Masks and their systems

Abstract

summary Masks and their systems The present invention relates to a face mask system for removing pathogens from exhaled breath. The device includes at least one flexible layer and a second surface opposite the first surface. The first surface is in sealing contact with the user's face and the second surface is exposed to the outside. Furthermore, at least one layer has an exhaust port and an intake port. This exhaust port is tightly connected to a deformable chamber, allowing the user to It features a one-way valve that opens when you exhale and closes when you inhale. do.

Description

[Technical field]

[0001] The present invention relates to a (face) mask and system thereof. The study is about masks and systems that have a high capture rate of pathogens that cause coughing and other respiratory infections. This is a mask that has a high capture rate of pathogens that spread through sneezing, etc. If this is done, the capture rate of pathogens expelled from coughs, sneezes, etc. will be increased without restricting the user's breathing. It concerns expensive masks. [Background technology]

[0002] 2. Background of the Invention Infection occurs when an infected person releases the pathogen into the surrounding area through exhalation, coughing, sneezing, etc. This is a well-known route of infection and is used by many , and plays a major role in the annual cycle of disease, including epidemics and pandemics such as SARS and H1N1. Tellier R, Review of Aerosol Transmission of Influenza A Virus R aymond Emerging Infectious Diseases, www.cdc.gov / eid Vol. 12, No. 11, November 2 006 (Tellier R, Review of aerosol transmission of influenza A viruses). Agencies such as the HO develop national and international plans to prevent the spread of the disease from becoming an epidemic or pandemic. The aim of the initiative is to provide plans and advice on how to prevent the spread of infection. Appropriate actions to prevent infection vary by pathogen, but especially for respiratory infections: The main route of infection is through droplets and aerosols released by infected people when they breathe, talk, cough, or sneeze. [Cough aerosol in healthy participants: fundamental knowledge to optimize droplet-spread infectious respiratory disease management Zayas et al. BMC Pulmo Nary Medicine 2012, 12:11 (Cough aerosols from healthy participants: droplet-type infection) (Basic knowledge for optimizing management of infectious respiratory diseases). Anyone who comes into contact with the product should wear an appropriate mask, possibly eye protection, and other protective clothing, and thoroughly wash their hands. Patients should be advised to avoid contact with the patient. There are small particles known as aerosols, the size of which is generally defined as less than 5 μm in diameter. These aerosols behave like gases, remain in the air for long periods of time, and travel long distances. This increases the possibility of infecting others. It penetrates into the lungs and reaches the alveoli, so a smaller amount of pathogen is needed to cause infection. [Roy CJ, Milton DK. Airborne transmission of communicable infection~the elusive pathway. N Engl J Med 2004;350:1710~2 (Elucidation of the airborne infection route)]. Aerosols are so small that they have a high chance of penetrating masks and behave more like gases. In order to show the patient's condition, the mask is placed between the patient's face and the mask, and the patient's face is exposed to the air. It is difficult to remove all of the material. The problem of poor fit of masks worn by patients and medical personnel is well known [https: / / www.h se.gov.uk / research / rrpdf / rr619.pdf, Evaluating the protection afforded by surgi cal masks against influenza bioaerosols Gross protection of surgical masks compa red to filtering facepiece respirators, Prepared by the Health and Safety Labora Tory for the Health and Safety Executive 2008, RR619 (Influenza Bioair Evaluation of the protective performance of surgical masks against chlorosols. Filtering facepiece-less (Compared to total protective performance of surgical masks) Although the "surgical mask" type, which significantly reduces the amount of body fluids, is common, may release gases and bacteria into the air When a patient coughs or sneezes, the force of the cough or sneeze can be described as explosive. The pressure in the mask increases rapidly, and expelled droplets and aerosols enter the gap between the mask and the skin. This is because the particles spread to the surrounding area. [ “Violent Expiratory Events: On Coughing and Sneezing and sneezing).” Bourouiba et al, Journal of Fluid Mechanics 745 (March 2 4, 2014): 537~563.

[0003] This includes ambulance personnel who transport patients to hospitals, nurses, doctors and other medical staff in hospitals. In addition to those infected, caregivers, including family members in the community and in infected homes, caregivers in residential care facilities, and health care workers This poses a significant risk to the individual and anyone who may come into contact with them.

[0004] N95 masks (see HSE above for details of mask types and references), FFP2 and FFP3 masks Masks with high filtering efficiency and that fit the face well can also be used, but aerosols Only the FFP3 mask has a high removal efficiency of inhalation of airborne contaminants, Efficacy of Chair Masks) David J. Pippin, DDS, MS, Richard A. Verderame, DDS, Kurt K. Weber, DDS‡ Journal of Oral and Maxillofacial Surgery, April 1987Volume 45, Issue 4, Pages 319-323]. However, masks such as FFP3 are prone to release harmful substances from the user. The amount of air that can't pass through the mask is so high that the pressure is high at the back of the mask. As a result, air, aerosols, and sometimes even larger particles can escape through the gaps between the mask and the wearer's face. The spread of small particles remains a problem for patients who cough or sneeze. In addition, the filter in high-performance masks is located at the front of the mask, so it can be used to block coughs and sneezes. When worn by a patient with symptoms, the amount of wet droplets produced with each cough or sneeze increases. As it becomes saturated with stomach.

[0005] Therefore, even if a high-performance filtering mask is available, the patient may still be unable to breathe. If you have respiratory symptoms, especially if you are coughing or sneezing, or if you are receiving oxygen therapy or other gas therapy, It is clearly not designed to be used when needed.

