Respiratory therapy system and apparatus

Abstract

To provide a respiratory therapy system and apparatus.SOLUTION: A respiratory therapy system comprises a respiratory therapy apparatus that is configured to provide a flow of a breathable gas at least at a first pressure and a second pressure to a patient. The respiratory therapy apparatus comprises a flow generator configured to provide the flow of breathable gas, a controller, coupled to a trigger sensor, to control respiratory therapy apparatus operations, a breathing conduit assembly that conveys the breathable gas to a patient via a patient interface, and a trigger that produces a signal detectable by the trigger sensor. The controller is configured to control the flow generator to provide the flow of the breathable gas at least at the first or second pressure on the basis of the detection of the signal from the trigger.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] The present invention relates to a respiratory therapy system and apparatus.

Background Art

[0002] During the period of performing respiration, resuscitation, or assisted respiration (ventilation), positive end expiratory pressure (PEEP) and / or peak inspiratory pressure (PIP) can be applied to a patient in a controllable state. PEEP is the pressure in the airway that remains above atmospheric pressure throughout the expiratory phase of positive pressure ventilation. PIP is the highest desired pressure applied to the lungs during inspiration. The patient can be a neonate or infant who requires respiratory assistance or resuscitation. When applying PEEP, the upper airway and lungs of the patient are maintained in an expanded state by the applied pressure.

[0003] An example of such a respiratory therapy device is provided in Patent Document 1 (International Publication No. 03 / 066146), which discloses a connector for use in a respiratory therapy device for neonatal or infant resuscitation. The connector includes a pressure regulator having a manifold provided with an inlet and two outlets. The first outlet supplies respiratory gas to the infant. The second outlet can be used by a user (i.e., a healthcare professional) to vary the pressure between a specified PIP and PEEP by manually closing the orifice, for example, using the user's finger. Also, the use of a valve is described, which is placed between the inlet and the orifice and opens at a predetermined flow rate, thereby assisting in maintaining the pressure within the manifold at a constant level.

[0004] Another example is provided by Patent Document 2 (International Publication No. 2012 / 030232), where an apparatus similar to that of Patent Document 1 (International Publication No. 03 / 066146) including a respiratory display for notifying when a patient is inhaling or exhaling is disclosed. Here too, a healthcare professional can manually block the orifice to change the pressure between PIP and PEEP and observe the respiratory display to monitor the respiration of an infant.

[0005] Another example is provided by Patent Document 3 (International Publication No. 2014 / 003578), which discloses an apparatus similar to that of Patent Document 1 (International Publication No. 03 / 066146). Here too, a pressure regulator can be used to change the pressure between PIP and PEEP by selectively blocking the orifice, for example, by placing a finger over it. Further, the pressure at which the valve operates can be adjusted by adjusting the relative position of the valve seat.

[0006] In this specification, when referring to external information sources including patent specifications and other documents, this is generally for the purpose of providing content for explaining the features of the present invention. Unless otherwise specified, such references to information sources are not to be regarded as an approval in any jurisdiction that such information sources are prior art or form part of the general technical knowledge well-known in the art.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

[0008] In a first aspect, the present disclosure relates to the implementation of ventilation to a patient by use of a respiratory therapy system configured to supply a gas suitable for breathing to the patient at a pressure elevated above atmospheric pressure, and the respiratory therapy system is configured to supply gas at at least a first and a second pressure based on the use of a trigger unit that selects between delivered gas pressures.

[0009] In a further aspect, the present disclosure relates to a respiratory therapy system, the respiratory therapy system comprising: a respiratory therapy device configured to provide at least a first pressure and a second pressure to a patient, a flow generator configured to supply a gas suitable for breathing to the patient, a trigger sensor, a controller coupled to the trigger sensor for controlling the operation of the respiratory therapy device comprising a respiratory therapy device; a breathing conduit configured to carry a gas suitable for breathing to the patient via a patient interface; a trigger unit that generates a signal detectable by the trigger sensor comprising; and the controller is configured to adjust the flow generator to deliver at least a first pressure or a second pressure based on the use of the trigger unit.

[0010] In a further aspect, the present disclosure relates to a respiratory therapy system, the respiratory therapy system comprising: a respiratory therapy device configured to provide a flow of a gas suitable for breathing to the patient at at least a first pressure and a second pressure, A flow generator configured to provide a gas flow suitable for breathing, A controller coupled to a trigger sensor for controlling the operation of a respiratory therapy device A respiratory therapy device comprising: A breathing conduit for delivering a gas suitable for breathing to a patient via a patient interface; A trigger portion that generates a signal detectable by the trigger sensor and; The controller is configured to adjust the flow generator to provide a gas flow suitable for breathing at at least a first pressure or a second pressure based on detection of a signal from the trigger portion.

[0011] Preferably, the first pressure is the peak end expiratory pressure. Preferably, the second pressure is the peak inspiratory pressure.

[0012] In a further aspect, the present disclosure relates to a respiratory therapy system, the respiratory therapy system comprising: A respiratory therapy device configured to provide at least a peak end expiratory pressure (PEEP) and a peak inspiratory pressure (PIP), A flow generator configured to supply a gas suitable for breathing to a patient, A trigger sensor, A controller coupled to the trigger sensor for controlling the operation of the respiratory therapy device A respiratory therapy device comprising: A breathing conduit for delivering a gas suitable for breathing to a patient via a patient interface; A trigger portion that generates a signal detectable by the trigger sensor and; The controller is configured to adjust the flow generator to deliver at least PEEP or PIP based on use of the trigger portion.

[0013] In a further aspect, the present disclosure relates to a respiratory therapy device configured to provide a flow of gas suitable for breathing to a patient at at least a first pressure and a second pressure, the respiratory therapy device comprising; · a flow generator configured to provide a flow of gas suitable for breathing, · a controller coupled to a trigger sensor for controlling the operation of the respiratory therapy device and comprising; the respiratory therapy device comprises; · a breathing conduit assembly for delivering a gas suitable for breathing to the patient via a patient interface, · a trigger section that generates a signal detectable by the trigger sensor and is configured to operate with; and the controller is configured to control the flow generator to provide a flow of gas suitable for breathing at at least a first pressure or a second pressure based on detection of a signal from the trigger section.

[0014] In a further aspect, the present disclosure relates to a connector element for use with a respiratory therapy system for delivering gas to a patient in need of resuscitation and / or respiratory assistance, the connector element comprising; a housing, an inlet adapted to be in fluid communication with or integrated with a respiratory therapy device for providing a gas suitable for breathing, an outlet adapted to be in fluid communication with a patient interface, a trigger section that generates a signal detectable by a trigger sensor on or within the respiratory therapy device comprising a housing and comprising; the respiratory therapy device comprises a controller configured to adjust the gas pressure provided to the inlet based on use of the trigger section.

[0015] In a further aspect, the present disclosure relates to a respiratory therapy device including a flow generator and delivering a gas suitable for breathing to a patient via a trigger section, detecting a signal generated by the trigger section, and In response to the detected signal, causing a maximum end-expiratory pressure (PEEP) or a maximum inspiratory pressure (PIP) in the patient relates to a method of delivering respiratory therapy to a patient, including

[0016] In a further aspect, the disclosure provides · providing the following ○ A respiratory therapy device configured to provide at least a maximum end-expiratory pressure (PEEP) and a maximum inspiratory pressure (PIP), including a flow generator configured to supply a gas suitable for respiration to the patient, at least one trigger sensor, and a controller coupled to the trigger sensor for controlling the operation of the respiratory therapy device; and ○ A breathing conduit configured to carry a gas suitable for respiration to the patient via a patient interface ○ Providing a trigger section that generates a signal detectable by the trigger sensor; and · Operating the respiratory therapy device to deliver at least a maximum end-expiratory pressure and a maximum inspiratory pressure, wherein the controller is configured to adjust the flow generator to deliver at least PEEP or PIP based on the use of the trigger mechanism relates to a method of delivering respiratory therapy to a patient, including

[0017] Any one or more of the following embodiments may relate to any of the aspects described herein or any combination thereof

[0018] Preferably, the second pressure is greater than the first pressure

[0019] Preferably, the connector element includes a hollow cylindrical body

[0020] In some embodiments, the connector element includes a monitoring port

[0021] In some embodiments, the monitoring port is shaped to receive a valve

[0022] Preferably, the trigger part is a biased trigger part.

[0023] In one embodiment, the trigger part is biased towards the inactive position, and the controller is configured to deliver the maximum end-expiratory pressure (PEEP).

[0024] In an alternative embodiment, the trigger part is biased towards the inactive position, and the controller is configured to deliver the maximum inspiratory pressure (PIP).

[0025] In one embodiment, the generation of a detectable signal by the trigger sensor correlates with a controller that controls the respiratory therapy device to deliver the maximum end-expiratory pressure (PEEP).

[0026] In an alternative embodiment, the generation of a detectable signal by the trigger sensor correlates with a controller that controls the respiratory therapy device to deliver the maximum inspiratory pressure (PIP).

[0027] In one embodiment, the respiratory therapy device delivers the maximum end-expiratory pressure (PEEP) during the duration that the trigger part is activated.

[0028] In an alternative embodiment, the respiratory therapy device delivers the maximum inspiratory pressure (PIP) during the duration that the trigger part is activated.

[0029] Preferably, the controller adjusts the gas pressure delivered by the respiratory therapy device by using a control loop mechanism. More preferably, the control loop mechanism uses feedback including at least a pressure sensor in the gas flow path.

[0030] In one embodiment, the respiratory therapy device includes a connector disposed between the breathing conduit and the patient interface. In this embodiment, the trigger mechanism can be disposed on the connector.

[0031] In one embodiment, the respiratory therapy device includes a humidifier configured to humidify the gas suitable for breathing.

[0032] In one embodiment, the humidifier is integrated with a respiratory therapy device.

[0033] In one embodiment, the breathing tube assembly includes a heated tube. More preferably, the heated tube includes a heater wire. Preferably, the heater wire is connected to a controller.

[0034] In one embodiment, the trigger unit is connected to a trigger sensor via a sensor line. More preferably, the sensor line is selected from a pneumatic line or an electric wire.

[0035] In one embodiment, the trigger unit generates a signal detected by the trigger sensor, and the signal is an electrical signal.

[0036] In one embodiment, the signal indicates that the trigger unit is actuated.

[0037] In one embodiment, the trigger unit is a switch, and when activated, it completes a circuit, so that it is detected by the trigger sensor or the controller.

[0038] In one embodiment, the trigger sensor can detect an electrical signal generated when the trigger unit is actuated.

[0039] In one embodiment, the actuation of the trigger unit generates an electrical signal detected by the trigger sensor, thereby causing the controller to adjust the target gas pressure.

[0040] In one embodiment, the actuation of the trigger unit can generate an electrical signal detected by the trigger sensor, thereby causing the controller to adjust the target gas pressure provided at the inlet of the connector element to a first pressure level during the duration that the trigger unit is actuated.

[0041] In one embodiment, the electrical switch can have two or more positions, and an electrical signal is transmitted when the switch is in one of those positions.

[0042] In one embodiment, the trigger unit may include two or more electrical switches. When the user actuates the first switch, an electrical signal is generated, and the generation of the electrical signal stops only when the user actuates the second or subsequent switch.

[0043] In one embodiment, the sensor line is installed outside the breathing tube.

[0044] Preferably, the sensor line is installed inside the connector element.

[0045] Preferably, the trigger sensor is a pressure sensor.

