METHODS, DEVICES, KITS AND SYSTEMS FOR DELIVERY OF LARGE VOLUME OF PRESSURIZED GAS BY INHALATION

Abstract

There are provided herein methods, devices, kits and systems utilizing respiratory mask for delivering pressurized fluid to a subject via inhalation in an efficient manner. The fluid may include gas and/or drug and by utilizing the methods, devices, kits and systems provided, efficient drug delivery to the subject's airways is achieved. The systems, devices, kits and methods further allow inducing insufflation/exsufflation in particular in subjects having impaired suffering from low neuromotor capacity, such as spinal cord injuries (SCI) patients.

Claims

1-67. (canceled)

68. A device for delivering pressurized gas to a subject, the device comprising: a tank holding a reservoir of pressurized gas; a pressure maintaining element located within the tank, wherein the pressure maintaining element comprises a moveable floor and a constant force element functionally connected to the movable floor and configured to exert a constant force thereon, such that when gas is expelled from the tank, the constant force element causes an elevation of the moveable floor, thereby reducing the volume of the tank so as to maintain an essentially constant pressure within the tank allowing delivery of the entire content of the gas in the tank at a constant pressure; an asymmetric valve comprising an insufflation activating element configured to directly or indirectly open the valve in coordination with the subject's inhalation, thereby releasing the pressurized gas from the pressurized gas reservoir to provide insufflation of the subject; and one or more resistance units configured to resist the reclosing of the valve, thereby controlling the duration of the insufflation, wherein the combined operation of the pressure maintaining element and the asymmetric valve ensure that the volume of pressurized gas delivered to the subject is a predetermined volume independent of the subject s inhalation volume, wherein the predetermined volume is in a range of 0.5-3 L; and a first adaptor, fluidly connected to the valve, configured to fluidly connect to a corresponding adaptor of a mask configured to interact with the airways of the subject.

69. The device according to claim 68, wherein the insufflation activating element is configured to activate insufflation on response to inhalation by a subject, or in response to manual activation.

70. The device according to claim 68, wherein the valve unit comprises a coupling element, connecting the insufflation activating element to a sealing unit, the coupling element configured to move the sealing unit upon activation of the insufflation activating element, to thereby allow opening of gas passages located between the pressurized gas reservoir and the first adaptor, to allow pressurized gas movement from the pressurized gas reservoir, through the valve unit, to the first adaptor.

71. The device according to claim 68, wherein the duration of insufflation is over about 0.7 seconds.

72. The device according to claim 68, wherein the one or more resistance units are selected from: springs, dashpots and/or electrical resistance units.

73. The device according to claim 68, wherein the gas comprises a drug.

74. The device according to claim 68, wherein the tank further comprises an aerosol chamber configured to aerosolize the drug.

75. The device according to claim 68, wherein the aerosol chamber further comprises a particle size filter configured to determine the aerosolized particle size.

76. The device according to claim 68, wherein the constant force element comprises one or more of: cables, springs, strings, motors, and/or motion units.

77. The device according to claim 68, wherein the combined operation of the pressure maintaining element and the asymmetric valve ensure that the volume of pressurized gas delivered to the subject is about 100-600% of the user's inhalation capacity.

78. The device according to claim 68, wherein the combined operation of the pressure maintaining element and the asymmetric valve ensure that a peak expiratory airflow (PEF) or peak coughing flow (PCF) of the pressurized gas delivered to the subject is over about 160 L/min.

79. The device according to claim 68, wherein the combined operation of the pressure maintaining element and the asymmetric valve ensure that the difference between the peak expiratory airflow (PEF) and the peak inspiratory airflow (PIF) is over about 20 L/min and/or a ratio between the peak inspiratory airflow (PIF) and the peak expiratory airflow (PEF), is lower than about 0.9.

80. The device according to claim 68, further comprising a safety valve configured to ensure that the maximal pressure insufflated is lower than about 75 cmH2O.

81. The device of claim 68, wherein the gas pressure in the pressurized fluid tank is between about 10 to about 50 atm.

82. The device of claim 68, wherein the pressurized gas tank comprises an expanded collapsible bag having a fixed maximum dimension, and wherein the bag is used for storing the gas, such that the bag minimal volume defines the remaining effective or operational volume.

83. The device of claim 68, for use in inducing coughing in a subject suffering from spinal cord injury (SCI) or neuromuscular deficiencies.

