WO2017067086A1 - Ventilation control apparatus, and breathing mask device provided with ventilation control apparatus - Google Patents

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) and a valve assembly (220). The cavity (210) is provided with an air delivery port (211) and a mask ventilation port (212) which are in communication with one another, the mask ventilation port (212) being used for being in communication with the breathing mask (20). The valve assembly (220) is provided with an air inlet channel and an air discharge channel in communication with the cavity (210) via the air delivery port (211). The valve assembly (220) is configured to connect the air inlet channel when the pressure (P₁) within the cavity (210) is less than or equal to the atmospheric pressure (P₀), and connect the air discharge channel when the difference (ΔP) between the pressure (P₁) within the cavity (210) and the atmospheric pressure (P₀) is greater than or equal to a predetermined value. 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 (such as a CPAP breathing machine) 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. A patient may carry the breathing mask (20) provided with the ventilation control apparatus (200) at any time for treatment. In addition, the ventilation control apparatus (200) is small in size, convenient 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. CN201510698686.0, 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 and a respiratory mask device having the ventilation control device.

A ventilation control device according to an aspect of the present invention includes: a cavity having a gas communication port communicating with each other, and a mask vent for communicating with a respiratory mask; and a valve assembly having an intake passage and An exhaust passage, the intake passage and the exhaust passage are in communication with the cavity through the gas delivery port, wherein the valve assembly is configured to cause a pressure in the cavity to be less than or equal to atmospheric pressure The intake passage is turned on, and the exhaust passage is turned on when a difference between a pressure in the chamber and an atmospheric pressure is greater than or equal to a predetermined value.

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

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

Preferably, the valve assembly includes: a first valve mechanism having a first closed position that closes the gas delivery port and a first open position that opens the gas delivery port, and the first valve mechanism is provided with a through hole And a second valve mechanism disposed at the through hole, having a second closed position that closes the through hole and a second open position that opens the through hole.

Preferably, the first valve mechanism comprises: a first valve core, the through hole is disposed on the first valve core; a first biasing member is abutted against the first valve core to give the The first spool provides a resistance to movement from the first closed position to the first open position.

Preferably, the valve assembly includes a valve seat connected to the gas delivery port, the valve seat is provided with an air outlet, and the first valve mechanism is disposed in the valve seat.

Preferably, the valve seat is provided with a limiting member for restricting movement of the first valve core between the first closed position and the first open position.

Preferably, the valve assembly includes an adjustment mechanism for adjusting the predetermined value, the adjustment mechanism comprising: a valve cover, one end of the first biasing member connected or abutting the first valve mechanism and the other end Connecting or abutting the valve cover, the valve cover being movably coupled to the valve seat to adjust a resistance to movement of the first biasing member; and a positioning structure for positioning relative to the valve seat The position of the bonnet.

Preferably, the second valve mechanism comprises: a second valve core that can open or close the through hole; a second biasing member that abuts against the second valve core to give the second valve core Providing from the second closed position to Movement resistance of the second open position.

Preferably, the valve assembly includes a valve cover connected to the first valve mechanism on an outer side of the cavity; the second valve mechanism includes a second valve core in the cavity The outer side may open or close the through hole; and a second biasing member disposed between the second spool and the valve cover to provide the second spool from the second closing The resistance to movement to the second open position.

Preferably, one end of the second biasing member is connected to or abuts against the second valve core and the other end is connected or abuts against the valve cover, and the valve cover is movably connected to the first valve mechanism, To adjust the resistance to movement of the second biasing member, the valve assembly further includes a positioning structure for positioning the valve cover relative to the first valve mechanism.

Preferably, the valve assembly includes a valve cover, the valve cover is coupled to the first valve mechanism, the second valve mechanism is a one-way valve, and the second valve mechanism is abutted against the first valve mechanism Between the valve cover, at least a portion of the second valve mechanism is made of an elastomeric material or a morphological memory material.

Preferably, the second valve mechanism comprises a valve flap made of an elastic or morphological memory material, the valve flap being coupled to the first valve mechanism.

Preferably, the 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 an 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 and the Breathing mask ventilation.

