Device for regulating pressure

Abstract

A device for regulating pressure, the device comprising: a body having: an inlet; the inner cavity is communicated with the inlet; and one or more flow features including a flow restrictor for restricting airflow through the lumen wherein downstream of the flow restrictor is a protective portion that helps protect the restrictor from damage.

Description

[0001] Cross-reference to related applications

[0002] This application is based on and claims priority to U.S. Provisional Patent Applications Nos. 63 / 515,028 and 63 / 589,614, filed on July 21, 2023 and October 11, 2023, respectively, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to a device for regulating pressure, and more specifically, a device for helping to regulate the pressure of gas supplied to a patient during respiratory therapy. Background Technology

[0004] Patients may experience breathing difficulties for a variety of reasons. For example, infants and young children may have lung problems that require respiratory assistance. In adults, airway collapse may also require respiratory assistance. Respiratory assist or respiratory therapy devices (collectively referred to as 'breathing equipment' or 'breathing apparatus') can be used to deliver breathable gases such as supplemental oxygen or other gases. The gas flow can also pass through a humidifier to deliver humidified gas to the patient. Respiratory assist devices can also allow for adjustment and control of the characteristics of the gas delivered to the patient.

[0005] Any references or discussions in this specification to any document, action, or knowledge item are provided solely for the purpose of providing context for this disclosure. It is not recommended or implied that any of these matters, or any combination thereof, constitutes common sense at the priority date, or is known to be related to any attempt to resolve any problem addressed in this specification. Summary of the Invention

[0006] The following outlines various aspects of this disclosure. It should be noted that various aspects and embodiments of this disclosure may be combined such that features and / or embodiments of one aspect may be used with features and / or embodiments of any other aspect, where compatible.

[0007] In a first aspect, this disclosure provides an apparatus for regulating pressure, the apparatus comprising: The subject, which has: Entrance; and The inner cavity, which communicates with the inlet; and One or more flow characteristics, including a flow limiter for restricting airflow through the cavity. Downstream of the flow limiter is a protection section, which helps protect the limiter from damage.

[0008] In a second aspect, this disclosure provides an apparatus for regulating pressure, the apparatus comprising: The subject, which has: Entrance; and The inner cavity, which communicates with the inlet; and One or more flow characteristics, including a flow limiter for restricting airflow through the cavity. The protective portion is located adjacent to the far end of the one or more flow characteristics to help protect the one or more flow characteristics from damage.

[0009] In a third aspect, this disclosure provides an expiratory pressure device configured to expel exhaled gas from a patient interface assembly, the device comprising: The subject, which includes: Entrance; and An inner cavity, which communicates with the inlet, includes a flow restrictor and a distal opening; and A protective portion, wherein the protective portion is configured to maintain an expiratory flow path from the distal end of the opening.

[0010] In some embodiments, the protective portion is configured to maintain the expiratory flow path from the flow limiter to the atmosphere and / or environmental conditions.

[0011] In some embodiments, the protection portion is configured to maintain a path from the flow limiter to atmospheric and / or environmental conditions.

[0012] In some embodiments, the protective portion extends away from the flow limiter.

[0013] In some embodiments, the protection portion covers at least a portion of the far end of the flow limiter.

[0014] In some embodiments, the protective portion extends over the flow limiter.

[0015] In some embodiments, the protective portion extends in a direction similar to that from the inlet to the flow limiter.

[0016] In some embodiments, the protective portion includes a radial surface configured to prevent substances from damaging the flow limiter.

[0017] In some embodiments, the protective portion provides a first surface that extends laterally into the axial direction of the body.

[0018] In some embodiments, the protective portion includes protective members. The protective member may include multiple protective members.

[0019] In some embodiments, the protective member has a free end at the distal end of the flow limiter.

[0020] In some embodiments, the protective member includes a protrusion.

[0021] In some embodiments, the protrusion extends from near the portion of the cavity that forms the flow restrictor.

[0022] In some embodiments, the protrusion extends above the flow limiter.

[0023] In some embodiments, the one or more flow characteristics include an orifice.

[0024] In some embodiments, the distal end of the opening includes an aperture. The aperture may include multiple apertures.

[0025] In some embodiments, the protective member includes the orifice.

[0026] In some embodiments, the orifice is in fluid communication with the atmosphere and / or environmental conditions.

[0027] In some embodiments, the orifice is biased relative to the flow limiter.

[0028] In some embodiments, the area of ​​the orifice is larger than that of the flow limiter.

[0029] In some embodiments, the area ratio of the flow limiter to the orifice is at least 1:15.

[0030] In some embodiments, the ratio of the flow limiter to the area of ​​the orifice is at least 1:20.

[0031] In some embodiments, the orifice forms the flow limiter.

[0032] In some embodiments, the protective portion extends from the cavity at the location of the flow limiter and terminates at the orifice.

[0033] In some embodiments, the protective member includes a secondary aperture. The secondary aperture may include a plurality of secondary apertures.

[0034] In some embodiments, the secondary aperture is located on a different plane from the main aperture.

[0035] In some embodiments, the protective member includes a tertiary aperture. The tertiary aperture may include multiple tertiary apertures.

[0036] In some embodiments, the tertiary orifice is located on a plane opposite to the plane of the orifice.

[0037] In some embodiments, the area ratio of the flow limiter to the secondary orifice and the tertiary orifice is at least 1:2.

[0038] In some embodiments, the area ratio of the flow limiter to the secondary orifice and the tertiary orifice is at least 1:5.

[0039] In some embodiments, the area ratio of the flow limiter to the orifice, the secondary orifice, and the tertiary orifice is at least 1:20.

[0040] In some embodiments, the area ratio of the flow limiter to the orifice, the secondary orifice, and the tertiary orifice is at least 1:25.

[0041] In some embodiments, the protective member forms a ring-shaped sleeve.

[0042] In some embodiments, the annular sleeve extends radially outward from the neck of the body.

[0043] In some embodiments, the shoulder portion connects the loop to the neck of the body.

[0044] In some embodiments, the shoulder includes the third-level opening.

[0045] In some embodiments, the shoulder extends substantially perpendicular to the longitudinal axis of the body.

[0046] In some embodiments, the protective member includes an expansion portion.

[0047] In some embodiments, the expansion portion is a conical portion.

[0048] In some embodiments, the protective member includes a member extending in the vicinity of the one or more flow characteristics.

[0049] In some embodiments, the member includes ribs extending toward the one or more flow characteristics. The member may include multiple ribs.

[0050] In some embodiments, the component is located inside the one or more flow characteristics.

[0051] In some embodiments, the protection portion extends both downstream and upstream of the flow limiter.

[0052] In some embodiments, if the flow limiter fails, the airflow will pass through another flow limiter.

[0053] In a fourth aspect, this disclosure provides an apparatus for regulating pressure, the apparatus comprising: The subject, which has: Entrance; The inner cavity, which communicates with the inlet; and One or more flow characteristics, including a flow limiter for restricting airflow through the cavity. When one of the flow characteristics is damaged, the airflow will pass through another of the flow characteristics.

[0054] In a fifth aspect, this disclosure provides a device for regulating pressure in respiratory therapy, the device comprising: The subject, which has: Entrance; The inner cavity, which communicates with the inlet; and One or more flow characteristics, including a flow limiter for restricting airflow through the cavity. The main body is configured to be detachably connected to the medical device.

[0055] In some embodiments, a protective portion is located immediately adjacent to the distal end of the one or more flow characteristics to help protect the one or more flow limiters from damage.

[0056] In some embodiments, the protection portion is located downstream of the one or more flow characteristics.

[0057] In some embodiments, the protective portion extends away from the flow limiter.

[0058] In some embodiments, the protection portion covers at least a portion of the remote end of the flow limiter.

[0059] In some embodiments, the protective portion extends over the flow limiter.

[0060] In some embodiments, the protective portion extends in a direction similar to that from the inlet to the flow limiter.

[0061] In some embodiments, the protective portion includes a protective member.

[0062] In some embodiments, the protective member has a free end at the distal end of the flow limiter.

[0063] In some embodiments, the protective member includes a protrusion.

[0064] In some embodiments, the protrusion extends from near the portion of the cavity that forms the flow restrictor.

[0065] In some embodiments, the protrusion extends above the flow limiter.

[0066] In some embodiments, the one or more flow characteristics include orifices. The one or more flow characteristics may include multiple orifices.

[0067] In some embodiments, the protective member includes the orifice.

[0068] In some embodiments, the orifice is in fluid communication with the atmosphere and / or environmental conditions.

[0069] In some embodiments, the orifice is biased relative to the flow limiter.

[0070] In some embodiments, the area of ​​the orifice is larger than that of the flow limiter.

[0071] In some embodiments, the area ratio of the flow limiter to the orifice is at least 1:15.

[0072] In some embodiments, the ratio of the flow limiter to the area of ​​the orifice is at least 1:20.

[0073] In some embodiments, the orifice forms the flow limiter.

[0074] In some embodiments, the protective portion extends from the cavity at the location of the flow limiter and terminates at the orifice.

[0075] In some embodiments, the protective member includes a secondary aperture. The secondary aperture may include a plurality of secondary apertures.

[0076] In some embodiments, the secondary aperture is located on a different plane from the main aperture.

[0077] In some embodiments, the protective member includes a tertiary aperture. The tertiary aperture may include multiple tertiary apertures.

[0078] In some embodiments, the tertiary orifice is located on a plane opposite to the plane of the orifice.

[0079] In some embodiments, the area ratio of the flow limiter to the secondary orifice and the tertiary orifice is at least 1:2.

[0080] In some embodiments, the area ratio of the flow limiter to the secondary orifice and the tertiary orifice is at least 1:5.

[0081] In some embodiments, the area ratio of the flow limiter to the orifice, the secondary orifice, and the tertiary orifice is at least 1:20.

[0082] In some embodiments, the area ratio of the flow limiter to the orifice, the secondary orifice, and the tertiary orifice is at least 1:25.

[0083] In some embodiments, the protective member forms a ring-shaped sleeve.

[0084] In some embodiments, the annular sleeve extends radially outward from the neck of the body.

[0085] In some embodiments, the shoulder portion connects the loop to the neck of the body.

[0086] In some embodiments, the shoulder includes the third-level opening.

[0087] In some embodiments, the shoulder extends substantially perpendicular to the longitudinal axis of the body.

[0088] In some embodiments, the protective member includes an expansion portion.

[0089] In some embodiments, the expansion portion is a conical portion.

[0090] In some embodiments, the protective member includes a member extending in the vicinity of the one or more flow characteristics. The member may include multiple members.

[0091] In some embodiments, the body includes accessory ports. The body may include multiple accessory ports.

[0092] In some embodiments, the accessory port is a sensor port.

[0093] In some embodiments, the sensor port communicates with a sensor orifice, which helps prevent airflow jets from entering the sensor port. The sensor orifice may include multiple sensor orifices.

