Exhaust port and pressure regulating device

Abstract

An exhaust port for use with a respiratory system arranged to deliver breathable gas to a patient, where the exhaust port allows gas from within the respiratory system to exit, the exhaust port comprising: a movable actuator, where the movable actuator is movable relative to the respiratory system; movement of the actuator adjusts a region of the vent for gas to exit from the respiratory system via the vent.

Description

Technical Field

[0001] The present disclosure relates to various devices, systems and methods suitable for use with a respiratory system arranged to deliver breathable gas to a patient. In at least one aspect, the present disclosure relates to an exhaust port for use with a respiratory system. In at least another aspect, the present disclosure relates to a pressure regulating device comprising an exhaust port and a flow-independent PEEP valve. Cross-references

[0002] This application is related to U.S. Provisional Application No. 63 / 269,289 filed on March 14, 2022, U.S. Provisional Application No. 63 / 369,020 filed on July 21, 2022, and U.S. Provisional Application No. 63 / 366,660 filed on June 20, 2022, the contents of which are incorporated herein by reference in their entirety. Background Art

[0003] During breathing, resuscitation, or assisted breathing (ventilation), positive end-expiratory pressure (PEEP) and / or peak inspiratory pressure (PIP) may be controllably provided to the patient.

[0004] PEEP is the pressure delivered to the patient throughout the expiratory phase of positive pressure ventilation, resuscitation or assisted breathing. PIP is the desired maximum pressure provided to the patient during the inspiratory phase of positive pressure ventilation, resuscitation or assisted breathing. The patient may be a newborn or infant who requires respiratory assistance or resuscitation. When PEEP or PIP is applied, the patient's upper airway and lungs remain open due to the applied pressure. During resuscitation, the fluid filled in the lungs is displaced, and air takes its place. This is a delicate process, because overinflation of the lungs constitutes the risk of IVH (intraventricular hemorrhage) and lung injury.

[0005] A self-inflating bag or a flow-inflating bag can be used to provide respiratory support to a patient. A self-inflating bag can deliver pressure in 'spikes' or 'pulses' (see e.g. Figure 6 'Pressure over time' waveform 5003 in Figure 5), which has no or limited PEEP, too high a PIP and / or a relatively short inspiratory time, which means that there are sudden rises and falls in the delivered pressure. This may pose a risk of potential lung damage to the patient. Compared to self-inflating bags and flow-inflating bags, T-piece resuscitators deliver more controlled and consistent PIP and PEEP (see e.g. Figure 6 'Pressure over time' in 5001), which helps protect the lungs of newborns.

[0006] Any reference or discussion of any document, act or item of knowledge is included in this specification solely for the purpose of providing a background to the present invention. It is not suggested or represented that any one of these matters, or any combination thereof, formed part of the common general knowledge at the priority date, or was known to be relevant in an attempt to solve any problem addressed in this specification. Summary of the invention

[0007] In a first aspect, the present disclosure provides an exhaust port for use with a breathing system arranged to deliver breathable gas to a patient, wherein the exhaust port allows gas from within the breathing system to escape, the exhaust port comprising: A movable actuator, wherein movement of the actuator adjusts an area of ​​the exhaust port available for gas to exit the respiratory system through the exhaust port.

[0008] In some embodiments, adjusting the area of ​​the exhaust port through which gas can exit regulates the pressure of the breathable gas delivered to the patient.

[0009] In some embodiments, the exhaust port comprises an orifice, wherein the gas is arranged to flow through the orifice when exiting from the breathing system.

[0010] In some embodiments, when the actuator moves in the first direction, the orifice is gradually occluded. The occlusion of the orifice causes an increase in the pressure of the breathable gas delivered to the patient.

[0011] In some embodiments, when the actuator moves in the second direction, the orifice is gradually unobstructed. The unobstructing of the orifice causes a decrease in the pressure of the breathable gas delivered to the patient.

[0012] In some embodiments, when the orifice is fully or substantially occluded, the pressure of breathable gas delivered to the patient is higher than the pressure of breathable gas delivered to the patient when the orifice is fully or substantially unobstructed.

[0013] In some embodiments, when the orifice is fully or substantially occluded, the pressure of the breathable gas delivered to the patient corresponds to PIP or peak inspiratory pressure. When the orifice is fully or substantially unobstructed, the pressure of the breathable gas delivered to the patient corresponds to PEEP or positive end-expiratory pressure. When the orifice is partially occluded or unobstructed, a pressure between PEEP and PIP is delivered to the patient.

[0014] In some embodiments, the shape or configuration of the aperture is configured based at least in part on a desired occlusion or de-occlusion rate of the aperture during movement of the actuator.

[0015] In some embodiments, the shape of the orifice is configured based at least in part on the ratio of inspiratory to expiratory air (I:E) supplied to the patient.

[0016] In some embodiments, the shape of the orifice is configured based on a desired pressure waveform of the breathable gas to be delivered to the patient.

[0017] In some embodiments, the shape of the aperture is configured such that the rate of occlusion or de-occlusion caused by the actuator varies along the direction of movement of the actuator when the actuator moves at a substantially constant speed.

[0018] In some embodiments, when the actuator moves at a constant speed, the pressure of the breathable gas is adjusted in a substantially non-linear manner.

[0019] In some embodiments, the rate at which the actuator blocks or unblocks the orifice is greater at one end of the orifice so that the resulting pressure change of the breathable gas delivered to the patient changes more rapidly.

[0020] In some embodiments, the rate of occlusion or de-occlusion caused by the actuator is less at the other end of the orifice so that the resulting pressure change of the breathable gas delivered to the patient changes less rapidly.

[0021] In some embodiments, the orifice is substantially circular in shape.

[0022] In some embodiments, the aperture is oval in shape.

[0023] In some embodiments, the aperture is triangular in shape.

[0024] In some embodiments, the shape of the aperture is configured such that the rate of occlusion or de-occlusion caused by the actuator remains substantially constant along the direction of movement of the actuator when the actuator moves at a constant speed.

[0025] In some embodiments, the aperture is square or rectangular in shape.

[0026] In some embodiments, the orifice is an irregular shape or a combination of the shapes mentioned above.

[0027] In some embodiments, the speed of movement of the actuator is at least partially manually controlled by an operator.

[0028] In some embodiments, the exhaust port includes a support structure, wherein the actuator is movably coupled to and supported by the support structure.

[0029] In some embodiments, the actuator is slidably coupled to the support structure, and the area of ​​the exhaust port available for gases to exit the respiratory system is adjusted by sliding the actuator along the support structure.

[0030] In some embodiments, the support structure includes one or more channels for guiding movement of the actuator.

[0031] In some embodiments, the one or more channels include at least two substantially parallel channels.

[0032] In some embodiments, the one or more channels are formed along a peripheral portion of the support structure. In other embodiments, the one or more channels may be disposed on a surface of the support structure.

[0033] In some embodiments, the support structure includes a hinge for guiding movement of the actuator.

[0034] In some embodiments, the actuator is rotatable relative to the hinge.

[0035] In some embodiments, the actuator comprises an engagement member arranged to be engaged by a finger or digit of an operator when sliding the actuator.

[0036] In some embodiments, the engagement member includes raised formations (eg, protrusions, buttons, ridges, and the like) and / or recessed formations (eg, recesses, grooves, and the like).

[0037] In some embodiments, the actuator and support structure are made of one or more of plastic, foam, and rubber materials, depending on the movement friction, comfort, and sealing ability.

[0038] In some embodiments, the vent includes a vent cap.

[0039] In some embodiments, the exhaust port cap comprises one or more apertures, wherein gases are arranged to exit from the breathing system via the one or more apertures.

[0040] In some embodiments, the one or more orifices are progressively occluded as the actuator moves in the first direction, the occlusion of the one or more orifices causing an increase in the pressure of the breathable gas delivered to the patient.

[0041] In some embodiments, the one or more orifices are progressively unobstructed as the actuator moves in the second direction, the unobstructedness of the one or more orifices causing a decrease in the pressure of the breathable gas delivered to the patient.

[0042] In some embodiments, when the one or more orifices are fully or substantially occluded, the pressure of breathable gas delivered to the patient is higher than the pressure of breathable gas delivered to the patient when the one or more orifices are fully or substantially unoccluded.

[0043] In some embodiments, when the one or more orifices are fully or substantially occluded, the pressure of the breathable gas delivered to the patient corresponds to PIP or peak inspiratory pressure. When the one or more orifices are fully or substantially unobstructed, the pressure of the breathable gas delivered to the patient corresponds to PEEP or positive end-expiratory pressure. When the one or more orifices are partially occluded or unobstructed, a pressure between PEEP and PIP is delivered to the patient.

[0044] In some embodiments, the one or more apertures comprise an array of cut-out apertures formed in the vent cap.

[0045] In some embodiments, the array of resection ports is formed as concentric circular resection ports.

[0046] In some embodiments, the array of resection ports is formed as concentric elliptical resection ports.

[0047] In some embodiments, the actuator comprises a deformable portion arranged to occlude or unocclude the one or more apertures.

[0048] In some embodiments, the deformable portion elastically deforms when a force is applied thereto and returns to its shape when the force is removed.

[0049] In some embodiments, the actuator is pressed against the vent cap such that the deformable portion gradually deforms to cover the one or more apertures.

[0050] In some embodiments, the deformable portion is configured such that the aperture or portion of an aperture that is closer to the center of the vent cap is blocked first.

[0051] In some embodiments, the deformable portion is formed in a dome shape.

[0052] In some embodiments, the deformable portion is at least partially formed from an elastic material.

[0053] In some embodiments, the resilient material comprises silicone.

[0054] In some embodiments, the vent includes a support structure for holding the actuator in close proximity to the vent cap.

[0055] In some embodiments, the support structure includes a body forming a cavity, wherein the vent cap is positioned within the cavity.

[0056] In some embodiments, the support structure includes two or more elongated members extending upwardly from the body.

[0057] In some embodiments, the elongated members each include a shoulder portion extending inwardly toward a center of the vent cap, wherein the shoulder portions of the elongated members assist in retaining the actuator in place.

[0058] In some embodiments, the support structure includes a ring connected to a shoulder portion of the elongated member, wherein the ring and the shoulder portion of the elongated member assist in holding the actuator in place.

[0059] In some embodiments, the actuator is formed in a dome shape.

[0060] In some embodiments, the actuator is formed as a piston, and the deformable portion is located at a lower end of the piston.

[0061] In some embodiments, the deformable portion includes a hollow interior to allow for easier deformation when the actuator is pressed against the vent cap.

[0062] In some embodiments, a pressure relief hole is provided in the deformable portion to reduce resistance when the actuator is pressed against the vent cap.

[0063] In some embodiments, the exhaust port comprises a housing comprising: A first opening and a second opening, wherein the first opening is fluidly connected to the respiratory system and the second opening is configured to movably receive an actuator, wherein a position of the actuator relative to the housing determines an area of ​​the exhaust port available for gas to exit the respiratory system through the exhaust port, thereby adjusting the pressure of breathable gas delivered to the patient.

[0064] In some embodiments, the actuator is arranged to slide into or out of the housing via the second opening.

[0065] In some embodiments, the first opening is located at or near a lower end of the housing and the second opening is located at or near an upper end of the housing.

[0066] In some embodiments, the housing is substantially cylindrical in shape.

[0067] In some embodiments, the actuator comprises a hollow body comprising: one or more air inlets for receiving gases from the breathing system, and A plurality of apertures, the one or more apertures being arranged to allow gas to exit from the hollow body.

[0068] In some embodiments, the hollow body is substantially cylindrical in shape.

[0069] In some embodiments, the hollow body includes an upper end and a lower end, and a sidewall extending between the upper end and the lower end.

[0070] In some embodiments, the one or more air inlets are disposed at or near a lower end of the hollow body.

[0071] In some embodiments, the plurality of apertures are formed in a side wall of the hollow body.

[0072] In some embodiments, the actuator is arranged to move between a first position and a second position to control the pressure of breathable gas delivered to the patient, wherein, in the first position, the actuator is elevated relative to the housing such that the plurality of apertures are exposed to ambient air and gas can exit the exhaust port via the apertures; wherein, in the second position, the actuator is at least partially inserted into the housing such that the plurality of apertures are not exposed to ambient air, and Wherein, between the first position and the second position, one or more of the plurality of apertures are exposed to the atmosphere, thereby allowing gas to escape through the exhaust port.

[0073] In some embodiments, the plurality of apertures are configured to have varying shapes and / or sizes.

[0074] In some embodiments, the plurality of apertures are disposed along a side wall of the hollow body, and a first aperture formed near an open end of the actuator has a larger size than the remaining apertures.

[0075] In some embodiments, the actuator is formed as an elongated plunger.

[0076] In another embodiment, the actuator comprises: The body portion includes a first end and a tapered end, wherein a diameter of the body portion decreases toward the tapered end.

[0077] In some embodiments, the actuator is arranged to move between a first position and a second position to control the pressure of breathable gas delivered to the patient, wherein, in the first position, the actuator is lifted relative to the housing so that gas is allowed to flow through a gap between the actuator and an inner wall of the housing, and Therein, in the second position, the actuator is at least partially inserted into the housing such that a gap between the actuator and an inner wall of the housing is reduced in size and / or substantially blocked such that gas cannot flow through the gap.

[0078] In some embodiments, when the actuator is in the second position, the pressure of breathable gas delivered to the patient is higher than the pressure of breathable gas delivered to the patient when the actuator is in the first position.

[0079] In some embodiments, when the actuator is in the first position, the pressure of breathable gas delivered to the patient corresponds to PEEP. When the actuator is in the second position, the pressure of breathable gas delivered to the patient corresponds to PIP. When the actuator moves between the first position and the second position, a pressure between PEEP and PIP is delivered to the patient.

[0080] In some embodiments, the actuator is manually operated by an operator to move between the first position and the second position.

[0081] In some embodiments, the actuator is pressed downwardly toward the housing by an operator to move from the first position to the second position.

[0082] In some embodiments, when the operator reduces or removes the force applied to the actuator, the actuator is allowed to gradually return to the first position. In other embodiments, the actuator can be pulled in an upward direction by the operator to move from the second position to the first position.

[0083] In some embodiments, the exhaust port further includes a biasing member to cause the actuator to remain in the first position when an operator is not applying force.

[0084] In some embodiments, the actuator includes a shoulder disposed on an outer surface of the actuator.

[0085] In some embodiments, the housing includes a recess, wherein the biasing member is held in place by a shoulder of the actuator and the recess of the housing.

[0086] In some embodiments, the housing includes a countersunk portion, wherein the biasing member is held in place by a shoulder of the actuator and the countersunk portion of the housing.

[0087] In some embodiments, the shoulder is formed as a flange that extends partially or completely around the circumference of the actuator.

[0088] In some embodiments, the biasing member is a spring disposed on an exterior of the actuator.

[0089] In some embodiments, a sealing member is provided to create a seal when the actuator is in the first position.

[0090] In some embodiments, the sealing member is an O-ring.

[0091] In some embodiments, the exhaust port comprises a housing comprising: a first opening and a second opening, wherein the first opening is configured to fluidly connect to a respiratory system and the second opening is configured to movably receive an actuator within the housing; A body extends between the first opening and the second opening, wherein the body includes one or more apertures configured to allow gas to escape to the atmosphere depending on a relative position of the actuator with respect to the housing.

[0092] In some embodiments, the actuator is arranged to move between a first position and a second position to adjust the pressure of the breathable gas delivered to the patient, wherein, in the first position, the actuator is lifted relative to the housing such that gas is allowed to flow through the exhaust port and out of the breathing system via the one or more apertures, and Therein, in the second position, the actuator is lowered into the housing to block the first opening of the housing.

[0093] In some embodiments, when the actuator is in the second position, the pressure of breathable gas delivered to the patient is higher than the pressure delivered when the actuator is in the first position.

[0094] In some embodiments, when the actuator is in the first position, the pressure of breathable gas delivered to the patient corresponds to PEEP, and when the actuator is in the second position, the pressure of breathable gas delivered to the patient corresponds to PIP. When the actuator moves between the first position and the second position, a pressure between PEEP and PIP is delivered to the patient.

[0095] In some embodiments, the one or more apertures include a plurality of apertures formed in the body of the housing.

[0096] In some embodiments, the plurality of apertures are disposed about the circumference of the body and extend along the length of the body.

[0097] In some embodiments, the vent includes a deformable membrane that assists in movement of the actuator.

[0098] In some embodiments, the membrane forms a chamber extending between the second opening of the housing and the shoulder of the actuator.

[0099] In some embodiments, the membrane is configured such that it biases the actuator in the first position when no force is applied to the actuator.

[0100] In some embodiments, the membrane is configured such that when a compressive force is applied to the actuator, it deforms to allow the actuator to move toward the second position.

[0101] In some embodiments, the membrane is configured such that when the actuator moves past a deflection point of the membrane, a portion of the membrane moves the actuator into the second position.

[0102] In some embodiments, the membrane is configured such that when the actuator moves past a deflection point of the membrane, a portion of the membrane deflects and moves the actuator into the second position.

[0103] In some embodiments, when the compressive force is removed from the actuator, the membrane returns the actuator to the first position.

[0104] In some embodiments, the actuator includes a substantially cylindrical body, wherein a bottom surface of the cylindrical body may have a curved or substantially flat surface.

[0105] In some embodiments, the actuator includes a sealing portion disposed on a body of the actuator.

[0106] In some embodiments, the sealing portion is a protrusion raised above the surface of the body of the actuator, the protrusion extending partially or substantially around the circumference of the body.

[0107] In some embodiments, the protrusion comprises an angled surface.

[0108] In some embodiments, a sealing portion of the actuator is configured to engage a complementary sealing portion disposed in the exhaust housing.

[0109] In some embodiments, the complementary sealing portion comprises a recess or chamfer formed in the body of the vent housing.

[0110] In some embodiments, the complementary sealing portion includes an angled surface configured to engage the sealing portion of the actuator when the actuator is in the second position.

[0111] In some embodiments, the exhaust port includes a component that assists in controlling the speed of movement of the actuator.

[0112] In some embodiments, the member is configured to contact the actuator during movement of the actuator to apply a friction force to the actuator.

[0113] In some embodiments, the friction force is greater when the actuator moves from the second position to the first position.

[0114] In some embodiments, the member comprises one or more petals arranged to deform and / or deflect during movement of the actuator.

[0115] In some embodiments, the exhaust port is permanently attached to the breathing system.

[0116] In some embodiments, the exhaust port includes connector portions that allow the exhaust port to be removably connected to a breathing system.

[0117] In some embodiments, the connector portion includes threaded portions configured to allow the exhaust port to be threadedly connected to a complementary connector portion disposed in the breathing system.

[0118] In some embodiments, the exhaust port is used in conjunction with a pressure regulating valve.

