first member 121 and the second member 122 will maintain their respective orientations and deflections.

[0290] Any change in the applied force (e.g., a change in its relative absolute value) from the rest state configuration will result in an increase in the size of the variable size orifice. For example, if the tracheostomy brace is in its rest state and is subjected to a negative net force, the first member 121 and / or the second member 122 will deflect inwardly and the size of the variable size orifice will increase. On the other hand, if the tracheostomy brace is in its rest state and is subjected to a positive net force, the first member 121 and / or the second member 122 will deflect outwardly, whereby the size of the variable size orifice will also increase.

[0291] As noted elsewhere, it will be appreciated that the net force applied may be at least partially related to or caused by the pressure within the second portion 12 of the tracheostomy guard 10, the ambient pressure outside the second portion 12 of the tracheostomy guard 10, and / or the pressure differential between the interior of the second portion 12 and the ambient environment outside / around the second portion 12. Alternatively or additionally, it will be appreciated that the net force applied may also be at least partially related to or caused by other forces applied to at least some portions of the second portion, such as the weight of saliva or forces from a user or clinician.

[0292] In an alternative embodiment, the tracheostomy guard 10 can be designed to achieve the minimum size of the variable-size orifice in response to a baseline gas flow rate. The baseline gas flow rate can relate to the lowest high flow rate associated with the patient type, such as 20 l / min for an adult patient, or 1 l / min for a neonatal patient. Alternatively, the baseline gas flow rate can relate to any high flow rate selected from the above-mentioned high flow rate range.

[0293] It should be understood that although reference has been made above to Fig.10a and Fig.10c describes a bidirectional operation, Fig.10a and Fig.10c Depicts the tracheostomy device Figure 2 Embodiments have a movable / deflectable first member 121, but in other embodiments, the orifice 13 and surrounding portions of the second portion 12 of the tracheostomy guard 10 can also behave in a bidirectional manner in response to an applied force; and, depending on the embodiment, this can be a function of the first member 121, the second member 122 and / or another area or portion of the second portion 12 being able to move in response to an applied force.

[0294] The patient interface 20 referred to herein may be a tracheostomy interface arranged to engage the patient at a tracheostomy opening. The tracheostomy interface 20 may optionally be arranged with a leak to reduce the chance of barotrauma due to the delivery of high flows.

[0295] Fig.13 and Fig.14 A perspective view of a patient interface 20 is shown. The patient interface 20 includes a first end 21 and a second end 22 connected by a body. The first end 21 of the patient interface 20 is configured to be connected to the airway fluid of the patient, such as by coupling to an endotracheal tube (not shown). The second end 22 of the patient interface 20 is configured to be coupled to the first portion 11 of the tracheostomy appliance 10. The port 23 is coupled to a supply tube or conduit 101 that delivers gas from a gas source (not shown) to the first end 21. The patient interface 20 may or may not include a vent to prevent the patient interface 20 from being accidentally blocked by the patient, a caregiver, or due to patient secretions within the patient interface 20.

[0296] The gas source may be any device capable of supplying a flow of gas to a patient interface in use, such as a blower, a flow generator, a ventilator and / or a humidifying device.

[0297] According to the second embodiment, referring to Figures 18 to 22 , the tracheostomy brace 10 further comprises a patient interface retaining unit 14, 15 to allow the tracheostomy brace 10 to be coupled to the patient interface 20. The patient interface retaining unit 14, 15 allows the tracheostomy brace 10 to remain on the patient interface 20 regardless of whether the first portion 11 is connected to or disconnected from the patient interface 20. Thus, the patient interface retaining unit 14, 15 prevents the tracheostomy brace 10 from being separated or disengaged from the patient interface 20 during use, for example when the tracheostomy brace 10 is disconnected for optional cleaning. The patient interface retaining unit 14, 15 may comprise a flexible member 14 (e.g., a tether) attached to one end of a patient interface attachment member 15, which may comprise a loop arrangement. The patient interface attachment member 15 may be arranged to be connected to or proximate to a first end 21 of the patient interface 20, the first end 21 being arranged to be fluidly connected to the airway of the patient or any other suitable member of the patient interface 20 during use. As described with reference to Figure 20 to Figure 22 As shown, the patient interface retaining units 14, 15 may be arranged around or near the first end 21 of the patient interface 20. The tether or flexible member 14 may be releasably or integrally attached to the first portion 11 of the tracheostomy brace 10.

