Tracheotomy guards and associated assemblies

Abstract

A tracheostomy guard (10, 30, 40, 50) for a patient interface is provided. The tracheostomy guard (10, 30, 40, 50) comprises a first part (11) arranged to connect to the patient interface in use, and a second part (12) configured to be attached to the first part and to be in fluid communication with the patient interface and / or the first part (11) in use. The second part (12) comprises at least one first member (121) and / or second member (122) forming at least one aperture in fluid communication with the surrounding environment, the size of the aperture (13) being variable in use in response to a force applied to at least a portion of the second part. An assembly (100) including the tracheostomy guard, a valve unit, valve components, and a kit of parts is also provided.

Description

[Technical field]

[0001] [Technical field] The present disclosure relates generally to respiratory assistance systems and, more particularly, to accessories and / or patient interfaces for delivering respiratory therapy to a patient.

[0002] [background] A tracheostomy is an opening surgically made in a patient's trachea to open an airway and remove secretions from the lungs. Respiratory gases may be delivered to the patient from a gas source via a patient interface, such as a tracheostomy interface, which may be connected to a port created in the tracheostomy to facilitate ventilation.

[0003] A tracheal coupler (e.g., in the form of a tracheal interface connector) may be used with conventional respiratory assistance systems such as that shown in FIG. 1a. The tracheal coupler provides a passage for breathing gases (such as oxygen) that interface between a high flow gas supply and a patient (such as a tracheotomized or intubated patient). The tracheal coupler may be in the form of a connector that connects to a tracheal intubation tube / interface in or on the tracheotomized or intubated patient. In one example, the tracheal interface may be attached to the tracheotomized / intubated patient.

[0004] A tracheotomy guard may be coupled to the tracheal interface to prevent obstruction of the patient interface by, for example, the patient's chin, bedding, or clothing. The tracheotomy guard includes an opening to allow air exchange therein.

[0005] During tracheal ventilation, patient secretions may be expelled from the patient interface. The secretions may be transferred to the caregiver, for example, through an opening in the tracheostomy guard or directly from the interface. Secretions may suddenly exit the opening with sufficient force to reach a caregiver positioned near the patient. The tracheostomy guard may divert secretions away from the caregiver while facilitating removal of secretions therefrom.

[0006] Providing high-flow therapy is used to flush the airway and reduce dead space, and may result in improved humidification due to positive expiratory end pressure (PEEP), which promotes mucociliary transport within the lungs. In some use cases, high-flow therapy may also provide dynamic positive pressure. However, traditional tracheotomy guards may not be suitable for such high gas flow environments. Therefore, an improved tracheotomy guard for high-flow tracheotomy would be advantageous.

[0007] [overview] The present disclosure relates to a tracheostomy guard (hereinafter also referred to as a "tracheal guard") to be used with a tracheostomy interface (hereinafter also referred to as a "tracheal interface" or a "patient interface").

[0008] In a first aspect, a tracheotomy guard for a patient interface may be provided comprising: a first part arranged to connect in fluid communication with the patient interface in use; and a second part including at least one first and / or second member forming at least one aperture in fluid communication with the first part and in fluid communication with the surrounding environment, the size of the aperture being variable in use in response to a force applied to at least a part of the second part.

[0009] In some embodiments, at least one first member is arranged to bias or move bidirectionally relative to the second member in response to an applied force.

[0010] In some embodiments, the size of the aperture relates to a cross-sectional dimension of the aperture.

[0011] In some embodiments, the applied force is related to the gas flow rate of the gas within the tracheotomy guard.

[0012] In some embodiments, gas flow rates relate to higher flows of 20 l / min to 150 l / min or 20 l / min to 80 l / min for adult patients and 1 l / min to 30 l / min for neonatal and pediatric patients.

[0013] In some embodiments, the variable size of the aperture is configured to allow expulsion of sputum therethrough in response to an applied force during use.

[0014] In some embodiments, during use, the force exerted on the second portion is due, at least in part, to the weight of sputum present within the second portion.

[0015] In some embodiments, the variable size of the aperture is configured to achieve a minimum set positive end expiratory pressure (PEEP) during use.

[0016] In some embodiments, the minimum PEEP setting is selected from the range: 1 cmH20 to 7 cmH20.

[0017] In some embodiments, at least one of the first member and / or the second member are relatively arranged to form at least one aperture of variable size.

[0018] In some embodiments, the one or more first members have a first material or structural characteristic and the one or more second members have a second material or structural characteristic, the first material or structural characteristic and the second material or structural characteristic being selected to enable the variable-sized aperture to change size in response to an applied force.

[0019] In some embodiments, the first material or structural property and the second material or structural property relate to at least one of the following: stiffness, stiffness, flexibility, elastic modulus, moment of inertia, length, width, and / or thickness.

[0020] In some embodiments, the first material or structural characteristic is related to a thickness of the first component and / or the second material or structural characteristic is related to a thickness of the second component.

[0021] 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 elastomer, or a thermoset polymer.

[0022] In some embodiments, the second portion is releasably attached to the first portion.

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

[0024] In some embodiments, at least a portion of the second portion is integral with the first portion.

[0025] In some embodiments, the applied force is related to the internal pressure of said second portion.

[0026] In some embodiments, the first and second parts together form a cavity which, in use, is in fluid communication with the surrounding environment only via one or more apertures of variable size.

[0027] In some embodiments, the aperture reaches its minimum size in the tracheotomy guard's rest state.

[0028] In some embodiments, at least one of the first member or the second member comprises a flap or panel.

[0029] In some embodiments, the first material or structural property and / or the second material or structural property are selected to enable reversible deformation or deflection or bending or flex of the first member and / or the second member based on an applied force.

[0030] In some embodiments, the size of the aperture is variable based on the reversible deformation.

[0031] In some embodiments, the second portion is configured, in use, to be in fluid communication with a patient interface.

[0032] In a second aspect, a tracheostomy guard for a patient interface may be provided, comprising: a first portion arranged for attachment in fluid communication with the patient interface in use, a second portion in fluid communication with the first portion, the second portion comprising at least a first member having a first material or structural characteristic and a second member having a second material or structural characteristic, the first material or structural characteristic being different from the second material or structural characteristic and selected to permit 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.

[0033] 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, where the aperture has an effective size that is variable in response to an applied force acting on the first member during use.

[0034] In some embodiments, at least one first member is arranged to bias or move relative to the second member in response to an applied force.

[0035] In some embodiments, the size of the aperture relates to a cross-sectional dimension of the aperture.

[0036] In some embodiments, the applied force is related to the flow rate of gas within the tracheotomy guard.

[0037] In some embodiments, gas flow rates relate to higher flows of 20 l / min to 150 l / min or 20 l / min to 80 l / min for adult patients and 1 l / min to 30 l / min for neonatal and pediatric patients.

[0038] In some embodiments, the variable size of the aperture is configured to allow expulsion of sputum therethrough in response to an applied force during use.

[0039] In some embodiments, during use, the force exerted on the second portion is due, at least in part, to the weight of sputum present in the second portion.

[0040] In some embodiments, the variable size of the aperture is configured to achieve a minimum set positive end expiratory pressure (PEEP) during use.

[0041] In some embodiments, the minimum PEEP setting is selected from the range: 1 cmH20 to 7 cmH20.

[0042] In some embodiments, the first material or structural property and the second material or structural property relate to at least one of the following: stiffness, stiffness, flexibility, elastic modulus, moment of inertia, length, width, and / or thickness.

[0043] In some embodiments, the first material or structural characteristic is related to a thickness of one or more first members and / or the second material or structural characteristic is related to a thickness of the second member.

[0044] 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 elastomer, or a thermoset polymer.

[0045] In some embodiments, the second portion is releasably attached to the first portion.

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

[0047] In some embodiments, at least a portion of the second portion is integral with the first portion.

[0048] In some embodiments, the applied force is related to the internal pressure of said second portion.

[0049] In some embodiments, the first and second parts together form a cavity which, in use, is in fluid communication with the surrounding environment only via one or more apertures of variable size.

[0050] In some embodiments, the aperture reaches its minimum size in the tracheotomy guard's rest state.

[0051] In some embodiments, the first member or the second member comprises a flap or a panel.

[0052] In some embodiments, the size of the aperture changes based on the reversible deformation.

[0053] In a third aspect, a tracheostomy guard for a patient interface may be provided, comprising: a first portion having an end arranged for releasable attachment to the patient interface, the first portion including 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 guard; 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 to be disconnected from the corresponding attachment member of the patient interface upon application of a directional force to the first portion.

[0054] In some embodiments, the alignment feature is related to the outer shape or boundary of the first portion.

[0055] In some embodiments, the alignment feature relates to the outer shape or boundary of an oblong or tongue-shaped extension of the first portion.

[0056] In some embodiments, the attachment member includes a release lip.

[0057] In some embodiments, the attachment member is defined by a smooth tubular inner surface of the first portion, the smooth tubular inner surface being arranged to mate with a corresponding smooth outer surface of the patient interface.

[0058] In some embodiments, the attachment members are arranged to mate with corresponding attachment members of the patient interface by a friction fit.

[0059] In some embodiments, the attachment member includes a protrusion configured to mate with a corresponding recess in the patient interface.

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

[0061] In some embodiments, the attachment member is configured to sealingly attach to a corresponding attachment member of a patient interface.

[0062] In a fourth aspect, there may be provided an assembly for performing a high flow tracheotomy comprising a tracheotomy guard as disclosed herein and at least one of the following: a tracheotomy patient interface for connecting to the tracheotomy guard, a conduit or tube arranged to connect a gas source at a first end thereof to the tracheotomy patient interface at a second end thereof, and a gas source for supplying a flow of gas to the patient interface, via the conduit, in use.

[0063] In some embodiments, the gas source includes a blower and a humidifier.

[0064] In some embodiments, the conduit or tube is a breathable tube that allows excess water vapor to escape from the tube to the atmosphere.

[0065] In some embodiments, the tracheotomy interface includes a tube suitable for breathing.

[0066] In a fifth aspect, there may be provided a tracheostomy interface assembly for performing a high flow tracheotomy, the tracheostomy interface assembly including a tracheostomy guard as disclosed herein and a tracheostomy interface (20) including a first end for connecting to a patient's airway, a port for connecting to a gas source for providing a flow of gas to the patient via the first end, and a second end for connecting to a first portion of the tracheostomy guard.

[0067] In some embodiments, the tracheotomy guard is releasably attachable to the second end of the tracheotomy interface via the first portion.

[0068] In a sixth aspect, a tracheotomy guard for a patient interface may be provided comprising: a first part arranged to connect to the patient interface in use; a second part attached to the first part and configured to be in fluid communication with the patient interface in use, the second part forming at least one aperture in fluid communication with the surrounding environment, the effective size of the aperture being variable in use in response to a force applied to at least a portion of the second part.

[0069] In some embodiments, the at least a portion of the second portion includes a region of the second portion proximate the aperture, the region configured to elastically deform such that the effective size of the aperture changes in response to a force applied to the region.

[0070] In some embodiments, the region is elastically deformable in two directions.

[0071] In some embodiments, the region is biased to a rest position, where the effective size of the aperture is at its minimum.

[0072] In some embodiments, the regions are configured to allow the effective size increase to occur in a controlled or gradual manner to maintain a desired pressure and prevent forceful expectoration of phlegm.

[0073] In some embodiments, the regions are configured such that, starting from the rest position, the effective size of the aperture increases as the absolute value of the applied force increases.

[0074] 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 form the at least one aperture.

[0075] In some embodiments, the at least one first member and / or second member of the second portion are resiliently movable in response to a force applied to the at least a portion of the second portion, thereby providing the at least one aperture of variable effective size.

[0076] In some embodiments, the at least one first member and / or second member of the second portion are elastically movable in two directions.

[0077] In some embodiments, the at least one first member is arranged to bias or move relative to the at least one second member in response to an applied force.

[0078] In some embodiments, the effective size of the aperture is related to the cross-sectional dimension of the aperture.

[0079] In some embodiments, the applied force is related to the gas flow rate of the gas within the tracheotomy guard.

[0080] In some embodiments, gas flow rates relate to higher flows of 20 l / min to 150 l / min or 20 l / min to 80 l / min for adult patients and 1 l / min to 30 l / min for neonatal and pediatric patients.

[0081] In some embodiments, the variable effective size of the aperture is configured to allow expulsion of sputum through the aperture in response to an applied force during use.

[0082] In some embodiments, the applied force is due, at least in part, to the weight of sputum present within the second portion.

[0083] In some embodiments, the variable size of the aperture is configured to achieve a minimum set positive end expiratory pressure (PEEP) during use.

[0084] In some embodiments, the minimum PEEP setting is selected from the range: 1 cmH20 to 7 cmH20.