[0046] In one embodiment, the trigger sensor is installed on or inside the breathing tube in the immediate vicinity of the patient interface.

[0047] In an alternative embodiment, the trigger sensor is installed on or inside the patient interface.

[0048] In an alternative embodiment, the trigger sensor is installed on the respiratory therapy device.

[0049] In one embodiment, the trigger unit is a compression chamber.

[0050] Preferably, the compression of the compression chamber is detected by the trigger sensor. Preferably, the trigger sensor is a differential pressure sensor.

[0051] Preferably, the compression chamber is formed by the trigger unit and the trigger sensor line.

[0052] Preferably, the trigger sensor is configured to provide an output indicating the compression chamber pressure to the controller.

[0053] Preferably, the trigger sensor is a gauge pressure, absolute pressure or differential pressure sensor.

[0054] Preferably, the controller is configured to control the respiratory therapy system such that when the compressor chamber pressure is below the compressor chamber pressure threshold, the first pressure is delivered, and when the compressor chamber pressure is above the compressor chamber pressure threshold, the second pressure is delivered.

[0055] Preferably, the controller is configured to control the respiratory therapy system such that when the compressor chamber pressure is below the compressor chamber pressure threshold, the second pressure is delivered, and when the compressor chamber pressure is above the compressor chamber pressure threshold, the first pressure is delivered.

[0056] In one embodiment, the respiratory therapy device includes a connector element having a first outlet in fluid communication with the patient interface, an inlet in fluid communication with the breathing conduit, and an aperture defining a chamber, and the trigger portion is disposed over the chamber.

[0057] In one embodiment, a portion of the trigger sensor line terminates at the trigger portion within the connector element.

[0058] In one embodiment, the connector element is in a "T" shape and includes a hollow cylindrical body provided with a gas inlet, a gas outlet, a monitoring port, and a trigger port.

[0059] In one embodiment, the connector element includes a monitoring port.

[0060] Preferably, the respiratory therapy device includes a vent arrangement.

[0061] Preferably, the vent arrangement is installed within the connector element or within the breathing conduit assembly.

[0062] Preferably, the controller controls the operation of both the respiratory therapy device and the humidifier.

[0063] Preferably, the respiratory therapy device is a) pure oxygen, or b) ambient air, or c) A gas selected from a combination of pure oxygen and ambient air is adapted to provide.

[0064] In one embodiment, the oxygen provided to the respiratory therapy device is provided by a low-pressure source or a high-pressure source.

[0065] Preferably, the controller is configured to detect the fitment of the patient interface to the patient.

[0066] Preferably, when the controller detects the attachment of the mask to the patient, it activates the respiratory therapy device to provide a maximum end-expiratory pressure. In one embodiment, the controller detects flow conductance as an indication of the attachment of the mask to the patient.

[0067] Preferably, when the respiratory therapy device detects the attachment of the mask to the patient, it provides a gas at a first pressure level to the patient. Preferably, the first pressure level is approximately equal to the maximum end-expiratory pressure.

[0068] Preferably, the trigger sensor detects the gas at the first pressure level. In one embodiment, the trigger sensor is installed within the respiratory therapy device. In an alternative embodiment, the trigger sensor is installed within the breathing conduit or the patient interface.

[0069] Preferably, when the respiratory therapy device detects a trigger by the trigger sensor, it provides a gas at a second pressure level to the patient. Preferably, the second pressure level is approximately equal to the maximum end-expiratory pressure.

[0070] Preferably, the respiratory therapy device is configured to detect leakage within the patient interface.

[0071] In one embodiment, the trigger portion is a pneumatic trigger portion including a movable member.

[0072] In one embodiment, the trigger part is a pneumatic trigger part including a housing and a movable member, and the housing and the movable member together define a compression chamber.

[0073] In one embodiment, the trigger part includes a plurality of protrusions in the chamber to define the limit of the inward deflection of the movable member.

[0074] In one embodiment, the trigger part includes protrusions that provide tactile feedback to the user regarding the position of the user's thumb / finger on the movable member.

[0075] In one embodiment, the sensor line is connected to the chamber through an opening.

[0076] Preferably, the trigger part includes a surrounding reference opening that prevents accidental triggering.

[0077] Preferably, the breathing tube assembly includes one or more holding mechanisms for holding the trigger sensor line. In one embodiment, the holding mechanism is disposed within the inner diameter of the breathing tube of the breathing tube assembly. In an alternative embodiment, the holding mechanism is installed on the outer surface of the breathing tube of the breathing tube assembly.

[0078] Preferably, the respiratory therapy device is for neonatal resuscitation.

[0079] Preferably, the calcium source reverting agent is about 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 or 9.5 weight % of the metaphosphate reverting agent mixture, and the preferred range can be selected from between any of these values. More preferably, the magnesium source reverting agent is about 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 or 9 weight % of the metaphosphate reverting agent mixture, and the preferred range can be selected from between any of these values.

[0080] References to numerical ranges disclosed herein (e.g., 1 to 10) are to be construed as including all rational numbers within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as references to any sub-ranges of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7).

[0081] The present invention also broadly relates to the parts, elements, and features referred to or shown in the specification of this application, individually or in combination, and to any or all combinations of any two or more of said parts, elements, or features, and specific integers are described herein as being known equivalents in the art to which the present invention pertains, and such known equivalents are considered to be incorporated herein as if individually set forth.

[0082] As used herein, the term "comprising" means "consisting at least in part of". When interpreting statements that include this term herein, the features preceding the term in each statement must all be present, but other features may also be present. Related terms, such as "comprise" and "comprised of", are to be interpreted in the same manner.

[0083] As used herein, the terms "respiratory therapy system" and "respiratory assistance system" are used interchangeably.

[0084] The present disclosure will now be described by way of example only and with reference to the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0085]

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DETAILED DESCRIPTION OF THE INVENTION

[0086] The present disclosure relates to a respiratory therapy system.

[0087] The use of a respiratory therapy system 1 having a respiratory therapy device 100, a respiratory conduit assembly 200, a trigger unit assembly 320, and a patient interface 340 is described.

[0088] The respiratory therapy device 100 including a flow generator 110 that generates a flow of pressurized gas has several advantages compared to the use of a typical wall source. For example, a given pressure can be varied. It provides the ability to detect and / or reduce leakage at the patient interface 340 and also means that fewer devices are required to perform a range of care or a range of respiratory therapies. Further, the respiratory therapy device 100 having an integrated humidifier 120 can be controlled by a single controller 130, thereby enabling the monitoring and control of various flow and / or pressure parameters. The respiratory therapy system 1 may be capable of performing other forms of therapy, thereby enhancing the continuous care of the device and enabling easy transition between different types of respiratory assistance when the patient's condition changes. Combining the devices also provides the benefit of reducing the capital investment of healthcare providers.

[0089] 1. Overview The respiratory therapy system 1 is shown in FIG. 1. Broadly speaking, the respiratory therapy system 1 includes a respiratory therapy device 100 (which may include a blower 110, a trigger sensor 33, and a controller 130), a respiratory conduit assembly 200, a trigger unit 320, and a patient interface 340. In at least one form, the flow generator 110 may be in the form of a blower 110.

[0090] As shown in FIG. 1B, the respiratory therapy system 1 may also include a connector element 310. When present, the connector element 310 connects the patient interface 340 to the breathing conduit assembly 200. The breathing conduit assembly 200 may include a breathing conduit 210. The breathing conduit 210 may include a hose and one or more hose end connectors. The breathing conduit 210 may be an assembly of the hose and one or more hose end connectors. The one or more hose end connectors may be disposed at respective ends of the hose. The hose end connectors may enable the breathing conduit 210 to be pneumatically and / or electrically connected to other components (such as the patient interface 340, the respiratory therapy device 100, the connector element 310, etc.). The breathing conduit 210 may include a first hose end connector at a first end of the hose and a second hose end connector at a second end of the hose. The breathing conduit assembly 200 may include an interface conduit 312. The illustrated breathing conduit assembly 200 includes the interface conduit 312 and the breathing conduit 210. The breathing conduit assembly 200 may also include a patient-side end connector 212. The patient-side end connector 212 may interface with or connect the breathing conduit 210 and the interface conduit 312. In other words, the patient-side end connector 212 may facilitate the connection of the interface conduit 312 to the breathing conduit 210.

[0091] The trigger unit 320 may be connected to a trigger sensor line 230 configured to provide a signal to the controller 130.

[0092] The respiratory therapy device 100 may also include a humidifier 120 in fluid connection with a flow generator 110.

[0093] Also, a controller 130 and a user interface 140 (e.g., a display and one or more input devices, such as one or more buttons, a touch screen, etc.) are included. The controller 130 is configured or programmed to control the components of the respiratory therapy system 1. The controller 130 is configured or programmed to control and / or interact with the components of the respiratory therapy device 100, for example: operate the flow generator 110 to produce a gas flow (gas flow) for delivery to a patient, operate the humidifier 120 (if present) to humidify and / or heat the generated gas flow, receive one or more inputs from sensors and / or the user interface 140 for reconfiguration and / or user-defined operation of the respiratory therapy device 100, and output information to the user (e.g., to a display). An example of a respiratory therapy device 100 with an integrated humidifier is described in Patent Document 4 (International Publication No. 2016 / 207838), which is incorporated herein by reference. The gas flow provided to the patient can be provided at a target flow rate. Alternatively, the gas flow provided to the patient can be provided at a target pressure. The user can be a patient (i.e., receiving respiratory therapy), a healthcare professional, or anyone else interested in the use of the respiratory therapy system 1.

[0094] The patient interface is used to administer respiratory therapy to the airway of a person suffering from any of several respiratory diseases or conditions. Such therapies can include, but are not limited to, neonatal resuscitation, positive airway pressure (PAP) therapy, continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), nasal high flow (NHF) therapy, or other therapies.

[0095] Regarding neonatal resuscitation, while in the womb, the fetus's lungs are filled with fluid and oxygen is provided by the placenta's blood vessels. At birth, a continuous transition to postnatal breathing occurs, which is assisted, i.e., aided, by the generation of negative pressure in the lungs due to compression of the lungs by the birth canal. Also, what aids the neonate in breathing is the presence of surfactant that covers the alveoli and lowers their surface tension. Neonatal resuscitation can occur in a range of circumstances.

[0096] Most neonates can withstand passage through the birth canal during an average labor duration, but a few who cannot may require assistance to establish normal breathing at birth. Resuscitation may also be required for neonates with significant fetal compromise at the time of delivery, i.e., neonates born before 35 weeks of gestation (especially those in whom surfactant production has not begun until 24 weeks of gestation and continues until 34 weeks of gestation), neonates delivered vaginally due to breech position, maternal infection, and multiple pregnancy. Furthermore, delivery by cesarean section, especially for deliveries before 39 weeks of gestation, is associated with an increased risk of problems with the transition to breathing that require medical intervention at birth.

[0097] As described above, the humidifiable gas flow generated by the respiratory therapy device 100 of the respiratory therapy system 1 is delivered to the patient through the patient-side terminal portion 26 of the patient interface 340 via the respiratory conduit assembly 200.