[0119] In some embodiments, the valve comprises: a valve body comprising an inlet configured to be in fluid communication with the respiratory system and an outlet configured to be in fluid communication with the exhaust port; a controller disposed within the valve body in a flow path between the valve inlet and the valve outlet, Wherein the controller is movable by the gas, the movement of the controller being at least partially dependent on the pressure of the gas at the inlet, wherein the movement adjusts the flow path between the inlet and the outlet of the valve to regulate the pressure of the gas in the breathing system within a predetermined range.

[0120] In some embodiments, the controller is biased toward the valve inlet.

[0121] In some embodiments, the valve comprises: a valve body including an inlet and an outlet, the inlet being configured to be in fluid communication with the respiratory system; a controller disposed within the valve body in the flow path between the inlet and the outlet, Wherein the controller is biased toward the inlet, and movement of the controller away from the inlet depends at least in part on the pressure of the gas at the inlet, the movement adjusting the flow path between the inlet and the outlet to regulate the pressure of the gas in the breathing system within a predetermined range.

[0122] In some embodiments, when the pressure exceeds a selected pressure level, the controller is caused to move away from the inlet.

[0123] In some embodiments, the predetermined range is a predetermined PEEP pressure range.

[0124] In some embodiments, the selected pressure level is within a predetermined PEEP pressure range.

[0125] In some embodiments, the valve comprises: a valve body including an inlet and an outlet, the inlet being configured to be in fluid communication with the respiratory system; a controller disposed within the valve body in the flow path between the inlet and the outlet, wherein the controller is biased toward the inlet, causing the controller to move away from the inlet when the pressure exceeds a selected pressure level, the movement adjusting the flow path between the inlet and the outlet to regulate the pressure of the gas in the breathing system within a predetermined PEEP pressure range, wherein the selected pressure level is within the predetermined PEEP pressure range.

[0126] In some embodiments, movement of the controller depends at least in part on a pressure differential between an upper surface and a lower surface of the controller.

[0127] In some embodiments, the valve includes a biasing member operatively coupled to the controller.

[0128] In some embodiments, the controller is biased toward the inlet by a biasing member.

[0129] In some embodiments, the biasing member applies a variable resistance to the controller during movement of the controller.

[0130] In some embodiments, the variable resistance applied by the biasing member counteracts the force applied to the controller caused by a pressure differential between the upper and lower surfaces of the controller.

[0131] In some embodiments, when the pressure differential is below a selected pressure level, the flow path between the inlet and outlet of the valve is closed.

[0132] In some embodiments, when the pressure differential is above a selected pressure level, it overcomes the variable resistance applied by the biasing member to the actuator and opens a flow path between the inlet and outlet of the valve.

[0133] In some embodiments, the biasing member biases the controller against the valve seat when the flow path is closed.

[0134] In some embodiments, when the controller is displaced from the valve seat, a flow path between the inlet and the outlet of the valve is opened.

[0135] In some embodiments, the flow path is determined at least in part by the relative displacement of the controller from the valve seat.

[0136] In some embodiments, the valve includes a support member for the controller, the support member being used to guide and stabilize the movement of the controller.

[0137] In some embodiments, the support member is an elongate shaft and the controller is arranged to slide along the elongate shaft during movement thereof.

[0138] In some embodiments, the valve outlet is fluidly connected to the first opening of the exhaust port.

[0139] In some embodiments, the pressure of the gas within the respiratory system is determined at least in part by flow variations caused by unintentional leaks (e.g., interface leaks) and / or intrinsic PEEP, resulting in pressures below or above a target PEEP pressure to be delivered to the patient.

[0140] In some embodiments, the valve is arranged to compensate for unintentional leakage by reducing the air flow through the valve.

[0141] In some embodiments, the valve is arranged to compensate for intrinsic PEEP by allowing a variable portion of gas within the respiratory system to flow through the valve while substantially maintaining the pressure delivered to the patient.

[0142] In some embodiments, the predetermined PEEP pressure range is between 5 and 12 cm H2O.

[0143] In some embodiments, movement of the controller can adjust the pressure of the breathable gas within the breathing system by a change of -2 to +2 cm H2O, -1 to +1 cm H2O, or 0.5 to +0.5 cm H2O.

[0144] In some embodiments, the selected pressure level is in the range of 4.5 to 5.5 cm H2O, or 4 to 6 cm H2O, or 3 to 7 cmH2O.

[0145] In some embodiments, the valve is a PEEP valve.

[0146] In a second aspect, the present disclosure provides a pressure regulating device for use with a breathing system arranged to deliver breathable gas to a patient, wherein the pressure regulating device allows gas from within the breathing system to escape, the pressure regulating device comprising: The exhaust port according to the first aspect of the present disclosure; A valve is operatively coupled to the exhaust port, the valve for regulating the pressure of breathable gas within the breathing system within a predetermined pressure range.

[0147] In some embodiments, the valve comprises: a valve body including an inlet and an outlet, the inlet being configured to be in fluid communication with the respiratory system; a controller disposed within the valve body in a flow path between the valve inlet and the valve outlet, Wherein the controller is movable by the gas, the movement of the controller being at least partially dependent on the pressure of the gas at the inlet, wherein the movement adjusts the flow path between the inlet and the outlet of the valve to regulate the pressure of the gas in the breathing system within a predetermined range.

[0148] In some embodiments, movement of the controller depends at least in part on a pressure differential between an upper surface and a lower surface of the controller.

[0149] In some embodiments, the controller is biased toward the valve inlet by a biasing member.

[0150] In some embodiments, when the pressure differential exceeds a selected pressure level, the controller is caused to move away from the inlet.

[0151] In some embodiments, the biasing member applies a variable resistance to the controller during movement of the controller.

[0152] In some embodiments, the variable resistance exerted by the biasing member counteracts the force applied to the controller caused by gas pressure at the valve inlet.

[0153] In some embodiments, when the pressure differential is below a selected pressure level, the flow path between the inlet and outlet of the valve is closed.

[0154] In some embodiments, when the pressure differential is above a selected pressure level, it overcomes the variable resistance applied by the biasing member to the actuator and opens a flow path between the inlet and outlet of the valve.

[0155] In some embodiments, a biasing member biases the controller against the valve seat.

[0156] In some embodiments, when the controller is displaced from the valve seat, a flow path between the inlet and the outlet of the valve is opened.

[0157] In some embodiments, the valve includes a support member for the controller, the support member being used to guide and stabilize the movement of the controller.

[0158] In some embodiments, the support member is an elongate shaft and the controller is arranged to slide along the elongate shaft during movement thereof.

[0159] In some embodiments, the valve outlet is fluidly connected to the first opening of the exhaust port.

[0160] In some embodiments, the biasing member is configured to be maintained in a compressed state within the valve body when the actuator is biased against the valve seat.

[0161] In some embodiments, the pressure of the gas within the respiratory system is determined at least in part by flow variations caused by unintentional leaks and / or intrinsic PEEP, causing pressures below or above a target PEEP pressure to be delivered to the patient.

[0162] In some embodiments, the valve is arranged to compensate for unintentional leakage by reducing the air flow through the valve.

[0163] In some embodiments, the valve is arranged to compensate for intrinsic PEEP by allowing a variable portion of the gas within the respiratory system to flow through the valve while substantially maintaining the pressure delivered to the patient.

[0164] In some embodiments, the predetermined range is a predetermined PEEP pressure range.

[0165] In some embodiments, the selected pressure level is within a predetermined PEEP pressure range.

[0166] In some embodiments, movement of the controller can adjust the pressure of the breathable gas within the breathing system by a change of -2 to +2 cm H2O, -1 to +1 cm H2O, or -0.5 to +0.5 cm H2O.

[0167] In some embodiments, the selected pressure level is in the range of 4.5 to 5.5 cm H2O, or 4 to 6 cm H2O, or 3 to 7 cmH2O.

[0168] In some embodiments, the pressure regulating device is configured to be removably attached to the exhaust orifice of the breathing system.

[0169] In some embodiments, the exhaust aperture is provided in the T-piece arrangement.

[0170] In a third aspect, the present disclosure provides a device for use with a respiratory system, wherein the device comprises: The housing comprises: an inlet arranged to receive breathable gas from a breathing apparatus; an outlet configured to be in fluid communication with the airway of a patient; A PEEP port, wherein the PEEP port is configured to be fluidly connected to the exhaust port or the pressure regulating device according to the first aspect or the second aspect of the present disclosure.

[0171] In some embodiments, the device is a T-piece device.

[0172] In some embodiments, the device additionally includes optional openings for inserting one or more auxiliary equipment, including one or more of the following: catheters for fluid removal or surfactant delivery to the patient, and / or monitoring devices for monitoring one or more parameters of inhaled and / or exhaled gases.

[0173] In some embodiments, the outlet of the device may be fluidly connected to or arranged in fluid communication with a patient interface.

[0174] In some embodiments, the respiratory apparatus is a resuscitation device or includes a flow generator.

[0175] In a fourth aspect, the present disclosure provides a kit of parts for use with a breathing system, the kit of parts comprising: An exhaust port according to the first aspect of the present disclosure or a pressure regulating device according to the second aspect of the present disclosure; and a T-piece device, wherein the exhaust port or the pressure regulating device is connectable to a PEEP port of the T-piece device.

[0176] In some embodiments, the kit of parts includes a patient interface connectable to a port of the T-piece device.

[0177] In some embodiments, the patient interface includes a range of different types, sizes and / or fits. The patient interface may include a suitable interface, such as a mask (including a nasal mask or a full-face mask), a nasal cannula, or an endotracheal (ET) tube. The patient interface may be an interface capable of creating a seal with at least one patient's airway.

[0178] In some embodiments, the kit of parts includes a flexible hose connectable to the inlet of the T-piece assembly.

[0179] In some embodiments, the kit of parts includes one or more conduits connectable to the breathing apparatus to receive the flow of breathable gas therefrom.

[0180] In some embodiments, the kit of parts includes connectors for establishing a connection between the exhaust port and the T-piece device, and / or between the pressure regulating device and the T-piece device, and / or between the one or more tubes and the breathing apparatus, and / or between the T-piece device and the flexible hose.

[0181] In a fifth aspect, the present disclosure provides a respiratory system for delivering respiratory therapy to a patient, the respiratory system comprising: a respiratory device that supplies a source of breathable gas flow at a targeted pressure and / or flow rate; a conduit assembly connectable to a breathing apparatus to receive a flow of breathable gas; a patient interface arranged to receive a breathable gas and operable to deliver respiratory therapy to a patient; a device arranged to form a fluid connection between the conduit assembly and a patient interface; and The exhaust port according to the first aspect of the present disclosure or the pressure regulating device according to the second aspect of the present disclosure.

[0182] In some embodiments, the breathing system may be connected to a gas source, which may be a wall mounted gas supply.

[0183] In some embodiments, the respiratory system may additionally include a humidifier for humidifying the breathable gas prior to delivery to the patient.

[0184] In some embodiments, the device comprises a housing comprising: an inlet arranged to receive breathable gas from a breathing apparatus; an outlet configured to be in fluid communication with an inlet of a patient interface; A PEEP port is arranged to allow gas from within the breathing system to exit the breathing system to ambient air.

[0185] In some embodiments, a vent or pressure regulating device may be connected to the PEEP port of the device.

[0186] In a sixth aspect, the present disclosure provides an exhaust port for use with a respiratory system arranged to deliver breathable gas to a patient, wherein the exhaust port allows gas from within the respiratory system to escape, the exhaust port comprising: a movable actuator configured to cover or uncover a port of the exhaust port, wherein the port allows gas from within the respiratory system to escape when uncovered; and a member that assists in controlling the speed of movement of the actuator.

[0187] In some embodiments, the member is configured to contact the actuator during movement of the actuator to apply a frictional force to the actuator. In some embodiments, the frictional force is greater when the actuator moves from a position where the area of ​​the exhaust port available for gas to exit the respiratory system via the exhaust port is minimized to another position where the area of ​​the exhaust port available for gas to exit the respiratory system via the exhaust port is maximized.

[0188] In some embodiments, the member comprises one or more petals arranged to deform and / or deflect during movement of the actuator.

[0189] In a seventh aspect, the present disclosure provides a device for use with a respiratory system, wherein the device comprises: a housing comprising: an inlet arranged to receive breathable gas from a respiratory device; an outlet configured to communicate with an airway fluid of a patient; a PEEP port, wherein the PEEP port is configured to be fluidly coupled to an exhaust port, the exhaust port comprising: a movable actuator, wherein movement of the actuator adjusts an area of ​​the exhaust port available for gas to exit from the respiratory system via a pressure regulating device.

[0190] In an eighth aspect, the present disclosure provides a pressure regulating device for use with a respiratory system, the respiratory system being arranged to deliver breathable gas to a patient, wherein the pressure regulating device allows gas from within the respiratory system to exit and is configured to regulate the pressure of the breathable gas within the respiratory system within a predetermined pressure range, the pressure regulating device comprising: an exhaust port, wherein the exhaust port comprises: a movable actuator, wherein movement of the actuator adjusts an area of ​​the exhaust port through which gas can exit the respiratory system via the pressure regulating device.

[0191] In a ninth aspect, the present disclosure provides a respiratory system for delivering respiratory therapy to a patient, the respiratory system comprising: a respiratory device that supplies a source of breathable gas flow at a targeted pressure and / or flow rate; a conduit assembly that can be connected to the respiratory device to receive the breathable gas flow; a patient interface that is arranged to receive breathable gas and can be used to deliver respiratory therapy to the patient; a device that is arranged to form a fluid connection between the conduit assembly and the patient interface; and an exhaust port or a pressure regulating device including the exhaust port, wherein the exhaust port includes a movable actuator and the pressure regulating device is configured to regulate the pressure of the breathable gas within the respiratory system within a predetermined pressure range, and wherein movement of the actuator adjusts the area of ​​the exhaust port available for gas to exit the respiratory system via the exhaust port.

[0192] In a tenth aspect, the present disclosure provides a parts kit for use with a respiratory system, the parts kit comprising: an exhaust port or a pressure regulating device comprising an exhaust port, wherein the exhaust port comprises a movable actuator and the pressure regulating device is configured to regulate the pressure of breathable gas within the respiratory system within a predetermined pressure range, and wherein movement of the actuator adjusts the area of ​​the exhaust port available for gas to exit from the respiratory system via the exhaust port; and a T-piece device, wherein the exhaust port or the pressure regulating device can be connected to a PEEP port of the T-piece device.

[0193] In an eleventh aspect, the present disclosure provides a continuous positive airway pressure (CPAP) system comprising: a respiratory device that supplies a source of breathable gas flow at a targeted pressure and / or flow rate; a conduit assembly comprising: an inspiratory breathing conduit that can be connected to the respiratory device to receive the breathable gas flow; and an expiratory breathing conduit; a patient interface that is arranged to receive breathable gas and can be used to deliver respiratory therapy to a patient; a device that is arranged to form a fluid connection between the inspiratory breathing conduit and the patient interface; an exhaust port or a pressure regulating device including an exhaust port, wherein the exhaust port includes a movable actuator and the pressure regulating device is configured to regulate the pressure of the breathable gas in the respiratory system within a predetermined pressure range, and wherein movement of the actuator adjusts the area of ​​the exhaust port available for gas to exit from the respiratory system via the exhaust port; and one or more connector portions that are configured to detachably connect the exhaust port or the pressure regulating device to the expiratory breathing conduit.

[0194] Further features and advantages of the present disclosure will become apparent from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0195] Various preferred embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 An exemplary breathing system according to the present disclosure is shown; Figure 2 Another exemplary breathing system according to the present disclosure is shown; Figure 3A An exemplary T-piece device with an obstructed PEEP port according to the present disclosure is shown; Figure 3B FIG. 1 shows a PEEP port having a deblocked PEEP port according to the present disclosure. Figure 3A An exemplary T-piece device; Figure 4A Another exemplary T-piece device having an obstructed PEEP port according to the present disclosure is shown; Figure 4B FIG. 1 shows a PEEP port having a deblocked PEEP port according to the present disclosure. Figure 4A An exemplary T-piece device; Figure 5 shows the direction of airflow in an example of a T-piece arrangement; Figure 6 A comparison of the pressure waveforms generated by a T-piece resuscitator and a self-inflating bag is shown; Fig. 7A A perspective isometric view showing an embodiment of an exhaust port of a device connected to a breathing system; Figure 7B Shows Fig. 7A A perspective side view of an exhaust port; Fig. 8A An embodiment of an exhaust port is shown with its actuator in a first position; Figure 8B Shows Fig. 8A an exhaust port wherein its actuator is in a second position; Fig. 9A , Fig. 9B and Fig. 9C Various exemplary configurations of exhaust ports are shown, each having a differently shaped orifice; Fig.10 shows how an exemplary circular orifice of a vent may be gradually opened or closed; Fig.11 is a diagram showing how the area of ​​a circular orifice available for gas flow may vary over time; Fig.12 is a graph showing how the pressure of breathable gas delivered to a patient may vary over time, corresponding to Fig.11 The area of ​​the circular orifice available for gas flow over time; Fig.13 shows how an exemplary triangular orifice of a vent may be gradually closed; Fig.14 is a diagram showing an example of how the area of ​​a triangular orifice available for gas flow may change over time; Fig.15 is a graph showing how the pressure of breathable gas delivered to a patient may vary over time, corresponding to Fig.14 The area of ​​the triangular orifice available for gas flow over time; Fig.16 Another example of how the triangular orifice of the exhaust port can be opened gradually is shown; Fig.17 is a diagram showing another example of how the area of ​​a triangular orifice available for gas flow may change over time; Fig.18 is a graph showing another example of how the pressure of breathable gas delivered to a patient may vary over time, corresponding to Fig.17 The area of ​​the triangular orifice available for flow over time; Fig.19 shows how an exemplary rectangular orifice of a vent may be gradually closed; Fig. 20 is a diagram showing an example of how the area of ​​a rectangular orifice available for gas flow may change over time; Fig.21is a graph showing an example of how the pressure of breathable gas delivered to a patient may vary over time, corresponding to Fig. 20 The area of ​​the rectangular orifice available for flow over time; FIG. 22 shows various exemplary configurations of actuators for exhaust ports; Fig.23 Another exemplary exhaust port is shown with its actuator in a series of different exemplary positions; Fig.24 Shows Fig.23 A perspective view of an exhaust port of the embodiment of the present invention, wherein the actuator thereof completely covers the orifice of the exhaust port; Fig.25 Shows Fig.23 Another perspective view of the exhaust port of the embodiment of the present invention, wherein the actuator thereof partially covers the orifice of the exhaust port; Fig.26A and Fig.26B showing a perspective view and a side view, respectively, of another exemplary exhaust port according to the present disclosure; Fig.26C and Fig.26D A plan view and a perspective view, respectively, of an exemplary vent cap according to one embodiment of the present disclosure are shown; Fig. 27 shows a plan view of another exemplary vent cap according to the present disclosure; Fig.28 It shows how the orifice of the exhaust port can be gradually obscured; Fig.29 Another exemplary exhaust port with an exemplary support structure is shown (actuator not shown); Fig.30 Another exemplary exhaust port with an exemplary support structure is shown (actuator not shown); Fig.31 Shows Fig.30 A cross-sectional view of an exhaust port; Fig.32 Shows Fig.30 A side view of an exhaust port; Fig.33A , Fig.33B and Fig.33C Another exemplary exhaust port is shown; Fig.34A , Fig.34B and Fig.34C Shows Fig.33A , Fig.33B and Fig.33C A cross-sectional view of an exhaust port of wherein the actuator thereof is in a first position, a second position and a third position, respectively; Fig.35 Shown when Fig.33A- how the pressure of breathable gas delivered to the patient changes over time when the actuator of the exhaust port of C is in different relative positions; Fig.36A , Figure 36b and Fig.36C shows a cross-sectional view of another exemplary exhaust port having a biasing member, wherein an actuator of the exhaust port is in a first position, a second position, and a third position, respectively; Fig.37 , Fig.38 and Fig.39 A diagram showing another exemplary exhaust port with its actuator in a first position, a second position, and a third position, respectively; Fig.40 shows a cross-sectional view of another exemplary exhaust port; Fig.41 Shows when using Figure 37-39 Examples of pressure waveforms of breathable gas delivered to a patient when the exhaust port of the device is at a position corresponding to different positions of its actuator; Fig.42 shows a plan view of a guide member and how it may be supported in an exhaust port; Fig.43A , Fig.43B , Fig.43C and Fig.43D shows a cross-sectional view of another exemplary exhaust port with its actuator in a series of different positions; Fig.44A , Fig.44B , Fig.44C and Fig.44D They are shown respectively Fig.43A , Fig.43B , Fig.43C and Fig.43D a corresponding side view of the exhaust port; Fig.45A , Fig.45B , Fig.45C , Fig.46A , Fig.46B and Fig.46C Shown with Fig.43A -D and Fig.44A - Further details of the membrane used with the exhaust port in D and its principle of operation; Fig.47A Another exemplary exhaust port is shown; Fig.47B Shows Fig.47A A close-up view of the components of the exhaust port; Fig.47C Shows Fig.47A A partial cross-sectional view of an exhaust port; Fig.48A and Fig.48BShows Fig.47A further details of how components of the exhaust port may deform as the actuator moves in different directions; Fig.49 Another exemplary vent is shown, comprising a sealing portion; Fig.50 A further exemplary vent is shown, comprising a sealing portion; Fig.51 shows an exploded perspective view of an exemplary PEEP valve according to one embodiment; Fig.52 Shows Fig.51 A side cross-sectional view of a PEEP valve; Fig.53 shows a schematic diagram of an exemplary controller and the pressure differential experienced by the controller; Fig.54 shows a perspective view of an exemplary pressure regulating device according to one embodiment; Fig.55 Shows Fig.54 A side cross-sectional view of a pressure regulating device; Figures 56A-56D The operation of the pressure regulating device when transitioning between PIP and PEEP is demonstrated. Fig.57 and Fig.58 An example of using an exemplary pressure regulating device with an exemplary CPAP breathing system is shown; Fig.59A , Fig.59B and Fig.59C Examples of releasable attachment mechanisms that may be used to transition between therapies using a single type of patient interface are shown. Fig.60 and Fig.61 Demonstrates the use of a T-piece assembly to connect an exemplary pressure regulating device to Fig.57 and Fig.58 Another example of use with a CPAP breathing system. DETAILED DESCRIPTION

