WO2017067083A1

WO2017067083A1 - Ventilation control apparatus, and breathing mask device provided with ventilation control apparatus

Info

Publication number: WO2017067083A1
Application number: PCT/CN2015/100045
Authority: WO
Inventors: 庄志; 王亚杰; 马德东; 周明钊
Original assignee: 北京怡和嘉业医疗科技有限公司
Priority date: 2015-10-23
Filing date: 2015-12-31
Publication date: 2017-04-27
Also published as: CN105194781A; CN109331309A; CN105194781B

Abstract

A ventilation control apparatus (200), and a breathing mask device (20) provided with the ventilation control apparatus (200). The ventilation control apparatus (200) comprises: a cavity (210), provided with one or a plurality of air delivery ports (212A, 212B), and a mask ventilation port (211) used for being in communication with the breathing mask (20); a valve assembly (220) arranged at at least one of the air delivery ports (212A, 212B), the valve assembly (220) being matched with the air delivery ports (212A, 212B) to form an air inlet port and an air discharge port, the valve assembly (220) being configured to connect the air inlet port to the mask ventilation port (211) when the pressure (P₁) within the cavity (210) is less than or equal to the atmospheric pressure (P₀), and connect the air discharge port to the mask ventilation port (211) when the pressure (P₁) within the cavity (210) is greater than the atmospheric pressure (P₀). The cross-sectional area of the air inlet port is greater than that of the air discharge port, and the air discharge port keeps the pressure (P₁) within the cavity (210) greater than the atmospheric pressure (P₀) during exhalation. The ventilation control apparatus (200) implements an exhalation phase positive pressure function, and prevents patient discomfort caused by continuous positive pressure. A positive pressure air supply apparatus and a pipeline etc. need not be connected during use, thereby facilitating patient movement, and the positive pressure air supply apparatus need not be carried when going out.

Description

Ventilation control device and respiratory mask device having the same

Cross-reference to related applications

The present application claims priority to Chinese Patent Application No. CN201510696678.2, entitled "Ventilation Control Device and Breathing Mask Device Having the Ventilation Control Device", filed on October 23, 2015, the entire contents of which is incorporated by reference. In this article.

Technical field

The present invention relates to the field of respiratory masks, and in particular to a ventilation control device for a respiratory mask and a respiratory mask device having such a ventilation control device.

Background technique

Current methods of treating obstructive sleep apnea hypopnea syndrome (OSAHS) include surgery, orthodontics, and continuous positive airway pressure (CPAP).

The most common method of surgery is uvulopalatopharyngoplasty and its improved surgery for upper airway oropharyngeal obstruction (including pharyngeal mucosal tissue hypertrophy, narrow pharyngeal cavity, uvula sulcus hypertrophy, soft palate too low, tonsil hypertrophy And apnea hypopnea index (AHI) <20 times / hour. Due to the need for surgery, the patient's acceptance is low, and the length of the surgical tissue may cause the disease to be repeated, and then the surgery cannot be performed again.

Oral orthoses are often used in patients with simple snoring and mild OSAHS (AHI <15 times / hour), especially in patients with mandibular retraction. The efficacy is unpredictable and can only be used.

The continuous positive pressure ventilation technique is to connect the respiratory mask 110 to the CPAP ventilator 130 through the connecting line 120 and wear the respiratory mask 110 to the face of the patient. The CPAP ventilator 130 produces a continuous positive pressure flow that provides physiological pressure support to the patient's upper airway to treat the OSAHS. The disadvantage of continuous positive pressure ventilation is that continuous positive pressure can cause discomfort to the patient, and some patients cannot accept it; the connecting line and the ventilator limit the night activity of the patient, and the compliance is low; the CPAP ventilator is inconvenient to carry and the cost is high. Breathing masks are used in a number of different situations for the treatment of respiratory disorders, such as the treatment of obstructive sleep apnea syndrome; or in other cases for providing a stable flow of breathables.

Therefore, there is a need for a ventilation control device for a respiratory mask and a call having the ventilation control device The mask device is sucked to at least partially solve the problems mentioned above.

Summary of the invention

In order to at least partially solve the problems in the prior art, the present invention provides a ventilation control device for a respiratory mask and a respiratory mask having the ventilation control device.

A ventilation control device according to an aspect of the present invention includes a cavity having a mask vent and one or more air ports for communicating with a respiratory mask, and a valve assembly disposed at least one The gas delivery port; the valve assembly cooperates with the gas delivery port to form an intake port and an exhaust port; the valve assembly is configured to cause the intake air when a pressure in the cavity is less than or equal to atmospheric pressure a port communicating with the mask vent, wherein the exhaust port is in communication with the mask vent when the pressure in the chamber is greater than atmospheric pressure; wherein a cross-sectional area of the air inlet is greater than the exhaust port The cross-sectional area, and the venting port is capable of maintaining a pressure in the chamber greater than atmospheric pressure when exhaling.

Preferably, the gas delivery port includes a first gas delivery port and a second gas delivery port which are disposed at intervals, and the valve assembly is disposed at the first gas delivery port; when the pressure in the cavity is less than or equal to atmospheric pressure Opening the first air inlet, the first air inlet and the second air outlet are the air inlet; when the pressure in the chamber is greater than atmospheric pressure, the first air outlet is closed, The second gas delivery port is the exhaust port.

Preferably, an adjustment mechanism is disposed at the second air inlet for adjusting a ventilation area of the second air outlet.

Preferably, the adjustment mechanism includes: a fixing member coupled to the cavity; a movable member movably coupled to the fixing member; and a positioning structure for positioning the relative to the fixing member a position of the movable member; and an adjusting member, the head of the adjusting member being configured to be accommodated in the second gas delivery port and having a different cross-sectional area along a gas flow direction of the second gas delivery port, The adjusting member is coupled to the movable member, and the movable member is configured to move the adjusting member along a gas flow direction of the second air inlet.

Preferably, the adjusting mechanism comprises an elastic member connected at the second air inlet and covering the second air inlet, and the elastic member is arranged to make the second air outlet The through hole communicating with the atmosphere, the ventilation area of the through hole increases as the pressure in the cavity increases.

Preferably, the adjustment mechanism further includes a resilient valve port in communication with the second air delivery port, the elastic valve mouth being tapered along an air outlet direction of the air delivery port.