[0098] In at least one form, the patient interface 340 may be in the form of a sealed patient interface. In at least one form, the patient interface 340 may be in the form of a breathing mask. The patient interface 340 may be configured to supply positive pressure air to the patient's airway via a seal or cushion that forms an airtight seal around the patient's nose and / or mouth at the patient-side termination 26. The patient interface 340 may be a full-face, nasal, direct nasal, and / or oral-type patient interface, which creates an airtight seal between the patient-side termination 26 and the patient's nose and / or mouth. In at least one form, the seal or cushion may be held in place on the patient's face by a headgear. In at least one form, the patient interface 340 may be held in place on the patient's face by a user or healthcare professional. Such a sealed patient interface may be used to perform pressure therapy on the patient. Alternative patient interfaces, such as those including nasal prongs, may be used. In some examples, the nasal prongs may be sealed or unsealed.

[0099] The breathing conduit 210 may have a heating element 220 for heating the gas flow passing through the breathing conduit 210 to the patient. In one form, the heating element 220 may be a heater wire. The heating element 220 may be in the form of a length of wire. The wire may have a predetermined resistance. The heating element 220 may be under the control of a controller, whether the controller is a central control device (e.g., controller 130) or an auxiliary controller.

[0100] The breathing conduit assembly 200 and / or the patient interface 340 may be considered part of the respiratory therapy system 1. Alternatively, the breathing conduit assembly 200 and / or the patient interface 340 may be considered peripheral devices of the respiratory therapy system 1. The respiratory therapy device 100, the breathing conduit assembly 200, and the patient interface 340 may together form at least a part of the respiratory therapy system 1. In other words, the respiratory therapy system 1 may include the respiratory therapy device 100, the breathing conduit assembly 200, and the patient interface 340. In one form, the respiratory therapy device 100, the breathing conduit assembly 200, and the patient interface 340 together form the respiratory therapy system 1. The trigger portion 320 and / or the connector element 310 may be considered peripheral devices of the respiratory therapy system 1.

[0101] The controller 130 may control the respiratory therapy device 100 to generate a gas flow at a desired pressure. The controller 130 may control the respiratory therapy device 100 to generate a gas flow at a desired flow rate. In particular, the controller 130 may control the flow generator 110 to generate a gas flow at a desired pressure and / or flow rate.

[0102] In one embodiment, the controller 130 controls one or more valves to control the mixing of air with oxygen or other alternative gases.

[0103] The controller 130 controls the humidifier 120 (if present) to humidify the gas flow and / or heat the gas flow to an appropriate level. The gas flow is directed to the patient through the breathing tube assembly 200 and the patient interface 340. The controller 130 can also control the heater element 220 of the humidifier 120 and / or the heater element 220 of the breathing tube 210 to heat the gas to a desired temperature and / or maintain the gas at a desired temperature. The controller 130 can be programmed or determine a suitable target temperature and / or humidity for the gas flow. The controller 130 can be programmed or determine a suitable target temperature and / or humidity for the gas flow, and can use one or more of the heater element 220, the humidifier heater element 220, and the flow generator 110 to control the flow, i.e., the flow rate and / or pressure, to the target temperature and / or humidity. The target temperature and / or humidity of the heated gas can be set to achieve a desired level of therapy and / or comfort for the patient.

[0104] Motion sensors 30, 31, and 32, such as flow, temperature, humidity, and / or pressure sensors, can be placed at various locations within the respiratory therapy device 100 and / or the breathing tube assembly 200 and / or the patient interface 340. One or more outputs from the sensors 30, 31, and 32 can be monitored by the controller 130 to assist in operating the respiratory therapy system 1 to deliver an optimal therapy. In some forms, delivering an optimal therapy includes meeting the patient's inspiratory demand. In at least one form, delivering an optimal therapy includes delivering a first target pressure to the patient on a first occasion and a second target pressure to the patient on a second occasion. The second target pressure can be greater than the first target pressure. The second target pressure can be set to achieve an inspiratory pressure target. The first target pressure can be set to achieve an expiratory pressure target. The first target pressure can be greater than the second target pressure. The first target pressure can be set to achieve an inspiratory pressure target. The second target pressure can be set to achieve an expiratory pressure target.

[0105] The respiratory therapy device 100 may have a transmitter 150, a receiver 150, and / or a transceiver 150 so that the controller 130 can receive signals transmitted from sensors and / or control various components of the respiratory therapy system 1. The controller 130 can receive signals transmitted from sensors related to, 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, such as the breathing tube assembly 200. For example, the transmitted signals can be related to the control of the components or processed to command the control of the components. In addition or alternatively, the transmitter 150, the receiver 150, and / or the transceiver 150 can send data to a remote server or enable remote control of the respiratory therapy system 1.

[0106] The respiratory therapy system 1 is configured to perform respiratory therapy. The respiratory therapy can be a pressure therapy such as CPAP or bubble CPAP or nasal CPAP that is delivered to or performed on a patient to assist breathing and / or treat a breathing disorder. The pressure therapy may require the respiratory therapy system 1 to provide pressure to the patient or near the patient at one or more target pressures within one or more time windows. The pressure therapy can be neonatal resuscitation therapy, airway positive pressure therapy (PAP), continuous airway positive pressure therapy (CPAP), bi-level set airway positive pressure therapy, non-invasive ventilation, bubble CPAP therapy, or another form of pressure therapy. In some forms, as shown, the device can perform bi-level set airway positive pressure therapy to achieve neonatal resuscitation.

[0107] In the present disclosure, "pressure therapy" may refer to delivering pressure to a patient at a pressure of about 4 cmH2O or more. In some forms, "pressure therapy" may refer to delivering gas to a patient at a pressure of about 20 cmH2O to about 30 cmH2O, or about 21 cmH2O to about 30 cmH2O, or about 22 cmH2O to about 30 cmH2O, or about 23 cmH2O and about 30 cmH2O, or about 24 cmH2O to about 30 cmH2O, or about 25 cmH2O to about 30 cmH2O, or about 20 cmH2O and about 25 cmH2O, or about 21 cmH2O to about 25 cmH2O, or about 22 cmH2O to about 25 cmH2O.

[0108] In some forms, the gas delivered to the patient is oxygen or contains oxygen. In some forms, the gas includes a blend of oxygen or oxygen-enriched gas and ambient air. In some forms, the percentage of oxygen in the delivered gas can be about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%. In at least one form, the delivered gas can be of atmospheric composition. In at least one form, the delivered gas can be ambient air.

[0109] As shown in FIGS. 2 and 3 described below, the respiratory therapy device 100 has various features to assist with the function, use, and / or form of the respiratory therapy device 100.

[0110] The pressure is controlled by driving the flow generator 110 of the respiratory therapy device 100 at a rate required to supply the desired pressure at the patient-side terminal 26 of the patient interface 340, and the controller 130 is used to adjust the flow generator 110 to achieve this.

[0111] The measure of flow conductance can be used to determine whether the mask is on the patient. In at least one form, the respiratory therapy system 1 can estimate whether the mask is on the patient using a leak detection system. The leak detection system can be implemented by the controller 130. The leak detection system can include a maximum allowable flow threshold. The controller 130 can be configured to monitor the gas flow through the respiratory therapy system 1. The controller 130 can be operably coupled to a flow sensor. The flow sensor can be configured to provide an indication of the measured flow rate through the respiratory therapy system 1 to the controller 130. The controller 130 is configured to compare the measured flow rate with the maximum allowable flow threshold and provide a leak output if the measured flow rate meets a leak condition. The leak condition can be that the measured flow rate continuously exceeds the maximum allowable flow threshold during a time window. The time window can be 200 ms.

[0112] The maximum allowable flow threshold can be constant. Alternatively, the maximum allowable flow threshold can be correlated to the measured pressure and the measured pressure differential. The maximum allowable flow threshold can further be correlated to the orifice conductance indicating the conductance of the orifice arrangement 25, the maximum leak conductance (Cmax) indicating an assumed leak comparable to the maximum allowable leak at the measured flow rate, and the lung compliance indicating the compliance of the user's respiratory system (the user's airway and / or lungs) in fluid communication with the respiratory therapy system 1. The maximum leak conductance can be correlated to the measured flow rate and the measured pressure. For example, the maximum leak conductance can be:

Equation

[0113] When excessive leakage is detected, the respiratory therapy system 1 may provide a leakage output in the form of a visual or audible alarm. The excessive leakage may be used as an indication that the patient interface 340 has been disconnected from the patient. A change in the excessive leakage, such as a transition from excessive leakage to an acceptable leakage level, may be used as an indication that the patient interface 340 is correctly positioned over the patient's face. The leakage output may be a first audible sound, for example, that sounds when an excessive leakage condition is detected. A transition from a condition where the leakage condition is not met to a condition where the leakage condition is met may be used as an indication that the patient interface 340 has been disconnected from the patient's face. In this case, the leakage output may be a second audible sound that sounds when this transition is detected. The first audible sound may be a different frequency than the second audible sound.

[0114] In some embodiments, the first pressure level is delivered to or near the patient-side termination 26 for the first time or within a first time window. The first pressure level may be delivered to or near the patient-side termination 26 once the fit of the mask, i.e., the attachment to the correct position, has been confirmed. The controller 130 may attempt to and control the first pressure level using a proportional-integral-derivative (PID) control system. The second pressure level may be delivered to or near the patient-side termination 26 for the second time or within a second time window. The second pressure level may be delivered to or near the patient-side termination 26 once the fit of the mask has been confirmed and a trigger signal is received by the respiratory therapy device 100 or the respiratory therapy system 1. The controller 130 may attempt to and continuously control the second pressure level using a PID control system. Alternatively, the controller 130 may attempt to and control the second pressure level using a second PID control system.

[0115] In one embodiment, the first pressure level is equal to the desired PEEP. Preferably, the first pressure is 1, 2, 3, 4, 5, 6, 7, or 8 cmH2O, and the effective range can be selected between any of these values (e.g., 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). Even more preferably, the first pressure is about 5 cmH2O.

[0116] Preferably, this pressure can be measured using a pressure sensor within the respiratory therapy device 100. Alternatively, this pressure can be measured at or near the patient interface 340. Alternatively, the pressure can be measured within the breathing conduit assembly 200. The pressure can then be stored in the memory of the controller 130.

[0117] The respiratory therapy device 100 can be configured to respond to a trigger signal by delivering a second pressure level.

[0118] When a trigger signal is detected by the controller 130, the second pressure level is delivered to or near the patient-side termination 26. In at least one embodiment, the second pressure level is equal to the desired PIP. Preferably, the second pressure is 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 cmH2O, and the effective range can be selected between any of these values (e.g., about 20 to about 30, about 30 to about 28, 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 cmH2O).

[0119] In some embodiments, the patient is inflated 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, or 60 times per minute, and the effective range can be selected between any of these values. The inflation can be performed with an inhalation time of 0.30, 0.32, 0.34, 0.36, 0.38, 0.40, 0.42, 0.44, 0.46, 0.48, or 0.50 seconds, and the effective range can be selected between any of these values.

[0120] In some embodiments, a higher pressure can be applied to the patient during the first, second, third, fourth, or fifth inflation.

[0121] In at least one embodiment, the trigger signal is provided by the operation of the trigger unit 320.

[0122] As described above, the controller 130 can return to the first pressure level once a further signal is detected or the signal stops. Once the trigger signal is received by the controller 130, the controller 130 may change the target pressure from the first pressure level to the second pressure level, or maintain the target pressure at the second pressure level during the duration that the trigger signal is continuously received by the controller 130. Once the operating trigger unit 320 is stopped or the generation of the signal of the trigger unit 320 stops, the controller 130 can return the target pressure to the first pressure level.

[0123] The reverse can also occur. That is, the target pressure can be set to the first pressure level during the duration that the trigger signal is received by the controller 130, and then set to the second pressure level once the trigger signal is no longer received.