84. The device of claim 68, wherein the mask is a mouthpiece.

85. The device of claim 68, wherein the mask is a facial mask.

86. A method for delivering a predetermined dose of a drug to a subject, the method comprising: adjusting a mask to the subject's face; and upon inhaling, triggering a release of a pressurized gas from a device for delivering pressurized gas to a subject, the device comprising: a pressurized gas tank holding a reservoir of pressurized gas; an aerosol chamber configured to aerosolize the drug; a pressure maintaining element located within the tank, wherein the pressure maintaining element comprises a moveable floor and a constant force element functionally connected to the movable floor and configured to exert a constant force thereon, such that when gas is expelled from the tank, the constant force element causes an elevation of the moveable floor, thereby reducing the volume of the tank so as to maintain an essentially constant pressure within the tank allowing delivery of the entire content of the gas in the tank at a constant pressure; an asymmetric valve comprising an insufflation activating element configured to directly or indirectly open the valve in coordination with the subject's inhalation, thereby releasing the pressurized gas and the aerosolized drug to the subject; and one or more resistance units configured to resist the reclosing of the valve, thereby controlling the duration of the insufflation, wherein the combined operation of the pressure maintaining element and the asymmetric valve ensure that the volume of pressurized gas delivered to the subject is a predetermined volume independent of the subject s inhalation volume, wherein the predetermined volume is in a range of 0.5-3 L thereby delivering the predetermined dose of the drug to the subject.

87. The method of claim 86, wherein the methods allows one or more of: treating acute pulmonary infections, shorten the duration of acute pulmonary infections, treat acute pulmonary complication, shorten the duration acute pulmonary complications, treat chronic pulmonary complication, shorten the duration chronic pulmonary complications, or any combination thereof.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0094] Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale. In the Figures:

[0095] FIG. 1 schematically depicts a device for delivering pressurized gas to a subject, according to some embodiments;

[0096] FIGS. 2A-B schematically depict mechanism of storing and delivering pressurized gas (such as gas air and/or aerosol) under a constant or predetermined pressure gradient, according to some embodiments. FIG. 2A—a schematic cross section of a device for delivering pressurized gas showing the mechanism at the state of storing the gas in a reservoir. FIG. 2B—a schematic cross section of a device for delivering pressurized gas showing the mechanism at a state after at least part of the gas has been dispensed (delivered).

[0097] FIGS. 3A-C—schematically depict a mechanism of delivering pressurized gas via insufflation upon inhalation by a subject, according to some embodiments. FIG. 3A a schematic illustration of a perspective side view of the mechanism for regulating passage of pressurized gas through a valve. FIGS. 3B-3C schematic illustrations of top view of a cross section of a valve for regulating passage of pressurized gas in a closed mode (FIG. 3B) and open mode (FIG. 3C), wherein the valve is activated by inhalation of a subject;

[0098] FIGS. 4A-C—schematically depict a mechanism of delivering pressurized gas via insufflation upon inhalation by a subject and/or manual activation, according to some embodiments. FIG. 4A a schematic illustration of a perspective side view of the mechanism for regulating passage of pressurized gas through a valve. FIGS. 4B-4C—schematic illustrations of a top view of cross section of a valve for regulating passage of pressurized gas in a closed mode (FIG. 4B) and open mode (FIG. 4C), wherein the valve is activated by manual activation;

[0099] FIGS. 5A-B—schematically depict a mechanism of delivering aerosol, with a device for delivering pressurized gas via insufflation by a subject, according to some embodiments;

[0100] FIG. 6 schematically depicts a perspective view of an exemplary design of a pharyngeal mask (mouthpiece-based mask), according to some embodiments;

[0101] FIG. 7A schematically depicts a front view of a cup member of a face mask, according to some embodiments;

[0102] FIG. 7B schematically depicts a side view of the cup member of, according to some embodiments;

[0103] FIG. 8 schematically depicts a distal part of a cup member which includes a valve that ensures one-directional flow, according to some embodiments; and

[0104] FIG. 9 schematically depicts an automatic system of delivering and extracting pressurized fluid (insufflation-exsufflation) to a subject via a face mask, according to some embodiments.

DETAILED DESCRIPTION

[0105] The principles, uses and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.

[0106] In the following description, various aspects of the invention will be described. For the purpose of explanation, specific details are set forth in order to provide a thorough understanding of the invention. However, it will also be apparent to one skilled in the art that the invention may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the invention.

[0107] The following are terms which are used throughout the description and which should be understood in accordance with the various embodiments to mean as follows:

[0108] As used herein, the term “insufflation” is directed to the blowing of a gas to a body cavity. For example, the term insufflation includes pressurized delivery of gas via the respiratory tract, to the lungs.

[0109] The term “exsufflation” is directed to forcible breathing or blowing out from the respiratory tract. For example, the term exsufflation relates to clearing the respiratory tract by forcing air from the lungs.

[0110] The terms “mask” and “respiratory mask” may interchangeably be used. The terms encompass any type of means capable of accessing the airways of a subject (patient) that is wearing/using/holding/biting the mask, to allow direct gas transfer to/from the respiratory airways of the subject. In some embodiments, the mask may be selected from, but not limited to: pharyngeal mask, laryngeal mask, face mask, endotracheal tube, and the like, or any combination thereof. Each possibility is a separate embodiment. In some exemplary embodiments, the mask may be a face mask. In some exemplary embodiments, the mask is a pharyngeal mask. In some exemplary embodiments, the mask is a combination of a face mask and pharyngeal mask.