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 a valve assembly, wherein the valve assembly can open the exhaust passage when the pressure in the chamber is higher than atmospheric pressure In turn, the positive pressure function of the expiratory phase is realized, and the patient's discomfort caused by the continuous (exhalation and inhalation) positive pressure is avoided; the ventilation control device uses its own mechanical structure to provide positive exhalation pressure, so there is no need to connect during use. Positive pressure gas supply device (such as CPAP ventilator) and pipelines, etc., to facilitate patient movement; no need to carry a positive pressure gas supply device when going out, the patient can wear a breathing mask with the ventilation control device for treatment at any time. In addition, the pass The gas 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 3A 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 3B 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 4 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 5 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 6 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 7 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 8 is a cross-sectional view of a respiratory mask having a ventilation control device in accordance with a seventh 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; 210, cavity; , gas outlet; 212, mask vent; 213, connection structure; 220, valve assembly; 221, 421, valve seat; 222, first valve mechanism; 223, second valve mechanism; 224, air outlet; 222A, a valve core; 222B, through hole; 222C, first biasing member; 223A, valve flap; 323, second valve mechanism; 323A, second valve core; 323B, second biasing member; 323C, seal; 425, bonnet; 425A, bonnet outlet; 521, valve seat; 525, bonnet; 610, cavity; 611, air inlet; 620, valve assembly; 621, first valve mechanism; a first valve core; 621B, a first biasing member; 622, a second valve mechanism; 622A, a second valve core; 622B, a second biasing member; 623, a through hole; 624, a valve cover; 721, a first valve mechanism; 724, a valve cover; 822, a second valve mechanism; 822A, a valve flap.

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, a cushion assembly 22, and a 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 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 a gas delivery port 211 and a mask vent 212. The air inlet 211 and the mask vent 212 communicate with each other. The mask vent 212 is for communication with the respiratory mask 20. The mask vent 212 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 connected To the respiratory mask 20, 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 the 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 to directly form the gas delivery port 211. On the mask body 21. Thus, the valve assembly 220 can be disposed directly on the mask body 21. In embodiments in which the cavity 210 is disposed separately from the mask body 21, a connection structure 213 may be provided at the mask vent 212 of the cavity 210. The connection structure 213 is for detachably connecting the ventilation control device 200 to the respiratory mask 20. The connecting structure 213 can be, for example, a snap connection structure, a screw connection structure, or an elastic body fastening 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 gas delivery port 211 is used for gas exchange between the respiratory mask 20 and the atmosphere, including inhalation of the patient and exhalation of the patient, all through the gas delivery port 211. The valve assembly 220 has an intake passage and an exhaust passage. The valve assembly 220 can be disposed at the gas delivery port 211. Both the intake passage and the exhaust passage of the valve assembly 220 are in communication with the cavity 210 through the gas delivery port 211. The valve assembly 220 is capable of achieving no resistance or small resistance when inhaling, and a positive pressure is created within the cavity 210 during exhalation. 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 valve assembly 220 is configured to conduct the intake passage when the pressure P ₁ within the chamber 210 is less than or equal to the atmospheric pressure P ₀ ; the difference ΔP between the pressure P _{1 of the} exhaust passage in the chamber 210 and the atmospheric pressure P ₀ is greater than or equal to Turns on when the value is predetermined. That is, only in the intake passage within the cavity pressure P is less than or equal to ₂₁₀₁ if the atmospheric pressure P ₀ is turned off immediately when the pressure P in the greater than atmospheric pressure P _{0 2101} once the cavity. Similarly, the exhaust passage is turned on 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 a predetermined value, and the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 210 is less than Turn off immediately when the value is predetermined. The intake passage corresponds to the inspiratory passage of the patient. When the patient inhales, the air pressure P _{1 in the} cavity 210 decreases, lower than the atmospheric pressure P ₀ , and the intake passage is turned on, at which time the exhaust passage is closed, corresponding to the patient's suction. Gas phase. The exhaust passage corresponds to the patient's expiratory passage, and when the patient exhales, the air pressure P _{1 in the} chamber 210 increases above the atmospheric pressure P ₀ . When the air pressure P _{1 in the} cavity 210 is increased to a difference ΔP from the atmospheric pressure P ₀ by a predetermined value, the exhaust passage is turned on, and the intake passage is closed, corresponding to the expiratory phase of the patient. This predetermined value is related to the treatment of OSAHS. The predetermined value may be greater than 0 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 gas delivery port 211 is disposed opposite the mask vent 212, so that the gas exhaled by the patient is directly discharged through the gas delivery port 211 to prevent carbon dioxide residue in the respiratory mask 20 and the cavity 210.