[0124] In one form, the trigger signal may indicate the trigger unit 320 during initial activation, and this trigger signal does not continuously follow during the duration that the trigger unit 320 is in the activated state. The target pressure is initially set to a first pressure level, and then may be changed to a second pressure level when the trigger signal is received by the controller 130. Therefore, the trigger signal may only be transmitted again after the trigger unit is activated. Therefore, the controller 130 may return the target pressure level to the first pressure level when it receives the activation signal.

[0125] In one form, the trigger unit 320 may include at least two separate trigger units corresponding to two separate trigger signals. The controller 130 may set the target pressure to one pressure level when one trigger signal is received, and then set the target pressure to a different pressure level when the other trigger signal is received by the controller 130.

[0126] The trigger signal may be used to initiate the patient's mechanical ventilation. For example, no further activation of the trigger unit is required. In such a case, once the mechanical ventilation starts, the respiratory therapy system may cycle between PEEP and PIP at regular time intervals based on the desired respiratory rate, i.e., the breathing frequency. The desired respiratory rate may be set by the user or set as a stored setting within the controller 130.

[0127] The user and / or the respiratory therapy system 1 may also monitor the patient's respiratory rate, suction to remove fluid, and deliver surfactant to reduce the tendency of lung collapse. In at least one form, the surfactant may be provided to the patient by gas flow.

[0128] In at least one embodiment, the respiratory therapy system 1 may be configured to control the flow generator 110 to compensate for the altitude at which the respiratory therapy system 1 is placed. The controller 130 may be configured to use signals provided by one or more of the sensors 30, 31, and 32, such as flow, temperature, humidity, and / or pressure sensors, to estimate altitude or calculate altitude parameters of the respiratory therapy system 1. The altitude parameter may indicate the altitude of the respiratory therapy system 1 during use. The controller 130 may be configured to use the estimated altitude and / or altitude parameter to adjust the operation of the flow generator 110. This enables more accurate PIP and PEEP to be delivered to the patient.

[0129] Since the pressure levels of PIP and PEEP are generally determined or measured relative to the ambient pressure, compensation for altitude and / or ambient pressure can make the control of PEEP / PIP more accurate.

[0130] The respiratory therapy system 1 may compensate for ambient pressure and cause any pressure level setting to be with respect to the ambient pressure. This may be achieved by using a gauge pressure sensor within a pressure control algorithm, where the gauge pressure sensor measures the difference between the pressure in the gas flow and the ambient pressure. Alternatively, the pressure signal used may be the difference between the measurements of two absolute pressure sensors, one of which is exposed to ambient air and the other is disposed in the gas flow path.

[0131] In at least one embodiment, the respiratory therapy system 1 may be configured to monitor a patient's heart rate. In at least one embodiment, the respiratory therapy system 1 may be configured to monitor a patient's blood oxygen concentration (e.g., peripheral capillary oxygen saturation (SpO2)). The respiratory therapy system 1 may simultaneously monitor a patient's heart rate and blood oxygen concentration. The patient's heart rate and / or blood oxygen concentration may be measured using a pulse oximeter. The respiratory therapy system 1 may be configured to communicate with a pulse oximeter to receive heart rate and / or blood oxygen concentration data. The respiratory therapy system 1 may be configured to connect directly or wirelessly to a pulse oximeter. For example, the respiratory therapy device 100 may be configured to communicate with a pulse oximeter wirelessly or directly (i.e., by a physical electrical connection, such as a wired connection). The heart rate and / or blood oxygen concentration may be displayed on the user interface 140.

[0132] 2. Respiratory Therapy Device 100 Examples of the respiratory therapy device 100 are shown in FIGS. 2 and 3. The respiratory therapy device 100 includes a main housing having an upper chassis 102 and a lower chassis 202 of the main housing.

[0133] The main housing upper chassis 102 has a peripheral wall arrangement 106. The peripheral wall arrangement 106 defines a humidifier or a liquid chamber bay 108 for receiving a removable liquid chamber 300. The removable liquid chamber 300 contains a suitable liquid, such as water, for humidifying the gas delivered to the patient.

[0134] In the illustrated form, the peripheral wall arrangement 106 of the upper chassis 102 of the main housing includes a substantially vertical left outer wall 115. The peripheral wall arrangement 106 includes a substantially vertical left inner wall 112. The peripheral wall arrangement 106 includes an interconnecting wall 114. The left outer wall 115 is oriented in the front-to-back direction of the main housing. The left inner wall 112 is oriented in the front-to-back direction of the main housing. The interconnecting wall 114 extends between and interconnects the upper ends of the left inner and outer walls 115, 112. The upper chassis 102 of the main housing further includes a substantially vertical right outer wall 116. The right outer wall 116 is oriented in the front-to-back direction of the respiratory therapy device 100. The upper chassis 102 of the main housing includes a substantially vertical right inner wall 118. The substantially vertical right inner wall 118 is oriented in the front-to-back direction of the main housing. The upper chassis 102 of the main housing includes a second interconnecting wall 120. The second interconnecting wall 120 extends between and interconnects the upper ends of the right inner and outer walls 116, 118. The interconnecting walls 114, 120 are angled towards the respective outer edges of the main housing. Alternatively, the interconnecting walls 114, 120 may be substantially horizontal or angled inwards.

[0135] The upper chassis 102 of the main housing further includes a substantially vertical rear outer wall 122. The upper portion of the upper chassis 102 of the main housing includes a forwardly angled surface 124. The surface 124 has a recess for receiving the user interface 140. In one form, the user interface 140 may include a display. In one form, the user interface 140 may be in the form of a user interface module. A third interconnecting wall 128 extends between and interconnects the upper end of the rear outer wall 122 and the rear edge of the surface 124.

[0136] A substantially vertical wall portion extends downward from the front end of surface 124. A substantially horizontal wall portion extends forward from the lower end of the wall portion to form a shelf. A substantially vertical wall portion extends downward from the front end of the wall portion and terminates at a substantially horizontal floor portion of the liquid chamber bay. The left inner wall 112, the right inner wall 118, the wall portion, and the floor portion together define the liquid chamber bay. The floor portion of the liquid chamber bay is provided with a recess for receiving a heater arrangement. The heater arrangement may include a humidifier heating element. The heater arrangement may include a heating plate or other suitable one or more heating elements for heating the liquid within the liquid chamber 300 for use during the humidification process. The heating plate may transfer heat to the humidifier heating element. Therefore, the humidifier heating element may transfer heat to the heating plate. Thereby, the heating plate may transfer heat from the humidifier heating element to the liquid chamber 300. The humidifier heating element may include one or more resistive heating components. The humidifier heating element may include one or more resistive heating tracks.

[0137] The respiratory therapy device 100 includes a flow generator 110 generally configured with a motor 402 having an impeller that operates to deliver gas to a patient interface via a humidifier 120. The removable liquid chamber 300 includes an outer housing 302 that defines a liquid reservoir, a liquid chamber gas inlet port 306 in fluid communication with the liquid reservoir, and a liquid chamber gas outlet port 308 in fluid communication with the liquid reservoir. The respiratory therapy device 100 includes a handle / lever 500 that assists in the insertion and / or retention and / or removal of the liquid chamber 300 to and / or from the chamber bay 108. Different configurations may be configured to assist in one, two, or all of the insertion, retention, removal of the liquid chamber 300 to and / or from the chamber bay 108. The handle / lever 500 is pivotally attached to the main housing 100.

[0138] The respiratory therapy device 100 shown in FIG. 2A also includes a connection manifold arrangement 351 that includes a manifold gas outlet port 352 that is in fluid communication with a gas flow path from a flow generator via a fixed L-shaped joint. The connection manifold arrangement 351 further includes a manifold gas inlet port 350 (return of humidified gas) that serves as a removable L-shaped joint.

[0139] FIG. 2C shows the bottom surface of the respiratory therapy device 100. The respiratory therapy device 100 provides a chamber shaped to receive a motor assembly 400 that is removable. The inner wall of the recess may have guide and / or mounting features to assist in positioning and / or attaching the motor 400 within the recess. The motor assembly 400 includes a motor 402 that is a blower and includes an impeller that operates as a blower for delivering gas to the patient interface 340 via the liquid chamber 300. It will be appreciated that the shape of the chamber may vary depending on the shape of the motor assembly 400.

[0140] In the form shown in FIG. 3, the motor assembly 400 includes a stacked arrangement of three main components: a base 403, an outlet gas flow path and sensing component layer 420 positioned above the base 403, and a cover layer 440. The sensing component layer 420 may be or may include a sensing unit or sensing module. Assembling the base 403, the sensing component layer 420, and the cover layer 440 forms the motor and / or sensor assembly 400, and this shape is complementary to the shape of the motor recess, so the motor assembly and / or sensor 400 can be received within the motor recess. The motor 402 has a body 408 that defines an impeller chamber for receiving the impeller. The motor can be any suitable gas blower motor and can be, for example, a motor and impeller assembly of the type described in Patent Document 5 (International Publication No. WO 2013 / 009193), which is a published PCT specification. FIG. 4 shows the path of gas exiting the motor through the impeller and via the gas outlet port 452, after which the gas moves to the humidifier 120.

[0141] The breathing tube assembly 200 is coupled to the gas flow output 344 of the respiratory therapy device 100 and is coupled to the patient interface 340.

[0142] 3. Breathing Tube Assembly 200 The breathing tube assembly 200 directs the flow of air from the respiratory therapy device 100 to the patient interface 340.

[0143] Broadly speaking, the breathing tube assembly 200 includes a tube adapted to connect to the respiratory therapy device 100 and to connect to the patient interface 340. The breathing tube assembly 200 is configured to provide a pneumatic connection between the respiratory therapy device 100 and the patient interface 340. The breathing tube assembly 200 generally includes a heated breathing tube 210, for example, to reduce internal condensation by using a heating element 220 that extends through the breathing tube 210. An example of a heated breathing tube is shown in the PCT patent application published as Patent Document 6 (International Publication No. 2012 / 164407, incorporated by reference). The patient interface 340 may be removably connected to the breathing tube assembly 200.

[0144] Various connectors for connecting the breathing tube assembly 200 to the respiratory therapy device 100 and / or the patient interface 340 are described in the PCT patent application published as Patent Document 7 (International Publication No. 2017 / 077485, incorporated by reference).

[0145] 4. Patient Interface 340 As described above, the respiratory therapy system 1 includes a breathing tube assembly 200 for receiving humidified gas from the respiratory therapy device 100 and directing the gas flow toward the patient interface 340.

[0146] References to the patient interface 340 may include any one or combination of the following types, which should be recognized as not being considered limiting: a face mask configured to at least partially or preferably substantially seal the patient's face; an oral mask configured to at least partially or preferably substantially seal the patient's mouth and around it; an oro-nasal mask configured to at least partially or preferably substantially seal the patient's mouth and around it, and one or more of the patient's external nostrils and around them, or around the patient's nose; a nasal mask configured to at least partially or preferably substantially seal one or more of the patient's external nostrils and around them, or around the patient's nose; one or a pair of nasal prongs; an endotracheal tube; a T-piece of a resuscitator breathing therapy device 100; a gas flow regulator or gas pressure regulator associated with any one or more of these. In one form, one or a pair of nasal prongs may be configured to at least partially or preferably substantially seal one or more of the patient's external nostrils and around them.

[0147] The neonatal interface may be any interface as described above configured for use in a neonate. The neonatal interface may be configured to at least partially and preferably substantially seal around the patient's nose and mouth.