Preferably, the valve assembly is configured to open when the pressure in the chamber is less than or equal to atmospheric pressure The air inlet is the air inlet; the valve assembly closes a portion of the air outlet when the pressure in the chamber is greater than atmospheric pressure, and the remaining portion of the air outlet is a row Air port.

Preferably, the valve assembly includes one or more valves for controlling gas flow of the gas delivery port, the valve being a one-way valve that opens when a pressure within the cavity is less than or equal to atmospheric pressure, The valve assembly has a vent opening that communicates the cavity with the atmosphere, the vent opening including a through bore disposed on the valve, and/or an opening formed by a plurality of valves that cooperate with the loser The overlapping area of the port is the exhaust port.

Preferably, the valve is made of an elastic material such that the venting area of the vent opening increases as the pressure within the chamber increases.

Preferably, the ventilation opening is provided with an adjustment mechanism for adjusting the ventilation area of the ventilation opening.

Preferably, the adjustment mechanism includes a resilient valve mouth disposed on the valve and in communication with the vent opening, the resilient ram being tapered along an air outlet direction of the vent opening.

Preferably, the adjustment mechanism includes: a fixing member coupled to the valve assembly; a movable member movably coupled to the fixing member; and a positioning structure for positioning the relative to the fixing member a position of the movable member; and an adjustment member, the head of the adjustment member being disposed to be receivable in the ventilation opening and having a different cross-sectional area along a gas flow direction of the ventilation opening, the adjustment member being connected To the movable member, the movable member is capable of driving the adjusting member to move along a gas flow direction of the vent opening.

Preferably, the valve assembly is disposed on the air inlet to cover the air inlet, and the valve assembly is provided with a through hole communicating with the air inlet; the valve assembly is configured to be When the pressure in the chamber is less than the atmospheric pressure, bulging toward the interior of the cavity to enlarge the through hole, and limiting the valve assembly to the cavity when the pressure in the cavity is greater than the atmospheric pressure External uplift.

Preferably, the valve assembly includes: an elastic valve piece disposed on the gas delivery port to cover the gas delivery port, and the elastic valve when the pressure in the cavity is less than the atmospheric pressure a sheet bulging into the cavity to enlarge the through hole, a stopper, the stopper being disposed on a side of the elastic valve piece away from the cavity for use in the cavity When the pressure is greater than the atmospheric pressure, the elastic valve piece is stopped to bulge outside the cavity.

A respiratory mask apparatus according to another aspect of the present invention includes: a respiratory mask; and any ventilation control device as described above, the ventilation control device being coupled to the respiratory mask, and through the A mask vent is vented to the breathing mask.

Preferably, the respiratory mask comprises a mask body and a pad assembly attached to the mask body for contacting a face of a patient, the mask body and the pad assembly being jointly formed for a cavity in communication with the mouth and/or nose of the patient, wherein the cavity of the ventilation control device is part of the cavity, the valve assembly of the ventilation control device being disposed on the mask body .

When the patient exhales, the pressure inside the breathing mask will be higher than atmospheric pressure. The invention utilizes the characteristics of the change of the expiratory pressure to provide a ventilation control device for the intake port and the exhaust port respectively having different cross-sectional areas during inhalation and exhalation, and the exhaust port has a relatively small cross. The cross-sectional area, in turn, achieves the positive pressure function of the expiratory phase, avoiding patient discomfort caused by continuous (exhalation and inhalation) positive pressure; the ventilation control device uses its own mechanical structure to provide positive exhalation pressure, so it is not necessary to use A positive pressure gas supply device (such as a CPAP ventilator) and a pipeline are connected to facilitate the patient's movement; when the patient is out, there is no need to carry a positive pressure gas supply device, and the patient can wear a respiratory mask having the ventilation control device for treatment at any time. In addition, the ventilation control device is small in size, convenient to carry, and low in cost.

A series of simplified forms of concepts are introduced in the Summary of the Invention, which will be described in further detail in the Detailed Description section. The summary is not intended to limit the key features and essential technical features of the claimed invention, and is not intended to limit the scope of protection of the claimed embodiments.

Advantages and features of the present invention are described in detail below with reference to the accompanying drawings.

DRAWINGS

The following drawings of the invention are hereby incorporated by reference in their entirety in their entirety. The embodiments of the invention and the description thereof are shown in the drawings In the drawing,

Figure 1 is a schematic view of a conventional continuous positive pressure ventilation system;

2A is a perspective view of a respiratory mask having a ventilation control device in accordance with one embodiment of the present invention;

Figure 2B is a full cross-sectional view of the ventilation control device and the respiratory mask of Figure 2A;

Figure 3 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a first embodiment of the present invention;

Figure 4 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a second embodiment of the present invention;

Figure 5 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a third embodiment of the present invention;

Figure 6 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a fourth embodiment of the present invention;

Figure 7A is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a fifth embodiment of the present invention;

Figure 7B is a perspective view of the ventilation control device and the respiratory mask of Figure 7A;

Figure 8 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a sixth embodiment of the present invention;

Figure 9 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a seventh embodiment of the present invention;

Figure 10 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with an eighth embodiment of the present invention.

110, breathing mask; 120, connecting pipeline; 130, CPAP ventilator; 20, breathing mask; 21, mask body; 22, pad assembly; 23, support portion; 24, forehead support; 200, ventilation control device; 210, cavity; 211, mask vent; 212A, first air outlet; 212B, second air outlet; 213, connection structure; 220, valve assembly; 300, adjustment mechanism; 310, fixing member; Moving member; 330, positioning structure; 340, adjusting member; 311, air outlet; 341, head; 400, adjusting mechanism; 410, elastic member; 420, through hole; 500, elastic valve mouth; 610, cavity; , mask vent; 612, gas outlet; 621, valve; 622, connector; 623, through hole; 710, cavity; 711, mask vent; 712, gas outlet; 721, valve; 722, connector 723, opening; 800, elastic valve mouth; 910, cavity; 912, gas outlet; 921, valve; 922, through hole; 923, biasing member; 930, adjusting mechanism; 931, fixing member; Moving member; 933, positioning structure; 934, adjusting member; 935, head; 940, vent; 1010, cavity; 1011 Vent hood; 1012, gas port; 1020, a valve assembly; 1021, elastic valve plate; 1022, a through hole; 1023, stopper; 1024, stomata.

detailed description

In the following description, numerous details are provided in order to provide a thorough understanding of the invention. However, those skilled in the art can understand that the following description is merely illustrative of a preferred embodiment of the invention, which may be practiced without one or more such details. Moreover, in order to avoid confusion with the present invention, some of the technical features well known in the art are not described in detail.

