WO2017067081A1 - Ventilation control apparatus, and breathing mask device provided with ventilation control apparatus - Google Patents

Ventilation control apparatus, and breathing mask device provided with ventilation control apparatus Download PDF

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Publication number
WO2017067081A1
WO2017067081A1 PCT/CN2015/100041 CN2015100041W WO2017067081A1 WO 2017067081 A1 WO2017067081 A1 WO 2017067081A1 CN 2015100041 W CN2015100041 W CN 2015100041W WO 2017067081 A1 WO2017067081 A1 WO 2017067081A1
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WO
WIPO (PCT)
Prior art keywords
cavity
valve
delivery port
heat
pressure
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PCT/CN2015/100041
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French (fr)
Chinese (zh)
Inventor
周明钊
马德东
王亚杰
庄志
Original Assignee
北京怡和嘉业医疗科技有限公司
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Publication of WO2017067081A1 publication Critical patent/WO2017067081A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks

Definitions

  • 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.
  • OSAHS obstructive sleep apnea hypopnea syndrome
  • CPAP continuous positive airway pressure
  • PEEP positive end-expiratory pressure
  • 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.
  • 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.
  • the present invention provides a ventilation control device for a respiratory mask and a respiratory mask device having the same.
  • a ventilation control apparatus for a respiratory mask includes a cavity having a gas delivery port, a valve assembly disposed at the gas delivery port, and the valve assembly configured to exhale Maintaining a pressure in the chamber greater than atmospheric pressure; and a heat and humidity exchanger having a mask vent connected to the gas delivery port, the mask vent being used for the heat and humidity exchanger In communication with the breathing mask, the heat and moisture exchanger is in communication with the gas delivery port such that both exhalation and inspiration are via the heat and humidity exchanger.
  • the heat and moisture exchanger comprises: a casing; a hydrophobic membrane filled in the casing; and a water absorbing and hydrophilic layer attached to the surface of the hydrophobic membrane.
  • the heat and humidity exchanger further comprises a filter assembly disposed within the housing for filtering particles and/or microorganisms.
  • said mask vent is disposed on said heat and moisture exchanger, said cavity further comprising an interface, and said heat and moisture exchanger is detachably coupled to said cavity at said interface to Having said heat and moisture exchanger vented to said interface; or said mask vent is disposed on said cavity, said heat and moisture exchanger being detachably coupled to said valve assembly at said gas delivery port or
  • the cavity is configured to communicate the heat and moisture exchanger with the gas delivery port; or the mask vent is disposed on the cavity, the heat and moisture exchanger is disposed in the cavity, A valve assembly is detachably coupled to the gas delivery port of the cavity.
  • the valve assembly has an intake passage and an exhaust passage, the intake passage and the exhaust passage being in communication with the cavity through the gas delivery port, wherein the valve assembly is configured to be
  • the intake passage is turned on when the pressure in the chamber is less than or equal to atmospheric pressure; and the exhaust passage is turned on when the difference between the pressure in the chamber and the atmospheric pressure is greater than or equal to a predetermined value.
  • 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.
  • 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 a first spool is provided from the first closed position The movement resistance to the first open position is set.
  • 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.
  • 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.
  • the gas delivery port includes an intake port and an exhaust port
  • the valve assembly includes: an intake valve disposed at the intake port, the intake valve being configured to be inside the cavity Opening when the pressure is less than or equal to atmospheric pressure; and an exhaust valve disposed at the exhaust port, the exhaust valve being configured to open when a difference between the pressure in the chamber and the atmospheric pressure is greater than or equal to a predetermined value.
  • the valve assembly includes an adjustment mechanism for adjusting the predetermined value.
  • the valve assembly cooperates with the air inlet to form an air inlet and an air outlet; the valve assembly is configured to cause the air inlet and the air when the pressure in the cavity is less than or equal to atmospheric pressure
  • the mask vent is connected, and the exhaust port is in communication with the mask vent when the pressure in the chamber is greater than atmospheric pressure, wherein a cross-sectional area of the air inlet is greater than a cross-section of the air outlet
  • the area, and the cross-sectional area of the exhaust port is set to maintain the pressure in the chamber greater than atmospheric pressure when exhaling.
  • the gas delivery port includes a first gas delivery port and a second gas delivery port which are disposed at intervals, and the valve assembly is disposed at the first gas delivery port; when the pressure in the cavity is less than or equal to atmospheric pressure Opening the first gas delivery port, the first gas delivery port and the second gas delivery port form the air inlet; when the pressure in the cavity is greater than atmospheric pressure, the first gas delivery port is closed.
  • the second gas delivery port is the exhaust port.
  • a respiratory mask apparatus 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.
  • the ventilation control device realizes the positive pressure function of the expiratory phase, avoids the patient discomfort caused by the continuous positive pressure; and does not need to be connected with the positive pressure gas supply device (such as a CPAP ventilator) and the pipeline, so as to facilitate the patient to move. There is no need to carry a positive pressure gas supply device when going out, and the patient can wear a breathing mask with the ventilation control device for treatment at any time.
  • the ventilating control device also adds a heat and humidity exchanger to heat and humidify the inhaled gas by using moisture and heat in the exhaled gas, so that moisture and heat are recycled, and avoiding mucus cilia in the respiratory tract caused by insufficient warming and humidification. Slower running system, accumulation of secretions, thickening of secretions, risk of bacterial colonization, improved lung compliance and patient comfort.
  • this type of heat and humidity exchanger is small in size, easy to use, and low in cost, so it can be done It is a one-time consumable, has no danger of breeding bacteria and troubles of cleaning and disinfecting; there is no danger of electricity and heat, and it can avoid insufficient humidification or excessive humidification to some extent.
  • Figure 1 is a schematic view of a conventional continuous positive pressure ventilation system
  • FIG. 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 cavity and valve assembly 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 cavity and valve assembly in accordance with a fourth embodiment of the present invention.
  • Figure 7A is a cross-sectional view of a cavity and valve assembly in accordance with a fifth embodiment of the present invention.
  • Figure 7B is a cross-sectional view of a cavity and valve assembly in accordance with a sixth embodiment of the present invention.
  • ventilation control device 210, cavity; 211, interface; 212A, first air inlet; 212B, second air outlet; 220, intake valve; 221, connecting member; 230, exhaust valve; 231, exhaust valve seat; , exhaust valve core; 233, exhaust valve biasing member; 234, air outlet; 240, heat and humidity exchanger; 241, mask vent; 242, connection structure; 243, interface; 310, cavity; 312A, a gas outlet; 312B, a second gas outlet; 320, a valve assembly; 400, a ventilation control device, 410, a cavity; 411, a mask vent; 412, a gas outlet; 413, a connection structure; 420, a valve assembly ;421, valve seat; 421A, air outlet; 421B, fixing member; 421C, movable member; 422, first valve mechanism; 422A
  • a ventilation control device for a respiratory mask.
  • a breathing mask using the ventilation control device will be briefly described herein.
  • 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.
  • the respiratory mask 20 includes a mask body 21, a cushion assembly 22, and a forehead support 24.
  • the respiratory mask 20 may not include one or both of the components, such as a nasal plug type respiratory mask that does not include 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.
  • 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 triangle shown in the drawing, and It is pear shape, trapezoidal, etc.
  • the mask body 21 and the pad assembly 22 may also take a shape that matches the shape of the nose and the like.
  • 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.
  • 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.
  • the support portion 23 employs a balloon or gel and can have an adaptive face function.
  • 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.
  • 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.
  • the vent control device 200 includes a cavity 210, a valve assembly (including 220 and 230), and a heat and humidity exchanger (HME) 240.
  • HME heat and humidity exchanger
  • the cavity 210 has a gas delivery port. Although the cavity 210 shown in the figures is generally cylindrical, but not In other embodiments shown, the cavity 210 can have any other shape as long as it can form a sealed space that can be vented with the respiratory mask 20.
  • 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 gas port is used for gas exchange between the chamber 210 and the atmosphere, including the patient's inhalation and the patient's exhalation, both through the gas delivery port.
  • two gas delivery ports namely a first gas delivery port 212A and a second gas delivery port 212B, are disposed on the chamber 210.
  • the first air outlet 212A serves as an air inlet
  • the second air outlet 212B serves as a air outlet.
  • the number of gas outlets may be one or more. In the case where one or more gas outlets are provided, it is also possible to make all or part of these gas outlets serve as both an air inlet and a gas port by the arrangement of the valve assembly. An embodiment of setting one or more gas outlets will also be described later.
  • the valve assembly is configured to maintain the chamber pressure P in the expiratory 2101 greater than atmospheric pressure P 0.
  • the valve assembly can include an intake valve 220 disposed at the first gas delivery port 212A and an exhaust valve 230 disposed at the second gas delivery port 212B.
  • the intake valve 220 can be opened, and the gas enters the cavity 210 from the first gas delivery port 212A.
  • the intake valve 220 can be closed, and the exhaust valve 230 can be opened under certain conditions.
  • the exhaust valve 230 is opened to allow the gas to exit the cavity 210 from the second gas delivery port 212B.
  • the opening area of the second gas delivery port 312B may be set to be small so that the gas discharge rate is smaller than the patient's expiratory rate to form a positive expiratory pressure during exhalation.
  • Valve assembly 320 is the same or similar to intake valve 220 in FIG. When inhaling, the valve assembly 320 opens the first gas delivery port 312A, and the second gas delivery port 312B also functions to assist the intake air.
  • the intake valve 220 includes a valve flap made of an elastomeric material or a morphological memory material.
  • the valve flap is coupled within the cavity 210 at the first gas delivery port 212A, such as directly to the wall of the cavity 210 or to the cavity 210 by an intermediate member (e.g., connector 221 in FIG. 2).
  • the intake valve 220 can be opened in one direction, that is, when the pressure P 1 in the cavity 210 is less than or equal to the atmospheric pressure P 0 , the intake valve 220 is opened to the inside of the cavity 210, and the air enters the cavity 210 through the first gas delivery port 212A.
  • the intake valve 220 Inside.
  • the intake valve may have other arrangements as long as the first air port 212A 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 first gas delivery port 212A can take various forms of design, and the sealing fit between the intake valve 220 and the first gas delivery port 212A includes line and plane fit, planar and planar fit, Line and cylindrical face fit, cylindrical and cylindrical fit, line and spherical fit, spherical and spherical fit, line and conical fit, conical and conical fit, etc.
  • the material of the sealing mating part can be a flexible combination of rigidity and flexibility.
  • the shape and material of the above-mentioned seal fitting portion can also be applied to various valves as described below.
  • the exhaust valve 230 may also include 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 second air inlet 212B, and the air outlet 234 is disposed on the exhaust valve seat 231.
  • the exhaust spool 232 is movably disposed within the exhaust valve seat 231 between its closed position and its open position. The movement includes translation and rotation.
  • Figure 2B illustrates an embodiment of a translational movement.
  • the exhaust spool 232 can close the second air port 212B when in its closed position and can have the second air port 212B in fluid communication with the air outlet 234 in its open position to form an exhaust passage.
  • the exhaust valve biasing member 233 applies a biasing force to the exhaust valve spool 232 against the exhaust direction, that is, when exhaling, the exhaust valve spool 232 needs to be overcome against the resistance generated by the exhaust valve biasing member 233.
  • the exhaled gas can be expelled by moving from its closed position to its open position.
  • 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 closed position. During this movement, the pressure applied by the exhaust valve biasing member 233 is increased.
  • 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. This pull force needs to be overcome during exhalation to move the exhaust spool 232 to the closed 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. Further, the exhaust valve 230 may also adopt a structure similar to the intake valve 220.
  • the heat and humidity exchanger 240 is used to warm and humidify the inhaled gas to reduce loss of air in the respiratory tract.
  • the heat and humidity exchanger 240 is of a passive humidification type, that is, when the gas is exhaled, the moisture and heat in the exhaled gas are retained to heat and humidify the inhaled gas, so that the moisture and heat are recycled.
  • This type of heat and moisture exchanger 240 is compact, easy to use, and low in cost, so it can be made into a disposable consumable, without the risk of breeding bacteria and the trouble of cleaning and disinfecting; there is no danger of electricity and heat, and it can be certain To the extent that insufficient wetting or excessive wetting is avoided.
  • a mask vent 241 for venting the respiratory mask 20 is disposed on the heat and humidity exchanger 240 or the cavity 210.
  • the heat and humidity exchanger 240 is in communication with the cavity 210 to allow both exhalation and inhalation.
  • the mask vent 241 is disposed on the heat and moisture exchanger 240.
  • the mask vent 241 is used to ventilate the breathing mask 20.
  • the mask vent 241 is, for example, connected to the mask through hole of the respiratory mask 20.
  • a connection structure 242 can be provided at the mask vent 241.
  • the connection structure 242 is used to detachably connect the ventilation control device 200 to the respiratory mask 20.
  • the connecting structure 242 can be, for example, a snap connection structure, a screw 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 cavity 210 also includes an interface 211.
  • the heat and moisture exchanger 240 is detachably coupled to the cavity 210 at the interface 211 to vent the heat and moisture exchanger 240 with the interface 211.
  • An interface 243 matching the interface 211 may be disposed on the heat and humidity exchanger 240 to detachably connect the heat and moisture exchanger 240 and the cavity 210.
  • connection of the interface 211 and the interface 243 can take various forms, for example, including a tapered shaft hole pressing and fixing form, a snap type, a threaded connection form, or an elastic body holding form.
  • the heat and humidity exchanger 240 and the chamber 210 can also be made integral and non-detachable. In the following embodiments, an embodiment in which the mask vent is provided on the cavity 210 will also be described.
  • the heat and moisture exchanger 240 includes a housing, a hydrophobic membrane, and a water absorbing and hydrophilic layer.
  • the hydrophobic film is filled in the housing.
  • the hydrophobic membrane can be folded in the housing.
  • the water absorbing and hydrophilic layer adheres to the surface of the hydrophobic film.
  • the hydrophobic film may be made of polyvinylidene fluoride (PVDF), polyurethane (PUR), polyester (PES), polylactic acid (PLA), polycaprolactone (PCL), polypropylene (PP), polyester (PES).
  • PVDF polyvinylidene fluoride
  • PUR polyurethane
  • PET polyurethane
  • PUR polyurethane
  • PET polylactic acid
  • PCL polycaprolactone
  • PP polypropylene
  • PET polypropylene
  • PET polypropylene
  • the water absorbing and hydrophilic layer may be made of a water absorbing material and a hydrophilic material.
  • the water absorbing material may be various natural or improved high molecular weight water absorbing resins and/or synthetic water absorbing resins.
  • Hydrophilic materials contain hydrophilic groups such as -COOH, -SO 3 H, -OH, etc. These groups are polar and can be absorbed by water.
  • a filter assembly is also provided in the heat and humidity exchanger 240 for filtering particles and/or microorganisms.
  • the filter assembly can include a PM2.5 filter, a PM10 filter, and/or an activated carbon filter assembly.
  • PM2.5 filters, PM10 filters, and activated carbon filter assemblies are all commercially available.