[0148] The use of the respiratory therapy system 1 improves the functions for the therapy method as compared to, for example, a respiratory therapy system that uses a wall source to provide a gas flow. Therefore, the assembly configuration of the respiratory therapy system 1 as described above improves the functions for resuscitation. For example, the use of the respiratory therapy device 100 as described above can detect excessive leakage conditions and enable user notifications that allow the user to reduce patient interface leakage. Patient interface leakage is the part of the flow at the patient-side terminal 26 that is not directly related to the patient's nose and / or mouth. Detection of patient interface leakage helps to ensure the proper and / or effective implementation of the therapy method for the patient. For example, if excessive leakage is detected at the patient interface, the patient interface 340 may need to be adjusted or replaced. The respiratory therapy system 1 may also include a function that enables determination of whether the patient interface 340 needs to be adjusted or replaced, and thus, when replaced, this function can place an automatic order for one or more parts or generate a request for inspection and repair services. Regarding determining whether the patient interface 340 needs to be adjusted or replaced, the controller 130 of the respiratory therapy device 100 can generate one or more messages for display on the user interface 140 to the user. The one or more messages may include advice and / or suggestions for improving the fit of the patient interface. In at least one form, the respiratory therapy system 1 can generate an audible signal indicating that the patient interface leakage is within an acceptable level (e.g., a target leakage flow rate range). For example, the respiratory therapy device 100 can generate an audible signal. The audible signal can be noise at a first frequency or within a first frequency range. The respiratory therapy device 100 of the respiratory therapy can generate a leakage audible signal indicating that the mask leakage is outside an acceptable level (e.g., a target leakage flow rate range). The leakage audible signal indicating that the mask leakage is outside an acceptable level can be at a different frequency from the audible signal indicating that the patient interface leakage is within an acceptable level.

[0149] 5. Connector element 310 In one embodiment, a connector element 310 is provided for use with a respiratory therapy system 1, the connector element 310 delivering gas to a patient in need of resuscitation and / or respiratory assistance. The connector element 310 includes: · An inlet 314 adapted to be in fluid communication with or integrated with a respiratory therapy device 100 that provides a supply of breathing suitable gas, · An outlet 316 adapted to be in fluid communication with a patient interface 340, and · A trigger portion 320 that produces a signal detectable by a trigger sensor 33 on or within the respiratory therapy device 100 including a housing.

[0150] Upon detecting a trigger signal (whether directly [e.g., pneumatic or electrical signal] or indirectly [e.g., wirelessly]), the controller 130 of the respiratory therapy device 100 is configured to adjust the target gas pressure provided to the inlet of the connector element 310.

[0151] The connector element 310 may be configured to be removably connected to the breathing conduit assembly 200. The connector element 310 may be configured to be removably connected to the patient interface 340. The connector element 310 may be directly connected to the breathing conduit assembly 200, for example, by being connected to a breathing conduit 210. In the illustrative form shown in FIG. 9A, the connector element 310 may be configured to be connected to an interface conduit 312. The interface conduit 312 defines an intermediate conduit between the connector element 310 and the breathing conduit 210. The interface conduit 312 may be configured to be removably connected to the breathing conduit 210.

[0152] The interface conduit 312 may have a different diameter than the breathing conduit 210. The outer diameter and / or cross-sectional area of the interface conduit 312 may be smaller than the inner diameter of the breathing conduit 210. The outer diameter of the interface conduit 312 may be smaller than the outer diameter of the breathing conduit 210. The inner diameter of the interface conduit 312 may be smaller than the inner diameter of the breathing conduit 210. In one embodiment, the breathing conduit assembly 200 includes a patient-side end connector 212. The patient-side end connector 212 may be at the boundary between the interface conduit 312 and the breathing conduit 210 to connect the interface conduit 312 and the breathing conduit 210 and ensure a continuous gas flow path.

[0153] The connector element 310 may further include a vent arrangement 25. The vent arrangement 25 may include one or more holes. The vent arrangement 25 provides an opening from the inside of the connector element 310 to the atmosphere. Therefore, the vent arrangement 25 may be configured to vent gas from the inside of the connector element 310 to the atmosphere. The vent arrangement 25 may assist in thermal flushing from the breathing circuit (e.g., flushing excessive heat generated by a flow generator), reduce rebreathing of CO2 by the patient, and maintain a stable oxygen concentration in the breathing conduit assembly 200.

[0154] In forms where the vent arrangement 25 has multiple holes, the holes may be the same size. Alternatively, the holes may be of a range of sizes. In some forms, the vent arrangement 25 includes one or more circular holes. In some forms, the vent arrangement 25 includes one or more oval holes. The vent arrangement 25 may be installed at one or more locations of the connector element 310. For example, the vent arrangement may be installed on the opposite side of the connector element 310 and / or on the surface of the connector element 310 around the inlet 314 or the outlet 316. The vent arrangement 25 may be installed towards the connector element outlet 316. Alternatively, the vent arrangement 25 may be installed very close to the trigger portion 320.

[0155] The connector element 310 may include a monitoring port 317. The monitoring port 317 allows access to the internal space of the connector element 310, for example enabling sampling of a gas in the connector element 310 or allowing introduction of a composition, such as a drug (e.g., a surfactant), into the connector element 310.

[0156] A specific embodiment of the connector element is shown in FIG. 10. The connector element 310 includes a hollow cylindrical body 313 having a gas inlet 314, a gas outlet 316, and a trigger port 321. The gas inlet 314 is in fluid connection with the gas outlet 316. A monitoring port 317 is also shown in FIG. 10. A helical rib 315 is provided outside the gas inlet 314 to enable attachment of an interface conduit 312. Other attachment forms, such as press fit, push fit, snap fit, or magnetic connection, are possible. As described, for example, in Patent Document 1 (International Publication No. 03 / 066146, incorporated by reference), the monitoring port 317 is shaped to receive a valve, a duckbill valve 311.

[0157] A concentric annular rim at the gas outlet 316 enables attachment of the patient interface 340. As long as the gas outlet 316 is attachable to the patient interface 340, other shapes are envisioned for the rim of the gas outlet 316. The interface conduit 312 may be removably connected to the gas inlet 314. The interface conduit 312 may be removably connected to the connector element 310, for example, by press fit, push fit, snap fit, screwing, or magnetic connection. Alternatively, the interface conduit 312 may be permanently connected to the gas inlet 314.

[0158] As shown in FIG. 5, the connector element 310 may include a protective cap 331. The protective cap 331 is removed before the connector element 310 and the patient interface 340 are coupled.

[0159] As shown in FIG. 10, the vent arrangement configuration 5 is installed at the trigger port 321. It will be recognized that the vent arrangement configuration 25 can be installed at another part of the connector element 310, provided that the gas can be discharged. For example, the vent arrangement configuration 25 can be installed at the gas inlet 314 and / or the gas outlet 316. In one embodiment, the vent arrangement configuration 25 may be installed on the hollow cylindrical body 313. In at least one form, the vent arrangement configuration 25 can be installed at the monitoring port 317. In at least one form, the connector element 310 can include two or more vent arrangement configurations 25. For example, one or more of the gas inlet 314, the gas outlet 316, the monitoring port 317, and the trigger port 321 can each include a respective vent arrangement configuration 25.

[0160] The connector element 310 includes one or more protrusions 322, 323. In at least one form, the trigger port 321 includes one or more protrusions 322, 323. In the form shown in FIG. 10, the connector element 310 includes four protrusions 322, 323. The protrusions facilitate the connection of the trigger part 320 to the connector element 310. In some embodiments, the vent arrangement configuration 25 is configured not to be blocked by the user's hand located directly below the trigger part 320 with respect to the outer surface of the patient interface. In other words, the vent arrangement configuration 25 can be shielded by the trigger part 320. In at least one form, the vent arrangement configuration 25 is shielded by the wall of the trigger part 320. Since a space is provided between the wall and the vent arrangement configuration, the vent arrangement configuration 25 remains in fluid connection with the atmosphere.

[0161] FIGS. 18B and 18C show alternative locations of the vent arrangement configuration 25. In these embodiments, ribs or other protruding features 319 prevent the user from accidentally blocking the vent arrangement configuration 25.

[0162] In one embodiment, the connector element 310 is in a "t", "T", or "Y" shape. Preferably, the trigger port 321 and the gas inlet 314 define the arms of the "t", "T" or "Y". Preferably, the gas outlet 316 defines the stem of the "t", "T" or "Y". In some embodiments, the stem of the connector element 310 includes a waist region or a small-diameter zone, and the waist or zone is where the trigger port 321 and the gas inlet 314 connect to the gas outlet 316. Preferably, the cross-sections of the arm region and the stem region of the "t", "T", or "Y"-shaped connector element 310 are circular.

[0163] As an alternative explanation, the connector element 310 can be formed as a cylindrical body having two or more zones of different diameters. Preferably, the diameter of the zone proximal to the gas outlet 316 is larger than the diameter of the zone distal to the gas outlet 316. Preferably, the trigger port 321 and the gas inlet 314 are cylindrical and connect to the cylindrical body of the connector element 310 in a small-diameter zone that defines the central portion of the connector element 310.

[0164] In embodiments including the monitoring port 317, the monitoring port 317 can exist as an extension of the cylindrical body of the connector element 310. For example, the monitoring port 317 can extend from the central portion of the connector element 310. Preferably, the monitoring port 317 can extend from the central portion of the connector element 310 as a circular protrusion. Preferably, the diameter of the protrusion defining the monitoring port 317 is smaller than the diameters of the gas outlet 316, the gas inlet 314, and the trigger port 321. In one embodiment, the monitoring port 317 includes a shelf extending around the circular protrusion of the monitoring port 317.

[0165] In some embodiments, as shown in FIG. 19B, the ventilation arrangement 25 is installed in the waist region of the connector element 310. That is, the ventilation arrangement 25 is installed on the cylindrical body of the connector element 310, where the diameter of the cylindrical body is reduced. For example, the ventilation arrangement 25 may be installed in the central portion of the connector element 310, where the gas inlet 314 and the trigger port 321 are connected to the cylindrical body of the connector element 310. The ventilation arrangement 25 may exist as one or more holes around the waist region of the cylindrical body of the connector element 310. In one embodiment, the ventilation arrangement 25 is arranged such that the spaced holes are in a concentric ring shape.

[0166] In some embodiments, as shown in FIG. 19C, the ventilation arrangement 25 is installed on a shelf extending around the circular protrusion of the monitoring port 317. That is, the ventilation arrangement 25 is installed on the base of the monitoring port, where it is connected to the central region of the connector element 310. The ventilation arrangement 25 may exist as one or more holes within the shelf. In one embodiment, the ventilation arrangement 25 is arranged as a concentric ring of spaced holes within the shelf.

[0167] In one embodiment, the connector element 310 includes ribs or other protruding features 319 adjacent to or very close to the ventilation arrangement 25. For example, the protruding feature 319 may be placed above, below, or both above and below the ventilation arrangement 25. As shown in FIG. 19B, the protruding feature 319 is installed above the ventilation arrangement 25. The protruding feature 319 may extend concentrically around the cylindrical body of the connector element 310, optionally as a continuous protrusion as shown in FIG. 19B, or as a series of discontinuous protrusions.

[0168] As shown in FIG. 19C, the protruding feature 319 may extend adjacent to or very close to the ventilation arrangement 25 installed on the shelf of the monitoring port 317. The protruding feature 319 may extend concentrically as a continuous protrusion as shown in FIG. 19C, or as a series of discontinuous protrusions.