According to an aspect of the invention, a ventilation control device (hereinafter referred to as a ventilation control device) for a respiratory mask is provided. In order to be able to accurately and completely understand the ventilation control device, a breathing mask using the ventilation control device will be briefly described herein. It will be understood that the nasal mask type breathing mask shown in the drawings is merely exemplary, and the ventilation control device provided herein is not limited to being applied only to the nasal mask type breathing mask, which can also be applied to the nose. Breathing mask in the form of a hood, full face mask or nasal plug.

As shown in the perspective view of FIG. 2A and the cross-sectional view of FIG. 2B, the respiratory mask 20 includes a mask body 21 and a lining. Pad assembly 22 and forehead support 24. In other embodiments not shown, the respiratory mask 20 may not include one or both of the components, such as not including the forehead support 24.

A mask through hole (not shown) is provided on the mask body 21. The pad assembly 22 is mounted on the mask body 21. The mask body 21 and the cushion assembly 22 together form a cavity. The cushion assembly 22 can be fixedly or detachably coupled to the mask body 21. The cushion assembly 22 can also form the cavity separately, in which case the mask body 21 can support the cushion assembly 22 outside of the cushion assembly 22. In use, the mask body 21 and pad assembly 22 will contact the patient's face (including the cheeks, bridge of the nose, upper and lower mouth, etc.) to form a seal to allow the cavity to communicate with the patient's nasal or nasal cavity. The mask body 21 may be made of a rigid material or a flexible material. The cushion assembly 22 is preferably made of a flexible material. The cushion assembly 22 can be an air bag or a membrane structure. The membrane structure can be a single layer or a separate bilayer. The cushion assembly 22 can also include adhesives (e.g., stickers, etc.) to enhance patient feel and sealing. The shape of the mask body 21 and the cushion assembly 22 as viewed from the front is not limited to the general triangular shape shown in the drawing, but may be a pear shape, a trapezoid shape or the like. The mask body 21 and the pad assembly 22 may also take a shape that matches the shape of the nose and the like. In a nasal-plug type respiratory mask, the cushion assembly 22 can also be designed as a conical film-shaped nasal plug that is sealed from the nasal orifice, and the structure can also have a single layer or a separate two-layer membrane structure. In the nose and mouth breathing mask, the nasal plug can also be combined with the mouth mask design. The cushion assembly 22 includes a support portion 23. The support portion 23 can be designed as a wrinkle, bellows, partially thinned, bent, curved, etc. structure to achieve a better fit of the respiratory mask 20 to the face, and even to achieve a cushioned portion of the cushion assembly 22 and The mask body 21 is suspended so that the angle of fit of the pad to the face can be adapted and the gas pressure in the cavity is used to assist the sealing. As an example, the support portion 23 employs a balloon or gel and can have an adaptive face function.

In addition, the respiratory mask 20 also includes fasteners for attaching the securing assembly, such as snaps, strap loops, and the like. The fixing member may be attached to the mask body 21 as a separate component or may be integrally formed with the mask body 21. The fixation assembly is used to secure the respiratory mask 20 in place on the patient's face, which may be a variety of existing headbands. The headband may have a structure that is connected to the mask body 21, such as a buckle and a Velcro strap. The material of the headband may be a braid, an elastomer or the like (wherein the elastomer may be foam, silica gel, etc.), or a multilayer structure in which the braid and the elastomer are composited to improve elasticity, gas permeability and human compliance. The shape of the headband can be made into various shapes such as a Y-shape, an I-shape, and the like, and parts which are relatively rigid in some directions and flexible in some other directions can be added to better fix the respiratory mask 20. The fixation component may also be a structure that is directly attached to the face, the outside of the nose, or the nasal cavity, such as a fixed structure that may be an adhesive member (eg, a sticker, etc.).

The forehead support 24 abuts against the patient's forehead when in use. The connection between the forehead support 24 and the mask body 21 can be fixed or detachable, and the split embodiment is, for example, snap-fit. The forehead support 24 includes a soft forehead contact. The forehead support 24 can also have adjustment means to adjust the distance from the forehead to ensure adaptation to different facial shapes.

The above rigid material may be plastic, alloy, etc., and the flexible material may be silica gel, gel, foam, air bag, textile, etc., and the definition of this material is also applicable to subsequent parts.

The various components included in the respiratory mask 20 can be constructed in a manner known in the art and therefore will not be described in further detail herein.

DETAILED DESCRIPTION OF THE INVENTION A plurality of preferred embodiments of the ventilation control device provided by the present invention will be described in detail below with reference to the accompanying drawings. Referring to Figures 2A-2B, the ventilation control device 200 includes a cavity 210 and a valve assembly 220.

The cavity 210 has one or more gas ports and a mask vent 211. In the embodiment of Figures 2A-2B, the gas delivery port includes, for example, a first gas delivery port 212A and a second gas delivery port 212B. The mask vent 211 is for venting with the respiratory mask 20. The mask vent 211 is, for example, connected to the mask through hole of the respiratory mask 20. Although the cavity 210 is generally cylindrical in shape, in other embodiments not shown, the cavity 210 may have any other shape as long as a sealed space that can be vented with the respiratory mask 20 can be formed. can. The wall thickness of the cavity may be disregarded below when it is described that the component is disposed inside/outside the cavity. If the wall thickness is taken into consideration, it will be understood by those skilled in the art after reading this application that it may be included in the cavity/outside of the cavity to be disposed on the inner face and the outer face of the cavity (the thickness between the inner face and the outer face is the wall thickness) Between the situation. For example, as will be mentioned below, "the elastic valve is connected to the through hole on the outside of the cavity", the elastic valve can be connected to the wall of the cavity in the through hole according to the understanding of the technical solution. The volume of the cavity 210 is not limited, and it is preferable to wear comfort. The cavity 210 can be made of a flexible material or a rigid material. The cavity 210 can be non-detachably coupled to the respiratory mask 20 such that the ventilation control device 200 is non-detachably coupled to the respiratory mask 20. The cavity 210 may even be integral with the cavity formed by the mask body 21 and the cushion assembly 22, such as by molding the cavity 210 integrally with the mask body 21. Where the cavity 210 is integral with the mask body 21, the cavity 210 and the cavity can be formed as two lumens that can be clearly distinguished and communicated. In addition, the cavity 210 can also be formed as part of a cavity, that is, for the embodiment shown in Figures 2A-2B, a portion of the cavity of the respiratory mask can be utilized as the cavity 210, and the gas delivery port can be formed in the mask. On the main body 21. Thus, the valve assembly 220 can be disposed directly on the mask body 21. In the embodiment in which the cavity 210 is separately provided from the mask body 21, the connection structure 213 may be provided at the mask vent 211 of the cavity 210. The connection structure 213 is for detachably connecting the ventilation control device 200 to the respiratory mask 20. Connection structure 213, for example It can be a snap connection structure, a threaded connection structure or an elastic body to hold the connection structure and the like. In this way, the ventilation control device 200 can be replaced at any time, and the ventilation control device 200 can be designed to be directly applied to an existing CPAP breathing mask to reduce the cost of use of the patient.