[0111] As used herein, the term “gas” is directed substances at their gaseous state, that continually flows under an applied shear stress, or external force. In some embodiments, the terms “gas” and “fluids” may interchangeably be used. In some embodiments, the term gas encompassed any type of pressurized gas capable of being stored and released from a closed container/chamber/tank. As used herein, a gas may include pure gas (such as, for example, pure oxygen), a mixture of gases (such as, for example, air), and/or a suspension of fine liquid droplets or fine solid particles in gas (for example, in the form of aerosol). Each possibility is a separate embodiment. In some exemplary embodiments, the gas is selected from, but not limited to: oxygen (O.sub.2), nitrogen (N.sub.2), carbon dioxide (CO.sub.2), Aragon (Ar), Helium (He), air or any combination thereof. Each possibility is a separate embodiment.

[0112] The term Forced Vital Capacity (“FVC”) relates to the volume of air in the lung upon a deep breath. In some embodiments, the volume of air is measured in units of Liter(s).

[0113] The term Residual Volume and Forced Residual Volume (“RV/FRV”) relates to the volume of air in the lung after forced exhale or a cough. In some embodiments, the Residual Volume or Forced Residual Volume are measured in units of Liter(s).

[0114] The term Forced Expiratory Volume (“FEV1”) relates to the volume of air, forcefully exerted from, the lungs in a period of one second.

[0115] The term “PEF-PIF” relates to the difference between the peak expiratory airflow and peak inspiratory airflow.

[0116] The term “PIF/PEF” relates to the ratio between the peak inspiratory airflow and the peak expiratory airflow.

[0117] Reference is now made to FIG. 1, which schematically illustrates a front perspective view of device for delivering pressurized gas via, for example, inhalation by a subject, according to some embodiments. As shown in FIG. 1, device (2), includes a closed chamber/container/tank (shown as tank 4), capable of storing a reservoir of pressurized gas, such as, air (shown as reservoir 6). The container has an opening at the top region thereof (5), which can allow transfer of gas to and from the gas reservoir (6) that is confined within tank (4). The opening at the top end of the container may be sealed/covered by a top cover (shown as cover 8), which can be used to close/seal/cover the opening, so as to control the gas flow into and out of the gas reservoir and/or filling or emptying/depleting the reservoir. On the top region of the container, a delivery regulator (shown as regulator 10) is situated. The regulator may include one or more functional elements and/or adaptors, allowing its operation in regulating the passage of gas to/from the gas reservoir. For example, the regulator may include an adaptor, 12 that may be used to connect the regulator to external means capable of ultimately accessing the subject's airways. In some embodiments, such means may include any suitable tube or mask, such as, but not limited to: pharyngeal mask, laryngeal mask, face mask, endotracheal tube, and the like. For example, adaptor (12) shown in FIG. 1, can be used to connect to a pharyngeal mask adaptor (shown as adaptor 14). The external pharyngeal mask (16) represented in FIG. 1 is shown in the form of a mouthpiece (16), that can be used for securing a sealed route for the gas to the patient's lungs by insufflation/exsufflation, as further detailed below.

[0118] Reference is now made to FIGS. 2A-B, which schematically depict mechanism of storing and delivering pressurized gas under a constant or predetermined gradient of pressure, according to some embodiments. Shown in FIG. 2A is a longitudinal cross section of container/chamber/tank 20, which has an external wall/shell (wall 22). The wall of the container is preferably rigid and is able to withstand high pressures. The shell of the container defines an internal gas reservoir volume (shown as reservoir 24). The container has an opening at the top region thereof (25), which can allow transfer of gas to and from the gas reservoir (24) that is confined within chamber (20). The opening at the top end of the container may be sealed/covered by a top cover (shown as cover/cap 28), which can be used to close/seal/cover the opening, so as to allow the gas flow into and out of the gas reservoir and/or filling or emptying/depleting the reservoir. Further shown in the internal volume of the container, is pressure maintaining element, 30. Pressure maintaining element 30 includes a floating/movable floor, shown as, movable floor 32. Movable floor 32 can move along a longitudinal (vertical) axis, from the bottom region of the container to an upper region of the container. The dimension of movable floor 32, are preferably such that they coincide to the internal dimensions of the container, to thereby create a seal with the verticals walls of the container, such that no leak of gas occurs between the floor circumference and the internal walls of the container. By the upward/downward movement of movable floor 32, the pressure and/or volume of gas reservoir 24 may be maintained/altered, by decreasing/increasing the region (volume) defined between the movable floor and the upper end of the container (i.e., defining the reservoir). Pressure maintaining element 30 further includes means to change the vertical position/location/height of the movable floor within the container. The exemplary means to change to vertical position of the movable floor, may include any type of cables/springs/strings (shown as exemplary spring motors 34A-B), that may change in length and be collected/dispensed to/from corresponding storing elements (shown as storing drums 36A-B), that are further connected/attached/formed with movable floor (32). The cables/springs may further be connected/attached to the internal walls of the container, at an upper region of the container (for example, at regions 38A-B). The cables may be made of flexible or elastic material that may change its tension/strength/flexibility/compression/stretchiness. In some embodiments, the cables are made of rubber, plastic, metal, polymers, carbon or any materials known to those skilled in the art, or any combination thereof. Reference is now made to FIG. 2B, which shows a schematic cross section of a container, showing the Pressure maintaining element at a state after at least part of the gas has been dispensed (delivered). As shown in FIG. 2B, movable floor 32 has moved up in a vertical direction of container 20. Movable floor has moved upwards, via the pulling/collapsing/compressing/stretching of the strings/cables/springs (34A′-B′), relative to their resting position (shown in FIG. 2A (34A-B)). The pulled strings, which are now in a more condensed state are collected in drums 36A′-B′. As shown in FIG. 2B, when the movable floor is moving upward, the volume between the floor and the upper region of the container is reduced (shown as gas reservoir 40). Consequently, the pressure of gas contained in the reservoir is increased, decreased or maintained according to a predetermined pattern created by the cables/springs/strings and directed towards the upper opening of the container. The void volume (i.e. the volume where no gas is found, below the surface of the floating floor (shown as void volume 38), is increased as the floor moves vertically towards the upper end of the container.