[0094] In some embodiments, the sensor port is radially offset relative to the sensor aperture.

[0095] In some embodiments, the sensor orifice is radially offset relative to the flow limiter.

[0096] In some embodiments, the cover is configured to close the port of the accessory.

[0097] In some embodiments, the cover is connected to at least a portion of the body via a connecting strap.

[0098] In some embodiments, one end of the body is tapered.

[0099] In some embodiments, the body includes a locking portion for detachable connection to the medical device.

[0100] In some embodiments, the locking portion includes a protrusion configured to engage a groove in the medical device.

[0101] In some embodiments, the body includes a component mounting portion that allows a clip to be placed near the one or more flow characteristics to help prevent damage to the one or more flow characteristics.

[0102] In some embodiments, the component mounting portion includes a channel.

[0103] In a sixth aspect, this disclosure provides a kit for a respiratory therapy system, the kit comprising: Multiple devices, One of the multiple devices provides a different flow limit compared to another of the multiple devices.

[0104] In some embodiments, the plurality of devices are as described herein.

[0105] In a seventh aspect, this disclosure provides a kit for a respiratory therapy system, the kit comprising: Device; and at least one or more of the following: Humidifier compartment; Patient interface; pipe; or A clip for attaching to the device.

[0106] In some embodiments, the device is as described herein.

[0107] In some embodiments, the kit may include a flow generator.

[0108] In some embodiments, the tube is an inhalation tube or an exhalation tube.

[0109] In some embodiments, the exhalation tube is configured to connect to the patient interface.

[0110] In some embodiments, the device is connected to the exhalation tube.

[0111] In an eighth aspect, this disclosure provides a system comprising: A patient interface for delivering breathable gas to a patient; and The device is connected to the patient interface.

[0112] In some embodiments, the device is as described herein.

[0113] In some embodiments, the patient interface includes a sealing formation structure configured to form a seal with the patient's airway during use.

[0114] In some embodiments, the sealing structure forms a seal with the patient's nose and / oronasal region.

[0115] In some embodiments, the inhalation port or branch is connected to the patient interface.

[0116] In some embodiments, the expiratory port or branch is connected to the device and / or patient interface.

[0117] In a ninth aspect, this disclosure provides a system comprising: a pipe; and a means for regulating pressure and being in communication with the pipe.

[0118] In some embodiments, the device is as described herein.

[0119] In some embodiments, the device is detachably connected to the tube and / or patient interface.

[0120] In some embodiments, the device is integrally formed with the tube and / or patient interface.

[0121] In some embodiments, the tube forms an expiratory branch.

[0122] In some embodiments, the sensor is connected to the device to help regulate flow and / or pressure.

[0123] In some embodiments, the sensor is a gas property sensor.

[0124] In a tenth aspect, this disclosure provides a pipe assembly comprising: a pipe; and a means for regulating pressure and communicating with the pipe.

[0125] In some embodiments, the device is as described herein.

[0126] In some embodiments, the device is detachably connected to the tube.

[0127] In some embodiments, the device is integrally formed with the tube.

[0128] In the eleventh aspect, this disclosure provides a patient interface component, which includes: Patient interface; and The device, which is connected to the expiratory side of the patient interface, includes: The subject, which has: Entrance; and The inner cavity, which communicates with the inlet; and One or more flow characteristics, including a flow limiter for restricting airflow through the cavity. Downstream of the flow limiter is a protection section, which helps protect the flow limiter from damage.

[0129] In a twelfth aspect, this disclosure provides a patient interface component, the patient interface component comprising: Patient interface; and The device, which is connected to the expiratory side of the patient interface, includes: The subject, which has: Entrance; and The inner cavity, which communicates with the inlet, One or more flow characteristics, the one or more flow characteristics including a flow limiter for restricting airflow through the cavity; The protective portion is located adjacent to the far end of the one or more flow characteristics to help protect the one or more flow characteristics from damage.

[0130] In a thirteenth aspect, this disclosure provides a patient interface component, the patient interface component comprising: Patient interface; and The device, which is connected to the expiratory side of the patient interface, includes: The subject, which has: Entrance; The inner cavity, which communicates with the inlet; and One or more flow characteristics, including a flow limiter for restricting airflow through the cavity. When one of the one or more flow characteristics is at least partially blocked, the airflow will pass through another of the one or more flow characteristics.

[0131] In a fourteenth aspect, this disclosure provides a patient interface component, the patient interface component comprising: Patient interface; and The device, which is connected to the expiratory side of the patient interface, includes: The subject, which has: Entrance; The inner cavity, which communicates with the inlet; and One or more flow characteristics, including a flow limiter for restricting airflow through the cavity. The main body is configured to be detachably connected to the medical device.

[0132] In some embodiments, the device is detachably connected to the patient interface.

[0133] In some embodiments, the device is integrally formed with the patient interface.

[0134] In a fifteenth aspect, this disclosure provides a system comprising: Breathing therapy device; and The device is in fluid communication with the respiratory therapy device.

[0135] In some embodiments, the device is as described herein.

[0136] In some embodiments, the device is connected to the expiratory branch.

[0137] In some embodiments, the device is in fluid communication with a patient interface.

[0138] In some embodiments, the device operates in conjunction with a respiratory therapy device to deliver a prescribed therapeutic pressure to the patient.

[0139] In some embodiments, the respiratory therapy device includes: Flow generator; A humidifier that is in fluid communication with the flow generator; Controller; and At least one gas property sensor, The controller is configured to control the flow rate and / or pressure of gas in the gas flow path based at least in part on the output of the at least one gas property sensor.

[0140] In some embodiments, in response to detecting a change in flow resistance in the system, the controller is configured to adjust the flow rate such that the pressure delivered to the patient is substantially maintained at the prescribed therapeutic pressure.

[0141] In a sixteenth embodiment, this disclosure provides a patient interface assembly for delivering pressurized gas to a patient, the patient interface assembly comprising: A patient interface including a sealing structure configured to form a seal with a patient's airway during use, the sealing structure having an inspiratory opening and an expiratory opening; An expiratory pressure device in fluid communication with an expiratory opening, the expiratory pressure regulator device including a cavity with a flow limiter; and a protection portion configured to maintain an expiratory flow path from the expiratory pressure device.

[0142] In one embodiment, the inhalation opening and the exhalation opening are located on opposite sides of the sealing structure.

[0143] In one embodiment, the inhalation opening is aligned with the exhalation opening.

[0144] In one embodiment, the sealing structure includes a mask structure, a nose plug, or a nose pillow.

[0145] Further features and advantages of this disclosure will become apparent from the following detailed description. Attached Figure Description

[0146] Various embodiments of this disclosure will now be described by way of example only, with reference to the accompanying drawings, in which: Figure 1A perspective view illustrating a pressure regulating device according to an embodiment of the present disclosure is shown; Figure 2 Examples Figure 1 Top view of the device shown; Figure 3 Examples Figure 2 The cross-sectional view of the device shown is obtained along line aa; Figure 4 Examples Figure 2 The cross-sectional view of the device shown is obtained along line bb. Figure 5 A side view of another device for regulating pressure according to an embodiment of the present disclosure is shown; Figure 6 Examples Figure 5 A cross-sectional side view of another device shown; Figure 7 Examples Figure 5 A cross-sectional perspective view of another device shown; Figure 8 Embodiments according to this disclosure are illustrated. Figure 5 A perspective view of the portion of another device shown, from the tube to the connector; Figure 9 Examples Figure 8 A first cross-sectional perspective view of another device shown; Figure 10 Examples Figure 8 A second cross-sectional perspective view of another device shown; Figure 11 Examples Figure 5 A cross-sectional front view of another device shown; Figure 12 A perspective view of a port cover according to an embodiment of the present disclosure is shown; Figure 13 A perspective view of a card holder according to an embodiment of the present disclosure is shown; Figure 14 A perspective view illustrating another device for regulating pressure according to an embodiment of the present disclosure is shown; Figure 15 Examples Figure 14 A side view of another device shown; Figure 16 Examples Figure 14 A cross-sectional view of another device shown; Figure 17 Examples Figure 14 Enlarged perspective view of the top portion of the other device shown; Figure 18 and Figure 19A cross-sectional view of another device is illustrated, showing an alternative outlet flow path from this other device; Figure 20 A schematic diagram of a respiratory therapy system according to an embodiment of the present disclosure is shown; Figure 21 A schematic diagram of another respiratory therapy system according to an embodiment of the present disclosure is illustrated; Figure 22 A perspective view of a nasal mask patient interface on a patient according to an embodiment of the present disclosure is illustrated; and Figure 23 A perspective view of a nasal congestion patient interface on a patient according to an embodiment of the present disclosure is shown. Detailed Implementation

[0147] Positive airway pressure (PAP) is a form of respiratory support that can be provided to patients with breathing difficulties. Various types of PAP therapy exist. For example, continuous PAP (CPAP) is a form of respiratory therapy in which a flow of gas is supplied to the patient via one or more tubes and a patient interface. The gas flow can be provided by a gas source (e.g., a gas source within the walls of a hospital or clinic) or by a compressed gas cylinder. The gas flow can also be provided by other respiratory assist devices, such as a flow generator or ventilator.

[0148] Bubble-type continuous positive airway pressure (bCPAP) is a type of CPAP specifically designed for infants and young children. The patient interface connects to two tubes: an inspiratory tube or branch and an expiratory tube or branch. The inspiratory tube delivers air to the patient via the patient interface. The expiratory tube provides a pathway for the patient's exhaled air. The expiratory tube communicates with the bubble-type CPAP pressure regulator, or 'bubble generator'. This bubble generator has a chamber for containing a column of water. Positive pressure is generated by placing the open end portion of the expiratory branch at a known depth of water in the chamber. The patient exhales against a set level of water pressure, thereby generating positive end-expiratory pressure (PEEP), which dilates and opens the airway. The pressure provided can be controlled by varying the depth to which the end portion of the expiratory tube is immersed in the column of water.

[0149] Modifying CPAP therapy in other ways (e.g., without the use of a bubble generator) can provide clinicians with an alternative option for personalized patient treatment. However, modifying CPAP therapy without a bubble generator presents other obstacles and challenges to overcome.

[0150] This disclosure relates to a device for regulating pressure, and more specifically, a device for minimizing flow obstruction or providing redundancy in the event of flow obstruction while regulating positive end-expiratory pressure in a respiratory therapy system.

[0151] This device helps regulate pressure by providing a limit. This limit can be static or fixed. The device works in conjunction with respiratory therapy devices, such as a flow generator, to maintain the pressure delivered to the patient within a desired range.

[0152] The device can be considered to passively regulate pressure. The breathing therapy device can be combined with the device to actively regulate pressure.