The gas port is used to exchange gas between the respiratory mask 20 and the atmosphere, including the patient's inhalation and the patient's exhalation, both through the gas delivery port. In the embodiment of Figures 2A-2B, the chamber 210 is provided with a first gas delivery port 212A and a second gas delivery port 212B that are spaced apart from one another. In other embodiments not shown, the number of gas outlets may be one or more than two. A preferred embodiment of setting one and more than two gas delivery ports will be discussed later. The valve assembly 220 is disposed at at least one gas delivery port. The valve assembly 220 cooperates with the gas delivery port to form an intake port and an exhaust port. Both the intake port and the exhaust port can communicate with the mask vent 211. As an example, when it is desired to form an exhaust port, the valve assembly may be in a closed state to block one or more of the air ports, or even block a portion of the one or more air ports; when it is desired to form the air ports, The valve assembly can be in an open state to enable all of the gas delivery ports to be conductive, or to have a smaller obscuration area to the gas delivery port when in the closed state, thus forming an air inlet for gas exchange. For example, in the embodiment of FIGS. 2A-2B, when the valve assembly 220 is closed, it blocks the first air inlet 212A, and the second air outlet 212B forms an exhaust port; when the valve assembly 220 is opened, the first air inlet 212A The second air inlet 212B forms an air inlet.

Configured as a pressure valve assembly 220 within the cavity 210 is less than or equal to P ₁ of the atmospheric pressure P ₀ time (i.e. the patient inhales), the intake port communicates with the vent mask. The valve assembly 220 is also configured as a pressure within the cavity 210 P ₀ P ₁ of greater than atmospheric pressure (i.e. when the patient exhales), the exhaust port in communication with the mask vent. The cross-sectional area S _{1 of the} intake port is larger than the cross-sectional area S _{2 of the} exhaust port. The cross-sectional area S _{1 of the} intake port is relatively large to achieve no resistance or small resistance when inhaling. The cross sectional area S _{2 of the} exhaust port is relatively small. The exhaust port can maintain the pressure P _{1 in the} cavity 210 greater than the atmospheric pressure P ₀ during exhalation, thereby forming a positive expiratory pressure. In the embodiment of Figures 2A-2B, the valve assembly 220 is disposed at the first gas delivery port 212A. When the pressure P in the cavity 210 _is less than or equal to atmospheric pressure P _0, so that the valve assembly 220 may be opened, the first gas from the

gas delivery port

212A and 212B into the second gas delivery port 210 within the cavity. The first gas delivery port 212A and the second gas delivery port 212B are intake ports. When the pressure P in the chamber 210 _is greater than the atmospheric pressure P _0, can make the valve assembly 220 is closed, the gas is discharged only from the second chamber gas delivery port 210 212B. The second gas delivery port 212B is an exhaust port. Cross sectional area of the second gas delivery port 212B can be set smaller, so that the rate of exhaust gas is less than the rate of exhalation of the patient, thereby ensuring holding chamber pressure P in ₂₁₀₁ greater than atmospheric pressure P ₀ exhale. When inhaling, the second air outlet 212B can also act as an auxiliary air intake, helping to make the inhalation tend to have no resistance. The results of related pathological studies showed that patients with OSAHS had no obstruction of the airway during inhalation and only had obstruction during exhalation. The present invention uses positive expiratory pressure to prevent the upper airway from collapsing, thereby treating the OSAHS.

In one embodiment, the valve assembly can include a valve made of an elastomeric material or a morphological memory material and a connector that connects the valve to the cavity 210 at the first gas delivery port 212A. Thus, when the pressure P ₁ is less than or equal to atmospheric pressure P _0, the valve body cavity 210 to open, allowing air to enter the cavity 210. In another embodiment, the valve assembly can include a valve and a biasing member disposed inside the cavity 210. When the valve is closed, the biasing member applies a moving resistance or no force to the valve against the direction of the intake air, and the valve abuts against the inner wall of the cavity 210; when there is a difference between the inner and outer air pressure, the gas overcomes the moving resistance to open the valve, allowing Air enters the cavity 210. Of course, the valve assembly 220 can also have various embodiments as long as the above functions can be achieved.