[0085] In some embodiments, at least one first member and second member are relatively positioned to form at least one aperture of variable size.

[0086] In some embodiments, the one or more first members have a first material or structural characteristic and the one or more second members have a second material or structural characteristic, the first material or structural characteristic and the second material or structural characteristic being selected to enable the variable-sized aperture to change size in response to an applied force.

[0087] In some embodiments, the first material or structural property and the second material or structural property relate to at least one of the following: stiffness, stiffness, flexibility, elastic modulus, moment of inertia, length, width, and / or thickness.

[0088] In some embodiments, the first material or structural characteristic is related to a thickness of the first component and / or the second material or structural characteristic is related to a thickness of the second component.

[0089] In some embodiments, the first member and / or the second member are made of a polymer, an elastomer, a thermoplastic polymer or elastomer, or a thermoset polymer.

[0090] In some embodiments, the second portion is releasably attached to the first portion.

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

[0092] In some embodiments, at least a portion of the second portion is integral with the first portion.

[0093] In some embodiments, the applied force is related to an internal pressure within said second portion.

[0094] In some embodiments, the applied force is related to the difference between the internal pressure and the ambient pressure outside the second portion.

[0095] In some embodiments, the second portion defines a cavity which, during use, is in fluid communication with the surrounding environment only via the at least one aperture of variable size.

[0096] In some embodiments, the aperture reaches its minimum effective size in the tracheotomy guard's rest state.

[0097] In some embodiments, the first member and / or the second member comprise a flap or panel.

[0098] In some embodiments, the first material or structural property and / or the second material or structural property are selected to enable reversible deformation of the first member and / or the second member based on an applied force.

[0099] In some embodiments, the effective size of the aperture is variable based on the reversible deformation.

[0100] In some embodiments, the attachment member is configured to sealingly attach to a corresponding attachment member of a patient interface.

[0101] In a seventh aspect, there may be provided a valve unit for use with a tracheostomy guard comprising: a hollow body having a first port for connecting to a corresponding port on the tracheostomy guard and a second port for fluid communication with the surrounding environment, at least one first member and a second member forming at least one aperture, the effective size of the aperture being variable in use in response to a force applied to the first member and / or the second member.

[0102] In some embodiments, the aperture of the valve component is configured to mate with an aperture in the second portion of the tracheotomy guard when the valve component is substantially mated with the second portion, in use.

[0103] In an eighth aspect, a valve component for use with a tracheostomy guard for a patient interface may be provided, the tracheostomy guard comprising: a first part arranged to connect to the patient interface in use; and a second part attached to the first part and configured to be in fluid communication with the patient interface in use, the valve component configured to provide at least one aperture that substantially mates with the second part and is in fluid communication with the surrounding environment, the effective size of the aperture being variable in use in response to an applied force.

[0104] In some embodiments, the aperture of the valve component is configured to mate with an aperture in the second portion of the tracheotomy guard when the valve component is substantially mated with the second portion, in use.

[0105] In a ninth aspect, a kit of parts may be provided comprising: a tracheostomy guard as disclosed herein, and at least one of the following: a tracheostomy patient interface for connection to the tracheostomy guard; a conduit or tube arranged to connect a gas source at a first end thereof to the tracheostomy patient interface at a second end thereof; and a gas source for supplying a flow of gas to the patient interface via the conduit or tube, in use.

[0106] In some embodiments the kit of parts includes a tracheal tube that is coupled or coupleable to a tracheostomy patient interface.

[0107] In some embodiments, the kit of parts includes a connector for connecting a tracheal tube to the tracheostomy patient interface.

[0108] In some embodiments, the kit of parts is configured to provide a tracheostomy interface assembly for administering high flow therapy.

[0109] In a tenth aspect, a kit of parts may be provided comprising: a tracheostomy guard; and a valve unit as disclosed herein or a valve component as disclosed herein for use together with said tracheostomy guard and at least one of the following: a tracheostomy patient interface for connection to the tracheostomy guard; a conduit or tube arranged to connect a gas source at a first end thereof to the tracheostomy patient interface at a second end thereof; and a gas source for supplying a flow of gas via the conduit or tube to the patient interface, in use.

[0110] In some embodiments the kit of parts includes a tracheal tube that is coupled or coupleable to a tracheostomy patient interface.

[0111] In some embodiments, the kit of parts includes a connector for connecting a tracheal tube to the tracheostomy patient interface.

[0112] In some embodiments, the kit of parts is configured to provide a tracheostomy interface assembly for administering high flow therapy.

[0113] [Brief description of the drawings] Some embodiments will now be illustrated, by way of example, with reference to the following drawings, in which: [Brief description of the drawings]

[0114] [Figure 1a] 1 shows a prior art respiratory assistance system. [Figure 1b] FIG. 1 shows a perspective view of a prior art tracheostomy connector and associated breathing tube connected to a patient's tracheostomy. [Figure 1c] 1 shows a diagram of an example of a respiratory assistance device. [Figure 1d] FIG. 1 shows a perspective view of an example of a respiratory support device. [Diagram 2] FIG. 1 shows a perspective view of a tracheotomy guard according to a first embodiment. [Diagram 3] FIG. 1 shows a perspective view of a tracheotomy guard according to a first embodiment. [Figure 4] FIG. 1 shows a perspective view of a tracheotomy guard according to a first embodiment. [Diagram 5] FIG. 1 shows a perspective view of a tracheotomy guard according to a first embodiment. [Figure 6] A bottom view of the tracheostomy guard of Figures 2 to 5 is shown. [Figure 7] 7 shows an enlarged section of the tracheotomy guard of FIG. 6. [Figure 8] FIG. 8 shows a front view of the tracheostomy guard of FIGS. [Figure 9] FIG. 9 shows a rear view of the tracheotomy guard of FIGS. [Figure 10a] 1 shows a cross-sectional view of the tracheotomy guard of the first embodiment in a rest state. [Figure 10b]10b shows a cross-sectional view of the tracheotomy guard of FIG. 10a when a portion of the tracheotomy guard is subjected to a first applied force and / or internal pressure. [Figure 10c] 10a and 10b show cross-sectional views of the tracheotomy guard when a portion of the tracheotomy guard is subjected to a second applied force and / or internal pressure. [Figure 11] FIG. 10 shows a perspective cross-sectional view of the tracheotomy guard of FIGS. [Figure 12] FIG. 10 shows a further perspective cross-sectional view of the tracheotomy guard of FIGS. [Figure 13] FIG. 1 shows a perspective view of a patient interface according to the prior art. [Figure 14] FIG. 1 shows a perspective view of a patient interface according to the prior art. [Figure 15] FIG. 15 shows a perspective view of the tracheotomy guard of FIGS. 2-12 connected to the patient interface of FIGS. 13-14. [Figure 16] FIG. 15 shows a perspective view of the tracheotomy guard of FIGS. 2-12 connected to the patient interface of FIGS. 13-14. [Figure 17a] FIG. 15 shows a perspective view of the tracheotomy guard of FIGS. 2-12 connected to the patient interface of FIGS. 13-14. [Figure 17b] FIG. 15 shows a perspective view of the tracheotomy guard of FIGS. 2-12 disconnected from the patient interface of FIGS. 13-14. [Figure 18] 1 shows a perspective view of a tracheotomy guard according to a second embodiment. [Figure 19] 1 shows a perspective view of a tracheotomy guard according to a second embodiment. [Figure 20] FIG. 15 shows a perspective view of the tracheotomy guard of the second embodiment when connected to the patient interface of FIGS. 13 and 14; [Figure 21] FIG. 15 shows a perspective view of the tracheotomy guard of the second embodiment when connected to the patient interface of FIGS. 13 and 14; [Figure 22] FIG. 15 shows a bottom view of the tracheotomy guard of the second embodiment when connected to the patient interface of FIGS. 13 and 14. [Figure 23] 13 shows a perspective view of a tracheotomy guard according to a third embodiment. [Figure 24] 13 shows a perspective view of a tracheotomy guard according to a third embodiment. [Diagram 25] 13 shows a perspective view of a tracheotomy guard according to a third embodiment. [Figure 26] 13 shows a perspective view of a tracheotomy guard according to a third embodiment. [Figure 27] FIG. 15 shows a perspective view of the tracheotomy guard of the third embodiment when connected to the patient interface of FIGS. 13-14. [Figure 28] FIG. 15 shows a front view of the tracheotomy guard of the third embodiment when connected to the patient interface of FIGS. 13-14. [Figure 29] FIG. 15 shows a rear view of the tracheotomy guard of the third embodiment when connected to the patient interface of FIGS. 13-14. [Diagram 30] FIG. 15 shows a cross-sectional view of the rear of the tracheotomy guard of the third embodiment when connected to the patient interface of FIGS. 13-14. [Diagram 31] 13 shows a perspective view of a tracheotomy guard according to a fourth embodiment. [Diagram 32] 13 shows a perspective view of a tracheotomy guard according to a fourth embodiment. [Diagram 33] 13 shows a bottom view of the tracheotomy guard according to the fourth embodiment. [Diagram 34] 13 shows a perspective view of a tracheotomy guard according to a fourth embodiment. [Diagram 35] FIG. 15 shows a perspective view of the tracheotomy guard of the fourth embodiment when connected to the patient interface of FIGS. 13-14. [Diagram 36] FIG. 15 shows a front view of the tracheotomy guard of the fourth embodiment when connected to the patient interface of FIGS. 13-14. [Figure 37] FIG. 15 shows a rear view of the tracheotomy guard of the fourth embodiment when connected to the patient interface of FIGS. 13-14. [Figure 38] 13A and 13B show perspective and bottom views of a tracheotomy guard according to a fifth embodiment. [Figure 39]13A and 13B show perspective and bottom views of a tracheotomy guard according to a fifth embodiment. [Diagram 40] 13A and 13B show perspective and bottom views of a tracheotomy guard according to a fifth embodiment. [Diagram 41] 13A and 13B show perspective and bottom views of a tracheotomy guard according to a fifth embodiment. [Diagram 42] FIG. 15 shows a perspective view of the tracheotomy guard of the fifth embodiment when connected to the patient interface of FIGS. 13-14. [Diagram 43] FIG. 15 shows a front view of the tracheotomy guard of the fifth embodiment when connected to the patient interface of FIGS. 13-14. [Diagram 44] FIG. 15 shows a rear view of the tracheotomy guard of the fifth embodiment when connected to the patient interface of FIGS. 13-14. [Diagram 45] FIG. 1 shows a perspective view of an assembly including a tracheostomy guard, a tube, and a patient interface of a first embodiment.

[0115] [Detailed Description] FIG. 1a shows a prior art respiratory assistance system in which a tracheal coupling, such as one or more tracheotomy guards disclosed herein, may be incorporated. An external portion for a tracheotomy tube 72 extends from the neck of a patient 71. A male connector 73 extends from the tracheotomy tube 72. A tracheotomy connector 74 includes a patient end 75 that is connected to the male connector 73 of the tracheotomy tube. The 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 gas to the patient. At least a section 80a of the breathing tube 80 proximal to the patient, as specified with reference to FIG. 1b, may be a breathable tube made of a breathable material. A cuff 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 that typically forms part of a breathing assistance apparatus arranged to provide a flow of breathing gas to the patient.

[0116] 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 so that fluid can exit the tracheostomy guard through a fixed-sized aperture at the outlet end 76 during gas flow therapy, or at least so that a clinician can aspirate fluid through a fixed-sized aperture. Because high-flow therapy is performed over a relatively wide range of flow rates (see below), it may be difficult to use a conventional tracheostomy guard to keep PEEP within suitable limits over the entire range of flow rates used for high-flow therapy. Furthermore, conventional tracheostomy guards may also be prone to clogging when used during high-flow therapy.

[0117] 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 connect to the cuff 81. Respiratory gas may be delivered to the user at or near the optimal temperature and humidity (37° C., 44 mg / L humidity) when the gas is delivered. By mimicking the conditions in a healthy adult lung (37° C., 44 mg / L humidity), it may help maintain healthy mucociliary function in users with respiratory diseases that affect secretions. Using a humidification system / humidifier when administering tracheal therapy may be advantageous since the upper airway is bypassed. Additionally, humidified gas flow makes high-flow therapy more comfortable and tolerable for the patient.

[0118] The flow generator 83 generally includes a blower that receives air from an air intake 85 and, optionally, oxygen from an oxygen supply line 86. A user interface may include a display screen 87 and user controls 88. The user controls may be in the form of buttons on the flow generator housing or in combination with a touch screen display screen of the flow generator. An exemplary flow generator for use in this application is the Fisher & Paykel Healthcare AIRVO 2™ or AIRVO 3.

