WO2016098132A1 - Breathing device for preventing airborne diseases - Google Patents

Breathing device for preventing airborne diseases Download PDF

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Publication number
WO2016098132A1
WO2016098132A1 PCT/IN2015/050210 IN2015050210W WO2016098132A1 WO 2016098132 A1 WO2016098132 A1 WO 2016098132A1 IN 2015050210 W IN2015050210 W IN 2015050210W WO 2016098132 A1 WO2016098132 A1 WO 2016098132A1
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WO
WIPO (PCT)
Prior art keywords
filter
breathing device
pad
chamber
filters
Prior art date
Application number
PCT/IN2015/050210
Other languages
French (fr)
Inventor
Sanjay Narayan GAIKWAD
Vijaya Sanjay GAIKWAD
Original Assignee
Gaikwad Sanjay Narayan
Gaikwad Vijaya Sanjay
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gaikwad Sanjay Narayan, Gaikwad Vijaya Sanjay filed Critical Gaikwad Sanjay Narayan
Publication of WO2016098132A1 publication Critical patent/WO2016098132A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0087Environmental safety or protection means, e.g. preventing explosion
    • A61M16/009Removing used or expired gases or anaesthetic vapours
    • A61M16/0093Removing used or expired gases or anaesthetic vapours by adsorption, absorption or filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/105Filters
    • A61M16/1055Filters bacterial
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/105Filters
    • A61M16/106Filters in a path
    • A61M16/1065Filters in a path in the expiratory path
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B23/00Filters for breathing-protection purposes
    • A62B23/02Filters for breathing-protection purposes for respirators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0468Liquids non-physiological

Definitions

  • the invention relates to a breathing device for preventing airborne diseases for preventing airborne infections and more particularly, to a device for filtering air by trapping and killing the infectious and contagious air borne germs by providing multi-tier filtration mechanism and advantageously resulting in safe breathing.
  • the common source of breathing air for all human beings is an atmospheric air.
  • the atmospheric air should be clean and free from infectious microbes. But if the source of breathing gets contaminated it can lead to uncontrolled growth of many air borne contagious diseases and various bacteria, viruses may contaminate the atmospheric air.
  • Tuberculosis is one of the most dangerous contaminants. Tuberculosis generally attacks the lungs, and may affect other parts of the body. Symptoms of this disease are a chronic cough with blood- tinged sputum, fever, night sweats, and weight loss. It spreads though the air contaminated by cough or sneeze of the infected person. People who are in prolonged, closed and frequent contact with the infected TB person are at high risk of getting infected. It may spread at faster rate in overcrowded areas. The person who gets infected may not show symptoms immediately, which may lead to development of the disease that remains untreated and results into death.
  • inhaling large or medium sized droplets tends to cause upper respiratory tract infections, while inhaling the smallest particles (droplet nuclei) can cause pneumonia.
  • Diseases that are typically spread by inhalation of medium sized droplets include bacteria (e.g., Neisseria meningitidis [a cause of bacterial meningitis] and Streptococcus) and viruses (e.g., many viruses causing the common cold, laryngitis, tracheitis and also influenza viruses).
  • tuberculosis (caused by the bacterium Mycobacterium tuberculosis is spread by droplet nuclei.3, 4
  • a susceptible individual can therefore acquire disease by inhalation of airborne particles.
  • the main thrust should be on prevention.
  • the Healthcare Infection Control Practices Advisory Committee HICP AC/CDC strategy proposed has been termed Respiratory Hygiene/Cough Etiquette and is intended to be incorporated into infection control practices as a new component of Standard Precautions.
  • the strategy is targeted at patients and accompanying family members and friends with undiagnosed transmissible respiratory infections, and applies to any person with signs of illness including cough, congestion, rhinorrhea, or increased production of respiratory secretions when entering a healthcare facility.
  • Patent no. US2009145445A1 discloses a cough catcher with protection against germ transmission by hand contact.
  • the device described is of oval or circular shape and made up of flexible impermeable material or rubber. It has single hallow chamber and filter vents are present at the bottom and at side. Filtered air is blown out from the side filter air vents.
  • the disinfectant system for this device is inbuilt. It can be used only during the day time, when a person is awake to hold the device by hand near mouth but does not give any protection to family members during night when the infected person is sleeping.
  • United States patent US2005194010A1 titled disposable contagion transmission prevention device and method of using a disposable contagion transmission prevention device discloses a device that has a single chamber with two surfaces, outer surface and interior surface. It covers nose and mouth when hold on the face, which may cause hand contamination. It is made up of absorbent fibrous material which has multiple filtering layers. Though the device is disposable, disinfectant provisions are not provided for disposal. It may spread infectious microbes through the used device if not disposed properly.
  • patent CN202445176U titled three-dimensional mask capable of filtering out particles discloses a device which is a hollow (without chambers) three layered structure, which acts as a three tier filtration system for inhaled/exhaled air. These layers are made up of materials such as cotton, textile fabrics, woven fabric compound polypropylene, non woven fabric filter disc etc. It is the disposable device where disinfection system is not provided. The device is to be put on the face with the help of laces, where hand contamination is possible.
  • the patent US4688566A discloses a disposable filter mask having cup shape.
  • It has three layered filter in which an outer layer made up of a relatively porous paper like material, the middle layer consist of polyethylene or polypropolyene, or other material, which are filtering materials.
  • the innermost layer is made up of a soft material for providing non-irritating surface. The device is held on the face with straps that avoids leakage of contaminated air out of the device.
  • a Chinese patent CN103263093A discloses a dust mask for elastically sealing two sides of nose bridge. It prevents inhalation of dust through nose.
  • This mask is of clock shape which seals only two sides of nose-bridge and does not covers mouth and entire nose. It has three filtering layers in which, outer layer is made up of non woven fabric, middle layer is of melt blown non woven fabric and inner layer of White sized non woven fabric.
  • the present invention discloses a breathing device for preventing airborne diseases.
  • the breathing device comprises a first chamber, a second chamber, a third chamber, an arcuate and a cap.
  • the first chamber, the second chamber, third chamber, the arcuate cover and the cap are aligned along an axis for a multi-tier filtration of air.
  • the first chamber is defined between a first pad and a first filter.
  • the first pad and the first filter are separated by a frame.
  • the first pad is positioned anteriorly on the frame.
  • the frame includes a plurality of windows on a top portion thereof. The plurality of windows acts as breathing window.
  • the first filter is positioned posteriorly on the plurality of the windows.
  • a nasal bridge cushion, a facial cushion and a chin cushion are lined anteriorly at a predefined position around the frame and a plurality of flexible straps is positioned on the sides of the frame through a plurality of opposed rivets ⁇ ' .
  • the second chamber is defined between a second pad and a second filter.
  • the second pad and the second filter are positioned posteriorly on the frame.
  • the second chamber defines a central airflow window thereon.
  • a top end of the second filter is adhesively attachable on an upper surface of the central air flow window and a bottom end of the second filter rests on the central air flow window thereby angularly rotating the second filter about the upper surface of the central air flow window.
  • the third chamber is defined between a third pad and a third filter positioning posteriorly on the central airflow window.
  • the arcuate cover is positioned posteriorly on the third chamber through an opposed pair of rivets ⁇ '.
  • the cap is positioned on the arcuate cover.
  • the cap receives the exhaled filtered air from the arcuate cover for passing into an atmosphere through an outlet.
  • the first filter, the second filter, the third filter and the first pad, the second pad and the third pad are removably attachable at predefined positions on the frame by an adhesive.
  • the first pad, the second pad and the third pad is made of non woven cotton material covered by woven cotton fibre gauze.
  • the first filter, the second filter and the third filter are arranged in multi- layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof.
  • the spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm.
  • the first filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
  • the second filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
  • the third filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
  • the first filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
  • the second filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
  • the third filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
  • the present invention provides a kit for preventing airborne diseases.
  • the kit comprises a breathing device, atleast one disinfectant solution bottle containing a disinfectant solution, atleast one measuring cylinder, atleast one disinfectant container, a plurality of pair of hand gloves, a user manual having guidelines and instructions.
  • the breathing device includes a plurality of chambers, each chamber having a filter and a pad.
  • the atleast one measuring cylinder is used for measuring the disinfectant solution to prepare required percentage and quantity of the disinfection solution.
  • the atleast one disinfectant container is used for disinfecting the contaminated and used filters and pads.
  • the plurality of pair of hand gloves is used for handling of the contaminated material.
  • a first filter, a second filter and a third filter are arranged in multi-layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof.
  • the spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm.
  • the plurality of pads is made of non woven cotton material covered by woven cotton fibre gauze.
  • FIG. 1 is an exploded view of a breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention
  • FIG. 2A is a front view of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention
  • FIG. 2B is a oblique view of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention.
  • FIG. 2C is a rear view of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention.
  • FIGS. 3 A to 3F is a sequential arrangement of a plurality of filters and a plurality of pads of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention
  • FIGS. 4A to 4H shows the breathing device for preventing airborne diseases in operation, in accordance with a preferred embodiment of the present invention
  • FIG. 5 is a kit with a breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention
  • FIG. 6A shows a test chamber for testing a filtration efficacy of the filters of the breathing device
  • FIG. 6B shows results of the filtration efficacy of the breathing device under GE Infinia gamma camera with a single head, low energy high resolution collimator
  • FIG. 6C shows results of the filtration efficacy of the breathing device under GE Infinia gamma camera with a single head, low energy high resolution collimator.
  • the present invention provides a breathing device for preventing airborne diseases in accordance with a preferred embodiment of the present invention.
  • the breathing device is removably positionable over a nasal bridge and extendable up to the chin.
  • the device is designed in such a way so as to provide a sealing fit over the bridge of the user's nose, extending downwards along the cheek lines beneath the user's chin so as to enclose user's mouth and nose within an interior cavity.
  • the principal object of the present invention is to effectively filter infectious exhaled air from the nostril and the mouth of the patient while coughing and sneezing. The coughed out air will pass through multi-tire filtration levels and then be exhaled out.
  • the aim is to exhibit high bacterial filtration efficacy.
  • a breathing device 100 comprises a first chamber, a second chamber, a third chamber, an arcuate cover 128 and a cap 132 aligned along an axis for a multi-tier filtration of air.
  • the first chamber is defined between a first pad 102 and a first filter 104.
