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WO2024105642A1 - Masque facial - Google Patents

Masque facial Download PDF

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Publication number
WO2024105642A1
WO2024105642A1 PCT/IB2023/061665 IB2023061665W WO2024105642A1 WO 2024105642 A1 WO2024105642 A1 WO 2024105642A1 IB 2023061665 W IB2023061665 W IB 2023061665W WO 2024105642 A1 WO2024105642 A1 WO 2024105642A1
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WO
WIPO (PCT)
Prior art keywords
facemask
shell
patient
vent
opening
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2023/061665
Other languages
English (en)
Inventor
Guy Dori
Shay BRIKMAN
Treystman ALEXANDER
Michael REMENNIK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2024105642A1 publication Critical patent/WO2024105642A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M16/0009—Accessories therefor, e.g. sensors, vibrators, negative pressure with sub-atmospheric pressure, e.g. during expiration
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0087—Environmental safety or protection means, e.g. preventing explosion
    • A61M16/009—Removing used or expired gases or anaesthetic vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0833—T- or Y-type connectors, e.g. Y-piece
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A61M16/161—Devices to humidify the respiration air with means for measuring the humidity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0024—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with an on-off output signal, e.g. from a switch
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/42—Rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/65—Impedance, e.g. conductivity, capacity

Definitions

  • Embodiments of the invention relate to a facemask, preferably for removing potential contaminated exhaled air of a patient from the patient’s vicinity and/or from mixing with air within a space where he/she is placed.
  • Air within a facility may be exposed to contamination due to e.g. secretions exhaled by dwellers of the facility.
  • a facility e.g. old age home, hospital, examination rooms for bronchoscopy or gastroscopy, operating rooms, dentist office, or the like, ambulance
  • infectious disease such as those caused by viruses, e.g. the novel corona virus SARS-Cov-2 or COVID-19
  • viruses e.g. the novel corona virus SARS-Cov-2 or COVID-19
  • Contaminated material from a patient's exhaled breath may be secreted by the actions of breathing, coughing, sneezing or talking.
  • Contaminated and contagious secreted material may spread in room air or float in air or land on surfaces of objects in the room or on humans.
  • pathogens that may possibly contaminate room air from a patient’s exhaled air may include: respiratory syncytial virus, influenza virus, adenovirus, rhinovirus, Mycoplasma pneumoniae, SARS-associated coronavirus (SARS-CoV), group A streptococcus, Mycobacterium Tuberculosis, Bordetella pertussis, and Neisseria meningitides, and currently the novel corona virus (SARS- Cov-2), all by droplet aerosols.
  • SARS-CoV SARS-associated coronavirus
  • SARS-Cov-2 novel corona virus
  • Examples of pathogens that may possibly contaminate air by airborne droplet nuclei may include: Mycobacterium tuberculosis, streptococcus pneumonia, Staphylococcus Aureus, Legionella pneumophila, Klebsiella pneumonia, rubella virus, measles, influenaza and varicella-zoster virus (chickenpox) [Siegel JD et al. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; Kowalski et al. Air-Treatment Systems for Controlling Hospital- Acquired Infections. Heating, Piping, and Air Conditioning • January 2007],
  • Contamination of air due to a patient’s contagious exhaled air can be enhanced by supportive measures aiding a patient to breathe, such as respiratory devices providing gases (e.g. oxygen) to such patients.
  • respiratory devices may include: high-flow oxygen (HFO) devices (for example high flow therapy nasal cannula system of Vapotherm Inc.), devices suitable for providing medications via nebulizers (or the like).
  • HFO devices increase the spread of exhaled material in a room, and likewise nebulizers increase the spread of aerosolized material further in room air ⁇ Chui BMJ 2021; 378: e065903 ⁇ .
  • HFO devices and nebulizers may in some cases be discouraged during times when infectious diseases are spreading [James A. McGrath, Andrew O’Sullivan, Gavin Bennett, Ciarrai O’Toole, Mary Joyce, Miriam A. Byrne, and Ronan MacLoughlin. Investigation of the Quantity of Exhaled Aerosols Released into the Environment during Nebulisation. Pharmaceutics. 2019 Feb; 11(2): 75; Barker et al. COVID-19: community CPAP and NIV should be stopped unless medically necessary to support life. Thorax 2020; 75: 367],
  • Known measures for removing contaminated room air may include airborne infection isolation room (AIIR), formerly termed: negative pressure rooms. Such rooms are expensive to construct and are not prevalent in all hospitals and long term facilities. Such rooms may also be less efficient in removing contaminated air within the proximity of infected patient's face.