[0298] Figure 20 to Figure 22 The tracheostomy protector 10 of the second embodiment is respectively shown in FIG. Fig.13 and Fig.14 A stereoscopic view, a side view and a bottom view of the patient interface 20.

[0299] It should be understood that the patient interface retaining unit 14, 15 may be provided on any one of the tracheostomy guard embodiments disclosed herein.

[0300] In some embodiments, the tracheostomy brace 10 includes a first portion 11 having an end arranged to be releasably attached to a patient interface 20. The first portion 11 may be configured to be sealingly attached to the patient interface 20. The first portion 11 may include an alignment feature 11a for aligning with a corresponding alignment feature 25 of the patient interface 20. The first portion 11 may also include an attachment member 11b arranged to be attached to a corresponding attachment member 221 of the patient interface 20. The attachment member 11b may be arranged to match the attachment member 221 of the patient interface 20 when the first portion 11 is attached to the patient interface 20. The attachment member 11b may be configured to be sealingly attached to the corresponding attachment member 221 of the patient interface 20. The attachment member 11b may be further arranged to be disconnected from the corresponding attachment member 221 of the patient interface 20 when a directional force is applied to the tracheostomy brace 10.

[0301] When the attachment member 11b mates with the corresponding attachment member 221 of the patient interface 20, the directional force may have a component that is opposite to the general mating direction.

[0302] The attachment member 11b may be arranged to be disconnected from the corresponding attachment member 221 of the patient interface 20 by applying a directional force opposite to the mating direction (such as a directional force substantially opposite to the mating direction) and then applying a torque to the tracheostomy brace 10 relative to the patient interface 20 .

[0303] In this manner, the attachment member 11b can be arranged to be disconnected from the corresponding attachment member 221 of the patient interface 20 by applying a force in a direction substantially opposite to the mating direction, wherein the force applied in a direction substantially opposite to the mating direction is, for example, by applying a force substantially along the longitudinal center axis of the first portion 11 (labeled A1 and at Figure 2 , Figure 6 , Figures 10a to 10c , Figure 17a to Figure 17b , Fig.21 , Fig. 27 , Fig.35 and Fig.42 ), exerting a force on the tracheostomy brace 10 to move away from the patient interface 20. This may be referred to as a "push-fit / pull-release" configuration, whereby a user may simply pull the tracheostomy brace 10 away from the patient interface 20 to disconnect the two.

[0304] The moment may be directed about a transverse or substantially transverse axis of the first portion 11 that intersects the longitudinal center axis of the first portion 11. The moment is given by Fig.17a , Fig.17b , Fig.21 , Fig. 27 , Fig.35 and Fig.42 The dotted arrow (marked as M) in the figure indicates.

[0305] The directional force is directed away from the longitudinal center axis of the first portion 11. The longitudinal center axis (labeled A1) is Figure 2 , Figure 6 , Figures 10a to 10c , Figure 17a to Figure 17b , Fig.21 , Fig. 27 , Fig.35 and Fig.42 Shown as a dotted line.

[0306] For example, a directional force or moment may be applied around the lower edge 250 of the patient interface 20. When removed by applying a moment, the lower edge 250 may form an effective "pivot point" for the tracheostomy guard 10. The directional force or moment may be directed about an axis, such as an axis 252 passing through the lower edge 250, which is substantially transverse to and / or intersects the longitudinal center axis of the first portion 11.

[0307] Alternatively, the attachment member 11b may be arranged to disconnect from the corresponding attachment member 221 of the patient interface 20 upon application of a torque by the patient or user.

[0308] In this manner, a transverse or substantially transverse axis (e.g., with reference to Fig.14 The first portion of the tracheostomy guard 10 is rotatably connected to the tracheostomy guard 10 and is preferably provided with a first portion and a second ...

[0309] In some embodiments, the attachment member 11 b may include an attachment release lip (eg, attachment release lip 11 c ) for mating with a corresponding attachment member 221 of the patient interface 20 .