[0153] The device may include protective components to minimize material blockage of parts within the device that could obstruct flow paths (e.g., expiratory or ventilatory flow paths). If at least partial blockage occurs in a flow path through or out of the device, the airflow will pass through one or more alternative flow paths that offer less flow resistance compared to the at least partially blocked flow path. Furthermore, the device passively regulates pressure by providing limitation. The device collaborates with a respiratory therapy device including a flow generator to maintain pressure within a desired range of gas flow. The flow generator, in conjunction with the device, actively regulates pressure.

[0154] Figure 1 A perspective view of a pressure regulating device 10a according to an embodiment of the present disclosure is illustrated. In this specification, reference numerals followed by lowercase letters generally indicate alternative embodiments of the general elements identified by those reference numerals. Thus, for example, device 10a is similar to but not identical to device 10b. Furthermore, references to elements identified solely by reference numerals refer to all embodiments of that element. Therefore, for example, references to device 10 are intended to include both device 10a and device 10b.

[0155] The device 10a includes a main body 100a. The main body 100a includes an inlet 200a, an inner cavity 300a, an outlet 400a, a flow restrictor 500a, and a protective portion 600a. The outlet 400a and the flow restrictor 500a form a flow characteristic 110a of the main body 100a. The main body 100a may include other components connected to the main body.

[0156] Inlet 200a is in fluid communication with lumen 300a. Inlet 200a is located at one end of body 100a. In this respect, body 100a includes inlet connector 250a. Inlet connector 250a includes a detachable connection portion 260a. In this embodiment, detachable connection portion 260a includes a detachable connection surface 270a. Detachable connection surface 270a is in the form of a tapered cylindrical surface. This tapered cylindrical surface is configured to detachably connect to a tube while providing a substantially airtight seal. The tube may be an expiratory tube / branch. In other embodiments, detachable connection portion 260a may connect to an opening, outlet (e.g., an expiratory or ventilation outlet), or expiratory branch of a patient interface.

[0157] The cavity 300a provides one or more flow paths from the inlet 200a to the outlet 400a. In this embodiment, the cavity 300a is substantially cylindrical, but other shapes may be used. The cavity 300a tapers toward the flow restrictor 500a. The cavity 300a expands toward the outlet 400a from the flow restrictor 500a. That is, a portion of the cavity 300a contracts toward the axis 12, while another portion expands away from the axis 12a.

[0158] The tapering nature of the cavity 300a can help (e.g.): i) prevent condensate buildup; and / or ii) attenuate sound to reduce unwanted noise. However, it should be understood that the cavity 300a can take other shapes.

[0159] The inner cavity 300a includes a flow restrictor 500a. The flow restrictor 500a is located between the inlet 200a and the outlet 400a. The flow restrictor 500a restricts fluid flow through the inner cavity 300a. Figure 1 In the example shown, the flow limiter 500a is in the form of an orifice 510a. The flow limiter 500a may take other forms, including as a separate limiting component.

[0160] The flow limiter 500a has the smallest cross-sectional area or diameter of the inner cavity 300a. The cross-sectional area of ​​the outlet 400a is larger than that of the flow limiter 500a.

[0161] (Restrictive) The minimum diameter of orifice 510a can be approximately 3.15 mm. In some examples, orifice 510a is between approximately 1 mm and 5 mm, or between approximately 2 mm and 4 mm, or between approximately 3 mm and approximately 4 mm. In some examples, orifice 510a can be larger than approximately 3 mm.

[0162] As a relatively large orifice, orifice 510a is likely less susceptible to clogging by substances with low viscosity compared to smaller orifices (e.g., flow feature 110b). The shape of orifice 510a can vary, but in this embodiment it is a circular orifice. That is, for example, orifice 510a appears as a circular opening when viewed from the end of device 10a. Orifice 510a can be of any shape and size that provides the desired flow resistance to the patient to maintain the desired pressure. As discussed further below, the size and / or shape of flow limiter 500a is tuned to facilitate the provision of the desired pressure, such as PEEP. The desired pressure can be a parameter set by the user for the respiratory therapy system. For example, the pressure can be set at the respiratory therapy device. For a given respiratory therapy system with a given flow resistance, a smaller orifice 510a typically provides a higher PEEP, while a larger orifice 510a provides a lower PEEP. For example, to maintain a set PEEP, a larger orifice 510a may require the flow generator of the respiratory therapy system to generate a higher pressure to allow airflow to move through the system.

[0163] The size of the flow limiter 500a is designed to achieve adequate CO2 removal, among other things. CO2 removal is achieved by flow through the system, including the patient interface, and out of the flow limiter 500a. In one example, the flow rate can be a parameter set by the user, for example, at the respiratory therapy device. In another example, the flow rate can be a value determined by the respiratory therapy system due to a pre-stored pressure-flow relationship. For a given flow rate produced in the respiratory therapy system, a smaller orifice 510a can provide a higher PEEP, and a larger orifice 510a can provide a lower PEEP (as indicated above).

[0164] The size of the flow restrictor 500a is designed to allow sufficient flow and pressure to be delivered to the patient. In one example, the area ratio of the opening size of the flow restrictor 500a to the opening size of the outlet 400a can be at least 1:20. In other examples, the area ratio of the opening size of the flow restrictor 500a to the opening size of one or more outlets 400a can be between about 1:1 and 1:50, or between about 1:10 and 1:40, or between about 1:15 and 1:30.

[0165] The flow limiter 500a provides flow resistance between 1 cmH2O and 6 cmH2O at a flow rate of 8 liters per minute (LPM). In some examples, the flow limiter 500a provides flow resistance between 1 cmH2O and 40 cmH2O at flow rates between approximately 1 LPM and 70 LPM.

[0166] The size of the flow limiter 500a can be designed to reduce noise generated during use as airflow passes through and exits the device 10a. The size of the flow limiter 500a can be designed to meet the patient's inspiratory needs without generating excessive back pressure in the system. This back pressure must not exceed the back pressure that the flow generator in the system can overcome. This means that for a desired CPAP range between 2 cmH2O and 20 cmH2O, the generated airflow must be sufficient to meet the patient's inspiratory needs.

[0167] The flow generator is discussed further below and can be operated, for example, by a mechanical device. In this disclosure, the flow generator can provide airflow via a blower or ventilator, etc. In other embodiments, the gas can be derived from other gas sources (e.g., pressurized containers, wall-mounted gas sources, etc.); however, a flow generator can have advantages. For example, a flow generator reduces the risk of gas depletion because the gas is derived from ambient air (optionally in combination with supplemental / auxiliary gases such as oxygen). Therefore, with a flow generator, the risk of therapy interruption due to gas source depletion is lower.

[0168] The currently disclosed device 10 is generally intended for use with a flow generator that can operate with different flow rates. The flow generator can adjust the flow rate to meet therapeutic pressure requirements as the patient breathes. For example, the flow generator can change the flow rate to meet a CPAP pressure requirement set by a user (such as a clinician). The flow generator can change the flow rate to deliver gas to the patient at different pressures. For example, a first pressure, such as a set inspiratory airway pressure, at the detection of the start of a spontaneous breathing cycle, and a second pressure, such as a set expiratory pressure, during exhalation.

[0169] More broadly, device 10 is part of a respiratory assist device that can provide one or more respiratory therapies (e.g., PAP / CPAP, and including variable flow CPAP). By another example, Figure 20 A breathing aid device with a flow generator is shown. The flow generator may include a blower. In another example, the flow generator may include a flow regulator, such as a proportional valve or a flow meter used in conjunction with a high-pressure gas source. In yet another example, the flow generator may include one or more of a piston or a bellows. The flow generator may include other types of flow generators. The flow generator may be connected separately to a humidifier. Figure 21 A breathing aid device with an integrated flow generator and humidifier is shown.

[0170] In such Figure 20 or Figure 21In the system shown, flow generators 2400a and 2400b generate flow and pressure to meet the patient's inspiratory needs. For example, a desired pressure for the PAP can be set, and the flow generator 2400 can be controlled, for example, by a controller (not shown), to achieve the set desired pressure. Downstream of the flow generators 2400a and 2400b may be components including tubing 2450a and 2450b, humidifiers 2500a and 2500b, inspiratory tubing 2200a and 2200b, some of which may be heated conduits 2250a and 2250b, expiratory tubing 2300, patient interface 2100, and device 10.

[0171] Each of these components may have an associated flow resistance (RTF or RTQ). That is, the circuit including these components has a circuit RTF. In use, the flow generator 2400 operates to supply pressure that overcomes the circuit RTF in order to achieve the desired set pressure. In other words, the pressure supplied to the patient is obtained by subtracting the circuit RTF from the supplied pressure.

[0172] The respiratory therapy device (e.g., flow generator 2400) may have a controller and a gas property sensor 2600. The respiratory therapy device operates in conjunction with device 10. The limiter 500 of device 10 can be tuned to provide a set patient pressure and / or expiratory flow rate.

[0173] The therapeutic pressure delivered to the patient by the respiratory therapy device can be specified. If the flow resistance through the respiratory therapy system changes, sensors 2600a and 2600b in the respiratory therapy device detect the pressure change. The controller can adjust the flow rate generated via the flow generator so that the pressure delivered to the patient is maintained at a specified or desired level. The flow rate can be adjusted, for example, by increasing or decreasing the rpm of the blower in the flow generator 2400 via the controller.

[0174] In other words, the controller is configured to control the flow generator 2400 based on pressure control, wherein the pressure control includes controlling the flow generator to provide a gas flow at a set pressure. This gas flow can be changed to provide the set pressure.

[0175] The flow controller can be configured to control the flow generator 2400 according to flow control, wherein the flow control includes controlling the flow generator to provide a gas flow at a set flow rate. The pressure can be changed to provide the set flow rate.

[0176] The respiratory therapy device allows for adjustment and control of gas flow characteristics, including flow rate, pressure, etc. Sensors 2600 (such as flow sensors and / or pressure sensors) can be used to measure the characteristics of the gas flow. In some examples, the respiratory therapy device is configured to be connected to and / or include at least one gas property sensor 2600. The controller can be configured to calculate a determined flow rate and / or a determined pressure of the gas in the gas flow path, at least in part based on the output of at least one gas property sensor 2600. The controller can be configured to generate one or more alarms based on the determined flow rate and / or determined pressure. These one or more alarms may include: a) an overpressure alarm; b) a high-pressure alarm; c) a low-pressure alarm; d) an excessive leakage alarm; e) a blockage alarm; f) an apnea alarm; or g) any combination of a) to f).

[0177] The circuit RTF can be tuned to achieve the desired circuit RTF by changing the RTF of the airflow through device 10. In the case that device 10 is a limiter 500a, the RTF is determined by the size of the limiter 500a.

[0178] Patients experience PEEP at the end of the expiratory phase. Considering the above, it should be understood that PEEP will also be determined at least in part by the associated flow area of ​​orifice 510a. Orifice 510a can be a constraint. That is, the total flow area of ​​orifice 510a will contribute to obtaining the desired PEEP. The flow area of ​​multiple smaller orifices 510a can be larger than that of a single larger orifice 510a. Therefore, a larger flow area of ​​smaller orifices can provide a relatively lower predetermined PEEP.