  • AIIR airborne infection isolation room
  • the refitting of an existing room to accommodate negative-pressure isolation was assumed to cost $120,000 per room [David W. Dowdy, Amelia Maters, Nicole Parrish, Christopher Beyrer, and Susan E. Dorman. Cost-Effectiveness Analysis of the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test as Used Routinely on Smear- Positive Respiratory Specimens. JOURNAL OF CLINICAL MICROBIOLOGY 2003; 41: 948-953],
  • Insufficient oxygenation means that lung alveoli (i.e. gas exchanging units of the lungs) fail to supply sufficient oxygenated blood to body tissues.
  • typical treatments may include the following types of therapies.
  • a first therapeutic type may be defined as aimed at increasing the fraction of inhaled oxygen (FiO2), so that e.g. instead of about 21% oxygen content typically in room air, it is possible to increase FiO2 up to about 100% depending on the supportive measures used.
  • Increasing the inhaled oxygen in certain cases may assist in washing out CO2 from the anatomic dead space (ADS) of a patient, e.g. by controlling a relative high inflow of such inhaled oxygen.
  • ADS of the respiratory system refers to the space in which oxygen (02) and carbon dioxide (CO2) gasses are not exchanged (or diffused) across the alveolar membrane in the respiratory tract.
  • a second therapeutic type may be aimed at increasing the gas pressure in the alveoli in order to keep them inflated especially at the end of expiration, thus providing a greater alveoli area for a greater capability of gas exchange.
  • Some respiratory supportive measures are able to keep alveoli expanded by creating positive end expiratory pressure (PEEP).
  • Example of such first type therapeutic measures may include the nasal cannula, which is a thin tubing that transports oxygen from an oxygen providing system to the patient's nostrils. This measure increases FiO2, however does not provide PEEP.
  • an oxygen mask that includes a plastic tubing transporting oxygen from an oxygen system to a patient's face mask.
  • the face mask has a strap for securing the mask to patient's face, and in some cases may also include a unidirectional valve, which allows exhaled air to flow outside of the mask while closing during inspiration to allow fresh oxygen supplied by the supportive measure to be inhaled.
  • Face masks increase FiO2, and however typically do not provide PEEP or substantial PEEP support.
  • facemasks such as non- rebreathing masks, are disposable and thus are typically manufactured in one adult size, and thus do not provide a good seal with an individual patient's face.
  • a high flow nasal cannula is an additional example of a supportive measure that increases FiO2, while providing humidified and warmed gas to the patient possibly resulting in washing out the ADS from exhaled CO2-rich gas.
  • a HFNC device provides a substantial constant inflow of FiO2, e.g. at a substantial constant flow rates of about 0.6 to 1 liter per second. This high flow of gas creates the wash-out effect of CO2-rich gas from the ADS. Therefore, when CO2 accumulates due to insufficient ventilation, HFNC therapy helps mitigating this adverse effect.
  • the HFNC supportive measure may also provide some PEEP, e.g. in cases where the patient's mouth is closed.
  • PEEP positive end expiratory pressure
  • Another example of a therapeutic measure that creates positive end expiratory pressure (PEEP) may be an endotracheal tube (ET), which is a flexible plastic tube that is placed through the mouth into the trachea to help a patient breath. The ET is then connected to a (mechanical) ventilator, which delivers oxygen to the lungs.
  • ET endotracheal tube
  • Non-Invasive Ventilation (NIV) and mechanical ventilation (MV) are examples of respiratory supportive measures that are closed systems for increasing patient's FiO2, creating PEEP, and providing various levels of mechanical ventilation to patient.
  • Insufficient ventilation means that the mechanisms involved in driving expiratory gas from the lungs to the ambient air (outside of the body), and driving fresh air into the lungs, are insufficient.