[0006] It is designed to increase the efficiency of capturing respiratory pathogens expelled through breathing, coughing and sneezing, while providing protection to patients. Until now, there has been no solution to the need to ensure access to medical care for people with cancer. Even patients who do not require airway support through mechanical ventilation can spread viruses and bacteria. Yes, do not remove your mask when eating or drinking, or cough or sneeze into a tissue for a short period of time without a mask on. If you remove your mask, you may be exposed to the airborne pathogens. This will result in more germs being released, especially if there is no protection from coughing or sneezing. In any case, if there was a device that could remove pathogens with high efficiency, it would be possible to eliminate the virus in the room. and bacterial load can be significantly reduced.

[0007] In the prior art, capturing droplets expelled by coughing or sneezing was not considered to be a “catch-all” measure. It is the subject of many patents, including a "tool for stimulating the brain" (US Patent US 7,997,275 B2, Quin, 201 1, US 2014 / 0251349 A1, Delatorre 2014).

[0008] When material is expelled during a cough or sneeze, it spreads bacterial or viral agents through the mask. There are devices aimed at this purpose (US Patent 4,790,307, Haber et al 1988), but Masks don't work as well as you'd think they would at physically containing a sniff or cough. None of them solved the well-known problem. (US 2015 / 0013681 A1, APPARATUS WITH EXHAUST SPACER TO IMPROVE FILTRATION OF PATHOGENS IN RESPRATORY EMISSIONS O F SNEEZES, and WO 2018 / 080577 A1 2017, Bird J.).

[0009] In the field of healthcare, there have been attempts to address this issue, such as in US Patent US005676133A (Hickle et Al, 1997) EXPIRATORY SCAVENGING METHOD AND APPARATUS AND OXYGEN CONTROL SYSTE M FOR POST ANESTHESA CARE PATIENTS (Method and device for expelling post-anesthesia patients and oxygen concentration The primary purpose of the anesthetic gas scavenging system is to scavenge anesthetic gases from exhaled substances. The invention also has the advantage of eliminating pathogens. Because they use gas, they cannot handle high-volume, high-pressure symptoms such as coughing and sneezing, and are used in wards and private areas. Not available at MarieCare.

[0010] Another highly technical approach is to manage the laminar air flow in the room. There is a method to create a large air flow and remove pathogens (U.S. Patent US 9,310,0 88 B2, Melikov et al. 2016), but this level of technology is not feasible for large-scale outbreaks such as epidemics and pandemics. It is not suitable for casual use or for use in the home, primary care, or emergency transport settings. US Patent 2004 / 0084.048 to Stenzler et al, 2002, provides high oxygen concentrations to patients. The company has also revealed its invention, which aims to prevent the spread of pathogens by providing an exhalation path through the mask. They say that a filter can be inserted into the pathway to remove the bacteria. The principle of filtering the exhalation tract of a patient is well known and exists in many commercial products, e.g. Flowguard Filters (Intersurgical Ltd UK) in-line filters are used to reduce the amount of artificial ventilation. The mask can filter the exhaled air from the patient over the inhaler. The filter is fitted to an exhalation port in the body of the mask. These can also be placed in the mouth and are commercially available, such as the Filta Mask from Intersurgical Ltd UK. Canadian patent CA2567266 C 2012 / 08 / 07 "DISPOSABLE MASK ASSEMBLY WITH EXHAUST FI Another example is given in "LTER AND METHOD OF ASSEMBLING SAME". Tenzler et al., 2002, "contains an inspiratory and expiratory valve, each of which contains a very low resistance one-way valve. The patent describes the device as a "mask assembly comprising a plurality of airways." The figure reproduces and explains FIG. A1. Here, I would like to point out two things. 1) The resistance pressure and flow rate are quoted only for the inhalation side, and the curves are not for the exhalation side. 2) The flow rate is The flow rate is given in L / min and, without further explanation, it is reasonable to assume that this is a continuous flow rate. For filter materials, such flow resistance curves are typical at steady flow rates. The flow rate and resistance were also compared with other commercially available filter materials (e.g., Intersurgical UK Flow Gu). This general approach does not address exhaled fluids from breathing. While it is acknowledged that the virus can spread, it cannot respond to the crucial symptoms of an infected person coughing or sneezing. This means that the relationship between resistance and flow rate when coughing or sneezing is This proves that the relationship between resistance and flow rate shown in the figure is completely different. It produces an aerosol bolus with a very high flow rate (rising from 0 to 10 L / s in 50–100 ms). Although the flow rate is not particularly high (there is a wide range in humans, (The rate for humans is said to be 2-12 L / s.) If a liquid bolus encounters some resistance, the bolus As the gas slows down and tries to pass through the filter material, a sudden increase in pressure is inevitable. We use filters that are rated for low resistance at steady flow to filter out cough and sneeze flows. The measurements demonstrated high pressure resistance against the amount of fluid. It is designed as a filter with a resistance of 0.4mmH2O at a steady flow of 30L / min. A low-resistance in-line filter (Intersurgical UK Flow Guard Filter) was used. The mask used was a commercially available Filta Mask (Intersurgical UK) with two built-in filters. The graph in Figure A1 shows the results for three masks (PS is a mask using the ultra-low resistance introduced in this application, ISF M is Intersurgical Filter Mask, H1 is Intersurgical Flow Guard in-line Filter for exp This mask has a peak flow rate of about 8 L / s. , which corresponds to a human cough flow profile with a time to peak flow of 0.1-0.2 s.