[0196] The present disclosure relates to various devices, systems, and methods suitable for use with a breathing system arranged to deliver breathable gas to a patient. In at least one aspect, the present disclosure relates to an exhaust port for use with a breathing system.

[0197] Respiratory therapy referred to throughout this disclosure may be resuscitation therapy, such as infant or neonatal resuscitation therapy, positive airway pressure therapy (PAP), bi-level positive airway pressure therapy, non-invasive ventilation, or another form of respiratory therapy. In some configurations, the system may provide bi-level positive airway pressure therapy to achieve infant resuscitation.

[0198] As used in this disclosure, 'pressure therapy' may refer to delivering breathable gas to a patient at a pressure of at least greater than or equal to about 1 cm H2O. Pressure therapy may be delivered to simulate a patient's natural breathing cycle and / or delivered according to the patient's breathing cycle to assist the patient's breathing.

[0199] In some configurations, the breathable gas delivered to the patient is oxygen or includes oxygen. In some configurations, the breathable gas includes a blend of oxygen or oxygen-enriched gas and ambient air. In some configurations, the percentage of oxygen in the delivered gas can be between about 20% and about 100%, or between about 30% and about 100%, or between about 40% and about 100%, or between about 50% and about 100%, or between about 60% and about 100%, or between about 70% and about 100%, or between about 80% and about 100%, or between about 90% and about 100%, or about 100%, or 100%. In at least one configuration, the delivered gas can have an atmospheric component. In at least one configuration, the delivered gas can be ambient air.

[0200] With respect to infant resuscitation, while in utero, the fetus' lungs are filled with fluid and oxygen is derived from the blood vessels of the placenta. At birth, the transition to continued postnatal breathing occurs, aided by compression of the lungs by the birth canal. Also aiding infant breathing is the presence of surfactant on the lining of the alveoli, which reduces surface tension. The need for infant resuscitation may occur in a range of circumstances, as will be further described below.

[0201] Any newborn may require respiratory assistance at birth to initiate or improve breathing. However, several factors can predict the need for resuscitation or respiratory assistance during the transition to sustained postnatal breathing. For example, birth before 35 weeks, signs of severe fetal compromise, maternal infection, or congenital anomalies, and emergency cesarean section are associated with an increased need for respiratory assistance at birth. Overview

[0202] Figure 1 An example of a breathing system 1 is shown in FIG. Figure 2 Another example of a breathing system 1 is shown in The breathing system 1 is configured to provide respiratory therapy to a patient by delivering a breathable gas to the airway of the patient.

[0203] In general, the respiratory system 1 includes: a respiratory device 100; a conduit assembly 200 arranged to deliver breathable gas from the respiratory device 100 to a patient; and a patient interface 340 arranged to communicate with the airway of the patient. Some embodiments may additionally include a device 320 configured to be fluidly connected to the patient interface 340 when delivering respiratory therapy. In at least some embodiments, the device 320 includes a suitable connector, allowing it to be fluidly coupled to an inlet of the patient interface 340 at one end and to a connector of the conduit assembly 200 at another end.

[0204] refer to Figure 1 , the respiratory therapy device 100 may include: a flow generator 110; an optional humidifier 120 for humidifying the gas generated by the flow generator 110; and an associated controller 130, which is configured to control the operation of the flow generator 110 and / or the humidifier 120 (when present). In one embodiment, the flow generator 110 may be in the form of a blower 110.

[0205] The tubing assembly 200 of the respiratory system 1 may include a respiratory duct 210 having a gas circuit 24 for guiding gas from the respiratory therapy device 100 to the patient interface 340. The tubing assembly 200 may include a heating element 220 to heat the airflow passing through the respiratory duct 210 to the patient. The heating element 220 may be in the form of a heater wire or a certain length of conductive wire. The conductive wire may have a predetermined resistance. The heating element 220 may be under the control of a controller (e.g., a central controller 130 or an auxiliary controller).

[0206] The breathing system 1 may include one or more sensors for sensing one or more parameters of the breathing system 1, such as flow, temperature, humidity, and / or pressure. Such sensors may be placed in various locations in the breathing system 1. One or more sensor outputs may be monitored by the controller 130 to assist in the operation of the breathing system 1.

[0207] Further references Figure 1 , breathing system 1 also includes a user interface 140, which includes, for example, a display and (multiple) input devices (e.g., (multiple) buttons, a touch screen, etc.). Controller 130 can be configured or programmed to control and / or interact with components of breathing system 1, including: operating flow generator 110 to generate a gas flow (airflow) for delivery to a patient, receiving one or more inputs from sensors and / or user interface 140 for reconfiguration of breathing system 1 and / or (multiple) user-defined operations, and providing output information to the user (e.g., on a display).

[0208] The respiratory system 1 may include a transmitter 150, a receiver 150, and / or a transceiver 150 to enable the controller 130 to receive transmitted signals from sensors and / or control various components of the respiratory system 1. The controller 130 may receive transmitted signals from sensors associated with components or control components, including but not limited to the flow generator 110, the humidifier 120, the humidifier heating element 220, or accessories or peripherals associated with the respiratory therapy device 100 (e.g., the respiratory tube assembly 200). For example, the transmitted signal may be associated with the control of the component, or processed to indicate the control of the component. Additionally or alternatively, the transmitter 150, the receiver 150, and / or the transceiver 150 may deliver data to a remote server or enable remote control of the respiratory system 1.

[0209] Figure 1 The blocks in represent functional components of the respiratory therapy device 100. It will be appreciated that the functionality may be provided by different or integrated physical components. For example, the flow generator 110 and the humidifier 120 may exist as an integrated device. An example of a device having an integrated flow generator 110 and humidifier 120 is the Airvo by Fisher & Paykel Healthcare, Inc. TM device. You will also learn that Figure 1 Not all functional or physical components of the respiratory system 1 or their alternatives are shown. For example, Figure 1 A power source is not depicted. Those skilled in the art will appreciate that respiratory therapy device 100 may include an integrated power source and / or be connected to an external power source.

[0210] Figure 2 Another example of a respiratory system 1 is shown that includes a respiratory therapy device 100, which may be a positive pressure ventilation device. The respiratory therapy device may be a resuscitator, such as a T-piece resuscitator device. An example of a T-piece resuscitator device is the Neopuff by Fisher & Paykel Healthcare, Inc. TM Infant T-piece resuscitator. Respiratory therapy device 100 receives a flow of breathable gas from a gas supply source 160 via a gas inlet. Respiratory therapy device 100 can be connected to an optional humidifier 120 via a gas outlet of the device. The humidified breathable gas is then supplied to the patient from the outlet of the humidifier via tubing assembly 200 and device 320, which can be connected to a patient interface (not shown). Gas supply source 160 typically supplies the flow of breathable gas to device 100 at a constant flow rate. Device 100 receives the flow of breathable gas and can be set to change the pressure of the breathable gas delivered to the patient. The device is typically configured in an initial calibration phase to select the level of pressure to be delivered to the patient.

[0211] As mentioned above, device 320 is provided for use with breathing system 1 and, when in use, fluidly connects tubing assembly 200 to patient interface 340. In some existing breathing systems, the operator of the system uses device 320 to adjust the pressure of the gas delivered to the patient, such as Figure 3A , Figure 3B , Figure 4A and Figure 4B As shown in .

[0212] refer to Figure 3A , Figure 3B , Figure 4A and Figure 4B , each device 320 includes an inlet 324 that is arranged to receive breathable gas from respiratory apparatus 100. An outlet 325 of device 320 is arranged to connect to patient interface 340 when delivering respiratory therapy. Each device 320 also includes a PEEP port 322 that is arranged to be occluded (i.e., blocked, obstructed, covered, plugged, or otherwise closed) or unobstructed (i.e., not blocked, unobstructed, uncovered, unplugged, or otherwise opened) by an object (e.g., an operator's finger or digit) when delivering respiratory therapy to the patient. When PEEP port 322 is occluded by the operator (e.g., Figure 3A or Figure 4A ), the breathable gas received from the respiratory device 100 is delivered to the patient via the patient interface 340, and the respiratory system 1 delivers the breathable gas to the patient at the first pressure. When the occlusion is removed from the PEEP port 322 (such as, for example Figure 3B 4B), PEEP port 322 allows gas from within breathing system 1 to escape from the interior cavity of device 320 to the ambient air, and breathing system 1 delivers breathable gas to the patient at the second pressure. In this way, resuscitation of the patient can be attempted by varying between the first pressure and the second pressure at a selected breathing rate.

[0213] Figure 5The direction of flow of breathable gas is shown as it enters the device via inlet 324 of the device 320 and exits the device 320 from the PEEP port 322 (if it is not blocked) and / or from the outlet 325, which is connected to the patient interface 340 when in use. An optional port (e.g., in the form of a duckbill valve 323) may also be included, which can be used to insert auxiliary equipment, such as a catheter for fluid removal or surfactant delivery, and / or a monitoring device for monitoring one or more parameters of inhaled and / or exhaled gas (e.g., a breathing indicator device or a gas detection device, such as a CO2 detector for detecting CO2 in exhaled gas). Examples of breathing indicators are described in International Patent Application Nos. PCT / NZ 2011 / 000174 (published as WO 2012 / 030232) and PCT / IB 2019 / 059813 (published as WO 2020 / 109915).

[0214] The patient interface 340 can be a sealing interface, i.e., an interface intended to create a seal with the patient's airway. The patient interface 340 can be a mask (including an oronasal mask or a nasal mask), a cannula (e.g., a nasal cannula), an endotracheal tube, or a laryngeal mask. The patient interface 340 can be in the form of a CPAP (continuous positive airway pressure) interface, which can be one or more of a mask (nasal or oronasal) or a nasal cannula. The patient interface 340 can be held in place on the patient's face by, for example, a headgear and / or an operator (e.g., a healthcare professional). It will be appreciated that the patient interface includes a range of different types, sizes, and / or fits.

[0215] A neonatal interface may be any interface (such as the interfaces described above) that is configured for use with an infant or neonate.A neonatal interface may be configured to at least partially and preferably substantially seal around a patient's nose and / or mouth.

[0216] In order to provide respiratory therapy to the patient, the pressure delivered to the patient can be adjusted to reduce or prevent harm to the patient. This is particularly relevant to infants and newborns (due to the fragility of their lungs and airways). The PEEP port 322 may include a pressure regulating valve that is actuated at a certain pressure level (i.e., at a set PEEP) to allow gas from within the respiratory system 1 to be discharged externally and reduce excess pressure within the respiratory system 1. In other words, the PEEP port 322 may include a PEEP valve. Another pressure regulating valve may be provided in the respiratory device 100 to control the pressure of the breathable gas delivered to the patient under PIP. In addition, a maximum pressure relief valve may also be provided in the respiratory device 100 to set the maximum amount of pressure relief that can be delivered to the patient.

[0217] In some embodiments, the patient terminal end 26 (eg, Figure 1 The first pressure level is delivered at or near the patient terminal end 26 as shown in FIG. Once the interface suitability is confirmed, the first pressure level can be delivered at or near the patient terminal end 26.

[0218] Similarly, a second pressure level can be delivered at or near the patient terminal end 26 at a second time or during a second time window. Once the interface fit is confirmed and / or once the expected second pressure level in the resuscitator has been confirmed (e.g., by sealing the outlet of the device with a protective cap), the second pressure level can be delivered at or near the patient terminal end 26. The breathing system 1 continuously provides breathable gas to the patient at a first pressure level and a second pressure level to simulate the patient's breathing cycle. Typically, 30-60 breathing cycles per minute are provided to the patient during respiratory therapy. In some applications, the patient's breathing cycle is manually determined by a clinician. It should be understood that the number of breathing cycles per minute required depends largely on the type of treatment to be provided to the patient, the patient's condition (age, respiratory condition, etc.), and generally varies from patient to patient.

[0219] In one embodiment, the first pressure level is equal to the target PIP or the desired PIP. In some examples, the first pressure can be 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60 cmH2O. , and useful values ​​can be selected between any of these ranges (e.g., about 15 to about 60, about 20 to about 25, about 21 to about 30, about 21 to about 27, about 21 to about 25, about 22 to about 30, about 22 to about 29, about 22 to about 25, about 23 to about 30, about 23 to about 28, about 23 to about 26, about 24 to about 30, about 24 to about 29, about 24 to about 28, about 24 to about 26, or about 25 to about 30 cm HO).

[0220] A higher PIP may be required for the first few respiratory cycles (to clear fluid from the airways and begin ventilating the lungs) and / or if the patient does not respond positively to the respiratory therapy initially administered. In addition, the pressure level required for resuscitation may vary from patient to patient, depending on factors such as lung maturity, presence of lung disease, disorder, and the like. The pressure values ​​and / or ranges mentioned above are provided as guidelines only, and in practice, the target pressure may be individually adjusted depending on, for example, the patient's response, patient requirements, and / or clinician preference.

[0221] In one embodiment, the second pressure level is equal to the target PEEP or the desired PEEP. In some examples, the second pressure can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 cm H2O, and a useful value can be selected between any of these ranges (e.g., about 1 to about 15, about 1 to about 14, about 1 to about 13, about 1 to about 12, about 1 to about 11, about 1 to about 10, about 1 to about 9, about 1 to about 8, about 1 to about 7, about 1 to about 6, about 1 to about 5, about 2 to about 8, about 2 to about 6, about 2 to about 5, about 3 to about 8, about 3 to about 5, about 4 to about 8, about 4 to about 7, about 4 to about 5, about 5 to about 8, or about 6 to about 8 cmH2O). The second pressure can be about 5 cm H2O, but can be set depending on factors as outlined above. The pressure values ​​and / or ranges mentioned above are provided for guidance only, and in practice, the target pressure may be adjusted individually depending on, for example, the patient's response, the patient's requirements, and / or the clinician's preference.

[0222] The described configuration of device 320 may allow for one-handed operation during respiratory therapy.

[0223] The changing pressure of breathable gas delivered to the patient over time may be represented by a generally square waveform, such as, for example, at Figure 3A , Figure 3B , Figure 4A and Figure 4B , where the vertical axis represents pressure (P) and the horizontal axis represents time (T). Figure 6 It also shows that according to Figure 2 5001 of an exemplary waveform of pressure over time provided by the device 320 in a -4 configuration. The square waveform 5001 indicates that there are generally rapid changes in pressure, as indicated by the sharp transition slope between the target PEEP and the target PIP. In at least some situations or applications, it may be desirable to provide a relatively or relatively smooth transition between different target pressures.

[0224] According to the present disclosure, an exhaust port may be provided for use with the breathing system 1 described above. The exhaust port includes a movable actuator, wherein movement of the actuator adjusts an area of ​​the exhaust port available for gas from within the breathing system 1 to exit the breathing system 1 via the exhaust port. Thus, the exhaust port allows for a greater level of control over the pressure waveform of the breathable gas delivered to the patient (particularly when the breathing system 1 is switched between different pressure settings), and may assist the breathing system 1 in providing a relatively smooth transition between different target pressures.

[0225] In some embodiments, the exhaust port is configured to be retrofitted to the PEEP port 322 of the device 320 via a suitable connection mechanism. For example, complementary threaded portions can be provided both in the exhaust port and near the PEEP port 322. In this example, the exhaust port is coupled to the device 320 via these threaded portions during use, and allows for gradual and / or stepwise closing or opening of the gas flow path via the PEEP port 322 and the exhaust port. In some embodiments, the device 320 can be configured so that it does not include a PEEP port 322 (with Figure 2 3 ). Alternatively, the exhaust port is coupled directly to the air outlet of the device and replaces the PEEP port 322 .

