WO2017067085A1

WO2017067085A1 - Ventilation control device and respiratory mask apparatus having same

Info

Publication number: WO2017067085A1
Application number: PCT/CN2015/100047
Authority: WO
Inventors: 马德东; 庄志; 周明钊; 王亚杰
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: CN105169543B; CN105169543A

Abstract

A respiratory mask apparatus (110, 20) having a ventilation control device (200) comprising: a cavity (210) comprising an air inlet port (211), an air outlet port (212), a mask ventilation port (213) in communication with the respiratory mask apparatus (110, 20); an air inlet valve (220) arranged at the air inlet port (211) and configured to open when the pressure inside the cavity (210) is less than or equal to the atmospheric pressure; and an air outlet valve (230, 330, 430, 530) arranged at the air outlet port (212) and configured to open when the difference between the pressure inside the cavity (210) and the atmospheric pressure is greater than or equal to a first predefined value. The ventilation control device (200) has the function of providing positive airway pressure during an exhalation phase, preventing patient discomfort resulting from continuous positive airway pressure (CPAP). In operation, it is not required to connect the ventilation control device (200) to a positive airway pressure supply device (130) (such as a CPAP respirator) and a tube (120), and therefore facilitates patient movement. Since it is not required to carry the positive airway pressure supply device (130) when going out, a patient can wear the respiratory mask apparatus (110, 20) comprising the ventilation control device (200) anytime for treatment. Furthermore, the ventilation control device (200) is compact in size, easy to carry, and low in cost.

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. CN201510699071.X filed on Oct. 23, 2015, the disclosure of which is incorporated herein by 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 and a respiratory mask device having the ventilation control device.

A ventilation control device for a respiratory mask according to an aspect of the present invention includes: a cavity having an intake port, an exhaust port, and a mask vent, the mask vent for ventilating the breathing mask; and an intake valve Provided at the air inlet for controlling ventilation of the air inlet, the intake valve being configured to be opened when a pressure in the chamber is less than or equal to atmospheric pressure; and an exhaust valve, the setting thereof At the exhaust port, for controlling the ventilation of the exhaust port, the exhaust valve is configured to be opened when a difference between a pressure in the cavity and an atmospheric pressure is greater than or equal to a first predetermined value.

Preferably, the exhaust valve includes an exhaust valve adjustment mechanism for adjusting the first predetermined value.

Preferably, the exhaust valve comprises: an exhaust valve seat connected to the exhaust port, and the exhaust valve seat is provided with a first air outlet; the exhaust valve core is in its closed position and a movably disposed between the open positions in the exhaust valve seat, the exhaust valve spool being capable of communicating the exhaust port with the first air outlet and in a closed position thereof when in an open position thereof Able to block communication between the exhaust port and the first air outlet; and an exhaust valve biasing member for biasing the exhaust valve core against a moving direction of the exhaust valve spool The direction of movement is a direction in which the exhaust spool moves from the closed position to the open position.

Preferably, the exhaust valve includes an exhaust valve adjusting mechanism for adjusting the first predetermined value, and the exhaust valve adjusting mechanism includes: an exhaust valve cover, the exhaust One end of the valve biasing member is coupled to or abuts against the exhaust valve spool and the other end is coupled to or abuts the exhaust valve cover, the exhaust valve cover being movably coupled to the exhaust valve seat for adjustment a biasing force of the exhaust valve biasing member; and an exhaust valve positioning structure for positioning a position of the exhaust valve cover relative to the exhaust valve seat.

Preferably, the exhaust valve positioning structure includes matching threads disposed on the exhaust valve cover and the exhaust valve seat.

Preferably, the exhaust valve is provided with an indicating member for indicating the adjusted first predetermined value.

Preferably, the exhaust valve includes: an exhaust valve seat connected to the exhaust port, and the exhaust valve seat is provided with a first air outlet; an exhaust valve core disposed at the row In the valve seat, and the exhaust valve core At least a portion of the elastomeric material or the morphological memory material is configured to provide the vent spool with a closed position and an open position, the vent valve being capable of causing the vent to be in the open position An air outlet is connected and has a first exhaust valve shape variable, the exhaust valve core being capable of blocking communication between the exhaust port and the first air outlet and having a second exhaust when in its closed position a valve shape variable, the first exhaust valve shape variable being greater than the second exhaust valve shape variable.