In a further preferred embodiment, an adjustment mechanism can be added at the second gas delivery port 212B for adjusting the venting area of the second gas delivery port 212B. This ventilation area refers to the area of the area where the second gas delivery port 212B can exchange gas with the atmosphere. For example, when a portion of the second gas delivery port 212B is blocked, the ventilation area is a cross-sectional area of the unobstructed portion; when the second gas delivery port 212B is not blocked, the ventilation area is the cross-section of the second gas delivery port 212B. area. The ventilation area mentioned below can be referred to the definition herein. By adjusting the ventilation area of the second gas delivery port 212B, the pressure P ₁ in the cavity 210 during exhalation can be controlled, thereby adjusting the positive expiratory pressure for treatment. Referring to the embodiment shown in Fig. 3, which is substantially identical to the embodiment shown in Figs. 2A-2B, only the differences will be described in detail herein, and the same or similar components will be given the same reference numerals. The adjustment mechanism 300 includes a fixture 310, a movable member 320, a positioning structure 330, and an adjustment member 340. The fixture 310 is coupled to the cavity 210. The movable member 320 is movably coupled to the fixture 310. The fixing member 310 and the movable member 320 do not close the second air outlet 212B. For example, the air outlet 311 may be disposed on the fixing member 310 and/or the movable member 320, and/or between the fixing member 310 and the movable member 320. The connection forms an air outlet, and/or the fixing member 310 and/or the movable member 320 are disposed in a frame or mesh form as long as the gas discharged through the second air outlet 212B can be discharged to the atmosphere. The positioning structure 330 is used to position the movable member 320 relative to the fixture 310. In the embodiment shown in FIG. 3, the positioning structure 330 can be a mating thread disposed on the fixture 310 and the movable member 320. In other embodiments not shown, the positioning structure can be a snap, a securing pin, or the like. The head 341 of the adjustment member 340 is configured to be receivable in the second air inlet 212B. The head portion 341 of the adjusting member 340 has a different cross-sectional area along the gas flow direction of the second gas delivery port 212B. As an example, the head portion 341 may have a conical shape, a truncated cone shape, a pyramid shape, a prismatic shape, or the like; the head portion 341 may also be stepped to have different cross-sectional areas along the gas flow direction. The second air inlet 212B can be adapted to the shape of the head 341. For example, as shown in FIG. 3, the head portion 341 and the second air delivery port 212B are both in the shape of a truncated cone. In addition, the second gas delivery port 212B may also be cylindrical. Thus, when the different positions of the head 341 enter the second air inlet 212B, the airflow flowing through the second air outlet 212B can be blocked, thereby adjusting the ventilation area of the second air outlet 212B. When the head 341 is completely removed from the second air outlet 212B, the second air outlet 212B has a maximum ventilation area. The adjustment member 340 is coupled to the movable member 320. The adjustment member 340 is moved along the gas flow direction of the second gas delivery port 212B by the movement of the movable member 320. And, after moving to the appropriate position, the relative position between the movable member 320 and the fixing member 310 is fixed by the positioning structure 330. It should be noted that the adjustment mechanism can be added to any of the embodiments mentioned above and below, and if necessary, those skilled in the art based on the understanding of the embodiment shown in FIG. 3, in order to increase the adjustment The mechanism can be appropriately modified for some components in other embodiments. The adjustment mechanism described above will be adjusted by the patient or medical staff according to the patient's condition and maintained in the adjusted position for a period of time, that is, the adjustment is not performed in real time. Next, we will describe an embodiment in which the venting area of the second gas delivery port 212B is adjusted in real time based on the pressure P _{1 in the} chamber 210.

In another embodiment, as shown in FIG. 4, the adjustment mechanism 400 includes an elastic member 410. The elastic member 410 is coupled to the second gas delivery port 212B and covers the second gas delivery port 212B. The elastic member 410 is provided with a through hole 420 that allows the second air inlet 212B to communicate with the atmosphere. The through hole 420 is used to form an exhaust port. The elastic member 410 can be formed into a sheet shape. The venting area of the through hole 420 varies with the change in the pressure P ₁ in the cavity 210. When exhaling, the pressure P _{1 in the} cavity 210 increases, and the elastic member 410 will expand toward the outside of the cavity 210, increasing the ventilation area of the through hole 420. Thereby, the change of the pressure P ₁ in the cavity 210 can be counteracted, and a certain adjustment effect can be achieved, so that the pressure P _{1 is} maintained within a certain range and does not increase sharply due to the patient's intense exhalation. Similarly, when the intake, the pressure P into the chamber 210 is reduced in _2101, opening the valve assembly 220, via a first gas and a second gas delivery outlet gas delivery port 212A 212B cavity. In addition, the elastic member 410 will also expand toward the inner side of the cavity 210 when inhaling, increasing the ventilation area of the through hole 420, and the deeper the ventilation area of the through hole 420 as the patient breathes deeper, contributing to the smooth suction of the patient. gas.

Further preferably, as shown in FIG. 5, the resilient valve opening 500 can be added to the adjustment mechanism shown in FIG. The elastic valve port 500 is in communication with the second air inlet 212B. As an example, the resilient valve nipple 500 is coupled to the through bore 420 on the outside of the cavity 210. Preferably, the elastic valve mouth 500 may be integrally formed with the elastic member 410. Of course, it is possible to adopt a manner in which the split bodies are formed and joined together. The elastic valve nozzle 500 is tapered along the air outlet direction of the through hole 420. When exhaling, the pressure P _{1 in the} cavity 210 increases, the elastic member 410 will expand toward the outside of the cavity 210, increase the ventilation area of the through hole 420, and the ventilation area of the elastic valve mouth 500 will also increase, thereby increasing The cross-sectional area of the large exhaust port. Thereby, the change of the pressure P ₁ in the cavity 210 can be counteracted, and a certain adjustment effect can be achieved, so that the pressure P _{1 is} maintained within a certain range and does not increase sharply due to the patient's intense exhalation. And the elastic valve nozzle 500 of tapered design, better control of the through hole 420 of the deformation, and thus more stably control the change in pressure within the cavity 210 of P _1. It will be appreciated that the resilient valve opening 500 can also be added to the embodiment illustrated in Figures 2A-2B. The elastic valve port 500 is in communication with the second air inlet 212B. As an example, the resilient valve nipple 500 is coupled to the second gas delivery port 212B on the outside of the cavity 210. When the patient exhales, the ventilation area of the elastic valve mouth 500 is increased, and the air pressure P ₁ in the cavity 210 is also adjusted.