[0310] In some examples, the attachment release lip 11c can be configured to enable a user to apply the torque required to disconnect the attachment member 11b from the corresponding attachment member 221. For example, the release lip 11c can be formed as a lug, tongue, or protrusion that the user can grasp and pull to generate the torque; the pulling motion generally follows the arc shown by the dashed arrow M (upward and then outward). Therefore, this configuration can be referred to as "pivot-release" because instead of applying a force that is substantially directly opposite to the mating force, the user applies a force that generates a torque about the point 250, thereby causing the tracheostomy brace 10 to pivotally disengage from the patient interface 20. In addition to the above, in some embodiments, the attachment member 11b may include the attachment release lip 11c. The attachment release lip 11c can form a part of the attachment member 11b, which is configured to be attached to the corresponding attachment member 221 of the patient interface 20. In addition, the attachment release lip 11c can be configured to enable a user to apply the torque required to disconnect the attachment member 11b from the corresponding attachment member 221. For example, the release lip 11c can be formed as a lug, tongue or protrusion that the user can grasp and pull to generate a torque; the pulling motion generally follows the arc shown by the dashed arrow M (upward and then outward).

[0311] At least a portion of the attachment member 11b, such as the attachment release lip 11c, may have a tubular smooth surface to mate with a corresponding smooth surface of a corresponding attachment member 221 of the patient interface 20, for example with reference to Figures 2 to 19 This configuration provides a friction fit between the tracheostomy guard 10 and the patient interface 20, such as to provide a sealed connection.

[0312] The friction fit may be achieved by a friction fit mechanism formed by the attachment member 11b and the corresponding attachment member 221 of the patient interface 20. In this regard, the cross-sections of the respective attachment members (11b, 221) may be complementary, for example both may be circular or other similar shapes to facilitate a tight coupling therebetween, for example providing a sealed connection.

[0313] The friction fit mechanism is configured to releasably couple the tracheostomy brace 10 and the patient interface 20 so that a user can connect and / or disconnect the tracheostomy brace 10 from the patient interface 20. This may be done in a push-fit and / or pull-release manner, whereby the shape of the tracheostomy brace 10 is circular or similar in shape to the patient interface 20 so that it can be tightly coupled thereto, such as to provide a sealed connection.

[0314] Alternatively or additionally, disconnection may be achieved using a pull-release or a pivot-release, for example in the manner described above.

[0315] The user may temporarily disconnect the tracheostomy brace 10, for example, for cleaning or better access to the patient interface 20. The coupling mechanism or friction fit mechanism is configured to facilitate coupling between the patient interface 20 and the tracheostomy brace 10 with sufficient retention force to reduce the likelihood of accidental disconnection or removal of the tracheostomy brace 10. Therefore, the force required to remove the tracheostomy brace 10 from the patient interface 20 should be greater than the force that may be encountered during use. Minimum force is required to connect the tracheostomy brace 10 to the patient interface 20 during use to reduce patient discomfort. In some embodiments, the force required to separate the tracheostomy brace 10 from the patient interface 20 is greater than the coupling force. The direction of the force required to separate the tracheostomy brace 10 from the patient interface 20 is determined by Fig.17a and Fig.17b The dotted arrow (marked as M) in FIG.

[0316] Requiring the application of a torque in order to remove the tracheostomy guard 10 in a “pivot-release” configuration, for example as described above, is one way of ensuring that the force required to remove the tracheostomy guard 10 can be relatively large (so as to securely hold the tracheostomy guard 10 in use), while also allowing the user to relatively easily apply the force required to separate the tracheostomy guard 10 from the patient interface 20.

[0317] In some embodiments, the attachment member 11b includes a protrusion that extends inwardly toward the longitudinal center axis of the first portion 11 to mate with a corresponding feature 24 (eg, a groove) of the patient interface 20. For an embodiment showing this feature, refer to Figures 23 to 30 As shown, such as Fig.25 The protrusion 11d is shown.

[0318] In some alternative embodiments, the attachment member 11 b includes a recess (not shown) configured to mate with a corresponding feature (eg, a protrusion) (not shown) of the patient interface 20 .

[0319] In some embodiments, the alignment feature 11a may be related to an outer shape or boundary of the first portion 11, such as an outer shape of an edge of the first portion 11. For example, referring to Figures 2 to 22 , the alignment feature 11a of the first portion 11 is related to the outer shape of an oblong or tongue-like extension (e.g., attachment release lip 11c) of the first portion 11. The alignment feature 11a can extend in a direction longitudinally away from the second portion 12 and in a user-facing direction toward the patient interface 20. A portion of this type can include an arcuate, generally rectangular, or other shape, and can, for example, include an edge profile that forms at least a portion of the alignment feature 11a.

[0320] Also refer to Fig.24 , Fig.32 , Fig.39 Other possible examples of alignment features 11a are shown.