Preferably, the exhaust valve core and a portion of the exhaust valve seat form an exhaust valve chamber, the cavity is in communication with the exhaust valve chamber through an aperture, and the exhaust valve seat forms the row a portion of the air valve chamber is provided with a second air outlet for communicating the exhaust valve chamber with the atmosphere, and the ventilation control device further includes: a pilot valve disposed at the second air outlet, the pilot valve The opening is configured when the difference between the pressure in the exhaust valve chamber and the atmospheric pressure is greater than or equal to a second predetermined value.

Preferably, the first predetermined value is 1.1-1.2 times the second predetermined value.

Preferably, the pilot valve includes a pilot valve adjustment mechanism for adjusting the second predetermined value.

Preferably, the pilot valve comprises: a pilot valve seat connected to the second air outlet, and the pilot valve seat is provided with a third air outlet; the pilot valve core is between the closed position and the open position Removably disposed within the pilot valve seat, the pilot valve spool capable of causing the second air outlet to communicate with the third air outlet when in its open position and capable of blocking the first position when in its closed position a communication between the two air outlets and the third air outlet; and a pilot valve biasing member for applying a biasing force to the first spool against the moving direction of the pilot spool, the moving direction The direction in which the pilot spool moves from its closed position to its open position.

Preferably, the pilot valve includes a pilot valve adjustment mechanism for adjusting the second predetermined value, the pilot valve adjustment mechanism comprising: a pilot valve cover, one end of the pilot valve biasing member connected or abutting a pilot spool having the other end coupled to or against the pilot valve cover, the pilot valve cover being movably coupled to the pilot valve seat to adjust a biasing force of the pilot valve biasing member; and pilot valve positioning And a position for positioning the pilot valve cover relative to the pilot valve seat.

Preferably, the pilot valve includes: a pilot valve seat connected to the second air outlet, and a third air outlet is disposed on the pilot valve seat; a pilot valve core disposed in the pilot valve seat And at least a portion of the pilot spool is made of an elastic material or a shape memory material such that the pilot spool has a closed position and an open position, and the pilot spool can close the second when in its closed position An air outlet having a first pilot valve shape variable, the pilot spool being capable of causing the second air outlet to be in the open position The third air outlet is connected and has a second pilot valve shape variable, the second pilot valve variable being greater than the first pilot valve variable.

Preferably, the first predetermined value is greater than 0 and less than or equal to 30 hPa, preferably between 5 and 20 hPa.

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 passing through the mask vent The breathing mask is vented.

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 intake valve and the exhaust valve of the ventilation control device Provided 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 expiratory pressure to provide a ventilation control device having a cavity ventilable with the breathing mask and an exhaust valve which can be opened when the pressure in the cavity is higher than atmospheric pressure, to realize the expiratory phase. Positive pressure function to avoid patient discomfort caused by continuous (exhalation and inspiration) positive pressure; the ventilation control device uses its own mechanical structure to provide positive exhalation pressure, so there is no need to connect a positive pressure gas supply device (such as CPAP) during use. The ventilator and the pipeline are convenient for the patient to move; when the patient is out, there is no need to carry a positive pressure gas supply device, and the patient can wear the respiratory mask with 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.

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, air inlet; 212, exhaust port; 213, mask vent; 214, connection structure; 220, intake valve; 221, valve flap; 222, connecting member; 230, exhaust valve; 231, exhaust valve seat; 232, exhaust valve core; 233, exhaust valve biasing member; 241, first air outlet; 330, exhaust valve; 331, exhaust valve seat; 341, first air outlet; 350, exhaust valve cover; 430, exhaust valve; 431, exhaust valve seat; 432, exhaust valve core; 530, exhaust valve; 531, exhaust valve seat; 532, exhaust valve core; 535, exhaust valve chamber; 541, first air outlet; 542, second air outlet; 543, third air outlet; 560, pilot valve; 561, pilot valve seat; 562, pilot valve core; 563, pilot valve Biasing member; 660, pilot valve; 661, pilot valve seat; 664, pilot valve cover.

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 structure such as a wrinkle, a bellows, a partial thinning, a bend, an arc, etc., to achieve a better fit of the respiratory mask 20 with the face, and even to realize the cushion 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 may 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. 2A-2B, the ventilation control device 200 includes a cavity 210, an intake valve 220, and an exhaust valve 230.