[0011] As shown in Figure A2, two examples of masks (ISFM of mask with filter material set in mask, S High resistance to cough and sneeze flow rates, as shown in H1) according to the principles set out in the Tenzler application This means that if "low resistance" filter material or in-line filters are used in the mask, This means that the expiratory pathway becomes a very high resistance pathway, in the range of 100 to 125 mmH2O. Thus, the solution proposed in US Patent 2004 / 0084.048 to Stenzler et al., 2002 It does not provide a "very low flow resistance" for normal physiological coughing or sneezing. Therefore, it is important to understand the physiological conditions, including coughing and sneezing, that are common in patients with respiratory illnesses. You can't catch pathogens from range. In addition, even if the pressure under the mask increases by just 50mmH2O when a patient coughs or sneezes, Not only can masks fall off your face and aerosols leak into the room, but they can also cause discomfort and discomfort when coughing or sneezing. Experiments have shown that proper installation may not be observed in order to create an air gap to release pressure. Therefore, the results show that the most common and major components of respiratory disease are Dealing with these pressures is a fundamental requirement for the functioning of the device to capture coughs and sneezes. Without a means to capture these, the capture of exhaled air fluids from normal breathing may also be compromised. High potential.

[0012] The aim of the present invention is to detect the migration of pathogens from the respiratory system of an infected person into the air, e.g. in a room or in an ambulance. The aim of this study is to reduce emissions of exhaled gases, aerosols and particles in the oral and nasal cavities. This is achieved by a mask and system that captures the air when the patient coughs or sneezes. The aim is to prevent a very large proportion of the emitted material from being released even when "Excreted substances" refers to substances excreted from the mouth and nose when the subject breathes, talks, coughs, sneezes, etc. This refers to the gases, droplets, and aerosols that are exhaled. And the exhaled substances are released into the air. The present invention also aims to eliminate pathogens while capturing them before they are killed or removed. It allows medical personnel access to provide treatment, such as oxygen.

[0013] This device reduces the explosive force of coughs and sneezes by creating a low-resistance path for expelled material. Prevents the pressure inside the mask from rising sufficiently even when the mask is closed, causing backflow to the edge of the mask. When you exhale, cough, or sneeze, the air is expelled by passing through a valve that opens and closes at low pressure. This reduces the amount of material that is reabsorbed into the body. The material that is then expelled can be transformed. The gas enters a chamber that can be used to filter the air before being released into the air or into the air passage. Here, equipment is used to suck in, filter and kill pathogens before they are released into the air. It is also possible to send it to. Summary of the Invention

[0014] Summary of the Invention In a first embodiment of the present invention, a face mask system for removing pathogens from exhaled breath is provided. The present invention provides a method for manufacturing a device comprising: a first surface that is in sealing contact with the user's face and a second surface that is opposite the first surface In addition, at least one layer has an exhaust port (exhaust port) and It has an intake port. This exhaust port is perfect for the transformable chamber. It is connected to a one-way valve that opens when the user exhales and closes when the user inhales. It is characterized by being equipped with a valve.

[0015] In a first embodiment of the present invention, the diameter of the exhaust port is such that the exhaust flows into the chamber through a one-way valve. It does not obstruct the flow of exhaled air.

[0016] Further, in the first embodiment, the air inlet is configured to open when a user inhales air. and an intake valve that closes when air is expelled, and the valve is connected to the first surface and the air. The deformable exhaust is configured to open due to a pressure difference between the two pressures. The outlet chamber may be hermetically connected to the processing unit by a flexible conduit. The conduit may be provided through an exhaust port or exhaust chamber in at least one layer. The ejected material is configured to be delivered through a nozzle.

[0017] The treatment device may also be connected to an exhaust or suction means, where said suction means is connected to the treatment unit. It provides suction through the knit and the deformable exhaust chamber conduit, which allows the exhaust The suction means is configured to define a path for exhaled air. Some also include electrostatic deposition units and filters to provide a clean gas output. The processing unit includes a valve and a sensor.

[0018] In an embodiment of the first aspect, the deformable exhaust chamber is connected to the suction means by a conduit. The conduit is also connected to the exhaust port of at least one layer. configured to convey material expelled from a user through a removable expulsion chamber. The flow rate in the exhalation path is determined by the feedback of the suction means and the sensor in the exhalation path. The valve allows air to flow from the intake manifold into the system. It can be configured to open to admit air and also to direct the discharged material through an overpressure line. It may also be configured to open to allow passage.

[0019] In an embodiment of the first aspect, the discharge is performed by contacting a user with a first surface of the at least one layer. The exhaust air is passed to the exhaust chamber without a significant increase in pressure between the exhaust and the exhaust Something that is accomplished.

[0020] In a second aspect of the present invention, there is provided a mask suitable for use with the mask system of the first aspect described above. Provide an exhaust chamber with a one-way inlet for sealing connection to the mask outlet. a lightweight, deformable chamber having a one-way exhaust valve distal to the inlet. The volume of this chamber increases as the internal pressure increases and decreases as the internal pressure decreases. The chamber further includes at least one support strip attached to a surface thereof. In this case, at least one support strip may be provided in the exhaust chamber. On the other hand, the first preferred shape is a concave shape, and the second preferred shape is a convex shape. When the strip is placed in the first preferred shape, the strip is biased toward the concave shape. When the pressure inside the chamber increases relative to the surrounding pressure, the support strips move from a concave position to a convex position. The support moves to the inside of the chamber, causing it to have a larger volume. The strips return to their concave position. The exhaust chamber is made up of multiple support strips. It can also be composed of

[0021] In one embodiment of the second aspect, the plurality of support strips are adapted to support the pressure of the exhaust chamber. As the change occurs, some move from a first position to a second position. [Brief description of the drawings]