[0169] 6. Trigger Unit Assembly and Sensor As described above, the respiratory therapy system 1 includes a trigger unit 320. The trigger unit 320 is configured to generate a signal detected by a trigger sensor 33 that communicates with the controller 130. Once the controller 130 determines that a signal has been detected by the trigger sensor, the controller 130 is configured to control the flow generator 110 to deliver at least a first pressure or a second pressure based on the use of the trigger unit 320.

[0170] In one embodiment, the trigger unit 320 is connected to a trigger sensor line 230, and the trigger sensor line 230 provides a signal to the trigger sensor 33.

[0171] In one embodiment, activation of the trigger unit provides a pneumatic signal to the trigger sensor 33 via the trigger sensor line 230. The trigger sensor line 230 may be separably connectable to the trigger sensor 33.

[0172] The trigger sensor line 230 may include reinforcing ribs in at least a portion of the internal lumen of the trigger sensor line 230. The benefit of the reinforcing ribs is that this may prevent overall or partial blockage of the trigger sensor line 230 when a compressive force is applied.

[0173] An embodiment of the pneumatic trigger unit 320 is shown in FIGS. 11-13. The illustrated trigger unit 320 includes a housing 326 and a movable member 332, which together define a compression chamber 341. In the embodiment shown in FIG. 11, the movable member 332 is an elastomeric button. The compression chamber 341 also includes a first trigger opening 328 and a second trigger opening 329. The trigger sensor line 230 is connected to the compression chamber 341 via the first trigger opening 328. The second trigger opening 329 provides an opening of the compression chamber 341 to the ambient conditions. The gas path through the first trigger opening 328 and the second trigger opening 329 is indicated by gas flow "A" in FIG. 12A. The second trigger opening 329 prevents false triggering due to changes in temperature or pressure by using the ambient conditions as a reference.

[0174] When the movable member 332 is pushed down to point "B" (as shown in FIG. 12B), the movable member 332 closes the second trigger opening 329. By subsequently moving the movable member 332 to point "C", a pressure increase in the compression chamber 341 is brought about, generating a pneumatic trigger signal, which is detected by the trigger sensor via the trigger sensor line 230 connected to the first trigger opening 328. In other words, the controller 130 is configured to monitor the pressure in the compression chamber 341 and the trigger sensor line 230 using the trigger sensor 33. The trigger pressure in the compression chamber 341 and the sensor line 230 may exceed a trigger pressure threshold, indicating activation of the trigger unit 320. The controller 130 may be configured to monitor the trigger pressure and provide an output when the trigger pressure exceeds the trigger pressure threshold.

[0175] In some embodiments, the trigger unit 320 includes an attachment device 327 on the housing 326 that holds the trigger unit 320 to the trigger port 321. As shown in FIG. 11, the attachment device 327 includes one or more clips that engage with corresponding holding elements on the trigger port 321.

[0176] In some embodiments, the trigger unit 320 includes an outer housing 324 that is placed surrounding the housing 326. Preferably, the outer housing 324 includes a housing holding member 325 that connects the housing 326 and the outer housing 324.

[0177] In some embodiments, the movable member 332 includes a feedback protrusion 333. The feedback protrusion may be on the upper surface of the movable member 332. The feedback protrusion 333 provides the user with tactile feedback regarding the position where the user's thumb / finger is placed on the upper surface of the movable member 332. It should be recognized that the feedback protrusion 333 can be any geometric shape that can indicate the position of the center point, such as a cross, a rounded square (squircle), or a hemisphere. The presence of the feedback protrusion 333 can also enhance the stability at the position where the thumb / finger is placed by functioning as a gripping surface.

[0178] In some embodiments, the trigger unit 320 includes a protruding collar 330 on the housing 326. Preferably, the protruding collar 330 holds the movable member 332 on the housing. In other words, the movable member 332 can be connected to the protruding collar 330. The movable member 332 can be removably connected to the protruding collar 330. The movable member 332 can be permanently connected to the protruding collar 330.

[0179] The surface of the feedback protrusion 333 can be textured to provide a gripping surface. The trigger sensor line 230 is connected to the compression chamber 341 through the first trigger opening 328. In particular, the first trigger opening 328 can be at least partially defined by the first trigger opening collar 328a. The trigger sensor line 230 can be connected to the first trigger port opening collar 328a. The trigger sensor line 230 can be removably or permanently connected to the first trigger port opening collar 328a by means such as interference fit, snap fit, etc.

[0180] In an embodiment where the signal is a pneumatic signal, the trigger sensor 33 can be a pressure sensor that detects a change in pressure. Alternatively, the trigger unit 320 can be a pneumatic switch that converts pneumatic pressure into an electrical signal, and the electrical signal is then detected by a sensor that communicates with the controller 130. The activation of the trigger unit 320 is detected by a differential pressure sensor via a sensor line, thereby generating a trigger signal. As an alternative, the differential pressure sensor can be disposed on the patient interface 340 or anywhere between the respiratory therapy device 100 and the patient interface 340 along the breathing conduit assembly 200.

[0181] If the differential pressure sensor is not disposed within the respiratory therapy system 1, the signal can be generated by the differential pressure sensor and sent to the respiratory therapy system 1, so the signal is transmitted wirelessly or by any other suitable means.

[0182] The trigger unit 320 can be installed on the respiratory therapy device 100, the breathing conduit 200, the connector element 310, or the patient interface 340. In an alternative embodiment, the trigger unit 320 can be installed away from the respiratory therapy device 100, the breathing conduit assembly 200, the connector element 310, or the patient interface 340. For example, the trigger unit can be electrically coupled to the respiratory therapy device 100 directly (i.e., wired) or indirectly (i.e., a removable plug). Alternatively, the trigger unit 320 can be transmitted to the flow respiratory therapy device 100 by using a wireless signal such as, for example, Wi-Fi, Bluetooth®, light, or infrared.

[0183] The trigger unit 320 can be configured to generate a signal detected by the trigger sensor 33, and the signal is an electrical signal. As shown in FIGS. 15A to 15D, the trigger unit 320 can be a switch, and when the switch is activated, it completes the circuit, so that it is detected by the trigger sensor 33 or the controller 130. Referring to FIGS. 15A to 15D for description, the connector element 310 can include a trigger unit 320 in the form of a switch installed, for example, on the housing 326. Therefore, the housing 326 can be installed on the outer housing 324 installed on the connector element 310. The housing 326 and the outer housing 324 can be formed as a single unitary component. When formed as separate components, a concentric annular ring 330 can be used to attach the housing 326 to the outer housing 324. The concentric annular ring 330 can include a mounting mechanism 335 that mates with a corresponding mechanism of the outer housing 324. The mounting mechanism 335 can be in the form of an interference fit, a press fit, a snap fit, or a magnetic connection. The housing 326 can be held in place by being sandwiched between the concentric annular ring 330 and the outer housing 324. The outer housing 324 includes spiral ribs and can be configured to threadably attach the housing 326 having corresponding spiral ribs to the outer housing 324.

[0184] As described above, the connector element can include a vent arrangement configuration 25 installed on the hollow cylindrical body 313 to allow the discharge of gas. As shown in FIG. 15C, the outer housing 324 can include a recess 337 adapted to the vent arrangement configuration 25 to allow the discharge of gas through the recess 337.

[0185] The outer housing 324 may include a retaining mechanism 334 that effects its attachment to the connector element 310 (as a component of the trigger portion 320), for example, via a corresponding attachment mechanism 322 on the connector element 310. This enables the trigger portion 320 to be removably connected to the connector element 310. As shown in FIG. 15C, the outer housing 324 may include a retaining mechanism 334 in the form of a clip or tab that engages in opposition to one or more protrusions 322 on the connector element 310. For example, the clip or tab of the retaining mechanism 334 may be elastically deformable to enable attachment and separation of the retaining mechanism 334 with respect to one or more protrusions 322 on the connector element 310. The clip or tab may include an attachment surface 336 that is positioned around one or more protrusions 322 to retain the outer housing 324 with respect to the connector element 310. In one embodiment, the pressure applied to the clip or tab on the distal side of the latch surface 336 may cause the body of the outer housing 324 to flex within a zone around the latch surface 336. The flexing of the body of the outer housing 324 within this zone may at least partially disengage the retaining mechanism 334 from the one or more protrusions 322, enabling the trigger portion 320 to be removed from the connector element 310. The removal of the trigger portion 320 may be in a direction perpendicular to the connector element 310. That is, in a direction parallel to the axis of rotation of the hollow cylindrical body 313. It will be appreciated that a range of retaining mechanisms may be used, such as a press fit, an interference fit, a snap fit, or a magnetic connection. It will also be appreciated that the retaining mechanism 334 also prevents inadvertent detachment or displacement of the trigger portion 320 from the connector element 310.

[0186] The trigger portion 320 may be installed on the connector element 310. When installed on the connector element 310, the trigger portion 320 is preferably installed at the trigger port 321. The trigger portion 320 may be separable from the trigger port 321.

[0187] By making the trigger unit 320 removably connectable to the trigger unit 320 and its components (i.e., the housing 326 and / or, if present, the outer housing 324), the trigger unit 320 can be reprocessed after use and, therefore, can be reused later.

[0188] The removably connectable trigger unit 320 also enables the trigger unit 320 to be actuated from a position remote from the connector element 310. For example, under usage conditions, a first person may hold the patient interface 340 in place so as to cover the upper side of the patient's mouth and / or nose (appropriately), at which time a second person may control the actuation of the trigger unit 320. The trigger unit 320 may include an extensible sensor line that can, for example, maintain a coiled shape within or above the connector element 310 when in a retracted position.

[0189] As described above, the trigger sensor 33 can detect an electrical signal generated when the trigger unit 320 is actuated. The electrical signal can be generated only when the trigger unit 320 is actuated, and each subsequent actuation of the trigger unit 320 provides an electrical signal for the trigger sensor 33. For example, actuation of the trigger unit 320 can generate an electrical signal detected by the trigger sensor 33, whereby the controller 130 of the respiratory therapy device 100 adjusts the target gas pressure provided at the inlet of the connector element 310 to a first pressure level. Subsequent actuation of the trigger unit 320 can generate an electrical signal detected by the trigger sensor 33, whereby the controller 130 of the respiratory therapy device 100 adjusts the target gas pressure provided at the inlet of the connector element 310 to a second pressure level.

[0190] Alternatively, the activation of the trigger unit 320 may generate an electrical signal detected by the trigger sensor 33, whereby the controller 130 of the respiratory therapy device 100 adjusts the target gas pressure applied to the inlet of the connector element 310 to a first pressure level during the duration that the trigger unit 320 is activated. That is, once the trigger unit 320 is no longer activated, the controller 130 adjusts the target gas pressure applied to the inlet of the connector element 310 to a second pressure level.

[0191] The electrical switch may have two or more positions, and the electrical signal is delivered when the switch is in one of those positions. The switch may be biased to a default position and generate an electrical signal by moving from the default position, causing the controller 130 to adjust the target gas pressure to the first pressure level. By releasing the switch, the switch may be returned to the default position, causing the controller 130 to adjust the target gas pressure to the second pressure level. The switch may not be biased; instead, the user may need to move the switch between two or more positions.

[0192] The trigger unit 320 may include two or more electrical switches, and the electrical signal is generated when the user activates the first switch and stops only when the user activates the second or subsequent switch. That is, the electrical signal causes the controller 130 to adjust the target gas pressure to the first pressure level and to the second pressure level when the signal generation stops.