The cavity 210 has an air inlet 211, an exhaust port 212, and a mask vent 213. The mask vent 213 is for venting with the respiratory mask 20. The mask vent 213 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 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 breathing mask can be utilized as the cavity 210, the air inlet 211 and the row Ports 212 are formed on the mask body 21. Thus, the intake valve 220 and the exhaust valve 230 can be directly disposed on the mask body 21. In an embodiment in which the cavity 210 is disposed separately from the mask body 21, as shown in FIG. 2B, a connection structure 214 may be provided at the mask vent 213 of the cavity 210. The connection structure 214 is for detachably connecting the ventilation control device 200 to the respiratory mask 20. The connection structure 214 can be, for example, a snap connection structure, a threaded connection structure, or an elastic body connection structure. 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 air inlet 211 serves as an intake passage of the breathing mask 20, and the air enters the breathing mask from the air inlet 211 while the patient is inhaling. The exhaust port 212 serves as an exhaust passage for the respiratory mask 20, and the gas exhaled by the patient during exhalation is discharged from the exhaust port 212 to the atmosphere. The intake valve 220 provided at the intake port 211 is configured to be opened when the pressure P _{1 in the} cavity 210 is less than or equal to the atmospheric pressure P ₀ to enable no resistance or small resistance when inhaling. That is, only the pressure P within the cavity 210 is less than or equal to ₁ before opening the intake valve 220 when the atmospheric pressure P _0, the intake valve 220 is closed immediately when the pressure P in the greater than atmospheric pressure P ₀ ₁ 210 once the cavity. When inhaling, the gas in the cavity 210 is inhaled by the patient to cause the pressure P _{1 to} decrease. When the pressure P _{1 is} less than or equal to the atmospheric pressure P ₀ , the intake valve 220 is opened, and the air enters the cavity 210 from the air inlet 211 . Inhaled by the patient. The exhaust valve 230 disposed at the exhaust port 212 is configured to be opened when the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 210 is greater than or equal to a first predetermined value to enable a positive pressure environment to be formed during exhalation . When exhaling, the pressure P _{1 is} increased in the cavity 210 due to the accumulation of the exhaled gas of the patient. When the difference ΔP between the pressure P ₁ and the atmospheric pressure P ₀ is greater than or equal to the first predetermined value, the exhaust valve 230 is opened. In other words, the exhaust valve 230 is opened only when the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 210 is greater than or equal to the first predetermined value, so that the exhaled gas exits the cavity 210 through the exhaust port 212. Once the difference ΔP between the pressure P ₁ and the atmospheric pressure P ₀ within the chamber 210 is below the first predetermined value, the exhaust valve 230 is immediately closed to maintain a positive pressure environment within the chamber 210. 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 invention adopts positive expiratory pressure to prevent the upper airway from collapsing, thereby further treating the OSAHS.

The first predetermined value described above is related to the therapeutic effect of the OSAHS. The first predetermined value may be greater than zero and less than or equal to 30 hPa, preferably between 5 and 20 hPa. The therapeutic effect is optimal within the preferred range. Preferably, the vent 212 is disposed opposite the mask vent 213 such that the gas exhaled by the patient is discharged straight through the vent 212 to avoid carbon dioxide residue in the respiratory mask 20 and the cavity 210.

In one embodiment, the exhaust valve 230 includes an exhaust valve seat 231, an exhaust valve spool 232, and an exhaust valve biasing member 233. The exhaust valve seat 231 is connected to the exhaust port 212, and the exhaust valve seat 231 is provided with a first air outlet 241. The first air outlet 241 is used for communication between the exhaust port 212 and the atmosphere. In essence, the object of the present invention can be achieved as long as the exhaust valve seat 231 does not close the exhaust port 212, and thus the manner in which the first air outlet 241 is disposed is not limited. The exhaust spool 232 is movably disposed within the exhaust valve seat 231 between its closed position and its open position. The open position of the exhaust valve plug 232 means that the exhaust valve spool 232 is in this position to allow the cavity 210 to communicate with the atmosphere through the exhaust valve 230. Conversely, the closed position of the exhaust valve plug 232 means that the cavity 210 cannot communicate with the atmosphere through the exhaust valve 230 when the exhaust valve plug 232 is in this position. The movement includes translation and rotation. Figure 2B illustrates an embodiment of a translational movement. The exhaust valve plug 232 can communicate the exhaust port 212 with the first air outlet 241 in its open position to form an exhaust passage. The exhaust valve plug 232 can block communication between the exhaust port 212 and the first air outlet 241 when in its closed position. When the exhaust spool When the 232 is in the closed position, the exhaust port 212 may be closed, and/or the first air outlet 241 may be closed, and/or the communication passage between the exhaust port 212 and the first air outlet 241 may be blocked. Preferably, the exhaust spool 232 can close the exhaust port 212 when in its closed position to simplify the structure of the breath control device. The exhaust valve biasing member 233 applies a biasing force to the exhaust valve spool 232 against the moving direction of the exhaust valve spool 232 from the closed position to the open position. That is, when exhaling, it is necessary to overcome the resistance generated by the exhaust valve biasing member 233 to move the exhaust valve spool 232 from its closed position to its open position to enable the exhaled gas to be discharged. The exhaust valve biasing member 233 may be disposed on a side of the exhaust spool 232 that faces away from the cavity 210 and applies pressure to the exhaust spool 232 when it is in the closed position. This pressure needs to be overcome during exhalation to move the exhaust spool 232 to the open position. During this movement, the pressure applied by the exhaust valve biasing member 233 is increased. In other embodiments not shown, the exhaust valve biasing member may be disposed on a side of the exhaust spool 232 that faces the cavity 210 and apply a pulling force to the exhaust spool 232 when it is in the closed position. It is necessary to overcome this pulling force when exhaling to move the exhaust valve core 232 to the open position. During this movement, the pulling force applied by the exhaust valve biasing member 233 is increased. The exhaust valve biasing member 233 may be a spring or other elastomer or the like, and may also be made of a shape memory material such as an alloy or plastic having morphological memory properties.