  • the first pad 102 and the first filter 104 are separated by a frame 106 such that the first pad 102 is positioned anteriorly on the frame 106.
  • the frame 106 includes a plurality of windows 108 on a top portion thereof.
  • the plurality of windows 108 acts as breathing windows.
  • the first filter 104 is positioned posteriorly on the plurality of windowsl08.
  • a nasal bridge cushion 110, a facial cushion 112 and a chin cushion 114 are lined anteriorly at a predefined position around the frame 106 such that the facial cushion 112 covers the entire inner portion of the frame 106 and the chin cushion 114 is at the bottom end of the facial cushion 112.
  • the frame 106 includes a plurality of flexible straps 116 positioned on the sides thereof through a plurality of opposed rivets ⁇ ' .
  • the device 100 is removably positionable on the nasal bridge of the user's face with the plurality of flexible straps 116 such that the user's nose and mouth are enclosed in accordance to the preferred embodiment of the present invention.
  • the anterior portion of the frame 106 is lined by the first pad 102 such that the first pad 102 covers the inner portion of the frame 106.
  • the first pad 102 is removably attachable by an adhesive at the anterior portion of the frame 106.
  • the second chamber is defined between a second pad 118 and a second filter 120.
  • the second pad 118 and the second filter 120 are positioned posteriorly on the frame 106.
  • the second chamber defines a central airflow window 122 thereon.
  • a top end of the second filter 120 is adhesively attachable on an upper surface of the central air flow window 122 and a bottom end of the second filter 120 rests on the central air flow window 122 thereby allowing an angular rotation of the second filter 120 about the upper surface of the central air flow window 122.
  • the second pad 118 and the first filter 104 are removably attached to the posterior portion of the frame 106 such that the second pad 118 is lined at the outer bottom portion of the frame 106 and the first filter 104 is lined at the outer top portion of the frame 106.
  • the second pad 118 and the first filter 104 are attached by an adhesive.
  • the third chamber is defined between a third pad 124 and a third filter 126.
  • the third pad 124 and the third filter 126 are positioned posteriorly on the central airflow window 122.
  • the first pad 102, the second pad 118 and the third pad 124 is made of non woven cotton material covered by woven cotton fibre gauze.
  • the filters 104, 120, 126 and the pads 102, 118, 124 are removably attachable at predefined positions on the frame 106 by an adhesive.
  • the second filter 120 acts as a central air flow filter and is lined at a predefined position on the third pad 124 such that the second filter 120 is attached at an anterior upper portion of the third pad 124.
  • the pads 102, 118, 124 are specially designed and have a predefine shape to appropriately fit at the predefined portions of the device 100.
  • the pads 102, 118, 124 further are lined by a medical grade adhesive at inner borders thereof for removably being attached inside the body of the device 100.
  • the filters 104, 120, 126 and the pads 102, 118, 124 play a very important role of entrapping the contagious respiratory mucosal droplets along with contagions and filtering out the contagious air which is forcefully exhaled out by the person wearing the device 100.
  • the arcuate cover 128 is positioned posteriorly on the third chamber through an opposed pair of rivets ⁇ ' .
  • the arcuate cover 128 is removably coupled on the frame 106 at predefined positions and includes a central airflow outlet window 130 to exhale the filtered air from the device 100.
  • the frame 106 and the arcuate cover 128 are connected with the central air flow window 122 for monitoring a unidirectional flow of air and filtering the air to safer level by filtration technique by removing the major mass of contagions present in the mucous droplet of cough and sneeze before entering into the common atmosphere.
  • the cap 132 is positioned on the central airflow outlet window 130 of the arcuate cover 128.
  • the cap 132 defines an outlet 134 at the bottom end portion thereof. The cap 132 receives the exhaled filtered air from the arcuate cover 128 for passing into an atmosphere through the outlet 134.
  • the first filter 104, the second filter 120 and the third filter 126 are arranged in multi-layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof.
  • the first filter 104 includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
  • the second filter 120 includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
  • the third filter 126 includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
  • each of the first filter 104, the second filter 120 and the third filter 126 include the plurality of layers arranged sequentially such that a first layer comprises spunbond filter of 12 gsm, a second layer comprises of meltblown of 18 gsm in a set of two layers and a third layer comprises of spunbond of 40 gsm, thereby forming multilaminate nonwoven layers of the filters 104, 120, 126 of device 100 of the present invention.
  • the first filter 104 includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
  • the second filter 120 includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
  • the third filter 126 includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter. The spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm.
  • each of the first filter 104, the second filter 120 and the third filter 126 include the plurality of layers arranged sequentially such that, a first layer comprises spunbond filter of 12 gsm, a second layer comprises of meltblown of 18 gsm in a set of three layers and a third layer comprises of spunbond of 40 gsm, thereby forming multilaminate nonwoven layers of the filters 104, 120, 126 of device 100 of the present invention.
  • the first filter 104 covers the posterior top portion of the frame 106 and is designed to cover the plurality of windows 108 and inner surface of the central air flow window 122 is kept uncovered. This facilitates safe breathing through the plurality of windows 108 which are covered with the first filter 104 and it facilitates pathway for the forceful exhaled air into the central air flow window 122 of the device 100 for multi- tier filtration of the forcefully exhaled air.
  • the inner surface of the first filter 104 facilitates the absorption of coughed and sneezed out aerosols.
  • the second filter 120 is placed at the posterior portion of the central air flow window 122 thereby covering the central air flow window 122.
  • the second filter 120 is removably attached at the upper surface of the air flow window 122 and rests on the central air flow window 122 thereby allowing angular rotation of the second filter 120 about the upper surface of the central air flow window 122 resulting in partial obstruction to the forceful exhaled air as disclosed in FIG. 3B and 3C.
  • the third filter 126 cover the posterior surface of the third pad 124 for filtering out the forcefully exhaled air coming from the central airflow window 122.
  • the breathing device 100 is designed to address the forceful exhalation which is the main component of the breathing device 100 to cover, catch and trap contagion aerosols of the infected individual forcefully exhaling out with the act of cough and sneeze.
  • the multi-tier filtration along with the cough aerodynamics of the device 100 and the placement of the windows 108, 122, 128 of the device 100 help in efficiently filtering the infected aerosols and addresses the issues of ventilation comfort of the respirator which is most important to the user while using the device 100.
  • the device 100 with its bacterial and particulate respiratory filtration efficiency addresses the forceful infected cough and sneezed aerosol thereby facilitating safe breathing.
  • the device 100 helps to break the chain of disease transmission by catching and trapping the aerosols with contagion.
  • FIGS. l to 4H a preferred method of operation of the device 100 in accordance with the present invention is described.
  • the device 100 provides the multi-tier protection mechanism in accordance to the present invention.
  • a first step the device 100 is positioned over the nasal bridge of the user so as to enclose the user's nose and the mouth.
  • the air flow is entrapped into the first pad 102 such that the air encounters for the first time by the first filter 104 and first pad 102. It is to be noted that in this step a first tier filtration of the air is achieved.
  • the first encountered air flows to the second filter 120.
  • the second filter 120 At this encounter of air flow to the second filter 120 most of the respiratory mucosal droplets get entrapped in the absorbable material of the second filter 120 to achieve a second tier filtration of the air.
  • the forceful air along with the infected mucosal droplets hit the second filter 120 coming across the flow thereby pushing the central air window 122 forward at the same time to filter the air and the filtered air flow then hits the third pad 124. In this process maximum mucosal droplets are absorbed and entrapped into the material of the second filter 120 resulting in change in the air flow direction.
  • Air flow passes towards the third pad 124 causing the isolation and entrapping of the respiratory mucosal droplets leading to reduced burden of the respiratory mucosal droplets along with airborne contagions from the air flow to achieve a third tier filtration of the air.
  • the air flows from the third pad 124 towards the third filter 126 resulting change of the airflow in upward direction thereby achieving fourth tire filtration.
  • the arcuate cover 128 includes the central airflow outlet window 130 at a predefined position to control and monitor the air flow coming from the third filter 126.
  • the third filter 126 anteriorly covers the central airflow outlet windowl30 of the arcuate cover 128.
  • the third filter 126 facilitates airflow change in the upward direction towards the central airflow outlet window 130 of the arcuate cover 128.
  • the filtered air from the central airflow outlet window 130 of the arcuate cover 128 enters into the cap 132, directing the air flow in downward direction to the outlet 134. Finally through the outlet 134, the filtered out air passes out and mixes into the general atmospheric air at the safest level.
  • the device 100 assures the complete isolation and entrapping of mucosal droplets from the cough and sneezed out contaminated air which is entering into the device and simultaneously the air gets filtered out through the multi-tier filtration process.
  • the device 100 of the present invention can advantageously be applied in varied industries such as the chemical industries, the coal mining industries and the like where there are chances of inhalation of harmful chemicals and smoke that can be hazardous to a healthy human being. Apart from the infected individual, the device 100 of the present invention can also be used by any healthy individual to prevent himself from polluted air and air borne diseases.
  • kits 500 in accordance to a preferred embodiment of the present invention comprises a breathing device 502, atleast one disinfectant solution bottle 504, atleast one measuring cylinder 506, atleast one disinfectant container 508, a plurality of pair of hand gloves 510, a user manual 512 and a stock of filters and pads 514.
  • the breathing device 502 includes the elements as disclosed in FIGS. 1 to 5.
  • the atleast one disinfectant solution bottle 504 contains a disinfectant solution.
  • the stock bottle of disinfectant solution contains 1 liter of 100% of sodium hypochlorite solution and the like.
  • the atleast one measuring cylinder 506 is used for measuring the disinfectant solution to prepare required percentage and quantity of the disinfection solution.
  • the atleast one disinfectant container 508 is used for disinfecting the contaminated and used filters and pads.
  • the disinfectant container 508 of about one litre capacity having rounded large size opening and being covered with tight fitting lid for easy to open and easy to close the container opening is used for the disinfection of the contaminated or used filters and pads.
  • the plurality of pair of hand gloves 510 is used for handling of the contaminated material.
  • the user manual 512 includes guidelines and instructions for the use of the kit 500 while replacing the used filters and pads and while disinfecting the used contaminated filters and pads.
  • the kit 500 acts as a personal home base disinfection system, thereby aiding to reuse the breathing device 502 by mere replacing the contaminated filters and pads by new sets of filters and pads from the kit 500.