[0193] When using an electrical switch, there may be an advantage in that the controller 130 can automatically determine when the trigger unit is correctly connected. For example, the controller 130 may detect the resistance in the circuit to determine whether it is correctly connected by comparing the detected resistance with a stored reference.

[0194] A portion of the trigger sensor line 230 may pass through at least a portion of the interface conduit 312 and terminate at the trigger portion 320 within the connector element 310. Incorporating a portion of the trigger sensor line 230 within the interface conduit 312 enhances the usability of the patient interface by minimizing obstacles that would otherwise affect the user. Alternative embodiments may include the trigger sensor line 230 disposed external to the patient interface 340. This may assist in reducing the resistance to flow in the main gas path. In an alternative embodiment, the interface conduit 312 may be a multi-lumen line and the sensor line may pass between lumen layers.

[0195] In one embodiment, the trigger portion 320 is pneumatic and the trigger portion 320 takes the form of a compression chamber 341.

[0196] Figures 18A - 18C illustrate alternative connector elements 310 to those described above. The connector elements 310 of Figures 18A - 18C provide an alternative path with respect to ambient reference by including an atmospheric reference orifice 329 in the movable member 332. In this embodiment, the housing 326 and the movable member 332 together define a compression chamber 341. As shown in Figure 11, the movable member 332 may include a feedback protrusion 333 on its upper surface. The feedback protrusion 333 provides the user with tactile feedback regarding the position of the user's thumb / finger placement on the upper surface of the movable member 332. It should be recognized that the feedback protrusion 333 may be any geometric shape that indicates the presence of a center point, such as a cross, a rounded square, or a hemisphere. The presence of the feedback protrusion 333 also enhances stability within the thumb / finger placement position by functionally defining a gripping surface. Therefore, when the user places the user's thumb or finger on the movable member 332 to generate a signal, the finger or thumb also blocks the atmospheric reference orifice 329.

[0197] In some embodiments, when the trigger unit 320 is installed on the breathing tube assembly 200 or the connector element 310 or the patient interface 340, the trigger sensor line 230 may extend on or over a portion of the outer surface of the breathing tube assembly 200. In such embodiments, the breathing tube assembly 200 may include a retaining element for retaining the trigger sensor line 230. The retaining element may be a clip or a sleeve that retains the trigger sensor line 230 relative to the breathing tube assembly 200.

[0198] As shown in FIG. 4, in a preferred embodiment, the trigger sensor line 230 extends from the first trigger opening 328 (or the first trigger port opening collar 328a), through the interface conduit 312, out through the sidewall of the interface conduit 312 to the L-shaped joint 231, and through a length portion of the breathing tube 210 to the sensor port 161.

[0199] In some embodiments, when the trigger unit 320 is installed on the breathing tube 210, the connector element 310 or the patient interface 340, the trigger sensor line 230 may extend within or over a portion of the breathing tube 210.

[0200] Preferably, the trigger sensor line 230 does not interfere with access to the connector element 310 of any peripheral device. This is particularly shown in FIG. 13, where the orientation of the trigger unit 320 is such that the trigger sensor line 230 does not interfere with access through the duckbill valve and / or the monitoring port of any peripheral device due to the orientation of the orifice 328.

[0201] In one embodiment, the respiratory therapy system 1 includes a sensor line connector 240. An example of the sensor line connector 240 is shown in FIGS. 7A and 7B. As can be seen from FIGS. 7A and 7B, the sensor line connector 240 includes a cylinder-shaped hollow body having a sensor line connector gas inlet 241 and a sensor line connector gas outlet 242, and further includes a line connection port 243. The inner diameter of the gas inlet is substantially the same as the outer diameter of the gas outlet of the interface connector 211, thereby enabling a coaxial connection. The outer diameter of the gas outlet 242 includes a spiral rib 244, the pitch of which is substantially the same as the optional beads of the interface tube 312, thereby enabling a coaxial connection by rotating and advancing the interface tube on the sensor line connector 240. The trigger sensor line 230 may include a first sensor line portion and a second sensor line portion. The first sensor line portion may be configured to connect to the first trigger opening 238. The second sensor line portion may be configured to connect to the sensor port 161. A sensor line port 245 within the lumen of the sensor line connector from the line connection port 243 provides a pneumatic path between the first sensor line portion and the second sensor line portion. The sensor line port 245 is shaped to minimize the flow resistance added to the main gas path 24. A cross-section of the sensor line connector as shown in FIG. 8 highlights the pneumatic path 247 for the trigger sensor line 230.

[0202] In at least one embodiment as shown in FIG. 4, a sensor line connector 240 is provided to connect between the patient interface 340 and the interface conduit 312. As shown by arrow "D" in FIG. 6, the main path of the gas path suitable for breathing passes through the internal portion of the breathing conduit assembly 200 via the patient-side end connector 212. Another patient-side end connector 212 is described in Patent Document 8 (International Publication No. 2017 / 037660), and is incorporated by reference thereto. In this embodiment, the trigger sensor line 230 passes through the outside up to the L-shaped joint connector 231 leading to the sensor line connection portion installed in the breathing conduit 210.

[0203] Therefore, the first sensor line portion 248 is disposed at least partially within the interface conduit 312. In some embodiments, this may further be substantially coaxial.

[0204] As described above, in an alternative embodiment, the trigger sensor line 230 may be outside the interface conduit 312. The interface connector 211 and the patient-side end connector 212 are utilized to connect between the interface conduit 312 and the breathing conduit 210. In one embodiment as shown, the interface connector 211 and the patient-side end connector 212 are separate elements. In an alternative embodiment, the interface connector 211 and the patient-side end connector 212 may be formed as a unitary interface connector and patient-side end connector. Further, the interface connector 211 and the patient-side end connector 212 may also incorporate the sensor line connector 240.

[0205] The patient-side end connector 212 is where the respiratory conduit assembly 200 and the heating wire 220 terminate. The respiratory conduit assembly 200 may further include a conduit sensor 32. The conduit sensor 32 may be configured to provide an indication of the temperature of the gas near the patient-side end connector 212. The controller 130 is configured to monitor the conduit sensor 32. The diameters of the interface conduit 312 and the respiratory conduit 210 may not be similar. Alternatively, the cross-sectional profiles of the interface conduit 312 and the respiratory conduit 210 may not be similar. The interface connector 211 mainly enables connection between the dissimilar cross-sectional profiles of the interface conduit 312 and the respiratory conduit 210. The cross-sectional profile of the interface conduit 312 may be smaller than the cross-sectional profile of the respiratory conduit 210. In other words, the cross-sectional area of the interface conduit 312 may be smaller than the cross-sectional area of the respiratory conduit 210. In at least one form, the diameter of the interface conduit 312 may be smaller than the diameter of the respiratory conduit 210.

[0206] Other interface connectors are described in Patent Document 9 (International Publication No. WO 2013 / 022356), which is incorporated by reference herein.

[0207] In one embodiment, the respiratory therapy device 100 includes a removable gas outlet 160. As shown in FIG. 17, the removable gas outlet 160 includes a sensor port 161. The device sensor 33 is operably coupled to the sensor port 161. Therefore, the device sensor 33 can provide a display of measurable parameters at the sensor port 161. The device sensor 33 is operably coupled to the controller 13. Therefore, the controller 13 can receive a display of measurable parameters using the device sensor 33. The device sensor 33 of this embodiment is a differential pressure sensor. The device sensor 33 includes a first port 162 for measuring the pressure in the compression chamber. The device sensor 33 includes a second port 163 for defining an ambient pressure reference. The removable gas outlet 160 includes a trigger sensor line 230 between the sensor port 161 and the first port 162. This device sensor 33 is connected to the controller 130 by an electrical connection 164. The trigger sensor line 230 can be operably coupled to the device sensor 33. For example, the trigger sensor line 230 can be connected to the sensor port 161.

[0208] FIG. 20 further shows an alternative interface connector 211 that includes features of the sensor line connector 240. The alternative interface connector 211 includes an L-shaped joint 240 that transfers the trigger sensor line 230 from outside the alternative interface connector 211 to inside the alternative interface connector 211. In one embodiment, the alternative interface connector 211 includes an internal conduit 246. Preferably, the sensor line passes through the internal conduit 246. The inner diameter of the interface connector 211 is substantially the same as the outer diameter of the interface conduit 312, thereby enabling a coaxial connection.

[0209] In one embodiment, the trigger portion can be a biased trigger portion. That is, the movable member 332 is movable between a first position and a second position and can be biased toward the first position.

[0210] Therefore, the trigger unit 320 is movable between an inactive state and an active state. Preferably, the active state is when the trigger unit 320 generates a detection by the signal or the trigger sensor 33. Preferably, when the trigger unit 320 is in the active position, the respiratory therapy device 100 adjusts the provided gas pressure from the first pressure to the second pressure. More preferably, when the trigger unit 320 is in the active position, the gas pressure is adjusted from PEEP to PIP. The active position may correspond to the active state of the trigger unit 320. The inactive position may correspond to the inactive state of the trigger unit 320. The movable member 332 may be movable between the active position and the inactive position. The inactive stop position may correspond to the first position. The active position may correspond to the second position.

[0211] In one embodiment, activation of the trigger unit 320 initiates continuous spontaneous breathing at 30, 35, 40, 45, 50, 55, 60 breaths per minute, and the effective range may be selected between any of these values (e.g., about 30 to about 60, about 30 to about 50, about 30 to about 45, about 35 to about 60, about 35 to about 45, about 40 to about 60, about 45 to about 60 breaths per minute).

[0212] In one embodiment, activation of the trigger unit results in continuous spontaneous breathing until the trigger unit is activated again. In one embodiment, activation of the trigger unit results in continuous spontaneous breathing until the patient interface is removed. In one embodiment, activation of the trigger unit results in continuous spontaneous breathing for the duration that the trigger unit is continuously activated.

[0213] 7. User Interface The user interface is configured to provide a visible output to the patient and / or user. The user interface 140 may be configured to provide a visible output representing the state of the respiratory therapy system 1 or the therapy parameters. The user interface is configured to deliver a message to the patient and / or user. The user interface may include a wireless communication system or a remote computer such as a tablet.

[0214] In some embodiments, the user interface 140 may include a touchscreen display that provides information to a patient or user of the respiratory therapy system 1. In some embodiments, the information may relate to the status of the respiratory therapy system 1 or its components, the status of the therapy being administered, the status of the patient, and / or the status of accessories or peripherals associated with the respiratory therapy system 1. The display may include one or more markers, each of which provides information about a respective aspect of the therapy; for example, the temperature of the gas, the oxygen concentration, the gas flow rate, the blood oxygen concentration (SpO2), and the heart rate. Other markers may also be provided. The markers may also serve as the function of "buttons" on the touchscreen, and by pressing one of the markers, the user can change the settings in terms of the therapy, the respiratory therapy system 1, and / or the accessories or peripherals associated with the respiratory therapy system 1, whereby the controller 130 then adjusts the respiratory therapy system 1 or the accessories or peripherals to the new settings.

[0215] FIG. 18 shows an example of a user interface 140 including a touchscreen used to monitor and control the operation of the device 100. A suitable user interface is described in Patent Document 10 (International Publication No. 2019 / 112447, incorporated by reference), which provides a disclosure of a graphical user interface for controlling the respiratory therapy device 100.