[0119] The flow generator 83 includes a flow sensor and feedback control that monitors the delivered flow and varies the blower speed to maintain the generator output flow at a level set by a user control.

[0120] One example of a respiratory assistance apparatus 90 is shown in Figure lc. The respiratory assistance apparatus 90 may include a housing 200 (e.g., as a single housing) containing one or more of: a flow generator 91, in some forms in the form of a motor / impeller arrangement (e.g., a blower), a humidifier 92 pneumatically connected to the flow generator 91, a controller 93, and a user interface 94 (e.g., including a display and one or more input devices, such as one or more buttons, a touch screen, etc.).

[0121] FIG. 1d also shows the respiratory aid apparatus 90 including the housing 200, and illustrates that the components of the respiratory aid apparatus 90 (including, for example, the humidifier 92 pneumatically connected to the flow generator 91) are integrated into a common housing. This provides for mobility, providing a compact device that can be easily moved or transported. Furthermore, the components of the respiratory aid apparatus 90 (e.g., the flow generator 91 and the humidifier 92) being combined within the same housing allows for a simpler set-up (i.e., the chamber 300 is positioned within the housing).

[0122] In some forms, the respiratory assistance device 90 may not include a flow generator 91. In this case, the respiratory assistance device 90 does not generate a flow of gas, but instead is configured to be connected to an external flow generator and configured to humidify the flow of gas from the external flow generator. For example, the respiratory assistance device 90 may be used as a stand-alone humidifier to humidify the gas flowing through the humidifier. The flow generator may include a wall gas supply (e.g., regulated by a flow meter or rotameter), or a ventilator, or other separate flow generator that may be configured to deliver high-flow therapy (e.g., for NIV, CPAP, BCPAP, etc.). The humidifier may include a battery coupled to the humidifier to provide power when an outlet is not available (as a battery power source). In some forms, the battery may be removably coupled to the device and is rechargeable. The humidifier is pneumatically coupled to the flow generator via a conduit, and a separate conduit is coupled to the humidifier to deliver humidified gas from the humidifier to the patient.

[0123] In some examples, the breathing conduit 96 is coupled at one end to a gas outlet 97 on the housing 200 of the breathing assistance apparatus 90. The breathing conduit 96 is coupled at another end to a patient interface, which for present purposes is provided by a tracheostomy interface and / or a tracheal coupling (e.g., a tracheostomy guard as disclosed herein). As described in more detail below, it will be understood that the combination of the tracheostomy interface and tracheal coupling is non-sealing (i.e., leak-proof) to create / provide a flushing effect (described further below) and reduce the risk of barotrauma.

[0124] A tracheal coupling, such as the tracheotomy guard disclosed herein and associated patient interface or interfaces, may be used to administer high-flow therapy to a spontaneously breathing patient. This means that a significant percentage of the air delivered to the connector is not breathed by the patient but is directly drawn into the room. As will be further described below, the tracheotomy guard may be connected to a tracheotomy or tracheal interface, for example as shown by connector 74 in FIG. 1a or FIG. 1b. A flow generator 83 such as that shown in FIG. 1a may be used as a gas source to provide a high flow of gas, and in some configurations, other high-flow gas sources may be used, such as a supply of air from a wall outlet or a ventilator. It will be understood that the tracheotomy guard disclosed herein is not limited to use with any particular type of gas source.

[0125] As mentioned above, the high gas flow environment, for example in high flow therapy, can be used to flush the airways to reduce dead space and provide positive end expiratory pressure (PEEP) and optionally generate elevated pressure in the patient's airways. Positive end expiratory pressure (PEEP) prevents airways and alveoli from collapsing at the end of expiration and reopens already collapsed airways and alveoli. Providing PEEP therapy can improve gas exchange (reducing intrapulmonary shunt), reduce resistance to airflow (pulmonary resistance), and make the lungs less stiff (increasing lung compliance). Oxygen and carbon dioxide levels also improve thanks to high flow gas delivery, reducing the need for supplemental oxygen and the sensation of breathlessness. High flow therapy can also increase humidification in the lungs, thereby improving mucociliary transport. PEEP can assist in the treatment of obstructive pulmonary diseases and heart failure, such as emphysema, bronchiectasis, chronic bronchitis, cystic fibrosis, and pulmonary edema.

[0126] High flow therapy as described herein is intended to be given its typical ordinary meaning as understood by those skilled in the art and generally refers to a respiratory assistance device that delivers a target flow of humidified respiratory gas through an intentionally unsealed patient interface at a flow rate generally intended to match or exceed the patient's inspiratory flow rate. Exemplary patient interfaces include, but are not limited to, nasal or tracheal patient interfaces. Typical flow rates for adults often range from about 15 liters per minute to about 60 liters per minute or more. Typical flow rates for pediatric patients (e.g., neonates, infants, and children) often range from about 1 liter per minute per kilogram of patient body weight to about 3 liters per minute per kilogram of patient body weight or more. High flow therapy may also optionally include a gas mixture composition that includes supplemental oxygen, and / or administration of a therapeutic drug. High flow therapy is often referred to as nasal high flow (NHF), humidified high flow nasal cannula (HHFNC), high flow nasal oxygen (HFNO), high flow therapy (HFT), or tracheal high flow (THF), among other common names. It will be appreciated that the present invention is particularly directed to the administration of high flow therapy via a tracheostomy interface or tracheal coupler.

[0127] For example, in some embodiments, in an adult patient, "high flow therapy" can refer to the delivery of gas to a patient at a flow rate of about 10 liters per minute (10 LPM) or greater, e.g., about 10 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. In some embodiments, for neonatal, infant, or pediatric patients, "high flow therapy" may refer to delivery of gas to the patient at a flow rate of greater than 1 LPM, such as from about 1 LPM to about 25 LPM, or from about 2 LPM to about 25 LPM, or from about 2 LPM to about 5 LPM, or from about 5 LPM to about 25 LPM, or from about 5 LPM to about 10 LPM, or from about 10 LPM to about 25 LPM, or from about 10 LPM to about 20 LPM, or from about 10 LPM to 15 LPM, or from about 20 LPM to 25 LPM. In some embodiments, a high flow therapy device for an adult, neonatal, infant, or pediatric patient may deliver gas to the patient at a flow rate of from about 1 LPM to about 100 LPM, or any of the subranges described above. The delivered gas may include a percentage of oxygen. In some embodiments, the percentage of oxygen in the delivered gas may be about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.

[0128] High-flow therapy can be effective to match or exceed a patient's inspiratory flow, increasing the patient's oxygenation and / or reducing the work of breathing.

[0129] High flow therapy may be administered to the patient's nostrils and / or orally or through a tracheostomy interface.

[0130] High-flow therapy creates a flushing effect in the airway such that the anatomical dead space of the airway is flushed with high incoming gas flow. This may reduce rebreathing of nitrogen and carbon dioxide while creating a reservoir of fresh gas available for each breath. High-flow therapy may be implemented using a non-sealing patient interface, such as a tracheostomy interface (which may be coupled to a tracheal coupler and / or tracheostomy guard). High-flow therapy may slow the patient's breathing rate. High-flow therapy may create expiratory resistance for the patient.

[0131] High flow therapy may be used to treat patients with obstructive pulmonary disease conditions, such as COPD, bronchiectasis, dyspnea, cystic fibrosis, emphysema, and / or patients with respiratory distress or hypercapnia.

[0132] The term "non-sealing patient interface" as used herein (i.e., a patient interface that is not sealed) may refer to an interface that provides a pneumatic link between a patient's airway and a gas flow source (e.g., from a flow generator 91) to avoid completely occluding the patient's airway. A non-sealing pneumatic link may include less than about 95% occlusion of the patient's airway. A non-sealing pneumatic link may include less than about 90% occlusion of the patient's airway. A non-sealing pneumatic link may include between about 40% and about 80% occlusion of the patient's airway. The airway may include one or both of the patient's nostrils and / or the patient's mouth. In a tracheotomy interface, the airway passes through the trachea.

[0133] As will be made clearer below, the tracheotomy guards disclosed in various embodiments herein are designed for such high gas flow environments.

[0134] The tracheotomy guard may be able to produce the desired PEEP pressure while still having the desired flushing effect at the associated high flow rates.

[0135] Figures 2-10c show various views of a tracheotomy guard (also referred to as "tracheal guard") 10 according to a first embodiment. The tracheotomy guard 10 comprises a first portion 11 arranged to connect to a tracheotomy patient interface 20. The patient interface may for example be a tracheotomy interface such as that shown in relation to Figures 13 and 14, which in use is in fluid communication with the first portion 11. "In fluid communication" here means that when the patient interface 20 is connected to the first portion 11, fluid in the patient interface can enter the tracheotomy guard via the first portion 11. The tracheotomy guard 10 further comprises a second portion 12 in fluid communication with the first portion. Since the second portion 12 is in fluid communication with the first portion 11, any fluid in the tracheotomy guard may move between the first portion 11 and the second portion 12, or vice versa. The second portion 12 includes at least one first member 121 and a second member 122 and forms or defines an aperture 13 in fluid communication with the surrounding environment. The aperture 13 has a size, which may hereinafter also be referred to as an effective size, which is variable. The size may be variable in response to a force applied to at least a portion of the second portion during use, as will be made clearer below.

[0136] The force applied to at least a portion of the second portion may be related to an internal pressure of the second portion, a pressure difference between the internal pressure of the second portion 12 and the ambient pressure surrounding the second portion, a pressure associated with the flow of fluid or sputum within the second portion, or a physical force exerted on at least a portion of the second portion by a user, operator, or clinician, as will be further elucidated below. Additionally, the detailed design of the first member 121 and the second member 121, the type of force applied, and which portion of the second portion 12 the force is applied to will affect how the size of the aperture changes, as will be further elucidated below.

[0137] The second portion 12 is connected to the first portion 11. In use, when the patient interface 20 is connected to the tracheostomy guard 10, the second portion 12 is in fluid communication with the patient interface 20. This means that fluid entering the tracheostomy guard 10 via the first portion 11 can freely enter the second portion 12. Vice versa, whereby fluid within the second portion 12 can freely enter the patient interface 20.

[0138] The size of aperture 13 may hereinafter also be referred to as the effective size. The size or effective size may actually relate to the area of ​​aperture 13 at a given time. The effective size is related to and / or affects the amount of flow that could theoretically pass through aperture 13 in a given time increment (assuming aperture 13 remained at that particular size over that time increment).

[0139] As can be observed from Figures 2-10c of the first embodiment, the second portion 12 may include one first member 121 and one second member 122. However, as will be further elucidated below with reference to Figures 23-44, the second portion 12 may also include one or more first members 121.

[0140] One or more of the first member 121 and the second member 122 may be relatively positioned to form at least one aperture 13 of variable size.

[0141] 2-12, the variable-sized aperture 13 may be formed or defined between a first circumferential edge 1211 of one or more first members 121 and a second circumferential edge 1221 of one or more second members 122. The respective circumferential edges 1211, 1221 may form an interface between the first member 121 and the second member 122, respectively.

[0142] The one or more first members 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 one or more first members with respect to the second member 122 changes the size of the variable-sized aperture 13.

[0143] Further, in some configurations, at least a portion of the variable-sized aperture 13 may be formed between a region of the first or second portion and the respective first and / or second member. For example, referring to FIG. 6, if the first member 121 is not directly attached to the second member 122, at least a portion of the variable-sized aperture may be defined between a region of the first or second portion and the respective member 121, 122. For example, the leftmost end of the aperture 13 in FIG. 6 may be said to be defined between a region of the first portion 11 and the respective member 121, 122.

[0144] In one embodiment, one or more first members 121 may be supported on only one side by the first portion 11. Such an arrangement is shown in relation to Figures 2-12 and 15-30.

[0145] Additionally or alternatively, the second member 122 may be supported on only one side by the first portion 11 .

[0146] In an alternative embodiment, the first member 121 may be supported on only one side by the second member 122. Additionally or alternatively, the second member 122 may be supported on only one side by the first member 121.

[0147] In an alternative embodiment, the one or more first members 121 may be attached to the first portion 11 by a hinge arrangement (not shown), such as a living hinge. The size of the variable-sized aperture 13 varies in response to the hinged orientation of the one or more first members 121. The one or more first members 121 and the hinge arrangement may be arranged such that in a rest state (towards which the one or more first members 121 are biased back), the variable-sized aperture 13 reaches its minimum size.

[0148] Figures 15-17 show perspective views of the tracheotomy guard of Figures 2-12 connected to the patient interface of Figures 13-14.

[0149] The first portion 11 may have a shape adapted to mate 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 female end that mates with a male end of the patient interface 20, the male end having a shape that corresponds to the shape of the female end, or vice versa.