[0119] Reference is now made to FIGS. 3A-C which schematically depict a mechanism of a pressurized gas delivery regulator (pressure and/or flow regulating element), configured to deliver pressurized gas via insufflation upon inhalation by a subject, according to some embodiments. Shown in FIG. 3A is a schematic illustration of a perspective side view of an exemplary pressure and/or flow regulating element (delivery regulator) used for regulating passage of pressurized gas through a valve. Regulator (50), is configured to be placed or situated on a top region of a pressurized gas container of a device for delivering pressurized gas via (as illustrated in details in FIG. 1, above) to regulate the passage of pressurized gas from/to the container. The regulator may be placed on the opening of the container, directly, or via an adapter, shown as adaptor 52 in FIG. 3A. The regulator further includes a valve (54) and further adaptor (56) configured to connect the regulator to external means capable of directly or indirectly accessing the subject's airways.

[0120] Reference is now made to FIGS. 3B-3C which show schematic illustrations of a cross section of a valve unit of a pressurized gas delivery regulator, for regulating passage of pressurized gas in a closed mode (FIG. 3B) and open mode (FIG. 3C), wherein the valve is activated by inhalation of a subject. As shown in FIG. 3B, valve unit 54 includes opening/channels (shown as channel 60), which ultimately allows passage of gas from the gas container/tank (not shown), via adaptor 56, to external means capable of directly or indirectly accessing the subject's airways. Further included with the valve is deformable membrane/flexible wall (shown as membrane 64 in FIG. 3B). Membrane 64 is positioned at a distal region, opposing opening 60 (i.e., opposing the side that can connect to the external means capable of directly or indirectly accessing the subject's airways). Deformable membrane 60 may change its shape/tension, as further detailed below. The membrane may be connected/attached/formed with one or more points/regions on valve body/valve walls and to one or more levers/handles, shown as levers 70A-B. Levers 70A-B are further connected on their distal end to covers/caps (shown as covers 66A-B), which are situated on a rail (shown as rail 80), allowing their movement along the rail. The valve further includes resistance units (shown as resistance units 68A-B), which are connected to the valve body on one end and to covers/caps (66A-B) on the opposing end thereof. The resistance units are preferentially located on rail 80, or in close proximity thereto. The resistance units may be composed by one or more resistance components, such as, but not limited to: springs, dashpots, electrical resistance units, or any suitable type of resistance units, configured to resist a change in their formation/tension and return to their previous state after they have been deformed/contracted. Each possibility is a separate embodiment. Reference is now made to FIG. 3C, which shows valve unit 54 in an open state, which allows transfer of gas from the pressurized gas container (not shown), via opening/channels (shown as channel 60), through adaptor 56, to external means capable of directly or indirectly accessing the subject's airways. As shown in FIG. 3C, after the deformable membrane has been deformed (changed its shape, shown as deformable membrane 64′), to move away from the valve body walls, levers 70A-B (of FIG. 3A) have changed their position (shown in position 70A-′-B′ in FIG. 3C). Consequently, the movement of the levers results in the movement of covers/caps (66A′-B′) along rail 80, such that channels/openings 62A-B, that were covered/blocked/sealed by caps 66A-B (in FIG. 3B), are now open. Opening of these channels (62A-B), by the movement of the caps (66A′-B′) allows the flow of pressurized gas from the pressurized gas container (not shown) through the open channels (62A-B), ultimately to the external means capable of directly or indirectly accessing the subject's airways (via one or more adaptors, as detailed above). As further shown in FIG. 3C, the resistance unit are compressed/deformed/collapsed (shown as compressed resistance units 68A-′-B′). According to some embodiments, the resistance units are configured to limit the movement of the caps, such that upon the movement of the caps, the resistance units attempt to return to their previous mode, causing movement of the caps at a defined rate/duration along the rail, back to their previous location, to cover/seal channels 62A-B, to thereby function as open/close modes of the valve. In some embodiments, the deformation of the membrane is induced by inhalation of a subject, via the external means capable of accessing the subject's airways. When inhaling, the membrane is deformed, consequently, opening the caps and allowing gas passage from the pressurized gas container to the subject's airways, to thereby cause insufflation and induce an insufflation-exsufflation cycle.