In another set of embodiments, as shown in FIG. 6, the cavity 610 is provided with a mask vent 611 and a gas delivery port 612. The gas delivery port 612 may be one as shown in the drawing or may be plural. In the case of a plurality of gas delivery ports 612, a plurality of gas delivery ports 612 may be opened and closed by valve assembly 620, or several of them may be opened and closed by valve assembly 620. The mask vent 611 is substantially identical to the mask vent described above. When the valve assembly 620 is open, the air inlet 612 is opened, and conversely, the air inlet 612 is closed. The valve assembly 620 is configured as a pressure within the cavity 610 is less than or equal to P ₁ of opening atmospheric pressure gas delivery port 612 P _0. That is to say, the valve assembly 620 is opened when inhaling, and the air inlet 612 is an intake port. The valve assembly 620 is also configured as a pressure within the cavity 610 of the closing portion of the gas delivery port 612 P is greater than the atmospheric pressure P ₀ _1. At this time, the remaining portion of the air inlet 612 is an exhaust port. The valve assembly 620 can have a venting opening that communicates the cavity 610 with the atmosphere. As an example, the valve assembly 620 can include a valve that is a one-way valve that is used to control the flow of gas to the gas delivery port 612. The valve is opened when the pressure P ₁ in the chamber is less than or equal to the atmospheric pressure P ₀ such that the gas delivery port 612 serves as an air inlet. The vent opening may be a through hole 623 provided in the valve. The through hole 623 has an overlapping area with the gas delivery port 612 as an exhaust port. In other embodiments, the venting opening may have other embodiments, which will be described later in connection with FIG. When exhaling, the pressure P _{1 in the} cavity 610 is greater than the atmospheric pressure P ₀ , the valve assembly 620 closes the gas delivery port 612, and the exhaled gas is discharged through the through hole 623. The through hole 623 serves as an exhaust port. In the embodiment illustrated in FIG. 6, valve 621 is pivotally coupled to cavity 610 at air delivery port 612 (eg, via connector 622). A through hole 623 is provided on the valve 621. In one embodiment, at least the portion of the valve 621 that is coupled to the connector 622 is resilient to pivot the valve 621 between the open position and the closed position. In other embodiments not shown, the valve is disposed separately from the cavity 610. The valve can be movably coupled to the cavity between an open position and a closed position (eg, by a biasing member). The biasing member urges the valve against the gas inlet 612 inside the cavity 610 and exerts a resistance to movement of the valve as the valve moves. Additionally, the valve may also be pivotally coupled to the cavity 610 in the presence of a parametric member. A valve assembly in which the valve is disposed separately from the cavity 610 will be described later in conjunction with FIG. It can be understood that the valve can be used in various forms as long as the above functions can be achieved. A through hole 623 is provided in the valve 621. The through hole 623 is in communication with the gas delivery port 612. The cross-sectional area of the through hole 623 is smaller than the cross-sectional area of the gas delivery port 612. When the pressure P _{1 in the} cavity 610 is greater than the atmospheric pressure P ₀ , the gas delivery port 612 is closed, and the gas in the cavity 610 is discharged through the through hole 623. The through hole 623 is generally small to maintain the pressure within the cavity 610 greater than the atmospheric pressure P0 during exhalation.

In the embodiment depicted in Figures 2A-2B, 3-5, there are a plurality of gas delivery ports that open and close one or more of the gas delivery ports through the valve assembly such that the ventilation control device has different air inlets and The exhaust port, in turn, adjusts the gas flow rate during exhalation and inhalation to achieve no resistance or small resistance during inhalation, and positive expiratory pressure. The embodiment shown in FIG. 6 is different in that, when inhaling, the valve assembly opens the air inlet to form an air inlet, so that there is no resistance or small resistance when inhaling. Upon venting, the valve assembly closes a portion of the gas delivery port, such as a through hole in a valve assembly (more specifically, a valve) to form an exhaust port. Further, in other embodiments not shown, it is also possible to have the valve assembly set to close the gas delivery port when the valve assembly valve does not completely cover the gas delivery port. An exhaust port is formed by a gap between the valve and the gas delivery port. In this way, a positive pressure environment is formed during exhalation.

7A-7B illustrate a respiratory mask having a ventilation control device in accordance with one embodiment of the present invention. As shown, the valve assembly 720 includes a plurality of valves 721 for controlling the flow of gas to the gas delivery ports 712. A plurality of valves 721 are pivotally or movably coupled to the cavity 710 at the gas delivery port 712 (eg, by a connector 722). The manner in which the plurality of valves 721 are coupled to the cavity 710 can be referred to the description for the portion of FIG. A plurality of valves 721 to a pressure within the cavity 710 is less than or equal to P ₁ of the gas delivery port opening when the atmospheric pressure P ₀ 712. When inhaling, the valve 721 is opened. It can be understood that the valve can be in various forms as long as the above functions can be achieved. The vent opening may be an opening 723 formed by the cooperation of a plurality of valves 721. For example, a plurality of valves 721 can be spaced apart to form an opening 723. The opening 723 has an overlapping area with the gas delivery port 712. When the pressure P _{1 in the} cavity 710 is greater than the atmospheric pressure P ₀ , the gas inlet 712 is partially closed, and the gas in the cavity 710 can be discharged through the overlapping area of the opening 723 and the gas delivery port 712. This overlapping area is an exhaust port. The area of the overlap region is smaller than the ventilation area of the gas delivery port 712. Gas delivery opening 723 and opening 712 overlapping area is usually small, to maintain the pressure within the exhalation chamber 710 greater than atmospheric pressure P _0. Other components of the ventilation control device shown in Fig. 7 may be the same as or similar to any of the foregoing embodiments and will not be described in detail herein.

Preferably, the air delivery ports (e.g., 612 and 712) are disposed opposite the mask vents (e.g., 611 and 711) such that the gas exhaled by the patient is discharged straight through the vent 212 to avoid breathing mask 20 and cavity 210. Carbon dioxide residue. In addition, the air inlet is disposed opposite the mask vent to allow the

chambers

610 and 710 to have a relatively small length, so that the ventilation control device is more compact and more compact. Small.

Further, the

valves

621 and 721 may be made of an elastic material such that the ventilation area of the through hole 623 and the opening 723 increases as the pressure P ₁ in the

cavities

610 and 710 increases. When exhaling, the pressure P _{1 in the} chambers 610 and 710 is increased, and the

valves

621 and 721 will expand or deform toward the outside of the

chambers

610 and 710, increasing the ventilation area of the through hole 623 and the opening 723, thereby increasing the row. Gas rate. Thereby, the change of the pressure P ₁ in the

cavities

610 and 710 can be counteracted, and a certain adjustment effect can be achieved, so that the pressure P _{1 is} kept within a certain range and does not increase sharply due to the severe exhalation of the patient.

Further preferably, as shown in FIG. 8, an adjustment mechanism, that is, an elastic valve port 800, may be added to the ventilation control device shown in FIG. The elastic valve mouth 800 is substantially identical in principle to the elastic valve nozzle 500 shown in FIG. The elastic valve mouth 800 is disposed on the valve 621 and communicates with the through hole 623. As an example, the elastomeric valve port 800 is coupled to the through bore 623 on the outside of the cavity. Preferably, the resilient valve mouth 800 can be formed integrally with the valve 621. Of course, it is possible to adopt a manner in which the split bodies are formed and joined together. The elastic valve mouth 800 tapers along the air outlet direction of the through hole 623. When exhaling, the pressure P _{1 in the} cavity 610 is increased, the elastic valve 621 will expand toward the outside of the cavity 610, increasing the ventilation area of the through hole 623, and the ventilation area of the elastic valve mouth 800 will also increase. Increase the exhaust rate. Thereby, the change of the pressure P ₁ in the cavity 610 can be counteracted, and a certain adjustment effect can be achieved, so that the pressure P _{1 is} maintained within a certain range and does not increase sharply due to the severe exhalation of the patient. And due to the elastic design of the orifice 800 is tapered, to better control the deformation of the through hole 623, and thus more stably control the variation within the cavity 610 of the pressure P ₁ is.