In one embodiment, the intake valve 220 is a one-way valve. The intake valve 220 may include a flap 221 made of an elastic material or a morphological memory material. The valve flap 221 can be directly connected to the air inlet 211, for example directly to the wall of the cavity 210. The flap 221 can also be coupled to the cavity 210 by an intermediate member, such as the connector 222 of FIG. When inhaling, the pressure P _{1 in the} cavity 210 is less than the atmospheric pressure P ₀ , the intake valve 220 opens to the inside of the cavity 210, and the gas enters the cavity 210. After the end of inhalation, the pressure P _{1 in the} cavity 210 gradually increases, and the flap 221 is returned to the closed position due to its own elasticity or shape memory characteristics. When exhaling, the pressure P _{1 in the} chamber 210 gradually rises above the atmospheric pressure P ₀ , and the valve flap 221 remains in the closed position due to the difference in pressure between the inside and the outside. Of course, the intake valve may have other arrangements as long as the intake port 211 can be opened when the pressure P ₁ in the cavity 210 is less than or equal to the atmospheric pressure P ₀ . The seal between the intake valve 220 and the intake port 211 can take a variety of forms of design. The sealing fit between the intake valve 220 and the intake port 211 includes line and plane fit, planar and planar fit, line and cylindrical fit, cylindrical and cylindrical fit, line and spherical fit, spherical and spherical fit, line and Conical surface fit, conical surface and conical surface fit and so on. The material of the sealing fit between the intake valve 220 and the air inlet 211 may be rigid, flexible, or a combination thereof. The shape and material of the above-mentioned sealing joint portion can also be applied to the sealing design of the exhaust valve and the pilot valve described below.

The positions of the intake valve 220 and the exhaust valve 230 may be set as shown in FIG. 2A, and other positions may be adopted. Mode setting. Also, the number of the intake valve 220 and the exhaust valve 230 may be one or more, respectively. The position and number of intake valve 220 and exhaust valve 230 are not limited herein.

Preferably, the exhaust valve may include an exhaust valve adjusting mechanism for adjusting a difference in air pressure that causes the exhaust valve to open, that is, adjusting the first predetermined value. Referring to the embodiment illustrated in FIG. 3, the exhaust valve 330 is substantially identical to the exhaust valve 230 illustrated in FIGS. 2A-2B, except that an exhaust valve adjustment mechanism is added and is illustrated with respect to FIG. 2B. The embodiment modifies the exhaust valve seat 231. In the embodiment shown in FIG. 3, the exhaust valve adjustment mechanism includes an exhaust valve cover 350. One end of the exhaust valve biasing member 233 is connected to or abuts against the exhaust valve plug 232 and the other end is connected or abuts against the exhaust valve cover 350. The exhaust valve cover 350 is movably coupled to the exhaust valve seat 331 to adjust the biasing force of the exhaust valve biasing member 233. The exhaust valve seat 331 can be coupled to the exhaust valve cover 350 and allows the exhaust valve biasing member 233 to be coupled or abutted against the exhaust valve cover 350 through the exhaust valve seat 331. Although in the embodiment of FIG. 3, the cavity 210 is in communication with the atmosphere through the first air outlet 341, in other embodiments not shown, an opening may be provided in the exhaust valve cover 350. At this time, a portion of the exhaust valve seat 331 for allowing the exhaust valve biasing member 233 to pass therethrough may be regarded as a first air outlet. Upon exhalation, gas enters the atmosphere from the chamber 210 through the exhaust port 212, the first air outlet, and the opening in the exhaust valve cover. Alternatively, the exhaust valve seat 331 and the exhaust valve cover 350 may be arranged to be non-sealed to allow gas to pass therethrough, in which case the exhaust valve seat 331 is adapted to allow the exhaust valve biasing member 233 to pass The past part is still considered to be the first air outlet. Upon exhalation, gas enters the atmosphere from the chamber 210 through the exhaust port 212, the first air outlet, and the gap between the exhaust valve seat 331 and the exhaust valve cover 350. Additionally, the exhaust valve adjustment mechanism further includes an exhaust valve positioning structure for positioning the exhaust valve cover 350 relative to the exhaust valve seat 331. In the embodiment shown in FIG. 3, the exhaust valve positioning structure may be a mating thread disposed on the exhaust valve seat 331 and the exhaust valve cover 350. In other embodiments not shown, the exhaust valve positioning structure may be a snap, a retaining pin, or the like. In addition, different positive expiratory pressures can also be achieved by replacing different exhaust valve biasing members 233. It should be noted that the exhaust valve adjusting mechanism can be added to any of the embodiments mentioned below, and accordingly, the first predetermined value can be realized by performing a modification similar to that described above on the exhaust valve seat. Pressure regulation function.

