Breathing apparatus and system for positive airway pressure ventilation and continuous positive airway pressure therapy for neonatal resuscitation

Abstract

A breathing device (10) for positive airway pressure (PPV) and continuous positive airway pressure (CPAP) treatment of neonatal resuscitation is described. The breathing apparatus comprises: a body member (20) comprising: a breathing gas inlet (22); a breathing gas outlet (24) fluidly coupled with the breathing gas inlet and fluidly coupleable with a patient interface (510); a first gas outlet (26) for releasing breathing gas to the surroundings; and a second air outlet (28) fluidly coupleable to an exhalation valve (32) or an exhalation branch (52) of a respirator (210); and a CPAP generator (30) fluidly coupled between the breathing gas inlet and the breathing gas outlet. The breathing device may operate in a CPAP mode based on release of breathing gas from the body component to the ambient environment through the first gas outlet, or in a PPV mode based on at least intermittent blocking of the first gas outlet.

Description

Technical Field

[0001] The present invention generally relates to the field of respiratory devices and systems. In particular, the present invention relates to a respiratory device and system for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment for neonatal resuscitation and / or initial respiratory support. Background Art

[0002] A large number of newborns are unable to initiate breathing on their own after birth and require respiratory support or artificial respiration (also known as mechanical ventilation). Generally, about 85% of newborns can initiate breathing on their own, about 10% of newborns require additional stimulation, and about 5% of newborns require respiratory support and / or mechanical ventilation. In particular, premature infants, such as newborns with a gestational age of less than 259 days, may experience respiratory distress and thus require neonatal resuscitation.

[0003] In neonatal resuscitation, newborns who can breathe spontaneously to a certain extent are usually treated with continuous positive airway pressure ventilation (CPAP treatment or ventilation). This non-invasive ventilation keeps the lungs "open" by applying a continuous low-level airway positive pressure (CPAP), i.e., positive end-expiratory pressure (PEEP). During CPAP ventilation, an oxygen-air mixture is usually delivered to the pharynx of the child in a slightly overpressurized manner, so that even during exhalation, a part of the air or the mixture remains in the lungs, thereby preventing alveolar collapse through positive end-expiratory pressure or continuous overpressure. For newborns who are completely unable or can only breathe weakly on their own, respiratory support is required through positive pressure ventilation (PPV).

[0004] In the field of neonatal resuscitation, positive pressure ventilation (such as when respiratory arrest occurs) is usually performed using a resuscitation bag or a T-piece device, for example, using a face mask as the interface with the newborn, or tracheal intubation (ET tube). In face mask ventilation, according to established guidelines, ventilation with CPAP and / or PEEP is preferably used. Since the resuscitation bag cannot maintain the CPAP and / or PEEP pressure, the T-piece device or ventilation system has been widely used in the clinical neonatal resuscitation and initial respiratory support workflow.

[0005] Traditional T-tubes or T-tube devices typically include three openings. One is for receiving fresh breathing gas, such as a flow supply or breathing gas supply (e.g., an oxygen-air mixture) from a first aid unit or a resuscitation device. Another opening is for delivering the breathing gas to the patient, which can be directly delivered to the patient's lungs through an interface (such as a breathing mask closely attached to the child's mouth and nose) or an endotracheal tube (ET tube). The third opening can be designed as an outlet or a valve for generating PEEP and / or CPAP pressure. In a resting state, all the gas can flow through this outlet to the environment, and CPAP / PEEP pressure is established in the pipeline system and the patient's lungs by means of flow resistance. When the patient has a certain degree of spontaneous breathing ability, fresh gas is inhaled and waste gas is exhaled through this outlet, thus maintaining the CPAP / PEEP pressure, and even at the end of exhalation, the pressure does not drop to the ambient pressure.

[0006] When respiratory arrest and / or PPV ventilation occur, the outlet of the T-tube can be manually blocked, for example, by covering it with a finger, so that the pressure in the pipeline system rises rapidly, enabling manual or mechanical inhalation and filling the lungs. To prevent lung damage caused by overinflation or overventilation, a pressure release valve or an expiratory valve is typically provided in a typical neonatal resuscitation device, which automatically opens when the pressure reaches the maximum value or the release threshold. Once the finger is removed from the outlet of the T-tube, the pressure can drop back to the CPAP / PEEP level, guiding the patient to exhale.

[0007] Resuscitation devices using T-tubes or CPAP devices based on the so-called Benveniste valve (described in detail later) differ in function and working principle from the mechanical ventilation and / or PPV methods of ventilators (also known as ventilators) used in hospitals. Such ventilators usually have a closed pipeline system and use a Y-shaped joint to divide the system into two branches: one is the inhalation branch for delivering fresh breathing gas; the other is the exhalation branch for discharging some or all of the used breathing gas. The lower end or the common end of the Y-shaped joint can be coupled with an ET tube to perform PPV ventilation. The infant ventilator continuously delivers breathing gas to the Y-shaped joint and the lungs in the inhalation branch and then returns through the exhalation branch. An expiratory valve is usually provided at the end of the exhalation branch, and the ventilator controls the pressure of the entire pipeline system or the CPAP pressure through this valve. When the expiratory valve closes, inhalation is triggered, and the pressure in the system rises, forming ventilation pressure or PPV to inflate the lungs; when the maximum pressure or release pressure is reached, the valve reopens, and after a short stay, the pressure drops to the initial or CPAP / PEEP pressure, guiding the exhalation process to occur.

[0008] Other examples of CPAP ventilation or treatment devices can be based on the Benveniste valve, which is designed as a pure non-invasive CPAP system dedicated to premature infants. One of the advantages of such dedicated CPAP devices compared to traditional T-tubes is that they can reduce the work of breathing of the child.

[0009] Generally speaking, the use of dedicated CPAP devices for CPAP ventilation or treatment has been recommended and established as a standard in the initial care of newborns. In particular, the T-piece device operating through a single-tube system as described above is recommended. However, in some cases, the infant cannot fully adapt under pure CPAP / PEEP ventilation, and mechanical ventilation still needs to be implemented. In such situations, it is usually necessary to replace the entire ventilation device, which may be complex in the routine hospital operation process and may also require additional manpower. In the initial care of premature infants, it may also be necessary to equip two sets of devices simultaneously, such as a ventilator and a dedicated CPAP device with a T-piece or a resuscitation device.

[0010] For example, during the conversion to mechanical or PPV ventilation using a resuscitation bag during neonatal resuscitation, ventilation should always be manually maintained in the delivery room. As a result, the operator will be unable to perform other tasks, and subsequent treatment steps may be delayed. On the other hand, if ventilation needs to continue through a ventilator, the ventilator needs to be activated and used to replace the T-piece device. This method is not convenient for manual intervention until switching back to the CPAP / PEEP device or the resuscitation device with a T-piece. Summary of the Invention

[0011] The object of the present invention is to provide an improved respiratory device and system for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment for neonatal resuscitation and / or initial respiratory support. In particular, the device and system can support both manual control ventilation such as a traditional T-piece and mechanical ventilation controlled by a ventilator.

[0012] This object is achieved by the subject matter of the independent claims. The improvements of the present invention are exemplified in the following description of the dependent claims and embodiments.

[0013] One aspect of the present disclosure relates to a respiratory device for neonatal resuscitation and / or initial respiratory support for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment, and to a respiratory system including the respiratory device. Any disclosure regarding the respiratory device herein also applies to the respiratory system, and vice versa.

[0014] According to one aspect of the present disclosure, there is provided a respiratory device for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment or ventilation for neonatal resuscitation and / or initial respiratory support. The respiratory device includes a body component, wherein the body component includes a) a respiratory gas inlet that can be fluidly coupled to a respiratory gas supply source and / or is configured to be coupled to a respiratory gas supply source for receiving a respiratory gas stream, such as fresh respiratory gas, such as an oxygen-air mixture, b) a respiratory gas outlet that is in fluid communication with the respiratory gas inlet and can be fluidly coupled to a patient interface and / or is configured to be coupled to a patient interface for delivering (fresh) respiratory gas to a patient, c) a first air outlet for releasing respiratory gas from the body component, the first air outlet being fluidly coupled to the surroundings or environment of the respiratory device, d) a second air outlet for releasing respiratory gas from the body component, the second air outlet being fluidly coupled to one or both of an expiratory valve and an expiratory branch of a ventilator or breathing machine, such as for mechanical ventilation. The respiratory device further includes at least one continuous positive airway pressure CPAP generator that is disposed between and fluidly coupled to the respiratory gas inlet and the respiratory gas outlet and is configured to generate positive end-expiratory pressure during CPAP treatment or ventilation. Wherein, the respiratory device is capable of operating in a CPAP mode, in which positive end-expiratory pressure PEEP is generated at at least a portion of the body component and / or at the respiratory gas outlet based on releasing respiratory gas from the body component to the surroundings or environment of the respiratory device through the first air outlet. Further, the respiratory device is capable of operating in a positive pressure ventilation PPV mode, in which ventilation pressure for PPV treatment is generated within the body component based on at least intermittently blocking and / or closing the first air outlet.

[0015] In particular, by providing the body component with a respiratory gas inlet, a respiratory gas outlet, and first and second air outlets, where one air outlet can be coupled to the surroundings of the respiratory device and the other air outlet can be coupled to a ventilator or breathing machine, particularly its expiratory branch, the respiratory device according to the present disclosure can advantageously be used for manual control ventilation in CPAP treatment and mechanical ventilation in PPV treatment controlled by a ventilator or breathing machine.