[0226] Respiratory therapy may be pressure therapy delivered to a patient to assist breathing and / or treat a respiratory disorder. Pressure therapy may involve the respiratory system 1 providing breathable gas to the patient at one or more target pressures over one or more time windows. The exhaust port allows the respiratory system 1 to provide a relatively smooth transition when switching between different target pressures. That is, a range of intermediate pressures may also be provided to the patient over one or more time windows.

[0227] In some embodiments of the present disclosure, the pressure waveform of the breathable gas delivered to the patient may be substantially symmetrical, meaning that pressure increases and pressure decreases follow substantially symmetrical waveforms. Providing a substantially symmetrical pressure waveform requires that the gradual increase in pressure and the gradual decrease in pressure occur over similar durations. In some embodiments of the present disclosure, the pressure waveform of the breathable gas delivered to the patient may be asymmetrical, meaning that the gradual increase in pressure and the gradual decrease in pressure may occur over different durations. In other embodiments, the exhaust port may be configured such that the pressure increases more rapidly than the pressure decreases. In some embodiments, the exhaust port may be configured such that the pressure decreases more rapidly than the pressure increases.

[0228] Now refer to FIG. 7A to FIG. 50 Various embodiments of the exhaust port are described below.

[0229] In general, an exhaust port allows gas from within the breathing system to exit through the exhaust port to ambient air. The exhaust port includes a movable actuator (e.g., operated by an operator), and movement of the actuator adjusts the area of ​​the exhaust port available for gas to flow through. In doing so, the pressure of the breathable gas delivered to the patient is gradually adjusted. The rate of change of pressure depends at least in part on the speed at which the operator delivers breaths to the patient, and the speed at which the operator moves the actuator.

[0230] Adjusting the area of ​​the exhaust port available for gas to flow through controls the resistance to flow of gas exiting the exhaust port, which in turn controls the pressure of breathable gas delivered to the patient. For example, when the actuator is moved to reduce the area of ​​the exhaust port, the resistance to flow through the exhaust port increases, which in turn will increase the pressure delivered to the patient for a given constant flow rate of gas passing through the respiratory system 1 over a period of time. When the actuator is moved to increase the area of ​​the exhaust port, the resistance to flow through the exhaust port decreases. For a given constant flow rate of gas passing through the respiratory system 1 over a period of time, this in turn reduces the pressure delivered to the patient.

[0231] When movement of the actuator causes the exhaust port to be completely blocked or closed and there is no area of ​​the exhaust port available for gas to flow through, the gas flow may exit elsewhere in the system 1. The gas flow may exit through another exhaust port or outlet included in the respiratory device 100. For example, the gas flow may exit via a PIP exhaust port or a PIP valve that actuates when the pressure in the system 1 increases to the PIP due to the exhaust port being completely blocked / closed by the actuator.

[0232] In some embodiments, the actuator may be moved to cause a gradual and / or stepped occlusion or unocclusion of an air outlet of the respiratory system (e.g., a PEEP port of a T-piece device) such that the pressure of the breathable gas delivered to the patient is gradually or stepwise changed. In some embodiments, the actuator may be moved to cause a gradual and / or stepped opening or closing of one or more orifices or openings of the exhaust port, thereby adjusting the pressure of the breathable gas delivered to the patient.

[0233] In some embodiments, the speed of movement of the actuator is primarily determined by the operator. In other embodiments, the speed of movement of the actuator may be determined at least in part by the configuration of the exhaust port, as will be described below.

[0234] Although the following embodiments are described with reference to the accompanying drawings which show certain combinations of various features of the exhaust port, it should be understood that features from different embodiments may also be combined and are not necessarily limited to what is shown in the accompanying drawings.

[0235] FIG. 7A to FIG. 50 Various embodiments of exhaust ports including movable actuators are shown.

[0236] Fig. 7A and Figure 7BA first exemplary exhaust port 600 is shown, which includes a movable actuator 601 connected to a device 620 of the respiratory system 1. The device 620 includes an inlet 624 arranged to receive a flow of breathable gas from the respiratory device 100. A first outlet 625 of the device 620 can be connected to a suitable patient interface (not shown) to deliver breathable gas to the patient. An optional port (e.g., in the form of a duckbill valve 623) is also included in the device 620 for inserting auxiliary equipment, such as a catheter for fluid removal or surfactant delivery to the patient, and / or a monitoring device for monitoring one or more parameters of the inhaled and / or exhaled gas (e.g., a breathing indicator device or a gas detection device, such as for detecting CO2 in the exhaled gas).

[0237] In this example, the exhaust port 600 is connected to a second outlet 626 of the device 620 via one or more suitable connectors. The second outlet 626 can be a PEEP port of the device 620, as described above. Fig. 7A and Figure 7B , the connector may include complementary threaded portions 610 disposed in both the exhaust port 600 and the device 620. In other embodiments, the connector may be in other forms, such as a detachable connector and / or an interchangeable connector. In other embodiments, the exhaust port 600 may be integrally formed with the device 620. When delivering respiratory therapy, the actuator 601 may be slid, for example by an operator, to adjust the area of ​​the exhaust port 600 available for gas to pass through and exit from the respiratory system 1, which in turn controls the pressure of the breathable gas delivered to the patient.

[0238] Fig. 8A and Figure 8B Another exemplary exhaust port 600 including a slidable actuator 601 is shown. For ease of presentation, device 620 is omitted from these figures. As indicated, the slidable actuator 601 can be movable (e.g., by an operator's finger) to cover, partially cover, or uncover an opening (e.g., in the form of an orifice 602 of the exhaust port 600). The area of ​​the exhaust port 600 through which gas can flow to exit the respiratory system 1 is determined based on the uncovered area of ​​the orifice 602. The exhaust port 600 can additionally include a support structure 603, and the actuator 601 is movably connected to and supported by this support structure 603. The support structure 603 includes one or more channels for holding and guiding the sliding movement of the actuator 601.

[0239] Fig. 7A and Figure 7BAn exemplary exhaust port 600 is shown that uses a single U-shaped channel 604 that extends the peripheral portion of a support structure 603. The peripheral portion can include the left side, top, and right side of the support structure 603. Fig. 8A and Figure 8B Another exemplary exhaust port 600 is shown, which includes two substantially parallel channels 604A, 604B disposed on either side of an orifice 602. The two parallel channels 604A, 604B may be disposed on a surface of a support structure 603. The channels 604, 604A, 604B receive the left and right edges of the actuator 601 to help guide the sliding movement of the actuator 601. The channels may also assist in maintaining the relative position of the actuator 601 and the support structure 603 so that the actuator 601 does not become accidentally disengaged from the support structure 603 during use.

[0240] like Fig. 8A As shown in , when the slidable actuator 601 slides to the lower end of the exhaust port 600, the orifice 602 is fully opened, thereby allowing gas from within the respiratory system to flow through the orifice 602 to the surrounding air. When the actuator 601 slides toward the upper end of the exhaust port 600, the orifice 602 is gradually covered by the actuator 601. The gradual covering of the orifice 602 reduces the area of ​​the exhaust port 600 available for gas to flow through, thereby increasing the pressure of the breathable gas delivered to the patient. Similarly, when the actuator 601 slides toward the lower end of the exhaust port 600, the orifice 602 is gradually uncovered by the actuator. The gradual uncovering of the orifice 602 increases the area of ​​the exhaust port 600 available for gas to flow through, which reduces the pressure of the breathable gas delivered to the patient.

[0241] In some embodiments, when orifice 602 is completely or substantially covered by actuator 601, the pressure of breathable gas delivered to the patient corresponds to PIP or positive inspiratory pressure. When orifice 602 is completely or substantially uncovered, the pressure of breathable gas delivered to the patient corresponds to PEEP or positive end-expiratory pressure. When orifice 602 is partially covered, a pressure between PEEP and PIP is delivered to the patient. As actuator 601 repeatedly moves up and down along exhaust port 600, different pressure levels of breathable gas are supplied to the patient according to the patient's needs.

[0242] exist Fig. 8A 8D, the orifice 602 forms a substantially circular shape. It should be appreciated that the orifice 602 may be provided in a variety of other shapes and configurations (eg, as shown in FIG. 9), and is not limited to Fig. 8A and the circular shape shown in FIG8D. In addition, a single orifice 602 is provided at Fig. 8A , Figure 8B9 . It should be appreciated that a plurality of orifices 602 may alternatively be disposed in exhaust port 600. In at least some embodiments, the configuration of orifices 602 may be determined at least in part based on a desired rate of change of covering or uncovering of orifices 602 during movement of actuator 601. The configuration of orifices 602 may also be determined at least in part based on an inhalation to exhalation ratio (I:E) of the patient. In some embodiments, the configuration of orifices 602 may be determined at least in part based on a desired shape of a pressure waveform of the breathable gas to be delivered to the patient over time.

[0243] FIG. 9 shows an example of an exhaust port 600 including three exemplary orifices, each having a different shape. For ease of presentation, actuator 601 is omitted from these embodiments. As indicated, orifice 602 may be provided in a circular shape (as indicated by 602A), an elliptical shape (as indicated by 602B), or a conical shape (as indicated by 602C). With these orifices, when the operator moves actuator 601 at a substantially constant speed, the rate of change of the open area of ​​the orifice varies along the direction of movement, which is likely to result in a nonlinear change in the pressure of the breathable gas delivered to the patient.

[0244] Fig.10 602A) indicates how the circular orifice 602 may be gradually covered and uncovered during the breathing cycle. The dark areas within the circular shape 602A (e.g., represented by 1001, 1003, 1005, and 1007) indicate the area of ​​the circular orifice 602 that is covered by the actuator 601, and the light areas within the circular shape 602A (e.g., represented by 1002, 1004, 1006, and 1008) indicate the open area of ​​the orifice 602 that allows gas from within the breathing system 1 to flow through. As the actuator 601 moves (e.g., along the path represented by Fig.10 ), the circular aperture 602 is completely covered (as shown by 1007). It will be appreciated that the actuator 601 moves along the same Fig.10 Moving in the opposite direction of the moving path shown in will gradually cover the circular aperture 602 .

[0245] Fig.11 601 is an exemplary diagram showing how the open area of ​​the orifice 602 changes when the actuator 601 moves to different positions relative to the orifice 602. If the actuator 601 moves along its movement path at a constant speed, the open area of ​​the orifice 601 changes in a nonlinear manner from a substantially fully open state at time T1 to a substantially fully closed state at time T2, and again to a substantially fully open state at time T3 (given by Fig.11 1111 in FIG. Fig.12The corresponding waveform 1211 of the pressure delivered to the patient due to the movement of the actuator 601 is shown in FIG. As described above, when the orifice 602 is substantially fully open, the pressure delivered to the patient is at a minimum level at times T1 and T3. Fig.12 The curve 1211 demonstrates a smoother transition between low and high pressures provided to the patient. Fig.12 The pressure waveform 1211 and Figure 3A , Figure 3B , Figure 4A , Figure 4B and Figure 6 Compared with the pressure waveform shown in , it can be observed that the pressure increase or decrease is more gradual and smooth, which may be desirable for some applications.

[0246] Similarly, Fig.13 602 is shown as the triangular aperture 602 is gradually covered by the actuator 601 during use. When the actuator 601 is moved to cover the vertex 602D of the aperture 602, the reduction in the open area of ​​the aperture 602 is relatively small. However, as the actuator 601 is moved to approach the side 602E (i.e., the base 602E) opposite the vertex 602D of the triangular aperture 602, the reduction in the open area 602 becomes more pronounced with each incremental movement of the actuator 601. This is reflected in the Fig.14 , the figure shows how the open area of ​​the triangular aperture 602 changes when the actuator 601 is moved to cover the triangular aperture 602 from the apex 602D to the base 602E and then to open the triangular aperture 602 again from the base 602E to the apex 602D. Fig.15 FIG. 6 shows a pressure waveform of breathable gas delivered to a patient using a triangular shaped orifice 602, corresponding to FIG. Fig.14 When the actuator 601 moves to the bottom of the triangular orifice 602 (i.e., 602E in this example) or moves away from the bottom, the pressure changes more rapidly than when the actuator moves to the apex of the triangular orifice 602 (i.e., 602D in this example) or moves away from the apex.

[0247] Figures 16 to 18 Demonstrates how the pressure waveforms can be different (even with the same orifice 602 configuration). Fig.16 The same triangular aperture 602 as shown in FIG. 6A , however, the actuator 601 moves to move from the base 602E (rather than Fig.13 As shown in FIG. 6A , the aperture 602 is gradually covered from the vertex 602D. In this case, as shown in FIG. Fig.17 The rate of change of the open area shown in (and hence the Fig.18The corresponding pressure delivered to the patient shown in ) is greater when the actuator 601 moves away from or toward the base of the triangular orifice 602 (e.g., 602E) and slower when the actuator 601 moves toward or away from the apex of the triangular orifice 602 (e.g., 602D).

[0248] In some embodiments, it is possible to configure the orifice 602 so that when the actuator 601 moves at a constant speed, the rate of change of the open area of ​​the orifice 602 also remains approximately constant. Fig.19 An example of how this can be achieved by using a rectangular aperture 602 is shown. As the actuator 601 is moved to gradually cover or uncover the aperture 602, the rate of change of the open area remains constant, as indicated by Fig. 20 The straight line in . Fig.21 The corresponding pressure waveform produced by using a rectangular orifice is shown. The pressure delivered to the patient still follows a more gradual and smooth curve, rather than abrupt increases or decreases as in previous systems (such as Figure 3A , Figure 3B , Figure 4A , Figure 4B and Figure 6 ).

[0249] Return to reference Fig. 7A and Figure 7B In some embodiments, the actuator 601 includes an engagement member 605 that is arranged to be engaged by, for example, an operator's finger or digit when operating the actuator 601. The engagement member 605 may include a formation that increases the friction between the operator's finger and the actuator 601 and / or affects the force distribution on the actuator 601. The formation may simply be a rough surface texture. Alternatively or additionally, the formation may include, for example, but not limited to, a protrusion, a button, one or more ridges, depressions, recesses, grooves, indentations, and the like, so as to allow the operator to easily move the actuator 601 when in use. The formation provides tactile feedback so that the operator of the system knows that their finger is correctly located on the actuator of the exhaust port. This may be useful if the operator needs to look elsewhere (e.g., to monitor the patient's condition or reaction) while operating the system.

[0250] Figure 22 shows various examples of actuator 601, which includes different types of engagement members 605A, 605B, 605C, 605D. It will be appreciated that actuator 601 and support structure 603 and its engagement members 605 can be made of the same material or different materials, including plastics, foam, rubber and the like, depending on movement friction, user comfort, sealing ability, etc. In addition, actuator 601 can be configured as a transparent or opaque component (such as, shown in Figure 22) of exhaust port 600. Actuator 605C and 605D are made of transparent plastic and are substantially transparent. Other actuators 605A and 605B are made of dark materials that may be opaque. Similarly, support structure 602 can also be made of transparent or opaque materials.

[0251] Fig.23 Another exemplary vent 600 is shown, which includes a movable actuator 601, wherein the actuator 601 moves to a series of different positions. As shown, the actuator 601 moves again to block or unblock the orifice 602 of the vent 600. The support structure 603 of this embodiment includes a hinge 603, and the actuator 601 can rotate relative to the hinge 603, such as when moved by an operator. In this example, the engagement member 605 can be formed as a circular recessed portion located in the central area of ​​the actuator 601, allowing the operator to place a finger on it when operating the vent 600. Fig.24 The actuator 601 is shown in a first state when it moves to a position where it completely covers the aperture 602. Fig.23 A side perspective view of the exhaust port 600. Fig.25 The actuator 601 is shown in a second state when it is rotated to a different position where the aperture 602 is partially blocked. Fig.23 600. A connector portion (e.g., a threaded connector 610) can be formed on the lower surface of the support structure 603 so that the exhaust port 600 can be removably connected to the second outlet of the device 620, as previously described. It will be appreciated that the connector 610 can be in other forms, such as a detachable connector and / or an interchangeable connector. In other embodiments, the exhaust port 600 can be integrally formed with the device 620.

[0252] Fig.26A and Fig.26B Another exemplary exhaust port 1100 according to the present disclosure is shown.

[0253] Similar to the previous embodiments, the device 1120 includes an inlet 1124 arranged to receive a flow of breathable gas from the respiratory apparatus 100. The first outlet 1125 of the device 1120 is connected to a suitable patient interface (not shown) to deliver breathable gas to the patient. An optional port (e.g., in the form of a duckbill valve 1123) may be included in the device 1120 for inserting auxiliary equipment, such as a catheter for fluid removal or surfactant delivery to a patient, and / or a monitoring device for monitoring one or more parameters of inhaled and / or exhaled gas (e.g., a breathing indicator device or a gas sampling or detection device, such as for detecting CO2 in exhaled gas). The device 1120 also includes a second outlet 1126 configured to receive a connection to the exhaust port 1100. The second outlet 1126 may be a PEEP port as described in the previous embodiments, or a conventional air outlet that does not include a PEEP valve.

[0254] The exhaust port 1100 includes an actuator 1101, which can be moved by an operator, for example, to cause a more gentle and gradual transition between different pressures. In this example, the actuator 1101 is formed in a dome shape, which includes a curved surface 1114 and a substantially flat surface 1113 opposite to the curved surface 1114. In some configurations, the curved surface 1114 can be formed into a hemispherical shape. In at least some embodiments, the actuator 1101 is not tethered or connected to another component (e.g., the exhaust port cap 1112) of the exhaust port 1100. The actuator 1101 can be moved by an operator, for example, by grasping it on its left and right sides with two fingers. The exhaust port 1100 includes one or more orifices 1102, which are arranged to be gradually covered or uncovered by the actuator 1101, as in the previous embodiments. In some embodiments, the one or more orifices 1102 can be arranged in the exhaust port cap 1112. The vent cap 1112 may be removably coupled to the second outlet 1126 of the device 1120 via a suitable connector arrangement. In alternative embodiments, the vent cap 1112 may be integrally formed with the device 1120.

[0255] Fig.26C and Fig.26D A plan view and a perspective view are shown, respectively, of an exemplary vent cap 1112 including a plurality of apertures 1102. For ease of illustration, the vent cap 1112 has been disconnected from the device 1120. In this example, the vent cap 1112 is generally circular in shape (eg, Fig.26C), wherein the cutout or array of openings is formed at or near the central area. The array of openings forms the plurality of orifices 1102 of the vent cap 1112, which allow air to flow through when not covered by the actuator 1101. In this example, the plurality of orifices 1102 are divided into four groups, with the bridging portion 1103 placed between them. The plurality of orifices 1102 are configured in a concentric arch shape, wherein the length of the openings placed near the central area of ​​the vent cap 1112 is shorter than the length of the openings placed farther from the central area.