In addition, other types of adjustment mechanisms can be provided at the through holes for adjusting the ventilation area of the through holes. As an example, as shown in FIG. 9, the adjustment mechanism 930 includes a fixing member 931, a movable member 932, a positioning structure 933, and an adjustment member 934. The adjustment mechanism 930 is similar to the adjustment mechanism 300 shown in FIG. The fixing member 931 is connected to the valve 921. In this embodiment, the valve assembly can include a valve 921 and a biasing member 923. Valve 921 is moveable between an open position and a closed position. A through hole 922 is provided in the valve 921. The biasing member 923 applies a resistance to movement of the valve 921 as the valve 921 moves from the closed position to the open position. As an example, the biasing member 923 can abut the valve 921 against the gas inlet 912 inside the cavity 910. Of course, valves or other forms of valves as shown in Figures 6, 7A-7B and 8 can also be used. The movable member 932 is movably coupled to the fixing member 931. The fixing member 931 and the movable member 932 do not close the through hole 922, and for example, a vent (for example, the vent 940) may be provided on the fixing member 931 and/or the movable member 932, and/or the fixing member 931 and the movable member 932 may be provided. The connection between the spaces forms a vent, and/or the fixing member 931 and/or the movable member 932 are provided in a frame or mesh form as long as the gas discharged through the through hole 922 can be made It can be discharged into the atmosphere. The fixing member 931 and the movable member 932 shown in the drawing are only one example. The positioning structure 933 is for positioning the movable member 932 with respect to the fixing member 931. In the embodiment shown in FIG. 9, the positioning structure 933 may be a mating thread disposed on the fixing member 931 and the movable member 932. In other embodiments not shown, the positioning structure 933 can be a snap, a securing pin, or the like. The head 935 of the adjustment member 934 is provided to be receivable in the through hole 923. The head 935 of the adjustment member 934 has a different cross-sectional area along the gas flow direction of the through hole 923. Thus, when the different positions of the head 935 enter the through hole 923, the airflow flowing through the through hole 923 can be blocked, thereby adjusting the ventilation area of the air inlet 912. The adjustment member 934 is coupled to the movable member 932. The movement of the movable member 932 is caused to move the regulating member 934 in the gas flow direction of the through hole 923. And, after moving to the appropriate position, the relative position between the movable member 932 and the fixing member 931 is fixed by the positioning structure.

In yet another set of embodiments, another form of ventilation control device is provided. The vent control device includes a cavity 1010 and a valve assembly 1020. The cavity 1010 has a mask vent 1011 and a gas delivery port 1012. The cavity 1010 is similar to the above embodiment. Valve assembly 1020 is disposed on gas delivery port 1012. As an example, the edge of the valve assembly 1020 is coupled to the air delivery port 1012 to cover the air delivery port 1012. The valve assembly 1020 can be coupled to the sidewall of the gas delivery port 1012 within the gas delivery port 1012 or to the end of the gas delivery port 1012 at the outside of the gas delivery port 1012. The valve assembly 1020 is provided with a through hole 1022 communicating with the gas delivery port 1012. Exhalation and intake of the patient are performed through the through hole 1022. In order to achieve when no inspiratory and expiratory resistance or pressure resistance is small, the valve assembly 1020 is configured as a pressure within the cavity 1010 P ₁ of less than atmospheric pressure P ₀ time (i.e., during inhalation) raised to the internal cavity 1010, to The through hole 1022 is made larger to form an air inlet. And the valve assembly 1020 is configured to further the pressure within the cavity 1010 P ₁ of greater than atmospheric pressure P (i.e., exhalation) limiting valve assembly 1020 to the body cavity outside the ridge 1010 _0:00. Thus, the ventilation area of the through hole is kept constant, and an exhaust port is formed. It should be noted that in this embodiment, the main difference between the intake port and the exhaust port is the change in the cross-sectional area. As an example, the valve assembly 1020 can be formed from any single or composite material having different shape variables in both directions. Additionally, the valve assembly 1020 can also be fabricated from a resilient material that also includes a resilient valve that can be similar to the resilient ram 500 of FIG. 5 and the resilient nipple 800 of FIG. Only the resilient valve port of the valve assembly 1020 is disposed inside the cavity 1010 and tapers along the direction of intake of the through hole. Thus, when the inhalation valve assembly 1020 is swelled into the cavity 1010, the size of the through hole becomes large and the opening size of the elastic valve port also increases. When exhaling, the elastic valve mouth gathers toward the center, causing the opening size to become smaller, forming a positive expiratory pressure.

In a preferred embodiment, the valve assembly 1020 can include a resilient valve plate 1021. The elastic valve plate 1021 is disposed on the air inlet 1012 to cover the air inlet 1012. The edge of the resilient valve plate 1021 is coupled to the air delivery port 1012. As an example, the resilient valve plate 1021 can be coupled to the air delivery port 1012 by a connector. The connector may be an adhesive, a collar or a threaded member or the like. Further, the elastic valve piece 1021 can also be connected to the gas delivery port 1012 through a crimping structure at the gas delivery port 1012. The elastic valve piece 1021 covers the gas delivery port 1012. The through hole 1022 is disposed on the elastic valve piece 1021 (for example, in a central region thereof). When inhaling, the pressure P1 in the cavity 1010 is smaller than the atmospheric pressure P0, and the elastic valve piece 1021 (especially its central region) is swelled into the cavity 1010, so that the through hole 1022 is enlarged to achieve no resistance or small resistance inhalation. The valve assembly 1020 also includes a stop 1023. The stopper 1023 is disposed on a side of the elastic valve piece 1021 away from the cavity 1010. When exhaling, the pressure P _{1 in the} cavity 1010 is greater than the atmospheric pressure P ₀ , and the elastic valve piece 1021 has a tendency to bulge or deform outside the cavity 1010. However, due to the limitation of the stopper 1023, the stopper elastic valve piece 1021 (especially the central portion thereof) is swelled outward from the cavity 1010, and the elastic valve piece 1021 cannot be deformed, so the size of the through hole 1022 is constant, and has a relative air suction. Smaller aeration area. The through hole 1022 is sized to maintain a positive expiratory pressure within the cavity 1010 when exhaling. It can be understood that the stopper 1023 can flow the airflow, for example, the air hole 1024 can be provided on the stopper 1023, or the metal member can be used to form the stopper 1023 and the like.