[0022] Brief explanation of the figure The invention will now be described in detail by way of example with reference to the drawings, in which: [Figure 1] A side view of a mask covering the nose and mouth. [Diagram 2] FIG. 1 is a side view of the system with a mask that covers only the mouth. [Diagram 3] FIG. 1 is a front view of a portion of the system showing the mask and upper air handling system. [Figure 4] FIG. 1 is a side view of a portion of the system showing the mask, exhaust port, and valve while a person wearing the device is exhaling. [Diagram 5] FIG. 2 is a side view of a portion of the device showing the mask, exhaust port, and valve, with a person wearing the device breathing in. [Figure 6-7] Figure 6 is a front view of the exhaust port without the exhaust valve, and Figure 7 is a front view of the exhaust port with the exhaust valve shown. [Figure 8] This is an example of the arrangement of subunits for removing or sterilizing pathogens on the cut surface of a processing unit. [Figure 9] FIG. 1 illustrates one embodiment of a sneeze-cough-exhalation valve (SCEV). [Figure 10] This is the skeleton flap of the SCEV. [Figure 11] Shows how to assemble the SCEV and mask together. [Figure 12] 1 illustrates an embodiment of an exhaust chamber. [Figure A1-A2] Figure A1 shows the pressure resistance when changing the airflow rate, as referenced by Stenzler et al. Figure A2 shows the pressure under the mask when coughing.

[0023] Figure Number mask Exhaust port One-way low resistance valve Exhaust chamber and variable compliance outflow chamber Intake port Gas intake port connection Connecting Pipe Processing Unit Suction pump Exhaust pipe Mouth mask Peak over exhaust port Flange around the exhaust port Exhaust port joint Mask fixing strap Pressure Sensor Vacuum pump signal cable Electrostatic deposition subunit Filter Subunit Pressure Regulating Sensors and Valves Overpressure Line Inlet Pipe Overpressure Line Filter Skeleton flap Low Pressure Exhalation Valve Flap Closure Bar Fixed closure edge Closure Spring Stabilizing Bar Cantilever flap for exhalation valve The proximal end closest to the mask wearer's face DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention is a system comprising a mask and an air treatment system, which is adapted to treat periodic breathing, coughing, and sneezing. It captures exhaled air, including gases, particles, and aerosols, and removes pathogens such as viruses and bacteria. It is a substance that removes germs from the body and can reduce the spread of pathogens to the surrounding area and other people. The mask covers the wearer's nose and mouth, and in some embodiments, covers only the mouth, preventing air and This system captures aerosols and other substances. The low resistance allows the exhaled material to pass through the exhaust chamber without causing a large increase in pressure under the mask. Low resistance exhaust means that the mask exhaust port is almost directly opposite the wearer's mouth. The port is located on the surface and has a large enough diameter that it offers low resistance to flow through the port. Inside the exhaust port, there is little pressure build-up when the patient breathes, coughs, or sneezes. It has a low resistance exhaust valve that can be opened with almost no lift. It closes when the user inhales, preventing substances in the breath, cough or sneeze from being inhaled again. The inhalation valve on the mask is designed to separate the inside of the mask from the inside of the mask when the wearer inhales. The mask is designed to open when the pressure difference between the outside and inside of the mask is large. It also has an additional fill port for mounting and a blanking cap when not in use. The exhaled air passes through the exhaust valve and enters the exhaust chamber, where it is released from the air and used for coughing and breathing. There is a volume larger than the volume of a sneeze or a single breath. Also, there is little resistance to the volume change here. The wall material used is non-insulating, so even if someone coughs or sneezes in, it hardly creates any excessive resistance. What?

[0025] The air in the exhaust chamber can then be filtered before being released into the atmosphere. A suction pump at the distal end of the system draws air from the chamber into the processing chamber. It can be sterilized, for example by UV irradiation, filtered, or dried by droplets or air. It is also possible to perform electrostatic deposition of the sol. The air after sterilization is either discharged into the room or If you are unsure about the effectiveness of the agent against bacteria or deposits, you can dispose of it outside the building and dilute it. Such uncertainties may arise when new pathogens emerge and how they respond to toxic substances. This may occur before the cause is known, and in that case, the system must be adjusted to prevent the spread. The wearer may be required to wear a mask if he or she is infected with or suspected of having a disease. , and the risk is acceptable, taking into account dilution in an open environment through risk assessment. If this is indicated, the product should be filtered and sterilized without going through a pathogen removal process, i.e., in a processing device. The exhaust air and materials can be discharged to the outside environment without the need for a separate exhaust port.

[0026] Even at low pressure, masks may not be completely sealed, or may not be completely filtration or killing pathogens. However, the efficiency of pathogen removal never reaches 100%. is reduced compared to standard masks, reducing the risk to healthcare workers and others.

[0027] About the mask and the system In one embodiment, the mask and the flow of material expelled from the space between the wearer's face and the mask. By providing a system with low resistance to the Allows capture of gases, droplets, particles, and aerosols (defined as gases, droplets, particles, and aerosols) from the subject's mouth and nose This low resistance is due to the high velocity (volume per second) of material expelled when coughing or sneezing. ) is faster. Here, the person wearing the mask is called the "wearer." Mask 1 has a general structure and is used in medical and manufacturing settings to supply oxygen and filter out substances in the air. This type is widely used for filtering quality inhaled and exhaled air. The mask is made of soft material and has a head strap 16 to keep it in contact with the face. The front of the mask is fitted with a protective barrier, placed at approximately the wearer's mouth height, that protects against the elements that are used when breathing, coughing or sneezing. An exhaust port with a circular diameter about the size of a person's mouth opening (40 mm in this embodiment) 2. The exact dimensions of the embodiment need to be adapted to the object being served. In some cases, different size fittings are used to more closely match the mask and exhaust port. The difference in size between adults and children is also taken into account. It passes through a low-resistance one-way valve 3. This opens with a pressure of about 5 mm of water, and the mask surface The pressure is low enough that the material discharged from the gap does not flow back. In this embodiment, the low resistance one-way valve 3 is open at both ends. It is made of thin flexible material such as thin vinyl tubing, and the pressure on the face side is It opens when the pressure in the outflow chamber exceeds the pressure in the outflow chamber, and closes to cut off the flow when the pressure reverses. This is shown in Figures 4 and 5. In Figure 4, B indicates exhaled air "E" escaping to the exhaust chamber 4. In Figure 5, the pressure is lost due to intake "I" and the material in the chamber is discharged as indicated by the arrow "NP". You cannot pass in the direction indicated.