[0256] Go to Fig.26D , the vent cap 1112 includes a connector 1110 disposed on a lower surface of the vent cap 1112. The connector 1110 includes a plurality of threaded portions. Complementary threaded portions may be disposed in the device 1120, wherein a connection is to be made between the vent cap 1112 and the device 1120. It will be appreciated that the connector 610 may be in other forms, such as a detachable connector and / or an interchangeable connector. Alternatively, the vent cap 1112 may be integrally formed with the device 1120. At or near a central region of the vent cap 1112, a protruding structure 1115 is provided in this example, which forms a cross shape in plan view, such as Fig.26C The protruding structure 1115 can be used to maintain a minimum distance between the actuator 1101 and the vent cap 1112 to avoid accidental obstruction of the orifice 1102.

[0257] In at least some embodiments, the actuator 1101 includes a deformable portion at or near the curved surface 1114. The deformable portion is elastically deformed when a force is applied thereto, and returns to its shape when the force is removed. The deformable portion may include materials such as silicon, foam, rubber, or the like. When the actuator 1101 is pressed against the vent cap 1112, such a deformable portion allows the actuator to flatten its curved surface 1104, thereby blocking the orifice 1102 of the vent cap 1112. Due to the dome shape of the actuator 1101, if, for example, a force is applied to the actuator 1101 substantially centrally or evenly, the orifice closer to the central area of ​​the vent cap 1112 will initially be blocked by the actuator 1101. As the actuator 1101 is further pressed against the vent cap 1102, more orifices of the vent cap 1102 will be blocked.

[0258] In some embodiments, in addition to or in lieu of providing a deformable portion at or near the curved surface 1114 of the actuator 1101 where or near the curved surface engages the orifice 1102, the vent cap 1112 may also be at least partially formed of an elastically deformable material. In one example, when the actuator 1101 is pressed against the vent cap 1112, a central region of the vent cap 1112 begins to elastically deform to a shape similar to the shape of the curved surface 1114 of the actuator 1101. When the actuator 1101 moves away from the vent cap 1112, it returns to its original shape.

[0259] Because orifice 1102 is blocked, there is a reduction in the area of ​​exhaust port 1100 available for gas from within respiratory system 1 to exit to ambient air via second outlet 1126 and orifice 1102. This increases the pressure of breathable gas delivered to the patient for a given flow rate from respiratory therapy device 100. When actuator 1101 moves away from exhaust port cap 1112, orifice 1102 becomes unblocked, resulting in an increase in the area of ​​exhaust port 1100 available for gas to exit from the respiratory system, which in turn reduces the pressure of breathable gas delivered to the patient for a given flow rate from respiratory therapy device 100.

[0260] In some embodiments, when orifices 1102 are completely or substantially blocked, the pressure of the breathable gas delivered to the patient corresponds to PIP or peak inspiratory pressure. When orifices 1102 are completely or substantially unobstructed, the pressure of the breathable gas delivered to the patient corresponds to PEEP or positive end-expiratory pressure. When the plurality of orifices 1102 are partially obstructed or unobstructed, a pressure between PEEP and PIP is delivered to the patient.

[0261] Fig. 27 Another exemplary vent cap 1112 is shown including a plurality of apertures 1105. The apertures 1105 are formed by an array of concentric elliptical cutouts positioned at or near a central region of the vent cap 1112.

[0262] In some embodiments, a single orifice 1102 may be disposed in a vent cap 1112. When the actuator 1101 is pressed against the vent cap 1112, the central area of ​​the single orifice 1102 will initially be blocked by the actuator 1101, and the blocked area will expand from the central area to the entire area of ​​the orifice 1102, as indicated by Fig.28 The dark areas indicate the areas of a single orifice 1102 that are blocked by the actuator 1101.

[0263] In some embodiments, it may be desirable to include a support structure 1103 in the vent 1110 for holding the actuator 1101 in close proximity to the vent cap 1102 and / or for preventing the actuator 1101 from accidentally falling. Fig.29 and Fig.30 Two examples of such support structures 1103 are shown.

[0264] In both embodiments, the support structure 1103 includes a body 1105 forming a cavity 1105A, wherein the vent cap 1112 is positioned within the cavity. The support structure 1103 includes two or more elongated members 1104A, 1104B, 1104C, 1104D extending from the body 1105 in a generally upward direction. A shoulder portion 1106 is formed in the elongated members 1104A, 1104B, 1104C, 1104D and extends inwardly toward the center of the vent cap 1112. The shoulder portions 1106 of the elongated members 1104A, 1104B, 1104C, 1104D assist in maintaining the actuator 1101 in close proximity to the vent cap 1112 without restricting its movement.

[0265] exist Fig.30 In the embodiment shown in FIG. 1 , support structure 1103 includes a ring 1107 connecting shoulder portions 1106 of elongated members 1104A-D. Fig.26A and Fig.26B 1101, it would be placed between the elongated members 1104A-D with the curved surface 1114 facing the vent cap 1112 and the peripheral area of ​​the flat surface 1113 engaging the shoulder portion 1106. The vent including such a support structure 1103 would still be operated in the same manner as previously described (i.e., by pressing the actuator against the vent cap 1112), however, because the actuator is held in place by the support structure 1103, the operator can simply operate the device with one finger rather than grasping with two fingers.

[0266] Fig.31 and Fig.32 Another exemplary exhaust port 1500 is shown having a Fig.30 The support structure of FIG. 1501 is similar to that of FIG. 1502 , but has a different actuator configuration. More specifically, the actuator 1501 is configured as a piston. In the example shown, the piston has a dome-shaped lower end. Fig.32 Demonstrated Fig.30 The support structure (i.e., having an elongated member 1504 Fig.32 1503) is a side view of the exhaust port 1500, and Fig.31 Shown Fig.32A cross-sectional view of the exhaust port 1500 (from section AA). For ease of presentation, Fig.31 The support structure is omitted in the cross-sectional view. Fig.26A and Fig.26B Unlike the embodiment shown in , the dome-shaped lower end is formed with a hollow interior. Since less material is deformed, the force required to deform the dome-shaped lower end is also considerably smaller. The actuator 1501 is provided with an engagement member 1505 at the upper surface, on which the operator can place their fingers to press the piston downwardly towards the orifice(s).

[0267] The pressure relief hole 1540 can be placed at the lower end of the piston to manipulate the resistance to ensure user comfort and control the time spent blocking the orifice. The pressure relief hole 1540 can provide compression deformation resistance due to discharge from the pressure relief hole 1540. In this example, the connector 1510 for connecting the exhaust port 1500 to the device (e.g., 1120, 620, 320) is also shown as a plurality of threaded portions. It will be appreciated that the connector 1510 can be in other forms, such as a detachable connector and / or an interchangeable connector. Alternatively, the bottom end portion of the exhaust port 1500 can be integrally formed with the device (e.g., 1120, 620, 320) without any connector portion.

[0268] Fig.33A -C and Fig.34A -C shows another exemplary exhaust port 1600 according to the present disclosure.

[0269] In this embodiment, the exhaust port 1600 includes an actuator 1601 and a housing 1603 . Fig.33B and Fig.33C The actuator 1601 and the housing 1603 are shown in a disassembled state. For ease of illustration, Fig.33A The actuator 1601 and the housing 1603 in an assembled state are shown in a three-dimensional cross-sectional view. The housing 1603 is formed as a hollow enclosure, wherein the first opening 1604 and the second opening 1606 are each provided at two opposite ends. The first opening 1604 can be fluidly connected to the breathing system 1 (e.g., by connecting to the outlet of the device), and the second opening 1606 is configured to movably receive the actuator 1601. A connector portion 1610 is formed at the bottom end of the housing 1603, thereby allowing a connection between the exhaust port 1600 and the device (e.g., 1120, 620, 320). Alternatively, the housing 1603 can be formed integrally with the device (e.g., 1120, 620, 320) without any connector portion.

[0270] In this embodiment, the actuator 1601 comprises a hollow body 1605. The actuator 1601 comprises a plurality of apertures 1602 arranged along the length of the hollow body 1605. The hollow body may also be provided with one or more air inlets 1650 at the lower end, thereby allowing gas within the enclosure of the housing 1603 to enter the internal cavity of the actuator 1601. In use, the actuator 1601 is movable relative to the housing 1603 between a raised position and an inserted position. Fig.34A Actuator 1601 is shown in a substantially or fully raised position. Fig.34B The actuator 1601 is shown in a partially raised or partially inserted position. Fig.34C Actuator 1601 is shown in a substantially or fully inserted position. In the substantially or fully raised position, all of orifices 1602 are exposed to ambient air, while in the substantially or fully inserted position, all of orifices 1602 are seated within an enclosure formed by housing 1603, thereby preventing gas from escaping to ambient air via exhaust port 1600. Between the substantially or fully inserted position and the substantially or fully raised position, one or more of the plurality of orifices 1602 are exposed to ambient air, thereby allowing gas to exit via exhaust port 1600 to ambient air. Thus, the relative position of actuator 1601 with respect to housing 1603 at least partially determines the area of ​​exhaust port 1600 available for gas to exit from respiratory system 1 to ambient air, and therefore determines the pressure of breathable gas delivered to the patient.

[0271] like Fig.13 AC and Fig.34A -C, the plurality of orifices 1602 are configured to have varying shapes and / or configurations. Some orifices are larger than other orifices. More specifically, the orifice positioned closer to the lower end of the actuator 1601 has a larger size than all the remaining orifices 1602. This is because this is the initial orifice that will be lowered into the enclosure as the actuator 1601 is pressed down. The size of this orifice is determined to ensure that there will be a pressure increase when it is lowered into the enclosure. If this orifice is not large enough or does not exist, there may be a minimum pressure rise when the smaller orifices are gradually lowered into the enclosure, at least until several of those orifices have been lowered into the enclosure. This is because, after covering the smaller orifices, the area of ​​the exhaust port available for gas to pass will not be fully increased, and air will escape through the remaining open orifices without a significant pressure increase. By first covering the larger orifice, the flow resistance may be large enough for the initial pressure rise, after which covering the smaller orifice will cause the pressure to gradually rise. It will be appreciated that the plurality of apertures 1602 may alternatively be configured to have the same shape and / or size.

[0272] When actuator 1601 is in the fully or substantially raised position, the pressure of breathable gas delivered to the patient corresponds to PEEP. When actuator is in the substantially or fully inserted position, the pressure of breathable gas delivered to the patient corresponds to PIP. As actuator moves between these two positions, a pressure between PEEP and PIP is delivered to the patient. Fig.35 An example of a pressure waveform generated by this embodiment is shown. It can be seen that when the actuator is in a fully or substantially raised position (position 1), PEEP is provided to the patient in about 0.75 seconds. When the actuator 1601 is pressed into the housing 1103 (e.g., from position 2 to position 6), the pressure begins to gradually increase until the pressure reaches the PIP pressure level when the actuator is in a fully or substantially inserted position (position 6). The rate of change of pressure depends on the speed at which the operator delivers breaths to the patient, and the speed at which the operator moves the actuator 1601.

[0273] In at least some embodiments, the actuator 1601 is manually operated by an operator to move between a fully or substantially raised position and a fully or substantially inserted position. The speed of movement is primarily determined by the operator. For example, the biasing member 1670 may be disposed in the exhaust port 1600, such as Fig.36A -C. When the operator does not apply force, the biasing member 1670 maintains the actuator 1601 in a fully or substantially raised position, as shown in FIG. Fig.36A Similarly, Fig.36B The actuator 1601 is shown in a partially raised or partially inserted position, while Fig.36C Actuator 1601 is shown in a fully or substantially inserted position. In addition, when actuator 1601 is depressed, biasing member 1670 also creates some resistance, which provides tactile feedback to the operator and / or helps the operator adjust the speed at which the actuator moves from the lifting position to the insertion position.

[0274] The biasing member may be a spring disposed on the exterior of the actuator 1601. Fig.36A In the example shown in FIG. 1-C, the biasing member 1670 surrounds the body 1605 of the actuator 1601. The actuator 1601 includes a shoulder 1680 that extends at least partially around the circumference of the actuator 1601. The shoulder 1680 can be formed as a flange (e.g., Fig.36A -C), or formed in other suitable configurations. In addition, the housing 1603 includes a recess, such as a countersunk hollow portion 1690. The biasing member is held in place by the shoulder 1680 of the actuator 1601 and the countersunk hollow portion 1690 of the housing 1603.

[0275] In some embodiments, a sealing member 1695 (eg, an O-ring) is also provided to help create a seal when the actuator 1601 is in the fully or substantially raised position.

[0276] Figure 37-39 Yet another exemplary exhaust port 2000 in accordance with the present disclosure is shown. This exhaust port 2000 uses similar principles as the exemplary exhaust port 1600 in that an operator needs to depress or insert an actuator 2001 in order to limit the area of ​​the exhaust port 2000 available for gas to exit the respiratory system to the ambient air, and retract or lift the actuator 2001 to increase the area of ​​the exhaust port 2000 available for gas to escape through the exhaust port 2000 to the ambient air. Fig.37 The side view, side cross-sectional view and top cross-sectional view of the exhaust port 2000 are shown (respectively Fig.37 A. Fig.37 B and Fig.37 C) wherein the actuator 2001 is in a fully or substantially raised position. Fig.38 A similar view of exhaust port 2000 is shown with actuator 2001 in a partially raised or partially inserted position. Fig.39 A similar view of the exhaust port 2000 is shown, wherein the actuator 2001 is in a fully or substantially inserted position. The exhaust port 2000 includes a housing 2003 configured to receive the actuator 2001 when it is depressed. The housing 2003 has two openings, one at each end. The first opening 2005 is configured to be blocked by the actuator 2001 when it is lowered into the housing 2003. The second opening 2007 is configured to movably receive the actuator 2001.

[0277] When the actuator 2001 is in a fully or substantially raised position, gas from within the respiratory system 1 escapes from the exhaust port 2000 via the area between the actuator 2001 and the inner wall of the housing 2003. As the actuator 2001 is gradually depressed, the size of this area decreases, thereby restricting the air flow and increasing the pressure delivered to the patient. In order to achieve a gradual change in the area between the actuator 2001 and the housing 2003, the actuator 2001 and / or the housing 2003 can be configured to have a tapered profile, such as Figure 37-39For example, the actuator 2001 includes a body portion 2011 including a first end 2013 that an operator can engage, and a tapered end 2015 opposite the first end 2013. The diameter of the body portion 2011 decreases toward the tapered end 2015 to achieve a gradual reduction in the area between the actuator and the inner wall of the housing 2003 when the actuator 2001 is pressed into the housing 2003. The tapered end 2015 can also assist in smooth insertion into the first opening of the housing 2003.

[0278] In another embodiment, the actuator 2001 can be configured in a substantially cylindrical form without a tapered end. Instead, the housing 2003 is formed with a tapered wall so that the diameter of the housing 2003 decreases toward the first opening 2005 into which the actuator 2001 is inserted. This will also achieve a gradual reduction in the area between the actuator 2001 and the wall of the housing 2003 as the actuator 2001 is lowered into the first opening 2005.

[0279] When the actuator 2001 is fully or substantially inserted so that the tapered end portion 2015 extends fully or substantially into the first opening 2005 of the housing 2003 (e.g. Fig.39 ), the area between the actuator 2001 and the housing 2003 is completely enclosed (as shown in Fig.39 (C)), and the air flow through the exhaust port 2000 is also stopped.

[0280] In at least some embodiments, one or more additional orifices may be formed in the wall of the housing 2003 to allow gas to flow through when leaving via the exhaust port 2000. In an earlier embodiment, the one or more orifices were arranged to be blocked or unblocked by the actuator as the actuator moved. In this embodiment, the one or more orifices in the wall of the housing 2003 are not configured to be blocked or unblocked to cause a pressure change. Instead, they are provided as additional air outlets that allow gas to escape more easily from the exhaust port 2000. The one or more orifices are designed to ensure that they have no significant effect on the restriction of air flow. In some embodiments, the one or more orifices are larger than the area between the actuator 2001 and the housing 2003 at any time during operation.

[0281] In some embodiments, the vent 2000 can also include a biasing member (not shown) that maintains the actuator 2001 in a fully or substantially raised position and creates some resistance when the actuator 2001 is depressed (eg, by an operator). Fig.40A cross-sectional view of an exemplary exhaust port 2100 configured to include such a biasing member is shown. Similar to the exemplary exhaust port 2000, the exhaust port 2100 includes an actuator 2101 that is movable between a fully or substantially raised position and a fully or substantially inserted position to change the area of ​​the exhaust port 2100 available for gases within the respiratory system to exit through the exhaust port 2100. More specifically, in the fully or substantially inserted position, the lower end 2105 of the actuator 2101 is inserted into the opening of the housing 2103 and completely blocks the air flow path through the exhaust port 2100. In the partially raised or partially inserted or fully / substantially raised position, a gap is created between the actuator 2101 and the inner wall of the housing 2103, which gap forms the area of ​​the exhaust port 2100 available for gases to flow through in order to exit the respiratory system 1.

[0282] In this example, the actuator 2101 is provided with a shoulder 2106 toward its upper end 2013. The shoulder 2106 (which may be formed as a flange) may extend partially or completely around the circumference of the actuator 2101. A substantially flat support surface 2103a surrounds an upper opening of the housing 2103, wherein the upper opening movably receives the actuator 2101. A biasing member (not shown) may be supported in place by the shoulder 2106 of the actuator 2101 and the flat support surface 2103a of the housing. In some embodiments, the biasing member may be a spring, and similar to Fig.36A -Exemplary actuator 1601 shown in FIG. 16A , actuator 2101 is positioned in the hollow center of the spring.

[0283] When the actuator 2101 is pressed, the spring becomes compressed, which at least in part provides some control over the speed at which the actuator 2101 is moved. When the operator releases their finger from the actuator 2101, the spring biases the actuator 2101 towards a fully or substantially lifted position. The spring determines how the actuator 2001 moves, and therefore the profile of the tapered end of the actuator 2001 and the spring (spring constant) are selected / configured relative to each other to achieve the desired effect. The spring may be selected for a given profile of the tapered end of the actuator 2001; and / or the profile of the tapered end of the actuator 2001 may be designed / selected for a given spring parameter / parameter range (e.g., spring constant). It may have a significant effect on the overall length of the tapered end of the actuator 2001. If the spring can be compressed by a length L, the tapered end may be less than L so that the spring can experience a full range of motion before 'bottoming out'.

[0284] The housing 2103 may also include one or more recesses 2104 formed in the upper opening of the housing. The one or more recesses 2104 may take the form of, for example, one or more threaded portions. One or more protrusions 2105 may also be formed on the body of the actuator 2101. The one or more protrusions may take the form of, for example, one or more threaded portions that are configured to correspond to the threaded portions (i.e., 2104) in the upper opening of the housing 2103. The (multiple) recesses 2104 and (multiple) protrusions 2105 cooperate to set the maximum lift position of the actuator 2101 so that it does not become accidentally disengaged from the housing 2103.