  • the filter assembly can include vinyl acetate resin bonded borosilicate ultrafine glass fibers having properties against common bacteria and viruses, Bacillus anthracis, tuberculosis, HBV virus, and HCV virus.
  • the filter assembly can include a polymeric nanofiber filtration layer, wherein the polymeric nanofiber filtration layer can also include a sterilizing material (eg, silver). The filter assembly can be disposed within the housing of the heat and humidity exchanger 240.
  • the mask vent can be disposed on the cavity.
  • the cavity 410 is provided with a mask vent 411, and the cavity 410 is further provided with a gas outlet 412.
  • the cavity 410 is generally cylindrical in shape, in other embodiments not shown, the cavity 410 may have any other shape as long as it can form a sealed space that can be vented with the respiratory mask. .
  • the volume of the cavity 410 is not limited, and it is preferable to wear comfort.
  • the cavity 410 can be made of a flexible material or a rigid material.
  • the cavity 410 may even be integral with the cavity formed by the mask body 21 of the respiratory mask 20, such as by molding the cavity 410 integrally with the mask body 21.
  • the cavity 410 and the cavity can be formed as two cavities that can be clearly distinguished and communicated.
  • the cavity 410 can also be formed as part of a cavity, that is, for the embodiment shown in Figure 4, a portion of the cavity of the breathing mask can be utilized as the cavity 410, with the air inlet 412 formed directly On the mask body 21.
  • the mask vent 411 is provided with a connection structure 413 for detachably connecting the ventilation control device 400 to the respiratory mask 20.
  • the connection structure 413 may be, for example, a snap connection structure, a screw connection structure, or an elastic body connection structure.
  • the ventilation control device 400 can be replaced at any time, and the ventilation control device 400 can be designed to be directly applied to an existing CPAP breathing mask to reduce the cost of use of the patient.
  • the heat and moisture exchanger 440 can be detachably coupled to the valve assembly 420 or the cavity 410 at the gas delivery port 412 to allow the heat and moisture exchanger 440 to communicate with the gas delivery port 412.
  • the cavity 410 can include an interface that removably couples the heat and moisture exchanger 440 to the cavity 410. As an example, such an interface may be included on valve assembly 420.
  • the structure of the interface may be a compression of a tapered shaft hole, a screw connection, a plug connection, an elastic body tight connection or a snap connection, etc., as long as the heat and moisture exchanger 440 can be connected to the air inlet 412.
  • the heat and humidity exchanger 440 and the chamber 410 or the valve assembly 420 can also be made integral and non-detachable.
  • the heat and moisture exchanger 440 can be disposed at the gas delivery port 412 by being coupled to the cavity 410 or to the valve assembly 420, as shown in FIG. Since the heat and humidity exchanger 440 is in communication with the gas delivery port 412, moisture and heat in the gas discharged through the gas delivery port 412 are retained as it passes through the heat and humidity exchanger 440. When exhaling, the gas first passes through the heat and humidity exchanger 440, and the retained moisture and heat are humidified and warmed, then enter the cavity 410 through the gas delivery port 412, and finally reach the respiratory mask 20. Similar to FIGS. 2A-2B, a heat and humidity exchanger 440 can also be disposed between the cavity 420 and the respiratory mask 20.
  • the heat and humidity exchanger 540 can be disposed within the cavity 510.
  • the heat and moisture exchanger 540 can be detachably disposed within the cavity 510 or can be fabricated as a one-piece member with the cavity 510.
  • the mask vent 511 is disposed on the cavity 510.
  • the valve assembly 520 is detachable The mode is connected to the air inlet 512 of the cavity 510.
  • the cavity 510 can be periodically removed to integrally clean or replace the cavity 510 and the heat and moisture exchanger 540 therein.
  • the heat and humidity exchanger is disposed between the chamber and the breathing mask, and the heat and humidity exchanger is detachable Connected to the cavity and the respiratory mask; or the heat and humidity exchanger is disposed within the cavity and the cavity is removably coupled to the respiratory mask and valve assembly. This allows the heat and humidity exchanger to be removed and cleaned or replaced periodically.
  • valve assembly A plurality of embodiments of the valve assembly and the cavity will be described in detail below with reference to the accompanying drawings. It will be appreciated that the chamber and valve assembly described below can be combined with any of the heat and humidity exchangers described above.
  • a valve assembly 420 is disposed at the gas delivery port 412 to control gas flow to the gas delivery port 412.
  • the valve assembly 420 has an intake passage and an exhaust passage. Both the intake passage and the exhaust passage communicate with the cavity 410 through the gas delivery port 412.
  • the valve assembly 420 is configured to conduct the intake passage when the pressure P 1 within the chamber 410 is less than or equal to the atmospheric pressure P 0 ; and the difference ⁇ P between the pressure P 1 and the atmospheric pressure P 0 within the chamber 410 is greater than or equal to a predetermined value When the exhaust passage is turned on.
  • the intake passage is only turned on when the pressure P 1 in the chamber 410 is less than or equal to the atmospheric pressure P 0 , and is immediately turned off once the pressure P 1 in the chamber 410 is greater than the atmospheric pressure P 0 .
  • the exhaust passage is turned on only when the difference ⁇ P between the chamber 410 and the atmospheric pressure is greater than or equal to a predetermined value, and is immediately turned off once the difference ⁇ P between the chamber 410 and the atmospheric pressure is less than a predetermined value.
  • the air pressure P 1 within the cavity 410 increases above the atmospheric pressure P 0 .
  • the air pressure P 1 in the cavity 410 is increased to a difference ⁇ P 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.
  • the valve assembly 420 includes a first valve mechanism 422 and a second valve mechanism 423.
  • the first valve mechanism 422 is disposed at the air delivery port 412.
  • the first valve mechanism 422 has a first closed position that closes the air inlet 412 and a first open position that opens the air inlet 412.
  • a through hole 422B is provided in the first valve mechanism 422.
  • the second valve mechanism 423 is disposed at the through hole 422B.
  • the second valve mechanism 223 has a second closed position that closes the through hole 422B and a second open position that opens the through hole 422B.
  • the first valve mechanism 422 and the second valve mechanism 423 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 422 and the second valve mechanism 423 due to respiration.
  • both the first valve mechanism 422 and the second valve mechanism 423 are in their respective closed positions.
  • the air inlet 412 is closed.
  • the second valve mechanism 423 moves along with the first valve mechanism 422 and moves to the aeration position (moving to the right).
  • the first valve mechanism 422 is now in the first open position and the second valve mechanism 423 is in the second closed position.
  • the gas delivery port 412 is opened to form an exhaust passage.
  • the second valve mechanism 423 can be disposed on the first valve mechanism 222.
  • the second valve mechanism 423 follows the first valve mechanism 422 to move to the venting position to form an exhaust passage, and is also capable of A positive pressure is maintained within the body 410.
  • the opening and closing action of the second valve mechanism 423 itself can form an intake passage when the patient inhales.
  • the pressure P 1 in the cavity 410 is continuously reduced.
  • the first valve mechanism 422 is in a first closed position that closes the air inlet 412.
  • the second valve mechanism 423 opens the through hole 422B to form an intake passage.
  • the pressure P 1 in the chamber 410 is increased.
  • the second valve mechanism 423 closes the through hole 422B and repeats the above process.
  • Heat and humidity exchanger 440 is coupled to valve assembly 420 and is in communication with the gas delivery port. As noted above, the heat and humidity exchanger 440 can also be disposed within the cavity 410 or between the cavity 410 and the respiratory mask 20.
  • Valve assembly 420 can also include a valve seat 421.
  • the valve seat 421 is connected to the air inlet 412.
  • the heat and humidity exchanger 440 can be coupled to the valve seat 421 of the valve assembly 420.
  • the first valve mechanism 422 and the second valve mechanism 423 may both be disposed within the valve seat 421.
  • An air outlet 421A is provided on the valve seat 421.
  • the heat and humidity exchanger 440 communicates with the gas delivery port 412 through the gas outlet 421A.
  • the air outlet 421A may be disposed at the distal end of the valve seat 421 or may be disposed on the side wall of the valve seat 421.
  • 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 first valve mechanism 422 can include a first spool 422A and a first biasing member 422C.
  • the first spool 422A is moveable between a first closed position and a first open position.
  • the through hole 422B is provided on the first valve body 422A.
  • the second valve mechanism 423 is disposed on the first valve body 422A at the through hole 422B.
  • the pressure P 1 in the cavity 410 increases during exhalation, and when increased to P 0 + ⁇ P, the first valve body 422A and the second valve mechanism 423, which originally close the gas delivery port 412, are moved to the right together, and the gas is delivered.
  • the port 412 is opened, and the air inlet 412 communicates with the air outlet 421A to form an exhaust passage.
  • the pressure difference ⁇ P may be provided by the first biasing member 422C.
  • the first biasing member 422C abuts against the first spool 422A to provide the first spool 422A with movement resistance from the first closed position to the first open position.
  • the first biasing member 422C applies a moving resistance to the first spool 422A at the original position shown in the drawing to form a positive expiratory pressure.
  • the second valve mechanism 423 can be a one-way valve.
  • the second valve mechanism 423 can include a valve flap made of an elastomeric material or a morphological memory material.
  • valve flap is coupled to the first valve mechanism 422 from a side proximate the cavity 410.
  • first valve mechanism 422 may also employ a one-way valve configuration similar to the second valve mechanism 423.
  • the first valve mechanism 422 can include a valve flap made of an elastomeric material or a morphological memory material that is coupled to the cavity 410 on a side facing away from the cavity 410.
  • the second valve mechanism 423 can also adopt a configuration similar to that of the first valve mechanism 422 described above, that is, including a spool and a biasing member, and the second valve mechanism having such a structure will be described later with reference to FIG. description.
  • the valve assembly may further include an adjustment mechanism for adjusting the predetermined value.
  • the valve seat 421 may include a fixing member 421B and a movable member 421C.
  • the movable member 421C is movably coupled to the fixing member 421B, and positions the movable member 421C with respect to the fixing member 421B by the positioning structure.
  • the positioning structure may be a mating thread disposed on the fixing member 421B and the movable member 421C. In other embodiments not shown, the positioning structure can include snaps, securing pins, and the like.
  • first biasing member 422C may be coupled to or abutted to the first spool 422A, and the other end may be coupled or abutted to the movable member 421C.
  • the biasing force of the first biasing member 422C can be adjusted, thereby adjusting the predetermined value.
  • the movable member 421C can also be removed, and the predetermined value can be adjusted by replacing the first biasing member 422C that provides a different biasing force.
  • the air outlet 421A may be disposed on the movable member 421C.
  • the heat and humidity exchanger 440 is connected to the gas outlet 421A.
  • the ventilation control device is provided with an indication 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.
  • a mechanical identification can be provided on the exhaust valve seat 331.
  • the exhaust valve cover 350 is adjusted to different positions and will be exposed. The same scale or color to indicate the adjusted first predetermined value.
  • 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 612 of the cavity 610, and the first valve mechanism 621 has a first closed position that closes the air inlet 612 and a first open position that opens the air inlet 612.
  • 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.
  • the first valve mechanism 621 and the second valve mechanism 622 cooperate to move between an original position and a venting position.
  • the air inlet 612 is closed.
  • the pressure P in the chamber is less than or equal to 610 atmospheric pressure P 0
  • the second valve mechanism 622 can be disposed on the first valve mechanism 621.
  • the first valve mechanism 621 and the second valve mechanism 622 is moved leftward, the first valve 621 and the gas delivery mechanism A gap is created between the ports 612, and the gas delivery port 612 is opened to form an intake passage corresponding to the inspiratory phase of the patient.
  • the opening and closing of the second valve mechanism 622 itself can also form an exhaust passage when the patient exhales.
  • the first valve mechanism 621 is in a closed gas delivery port 612 of the first closed position.
  • the first valve mechanism 621 can be disposed inside the cavity 610.
  • the edge wall of the gas delivery port 611 can restrict the first valve mechanism 621 from moving to the right, keeping the first valve mechanism 621 in the home 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.
  • 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.
  • the second valve mechanism 622 opens the through hole 623 to form an exhaust passage.
  • the difference ⁇ P between the pressure P 1 and the atmospheric pressure P 0 in the cavity 610 is smaller than the predetermined value, the second valve mechanism 622 is in a state in which the through hole 623 is closed.
  • the heat and humidity exchanger may be coupled between the cavity 610 and the respiratory mask, or may be coupled to the cavity 610 at the gas delivery port 612, such as to the extension wall 613 of the cavity 610.
  • the valve assembly 720 includes a valve seat 721, a first valve mechanism 722, and a second valve mechanism 723.
  • the first valve mechanism 722 is provided with a through hole 722B.
  • the first valve mechanism 722 and the second valve mechanism 723 are each movable between respective open and closed positions.
  • the first valve mechanism 722 is primarily disposed within the valve seat 721, and the second valve mechanism 723 is disposed primarily within the cavity. Both the first valve mechanism 722 and the second valve mechanism 723 are controlled by a biasing member.
  • the first valve mechanism 722 can include a first spool 722A and a first biasing member 722C.
  • the through hole 722B is provided on the first spool 722A.
  • the first biasing member 722C abuts against the first spool 722A to provide the first spool 722A with movement resistance from the first closed position to the first open position.
  • the second valve mechanism 723 can include a second spool 723A and a second biasing member 723B.
  • the second spool 723A has a second closed position that closes the through hole 722B on the first spool 722A and a second open position that opens the through hole 722B.
  • the second biasing member 723B abuts against the second spool 723A to provide the second spool 723A with movement resistance from the second closed position to the second open position.
  • the second biasing member 723B may be disposed on a side of the second spool 723A facing the cavity 710 and apply pressure to the second spool 723A as it moves from its closed position to its open position (ie, to the left). In other embodiments not shown, the second biasing member may be disposed on a side of the second spool that faces away from the cavity 710 and move from the closed position of the second spool 723A to its open position (ie, Left) applies a pulling force to it.
  • the first biasing member 722C and the second biasing member 723B may be springs or other elastomers, etc., and may also be morphological memory materials such as alloys or plastics having morphological memory properties.
  • the second spool 723A and the first spool 722A move together to the right, i.e., toward their venting position.
  • the internal and external air pressure difference ⁇ P generated by the exhalation is to overcome the resultant force of the movement resistance generated by the first biasing member 722C and the second biasing member 723B. Since the biasing force generated by the second biasing member 723B is only used to achieve that the pressure P 1 in the cavity 710 is equal to or less than the atmospheric pressure P 0 , the second biasing force generated by the second biasing member 723B is set. Smaller, the second biasing force is less than the first biasing force generated by the first biasing member 722C.
  • the heat and humidity exchanger can be coupled between the cavity 710 and the breathing mask, or can be coupled to the cavity 710 or to the valve assembly 720 at the gas delivery port 712.
  • the seal between the first valve mechanism 722 and the second valve mechanism 723 and the gas delivery port 712 may be achieved by either or both.
  • a seal ring or a gasket or the like may be provided on at least one of the first valve mechanism 722 and the second valve mechanism 723.
  • a seal may be provided on the first spool 722A of the first valve mechanism 722.
  • a seal 723C may be provided on the second valve body 723A of the second valve mechanism 723.