  • the stock of filters and pads 514 contains atleast fifteen respective filters and respective pads. The used filters and pads are replaceable with the new filters and pads.
  • the breathing device 100/502 for preventing airborne diseases is designed on the principle of catching, trapping and killing of the infectious air borne germs coughed and sneezed out in the common atmosphere.
  • the kit 500 of the present invention works on the principle of noninvasive isolation, entrappment and killing of the infectious airborne germs before transmitting them into the environment.
  • the body of the device 100/502 is made of medical grade polymer, preferably by medium density poly ethlylene or high density poly ethylene.
  • Example 1 Determination of particulate filtration efficacy of filters
  • the filters used for the tests were spunbond of 12 gsm, meltblown of 18 gsm and spunbond of 30 gsm.
  • a cylindrical container was used for the test. The container was divided into four chambers as follows:
  • Chamber 2 and 3 was separated by meltblown 18 gsm - filter 2 ⁇ Chamber 3 and 4 was separated by spunbond 30 gsm - filter 3
  • Example 2 Bacterial filtration efficacy test of breathing device The bacterial filtration efficacy test at the South India Textile Research Association, Coimbatore was conducted to detect the filtration efficiency of device 100 by employing a ratio of the upstream bacterial challenge to downstream residual concentration. The test was a quantitative method and evaluated the filters. In this test, approximately 10 ml of Tryptic soy broth was inoculated with Staphylococcus aureus ATCC 6538 and incubated at 37 ⁇ 2°C with mild shaking for 24 ⁇ 2 hrs.
  • the culture was then diluted in peptone water to achieve a concentration of 5 x 105 cfu/ml.
  • the challenge delivery rate was maintained at 2200 ⁇ 500 viable particles per test sample.
  • the challenge suspension was pumped through a nebulizer at a controlled flow rate (28.3 L/min) and fixed air pressure which in turn formed aerosol droplets of 3.0 ⁇ 0.3 ⁇ .
  • the aerosol droplets generated in aerosol chamber was drawn through Anderson samplers for collection. The collection flow rate through the test sample and Andersen Sampler was maintained at 28.3 L/min. Negative control sampling was done by collecting a 2 min sample of air from the aerosol chamber to confirm the sterility.
  • test sample was carried out for a minute with the aerosol through the cascade impactor. All the plates were incubated at 37 ⁇ 2°C for 48 ⁇ 4 hrs and the colonies formed in each plate were counted and converted to % filtration efficiency using the following formula:
  • sample 1 was the first set of S-M-M-S multilaminate non woven fabric polypropylene filters tested three times in Trail 1, Trail 2, and Trail 3.
  • the result showed 99.82 % bacterial filtration efficiency in trail 1, 99.92 % bacterial filtration efficiency in trail 2 and 99.7 % bacterial filtration efficiency in trail 3, thus with an average bacterial filtration efficiency as 99.81 %.
  • the bacterial filtration efficacy of the first filter set was 99.81 %.
  • Sample 2 was the second set of S-M-M-M-S multilaminate non woven fabric polypropylene filters tested three times in Trail 1, Trail 2 and Trail 3.
  • the particle filtration efficacy test at the South India Textile Research Association, Coimbatore was conducted according to the ASTM Designation F2299. This test was performed on device 100 that allowed a flow rate of 1 cubic foot per minute (CFM) of aerosol particles through it. Minimum 5 samples were taken, each sample being 5 x 5 inches (minimum 12 x 12 cm).
  • CFM cubic foot per minute
  • the procedure followed for the particle filtration efficiency test involved the generation of the particle aerosol using NIST traceable polystyrene microspheres (latex particles).
  • the aerosol particles were passed through the filters of device 100.
  • the filtered aerosol particles were then passed to the particle counter which was used to count the number of aerosol present in the filtered aerosol.
  • the latex particles used in this test have a narrow standard deviation and the design of the aerosol generator produced consistent aerosol particles. Testing was carried out with a particle size of 0.3 ⁇ .
  • the particle counter was an optical laser based device and operated at a flow rate of 1 cubic foot per minute (CFM) or 28.3 liters per minute (LPM).
  • Example 4 Air permeability test or the Breathing Resistance (Delta P) test of the breathing device
  • the air permeability test or the Breathing Resistance (Delta P) test at the South India Textile Research Association, Coimbatore was performed to determine the resistance airflow of the device 100.
  • the test was performed according to MIL-M-36954C.
  • a controlled flow of air was driven through two samples, namely the first set and the second set of filters of the present invention.
  • the pressure before and after the sample was measured and the difference in pressure was divided by the surface (in cm2) of the samples. Results were expressed in mmH20/cm2.
  • the device 100 felt cooler and easier to breathe through, and that the device 100 maintained its shape in a better way as there was less pressure on the samples. There was less unfiltered air escaping around the device 100.
  • the samples were tested at : R.H. 65 % +/- 2% and temperature 21 degree C+/-1 degree C. It is known that air permeability measures the air flow resistance and this was the objective of this test for device 100 to measure of breathability. A controlled flow of air was driven through the device 100 and the pressure on either side of the device 100 was determined. The difference in pressure was measured and divided by the surface area (cm2) of the device 100 segment tested as shown in Table 5.
  • the first set of filters S-M-M-S of the device 100 had Delta P value of 3.24 mm H 2 0/cm2 and the second set of filters S-M-M-M-S had the Delta P value of 3.7 mm H 2 0/cm2 as shown in Table 6. Both the sample values indicated that, the device 100 is acceptable for the breather and that the delta value of 3.2 mm H 2 0/cm2 is very close to 2 mm H 2 0/cm2 indicating comfortable acceptance to the user.
  • Example 5 Multi-tier filtration efficiency test of the breathing device
  • the multi-tier filtration efficiency test of the device 100 of the present invention at the Department of Nuclear Medicine, Seth G.S. Medical College and K.E.M. Hospital, Mumbai was conducted. The aim of this test was to evaluate the multitier filtration efficiency of the device 100 of the present invention and to assess the particulate filtration efficiency of the device 100 of the present invention.
  • the filter set was prepared having filters in sequence of S-M-M-M-S i.e spunbond of 40 gsm, 3 layers of meltblown of 18 gsm, and spunbond 12gsm.
  • the device 100 included 4 filter levels, namely: a. Filter 1- Inner chamber filter- covering the breathing window and inner surface of the inner chamber b. Filter 2- Flap valve filter- covering the cough window c.
  • Filter 3 Outer chamber filter- covering the outlet window d.
  • Filter 4 Collection strip filter- placed over the outlet window
  • the multi-tier device 100 was exposed to 50mciof Tc and DTPA was nebulised into aerosol of particle size ranging between 0.1 and 0.5 um and passed through the inlet of device 100 for 10 minutes. Immediately the filters were separated from the device 100 and were scanned under GE Infinia gamma camera with a single head, low energy high resolution collimator for 2 minutes. The counts were measured and the results were as follows as shown in Table 7 below:
  • the Filter 4 that acts as a collection strip which is placed on the outer side of the second chamber covering the air flow outlet window determined that the particles escaping from the device 100 correlate the filtration efficiency of the entire device 100.
  • the particles trapped in the Filter 4 formed only 5 % of the entire particle count trapped in device 100.
  • This marked decline of the radioactive particles from 12000 particles to 2000 to 3000 to finally 1000 particles escaping from the air flow outlet window on the consecutive filters proved that the device 100 is a multitier filtration device.
  • Example 6 Microbial testing of the breathing device
  • the aim of this study was to check the bacterial filtration efficacy of the multitier filtration system of the device 100.
  • the study was a cross sectional interventional study conducted at Department of Pulmonary
  • series 1 was sputum collected in a sterile container for gram staining and bacterial culture
  • series 2 was open cough in a blood agar plate
  • series 3 was covered cough with application of device 100 in a blood agar plate.
  • a series consisted of Al, A2, A3.
  • B had Bl, B2 and B3 and the like for C,D and E.
  • the multi-tier filtration device 100 showed 100 % filtration efficacy since no growth was obtained from the samples collected after the application of device 100 with its filtration system by the patients. This result proved the efficiency of the device 100. Further, the test report of microbial testing of the device 100 was conducted by Department of Pulmonary Medicine and Department, of Microbiology, B J Medical College, Pune as shown in Table 9.
  • cases were selected as per protocol for having respiratory tract infection.
  • the cough containing contagious aerosol was spread on blood agar plates.
  • the open cough in a blood agar plates showed growth of contagious bacteria.
  • the same cases were tested after applying the device 100 having effectively covering cough aerosol and it was observed that after applying device 100 over the case's face covering nose and mouth gave no growth of bacteria on blood agar plates placed in front of device air flow outlet window. This showed effective filtration of the cough and forced exhaled contagious aerosol air and resulted in effective breaking of chain of disease transmission of challenging airborne diseases.
  • the device 100 have a bacterial filtration efficiency of 99.98 % and particulate filtration efficiency range from
  • the air permeability was in the range of 3.2- 3.7 mmH20/cm2 indicating acceptable levels according to International standards and higher comfort ability for the user.
  • the clinical study on the respiratory infection cases showed 100 % bacterial filtration efficiency thereby proving device 100 efficacy and safety for user and the community.
  • the radio nuclear study with higher challenge to the device 100 continuously for 20 minutes proved its multitier filtration efficiency along with total particulate filtration efficiency.
  • the device 100 of the present invention is a multitier filtration system for forcefully exhaled air, thereby preventing disease transmission.
  • the device 100 is a main device in near future to control air borne diseases globally.
  • the breathing device 100 for preventing airborne diseases helps the infected person who is the user of this device receive filtered air to avoid further damage to his health.
  • the breathing device 100 of the present invention Further, family or people in frequent contact with the infected person are at minimum risk of getting infected as the air breathed out by the infected person is filtered by the breathing device 100 of the present invention.
  • the breathing device 100 of the present invention The breathing device
  • the breathing device 100 for preventing airborne diseases of the present invention is reusable and can be kept on the face or used even during the night when the person using it is sleeping. Furthermore, the breathing device 100 for preventing airborne diseases of the present invention also includes a disinfection kit to make sure that all the parts of the device are disinfected before they are replaced or disposed in order to avoid spreading microbes through used device 100. All the equipments necessary for comfortable use and disinfection are available in the kit along with the breathing device 100 for preventing airborne diseases.
  • the Straps provided for putting the device on the face are of suitable material and the breathing device 100 of the present invention is designed in such a way that gives maximum comfort to the user.