[0285] In this example, the connector portion 2110 can be disposed in the lower end of the housing 2103, thereby allowing a removable connection between the exhaust port 2100 and a suitable component of the respiratory system 1, such as an air outlet of a device (e.g., 1120, 620, 320) that fluidly connects the tubing assembly and the patient interface. In some configurations, the air outlet can be a PEEP port of a T-piece device. It should be understood that the connector portion 2110 is optional and is provided as an example, and other forms of releasable connectors may also be used. In addition, in some embodiments, it may be desirable to have the exhaust port 2100 integrally formed in the outlet of the device (e.g., 1120, 620, 320), which means that the connector portion 2110 may not be required.

[0286] Fig.41 Shows that when using Figure 37-39 2001 is an example of a pressure waveform of breathable gas delivered to a patient when the exhaust port 2000 of the embodiment of the present invention is opened. Here, when the actuator 2001 is in a fully or substantially raised position (i.e., position 1), PEEP is delivered from 0 to 0.75 seconds. As the actuator 2001 is pushed downward, the area between the actuator 2001 and the housing 2003 gradually closes. When the actuator 2001 is in a fully or substantially inserted position (i.e., position 5), PIP is delivered. This provides a controlled pressure rise from PEEP to PIP. Additionally, as the actuator 2001 is raised, the area between the actuator 2001 and the housing 2003 gradually opens. This provides a controlled pressure drop from PIP to PEEP.

[0287] In some embodiments, a guide member can be disposed in the exhaust port 2001 that helps maintain the actuator 2001 in an upright orientation as the actuator 2001 moves between the raised position and the inserted position. Fig.41 An example of such a guide member 2096 is shown, which is formed as a vertical rod and is positioned below the tapered end 2015 of the actuator 2001. Fig.41 In, with reference Figure 37-39Like components and features to those described are shown with like reference numerals.A receiving channel 2097 is formed in the actuator 2001 and receives the guide member 2096 when the actuator is slowly depressed.

[0288] Similar to the previous embodiments, a connector portion 2010 is formed in the base of the exhaust port 2000, thereby allowing a connection between the exhaust port 2000 and a suitable component of the respiratory system 1 (e.g., an outlet of a device that fluidly connects between the tubing assembly and the patient interface). In some embodiments, the outlet can be a PEEP port of a device (e.g., 1120, 620, 320). The base also serves as a seat for the housing 2003 of the exhaust port 2000 and accommodates the lower end of the housing 2003. In addition, referring to Fig.42 (which shows a plan view of the base), one or more arms 2098 may be provided in the base to support the guide member 2096 in the center of the base. The guide member 2096 may be positioned to extend in a generally vertical direction and align with the receiving channel 2097 of the actuator 2001.

[0289] Fig.43A -D and Fig.44A -D shows another embodiment of the exhaust port 2200. Fig.43A -D shows a side cross-sectional view of the exhaust port 2200 with various positions of the actuator, and Fig.44A -D shows a corresponding sideon view of exhaust port 2200.

[0290] Similar to exemplary exhaust port 2000, exhaust port 2200 includes a housing 2203 including a first opening and a second opening at opposite ends of housing 2203. When delivering respiratory therapy, the first opening can be fluidly connected to an air outlet of respiratory system 1, and the second opening is configured to movably receive actuator 2201. Housing 2203 includes a body extending between the first opening and the second opening, the body forming a hollow cavity within housing 2203. The sidewalls of the body taper from the second opening to the first opening, such that the first opening has a smaller diameter than the second opening. Fig.44A As shown in FIG. 2A -D , a plurality of apertures 2202 are formed in the side wall of the body, the plurality of apertures being configured to allow gas from within the breathing system 1 to flow therethrough depending on the relative position between the actuator 2201 and the housing 2203 .

[0291] The actuator 2201 is arranged to be in a fully or substantially raised position (such as Fig.43D ) and a completely or substantially inserted position (as shown in e.g. Fig.43A2201 is moved between the first opening of the housing 2203 and the second opening of the housing 2203 to adjust the area of ​​the exhaust port 2200 through which gas can flow when exiting the respiratory system 1, which in turn adjusts the pressure of the breathable gas delivered to the patient. In the fully or substantially raised position, gas from within the respiratory system 1 can flow through the first opening of the housing 2203 and then flow through the orifice 2202 to exit the respiratory system 1 to the ambient air. This has the effect of reducing the pressure delivered to the patient compared to when the actuator 2201 is in the partially inserted, partially raised or fully / substantially inserted position. In the fully or substantially inserted position, the actuator 2201 is lowered into the housing 2203 to block the first opening of the housing 2203. This will block the air flow path so that air cannot escape from the respiratory system 1 via the exhaust port 2200, thereby increasing the pressure delivered to the patient. When actuator 2201 is in the fully or substantially raised position, the pressure of breathable gas delivered to the patient corresponds to PEEP, and when actuator 2201 is in the fully or substantially inserted position, the pressure of breathable gas delivered to the patient corresponds to PIP. As actuator 2201 moves between these two positions, a pressure between PEEP and PIP is delivered to the patient.

[0292] The exhaust port 2201 may include a deformable membrane 2270 that assists in the movement of the actuator 2201. Fig.43A As shown in Figure 2-D, the membrane 2270 forms a chamber extending between the second opening of the housing 2203 and the shoulder of the actuator 2201. The membrane 2270 is configured so that when no force is applied to the actuator 2201, it biases the actuator 2201 in a lifted position. When a pressing force is applied to the actuator 2201 (e.g., by an operator), the membrane 2270 begins to deform. When the actuator 2201 moves past the deflection point of the membrane 2270, it biases the actuator 2201 to a position in which it is fully or substantially inserted.

[0293] The mechanism that allows the membrane 2270 to bias the actuator 2201 into its fully or substantially raised position and into its fully or substantially inserted position is controlled by the elasticity and geometry of the material used to construct the membrane 2270. Fig.45A -C and Fig.46A -C shows more details about how the mechanism works. In the example shown, the membrane 2270 includes a first member 2270-1 and a second member 2270-2 connected at a certain angle. The joint between the two members acts as a flexible hinge, thereby allowing the two members of the membrane 2270 to perform relative flexural movement. Fig.45A In the embodiment, actuator 2201 is in a fully or substantially raised position, and both members 2270-1 and 2270-2 are stationary, as shown in FIG. Fig.46AThis is the stable and static position of the membrane 2270. For demonstration purposes, Fig.46A Also shown is the equivalent spring at rest.

[0294] When the actuator 2201 is depressed, the membrane 2270 begins to stretch or deform until it reaches a deflection point, such as Fig.45B and Fig.46B At the deflection point, the second member 2270-2 can be substantially horizontal, causing the first member 2270-1 to deflect. For illustration purposes, Fig.46B An equivalent spring with maximum force is also shown. Once the actuator 2201 moves past this deflection point, due to the elasticity of the membrane, it biases the actuator 2201 into a fully or substantially inserted position, such as Fig.45C As indicated in Fig.46C As shown in FIG. 2 , the second member 2270-2 is below the horizontal position, which means that Fig.46B The state shown in is less deflected than the first member 2270-1. This is a semi-stable position of the membrane 2270, which is less than Fig.46B The state shown in is more stable, but Fig.46A The state shown in is less stable. As soon as the force applied to the actuator 2201 is removed, the membrane 2270 will move itself back to Fig.46A and Fig.45A stable position.

[0295] Fig.43A -D and Fig.44A - The actuator 2201 shown in D is Figure 37-39 and Fig.41 2201. It may include a body portion 2211 including a first end 2213 and a tapered end 2215. The diameter of the body portion 2211 decreases toward the tapered end 2215 to cause the area between the actuator and the housing 2203 to gradually decrease as the actuator 2201 moves from the fully or substantially raised position to the fully or substantially inserted position. A guide member 2296 may also be provided in the exhaust port 2201 to help maintain the actuator in an upright orientation as the actuator 2201 moves between the fully or substantially raised position and the fully or substantially inserted position. Fig.43A -D and Fig.44A -D shows an example of such a guide member 2296 formed as a vertical rod and positioned below the tapered end 2215 of the actuator 2201. A corresponding receiving channel 2297 is formed in the actuator 2201 and receives the guide member 2296 when the actuator 2201 is moved into its fully or substantially inserted position.

[0296] Similar to the previous embodiments, a connector portion 2210 can be formed in the base of the exhaust port 2200 to allow for connection between the exhaust port 2200 and a suitable component of the respiratory system 1 (e.g., an outlet of a device interconnecting a tubing assembly and a patient interface). The air outlet can be a PEEP port of a T-piece device (e.g., 1120, 620, 320), as in the previous embodiments.

[0297] In at least some embodiments, the actuator 2001, 2101, or 2201 can be formed as a straight plunger, without necessarily having a tapered end, that is, the diameter of the actuator can remain substantially constant along the length of the actuator. When the actuator is inserted into the housing, the configuration of the housing can be adjusted accordingly to accommodate the actuator.

[0298] Fig.47A and Fig.47B A further embodiment of an exhaust port 2500 is shown that is coupled to a device 2520 of the respiratory system 1. The intent of this embodiment is to provide an asymmetric waveform profile in which the pressure transition between PIP and PEEP occurs at different durations. More specifically, this embodiment aims to provide a longer duration when PIP transitions to PEEP and a shorter duration when PEEP transitions to PIP. The benefit of extending the transition from PIP to PEEP is to make the pressure change more gradual and further reduce any potential injury caused by rapid pressure changes. Or alternatively, this embodiment can be configured so that a shorter duration is provided when PIP transitions to PEEP and a longer duration is provided when PEEP transitions to PIP. This embodiment can be combined with previously described embodiments (e.g., Fig.43A -D. Fig.44A -D and Fig.45A -Some of the embodiments shown in D) are combined to produce an asymmetric pressure waveform.

[0299] As previously mentioned, the pressure waveform generated by various embodiments of the exhaust port depends on the speed at which the actuator is moved by the operator, and the desired treatment to be provided to the patient. The present embodiment intentionally introduces some resistance to the actuator as the actuator moves in a predetermined direction. As the actuator moves in different directions, the resistance applied to the actuator decreases. This can be achieved, for example, by introducing a member into the path of movement of the actuator and creating a certain level of friction between the member and the actuator as the actuator moves in the predetermined direction.

[0300] In one form, the member may be a length of material extending into the path of travel of the actuator. Fig.47AAn example of such a member 2580 is shown, which is configured to slow the movement of the actuator 2501 as it moves from the fully or substantially inserted portion back to the fully or substantially raised position. This may be preferred when a more rapid increase in inspiratory pressure and a more gradual collapse of the patient's lungs during the exhalation phase are preferred. Fig.47B A close-up view of component 2580 is provided in FIG. Fig.48A and Fig.48B Further details are shown of how member 2580 deflects to apply frictional forces to actuator 2501 as actuator 2501 moves in different directions.

[0301] Member 2580 is disposed on the inner surface of housing 2503, and more specifically, at an opening of housing 2503 that movably receives actuator 2501. Member 2580 may extend partially around the opening of the housing, or it may form a ring and extend the circumference of the opening. Fig.47A and Fig.47B As shown in , member 2580 includes a support member 2582 and a flap 2581 that extends out at an angle θ relative to the support member 2582. As shown, angle θ may be less than 90°. The support member 2582 and the flap 2581 may both be constructed of a deformable material, thereby allowing the flap 2581 to deflect or flex relative to the support member 2582. When the actuator 2501 is pushed downward to its fully or substantially inserted position, the lower end and / or sidewall of the actuator 2501 contacts the flap 2581 and flexes it, causing the flap 2581 to move toward the support member 2582. When the actuator 2501 begins to move upward to return to its fully or substantially raised position, due to the orientation of the flap 2581, the flap 2581 applies a greater friction force to the actuator 2501, which has the effect of slowing down the movement of the actuator 2501. This helps produce a smooth exhalation profile due to the controlled movement of actuator 2501 without any operator input or with only limited operator input.

[0302] Fig.48A and Fig.48B 25 shows how the flap 2581 deflects when the actuator 2501 moves in different directions. Fig.48A As shown in , when the actuator 2501 is pressed or lowered, there is a small amount of deflection of the flap 2581 and therefore low friction / resistance to the actuator movement. Fig.48B As shown in , when the actuator 2501 is lifted or raised, there is greater deflection of the flap 2581 and therefore a relatively greater friction / resistance to actuator movement.

[0303] The parameters that affect how much resistance the member 2580 can provide include at least the length of the flap 2581, the overlapping length L of the flap 2581 and the actuator 2501, and / or the angle θ at which it extends relative to the support member 2582 (e.g., Fig.47B ). These parameters will determine the amount of contact of the actuator 2501 with the flap 2581. The amount of contact then determines how much the actuator can be slowed down when the actuator 2501 returns to its fully or substantially raised position. In some embodiments, the angle θ is in the range of 40° to 70°. In addition, a further factor affecting the resistance is the coefficient of friction between the member 2580 and the actuator 2501. Selecting a material for the member 2580 that exhibits a greater coefficient of friction with the actuator 2501 increases the resistance provided.

[0304] exist Fig.47B In the example shown in , the flap 2581 extends inwardly toward the center of the housing 2503 and extends downwardly from the upper edge of the support 2582. This has the effect of slowing down the movement of the actuator 2501 as it returns to its fully or substantially raised position. In an alternative embodiment, the flap 2581 can be configured so that it extends inwardly toward the center of the housing 2503, but extends upwardly from the support 2582. This will produce a similar Fig.47B , and slows down the movement of the actuator 2501 as it is pushed from the fully or substantially raised portion to the inserted position.

[0305] In at least some embodiments, the actuator can include a sealing portion to improve the seal between the actuator and the exhaust port housing, particularly when a PIP is applied. In some embodiments, a complementary sealing portion can be provided in the housing that is configured to engage the sealing portion of the actuator during PIP delivery. Fig.49 and Fig.50 An example of such a sealing section is shown in .

[0306] refer to Fig.49 , the sealing portion may include a protrusion 2690 formed on the outer surface of the actuator 2601. The protrusion 2690 may extend completely, partially, or at least a substantial portion of the circumference of the actuator 2601. From a side view, the protrusion 2690 may have a triangular cross-sectional profile formed by two angled surfaces. At or toward the lower end of the housing 2603, a complementary sealing portion 2691 is formed on the inner wall of the housing 2603, at a position that will create a seal between the actuator 2601 and the housing 2603 when the actuator 2601 is lowered into the housing to reach its fully or substantially inserted position. Fig.49In the embodiment shown in , the complementary sealing portion is formed as a chamfer 2691 in the inner wall of the recess or housing 2603, which includes a surface 2691a that is disposed at a similar inclination angle as the lower surface 2690a of the protrusion 2690. When the actuator 2601 is lowered into the insertion position to block the first opening 2605 of the housing 2603, the protrusion 2690 of the actuator 2601 is arranged to rest on or engage the complementary sealing portion 2691 of the housing 2603, thereby improving the seal between the actuator 2601 and the housing 2603.

[0307] Fig.50 Another example of how such a seal can be achieved between the actuator 2601 and the housing 2603 is shown. In this embodiment, the exhaust port 2600 is positioned on the top of a PEEP valve (discussed in more detail below) that is fluidly coupled to the PEEP port of a T-piece device (e.g., 1120, 620, 320). The sealing portion 2690 of the actuator 2601 is formed by one or more surfaces of an edge portion of the actuator 2601. For example, the actuator 2601 (which is formed as a plunger) is configured to have a cylindrical body having a substantially flat bottom surface 2690a. The housing 2603 includes a complementary sealing portion 2691 formed by an inner vertical sidewall 2691a and a horizontal surface 2691b at the bottom of the housing 2603. When the actuator 2601 is depressed, the flat horizontal surface 2690a of the actuator is allowed to rest on the horizontal surface 2691b of the housing, thereby improving the seal between the actuator 2601 and the housing 2603. It will be appreciated that the sealing arrangement shown in Figures 26a and 26b is provided as an example only. Other types of sealing portions may be provided as alternatives.

[0308] Fig.50 Another configuration of a member 2680 is also shown that can be used to slow the movement of the actuator 2601 as it moves in a selected direction (e.g., when the actuator 2601 moves from a fully or substantially inserted portion back to a fully or substantially raised position). The member 2680 is formed as a flap 2681 that extends into the path of movement of the actuator 2601 and contacts the sidewalls of the actuator 2601 to apply a friction force. In this embodiment, the flap 2681 is formed directly as part of the deformable membrane 2670. Pressure regulating device

[0309] As mentioned above, a PEEP valve can be provided in the PEEP port of the device, which is actuated at a selected pressure to allow the breathable gas to be vented externally and to regulate the gas pressure administered to the patient. Examples of such PEEP valves are shown at least in International Patent Application No. PCT / NZ 2013 / 000111 (published as WO 2014 / 003578) and U.S. Provisional Patent Application 63 / 366,660. The exhaust port of the present disclosure can be used in conjunction with a PEEP valve, and more preferably, in conjunction with a flow-independent PEEP valve, to further improve the mechanical ventilation delivered to the patient during resuscitation or other types of respiratory therapy.

[0310] In a further embodiment, the present disclosure provides a pressure regulating device comprising the exhaust port described above and at least one of the flow-independent PEEP valves additionally operatively connected to the exhaust port. "Flow-independent" means that the PEEP valve is configured to compensate for unintentional flow changes (e.g., interface leakage or intrinsic PEEP often experienced by the respiratory system 1 near the patient end) so that the PEEP pressure delivered to the patient remains within a target PEEP pressure range. This combination enables a smoother delivery of PIP and PEEP by gradually blocking the PEEP port, as described above with respect to various embodiments of the exhaust port. Further, due to the inclusion of the flow-independent PEEP valve, when PEEP is applied, the gas pressure delivered to the patient is maintained within a predetermined pressure range, regardless of flow changes caused by interface leakage or intrinsic PEEP.

[0311] Fig.51 and Fig.52 An example of a spring-controlled PEEP valve 50 is shown in FIG. The valve 50 includes a valve body 501 that defines an inlet 502 and an outlet 503 through which air can enter and leave the valve 50 when the valve 50 is open. A controller 510 is housed within the valve body 501, for example, in the form of a Fig.51 and Fig.52 , which is configured to move along axis 504 to effectuate opening and closing of valve 50. Movement of controller 510 at least partially assists pressure regulation by valve 50, particularly during PEEP delivery.