[0179] As indicated above, the desired PEEP is also based on the flow generator settings and limits. In other words, the flow generator can play a role in achieving the desired PEEP. For example, a predetermined PEEP can be set, and the flow generator can modify the flow to achieve the desired PEEP, thereby compensating for other factors, including congestion.

[0180] At least a portion of the protective portion 600a may be located downstream of the flow restrictor 500a. The protective portion 600a helps protect the flow restrictor 500a from blockage. The protective portion 600a is adjacent to the distal end of the flow restrictor 500a. That is, further along the flow path from the flow restrictor 500a, in the flow direction moving away from the inlet 200a, the protective portion 600a provides protection to deflect foreign objects from entering the flow restrictor 500a. In this respect, at least a portion of the protective portion 600a is further positioned along axis 12a in the direction away from the inlet 200a.

[0181] The protective portion 600a may extend away from the flow limiter 500a. In this example, the protective portion 600a covers the distal end of the flow limiter 500a. In this respect, at least a portion of the protective portion 600a extends over the flow limiter 500a. That is, the protective portion 600a protrudes longitudinally away from the adjacent flow limiter 500a.

[0182] The protective portion 600a can help mitigate the risk of substances entering the flow limiter 500a or surrounding objects and causing damage. For example, due to the nature of the protective portion 600a, foreign objects may be unable to enter the flow limiter 500a along path (a). Based on this, the protective portion 600a includes a protective member 605a. The protective member 605a has a free end at the distal end of the flow limiter 500a. In this example, the protective member 605a forms a protrusion. This protrusion extends from near the portion of the body 100a that forms the flow limiter 500a.

[0183] The protective member 605a may include a protective surface 610a that helps reduce the direction of material travel and mitigate blockage of the flow limiter 500a. The protective surface 610a can reduce the likelihood of material potentially entering the flow limiter 500a along the axis 12a. Furthermore, the protective portion 600a makes it more difficult for items such as blankets and fingers to cover the device 10a in a way that would block the flow limiter 500a. In this scenario, the blockage of the flow limiter 500a is achieved in a way that prevents gas from properly passing through the flow limiter to meet atmospheric and / or environmental conditions.

[0184] The protective surface 610a includes a radial surface 620a. The radial surface 620a is generally circular, but in other embodiments, it should be understood that the protective surface 610a may have a different shape. The protective surface 610a is located outside the flow limiter 500a. That is, in this embodiment, the protective surface 610a is further away from the axis 12a compared to the flow limiter 500a.

[0185] In this embodiment, the protective surface 610a extends both upstream and downstream of the flow limiter 500a. That is, the protective surface 610a extends, for example, more towards the inlet 200a and outlet 400a than the flow limiter 500a.

[0186] The flow direction (main or expiratory) through device 10a is from Figure 1An arrow is shown on axis 12a. This arrow points downstream or in the direction of exhalation (i.e., from the inlet towards the outlet). The protective surface 610a extends axially beyond the flow restrictor 500a. The protective surface 610a also extends radially relative to axis 12a to surround the flow restrictor 500a. Therefore, in this example, the protective surface 610a is also tubular. The tubular protective surface 610a may have a circular cross-section, wherein the cross-section is cut perpendicular to axis 12a. The protective surface 610a may form a quadrilateral cross-section.

[0187] The first surface 630a extends laterally to the radial surface 620a. More specifically, the first surface 630a extends substantially perpendicular to the radial surface 620a. The first surface 630a forms a radial ring at the end of the protective portion 600a. The shape of the first surface 630a and its distance from the flow limiter 500a can vary as part of protecting the flow limiter 500a from blockage.

[0188] like Figures 2 to 4 As further shown, the protective surface 610a may include one or more components 640a, which also help protect the flow restrictor 500a from blockage. That is, the component 640a prevents obstruction from moving from the outlet 400a toward the flow restrictor 500a. The component 640a may also act as a safety feature by preventing the outlet 400a from being mistakenly connected to other items. In this embodiment, the component 640a is in the form of a rib.

[0189] Component 640a extends from the inner surface of the protective portion 600a toward the flow feature 110a, which is in the form of a flow limiter 500a. Component 640a extends from the inner surface of the radial surface 620a toward the flow limiter 500a. That is, component 640a extends from the inner surface of the protective portion 600a. Figure 2 As shown, components 640a are spaced at equal distances around the protective portion 600a. Components 640a include a tapered surface angled toward the flow limiter 500a. In other embodiments, it should be understood that the number of components 640a may be greater or less, and that the components may be randomly distributed rather than equally spaced. The shape of components 640a may also vary.

[0190] The protective portion 600a may include an outlet 400a. The protective portion 600a may terminate at the outlet 400a. The outlet 400a may include multiple outlets 400a. The outlet 400a may form part of the protective portion 600a in the device 10a. The outlet (or orifice) 400a includes one or more of the following two types: a first outlet orifice 410a and a second outlet orifice 420a. The first outlet orifice 410a is located at one end of the protective portion 600a. The first outlet orifice 410a is located at the end of the device 10a. A first surface 630a helps to define the first outlet 410a. The first surface 630a may be annular.

[0191] The first outlet orifice 410a extends laterally to axis 12a in the same manner as orifice 510a. The first outlet orifice 410a is substantially concentric with orifice 510a and / or inlet 200a. The first outlet orifice 410a is larger than each of the second outlet orifices, including inlet 200a and the second outlet orifice 420a. In other embodiments, the first outlet orifice 410a may be smaller (in area) than inlet 200a and / or the second outlet orifice 420a.

[0192] The second outlet orifice 420a is located on the outer surface of the main body 100a. More specifically, the second outlet orifice 420a is located on the protective surface 610a, i.e., the radial surface 620a. The second outlet orifice 420a extends laterally to the first outlet orifice 410a. In other words, the second outlet orifice 420a extends to the first outlet orifice 410a in a non-parallel manner.

[0193] The second outlet orifice 420a extends substantially parallel to axis 12a. The first outlet orifice 410a extends perpendicular to axis 12a. The second outlet orifice 420a is located between a pair of components 640a. The second outlet orifice 420a contributes to improving the robustness of the device 10a. The second outlet orifice 420a provides multiple flow paths for airflow to exit the device 10a when orifice 410a is completely or partially blocked. That is, when the first outlet orifice 410a is at least partially blocked, another airflow can pass through the second outlet orifice 420a, which (commonly) provides a less resistant flow path compared to the at least partially blocked first outlet orifice 410a.

[0194] Providing multiple flow paths helps maintain a predetermined PEEP and mitigates the risk of high PEEP due to blockage. The predetermined PEEP can be between 2 cmH2O and 20 cmH2O. As part of this range, the predetermined PEEP can also be between 3 cmH2O and 15 cmH2O. Similarly, the first outlet orifice 410a can provide a suitable outlet if one or more of the second outlet orifices 420a are blocked.

[0195] Figure 5 A side view of another example device 10b for regulating pressure is shown. Like device 10a, device 10b includes a body 100b. The body 100b is substantially cylindrical. That is, the body 100b is substantially tubular about a central axis 12b.

[0196] The body 100b has a section with a different outer diameter relative to the central axis 12b. The body 100b includes an inlet 200b and an inner cavity 300b. The device 10b also includes a flow characteristic 110b having a flow restrictor 500b forming an outlet 400b. A protective portion 600b is also connected downstream of the flow characteristic 110b. In this embodiment, the body 100b is integrally formed to include the inlet 200b, the inner cavity 300b, the flow characteristic 110b, and the protective portion 600b; however, in other embodiments, these components may be detachably connected. The device 10b may also optionally include a fitting port 700b, a connector cover 800b, and a clip 1000b.

[0197] Inlet 200b is located at one end of body 100b. Inlet 200b is substantially circular. Inlet 200b is configured to receive a component (such as the end of a tube) or otherwise connect to such a component. Inlet 200b can be configured to connect to the expiratory or ventilatory port of the patient interface. Inlet 200b can be configured to connect to the expiratory branch of the patient interface.

[0198] The inner surface of the body 100b, extending from the inlet 200b, provides connecting features for engaging components such as tubes and patient interfaces. Figures 6 to 7 and Figures 9 to 10 As further shown, the device 10b includes an inlet connector 250b having a detachable connection portion 260b.

[0199] The detachable connection portion 260 includes a connection surface 270b. In this example, the connection surface 270b includes a protrusion. The connection surface 270b is configured to engage with one or more components of another component to provide a detachable locking connection. For example, the connection surface 270b may engage with one or more recesses to be detachably connected to said one or more recesses. In other examples, the connection surface 270b may also form one or more recesses. In this respect, the detachable connection portion 260b may form a detachable locking portion (with an associated locking surface).

[0200] exist Figures 8 to 10 In this configuration, device 10b is detachably connected to a portion of the connector from the tube. Device 10b can be detachably connected in a manner that allows for disconnection when needed. Figure 9 and Figure 10In the example shown, device 10b also provides alignment feature 280b for aligning device 10b to a certain orientation for connection with other components. In this embodiment, these components include one or more intermediate connectors.

[0201] exist Figure 9 and Figure 10 In the example shown, the intermediate connector includes a connection adapter with at least one locking finger. Each locking finger has a locking groove on its outer surface. Each locking finger extends longitudinally from an end of the adapter body. In the example shown, each locking finger gradually widens from its end to its base. The end of each locking finger may have a rounded or curved profile.

[0202] Alignment feature 280b is configured to guide a locking finger to a position for engagement. In the example shown, alignment feature 280b includes an alignment tab on the inner surface of the inlet end of the device. Alignment feature 280b can take various forms, such as a protrusion or ridge formed on the inner surface.

[0203] The alignment feature 280b can be configured to rotate the connector until the locking tab of the connector surface 270b is aligned with the locking groove.

[0204] In other embodiments, the locking arrangement of device 10 may include locking / engaging mechanisms as described in WO2013 / 022356 and / or WO2017037660 (the entire contents of which are incorporated herein by reference). In another embodiment, inlet 200b may be non-detachably connected to another component.

[0205] The inner cavity 300b extends from the inlet 200b to the flow characteristic 110b. The flow characteristic 110b includes a flow restrictor 500b that forms an outlet 400b for gas to exit from the device 10b. The flow characteristic 110b may include multiple orifices. That is, in an example embodiment of the device, the flow restrictor 500b may also be the outlet 400b.