The valve assembly 220 can include a first valve mechanism 222 and a second valve mechanism 223. As shown in FIG. 2B, the first valve mechanism 222 is disposed at the air delivery port 211. The first valve mechanism 222 has a first closed position that closes the air inlet 211 and a first open position that opens the air inlet 211. The second valve mechanism 223 is disposed at the through hole 222B. The second valve mechanism 223 has a second closed position that closes the through hole 222B and a second open position that opens the through hole 222B. Through the interaction of the two valve mechanisms, the patient's intake air flow and exhalation air flow can be used to automatically control their opening and closing, thereby achieving inspiratory no resistance or small resistance and positive expiratory pressure.

In one embodiment, in one aspect, the first valve mechanism 222 and the second valve mechanism 223 can cooperate to move between an original position and a venting position. The home position refers to a state in which an external force is not applied to the first valve mechanism 222 and the second valve mechanism 223 due to respiration. At this time, both the first valve mechanism 222 and the second valve mechanism 223 are in their respective closed positions. When the first valve mechanism 222 and the second valve mechanism 223 are in the home position, the gas delivery port 211 is closed. 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 predetermined value, the second valve mechanism 223 moves along with the first valve mechanism 222 to move to the vent position. The first valve mechanism 222 is now in the first open position and the second valve mechanism 223 is in the second closed position. The gas delivery port 211 is opened to form an exhaust passage. In this embodiment, the second valve mechanism 223 can be disposed on the first valve mechanism 222. Thus, at the time of exhalation, the pressure P _{1 in the} cavity 210 is continuously increased. When the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 210 is less than a predetermined value, the first valve mechanism 222 and the second valve mechanism 223 are always in the home position, and the gas inlet 211 is in the closed state. Once 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 predetermined value, the second valve mechanism 223 follows the first valve mechanism 222 to move to the venting position to form an exhaust passage, and is also capable of A positive pressure is maintained within the body 210.

On the other hand, the opening and closing action of the second valve mechanism 223 itself can form an intake passage when the patient inhales. Specifically, at the time of inhalation, the pressure P _{1 in the} cavity 210 is continuously reduced. The first valve mechanism 222 is in a first closed position in which the air inlet 211 is closed. When the pressure P _{1 in the} cavity 210 is less than or equal to the atmospheric pressure P ₀ , the second valve mechanism 223 is in the second open position in which the through hole 222B is opened to form an intake passage. Once the pressure P ₁ within the cavity 210 is greater than the atmospheric pressure P ₀ , the second valve mechanism 223 closes the through hole 222B. Since the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 210 at the time of inhalation does not reach the above predetermined value, the first valve mechanism 222 is maintained at its first closed position. The first valve mechanism 222 and the second valve mechanism 223 are of various embodiments, and some preferred embodiments will be described hereinafter with reference to the accompanying drawings.

Valve assembly 220 may also include a valve seat 221. The valve seat 221 is connected to the gas supply port 211. The first valve mechanism 222 and the second valve mechanism 223 may both be disposed within the valve seat 221. In the embodiment to be described later, the first valve mechanism may be disposed in the valve seat, and the second valve mechanism may be disposed in the cavity. An air outlet 224 is provided on the valve seat 221. The gas outlet 211 can communicate directly with the gas outlet 224. The air outlet 224 may be disposed at the distal end of the valve seat 221 or may be disposed on the side wall of the valve seat 221. 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. The air outlet 224 may be provided as shown in FIG. 2A, or may be provided in other manners as long as the valve seat 221 can communicate with the atmosphere. This article does not limit the way and number of outlets 224.