  • the breathing device 100 is user friendly and can advantageously be applied in varied industries such as the cotton industries, chemical industries, the coal mining industries, etc where there are chances of inhalation of harmful chemicals and smoke that can be hazardous to a healthy human being.
  • the device 100 of the present invention can also be used by any healthy individual to prevent himself from polluted air and air borne diseases.
  • the breathing device 100 for of the present invention has a low manufacturing cost and can be affordable by a common man of the society.
  • the device 100 acts as an effective barrier for controlling the spreading of airborne diseases or other respiratory problems in workers working as garbage cleaners, sweepers, cleaners of public transport places, savage workers, traffic police personals, construction workers, cotton mill and handloom and power loom workers, workers of different food industries exposed to the organic dust of gridding of the seeds and grains, farmers exposed to the many allergens and organic dust contaminated with many fungi giving the hyper sensitive pneumonitis and many respiratory disorders related to the occupational exposer, sugar factory workers which are at risk of developing occupational respiratory disorders, other related industries, etc.
  • the device 100 of the present invention if used according to the preferred embodiment disclosed above is very easy to use. It will be further appreciated that the device 100 of the present invention has got high adaptability among the users because of the novel structure and standardized operational use as disclosed in the present invention.

Abstract

Disclosed is a breathing device for preventing airborne diseases. The breathing device comprises a first chamber, a second chamber, a third chamber, an arcuate cover, a cap, an outlet and a plurality of flexible straps. The breathing device is removably positionable over the nasal bridge and extendable up to the chin. The breathing device acts on the principle of catching, trapping and killing of the infectious air borne germs coughed and sneezed out in the common atmosphere. The breathing device provides an effective contaminated air barrier and a reusable multi-tier filtration system to prevent disease transmission. The present invention also provides a kit to make sure that all the parts of the breathing device are disinfected before they are replaced or disposed.

Description

BREATHING DEVICE FOR PREVENTING AIRBORNE DISEASES Field of the invention
The invention relates to a breathing device for preventing airborne diseases for preventing airborne infections and more particularly, to a device for filtering air by trapping and killing the infectious and contagious air borne germs by providing multi-tier filtration mechanism and advantageously resulting in safe breathing. Background of the invention
The common source of breathing air for all human beings is an atmospheric air. For healthy and disease free life the atmospheric air should be clean and free from infectious microbes. But if the source of breathing gets contaminated it can lead to uncontrolled growth of many air borne contagious diseases and various bacteria, viruses may contaminate the atmospheric air.
Once the air gets contaminated, it leads to various air borne diseases like tuberculosis, influenza, swine flu, SARS, etc. Tuberculosis is one of the most dangerous contaminants. Tuberculosis generally attacks the lungs, and may affect other parts of the body. Symptoms of this disease are a chronic cough with blood- tinged sputum, fever, night sweats, and weight loss. It spreads though the air contaminated by cough or sneeze of the infected person. People who are in prolonged, closed and frequent contact with the infected TB person are at high risk of getting infected. It may spread at faster rate in overcrowded areas. The person who gets infected may not show symptoms immediately, which may lead to development of the disease that remains untreated and results into death.
One third of the world's population is thought to have been infected by tuberculosis. The rate is increasing each year by 1% of the population. Treatment for this disease is difficult and time taking. It involves prolonged consumption of multiple antibiotics. Some antibiotics and vaccines are available for the treatment. Use of these medicines for long time may affect the health and cause some side effects. Now-a-days tuberculosis has developed resistance for antibiotics. One basic principle is that the atmospheric air is the common source of breathing air for all the living beings on this earth. Humans inspire n-number of breathes per minute (12-16 per minute) and throughout the day and night. This process starts from birth until death. It is well known that infinite number of viruses and bacteria are the main contaminants of the atmospheric air. Inspired air is the common associated factor for all living being and as they come in contact with the infected or contaminated air, they are vulnerable for many air borne diseases. Air borne diseases are the largest infectious diseases affecting mankind leading to the highest morbidity and mortality.
In addition to elimination of the contagious organism it is a most essential to decrease the environmental load of the contagions. (The commonly shared environment of day today life - the environment of the living houses, work places, and the all other public places which are shared together by many.) The process of personal respiratory sanitation, by using effective tool barrier and standard process of contagion elimination will lead to successful control over the spread of air borne disease. This can be lead to disease control. And with sustained efforts and personal respiratory sanitation practices we can dream for disease elimination.
Till date, many efforts have been done to achieve the state of control and eradication of air borne diseases. Pneumonia is a leading cause of childhood mortality. With 43 million new cases India tops the list of 15 countries across the world with high burden setting. Importantly Tuberculosis transmission in the community remains an important obstacle to achieving control of the RNTCP. In the background of TB endemicity and resource limited setting we have poor infection control strategies of Tuberculosis. Globally 3.5 % of new cases and 20% of previously treated cases have MDR. 9 % of MDR cases have TDR TB. According to WHO 2014 half of the estimated MDR cases are in India, China and Russian Federation.
Many diseases are spread via respiratory droplets that are propelled into the air by sneezing and coughing. The aerosols generated by coughing and sneezing contain droplets of moisture of varying size that are contaminated with infectious agents. Medium sized droplets enter the nasopharynx of another healthy individual, and can adhere to nasopharyngeal epithelial cells thereby causing infection. Moisture in the smallest particles usually evaporate rapidly, and form droplet nuclei, which are very light and remain airborne for some time. The small size and light weight, droplet nuclei are dictated air currents, and, if inhaled, they flow with inhaled air far down the respiratory tract, possibly reaching the alveoli. As a result, inhaling large or medium sized droplets tends to cause upper respiratory tract infections, while inhaling the smallest particles (droplet nuclei) can cause pneumonia. Diseases that are typically spread by inhalation of medium sized droplets include bacteria (e.g., Neisseria meningitidis [a cause of bacterial meningitis] and Streptococcus) and viruses (e.g., many viruses causing the common cold, laryngitis, tracheitis and also influenza viruses). In contrast, tuberculosis (caused by the bacterium Mycobacterium tuberculosis is spread by droplet nuclei.3, 4
A susceptible individual can therefore acquire disease by inhalation of airborne particles. On the paucity of research in new drug molecules of tuberculosis it is a great challenge to control and cure the disease. Thus in developing countries like India, the main thrust should be on prevention.
The earliest intervention is required if an individual is suffering from cough or sneeze in the origin of suspicious airborne disease. Giving a barrier can prevent the individual and his family and society by earliest intervention of breaking the chain of disease transmission. In India with a background of malnutrition and multi factorial immune suppression is a larger problem, and therefore it is better to protect the society. Respiratory illnesses are frequently avoidable, and prevention costs only a fraction of treatment. The ability to control and eliminate respiratory diseases worldwide relies on public health measures, which include increasing awareness, education, and capacity. Personal respiratory protection for the community and infectious patient isolation will be difficult to implement. The Healthcare Infection Control Practices Advisory Committee HICP AC/CDC strategy proposed has been termed Respiratory Hygiene/Cough Etiquette and is intended to be incorporated into infection control practices as a new component of Standard Precautions. The strategy is targeted at patients and accompanying family members and friends with undiagnosed transmissible respiratory infections, and applies to any person with signs of illness including cough, congestion, rhinorrhea, or increased production of respiratory secretions when entering a healthcare facility.
There are industries like the cotton industries, chemical industries, coal mining industries, etc where there is high risk of getting various respiratory infections to the workers. There is a very high risks of infection or respiratory problems to workers working as garbage cleaners, sweepers, cleaners of public transport places, savage workers, traffic police personals, construction workers, cotton mill and handloom and power loom workers, workers of different food industries exposed to the organic dust of gridding of the seeds and grains, farmers exposed to the many allergens and organic dust contaminated with many fungi giving the hyper sensitive pneumonitis and many respiratory disorders related to the occupational exposer, sugar factory workers which are at risk of developing occupational respiratory disorders, etc. Currently available surgical mask are not reusable and are not effective barriers in the prevention of transmission of air borne disease. CDC recommends N95 respirator mask as a protective device for air borne disease. Patent no. US2009145445A1 discloses a cough catcher with protection against germ transmission by hand contact. The device described is of oval or circular shape and made up of flexible impermeable material or rubber. It has single hallow chamber and filter vents are present at the bottom and at side. Filtered air is blown out from the side filter air vents. The disinfectant system for this device is inbuilt. It can be used only during the day time, when a person is awake to hold the device by hand near mouth but does not give any protection to family members during night when the infected person is sleeping.
Similarly, United States patent US2005194010A1 titled disposable contagion transmission prevention device and method of using a disposable contagion transmission prevention device discloses a device that has a single chamber with two surfaces, outer surface and interior surface. It covers nose and mouth when hold on the face, which may cause hand contamination. It is made up of absorbent fibrous material which has multiple filtering layers. Though the device is disposable, disinfectant provisions are not provided for disposal. It may spread infectious microbes through the used device if not disposed properly.
Further, patent CN202445176U titled three-dimensional mask capable of filtering out particles discloses a device which is a hollow (without chambers) three layered structure, which acts as a three tier filtration system for inhaled/exhaled air. These layers are made up of materials such as cotton, textile fabrics, woven fabric compound polypropylene, non woven fabric filter disc etc. It is the disposable device where disinfection system is not provided. The device is to be put on the face with the help of laces, where hand contamination is possible. Similarly, the patent US4688566A discloses a disposable filter mask having cup shape. It has three layered filter in which an outer layer made up of a relatively porous paper like material, the middle layer consist of polyethylene or polypropolyene, or other material, which are filtering materials. The innermost layer is made up of a soft material for providing non-irritating surface. The device is held on the face with straps that avoids leakage of contaminated air out of the device.
Furthermore, a Chinese patent CN103263093A discloses a dust mask for elastically sealing two sides of nose bridge. It prevents inhalation of dust through nose. This mask is of clock shape which seals only two sides of nose-bridge and does not covers mouth and entire nose. It has three filtering layers in which, outer layer is made up of non woven fabric, middle layer is of melt blown non woven fabric and inner layer of White sized non woven fabric.