[0206] exist Figures 6 to 7 and 9 to Figure 10 In the example shown, the cavity 300b is substantially cylindrical and decreases in size (or diameter) toward the flow feature 110b. The flow feature 110b includes multiple outlets (or orifices) 400b / flow restrictors 500b in the wall of the body 100b. The flow feature 110b is tuned to provide a predetermined PEEP. That is, the shape of the flow feature 110b is configured to provide a certain resistance to restrict airflow through the cavity 300b. In other words, the flow feature 110b provides a desired pressure drop to regulate at least a portion of the airflow through the cavity 300b.

[0207] Flow characteristics 110b provide a plurality of orifices spaced around axis 12b. In this respect, if one or more flow characteristics 110b become at least partially blocked, airflow can pass through one or more other flow characteristics 110b (providing a flow path with less resistance). This also reduces the risk of overpressure when delivering airflow to the patient. In this scenario, the predetermined PEEP may not be substantially affected, and therefore, device 10b provides further redundancy in the event of blockage.

[0208] Furthermore, the flow generator can modify the flow rate to maintain the desired PEEP. That is, in practice, if the flow characteristic 110b becomes blocked, the flow generator can be controlled to reduce the airflow entering the system 1000. By reducing the airflow, pressure is prevented from rising above the set point or exceeding acceptable limits. To mitigate the risk of blockage of the flow characteristic 110b, a protective portion 600b extends downstream of the flow characteristic 110b. That is, the protective portion 600b extends from near the flow characteristic 110b, for example, in a direction parallel to the axis 12b away from the inlet 200b.

[0209] The protective portion 600b includes a protective member 605b. The protective member 605b has a free end distal to the flow feature 110b. In this example, the protective member 605a forms a protrusion. This protrusion extends from near the portion of the body 100a in which the flow feature 110b is formed. The protective member 605b may include a member 640b. The member 640b is positioned inside the flow feature 110b. The member 640b may be closer to the axis 12b than the flow feature 110b.

[0210] At one end, member 640b extends linearly away from flow feature 110b. In this respect, member 640b extends parallel to axis 12b. In the example shown, member 640b is substantially cylindrical. Protective member 605b includes protective surface 610b.

[0211] A radial surface 620b is located at the other end of member 640b at the distal end of inlet 200b. Radial surface 620b is formed by a portion extending from member 640b. Radial surface 620b is further away from axis 12b than the surface of member 640b. Therefore, the diameter of radial surface 620b is larger than that of member 640b. Adjacent to radial surface 620b is a first surface 630b, which extends laterally to radial surface 620b and / or member 640b. First surface 630b, along with radial surface 620b and member 640b, helps protect flow feature 110b from blockage. For example, substances can be prevented from entering flow feature 110b along flow path (b). Furthermore, the protective portion 600b minimizes blockages caused by things like fingers and bedding.

[0212] At least Figures 5 to 7 In this embodiment, the restrictor 500b forms an outlet 400b. The outlet 400b allows airflow to exit from the device 10b into the atmosphere.

[0213] The outlet 400b is located on a first end face perpendicular to axis 12b. This first end face is spaced apart from a second end face of the protective portion 600b. In the illustrated embodiment, the first and second end faces are axially offset and opposite to each other. The first and second end faces are spaced apart by member 640b. In the illustrated embodiment, member 640b forms a neck connecting the first and second end faces.

[0214] The distance between the first and second end faces is designed to allow fluids (such as gas or condensate) to drain from the device 10b. This distance can be small enough to mitigate the risk of objects such as bedding or a user's finger entering and clogging the outlet 400b. The distance between the first and second end faces can be, for example, less than about 10 mm, or less than about 5 mm, or less than about 2 mm.

[0215] For example Figures 6 to 10 As shown, the protective portion 600b includes a fitting port 700b, but this fitting port may be located in other parts of the body 100b. In this embodiment, the fitting port 700b may be used as a sensor port; however, other uses are possible. The fitting port 700b may be a sampling port. The fitting port 700b may be substantially circular. The fitting port 700b may be tapered. The fitting port 700b is in fluid communication with a plurality of fitting orifices 750b. The fitting orifices 750b are in fluid communication with the cavity 300b. The member 640b may accommodate the fitting port 700b and the fitting orifices 750b.

[0216] exist Figure 11In the example shown, the fitting orifice 750b is located inside the flow characteristic 110b. Therefore, in this example, the fitting orifice 750b is radially offset relative to the flow characteristic 110b. The fitting orifices 750b are positioned at equal intervals around the axis 12b. In other words, the distance between adjacent orifices 750b around the axis 12b is substantially equal. The fitting orifice 750b helps prevent gas jets into the fitting port 700b. That is, the fitting orifice 750b is positioned in a manner that slows the airflow entering the fitting port 700b. This better indicates the pressure at the patient end due to the minimized dynamic airflow. In this embodiment, the fitting orifice 750b is located outside the fitting port 700b. Therefore, this forces the airflow to travel along a non-linear path into the fitting port 700b, thereby limiting the airflow. In other embodiments, other forms of resistance may be applied to the airflow entering the fitting port 700b.

[0217] To close the port 700b when it is not needed, at least a portion of the port cover 800b can be used. As an example, Figure 12 The port cover 800b includes a sealing portion 810b, a protrusion 820b, a connecting strip 830b, and a connecting portion 840b. In this embodiment, the sealing portion 810b is located on the protrusion 820b. The sealing portion 810b is configured to seal against the wall of the fitting port 700b. This prevents gas from escaping from the fitting port 700b. The protrusion 820b is configured to insert into the fitting port 700b to: i) removably retain the fitting port; and ii) maintain engagement between the sealing portion 810b and the wall of the fitting port 700b. The protrusion 820b is tapered. To attach the port cover 800b to a portion of the body 100b, the connecting portion 840b may be positioned over at least a portion of the body 100b. The connecting strip 830b connects the connecting portion 840b to the sealing portion 810b and / or the protrusion 820b.

[0218] Figure 13 An example of a clip 1000 is illustrated. The clip 1000 includes a body 1010 configured to be received within a component mounting portion 120b of the body 100b. In this embodiment, the component mounting portion 120b takes the form of a clip receiving portion. The component mounting portion 120b is located between a portion of the protective portion 600b and a main portion of the body 100b. A member 640b facilitates the formation of the component mounting portion 120b. The component mounting portion 120b provides a channel for receiving the clip 1000.

[0219] The clip 1000 includes a first arm 1100, a second arm 1200, and a clip locking portion 1300. The first arm 1100 and the second arm 1200 are resiliently flexible, allowing them to: i) expand above the component mounting portion 120b; and ii) retract to be positioned within a channel formed by the component mounting portion 120b. Once positioned on the component mounting portion 120b, the clip locking portions 1300 at the ends of the arms 1100, 1200 can be interconnected. This helps prevent the clip 1000 from detaching from the clip receiving portion 120b. Furthermore, once positioned on the component mounting portion 120b, the clip 1000 also helps prevent material from clogging the flow feature 110b.

[0220] Furthermore, the positioning portion 1400 on the clip can be used to detachably attach the device 10 to a specific location. For example, the positioning portion 1400 can be used to detachably attach the device 10 to a patient's bed. In this regard, the clip 1000 can provide tube management—connecting to bedding, etc., or to the inspiratory tube, tube connector, or patient interface itself—to prevent the expiratory tube from unintentionally drooping into a certain space. The clip 1000 shown is merely an example. Other clips including a ring that can be fitted, rotated about the component mounting portion 120b, and prevent blockage of the flow feature 110b can be employed.

[0221] Figures 14 to 17 A perspective view of another device 10c having a body 100c according to an embodiment of the present disclosure is illustrated. The device 10c includes an inlet 200c, an inner cavity 300c, (primary, secondary, and tertiary) outlets 400c, a flow limiter 500c, and a protective portion 600c. The outlet 400c and / or the flow limiter 500c form a flow characteristic 110c of the body 100c.

[0222] Inlet 200c is configured to connect to another component (not shown). For example, this other component may include an exhalation port or an exhalation tube / branch. This other component is adapted to deliver a gas flow to inlet 200c. Inlet 200c includes an inlet connector 250c. Inlet connector 250c includes a connection portion 260c. In this embodiment, connection portion 260c is configured to provide a detachable connection, but in other examples, the connection portion may be fixed. Connection portion 260c includes a connection surface 270c. Connection surface 270c is adapted to be detachably connected to another component (as part of delivering the gas flow).

[0223] exist Figure 16 , Figures 18 to 19In the example shown, the connecting portion 260c also includes an alignment feature 280c. The alignment feature 280c facilitates the alignment of the connecting portion 260c with another component as part of the detachable connection of the device 10c to the other component. It should be understood that the connecting portion 260c is merely an example, and any connecting portion having a feature that allows engagement / connection with another component may be an option. This other component may be the exhalation tube 2300 or an exhalation or ventilation port.

[0224] The inner cavity 300c provides a gas flow path from the inlet 200c to the outlet 400c. The inner cavity 300c comprises multiple sections with varying diameters. The inner cavity 300c decreases in size towards the flow limiter 500c. Figure 16 As further shown, the inner cavity 300c can gradually narrow inward from the inlet 200c toward the flow limiter 500c.

[0225] The flow limiter 500c can be configured to deliver effective therapy to a given patient using a given respiratory therapy device. The flow limiter 500c can be configured, for example, by setting the size of one or more features to achieve a predictable / desirable pressure range at a given flow rate. Ideally, a respiratory therapy device incorporating the flow limiter 500c can save energy / resources, such as avoiding excessive O2 use (if combined with ambient airflow). This may require appropriate increases or decreases in the flow generator to compensate.

[0226] With this in mind, the flow limiter 500c has an outlet in the form of an orifice 510c. The size of the orifice 510 can be configured to meet the patient's needs and / or be suitable for components of a respiratory therapy system.

[0227] If the orifice 510c is too large, the flow generator may need to provide a higher flow rate to meet the patient's inspiratory needs, which could lead to system inefficiency. For example, the flow generator motor may need to operate at a higher speed to achieve the desired pressure, and / or, if the system has supplemental oxygen added to the gas flow, a larger amount of oxygen may be required to achieve a similar fraction of inhaled oxygen for the patient.

[0228] An orifice size of 510c that is too small may cause overpressure on the system and / or the patient. Although a lower flow rate from the flow generator can achieve the desired PEEP, the therapy may not be very effective if the flow rate is too low.

[0229] By way of example only, the size of orifice 510c can be such that when the flow generator is set to deliver 8 L / min, a pressure of approximately 3 cmH2O is delivered at the patient interface (e.g., face mask, nasal cannula, etc.). In other words, the size of orifice 510c can be set to deliver the desired PEEP at a given flow rate. Therefore, it is advantageous to obtain a suitable pressure drop at the flow limiter 500c. The size of orifice 510c can range from 2 mm to 4 mm, and anywhere within this range, including 2.1 mm to 3.9 mm, 2.2 mm to 3.8 mm, 2.3 mm to 3.7 mm, 2.4 mm to 3.6 mm, 2.5 mm to 3.5 mm, 2.6 mm to 3.4 mm, 2.7 mm to 3.3 mm, and 2.8 mm to 3.3 mm. It should also be understood that orifice 510c can be considered as an outlet.