In one particular embodiment, as shown in FIG. 2B, the first valve mechanism 222 can include a first spool 222A. The first spool 222A is movable between a first closed position and a first open position. The through hole 222B is provided on the first valve body 222A. The second valve mechanism 223 is disposed on the first valve body 222A at the through hole 222B. The pressure P ₁ in the cavity 210 is increased when exhaling, and when it is increased to P ₀ + ΔP, the first valve body 222A and the second valve mechanism 223 which originally close the gas supply port 211 are moved to the right together, and the gas is delivered. The port 211 is opened, and the air inlet 211 communicates with the air outlet 224 to form an exhaust passage. The pressure difference ΔP may be provided by the first biasing member 222C. The first biasing member 222C abuts against the first spool 222A to provide the first spool 222A with movement resistance from the first closed position to the first open position. The first biasing member 222C may be disposed on a side of the first spool 222A remote from the cavity 210 and apply pressure to the first spool 222A when it is in the home position. This pressure needs to be overcome during exhalation to move the first spool 222A and the second valve mechanism 223 together to the venting position. During this movement, the pressure applied by the first biasing member 222C is continuously increased. In other embodiments not shown, the first biasing member may be disposed on a side of the first spool adjacent the cavity 210 and apply a pulling force to the first spool when it is in the home position. It is necessary to overcome this pulling force during exhalation to move the first spool 222A and the second valve mechanism 223 together to the venting position. During this movement, the pulling force applied by the first biasing member 222C is continuously increased. The first biasing member 222C 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.

The second valve mechanism 223 can be a one-way valve that allows gas to enter the cavity 210 from the through bore 222B. The second valve mechanism 223 includes a flap 223A made of an elastic material or a morphological memory material, as shown in Fig. 2B. The flap 223A can be directly coupled to the first valve mechanism 222, such as directly to the first spool 222A. The valve flap 223A can also be coupled to the first valve mechanism 222 by an intermediate member (not shown). As an example, the second valve mechanism 223 can be coupled to the first valve mechanism 222 from a side proximate the cavity 210, such as to the first spool 222A. Thus, the first spool 222A can restrict the flap 223A from opening only in the intake direction. When inhaling, the pressure P _{1 in the} cavity 210 is lowered, and the second valve mechanism 223 is deflected toward the inner side of the cavity 210 to open the through hole 222B to form an intake passage. The seal between the second valve mechanism 223 and the through hole 222B can take a variety of forms of design. The sealing fit between the second valve mechanism 223 and the through hole 222B includes line and plane fit, plane and plane 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 seal fitting portion can also be applied to the respective components to be sealed as described below.

The first valve mechanism can also adopt a similar structure, that is, a valve flap made of an elastic material or a shape memory material. The flap can be connected to the cavity 210 directly or indirectly. As an example, the first valve mechanism can be coupled to the cavity 210 at the gas delivery port 211 from a side facing away from the cavity 210. When exhaling, the pressure P _{1 in the} cavity 210 increases, and when the pressure P ₁ increases to a difference ΔP from the atmospheric pressure P ₀ that is greater than a predetermined value, the first valve mechanism and the second valve mechanism together toward the cavity 210 The outer side deflects to open the air inlet 211 to form an exhaust passage.

Further, the second valve mechanism may also adopt a configuration similar to that of the first valve mechanism shown in FIG. 2B. As shown in FIG. 3A, the second valve mechanism 323 may include a second spool 323A and a second biasing member 323B. The second valve mechanism 323 can be disposed within the cavity 210. The second spool 323A is movable between a second closed position and a second open position. Other components or structures included in this embodiment may be the same or similar to the embodiment shown in FIG. 2B, and the same reference numerals will be used for the same or similar components. The second spool 323A can open or close the through hole 222B on the first spool 222A. The second biasing member 323B abuts against the second spool 323A to provide the second spool 323A with movement resistance from the second closed position to the second open position. The second biasing member 323B may be disposed on a side of the second spool 323A facing the cavity 210 and when the second spool 323A is moved from its second closed position to its second open position (ie, to the left) It exerts pressure. If it is desired to provide a small resistance to inhalation, the second biasing member 323B can also apply a small resistance to movement when the second spool 323A is in the second closed position. In other embodiments not shown, the second biasing member may be disposed on a side of the second spool 323A that faces away from the cavity 210 and in the second spool 323A from its second closed position to its second opening The position is moved (ie, to the left) when it is pulled. The second biasing member may be a spring or other elastomer or the like, and may also be a shape memory material such as an alloy or plastic having morphological memory properties. In this embodiment, when exhaling, the second spool 323A and the first spool 222A move together to the right, i.e., toward their venting positions. At this time, the internal and external air pressure difference ΔP generated by the exhalation is to overcome the resultant force of the movement resistance generated by the first biasing member 222C and the second biasing member 323B. Since the movement resistance generated by the second biasing member 323B is only used to realize that the pressure P _{1 in the} cavity 210 is equal to or less than the atmospheric pressure P ₀ , the movement resistance generated by the second biasing member 323B is set smaller, smaller than the first The movement resistance generated by a biasing member 222C. When inhaling, the first spool 222A remains stationary at the original position, and the second spool 323A moves to the left when the pressure P ₁ in the chamber 210 is equal to or less than the atmospheric pressure P ₀ , and enters the cavity 210 to open Through hole 222B. The seal between the first valve mechanism 222 and the second valve mechanism 323 and the gas delivery port 211 can be achieved by either or both. For example, a seal ring or a gasket or the like may be provided on at least one of the first valve mechanism and the second valve mechanism. As shown in FIG. 3A, a seal may be provided on the first spool 222A. As shown in FIG. 3B, a seal 323C may be provided on the second valve body 323A. In addition, a seal may be provided on both the first valve body 222A and the second valve body 323A.