Till date, many efforts have been done to achieve the state of control and eradication of various air borne diseases. However, it must be accepted universally that in spite of our strenuous efforts, we have still not reached a point where we have successfully eradicated the spread of airborne diseases or air contaminants. Further, there are no devices in art that can provide a foolproof protection to any healthy human being including family members of the infected person, or the workers working in various industries that have risk of getting respiratory infections To overcome the aforesaid problems of the prior art, safer and the most effective way is to prevent contamination by using devices that prevents spreading of harmful bacteria and viruses, prevents inhalation of harmful and toxic compounds. Thus, there exists a need for a safe and effective breathing device for preventing airborne diseases that avoid further contamination of air and that provides foolproof protection to other healthy human beings as well as the user himself to control transmission of the dreaded air borne diseases by providing an effective contaminated air barrier and a reusable multi-tier filtration system to prevent disease transmission. Summary of the Invention
Accordingly, the present invention discloses a breathing device for preventing airborne diseases. The breathing device comprises a first chamber, a second chamber, a third chamber, an arcuate and a cap. The first chamber, the second chamber, third chamber, the arcuate cover and the cap are aligned along an axis for a multi-tier filtration of air.
The first chamber is defined between a first pad and a first filter. The first pad and the first filter are separated by a frame. The first pad is positioned anteriorly on the frame. The frame includes a plurality of windows on a top portion thereof. The plurality of windows acts as breathing window. The first filter is positioned posteriorly on the plurality of the windows. A nasal bridge cushion, a facial cushion and a chin cushion are lined anteriorly at a predefined position around the frame and a plurality of flexible straps is positioned on the sides of the frame through a plurality of opposed rivets Ά' .
The second chamber is defined between a second pad and a second filter. The second pad and the second filter are positioned posteriorly on the frame. The second chamber defines a central airflow window thereon. A top end of the second filter is adhesively attachable on an upper surface of the central air flow window and a bottom end of the second filter rests on the central air flow window thereby angularly rotating the second filter about the upper surface of the central air flow window. The third chamber is defined between a third pad and a third filter positioning posteriorly on the central airflow window. The arcuate cover is positioned posteriorly on the third chamber through an opposed pair of rivets Ά'. The cap is positioned on the arcuate cover. The cap receives the exhaled filtered air from the arcuate cover for passing into an atmosphere through an outlet. The first filter, the second filter, the third filter and the first pad, the second pad and the third pad are removably attachable at predefined positions on the frame by an adhesive. The first pad, the second pad and the third pad is made of non woven cotton material covered by woven cotton fibre gauze.
The first filter, the second filter and the third filter are arranged in multi- layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof. The spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm. In one embodiment, the first filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter. The second filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter. The third filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
In other embodiment, the first filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter. The second filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter. The third filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
In another embodiment, the present invention provides a kit for preventing airborne diseases. The kit comprises a breathing device, atleast one disinfectant solution bottle containing a disinfectant solution, atleast one measuring cylinder, atleast one disinfectant container, a plurality of pair of hand gloves, a user manual having guidelines and instructions. The breathing device includes a plurality of chambers, each chamber having a filter and a pad. The atleast one measuring cylinder is used for measuring the disinfectant solution to prepare required percentage and quantity of the disinfection solution. The atleast one disinfectant container is used for disinfecting the contaminated and used filters and pads. The plurality of pair of hand gloves is used for handling of the contaminated material. A first filter, a second filter and a third filter are arranged in multi-layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof. The spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm. The plurality of pads is made of non woven cotton material covered by woven cotton fibre gauze.
Brief description of the drawings
FIG. 1 is an exploded view of a breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention;
FIG. 2A is a front view of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention;
FIG. 2B is a oblique view of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention;
FIG. 2C is a rear view of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention;
FIGS. 3 A to 3F is a sequential arrangement of a plurality of filters and a plurality of pads of the breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention;
FIGS. 4A to 4H shows the breathing device for preventing airborne diseases in operation, in accordance with a preferred embodiment of the present invention; FIG. 5 is a kit with a breathing device for preventing airborne diseases, in accordance with a preferred embodiment of the present invention;
FIG. 6A shows a test chamber for testing a filtration efficacy of the filters of the breathing device; FIG. 6B shows results of the filtration efficacy of the breathing device under GE Infinia gamma camera with a single head, low energy high resolution collimator; and
FIG. 6C shows results of the filtration efficacy of the breathing device under GE Infinia gamma camera with a single head, low energy high resolution collimator.
Detailed description of the drawings
Although specific terms are used in the following description for sake of clarity, these terms are intended to refer only to particular structure of the invention selected for illustration in the drawings, and are not intended to define or limit the scope of the invention.
In general aspect, the present invention provides a breathing device for preventing airborne diseases in accordance with a preferred embodiment of the present invention is disclosed. The breathing device is removably positionable over a nasal bridge and extendable up to the chin. The device is designed in such a way so as to provide a sealing fit over the bridge of the user's nose, extending downwards along the cheek lines beneath the user's chin so as to enclose user's mouth and nose within an interior cavity. In the context of the present invention, the principal object of the present invention is to effectively filter infectious exhaled air from the nostril and the mouth of the patient while coughing and sneezing. The coughed out air will pass through multi-tire filtration levels and then be exhaled out. The aim is to exhibit high bacterial filtration efficacy.
Referring to FIGS. 1 to 4H, a breathing device 100 comprises a first chamber, a second chamber, a third chamber, an arcuate cover 128 and a cap 132 aligned along an axis for a multi-tier filtration of air.
The first chamber is defined between a first pad 102 and a first filter 104. The first pad 102 and the first filter 104 are separated by a frame 106 such that the first pad 102 is positioned anteriorly on the frame 106. The frame 106 includes a plurality of windows 108 on a top portion thereof. The plurality of windows 108 acts as breathing windows. The first filter 104 is positioned posteriorly on the plurality of windowsl08. A nasal bridge cushion 110, a facial cushion 112 and a chin cushion 114 are lined anteriorly at a predefined position around the frame 106 such that the facial cushion 112 covers the entire inner portion of the frame 106 and the chin cushion 114 is at the bottom end of the facial cushion 112. The frame 106 includes a plurality of flexible straps 116 positioned on the sides thereof through a plurality of opposed rivets Ά' . The device 100 is removably positionable on the nasal bridge of the user's face with the plurality of flexible straps 116 such that the user's nose and mouth are enclosed in accordance to the preferred embodiment of the present invention. The anterior portion of the frame 106 is lined by the first pad 102 such that the first pad 102 covers the inner portion of the frame 106. The first pad 102 is removably attachable by an adhesive at the anterior portion of the frame 106.
The second chamber is defined between a second pad 118 and a second filter 120. The second pad 118 and the second filter 120 are positioned posteriorly on the frame 106. The second chamber defines a central airflow window 122 thereon. A top end of the second filter 120 is adhesively attachable on an upper surface of the central air flow window 122 and a bottom end of the second filter 120 rests on the central air flow window 122 thereby allowing an angular rotation of the second filter 120 about the upper surface of the central air flow window 122.
The second pad 118 and the first filter 104 are removably attached to the posterior portion of the frame 106 such that the second pad 118 is lined at the outer bottom portion of the frame 106 and the first filter 104 is lined at the outer top portion of the frame 106. The second pad 118 and the first filter 104 are attached by an adhesive.
The third chamber is defined between a third pad 124 and a third filter 126. The third pad 124 and the third filter 126 are positioned posteriorly on the central airflow window 122. The first pad 102, the second pad 118 and the third pad 124 is made of non woven cotton material covered by woven cotton fibre gauze. The filters 104, 120, 126 and the pads 102, 118, 124 are removably attachable at predefined positions on the frame 106 by an adhesive. The second filter 120 acts as a central air flow filter and is lined at a predefined position on the third pad 124 such that the second filter 120 is attached at an anterior upper portion of the third pad 124.
The pads 102, 118, 124 are specially designed and have a predefine shape to appropriately fit at the predefined portions of the device 100. The pads 102, 118, 124 further are lined by a medical grade adhesive at inner borders thereof for removably being attached inside the body of the device 100. The filters 104, 120, 126 and the pads 102, 118, 124 play a very important role of entrapping the contagious respiratory mucosal droplets along with contagions and filtering out the contagious air which is forcefully exhaled out by the person wearing the device 100.
The arcuate cover 128 is positioned posteriorly on the third chamber through an opposed pair of rivets Ά' . The arcuate cover 128 is removably coupled on the frame 106 at predefined positions and includes a central airflow outlet window 130 to exhale the filtered air from the device 100. The frame 106 and the arcuate cover 128 are connected with the central air flow window 122 for monitoring a unidirectional flow of air and filtering the air to safer level by filtration technique by removing the major mass of contagions present in the mucous droplet of cough and sneeze before entering into the common atmosphere. The cap 132 is positioned on the central airflow outlet window 130 of the arcuate cover 128. The cap 132 defines an outlet 134 at the bottom end portion thereof. The cap 132 receives the exhaled filtered air from the arcuate cover 128 for passing into an atmosphere through the outlet 134.
As shown in FIG. 1, the first filter 104, the second filter 120 and the third filter 126 are arranged in multi-layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof. In an embodiment, the first filter 104 includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter. The second filter 120 includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter. The third filter 126 includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter. The spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm. However, it is understood that these spunbond filter and the meltblown filter are used in other gsm range in alternative embodiments of the breathing device. In this preferred embodiment, each of the first filter 104, the second filter 120 and the third filter 126 include the plurality of layers arranged sequentially such that a first layer comprises spunbond filter of 12 gsm, a second layer comprises of meltblown of 18 gsm in a set of two layers and a third layer comprises of spunbond of 40 gsm, thereby forming multilaminate nonwoven layers of the filters 104, 120, 126 of device 100 of the present invention.
In another embodiment, the first filter 104 includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter. The second filter 120 includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter. The third filter 126 includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter. The spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm. In this preferred embodiment, each of the first filter 104, the second filter 120 and the third filter 126 include the plurality of layers arranged sequentially such that, a first layer comprises spunbond filter of 12 gsm, a second layer comprises of meltblown of 18 gsm in a set of three layers and a third layer comprises of spunbond of 40 gsm, thereby forming multilaminate nonwoven layers of the filters 104, 120, 126 of device 100 of the present invention.
Now referring to FIG. 3A to 3F, a sequential arrangement of the filters
104, 120, 126 and the pads 102, 118, 124 of the breathing device 100 for preventing airborne diseases in accordance with the present invention is shown.