  • Expiratory air contains relatively high CO2 and low oxygen content, while inspiratory fresh air contains almost no CO2 and about 21% oxygen.
  • PCT patent application no. IL2021/050695 describes a personal exhaled air removal (PEAR) system for removing/evacuating exhaled air from a vicinity of a patient.
  • the system is designed to remove the exhaled air during an exhalation cycle of a patient and is synchronized with a patient's breathing cycle for activating suction of exhaled air via at least one suction inlet.
  • the system further describes use of a suction tank for assisting in the drawing of air exhaled by a patient. Negative pressure below pressure present in the ambient environment may be formed within suction tank by a pressure pump in communication with the suction tank. An internal volume of the suction tank may be suited to the amount of exhaled air that the PEAR system may be expected to evacuate in each exhalation phase of the patient.
  • a facemask comprising a shell for covering a patient’s mouth and nose and a conduit for evacuating exhaled air out of the shell, the shell comprising an internal passageway in fluid communication via at least one outer opening with an outer side of the shell and via at least one inner opening with an inner side of the shell.
  • the conduit being in fluid communication with the inner side of the shell and the internal passageway being also in fluid communication with the conduit by opening into the conduit and/or by being in direct communication with the conduit, wherein the facemask further comprising at least one sensor located at the inner side of the shell.
  • the shell comprises two inner and outer layers and the internal passageway is formed between the inner and outer layers, e.g. by being sandwiched between the inner and outer layers.
  • the at least one outer opening can be formed through the outer layer and the at least one inner opening can be formed through the inner layer, to possibly form a pair, and possibly one or more pairs may be present in a facemask, possibly on opposing lateral sides of the facemask or shell.
  • a facemask comprising a shell for covering at least a portion of a patient’s face and a conduit for evacuating exhaled air out of the shell, the shell comprising an internal passageway in fluid communication via at least one outer opening with an outer side of the shell and via at least one inner opening with an inner side of the shell, the conduit being in fluid communication with the inner side of the shell and the internal passageway being also in fluid communication with the conduit,
  • the timing of evacuation of exhaled air according is according to start and end of an exhalation phase of the patient.
  • FIG. 1 schematically shows a perspective view of an embodiment of a facemask of the present invention
  • FIG. 2 A and 2B schematically show sectional views taken along planes A-A and B-B, respectively, of the facemask seen in Fig. 1;
  • Fig. 3 A and 3B are generally similar to 2 A and 2B and show various possible flow patterns through flow paths in the facemask;
  • FIGs. 4 and 5 schematically show perspective and cross sectional views of another embodiment of a facemask of the present invention.
  • FIG. 1 schematically showing a perspective view of an embodiment of a facemask 10 of the present invention.
  • the facemask has a shell 1 for covering a patient’s mouth and nose that includes one or more internal passageways 13.
  • shell 1 is comprised of two spaced apart generally overlapping inner and outer layers 12, 14 with the passageway 13 being formed at least partially in-between these layers substantially sandwiched between the layers.
  • the internal passageway(s) 13 may be formed as one or more channels passing through the material of the shell, possibly instead of using such a double-layered structure.
  • the inner layer 12 can be seen enclosing an inner cavity 16 of the facemask that is designed to overlay a mouth and nostrils of a patient when fitted to a patient’s face. The enclosing of the inner cavity 16 as discussed herein below may not be in a sealing manner.
  • timer cavity 16 may be designed to be in fluid communication via a vent 17 of the shell 1 with a conduit 18 of the facemask that may be either integrally formed with the facemask or attachable/detachable to the facemask.
  • inner cavity 16 and the vent 17 and conduit 18 may be in this shown example via an aperture 181 formed in inner layer 12, which in this example may be located at a generally central region of the facemask substantially opposite a patient’s mouth during use.
  • Passageway 13 may also be designed to be in fluid communication via vent 17 with the conduit 18 at a location just outside of cavity 16 beyond aperture 181.
  • At least one inner opening 121 may be formed through the inner layer 12 and at least one outer opening 141 may be formed through the outer layer 14.
  • An inner opening 121 communicates between passageway 13 and cavity 16 and an outer opening 141 communicates between the ambient environment outside of the facemask and passageway 13.