[0321] Corresponding alignment features 25 may be arranged on the patient interface 20. Figure 13 to Figure 17b The alignment feature 25 may be formed by one or more protrusions protruding outwardly from the attachment member 221 of the patient interface 20. The alignment feature 25 may have an outer shape or boundary that aligns with a corresponding shape or boundary of the alignment feature 11a of the tracheostomy brace 10, for example, with reference to Figure 15 to Figure 17b shown.

[0322] The protrusions 25 of the patient interface 20 may be symmetrically arranged on either side of the patient interface 20 to align with corresponding alignment features 11a of the tracheostomy brace 10. For example, Fig.16 The boundary of the first protrusion 25 of the patient interface 20 is shown, which is aligned with the right boundary of the tongue-shaped extension 11a, and Fig.17a The boundary of the second protrusion 25 arranged symmetrically to the first protrusion is shown, which is aligned with the left side boundary of the tongue-shaped extension 11a.

[0323] It should be understood that in other embodiments, the alignment feature 11a may alternatively or additionally be associated with or provided by a marking, such as Figure 2 , Fig.16 , Figure 17a to Figure 17b , Fig.32 , Fig.39 , Fig.43 In such an embodiment, the user can position the marker in an upward direction, for example when connecting the tracheostomy brace 10 to the patient interface 20. Additionally or alternatively, the alignment feature 11a can be aligned with the Fig.32 Arrow Fig.24 Other alignment feature configurations are also within the scope of the present invention.

[0324] In addition to the above description, other configurations of the aperture 13 in the second portion 12 of the tracheostomy guard 10 are within the scope of the present invention. In some examples, the second portion 12 may include additional (i.e., more than two) components that form or define the aperture 13. And although some of the drawings show a single first component 121, it should be understood that the second component 122 and the first component 121 may alternatively be formed by multiple elements, such as multiple flaps.

[0325] For example, the components can have a "petal" configuration such that, depending on an applied force acting on or near the components (e.g., acting in an inward or outward direction relative to the second portion 12), they elastically move inwardly or outwardly away from each other to increase the effective size of the orifice 13. In another example, the first component 121 can be divided into sub-components, such as two identical sub-components, also referred to as flaps, again achieving a "petal" effect, whereby the sub-components generally move inwardly or outwardly when a force is applied to or near the flaps. In such a configuration, the components or sub-components will have an appropriate level of rigidity such that saliva is initially retained in the second portion 12 before the components or sub-components are ultimately elastically deformed in a controlled manner to release saliva through the orifice 13, as discussed herein.

[0326] Another possible example is that the orifice 13 is formed in the second portion 12, but is not defined by different "members" in / on the second portion 12. For example, the second portion 12 may be provided by a single continuous component, which is substantially "thimble-shaped", and the orifice 13 may be provided by a slit or cut (e.g., a cross-shaped cut) located at the distal end or tip of the second portion 12 (i.e., the end farthest from the first portion 11). The material near the cut will have elastic deformation properties, so that the effective size of the orifice 13 changes according to the force applied to at least a portion of the second portion 12 (particularly, the force applied to the vicinity of the slit or cut), which forces the slit or cut to open. In a further variation, the orifice 13 is not provided by a simple slit or cut on the surface of the second portion 12, but the orifice 13 may have a "cusp" configuration somewhat similar to a prosthetic or bioprosthetic heart valve, which includes a plurality of "cusps" or "leaflets" extending in three dimensions, i.e., having depth and a three-dimensional profile.

[0327] Some configuration examples of the tracheostomy guard discussed above are described in more detail below with reference to the accompanying drawings.

[0328] Figure 23 to Figure 26 A perspective view of a tracheostomy guard 30 according to a third embodiment is shown. The tracheostomy guard 30 comprises two first members 121 between which a variable-size orifice 13 is at least partially formed or defined. Furthermore, the variable-size orifice 13 may be at least partially formed between at least one region 140 of the second part 12 and the respective first member 121. In this way, it can be said that the region 140 acts similarly to the second member of the first part 12. The region 140 may be provided by the body of the second part 12 near the orifice 13.