Referring to FIG. 3 A, the first filter 104 covers the posterior top portion of the frame 106 and is designed to cover the plurality of windows 108 and inner surface of the central air flow window 122 is kept uncovered. This facilitates safe breathing through the plurality of windows 108 which are covered with the first filter 104 and it facilitates pathway for the forceful exhaled air into the central air flow window 122 of the device 100 for multi- tier filtration of the forcefully exhaled air. The inner surface of the first filter 104 facilitates the absorption of coughed and sneezed out aerosols. The second filter 120 is placed at the posterior portion of the central air flow window 122 thereby covering the central air flow window 122. The second filter 120 is removably attached at the upper surface of the air flow window 122 and rests on the central air flow window 122 thereby allowing angular rotation of the second filter 120 about the upper surface of the central air flow window 122 resulting in partial obstruction to the forceful exhaled air as disclosed in FIG. 3B and 3C. Now referring to FIG. 3D and FIG. 3F, the third filter 126 cover the posterior surface of the third pad 124 for filtering out the forcefully exhaled air coming from the central airflow window 122. The breathing device 100 is designed to address the forceful exhalation which is the main component of the breathing device 100 to cover, catch and trap contagion aerosols of the infected individual forcefully exhaling out with the act of cough and sneeze. The multi-tier filtration along with the cough aerodynamics of the device 100 and the placement of the windows 108, 122, 128 of the device 100 help in efficiently filtering the infected aerosols and addresses the issues of ventilation comfort of the respirator which is most important to the user while using the device 100. In the context of the present invention, the device 100 with its bacterial and particulate respiratory filtration efficiency addresses the forceful infected cough and sneezed aerosol thereby facilitating safe breathing. The device 100 helps to break the chain of disease transmission by catching and trapping the aerosols with contagion. In operation, referring to FIGS. l to 4H, a preferred method of operation of the device 100 in accordance with the present invention is described. It is understood, however, that the device 100 provides the multi-tier protection mechanism in accordance to the present invention. In a first step, the device 100 is positioned over the nasal bridge of the user so as to enclose the user's nose and the mouth. When the user exhales through the nose and mouth, the air flow is entrapped into the first pad 102 such that the air encounters for the first time by the first filter 104 and first pad 102. It is to be noted that in this step a first tier filtration of the air is achieved.
In a second step, the first encountered air flows to the second filter 120. At this encounter of air flow to the second filter 120 most of the respiratory mucosal droplets get entrapped in the absorbable material of the second filter 120 to achieve a second tier filtration of the air. In a further step, the forceful air along with the infected mucosal droplets hit the second filter 120 coming across the flow thereby pushing the central air window 122 forward at the same time to filter the air and the filtered air flow then hits the third pad 124. In this process maximum mucosal droplets are absorbed and entrapped into the material of the second filter 120 resulting in change in the air flow direction. Air flow passes towards the third pad 124 causing the isolation and entrapping of the respiratory mucosal droplets leading to reduced burden of the respiratory mucosal droplets along with airborne contagions from the air flow to achieve a third tier filtration of the air. The air flows from the third pad 124 towards the third filter 126 resulting change of the airflow in upward direction thereby achieving fourth tire filtration.
The arcuate cover 128 includes the central airflow outlet window 130 at a predefined position to control and monitor the air flow coming from the third filter 126. The third filter 126 anteriorly covers the central airflow outlet windowl30 of the arcuate cover 128. On receiving the air from the third pad 124, the third filter 126 facilitates airflow change in the upward direction towards the central airflow outlet window 130 of the arcuate cover 128.
In a final filtration step, the filtered air from the central airflow outlet window 130 of the arcuate cover 128 enters into the cap 132, directing the air flow in downward direction to the outlet 134. Finally through the outlet 134, the filtered out air passes out and mixes into the general atmospheric air at the safest level. Thus, the device 100 assures the complete isolation and entrapping of mucosal droplets from the cough and sneezed out contaminated air which is entering into the device and simultaneously the air gets filtered out through the multi-tier filtration process.
The device 100 of the present invention can advantageously be applied in varied industries such as the chemical industries, the coal mining industries and the like where there are chances of inhalation of harmful chemicals and smoke that can be hazardous to a healthy human being. Apart from the infected individual, the device 100 of the present invention can also be used by any healthy individual to prevent himself from polluted air and air borne diseases.
In another embodiment, referring to FIG.5, a kit 500 in accordance to a preferred embodiment of the present invention is disclosed. The kit 500 comprises a breathing device 502, atleast one disinfectant solution bottle 504, atleast one measuring cylinder 506, atleast one disinfectant container 508, a plurality of pair of hand gloves 510, a user manual 512 and a stock of filters and pads 514. The breathing device 502 includes the elements as disclosed in FIGS. 1 to 5.
The atleast one disinfectant solution bottle 504 contains a disinfectant solution. In this one embodiment, the stock bottle of disinfectant solution contains 1 liter of 100% of sodium hypochlorite solution and the like. The atleast one measuring cylinder 506 is used for measuring the disinfectant solution to prepare required percentage and quantity of the disinfection solution. The atleast one disinfectant container 508 is used for disinfecting the contaminated and used filters and pads. The disinfectant container 508 of about one litre capacity having rounded large size opening and being covered with tight fitting lid for easy to open and easy to close the container opening is used for the disinfection of the contaminated or used filters and pads. The plurality of pair of hand gloves 510 is used for handling of the contaminated material. The user manual 512 includes guidelines and instructions for the use of the kit 500 while replacing the used filters and pads and while disinfecting the used contaminated filters and pads. The kit 500 acts as a personal home base disinfection system, thereby aiding to reuse the breathing device 502 by mere replacing the contaminated filters and pads by new sets of filters and pads from the kit 500. The stock of filters and pads 514 contains atleast fifteen respective filters and respective pads. The used filters and pads are replaceable with the new filters and pads.
In the context of the present invention, the breathing device 100/502 for preventing airborne diseases is designed on the principle of catching, trapping and killing of the infectious air borne germs coughed and sneezed out in the common atmosphere. Further, the kit 500 of the present invention works on the principle of noninvasive isolation, entrappment and killing of the infectious airborne germs before transmitting them into the environment. The body of the device 100/502 is made of medical grade polymer, preferably by medium density poly ethlylene or high density poly ethylene.
The invention is further illustrated hereinafter by means of examples. The following examples are given by way of illustration only and therefore should not be construed to limit the scope of the present invention.
In the context of the above-mentioned embodiments of the present invention, studies had been conducted at 4 different sites, namely Centre of Excellence for Medical textiles- Microbiology Laboratory The South India Textile Association- Coimbatore, Department of Pulmonary Medicine and Microbiology department, B.J.G.Medical College, Pune, Department of Nuclear Medicine, Seth G.S. Medical College and K.E.M. Hospital, Mumbai using different methodologies.
In the context of the present invention, the tests that were conducted to study the overall efficacy of the device 100, to evaluate filtration efficacy of the device 100, to evaluate particle filtration efficiency and air permeability of the device 100, are described hereinafter: Example 1: Determination of particulate filtration efficacy of filters Referring to FIG. 6A and FIG. 6B, the particulate filtration efficacy of the filters at the Department of Nuclear Medicine, Seth G.S. Medical College and K.E.M. Hospital, Mumbai was conducted as shown in FIG. 6. Aim of this test was to evaluate the efficacy of the filters of device 100. The filters used for the tests were spunbond of 12 gsm, meltblown of 18 gsm and spunbond of 30 gsm. A cylindrical container was used for the test. The container was divided into four chambers as follows:
• Chamber 1 and 2 was separated by spunbond 12 gsm - filter 1
• Chamber 2 and 3 was separated by meltblown 18 gsm - filter 2 · Chamber 3 and 4 was separated by spunbond 30 gsm - filter 3
• The 4th chamber was sealed and it acted as an collection strip - filter 4
In this test, set of filter materials for particulate filtration efficiency was tested, wherein the filter material used was spunbond of 12 gsm, meltblown of 18gsm and spunbond of 30gsm. Around 50mciof Tc DTPA was nebulised into aerosol of particle size ranging between 0.1 and0.5 um and was passed through the inlet of the device 100 for 10 minutes. The chambers were separated and the filters removed from them. All the filters were scanned under GE Infinia gamma camera with a single head, low energy high resolution collimator for 2 minutes. The counts were measured and the result was as follows as shown in Table 1 : Table 1 : Filters Counts Percentage %
Filter 1 14969 20.6 %
Filter 2 52970 73.02%
Filter 3 4224 5.8%
Filter 4 377 0.5%
The results under GE Infinia gamma camera with a single head, low energy high resolution collimator showed the following results as shown in FIG. 6B:
It was concluded from the above results that the particulate filtration efficacy tested in the specially designed chamber with use of spunbond of 12 gsm, meltblown of 18 gsm and spunbond of 30 gsm had a filtration efficacy of 99.5 % for particle size 0.1-0.5 um using 50mci of Tc DTPA and gamma scanning. It was observed that the meltblown of 18 gsm caught the highest number of particles i.e 73.02 %. These 3 sets of filters gave around 99. 5% of particulate filtration efficiency in a particle size of 0.1-0.5 um. Further, with the addition of an additional meltblown layer in the middle portion gave near to 100 % particulate filtration efficiency. This test helped in the selection of the filters for the device 100 of the present invention and in selection of required layers for the reusable device 100 of the present invention. Example 2: Bacterial filtration efficacy test of breathing device The bacterial filtration efficacy test at the South India Textile Research Association, Coimbatore was conducted to detect the filtration efficiency of device 100 by employing a ratio of the upstream bacterial challenge to downstream residual concentration. The test was a quantitative method and evaluated the filters. In this test, approximately 10 ml of Tryptic soy broth was inoculated with Staphylococcus aureus ATCC 6538 and incubated at 37±2°C with mild shaking for 24±2 hrs. The culture was then diluted in peptone water to achieve a concentration of 5 x 105 cfu/ml. The challenge delivery rate was maintained at 2200 ± 500 viable particles per test sample. The challenge suspension was pumped through a nebulizer at a controlled flow rate (28.3 L/min) and fixed air pressure which in turn formed aerosol droplets of 3.0 ± 0.3 μΜ. The aerosol droplets generated in aerosol chamber was drawn through Anderson samplers for collection. The collection flow rate through the test sample and Andersen Sampler was maintained at 28.3 L/min. Negative control sampling was done by collecting a 2 min sample of air from the aerosol chamber to confirm the sterility. Similarly positive control sampling was made for a minute without test specimen to determine the generation of total of number of viable colonies. Finally, the sampling of test sample was carried out for a minute with the aerosol through the cascade impactor. All the plates were incubated at 37±2°C for 48±4 hrs and the colonies formed in each plate were counted and converted to % filtration efficiency using the following formula:
(C-T/C)* 100, where
C=average plate count total for test controls and T=plate count total for test sample.