The invention also provides a respiratory mask device. The respiratory mask device includes any of the respiratory masks described above and any of the aeration control devices described above. The ventilation control is connected to the breathing mask and is vented through the mask vent with the breathing mask. For the various components and structures they contain, reference can be made to the description of the corresponding parts above.

The present invention has been described by the above-described embodiments, but it should be understood that the above-described embodiments are only for the purpose of illustration and description. Further, those skilled in the art can understand that the present invention is not limited to the above embodiments, and various modifications and changes can be made according to the teachings of the present invention. These modifications and modifications are all claimed in the present invention. Within the scope. The scope of the invention is defined by the appended claims and their equivalents.

Claims

A ventilation control device for a respiratory mask, comprising:

a cavity having a mask vent and one or more gas ports for communicating with the respiratory mask;

a valve assembly disposed at at least one of said gas delivery ports;

The valve assembly cooperates with the air inlet to form an air inlet and an air outlet; the valve assembly is configured to make the air inlet and the mask air vent when the pressure in the chamber is less than or equal to atmospheric pressure Connected to connect the exhaust port to the mask vent when the pressure in the chamber is greater than atmospheric pressure;

Wherein, the cross-sectional area of the air inlet is larger than the cross-sectional area of the air outlet, and the air outlet can maintain the pressure in the cavity greater than atmospheric pressure when exhaling.
The ventilation control device according to claim 1, wherein said air delivery port comprises a first air delivery port and a second air delivery port which are disposed at intervals, and said valve assembly is disposed at said first air delivery port; The first gas delivery port is opened when the pressure in the cavity is less than or equal to atmospheric pressure, and the first gas delivery port and the second gas delivery port are the air inlet; when the pressure in the cavity is greater than atmospheric pressure The first gas delivery port is closed, and the second gas delivery port is the exhaust port.
The ventilation control device according to claim 2, wherein said second air delivery port is provided with an adjustment mechanism for adjusting a ventilation area of said second air delivery port.
The ventilation control device according to claim 3, wherein said adjustment mechanism comprises:

a fixing member coupled to the cavity;

a movable member movably coupled to the fixing member;

a positioning structure for positioning a position of the movable member relative to the fixing member;

An adjusting member, the head of the adjusting member being configured to be accommodated in the second air inlet and having a different cross-sectional area along a gas flow direction of the second air inlet, the adjusting member being connected to the The movable member is capable of driving the adjusting member to move along a gas flow direction of the second air inlet.
The ventilation control device according to claim 3, wherein said adjustment mechanism includes an elastic member connected to said second air delivery port and covering said second air delivery port, said elastic member A through hole is provided in which the second gas delivery port communicates with the atmosphere, and a ventilation area of the through hole increases as the pressure in the cavity increases.
The ventilation control device according to claim 3 or 5, wherein said adjustment mechanism further comprises The elastic valve port of the second air inlet is connected to the elastic valve mouth, and the elastic valve mouth is tapered along the air outlet direction of the second air inlet.
The ventilation control device according to claim 1, wherein the valve assembly is configured to open the air inlet when a pressure in the chamber is less than or equal to atmospheric pressure, and the air inlet is the air inlet; The valve assembly closes a portion of the gas delivery port when the pressure in the chamber is greater than atmospheric pressure, and the remaining portion of the gas delivery port is an exhaust port.
The ventilating control apparatus according to claim 7, wherein said valve assembly includes one or more valves for controlling gas flow of said gas delivery port, said valve being such that when pressure in said cavity is less than or equal to a one-way valve that opens at atmospheric pressure, the valve assembly having a venting opening that communicates the cavity with the atmosphere, the venting opening including a through hole disposed in the valve, and/or formed by a plurality of valves An opening, the overlapping area of the vent opening and the air inlet is the exhaust port.
The ventilation control device according to claim 8, wherein said valve is made of an elastic material such that a ventilation area of said ventilation opening increases as pressure in said chamber increases.
The ventilation control device according to claim 8, wherein an adjustment mechanism is provided at the ventilation opening for adjusting a ventilation area of the ventilation opening.
The ventilating control apparatus according to claim 10, wherein said adjustment mechanism includes a resilient valve port disposed on said valve and communicating with said vent opening, said resilient ram of said resilient vent along said venting opening Gradually.
The ventilation control device according to claim 10, wherein said adjustment mechanism comprises:

a fixing member coupled to the valve assembly;

a movable member movably coupled to the fixing member;

a positioning structure for positioning a position of the movable member relative to the fixing member;

An adjustment member, the head of the adjustment member being disposed to be receivable in the ventilation opening and having a different cross-sectional area along a gas flow direction of the ventilation opening, the adjustment member being coupled to the movable member, The movable member is capable of driving the adjusting member to move along a gas flow direction of the vent opening.
The ventilation control device according to claim 1, wherein the valve assembly is disposed on the air inlet to cover the air inlet, and the valve assembly is provided with a through hole communicating with the air inlet. ;

The valve assembly is configured to bulge into an interior of the cavity when the pressure in the cavity is less than the atmospheric pressure to enlarge the through hole, and to limit the pressure when the pressure in the cavity is greater than the atmospheric pressure The valve assembly is raised to the exterior of the cavity.
The ventilating control device of claim 13 wherein said valve assembly comprises:

An elastic valve piece is disposed on the air inlet to cover the air inlet, and when the pressure in the cavity is less than the atmospheric pressure, the elastic valve piece is raised toward the cavity, so that The through hole becomes large,

a stopper, the stopper being disposed on a side of the elastic valve piece away from the cavity, for stopping the elastic valve piece when the pressure in the cavity is greater than the atmospheric pressure The cavity is bulged in vitro.
A respiratory mask device, comprising:

Breathing mask;

The ventilation control device according to any one of claims 1 to 14, wherein the ventilation control device is coupled to the respiratory mask and is ventilated with the respiratory mask through the mask vent.
A respiratory mask apparatus according to claim 15 wherein said respiratory mask comprises a mask body and a pad assembly attached to said mask body for contacting a face of a patient, said mask body Forming a cavity for communicating with a patient's mouth and/or nose, in conjunction with the cushion assembly,

Wherein the cavity of the ventilation control device is part of the cavity, and the valve assembly of the ventilation control device is disposed on the mask body.