  • a seal may be provided on both the first valve body 722A and the second valve body 723A.
  • a limiting member such as a stopper, a projection or the like may be provided on the valve seat 721.
  • the limiting member is used to limit the movement of the first spool 722A only between the home position and the venting position to avoid excessive vibration caused by severe vibration of the first spool 722A when the patient exhales.
  • the valve seat 721 may include a fixing member 721B and a movable member 721C, see FIG. 7A.
  • One end of the first biasing member 722C is coupled to or abuts against the first spool 722A and the other end is coupled to or abuts against the movable member 721C.
  • the movable member 721C is movably coupled to the fixing member 721B to adjust the first biasing force of the first biasing member 722C.
  • the adjustment mechanism further includes a positioning structure for positioning the movable member 721C with respect to the fixing member 721B.
  • different predetermined biasing forces may be provided by replacing the different first biasing members 722C to adjust the predetermined value.
  • the valve assembly 320 can cooperate with the air delivery port to form an air inlet and an air outlet.
  • the valve assembly 320 is configured as a pressure within the cavity 310 is less than or equal to P 1 of the atmospheric pressure P 0 time (i.e. the patient inhales), the intake port in communication with the mask vent and the pressure within the cavity 310 P 1 of When the pressure is greater than the atmospheric pressure P 0 (that is, when the patient exhales), the exhaust port is connected to the mask vent.
  • the gas delivery port includes a first gas delivery port 312A and a second gas delivery port 312B that are spaced apart.
  • the valve assembly 320 is disposed only at the first gas delivery port 312A for controlling the gas flow of the first gas delivery port 312A.
  • the first gas delivery port 312A and the second gas delivery port 312B form an air inlet. Gas enters the cavity 310 from the first gas delivery port 312A and the second gas delivery port 312B.
  • the second gas delivery port 312B forms an exhaust port, and the gas is discharged from the cavity 310 only from the second gas delivery port 312B.
  • the cross-sectional area S 1 of the intake port is larger than the cross-sectional area S 2 of the exhaust port.
  • the cross-sectional area S 2 of the exhaust port is set to maintain the pressure P 1 in the cavity 310 greater than the atmospheric pressure P 0 when exhaling, for example, the opening area of the second gas delivery port 312B can be set smaller to make the gas discharge rate Less than the patient's expiratory rate.
  • the second air inlet 312B can also function as an auxiliary air intake.
  • the heat and moisture exchanger is preferably coupled between the cavity 310 and the respiratory mask.
  • 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.
  • the ventilation control device realizes the positive pressure function of the expiratory phase, avoids the patient discomfort caused by the continuous positive pressure; and does not need to be connected with the positive pressure gas supply device (such as a CPAP ventilator) and the pipeline, so as to facilitate the patient to move. There is no need to carry a positive pressure gas supply device when going out, and the patient can wear a breathing mask with the ventilation control device for treatment at any time.
  • the ventilating control device also adds a heat and humidity exchanger to heat and humidify the suction gas by using moisture and heat in the exhaled gas, so that moisture and heat are recycled.
  • this type of heat and humidity exchanger is small in size, easy to use, and low in cost, so it can be made into a disposable consumable, without the risk of breeding bacteria and the trouble of cleaning and disinfecting; there is no danger of electricity and heat, To a certain extent, avoid insufficient humidification or excessive humidification.

Abstract

A ventilation control apparatus, and a breathing mask device provided with the ventilation control apparatus. The ventilation control apparatus comprises: a cavity (210, 310, 410, 510, 610, 710), provided with air delivery ports (212A, 212B, 312A, 312B, 412, 512, 612, 712); a valve assembly (220, 230, 320, 420, 520, 620, 720), arranged at the air delivery ports (212A, 212B, 312A, 312B, 412, 512, 612, 712), the valve assembly (220, 230, 320, 420, 520, 620, 720) being configured to keep the pressure within the cavity (210, 310, 410, 510, 610, 710) greater than the atmospheric pressure during exhalation; a heat and moisture exchanger (240, 440, 540), a mask ventilation port (241, 411, 511) in communication with the air delivery ports (212A, 212B, 312A, 312B, 412, 512, 612, 712) being arranged on the heat and moisture exchanger (240, 440, 540) or the cavity (210, 310, 410, 510, 610, 710), the mask ventilation port (241, 411, 511) being used for ventilation with a breathing mask, the heat and moisture exchanger (240, 440, 540) being in communication with the air delivery ports (212A, 212B, 312A, 312B, 412, 512, 612, 712), so that both exhalation and inhalation occur via the heat and moisture exchanger (240, 440, 540). The ventilation control apparatus implements an exhalation phase positive pressure function, and prevents patient discomfort caused by continuous positive pressure. A positive pressure air supply apparatus and a pipeline etc. need not be connected during use, thereby facilitating patient movement, and the positive pressure air supply apparatus need not be carried when going out. In addition, the ventilation control apparatus is small in size, convenient to carry, and low in cost.

Description

通气控制装置和具有该通气控制装置的呼吸面罩设备Ventilation control device and respiratory mask device having the same
相关申请的交叉引用Cross-reference to related applications
本申请要求享有于2015年10月23日提交的名称为“通气控制装置和具有该通气控制装置的呼吸面罩设备”的中国专利申请CN201510696722.X的优先权,该申请的全部内容通过引用并入本文中。The present application claims priority to Chinese Patent Application No. CN201510696722.X filed on Oct. 23, 2015, the disclosure of which is incorporated herein by In this article.
技术领域Technical field
本发明涉及呼吸面罩技术领域,具体地涉及一种用于呼吸面罩的通气控制装置以及具有这种通气控制装置的呼吸面罩设备。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.
背景技术Background technique
目前治疗阻塞性睡眠呼吸暂停低通气综合症(OSAHS)的方法主要有外科手术、口腔矫正器、持续正压通气(CPAP)和呼气终末正压(positive end-expiratory pressure,PEEP)治疗。Current methods for treating obstructive sleep apnea hypopnea syndrome (OSAHS) include surgery, orthodontics, continuous positive airway pressure (CPAP), and positive end-expiratory pressure (PEEP).
外科手术最常用的方式是悬雍垂腭咽成形术及其改良手术,用于上气道口咽部阻塞(包括咽部粘膜组织肥厚、咽腔狭小、悬雍垂肥大、软腭过低、扁桃体肥大)并且呼吸暂停低通气指数(AHI)<20次/小时。这种方法由于需动手术,患者接受度低,而且手术组织再长会造成病情反复,而之后无法再次手术。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.
口腔矫形器常用于单纯鼾症及轻度OSAHS患者(AHI<15次/小时),特别是下颌后缩者,其疗效无法预计,只能试用。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.
持续正压通气技术是将呼吸面罩110通过连接管路120连接至CPAP呼吸机130,并将该呼吸面罩110佩戴至患者的面部。CPAP呼吸机130产生持续的正压气流,从而给患者的上气道提供生理性压力支撑,进而治疗OSAHS。持续正压通气的缺点在于:持续正压会引起患者不适,部分患者不能接受;连接管路跟呼吸机限制患者夜间活动,依从性低;CPAP呼吸机不方便携带且成本较高。呼吸面罩在若干不同的情况中用于呼吸紊乱治疗,例如阻塞性睡眠呼吸暂停综合症的治疗等;或在其他情况下用于提供稳定的可吸入气流。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.
因此,需要一种用于呼吸面罩的通气控制装置以及具有该通气控制装置的呼 吸面罩设备,以至少部分地解决上文提到的问题。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.
发明内容Summary of the invention
为了至少部分地解决现有技术中存在的问题,本发明提供一种用于呼吸面罩的通气控制装置以及具有该通气控制装置的呼吸面罩设备。In order to at least partially solve the problems in the prior art, the present invention provides a ventilation control device for a respiratory mask and a respiratory mask device having the same.
根据本发明的一个方面提供的用于呼吸面罩的通气控制装置,包括:腔体,其具有输气口;阀组件,其设置在所述输气口处,所述阀组件构造为呼气时保持所述腔体内的压力大于大气压;以及热湿交换器,所述热湿交换器或所述腔体上设置有与所述输气口相连通的面罩通气口,所述面罩通气口用于与呼吸面罩连通,所述热湿交换器与所述输气口连通,以使呼气和吸气都经由所述热湿交换器。A ventilation control apparatus for a respiratory mask according to an aspect of the invention includes a cavity having a gas delivery port, a valve assembly disposed at the gas delivery port, and the valve assembly configured to exhale Maintaining a pressure in the chamber greater than atmospheric pressure; and a heat and humidity exchanger having a mask vent connected to the gas delivery port, the mask vent being used for the heat and humidity exchanger In communication with the breathing mask, the heat and moisture exchanger is in communication with the gas delivery port such that both exhalation and inspiration are via the heat and humidity exchanger.
优选地,所述热湿交换器包括:壳体;疏水膜,其填充在所述壳体内;吸水及亲水层,其附着在所述疏水膜的表面。Preferably, the heat and moisture exchanger comprises: a casing; a hydrophobic membrane filled in the casing; and a water absorbing and hydrophilic layer attached to the surface of the hydrophobic membrane.
优选地,所述热湿交换器中还包括设置于所述壳体内的过滤组件,用于过滤颗粒和/或微生物。Preferably, the heat and humidity exchanger further comprises a filter assembly disposed within the housing for filtering particles and/or microorganisms.
优选地,其中所述面罩通气口设置在所述热湿交换器上,所述腔体还包括接口,且所述热湿交换器在所述接口处可拆卸地连接至所述腔体,以使所述热湿交换器与所述接口通气;或者所述面罩通气口设置在所述腔体上,所述热湿交换器在所述输气口处可拆卸地连接至所述阀组件或所述腔体,以使所述热湿交换器与所述输气口连通;或者所述面罩通气口设置在所述腔体上,所述热湿交换器设置在所述腔体内,所述阀组件可拆卸地连接至所述腔体的所述输气口。Preferably wherein said mask vent is disposed on said heat and moisture exchanger, said cavity further comprising an interface, and said heat and moisture exchanger is detachably coupled to said cavity at said interface to Having said heat and moisture exchanger vented to said interface; or said mask vent is disposed on said cavity, said heat and moisture exchanger being detachably coupled to said valve assembly at said gas delivery port or The cavity is configured to communicate the heat and moisture exchanger with the gas delivery port; or the mask vent is disposed on the cavity, the heat and moisture exchanger is disposed in the cavity, A valve assembly is detachably coupled to the gas delivery port of the cavity.
优选地,所述阀组件具有进气通道和排气通道,所述进气通道和所述排气通道通过所述输气口与所述腔体连通,其中所述阀组件构造为在所述腔体内的压力小于或等于大气压时使所述进气通道导通;且在所述腔体内的压力与大气压之差大于或等于预定值时使所述排气通道导通。Preferably, the valve assembly has an intake passage and an exhaust passage, the intake passage and the exhaust passage being in communication with the cavity through the gas delivery port, wherein the valve assembly is configured to be The intake passage is turned on when the pressure in the chamber is less than or equal to atmospheric pressure; and the exhaust passage is turned on when the difference between the pressure in the chamber and the atmospheric pressure is greater than or equal to a predetermined value.
优选地,所述阀组件包括:第一阀机构,具有关闭所述输气口的第一关闭位置和打开所述输气口的第一开启位置,所述第一阀机构上设置有通孔;以及第二阀机构,其设置在所述通孔处,具有关闭所述通孔的第二关闭位置和打开所述通孔的第二开启位置。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.
优选地,所述第一阀机构包括:第一阀芯,所述通孔设置在所述第一阀芯上;第一偏置构件,顶抵在所述第一阀芯上以给所述第一阀芯提供从所述第一关闭位 置到所述第一开启位置的移动阻力。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 a first spool is provided from the first closed position The movement resistance to the first open position is set.
优选地,所述阀组件包括连接在所述输气口处的阀座,所述阀座上设置有出气口,所述第一阀机构设置在所述阀座内。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.
优选地,所述第二阀机构包括由弹性或形态记忆材料制成的阀瓣,所述阀瓣连接至所述第一阀机构。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.
优选地,所述输气口包括进气口和排气口,所述阀组件包括:进气阀,其设置在所述进气口处,所述进气阀构造为当所述腔体内的压力小于或等于大气压时开启;以及排气阀,其设置在所述排气口处,所述排气阀构造为当所述腔体内的压力与大气压之差大于或等于预定值时开启。Preferably, the gas delivery port includes an intake port and an exhaust port, and the valve assembly includes: an intake valve disposed at the intake port, the intake valve being configured to be inside the cavity Opening when the pressure is less than or equal to atmospheric pressure; and an exhaust valve disposed at the exhaust port, the exhaust valve being configured to open when a difference between the pressure in the chamber and the atmospheric pressure is greater than or equal to a predetermined value.
优选地,所述阀组件包括调节机构,所述调节机构用于调节所述预定值。Preferably, the valve assembly includes an adjustment mechanism for adjusting the predetermined value.
优选地,所述阀组件与所述输气口配合形成进气口和排气口;所述阀组件构造为在所述腔体内的压力小于或等于大气压时使所述进气口与所述面罩通气口连通,且在所述腔体内的压力大于大气压时使所述排气口与所述面罩通气口连通,其中,所述进气口的横截面积大于所述排气口的横截面积,且所述排气口的横截面积设置为呼气时保持所述腔体内的压力大于大气压。Preferably, the valve assembly cooperates with the air inlet to form an air inlet and an air outlet; the valve assembly is configured to cause the air inlet and the air when the pressure in the cavity is less than or equal to atmospheric pressure The mask vent is connected, and the exhaust port is in communication with the mask vent when the pressure in the chamber is greater than atmospheric pressure, wherein a cross-sectional area of the air inlet is greater than a cross-section of the air outlet The area, and the cross-sectional area of the exhaust port is set to maintain the pressure in the chamber greater than atmospheric pressure when exhaling.
优选地,所述输气口包括间隔设置的第一输气口和第二输气口,所述阀组件设置在所述第一输气口处;所述腔体内的压力小于或等于大气压时开启所述第一输气口,所述第一输气口和所述第二输气口形成所述进气口;所述腔体内的压力大于大气压时关闭所述第一输气口,所述第二输气口为所述排气口。Preferably, the gas delivery port includes a first gas delivery port and a second gas delivery port which are disposed at intervals, and the valve assembly is disposed at the first gas delivery port; when the pressure in the cavity is less than or equal to atmospheric pressure Opening the first gas delivery port, the first gas delivery port and the second gas delivery port form the air inlet; when the pressure in the cavity is greater than atmospheric pressure, the first gas delivery port is closed. The second gas delivery port is the exhaust port.
根据本发明的另一个方面提供的呼吸面罩设备,包括:呼吸面罩;以及如上所述的任一种通气控制装置,所述通气控制装置连接至所述呼吸面罩,并通过所述面罩通气口与所述呼吸面罩通气。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.