Following results were obtained for the bacterial filtration efficiency test ASTM F-2101-07 as shown in Table 2 and Table 3 below:
Table 2- Sample 1 : Was the first set of filters used for the study
Figure imgf000027_0001
5 815 1 1 3
6 452 1 1 2
Total 10596 19 8 24
Average 1766 3.16 1.3 4
S.No Sample 1
7 Sample 40-spunbond, 18-meltblown, 18 meltblown, 12 spunbond details (First set of filters of the device 100 of the present invention)
8. Bacterial Traill Trail 2 Trail 3 filtration
99.82 % 99.92 % 99.7 %
efficienc y test
Table 3- Sample 2: Was the second set of filters used for the study
Figure imgf000028_0001
4 Average plate count of positive control 1766
5 Average plate count of negative control 0
3 Plate count total of each stage
Plate No Positive Traill Trail 2 Trail 3
control
1 4840 0 0 1
2 2414 0 0 1
3 1112 0 0 0
4 963 0 0 0
5 815 0 0 0
6 452 0 0 0
Total 10596 0 0 2
Average 1766 0 0 0.3
S.No Sample 2
7 Sample 40-spunbond, 18-meltblown, 18 meltblown, 18 meltblown, 12 details spunbond (Second set of filters of the device 100 of the present invention) 8. Bacterial Traill Trail 2 Trail 3 filtration
99.99 % 99.99 % 99.98 %
efficienc y test
It is evident from the above results that sample 1 was the first set of S-M-M-S multilaminate non woven fabric polypropylene filters tested three times in Trail 1, Trail 2, and Trail 3. The result showed 99.82 % bacterial filtration efficiency in trail 1, 99.92 % bacterial filtration efficiency in trail 2 and 99.7 % bacterial filtration efficiency in trail 3, thus with an average bacterial filtration efficiency as 99.81 %. Thus the bacterial filtration efficacy of the first filter set was 99.81 %. Sample 2 was the second set of S-M-M-M-S multilaminate non woven fabric polypropylene filters tested three times in Trail 1, Trail 2 and Trail 3. The result showed 99.99 % bacterial filtration efficiency in trail 1, 99.99 % filtration efficiency in trail 2 and 99.98% filtration efficiency in trail 3, thus with an average bacterial filtration efficiency as 99.98 %. Thus the bacterial filtration efficacy of the second filter set was 99.98 %. The above mentioned results indicated that the device 100 of the present invention filters out 99.89 % bacteria on an average and prevents them from entering the atmosphere and thereby decreases the risk of disease transmission from infected individuals to non infected individuals. Example 3: Particle filtration efficacy test of the breathing device
The particle filtration efficacy test at the South India Textile Research Association, Coimbatore was conducted according to the ASTM Designation F2299. This test was performed on device 100 that allowed a flow rate of 1 cubic foot per minute (CFM) of aerosol particles through it. Minimum 5 samples were taken, each sample being 5 x 5 inches (minimum 12 x 12 cm). The procedure followed for the particle filtration efficiency test involved the generation of the particle aerosol using NIST traceable polystyrene microspheres (latex particles). The aerosol particles were passed through the filters of device 100. The filtered aerosol particles were then passed to the particle counter which was used to count the number of aerosol present in the filtered aerosol. The latex particles used in this test have a narrow standard deviation and the design of the aerosol generator produced consistent aerosol particles. Testing was carried out with a particle size of 0.3 μπι. The particle counter was an optical laser based device and operated at a flow rate of 1 cubic foot per minute (CFM) or 28.3 liters per minute (LPM).
Filtration Efficiency (%) = Number of aerosol particles without specimen - Number of aerosol with specimen * 100
Number of aerosol without specimen Table 4:
Figure imgf000032_0001
The above tests were done under standard test method for determining the initial efficiency of filters of the device 100 to penetration by particulates using latex spheres. The particulate filtration efficiency had been used to evaluate materials when exposed to aerosols particles size 0.3 um. In this test, the S-M-M-S sample of the first set of filters as seen in Table 4 showed a particulate filtration efficiency of 91.24 % and S-M-M-M-S sample of the second set of filters showed an particulate filtration efficiency of 95.11 %. This observation indicated that both the sample sets had an average range efficiency of particulate filtration of 91.24- 95.11 % . The aforesaid test had been done in 0.3 um particulate size. In the context of the test, the higher the percentage, the better the efficiency of device 100 of the present invention.
Example 4: Air permeability test or the Breathing Resistance (Delta P) test of the breathing device The air permeability test or the Breathing Resistance (Delta P) test at the South India Textile Research Association, Coimbatore was performed to determine the resistance airflow of the device 100. The test was performed according to MIL-M-36954C. To test, a controlled flow of air was driven through two samples, namely the first set and the second set of filters of the present invention. The pressure before and after the sample was measured and the difference in pressure was divided by the surface (in cm2) of the samples. Results were expressed in mmH20/cm2. A lower breathing resistance indicated a better comfort level for the user. It means that the device 100 felt cooler and easier to breathe through, and that the device 100 maintained its shape in a better way as there was less pressure on the samples. There was less unfiltered air escaping around the device 100. The samples were tested at : R.H. 65 % +/- 2% and temperature 21 degree C+/-1 degree C. It is known that air permeability measures the air flow resistance and this was the objective of this test for device 100 to measure of breathability. A controlled flow of air was driven through the device 100 and the pressure on either side of the device 100 was determined. The difference in pressure was measured and divided by the surface area (cm2) of the device 100 segment tested as shown in Table 5.
Table 5:
Figure imgf000034_0001
It is known that, the higher the Delta P value, the harder it is for the wearer to breathe. The Delta P is measured in units of mm H20/cm2. In the context of the aforesaid test, the ASTM (American Society of Testing Material) standard requires that the devices have a Delta P of less than 5.0, as a higher value would be considered too "hot" for general medical or surgical use and devices with a Delta P of less than 4.0 are considered acceptable, while devices with a Delta P less than 2.0 would be considered "cool". Table 6:
Figure imgf000034_0002
It was observed that the first set of filters S-M-M-S of the device 100 had Delta P value of 3.24 mm H20/cm2 and the second set of filters S-M-M-M-S had the Delta P value of 3.7 mm H20/cm2 as shown in Table 6. Both the sample values indicated that, the device 100 is acceptable for the breather and that the delta value of 3.2 mm H20/cm2 is very close to 2 mm H20/cm2 indicating comfortable acceptance to the user.
Example 5: Multi-tier filtration efficiency test of the breathing device
The multi-tier filtration efficiency test of the device 100 of the present invention at the Department of Nuclear Medicine, Seth G.S. Medical College and K.E.M. Hospital, Mumbai was conducted. The aim of this test was to evaluate the multitier filtration efficiency of the device 100 of the present invention and to assess the particulate filtration efficiency of the device 100 of the present invention. The filter set was prepared having filters in sequence of S-M-M-M-S i.e spunbond of 40 gsm, 3 layers of meltblown of 18 gsm, and spunbond 12gsm. The device 100 included 4 filter levels, namely: a. Filter 1- Inner chamber filter- covering the breathing window and inner surface of the inner chamber b. Filter 2- Flap valve filter- covering the cough window c. Filter 3 - Outer chamber filter- covering the outlet window d. Filter 4 - Collection strip filter- placed over the outlet window The multi-tier device 100 was exposed to 50mciof Tc and DTPA was nebulised into aerosol of particle size ranging between 0.1 and 0.5 um and passed through the inlet of device 100 for 10 minutes. Immediately the filters were separated from the device 100 and were scanned under GE Infinia gamma camera with a single head, low energy high resolution collimator for 2 minutes. The counts were measured and the results were as follows as shown in Table 7 below:
Table 7:
Figure imgf000036_0001
The results under GE Infinia gamma camera with a single head, low energy high resolution collimator showed the following results as shown in FIG. 6C. It was observed that filter 1 of the first chamber was shown to be exposed more and there was trapping of higher number of radioactive particles. Filter 2 that acts as a flap wall filter placed on the outer surface of the first chamber covering the cough window provided partial obstruction to the air flow and diverted the air flow, thereby reflecting trapping of lower number of particles. Filter 3 that is placed covering the outlet window in the inner surface of second chamber, which is exposed to the entering aerosol from the first chamber filtered out the particles entering the second chamber, thereby reflecting less than one fifth of the trapped particles. Finally, the Filter 4 that acts as a collection strip which is placed on the outer side of the second chamber covering the air flow outlet window determined that the particles escaping from the device 100 correlate the filtration efficiency of the entire device 100. The particles trapped in the Filter 4 formed only 5 % of the entire particle count trapped in device 100. This marked decline of the radioactive particles from 12000 particles to 2000 to 3000 to finally 1000 particles escaping from the air flow outlet window on the consecutive filters proved that the device 100 is a multitier filtration device. In a comparative assessment it was proved that around 94. 5 % radioactive aerosol of 0.1- 0.5 um size particles were trapped by the device 100, allowing only 5.5 % of the particle to escape. Example 6: Microbial testing of the breathing device
The microbial testing of the device 100 on infected individuals at the
Department of Pulmonary Medicine and Microbiology department, B.J.G.Medical
College, Pune was conducted. The aim of this study was to check the bacterial filtration efficacy of the multitier filtration system of the device 100. The study was a cross sectional interventional study conducted at Department of Pulmonary
Medicine and Microbiology department. The study population were adults with suspected respiratory tract infection. The adult patients coming to Pulmonary and
Medicine OPD were screened for respiratory symptoms in the form cough with expectoration, fever, coryza, throat pain and breathlessness and hemoptysis. The patients were counseled regarding the procedure and confidentiality was maintained. The patients with suspected respiratory tract infection, clinical findings and examinations were done in detail by the physician. Radiological examination of chest was done after clinical finding confirmation of lower respiratory tract infection. The further process of sample collection was done in a specially prepared room (by fumigation and sterilization procedure) situated near the pulmonary medicine ward. The samples were coded in series of A,B,C,D,E for 5 patients. Each of these series were further coded in three series of 1, 2 and 3, wherein series 1 was sputum collected in a sterile container for gram staining and bacterial culture, series 2 was open cough in a blood agar plate and series 3 was covered cough with application of device 100 in a blood agar plate. For example: A series consisted of Al, A2, A3.