[0230] At least a portion of the protective portion 600c is located downstream of the flow restrictor 500c. This helps protect the flow restrictor 500c from clogging, and more specifically, protects the orifice 510c from clogging. The protective portion 600c includes a protective member 605c. The protective portion 600c can generally extend away from the flow restrictor 500c. In this respect, the protective member 605c forms an extension. The protective portion 600c can overhang the flow restrictor 500c and can cover at least a portion of the flow restrictor 500c. The protective member 605c has a free end at the distal end of the flow restrictor 500c. The protective member 605c includes a protective surface 610c.

[0231] exist Figures 14 to 19 In the example shown, the protective surface 610c includes a radial surface 620c. At least a portion of the radial surface 620c may extend downstream of the flow limiter 500c. Figure 15 As shown, at least a portion of the radial surface 620c expands away from the axis 12c. In this respect, the protective member 605c includes an expansion portion 607c. The expansion portion 607c is generally conical. The protective member 605c can be considered as an annular sleeve extending from a portion of the body 100c.

[0232] In some embodiments, the protective surface 610c may be quadrilateral or other polygonal in shape. In some embodiments, the protective surface 610c may have a constant cross-sectional shape over its entire length.

[0233] exist Figure 15In the example shown, the protective portion 600c includes a member 640c. The member 640c extends over at least a portion of the flow limiter 500c. The member 640c extends substantially from one side of the protective portion 600c to the other side. That is, the member 640c extends, for example, from one side of the radial surface 620c to the other side.

[0234] Component 640c includes a first edge 642c. The first edge 642c extends at least partially over / outward from another portion of the protective surface 610c. That is, the first edge 642c extends a distance 'a' over the first surface 630c of the protective portion 600c. In this embodiment, the distance 'a' is approximately 2 mm, but can vary. The first edge 642c extends outward relative to the first surface 630c.

[0235] The first surface 630c can be substantially planar. In this respect, the member 640c prevents the orifice 410c from being blocked. The first edge 642c can be arcuate in shape, for example, and can have a convex curvature or be parabolic. The properties of the first edge 642c help to: i) prevent the outlet 400c from being blocked by fingers or other surfaces; and ii) prevent other components from being mistakenly connected to the outlet 400c. In other words, the member 640c prevents unintended connections and potential blockages with the device 10c to maintain the desired PEEP.

[0236] Component 640c also includes a second edge 644c. The second edge 644c includes a portion offset relative to orifice 510c. This portion of the second edge 644c (in the downstream direction) is offset by a distance 'b' relative to the flow restrictor 500c (or orifice 510c). The distance 'b' is selected based on a trade-off between noise and flow resistance. A shorter distance 'b' reduces noise but increases flow resistance. Conversely, increasing the distance 'b' provides lower flow resistance but increases noise. The second edge 644c provides a groove in component 640c. Figure 16 As shown, the grooves are symmetrical around the flow limiter 500c. Figures 17 to 19 As further shown, the second edge 644c extends partially above the flow limiter 500c.

[0237] Component 640c can take various shapes. Figures 14 to 19 In the example shown, the member extends linearly between opposing radial surfaces 620c and / or toward opening 400c. However, in other examples, member 640c may extend linearly and / or non-linearly. For example, member 640c may be formed as: i) an 'S' shape; ii) a shape having both linear and curved surfaces; and / or iii) a serrated shape.

[0238] like Figure 18 and Figure 19 As further shown, airflow can exit from device 10c in various ways. Specifically, device 10c provides multiple outlets 400c (or orifices), which help reduce the risk of clogging device 10c. Outlet 400c provides a larger opening area compared to flow restrictor 500c. Outlet 400c includes a first orifice 410c, a second orifice 420c, and a third orifice 430c. The first orifice 410c is located at one end of the protective portion 610a. Member 640c separates / isolates the first orifice 410c.

[0239] In the example shown, the first orifice 410c provides a vent. In one or more examples, the first orifice 410c can be considered as the distal end of the opening of the inner cavity 300c. It should be understood that the vent can be designed in various shapes and provide the same function. During use, the main outlet of the device 10c is the orifice 510c, which directs the gas flow to the first orifice 410c. Figure 18 As shown, the airflow exits substantially axially from the first orifice 410c (from the flow restrictor 500c). The axial direction is typically along axis 12c. The device 10c typically provides a main vent in the form of the first orifice 410c, from which gas is primarily discharged. When the first orifice 410c is restricted—other orifices in the protective section 600c can provide exhaust paths, but these orifices are not necessarily always used as 'outlets'.

[0240] Considering the above, the second orifice 420c extends laterally to the first orifice 410c. That is, the second orifice 420c extends substantially on a different plane than the first orifice 410c. The second orifice 420c extends through the sidewall of the protective portion 610c. The second orifice 420c comprises two orifices on opposite sides of the protective portion 610c. Figure 19 As shown, the second orifice 420c provides a secondary path for gas flow to exit from the device 10c, and can further assist when the first orifice 410c is at least partially blocked. In another example, it should be understood that the second orifice 420c may be a single orifice.

[0241] The third orifice 430c is located at the opposite end of the protective portion 600c and the first orifice 410c. The third orifice 430c extends through the proximal end of the protective portion 600c. That is, the third orifice 430c provides an outlet in one end of the protective member 605c. The third orifice 430c extends laterally to the sidewall of the protective member 605c. The third orifice 430c is substantially adjacent to the flow limiter 500c (or the neck 130c of the body 100c). In this respect, the third orifice 430c is located in a similar position to the flow limiter 500c along axis 12c.

[0242] like Figure 19 As shown, the third orifice 430c provides a three-stage flow path for gas flow to exit from device 10c. By way of example only, in the event that the first orifice 410c and / or the second orifice 420c are blocked, the third orifice 430c can provide an alternative path for the gas flow to exit. As part of the gas flow exiting through the third orifice 430c, the gas flow is diverted and directed toward inlet 200c. In other words, the gas flow is redirected / diverted by approximately 180°.

[0243] As indicated above, the third opening 430c can be located between the sidewall of the protective member 605c and the neck 130c of the main body 100c. The third opening 430c can be located on the shoulder 650c of the neck 130c that connects the protective member 605c to the main body 100c. The protective portion 600c has a larger cross-sectional area compared to the neck 130c. The shoulder 650c can extend substantially perpendicular to the axis 12c. The third opening is relatively small. The size and location of the third opening can help make it difficult to block.

[0244] The main body 100c (neck 130c) also includes a component mounting portion 120c. The component mounting portion 120c provides a channel for receiving the clip 1000. The width and nature of the channel allow gas flow to still escape from the third port 430c when the clip 1000 is received.

[0245] Figure 20 An example system 2000a for providing respiratory therapy is illustrated. As indicated above, system 2000a is configured to provide a form of PAP therapy. In this embodiment, a variable flow CPAP (a form of PAP) can be used with device 10. System 2000a includes a patient interface 2100a, an inspiratory branch 2200a, an expiratory branch 2300a, a flow generator 2400a, and a humidifier 2500a. In this example, device 10 is connected to the expiratory branch 2300a to form a tubing assembly. Device 10 is detachably connected to the expiratory branch 2300a, but in another embodiment, the device may be integrally formed. In other embodiments, device 10 may be directly connected to, for example, the patient interface 2100a to form a patient interface assembly. In this embodiment, device 10 may be detachably connected to or integrally formed with the patient interface 2100a.

[0246] The patient interface 2100a is configured to form a seal with the patient's airway. The patient interface 2100a may be a face mask, a nasal pillow, or a nasal plug that seals at least to the patient's nostrils. The patient interface may be an oral interface, a nasal interface, or an oronasal interface. The patient interface may or may not have a mechanical seal with the patient's airway. In the example shown, the patient interface 2100a includes a padding component. This padding component is attached to a frame (not shown). The padding component will typically include a sealing portion, and in the case of the nasal plug version, the nasal plug itself may provide a sealing portion. The padding portion in a face mask is typically the portion that contacts the patient's face. In other embodiments, the patient interface may be employed as shown, for example, in International Patent Applications No. PCT / NZ2002 / 000180, No. PCT / NZ2019 / 050073, or No. PCT / IB2020 / 058973 (the entire contents of which are incorporated herein by reference).

[0247] Inspiratory branch 2200a and expiratory branch 2300a are tubing configured to connect to patient interface 2100a. One or both branches 2200a, 2300a may be heated to prevent or minimize condensation. In some embodiments, one or both branches 2200a, 2300a may be partially unheated to improve patient safety. For example, the unheated section of inspiratory branch 2200a may be located inside an incubator.

[0248] Flow generator 2400a generates an airflow that is carried to humidifier 2500a. In another embodiment, flow generator 2400a and humidifier 2500a may form a single unit, but they are separate in this embodiment. In other embodiments, humidifier 2500a may also be removed. Intake branch 2200a is connected to the outlet of humidifier 2500a (i.e., the outlet of the humidification chamber), which contains a certain amount of water. When a certain amount of water in the humidification chamber is heated by the heater plate in humidifier 2500a, water vapor begins to fill the volume above the water surface in the chamber. The water vapor can heat and / or humidify the gas flow (e.g., air) entering the chamber through the inlet. The heated and humidified gas flows out from the outlet of the humidification chamber and into intake branch 2200a.

[0249] The humidified gas can pass through the inhalation conduit 2200a to a patient interface, such as patient interface 2100a, attached to and / or sealed around the patient's mouth, nose, and / or nostrils. The inhalation conduit 2200a provides a gas flow to the patient, which can be ambient air, oxygen, a mixture of both, or a mixture of ambient air and other auxiliary gases. This gas may include a medication, which can be added via nebulization. The gas flow through the inhalation conduit 2200a can be delivered at different flow rates to achieve the desired PEEP. In this respect, the different flow rates can also be stabilized to a substantially constant flow rate as part of achieving the desired PEEP. In some embodiments, a gas flow supplied by a wall source is provided. This wall source can deliver gas at a target flow rate to maintain the flow of gas delivered to the patient. However, the gas flow will typically be delivered by a flow generator.

[0250] As indicated above, the inspiratory branch 2200a may house a heater, such as one or more heating wires, which heat the walls of the conduit to promote a substantially constant humidity distribution along the inspiratory branch 2200a and thus reduce condensation of the humidified gas within the inspiratory branch 2200a. The system 2000a (e.g., a breathing aid / flow generator, etc.) may be powered, for example, by input from one or more sensors in the system, to heat the inspiratory branch 2200a and the heater plate. Excess gas may flow through the expiratory branch 2300a to the device 10.