[0329] In this embodiment, the two first members 121 are arranged in a plane that is orthogonal or substantially orthogonal to the longitudinal center axis of the tracheostomy guard 10. The variable size orifice 13 is formed or defined between the peripheral ends 1211a, 1211b of each first member 121. In response to a force applied to at least a portion of the second portion 12, the corresponding first members 121 can move relative to each other, thereby changing the size of the variable size orifice 13. The second portion 12 may include an optionally curved deflection stopping member 42 (shown here in conjunction with the support / reinforcement structure 41), which extends at a certain angle to the longitudinal center axis, for example perpendicular to the longitudinal center axis. The deflection stopping member 42 is used to capture and / or deflect any saliva or secretions or gases that leave the tracheostomy guard 10 via the variable size orifice 13, for example to prevent them from being ejected in an uncontrolled manner. From Figure 23 to Figure 26 As can be seen, the variable-size aperture 13 may have or be formed by at least one straight extension 131 and one or more curved extensions 132 , the extensions 132 being optionally arranged substantially transverse to the straight extensions. Figures 27 to 31 The tracheostomy guard 30 of the third embodiment is shown when connected to Figure 13 to Figure 14 Various views of the patient interface 20 .

[0330] In some embodiments, the variable-size orifice 13 may be arranged in a static state on a joint surface having one or more curvatures, rather than referring to Figures 2 to 30 The joint plane is shown.

[0331] Figure 31 to Figure 34 A perspective view of a tracheostomy brace 40 according to a fourth embodiment is shown respectively. Similar to the third embodiment, the tracheostomy brace 40 comprises two first members 121 between which at least a portion of the variable-size aperture 13 is formed.

[0332] As in the third embodiment, the variable size aperture 13 may be at least partially formed between at least one region 140 of the second part 12 and the respective first member 121. The region 140 may be said to be provided by the bulk of the second part 12 in the vicinity of the aperture 13.

[0333] However, in a fourth embodiment, the two first members 121 are arranged on one side of the tracheostomy guard 10, such as the bottom side when in use, to take advantage of the gravity acting on any saliva or secretions present in the second portion 12, and / or so that the deflection of the two first members 121 is assisted by gravity when saliva deposits are present on the two first members 121. In this embodiment, the variable size orifice 13 is formed or defined between the peripheral ends 1211a, 1211b of each first member 121. In response to a force applied to at least a portion of the second portion 12, the corresponding first members 121 can move relative to each other, thereby changing the size of the variable size orifice 13. From Figure 32 to Figure 34 As can be seen, the variable size orifice 13 may have at least one straight extension 133 arranged parallel or substantially parallel to the longitudinal center axis of the tracheostomy guard 10. The variable size orifice 13 may also have one or more curved extensions 134, which may optionally be arranged substantially transverse to the straight extension 133. Figure 35 to Figure 37 The tracheostomy protector 40 of the fourth embodiment is shown connected to Figure 13 to Figure 14 Various views of the patient interface.

[0334] Figures 38 to 41 1 and 2 show a perspective view of a tracheostomy guard 50 according to a fifth embodiment. In this embodiment, the tracheostomy guard 50 includes two groups of four first members 121a-d arranged on opposite sides of the tracheostomy guard 50. The opposite sides may be referred to as the top side and the bottom side, or non-lateral sides, relative to the intended orientation of the tracheostomy guard 50 in use. Each group of first members 121a-d is arranged to form a corresponding variable-size orifice 13 therebetween.

[0335] Similar to the second and third embodiments, at least a portion of the variable size aperture 13 may additionally be formed between at least one region 140 of the second portion 12 and the respective first member 121a-d. Thus, the region 140 proximate the aperture 13 may be said to function similarly to the second member of the first embodiment.

[0336] The respective variable-size orifices 13 of the tracheostomy guard 50 may form a cross with two intersecting straight extensions. Each variable-size orifice 13 is formed or defined by the peripheral end 1211a of the respective first member 121 of each group and has a size that changes in response to the force applied to at least a portion of the second portion 12 during use. With two variable-size orifices 13, one may act as a safety backup. As previously described, when the first member 121 is arranged on the bottom side (in terms of its intended orientation in use), it may advantageously utilize the gravity acting on any saliva or secretions present in the second portion 12. In response to the force applied to at least a portion of the second portion 12, the groups of first members 121a-121d may move relative to each other, thereby changing the size of the associated variable-size orifice 13. Figures 42 to 44 The fifth embodiment of the tracheostomy guard 50 is shown when connected to Figure 13 to Figure 14 Various views of the patient interface.