On the basis of the above and below embodiments, a limit member (not shown) such as a stopper, a projection or the like may be provided on the valve seat 221. The limiting member is configured to restrict the first valve body 222A from moving only between the first open position and the first closed position to prevent excessive vibration caused by the severe vibration of the first valve body 222A when the patient exhales.

In addition, an adjustment mechanism may be added to the valve assembly for adjusting the difference in air pressure that causes the exhaust passage to conduct, that is, adjusting the predetermined value. Referring to the embodiment illustrated in Figure 4, this embodiment is substantially identical to the embodiment illustrated in Figures 2A-2B, except that an adjustment mechanism is added that includes a valve cover 425. One end of the first biasing member 222C is coupled to or abuts the first spool 222A and the other end is coupled to or abuts the valve cover 425. The valve cover 425 is movably coupled to the valve seat 421 to adjust the resistance to movement of the first biasing member 222C. The valve seat 421 is different from the valve seat 221 shown in FIG. 2B, and the valve seat 421 can be coupled to the valve cover 425 and allows the first biasing member 222C to be coupled or abutted against the valve cover 425 through the valve seat 421. A bonnet air outlet 425A may be disposed on the bonnet 425 such that the air outlet 424 of the valve seat 421 communicates with the atmosphere through the bonnet air outlet 425A. In addition, the valve seat air outlet 424 may be disposed to communicate directly with the atmosphere, such as on the side wall of the valve seat 421. Alternatively, the valve seat 421 and the valve cover 425 can also be configured to be non-sealed to allow gas to pass. When exhaling, gas enters the atmosphere from the chamber 210 through the gas inlet 211 and the gap between the valve seat 421 and the valve cover 425. In addition, the adjustment mechanism also includes a positioning structure for positioning the valve cover 425 relative to the valve seat 421. In the embodiment shown in FIG. 4, the positioning structure can be a mating thread disposed on the valve seat 421 and the valve cover 425. In other embodiments not shown, the positioning structure can be a snap, a securing pin, or the like. It should be noted that the adjustment mechanism can be added to any of the embodiments mentioned above and below, and accordingly, a predetermined value of the pressure adjustment function can be realized by performing a modification similar to that described above on the valve seat. .

Further preferably, the valve assembly is provided with an indicating member (not shown) for indicating the adjusted 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 marking can be provided on the valve seat 421. Adjusting the bonnet 425 to a different position reveals a different scale or color to indicate the adjusted first predetermined value.

Similarly, an adjustment mechanism may be added to the embodiment shown in FIGS. 3A-3B. As shown in FIG. 5, one end of the first biasing member 222C is connected or abuts against the first spool 222A and the other end is connected or Abut the valve cover 525. The valve cover 525 is movably coupled to the valve seat 521 to adjust the resistance to movement of the first biasing member 222C. The adjustment mechanism is similar to the adjustment mechanism shown in Figure 4, and the description of the adjustment mechanism applies to the description of the corresponding portions above, and will not be described in further detail herein. It will be appreciated that the adjustment mechanism can be assembled into any embodiment suitable for mounting the adjustment mechanism.