Further preferably, the exhaust valve is provided with an indicating member (not shown) for indicating the adjusted first predetermined value. The indicator member can be a mechanical logo such as a scale, a color logo, or the like. As an example, a mechanical identification can be provided on the exhaust valve seat 331. Adjusting the exhaust valve cover 350 to a different position reveals a different scale or color to indicate the adjusted first predetermined value.

The exhaust valve can also have other configurations. In another embodiment, the exhaust valve includes an exhaust valve seat, an exhaust valve spool. The exhaust valve seat is connected to the exhaust port, and the exhaust valve seat is provided with a first air outlet. The exhaust valve seat can adopt a configuration similar to that of FIGS. 2B and 3. And similarly, the exhaust spool is also disposed within the exhaust valve seat. The difference is mainly that the exhaust valve biasing member is omitted with respect to the embodiment shown in FIGS. 2B and 3. However, in order to achieve positive pressure opening of the exhaust valve, at least a portion of the exhaust valve spool is set to have elasticity, and the exhaust valve spool has a closed position and an open position by the elasticity of the exhaust spool itself. The distal or all of the exhaust spool may be provided to be made of an elastic material or a morphological memory material. The proximal and distal ends described herein are relative to the patient wearing the respiratory mask, and the end adjacent the patient is referred to as the proximal end, and vice versa. For example, the exhaust valve plug 232 shown in FIGS. 2B and 3 may be integrally formed with the exhaust valve biasing member 233 as the exhaust valve spool in the present embodiment, in which the exhaust valve biasing member 233 is present The distal end of the exhaust spool in the embodiment. The exhaust valve biasing member 233 as the distal end of the exhaust valve spool is preferably made of an elastic material or a shape memory material such as a block, a sheet, a rod, or the like. The distal end of the exhaust spool may extend to abut or be connected to valve seat 231 or valve cover 350. When the exhaust valve spool moves from its closed position to its open position, the proximal end of the exhaust valve spool moves to the right, for example, from the position shown in the drawing, thereby enabling the exhaust port 212 to communicate with the first air outlet 341. At this time, the distal end of the exhaust valve spool has a first exhaust valve shape variable. When the exhaust valve spool is in the closed position (the position shown in the drawing), the proximal end of the exhaust valve spool can block the communication between the exhaust port 212 and the first air outlet 341, and the exhaust spool is far The end has a second exhaust valve shape variable. When the exhaust valve spool is in the closed position, the exhaust port 212 may be closed, and/or the first air outlet 341 may be closed, and/or the communication passage between the exhaust port 212 and the first air outlet 341 may be blocked. Preferably, the exhaust spool is capable of closing the exhaust port 212 when in its closed position. The first exhaust valve shape variable is greater than the second exhaust valve shape variable. When exhaling, it is necessary to overcome the potential energy required by the second exhaust valve shape variable (corresponding to the closed position) to the first exhaust valve shape variable (corresponding to the open position), thereby forming a positive expiratory pressure. That is, when the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 210 is greater than or equal to the first predetermined value, the exhaust valve spool opens the exhaust port 212 to form an exhaust passage.