[0337] In alternative embodiments, rather than the first member 121 being formed of a plurality of tabs, the portion of the first member 121 at the distal end may be segmented, thereby enabling a portion of the first member 121 to be discretely and locally deformed due to flow or otherwise.

[0338] According to another embodiment, a valve unit is provided. The valve unit comprises a hollow body having a first port for connecting to a corresponding port of a tracheostomy guard and a second port in fluid communication with the surrounding environment. The valve unit further comprises at least one first member 121 and a second member 122 forming at least one orifice, the orifice having an effective size that changes in response to a force applied to the first member 121 and / or the second member 122 in use. The first member 121 and / or the second member 122 may be attached to the body of the valve unit. The variable size orifice may be arranged at the first port, at the second port, or between the first port and the second port in a stationary state.

[0339] According to an alternative embodiment, an insert or valve component for fitting or retrofitting to an existing tracheostomy protector is provided. The insert or valve component can be configured to facilitate an orifice having a size that changes in response to an applied force during use. An example of an existing tracheostomy protector is a saliva protector (OPT971) used / sold with the Optiflow+ tracheostomy interface (OPT970). The OPT971 saliva protector is attached to the OPT970 interface and has upper and lower rigid orifices. It is within the scope of the present invention to provide an insert or valve component for the OPT971 saliva protector, the insert including a variable size orifice as described herein. For example, the insert can be made of a suitable flexible material and can have a configuration that is substantially complementary to the OPT971 saliva protector so as to substantially match the OPT971 saliva protector, such as fitting snugly inside (or even outside) the OPT971 saliva protector. The insert will include a variable size orifice of the present invention (e.g. provided by one or more slits in the flexible material) positioned to coincide with the rigid orifice of the OPT971 saliva guard. Likewise, such an insert or valve component may be provided for fitting or retrofitting to other types, brands or models of tracheostomy guards with appropriate modifications.

[0340] Fig.45 A perspective view of an assembly 100 for a respiratory support system is shown, comprising a first embodiment of a tracheostomy brace 10. The assembly 100 further comprises: a tracheostomy patient interface 20 for connection to the tracheostomy brace 10; and a supply tube or conduit 101 for connection to a port 23 of the patient interface 20 for providing a flow of gas from a gas source (not shown).

[0341] The supply tube or conduit 101 may have a connector 102 for connecting to a gas source.

[0342] The supply tube or conduit 101 may mainly include an inlet, an outlet and a surrounding wall defining a gas passage between the inlet and the outlet. At least one area of ​​the wall includes a membrane made of a gas permeable material to allow water vapor to pass through without allowing liquid water or breathing gas to pass through. Preferably, substantially the entire length of the supply tube or conduit 101 is configured to allow water vapor to pass through without allowing liquid water or breathing gas to pass through.

[0343] According to the utility model, a tracheostomy protector can provide a set of components, which may include one or more of the following: a tracheal coupler (for example, a tracheostomy protector 10, 30, 40 or 50); a tracheostomy patient interface 20; a valve component configured to be assembled to the tracheal coupler; a tracheal tube connected or connectable to the tracheostomy patient interface 20 and / or configured to connect the tracheostomy patient interface 20 with the patient's airway fluid; a connector for connecting the tracheal tube to the tracheostomy patient interface 20; a catheter or tube arranged to connect the tracheostomy patient interface 20 to a gas source; and a gas source.

[0344] In one example, a kit of parts is provided, including a tracheostomy brace 10, 30, 40 or 50 and any one or more of: a patient interface 20; a tracheal tube; a connector for connecting the tracheal tube to the tracheostomy patient interface 20; a conduit or tube arranged to connect the tracheostomy patient interface 20 to a gas source; and a gas source.

[0345] In another example, a kit of parts is provided, including a valve component and any one or more of the following: a tracheal coupler (adapted to receive the valve component); a patient interface 20; a tracheal tube; a connector for connecting the tracheal tube to the tracheostomy patient interface 20; a conduit or tube arranged to connect the tracheostomy patient interface 20 to a gas source; and a gas source.

[0346] It will be appreciated that at least some portions of the kit may be pre-assembled (eg, the tracheostomy brace 10 and the tracheostomy patient interface 20 may be pre-assembled together) for easier packaging and / or installation for first use.

[0347] As used herein, the term "breathable" generally refers to a material that is highly permeable to water vapor and substantially impermeable to the volume movement of liquid water and gases. As used herein, a "breathable material" generally refers to a material that is highly permeable to water vapor and substantially impermeable to the volume movement of liquid water and gases.