[0150] When connected to the patient interface 20, the first portion 11 is positioned to allow fluid flow between the tracheostomy guard 10 and the patient interface 20. This allows gas flow and / or phlegm to enter the tracheostomy guard 10 from the patient interface 20 via the first portion 11 and exit the tracheostomy guard 10 via the variable sized apertures 13. The second portion 12 together with the first portion 11 forms a cavity in the tracheostomy guard 10 that allows it to retain an amount of phlegm captured by the tracheostomy guard 10. This means that the tracheostomy guard 10 can retain a certain amount of phlegm before being released into the surrounding environment via the variable sized apertures 13.

[0151] It will be appreciated that the patient interface 20 may be connected to the first portion 11 at different depths or distances depending on the configuration. In some configurations, the patient interface 20 may be positioned to connect to the first portion 11. In alternative configurations, the patient interface 20 may be positioned to connect over and / or around the first portion. Upon connection, the patient interface 20 seals to the first portion 11.

[0152] When the patient interface 20 is connected to the first portion 11, in some configurations, a terminal portion of the patient interface 20 may be positioned within the first portion 11. However, in other configurations, a terminal portion of the patient interface 20 may be positioned within the second portion 12. The relative penetration depth of the patient interface 20 into the first portion 11 depends on the detailed design of the patient interface 20 as well as the design of the first portion 11. Therefore, depending on the actual design, fluid exiting or entering the patient interface 20, when connected to the first portion 11, may flow through a cavity formed by the first portion 11, a cavity formed by the second portion 12, or a cavity shared by the first portion 11 and the second portion 12.

[0153] The cavity formed by the second portion 12 is designed to retain the amount of phlegm that is captured by the tracheostomy guard 10. Throughout the embodiments disclosed herein, when connected to the first portion 11, the cavity of the second portion 12 is in fluid communication with the patient interface 20.

[0154] The first member 121 and / or the second member 122 may include one or more flaps or panels. One or more of the first member 121 and / or the second member 122, or the flaps or panels thereof, may be configured to move in two directions, thereby allowing both inward and outward relative movement or bias in response to a force applied to at least a portion of the second portion 12 during use.

[0155] The first member 121 and / or the second member 122 may be physically positioned such that the size of the variable-sized aperture 13 is greater than zero throughout the bidirectional movement resulting from a force applied to at least a portion of the second portion 12. The greater than zero size means that the variable-sized aperture is always open to allow gas flow and sputum expulsion therethrough.

[0156] Furthermore, a size above zero means that the variable size aperture 13 is always open. It will be appreciated that sputum may be initially retained by the second portion 12 and then released in a delayed / controlled manner once a certain degree or amount is reached within the second portion 12.

[0157] The first member 121 and / or the second member 122 may be positioned such that their peripheral edges 1211, 1221 do not engage each other or other portions of the tracheotomy guard 10 in response to a force applied to at least a portion of the second member during use.

[0158] By positioning the first and second members 121, 122 such that there is some distance between them for all relative positions of each of the first and second members 121, 122, the variable sized aperture 13 formed or defined therebetween remains open, thereby allowing gas to flow through the variable sized aperture 13 regardless of the amount or degree of force applied during use. Because the peripheral edge 1211 of the first member 121 and the peripheral edge 1221 of the second member 122 do not engage each other or other portions of the tracheotomy guard 10, the variable sized aperture 13 forms an unobstructed passageway allowing gas to flow therethrough regardless of the amount of force applied to at least a portion of the second portion. Thus, one or more of the first and / or second members 121, 122 are positioned such that they do not completely impede gas from flowing inwardly or outwardly through the tracheotomy guard 10. This is advantageous in terms of patient safety, since in case of flow generator failure the patient can breathe, e.g. directly, through aperture 13. Moreover, aperture 13 remaining open all the time, and the first and / or second members and / or their respective flaps being bi-directional, further enable such technical effect.

[0159] Furthermore, as mentioned above, in high flow therapy, a significant proportion of the air delivered to the connector is directly discharged into the room without being breathed by the patient, so the aperture must always remain open or be able to open. However, at the same time, it is desirable to provide PEEP, which requires resistance during the expiratory phase. The tracheotomy guard 10 disclosed with reference to Figs. 2-12 may meet both of these conditions: the variable size aperture 13, which is biased towards a closed or relatively or substantially closed position, provides resistance to expiratory airflow, thus facilitating the provision of PEEP, and at the same time, the design of the aperture 13 may also ensure that a path for air to escape is always open. These two aspects may also have a further synergistic effect, allowing the aperture 13 to be opened as well, since any clogging of the aperture 13 may immediately increase the pressure in the second portion 12.

[0160] In some embodiments, one or more of the first members 121 may be arranged to move or deflect 1-3 mm under normal operating conditions, but may deflect more when expectorating sputum or secretions.

[0161] As shown in connection with Figures 2-12, the first member 121 may be shaped to include a partially tubular portion 1212 extending longitudinally from the first portion 11. Additionally, the first member 121 may further include a partially hemispherical terminal portion 1213 extending longitudinally from the partially tubular portion 1212 distally from the first portion 11. The peripheral edge 1211 of the first member 121 may be said to extend along the boundary of the partially tubular portion 1212 and the partially hemispherical terminal portion 1213. Such a shape may provide the first member 121 with desired deformation characteristics.

[0162] By providing the first member 121 with the partially tubular portion 1212 and the partially hemispherical end portion 1213, the degree of deflection and movement of the first member 121 may be more easily controlled. This may be made possible by providing the first member 121 with the desired deformation characteristics, such as a degree of stiffness to prevent premature and / or excessive deflection of the first member 121, but also a necessary degree of flexibility to ensure or allow the first member 121 to deflect in a controlled manner in response to applied forces. Furthermore, this configuration may further reduce or mitigate the effects of aeroelastic fluttering of the first member 121.

[0163] By positioning the first member 121 at a thickness less than the thickness of the second member 122, the first member 121 biases or moves to a greater extent than the second member 122 in response to forces applied to at least a portion of the second portion 12 during use.

[0164] However, other configurations are within the scope of the present invention. For example, a desired bias behavior of the first member 121 relative to the second member may be achieved by their relative proportions (e.g., by the first member 121 having a "shallower" cross section than the second member 122) even if they have the same thickness. It is also within the scope of the present invention for the first and second members 121, 122 to be substantially identical, where both may be configured and dimensioned to bias in response to an applied force to change the effective size of the aperture 13, and the bias of the first member 121 is further effected by gravity due to accumulation of phlegm in or on the first member 121.

[0165] Furthermore, by providing the first member 122 with a partially tubular portion and a partially hemispherical end portion, the degree of deflection and movement of the first member may be more easily controlled, and such a shape may reduce or mitigate the effects of aeroelastic flutter of the first member 121.

[0166] Similar to the one or more first members 121, the second member 122 may be shaped to include a partially tubular portion 1222 extending longitudinally from the first portion 11. Additionally, the second member 122 may further include a partially hemispherical terminal portion 1223 extending longitudinally from the partially tubular portion 1222, distal from the first portion 11. The peripheral edge 1221 of the second member 122 may be said to extend along the boundary of the partially tubular portion 1222 and the partially hemispherical terminal portion 1223.

[0167] The partially tubular portion 1212 of the first member 121 and the partially tubular portion 1222 of the second member 122 may be arranged within the tracheostomy guard 10 to form a substantially cylindrical cavity therebetween. The partially hemispherical end portion 1213 of the first member 121 and the partially hemispherical end portion 1223 of the second member 122 may be arranged within the tracheostomy guard 10 to form a substantially hemispherical cavity therebetween.

[0168] 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.

[0169] 2-12, the partially hemispherical end portion 1223 of the second member 122 may extend longitudinally beyond the corresponding partially hemispherical end portion 1213 of the first member 121. This configuration may act to deflect or direct gases and phlegm toward the variable-sized aperture 13 formed or defined between the first member 121 and the second member 122.

[0170] The configuration of Figures 2-12 may help aperture 13 to always be open, even in the absence of applied force, with second member 122 overlapping and projecting beyond first member 121, because first member 121 has a smaller gap than second member 122 forming aperture 13 therebetween. Furthermore, because aperture 13 generally faces downward in this configuration, explosively expelled sputum tends to be blocked and redirected in a controlled manner by the partially hemispherical end portion 1223 of second member 122, rather than forcefully exiting immediately through aperture 13. Furthermore, when second member 122 is positioned above first member 121 in the "in use" configuration, gravity may act to assist in the release of deflected sputum via the partially hemispherical end portion 1223 of second member 122.

[0171] In some embodiments, the one or more first members 121 may be arranged so that they do not bias or deform solely due to gravity and their own weight. For example, the above-described shape of the first member 121, including the partially hemispherical end portions 1213, is designed so that they do not bias or deform solely due to gravity and the weight of the first member 121. To this end, a non-planar arrangement of the one or more first members 121 may be advantageous to achieve this effect.

[0172] It will be appreciated that other shapes for the second portion, first member, and second member are also possible, such as those shown in Figures 23-44, or any other suitable shapes.

[0173] Thus, while some of the tracheotomy guards disclosed herein have a substantially convex hemispherical terminal portion 1213, 1223, it will be understood that this may instead be substantially planar or have a concave curvature with respect to a given reference point within the tracheotomy guard.

[0174] The variable-sized aperture 13 may be formed or defined, at least in part, by a peripheral edge 1211 of the first member 121 and a peripheral edge 1221 of the second member 122. Thus, each peripheral edge may act as a boundary or wall of the aperture. Additionally, one or more portions of the first portion 11 or the second portion 12 may act as a boundary or wall of the aperture.

[0175] Thus, the first member 121 and the second member 122 may have corresponding, eg, complementary, shapes that form an aperture 13 of variable size therebetween.

[0176] The size of the variable-sized aperture 13 may relate to a cross-sectional dimension of the aperture 13 .

[0177] Additionally or alternatively, the size of the variable sized aperture 13 may relate to an area formed or defined between the peripheral edge 1211 of the first member 121, and / or the peripheral edge 1221 of the second member 122, and / or the portions of the first portion 11 that optionally form or define the boundary walls of the aperture 13. The area may be defined as an unobstructed area or passageway, allowing gas to flow and, optionally, phlegm and secretions to be released therethrough.

[0178] 2-12 and 15-17, the variable-sized apertures 13 may be said to be formed in a joining plane (labeled A2 in FIG. 2) that is offset a perpendicular distance from a mid-plane (labeled A1 in FIG. 2) that includes the central longitudinal axis of the tracheostomy guard 10. As can be observed from FIG. 2, the mid-plane A1 extends through the first portion 11 and the second portion 12. Referring to FIG. 2, the joining plane may be located below such mid-plane.

[0179] However, it will be appreciated that the bond plane may 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 larger vertical distance from the mid-plane / central longitudinal axis, may lead to a more compliant first member 121, while a smaller offset may provide a stiffer first member 121.

[0180] This is because, assuming the outer dimensions of the second portion are fixed, a larger offset, i.e., a greater vertical distance from the mid-plane / central longitudinal axis, will result in a relatively "shallow" cross-section of the first member 121, which may lead to a more compliant first member 121. On the other hand, a smaller offset, which results in a relatively "deep" cross-section of the first member 121, may provide a stiffer first member 121.

[0181] With reference to Figures 2-12, the second part 12, including the first member 121 and the second member 122, may extend longitudinally away from the first part 11 relative to the longitudinal axis of the first part 11. As can be seen in Figure 2, the second part 12 thus extends towards the right-hand side away from the first part 11. This means that both the first member 121 and the second member 122 may extend, e.g. longitudinally away, away from the first part 11. As can be seen from Figures 2-6 and Figures 10a-10c, the second member 122 may extend, e.g. longitudinally beyond the first member 121, and given the partially hemispherical peripheral end portion 1223, the second member 122 may therefore divert the gas flow and / or sputum towards the aperture 13.

[0182] This is advantageous when the second member 122 is disposed above the first member 121 with respect to the intended orientation of the tracheotomy guard 10 during use. In this configuration, the variable sized aperture 13 is in fluid communication with the surrounding environment below the tracheotomy guard 10 during use. As will be made clearer below, in this configuration, gravity assists in biasing the first member 121 outwardly (i.e. downwardly with respect to the intended use orientation of the tracheotomy guard) to allow improved release of sputum contained within the second portion 12.

[0183] In some embodiments, the first portion 11 is integrally formed with the second portion 12. As such, 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.

[0184] When integrally formed, the thickness of the first member 121 may be arranged to be different than the second member 122. A thinner member will deflect or move more easily in response to a force applied to at least a portion of the second portion 12 during use. In the illustrated embodiment, and with reference to Figures 2-12, the thickness of the first member 121 is less than the thickness of the second member 122. This means that 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 during use.