[0251] The flow generator 2400a generates a constant pressure, making it easier for the patient to inhale. To ensure the patient experiences sufficient PEEP to prevent airway collapse, multiple devices 10 can be provided to allow selection of preferred resistance within the system 2000. That is, different devices 10 can be exchanged in and out of the system 2000a to achieve preferred PEEP for a particular patient. Therefore, for the patient's benefit, the system 2000a can be tuned based on the flow restrictor 500. This tuning can be achieved by, for example, the following: i) the outlet area of ​​the orifice of the flow restrictor 500; ii) the geometry of either side of the orifice; iii) the geometry of the interior and exterior of the body 100; iv) surface texture; and / or v) the material acting as the restrictor (e.g., filter material, etc.). PEEP can also be varied via the flow generator 2300 (e.g., the flow generator can operate at higher / lower flow rates to achieve a specific PEEP).

[0252] Figure 20The 2000a system is particularly well-suited for delivering variable-flow CPAP. A variable-flow CPAP is a form of respiratory therapy in which a flow of gas is delivered to a patient (typically an infant) at a set pressure via a patient interface. Variable-flow CPAPs can also be referred to as single-branch CPAPs. Unlike bubble CPAPs, where the flow rate of delivered gas is constant, in a variable-flow CPAP, the pressure of the delivered gas is controlled (and the flow rate is variable). The expiratory branch 2300a is connected to a pressure regulator.

[0253] The pressure regulator can be an expiratory orifice (i.e., device 10) configured to provide flow restriction. The expiratory orifice connected to expiratory branch 2300a allows any exhaled gas to escape away from the patient 3000. This means that in the case where the patient 3000 is a newborn or infant in an incubator, exhaled gas can be exhausted to the outside of the incubator. In some examples, the expiratory orifice can be located elsewhere in the system, rather than on expiratory branch 2300a, for example... Figure 21 The patient interface 2100b is shown. The patient interface 2100b is connected to the inspiratory branch 2200b.

[0254] Figure 21 It should also be noted that the flow generator 2400b and humidifier 2500b are integrated into a single unit. This is advantageous because it means fewer individual components are required in the system 2000b, and reduces the number of interconnections between devices, thus simplifying its setup and usability for clinicians. Furthermore, the system 2000b occupies less space due to fewer individual components connected by tubing. Even further, a single controller can be set up to control the therapy provided to the user (i.e., humidity, flow rate, pressure, etc.). Having a single user interface for controlling the flow generator and humidifier also simplifies usability. Figure 15 The integrated humidifier 2500b and flow generator 2400b can be used in conjunction with any embodiment of the apparatus 10 and system described herein.

[0255] Figure 20The System 2000a can also be adapted to deliver asynchronous and / or synchronous nasal intermittent positive pressure ventilation (NPPV). NPPV is a form of respiratory therapy in which an inspiratory airway pressure is set during at least a portion of the inspiratory phase of a respiratory cycle and an expiratory airway pressure is set during at least a portion of the expiratory phase of a respiratory cycle. In asynchronous NPPV, the setting of the inspiratory and expiratory airway pressures is independent of any spontaneous breathing by the patient. In synchronous NPPV, the setting of the inspiratory airway pressure can be synchronized at least with the start of the respiratory cycle (i.e., the beginning of inspiration). In other words, the provision of the inspiratory airway pressure can be triggered by the start of the respiratory cycle.

[0256] For example, System 2000 can utilize a suitable patient interface, such as Figure 22 and Figure 23 Patient interfaces 2100c and 2100d are shown respectively. Patient interfaces 2100c and 2100d each include sealing structures 2110c and 2110d. Sealing structures 2110c and 2110d can be accommodated within a frame. Sealing structures 2110c and 2110d can form a substantially hermetically sealed seal with the frame. Sealing structures 2110c and 2110d can be removably attached to the frame.

[0257] The sealing structure 2110c includes a face mask 2112. The face mask 2112 is configured to provide a seal at least with respect to the nasal passage. The sealing structure 2110d includes a nasal plug 2114d. The nasal plug 2114d is configured to provide a substantially seal with respect to the patient's nasal passage.

[0258] The sealing structures 2110c and 2110d each include inhalation openings 2120c and 2120d and exhalation openings 2130c and 2130d. The inhalation openings 2120c and 2120d are located on one side of the sealing structures 2110c and 2110d. The exhalation openings 2130c and 2130d are located on the opposite side of the sealing structures 2110c and 2110d. The inhalation openings 2120c and 2120d are aligned with the exhalation openings 2130c and 2130d.

[0259] It should be understood that the frame / seal forming structure opening can be inspiratory or expiratory, depending on the direction of gas flow. For example, if the opening accommodates a gas flow from a flow generator, then the opening will be an inspiratory opening. If the opening is through which exhaled gas or expiratory gas exiting from the patient interface passes, then the opening will be an expiratory opening. The device 10 of this disclosure is intended to be attached at the end of the expiratory flow path.

[0260] exist Figure 22 and Figure 23In the example shown, similarly, the frame has a pair of openings on either side. These frame openings are typically aligned with or cover the inhalation / exhalation openings that form a sealed structure.

[0261] Inspiratory openings 2120c and 2120d are configured to be in fluid communication with an inspiratory tube. The inspiratory tube may be connected to a sealing structure and / or a frame. Similarly, expiratory openings 2130c and 2130d are configured to be in fluid communication with an expiratory tube or expiratory port.

[0262] Device 10 is configured to be in fluid communication with expiratory openings 2130c, 2130d. Device 10 can be connected to a patient interface at the expiratory opening. Device 10 can be connected at the distal or expiratory end of the expiratory tubing. In each arrangement, expiratory gas and / or condensate are expelled into the atmosphere and away from the patient via the expiratory flow path. Other suitable patient interfaces can be used with device 10. For example, the body of device 10 of this disclosure can be attached to the expiratory branch of a CPAP midline interface. An example of a CPAP midline interface is the FlexiTrunk transnasal CPAP interface from Fisher & Paykel Healthcare.

[0263] As indicated above, device 10 may provide a protective section 600 that helps prevent blockage of flow feature 110. This allows system 2000 to be more robust and provides additional design options for flow resistor 500 to tune device 10 to achieve a predetermined PEEP. Adding clip 1000 also helps prevent blockage of flow feature 110 while providing the ability to easily connect device 10 to another fixture. The ability of flow feature 110 to redirect airflow to other flow features 110 when at least one flow feature 110 becomes blocked further improves the system's reliability in maintaining a proper PEEP.

[0264] The ability to detachably connect device 10 to other medical devices provides, for example, a convenient way to exchange device 10 while tuning system 2000 to a predetermined PEEP for the patient. This allows device 10 to be included in a kit that provides versatility to healthcare professionals. In a similar manner, accessory port 700 enhances the versatility of system 2000 and allows for the addition of, for example, sensors for better control of the patient's breathing.

[0265] Furthermore, compared to using a bubble-type CPAP (including a bubble generator with a certain amount of water), device 10 can have: i) fewer parts, which means lower costs for the user; ii) less waste; iii) less condensate in the system 2000 overall, as long tubing may not be required; iv) less sloshing; v) better transport capacity; vi) a wider range of pressures available – bubble generators are limited by a certain amount of water; vii) the bubble / oscillation effect can be controlled by a flow generator – this can be achieved by motor oscillation; and viiii) better suited for kangaroo care, as there is no heavy expiratory tubing connected to the interface / patient.

[0266] In this specification, adjectives such as left and right, top and bottom, hot and cold, and first and second may be used to distinguish one element or action from another without requiring or implying any actual such relationship or order. Where the context permits, references to components, integers, or steps (or the like) should not be construed as limited to one of those components, integers, or steps, but may be one or more of them.

[0267] In this specification, the terms “comprising,” “including,” or similar terms mean non-exclusive inclusion, such that a method, system, or apparatus that includes a list of elements includes not only those elements but may also include other elements not listed.

[0268] The above description of embodiments of this disclosure is intended to illustrate the invention to those skilled in the art and is not intended to exhaustively explain the disclosure, nor is it intended to limit the disclosure to a single disclosed embodiment. As described above, those skilled in the art will recognize many alternatives and variations of this disclosure based on the foregoing teachings. Therefore, while some alternative embodiments have been specifically discussed, other embodiments will be apparent or relatively easy to develop to those skilled in the art. This disclosure is intended to cover all modifications, alternatives, and variations discussed herein, as well as other embodiments falling within the spirit and scope of the foregoing description.

[0269] Project List: .

Claims

1. A device for modulating pressure, the device comprising: a body having: an inlet; and an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting airflow through the internal lumen, wherein downstream of the flow restrictor is a guard portion that helps protect the flow restrictor from damage.

2. A device for modulating pressure, the device comprising: a body having: an inlet; and an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting airflow through the internal lumen, wherein a guard portion is immediately proximal to a distal end of the one or more flow features to help protect the one or more flow features from damage.

3. An exhalation pressure device configured to expel exhaled gases from a patient interface assembly, the exhalation pressure device comprising: a body comprising: an inlet; and an internal lumen in communication with the inlet, the internal lumen comprising a flow restrictor and an open distal end; and a guard portion, wherein the guard portion is configured to maintain an exhalation flow path from the open distal end.

4. The device of claim 3, wherein the guard portion is configured to maintain the exhalation flow path from the flow restrictor to atmosphere and / or ambient conditions.

5. The device of any one of claims 1 to 4, wherein the guard portion projects away from the flow restrictor.

6. The device of any one of claims 1 to 5, wherein the guard portion encompasses at least a portion of a distal end of the flow restrictor.

7. The device of any one of claims 1 to 6, wherein the guard portion comprises a radial surface.

8. The device of any one of claims 1 to 7, wherein the guard portion provides a first surface that extends transversely to an axial direction of the body.

9. The device of any one of claims 1 to 8, wherein the guard portion comprises a guard member.

10. The device of claim 9, wherein the guard member has a free end distal of the flow restrictor.

11. The device of claim 9 or 10, wherein the guard member comprises a projection.

12. The device of claim 11, wherein the projection projects from the internal lumen proximate to a portion of the flow restrictor.

13. The device of any one of claims 1 to 12, wherein the one or more flow features comprises an orifice.

14. The device of any one of claims 3 to 12, wherein the open distal end comprises an orifice.

15. The device of claim 13 or 14, wherein the guard member comprises the orifice.

16. The device of any one of claims 13 to 15, wherein an area of the orifice is greater than the flow restrictor. ​ ​ ​ ​ 17. The device of any one of claims 13 to 16, wherein the area ratio of the flow restrictor to the orifice is at least 1 :

15.

18. The device of any one of claims 13 to 17, wherein the area ratio of the flow restrictor to the orifice is at least 1 :

20.

19. The device of any one of claims 13 to 15, wherein the orifice forms the flow restrictor.

20. The device of any one of claims 13 to 19, wherein the protective portion extends from the lumen at the location of the flow restrictor and terminates at the orifice.