[0016] In addition, the respiratory device can be used in conjunction with a single-tube (or single-hose) system, such as in a resuscitator device, as shown in Figure 2 ; it can also be used in conjunction with a double-tube system, such as in a ventilator or breathing machine, as shown in Figure 3As shown. Therefore, the breathing device according to the present disclosure can combine the functions of the above-mentioned traditional T-shaped device and Y-shaped device. Thereby, the versatility of the breathing device can be improved, and / or when a patient or a neonate cannot be fully adapted under pure CPAP / PEEP ventilation, the need to switch between different ventilation devices or systems for CPAP and PPV treatments can be avoided. In addition, it can be ensured that manual ventilation intervention can always be performed by setting the breathing device to the CPAP mode, for example, based on CPAP treatment.

[0017] For example, the resuscitation process can start in the CPAP mode in a manually controlled manner and be switched to mechanical ventilation in the PPV mode when necessary, and vice versa, without replacing the ventilator or other devices, such as hoses and tubing. This can save time and personnel resources and eliminate the need to configure two sets of devices for CPAP and PPV treatments respectively.

[0018] In the present application, the body part or the body of the breathing device may refer to a support structure, such as a substantially solid support structure, in which a breathing gas inlet, a breathing gas outlet, a first air outlet, and a second air outlet are provided. At least a part of the breathing gas inlet, the breathing gas outlet, the first air outlet, and the second air outlet may be formed of the material of the body part. The fluid coupling between the interfaces may be provided by the material of the body part or by one or more other components (such as tubes, hoses, or other coupling devices) coupled to the body part. The body part may be manufactured from a variety of different materials, including metals, steels, aluminum, plastics, resin-based materials, reinforced materials, or other materials. Alternatively or additionally, the body part may include multiple components and be assembled, or may be formed integrally. For example, at least a part of the body part and / or the breathing device may be made of plastic material by a blow molding process.

[0019] In the present disclosure, the terms "outlet" and "air outlet" and "inlet" and "air inlet" may be used interchangeably or regarded as synonyms. The breathing gas inlet, the breathing gas outlet, the first air outlet, and the second air outlet may each include or define at least one opening, orifice, or through hole for receiving and / or releasing breathing gas. The breathing gas inlet, the breathing gas outlet, the first air outlet, and the second air outlet may include or define physically separated openings. For example, these openings may be formed or provided in different parts of the body part. In addition, at least a part or subset of the breathing gas inlet, the breathing gas outlet, the first air outlet, and the second air outlet are optionally in fluid communication with each other.

[0020] The CPAP mode and the PPV mode used in this text may refer to different and independent operating modes of the respiratory device. The respiratory device may switch between the CPAP mode and the PPV mode based on the first air outlet. For example, the respiratory device may switch from the CPAP mode to the PPV mode by at least partially blocking and / or closing the first air outlet and its opening, thereby generating a PPV pressure that may be higher than the CPAP or PEEP pressure. By removing the blockage and / or releasing the first air outlet, the respiratory device may switch back from the PPV mode to the CPAP mode. The blockage and / or closing of the first air outlet and its opening may be performed manually, such as by placing a finger or any object on the air outlet and its opening. The blockage and / or closing may be intermittent. This manual blockage and / or closing may be herein referred to as the "manual PPV mode". For example, when the respiratory device is connected to a resuscitator device to form a respiratory system, especially through its respiratory gas inlet, the manual PPV mode may be used in this system.

[0021] The respiratory gas supply source may include one or more respiratory gas sources for supplying (fresh) respiratory gas, such as an oxygen-air mixture, to the respiratory gas inlet. In particular, the respiratory gas inlet may receive a substantially continuous (fresh) respiratory gas flow from the respiratory gas supply source. The respiratory gas supply source may be directly or through a corresponding coupling device coupled to the respiratory gas inlet, such as including one or more hoses. At least a part of the respiratory gas supply source may be integrated in a ventilator, a ventilator and / or a resuscitator device. Alternatively, the respiratory gas supply source may be an independent device.

[0022] The patient interface may refer to or include any interface or device for establishing a fluid connection between the respiratory gas outlet and the patient, such as the patient's pharynx. Exemplary patient interfaces may include nasal plugs, a pair of nasal plugs, a face mask or any other suitable device. The patient interface may be directly or through a corresponding coupling device coupled to the respiratory gas outlet, such as including one or more hoses.

[0023] The "patient" described in this text generally refers to an individual or subject in need of ventilation or treatment through CPAP and / or PPV treatment. In particular, the patient may be a neonate, a child, an infant and / or a premature infant.

[0024] In addition, a CPAP generator may refer to any device configured to generate CPAP and / or PEEP pressures, such as at or near the breathing gas outlet of the body component at least, such that breathing gas or a breathing gas stream can be delivered to a patient at that CPAP / PEEP pressure. Herein, the CPAP generator may be configured to generate the CPAP / PEEP pressure based on one or more physical principles, such as the Venturi effect (the smaller the cross-section, the greater the flow rate), Bernoulli's principle (the greater the flow rate, the smaller the pressure), or the Coanda effect (a gas flow attached to a curved surface tends to flow along it). The CPAP generator may be composed of one or more independent components and mounted on the body component. Alternatively and / or additionally, at least a part of the CPAP generator may be provided inside the body component. Alternatively and / or additionally, at least a part of the CPAP generator may be integrally formed with the body component. For example, at least a part or a region of the body component may be configured as a CPAP generator.

[0025] According to one embodiment, the first air outlet includes an opening for releasing breathing gas received through the breathing gas inlet and / or exhaled by the patient and received through the breathing gas outlet to the surroundings or environment of the breathing device. Specifically, in the CPAP mode, fresh and / or used breathing gas may be released to the environment of the breathing device, but at least part of the used or exhaled breathing gas supplied to the breathing device through the breathing gas outlet may also be released through the first air outlet.

[0026] In an exemplary embodiment, the breathing device may operate in the PPV mode based on at least partially blocking the first air outlet and / or at least one of its openings. Alternatively and / or additionally, the breathing device may operate in the CPAP mode based on opening the first air outlet and / or releasing at least one of its openings. Alternatively and / or additionally, the breathing device may switch from the PPV mode to the CPAP mode based on opening the first air outlet, and / or may switch from the CPAP mode to the PPV mode based on at least partially closing the first air outlet.

[0027] Alternatively and / or additionally, the breathing device may switch from the PPV mode to the CPAP mode based on adjusting the outlet resistance of the breathing gas passing through the first air outlet to a first resistance value, and the breathing device may switch from the CPAP mode to the PPV mode based on adjusting the outlet resistance of the breathing gas passing through the first air outlet to a second resistance value greater than the first resistance value. In other words, the breathing device may switch between the CPAP mode and the PPV mode based on adjusting, modifying, and / or changing the outlet resistance of the breathing gas passing through the first air outlet. Adjusting the outlet resistance may include adjusting and / or changing the diameter and / or cross-sectional area of the opening of the first air outlet.

[0028] As will be described in more detail below, the regulation of the outlet resistance of the first outlet, for example, opening and closing the outlet, can be performed manually, for example, using a finger or by a manually actuable closing element. This enables the operator or user to operate and use the breathing device in a simplified and safe manner. An electronic or mechanical device can also be used to regulate the outlet resistance of the first outlet, for example, for opening and closing the outlet.

[0029] In this specification, "in the PPV mode" can be understood as "when the breathing device is operating in the PPV mode and / or is switched to the PPV mode for PPV treatment or ventilation"; or and / or additionally, "in the CPAP mode" can be understood as "when the breathing device is operating in the CPAP mode and / or is switched to the CPAP mode for CPAP treatment or ventilation".

[0030] According to one embodiment, in the PPV mode of the breathing device, the ventilation pressure or PPV is generated entirely or only by the fresh breathing gas flow received through the breathing gas inlet. In other words, in the PPV mode, only the breathing gas flow received through the breathing gas inlet can be delivered to the patient through the breathing gas outlet to fill the patient's lungs and / or perform mechanical ventilation. Therefore, in the PPV mode, a single breathing gas flow supplied through a single interface or the breathing gas inlet is used for mechanical ventilation or PPV.

[0031] Or and / or additionally, in the PPV mode of the breathing device, the ventilation pressure or PPV pressure can be generated entirely or only based on storing the fresh breathing gas flow received through the breathing gas inlet in the internal volume and / or the hollow cavity of the body component. For example, in the PPV mode, compared to the CPAP mode, the outlet resistance of the first outlet can be increased. In particular, in the PPV mode, the first outlet can be at least partially, for example, completely, blocked and / or closed. The body component can be at least partially hollow and / or include one or more hollow cavities for fluidly coupling the breathing gas inlet to the breathing gas outlet and optionally fluidly coupling to the first and / or second outlets, and is configured to store or block the fresh breathing gas flow from the breathing gas inlet, thereby generating a PPV ventilation pressure in the body component for mechanically filling the lungs.