[0185] As will be made clearer below, the force applied to at least a portion of the second portion may result from pressure on the second portion 12 during use.

[0186] Although some of the figures disclosed herein show a tracheotomy guard of unitary construction, it will be understood that the tracheotomy guard according to some embodiments may instead be further divided into multiple components made from different materials.

[0187] It will therefore be appreciated that the first portion 11 and the second portion 12 need not be integrally formed. In some embodiments, the second portion 12 is releasably attached to the first portion 11. Additionally or alternatively, the second portion 12 may be sealingly attached to the first portion 11.

[0188] 2-12 and 15-17b, the cavity formed or defined by the first portion 11 and the second portion 12, or alternatively the second portion 12 itself, is in fluid communication with the surrounding environment, in use, only via one or more variable sized apertures 13. The first portion 11, in use, allows fluid access to the cavity via the patient interface 20, but the environment within the patient interface 20 does not share with the surrounding environment.

[0189] The tracheostomy guard 10 of Figures 2-12 and 15-17b may be said to have two access points to its cavity, one access point formed in the first portion 11 that is in fluid communication with the patient interface 20 (i.e. the non-ambient environment) and one access point formed by an aperture 13 that is in fluid communication with the ambient environment.

[0190] As will be made clearer below, the tracheostomy guard 10 may be provided with two or more variably sized apertures 13 each in fluid communication with the surrounding environment (as shown in connection with Figures 38-44).

[0191] It will also be appreciated that one or more fixed-sized, i.e. non-variable-sized apertures in fluid communication with the surrounding environment may be used in combination with variable-sized apertures according to some embodiments.

[0192] When undergoing invasive or high-flow ventilation, there is a risk that the patient may feel uncomfortable and attempt to remove or adjust the patient interface 20. Therefore, the at least one variable-sized aperture 13 of the tracheotomy guard 10 may be positioned and / or shaped to protect against such interference. For example, by locating the variable-sized aperture 13 on the bottom side or underside of the tracheotomy guard 10 so that it faces downwards during use, patient interference may be reduced and excess phlegm may be allowed to be removed or drained by gravity. Alternatively or additionally, by locating the variable-sized aperture 13 on the upper side of the tracheotomy guard 10 (with respect to the orientation of the tracheotomy guard 10 during use), patient interference may be reduced.

[0193] The first member 121 may have a first material or structural characteristic and the second member 122 may have a second material or structural characteristic selected to enable the variable-sized aperture 13 to change size in response to an applied force.

[0194] According to some embodiments, the first material or structural property and the second material or structural property relate to at least one of the following: stiffness, stiffness, flexibility, elastic modulus, moment of inertia, length, width, and thickness.

[0195] The first and second material or structural characteristics may be effected or may be effected in part by the respective profiles and / or cross-sections and / or dimensions of the first and second members 121, 122. For example, as discussed above, in the embodiment of Figures 2-12, for a given material and a given thickness, a first member 121 having a relatively "shallow" cross-section will tend to be biased more than a first member 121 having a relatively "deep" cross-section.

[0196] In some embodiments, the second member 122 may be stiffer than the first member 121. Additionally or alternatively, the second member 122 may be substantially stiff to prevent near complete obstruction of the exhalation flow path by one or more external objects, such as the user's hand impacting an exterior surface of the second member 122. Additionally or alternatively, the second member 122 may be substantially stiff to redirect sputum advanced from the tracheostomy cannula and impacting an interior surface of the second member 122.

[0197] As discussed above, the first material or structural characteristic and the second material or structural characteristic may relate to the thickness or moment of area of ​​the first member 121 or the second member 122. For example, from Figures 10a-10c, it can be observed that the thickness of the first member 121 is thinner (i.e., less than) the thickness of the second member 122, which in turn allows the first member 121 to reversibly bias inwardly or outwardly relative to the second member 122 from its rest state shown in Figure 10a, given the manner in which the first member 121 is disposed or attached to the first portion 11. By simply making the second member 122 thicker than the first member 121, the first member 121 will bias or move more than the second member 122 in response to any given force applied to at least a portion of the second portion 12 during use, since increasing the thickness may: increase stiffness, and vice versa.

[0198] In some embodiments, tracheostomy guard 10, first portion 11, second portion 12, first member 121 and / or second member 122 may be made from either a thermoset or a thermoplastic polymer. In some embodiments, the polymer is an elastomer. In some embodiments, the polymer is a thermoplastic elastomer. It will be appreciated that one or more components of tracheostomy guard 10 may be made from different materials.

[0199] In some embodiments, the tracheostomy guard 10 is made from a single material.

[0200] The first material or structural properties and / or the second material or structural properties may be selected to enable reversible deformation of the first member 121 and / or the second member 122 based on a force applied to at least a portion of the second portion 12 during use. The size of the variable-sized aperture 13 may be variable based on or in response to the reversible deformation. The reversible deformation may be referred to as elastic deformation, where the associated material returns to its original resting shape after a load associated with the applied force is removed.

[0201] Thus, by reversible deformation it is meant that the associated material returns to its resting state once the force applied to cause the deformation is removed. In general, elastomeric materials are capable of reversible deformation.

[0202] In some embodiments, reversible deformation may be associated with a material being biased or bent or flexed or otherwise deformed from its resting state.

[0203] The material or structural characteristics of the first member 121 may be selected such that the elastomeric nature of the material biases the first member 121 to close or return to its resting state as shown in Figure 10a. Additionally or alternatively, additional structural features, such as ribs or reinforcing features (including increased thickness), may be used to further enhance the behavior or tendency of the first member 121 to close or return to its resting state upon removal of a force applied to at least a portion of the second portion 12 during use.

[0204] In some embodiments, the first member 121 is sufficiently flexible to allow access for suction.

[0205] The tracheotomy guard 10 disclosed herein is specifically designed to be suitable for high-flow tracheotomy. In high-flow tracheotomy, flow rates typically vary from about 1 l / min to 150 l / min depending on the type of patient. For example, high flow rates for neonatal and pediatric patients may typically range from about 1 l / min to about 30 l / min. For most adults, high flow rates may range from about 20 l / min to about 80 l / min. Furthermore, in contrast to the prior art, the tracheotomy guard disclosed in connection with various embodiments herein is provided with a variable-sized aperture 13, the size of which controllably changes in response to a force applied to at least a portion of the second portion 12 under normal operating conditions. This means that the tracheotomy guard 10 is capable of maintaining a high PEEP advantageously for high-flow applications, while still allowing the release of secretions and sputum.

[0206] Therefore, according to some embodiments, the variable size of the aperture 13 is configured to allow for the expulsion of sputum therethrough in response to an applied force during use, thereby reducing the risk of blockage or clogging of the patient interface 20. Clogging can undesirably cause both barotrauma and / or CO2 buildup, and can further lead to rebreathing of CO2. The variable size aperture 13 disclosed herein allows for a pathway, e.g., an escape route, for exhaled air from the patient. To this end, it will be appreciated that while a fixed size aperture (or PEEP valve arrangement) of the prior art may increase PEEP at higher flow rates, such a configuration is more prone to clogging due to sputum and secretions. The biasing of the reversibly deformable one or more first members 121 and / or second members 122 disclosed herein allows for the size of the variable size aperture 13 to be varied, thereby reducing the risk of clogging.

[0207] Additionally, with variable sized apertures 13, the tracheotomy guard 10 according to some embodiments may provide a desired PEEP for a given range of high gas flows while still allowing for the expulsion of phlegm or secretions.

[0208] By way of non-limiting example, a tracheotomy guard according to some embodiments, in use: 1~3cmH20 at 20l / min flow rate, 2~3.2cmH20 at 30l / min flow rate, 2.5~3.6cmH20 at 40l / min flow rate, 3.3~4.5cmH20 at 50l / min flow rate, 3.8~5.2cmH20 at a flow rate of 60l / min, or 4.5~6cmH20 at 70l / min flow rate It is possible to achieve a PEEP of 100%.

[0209] According to some embodiments, the variable size of the aperture 13 is configured to achieve a minimum positive end expiratory pressure (PEEP) setting during use. The minimum PEEP setting may be selected from the range: 1 cmH20 to 7 cmH20. As noted above, the PEEP achieved is flow dependent, and the selection of the minimum PEEP setting is at the discretion of the clinician.

[0210] It will be appreciated that for any given gas flow rate, a decrease in the size of the variable-sized aperture 13 will generally result in an increase in PEEP, and vice versa.

[0211] During use, depending on the amount of applied force experienced by at least a portion of the second portion 12, the relative orientation between the first member 121 and the second member 122 will change, causing the size of the aperture 13 formed or defined between the first member 121 and the second member 122 to change or vary.

[0212] During use, a force applied to at least a portion of the second portion 12 (which in turn changes the size of the variable-sized aperture 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 resulting from, the internal pressure of said second portion 12.

[0213] The form, shape, material properties, and / or structural properties of each of the first member 121 and the second member 122 affect how the first member 121 and / or the second member 122 behave in terms of movement and / or deflection when a force is applied. This, in turn, affects how portions of the first member 121 and the second member 122 behave when subjected to an applied force. Furthermore, portions of the second members, e.g., at least a portion of the first member 121 and / or the second member 122 to which a force is applied, affect how the first member 121 and the second member 122 behave when subjected to an applied force.

[0214] As an example, isolating structural properties, if both first member 121 and second member 122 are made of the same material, and first member 121 is made thinner than second member 122, for a given configuration, first member 121 will tend to move or deflect more from its original orientation when subjected to the same force than second member 122. This scenario can be observed in Figures 10a-10c, where first member 121 is made thinner than second member 122.

[0215] As will be made clearer herein, the configuration and / or shape of each member 121, 122 also affects the behavior of that member 121, 122 in terms of movement and / or deflection when subjected to an applied force.

[0216] In at least one example, the second member 122 is designed to provide less or substantially less deflection when subjected to a given applied force than the first member 121. Returning to Figures 10a-10c, the second member 122 is designed to provide substantially less deflection when subjected to an applied force than the first member 121 when subjected to a given applied force.

[0217] The internal pressure of the second portion 12 may be related, at least in part, 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 related, at least in part, to the resultant pressure created by the weight of sputum or secretions acting on the second portion 12, e.g., its first member 121, during use. The force applied to at least a portion of the second portion, e.g., the force applied to the second portion 12 or at least a portion thereof, may be related, at least in part, to the weight of sputum or secretions present within the second portion 12 during use.

[0218] During use, the force applied to at least a portion of the second portion 12 may further be related to the flow rate of gas within the tracheotomy guard 10. For example, when a patient coughs, a higher gas flow rate through the tracheotomy guard 10 increases the force applied to at least a portion of the second portion 12, e.g., its first member 121 and / or second member 122, causing the size of the aperture 13 to change accordingly.

[0219] During use, the force applied to at least a portion of the second portion 12, according to some embodiments, may be referred to as an operational force, which depends on, among other things, the gas flow rate delivered, the patient's breathing cycle, sudden pressure changes due to the patient coughing, and / or the amount of phlegm or secretions present within the tracheostomy guard 10.

[0220] Additionally or alternatively, the force applied to at least a portion of second portion 12 may further relate to a physical force, e.g., a force applied by a user, such as a clinician, to deform one or more of first members 121 and / or second members 122 to change the size of variable-sized aperture 13. Optionally, the physical force may be applied by a tool, e.g., a suction catheter, which is inserted through aperture 13 during use.

[0221] In some embodiments, the applied force, i.e. the force applied to at least a portion of the second portion, relates to the resultant force (net force) of all forces acting on the second portion 12 or its associated parts including the first member 121 and / or the second member 122.

[0222] In some embodiments, when a positive and / or negative resultant force is applied to the second portion 12 or a portion thereof, including its first member 121 and / or second member 122, the size of the variable size aperture 13 changes. In this manner, the size of the variable size aperture 13 changes as a result of a positive and / or negative resultant force being applied to the second portion 12 or a portion thereof, such as its first member 121 and / or second member 122. Here, a positive resultant force is defined as a force having a component directed outward from the second portion 12 towards the surrounding environment, e.g., a force acting on at least a portion of the second portion 12. Here, a negative resultant force is defined as a force having a component directed inward or from the surrounding environment towards the second portion 12, e.g., a force acting on at least a portion of the second portion 12. When the resultant force is zero, the tracheostomy guard 10 may be said to be in its rest state. In other words, the rest state may be defined as a state of equilibrium, rest or balance, where all external forces acting on the tracheostomy guard 10 are in equilibrium. For example, the tracheostomy guard 10 may be in its rest state when not connected to a patient interface 20, or when, in use, it is connected to a patient interface 20 but not to a flow generator, such that the internal pressure of the second portion 12 is equal to the ambient pressure.