本发明提供的通气控制装置实现了呼气相的正压功能,避免持续正压引起的患者不适;使用时无需连接正压气体供给装置(例如CPAP呼吸机)及管路等,从而方便患者移动;外出时无需携带正压气体供给装置,患者可以随时佩戴具有该通气控制装置的呼吸面罩进行治疗。该通气控制装置还增加了热湿交换器,利用呼出气体内的水分和热量对吸入气体进行加热湿化,使水分和热量被循环利用,避免温化和湿化不足带来的呼吸道内粘液纤毛运转系统变慢、分泌物聚集、分泌物变粘稠、细菌定植的危险,提高肺顺应性和病人舒适度。The ventilation control device provided by the invention realizes the positive pressure function of the expiratory phase, avoids the patient discomfort caused by the continuous positive pressure; and does not need to be connected with the positive pressure gas supply device (such as a CPAP ventilator) and the pipeline, so as to facilitate the patient to move. There is no need to carry a positive pressure gas supply device when going out, and the patient can wear a breathing mask with the ventilation control device for treatment at any time. The ventilating control device also adds a heat and humidity exchanger to heat and humidify the inhaled gas by using moisture and heat in the exhaled gas, so that moisture and heat are recycled, and avoiding mucus cilia in the respiratory tract caused by insufficient warming and humidification. Slower running system, accumulation of secretions, thickening of secretions, risk of bacterial colonization, improved lung compliance and patient comfort.
此外,这种类型的热湿交换器结构小巧、使用简便、成本较低,因此可以做 成一次性消耗品,没有滋生细菌的危险和清洗消毒的麻烦;也没有电和热的危险,可在一定程度上避免湿化不足或湿化过度。In addition, this type of heat and humidity exchanger is small in size, easy to use, and low in cost, so it can be done It is a one-time consumable, has no danger of breeding bacteria and troubles of cleaning and disinfecting; there is no danger of electricity and heat, and it can avoid insufficient humidification or excessive humidification to some extent.
在发明内容中引入了一系列简化形式的概念,这将在具体实施方式部分中进一步详细说明。本发明内容部分并不意味着要试图限定出所要求保护的技术方案的关键特征和必要技术特征,更不意味着试图确定所要求保护的技术方案的保护范围。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.
以下结合附图,详细说明本发明的优点和特征。Advantages and features of the present invention are described in detail below with reference to the accompanying drawings.
附图说明DRAWINGS
本发明的下列附图在此作为本发明的一部分用于理解本发明。附图中示出了本发明的实施方式及其描述,用来解释本发明的原理。在附图中,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,
图1为现有的持续正压通气系统的示意图;Figure 1 is a schematic view of a conventional continuous positive pressure ventilation system;
图2A为具有根据本发明一个实施例的通气控制装置的呼吸面罩的立体图;2A is a perspective view of a respiratory mask having a ventilation control device in accordance with one embodiment of the present invention;
图2B为图2A中的通气控制装置和呼吸面罩的全剖视图;Figure 2B is a full cross-sectional view of the ventilation control device and the respiratory mask of Figure 2A;
图3为根据本发明第一实施例的腔体和阀组件的剖视图;Figure 3 is a cross-sectional view of a cavity and valve assembly in accordance with a first embodiment of the present invention;
图4为具有根据本发明第二实施例的通气控制装置的呼吸面罩的剖视图;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;
图5为具有根据本发明第三实施例的通气控制装置的呼吸面罩的剖视图;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;
图6为根据本发明第四实施例的腔体和阀组件的剖视图;Figure 6 is a cross-sectional view of a cavity and valve assembly in accordance with a fourth embodiment of the present invention;
图7A为根据本发明第五实施例的腔体和阀组件的剖视图;以及Figure 7A is a cross-sectional view of a cavity and valve assembly in accordance with a fifth embodiment of the present invention;
图7B为根据本发明第六实施例的腔体和阀组件的剖视图。Figure 7B is a cross-sectional view of a cavity and valve assembly in accordance with a sixth embodiment of the present invention.
110、呼吸面罩;120、连接管路;130、CPAP呼吸机;20、呼吸面罩;21、面罩主体;22、衬垫组件;23、支撑部分;24、前额支撑件;200、通气控制装置、210、腔体;211、接口;212A、第一输气口;212B、第二输气口;220、进气阀;221、连接件;230、排气阀;231、排气阀座;232、排气阀芯;233、排气阀偏置构件;234、出气口;240、热湿交换器;241、面罩通气口;242、连接结构;243、接口;310、腔体;312A、第一输气口;312B、第二输气口;320、阀组件;400、通气控制装置、410、腔体;411、面罩通气口;412、输气口;413、连接结构;420、阀组件;421、阀座;421A、出气口;421B、固定件;421C、可移动件;422、第一阀机构;422A、第一阀芯;422B、通孔;422C、第一偏置 构件;423、第二阀机构;440、热湿交换器;510、腔体;511、面罩通气口;512、输气口;520、阀组件;540、热湿交换器;610、腔体;612、输气口;613、腔体的延伸壁;620、阀组件;621、第一阀机构;622、第二阀机构;623、通孔;710、腔体;712、输气口;720、阀组件;721、阀座;721B、固定件;721C、可移动件;722、第一阀机构;722A、第一阀芯;722B、通孔;722C、第一偏置构件;723、第二阀机构;723A第二阀芯;723B、第二偏置构件;723C、密封件。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, interface; 212A, first air inlet; 212B, second air outlet; 220, intake valve; 221, connecting member; 230, exhaust valve; 231, exhaust valve seat; , exhaust valve core; 233, exhaust valve biasing member; 234, air outlet; 240, heat and humidity exchanger; 241, mask vent; 242, connection structure; 243, interface; 310, cavity; 312A, a gas outlet; 312B, a second gas outlet; 320, a valve assembly; 400, a ventilation control device, 410, a cavity; 411, a mask vent; 412, a gas outlet; 413, a connection structure; 420, a valve assembly ;421, valve seat; 421A, air outlet; 421B, fixing member; 421C, movable member; 422, first valve mechanism; 422A, first valve core; 422B, through hole; 422C, first offset Member; 423, second valve mechanism; 440, heat and moisture exchanger; 510, cavity; 511, mask vent; 512, gas outlet; 520, valve assembly; 540, heat and humidity exchanger; 610, cavity; 612, gas outlet; 613, extension wall of the cavity; 620, valve assembly; 621, first valve mechanism; 622, second valve mechanism; 623, through hole; 710, cavity; 712, gas outlet; , valve assembly; 721, valve seat; 721B, fixing member; 721C, movable member; 722, first valve mechanism; 722A, first valve core; 722B, through hole; 722C, first biasing member; Two valve mechanism; 723A second valve core; 723B, second biasing member; 723C, seal.
具体实施方式detailed description
在下文的描述中,提供了大量的细节以便能够彻底地理解本发明。然而,本领域技术人员可以了解,如下描述仅示例性地示出了本发明的优选实施例,本发明可以无需一个或多个这样的细节而得以实施。此外,为了避免与本发明发生混淆,对于本领域公知的一些技术特征未进行详细描述。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.
根据本发明的一个方面,提供一种用于呼吸面罩的通气控制装置(以下简称通气控制装置)。为了能够准确、完整地理解该通气控制装置,本文将首先对采用该通气控制装置的呼吸面罩进行简单描述。可以理解的是,附图中所示出的口鼻罩型呼吸面罩仅为示例性的,本文提供的通气控制装置并不限于仅应用至该口鼻罩型呼吸面罩,其还可以应用至鼻罩型、全脸罩型或鼻塞型等形式的呼吸面罩。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.
如图2A的立体图和图2B的剖视图所示,呼吸面罩20包括面罩主体21、衬垫组件22和前额支撑件24。在未示出的其它实施例中,呼吸面罩20可能会不包括其中的一个或两个部件,例如鼻塞型呼吸面罩不包括前额支撑件24。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 a nasal plug type respiratory mask that does not include the forehead support 24.
面罩主体21上设置有面罩通孔(未标示出)。衬垫组件22安装在面罩主体21上。面罩主体21和衬垫组件22共同形成空腔。衬垫组件22可以固定地连接或可拆卸地连接到面罩主体21。衬垫组件22也可以单独形成该空腔,在此实施例中面罩主体21可以在衬垫组件22的外部支撑衬垫组件22。在使用时,面罩主体21和衬垫组件22将与患者的脸部(包括脸颊、鼻梁、嘴巴上下部等)接触,形成密封,以使该空腔与患者的鼻腔或者口鼻腔连通。面罩主体21可以由刚性材料制成,也可以由柔性材料制成。衬垫组件22优选地由柔性材料制成。衬垫组件22可以是气囊,也可以是膜结构。膜结构可以是单层或分离的双层。衬垫组件22也可包括粘合件(例如不干胶等),以提升病人感受和密封效果。面罩主体21和衬垫组件22的从正面看的形状不限于图中所示的大体三角形,还可以 为梨形、梯形等等。面罩主体21和衬垫组件22还可以采用与口鼻部形状相适配的形状等等。在鼻塞型呼吸面罩中,衬垫组件22也可以设计成与鼻孔口密封的锥形膜形状的鼻塞,此结构同样可具有单层或分离的双层膜结构。在口鼻型呼吸面罩中,还可以将鼻塞与口部罩型设计相结合。衬垫组件22包括支撑部分23。支撑部分23可设计成皱褶、波纹管、局部减薄、弯折、弧形等结构,以实现此呼吸面罩20与脸部更好的贴合,甚至实现衬垫组件22的软垫部分与面罩主体21间悬浮,从而可自适应衬垫与脸部的贴合角度,并利用腔内气体压力辅助密封。作为一个实例,支撑部分23采用气囊或凝胶,可具有自适应脸型的功能。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 triangle shown in the drawing, and It is pear shape, trapezoidal, etc. 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.
此外,该呼吸面罩20还包含用于连接固定组件的固定件,例如卡扣、绑带环等。固定件可以作为单独零件连接于面罩主体21上,也可与面罩主体21一体形成。固定组件用于把呼吸面罩20固定在患者面部的适当位置,可以是现有的各种头带。头带上可以有与面罩主体21连接的结构,比如扣、带魔术贴的绑带。头带的材料可以采用编织物、弹性体等(其中弹性体可以是泡沫、硅胶等),也可以采用编织物和弹性体复合的多层结构,以提高其弹性、透气性及人体顺应性。头带的形状可做成Y字形、工字形等各种形态,同时可加入某些方向相对刚性而另外某些方向柔性的零件,以更好固定该呼吸面罩20。固定组件也可以是直接固定于脸部、鼻子外部或鼻腔内的结构,比如可以是粘合件(例如不干胶等)的固定结构。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.).
前额支撑件24在使用时抵靠在患者的额头上。前额支撑件24与面罩主体21之间的连接可以是固定式的或可分拆式的,分拆式的实施例例如是卡接。前额支撑件24包含柔软的额头接触部。该前额支撑件24还可以具有调整装置,以调整与额头距离,保证适应不同面型。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.
上述刚性材料可以是塑料、合金等,柔性材料可以是硅胶、凝胶、泡沫、气囊、纺织品等,此材料定义也适用于后续各部分内容。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.
呼吸面罩20所包含的各个部件都可以采用本领域已知的构造,因此这里不再进一步详细描述。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.
下面将结合附图对本发明提供的通气控制装置的多个优选实施例进行详细描述。参见图2A-2B,通气控制装置200包括腔体210、阀组件(包括220和230)和热湿交换器(HME)240。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 vent control device 200 includes a cavity 210, a valve assembly (including 220 and 230), and a heat and humidity exchanger (HME) 240.
腔体210具有输气口。虽然图中示出的腔体210大体上呈圆柱形,但是在未 示出的其他实施例中,腔体210还可以具有其他任意形状,只要能够形成可以与呼吸面罩20进行通气的密封空间即可。腔体210的体积不限,以佩戴舒适为佳。腔体210可以由柔性材料或刚性材料制成。The cavity 210 has a gas delivery port. Although the cavity 210 shown in the figures is generally cylindrical, but not In other embodiments shown, the cavity 210 can have any other shape as long as it can form a sealed space that can be vented with the respiratory mask 20. 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.
输气口用于腔体210与大气之间的气体交换,包括患者的吸气和患者的呼气,均通过该输气口来完成。在图2A-2B的实施例中,腔体210上设置两个输气口,即第一输气口212A和第二输气口212B。其中,第一输气口212A用作进气口,而第二输气口212B用作出气口。在未示出的其他实施例中,输气口的数量可以为一个或更多个。在设置一个或多个输气口的情况下,也可以通过阀组件的设置使这些输气口的全部或部分既用作进气口又用作出气口。后文还将介绍设置一个和多个输气口的实施例。The gas port is used for gas exchange between the chamber 210 and the atmosphere, including the patient's inhalation and the patient's exhalation, both through the gas delivery port. In the embodiment of Figures 2A-2B, two gas delivery ports, namely a first gas delivery port 212A and a second gas delivery port 212B, are disposed on the chamber 210. Wherein, the first air outlet 212A serves as an air inlet, and the second air outlet 212B serves as a air outlet. In other embodiments not shown, the number of gas outlets may be one or more. In the case where one or more gas outlets are provided, it is also possible to make all or part of these gas outlets serve as both an air inlet and a gas port by the arrangement of the valve assembly. An embodiment of setting one or more gas outlets will also be described later.
阀组件构造为呼气时保持腔体210内的压力P1大于大气压P0。在图2A-2B的实施例中,阀组件可以包括设置在第一输气口212A处的进气阀220和设置在第二输气口212B处的排气阀230。当腔体210内的压力P1小于或等于大气压P0时,可以令进气阀220开启,气体从第一输气口212A进入腔体210内。当腔体210内的压力P1大于大气压P0时,可以令进气阀220关闭,令排气阀230在一定情况下开启。例如在腔体210内的压力P1与大气压P0之差大于预定值时令排气阀230开启,以使气体从第二输气口212B排出腔体210。这样可以保持腔体210内的压力P1大于大气压P0。此外,如图3所示,还可以将第二输气口312B的开口面积设置得较小,使气体的排出速率小于患者的呼气速率,以在呼气时形成呼气正压。阀组件320与图2中的进气阀220相同或相似。吸气时,阀组件320开启第一输气口312A,第二输气口312B还能起到辅助进气的作用。这样,可以实现吸气时无阻力或小阻力。相关病理研究成果表明,OSAHS患者在吸气时气道没有阻塞,只在呼气时有阻塞。本发明采用呼气正压来防止上呼吸道塌陷,进而对OSAHS起到治疗作用。The valve assembly is configured to maintain the chamber pressure P in the expiratory 2101 greater than atmospheric pressure P 0. In the embodiment of Figures 2A-2B, the valve assembly can include an intake valve 220 disposed at the first gas delivery port 212A and an exhaust valve 230 disposed at the second gas delivery port 212B. When the pressure P 1 in the cavity 210 is less than or equal to the atmospheric pressure P 0 , the intake valve 220 can be opened, and the gas enters the cavity 210 from the first gas delivery port 212A. When the pressure P 1 in the cavity 210 is greater than the atmospheric pressure P 0 , the intake valve 220 can be closed, and the exhaust valve 230 can be opened under certain conditions. For example, when the difference between the pressure P 1 and the atmospheric pressure P 0 in the cavity 210 is greater than a predetermined value, the exhaust valve 230 is opened to allow the gas to exit the cavity 210 from the second gas delivery port 212B. This maintains the pressure P 1 within the cavity 210 greater than the atmospheric pressure P 0 . Further, as shown in FIG. 3, the opening area of the second gas delivery port 312B may be set to be small so that the gas discharge rate is smaller than the patient's expiratory rate to form a positive expiratory pressure during exhalation. Valve assembly 320 is the same or similar to intake valve 220 in FIG. When inhaling, the valve assembly 320 opens the first gas delivery port 312A, and the second gas delivery port 312B also functions to assist the intake air. In this way, it is possible to achieve no resistance or small resistance when inhaling. 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.