[0032] In yet another exemplary embodiment, the ventilation pressure in the PPV mode and the positive end-expiratory pressure in the CPAP mode are both fully, only, and / or exclusively generated by the (fresh) breathing gas flow received through the breathing gas inlet. In other words, no other breathing gas flow is used to generate the CPAP or PEEP pressure in the CPAP mode and the ventilation pressure in the PPV mode, except for the breathing gas flow received through the breathing gas inlet. Thus, a single breathing gas flow received through a single interface, i.e., the breathing gas inlet, can be used to generate the PEEP pressure in the CPAP mode and the ventilation pressure in the PPV mode. Thereby, a single breathing gas source or a single breathing gas supply device, such as from a ventilator or a resuscitator device, can also be used in both modes. This can save space in hospitals and operating rooms, simplify the connection of the breathing device to other equipment (including breathing gas supply), and simplify maintenance and operation.

[0033] According to one embodiment, in the PPV mode, when the ventilation pressure reaches or exceeds a set value, the breathing device is configured to release excess breathing gas from the body component through the second outlet. At this time, the excess breathing gas or the breathing gas with a pressure exceeding the ventilation pressure can be released through the expiratory branch of a ventilator or a ventilator coupled or couplable to the second outlet. This configuration of the breathing device can avoid over-inflation and over-ventilation, thereby reducing or eliminating the risk of lung injury.

[0034] According to one embodiment, the ventilation pressure in the PPV mode is adjustable and / or controllable, and its adjustment and / or control can be based on controlling the expiratory valve and / or adjusting the release pressure of the expiratory valve couplable to the second outlet. The release pressure can be expressed as an adjustable maximum pressure at which the expiratory valve opens. The expiratory valve can be directly coupled or already coupled to the second outlet, such as through a hose; can also be integrated into the second outlet; and / or can be part of the expiratory branch or expiratory section of a ventilator or a ventilator.

[0035] Generally speaking, the ventilation pressure required to fill the patient's lungs can vary from patient to patient and can depend on, for example, the patient's anatomy. Therefore, by setting an adjustable expiratory valve, an optimal patient-specific ventilation pressure and overall ventilation effect can be achieved.

[0036] According to one embodiment, the expiratory valve is an adjustable or controllable overflow valve. In other words, the expiratory valve can be a pressure-controlled valve, and the release pressure (i.e., the pressure required for the valve to open) can be adjusted or controlled, for example, by mechanical means and / or electronic means. This can ensure that over-inflation of the patient's lungs does not occur. Additionally, a volume-controlled valve can also be used alternatively or additionally.

[0037] According to one embodiment, in the CPAP mode, the breathing device is configured to release excess breathing gas from the body part only through the first air outlet. Herein, "excess breathing gas" may refer to the breathing gas received through the breathing gas inlet but not inhaled by the patient, and / or the breathing gas exhaled by the patient and received through the breathing gas outlet. For example, in the CPAP mode, the first air outlet may be substantially open or unblocked, and the air outlet resistance of the first air outlet can be adjusted or selected such that a CPAP or PEEP pressure is generated in at least a part of the body part, especially at or adjacent to the breathing gas outlet.

[0038] According to one embodiment, the expiratory valve can be part of the breathing device. Preferably, the expiratory valve is integrated in the second air outlet and / or the body part. Thereby, in the PPV mode, especially in the manual PPV mode, the second air outlet can be used without connecting any hose or pipe with an expiratory valve, which simplifies the setup of the manual PPV mode. In the manual PPV mode, the breathing device can be connected to a resuscitator device through its breathing gas inlet and generate the ventilation pressure in the PPV mode by at least intermittently blocking the first air outlet.

[0039] According to one embodiment, the breathing device can operate in the manual PPV mode, in which, for PPV treatment, based on at least intermittently blocking the first air outlet, the ventilation pressure required for PPV treatment is generated within the body part, and the ventilation pressure in the PPV mode can be adjusted by controlling the expiratory valve and / or adjusting the release pressure of the expiratory valve of the breathing device. Therefore, the manual PPV mode can be achieved, especially applicable to the situation where the second air outlet is not connected to a ventilator through a hose or other fluid coupling device, but is connected to a resuscitator device or other device that is only fluid-coupled to the breathing gas inlet.

[0040] According to one embodiment, the breathing device can operate in a mechanical PPV mode, in which, for PPV treatment, based on the operation of the ventilator, within the body part, especially by the ventilator, with the second outlet fluidly coupled to the exhalation branch of the ventilator and the breathing gas inlet fluidly coupled to the breathing gas supply source of the ventilator, a PPV ventilation pressure is generated. Thereby, a mechanical PPV mode can be provided as opposed to a manual PPV mode, in which the operator can use an object or a device, and if necessary, fingers, to block the first outlet. In the mechanical mode, in contrast to the manual PPV mode, the operator does not need to operate the breathing device, for example, does not need to block the first outlet with a finger. Instead, in the mechanical mode, the PPV mode can be achieved mechanically, especially automatically, by the operation of the ventilator, preferably by controlling the exhalation valve and / or controlling the breathing gas flow (as further described below). The ventilator can be an automated device that can automatically control the PPV mode and its parameters, such as the breathing gas flow rate. To switch between the manual PPV mode and the mechanical PPV mode, the exhalation branch can be connected to the ventilator, while the inhalation branch fluidly coupled to the breathing gas inlet is disconnected from the resuscitator device or other equipment and instead connected to the ventilator.

[0041] According to one embodiment, for PPV treatment, the breathing device can operate in a mechanical PPV mode, which is based on at least intermittently blocking the second outlet and / or the exhalation branch by the operation of the ventilator, thereby generating a ventilation pressure within the body part. Thus, in the manual PPV mode and the mechanical PPV mode, the outlets that may be blocked are different. In the manual PPV mode, the first outlet is blocked, while in the mechanical mode, the second outlet or the exhalation branch is blocked. In particular, the second outlet can be intermittently blocked by the control of an exhalation valve, which is especially part of the ventilator, as further explained below. The blocking of the second outlet does not have to occur directly at the second outlet body, but can occur at other locations in the exhalation branch of the ventilator, especially at the ventilator body, thereby substantially achieving the blocking of the second outlet.

[0042] According to one embodiment, the first air outlet or the body part may include an opening for receiving a closing element for preferably substantially completely closing the first air outlet; and / or the breathing device may include a closing element for preferably substantially completely closing the first air outlet. The closing element may be manually movable. The closing element may include a knurled screw. For example, other devices such as a movable bolt or pin may also be used. The present disclosure contemplates that the opening may be threaded or otherwise designed to receive and cooperate with the closing element. The opening may, for example, be substantially perpendicular to the extension direction of the body part or the first air outlet. The closing element may be part of the exhaust valve described in this specification, and the exhaust valve includes the manually movable closing element configured to at least partially block and / or close the first air outlet to generate positive end-expiratory pressure for CPAP treatment. Closing the first air outlet may provide a way for the breathing device and the ventilator to achieve a mechanical mode. In particular, when the first air outlet is closed, the ventilator may control the flow of breathing gas released through the second air outlet through its expiratory valve, thereby achieving mechanical ventilation.

[0043] According to one embodiment, for PPV treatment, the breathing device may operate in a mechanical PPV mode, which is based on the ventilator controlling the expiratory valve and / or controlling the flow of breathing gas (into the breathing gas inlet). Through the expiratory valve controlled by the ventilator, when the first air outlet is closed by the closing element, the ventilator may control the flow of breathing gas released through the second air outlet, thereby achieving mechanical ventilation. By controlling the flow of breathing gas into the breathing gas inlet, the ventilator may alternatively provide mechanical ventilation, in which case it may not be necessary to close the first air outlet. Preferably, the breathing device may be configured to operate in the mechanical PPV mode by both - controlling the expiratory valve and controlling the flow of breathing gas - such that the breathing device has good adaptability and is compatible with different ventilators or ventilator function configurations.

[0044] According to one embodiment, the expiratory valve controlled by the ventilator may belong to the ventilator itself. This enables a simple coupling between the ventilator and the breathing device without the need to connect an external expiratory valve for control.

[0045] According to one embodiment, the expiratory valve of the ventilator may be an additional element of the expiratory valve of the breathing device. In other words, the breathing device and the ventilator may each have an independent expiratory valve, where the ventilator may control its own expiratory valve. This facilitates the breathing device to operate using its own expiratory valve in the manual PPV mode and using the expiratory valve controlled by the ventilator in the mechanical PPV mode. The expiratory valve of the breathing device may be manually adjustable. Thus, before connecting to the ventilator, the expiratory valve may be manually opened so that the control of its own expiratory valve by the ventilator can be utilized subsequently to enter the mechanical mode.

[0046] According to one embodiment, the breathing device includes a single air inlet for receiving fresh breathing gas, which is formed by a breathing gas inlet. Alternatively and / or additionally, the breathing gas inlet constitutes the single air inlet of the breathing device for receiving fresh breathing gas. Therefore, it is also possible to generate CPAP or PEEP pressure in CPAP mode and ventilation pressure in PPV mode through a single breathing gas supply source. Alternatively and / or additionally, the breathing device may generally include three outlets or air outlets, namely a breathing gas outlet, a first air outlet, and a second air outlet.

[0047] According to one embodiment, at least a part of the CPAP generator is integrally formed in the body member. Alternatively and / or additionally, the CPAP generator may be integrated into the body member. For example, the CPAP generator may be constituted by an area or part of the body member. Alternatively and / or additionally, the CPAP generator may be formed of the material of the body member. Integrating the CPAP generator into the body member helps to simplify the manufacture of the breathing device. In addition, the operation of using the breathing device can also be simplified, and its structural strength can be improved.