  • adjacent inner and outer openings 121, 141 can be seen forming a pair, and the facemask of this embodiment can be seen optionally including two such pairs of adjacent openings 121, 141 at opposing lateral sides of the facemask. It is noted that any number (i.e. one or more) of such pairs may be possible in various facemask embodiments.
  • the openings 121, 141 of a pair do not fully overlap and preferably do not overlap at all.
  • the outer opening 141 in a downstream direction D of flow through passageway 13 towards vent 17 and conduit 18, in a given pair of openings 121, 141 - the outer opening 141 is located more downstream in relation to the inner opening 121, and/or the outer opening 141 comprises portions that are more downstream in relating to portions of the inner opening 121.
  • Such downstream direction may also mean, as seen in this example, that along the facemask’s shell the outer opening 141 is closer (with respect to the inner opening 121) to the vent 17 and conduit 18.
  • Such relative downstream position within a pair, of an outer opening 141 (or one or more portions thereof) with respect to its associated inner opening 121 - may in certain cases be aimed at “encouraging” ambient air entering passageway 13 from an outer opening 141 - to flow substantially exclusively or to a larger extent downstream towards vent 17 and conduit 18 when suction is applied at vent 17 or conduit 18, rather than through inner opening 121 towards cavity 16.
  • Conduit 18 seen in the embodiment of Figs. 1 to 3 may be adapted to be used for a dual function of both supplying gaseous/medications towards the patient and for removal of air being exhaled by the patient.
  • the conduit 18 in this example may be either assembled or integrally formed to be coupled to two branches 101, 102 that merge and connect to conduit 18 to create an optional T-shaped formation with branch 101 being generally perpendicular to branch 102 and to conduit 18.
  • Provision of gaseous/medications towards inner cavity 16 and hence towards the patient may be applied via one of the branches, e.g. 101, that acts as an incoming passage (together with conduit 18) for provision of gaseous/medications to the patient - while the removal of exhaled air via the other branch, e.g. 102, that acts as an outgoing passage (together with conduit 18) for evacuation/removal of exhaled air.
  • a facemask 10 may be provided where the incoming and outgoing passages may be formed as separate conduits, with one of the conduits here indicated by numeral 18 serving as an outgoing passage and the other here indicated by numeral 19 serving as an incoming passage.
  • the outgoing passage of conduit 18 may be designed to be in fluid communication with conduit 18 via a vent 171 and an aperture 181 (in a similar maimer to the design seen in the former embodiments), with passageway 13 being designed to be in fluid communication with vent 171 and conduit 18 at a location just outside of cavity 16 beyond aperture 181.
  • the incoming passage of conduit 19 may be designed to be in direct fluid communication via a vent 172 with inner cavity 16, in this example avoiding communication with passageway 13.
  • provision of gaseous/medications towards the patient may be constantly applied and the removal of exhaled air may be applied periodically substantially from the start of an exhalation phase of a patient and until substantially the end of the exhalation phase.
  • one or more sensors may be located within cavity 16 in order to sense parameters relating to air exhaled by a patient.
  • locating such sensors within cavity may be advantageous for targeting measurement of various parameters relating to exhaled air.
  • Such sensors may be suited for measuring, e.g., pH, breathing rate, breathing volume, impedance, flow, flow meter, co2, sound, humidity, temperature (etc.).
  • audio/visual elements/means may be provided on or associated with the facemask in order to provide indications relating to the sensed data.
  • such elements/means may be used for indicating alerts or the like relating to the sensed data.
  • sensed data may be communicated out of the facemask e.g. to medical staff (e.g. via a GUI or the like) in order to communicate such sensed data and/or indications relating to the sensed data for further use, such as analysis by medical personal, storage (or the like).
  • on or more sensors located within cavity 16 may be used for assisting in triggering start and end of active evacuation of exhaled air, e.g. by triggering start and end of suction applied to the facemask - by sensing parameters indicative of start and end of a patient’s exhalation cycle.
  • a trigger for the start and end of removal of exhaled air may be applied by various measures.
  • a temperature sensor 20 such as a thermistor, may be used for triggering the start and end of evacuation of exhaled air.