[0223] In some embodiments, the applied resultant force may also be referred to as or may be related to the relative pressure difference between the internal pressure acting on second portion 12 and the external pressure acting on second portion 12. Therefore, whenever the internal pressure is higher than the external pressure, the applied force may be said to be related to a positive relative pressure difference, and vice versa, which in turn acts to change the size of variable-sized aperture 13.

[0224] The size of the tracheostomy guard 10 may be selected so as not to impede the patient and / or caregiver, yet provide a sufficient barrier against obstruction and / or divert patient secretions so as not to be transferred to the caregiver, or in other words, to be uncontrolled spit or sprayed into the environment.

[0225] In some embodiments, the area of ​​the variable size aperture 13 in the static state is approximately 25-30 mm 2 , for example 27mm 2 It is.

[0226] As previously mentioned, the variable-sized aperture 13 formed or defined between the first member 121 and the second member 122 changes size in use 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 member 121 and the second member 122.

[0227] In some embodiments, for example as described with reference to Figures 10a-10c, the first member 121 is arranged to move relative to the second member 122 in response to an applied force, thereby varying the size of the variable-sized aperture 13.

[0228] The variable-sized aperture 13 may increase or decrease in size depending on a change in the force applied to at least a portion of the second portion 12. For example, when the applied force is related to and / or includes a positive resultant force, defined as a force having a component directed outwardly from the second portion, i.e., outwardly from the second portion towards the surrounding environment, this causes an outward deflection or movement of one or more of the first members 121 and / or second members 122.

[0229] Alternatively or additionally, the size of the variable sized aperture may also be influenced by what portion of the second portion the force is applied to.

[0230] When the applied force is associated with and / or includes a negative resultant force, defined as a force having a component directed inward from the surrounding environment towards the second portion 12, i.e., inward from the surrounding environment, this causes an inward bias or movement of one or more of the first members 121 and / or second members 122.

[0231] For all configurations except the rest state where the variable-sized aperture 13 reaches its minimum size, the size of the variable-sized aperture 13 decreases in response to a negative resultant force change and increases in response to a positive resultant force change. Therefore, for any given orientation except the rest state, when there is a negative change in the resultant force, the size of the variable-sized aperture 13 decreases, where a negative change in the resultant force implies a scenario where the new resultant force is smaller or lower than the original resultant force before the change. Furthermore, for any given orientation except the rest state, when there is a positive change in the resultant force, the size of the variable-sized aperture 13 increases, where a positive change in the resultant force implies a scenario where the new resultant force is larger or higher than the original resultant force before the change. In other words, in this context, larger and higher imply a larger magnitude of the associated resultant force.

[0232] Under some conditions (e.g., for symmetric aperture configurations that reach the same size for negative and positive resultant forces of the same magnitude or absolute value, or as long as there are no crossings of the quiescent state for asymmetric aperture configurations), the size of the variable-sized aperture 13 may be said to decrease when the absolute value (i.e., magnitude) of the resultant force decreases (i.e., becomes smaller) and to increase when the absolute value (i.e., magnitude) of the resultant force increases (i.e., becomes larger). Under these conditions, for any given orientation except the quiescent state, the size of the variable-sized aperture 13 decreases when the absolute value (i.e., magnitude) of the resultant force decreases. Furthermore, under these conditions, for any given orientation except the quiescent state, the size of the variable-sized aperture 13 increases when the absolute value (i.e., magnitude) of the resultant force increases.

[0233] Figures 10a-10c show respective cross-sectional views of the tracheotomy guard 10 of the first embodiment when subjected to three different forces applied to at least a portion of the second portion 12. Each of the different applied forces causes the first member 121 to move relative to the second member 122, thereby changing the size of the variable size aperture 13. Figure 10a shows the tracheotomy guard 10 when in its rest state, i.e., when the size of the variable size aperture has reached its minimum size. In this configuration, the resultant forces acting on at least a portion of the second portion 12 are all in equilibrium. Figure 10b shows a situation where a negative resultant force is applied to at least a portion of the second portion 12. As a result of the negative change in resultant force, the first member 121 is biased or moved inwardly from its rest state position shown in Figure 10a. The configuration of Fig. 10b may, for example, result in the unlikely event that there is a complete or partial blockage of the patient interface 20, or a complete or partial blockage of the gas flow inhaled by the patient from the gas source. Fig. 10c depicts the configuration of the tracheostomy guard 10 when, in use, a positive resultant force is applied to at least a portion of the second portion 12. As previously discussed, the positive resultant force may be due to the gas flow rate provided to the patient from the gas source via the patient interface 20, the patient exhaling, the patient coughing, or the weight of sputum (not shown) acting on at least a portion of the second portion 12, such as the first member 121 and / or the second member 122.

[0234] If the applied force, e.g. the resultant applied force, decreases when the tracheotomy guard 10 is already on the negative force side of its rest state configuration, i.e. when the first member 121 (as shown in FIG. 10b) and / or the second member 122 (not observable from FIG. 10b because with that particular design the inward bias of the second member 122 in FIG. 10b is substantially negligible) are biased or moved inward from the rest state, the variable size aperture 13 increases as the tracheotomy guard 10 configuration moves further and further away from the rest state on the negative force side of the rest state.

[0235] When the tracheostomy guard is on the negative force side of its rest configuration, this means that the resultant force applied to the second portion is defined as negative. In other words, all forces acting inwardly on said second portion or at least a part thereof are greater than the forces acting outwardly on the second portion. In this configuration, the at least one first member is biased inwardly.

[0236] When the tracheostomy guard is on the positive force side of its rest configuration, this means that the resultant force applied to the second portion is defined as positive. In other words, all forces acting inwardly on said second portion or at least a part thereof are less than the forces acting outwardly on the second portion. In this configuration, the at least one first member is biased outwardly.

[0237] When the tracheostomy guard is already in its rest state, this means that the resultant force applied to the second part is defined to be zero. In the rest state, all forces acting inwardly on said second part or at least a part thereof are in equilibrium with forces acting outwardly on the second part. In this configuration, the at least one first member is neither biased inwardly nor outwardly.

[0238] Depending on how the total inward force acting on the second portion and the total outward force acting on the second portion change over time, this will affect whether the tracheotomy guard reaches a negative force side, a positive force side, or a resting state.

[0239] For completeness, it should be noted that an increase in the absolute value of the applied negative resultant force could instead be referred to as a "reduction" of the force, in the sense of it becoming more negative in value. However, in this description, the term "increase / reduction in absolute value" is used to indicate a change in the magnitude of the force itself; and "positive / negative" is used to indicate the general direction of said 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.

[0240] On the other hand, if the applied force, e.g. the resultant applied force, is reduced, when the tracheotomy guard 10 is already on the positive force side of its rest state configuration, i.e. when the first member 121 and / or the second member 122 are biased or moved outward from the rest state as in FIG. 10c, the variable size apertures 13 will shrink as the reduction in applied force brings the configuration closer to the rest state, but after passing the rest state shown in FIG. 10a, provided that the applied force is still continuing to decrease, the variable size apertures 13 will increase as the tracheotomy guard 10 configuration moves further and further away from the rest state on the negative force side of the rest state as shown in FIG. 10b.

[0241] Alternatively or additionally, if the absolute value of the applied positive resultant force is decreased, the variable size aperture 13 will decrease as the decrease in absolute value of the applied force brings the configuration closer to the rest state (as shown in FIG. 10a). However, if a negative force (i.e., a force acting inwardly) is applied (or continues to be applied) after the tracheotomy guard 10 has reached the rest state, the variable size aperture 13 will increase as the configuration of the tracheotomy guard 10 moves further and further away from the rest state on the negative force side of the rest state as shown in FIG. 10b.

[0242] Depending on the resultant applied force, positive or negative, acting on at least a portion of the second portion 12, the size of the variable-sized aperture may eventually stabilize (i.e., reach an equilibrium state) and remain so until the applied force is further altered. In this stabilized state, the first member 121 and the second member 122 maintain their respective orientations and biases.

[0243] When the tracheostomy guard 10 is already on the positive force side of its rest state configuration (e.g., when it is subjected to an applied positive resultant force acting outwardly and the absolute value of the applied positive resultant force increases), if the applied force increases, the variable size aperture becomes larger by the tracheostomy guard configuration moving further and further away from the rest state on the positive force side of the rest state.

[0244] On the other hand, if the tracheotomy guard 10 is already on the positive force side of its rest configuration (i.e., receiving an applied positive resultant force (acting outwardly)) and the absolute value of the applied positive resultant force decreases, the variable size aperture will become smaller as the tracheotomy guard configuration moves closer to the rest configuration.

[0245] On the other hand, if the applied force is increased and the absolute value of the applied negative resultant force decreases when the tracheotomy guard 10 is already on the negative force side of its rest state configuration (e.g., subjected to an applied negative resultant force (acting inwardly)), as shown in FIG. 10b, the variable size apertures will become smaller as the increase in applied force brings the configuration closer to the rest state as shown in FIG. 10a, but after passing the rest state, the variable size apertures will become larger as the tracheotomy guard configuration moves further and further away from the rest state on the positive force side of the rest state as shown in FIG. 10c.

[0246] In this manner, the variable size aperture may be said to shrink as a reduction in the magnitude of the applied force brings the configuration closer to the rest state as shown in FIG. 10a.

[0247] On the other hand, as shown in FIG. 10b, if the tracheostomy guard 10 is already on the negative force side of its rest-state configuration (i.e., subjected to a negative (inward acting) applied resultant force) and the absolute value of the applied negative resultant force increases, the variable size aperture becomes larger as the increasing magnitude of the applied force urges the first member 121 further inward and away from the rest state.

[0248] It will be appreciated that the second portion 12 is configured such that the size of the aperture may increase in two directions; that is, the smallest size of the aperture is when the second portion 12 is in a rest state, and an applied force (in the inward (negative) or outward (positive) direction), whether inward or outward, causes the size of the aperture to increase with the first member 121 being urged away from the rest state. It will also be appreciated that if the displaced first member returns toward the rest state and a force in the other direction is applied or continues to be applied, the first member 121 will again increase the size of the aperture as it moves past the rest state in the other direction. Thus, if the tracheostomy guard 10 is on the negative force side of its rest state and the absolute value (magnitude) of the applied negative resultant force decreases, the first member 121 will move toward the rest state until the applied resultant force reaches or passes zero (the point at which the tracheostomy guard reaches its rest state). Therefore, when a positive resultant force is applied, the first member 121 moves outwardly away from the rest position.

[0249] As discussed above, depending on the magnitude of the applied forces, e.g., the applied resultant force, the system may reach an equilibrium state where the size of the variable-sized aperture stabilizes and is maintained until the applied force is further altered. In this stabilized state, the first member 121 and the second member 122 maintain their respective orientations and biases.

[0250] Any change in the applied force from its rest state configuration, such as a change in its relative absolute value, will increase the size of the variable-sized aperture. For example, when the tracheotomy guard is in its rest state and is subjected to a negative resultant force, the first member 121 and / or the second member 122 will be biased inward and the size of the variable-sized aperture will increase. On the other hand, when the tracheotomy guard is in its rest state and is subjected to a positive resultant force, the first member 121 and / or the second member 122 will be biased outward and the size of the variable-sized aperture will also increase.

[0251] As discussed elsewhere herein, it will be appreciated that the resultant applied force may be at least partially related to or attributable to the pressure within the second portion 12 of the tracheostomy guard 10, the ambient environmental pressure outside the second portion 12 of the tracheostomy guard 10, and / or the pressure difference between the interior of the second portion 12 and the ambient environment outside / around the second portion 12. Alternatively or in addition, it will be appreciated that the resultant applied force may also be at least partially related to or attributable to other forces exerted on at least some portions of the second portion (e.g., the weight of sputum or forces from a user or clinician).

[0252] In alternative embodiments, the tracheostomy guard 10 may be designed to reach a minimum size of the variable sized aperture in response to a baseline gas flow rate. The baseline gas flow rate may relate to the lowest high flow rate associated with the patient type, e.g., 20 l / min for an adult patient, or 1 l / min for a neonatal patient. Alternatively, the baseline gas flow rate may relate to any high flow rate selected from the high flow rate ranges discussed above.

[0253] While bidirectional movement has been described above with reference to Figures 10a and 10c, which show the embodiment of Figure 2 of a tracheotomy guard having one or more movable / deflectable first members 121, it will be appreciated that in other embodiments the aperture 13 and surrounding portions of the second portion 12 of the tracheotomy guard 10 may similarly behave bidirectionally in response to an applied force; and depending on the embodiment, this may be a function of one or more other areas or portions of the first member 121, second member 122, and / or second portion 12 that are movable in response to an applied force.