[0121] Reference is now made to FIGS. 4A-C which schematically depict a mechanism of a gas delivery regulator, configured to deliver pressurized gas via manual activation by a subject, according to some embodiments. According to some embodiments, the mechanism illustrated in FIGS. 4A-C resembles the mechanism illustrated in FIGS. 3A-C, however, the activation of the mechanism (i.e., the deformation of the membrane) is achieved by manually deforming the membrane, using a dedicated activation button, which is connected to or associated with the deformable membrane 164. By pressing or otherwise manipulating the activation button, the membrane is deformed, to activate the delivery mechanism (i.e., activate the valve).

[0122] Shown in FIG. 4A is a schematic illustration of a perspective side view of an exemplary delivery regulator (pressure and/or flow regulating element) used for regulating passage of pressurized gas through a valve. Regulator (150), is configured to be placed or situated on a top region of a pressurized gas container of a device for delivering pressurized gas via (as illustrated in details in FIG. 1, above) to regulate the passage of pressurized gas from/to the container. The regulator may be placed on the opening of the container, directly, or via an adapter, shown as adaptor 152 in FIG. 4A. The regulator further includes a valve unit (154) and optionally further adaptor (156) configured to connect the regulator to external means capable of directly or indirectly accessing the subject's airways. Further included is activation button (shown as button 110).

[0123] Reference is now made to FIGS. 4B-4C which show schematic illustrations of a cross section of a valve of delivery regulator, for regulating passage of pressurized gas in a closed mode (FIG. 4B) and open mode (FIG. 4C), wherein the valve unit is activated by manual manipulation (pressing) of activation button (Button 110), by a user. As shown in FIG. 4B, valve unit 154 includes an opening/channels (shown as channel 160), which ultimately allows passage of gas from the gas container (not shown), via adaptor 156, to external means capable of directly or indirectly accessing the subject's airways. Further included with the valve is deformable membrane/flexible wall (shown as membrane 164 in FIG. 4B). Membrane 164 is positioned at a distal region, opposing opening 160 (i.e., opposing the side that can connect to the external means capable of directly or indirectly accessing the subject's airways). Deformable membrane 160 may change its shape/tension, as further detailed below, by manually deforming the membrane, via an activation button, to which it is attached/connected with. The membrane may be connected/attached/formed with the valve body at one or more points/regions and to one or more levers/handles, shown as levers 170A-B. Levers 170A-B are further connected on their distal end to covers/caps (shown as covers 166A-B), which are situated on a rail (shown as rail 180), allowing their movement along the rail. The valve further includes resistance units (shown as resistance units 168A-B), which are connected to the valve body on one end and to covers (166A-B) on the opposing end thereof. The resistance units are preferentially located on rail 180, or in close proximity thereto. The resistance units may be composed by one or more resistance components, such as, but not limited to: springs, dashpots (for example, dampers which can resist the motion via viscous friction), electrical resistance units, or any suitable type of resistance units, configured to resist a change in their formation/tension and return to their previous state after they have been deformed/contracted. Reference is now made to FIG. 4C, which shows valve 154 in an open state, which allows transfer of fluid from the pressurized fluid container (not shown), via opening/channels (shown as channel 160), through adaptor 156, to external means capable of directly or indirectly accessing the subject's airways. As shown in FIG. 4C, after the deformable membrane has been deformed (changed its shape, shown as deformable membrane 164′), to move away from the valve body walls, levers 170A-B (of FIG. 4A) have changed their position (shown as position 170A-′-B′ in FIG. 4C). Consequently, the movement of the levers results in the movement of covers/caps (166A′-B′) along rail 180, such that channels/openings 162A-B, that were covered/blocked/sealed by caps 166A-B (in FIG. 4B), are now open. Opening of these channels (162A-B), by the movement of the caps (166A′-B′) allows the flow of pressurized fluid from the pressurized fluid container (not shown) through the open channels (162A-B), ultimately to the external means capable of directly or indirectly accessing the subject's airways (via one or more adaptors, as detailed above). As further shown in FIG. 4C, the resistance unit are compressed/deformed/collapsed (shown as compressed resistance units 168A-′-B′). In some embodiments, the resistance units are configured to limit the movement of the caps, such that upon the movement of the caps, the resistance units attempt to return to their previous mode, causing movement of the caps at a defined rate/duration along the rail, back to their previous location, to cover/seal channels 162A-B, to thereby function as open/close modes of the valve. In some embodiments, the deformation the membrane is induced by pressing/activating/manipulating, activation button, 110, which is connected or associated with the membrane, at the distal region thereof. When the button is activated, the membrane is deformed, detach from the valve walls and consequently, the respective caps are opened and gas passage from the pressurized gas container to the subject's airways is allowed.