[0048] According to one embodiment, the body member includes one or more hollow cavities for fluid-coupling the breathing gas inlet, the breathing gas outlet, the first air outlet, and the second air outlet. Therefore, at least a part of the internal volume of the body member may be a hollow structure and can be used to fluid-couple the breathing gas inlet and the breathing gas outlet, so that the breathing gas received through the breathing gas inlet can be transmitted to the breathing gas outlet via the body member, one or more hollow cavities, and / or the internal volume.

[0049] According to one embodiment, the body member includes a tubular middle region, where the breathing gas inlet and / or the second air outlet are formed laterally in the tubular middle region of the body member. The breathing gas inlet and the second air outlet may be formed on the same side or different sides of the tubular middle region.

[0050] According to one embodiment, at least a part of the breathing gas inlet and / or a part of the second air outlet may extend substantially perpendicular to the tubular middle region of the body member. In particular, a part of the breathing gas inlet and / or a part of the second air outlet may extend substantially perpendicular to the length direction of the tubular middle region in the length direction. This helps to achieve an intuitive, compact, and easy-to-use design, making the air inlet and air outlet that can be fluid-coupled with a resuscitator device or a ventilator easily accessible.

[0051] Optionally, at least a portion of the breathing gas inlet and / or at least a portion of the second outlet may project laterally from the tubular central region of the body member. The breathing gas inlet and the second outlet may project in a parallel direction to each other, in an opposite direction to each other, or at an angle to each other. Optionally, the breathing gas inlet and the second outlet may be arranged spaced apart from each other along the longitudinal axis of the tubular central region.

[0052] According to one embodiment, the breathing gas outlet and / or the first outlet is formed at the end face or end of the tubular central region of the body member. For example, the breathing gas outlet and the first outlet may be formed on two opposite end faces of the tubular central region.

[0053] According to one embodiment, the breathing gas outlet and / or the first outlet may be configured as a tubular extension of the tubular central region of the body member.

[0054] According to one embodiment, the breathing gas outlet and the first outlet may extend longitudinally along a common central axis (preferably a symmetry axis). This common central axis may correspond to the longitudinal axis described herein. This structural design gives the breathing device an intuitive and compact usage feature.

[0055] According to one embodiment, this common axis may extend longitudinally along the tubular central region of the body member, thereby further achieving a compact and easy-to-use design.

[0056] It should be noted that other structural designs or arrangements of the breathing gas outlet and / or the first outlet, such as being arranged laterally along the tubular central region of the body member, are also included in the present disclosure. Alternatively and / or additionally, the breathing gas inlet and / or the second outlet may also be provided at the end face or end of the tubular central region.

[0057] According to one embodiment, the CPAP generator includes an adjustable exhaust valve provided at the first outlet, and the exhaust valve is configured to adjust the pressure of the breathing gas in the body member to the end-expiratory positive pressure for CPAP treatment in the CPAP mode. Based on this adjustable exhaust valve, a patient-specific and optimal CPAP or PEEP pressure can be adjusted or set.

[0058] According to one embodiment, the exhaust valve is manually adjustable or manually controllable. Optionally and / or additionally, the exhaust valve may include a manually movable closing element configured to at least partially block and / or close the first air outlet to generate positive end-expiratory pressure for CPAP therapy. The manually movable element may be configured to adjust and / or control the air outlet resistance and / or the opening diameter of the first air outlet. The manually movable element may be moved by an operator or user, or by other means. The manually movable element may extend longitudinally or transversely into the first air outlet so as to be able to control or adjust the cross-sectional area and / or the opening diameter of the first air outlet, and thus adjust its flow resistance.

[0059] In an exemplary embodiment, the manually movable closing element may include a knurled screw. The use of other devices or components, such as a movable bolt or pin, is also contemplated.

[0060] According to one embodiment, the CPAP generator includes a Benveniste valve. The use of a Benveniste valve is particularly advantageous in that it can reduce or minimize fluctuations in CPAP / PEEP pressure, which may reduce the patient's respiratory workload and improve comfort. At least a part or the whole of the Benveniste valve may be integrated into the body component, for example formed from the material of the body component.

[0061] According to one embodiment, the Benveniste valve includes a tubular portion fluidly coupled to the breathing gas inlet and configured to generate a breathing gas jet within a first hollow cavity or a first portion of the body component. The first hollow cavity enables fluid coupling between the breathing gas inlet and the first air outlet. Optionally, the body component may include a second hollow cavity or a second portion, which is physically separated from the first hollow cavity or portion and is downstream of the gas flow received through the breathing gas inlet. The second hollow cavity enables fluid coupling between the second air outlet and the breathing gas outlet. Further optionally, the first hollow cavity or portion may be fluidly coupled to the second hollow cavity through an opening, and the tubular portion of the Benveniste valve may be configured to direct the breathing gas jet onto and / or between the opening coupling the first hollow cavity (or portion) and the second hollow cavity (or portion), so that positive end-expiratory pressure for CPAP therapy is generated downstream of the opening and / or within the second hollow cavity or portion.

[0062] According to one aspect of the present disclosure, there is provided a respiratory system for positive pressure ventilation and continuous positive airway pressure treatment for neonatal resuscitation and respiratory support. The respiratory system includes at least one respiratory device as described above and further described below, and at least one expiratory valve fluidly coupled to a second outlet of the at least one respiratory device.

[0063] It should be emphasized that, where technically feasible, any feature, function, or element described herein with respect to the respiratory device is equally applicable to the respiratory system, and vice versa.

[0064] According to one embodiment, the respiratory system further includes a ventilator and / or a breathing machine, for example for mechanical ventilation, wherein the at least one expiratory valve is provided in an expiratory branch of the ventilator. In other words, the expiratory valve can be part of the ventilator or breathing machine. Accordingly, the footprint and complexity of the respiratory system can be reduced, and equipment commonly available in hospitals can be utilized, thereby also reducing costs. Alternatively and / or additionally, the respiratory system can include a resuscitator device. Similarly, alternatively and / or additionally, the respiratory device can include an expiratory valve or an additional expiratory valve.

[0065] According to one embodiment, the respiratory system further includes at least one respiratory gas supply source fluidly coupled to a respiratory gas inlet. Preferably, the respiratory gas supply source includes a mixing device or a mixer configured to adjust one or more of the following: the oxygen concentration of the respiratory gas, the flow rate of the respiratory gas, the composition of the respiratory gas, and the initial pressure of the respiratory gas.

[0066] According to one embodiment, the respiratory system further includes at least one flow meter configured to determine at least one of the following: the flow rate of the respiratory gas flowing into the at least one respiratory device, and the flow rate of the respiratory gas discharged from the at least one respiratory device. The respiratory system can also include other elements or components, such as pressure sensors, one or more hoses, etc.

[0067] When the respiratory system includes a ventilator and / or a breathing machine for mechanical ventilation, the respiratory system can be used for PPV treatment in the mechanical mode described herein. This operation can be based on the operation of the ventilator, for example by controlling the expiratory valve and / or controlling the respiratory gas flow, as described herein. Alternatively, when the respiratory system does not include a ventilator and the respiratory device is used in conjunction with another device (such as a resuscitator device), the respiratory system can be used for PPV treatment in the manual PPV mode by at least intermittently occluding the first outlet, for example by placing a finger on the first outlet.

[0068] Another aspect of the present disclosure relates to the use of the respiratory device and / or system as described above and below in neonatal resuscitation and / or respiratory support.

[0069] These and other aspects of the invention will be apparent from the embodiments described below and will be elucidated in conjunction with the reference description. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1 A respiratory device according to an exemplary embodiment is schematically illustrated;

[0071] Figure 2 A respiratory system according to an exemplary embodiment is schematically illustrated;

[0072] Figure 3 A respiratory system according to an exemplary embodiment is schematically illustrated;

[0073] Figures 4A to 4C The operation of a respiratory device according to an exemplary embodiment is schematically illustrated respectively;

[0074] Figures 5A to 5C A respiratory device according to an exemplary embodiment is schematically illustrated respectively;

[0075] Figures 6A to 6D A respiratory device according to an exemplary embodiment is schematically illustrated respectively.

[0076] The drawings are only schematic illustrations and are not drawn to scale. In principle, the same or similar components and / or elements are labeled with the same or similar reference numerals in the drawings. DETAILED DESCRIPTION

[0077] According to an exemplary embodiment, Figure 1 A respiratory device 10 for positive pressure ventilation and continuous positive airway pressure treatment for neonatal resuscitation is schematically illustrated.

[0078] The respiratory device 10 includes a body member 20, on which a respiratory gas inlet 22, a respiratory gas outlet 24, a first air outlet 26, and a second air outlet 28 are provided. The body member 20 may be a substantially solid structure, for example, made of plastic material and / or metal. The body member 20 may have any shape, geometric structure, and volume. For example, the body member 20 may be substantially tubular, cylindrical, cubic, or cuboid. Other shapes and geometric configurations are also feasible.

[0079] The respiratory gas inlet 22 may be connected to a respiratory gas supply source 200 (see Figure 2 and Figure 3)A fluid coupling for receiving a respiratory gas flow 23, such as fresh respiratory gas, from a respiratory gas supply source 200. The respiratory gas outlet 24 is in fluid communication with and / or fluid-coupled to the respiratory gas inlet 22 such that at least a portion of the respiratory gas flow 23 received through the respiratory gas inlet 22 is conveyed and / or directed via at least a portion of the body member 20 to the respiratory gas outlet 24. Additionally, the respiratory gas outlet 24 may be fluid-coupled to a patient interface 510 (see Figure 2 and Figure 3 ) such as a face mask 510 for delivering (fresh) respiratory gas to a patient 500 (see Figure 2 and Figure 3 ). Specifically, at least a portion 25 of the received respiratory gas flow 23 may be conveyed via the respiratory gas outlet 24 to the patient 500.