In another embodiment, as shown in FIG. 6, the valve assembly 620 can include a first valve mechanism 621 and a second valve mechanism 622. The first valve mechanism 621 is disposed at the air inlet 611 of the cavity 610. The first valve mechanism 621 has a first closed position that closes the air inlet 611 and a first open position that opens the air inlet 611. A through hole 623 is provided in the first valve mechanism 621. The second valve mechanism 622 is disposed at the through hole 623. The second valve mechanism 622 has a second closed position that closes the through hole 623 and a second open position that opens the through hole 623. In one aspect, the first valve mechanism 621 and the second valve mechanism 622 cooperate to move between an original position and a venting position. When the first valve mechanism 621 and the second valve mechanism 622 are in the home position, the air inlet 611 is closed. When the pressure P _{1 in the} cavity 610 is less than or equal to the atmospheric pressure P ₀ , the first valve mechanism 621 and the second valve mechanism 622 move together to the aeration position, and the gas delivery port 611 opens to form an intake passage. The second valve mechanism 622 can be disposed on the first valve mechanism 621. In the embodiment illustrated in FIG. 6, when the pressure P in the chamber 610 _is less than or equal to atmospheric pressure P _0, the first valve mechanism 621 with the left drive mechanism 622 moves the second valve, the first valve mechanism 621 and the output A gap is formed between the ports 611, and the gas port 611 is opened to form an intake passage corresponding to the inspiratory phase of the patient. On the other hand, the opening and closing of the second valve mechanism 622 itself can also form an exhaust passage when the patient exhales. When the pressure P _{1 in the} cavity 610 is greater than the atmospheric pressure P ₀ , the first valve mechanism 621 is in the first closed position in which the gas inlet 611 is closed. As an example, the first valve mechanism 621 can be disposed inside the cavity 610. Thus, when the pressure P in the chamber 610 _is greater than the atmospheric pressure P _0, the peripheral wall 611 of the gas delivery port of the first valve mechanism 621 may limit the rightward movement of the first valve mechanism 621 remains in its first closed position. Limiting the first valve mechanism 621 may be P ₁ is greater than atmospheric pressure P ₀ by other components within the cavity 610 is in its first closed position. When the patient is switched from inspiratory to expiratory, the pressure P _{1 in the} cavity 610 gradually increases. Since the pressure P _{1 in the} cavity 610 is greater than the atmospheric pressure P ₀ , the first valve mechanism 621 remains at its first Close the location. When the pressure P _{1 in the} cavity 610 is increased to a difference ΔP from the atmospheric pressure P ₀ by more than or equal to the predetermined value, the second valve mechanism 622 opens the through hole 623 to form an exhaust passage. When the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 610 is less than the predetermined value, the second valve mechanism 622 is in the second closed position in which the through hole 623 is closed.

In the embodiment shown in FIG. 6, the first valve mechanism 621 can include a first spool 621A and a first biasing member 621B. The first spool 621A has a first open position and a first closed position. The through hole 623 is provided on the first valve body 621A. The first biasing member 621B abuts against the first spool 621A to provide the first spool 621A with movement resistance from the first closed position to the first open position. If it is desired to provide a small resistance during inhalation, the first biasing member 621B can apply a small movement resistance to the first spool 621A when it is in the first closed position. The movement of the first spool 621A from the first closed position to the first open position causes the second valve mechanism 622 to move together, which is the process of moving the first valve mechanism 621 and the second valve mechanism 622 from the original position to the vent position. . The first biasing member 621B may be disposed on a side of the first spool 621A facing the cavity 610 and applied thereto when the first spool 621A moves from the first closed position to the first open position (ie, to the left) pressure. In other embodiments not shown, the first biasing member may be disposed on a side of the first spool that faces away from the cavity 610 and move from the first closed position to the first open position at the first spool 621A ( When it is to the left, it applies a pulling force to it. Accordingly, if it is desired to achieve a small resistance at the time of inhalation, the first biasing member 621B can apply pressure or tension to the first spool 621A when it is in the first closed position. The first biasing member 621B may be a spring or other elastomer or the like, and may also be a shape memory material such as an alloy or plastic having morphological memory properties. Preferably, the first biasing member 621B is disposed within the cavity 610, and a portion of the first spool 621A is disposed within the cavity 610 for closing the gas delivery port 611. This can reduce the size of the valve assembly.