[0254] The patient interface 20 referred to herein may be a tracheostomy interface arranged to engage a patient at a tracheostomy. The tracheostomy patient interface 20 may optionally be arranged to have a leak to reduce the chance of barotrauma caused by delivering a high flow.

[0255] 13 and 14 show perspective views of the patient interface 20. 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 fluidly connect with a patient's airway, for example, by mating with a tracheal tube (not shown). The second end 22 of the patient interface 20 is configured to mating with the first portion 11 of the tracheotomy guard 10. A port 23 mating with 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 accidental blockage of the patient interface 20 by the patient, a caregiver, or due to patient secretions within the patient interface 20.

[0256] The gas source may be any device capable of providing a flow of gas to the patient interface during use, such as a blower, a flow generator, a ventilator, and / or a humidifier.

[0257] According to a second embodiment, and with reference to Figures 18-22, the tracheostomy guard 10 further includes a patient interface retaining unit 14, 15 that allows the tracheostomy guard 10 to be coupled to the patient interface 20. The patient interface retaining unit 14, 15 may allow the tracheostomy guard 10 to be retained on the patient interface 20 independent of the first part 11 being connected or disconnected from the patient interface 20. The patient interface retaining unit 14, 15 therefore prevents the tracheostomy guard 10 from being separated or detached from the patient interface 20, for example when the tracheostomy guard 10 is disconnected during use, for optional cleaning. The patient interface retaining unit 14, 15 may include a flexible member 14 (e.g. a tether) attached to one end of the patient interface attachment member 15, which may include a loop arrangement. The patient interface attachment member 15 may be arranged to connect to or be adjacent to a first end 21 of the patient interface 20 which, during use, is arranged to fluidly connect to the patient's airway or to any other suitable member of the patient interface 20. As shown in relation to Figures 20-22, the patient interface retention unit 14, 15 may be arranged around or adjacent to 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 guard 10.

[0258] 20-22 show perspective, side and bottom views, respectively, of the tracheotomy guard 10 of the second embodiment when connected to the patient interface 20 of FIGS. 13 and 14.

[0259] It will be appreciated that the patient interface retaining units 14, 15 may be provided in any one of the embodiments of the tracheotomy guard disclosed herein.

[0260] In some embodiments, the tracheostomy guard 10 includes a first portion 11 having an end portion arranged for releasable attachment to the patient interface 20. The first portion 11 may be configured for sealing attachment 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 further include an attachment member 11b arranged for attachment to a corresponding attachment member 221 of the patient interface 20. The attachment member 11b may be arranged to mate with 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 for sealing attachment to the corresponding attachment member 221 of the patient interface 20. The attachment member 11b may further be arranged to disengage from the corresponding attachment member 221 of the patient interface 20 upon application of a directional force to the tracheostomy guard 10.

[0261] The directional force may have a component opposite to the component in the general mating direction when the attachment member 11 b mates with the corresponding attachment member 221 of the patient interface 20 .

[0262] The attachment member 11b may be positioned to be disconnected from the corresponding attachment member 221 of the patient interface 20 by applying a directional force opposite to the mating direction, for example a directional force substantially opposite to the mating direction, followed by applying a moment to the tracheotomy guard 10 associated with the patient interface 20.

[0263] In this manner, the attachment member 11b may 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, for example by applying a force acting on the tracheostomy guard 10 away from the patient interface 20 substantially along the central longitudinal axis of the first portion 11 (shown in phantom and labeled A1 in Figures 2, 6, 10a-10c, 17a-17b, 21, 27, 35 and 42). This may be referred to as a "push-fit / pull-release" configuration, whereby the user simply pulls the tracheostomy guard 10 off the patient interface 20 to disconnect the two.

[0264] The moment may be directed about, or substantially about, a transverse axis of the first portion 11 that intersects with the central longitudinal axis of the first portion 11. The moment is illustrated by the dashed arrows (labeled M) in Figures 17a, 17b, 21, 27, 35, and 42.

[0265] The directional force is directed away from the central longitudinal axis of the first portion 11. The central longitudinal axis (labeled A1) is shown as a dashed line in Figures 2, 6, 10a-10c, 17a-17b, 21, 27, 35, and 42.

[0266] For example, a directional force or moment may be applied about the lower edge 250 of the patient interface 20. The lower edge 250 may form an effective "pivot point" for the tracheostomy guard 10 when removed by applying a moment. The directional force or moment may be directed about an axis through said lower edge 250, such as axis 252, which is substantially transverse to and / or intersects with the central longitudinal axis of the first portion 11.

[0267] Alternatively, the attachment member 11b may be arranged to disconnect from the corresponding attachment member 221 of the patient interface 20 upon the application of a moment by the patient or user.

[0268] In this manner, a transverse or substantially transverse axis, such as indicated by dotted line 252 with reference to Figure 14, intersects the lower edge 250 of the patient interface 20 such that said lower edge 250 forms an effective "pivot point" for the tracheostomy guard 10 when it is removed by the application of a moment. In use, a user applies a force to the first portion (e.g. via lip 11c, described below), thereby generating a moment to pivot the tracheostomy guard 10 away from the patient interface 20, thus disengaging it.

[0269] In some embodiments, the attachment member 11 b may include a release lip (eg, release lip 11 c ) for mating with a corresponding attachment member 221 of the patient interface 20 .

[0270] In some examples, the release lip 11c may be configured to allow a user to apply the necessary moment to disconnect the attachment member 11b from the corresponding attachment member 221. For example, the release lip 11c may be formed as a tab, tongue, or protrusion that the user can grasp and pull to create the moment; the pulling motion generally follows an arc shown by dashed arrow M (upwards and then outwards). This configuration may therefore be referred to as a "pivot release," where rather than applying a force substantially opposite to the mating force, the user instead applies a force that creates a moment about point 250, thereby pivoting and disengaging the tracheostomy guard 10 from the patient interface 20. In addition to the above, in some embodiments, the attachment member 11b may include a release lip 11c. The release lip 11c may form part of the attachment member 11b that is configured to attach to the corresponding attachment member 221 of the patient interface 20. Additionally, release lip 11c may be configured to allow a user to apply the moment required to disconnect mounting member 11b from the corresponding mounting member 221. For example, release lip 11c may be formed as a tab, tongue, or protrusion that the user can grasp and pull to create the moment; the pulling motion generally follows the arc indicated by dashed arrow M (upward and then outward).

[0271] 2-19, at least a portion of the attachment member 11b, such as the release lip 11c, may have a tubular smooth surface that mates with a corresponding smooth surface of a corresponding attachment member 221 of the patient interface 20. Such a configuration provides a friction fit between the tracheostomy guard 10 and the patient interface 20 to provide a sealed connection.

[0272] The friction fit may be achieved by a friction fit mechanism formed by the attachment member 11b and a 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, e.g., both may be circular or otherwise similar in shape, to facilitate a snug coupling therebetween, e.g., to provide a sealed connection.

[0273] The friction fit mechanism is configured to releasably couple the tracheostomy guard 10 and the patient interface 20, allowing a user to connect and / or disconnect the tracheostomy guard 10 to the patient interface 20. This may be by a push-fit and / or pull-release, whereby the shape of the guard 10 may be circular or otherwise similar in shape to the patient interface 20 so that it can be securely coupled thereto, e.g., to provide a sealed connection.

[0274] Alternatively or additionally, disconnection may be accomplished using a pull-release or pivot release, for example, as described above.

[0275] A user may temporarily disconnect the tracheostomy guard 10, for example, for cleaning or to better access the patient interface 20. A coupling or friction fit mechanism is configured to facilitate coupling between the patient interface 20 and the tracheostomy guard 10, with sufficient retention force to reduce the likelihood of accidental disengagement or removal of the tracheostomy guard 10. As such, the force to remove the tracheostomy guard 10 from the patient interface 20 should be greater than the force that may be encountered during use. To reduce patient discomfort, minimal force should be required to couple the tracheostomy guard 10 to the patient interface 20 during use. In some embodiments, the force required to detach the tracheostomy guard 10 from the patient interface 20 exceeds the coupling force. The direction of the force required to remove the tracheostomy guard 10 from the patient interface 20 is indicated by the dashed arrow (labeled M) in Figures 17a and 17b.

[0276] Requiring the application of a moment to remove the tracheostomy guard 10, as in the "pivot release" configuration described above, is one way of ensuring that while the force required to remove the tracheostomy guard 10 may be relatively large (to hold the tracheostomy guard 10 firmly in place during use), it is relatively easy for a user to apply the force required to remove the tracheostomy guard 10 from the patient interface 20.

[0277] In some embodiments, the attachment member 11b includes a protrusion that extends inwardly toward the central longitudinal axis of the first portion 11 to mate with a corresponding feature 24, such as a recess, of the patient interface 20. An embodiment exhibiting this feature is shown with reference to Figures 23-30, such as protrusion 11d shown in Figure 25.

[0278] In some alternative embodiments, the mounting member 11b includes a recess (not shown) configured to mate with a corresponding feature, such as a protrusion (not shown), of the patient interface 20.

[0279] In some embodiments, the alignment feature 11a may relate to an outer shape or boundary of the first portion 11, such as the outer shape of an edge of the first portion 11. For example, referring to Figures 2-22, the alignment feature 11a of the first portion 11 may relate to the outer shape of a stretched or tongue-shaped extension (e.g., release lip 11c) of the first portion 11. The alignment feature 11a may extend longitudinally away from the second portion 12 and in a direction toward the patient interface 20 during use. Such portions may include an arched, generally rectangular, or another shape, and may include, for example, an edge contour that forms at least a portion of the alignment feature 11a.

[0280] Further possible examples of alignment features 11a are also shown in relation to FIGS.

[0281] A corresponding alignment feature 25 may be disposed on the patient interface 20. Referring to Figures 13-17b, the alignment feature 25 may be formed by one or more protrusions that protrude outwardly from the mounting member 221 of the patient interface 20. For example, as shown in connection with Figures 15-17b, 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 guard 10.

[0282] One or more protrusions 25 of the patient interface 20 may be symmetrically positioned on either side of the patient interface 20 to align with one or more corresponding alignment features 11a of the tracheostomy guard 10. For example, Fig. 16 shows a boundary of a first protrusion 25 of the patient interface 20 that aligns with a right boundary of the tongue-shaped extension 11a, and Fig. 17a shows a boundary of a second protrusion 25 that is symmetrically positioned on the first protrusion and aligns with a left boundary of the tongue-shaped extension 11a.

[0283] It will be appreciated that in other embodiments, alignment feature 11a may instead or additionally be referred to, associated with, or provided by a logo as best shown in Figures 2, 16, 17a-17b, 32, 39, 43. In such embodiments, a user may position the logo facing up, for example, when connecting tracheostomy guard 10 to patient interface 20. Additionally or alternatively, alignment feature 11a may be associated with an arrow in Figure 32, a rib in Figure 24. Still other forms of alignment features are within the scope of the present invention.

[0284] Other configurations of aperture 13 in second portion 12 of tracheostomy guard 10 other than those described above are within the scope of the present invention. In some examples, second portion 12 may include additional (i.e., more than two) members that form or define aperture 13. And, while some of the drawings show a single first member 121, it will be understood that second member 122 and first member 121 may instead be formed from multiple elements, such as multiple flaps.

[0285] For example, the members may have a "petal" configuration such that, in response to a force applied to or adjacent the members (e.g., acting in an inward or outward direction relative to the second portion 12), they resiliently move inwardly or outwardly away from one another to increase the effective size of the aperture 13. In another example, the first member 121 may be split into sub-members, e.g., two equal sub-members, also known as flaps, again achieving a "petal" effect, whereby the sub-members move generally inwardly or outwardly upon the application of a force to or adjacent the flap. In such a configuration, the members or sub-members have an appropriate level of stiffness, as described herein, to ensure that sputum is initially held within the second portion 12 before the members or sub-members ultimately resiliently deform in a controlled manner to release the sputum via the aperture 13.

[0286] Another possibility is that the aperture 13 is formed in the second portion 12, but is not defined by a separate "member" in / on the second portion 12. For example, the second portion 12 may be provided by a single continuous component that is substantially "thimble-like", and the aperture 13 may be provided by a slit or notch, e.g. a cross-shaped notch, at the distal end or tip of the second portion 12, i.e. the end furthest from the first portion 11. The material proximate the notch may have elastically deformable properties such that the effective size of the aperture 13 changes depending on the force applied to at least a portion of the second portion 12 (specifically, the force applied proximate the slit or notch), thereby causing the slit or notch to open. In a further variation, instead of the aperture 13 being provided by a simple slit or slits or cut or cuts on the surface of the second portion 12, the aperture 13 may have a "pointed" form that extends in three dimensions, i.e. somewhat resembles an artificial heart valve or heart valve bioprosthesis that includes a number of "cusps" or "leaflets" having depth and three-dimensional contours.