[0080] The first gas outlet 26 is configured to release respiratory gas from the body member 20, such as at least a portion 27 of the respiratory gas flow 23 received through the inlet 22, or gas exhaled by the patient 500 and received via the respiratory gas outlet 24. In particular, the respiratory gas may be released through the first gas outlet 26 to the surroundings of the respiratory device 10. Thus, the first gas outlet 26 may be in fluid communication with and / or be coupled to the environment of the respiratory device 10.

[0081] The second gas outlet 28 is configured to release respiratory gas from the body member 20 through an exhalation valve 32 (see Figures 2 to 4C ). Additionally, the second gas outlet 28 may be fluid-coupled to one or both of the exhalation valve 32 and / or an exhalation branch 252 of a mechanical ventilation device 210b (see Figure 3 ). The exhalation valve 32 may be directly coupled to the second gas outlet 28 or connected via a fluid coupling device (such as a hose), where the exhalation valve 32 may also be part of a ventilator or breathing machine 210b for performing mechanical ventilation. Alternatively and / or additionally, the exhalation valve 32 may be integrated in the second gas outlet 28 and / or the body member 20.

[0082] Any one or more of the respiratory gas inlet 22, the respiratory gas outlet 24, the first gas outlet 26, and the second gas outlet 28 may be mounted or fixed on the body member 20 as separate components. Alternatively and / or additionally, any one or more of the respiratory gas inlet 22, the respiratory gas outlet 24, the first gas outlet 26, and the second gas outlet 28 may be integrally formed with the body member 20. Thus, one or more of the respiratory gas inlet 22, the respiratory gas outlet 24, the first gas outlet 26, and the second gas outlet 28 may be formed and / or defined by the body member 20 or its material.

[0083] In addition, fluid communication between one or more of the breathing gas inlet 22, the breathing gas outlet 24, the first air outlet 26, and the second air outlet 28 can be achieved through the internal volume of the body member 20, which is connected to one or more of the interfaces. For example, the body member 20 may include one or more channels or hollow cavities for connecting the interfaces. Alternatively and / or additionally, fluid communication between the interfaces can also be achieved through a fluid connection device (such as one or more hoses).

[0084] The breathing device 10 further includes a continuous positive airway pressure (CPAP) generator 30, which is disposed between the breathing gas inlet 22 and the breathing gas outlet 24 and fluidly coupled thereto for generating positive end-expiratory pressure (PEEP) during CPAP treatment or ventilation. The present disclosure contemplates various structural forms of the CPAP generator 30. An exemplary CPAP generator 30 will be described in detail in Figures 5A to 6D below.

[0085] Generally speaking, the CPAP generator 30 can be provided as an independent component on or inside the body member 20. Alternatively, the CPAP generator 30 can be integrally formed with the body member 20. For example, the CPAP generator 30 can be formed by a region or part of the body member 20. The CPAP generator 30 can be directly coupled to one or both of the breathing gas inlet 22 and / or the breathing gas outlet 24 through a hose, a pipe, or through the internal volume of the body member.

[0086] As Figures 4A to 6D shown and will be described in detail below, the breathing device 10 can operate in two different operating modes, namely, the CPAP mode for CPAP treatment and the PPV mode for PPV treatment.

[0087] In the CPAP mode, the first air outlet 26 is substantially open and / or unblocked, such that the breathing gas received through the breathing gas inlet 22 and / or the exhaled gas received from the patient 500 through the breathing gas outlet 24 can be released from the internal volume of the body member 20 via the first air outlet 26, for example, released to the environment or surroundings of the breathing device 10. In the CPAP mode, the CPAP generator 30 generates a substantially continuous positive end-expiratory pressure (PEEP), so that even when the patient 500 is fully exhaling, their lungs can remain open or partially inflated.

[0088] In the PPV mode, the first air outlet 26 is intermittently substantially closed and / or blocked, for example, by a closing element and / or the finger of an operator or user. In particular, when the first air outlet 26 is blocked, the respiratory gas flow 23 received through the respiratory gas inlet 22 causes the gas pressure inside the body part 20 to increase. When the ventilation pressure sufficient to mechanically fill the lungs of the patient 500 is reached, at least a portion 25 of the respiratory gas flow is delivered to the patient 500. After the lungs of the patient 500 are substantially completely filled, the blockage or closure of the first air outlet 26 can be released, so that the respiratory gas pressure drops, and the patient 500 can exhale the respiratory gas through the respiratory gas outlet 24, the body part 20, and the first air outlet 26. To refill the lungs again, the first air outlet 26 can be blocked or closed again.

[0089] To prevent over-inflation of the lungs of the patient 500 in the PPV mode, the expiratory valve 32 can be configured as a relief valve that opens when the release pressure is reached. The expiratory valve 32 can be controllable and / or adjustable, and its control method is based on the adjustment of the release pressure. Exemplary and non-limiting release pressures or release pressure ranges can be from 5 mbar to 100 mbar, for example, from 10 mbar to 80 mbar, preferably from 20 mbar to 60 mbar, and more preferably from 30 mbar to less than 60 mbar. For example, 30 mbar can be used as the starting release pressure and increased or decreased according to the breathing condition of a specific patient.

[0090] As previously described, in the PPV mode of the respiratory device 10, the ventilation pressure is completely generated by the fresh respiratory gas flow 23 received through the respiratory gas inlet 22. In particular, the ventilation pressure for mechanically filling the lungs of the patient 500 is achieved by storing the fresh respiratory gas flow 23 in the internal volume of the body part 20 in the PPV mode. For example, in the PPV mode, compared with the CPAP mode, the outlet resistance of the first air outlet 26 can be at least intermittently increased. In addition, even in the CPAP mode, the CPAP pressure or PEEP is only based on or generated by the respiratory gas flow 23 received through the respiratory gas inlet 22. To generate the ventilation pressure in the PPV mode and the CPAP / PEEP pressure in the CPAP mode, no other sources or additional respiratory gas flows are required.

[0091] Therefore, the respiratory device 10 described in the present disclosure has significant advantages. It can be connected or coupled to a ventilator 210b or a resuscitator device 210a (see Figure 2 ) and can achieve manually controlled ventilation in the CPAP mode like a traditional T-tube, and can also achieve mechanically controlled ventilation in the PPV mode through the ventilator 210b or the resuscitator device 210a. This means that there is no need to switch between different ventilation devices, for example Figure 2between the shown single-tube resuscitator device 210a and Figure 3 the shown double-tube ventilator 210b.

[0092] To achieve the above functions, the breathing device 10 is configured to generate a continuous CPAP pressure, and this pressure can be manually adjusted. To perform positive pressure ventilation in the PPV mode, the user can establish a peak pressure or ventilation pressure that is higher than the continuous CPAP pressure. This can be achieved by intermittently blocking and / or closing the first air outlet 26, for example, by a finger or other device. By blocking the first air outlet 26 or the resulting increase in the air outlet resistance, a positive pressure for filling the lungs of the patient 500 can be established. For Figure 3 pure mechanical ventilation using the ventilator 210b as shown, the first air outlet 26 can be completely closed, for example, by a plugging member and / or a closing element, and the release pressure of the exhalation valve 32 can be correspondingly selected so that the excess breathing gas can be released through the second air outlet 28.

[0093] To achieve the switch from manual ventilation to mechanical ventilation, the ventilator 210b can be programmed accordingly, for example, to ensure that the exhalation valve 32 is correctly controlled and remains open for a sufficient period of time to exhaust the lungs of the patient 500.

[0094] Figure 2 Schematically shows a respiratory system 100 with a breathing device 10 according to an exemplary embodiment. Unless otherwise specified, Figure 2 the shown respiratory system 100 or device 10 includes the Figure 1 same features, components and functions as described above.

[0095] The respiratory system 100 further includes a resuscitator device 210a, which can be used in cooperation with a traditional T-shaped tube, for example. The resuscitator device 210a can provide or include a breathing gas supply source 200. Generally speaking, the resuscitator device 210a can also be referred to as a single-tube or single-hose breathing device for neonatal resuscitation and initial respiratory support, because the system 100 only provides (fresh) breathing gas, and the exhaled gas is discharged into the environment.

[0096] Figure 2The resuscitator device 210a and / or the breathing gas supply source 200 shown includes an oxygen interface 212 for receiving oxygen, a pressure interface 214 for receiving pressurized air, and an oxygen-air mixer 216 for mixing oxygen and pressurized air to provide a breathing gas stream 23 or a fresh breathing gas stream. For example, the outlet 218 of the mixer 216 can be connected to the breathing gas inlet 22 of the breathing device 10 via a hose or pipe 220. The breathing gas enters the breathing device 10 via the breathing gas inlet 22 and can be delivered to the patient 500 through the breathing gas outlet 24, which can be connected to the patient interface 510, such as a face mask 510, via a hose or pipe. Alternatively, an endotracheal tube can also be used to deliver the breathing gas directly to the lungs.