In yet another embodiment, referring to FIG. 4, the exhaust valve 430 employs a one-way valve similar to the intake valve 220. It includes an exhaust valve spool (also referred to as a valve flap) 432 made of an elastomeric material or a morphological memory material. When the exhaust spool 432 is in the closed position, the exhaust spool 432 can close the exhaust port 212 and have a second exhaust valve shape variable. When the exhaust valve plug 432 is moved from its closed position to its open position, the exhaust valve core 432 is rotated to the right, for example, to enable the exhaust port 212 to communicate with the first air outlet 241, at which time the exhaust valve plug 432 There is a first exhaust valve shape variable. The first exhaust valve shape variable is greater than the second exhaust valve shape variable. When exhaling, it is necessary to overcome the potential energy required for the second exhaust valve shape variable to the first exhaust valve shape variable, thereby forming a positive expiratory pressure. That is, when the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 210 is greater than or equal to the first predetermined value, the exhaust valve plug 432 opens the exhaust port 212 to form an exhaust passage. Although the exhaust valve 430 in FIG. 4 further includes an exhaust valve seat 431, and the exhaust valve core 432 is disposed in the exhaust valve seat 431 to protect the exhaust valve plug 432 and to make the appearance of the ventilation control device more compact, However, it will be understood by those skilled in the art that the exhaust valve seat 431 is not required.

It will be appreciated that the resilient exhaust spool 432 may also be combined with the exhaust valve biasing member as shown in Figures 2B and 3, depending on the elasticity of the exhaust spool 432 itself and the biasing of the biasing member. Force to achieve the above positive breathing pressure.

Preferably, the pilot valve can be added to the various exhaust valves described above. In an embodiment in which the pilot valve is added, the exhaust valve has an exhaust valve chamber in communication with the cavity. The exhaust valve chamber communicates with the atmosphere through the pilot valve for regulating the gas pressure in the exhaust valve chamber. Since the pressure of the exhaust valve chamber is between the pressure of the chamber and the atmospheric pressure, the pressure difference between the sides of the exhaust valve core can be adjusted during the exhalation process, so that it changes smoothly.

In one particular embodiment, as shown in FIG. 5, the exhaust spool 532 of the exhaust valve 530 is disposed within its exhaust valve seat 531. The exhaust spool 532 and a portion of the exhaust valve seat 531 form an exhaust valve chamber 535. An aperture 534 is provided on the exhaust valve plug 532, and/or on the exhaust valve seat 531, and/or between the exhaust valve plug 532 and the exhaust valve seat 531. The cavity 210 is in communication with the exhaust valve chamber 535 through an aperture 534. Due to the presence of the aperture 534, the pressure within the exhaust valve chamber 535 changes with breathing. In addition to the first air outlet 541, the exhaust valve seat 531 is provided with a second air outlet 542 at a portion where the exhaust valve chamber 535 is formed. The exhaust valve chamber 535 can communicate with the atmosphere through the second air outlet 542. The pilot valve 560 is disposed at the second air outlet 542. The pressure differential created by the respiration between the exhaust valve chamber 535 and the atmosphere controls the pilot valve 560 to open and close. In the present invention, the pilot valve 560 is configured to open when the difference between the pressure P ₂ and the atmospheric pressure P _{0 in} the exhaust valve chamber 535 is greater than or equal to a second predetermined value. The opening and closing of the pilot valve 560 affects the pressure P _{2 in the} exhaust valve chamber 535, and the change in the pressure P ₂ causes the difference between the pressure P ₁ and the pressure P ₂ in the chamber 210 to change, thereby affecting the exhaust valve. Movement of the core 532. Specifically, when no gas flows out of the chamber 210, the pressure P _{1 in the} chamber 210 is equal to the pressure P _{2 in the} exhaust valve chamber 535. During exhalation, the pressure P ₁ inside the cavity 210 is gradually increased, while part of the gas enters the discharge valve chamber 535 through the aperture 534, such that the pressure P ₂ increases. The pilot valve 560 opens when the pressure P ₂ increases to a difference from the atmospheric pressure P ₀ that is greater than or equal to a second predetermined value. Since the exhalation continues, increased pressure P ₁ is sustained, through the apertures 534 into the gas in the discharge valve chamber 535 and the pressure P ₂ will rise, but the pressure P ₁ is increased with respect to more slowly. When the difference between the pressure P ₁ and the pressure P ₂ reaches a certain value, the exhaust valve body 532 is moved to the right to open. After the exhaust valve core 532 is opened, the first air outlet 541 is no longer closed, so that the cavity 210 communicates with the atmosphere through the exhaust port 212 and the first air outlet 541 to form an exhaust passage. In the present embodiment, the change in the pressure P ₂ is gradually performed and increases as the pressure P ₁ increases, but is still higher than the atmospheric pressure P ₀ . The movement of the exhaust spool 532 depends on the difference between the pressure P ₁ and the pressure P ₂ . Therefore, compared with the embodiment in which the pilot valve is not provided, the exhaust valve spool 532 is not vibrated to cause noise due to a drastic change in the pressure P ₁ in the cavity 210 due to rapid breathing. Preferably, the first predetermined value is not too large, and is slightly larger than the second predetermined value. For example, the first predetermined value may be 1.1 to 1.2 times the second predetermined value. Thus, the exhaust valve 530 provides a biasing force or an elastic force that is small, and the noise generated by the movement during exhalation is small.