[0312] like Fig.52 As indicated in , the peripheral area of ​​the controller 510 is configured to engage or rest on a valve seat 523 formed by the inner wall of the body 502. Since the valve 50 is fluidly coupled to the PEEP port of the device 2720, the lower surface of the controller 510 is exposed to the gas at the inlet 502 of the valve 50. The controller 510 is subjected to a lifting force (F) generated by the gas pressure difference between the upper and lower surfaces of the controller 510 in a direction consistent with the axis of the shaft 504.提升 ). refer to Fig.53 , the lifting force (F 提升 ) is equal to P2*A2–P1*A1, where P1 and P2 are the gas pressures experienced by the upper and lower surfaces of the controller 510, respectively, and A1, A2 represent the upper and lower areas of the controller 510 exposed to the relevant gas pressures. When the valve 50 is configured to discharge the gas of the breathing system 1 directly to the ambient air and the difference between A1 and A2 is relatively small or negligible, the difference between A1 and A2 is used to calculate F 提升 The equation can be simplified to P*A, where P is the gas pressure at the inlet 502 of the valve 50 (e.g., 5 cm H2O), and A is the area of ​​the controller 510 exposed to the gas pressure. Alternatively, when the outlet 503 of the valve 50 is fluidly connected to the exhaust port of the present disclosure (e.g., Fig.54 , Fig.55 and Fig.56A -D) and if the difference between A1 and A2 is still small or negligible, it is used to calculate F 提升 The equation can be simplified to ΔP*A, where ΔP is equal to the pressure difference across the upper and lower surfaces of the controller 510, and A is the lower surface area of ​​the controller 510 exposed to the pressure difference ΔP.

[0313] Return to Fig.52 , the preloaded biasing member 530 is sandwiched between the controller 510 and the top wall of the valve body 501. That is, Fig.52 The height of the biasing member 530 in FIG. 5 is less than the uncompressed natural height of the biasing member 530. Since the biasing member 530 has been compressed, it will resist the force (F 偏置 ) is applied to the controller 510, which pushes the controller 510 toward the inlet 502 of the valve 50 until it engages the valve seat 523. When in this seated position, the controller 510 closes the gas flow path between the inlet 502 and the outlet 503, thereby minimizing or preventing any gas flow through the valve 50.

[0314] In at least one form, the biasing member 530 is a spring. Thus, the resistance generated by the biasing member 503 can be determined based on F 偏置 = k*(x_initial compression + x_boost), where k = spring constant; x_initial_compression = the initial compressed length of the spring when the flow path is closed (ie, the difference between the original uncompressed length of the spring and the length of the spring after the spring has been initially compressed and placed within the valve body 501); x_lift = displacement of controller 510 from valve seat 523 at pressure P.

[0315] It will be appreciated that the resistance caused by the biasing member 530 is a variable resistance due to x_lift. When the controller 510 is biased against the valve seat 523, x_lift is equal to zero because there is no relative displacement of the controller 510 from the valve seat 523. The initial variable resistance applied by the biasing member 530 can be simplified to F 偏置 = k*x_initial compression When the controller 510 is lifted off the valve seat 523 and starts to slide along the axis 504 together with the valve body 501 , x_lift is equal to the displacement distance of the controller 510 relative to the valve seat 523 , which is a variable parameter.

[0316] In addition to the variable resistance (F 偏置 ), the controller 510 is also subjected to an upward lifting force (F 提升 ), as mentioned above. The lifting force depends on the pressure difference (ΔP) between the upper and lower surfaces of the controller 510 and the area of ​​the controller 510 exposed to such pressure (F 提升 =ΔP*A). Therefore, the position and movement of the controller 510 relative to the valve seat 523 are determined by two forces F 偏置 and F 提升 The relative strength of the spring constant, x_initial compression, and the exposed area A of the controller 510 are determined. Using the equation mentioned above, the minimum pressure differential required to lift the controller 510 off the valve seat 523 can be determined, which is k*x_initial compression / A. This minimum pressure differential level determines the selected pressure level at which the valve 50 opens, as well as the predetermined pressure range that the valve 50 is configured to adjust. When the flow-independent valve 50 is used to adjust the PEEP pressure, the spring constant, x_initial compression, and the exposed area A of the controller 510 are selected so that the selected pressure level at which the valve 50 opens is within the target PEEP pressure range.

[0317] When valve 50 is configured to discharge gas directly to the surrounding air (e.g. Fig.51 and Fig.52 ), the pressure difference across the controller 510 can be considered as the gas pressure at the valve inlet 502. If this pressure is below the selected pressure level, then F 提升 is insufficient to lift the controller 510 off the valve seat 523. Therefore, the net effect of the two forces maintains the controller 510 in its seated position on the valve seat 523 (F 偏置 >F 提升 ). As the gas pressure at the inlet begins to increase, it converts to F 提升 When the gas pressure exceeds the selected pressure level (which causes F 提升 Greater than F 偏置 ), the lifting force will overcome the variable resistance (F 提升 >F 偏置 ) and lift the controller 510 above the valve seat 523.

[0318] When the controller 510 is lifted off the valve seat 523, a gap is formed between the edge of the controller 510 and the valve seat 523. Gas flow can then begin to enter the valve body 501 through this gap and flow out of the valve 50 via the outlet 503. In other words, the gas flow path between the inlet 502 and the outlet 503 of the valve body 501 is now open, and gas within the breathing system 1 can now flow through the valve 50. If the gas pressure is above the selected pressure level, even if the controller 510 has been lifted off the valve seat 523, the F 提升 The actuator 510 will also continue to be displaced along the axis 504 to increase the clearance between the controller 510 and the valve seat 523, thereby allowing more air to flow through the valve 50. At the same time, the lifting of the controller 510 causes the biasing member 530 to be further compressed, which increases the variable resistance generated by the biasing member 530 until it reaches the position where F 提升 Equal to F 偏置 The controller 510 remains in that position to vent the gas flow externally until the gas pressure changes again. 提升 Less than F 偏置 , the net effect of these two forces will begin to move the controller 510 toward the valve seat 523, thereby reducing the size of the flow path within the valve 50.

[0319] In addition to selecting an appropriate spring constant (k), the initial compression of the spring (x_initialcompression), and the exposed area (A) of the controller 510, there are other design considerations that contribute to how the valve 50 can be configured, at least some of which are set forth below.

[0320] Gas flow rate via valve 50: To adjust the PEEP pressure, the gas flow rate that valve 50 can adjust when used with an infant may be in the range of 0 to 20 L / min. This range is approximately the same as the source flow rate that the breathing system 1 is set to provide to the patient.

[0321] Predetermined range of PEEP pressure: For infant resuscitation, the target PEEP pressure is typically in the range of 4 to 15 cm H2O. Valve 50 can be configured so that it can adjust the gas pressure within the breathing system 1 so that it remains within this range. In some embodiments, valve 50 is configured to adjust the pressure of the breathable gas within the breathing system 1 by a change of -2 to +2 cmH2O, -1 to +1 cmH2O, or -0.5 to +0.5 cmH2O. That is, if the breathing system 1 is set to deliver PEEP to the patient at a given or predetermined flow rate at 5 cmH2O, valve 50 is configured to adjust the PEEP pressure so that it remains in the range of 3-7 cmH2O, or 4-6 cmH2O, or 4.5-5.5 cmH2O at that given flow rate, regardless of any unintentional flow changes experienced by the system.

[0322] Depth of valve: The depth of valve 50 determines at least in part the initial compression length (x_initial_compression) of biasing member 530, as well as the maximum x_lift that can be achieved. In at least one embodiment, the depth of the valve is approximately 3 to 4 mm.

[0323] Configuration of biasing member 530: The configuration of the biasing member includes selecting a suitable spring constant, spring wire diameter, spring coil size, number of spring coils, spring pitch, etc. In at least one embodiment, the spring constant is less than 0.05 N / mm. Preferably, the spring constant is in the range of 0.005 to 0.02 N / mm.

[0324] Controller: The exposed area of ​​the controller 510 and the size of the valve inlet 502 can be selected so that the pressure to open the valve 50 is similar to the pressure that the valve regulates. Further, the exposed lower surface area and spring constant of the controller 510 are selected so that a relatively small displacement of the controller 510 relative to the valve seat 523 (i.e., in the mm range, or a fraction of a millimeter) is sufficient to allow the valve 50 to achieve its pressure regulating effect. The cross-sectional area of ​​the controller is preferably smaller than or significantly smaller than the internal lateral dimensions of the valve body 501, so that there is no significant additional flow resistance when gas passes between the internal sidewalls of the valve body 501 and the controller 510. In at least some embodiments, the cross-sectional area of ​​the controller 510 is between 50-320 mm2.

[0325] References below Fig.54 , Fig.55 and Fig.56A -D to describe an exemplary pressure regulating device. The pressure regulating device 70 includes an exhaust port 2800 having a Fig.50. It will be appreciated that the exhaust port 2800 may be replaced with any of the exhaust ports described above. Similarly, the illustrated embodiment includes a spring-controlled flow-independent PEEP valve 50, such as described, for example, in U.S. Provisional Application No. 63 / 366,660. This valve 50 may alternatively be replaced with another suitable flow-independent PEEP valve, such as an umbrella valve as described in International Patent Application No. PCT / NZ 2013 / 000111 (published as WO 2014 / 003578).

[0326] Fig.54 A side perspective view of a T-piece device 2820 coupled to a pressure regulating device 70 at its PEEP port 2823 is shown. Fig.55 28 and 29. A side cross-sectional view of the pressure regulating device 70 is shown. The pressure regulating device 70 in this example includes an exhaust port 2800 and a PEEP valve 50 (e.g., Fig.52 ). The exhaust port 2800 and the PEEP valve 50 may be integrally or detachably connected together, for example, by a suitable connector portion. In one embodiment, complementary connector portions may be formed in the housing 2803 of the exhaust port 2800 and in the body 501 of the PEEP valve 50, thereby allowing the two components to be detachably connected to each other. In use, when both the PEEP valve 50 and the exhaust port 2800 are open, breathable gas may flow through the two components and be discharged externally to the surrounding air.

[0327] Fig.56A -D shows how the pressure regulating device 70 operates when transitioning between PEEP and PIP. The illustrated embodiment includes a flap 2881 that is configured to slow the movement of the actuator 2801 as it returns from a fully or substantially inserted position to a fully or substantially raised position. It will be appreciated that in other embodiments of the pressure regulating device 70, the flap 2881 may be omitted.

[0328] Fig.56AThe position (position 1) at which the actuator 2801 and controller 510 of the exhaust port 2800 are likely to be positioned when PEEP is delivered to the patient is indicated. If the pressure differential across the controller 510 exceeds a selected pressure level at which the valve 50 is configured to open, the controller 510 is lifted off the valve seat 523, thereby opening the valve 50. Since no external force is applied to the actuator 2801 during PEEP delivery, the actuator 2801 is also in its raised position and is preferably at its maximum height relative to the housing 2803, thereby allowing breathable gas to exit the exhaust port via one or more orifices 2802 formed in the wall of the housing 2803. When both the actuator 2801 and the controller 510 are lifted, the entire gas flow path within the pressure regulating device 70 is opened, thereby allowing gas flow to pass freely through the device 70.

[0329] Flow changes (e.g., intrinsic PEEP or interface leakage) often occur near the end of the patient. The PEEP valve 50 compensates for such flow changes by changing the relative displacement of the controller 510 relative to the valve seat 523. For example, in the case of intrinsic PEEP, the pressure and / or flow at the valve inlet 502 may be increased to a higher level due to the patient's breathing. The controller 510 is displaced farther from the valve seat 523, thereby allowing more gas to enter the valve 50 and flow through the pressure regulating device 70. Alternatively, if there is an interface leakage, the gas pressure at the valve inlet may be lower. Lower airflow will produce lower pressure, which will cause the controller 510 to move closer to the valve seat 523, thereby increasing the restriction, reducing the amount of breathable gas entering the valve 50 and discharged externally. In this way, the PEEP valve 50 assists in regulating the gas pressure so that it remains within a predetermined PEEP pressure range. To provide an example, for infants or newborns, the target PEEP pressure range can be approximately 5cm H2O, with a variation of -2 to +2cm H2O. That is, the predetermined and acceptable PEEP pressure range may be approximately 3 to 7 cm H2O. In this case, the selected pressure level (at which point the controller 510 is lifted off the valve seat 523) may be set at 3.5 to 4.5 cm H2O. This ensures that the valve 50 remains open during PEEP delivery as long as the pressure is above the selected pressure level. When used with an infant or neonate, the gas flow rate that the valve 50 is configured to regulate may be in the range of 0 to 20 L / min. This range is approximately the same as the source flow rate that the breathing system 1 is set to provide to the patient.

[0330] exist Fig.56B In the embodiment of the present invention, the operator begins to press the actuator 2801 downward (position 2 - partially inserted position of the actuator 2801) until the actuator 2801 reaches its fully or substantially inserted position, such as Fig.29C at position 3. As the exhaust port 2800 gradually closes as the actuator 2801 is pressed from its fully or substantially raised position to its fully or substantially inserted position, this transitions the respiratory system 1 from PEEP to PIP. A pressure differential exists across the upper and lower surfaces of the controller 510 until the actuator 2801 reaches its fully or substantially inserted position. Fig.56C , the gas flow path within the pressure regulating device 70 is completely or substantially closed due to the sealing arrangement between the actuator 2801 and the exhaust port housing 2803. At this position, the gas within the respiratory system 1 is no longer allowed to flow through the pressure regulating device 70, thereby causing PIP to be delivered to the patient.

[0331] exist Fig.56C , during the delivery of PIP, the controller 510 is biased against the valve seat 523. When the exhaust port 2800 is fully closed, the flow path within the pressure regulating device 70 is closed, which means that gas will no longer flow through the controller 510, and the pressure difference across the controller becomes zero (i.e., the pressure applied to the upper and lower surfaces of the controller 510 may both be equal to the PIP pressure currently being administered to the patient). Since the pressure difference is zero, F 提升 The force applied to the controller 510 is the biasing force caused by the biasing member 530 and the equal and opposite force of the valve seat, which maintains the controller 510 in its seated position.

[0332] When the respiratory system 1 transitions from PIP to PEEP, the actuator 2801 is allowed to return to its raised position by reducing or removing the compressive force applied to the actuator 2801. When the actuator 2801 returns to its fully or substantially raised position, the exhaust port 2800 opens to allow gas to escape to the ambient air. This has the effect of introducing a pressure differential across the upper and lower surfaces of the controller 510, because the pressure applied to the upper surface of the controller 510 is no longer equal to the PIP. If this pressure differential is greater than the pressure required to lift the controller 510 off the valve seat 523, the controller 510 is displaced away from the valve seat 523 (e.g., Fig.56D ), thereby opening valve 50. It will be understood that the drawings are for illustration purposes only and may not present every detail of components and / or features. Fig.56B Position 2 shown in Fig.56D With respect to the position 4 shown in FIG. 1 , it will be understood that there is at least one path for the gas to escape to the surrounding air (or atmosphere), although such path(s) may not be readily apparent.

[0333] As previously mentioned, the exhaust port of the present disclosure allows the respiratory system 1 to provide a relatively smooth transition when switching between different target PIP pressures and PEEP pressures. That is, a range of intermediate pressures can also be provided to the patient within one or more time windows. Asymmetric transitions between PIP and PEEP can also be achieved using selected embodiments of the present disclosure. When the exhaust port is used in conjunction with a flow-independent PEEP valve, as described above, a greater degree of certainty in the PEEP pressure applied to the patient can be achieved. This is because the flow-independent PEEP valve compensates for the flow changes experienced near the end of the patient so that the PEEP pressure applied to the patient remains within a predetermined range without being affected by flow changes. This will give the operator a greater level of confidence that the desired respiratory therapy is being supplied to the patient. In the case of intrinsic PEEP, the flow-independent PEEP valve is able to shift the controller farther from its valve seat to allow more gas to flow out of the respiratory system 1 so that the intrinsic PEEP does not inadvertently increase the PEEP pressure to a higher level. In the event of an unintentional leak (e.g., at the patient interface), the flow-independent PEEP valve is able to automatically adjust the position of the controller again so that the effect of the leaking gas on the PEEP pressure is reduced and the PEEP delivered to the patient is still maintained within the predetermined PEEP pressure range.

[0334] Figure 57 to Figure 61 Further applications of the vent or pressure regulating device as presently disclosed are presented. In at least some of the previous embodiments described above, the vent or pressure regulating device may be attachable to or formed as part of a T-piece device. A releasable connection mechanism may be used to reduce setup complexity and enable resuscitation therapy to be provided through different interfaces (e.g., through a CPAP interface or other sealing interface).

[0335] Fig.57 , Fig.58 , Fig.60 and Fig.61 An example of a pressure regulating device 70 is shown that includes an example of a vent as disclosed that is releasably connected to a CPAP interface. Such attachment can enable a clinician to modify the CPAP interface to deliver resuscitation therapy, such as administering resuscitation or artificial respiration to a patient as needed. Such modifications can be made while the CPAP interface remains on the patient.

[0336] FIG. 59A to FIG. 59C An example of a releasable attachment mechanism that can be used to transition between treatments using a single type of patient interface is shown. Fig.59A In the embodiment shown in , a connector portion 660 is provided to the pressure regulating device 70, thereby allowing the regulating device 70 to be removed / attached to other locations of the CPAP breathing system 1a. Fig.59A (a perspective view of a connector portion 660 engaged with a pressure regulating device 70), the connector portion 660 is configured to engage with a male connector portion 661 to form a releasable connection. The male connector portion 661 may include one or more locking fingers. The or each locking finger may have a recess or aperture on its outer surface. The recess or aperture may be configured to engage with a corresponding locking tab (not shown) located on the inner surface or inner wall of the connector portion 660. Similar releasable attachment mechanisms are described in International Patent Application No. PCT / NZ 2012 / 000142, the contents of which are incorporated herein in their entirety.

[0337] Fig.59B (Side view of connector portion 660 engaged with pressure regulator 70) and Fig.59C (Side view of connector portion 660 disengaged from pressure regulator 70) shows a further example of a releasable attachment mechanism. In this example, connector portion 660 is a male connector portion that is configured to engage with a female connector portion of pressure regulator 70 by a friction fit or interference fit. Connector portion 660 can be configured to have a tapered profile, thereby enabling direct insertion into pressure regulator 70. Alternatively, connector portion 660 can be a female connector portion that is configured to engage with a male connector portion, such as provided to pressure regulator 70.

[0338] Fig.57 and Fig.58 An example of how a pressure regulating device 70 having a releasable attachment mechanism may be used with an exemplary CPAP breathing system 1a is shown. In the illustrated arrangement, the patient interface 340 receives an inspiratory gas flow via the first breathing conduit 210a. The expiratory gas flow may be directed from the interface 340 via the second breathing conduit 210b to the pressure regulating device 70. It will be appreciated that the pressure regulating device 70 may be replaced with another pressure regulating device or exhaust port or flow resistance device (e.g., a valve) of the present disclosure to control the pressure delivered to the patient.

[0339] Fig.60 and Fig.61 Another example of using a pressure regulating device or exhaust port (e.g., pressure regulating device 70) of the present disclosure with a CPAP breathing system 1a in combination with a T-piece device (e.g., device 320, 620, 1120) is shown. Similarly, a connector portion 660 is provided to allow removal / attachment of the T-piece device to the expiratory breathing tube 210b of the CPAP breathing system 1a. Fig.61, a male connector portion 661 is provided to the expiratory conduit 201b. A corresponding female connector portion may be provided to an inlet of a T-piece device (e.g., inlet 324, 624, 1124). This configuration allows for a quick connection between the T-piece device and the CPAP interface 340. Alternatively, a female connector portion (not shown) at the end of the expiratory conduit 201b may engage with a corresponding male connector portion (e.g., provided to an inlet of a T-piece device).