[0124] According to some embodiments, the pressure regulator illustrated in FIG. 3A-C or 4A-C, may further include aerosolisation chamber, that can aerosolize fluid or solid particles (the aerosol being any suitable solid or liquid that can be aerosolized, such as, for example, but not limited to: a drug solution, water, saline and any other solution or particles that could be aerosolized), stored within an aerosolisation chamber. The aerosolisation may be performed by perpendicular, swirling, jet, ultrasonic aerosolisation, or any other suitable method. In some embodiments, the aerosolisation chamber may include a particle filtering membrane (for example, a mesh or other suitable filter), to determine the particle size of the aerosolized particles delivered. Reference is now made to FIGS. 5A-B, which schematically depict mechanism of a perspective side view of an exemplary delivery regulator used for regulating passage of pressurized gas through a valve, and further having an aerosolisation chamber. As shown in FIG. 5A, pressure regulator (500), includes a valve (502) and aerosolisation chamber (510). As shown in FIG. 5B, pressure regulator (500), includes a valve (502), aerosolisation chamber (510) and filter membrane (512).

[0125] In some embodiments, the gas pressure and/or flow regulator, includes a chamber, which is a hollow body configured to facilitate equilibration. Such chamber is configured to fluidly connect between the pressurized gas container and the external means capable of accessing the subject's airways, via the various adaptors, as detailed above herein.

[0126] According to some embodiments, the chamber may also include a positive expiratory pressure (PEP) or a one-way valve to ensure one directional flow of air. In some embodiments, the pressure chamber may also include a safety valve, ensuring that the pressure introduced to the patient does not pass a set limit, based on the configuration and reservoir volume attached to the pressure regulator unit, for example, limiting the maximal pressure to, for example, 70 cmH2O, a recommended insufflation pressure for administration of 0.5-1 L of air. In some embodiments the chamber, valve or tank may further include an indicator presenting/showing the amount of stored gas or delivery units available for further use.

[0127] According to some embodiments, when hyperinflation is used to remove secretions, the tank and/or chamber can maintain constant or steady change in pressure to ensure PEF (PCF) of over about 160 L/min, PEF-PIF over about 20 L/min, and/or PIF/PEF bellow about 0.9. In some embodiments, the valve ensures predetermined insufflation time of about 1-6 seconds regardless to the user's inhalation, delivering a predetermined volume of about 0.5-2 L of gas in accordance to the user's lung compliance and physiology.

[0128] According to some embodiments, the gas pressure in the tank may be between about 10-50 atm.

[0129] According to some embodiments, the tank may include an expanded collapsible bag having a fixed maximum dimension and resizing capability, and wherein the bag is used for storing the gas, such that the bag volume defines the remaining effective/operational volume and the pressure change rate of the gas.

[0130] According to some embodiments, the tank's volume may change during insufflation to maintain a steady pressure or to control pressure changing rates. This control of pressure parameters may be obtained by using vacuum-induced force, a spring, a constant force spring or any other force inducing mechanism.

[0131] According to some embodiments, when long insufflation time is needed, the valve may not include or may not induce a closing (shut-off) mechanism, thereby delivering the entire gas content of the tank at once.

[0132] According to some embodiments, when multi-use is needed, the valve can include a spring or spring-like component to stop insufflation. According to some embodiment, when long insufflation time is needed for multi-use, a spring and dashpot dashpot (any suitable dashpot arrangement) or any other damping components may be used. Each possibility is a separate embodiment.

[0133] Reference is now made to FIG. 6, which schematically depicts a perspective view of an exemplary design of a pharyngeal mask, according to some embodiments. As shown in FIG. 6, a mask, embodied as a pharyngeal mask 200, which is a mouthpiece used for securing a fluidly sealed route for the gas from the pressurized gas container device to the patient's airways (in particular), the patients lungs, by insufflation/exsufflation. As shown in FIG. 6, mouthpiece mask (200) has on one end an adapter, configured to connect/adapt/attach to a corresponding adaptor of a gas delivery regulator of a device for delivering pressurized gas (such as, for example, adaptor 14 in FIG. 1, or adaptor 56 in FIG. 3A), or any other suitable adaptor (as further detailed below). On the opposing end, the mask further includes a biting (securing) surface (202), which the user (patient) can bite/hold with his teeth or tongue, to secure the mask in the oral/pharyngeal cavity. The biting region (surface) is designed to fit the teeth of the subject and is thus curved, so that, by biting and gripping the biting surface, the mask can be secured in the subject's mouth. This design further allows using the mask minimal hand-assistance. Hence, the mask is configured for self-use, also among subjects suffering from low neuromotor capacity. The biting surface is further configured to facilitate a tight seal of the mask, with the aid of a sealing element (shown as sealing element 204), which once placed in the pharyngeal cavity, ensures a direct, uninterrupted path from of the passing of the gas from the pressurized gas container of the device, via the corresponding adaptors, via a dedicated channel/passage (shown as channel 206) on the mask to the subjects airways. Channel 206, located on the adaptor end of the mask, allows the uninterrupted, sealed passage of gas from the pressurized gas container, via the pressure regulator, via the respective adaptors on the pressure regulator and on the mask to the into the patient's airway, upon activation of the pressure regulator of device (for example, by inhalation, manual pressure or any other suitable activation route, as detailed herein). Thus, when the mask is placed and secured in the subject's mouth, the gas which eventually flows via opening/channel 206, is directly directed into the subject's mouth, to thereby substantially reduce the risk of leakage and, therefore, the desired gas volume is inhaled by the subject, and does not need to rely on distribution or diffusion of the gas in the mask. In some embodiments, this is particularly of importance when the gas includes a drug (for example, in the form of aerosol). In this manner, by providing a direct, secured, and sealed path for the drug directly to the patients mouth, the leakage of the drug is substantially reduced and the effective amount of the drug directly reaching its target tissue (for example, the lung) is increased, compared to other means of providing a drug via inhalation, which are affected by distribution and diffusion of the drug in other types of masks.