In one embodiment, the pilot valve 560 includes a pilot valve seat 561, a pilot spool 562, and a pilot valve biasing member 563. It will be appreciated that the pilot valve 560 can be configured similar to the structure of any of the exhaust valves mentioned above. The pilot valve seat 561 is connected to the second air outlet 542, and the third air outlet 543 is disposed on the pilot valve seat. The pilot spool 562 is movably disposed within the pilot valve seat 561 between a closed position and an open position. Similar to the exhaust spool, the open position of the pilot spool 562 means that the pilot spool 562 is in this position to allow the exhaust valve chamber 535 to communicate with the atmosphere through the pilot valve 560. Conversely, the closed position of the pilot spool 562 means that the exhaust valve chamber 535 cannot communicate with the atmosphere through the pilot valve 560 when the pilot spool 562 is in this position. The movement includes translation and rotation. Figure 5 illustrates an embodiment of a translational movement. The pilot spool 562 can communicate the second air outlet 542 with the third air outlet 543 when in its open position. The pilot spool 562 can block communication between the second air outlet 542 and the third air outlet 543 when in its closed position, such as closing the second air outlet 542, and/or closing the third air outlet 543, and/or closing A communication passage between the second air outlet 542 and the third air outlet 543. Preferably, the pilot spool 562 can close the second air outlet 542 when in its closed position. The pilot valve biasing member 563 is used to apply a biasing force against the direction of movement of the pilot spool 562 as the pilot spool 562 moves from its closed position to its open position. The pilot valve biasing member 563 can be disposed on the side of the pilot spool 562 that faces away from the exhaust valve chamber 535 and applies pressure to the pilot spool 562 as it is in the closed position. In other embodiments not shown, the pilot valve biasing member 563 can be disposed on a side of the pilot spool 562 that faces the exhaust valve chamber 535 and applies a pulling force to the pilot spool 562 when it is in the closed position. The pilot valve biasing member 563 may be a spring or other elastomer or the like, and may also be made of a shape memory material such as an alloy or plastic having morphological memory properties.

Preferably, the pilot valve may also include a pilot valve adjustment mechanism for adjusting the pressure differential that causes the pilot valve to open, ie, a second predetermined value. Referring to the pilot valve 660 shown in FIG. 6, the pilot valve 660 is substantially identical to the embodiment shown in FIG. 5, except that the pilot valve adjustment mechanism is added and the pilot valve is shown with respect to the embodiment shown in FIG. Seat 561 is modified. In the embodiment shown in Figure 3, the pilot valve adjustment mechanism includes Pilot valve cover 664. One end of the pilot valve biasing member 563 is coupled to or abuts the pilot spool 562 and the other end is coupled to or abuts the pilot valve cover 664. The pilot valve cover 664 is movably coupled to the pilot valve seat 661 to adjust the biasing force of the pilot valve biasing member 563. The pilot valve locator is used to position the pilot bonnet 664 relative to the pilot valve seat 661. The pilot valve adjustment mechanism can have a similar structure to the exhaust valve adjustment mechanism described above, and will not be described in further detail herein for the sake of brevity.

In another embodiment, the pilot valve is also similar to one of the above embodiments of the exhaust valve, the pilot valve including a pilot valve seat and a pilot spool. The pilot valve seat is connected to the second air outlet, and the third air outlet is disposed on the pilot valve seat. The pilot spool is disposed within the pilot valve seat and at least a portion of the pilot spool is formed of a resilient material or a morphological memory material to provide the pilot spool with a closed position and an open position. The pilot spool can communicate the third air outlet with the third air outlet in its open position and has a first pilot valve shape variable, and the pilot spool can block the second air outlet and the third air outlet when in the closed position The communication between and has a second pilot valve shape variable. Wherein, the first pilot valve shape variable is greater than the second pilot valve shape variable.