[0028] Details of the exhaust port 2 and low pressure exhaust valve 3 of this embodiment are shown in Figures 4, 5 and 6. In Figures 4 and 5 a flange 14 is shown, which may be a circular clip or an "O-ring" (Figure 4 15) or a ring or clip formed in the bag-shaped neck of the exhaust chamber. In this embodiment, the exhaust pipe is attached to the neck portion by using a cap. There is a protrusion 13 on the top of the air port. This is very similar to the shape of the brim of a brim cap. The flange is used to restrict the exhaust chamber wall material from entering the exhaust chamber. It has the function of keeping the movable valve away from pressure for the purpose of

[0029] The discharged material then enters the exhaust chamber 4, which in this embodiment is made of plastic It is made up of a very soft substance that resembles a thin wall of It is designed to hold twice the volume of a cough. This volume is determined by the subject. An important feature of a gas chamber is the relationship between pressure and volume when a constant amount of air is suddenly introduced. Select a material that has low resistance to the increase in internal volume, and reduce the pressure that accompanies the increase in volume. It is necessary to minimize the change. In this embodiment, a material such as a thin plastic bag is used. This requirement is met by using a mask that is designed to protect against the wearer coughing, sneezing, or other large airborne particles. When expelled all at once, the expelling chamber fills up quickly, but at least it is enough to suppress an adult cough. It has enough volume to contain two loads, and its thin, flexible walls easily deform under low pressure, making it ideal for exhaust ports. The mask maintains low pressure on the wearer's face. The low pressure inside the mask reduces the contact between the face and the mask. Large backflows of excreted material between the masks allow an infected wearer to release pathogens into the air indefinitely That will never happen.

[0030] The valve in the exhaust port closes when the pressure on the chamber side exceeds the pressure on the face side, e.g. When the user inhales, the mask closes and the intake port 5 on the mask opens to let air in. When installing the mask, air or oxygen may be introduced into the mask through the gas inlet port 6. The air inlet 5 is one-way so that it closes when the patient exhales, sneezes, or coughs. It is equipped with a valve.

[0031] The exhaust gas in the exhaust chamber must be removed. The OC fluid must be filtered. Either through the exhaust chamber 4 and into the room air, or through the connection 7 at the bottom of the exhaust chamber 4. This can be achieved by arranging the flow of discharged materials in a way that This can be achieved using a variable compliance outflow chamber, as described in Optionally, a suction pump 10 can be used to draw air through the treatment unit 9. By this, suction is performed using the connecting tube 8 to remove the residue in the exhaust chamber 4. This flow reduces the volume of gas in the exhaust chamber, and the exhaust gas from exhaust port 2 It is ready to accept more flow and keeps the pressure from the exhaust chamber low The flow rate discharged along the connecting pipe 8 is the average flow rate appropriate for the patient. The variable control of the suction pump 10 rate can be set to adjust the rate of breathing. Since coughs and sneezes fluctuate, sensors must be installed in the exhaust chamber and other outlets. The pressure sensor 17 detects the pressure and feeds it back to the suction pump 10 via an electrical signal cable 18. It is preferable to increase or decrease the suction, thereby varying the flow rate and pressure in the exhaust chamber. stomach.

[0032] In terms of ensuring the safety of the system, i.e. applying negative pressure to the exhaust chamber, The point is to prevent the valve 3 from opening too fast and creating negative pressure in the patient's mouth and nose. Install sensors and valves to maintain low pressure through physical or electrical monitoring. In one embodiment, the sensor and valve are located within the processing unit. (Figure 8, 21) If the air pressure is too low, the valve opens and the air is introduced into the system through the intake pipe 23. If the pressure is too high, the air passes through the filter 24 in the overpressure line and enters the overpressure line. It opens to allow material to be discharged along the nozzle 22. Furthermore, the overpressure valve opens until the pressure is reduced. Can be configured to sound a rumble. Once the discharged material enters the treatment unit (9), it is subjected to physical filtering processes such as filtration or electrostatic deposition. The bacteria then pass through a subsystem to remove the pathogens by sterilization. After passing through other subsystems for the purpose of reducing the amount of air that is being discharged, the air is exhausted through a pump (10) and an exhaust pipe (11) to the room or the environment. You can feel at ease.

[0033] The treatment unit in this embodiment removes pathogens from the discharge, for example, as shown in FIG. The discharge is then discharged to an electrostatic deposition unit (19) by using two of the methods for removing the discharge. Then, the purified gas is sent to the suction pump, The gas can be exhausted indoors, or a pipe can be extended to allow the purified gas to be discharged outdoors.

[0034] There are many other variations in the method of embodying the present invention, and the possible variations are as follows: Some of the options are listed below:

[0035] Mouth-only masks (Figure 2) are used in patients with diseases that produce low levels of nasal discharge, certain clinical conditions, and It is also suitable for certain patients who require improved nasal access, such as for oxygen therapy. In some cases, oxygen therapy can also be given using a full nose and mouth mask as described above.