在一个实施例中,进气阀220包括由弹性材料或形态记忆材料制成的阀瓣。阀瓣在腔体210内连接在第一输气口212A处,例如直接连接在腔体210的壁上或者通过中间部件(例如图2中的连接件221)连接到腔体210上。进气阀220可以单向开启,即当腔体210内的压力P1小于或等于大气压P0时,进气阀220向腔体210内侧开启,空气通过第一输气口212A进入腔体210内。当然,进气阀还可以具有其他设置方式,只要能够在腔体210内的压力P1小于或等于大气压 P0时开启第一输气口212A即可。进气阀220与第一输气口212A之间的密封可以采用多种形式的设计,进气阀220与第一输气口212A之间的密封配合包括线和平面配合、平面和平面配合、线和圆柱面配合、圆柱面和圆柱面配合、线和球面配合、球面和球面配合、线和圆锥面配合、圆锥面和圆锥面配合等等形状。密封配合部分的材质可为刚性、柔性的灵活组合。上述密封配合部分的形状和材质也可应用到下述的各种阀门中。In one embodiment, the intake valve 220 includes a valve flap made of an elastomeric material or a morphological memory material. The valve flap is coupled within the cavity 210 at the first gas delivery port 212A, such as directly to the wall of the cavity 210 or to the cavity 210 by an intermediate member (e.g., connector 221 in FIG. 2). The intake valve 220 can be opened in one direction, that is, when the pressure P 1 in the cavity 210 is less than or equal to the atmospheric pressure P 0 , the intake valve 220 is opened to the inside of the cavity 210, and the air enters the cavity 210 through the first gas delivery port 212A. Inside. Of course, the intake valve may have other arrangements as long as the first air port 212A 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 first gas delivery port 212A can take various forms of design, and the sealing fit between the intake valve 220 and the first gas delivery port 212A includes line and plane fit, planar and planar fit, Line and cylindrical face fit, cylindrical and cylindrical fit, line and spherical fit, spherical and spherical fit, line and conical fit, conical and conical fit, etc. The material of the sealing mating part can be a flexible combination of rigidity and flexibility. The shape and material of the above-mentioned seal fitting portion can also be applied to various valves as described below.
在一个实施例中,排气阀230还可以包括排气阀座231、排气阀芯232和排气阀偏置构件233。排气阀座231连接至第二输气口212B,且排气阀座231上设置有出气口234。排气阀芯232在其关闭位置和其开启位置之间可移动地设置在排气阀座231内。所述移动包括平移和旋转。图2B示出了平移移动的实施例。排气阀芯232在其关闭位置时能够关闭第二输气口212B,且在其开启位置时能够使第二输气口212B与出气口234流体连通,以形成排气通道。排气阀偏置构件233逆着排气方向对排气阀芯232施加偏置力,也就是说,当呼气时,需要克服排气阀偏置构件233产生的阻力使排气阀芯232从其关闭位置移动到其开启位置,才能够使呼出的气体排出。排气阀偏置构件233可以设置在排气阀芯232的背离腔体210的一侧,并在排气阀芯232处于关闭位置时就对其施加压力。呼气时需要克服该压力使排气阀芯232移动到关闭位置。在该移动过程中,排气阀偏置构件233施加的压力增大。在未示出的其他实施例中,排气阀偏置构件可以设置在排气阀芯232的面向腔体210的一侧,并在排气阀芯232处于关闭位置时对就其施加拉力。呼气时需要克服该拉力使排气阀芯232移动到关闭位置。在该移动过程中,排气阀偏置构件233施加的拉力增大。排气阀偏置构件233可以为弹簧或其他弹性体等,还可以由形态记忆材料制成,形态记忆材料例如是具有形态记忆性能的合金或塑料等。此外,排气阀230也可以采用类似于进气阀220的结构。In one embodiment, the exhaust valve 230 may also include 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 second air inlet 212B, and the air outlet 234 is disposed on the exhaust valve seat 231. The exhaust spool 232 is movably disposed within the exhaust valve seat 231 between its closed position and its open position. The movement includes translation and rotation. Figure 2B illustrates an embodiment of a translational movement. The exhaust spool 232 can close the second air port 212B when in its closed position and can have the second air port 212B in fluid communication with the air outlet 234 in its open position to form an exhaust passage. The exhaust valve biasing member 233 applies a biasing force to the exhaust valve spool 232 against the exhaust direction, that is, when exhaling, the exhaust valve spool 232 needs to be overcome against the resistance generated by the exhaust valve biasing member 233. The exhaled gas can be expelled by moving from its closed position to its open position. 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 closed 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. This pull force needs to be overcome during exhalation to move the exhaust spool 232 to the closed 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. Further, the exhaust valve 230 may also adopt a structure similar to the intake valve 220.
热湿交换器240用于对吸入的气体进行温化和湿化,以减少呼吸道失水。热湿交换器240为被动湿化型,即当气体呼出时,将呼出气体内的水分和热量保留下来,以对吸入气体进行加热湿化,使水分和热量被循环利用。这种类型的热湿交换器240结构小巧、使用简便、成本较低,因此可以做成一次性消耗品,没有滋生细菌的危险和清洗消毒的麻烦;也没有电和热的危险,可在一定程度上避免湿化不足或湿化过度。热湿交换器240或腔体210上设置有用于与呼吸面罩20通气的面罩通气口241。热湿交换器240与腔体210连通,以使呼气和吸气都经 由该热湿交换器240。在图2A-2B所示的实施例中,面罩通气口241设置在热湿交换器240上。面罩通气口241用于与呼吸面罩20通气。面罩通气口241例如连接至呼吸面罩20的面罩通孔。在其他实施例中,可以在面罩通气口241处设置连接结构242。该连接结构242用于将通气控制装置200可拆卸地连接至呼吸面罩20。连接结构242例如可以为卡扣连接结构、螺纹连接结构或弹性体抱紧连接结构等。这样,可以随时更换通气控制装置200,并且可以将该通气控制装置200设计成可以直接应用于现有的CPAP呼吸面罩,以降低患者的使用成本。另外,腔体210还包括接口211。热湿交换器240在该接口211处可拆卸地连接至腔体210,以使得热湿交换器240与接口211通气。热湿交换器240上可以设置与接口211相匹配的接口243,使热湿交换器240和腔体210可拆卸地连接。接口211与接口243的连接方式可以采用多种形式的,例如包括锥形轴孔压紧固定形式、卡扣形式、螺纹连接形式或弹性体抱紧形式等。热湿交换器240和腔体210也可以制作成一体不可拆分的。在后文的实施例中,还将介绍面罩通气口设置在腔体210上的实施例。The heat and humidity exchanger 240 is used to warm and humidify the inhaled gas to reduce loss of air in the respiratory tract. The heat and humidity exchanger 240 is of a passive humidification type, that is, when the gas is exhaled, the moisture and heat in the exhaled gas are retained to heat and humidify the inhaled gas, so that the moisture and heat are recycled. This type of heat and moisture exchanger 240 is compact, easy to use, and low in cost, so it can be made into a disposable consumable, without the risk of breeding bacteria and the trouble of cleaning and disinfecting; there is no danger of electricity and heat, and it can be certain To the extent that insufficient wetting or excessive wetting is avoided. A mask vent 241 for venting the respiratory mask 20 is disposed on the heat and humidity exchanger 240 or the cavity 210. The heat and humidity exchanger 240 is in communication with the cavity 210 to allow both exhalation and inhalation. By the heat and humidity exchanger 240. In the embodiment illustrated in Figures 2A-2B, the mask vent 241 is disposed on the heat and moisture exchanger 240. The mask vent 241 is used to ventilate the breathing mask 20. The mask vent 241 is, for example, connected to the mask through hole of the respiratory mask 20. In other embodiments, a connection structure 242 can be provided at the mask vent 241. The connection structure 242 is used to detachably connect the ventilation control device 200 to the respiratory mask 20. The connecting structure 242 can be, for example, a snap connection structure, a screw 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. Additionally, the cavity 210 also includes an interface 211. The heat and moisture exchanger 240 is detachably coupled to the cavity 210 at the interface 211 to vent the heat and moisture exchanger 240 with the interface 211. An interface 243 matching the interface 211 may be disposed on the heat and humidity exchanger 240 to detachably connect the heat and moisture exchanger 240 and the cavity 210. The connection of the interface 211 and the interface 243 can take various forms, for example, including a tapered shaft hole pressing and fixing form, a snap type, a threaded connection form, or an elastic body holding form. The heat and humidity exchanger 240 and the chamber 210 can also be made integral and non-detachable. In the following embodiments, an embodiment in which the mask vent is provided on the cavity 210 will also be described.
在一个优选实施例中,热湿交换器240包括壳体、疏水膜和吸水及亲水层。疏水膜填充在壳体内。疏水膜在壳体内可以呈折叠状。吸水及亲水层附着在疏水膜的表面。疏水膜的材质可以为聚偏氟乙烯(PVDF)、聚氨酯(PUR)、聚酯(PES)、聚乳酸(PLA)、聚己酸内酯(PCL)、聚丙烯(PP)、聚酯(PES)中的一种或多种。吸水及亲水层可以由吸水材料和亲水材料制成。吸水材料可以为各种天然或改进高分子累吸水性树脂和/或人工合成吸水性树脂。亲水性材料含有亲水性基团,这些基团比如:-COOH、-SO3H、-OH、等等,这些基团有极性,可与水相吸。In a preferred embodiment, the heat and moisture exchanger 240 includes a housing, a hydrophobic membrane, and a water absorbing and hydrophilic layer. The hydrophobic film is filled in the housing. The hydrophobic membrane can be folded in the housing. The water absorbing and hydrophilic layer adheres to the surface of the hydrophobic film. The hydrophobic film may be made of polyvinylidene fluoride (PVDF), polyurethane (PUR), polyester (PES), polylactic acid (PLA), polycaprolactone (PCL), polypropylene (PP), polyester (PES). One or more of them. The water absorbing and hydrophilic layer may be made of a water absorbing material and a hydrophilic material. The water absorbing material may be various natural or improved high molecular weight water absorbing resins and/or synthetic water absorbing resins. Hydrophilic materials contain hydrophilic groups such as -COOH, -SO 3 H, -OH, etc. These groups are polar and can be absorbed by water.
在一个优选实施例中,热湿交换器240中还设置有过滤组件,用于过滤颗粒和/或微生物。作为示例,过滤组件可以包括PM2.5过滤网、PM10过滤网和/或活性炭过滤组件。PM2.5过滤网、PM10过滤网和活性炭过滤组件都可以是市场上可买到的。作为示例,过滤组件可以包括醋酸乙烯树脂粘合硼硅酸盐超细玻璃纤维,其具有抗普通细菌和病毒、炭疽杆菌、肺结核、HBV病毒和HCV病毒的特性。作为示例,过滤组件可以包括聚合物纳米纤维过滤层,其中聚合物纳米纤维过滤层还可以包括杀菌物质(例如银)。过滤组件可以设置在热湿交换器240的壳体内。 In a preferred embodiment, a filter assembly is also provided in the heat and humidity exchanger 240 for filtering particles and/or microorganisms. As an example, the filter assembly can include a PM2.5 filter, a PM10 filter, and/or an activated carbon filter assembly. PM2.5 filters, PM10 filters, and activated carbon filter assemblies are all commercially available. As an example, the filter assembly can include vinyl acetate resin bonded borosilicate ultrafine glass fibers having properties against common bacteria and viruses, Bacillus anthracis, tuberculosis, HBV virus, and HCV virus. As an example, the filter assembly can include a polymeric nanofiber filtration layer, wherein the polymeric nanofiber filtration layer can also include a sterilizing material (eg, silver). The filter assembly can be disposed within the housing of the heat and humidity exchanger 240.
在另一组实施例中,面罩通气口可以设置在腔体上。如图4所示,腔体410上设置有面罩通气口411,腔体410上还设置有输气口412。虽然图中示出的腔体410大体上呈圆柱形,但是在未示出的其他实施例中,腔体410还可以具有其他任意形状,只要能够形成可以与呼吸面罩进行通气的密封空间即可。腔体410的体积不限,以佩戴舒适为佳。腔体410可以由柔性材料或刚性材料制成。该腔体410甚至可以与呼吸面罩20的面罩主体21形成的空腔成一体,例如采用模制工艺使腔体410与面罩主体21一体成型。作为示例,腔体410与空腔可以形成为两个可以明显区分并连通的腔。作为示例,腔体410也可以做成空腔的一部分,也就是说,针对图4所示的实施例,可以利用呼吸面罩的空腔的一部分作为腔体410,将输气口412直接形成在面罩主体21上。优选地,面罩通气口411处设置有连接结构413,该连接结构413用于将通气控制装置400可拆卸地连接至呼吸面罩20。连接结构413例如可以为卡扣连接结构、螺纹连接结构或弹性体抱紧连接结构等。这样,可以随时更换通气控制装置400,并且可以将该通气控制装置400设计成可以直接应用于现有的CPAP呼吸面罩,以降低患者的使用成本。另外,热湿交换器440在输气口412处可以可拆卸地连接至阀组件420或腔体410,以使热湿交换器440与输气口412连通。作为示例,腔体410可以包括将热湿交换器440可拆卸地连接至腔体410的接口。作为示例,阀组件420上可以包括这样的接口。接口的结构可以采用锥形轴孔压紧固定、螺纹连接、插接、弹性体抱紧连接或卡扣连接等等,只要能使热湿交换器440与输气口412连通即可。热湿交换器440与腔体410或者与阀组件420也可以制作成一体不可拆分的。In another set of embodiments, the mask vent can be disposed on the cavity. As shown in FIG. 4, the cavity 410 is provided with a mask vent 411, and the cavity 410 is further provided with a gas outlet 412. Although the cavity 410 is generally cylindrical in shape, in other embodiments not shown, the cavity 410 may have any other shape as long as it can form a sealed space that can be vented with the respiratory mask. . The volume of the cavity 410 is not limited, and it is preferable to wear comfort. The cavity 410 can be made of a flexible material or a rigid material. The cavity 410 may even be integral with the cavity formed by the mask body 21 of the respiratory mask 20, such as by molding the cavity 410 integrally with the mask body 21. As an example, the cavity 410 and the cavity can be formed as two cavities that can be clearly distinguished and communicated. As an example, the cavity 410 can also be formed as part of a cavity, that is, for the embodiment shown in Figure 4, a portion of the cavity of the breathing mask can be utilized as the cavity 410, with the air inlet 412 formed directly On the mask body 21. Preferably, the mask vent 411 is provided with a connection structure 413 for detachably connecting the ventilation control device 400 to the respiratory mask 20. The connection structure 413 may be, for example, a snap connection structure, a screw connection structure, or an elastic body connection structure. In this way, the ventilation control device 400 can be replaced at any time, and the ventilation control device 400 can be designed to be directly applied to an existing CPAP breathing mask to reduce the cost of use of the patient. Additionally, the heat and moisture exchanger 440 can be detachably coupled to the valve assembly 420 or the cavity 410 at the gas delivery port 412 to allow the heat and moisture exchanger 440 to communicate with the gas delivery port 412. As an example, the cavity 410 can include an interface that removably couples the heat and moisture exchanger 440 to the cavity 410. As an example, such an interface may be included on valve assembly 420. The structure of the interface may be a compression of a tapered shaft hole, a screw connection, a plug connection, an elastic body tight connection or a snap connection, etc., as long as the heat and moisture exchanger 440 can be connected to the air inlet 412. The heat and humidity exchanger 440 and the chamber 410 or the valve assembly 420 can also be made integral and non-detachable.