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 an air inlet, an exhaust port, and a mask vent for venting the breathing mask;

An intake valve disposed at the intake port for controlling ventilation of the intake port, the intake valve configured to be opened when a pressure in the chamber is less than or equal to atmospheric pressure;

An exhaust valve disposed at the exhaust port for controlling ventilation of the exhaust port, the exhaust valve configured to have a difference between a pressure in the cavity and an atmospheric pressure greater than or equal to a first predetermined value Open when.
The ventilation control device according to claim 1, wherein said exhaust valve includes an exhaust valve adjusting mechanism for adjusting said first predetermined value.
The ventilating control device of claim 1 wherein said venting valve comprises:

An exhaust valve seat connected to the exhaust port, and the exhaust valve seat is provided with a first air outlet;

An exhaust spool that is movably disposed within the exhaust valve seat between its closed position and its open position, the exhaust spool being capable of causing the exhaust port to be in the open position The first air outlet is connected and is capable of blocking communication between the air outlet and the first air outlet when in its closed position;

An exhaust valve biasing member for applying a biasing force to the exhaust valve spool against a moving direction of the exhaust valve spool, the moving direction being the exhaust spool from the closed position to the The direction in which the open position moves.
The ventilation control device according to claim 3, wherein said exhaust valve includes an exhaust valve adjusting mechanism for adjusting said first predetermined value, said exhaust valve adjusting mechanism comprising :

An exhaust valve cover, one end of the exhaust valve biasing member being coupled to or abutting the exhaust valve spool and the other end connected or abutting the exhaust valve cover, the exhaust valve cover being movably coupled to The exhaust valve seat to adjust a biasing force of the exhaust valve biasing member;

An exhaust valve positioning structure for positioning a position of the exhaust valve cover relative to the exhaust valve seat.
The ventilating control device of claim 4 wherein said venting valve positioning structure includes mating threads disposed on said exhaust valve cover and said exhaust valve seat.
The ventilation control device according to claim 2 or 4, wherein the exhaust valve is provided with an indicating member for indicating the adjusted first predetermined value.
The ventilating control device of claim 1 wherein said venting valve comprises:

An exhaust valve seat connected to the exhaust port, and the exhaust valve seat is provided with a first air outlet;

An exhaust valve spool disposed in the exhaust valve seat, and at least a portion of the exhaust valve spool is made of an elastic material or a shape memory material to have the exhaust valve spool have a closed position and an open position .
A ventilation control device according to any one of claims 3 to 7, wherein the exhaust valve core and a portion of the exhaust valve seat form an exhaust valve chamber, the cavity passing through the aperture and the row The air valve chamber is in communication, and a portion of the exhaust valve seat that forms the exhaust valve chamber is provided with a second air outlet that communicates the exhaust valve chamber with the atmosphere, and the ventilation control device further includes:

a pilot valve is disposed at the second air outlet, the pilot valve being configured to open when a difference between a pressure in the exhaust valve chamber and an atmospheric pressure is greater than or equal to a second predetermined value.
The ventilation control device according to any one of claims 8 to 8, wherein the first predetermined value is 1.1 to 1.2 times the second predetermined value.
The ventilation control device according to claim 8, wherein said pilot valve includes a pilot valve adjustment mechanism for adjusting said second predetermined value.
The ventilating control device of claim 8 wherein said pilot valve comprises:

a pilot valve seat connected to the second air outlet, and a third air outlet is disposed on the pilot valve seat;

a pilot spool movably disposed in the pilot valve seat between a closed position and an open position, the pilot spool being capable of causing the second air outlet and the third air outlet when in an open position thereof Being able to block communication between the second air outlet and the third air outlet when communicating and in its closed position;

a pilot valve biasing member for applying a biasing force to the first spool against a moving direction of the pilot spool, the moving direction being a movement of the pilot spool from its closed position to its open position direction.
The ventilating control apparatus according to claim 11, wherein said pilot valve includes a pilot valve adjusting mechanism for adjusting said second predetermined value, said pilot valve adjusting mechanism comprising:

a pilot valve cover having one end connected to or abutting the pilot spool and the other end connected or abutting the pilot valve cover, the pilot valve cover being movably coupled to the pilot valve seat To adjust the biasing force of the pilot valve biasing member;

A pilot valve locator for positioning the pilot valve cover relative to the pilot valve seat.
The ventilating control device of claim 8 wherein said pilot valve comprises:

a pilot valve seat connected to the second air outlet, and a third air outlet is disposed on the pilot valve seat;

A pilot spool is disposed within the pilot valve seat, and at least a portion of the pilot spool is made of an elastomeric material or a morphological memory material to provide the pilot spool with a closed position and an open position.
The ventilation control device according to claim 1, wherein said first predetermined value is greater than 0 and small At or equal to 30 hPa, preferably between 5-20 hPa.
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 a part of the cavity, and the intake valve and the exhaust valve of the ventilation control device are disposed on the mask body.