[0287] Some of the examples of tracheotomy guard configurations mentioned above are described in further detail below with reference to the drawings.

[0288] 23-26 show perspective views of a tracheotomy guard 30 according to a third embodiment. The tracheotomy guard 30 includes two first members 121 between which a variable-sized aperture 13 is at least partially formed or defined. Furthermore, the variable-sized aperture 13 may be at least partially formed between at least one region 140 of the second portion 12 and the respective first member 121. In this manner, the region 140 may be said to act similarly to the second member of the first embodiment. The region 140 may be provided by the body of the second portion 12 in the vicinity of the aperture 13.

[0289] In this embodiment, the two first members 121 are disposed in a plane perpendicular or substantially perpendicular to the central longitudinal axis of the tracheotomy guard 10. A variable-sized aperture 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 respective first members 121 may move relative to one another, thus varying the size of the variable-sized aperture 13. The second portion 12 may include an optionally curved deflecting end member 42 (here shown in conjunction with a support / reinforcement structure 41) that extends at an angle to the central longitudinal axis, e.g., perpendicular to the central longitudinal axis. The deflecting end member 42 acts to block and / or deflect any phlegm, secretions or gases exiting the tracheotomy guard 10 via the variable-sized aperture 13, e.g., to prevent them from being discharged in an uncontrolled manner. As can be observed from Figures 23-26, the variable size aperture 13 may have or be formed by at least one straight extension 131 and optionally one or more curved extensions 132 disposed substantially transversely to the straight extension. Figures 27-31 show various views of the tracheotomy guard 30 of the third embodiment when connected to the patient interface 20 of Figures 13-14.

[0290] In some embodiments, the variable size aperture 13 may, in its quiescent state, be disposed on a bonding surface that has one or more curvatures, rather than a bonding plane as shown in connection with Figures 2-30.

[0291] 31-34 show respective perspective views of a tracheotomy guard 40 according to a fourth embodiment. As in the third embodiment, the tracheotomy guard 40 includes two first members 121 forming at least a portion of a variable-sized aperture 13 disposed therebetween.

[0292] As in the third embodiment, the variable-sized aperture 13 may be at least partially formed between at least one region 140 of the second portion 12 and the respective first member 121. The region 140 may be said to be provided by the body of the second portion 12 in the vicinity of the aperture 13.

[0293] However, in the fourth embodiment, the two first members 121 are positioned on the sides, e.g., bottom sides, of the tracheotomy guard 10 during use to utilize gravity to act on any phlegm or secretions present within the second portion 12 and / or to allow gravity to assist the biasing of the two first members 121 when a deposit of phlegm is present on the two first members 121. In this embodiment, the variable-sized apertures 13 are 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 respective first members 121 may move relative to each other, thus changing the size of the variable-sized apertures 13. As can be observed from FIGS. 32-34, the variable-sized apertures 13 may have at least one straight extension 133 disposed parallel or substantially parallel to a central longitudinal axis of the tracheotomy guard 10. The variable size aperture 13 may further optionally have one or more curved extensions 134 disposed substantially across the straight extension 133. Figures 35-37 show various views of the tracheotomy guard 40 of the fourth embodiment when connected to the patient interface of Figures 13-14.

[0294] 38-42 show respective perspective views of a tracheotomy guard 50 according to a fifth embodiment. In this embodiment, the tracheotomy guard 50 includes two sets of four first members 121a-d disposed on opposing sides of the tracheotomy guard 50. The opposing sides may be referred to as the top and bottom sides, or non-sides, with respect to the intended orientation of the tracheotomy guard 50 during use. The first members 121a-d of each set are positioned to form a respective variable-sized aperture 13 therebetween.

[0295] As with the second and third embodiments, at least a portion of the variable-sized aperture 13 may further be formed between at least one region 140 of the second portion 12 and a respective first member 121a-d. In this manner, the region 140 adjacent the aperture 13 may be said to act similarly to the second member of the first embodiment.

[0296] Each variable-sized aperture 13 of the tracheotomy guard 50 may form a cross shape by two intersecting straight extensions. Each variable-sized aperture 13 is formed or defined by the peripheral edge 1211a of each pair of the respective first members 121 and has a size that varies in response to a force applied to at least a portion of the second portion 12 during use. Two variable-sized apertures 13 may be provided, one acting as a safety back-up. As mentioned above, when the first member 121 is positioned on its bottom side (with respect to its intended orientation during use), it may be advantageous to utilize gravity to act on any phlegm or secretions present in the second portion 12. In response to a force applied to at least a portion of the second portion 12, the pair of first members 121a-121d may move relative to each other, thus changing the size of the associated variable-sized aperture 13. Figures 42-44 show various views of the tracheotomy guard 50 of the fifth embodiment when connected to the patient interface of Figures 13-14.

[0297] In an alternative embodiment, rather than first member 121 being formed from multiple flaps, the portion of first member 121 at the distal end may be segmented, thereby allowing for discrete and localized deformation of sections of first member 121 due to flow or otherwise.

[0298] According to a further embodiment, a valve unit is provided. The valve unit includes a hollow body having a first port for connecting to a corresponding port of the tracheotomy guard and a second port in fluid communication with the surrounding environment. The valve unit further includes at least one first member 121 and a second member 122 forming at least one aperture having an effective size that is variable in use in response to a force applied to the first member and / or the second member 122. The first member 121 and / or the second member 122 may be attached to the body of the valve unit. The variable size aperture may be located at the first port, the second port, or between the first and second ports in a resting state.

[0299] According to an alternative embodiment, an insertion tube or valve component is provided for attachment or retrofitting to an existing tracheostomy guard. The insertion tube or valve component may be configured to facilitate an aperture having a variable size during use in response to an applied force. An example of an existing tracheostomy guard is the sputum guard (OPT971) used / sold in conjunction with the Optiflow+Tracheostomy interface (OPT970). The OPT971 sputum guard attaches to the OPT970 interface and has upper and lower rigid apertures. It is within the scope of the present invention to provide an insertion tube or valve component for the OPT971 sputum guard, said insertion tube including one or more variable size apertures as described herein. For example, the insertion tube may be formed from a suitably flexible material and may have a configuration substantially complementary to that of the OPT971 sputum guard, such that it substantially mates with the OPT971 sputum guard, e.g., fits snugly within (or even outside) the OPT971 sputum guard. The insertion tube includes a variable size aperture of the present invention (e.g., provided by one or more slits in the flexible material) that is positioned in concert with a rigid aperture of the OPT971 sputum guard. Similarly, with appropriate modifications, e.g., the insertion tube or valve component may be provided for attachment to or incorporation into other types, brands, or models of tracheotomy guards.

[0300] 45 shows a perspective view of an assembly 100 for a respiratory assistance system including a first embodiment tracheotomy guard 10. The assembly 100 further includes a tracheotomy patient interface 20 for connection to the tracheotomy guard 10, and a supply tube or conduit 101 for connection to port 23 of the patient interface 20 to provide gas flow from a gas source (not shown).

[0301] A supply tube or conduit 101 may have a connector 102 for connecting to a gas source.

[0302] The supply tube or conduit 101 may primarily include an inlet, an outlet, and an enclosure wall defining a gas passage between the inlet and the outlet. At least a region of the wall includes a membrane of breathable material to allow the passage of water vapor without allowing the passage of liquid water or breathing gas. Preferably, substantially the entire length of the supply tube or conduit 101 is configured to allow the passage of water vapor without allowing the passage of liquid water or breathing gas.

[0303] A tracheostomy guard according to the present invention may be provided in a kit of parts, which may include one or more of the following: a tracheal coupler (e.g., tracheostomy guard 10, 30, 40 or 50); a tracheostomy patient interface 20; a valve component configured to attach to the tracheal coupler; a tracheal tube coupled or coupleable to the tracheostomy patient interface 20 and / or configured to fluidly connect the tracheostomy patient interface 20 with the patient's airway; 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.

[0304] In one example, a kit of parts is provided including the tracheostomy guard 10, 30, 40 or 50 and any one or more of the following: 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.

[0305] In another example, a kit of parts is provided that includes 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.

[0306] It will be appreciated that at least some of the components of the kit may be pre-assembled (e.g., the tracheostomy guard 10 and tracheostomy patient interface 20 may be pre-assembled) to facilitate packaging and / or installation upon first use.

[0307] The term "breathable" as used herein generally means highly permeable to water vapor and substantially impermeable to liquid water and bulk gas flow. A "breathable material" as used herein generally refers to a material that is highly permeable to water vapor and substantially impermeable to liquid water and bulk gas flow.

[0308] The supply tube or conduit 101 may include at least one spirally wound polymeric tape or strip, some or all of which includes a membrane, and the edges of adjacent turns of the strip abut or overlap and are bonded to form an enclosure wall.

[0309] One possible material for the breathable area is an active perfluorinated polymeric material that has extremely hydrophilic properties. An example of this polymeric material is sold under the trade name NAFION® by DuPont Fluoro products (Fayetteville USA). This material is useful due to its extreme hydrophilic properties and its ability to be extruded, especially coextruded in combination with other plastic materials.

[0310] Alternative materials include: (a) a hydrophilic thermoplastic; (b) Woven fabric products that are marked as breathable Includes.

[0311] A particularly suitable material is a hydrophilic polyester block copolymer formed into a homogeneous flat film. An example of such a film is sold under the brand SYMPATEX®. This material is particularly suitable for thin film production.

[0312] The supply tube or conduit 101 may include lateral reinforcement against deformation of the breathing gas conduit, such as a helical bead disposed across the adjacent or overlapping edges between turns of the strip, or a series of annular ring beads or ribs distributed over the length of the conduit. The beads may be formed from a thermoplastic material, and are preferably made of a polyester-based polymer. Both the tape or strip and the beads are polyester-based polymers, which improves the bond between them. The beads are made of a material sold under the trade name Arnitel® EM550.

[0313] The supply tube or conduit 101 may additionally or alternatively include longitudinal reinforcement against stretching of the supply tube or conduit 101 .

[0314] The gas source may be, for example, a flow generator, a ventilator, a humidifier, or any other gas source for providing a gas flow to a patient interface. In some embodiments, the assembly 100 includes a gas source.

[0315] The assembly 100 of FIG. 45 is shown with reference to the tracheotomy guard 10 according to the first embodiment, however, it will be understood that the assembly 100 may also include a tracheotomy guard according to any of the embodiments disclosed herein.

Claims

1. 1. A tracheostomy guard for a patient interface comprising: a first portion arranged to be connected in fluid communication with a patient interface in use; a second portion in fluid communication with the first portion, the second portion including at least one first and / or second member forming at least one aperture in fluid communication with an ambient environment, the size of the aperture being variable in use in response to a force applied to at least a portion of the second portion; Includes a tracheostomy guard.

2. 10. The tracheostomy guard of claim 1, wherein the at least one first member is arranged to bias or move bidirectionally relative to the second member in response to the applied force.

3. 3. The tracheostomy guard of claim 1 or 2, wherein the size of the aperture relates to a cross-sectional dimension of the aperture.

4. 3. A tracheostomy guard according to claim 1 or 2, wherein the variable size of the aperture is configured to allow expulsion of sputum therethrough in response to the applied force during use.

5. 3. A tracheostomy guard according to claim 1 or 2, wherein, in use, the force exerted on the second portion is due at least in part to the weight of sputum present within the second portion.

6. 3. A tracheostomy guard according to claim 1 or 2, wherein the variable size of the aperture is configured to achieve a minimum set positive end-expiratory pressure (PEEP) during use.

7. The minimum PEEP setting is: 1 cmH ２ 0-7cmH ２ 7. The tracheostomy guard of claim 6, wherein the axial length is selected from the range of 0.

8. 3. A tracheostomy guard according to claim 1 or 2, wherein the at least one first member and / or the second member are relatively arranged to form the at least one aperture of variable size.

9. 3. A tracheostomy guard according to claim 1 or 2, wherein at least a portion of the second portion is integral with the first portion.

10. 3. The tracheostomy guard of claim 1 or 2, wherein the applied force is related to the internal pressure of the second portion.

11. 3. The tracheostomy guard of claim 1 or 2, wherein the first and second parts together form a cavity that, in use, is in fluid communication with the surrounding environment only via the one or more variable-sized apertures.

12. 3. The tracheostomy guard of claim 1 or 2, wherein the aperture reaches its minimum size in a rest state of the tracheostomy guard.

13. 3. The tracheostomy guard of claim 1 or 2, wherein the at least one first member or second member comprises a flap or panel.

14. 3. The tracheostomy guard of claim 1 or 2, wherein the second portion is configured, in use, to be in fluid communication with the patient interface.

Images