21. The device of any one of claims 13 to 20, wherein the protective member comprises a secondary orifice.

22. The device of claim 21, wherein the secondary orifice is located in a different plane to the orifice.

23. The device of any one of claims 13 to 22, wherein the protective member comprises a tertiary orifice.

24. The device of claim 23, wherein the tertiary orifice is located on a plane opposite to the plane of the orifice.

25. The device of claim 23 or 24 when dependent on claim 21, wherein the area ratio of the flow restrictor to the secondary and tertiary orifices is at least 1 :

2.

26. The device of any one of claims 23 to 25 when dependent on claim 21, wherein the area ratio of the flow restrictor to the secondary and tertiary orifices is at least 1 :

5.

27. The device of any one of claims 23 to 24 when dependent on claim 21, wherein the area ratio of the flow restrictor to the orifice, secondary and tertiary orifices is at least 1 :

20.

28. The device of any one of claims 23 to 25 when dependent on claim 21, wherein the area ratio of the flow restrictor to the orifice, secondary and tertiary orifices is at least 1 :

25.

29. The device of any one of claims 1 to 26 when dependent on claim 9, wherein the protective member forms a ring-like sleeve.

30. The device of claim 29, wherein the ring-like sleeve is radially outward from a neck portion of the body.

31. The device of claim 29 or 30, wherein a shoulder connects the ring-like sleeve to the neck portion of the body.

32. The device of any one of claims 29 to 31 when dependent on claim 23, wherein the shoulder comprises the tertiary orifice.

33. The device of any one of claims 1 to 32, wherein the protective member comprises a flared portion.

34. The device of any one of claims 1 to 33 when dependent on claim 9, wherein the protective member comprises a member extending proximate to the one or more flow features.

35. The device of claim 34, wherein the member comprises a rib extending towards the one or more flow features.

36. The device of claim 34 or 35, wherein the member is located inboard of the one or more flow features.

37. The device of any one of claims 1 to 36, wherein the protection portion extends both downstream and upstream of the flow restrictor.

38. The device of any one of claims 1 to 37, wherein, upon damage to the flow restrictor, gas flow will pass through another flow restrictor.

39. A device for regulating pressure, the device comprising: a body having: an inlet; an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting gas flow through the internal lumen, wherein, upon damage to one of the one or more flow features, gas flow will pass through another of the one or more flow features.

40. A device for regulating pressure in respiratory therapy, the device comprising: a body having: an inlet; an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting gas flow through the internal lumen, wherein the body is configured to detachably connect with a medical device.

41. The device of claim 39 or 40, wherein a protection portion is immediately proximal to a distal end of the one or more flow features.

42. The device of any one of claims 39 to 41, wherein the protection portion is located downstream of the one or more flow features.

43. The device of any one of claims 39 to 41, wherein the protection portion projects away from the flow restrictor.

44. The device of any one of claims 39 to 43, wherein the protection portion encompasses at least a portion of the distal end of the flow restrictor.

45. The device of any one of claims 39 to 44, wherein the protection portion overhangs the flow restrictor.

46. The device of any one of claims 39 to 45, wherein the protection portion comprises a protection member.

47. The device of claim 46, wherein the protection member has a free end distal of the flow restrictor.

48. The device of claim 46 or 47, wherein the protection member comprises a projection.

49. The device of claim 48, wherein the projection projects from the internal lumen proximate to the portion of the flow restrictor.

50. The device of any one of claims 39 to 49, wherein the one or more flow features comprises an orifice.

51. The device of claim 50, wherein the protection member comprises the orifice.

52. The device of claim 50 or 51, wherein the orifice is in fluid communication with the atmosphere and / or ambient conditions.

53. The device of any one of claims 50 to 52, wherein the orifice is offset relative to the flow restrictor. ​ ​ 54. The device of any one of claims 50 to 53, wherein the orifice has an area greater than the flow restrictor.

55. The device of any one of claims 50 to 54, wherein the flow restrictor has an area ratio to the orifice of at least 1 :

15.

56. The device of any one of claims 50 to 55, wherein the flow restrictor has the area ratio to the orifice of at least 1 :

20.

57. The device of any one of claims 50 to 52, wherein the orifice forms the flow restrictor.

58. The device of any one of claims 50 to 57, wherein the protective portion extends from the lumen at the location of the flow restrictor and terminates at the orifice.

59. The device of any one of claims 50 to 58, wherein the protective member comprises a secondary orifice.

60. The device of claim 59, wherein the secondary orifice is located in a different plane than the orifice.

61. The device of any one of claims 50 to 60, wherein the protective member comprises a tertiary orifice.

62. The device of claim 61, wherein the tertiary orifice is located on a plane opposite the plane of the orifice.

63. The device of claim 61 or 62 when dependent on claim 59, wherein the flow restrictor has an area ratio to the secondary orifice and the tertiary orifice of at least 1 :

2.

64. The device of any one of claims 61 to 63 when dependent on claim 59, wherein the flow restrictor has the area ratio to the secondary orifice and the tertiary orifice of at least 1 :

5.

65. The device of any one of claims 61 to 64 when dependent on claim 59, wherein the flow restrictor has an area ratio to the orifice, the secondary orifice, and the tertiary orifice of at least 1 :

20.

66. The device of any one of claims 61 to 65 when dependent on claim 59, wherein the flow restrictor has the area ratio to the orifice, the secondary orifice, and the tertiary orifice of at least 1 :

25.

67. The device of any one of claims 39 to 66 when dependent on claim 46, wherein the protective member forms a ring-shaped sleeve.

68. The device of claim 67, wherein the ring-shaped sleeve is radially outward from a neck of the body.

69. The device of claim 68, wherein a shoulder connects the ring-shaped sleeve to the neck of the body.

70. The device of claim 69 when dependent on claim 61, wherein the shoulder comprises the tertiary orifice.

71. The device of any one of claims 39 to 70 when dependent on claim 46, wherein the protective member comprises a flared portion.

72. The device of any one of claims 39 to 71 when dependent on claim 46, wherein the protective member comprises a member extending proximate the one or more flow features.

73. The device of any one of claims 1 to 72, wherein the body comprises a fitting port.

74. The device of claim 73, wherein the fitting port is a sensor port.

75. The device of claim 86, wherein the sensor port is in communication with a sensor orifice that helps to avoid airflow impingement into the sensor port.

76. The device of any one of claims 1 to 75, wherein one end of the body is tapered.

77. The device of any one of claims 1 to 76, wherein the body comprises a component mounting portion that allows a clip to be placed adjacent to the one or more flow features to help prevent damage to the one or more flow features.

78. The device of claim 77, wherein the component mounting portion comprises a channel.

79. A kit for a respiratory therapy system, the kit comprising: a plurality of devices as claimed in any one of claims 1 to 78, wherein one device of the plurality of devices provides a different flow restriction compared to another device of the plurality of devices.

80. A kit for a respiratory therapy system, the kit comprising: a device as claimed in any one of claims 1 to 78; and at least one or more of: a humidifier chamber; a patient interface; a tube; or a clip for attachment to the device.

81. The kit of claim 80, wherein the tube is an inspiratory tube or an expiratory tube.

82. A system comprising: a patient interface for delivering breathable gas to a patient; and a device as claimed in any one of claims 1 to 78 in communication with the patient interface.

83. The system of claim 82, wherein the patient interface comprises a seal-forming structure configured to form a seal with an airway of a patient when in use.

84. A system comprising: a tube; and a device as claimed in any one of claims 1 to 78 in communication with the tube.

85. The system of claim 84, wherein a sensor is in communication with the device to help regulate flow and / or pressure.

86. The system of claim 85, wherein the sensor is a gas property sensor.

87. A tube assembly comprising: a tube; and a device as claimed in any one of claims 1 to 78 in communication with the tube.

88. A patient interface assembly comprising: a patient interface; and a device in communication with an expiratory side of the patient interface, the device comprising: a body having: an inlet; and an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting airflow through the internal lumen, wherein downstream of the flow restrictor is a protection portion that helps to protect the flow restrictor from damage.

89. A patient interface assembly comprising: a patient interface; and a device in communication with an expiratory side of the patient interface, the device comprising: a device in communication with an expiratory side of the patient interface, the device comprising: a body having: an inlet; and an internal lumen in communication with the inlet, one or more flow features comprising a flow restrictor for restricting flow of gas through the internal lumen, wherein a protective portion is proximate a distal end of the one or more flow features to help protect the one or more flow features from damage.

90. A patient interface assembly comprising: a patient interface; and a device in communication with an expiratory side of the patient interface, the device comprising: a body having: an inlet; an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting flow of gas through the internal lumen, wherein upon at least partial occlusion of one of the one or more flow features, gas flow will pass through another of the one or more flow features.

91. A patient interface assembly comprising: a patient interface; and a device in communication with an expiratory side of the patient interface, the device comprising: a body having: an inlet; an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting flow of gas through the internal lumen, wherein the body is configured to detachably connect with a medical device.

92. A system comprising: a respiratory therapy device; and a device according to any one of claims 1 to 78 in fluid communication with the respiratory therapy device.

93. The system of claim 92, wherein the device is connected to an expiratory limb.

94. The system of claim 92 or 93, wherein the device is in fluid communication with a patient interface.

95. The system of any one of claims 92 to 94, wherein the device cooperates with a respiratory therapy device to deliver a prescribed therapy pressure to a patient.

96. The system of any one of claims 92 to 95, wherein the respiratory therapy device comprises: a flow generator; a humidifier in fluid communication with the flow generator; a controller; and at least one gas property sensor, wherein the controller is configured to control a flow and / or pressure of gas in a gas flow path based at least in part on an output of the at least one gas property sensor.

97. The system of claim 96, wherein in response to detecting a change in flow resistance in the system, the controller is configured to adjust the flow such that a pressure delivered to the patient is substantially maintained at the prescribed therapy pressure.

98. A patient interface assembly for use in delivering pressurized gas to a patient, the patient interface assembly comprising: a patient interface; and a device in communication with an expiratory side of the patient interface, the device comprising: a body having: an inlet; an internal lumen in communication with the inlet; and one or more flow features comprising a flow restrictor for restricting flow of gas through the internal lumen, wherein the one or more flow features are configured to be at least partially occluded by a user's nose. a patient interface comprising a seal-forming structure configured to form a seal with an entrance to the patient's airways when in use, the seal-forming structure having an inhalation opening and an exhalation opening; an exhalation pressure device in fluid communication with the exhalation opening, the exhalation pressure regulator device comprising an internal lumen having a flow restrictor; and a guard portion configured to maintain an exhalation flow path from the exhalation pressure device.

99. The patient interface assembly of claim 98, wherein the inhalation opening and the exhalation opening are located on opposite sides of the seal-forming structure.

100. The patient interface assembly of claim 98 or 99, wherein the seal-forming structure comprises a mask structure, a nasal plug, or a nasal pillow.

Images