[0036] The masks don't have to be made of cloth, they can be made of hard materials, which makes it easier to 3D print them. It will also be possible to scan an individual's face with a 3D scanner and print a mask to their measurements. Because of the reduced pressure, this invention does not require a good fit. Although the mask does not fit snugly around the face, a better fit on the face improves the overall ability to contain pathogens. It becomes.

[0037] The exhaust chamber may be constructed of any material and structure that achieves the pressure and volume relationships described herein. For example, a hard material can be molded into a concertina shape and expanded according to the relationship between pressure and volume. This reduces the amount of air required to evacuate the chamber when no suction is being applied. The pressure may be generated internally. There are other variations that can achieve the required performance. This is one possible reason.

[0038] This exhaust chamber concept allows the tube from the mask to be of a relatively large diameter, e.g. This can be achieved by making the cable 50mm or larger, for example. This allows direct connection to the processing equipment, and even larger This results in a larger volume, which reduces the pressure changes caused by breathing or sneezing. The tube expands at low pressure and increases in pressure as more coughing and sneezing occur. The walls can be made of materials that satisfy the force-volume relationship. For example, thin, soft plastic Examples of such materials include rubber, and even hard materials that stretch with just a little pressure.

[0039] If the exhaust from the exhaust chamber is exhausted to the outside through a filter, no treatment device is required. This will achieve the goal of eliminating pathogens from the indoor environment. Conduct a survey to ensure that such outdoor air cannot re-enter the occupied space and that it is not possible to The impact on people needs to be considered. This can be caused by outbreaks of infection, shortages of supplies due to pandemics, etc. This could be a way to address shortages of spare filters and other supplies needed for treatment equipment at times like these. In ambulances transporting patients, the risk assessment of the patient, possible illnesses, and the environment in which the ambulance will pass must be considered. Outdoor roof vents may be used, taking into consideration boundaries, etc. The treatment unit is arranged with a tube to discharge the air from the mask wearer to a common treatment unit. The device may be configured to deliver items to accommodate multiple mask wearers. For example, in a hospital ward where patients with the same disease live together during an epidemic or pandemic. To support the use of the mask, all that is needed is a pump to provide suction. When using suction with this system, the wearer may be seated in a home or hospital bed. For outpatients, those moving around the hospital such as those taking radiology exams, and patients suspected of having a highly infectious disease It can also be used when transporting patients in an ambulance. For this purpose, the length of the tube must be appropriate. It is necessary that the system is of an appropriate size, e.g. A small battery-powered processing device that can be attached to a wheelchair or stretcher It is.

[0040] The dimensions of the system components, especially the mask and exhaust chamber, are designed to fit an adult human body. The device can be configured to accommodate a wide range of lung capacities, and can also be configured to accommodate children. The system that directs air from the exhaust chamber is sensitive to pressure changes and to the presence of a built-in mask, for example. The device is configured to be triggered by a sensor that monitors the breathing of the patient. The sensor detects when the wearer breathes, coughs, sneezes, and when pressure is released from the exhaust chamber. and aspirate only when it exceeds the limit set by the control software. is also possible.

[0041] Sneeze-Cough-Expiration Valve (SCEV) In a preferred embodiment, the valves used are sneeze, cough and exhalation valves (S The exhaust port tube 2 is a tube with a circular or elliptical cross section. The soft valve and exhaust port liners 3 are lined with a soft material that is open on both ends. The exhaust port tube 2 slides into the fixed exhaust port guide 33. (See FIG. 11.) At the end of the exhaust port 33 closest to the face of the mask wearer, a soft liner 3 The tube is attached in some way to the rim and configured to maximize the opening. At the other end of the exhaust port, the soft liner flows along an arc between points A, B, and C. The soft valve material is attached to the underside of the lip of the port tube. When cut and folded, there are minimal wrinkles due to the application of gravity and other closing forces. The exhaust port and the fixed closing edge 28 are curved in shape. This provides an optimal seal to prevent backflow of soft materials.

[0042] A skeleton flap 25 is attached to the top of the exhaust liner. A closing bar 27 is installed, and when the flap 25 opens the valve, gravity and the tension of the soft valve material 2 and 3. The closing force of the closing edge 28 is applied to the closing edge 28 by a spring 29. Alternatively, magnets may be attached to the closing bar 27 and the closing edge 28 to allow for magnetic closure. The closing edge 28 is shaped as shown in FIG. 9b to facilitate valve closure and mass transfer. The seal is tightly fitted to prevent air from entering the housing.

[0043] The skeleton flap may also have a stabilizing bar 30 at the proximal end. The liner is pressed against the top of the exhaust tube by tension in the soft liner material to which it is attached. The attachment prevents the skeleton flap from twisting around its long axis.

[0044] The low pressure opening breather valve 26 is an opening through the skeleton flap 25 that is covered by a cantilever flap 31. The cantilevered flap 31 can be raised to allow the exhaust air to flow through the flap. The flow of material inside the mask is adjusted to a positive pressure corresponding to the pressure in the chamber for use.

[0045] The exhaust port tube dimensions are as follows: the angle from the top of the exhaust tube 33 inlet to the fixed closed end is Choose one that is about 50 to 60 degrees. This is because gravity exerts a closing force on the valve. Here, the exhaust port length is set to about 40 mm and the height is set to about 35 mm.