[0216] In the proposed system, the touchscreen may provide a graphical real-time display of the pressure delivered to the patient at the distal end 26 during use, an example of which is shown in FIG. 18. The solid-line waveform represents the display of the delivered pressure, and the dotted line provides the display of the desired PIP 502 and PEEP 501. The touchscreen may further include a start / stop button for starting or interrupting the therapy, a target PIP setting for defining the delivered PIP, a target PEEP setting for defining the delivered PEEP, and a display of the respiratory rate delivered based on the rate at which the user triggers the delivery of the PIP.

Claims

1. 1. A respiratory therapy device configured to provide a flow of breathable gas to a patient at at least a first pressure and a second pressure, the respiratory therapy device comprising: a flow generator configured to provide said flow of breathable gas; a controller coupled to the trigger sensor for controlling operation of the respiratory therapy device; Including, The respiratory therapy device comprises: a respiratory conduit assembly for delivering said breathable gas to a patient via a patient interface; a trigger portion for generating a signal detectable by the trigger sensor; and The controller is configured to control the flow generator to provide a flow of breathable gas at at least the first pressure or the second pressure based on detection of the signal from the trigger.

2. a respiratory therapy device configured to provide a flow of breathable gas to a patient at at least a first pressure and a second pressure; a flow generator configured to provide said flow of breathable gas; A controller coupled to the trigger sensor for controlling operation of the respiratory therapy device. a respiratory therapy device comprising: a respiratory conduit assembly for delivering said breathable gas to a patient via a patient interface; a trigger section for generating a signal detectable by the trigger sensor; 1. A respiratory therapy system comprising: The controller is configured to control the flow generator to provide a flow of breathable gas at at least the first pressure or the second pressure based on detection of the signal from the trigger.

3. 3. A respiratory therapy device or system as described in claim 1 or 2, wherein the second pressure is greater than the first pressure.

4. A respiratory therapy device or system according to any preceding claim, wherein the first pressure is related to maximum end-expiratory pressure (PEEP).

5. A respiratory therapy device or system according to any preceding claim, wherein the second pressure is related to maximum inspiratory pressure (PIP).

6. A respiratory therapy device or system according to any preceding claim, wherein the trigger is a biased trigger.

7. the trigger portion includes a movable member biased toward an inactive position; and 7. A respiratory therapy device or system according to claim 6, wherein the controller is configured to deliver a maximum end-expiratory pressure (PEEP) when the movable member is in the inactive position.

8. 7. The respiratory therapy device or system of claim 6, wherein the controller is configured to deliver a peak inspiratory pressure (PIP) when the movable member is in the inactive position.

9. A respiratory therapy device or system according to any preceding claim, wherein the controller is configured to deliver a maximum end-expiratory pressure (PEEP) based on the detection of a signal produced by the trigger.

10. A respiratory therapy device or system according to any preceding claim, wherein the controller is configured to deliver a peak inspiratory pressure (PIP) based on the detection of a signal produced by the trigger.

11. 10. The respiratory therapy device or system of claim 9, wherein the respiratory therapy system delivers a maximum end-expiratory pressure (PEEP) for the duration that the trigger is activated.

12. 11. The respiratory therapy device or system of claim 10, wherein the respiratory therapy system delivers a peak inspiratory pressure (PIP) for the duration that the trigger is activated.

13. A respiratory therapy device or system according to any preceding claim, comprising a humidifier configured to humidify the breathable gas.

14. 14. The respiratory therapy device or system of claim 13, wherein the humidifier is integrated with the respiratory therapy device.

15. A respiratory therapy device or system according to any preceding claim, wherein the respiratory conduit assembly includes a heated respiratory conduit.

16. The respiratory therapy device or system according to any one of claims 1 to 15, wherein the trigger unit is connected to the trigger sensor via a trigger sensor line.

17. A respiratory therapy device or system according to any preceding claim, wherein the trigger portion includes a compression chamber.

18. 20. A respiratory therapy device or system as claimed in claim 17, wherein the trigger sensor is configured to provide an output to the controller indicative of compression chamber pressure.

19. A respiratory therapy device or system according to any preceding claim, wherein the trigger sensor is a gauge pressure, absolute pressure or differential pressure sensor.

20. 20. The respiratory therapy device or system of claim 18 or 19, wherein the controller is configured to control the respiratory therapy system to deliver the first pressure when the compression chamber pressure is below a compression chamber pressure threshold and the second pressure when the compression chamber pressure is above the compression chamber pressure threshold.

21. 21. The respiratory therapy device or system of claim 19 or 20, wherein the controller is configured to control the respiratory therapy system to deliver the second pressure when the compression chamber pressure is below a compression chamber pressure threshold, and to deliver the first pressure when the compression chamber pressure is above the compression chamber pressure threshold.

22. A respiratory therapy device or system according to any one of claims 16 to 21, wherein the trigger sensor line is located external to the respiratory conduit assembly.

23. A respiratory therapy device or system according to any one of claims 16 to 22, wherein the trigger sensor line is located internal to the respiratory conduit assembly.

24. A respiratory therapy device or system according to any preceding claim, wherein the respiratory therapy system includes a connector element disposed between the respiratory conduit assembly and the patient interface.

25. 25. The respiratory therapy device or system of claim 24, wherein the trigger portion is disposed on the connector element.

26. 26. The respiratory therapy device or system of claim 24 or 25, wherein the connector element has a first outlet in fluid communication with the patient interface, an inlet in fluid communication with the respiratory conduit assembly, and an opening defining a chamber, and the trigger portion is located on the chamber.

27. A respiratory therapy device or system according to any one of claims 16 to 26, wherein a portion of the trigger sensor line terminates at the trigger portion within the connector element.

28. 28. A respiratory therapy device or system as described in any one of claims 24 to 27, wherein the connector element is "T" shaped and includes a hollow cylindrical body provided with a gas inlet, a gas outlet, a monitoring port, and a trigger port.

29. A respiratory therapy device or system according to any preceding claim, wherein the respiratory therapy device includes a vent arrangement.

30. 30. The respiratory therapy device or system of claim 29, wherein the vent arrangement is located on the connector element or the respiratory conduit assembly.

31. A respiratory therapy device or system according to any preceding claim, wherein the trigger sensor is located on the respiratory conduit assembly or the patient interface.

32. A respiratory therapy device or system as described in any one of claims 17 to 31, wherein the trigger portion is a pneumatic trigger portion including a housing and a movable member, the housing and the movable member at least partially defining the compression chamber.

33. 33. A respiratory therapy device or system as described in claim 32, wherein the trigger portion includes a plurality of protrusions within the compression chamber to define limits of inward deflection of the movable member.

34. 34. A respiratory therapy device or system as claimed in claim 32 or 33, wherein the trigger portion includes a protrusion that provides tactile feedback to the user relating to the position of the user's thumb / finger relative to the movable member.

35. A respiratory therapy device or system according to any preceding claim, wherein the triggering portion includes at least one electrical switch.

36. 36. A respiratory therapy device or system as described in claim 35, wherein the switch, when activated, completes a circuit so that it is detected by the trigger sensor or the controller.

37. 37. A respiratory therapy device or system as described in claim 35 or 36, wherein actuation of the trigger generates an electrical signal that is detected by the trigger sensor, thereby causing the controller to adjust the target gas pressure.

38. 37. A respiratory therapy device or system as described in claim 35 or 36, wherein actuation of the trigger portion generates an electrical signal that is detected by the trigger sensor, thereby causing the controller to adjust the target gas pressure provided to the inlet of the connector element for the duration that the trigger portion is actuated.

39. A respiratory therapy device or system according to any one of claims 35 to 38, wherein the electrical switch has two or more positions, and an electrical signal is delivered when the switch is in one of the positions.

40. A respiratory therapy device or system as described in any one of claims 35 to 38, wherein the trigger portion includes two or more electrical switches, and when a user activates a first switch, an electrical signal is generated, and generation of the electrical signal ceases only when the user activates a second or subsequent switch.

41. The trigger portion is removably attached to the connector element, and the trigger portion comprises: i) a respiratory therapy device or system; ii) a connector element, or iii) (i) and (ii) 41. A respiratory therapy device or system according to any preceding claim adapted to interact with:

42. 1. A connector element for use with a respiratory therapy system for delivering gas to a patient in need of resuscitation and / or respiratory assistance, the connector element comprising: A housing, an inlet adapted to be in fluid communication with or integrated into a respiratory therapy device providing a supply of breathable gas; an outlet adapted to be in fluid communication with a patient interface; A trigger that produces a signal detectable by a trigger sensor on or within the respiratory therapy device. Including, housing Including, The respiratory therapy device includes a controller configured to control a gas pressure provided to the inlet based on the signal from the trigger.

43. The connector element of claim 42, wherein the trigger portion is connected to the trigger sensor via a trigger sensor line.

44. 44. The connector element of claim 42 or 43, wherein the trigger portion is removably connected to the connector element.

45. The connector element of claim 44, wherein the trigger portion is separable from the housing.

46. 46. ​​A connector element according to claim 44 or 45, wherein the trigger portion comprises an expandable sensor line.

47. A connector element according to any one of claims 44 to 46, wherein the sensor line is mounted on or contained within the connector element when the trigger portion is connected (i.e. attached) to the connector element.

48. A connector element according to claim 44 or 45, wherein the trigger portion transmits to the trigger sensor by using a wireless signal, for example a Wi-Fi, Bluetooth, light or infrared signal.

49. A connector element according to any one of claims 42 to 48, wherein the signal is indicative of the trigger portion being actuated.

50. The connector element of any one of claims 42 to 49, configured to be removably connected to a respiratory conduit assembly in fluid communication with the respiratory therapy device.

51. A connector element according to any one of claims 42 to 50, configured for releasable connection to the patient interface.

52. A connector element according to any one of claims 42 to 51, comprising a monitoring port.

53. A connector element according to any one of claims 42 to 52, including a vent arrangement, said vent arrangement providing an opening from within the connector element to atmosphere.

54. A connector element according to any one of claims 42 to 53, wherein the vent arrangement is located in close proximity to the trigger portion.

55. A connector element according to any one of claims 42 to 54, wherein the vent arrangement is located in close proximity to the monitoring port.

56. A connector element according to any one of claims 42 to 55, wherein the vent arrangement comprises one or more holes.

57. A connector element according to any one of claims 42 to 56, comprising one or more protrusions adjacent the vent arrangement, the one or more protrusions preventing the user from inadvertently blocking the vent arrangement.

58. The connector element of any one of claims 42 to 57, having a "t", "T", or "Y" shape.

59. 1. A method of administering pressure therapy to a patient, comprising: delivering breathable gas to a patient via a respiratory therapy system including a flow generator and a trigger; - detecting a signal generated by the trigger portion; and providing a maximum end-expiratory pressure (PEEP) or a maximum inspiratory pressure (PIP) to the patient in response to the detected signal; A method comprising:

60. 1. A method of administering pressure therapy to a patient, comprising: a respiratory therapy system configured to provide at least a maximum end-expiratory pressure (PEEP) and a maximum inspiratory pressure (PIP), the respiratory therapy system including a flow generator configured to deliver breathable gas to a patient, at least one trigger sensor, and a controller coupled to the trigger sensor for controlling operation of the respiratory therapy system; a respiratory conduit assembly for delivering said breathable gas to a patient via a patient interface; a trigger section for generating a signal detectable by the trigger sensor; To provide: and operating the respiratory therapy device to deliver at least a maximum end-expiratory pressure (PEEP) and a maximum inspiratory pressure (PIP) at the patient interface, the controller being configured to adjust the flow generator to deliver at least a PEEP or a PIP based on use of the trigger. A method comprising:

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