[0134] Reference is now made to FIGS. 7A-7B, which schematically depict a front view and a side view of exemplary a cup member of a mask, according to some embodiments.

[0135] FIG. 7A schematically depicts a front view of an exemplary cup member, 350, of a mask (such as, for example, a face mask). Cup member 350 is configured to fluidly connect to the pressurized gas container coupled at a distal end of the cup member, and optionally to the distal end of an adaptor (such as an adaptor of a mouth piece), at the proximal end of the cup member.

[0136] Since the gas is configured to be delivered directly, without any spacer, into the subject's mouth, the eyes of the patient will not be subjected to damage by the delivery of high volume of gas, or, a drug, if present within the gas, even if the mask is not completely sealed. The cup member may include a nose bridge (not shown) configured to seal the nose if needed. In some embodiments, the cup member may include a chin support assembly (352), located in a bottom section of the cup member, for mounting the mask on the subject's face. In some embodiments, the face mask may include or may be made of an elastic material that may be selected from, but not limited to: rubber, silicone, cloth, polyvinyl chloride (PVC), or any derivative or combination thereof.

[0137] In some embodiments, the facemask may contain one or more straps located in one of the outer surfaces of the mask which enables a user to place on the face without the use of digits. In some embodiments, the strap can be large enough for a wrist or a first or one or more digits to fit into the strap, upon doing so, the user can bring the mask upon the face without the usage of fine motor skills.

[0138] Reference is now made to FIG. 7B, which schematically depicts a side view of cup member 350 of FIG. 7A, used for placement against the face of the subject. Cup member 350 may include a PEP or a one-way membrane valve (360) and/or an optional filter (filter 362) positioned between the inner volume of cup member 350 and valve 360, and configured to prevent patient's secretions from blocking of valve 360. The cup member may further include a chin support assembly 352, an optional thumb loop 364, and a mouth-piece vector (366), configured to aid in placing the cup member in the mouth and/or to attach a suitable mouthpiece to be placed in the mouth of the patient. Thumb loop 364 is an optional assembly that is configured to provide comfortable access to the face mask and to enable easy wear of the mask.

[0139] Reference is now made to FIG. 8, which in some embodiments is a schematic depiction of a connector, configured to connect to a cup member of a face mask and/or pharyngeal mask, which includes a valve. As shown in FIG. 8, connector (400) includes a valve (430), which can control/regulate/allow the gas connection between the cup member to a pressurized gas tank/container (not shown), positioned at a distal end (440) of the cup member (and optionally connected via suitable adaptors). Valve 430 may include a PEP or a one-way valve to prevent backflow and to allow deeper gas (for example, air or aerosol) delivery into the subject's lungs and improve hyperinflation capacity. This is beneficial in particular for SCI patients and may improve effectivity among subjects with high residual volume and/or low respiratory capacity of the lungs. Also shown in FIG. 8 is separation membrane (410) and chamber 450. In some embodiments, upon exhalation by a subject, membrane 410 can deform to seal valve 430, ultimately preventing the inhaled gas to be released to the pressurized gas tank, from chamber 450. In some embodiments, chamber 450 comprises an elastic and biocompatible material selected from the group consisting of: polylactic acid (PLA), polypropylene (PP), or any combination thereof.