[0046] With conventional valve flap mechanisms, the humidity of exhaled air is high, and droplets and mucus are easily splashed when coughing or sneezing. In contrast, the present invention allows the exhaust tube to be easily removed. The exhaust pipe can be removed and inserted in the tank, and the liner ensures hygiene. Masks should be disposable and replaced within a certain time. By using masks for a long period of time, costs and waste can be reduced. The mask itself only needs to be used once, so it can be washed regularly. The exhaust tube and valve assembly can be disposable.

[0047] The SCEV valve assembly consists of an exhaust tube and a soft valve, installed as shown in Figure 9. will be done.

[0048] The valve assembly is attached to the mask by pushing it onto the fixed exhaust port 33. The mask wearer, referred to here as the "wearer," is a mask that is worn by the mask wearer and the mask wearer is a mask wearer. Similarly, a mask secured with straps is put on.

[0049] When inhaling, the pressure inside the mask drops, and the negative pressure pushes against the soft material of the SCEV, causing the The cap closure bar 27 is pressed against the fixed closure edge 28 to create high resistance to reflux within the mask. The air intake valve on the mask body opens, allowing air to enter the mask for the wearer to inhale. At the end of the inhalation phase, the pressure in the mask is equal to atmospheric pressure because the inhalation valve is open. When the wearer exhales, pressure inside the mask increases, which causes the soft valve to open. The low pressure exhalation valve is optional. If it is not present, gravity, skeleton flaps, The sum of the pressures due to the tension of the soft valve attached to the valve, any spring forces, etc., determines the closing pressure. When the wearer's head is tilted forward significantly (50-60 degrees or more), the device will open. , since gravity acting on the valve is zero or tends to open the valve when the wearer is at rest. It is desirable for the valve to close when the wearer finishes breathing. The force is applied to the skeletal flap so that the soft valve material is stretched as the valve opens. This also provides the tension to close the valve. If we could realize a device that exerts a positive force to close the valve by other means, the air flow during breathing would When a person is at rest, the flow rate is very low. This quiet breathing technique reduces the risk of aerosol generation, so breathing is Although it is not necessary to capture all of the air, the end-expiratory pressure will increase and air will be drawn between the mask and the skin. Leaking may be clinically undesirable. On the other hand, if the mask fits too tightly to the face, In this case, the oxygen that was exhaled is inhaled again, which is unacceptable. In these embodiments, an exhalation valve 26 is employed that opens at low pressures, allowing for low-velocity and low-pressure exhalation. The valve in the embodiment is optimized to allow the flow of air and fluid. The valve meets the requirement of opening at low pressure of less than H2O. The closing force is less than 10mmH2O. This can be achieved with any spring, magnetic, or soft valve material so that it can be opened with a pressure of 100 psi.

[0050] At the end of breathing, flow through the valve stops and the pressure difference disappears. The soft valve opens during breathing. If the low pressure breathing valve is open, the valve will close due to gravity and other closing forces. When the flap is pulled up, the soft material of the cantilever flap is subjected to a restoring force and gravity is applied. Flip and close. When you cough or sneeze, the flow is very fast, even explosive, causing a sudden increase in pressure. The soft valve opens to allow fluid to pass. A low pressure exhalation valve also opens, but even when it does, the This is not critical as the wrap closes when pressed against the top of the exhaust port tube. When the pressure of the cough or sneeze subsides, the valve is forced to close. This is due to the soft material of the valve that the valve is attached to. It will be closed by some other spring or other means.

[0051] Variable compliance auto-emptying exhaust chamber In some embodiments, the exhaust chamber is provided with a suction to allow the flow out of the chamber. This creates a gap in the chamber so that there is always enough space for people to Coughing or sneezing does not increase the pressure inside the chamber and therefore does not increase the volume. This can be done. Adding suction not only makes the system more complex and expensive, but also increases the exhaust chamber. It is also necessary to ensure that the pressure at the bar does not drop to negative values. This is because the mask's exhaust valve This is to allow air to be sucked out before the wearer exhales. This is possible, but requires additional design features that make it more complex and costly.

[0052] Furthermore, requiring external suction can result in the device being unsafe if the external suction fails. A method or mechanism is needed to ensure that the exhaust chamber is clear. The inside of the chamber becomes full, increasing resistance to coughing and breathing, When a cough or sneeze creates a rapid air current, the air can flow back up and pathogens can escape to the outside. or the chamber may be damaged due to a sudden increase in pressure. Therefore, if the chamber could function without external suction, it would be safer and simpler. This allows for a low-cost device. When moving patients from the respiratory ward to the radiology department, etc., power sources for suction cannot be secured. But it can also be used.

[0053] One preferred embodiment using an exhaust chamber 4 is shown in Figure 12. The mask 1 is In this embodiment, a low resistance and easy It uses a thin plastic bag with variable volume. It consists of air, droplets, and aerosols. As fluid is exhausted into the OC through a one-way exhaust valve, the volume inside the OC increases. With a very low pressure (P1) increase, the volume increases from a minimum to an initial volume V1, and then to V2. To increase the pressure to V3, pressure P3 is required, and so on. In this way, the compliance, which expresses the relationship between volume and pressure, is changed. There are several ways to achieve this. In the example in Figure 12, , 12a shows strips of material 43a, 44a, 45a, which are attached to the OC wall, The strip has a pre-concave shape. The strip is flexible, as shown by D in FIG. 12b. It deforms under pressure in the direction of the axis. Therefore, increasing the pressure increases the volume of the exhaust chamber. The strips have different stiffnesses, so they deform under different pressures. Also, because they have different curvatures, each strip The deformation of the strips causes the volume to change at different rates. Although shown on the front of the exhaust chamber, it may be provided on any or all of the surfaces of the exhaust chamber. is also good. In normal breathing, about 0.5 L of air flows into the OC when you exhale. On the other hand, strip 43a The rigidity may be such that the pressure rises by 2mmH2O to 5mmH2O. The difference is measured in mmH2O of meters of water column (1 Pa = 0.1 mmH2O). The strip 43a is then 2B to a position shown as 43b. Since the strip 43a has a restoring force, When breathing stops, the pressure inside the OC becomes slightly higher than atmospheric pressure. The OC flows out of the exhaust port 46 through a low resistance filter 47. The OC is then filled with water before the next breath. If the next breath is too high, the OC expands. When strip 43a is fully expanded, the pressure increases and strip 44a moves in direction D towards strip 44b. When breathing ends, the strip is restored to its original shape and the air is expelled from the exhaust port 46. The strip maintains the OC at an OC pressure of 10mmH2O or less while maintaining the expected results. It is constructed so as to be capable of containing the amount of human breathing.