[0097] The first outlet 26 can be designed and configured as a valve for generating PEEP pressure. In the static state, the second outlet 28 can be in a closed state, and the breathing gas can flow out to the environment or surroundings of the breathing device 10 via the first outlet 26 (such as its opening or orifice). Thus, the CPAP generator 30 (which can include the first outlet 26 or at least a part thereof) generates continuous positive airway pressure (CPAP) and / or PEEP. By adjusting the orifice, opening diameter, and / or outlet resistance of the first outlet 26, the CPAP / PEEP pressure can be adjusted and / or set. In the CPAP mode, when the patient 500 has sufficient spontaneous breathing ability, the inhaled breathing gas enters and is exhaled through the first outlet 26, so that a certain pressure (CPAP / PEEP) can still be maintained at the end of exhalation without dropping to zero pressure.

[0098] To switch to the PPV mode, for example, in the case of respiratory arrest, the first outlet 26 on the breathing device 10 can be closed by finger or other means. This will cause the pressure in the breathing device 10 or its body component 20 to rise rapidly, generating a (manual) mechanical inspiration. To prevent excessive pressure that may damage the patient's lungs, for example, the exhalation valve 32 (which can be a pressure relief valve and / or an overflow valve 32) can be connected to the second outlet 28. Alternatively and / or additionally, the pressure relief valve 221 of the resuscitator device 210a can be opened, and this valve can be provided between the oxygen-air mixer 216 and the breathing device 10.

[0099] Figure 3 A respiratory system 100 with a breathing device 10 is schematically shown according to an exemplary embodiment. Unless otherwise specified, Figure 3 The respiratory system 100 or the device 10 shown includes Figure 1 and Figure 2 the same features, components, and functions as described above.

[0100] and Figure 2different from the single - tube resuscitator device 210a shown, Figure 3 A ventilator 210b or a breathing machine 210b for mechanical ventilation is shown. Generally, such a breathing machine 210b has a closed hose or pipeline loop that is divided into two parts or branches, namely an inhalation branch 250 for supplying (fresh) breathing gas and an exhalation branch 252 for discharging (at least part of) the exhaled breathing gas.

[0101] As Figure 3 shown, the breathing gas can be supplied to the breathing gas inlet 22 of the breathing device 10 through the outlet 218 of the oxygen - air mixer 216 and a pipeline 220. The breathing gas outlet 24 can be connected to the patient 500 through a patient interface 510, such as a face mask 510, an endotracheal tube or a tracheostomy. The ventilator 210b provides a continuous flow of breathing gas 23 that flows through the inhalation branch 250 to the breathing device 10 and then returns to the ventilator 210b through the exhalation branch 252. For example, the second outlet 28 can be connected to the exhalation valve 32 of the ventilator 210b through a pipeline 221. Based on the exhalation valve 32, the CPAP pressure in the entire pipeline system can be controlled, for example, by the ventilator 210b.

[0102] When the exhalation valve 32 is closed, inhalation occurs, that is, the ventilation pressure is established; when the peak, maximum or release pressure of the exhalation valve 32 is reached, the valve opens again, the pressure remains for a short period of time and then drops back to the initial pressure or the CPAP / PEEP level, and then exhalation occurs.

[0103] Figure 2 The ventilator 210b and / or the resuscitator device 210a shown can include more components, such as a measurement and control system. For example, the pressure can be monitored by a pressure sensor 222. Or and / or additionally, the fresh breathing gas flow 23 and / or the breathing gas flow 25 discharged through the second outlet 28 can be monitored by one or more flow sensors 223.

[0104] As previously mentioned, the breathing device 10 can be used in conjunction with Figure 2 the resuscitator device 210a shown or Figure 3 the ventilator 210b shown. Therefore, it is convenient to switch between CPAP treatment and PPV treatment without a double - set of equipment. For example, when a respiratory arrest occurs, switch to PPV treatment and then back to the CPAP mode without changing the equipment.

[0105] Furthermore, for example, in Figure 2 the respiratory system 100 shown, the breathing device 10 can operate in the manual PPV mode during PPV treatment. For this purpose, as described above, the first outlet 26 can be intermittently closed, for example, by the finger of the person operating the respiratory system 100. And in Figure 3In the respiratory system 100 shown, the breathing device 10 can operate in a mechanical PPV mode during PPV treatment. To this end, the first air outlet 26 can be closed. The ventilator 210b can (be configured to) control the expiratory valve 32 to generate the ventilation pressure required for PPV treatment in the body member 20. Alternatively, the first air outlet 26 can be kept open, and the ventilator 210b can (be configured to) control the flow rate of the breathing gas entering the breathing gas inlet 22 to generate the ventilation pressure for PPV treatment in the body member 20, for example, by increasing the gas flow rate to increase the pressure. Thus, when switching between Figure 2 the resuscitator device 210a and Figure 3 the ventilator 210b, the breathing device 10 can support both the manual PPV mode and the mechanical PPV mode simultaneously without replacing the breathing device 10 and only requiring a very small amount of hose or pipe switching, such as connecting the inhalation branch 250 and the exhalation branch 252 to the corresponding device 210a or machine 210b.

[0106] By providing the breathing device 10 with a breathing gas inlet 22, a breathing gas outlet 24, a first air outlet 26, and a second air outlet 28, the exhalation branch 252 of the ventilator 210b can be coupled to the second air outlet 28, where the expiratory valve 32 should be provided on the second air outlet 28 and / or the exhalation branch 252. In a traditional system, the expiratory valve is usually provided in the inhalation branch 250 and thus cannot be compatible with the ventilator 210b or the respirator 210b.

[0107] As described above, the ventilator 210b can be configured with dedicated software, such as providing corresponding ventilation modes for use in conjunction with the breathing device 10. This mode can ensure that the CPAP pressure is not generated by the expiratory valve 32 of the machine 210b but is generated through the first air outlet 28 of the breathing device 10. Thus, in a stationary state or in the CPAP mode, the breathing gas enters the breathing device 10 through the breathing gas inlet 22 and is released to the environment from the first air outlet 22.

[0108] Figures 4A to 4C The working states of the breathing device 10 in cooperation with the ventilator 210b are schematically shown respectively, as Figure 3 described. Figures 4A to 4C The breathing device 10 in Figure 2 can also be used in cooperation with the resuscitator device 210a shown. Unless otherwise specified, Figures 4A to 4C the breathing device 10 shown includes the same features, elements, and functions as the corresponding parts in the foregoing figures.

[0109] Figure 4AShows the breathing device 10 in a stationary state or in CPAP mode. The breathing gas flow 23 is input through the breathing gas inlet 22, and the excess breathing gas can be discharged to the environment through the first air outlet 26 that is not closed and / or in an open state. At this time, the CPAP pressure is generated by the CPAP generator 30, which may include, for example, the first air outlet 26, and generates the CPAP / PEEP pressure by adjusting the outlet resistance, the opening diameter, and / or the opening structure. The exhalation valves 32 of the ventilators 210a, 210b and / or the exhalation valve 32 coupled to the second air outlet 28 can be in a fully closed state.

[0110] Figure 4B Shows the process of switching the device 10 to the PPV mode, in which the first air outlet 26 is closed or shut off by the finger 40. If the first air outlet 26 on the device 10 is closed, the ventilation pressure begins to build up and an inhalation is generated. When the pressure rises to a preset peak or release pressure, the ventilator 210b and / or the exhalation valve 32 coupled to the second air outlet 28 opens, and the breathing gas flows out to the environment or surroundings through the exhalation branch 252 (when using the ventilator 210b) or directly through the second air outlet 28 (when using the resuscitator device 210a).

[0111] As Figure 4C shown, once the opening of the first air outlet 26 is released by the finger, the pressure drops to the CPAP level, and the exhalation valve 32 can be fully closed again. Therefore, there may no longer be an air flow in the exhalation branch 252 when using the ventilator 210b. In addition, the breathing gas is discharged again through the first air outlet 26 of the device 10, and this air outlet 26 can then be closed again for the next inhalation.

[0112] Figures 5A to 5C Schematically shows the breathing device 10 according to an exemplary embodiment. Unless otherwise specified, Figures 5A to 5C the breathing device 10 shown includes the same features, components and functions as those shown in the foregoing drawings.

[0113] The body member 20 includes a generally tubular central region 52. The first air outlet 26 is provided at the first end 54a or the end face 54a of the tubular central region 52. The breathing gas outlet 24 is provided at the second end 54b or the end face 54b opposite to the first end 54a. In addition, the breathing gas inlet 22 and the second air outlet 28 extend outward from the tubular central region 52. The inlet 22 and the air outlet 28 can be arranged vertically up and down, or separated along the longitudinal axis 49 direction of the tubular central region 52. The breathing gas inlet 22 and the second air outlet 28 can be provided on the same side or different sides of the body member 20.

[0114] The breathing gas inlet 22 includes an interface portion 43 protruding from the tubular middle region 52 of the body member 20. The breathing gas inlet 22 and / or its interface portion 43 defines an opening 42, the opening diameter of which is, for example, 2 mm to 7 mm, for example, about 3 mm. Other diameters are also possible.

[0115] The second end 54b or end face 54b of the tubular middle region 52 defines the breathing gas outlet 24 and / or its opening 44, the exemplary opening diameter being 10 mm to 25 mm, for example, about 15 mm. Other diameters are also possible.

