WO2017067081A1 - Appareil de commande de ventilation, et dispositif de masque respiratoire muni d'appareil de commande de ventilation - Google Patents

Appareil de commande de ventilation, et dispositif de masque respiratoire muni d'appareil de commande de ventilation 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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WIPO (PCT)
Prior art keywords
cavity
valve
delivery port
heat
pressure
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PCT/CN2015/100041
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English (en)
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/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory 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.

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

La présente invention concerne un appareil de commande de ventilation, et un dispositif de masque respiratoire muni de l'appareil de commande de ventilation. L'appareil de commande de ventilation comprend : une cavité (210, 310, 410, 510, 610, 710), pourvue d'orifices de distribution d'air (212A, 212B, 312A, 312B, 412, 512, 612, 712) ; un ensemble de soupape (220, 230, 320, 420, 520, 620, 720), disposé au niveau des orifices de distribution d'air (212A, 212B, 312A, 312B, 412, 512, 612, 712), l'ensemble de soupape (220, 230, 320, 420, 520, 620, 720) étant conçu pour maintenir la pression à l'intérieur de la cavité (210, 310, 410, 510, 610, 710) supérieure à la pression atmosphérique pendant l'expiration ; un échangeur de chaleur et d'humidité (240, 440, 540), un orifice de ventilation de masque (241, 411, 511) en communication avec les orifices de distribution d'air (212A, 212B, 312A, 312B, 412, 512, 612, 712) étant disposé sur l'échangeur de chaleur et d'humidité (240, 440, 540) ou la cavité (210, 310, 410, 510, 610, 710), l'orifice de ventilation de masque (241, 411, 511) étant utilisé pour la ventilation avec un masque respiratoire, l'échangeur de chaleur et d'humidité (240, 440, 540) étant en communication avec les orifices de distribution d'air (212A, 212B, 312A, 312B, 412, 512, 612, 712), de sorte qu'à la fois l'expiration et l'inspiration se produisent par l'intermédiaire de l'échangeur de chaleur et d'humidité (240, 440, 540). L'appareil de commande de ventilation met en œuvre une fonction de pression positive de phase d'expiration, et prévient l'inconfort du patient provoqué par la pression positive continue. Un appareil d'alimentation d'air à pression positive et une conduite etc. n'ont pas besoin d'être connectés pendant l'utilisation, facilitant ainsi les déplacements du patient, et l'appareil d'alimentation d'air à pression positive n'a pas besoin d'être porté lors des sorties. De plus, l'appareil de commande de ventilation est de petite taille, pratique à transporter et de faible coût.
PCT/CN2015/100041 2015-10-23 2015-12-31 Appareil de commande de ventilation, et dispositif de masque respiratoire muni d'appareil de commande de ventilation WO2017067081A1 (fr)

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CN201510696722.XA CN105169541B (zh) 2015-10-23 2015-10-23 通气控制装置和具有该通气控制装置的呼吸面罩设备

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SE2050231A1 (en) * 2020-03-02 2021-09-03 Fogless Int Ab An apparatus for humidifying air entering into a tracheostomy valve
GB2596835A (en) * 2020-07-08 2022-01-12 Nnachi Enwo Otu Microbial filtering and humidifying mask system
CN114470545A (zh) * 2022-03-14 2022-05-13 胡加斌 便捷可靠的消防自救器
US11351324B2 (en) * 2017-01-06 2022-06-07 ResMed Pty Ltd Vent adaptor for patient interface system

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CN105169541B (zh) * 2015-10-23 2018-12-14 北京怡和嘉业医疗科技股份有限公司 通气控制装置和具有该通气控制装置的呼吸面罩设备
CN105457133A (zh) * 2015-12-30 2016-04-06 刘修武 一种结核内科用智能呼吸系统
CN112089943A (zh) * 2020-09-18 2020-12-18 北京怡和嘉业医疗科技股份有限公司 通气保湿装置、呼吸面罩、呼吸面罩组件和呼吸支持设备
CN112870507B (zh) * 2021-01-08 2023-06-30 苏州银雀智能科技有限公司 一种呼吸交换器

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US12102766B2 (en) 2017-01-06 2024-10-01 ResMed Pty Ltd Vent adaptor for patient interface system
SE2050231A1 (en) * 2020-03-02 2021-09-03 Fogless Int Ab An apparatus for humidifying air entering into a tracheostomy valve
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GB2596835A (en) * 2020-07-08 2022-01-12 Nnachi Enwo Otu Microbial filtering and humidifying mask system
CN114470545A (zh) * 2022-03-14 2022-05-13 胡加斌 便捷可靠的消防自救器

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