Al - sputum collected in a sterile container for gram staining and bacterial culture A2- Open cough in a blood agar plate
A3 - Covered cough with application of device in a blood agar plate.
Similarly, B had Bl, B2 and B3 and the like for C,D and E. The patients cough was collected as induced sputum in a sterile container and sent for gram stain and culture. The patient was asked to cough on a blood agar plate kept at a distance of 6 inch from the mouth. After the sample collection of cough on the agar plate the agar plate with strict sterile precautions was sent for culture in a sterile container immediately to the laboratory. The patient with due consent was then intervened with the application of device 100 on the face. The patient was asked to cough voluntarily for 6 times with forceful exhalation in the device 100 with placing the blood agar plate 4 inches away from the airflow outlet window of the device 100. After this step the blood agar plate are was sent to the laboratory in a sterile container for culture. The gram stain report was obtained on the same day and the culture report was obtained after 2 days. The patients were referred to Pulmonary Medicine department for further treatment. It was observed that there were no adverse events, as this study involved use of device 100 which covered only nose and mouth while coughing to collect the sample. The health care workers took appropriate measures while using device 100 for preventing the infection. The detailed study results were as follows as shown in table 8 below:
Figure imgf000039_0001
The multi-tier filtration device 100 showed 100 % filtration efficacy since no growth was obtained from the samples collected after the application of device 100 with its filtration system by the patients. This result proved the efficiency of the device 100. Further, the test report of microbial testing of the device 100 was conducted by Department of Pulmonary Medicine and Department, of Microbiology, B J Medical College, Pune as shown in Table 9.
Table 9:
Figure imgf000040_0001
4 Sp. 1933 Streptococc 48 No Growth us spp.
5 Sp. 1974 Streptococc 300 No Growth
us spp.
6 Sp. 1975 Streptococc 12-15 No Growth
us spp.
In this experiment, cases were selected as per protocol for having respiratory tract infection. The cough containing contagious aerosol was spread on blood agar plates. The open cough in a blood agar plates showed growth of contagious bacteria. The same cases were tested after applying the device 100 having effectively covering cough aerosol and it was observed that after applying device 100 over the case's face covering nose and mouth gave no growth of bacteria on blood agar plates placed in front of device air flow outlet window. This showed effective filtration of the cough and forced exhaled contagious aerosol air and resulted in effective breaking of chain of disease transmission of challenging airborne diseases.
In the light of above-mentioned studies, it was observed that the device
100 of the present invention is in accordance with the guidelines of American
Society of Testing Material. It was proved that the device 100 have a bacterial filtration efficiency of 99.98 % and particulate filtration efficiency range from
91.24 % to 95.11 %. Further the air permeability was in the range of 3.2- 3.7 mmH20/cm2 indicating acceptable levels according to International standards and higher comfort ability for the user. The clinical study on the respiratory infection cases showed 100 % bacterial filtration efficiency thereby proving device 100 efficacy and safety for user and the community. Further the radio nuclear study with higher challenge to the device 100 continuously for 20 minutes proved its multitier filtration efficiency along with total particulate filtration efficiency. These aforesaid tests proved that the device 100 has an effective multitier filtration system addressing the problem of forcefully exhaled aerosol which is a concern of transmission of air borne diseases. In the context of the device 100 of the present invention, is observed that the device 100 of the present invention is a multitier filtration system for forcefully exhaled air, thereby preventing disease transmission. The device 100 is a main device in near future to control air borne diseases globally.
In the context of the device 100 of the present invention, the breathing device 100 for preventing airborne diseases helps the infected person who is the user of this device receive filtered air to avoid further damage to his health.
Further, family or people in frequent contact with the infected person are at minimum risk of getting infected as the air breathed out by the infected person is filtered by the breathing device 100 of the present invention. The breathing device
100 for preventing airborne diseases of the present invention is reusable and can be kept on the face or used even during the night when the person using it is sleeping. Furthermore, the breathing device 100 for preventing airborne diseases of the present invention also includes a disinfection kit to make sure that all the parts of the device are disinfected before they are replaced or disposed in order to avoid spreading microbes through used device 100. All the equipments necessary for comfortable use and disinfection are available in the kit along with the breathing device 100 for preventing airborne diseases. The Straps provided for putting the device on the face are of suitable material and the breathing device 100 of the present invention is designed in such a way that gives maximum comfort to the user. Further, the breathing device 100 is user friendly and can advantageously be applied in varied industries such as the cotton industries, chemical industries, the coal mining industries, etc where there are chances of inhalation of harmful chemicals and smoke that can be hazardous to a healthy human being. Apart from the infected individual, the device 100 of the present invention can also be used by any healthy individual to prevent himself from polluted air and air borne diseases. Furthermore, the breathing device 100 for of the present invention has a low manufacturing cost and can be affordable by a common man of the society. Further, the device 100 acts as an effective barrier for controlling the spreading of airborne diseases or other respiratory problems in workers working as garbage cleaners, sweepers, cleaners of public transport places, savage workers, traffic police personals, construction workers, cotton mill and handloom and power loom workers, workers of different food industries exposed to the organic dust of gridding of the seeds and grains, farmers exposed to the many allergens and organic dust contaminated with many fungi giving the hyper sensitive pneumonitis and many respiratory disorders related to the occupational exposer, sugar factory workers which are at risk of developing occupational respiratory disorders, other related industries, etc. A person skilled in the art will appreciate that the device 100 of the present invention if used according to the preferred embodiment disclosed above is very easy to use. It will be further appreciated that the device 100 of the present invention has got high adaptability among the users because of the novel structure and standardized operational use as disclosed in the present invention.
The embodiments of the invention shown and discussed herein are merely illustrative of modes of application of the present invention. Reference to details in this discussion is not intended to limit the scope of the claims to these details, or to the figures used to illustrate the invention.

Claims

Claims:
A breathing device for preventing airborne diseases, the breathing device comprising:
a first chamber defining between a first pad and a first filter, the first pad and the first filter being separated by a frame, the first pad positioning anteriorly on the frame, the frame having a plurality of windows on a top portion thereof, the first filter positioning posteriorly on each of the window, a nasal bridge cushion, a facial cushion and a chin cushion lined anteriorly at a predefined position around the frame and a plurality of flexible straps positioning on the sides of the frame through a plurality of opposed rivets;
a second chamber defining between a second pad and a second filter, the second pad and the second filter positioning posteriorly on the frame, the second chamber defining a central airflow window thereon;
a third chamber defining between a third pad and a third filter positioning posteriorly on the central airflow window;
an arcuate cover positioning posteriorly on the third chamber through an opposed pair of rivets; and
a cap positioning on a central outflow window of the arcuate cover, the cap receiving the exhaled filtered air from the arcuate cover for passing into an atmosphere through an outlet,
wherein the first chamber, the second chamber, third chamber, the arcuate cover and the cap are aligned along an axis for a multi-tier filtration of air.
2. The breathing device as claimed in claim 1, wherein the plurality of windows on the top portion of the first chamber is a breathing window.
3. The breathing device as claimed in claim 1, wherein the first filter, the second filter and the third filter are arranged in multi-layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof.
4. The breathing device as claimed in claim 1, wherein the first filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
5. The breathing device as claimed in claim 1, wherein the first filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
6. The breathing device as claimed in claim 1, wherein the second filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
7. The breathing device as claimed in claim 1, wherein the second filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
8. The breathing device as claimed in claim 1, wherein the third filter includes a plurality of layers of one polypropylene spunbond filter: two meltblown filters: one polypropylene spunbond filter.
9. The breathing device as claimed in claim 1, wherein the third filter includes a plurality of layers of one polypropylene spunbond filter: three meltblown filters: one polypropylene spunbond filter.
10. The breathing device as claimed in claim 4, wherein the spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm.
11. The breathing device as claimed in claim 1, wherein the first pad, the second pad and the third pad is made of non woven cotton material covered by woven cotton fibre gauze.
12. The breathing device as claimed in claim 1, wherein the first filter, the second filter, the third filter and the first pad, the second pad and the third pad are removably attachable at predefined positions on the frame by an adhesive.
13. The breathing device as claimed 1, wherein a top end of the second filter is adhesively attachable on an upper surface of the central air flow window and a bottom end of the second filter rests on the central air flow window thereby angularly rotating the second filter about the upper surface of the central air flow window .
14. A kit for preventing airborne diseases, the kit comprising:
a. a breathing device having a plurality of chambers, each chamber having a filter and a pad;
b. atleast one disinfectant solution bottle containing a disinfectant solution; c. atleast one measuring cylinder for measuring the disinfectant solution to prepare required percentage and quantity of the disinfection solution;
d. atleast one disinfectant container for disinfecting the contaminated and used filters and pads;
e. a plurality of pair of hand gloves for handling of the contaminated material; and
f. a user manual having guidelines and instructions.
15. The kit as claimed in claim 14, wherein a first filter, a second filter and a third filter are arranged in multi-layers and are selected from any one of a polypropylene spunbond filter, meltblown filter and a combination thereof.
16. The kit as claimed in claim 15, wherein the spunbond filter and the meltblown filters are used in a range of 12 gsm to 40 gsm.
17. The kit as claimed in claim 14, wherein the plurality of pads are made of non woven cotton material covered by woven cotton fibre gauze.
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WO2021209098A1 (en) * 2020-04-14 2021-10-21 Lorentsen Jan A respiratory device
US20230218931A1 (en) * 2020-05-04 2023-07-13 Upbiocare S.R.L. Bidirectional reusable filtering face mask

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US20110209711A1 (en) * 2008-08-26 2011-09-01 Vianney Brillat Multilayer Composition for a Breathing Mask
EP2412407A1 (en) * 2010-07-26 2012-02-01 3M Innovative Properties Co. Filtering face-piece respiratory having foam shaping layer

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021209098A1 (en) * 2020-04-14 2021-10-21 Lorentsen Jan A respiratory device
US20230218931A1 (en) * 2020-05-04 2023-07-13 Upbiocare S.R.L. Bidirectional reusable filtering face mask

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