  • a temperature sensor will be described for detecting start and end of exhalation, however it should be understood that other sensed parameters, such as flow, humidity, sound (or the like) can be equally used with the disclosed structures herein below,
  • Sensor 20 as here seen may be positioned within the inner cavity 16 of the facemask at a position that is set aside from the aperture 181 leading into the vent 17 and the outgoing passage of conduit 18.
  • a bypass inlet 201 formed in inner layer 12 adjacent sensor 20 may form an entry into the passageway 13 formed inbetween the inner and outer layers 12, 14 of the facemask.
  • the higher temperature of the exhaled air filling inner cavity 16 may be sensed by sensor 20.
  • a controller (not shown), associated with or forming part of the facemask, receiving sensed data from sensor 20 may be configured to start an evacuation phase of the air exhaled by the patient via the vent 17 and the outgoing passage of conduit 18 as the sensed temperature exceeds a certain, possibly pre-defined, value.
  • air exhaled by the patient may be evacuated towards vent 17 and conduit 18 together with ambient stream(s) of airflow that may be drawn into cavity 16 as will be detailed herein below.
  • the evacuation of exhaled air may be achieved by various means.
  • the facemask may be coupled at a downstream side of conduit 18 to a suction system typically available in medical facilities, such as in hospitals (or the like).
  • a suction system typically available in medical facilities, such as in hospitals (or the like).
  • Such suction system may be powered by a central pump station and typically may provide wall outlets to which various medical devices requiring suction may be coupled.
  • a suction tank (not shown) may be used for assisting in the drawing of air exhaled by a patient, where negative pressure below pressure present in the ambient environment may be formed within the suction tank by a pressure pump (or the like).
  • a suction tank may be used alone and not in conjunction with an available suction systems in a medical facility in order to remove exhaled air.
  • a normal person evacuates about 0.5 liter of air during exhalation, while the average human respiratory rate is between about 30-60 breaths per minute at birth, decreasing to 12-20 breaths per minute in adults. Taking 12 breaths per minute as the lower limit of breathing rate, renders that such a breathing cycle lasts about 5 seconds and hence the average duration of exhalation is about 2.5 or possibly 3 seconds.
  • the evacuation of exhaled air may be at a substantially higher flow rate to that expected by a typical patient, e.g. at a rate of between about 1 liter per second and a higher flow rate of e.g. about 10 liters per second (or the like) and possibly more.
  • Such lower limit of about 1 liter per second may be substantially greater (i.e. about 5 times greater) than the corresponding lower limit of expected flow rate during exhalation (i.e. about 0.2 liter per second).
  • facemask 10 may be designed to provide flow paths that enable air from the ambient environment to be drawn together with exhaled air out of the facemask.
  • Facemask 10 in at least certain embodiments may be of a type that does not necessarily provide a good seal with an individual patient's face along its outer rim 11. And therefore, some air from the ambient environment may seep into the cavity 16 passed the outer rim 11 of the facemask to be safely evacuated via vent 17 and conduit 18 together with the air exhaled by the patient.
  • FIGs. 3A and 3B Additional routes through which air from the ambient environment may be drawn towards vent 17 and conduit 18 may be via the outer opening(s) 141.
  • air from the ambient environment that is drawn into the facemask via an outer opening 141 - may be urged to flow downstream through passageway 13 to be evacuated via vent 17 and conduit 18 together with the air exhaled by the patient that mainly exits inner cavity 16 towards the vent 17 and conduit 18 via aperture 181 as indicated by the ‘dotted’ double sided arrow in Fig. 3B.
  • air from the ambient environment entering through an outer opening 141 may be forced to also at least partially flow through an inner opening 121 into cavity 16 to then be evacuated together with the patient’s exhaled air via aperture 181 towards conduit 18.
  • the air being exhaled by the patient may at least partially be drawn out of inner cavity 16 via an inner opening 121 to then flow onwards through passageway 13 to be safely evacuated from the facemask towards the conduit 18.
  • the temperature sensed by sensor 20 may be used for providing a signal for start and cessation of forced evacuation of air, in light of the paths permitting flow of cooler air from the ambient environment through the facemask, it would be desirable to maintain the sensor 20 in substantial constant communication with the relative hotter air exhaled by the patient in order to ensure proper detection of the instance e.g. when the exhalation phase of the patient ends.