[0348] The supply tube or conduit 101 may comprise at least one helically wound polymeric ribbon or strip, part or all of which comprises a film, with respective edges of adjacent turns of the strip abutting or overlapping and bonding to form a surrounding wall.

[0349] One possible material for the breathable region is an activated perfluorinated polymer material having extremely strong hydrophilic properties. An example of such a polymer material is manufactured by DuPont Fluoro Products of Fayetteville, USA under the trade name This material is useful because it is extremely hydrophilic and because it can be extruded, especially coextruded with other plastic materials.

[0350] Alternative materials include:

[0351] (a) Hydrophilic thermoplastics,

[0352] (b) Woven treated fabric products with breathable characteristics.

[0353] Particularly suitable materials are hydrophilic polyester block copolymers that form uniform flat films. An example of such a film is This material is particularly suitable for film production.

[0354] The supply tube or conduit 101 may include lateral reinforcements to prevent deformation of the breathing gas conduit, such as helical beads disposed on the abutting or overlapping edges between two turns of the tape, or a series of annular beads or ribs distributed over the length of the conduit. The beads may be formed of a thermoplastic, preferably a polyester-based polymer. Both the tape or strip and the beads may be a polyester-based polymer, which improves the bond between them. The beads may be made of a material known under the trade name The EM550 is made of the materials sold.

[0355] The supply tube or conduit 101 may further or alternatively include longitudinal reinforcements to prevent stretching of the supply tube or conduit 101 .

[0356] The gas source may be, for example, a flow generator, a ventilator, a humidifier, or any other gas source for supplying a gas flow rate to a patient interface. In some embodiments, assembly 100 includes a gas source.

[0357] Although the tracheostomy guard 10 according to the first embodiment is shown Fig.45 However, it should be understood that the assembly 100 may also include a tracheostomy guard according to any embodiment disclosed herein.

Claims

1. A tracheostomy protector for a patient interface, characterized in that: include: a first portion having an end arranged to be releasably attached to a patient interface, the first portion comprising: an alignment feature having an outer shape or boundary for aligning with a corresponding alignment feature of the patient interface when connected to the tracheostomy brace; and an attachment member arranged to mate with a corresponding attachment member of the patient interface when the first portion is attached to the patient interface; and A second portion having at least one aperture in fluid communication with an ambient environment, wherein the aperture is at a first end of the tracheostomy brace and the attachment member is located at an opposite second end of the tracheostomy brace.

2. The tracheostomy protector according to claim 1, characterized in that: The attachment member is arranged to disconnect from a corresponding attachment member of the patient interface upon application of a directional force to the tracheostomy brace.

3. The tracheostomy protector according to claim 1, characterized in that: The alignment feature relates to an outer shape or border of the first portion.

4. The tracheostomy protector according to claim 1, characterized in that: The alignment feature relates to the outer shape or border of the oblong or tongue-like extension of the first portion.

5. The tracheostomy protector according to claim 1, characterized in that: The attachment member includes an attachment release lip.

6. The tracheostomy protector according to claim 5, characterized in that: The attachment release lip is configured to enable a user to apply a torque that disconnects the attachment member from the attachment member of the patient interface.

7. The tracheostomy protector according to claim 5 or 6, characterized in that: The attachment release lip is formed as a lug, tongue or protrusion that a user grasps.

8. The tracheostomy protector according to claim 1, characterized in that: The attachment member is formed by a smooth tubular inner surface of the first portion, wherein the smooth tubular inner surface is arranged to mate with a corresponding smooth outer surface of the patient interface.

9. The tracheostomy protector according to claim 1, characterized in that: The attachment member is arranged to mate with a corresponding attachment member of the patient interface by means of a friction fit.

10. The tracheostomy protector according to claim 1, characterized in that: The attachment member comprises a protrusion extending inwardly towards a longitudinal centre axis of the first portion or a recess configured to mate with a corresponding feature of the patient interface.

11. The tracheostomy protector according to claim 1, characterized in that: The attachment member comprises: a projection configured to mate with a corresponding recess of the patient interface; or A recess is configured to mate with a corresponding protrusion of the patient interface.

12. The tracheostomy protector according to claim 1, characterized in that: The attachment member is configured to sealingly attach to a corresponding attachment member of the patient interface.

Images