[0054] When the wearer coughs or sneezes, a very rapid flow of fluid is created in the chamber. For men, a typical value is 4L in 0.1 seconds. Strips 43a, 44a, and 45a When pressure rises suddenly, the mask deforms, causing backflow (air passing through the mask and being expelled) inside the mask. The compliance of the OC is low and the pressure rise is low. Typically, the amount of water in the blood should be less than 10 mmH2O. After coughing, the strip should be removed. The original tension maintains pressure within the OC and is exhausted through port 46 and filter 47.

[0055] If the treatment device requires filtration or sterilization, it can be connected to a filter and suctioned from the outside. Alternatively, the filter unit can be adapted to allow for suction. The filtered fluid can then be diverted to another filter or vented to the environment. Cut.

[0056] Another method for achieving variable compliance is to use an exhaust chamber with walls of variable stiffness. The chamber walls have thin sections to provide very low resistance. By gradually thickening it or changing its resistance, the volume vs. pressure curve can be adjusted to a given characteristic. The wall shape of the concertina and other walls will also work as expected. It can be configured as follows. The present invention has been described in detail with reference to preferred embodiments thereof. This description is provided to enable those skilled in the art to practice the invention. The following description is intended to illustrate, but not to limit the scope of the present invention. is determined by the scope of the claims.

Claims

1. A system of a face mask (1) for removing pathogens from exhaled breath, comprising: The face mask (1) system comprises at least one flexible layer having a first surface and a second surface, the second surface is opposite the first surface, the first surface being sealed against a face of a wearer in use and the second surface being exposed to the exterior; The at least one flexible layer includes an exhaust port (2) and an intake port (5); The exhaust port (2) is tightly connected to a deformable exhaust chamber (4); The exhaust port (2) further includes a one-way exhaust valve (3); the one-way exhaust valve (3) is configured to open when the wearer exhales and to close when the wearer inhales; A face mask system, wherein the volume of the deformable exhaust chamber (4) increases when the internal pressure increases and decreases when the internal pressure decreases.

2. A face mask system as described in claim 1, wherein the exhaust port (2) has a diameter large enough not to obstruct the flow of exhaled air into the deformable exhaust chamber (4) through the one-way exhaust valve (3).

3. The intake port (5) includes an intake valve, the intake valve is configured to open when the wearer inhales and close when the wearer exhales; 2. The face mask system of claim 1, wherein the intake valve is configured to open due to a pressure difference between the first surface of the at least one flexible layer and the atmospheric pressure of the environment.

4. The deformable exhaust chamber (4) is hermetically connected to a processing unit by a flexible conduit, 3. The face mask system of claim 2, wherein the conduit is configured to transport matter exhaled from a wearer through the exhaust port (2) in the at least one flexible layer and the deformable exhaust chamber (4).

5. The processing unit (9) is connected to a suction means (10) having an exhaust port, the suction means (10) is configured to provide suction through the conduit via the processing unit (9) and the deformable exhaust chamber (4) and define a path for exhaled air from the exhaust port (2); said suction means (10) optionally comprising an electrostatic deposition unit (19) and a filter to provide a clean gas output at the outlet of said suction means (10); 5. The system of claim 4, wherein the processing unit (9) further comprises a valve and a sensor.

6. The deformable exhaust chamber (4) is closely connected to the suction means (10) by a conduit; 2. The face mask system of claim 1, wherein the conduit is configured to transport matter exhaled from a wearer through the exhaust port (2) in the at least one flexible layer and the deformable exhaust chamber (4).

7. 6. The face mask system according to claim 5, characterized in that the flow rate in the exhalation path can be set or variably controlled by feedback from the suction means or a sensor optionally installed in the exhalation path.

8. A face mask system as described in claim 6, wherein the valve is configured to open to pass air through an intake pipe or to open to pass material exhausted through an overpressure line through a filter.

9. 2. A face mask system according to claim 1, wherein the exhaust air passes through the deformable exhaust chamber (4) with low resistance, without causing a significant increase in pressure between the wearer and the first surface of the at least one flexible layer.

10. An exhaust chamber in a face mask system according to claim 1, the exhaust chamber further comprises at least one support strip attached to a surface of the exhaust chamber; the at least one support strip is deformable between a first preferred concave shape and a second preferred convex shape relative to the exhaust chamber (4), the support strip being biased toward the first preferred concave shape; When the internal pressure of the exhaust chamber (4) increases compared to the ambient pressure, the support strip moves from a concave position to a convex position, allowing the exhaust chamber (4) to have a larger volume, while when the internal pressure decreases, the support strip moves back to the concave position.

11. An exhaust chamber as described in claim 10, comprising a plurality of support strips.

12. The exhaust chamber of claim 11, wherein each of the plurality of support strips moves from a first position to a second position due to a pressure difference within the exhaust chamber.

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