In one embodiment, the valve assembly 620 can also include a valve cover 624. The valve cover 624 is coupled to the first valve mechanism 621 on the outside of the cavity 610. The valve cover 624 may be fixedly coupled to the first valve mechanism 621 (including the case where the valve cover 624 is integral with the first valve mechanism 621), or may be detachably or movably coupled to the first valve mechanism 621. The detachable connection method is, for example, a buckle (as shown in FIG. 6) or an elastic body. The movable connection method is, for example, a threaded connection, a snap connection, or the like. The second valve mechanism 622 can include a second spool 622A and a second biasing member 622B. The second spool 622A can open and close the through hole 623 outside the cavity 610. The second biasing member 622B may be disposed between the second spool 622A and the valve cover 624. The second biasing member 622B provides the second spool 622A with movement resistance from the second closed position to the second open position. Both ends of the second biasing member 622B are connected or abutted to the second valve body 622A and the valve cover 624, respectively. When the pressure P _{1 in the} cavity 610 is increased to a difference ΔP from the atmospheric pressure P ₀ by a predetermined value, the second valve body 622A opens the through hole 623 against the moving resistance of the second biasing member 622B to form the exhaust gas. aisle. The through hole 623 may communicate with the atmosphere through an air outlet provided on the first spool 621A (for example, disposed on a sidewall of the first spool 621A); or the through hole 623 may also be disposed through the first spool 621A and the valve The air outlet on the cover 624 is in communication with the atmosphere, as shown in FIG. 6; or there is no seal between the first valve body 621A and the valve cover 624 to form an exhaust passage.

In an embodiment in which the valve cover 624 is detachably or movably coupled to the first valve mechanism 621, further preferably, as shown in FIG. 7, the valve assembly 620 may have a function of adjusting a difference in air pressure that conducts the exhaust passage That is, the function of adjusting the above predetermined value. The embodiment shown in Fig. 7 is basically the same as the embodiment shown in Fig. 6, except that the adjustment function is added. Similar to FIG. 6, one end of the second biasing member 622B is coupled to or abuts the second spool 622A and the other end is coupled to or abuts the valve cover 724. The valve cover 724 is movably coupled to the first valve mechanism 721 to adjust the resistance to movement of the second biasing member 622B. Additionally, the adjustment mechanism further includes a positioning structure for positioning the valve cover 724 relative to the first valve mechanism 721. In the embodiment shown in FIG. 4, the positioning structure can be a mating thread disposed on the first valve mechanism 721 and the valve cover 724. In other embodiments not shown, the positioning structure can be a snap, a securing pin, or the like.

Moreover, in embodiments where the valve cover 624 is detachably coupled to the first valve mechanism 621, different bias forces can be provided by replacing the different second biasing members 622B to adjust the predetermined value.

In another embodiment, as shown in Figure 8, this embodiment is substantially identical to the embodiment shown in Figure 6, except that the second valve mechanism 822 can include a valve made of an elastomeric or morphological memory material. Petal 822A. The flap 822A can be coupled to the first valve mechanism 621 either directly or indirectly. As an example, the valve flap 822A can be coupled to the first valve mechanism 621 from a side remote from the cavity 610. When the difference ΔP between the pressure P ₁ and the atmospheric pressure P _{0 in} the cavity 610 is greater than or equal to a predetermined value, the second valve mechanism 822 opens the through hole 611 to form an exhaust passage.

Further, on the basis of Fig. 6, the second valve mechanism 622 can also be deformed, and the other components are substantially the same as the embodiment shown in Fig. 6. Specifically, the valve assembly includes a valve cover 624 that is fixedly, movably or detachably coupled to the first valve mechanism 621, for example. The second valve mechanism 622 is disposed between the first valve mechanism 621 and the valve cover 624. The difference is that at least a portion of the second valve mechanism 622 is made of an elastic material or a shape memory material, and the second valve mechanism 622 has a first shape variable when the second valve mechanism 622 closes the through hole 623. When the second valve mechanism 622 opens the through hole 623, the second valve mechanism has a second shape variable, wherein the second shape variable is greater than the first shape variable. The portion of the second valve mechanism 622 that is adjacent to the valve cover 624 can be It is provided to be made of an elastic material or a shape memory material, and when the second valve mechanism 622 is moved from the position where the through hole 623 is closed to the position where the through hole 623 is opened, since its distance from the valve cover 624 becomes short, it is caused to be relatively small. The small first shape variable is transformed into a larger second shape variable. This movement process needs to overcome the resistance, which achieves a positive pressure in the expiratory phase.

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.