[0116] The first end 54a or end face 54a of the tubular middle region 52 defines the first air outlet 26 and / or its opening 46, the exemplary opening diameter being 5 mm to 15 mm, for example, about 8 mm. Other diameters are also possible.

[0117] The second air outlet 28 includes an interface portion 49 protruding from the tubular middle region 52. The second air outlet 28 and / or its interface portion 49 defines an opening 48, the exemplary opening diameter being 5 mm to 20 mm, for example, about 10 mm. Other diameters are also possible.

[0118] Figures 5A to 5C The illustrated breathing device 10 or its CPAP generator 30 is based on or includes the Benveniste valve 60. The CPAP generator 30 or the Benveniste valve 60 includes a tubular portion 62 fluidly coupled to the breathing gas inlet 22 and / or its opening 42, and the tubular portion 62 is configured to generate a breathing gas jet within the first hollow cavity 70a of the body member 20. Figures 5A to 5C The illustrated breathing device 10 can be particularly used in conjunction with a double - tube ventilation system, such as Figure 3 the ventilator 210b described above.

[0119] The body member 20 includes a second hollow cavity 70b, which is physically separated from the first hollow cavity 70a and is located downstream of the first hollow cavity 70a in the breathing gas flow direction. The first hollow cavity 70a and the second hollow cavity 70b are fluidly coupled through an opening 72, and the tubular portion 62 of the Benveniste valve is configured to direct the breathing gas jet towards the opening 72 to couple the first hollow cavity 70a and the second hollow cavity 70b, thereby generating an end - expiratory positive pressure for CPAP treatment downstream of the opening 72 and / or within the second hollow cavity 70b. Figure 5B As shown, the opening 72 can form a tubular portion protruding towards the tubular portion 62 or its end 64 or nozzle 64.

[0120] Thus, the opening 72 can be formed on a physical partition separating the first and second hollow cavities 70a, 70b, or at the end of the tubular portion 62 protruding from the partition towards the first hollow cavity 70a.

[0121] Exemplary embodiments with the Benveniste valve 60 will be summarized below. In this Benveniste valve 60, a high-speed breathing gas flow can be accelerated from a gas source through the tubular portion 62 to its end 64 or nozzle 64, such that the gas jet impacts the opening 72. The nozzle 64 can be disposed opposite the opening 72, for example, at a distance of about 3 to 4 mm. The high-speed jet generates a backpressure in the downstream region of the breathing device 10, which is then transmitted to the child 500 or patient 500 as CPAP pressure, for example, through a breathing mask 510. In the CPAP mode, the excess jet breathing gas can be freely discharged into the environment through the first air outlet 26.

[0122] The pressure in the CPAP mode or in the second hollow cavity 70b can be controlled by the gas flow rate supplied to the breathing gas inlet 22 of the device 10. Different from traditional Benveniste valves, in this embodiment, the excess breathing gas cannot be freely discharged, but must be discharged through the second hollow cavity 70b, the first hollow cavity 70a, and the first air outlet 26 or its opening 46.

[0123] If the opening 46 is blocked by a finger, the device 10 is switched to the (manual) PPV mode and PPV ventilation is performed. The rapidly incoming breathing gas will quickly establish a ventilation pressure throughout the device 10. To adjust this pressure, the second hollow cavity 70b is connected to the second air outlet 28, and an adjustable pressure relief valve 32 or an expiratory valve 32 can be installed thereon. The expiratory valve 32 is not integrated in the breathing gas inlet 22, and the breathing gas inlet 22 and the second air outlet 28 have physically separated openings 42, 48. The expiratory valve 32 can be directly connected to the device 10, or connected through a breathing hose; it can also be integrated in the second air outlet 48, for example, in its protruding portion 49.

[0124] Overall, this structure is applicable to Figure 3The standard dual-tube system of the neonatal ventilator 210b shown. Through the inhalation branch 250, breathing gas is introduced via the breathing gas inlet 22 into the nozzle 64, and the resulting jet generates the CPAP pressure, which can be adjusted by the breathing gas flow 23 input to the device 10. The second outlet 28 connects the second hollow cavity 70b to the exhalation valve 32 of the ventilator 210b via the exhalation branch 252, whereby the peak or ventilation pressure can be adjusted. As long as the first outlet 26 remains open, the exhalation valve 32 can remain closed, and the CPAP pressure is generated only by the flow through the Benveniste valve 60 or the CPAP generator 30. When the first outlet 26 is blocked and gas cannot escape freely, the PPV pressure is established and can be adjusted by the exhalation valve 32.

[0125] If switching to mechanical ventilation in the PPV mode, especially when switching from the manual PPV mode to the mechanical PPV mode, a plug or other suitable device can be used to block the first outlet 26. This enables mechanical ventilation without replacing the equipment and pipeline system.

[0126] Figures 6A to 6D A respiratory device 10 according to an exemplary embodiment is schematically shown respectively. Unless otherwise specified, Figures 6A to 6D The shown respiratory device 10 includes the same features, elements and functions as those described in the foregoing drawings.

[0127] The breathing gas inlet 22 includes an interface portion 43 protruding outward from the tubular middle region 52 of the body member 20. The breathing gas inlet 22 and / or its interface portion 43 defines an opening 42, the exemplary opening diameter of which is 5 mm to 15 mm, for example about 10 mm. Other diameters can also be used.

[0128] The second end 54b or end face 54b of the tubular middle region 52 defines the breathing gas outlet 24 and / or its opening 44, the exemplary opening diameter of which is 10 mm to 25 mm, for example about 15 mm. Other diameters can also be used.

[0129] The first end 54a or end face 54a of the tubular middle region 52 defines the first outlet 26 and / or its opening 46, the exemplary opening diameter of which is 5 mm to 15 mm, for example about 6 mm. Other diameters can also be used.

[0130] The second outlet 28 includes an interface portion 49 protruding outward from the tubular middle region 52 of the body member 20. The second outlet 28 and / or its interface portion 49 defines an opening 48, the exemplary opening diameter of which is 5 mm to 15 mm, for example about 10 mm. Other diameters can also be used.

[0131] In contrast to Figures 5A to 5C the shown embodiment,Figures 6A to 6D The CPAP generator 30 of the illustrated device 10 generates CPAP / PEEP pressure through the opening 46 of the first air outlet 26. To this end, the CPAP generator 30 includes an adjustable exhaust valve 80 disposed at the first air outlet 26, and the exhaust valve 80 is configured to adjust the pressure of the breathing gas in the body member 20 to the end-expiratory positive pressure for CPAP treatment in the CPAP mode, for example when the first air outlet 26 is unblocked and / or in an open state. In particular, the exhaust valve 80 can be manually adjustable or controllable. For example, the exhaust valve 80 can include a manually movable closing element 83, which is configured to at least partially block the first air outlet 26 and / or its opening 46 to generate, adjust, and / or control the end-expiratory positive pressure in the CPAP mode.

[0132] As Figure 6A 、 6C shown in FIGS. 8 and 6D, the closing element 83 can project transversely into the first air outlet 26, for example orthogonally or transversely to the longitudinal axis of the tubular middle region 52 of the body member. According to its position, the opening diameter and / or the air outlet resistance of the first air outlet 26 can be adjusted and / or controlled. In Figures 6A to 6D the illustrated embodiment, the closing element 83 can be moved by or include a knurled screw 82. Other structural forms can also be adopted.

[0133] The breathing gas can enter the breathing device 10 through the breathing gas inlet 22 or the second air outlet 28. Both openings can be used as the inhalation port or the exhalation port, and no additional significant air flow resistance will be generated. If the breathing gas is supplied through the second air outlet 28, the exhalation valve 32 can be connected to the breathing gas inlet 22, and vice versa.

[0134] When performing manual or mechanical ventilation in the PPV mode, the breathing gas can flow out of the breathing device 10 through the first air outlet 26 and be discharged into the environment or the surrounding space. According to the setting of the exhaust valve 80 at this time, a stable CPAP pressure can be formed. This pressure can be manually adjusted by operating or controlling the exhaust valve 80. In the CPAP mode, the exhalation valve 32 can be kept closed.

[0135] If the operator closes the first air outlet 26 with a finger during manual ventilation, overpressure will be generated inside the device 10 or its body member 20. This pressure can be adjusted by the exhalation valve 32. Once the pressure exceeds the peak value, the maximum value, or the release pressure, the exhalation valve will open, and the excess breathing gas will be discharged through it. If the operator releases the first air outlet 26, the pressure will drop to the CPAP level, the exhalation valve 32 will close, and the breathing gas will be discharged through the first air outlet 26 to the environment again until the next closing starts.

[0136] When switching to mechanical ventilation in the PPV mode, the first air outlet 26 can be completely closed, for example, by a knurled screw 82, a plug or other closing structures.

[0137] Figures 6A to 6D The illustrated breathing device 10 is particularly suitable for a single-tube resuscitator device 210a, for example Figure 2 as described, wherein the second air outlet 28 can be closed by a plug or other means. When using Figures 6A to 6D the illustrated breathing device 10 in cooperation with a dual-tube ventilation system (such as Figure 3 the ventilator 210b or the respirator 210b as described), the opening 28 can be connected to the ventilator 210b.

[0138] Although the present invention has been illustrated and described in the drawings and the foregoing description, these illustrations and descriptions should be regarded only as illustrative examples and not restrictive; the present invention is not limited to the disclosed embodiments. From the specification, the drawings and the claims, those skilled in the art can understand and implement various variations and improvements of the disclosed embodiments of the present invention.