[0340] A pressure regulating device 70, which may be coupled to a patient interface (e.g., a CPAP interface), may enable a seamless transition between different types of therapy. For example, a patient receiving CPAP therapy may require additional respiratory support, such as resuscitation or (multiple) artificial respirations. A pressure regulating device 70 having a releasable attachment mechanism may be connected to a CPAP interface, such as described above. The pressure regulating device 70 may be operated as described to deliver resuscitation therapy / artificial respiration. Once the patient is sufficiently stable, the patient may be transitioned back to CPAP therapy by disengaging the pressure regulating device 70 from the expiratory conduit 210b and reengaging an expiratory resistance device, such as a bubbler device (not shown).

[0341] Positive end-expiratory pressure (PEEP) is also referred to as peak end-expiratory pressure, and the two terms are often used interchangeably in the context of respiratory therapy systems and methods.

[0342] In this specification, adjectives (e.g., left and right, top and bottom, hot and cold, first and second, etc.) may be used to distinguish one element or action from another without necessarily requiring or implying any actual such relationship or order. Where the context permits, references to components, integers, or steps (or the like) are not to be construed as being limited to only one of the components, integers, or steps, but may be one or more of the components, integers, or steps.

[0343] In this specification, the terms 'comprises', 'comprising', 'includes', 'including' or similar terms are intended to mean a 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 that are not listed.

[0344] The above description related to the embodiments of the present disclosure is provided to those of ordinary skill in the relevant art for the purpose of description. It is not intended to be exhaustive or to limit the present disclosure to a single disclosed embodiment. As mentioned above, for those skilled in the art, numerous alternatives and variations of the present disclosure will be apparent from the above teachings. Therefore, although some alternative embodiments have been clearly discussed, it will be apparent to those of ordinary skill in the art or relatively easy to develop other embodiments. The present disclosure is intended to cover all modifications, alternatives and variations discussed herein, and other embodiments falling within the spirit and scope of the above description.

[0345] The reference to any prior art in the specification does not acknowledge or imply that this prior art forms part of the common general knowledge in any jurisdiction, or that this prior art could reasonably be expected to be understood by a person skilled in the art, to be relevant and / or to be combined with other prior art.

Claims

1. An exhaust port for use with a breathing system arranged to deliver breathable gas to a patient, wherein: The exhaust port allows gases from within the breathing system to escape, and the exhaust port comprises: A movable actuator, wherein movement of the actuator adjusts an area of ​​the exhaust port available for the gas to exit the breathing system through the exhaust port.

2. The exhaust port according to claim 1, wherein: Adjusting the area of ​​the exhaust port available for the gas to exit regulates the pressure of the breathable gas delivered to the patient.

3. The exhaust port according to claim 1 or 2, wherein: The exhaust port comprises one or more apertures, wherein the gas is arranged to flow through the one or more apertures when exiting from the gas delivery system.

4. The exhaust port according to claim 3, wherein: As the actuator moves in the first direction, the one or more apertures are gradually obscured.

5. The exhaust port according to claim 4, wherein: Occlusion of the one or more orifices results in an increase in the pressure of breathable gas delivered to the patient.

6. The exhaust port according to claim 4 or 5, wherein: As the actuator moves in the second direction, the one or more apertures are progressively unobstructed.

7. The exhaust port according to claim 6, wherein: Unobstructing the one or more orifices results in a decrease in the pressure of breathable gas delivered to the patient.

8. The exhaust port according to any one of claims 3 to 7, wherein: When the one or more orifices are fully or substantially occluded, the pressure of breathable gas delivered to the patient is higher than the pressure of breathable gas delivered to the patient when the one or more orifices are fully or substantially unoccluded.

9. The exhaust port according to any one of claims 3 to 8, wherein: When the one or more orifices are fully or substantially occluded, the pressure of the breathable gas delivered to the patient corresponds to the peak inspiratory pressure (PIP); when the one or more orifices are fully or substantially unobstructed, the pressure of the breathable gas delivered to the patient corresponds to the positive end-expiratory pressure (PEEP); when the one or more orifices are partially occluded or unobstructed, a pressure between PEEP and PIP is delivered to the patient.

10. The exhaust port according to any one of claims 3 to 9, wherein: The shape or configuration of at least one of the one or more apertures is configured based at least in part on a desired occlusion or de-occlusion rate of the one or more apertures during movement of the actuator.

11. The exhaust port of claim 10, wherein: The shape of the at least one of the one or more orifices is configured based at least in part on an inspiratory to expiratory ratio (I:E) of air supplied to the patient.

12. An exhaust port as claimed in claim 10 or claim 11, wherein: The shape of the at least one of the one or more orifices is configured based on a desired waveform shape of the pressure of breathable gas to be delivered to the patient.

13. The exhaust port according to any one of claims 10 to 12, wherein: The shape of the at least one of the one or more apertures is configured such that a rate of occlusion or de-occlusion caused by the actuator varies along a direction of movement of the actuator when the actuator moves at a substantially constant speed.

14. The exhaust port according to any one of claims 2 to 13, wherein: When the actuator moves at a constant speed, the pressure of the breathable gas is adjusted in a substantially non-linear manner.

15. The exhaust port of claim 13, wherein: The rate of occlusion or unocclusion of the one or more orifices by the actuator is greater at one end of the one or more orifices, such that the resulting pressure change of the breathable gas delivered to the patient changes more rapidly.

16. The exhaust port of claim 13, wherein: The rate of occlusion or unocclusion of the one or more orifices by the actuator is less at the other end of the one or more orifices so that the resulting pressure changes of the breathable gas delivered to the patient change less rapidly.

17. The exhaust port according to any one of claims 3 to 16, wherein: At least one of the one or more apertures is substantially circular in shape.

18. The exhaust port according to any one of claims 3 to 16, wherein: At least one of the one or more apertures is oval in shape.

19. The exhaust port according to any one of claims 3 to 16, wherein: At least one of the one or more apertures is triangular in shape.

20. The exhaust port of any one of claims 17 to 19, wherein: The shape of the at least one of the one or more apertures is configured such that a rate of occlusion or de-occlusion caused by the actuator remains substantially constant along a direction of movement of the actuator when the actuator moves at a constant speed.

21. The exhaust port of claim 20, wherein: Each of the one or more apertures is square or rectangular in shape.

22. The exhaust port of any one of claims 3 to 16, wherein: At least one of the one or more apertures is of irregular shape or a combination of shapes.

23. The exhaust port of any one of claims 1 to 22, wherein: The speed of movement of the actuator is at least partially manually controlled by an operator.

24. The exhaust port of any one of claims 1 to 22, further comprising: A housing, the housing comprising: A first opening and a second opening, wherein the first opening is fluidly connectable to the breathing system and the second opening is adapted to movably receive the actuator, wherein the position of the actuator relative to the housing determines an area of ​​the exhaust port available for the gas to exit the breathing system through the exhaust port, thereby adjusting the pressure of the breathable gas delivered to the patient.

25. The exhaust port of claim 24, wherein: The actuator is arranged to slide into or out of the housing via the second opening.

26. The exhaust port of claim 24 or 25, wherein: The first opening is located at or near a lower end of the housing, and the second opening is located at or near an upper end of the housing.

27. An exhaust port as claimed in any one of claims 24 to 26, wherein: The housing is substantially cylindrical in shape.

28. An exhaust port as claimed in any one of claims 24 to 27, wherein: The actuator comprises a hollow body comprising: one or more air inlets for receiving the gas from the breathing system, and One or more apertures arranged to allow the gas to exit from the hollow body.

29. The exhaust port of claim 28, wherein: The hollow body is substantially cylindrical in shape.

30. The exhaust port of claim 28 or 29, wherein: The hollow body includes an upper end portion for engaging with an operator and a lower end portion for inserting into the housing, and a side wall extending between the upper end portion and the lower end portion.

31. The exhaust port of claim 30, wherein: The one or more air inlets are disposed at or near a lower end of the hollow body.

32. The exhaust port of claim 30 or 31, wherein: The one or more apertures of the hollow body are formed in a side wall of the hollow body.

33. An exhaust port as claimed in any one of claims 28 to 32, wherein: the actuator being arranged to move between a first position and a second position to control a pressure of breathable gas delivered to the patient, wherein, in the first position, the actuator is fully or substantially lifted relative to the housing such that the one or more apertures of the hollow body are exposed to ambient air and the gas is able to exit through the exhaust port via the one or more apertures; wherein, in the second position, the actuator is fully or substantially inserted into the housing such that the one or more apertures are not exposed to ambient air, and Wherein, between the first position and the second position, at least one of the one or more apertures is exposed to the atmosphere, thereby allowing the gas to exit through the exhaust port.

34. The exhaust port of claim 33 or 34, wherein: The one or more apertures of the hollow body are configured to have varying shapes and / or sizes.

35. The exhaust port of claim 34, wherein: A first aperture of the one or more apertures formed at a lower end of the actuator has a larger size than the remaining apertures.

36. The exhaust port of any one of claims 24 to 27, wherein: The actuator comprises: The body portion includes a first end and a tapered end, wherein a diameter of the body portion decreases toward the tapered end.

37. The exhaust port of claim 36, wherein: The actuator is arranged to move between a first position and a second position to control the pressure of breathable gas delivered to the patient, wherein, in the first position, the actuator is fully or substantially lifted relative to the shell so as to allow the gas to flow through a gap between the actuator and the inner wall of the shell; and wherein, in the second position, the actuator is fully or substantially inserted into the shell so that the gap between the actuator and the inner wall of the shell is substantially reduced in size and / or substantially blocked so that the gas does not flow through the gap.

38. The exhaust port of claim 37, wherein: When the actuator is in the second position, the pressure of breathable gas delivered to the patient is higher than the pressure of breathable gas delivered to the patient when the actuator is in the first position.

39. An exhaust port as claimed in claim 37 or 38, wherein: When the actuator is in the first position, the pressure of the breathable gas delivered to the patient corresponds to PEEP; when the actuator is in the second position, the pressure of the breathable gas delivered to the patient corresponds to PIP; when the actuator moves between the first position and the second position, a pressure between PEEP and PIP is delivered to the patient.

40. The exhaust port of any one of claims 33 to 39, wherein: The actuator is manually operated by an operator to move between the first position and the second position.

41. The exhaust port of claim 40, wherein: The actuator is pressed downwardly toward the housing by the operator to move from the first position to the second position.

42. The exhaust port of claim 41, wherein: As the operator reduces or removes the force applied to the actuator, the actuator is allowed to gradually return to the first position.

43. The exhaust port of claim 42, wherein: The actuator can be pulled in an upward direction by the operator to move from the second position to the first position.

44. The exhaust port of claim 33 or 43, wherein: The exhaust port further includes a biasing member to cause the actuator to remain in the first position when no force is applied by the operator.

45. The exhaust port of claim 44, wherein: The actuator includes a shoulder disposed on an outer surface of the actuator.

46. ​​An exhaust port as claimed in claim 44 or claim 45, wherein: The housing includes a countersunk portion, wherein the biasing member is held in place by a shoulder of the actuator and the countersunk portion of the housing.

47. The exhaust port of claim 46, wherein: The shoulder is formed as a flange that extends partially or completely around the circumference of the actuator.

48. An exhaust port as claimed in any one of claims 44 to 47, wherein The biasing member is a spring disposed on an exterior of the actuator.

49. The exhaust port of claim 33 or 37, wherein: A sealing member is provided to create a seal when the actuator is in the first position.

50. The exhaust port of claim 1, wherein: The exhaust port includes a housing, the housing including: a first opening and a second opening, wherein the first opening is fluidly connected to the breathing system and the second opening is adapted to movably receive the actuator within the housing; A body extends between the first opening and the second opening, wherein the body includes one or more apertures adapted to allow the gas to escape to atmosphere depending on a relative position of the actuator with respect to the housing.

51. The exhaust port of claim 50, wherein: The first opening is located at or near a lower end of the housing, and the second opening is located at or near an upper end of the housing.

52. An exhaust port as claimed in claim 50 or claim 51, wherein: The housing forms a hollow cavity to receive the actuator therein.

53. An exhaust port as claimed in any one of claims 50 to 52, wherein: The first opening has a smaller diameter than the second opening.

54. An exhaust port as claimed in any one of claims 50 to 53, wherein: the actuator being arranged to move between a first position and a second position to adjust a pressure of breathable gas delivered to the patient, wherein, in the first position, the actuator is fully or substantially lifted relative to the housing so as to allow the gas to flow through the exhaust port and exit the gas delivery system via the one or more orifices, and Wherein, in the second position, the actuator is lowered into the housing to block the first opening of the housing.

55. The exhaust port of claim 54, wherein: When the actuator is in the second position, a pressure of breathable gas delivered to the patient is higher than a pressure delivered when the actuator is in the first position.

56. The exhaust port of claim 54 or 55, wherein: When the actuator is in the first position, the pressure of the breathable gas delivered to the patient corresponds to PEEP, and when the actuator is in the second position, the pressure of the breathable gas delivered to the patient corresponds to PIP; when the actuator moves between the first position and the second position, a pressure between PEEP and PIP is delivered to the patient.

57. An exhaust port as claimed in any one of claims 50 to 56, wherein: The one or more apertures include a plurality of apertures formed in a body of the housing.

58. The exhaust port of claim 57, wherein: The plurality of apertures are disposed about the circumference of the body and extend along the length of the body.

59. An exhaust port as claimed in any one of claims 50 to 58, wherein The vent includes a membrane that assists in movement of the actuator.

60. The exhaust port of claim 59, wherein: The membrane is a deformable membrane.

61. The exhaust port of claim 59 or claim 60, wherein: The membrane forms a chamber extending between the second opening of the housing and a shoulder of the actuator.

62. An exhaust port as claimed in any one of claims 59 to 61, wherein: The membrane is configured such that it biases the actuator in the first position when no force is applied to the actuator.

63. An exhaust port as claimed in any one of claims 59 to 62, wherein: The membrane is configured such that when a compressive force is applied to the actuator, it deforms to allow the actuator to move toward the second position.

64. An exhaust port as claimed in any one of claims 59 to 63, wherein: The membrane is configured such that when the actuator moves past a deflection point of the membrane, a portion of the membrane moves the actuator into the second position.

65. An exhaust port as claimed in any one of claims 59 to 64, wherein: The membrane is configured such that when the actuator moves past a deflection point of the membrane, a portion of the membrane deflects and biases the actuator into the second position.

66. An exhaust port as claimed in any one of claims 59 to 65, wherein When the compressive force is removed from the actuator, the membrane returns the actuator to the first position.

67. The exhaust port of any one of claims 50 to 66, wherein: The actuator comprises: The body portion includes a first end and a tapered end, wherein a diameter of the body portion decreases toward the tapered end.

68. The exhaust port of any one of claims 1 to 67, wherein: The actuator comprises a substantially cylindrical body, wherein a bottom surface of the cylindrical body can have a curved or substantially flat surface.

69. An exhaust port for use with a breathing system arranged to deliver breathable gas to a patient, wherein: The exhaust port allows gases from within the breathing system to escape, and the exhaust port comprises: a movable actuator configured to cover or uncover a port of the exhaust port, wherein the port allows gases from within the breathing system to escape when uncovered; and A member that assists in controlling the speed of movement of the actuator.

70. The exhaust port of claim 69, wherein: The member is configured to contact the actuator during movement of the actuator to apply a friction force to the actuator.

71. The exhaust port of claim 70, wherein: The friction force is greater when the actuator moves from a position where the area of ​​the exhaust port available for the gas to exit the respiratory system through the exhaust port is minimized to another position where the area of ​​the exhaust port available for the gas to exit the respiratory system through the exhaust port is maximized.

72. The exhaust port of any one of claims 69 to 71, wherein: The member comprises one or more flaps arranged to deform and / or deflect during movement of the actuator.

73. A device for use with a respiratory system, wherein: The device includes: The housing comprises: an inlet arranged to receive breathable gas from a breathing apparatus; an outlet configured to be in fluid communication with the airway of a patient; A PEEP port, wherein the PEEP port is configured to be fluidly coupled to the exhaust port of any one of claims 1-72.

74. A pressure regulating device for use with a breathing system arranged to deliver breathable gas to a patient, wherein: The pressure regulating device allows gas from within the breathing system to exit and is configured to regulate the pressure of breathable gas within the breathing system within a predetermined pressure range, the pressure regulating device comprising: An exhaust port, wherein the exhaust port comprises: A movable actuator, wherein movement of the actuator adjusts the area of ​​the exhaust port available for the gas to exit the breathing system via the pressure regulating device.

75. A breathing system for delivering respiratory therapy to a patient, the breathing system comprising: a respiratory device that supplies a source of breathable gas flow at a targeted pressure and / or flow rate; a conduit assembly connectable to the breathing apparatus to receive the flow of breathable gas; a patient interface arranged to receive the breathable gas and usable to deliver the respiratory therapy to the patient; a device arranged to form a fluid connection between the conduit assembly and the patient interface; as well as an exhaust port or a pressure regulating device including such an exhaust port, wherein the exhaust port comprises a movable actuator, and the pressure regulating device is configured to regulate the pressure of the breathable gas within the breathing system within a predetermined pressure range, and wherein movement of the actuator adjusts the area of ​​the exhaust port available for the gas to exit from the breathing system via the exhaust port.

76. A kit of parts for use with a breathing system, the kit of parts comprising: an exhaust port or a pressure regulating device including such an exhaust port, wherein the exhaust port comprises a movable actuator and the pressure regulating device is configured to regulate the pressure of breathable gas within the breathing system within a predetermined pressure range, and wherein movement of the actuator adjusts an area of ​​the exhaust port available for gas to exit the breathing system via the exhaust port; and A T-piece device, wherein the exhaust port or the pressure regulating device is connectable to the PEEP port of the T-piece device.

77. A continuous positive airway pressure (CPAP) system comprising: a respiratory device that supplies a source of breathable gas flow at a targeted pressure and / or flow rate; Pipeline components, including: an inspiratory breathing conduit connectable to the breathing apparatus to receive the flow of breathable gas; and expiratory breathing tube; a patient interface arranged to receive the breathable gas and usable to deliver the respiratory therapy to the patient; means arranged to form a fluid connection between the inspiratory breathing conduit and the patient interface; an exhaust port or a pressure regulating device including such an exhaust port, wherein the exhaust port comprises a movable actuator and the pressure regulating device is configured to regulate the pressure of breathable gas within the breathing system within a predetermined pressure range, and wherein movement of the actuator adjusts an area of ​​the exhaust port available for gas to exit the breathing system via the exhaust port; and One or more connector portions are configured to removably connect the exhaust port or the pressure regulating device to the expiratory breathing tube.

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