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 a valve assembly, wherein the valve assembly can guide the exhaust passage when the pressure in the cavity is higher than atmospheric pressure Through, the positive pressure function of the expiratory phase is realized, and the patient's discomfort caused by the continuous (exhalation and inhalation) positive pressure is avoided; the ventilation control device uses its own mechanical structure to provide positive exhalation pressure, so it is not necessary to use it. 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.

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 (16)

1. A ventilation control device for a respiratory mask, comprising:

   a cavity having a gas communication port communicating with each other and a mask vent for communicating with the respiratory mask;

   a valve assembly having an intake passage and an exhaust passage, the intake passage and the exhaust passage being in communication with the cavity through the air delivery port,

   Wherein the valve assembly is configured to conduct the intake passage when a pressure in the chamber is less than or equal to atmospheric pressure, and cause the row when a difference between a pressure in the chamber and an atmospheric pressure is greater than or equal to a predetermined value The gas passage is turned on.
2. The ventilation control device according to claim 1, wherein said valve assembly includes an adjustment mechanism for adjusting said predetermined value.
3. The ventilation control device according to claim 2, wherein said valve assembly is provided with an indicating member for indicating a predetermined value after adjustment.
4. The ventilating control device of claim 1 wherein said valve assembly comprises:

   a first valve mechanism having a first closed position for closing the gas delivery port and a first open position for opening the gas delivery port, wherein the first valve mechanism is provided with a through hole;

   A second valve mechanism is disposed at the through hole, having a second closed position that closes the through hole and a second open position that opens the through hole.
5. The ventilation control device according to claim 4, wherein said first valve mechanism comprises:

   a first valve core, the through hole is disposed on the first valve core;

   A first biasing member abuts against the first spool to provide the first spool with a resistance to movement from the first closed position to the first open position.
6. The ventilating control apparatus according to claim 5, wherein said valve assembly includes a valve seat connected to said gas delivery port, said valve seat being provided with an air outlet, said first valve mechanism being disposed at said Inside the valve seat.
7. The ventilation control device according to claim 6, wherein said valve seat is provided with a limiting member for restricting said first spool in said first closed position and said first opening Move between positions.
8. The ventilating control apparatus according to claim 6, wherein said valve assembly includes an adjustment mechanism for adjusting said predetermined value, said adjustment mechanism comprising:

   a valve cover, one end of the first biasing member is coupled to or abuts against the first spool and the other end is coupled to or abuts the valve cover, the valve cover being movably coupled to the valve seat for adjustment Movement resistance of the first biasing member;

   A positioning structure for positioning the valve cover relative to the valve seat.
9. The ventilation control device according to claim 4, wherein said second valve mechanism comprises:

   a second spool that can open or close the through hole;

   A second biasing member abuts against the second spool to provide movement resistance of the second spool from the second closed position to the second open position.
10. The ventilating control apparatus according to claim 4, wherein said valve assembly includes a valve cover, said valve cover being coupled to said first valve mechanism at an outer side of said cavity; said second valve mechanism comprising:

    a second spool that opens or closes the through hole on an outer side of the cavity;

    a second biasing member disposed between the second spool and the valve cover to provide the second spool with a resistance to movement from the second closed position to the second open position.
11. The ventilation control device according to claim 10, wherein one end of said second biasing member is coupled to or abuts against said second spool and the other end is coupled to or abuts said valve cover, said valve cover being movable Connected to the first valve mechanism to adjust the movement resistance of the second biasing member, the valve assembly further comprising a positioning structure for positioning the valve cover relative to the first valve mechanism .
12. The ventilation control device according to claim 4, wherein said valve assembly includes a valve cover, said valve cover being coupled to said first valve mechanism, said second valve mechanism being a one-way valve, said second valve The mechanism is abutted between the first valve mechanism and the valve cover, at least a portion of the second valve mechanism being made of an elastomeric material or a morphological memory material.
13. The ventilation control device according to claim 4, wherein said second valve mechanism comprises a valve flap made of an elastic or morphological memory material, said valve flap being coupled to said first valve mechanism.
14. The ventilation control device according to claim 1, wherein said predetermined value is greater than 0 and less than or equal to 30 hPa, preferably between 5 and 20 hPa.
15. 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.
16. A respiratory mask apparatus according to claim 15 wherein said respiratory mask comprises a mask master And a pad assembly attached to the mask body for contacting a face of a patient, the mask body and the pad assembly co-formed for communication with a patient's mouth and/or nose Cavity,

    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.

Images