[0139] In the claims, the term "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. Just because certain features appear in different dependent claims respectively does not mean that these features cannot be used advantageously in combination. The reference signs in the claims should not be construed as limiting the scope of the claims.

Claims

1. A breathing device (10) for positive pressure ventilation and continuous positive airway pressure treatment in neonatal resuscitation, the breathing device (10) comprising: A body component (20), which includes: a) a breathing gas inlet (22), which can be fluidly coupled to a breathing gas supply source (200) for receiving a breathing gas flow; b) a breathing gas outlet (24), which is fluidly coupled to the breathing gas inlet (22) and can be fluidly connected to a patient interface (510) for delivering breathing gas to a patient (500); c) a first air outlet (26) for releasing the breathing gas from the body component (20), and the first air outlet (26) can be fluidly coupled to the surrounding environment of the breathing device (10); d) a second air outlet (28) for releasing the breathing gas from the body component (20), and the second air outlet (28) can be fluidly coupled to one or both of an expiratory valve (32) of a ventilator (210b) and an expiratory branch (252). A continuous positive airway pressure (CPAP) generator (30), which is arranged between the breathing gas inlet (22) and the breathing gas outlet (24) and is configured to generate positive end-expiratory pressure during CPAP treatment. Wherein the breathing device (10) can operate in the CPAP mode. In this mode, for continuous positive airway pressure (CPAP) treatment, based on releasing the breathing gas from the body component (20) to the surrounding of the breathing device (10) through the first air outlet (26), positive end-expiratory pressure is generated within the body component (20); and Wherein the breathing device (10) can operate in the positive pressure ventilation (PPV) mode. In this mode, for PPV treatment, based on at least intermittently blocking the first air outlet (26), ventilation pressure for the PPV treatment is generated within the body component (20).

2. The breathing device (10) according to claim 1, wherein in the PPV mode of the breathing device (10), the ventilation pressure is completely generated by a fresh breathing gas flow (23) received through the breathing gas inlet (22); and / or Among them, In the PPV mode of the breathing device (10), the ventilation pressure is completely generated based on storing the fresh breathing gas flow (23) received through the breathing gas inlet (22) in the internal volume of the body component (20).

3. The breathing device (10) according to any one of the preceding claims, wherein both the ventilation pressure in the PPV mode and the positive end-expiratory pressure in the CPAP mode are completely generated by the fresh breathing gas flow (23) received through the breathing gas inlet (22).

4. The breathing device (10) according to any one of the preceding claims, wherein in the PPV mode, when the ventilation pressure reaches or exceeds a predetermined value, the breathing device (10) is configured to release excess breathing gas from the body component (20) through the second air outlet (28).

5. The breathing device (10) according to any one of the preceding claims, wherein in the CPAP mode, the breathing device (10) is configured to release the excess breathing gas from the body part (20) only through the first outlet (26).

6. The breathing device (10) according to any one of the preceding claims, wherein the ventilation pressure in the PPV mode can be adjusted by controlling the expiratory valve (32) and / or adjusting the release pressure of the expiratory valve (32) fluidly coupled to the second outlet (28), preferably, wherein the expiratory valve (32) is an adjustable or controllable overflow valve.

7. The breathing device (10) according to any one of the preceding claims, wherein the expiratory valve (32) is part of the breathing device (10), preferably integrated in the second outlet (28) and / or the body part (20).

8. The breathing device (10) according to claim 7, wherein the breathing device (10) can operate in a manual PPV mode, in which, for performing the PPV treatment, based on at least intermittently blocking the first outlet (26), the ventilation pressure for the PPV treatment is generated within the body part (20), wherein the ventilation pressure in the PPV mode can be adjusted by controlling the expiratory valve (32) and / or adjusting the release pressure of the expiratory valve (32) of the breathing device (10).

9. The breathing device (10) according to any one of the preceding claims, wherein the breathing device (10) can operate in a mechanical PPV mode, in which, for performing the PPV treatment, based on the operation of the ventilator (210b), the ventilation pressure required for the PPV treatment is generated within the body part (20), preferably, when the second outlet (28) is fluidly coupled to the expiratory branch (252) of the ventilator (210b), and the breathing gas inlet (22) is fluidly coupled to the breathing gas supply source (200) of the ventilator (210b).

10. The breathing device (10) according to claim 9, wherein the breathing device (10) can operate in a mechanical PPV mode, in which, for performing the PPV treatment, based on the operation of the ventilator (210b) to at least intermittently close the second outlet (28) and / or the expiratory branch (252), the ventilation pressure is generated within the body part (20).

11. The breathing device (10) according to claim 9 or 10, wherein the first outlet (26) or the body part (20) includes an opening for receiving a closing element (83) for closing the first outlet (26); and / or the breathing device (10) includes a closing element (83) for closing the first outlet (26).

12. The breathing device (10) according to any one of claims 9 to 11, wherein the breathing device (10) is operable in a mechanical PPV mode, in which, for performing the PPV treatment, the ventilation pressure is generated based on controlling the expiratory valve (32) and / or controlling the respiratory gas flow by the ventilator (210b).

13. The breathing device (10) according to claim 12, wherein the expiratory valve (32) controlled by the ventilator (210b) belongs to the ventilator (210b).

14. The breathing device (10) according to any one of the preceding claims, wherein the breathing device (10) comprises a single inlet (22) for receiving the fresh respiratory gas, the single inlet (22) being formed by the respiratory gas inlet (22); and / or the respiratory gas inlet (22) constitutes the single inlet (22) for receiving the fresh respiratory gas.

15. The breathing device (10) according to any one of the preceding claims, wherein at least a part of the CPAP generator (30) is integrally formed in and / or integrated with the body member (20).

16. The breathing device (10) according to any one of the preceding claims, wherein the body member (20) comprises one or more hollow cavities (70a, 70b) for fluidly coupling the respiratory gas inlet (22), the respiratory gas outlet (24), the first outlet (26) and the second outlet (28).

17. The breathing device (10) according to any one of the preceding claims, wherein the body member (20) comprises a tubular middle region (52), and wherein the respiratory gas inlet (22) and the second outlet (28) are formed laterally in the tubular middle region (52) of the body member (20), wherein at least a part of the respiratory gas inlet (22) and at least a part of the second outlet (28) project laterally from the tubular middle region (52) of the body member (20).

18. The breathing device (10) according to claim 17, wherein at least a part of the respiratory gas inlet (22) and / or a part of the second outlet (28) extends substantially perpendicular to the tubular middle region (52) of the body member (20).

19. The breathing device (10) according to claim 17 or 18, wherein the respiratory gas outlet (24) and / or the first outlet (26) are formed on end faces (54a, 54b) of the tubular middle region (52) of the body member (20), preferably, wherein the respiratory gas outlet (24) and the first outlet (26) are respectively formed on two opposite end faces (54a, 54b) of the tubular middle region (52) of the body member (20).

20. The breathing device (10) according to claim 19, wherein the breathing gas outlet (24) and / or the first air outlet (26) are configured as a tubular extension of the tubular central region (52) of the body member (20).

21. The breathing device (10) according to any one of the preceding claims, wherein the breathing gas outlet (24) and the first air outlet (26) extend longitudinally along a common central axis (preferably a symmetry axis).

22. The breathing device (10) according to any one of claims 17 to 21 and claim 22, wherein the common axis extends longitudinally through the tubular central region (52).

23. The breathing device (10) according to any one of the preceding claims, wherein the CPAP generator (30) includes an adjustable exhaust valve (80) provided at the first air outlet (26), the exhaust valve (80) being configured to adjust the breathing gas pressure in the body member (20) to end-expiratory positive pressure in the CPAP mode. Preferably, the exhaust valve (80) is manually adjustable, and / or the exhaust valve (80) includes a manually movable closing element (83), the closing element (83) being configured to at least partially block the first air outlet (26) to generate the end-expiratory positive pressure for the CPAP treatment.

24. The breathing device (10) according to any one of the preceding claims, wherein the CPAP generator (30) includes a Benveniste valve (60).

25. The breathing device (10) according to claim 24, wherein the Benveniste valve (60) includes a tubular portion (62) fluidly coupled to the breathing gas inlet (22), the tubular portion being configured to generate a breathing gas jet in a first hollow cavity (70a) of the body member (20); wherein the body member (20) includes a second hollow cavity (70b), the second hollow cavity being disposed downstream of the first hollow cavity (70a) with respect to the breathing gas flow received through the breathing gas inlet (22) and being physically separated therefrom; wherein the first hollow cavity (70a) is fluidly coupled to the second hollow cavity (70b) through an opening (72); wherein the tubular portion (62) of the Benveniste valve (60) is configured to direct the breathing gas jet to the opening (72) coupling the first hollow cavity (70a) and the second hollow cavity (70b) so as to generate the end-expiratory positive pressure for the CPAP treatment downstream of the opening (72) and / or within the second hollow cavity (70b).

26. A respiratory system (100) for positive pressure ventilation and continuous positive airway pressure treatment for neonatal resuscitation, the respiratory system comprising: at least one breathing device (10) according to any one of the preceding claims; at least one expiratory valve (32) fluidly coupled to the second air outlet (28) of the breathing device (10); and Optionally including one or more ventilators (210b), wherein the at least one exhalation valve (32) is provided in an exhalation branch (252) of the ventilator (210b) and a resuscitator device (210a).

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