对于进气阀和排气阀组合在一起的阀组件,热湿交换器440可以通过连接至腔体410或连接至阀组件420而设置在输气口412处,如图4所示。由于热湿交换器440与输气口412连通,经输气口412排出的气体中的水分和热量在经过热湿交换器440时被保留下来。呼气时,气体首先经过热湿交换器440,被保留下来的水分和热量湿化和温化后经过输气口412进入腔体410,最终到达呼吸面罩20。类似于图2A-2B所示地,热湿交换器440也可以设置在腔体420与呼吸面罩20之间。For a valve assembly in which the intake and exhaust valves are combined, the heat and moisture exchanger 440 can be disposed at the gas delivery port 412 by being coupled to the cavity 410 or to the valve assembly 420, as shown in FIG. Since the heat and humidity exchanger 440 is in communication with the gas delivery port 412, moisture and heat in the gas discharged through the gas delivery port 412 are retained as it passes through the heat and humidity exchanger 440. When exhaling, the gas first passes through the heat and humidity exchanger 440, and the retained moisture and heat are humidified and warmed, then enter the cavity 410 through the gas delivery port 412, and finally reach the respiratory mask 20. Similar to FIGS. 2A-2B, a heat and humidity exchanger 440 can also be disposed between the cavity 420 and the respiratory mask 20.
在另一个实施例中,如图5所示,可以将热湿交换器540设置在腔体510内。热湿交换器540可以可拆卸地设置在腔体510内,也可以与腔体510制作成一件式构件。面罩通气口511设置在腔体510上。优选地,阀组件520采用可拆卸的 方式连接至腔体510的输气口512。这样,在腔体510能够可拆卸地连接至呼吸面罩20的实施例中,可以定期地将腔体510拆卸下来,以便整体地清洗或更换腔体510和里面的热湿交换器540。返回参见图2A-2B以及图3,对于进气口与排气口分开设置的实施例,优选地,将热湿交换器设置在腔体与呼吸面罩之间,并且使热湿交换器可拆卸地连接至腔体和呼吸面罩;或者将热湿交换器设置在腔体内,并且使腔体可拆卸地连接至呼吸面罩和阀组件。这样可以定期地将热湿交换器拆卸下来清洗或更换。In another embodiment, as shown in FIG. 5, the heat and humidity exchanger 540 can be disposed within the cavity 510. The heat and moisture exchanger 540 can be detachably disposed within the cavity 510 or can be fabricated as a one-piece member with the cavity 510. The mask vent 511 is disposed on the cavity 510. Preferably, the valve assembly 520 is detachable The mode is connected to the air inlet 512 of the cavity 510. Thus, in embodiments where the cavity 510 can be detachably coupled to the respiratory mask 20, the cavity 510 can be periodically removed to integrally clean or replace the cavity 510 and the heat and moisture exchanger 540 therein. Referring back to Figures 2A-2B and Figure 3, for embodiments in which the inlet and outlet are separately provided, preferably the heat and humidity exchanger is disposed between the chamber and the breathing mask, and the heat and humidity exchanger is detachable Connected to the cavity and the respiratory mask; or the heat and humidity exchanger is disposed within the cavity and the cavity is removably coupled to the respiratory mask and valve assembly. This allows the heat and humidity exchanger to be removed and cleaned or replaced periodically.
下面将结合附图对阀组件和腔体的多个实施例进行详细描述。可以理解,下述的腔体和阀组件可以与上述的任一种热湿交换器相结合。A plurality of embodiments of the valve assembly and the cavity will be described in detail below with reference to the accompanying drawings. It will be appreciated that the chamber and valve assembly described below can be combined with any of the heat and humidity exchangers described above.
在一组实施例中,参见图4,阀组件420设置在输气口412处,以控制输气口412的气体流通。该阀组件420具有进气通道和排气通道。进气通道和排气通道均通过输气口412与腔体410连通。阀组件420构造为在腔体410内的压力P1小于或等于大气压P0时使进气通道导通;且在腔体410内的压力P1与大气压P0之差ΔP大于或等于预定值时使排气通道导通。也就是说,进气通道只有在腔体410内的压力P1小于或等于大气压P0时才导通,一旦腔体410内的压力P1大于大气压P0立即关断。同样地,排气通道只有在腔体410与大气压之差ΔP大于或等于预定值时才导通,一旦腔体410与大气压之差ΔP小于预定值立即关断。当患者吸气时,腔体410内的气压P1降低,低于大气压P0,进气通道导通,此时排气通道截止,对应患者的吸气相。当患者呼气时,腔体410内的气压P1增大,高于大气压P0。当腔体410内的气压P1增大到与大气压P0之差ΔP高于某一预定值时,排气通道导通,此时进气通道关断,对应患者的呼气相。In one set of embodiments, referring to FIG. 4, a valve assembly 420 is disposed at the gas delivery port 412 to control gas flow to the gas delivery port 412. The valve assembly 420 has an intake passage and an exhaust passage. Both the intake passage and the exhaust passage communicate with the cavity 410 through the gas delivery port 412. The valve assembly 420 is configured to conduct the intake passage when the pressure P 1 within the chamber 410 is less than or equal to the atmospheric pressure P 0 ; and the difference ΔP between the pressure P 1 and the atmospheric pressure P 0 within the chamber 410 is greater than or equal to a predetermined value When the exhaust passage is turned on. That is, the intake passage is only turned on when the pressure P 1 in the chamber 410 is less than or equal to the atmospheric pressure P 0 , and is immediately turned off once the pressure P 1 in the chamber 410 is greater than the atmospheric pressure P 0 . Similarly, the exhaust passage is turned on only when the difference ΔP between the chamber 410 and the atmospheric pressure is greater than or equal to a predetermined value, and is immediately turned off once the difference ΔP between the chamber 410 and the atmospheric pressure is less than a predetermined value. When the patient inhales, the air pressure P 1 in the cavity 410 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 inspiratory phase of the patient. When the patient exhales, the air pressure P 1 within the cavity 410 increases above the atmospheric pressure P 0 . When the air pressure P 1 in the cavity 410 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.
在一个实施例中,阀组件420包括第一阀机构422和第二阀机构423。如图4所示,第一阀机构422设置在输气口412处。第一阀机构422具有关闭输气口412的第一关闭位置和打开输气口412的第一开启位置。在第一阀机构422上设置有通孔422B。第二阀机构423设置在通孔422B处。第二阀机构223具有关闭通孔422B的第二关闭位置和打开通孔422B的第二开启位置。通过两个阀机构的相互配合,可以利用患者的进气气流和呼气气流自动地控制它们的开启和关闭,进而实现吸气无阻力或小阻力和呼气正压。In one embodiment, the valve assembly 420 includes a first valve mechanism 422 and a second valve mechanism 423. As shown in FIG. 4, the first valve mechanism 422 is disposed at the air delivery port 412. The first valve mechanism 422 has a first closed position that closes the air inlet 412 and a first open position that opens the air inlet 412. A through hole 422B is provided in the first valve mechanism 422. The second valve mechanism 423 is disposed at the through hole 422B. The second valve mechanism 223 has a second closed position that closes the through hole 422B and a second open position that opens the through hole 422B. 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.
在一个实施例中,一方面,第一阀机构422和第二阀机构423可以相互协作,在原始位置和通气位置之间可移动。原始位置是指未由于呼吸作用对第一阀机构 422和第二阀机构423施加外力的状态。此时第一阀机构422和第二阀机构423均处于各自的关闭位置。第一阀机构422和第二阀机构423处于该原始位置时,输气口412关闭。腔体410内的压力P1与大气压P0之差ΔP大于或等于该预定值时,第二阀机构423跟随第一阀机构422一起移动,移动至通气位置(向右移动)。此时第一阀机构422处于第一开启位置,而第二阀机构423处于第二关闭位置。输气口412开启,形成排气通道。在该实施例中,第二阀机构423可以设置在第一阀机构222上。这样,呼气时,腔体410内的压力P1不断增大。当腔体410内的压力P1与大气压P0之差ΔP小于预定值时,第一阀机构422和第二阀机构423始终处于原始位置,输气口412关闭。一旦腔体410内的压力P1与大气压P0之差ΔP大于或等于该预定值,第二阀机构423跟随第一阀机构422移动至通气位置,以形成排气通道,并且还能够在腔体410内保持正压。In one embodiment, in one aspect, the first valve mechanism 422 and the second valve mechanism 423 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 422 and the second valve mechanism 423 due to respiration. At this time, both the first valve mechanism 422 and the second valve mechanism 423 are in their respective closed positions. When the first valve mechanism 422 and the second valve mechanism 423 are in the home position, the air inlet 412 is closed. When the difference ΔP between the pressure P 1 and the atmospheric pressure P 0 in the cavity 410 is greater than or equal to the predetermined value, the second valve mechanism 423 moves along with the first valve mechanism 422 and moves to the aeration position (moving to the right). The first valve mechanism 422 is now in the first open position and the second valve mechanism 423 is in the second closed position. The gas delivery port 412 is opened to form an exhaust passage. In this embodiment, the second valve mechanism 423 can be disposed on the first valve mechanism 222. Thus, when exhaling, the pressure P 1 in the cavity 410 is continuously increased. When the difference ΔP between the pressure P 1 and the atmospheric pressure P 0 in the cavity 410 is less than a predetermined value, the first valve mechanism 422 and the second valve mechanism 423 are always in the home position, and the gas delivery port 412 is closed. Once the difference ΔP between the pressure P 1 and the atmospheric pressure P 0 in the cavity 410 is greater than or equal to the predetermined value, the second valve mechanism 423 follows the first valve mechanism 422 to move to the venting position to form an exhaust passage, and is also capable of A positive pressure is maintained within the body 410.
另一方面,第二阀机构423自身的开启和关闭动作能够在患者吸气时形成进气通道。具体地,吸气时,腔体410内的压力P1不断减小。第一阀机构422处于关闭输气口412的第一关闭位置。当腔体410内的压力P1小于或等于大气压P0时,第二阀机构423开启通孔422B,以形成进气通道。吸气转为呼气时,腔体410内的压力P1增大,当压力P1大于大气压P0,第二阀机构423就会关闭通孔422B并重复上述过程。由于吸气时腔体410内的压力P1与大气压P0之差ΔP达不到上述预定值,因此第一阀机构422保持在原始位置。第一阀机构422和第二阀机构423有多种实施方式,本发明将结合附图对一些优选实施方式进行描述。热湿交换器440连接至阀组件420,并与输气口连通。如上所述地,热湿交换器440也可以设置在腔体410内、或者设置在腔体410与呼吸面罩20之间。On the other hand, the opening and closing action of the second valve mechanism 423 itself can form an intake passage when the patient inhales. Specifically, at the time of inhalation, the pressure P 1 in the cavity 410 is continuously reduced. The first valve mechanism 422 is in a first closed position that closes the air inlet 412. When the pressure P 1 in the cavity 410 is less than or equal to the atmospheric pressure P 0 , the second valve mechanism 423 opens the through hole 422B to form an intake passage. When the inhalation is switched to exhalation, the pressure P 1 in the chamber 410 is increased. When the pressure P 1 is greater than the atmospheric pressure P 0 , the second valve mechanism 423 closes the through hole 422B and repeats the above process. Since the difference ΔP between the pressure P 1 and the atmospheric pressure P 0 in the cavity 410 at the time of inhalation does not reach the above predetermined value, the first valve mechanism 422 is maintained at the original position. The first valve mechanism 422 and the second valve mechanism 423 have various embodiments, and the present invention will be described with reference to the accompanying drawings. Heat and humidity exchanger 440 is coupled to valve assembly 420 and is in communication with the gas delivery port. As noted above, the heat and humidity exchanger 440 can also be disposed within the cavity 410 or between the cavity 410 and the respiratory mask 20.
阀组件420还可以包括阀座421。阀座421连接在输气口412处。热湿交换器440可以连接至阀组件420的阀座421。第一阀机构422和第二阀机构423可以均设置在阀座421内。阀座421上设置有出气口421A。热湿交换器440通过该出气口421A与输气口412连通。出气口421A可以设置在阀座421的远端,也可以设置在阀座421的侧壁上。本文所述的近端和远端是相对于佩戴该呼吸面罩的患者而言的,靠近患者的一端称为近端,反之称为远端。 Valve assembly 420 can also include a valve seat 421. The valve seat 421 is connected to the air inlet 412. The heat and humidity exchanger 440 can be coupled to the valve seat 421 of the valve assembly 420. The first valve mechanism 422 and the second valve mechanism 423 may both be disposed within the valve seat 421. An air outlet 421A is provided on the valve seat 421. The heat and humidity exchanger 440 communicates with the gas delivery port 412 through the gas outlet 421A. The air outlet 421A may be disposed at the distal end of the valve seat 421 or may be disposed on the side wall of the valve seat 421. 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.