  • the aforementioned “encouraged” downstream flow within a pair - of ambient air from an outer more downstream opening 141 towards conduit 18 during exhalation - may be aimed at least in certain cases at eliminating or substantially limiting flow through the associated inner opening 121 towards inner cavity 16 - a flow that may lower the temperature within inner cavity 16 during an exhalation phase of a patient and by that affect the ability of the sensor 20 within cavity 16 to properly detect start and in particular the end of the exhalation phase.
  • the likelihood of substantial constant communication of the sensor 20 with a patient’s exhaled air may be increased by the proximity of the bypass inlet 201 to the sensor 20.
  • Such proximity to the sensor 20 may result in at least part of the air exhaled by the patient remaining close to the sensor as it flows through the bypass inlet 201 and past sensor 20 to be evacuated via passageway 13 into vent 17 and onwards to conduit 18 as indicated by the ‘dash-dotted’ arrow in Fig. 3 A together with the larger flow of exhaled air that directly exits cavity 16 into vent 17 and conduit 18 via aperture 181 as indicated by the ‘dotted’ double sided arrow.
  • Cessation of evacuation of exhaled air from within cavity 16 may be triggered when a drop in temperature is detected by sensor 20 as the patient stops exhaling or reaches the end of the exhalation phase.
  • a controller receiving the sensed data from sensor 20 may be configured to control the stop of suction that is applied to vent 17 and the outgoing passage of conduit 18, which was used for urging the evacuation.
  • a change in direction of air flowing passed sensor 20 when the patient starts inhaling may result in additional drop in sensed temperature within cavity 16 that may be assessed by a controller receiving such sensed data for controlling the cessation of evacuation of exhaled air.
  • each of the verbs, “comprise” “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Ecology (AREA)
  • Biodiversity & Conservation Biology (AREA)
  • Environmental Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Textile Engineering (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne un masque facial ayant une coque pour recouvrir la bouche et le nez d'un patient et un évent/conduit pour évacuer l'air expiré hors de la coque. La coque ayant des couches interne et externe et un passage interne formé entre les couches interne et externe. Le passage est en communication fluidique par l'intermédiaire d'au moins une ouverture externe avec un côté externe de la coque et par l'intermédiaire d'au moins une ouverture interne avec un côté interne de la coque et l'évent/conduit est en communication fluidique avec le côté interne de la coque. Le passage interne est également en communication fluidique avec l'évent/conduit et le masque facial comprend au moins un capteur situé sur le côté interne de la coque.
PCT/IB2023/061665 2022-11-20 2023-11-19 Masque facial Ceased WO2024105642A1 (fr)

Applications Claiming Priority (2)

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US202263426766P 2022-11-20 2022-11-20
US63/426,766 2022-11-20

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WO2024105642A1 true WO2024105642A1 (fr) 2024-05-23

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160074615A1 (en) * 2011-09-07 2016-03-17 Monitor Mask Inc. Oxygen facemask with capnography monitoring ports
US20190009114A1 (en) * 2015-12-29 2019-01-10 Ga Hyun HAN Harmful-substance-blocking health mask using air curtain
US20200121005A1 (en) * 2017-05-30 2020-04-23 MPOINTAERO Inc. Surgical masks
US20210368876A1 (en) * 2018-03-02 2021-12-02 O2 Industries Inc. Face mask and method for conforming a face mask to a face
US20220071562A1 (en) * 2020-09-08 2022-03-10 Masimo Corporation Face mask with integrated physiological sensors

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160074615A1 (en) * 2011-09-07 2016-03-17 Monitor Mask Inc. Oxygen facemask with capnography monitoring ports
US20190009114A1 (en) * 2015-12-29 2019-01-10 Ga Hyun HAN Harmful-substance-blocking health mask using air curtain
US20200121005A1 (en) * 2017-05-30 2020-04-23 MPOINTAERO Inc. Surgical masks
US20210368876A1 (en) * 2018-03-02 2021-12-02 O2 Industries Inc. Face mask and method for conforming a face mask to a face
US20220071562A1 (en) * 2020-09-08 2022-03-10 Masimo Corporation Face mask with integrated physiological sensors

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