在图4所示的实施例中,第一阀机构422可以包括第一阀芯422A和第一偏置构件422C。第一阀芯422A能够在第一关闭位置和第一开启位置之间移动。通孔422B设置在第一阀芯422A上。第二阀机构423在通孔422B处设置在第一阀 芯422A上。呼气时腔体410内的压力P1增大,当增大到P0+ΔP时,使得本来关闭输气口412的第一阀芯422A和第二阀机构423一起向右移动,输气口412打开,输气口412与出气口421A连通,形成排气通道。压力差ΔP可以由第一偏置构件422C来提供。第一偏置构件422C抵顶在第一阀芯422A上,以给第一阀芯422A提供从第一关闭位置到第一开启位置的移动阻力。第一偏置构件422C在图中所示的原始位置就对第一阀芯422A施加移动阻力,以形成呼气正压。第二阀机构423可以是单向阀。第二阀机构423可以包括由弹性材料或形态记忆材料制成的阀瓣。作为示例,阀瓣从靠近腔体410的一侧连接至第一阀机构422。可以理解的是,第一阀机构422也可以采用类似于与第二阀机构423的单向阀结构。具体地,第一阀机构422可以包括由弹性材料或形态记忆材料制成的阀瓣,该阀瓣在背离腔体410的一侧连接至腔体410。同样地,第二阀机构423也可以采用与上述第一阀机构422类似的构造,即包括阀芯和偏置构件,后文还将参照图7对具有这种结构的第二阀机构进行详细描述。In the embodiment shown in FIG. 4, the first valve mechanism 422 can include a first spool 422A and a first biasing member 422C. The first spool 422A is moveable between a first closed position and a first open position. The through hole 422B is provided on the first valve body 422A. The second valve mechanism 423 is disposed on the first valve body 422A at the through hole 422B. The pressure P 1 in the cavity 410 increases during exhalation, and when increased to P 0 + ΔP, the first valve body 422A and the second valve mechanism 423, which originally close the gas delivery port 412, are moved to the right together, and the gas is delivered. The port 412 is opened, and the air inlet 412 communicates with the air outlet 421A to form an exhaust passage. The pressure difference ΔP may be provided by the first biasing member 422C. The first biasing member 422C abuts against the first spool 422A to provide the first spool 422A with movement resistance from the first closed position to the first open position. The first biasing member 422C applies a moving resistance to the first spool 422A at the original position shown in the drawing to form a positive expiratory pressure. The second valve mechanism 423 can be a one-way valve. The second valve mechanism 423 can include a valve flap made of an elastomeric material or a morphological memory material. As an example, the valve flap is coupled to the first valve mechanism 422 from a side proximate the cavity 410. It will be appreciated that the first valve mechanism 422 may also employ a one-way valve configuration similar to the second valve mechanism 423. In particular, the first valve mechanism 422 can include a valve flap made of an elastomeric material or a morphological memory material that is coupled to the cavity 410 on a side facing away from the cavity 410. Similarly, the second valve mechanism 423 can also adopt a configuration similar to that of the first valve mechanism 422 described above, that is, including a spool and a biasing member, and the second valve mechanism having such a structure will be described later with reference to FIG. description.
在一个优选实施例中,阀组件还可以包括调节机构,用于调节上述预定值。作为示例,如图4所示,阀座421可以包括固定件421B和可移动件421C。可移动件421C可移动地连接至固定件421B,并通过定位结构相对于固定件421B定位可移动件421C的位置。定位结构可以是设置在固定件421B和可移动件421C上的相互匹配的螺纹。在未示出的其他实施例中,定位结构可以包括卡扣、固定销等等。第一偏置构件422C的一端可以连接或抵靠至第一阀芯422A,而另一端可以连接或抵靠至可移动件421C。这样通过调节可移动件421C相对于固定件421B的位置,就能够调节第一偏置构件422C的偏置力,进而调节预定值。另外,还可以将可移动件421C移除,通过更换提供不同偏置力的第一偏置构件422C来调节预定值。另外,需要说明的是,当存在可移动件421C的情况下,出气口421A可以设置在可移动件421C上。热湿交换器440连通至出气口421A。In a preferred embodiment, the valve assembly may further include an adjustment mechanism for adjusting the predetermined value. As an example, as shown in FIG. 4, the valve seat 421 may include a fixing member 421B and a movable member 421C. The movable member 421C is movably coupled to the fixing member 421B, and positions the movable member 421C with respect to the fixing member 421B by the positioning structure. The positioning structure may be a mating thread disposed on the fixing member 421B and the movable member 421C. In other embodiments not shown, the positioning structure can include snaps, securing pins, and the like. One end of the first biasing member 422C may be coupled to or abutted to the first spool 422A, and the other end may be coupled or abutted to the movable member 421C. Thus, by adjusting the position of the movable member 421C with respect to the fixed member 421B, the biasing force of the first biasing member 422C can be adjusted, thereby adjusting the predetermined value. In addition, the movable member 421C can also be removed, and the predetermined value can be adjusted by replacing the first biasing member 422C that provides a different biasing force. In addition, it should be noted that, in the case where the movable member 421C is present, the air outlet 421A may be disposed on the movable member 421C. The heat and humidity exchanger 440 is connected to the gas outlet 421A.
类似地,上述调节机构也可以增加到图2A-2B、图5所示的实施例以及下述可能的实施例中。其原理与图4大致相同,这里不再详细描述。在未示出的其他实施例中,还可以采用其他方式来调节所述预定值。Similarly, the above adjustment mechanism can also be added to the embodiment shown in Figures 2A-2B, Figure 5 and the following possible embodiments. The principle is substantially the same as that of FIG. 4 and will not be described in detail herein. In other embodiments not shown, other methods may be employed to adjust the predetermined value.
进一步优选地,通气控制装置上设置有指示构件(未示出),用于指示调节后的预定值。该指示构件可以是机械标识,例如刻度、颜色标识等。作为示例,机械标识可以设置在排气阀座331上。排气阀盖350调节到不同的位置会露出不 同的刻度或颜色,以指示调节后的第一预定值。Further preferably, the ventilation control device is provided with an indication 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 identification can be provided on the exhaust valve seat 331. The exhaust valve cover 350 is adjusted to different positions and will be exposed. The same scale or color to indicate the adjusted first predetermined value.
在另一实施例中,如图6所示,阀组件620可以包括第一阀机构621和第二阀机构622。第一阀机构621设置在腔体610的输气口612处,且第一阀机构621具有关闭输气口612的第一关闭位置和打开输气口612的第一开启位置。第一阀机构621上设置有通孔623。第二阀机构622设置在通孔623处。第二阀机构622具有关闭通孔623的第二关闭位置和打开通孔623的第二开启位置。一方面,第一阀机构621和第二阀机构622相互协作,在原始位置和通气位置之间可移动。第一阀机构621和第二阀机构622处于该原始位置时,输气口612关闭。当腔体610内的压力P1小于或等于大气压P0时,第一阀机构621和第二阀机构622一起移动至通气位置,输气口612开启,形成进气通道。第二阀机构622可以设置在第一阀机构621上。在图6所示的实施例中,当腔体610内的压力P1小于或等于大气压P0时,第一阀机构621和第二阀机构622向左移动,第一阀机构621与输气口612之间产生缝隙,输气口612开启,以形成进气通道,对应患者的吸气相。另一方面,第二阀机构622自身的开启和关闭还能够在患者呼气时形成排气通道。当腔体610内的压力P1大于大气压P0,第一阀机构621处于关闭输气口612的第一关闭位置。作为示例,第一阀机构621可以设置在腔体610的内部。这样,当腔体610内的压力P1大于大气压P0,输气口611的边缘壁可以限制第一阀机构621向右移动,使第一阀机构621保持在原始位置。第一阀机构621也可以通过其他部件在腔体610内的压力P1大于大气压P0时限制其处于第一关闭位置。当患者由吸气相转为呼气相后,腔体610内的压力P1逐渐增大,由于腔体610内的压力P1大于大气压P0,因此第一阀机构621保持在其第一关闭位置。而当腔体610内的压力P1增大到与大气压P0之差ΔP大于或等于该预定值时,第二阀机构622开启通孔623,以形成排气通道。当腔体610内的压力P1与大气压P0之差ΔP小于该预定值时,第二阀机构622则处于关闭通孔623的状态。热湿交换器可以连接在腔体610与呼吸面罩之间,也可以在输气口612处连接至腔体610,例如连接在腔体610的延伸壁613上。In another embodiment, as shown in FIG. 6, 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 612 of the cavity 610, and the first valve mechanism 621 has a first closed position that closes the air inlet 612 and a first open position that opens the air inlet 612. 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 612 is closed. When the pressure P in the chamber is less than or equal to 610 atmospheric pressure P 0, moving the first valve and the second valve mechanism 621 to the breather mechanism 622 together with the position, gas port 612 open, 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 and the second valve mechanism 622 is moved leftward, the first valve 621 and the gas delivery mechanism A gap is created between the ports 612, and the gas delivery port 612 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 in the chamber 610 is greater than the atmospheric pressure P 0, the first valve mechanism 621 is in a closed gas delivery port 612 of the first closed position. As an example, the first valve mechanism 621 can be disposed inside the cavity 610. Thus, when the pressure P 1 in the cavity 610 is greater than the atmospheric pressure P 0 , the edge wall of the gas delivery port 611 can restrict the first valve mechanism 621 from moving to the right, keeping the first valve mechanism 621 in the home 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 smaller than the predetermined value, the second valve mechanism 622 is in a state in which the through hole 623 is closed. The heat and humidity exchanger may be coupled between the cavity 610 and the respiratory mask, or may be coupled to the cavity 610 at the gas delivery port 612, such as to the extension wall 613 of the cavity 610.
在又一实施例中,参见图7A,阀组件720包括阀座721、第一阀机构722和第二阀机构723。第一阀机构722上设置有通孔722B。第一阀机构722和第二阀机构723分别能够在各自的开启位置和关闭位置之间移动。第一阀机构722主要设置在阀座721内,而第二阀机构723主要设置在腔体内。第一阀机构722和第 二阀机构723均通过偏置构件来控制。第一阀机构722可以包括第一阀芯722A和第一偏置构件722C。通孔722B设置在第一阀芯722A上。第一偏置构件722C抵顶在第一阀芯722A上,以给第一阀芯722A提供从第一关闭位置到第一开启位置的移动阻力。第二阀机构723可以包括第二阀芯723A和第二偏置构件723B。第二阀芯723A具有关闭第一阀芯722A上的通孔722B的第二关闭位置和打开通孔722B的第二开启位置。第二偏置构件723B抵顶在第二阀芯723A上以给第二阀芯723A提供从第二关闭位置到第二开启位置的移动阻力。第二偏置构件723B可以设置在第二阀芯723A的面向腔体710的一侧,并在第二阀芯723A从其关闭位置向其开启位置移动(即向左)时对其施加压力。在未示出的其他实施例中,第二偏置构件可以设置在第二阀芯的背离腔体710的一侧,并在第二阀芯723A从其关闭位置向其开启位置移动(即向左)时对其施加拉力。第一偏置构件722C和第二偏置构件723B可以为弹簧或其他弹性体等,还可以为形态记忆材料,比如具有形态记忆性能的合金或塑料等。在该实施例中,呼气时,第二阀芯723A和第一阀芯722A一起向右移动,即朝向它们的通气位置移动。此时呼气产生的内外气压差ΔP要克服第一偏置构件722C和第二偏置构件723B产生的移动阻力的合力。由于第二偏置构件723B产生的偏置力仅用于实现腔体710内的压力P1等于或以小于大气压P0就开启,因此第二偏置构件723B产生的第二偏置力设置得较小,第二偏置力小于第一偏置构件722C产生的第一偏置力。热湿交换器可以连接在腔体710与呼吸面罩之间,也可以在输气口712处连接至腔体710或连接至阀组件720。In yet another embodiment, referring to FIG. 7A, the valve assembly 720 includes a valve seat 721, a first valve mechanism 722, and a second valve mechanism 723. The first valve mechanism 722 is provided with a through hole 722B. The first valve mechanism 722 and the second valve mechanism 723 are each movable between respective open and closed positions. The first valve mechanism 722 is primarily disposed within the valve seat 721, and the second valve mechanism 723 is disposed primarily within the cavity. Both the first valve mechanism 722 and the second valve mechanism 723 are controlled by a biasing member. The first valve mechanism 722 can include a first spool 722A and a first biasing member 722C. The through hole 722B is provided on the first spool 722A. The first biasing member 722C abuts against the first spool 722A to provide the first spool 722A with movement resistance from the first closed position to the first open position. The second valve mechanism 723 can include a second spool 723A and a second biasing member 723B. The second spool 723A has a second closed position that closes the through hole 722B on the first spool 722A and a second open position that opens the through hole 722B. The second biasing member 723B abuts against the second spool 723A to provide the second spool 723A with movement resistance from the second closed position to the second open position. The second biasing member 723B may be disposed on a side of the second spool 723A facing the cavity 710 and apply pressure to the second spool 723A as it moves from its closed position to its open position (ie, to the left). In other embodiments not shown, the second biasing member may be disposed on a side of the second spool that faces away from the cavity 710 and move from the closed position of the second spool 723A to its open position (ie, Left) applies a pulling force to it. The first biasing member 722C and the second biasing member 723B may be springs or other elastomers, etc., and may also be morphological memory materials such as alloys or plastics having morphological memory properties. In this embodiment, when exhaling, the second spool 723A and the first spool 722A move together to the right, i.e., toward their venting position. 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 722C and the second biasing member 723B. Since the biasing force generated by the second biasing member 723B is only used to achieve that the pressure P 1 in the cavity 710 is equal to or less than the atmospheric pressure P 0 , the second biasing force generated by the second biasing member 723B is set. Smaller, the second biasing force is less than the first biasing force generated by the first biasing member 722C. The heat and humidity exchanger can be coupled between the cavity 710 and the breathing mask, or can be coupled to the cavity 710 or to the valve assembly 720 at the gas delivery port 712.
在上述实施例中,第一阀机构722和第二阀机构723与输气口712之间的密封可以由两者之一来实现,或者由它们共同实现。例如,可以在第一阀机构722和第二阀机构723中的至少一个上设置密封圈或密封垫等。如图7A所示,可以在第一阀机构722的第一阀芯722A上设置密封件。如图7B所示,可以在第二阀机构723的第二阀芯723A上设置密封件723C。另外,还可以在第一阀芯722A和第二阀芯723A上都设置密封件。在上述实施例的基础上,可以在阀座721上设置有限位件(未示出),例如挡块、凸起等。限位件用于限制第一阀芯722A仅在原始位置和通气位置之间移动,以避免患者呼气时第一阀芯722A的剧烈震动导致噪音过大。In the above embodiment, the seal between the first valve mechanism 722 and the second valve mechanism 723 and the gas delivery port 712 may 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 722 and the second valve mechanism 723. As shown in FIG. 7A, a seal may be provided on the first spool 722A of the first valve mechanism 722. As shown in FIG. 7B, a seal 723C may be provided on the second valve body 723A of the second valve mechanism 723. In addition, a seal may be provided on both the first valve body 722A and the second valve body 723A. On the basis of the above embodiment, a limiting member (not shown) such as a stopper, a projection or the like may be provided on the valve seat 721. The limiting member is used to limit the movement of the first spool 722A only between the home position and the venting position to avoid excessive vibration caused by severe vibration of the first spool 722A when the patient exhales.
此外,还可以在阀组件中增加调节机构,用于调节使排气通道开启的气压差, 即调节上述预定值。类似于图4所示的实施例,阀座721可以包括固定件721B和可移动件721C,参见图7A。第一偏置构件722C的一端连接或抵靠第一阀芯722A且另一端连接或抵靠可移动件721C。可移动件721C可移动地连接至固定件721B,以调节第一偏置构件722C的第一偏置力。此外,该调节机构还包括定位结构,其用于相对于固定件721B定位可移动件721C的位置。或者,可以通过更换不同的第一偏置构件722C来提供不同的偏置力,进而调节上述预定值。In addition, an adjustment mechanism can be added to the valve assembly for adjusting the air pressure difference that causes the exhaust passage to open. That is, the above predetermined value is adjusted. Similar to the embodiment shown in FIG. 4, the valve seat 721 may include a fixing member 721B and a movable member 721C, see FIG. 7A. One end of the first biasing member 722C is coupled to or abuts against the first spool 722A and the other end is coupled to or abuts against the movable member 721C. The movable member 721C is movably coupled to the fixing member 721B to adjust the first biasing force of the first biasing member 722C. Further, the adjustment mechanism further includes a positioning structure for positioning the movable member 721C with respect to the fixing member 721B. Alternatively, different predetermined biasing forces may be provided by replacing the different first biasing members 722C to adjust the predetermined value.
在再一实施例中,返回参见图3,阀组件320可以与输气口配合形成进气口和排气口。阀组件320构造为在腔体310内的压力P1小于或等于大气压P0时(也就是患者吸气时),使进气口与面罩通气口连通,且在腔体310内的压力P1大于大气压P0时(也就是患者呼气时),使排气口与面罩通气口连通。在图3的实施例中,输气口包括间隔设置的第一输气口312A和第二输气口312B。阀组件320仅设置在第一输气口312A处,用于控制第一输气口312A的气体流通。当腔体310内的压力P1小于或等于大气压P0时,可以令阀组件320开启。第一输气口312A和第二输气口312B形成进气口。气体从第一输气口312A和第二输气口312B进入腔体310内。当腔体310内的压力P1大于大气压P0时,可以令阀组件320关闭。第二输气口312B形成排气口,气体仅从第二输气口312B排出腔体310。这样来控制进气口和排气口具有不同的横截面积。进气口的横截面积S1大于排气口的横截面积S2。排气口的横截面积S2设置为呼气时保持腔体310内的压力P1大于大气压P0,例如可以将第二输气口312B的开口面积设置得较小,使气体的排出速率小于患者的呼气速率。吸气时,第二输气口312B还能起到辅助进气的作用。在此实施例中,热湿交换器优选地连接在腔体310与呼吸面罩之间。In still another embodiment, referring back to FIG. 3, the valve assembly 320 can cooperate with the air delivery port to form an air inlet and an air outlet. The valve assembly 320 is configured as a pressure within the cavity 310 is less than or equal to P 1 of the atmospheric pressure P 0 time (i.e. the patient inhales), the intake port in communication with the mask vent and the pressure within the cavity 310 P 1 of When the pressure is greater than the atmospheric pressure P 0 (that is, when the patient exhales), the exhaust port is connected to the mask vent. In the embodiment of FIG. 3, the gas delivery port includes a first gas delivery port 312A and a second gas delivery port 312B that are spaced apart. The valve assembly 320 is disposed only at the first gas delivery port 312A for controlling the gas flow of the first gas delivery port 312A. When the pressure P in the chamber is less than or equal to the atmospheric pressure 3101 P 0, so that the valve assembly 320 can be opened. The first gas delivery port 312A and the second gas delivery port 312B form an air inlet. Gas enters the cavity 310 from the first gas delivery port 312A and the second gas delivery port 312B. When the pressure P in the chamber 310 is greater than the atmospheric pressure P 0, so that the valve assembly 320 may be closed. The second gas delivery port 312B forms an exhaust port, and the gas is discharged from the cavity 310 only from the second gas delivery port 312B. This controls the inlet and outlet ports to have different cross-sectional areas. The cross-sectional area S 1 of the intake port is larger than the cross-sectional area S 2 of the exhaust port. The cross-sectional area S 2 of the exhaust port is set to maintain the pressure P 1 in the cavity 310 greater than the atmospheric pressure P 0 when exhaling, for example, the opening area of the second gas delivery port 312B can be set smaller to make the gas discharge rate Less than the patient's expiratory rate. When inhaling, the second air inlet 312B can also function as an auxiliary air intake. In this embodiment, the heat and moisture exchanger is preferably coupled between the cavity 310 and the respiratory mask.
本发明还提供一种呼吸面罩设备。该呼吸面罩设备包括上文所述的任一种呼吸面罩以及上文所述的任一种通气控制装置。通气控制装置连接至呼吸面罩,并通过面罩通气口与呼吸面罩通气。对于它们所包含的各个部件、结构可以参照上文相应部分的描述。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.
本发明提供的通气控制装置实现了呼气相的正压功能,避免持续正压引起的患者不适;使用时无需连接正压气体供给装置(例如CPAP呼吸机)及管路等,从而方便患者移动;外出时无需携带正压气体供给装置,患者可以随时佩戴具有该通气控制装置的呼吸面罩进行治疗。该通气控制装置还增加了热湿交换器,利用呼出气体内的水分和热量对吸入气体进行加热湿化,使水分和热量被循环利用, 避免温化和湿化不足带来的呼吸道内粘液纤毛运转系统变慢、分泌物聚集、分泌物变粘稠、细菌定植的危险,提高肺顺应性和病人舒适度。此外,这种类型的热湿交换器结构小巧、使用简便、成本较低,因此可以做成一次性消耗品,没有滋生细菌的危险和清洗消毒的麻烦;也没有电和热的危险,可在一定程度上避免湿化不足或湿化过度。The ventilation control device provided by the invention realizes the positive pressure function of the expiratory phase, avoids the patient discomfort caused by the continuous positive pressure; and does not need to be connected with the positive pressure gas supply device (such as a CPAP ventilator) and the pipeline, so as to facilitate the patient to move. There is no need to carry a positive pressure gas supply device when going out, and the patient can wear a breathing mask with the ventilation control device for treatment at any time. The ventilating control device also adds a heat and humidity exchanger to heat and humidify the suction gas by using moisture and heat in the exhaled gas, so that moisture and heat are recycled. Avoid the insufficiency of warming and humidification, the mucus cilia running system in the respiratory tract slows down, the secretions accumulate, the secretion becomes thick, the risk of bacterial colonization, improve lung compliance and patient comfort. In addition, this type of heat and humidity exchanger is small in size, easy to use, and low in cost, so it can be made into a disposable consumable, without the risk of breeding bacteria and the trouble of cleaning and disinfecting; there is no danger of electricity and heat, To a certain extent, avoid insufficient humidification or excessive humidification.
本发明已经通过上述实施例进行了说明,但应当理解的是,上述实施例只是用于举例和说明的目的,而非意在将本发明限制于所描述的实施例范围内。此外本领域技术人员可以理解的是,本发明并不局限于上述实施例,根据本发明的教导还可以做出更多种的变型和修改,这些变型和修改均落在本发明所要求保护的范围以内。本发明的保护范围由附属的权利要求书及其等效范围所界定。 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 (14)

  1. 一种用于呼吸面罩的通气控制装置,其中,包括:A ventilation control device for a respiratory mask, comprising:
    腔体,其具有输气口;a cavity having a gas outlet;
    阀组件,其设置在所述输气口处,所述阀组件构造为呼气时保持所述腔体内的压力大于大气压;以及a valve assembly disposed at the gas delivery port, the valve assembly configured to maintain a pressure within the chamber greater than atmospheric pressure when exhaled;
    热湿交换器,所述热湿交换器或所述腔体上设置有与所述输气口相连通的面罩通气口,所述面罩通气口用于与呼吸面罩连通,所述热湿交换器与所述输气口连通,以使呼气和吸气都经由所述热湿交换器。a heat and humidity exchanger, the heat and humidity exchanger or the cavity is provided with a mask vent communicating with the gas outlet, the mask vent for communicating with a breathing mask, the heat and humidity exchanger Communicating with the gas delivery port such that both exhalation and inspiration are via the heat and humidity exchanger.
  2. 如权利要求1所述的通气控制装置,其中,所述热湿交换器包括:The ventilating control device of claim 1 wherein said heat and humidity exchanger comprises:
    壳体;case;
    疏水膜,其填充在所述壳体内;a hydrophobic membrane filled in the housing;
    吸水及亲水层,其附着在所述疏水膜的表面。A water absorbing and hydrophilic layer attached to the surface of the hydrophobic film.
  3. 如权利要求2所述的通气控制装置,其中,所述热湿交换器中还包括设置于所述壳体内的过滤组件,用于过滤颗粒和/或微生物。The ventilating control apparatus according to claim 2, wherein said heat and humidity exchanger further comprises a filter assembly disposed in said housing for filtering particles and/or microorganisms.
  4. 如权利要求1所述的通气控制装置,其中,其中The ventilation control device according to claim 1, wherein
    所述面罩通气口设置在所述热湿交换器上,所述腔体还包括接口,且所述热湿交换器在所述接口处可拆卸地连接至所述腔体,以使所述热湿交换器与所述接口通气;或者The mask vent is disposed on the heat and moisture exchanger, the cavity further includes an interface, and the heat and moisture exchanger is detachably coupled to the cavity at the interface to cause the heat The wet exchanger is vented to the interface; or
    所述面罩通气口设置在所述腔体上,所述热湿交换器在所述输气口处可拆卸地连接至所述阀组件或所述腔体,以使所述热湿交换器与所述输气口连通;或者The mask vent is disposed on the cavity, the heat and moisture exchanger being detachably coupled to the valve assembly or the cavity at the gas delivery port to cause the heat and moisture exchanger to The gas outlet is connected; or
    所述面罩通气口设置在所述腔体上,所述热湿交换器设置在所述腔体内,所述阀组件可拆卸地连接至所述腔体的所述输气口。The mask vent is disposed on the cavity, the heat and moisture exchanger is disposed within the cavity, and the valve assembly is detachably coupled to the gas delivery port of the cavity.
  5. 如权利要求1所述的通气控制装置,其中,所述阀组件具有进气通道和排气通道,所述进气通道和所述排气通道通过所述输气口与所述腔体连通,其中所述阀组件构造为在所述腔体内的压力小于或等于大气压时使所述进气通道导通;且在所述腔体内的压力与大气压之差大于或等于预定值时使所述排气通道导通。The ventilating control device according to claim 1, wherein the valve assembly has an intake passage and an exhaust passage, and the intake passage and the exhaust passage communicate with the cavity through the gas delivery port, Wherein the valve assembly is configured to cause the intake passage to conduct when a pressure within the chamber is less than or equal to atmospheric pressure; and to cause the difference between a pressure in the chamber and an atmospheric pressure to be greater than or equal to a predetermined value The gas passage is turned on.
  6. 如权利要求5所述的通气控制装置,其中,所述阀组件包括:The ventilating control device of claim 5 wherein said valve assembly comprises:
    第一阀机构,具有关闭所述输气口的第一关闭位置和打开所述输气口的第一 开启位置,所述第一阀机构上设置有通孔;以及a first valve mechanism having a first closed position to close the gas delivery port and a first opening to open the gas delivery port An open position, the first valve mechanism is provided with a through hole;
    第二阀机构,其设置在所述通孔处,具有关闭所述通孔的第二关闭位置和打开所述通孔的第二开启位置。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.
  7. 如权利要求6所述的通气控制装置,其中,所述第一阀机构包括:The ventilating control device of claim 6 wherein said first valve mechanism comprises:
    第一阀芯,所述通孔设置在所述第一阀芯上;a first valve core, the through hole is disposed on the first valve core;
    第一偏置构件,顶抵在所述第一阀芯上以给所述第一阀芯提供从所述第一关闭位置到所述第一开启位置的移动阻力。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.
  8. 如权利要求6所述的通气控制装置,其中,所述阀组件包括连接在所述输气口处的阀座,所述阀座上设置有出气口,所述第一阀机构设置在所述阀座内。The ventilating control apparatus according to claim 6, 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.
  9. 如权利要求6所述的通气控制装置,其中,所述第二阀机构包括由弹性或形态记忆材料制成的阀瓣,所述阀瓣连接至所述第一阀机构。The ventilating control device of claim 6 wherein said second valve mechanism comprises a valve flap made of a resilient or morphological memory material, said valve flap being coupled to said first valve mechanism.
  10. 如权利要求1所述的通气控制装置,其中,所述输气口包括进气口和排气口,所述阀组件包括:The ventilating control apparatus according to claim 1, wherein said gas delivery port comprises an intake port and an exhaust port, and said valve assembly comprises:
    进气阀,其设置在所述进气口处,所述进气阀构造为当所述腔体内的压力小于或等于大气压时开启;以及An intake valve disposed at the intake port, the intake valve being configured to open when a pressure within the chamber is less than or equal to atmospheric pressure;
    排气阀,其设置在所述排气口处,所述排气阀构造为当所述腔体内的压力与大气压之差大于或等于预定值时开启。An exhaust valve is disposed at the exhaust port, the exhaust valve being configured to open when a difference between a pressure in the chamber and an atmospheric pressure is greater than or equal to a predetermined value.
  11. 如权利要求5或10所述的通气控制装置,其中,所述阀组件包括调节机构,所述调节机构用于调节所述预定值。The ventilation control device according to claim 5 or 10, wherein the valve assembly includes an adjustment mechanism for adjusting the predetermined value.
  12. 如权利要求1所述的通气控制装置,其中,所述阀组件与所述输气口配合形成进气口和排气口;所述阀组件构造为在所述腔体内的压力小于或等于大气压时使所述进气口与所述面罩通气口连通,且在所述腔体内的压力大于大气压时使所述排气口与所述面罩通气口连通,其中,所述进气口的横截面积大于所述排气口的横截面积,且所述排气口能够在呼气时保持所述腔体内的压力大于大气压。The ventilating control apparatus according to claim 1, wherein said valve assembly cooperates with said air inlet to form an intake port and an exhaust port; said valve assembly is configured such that a pressure in said chamber is less than or equal to atmospheric pressure The air inlet is communicated with the mask vent, and the air vent is communicated with the mask vent when the pressure in the chamber is greater than atmospheric pressure, wherein the air inlet crosses The area is greater than the cross-sectional area of the exhaust port, and the exhaust port is capable of maintaining a pressure in the chamber greater than atmospheric pressure when exhaling.
  13. 如权利要求12所述的通气控制装置,其中,所述输气口包括间隔设置的第一输气口和第二输气口,所述阀组件设置在所述第一输气口处;所述腔体内的压力小于或等于大气压时开启所述第一输气口,所述第一输气口和所述第二输气口形成所述进气口;所述腔体内的压力大于大气压时关闭所述第一输气口,所述第二输气口为所述排气口。The ventilation control device according to claim 12, wherein said gas delivery port comprises a first air delivery port and a second air delivery port which are disposed at intervals, and said valve assembly is disposed at said first air delivery port; Opening the first gas delivery port when the pressure in the cavity is less than or equal to atmospheric pressure, the first gas delivery port and the second gas delivery port forming the gas inlet; when the pressure in the cavity is greater than atmospheric pressure The first gas delivery port is closed, and the second gas delivery port is the exhaust port.
  14. 一种呼吸面罩设备,其中,包括: A respiratory mask device, comprising:
    呼吸面罩;以及Breathing mask;
    如权利要求1-13中任一项所述的通气控制装置,所述通气控制装置连接至所述呼吸面罩,并通过所述面罩通气口与所述呼吸面罩通气。 The ventilation control device according to any one of claims 1 to 13, wherein the ventilation control device is coupled to the respiratory mask and is ventilated with the respiratory mask through the mask vent.
PCT/CN2015/100041 2015-10-23 2015-12-31 Ventilation control apparatus, and breathing mask device provided with ventilation control apparatus WO2017067081A1 (en)

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