[0140] Reference is now made to FIG. 9, which schematically depicts an automatic system of delivering and extracting pressurized gas (insufflation-exsufflation) to a subject via a mask, according to some embodiments. As shown in FIG. 9, automatic system, 300, includes two units/devices that are functionally and/or physically connected or associated, to ultimately provide and extract gas to a subject's airways, via a suitable mask. System 300 includes two units, a first unit connected to the pressurized gas device (302), via regulator (306) to an insufflation port (304; left) and a second unit connected to venturi-based device (314), via an exsufflation port (304; right). The system further includes a pressure sensor (not shown) imbedded in the pressure regulator (306) (for example, in the form of an electrical pressure regulator), for allowing fluid gas from the pressurized gas device (302) to a mask of the subject, via an adaptor, 310 that connects/adapts/attaches to the mask airway. According to some embodiments, insufflation is triggered by inhalation (as detected by a sensor imbedded in regulator 306) and once inhalation is completed and exhalation (cough) begins, exsufflation is assisted as follows: gas flow from the pressurized gas device (302) is directed through a bypass (shown as bypass 312), into venturi device (314), thus creating negative pressure resulting in extraction of gas from the exsufflation port (304; right), in accordance with the Bernoulli law. According to some embodiments, by varying the ratios of the chambers in the pressure changing device (314), it can be adapted to fit various ranges of negative pressures, extraction rates of the fluid and/or fluid volumes dispensed. According to some embodiments, exsufflation is triggered by exhalation (cough; as detected by a sensor imbedded in regulator 306).

[0141] According to some embodiments, using the platform disclosed herein, enables insufflation of 0.5-3 L of gas (such as, air), in a single administration, to the pulmonary system from the pressurized gas tank, and in some embodiments, exsufflation of the same, higher or lower volume of gas. Throughout this process, the device is able to assist coughing, increasing the FVC. In some embodiments, where exsufflation is enabled, the device also increases FEV1 and reduce FRV.

[0142] According to some embodiments, when utilized, the face mask may be used to absorb, wipe and/or store extracted mucus and other pulmonary disturbances.

[0143] In some embodiments, after insufflation, air may be redirected by the patient to induce an effective sneeze or nose blowing, clearing the nasal airways and the nasal cavity. Such actions are limited or unable to be performed effectively by SCI and other neuromuscular deficient patients, for similar reasons to ineffective coughing described above. Accordingly, utilizing the disclosed platform can allow, in some embodiments, for secretions to be collected or absorbed by the respiratory mask.

[0144] In some embodiments, the methods, devices and systems, may be personalized, adapted and repeatedly used for multiple times. In some embodiments the methods, devices and systems, may be meant for a single-use. In some embodiments, the mask is configured for a single use, even if the other components (such as, pressurized gas tank, regulators, etc.), are multiplicity used.

[0145] According to some embodiments, the gas (such as air and/or aerosol) is administered directly into the subject's respiratory system and delivered to the lungs, including lower and upper respiratory tracts and pulmonary alveoli. In some embodiments, such as an active targeted drug delivery decreases the effective dose required, by reducing drug loss on the way to the target site to thus reduce adverse effects or to enable the use of other drugs with an active site that is unlikely to be accessed in other methods of administration. According to further embodiments, avoiding the gastrointestinal tract and a systemic drug delivery is generally beneficial and in particular for patients suffering from a neuromuscular deficiency. The active delivery of a large volume of pressurized gas and/or drug directly to the lungs is advantageous particularly to subjects having high residual volume of air in the lungs and/or low respiratory capacity.

[0146] According to some embodiments, the gas (such as air and/or aerosol) is administered in a cumulative manner, which is advantageous for delivery of a pulmonary drug having an immediate effect or indications of effectiveness, e.g., Ventolin or capsaicin. Ventolin is a short-term bronchodilator used also for treating acute asthma episodes. Using the platform for cumulative dosing of Ventolin enables the subject to stop inhaling the drug when the episode is over. This provides, in some embodiments, individualization of drug dosage or personalized drug dosage according to immediate response. This may further reduce adverse effects and insensitivity and overdosing events, since patients can adjust drug dosage by halting/stopping administration upon achieving a desired effect.

[0147] According to some embodiments, the platforms disclosed herein can be used in targeted delivery of the drug to a specific target site/region/tissue in the subject airways, by adjusting the pressure parameters and/or the particle size of the drug.

[0148] In some embodiments, the drug may be selected from, but not limited to: a chemotherapeutical drug, anti-cancer drug, anti-inflammatory drug, a corticosteroid, a respiratory drug, a cough inducer, an anti-microbial drug, an anti-viral drug, an anti-fungal drug, or any combination thereof. Each possibility is a separate embodiment.

[0149] In some embodiments, the drug includes a bronchodilator. In some embodiments, the drug includes Ventolin. In some embodiments, the drug includes Capsaicin.

[0150] In some embodiments, Capsaicin is provided to induce coughing. Capsaicin-induced coughing may be used to clear respiratory secretions and/or for diagnosis of respiratory compromisation of patients having a nervous system disorder or injury, such as central nervous system (CNS) disorders, cervical injuries and/or spinal cord injuries (SCI). The concentration of capsaicin used to induce coughing indicates the respiratory involvement of the disorder or severity of injury. Furthermore, when the subject coughs, further delivery of drug ceases thus prevents a drug overdose.

[0151] In some embodiments, the drug is used for treating respiratory infections (e.g., influenza, pneumonia) or excessive secretions (e.g., mucus), difficulty in breathing (e.g., asthma), bronchospasm, bronchiectasis, chronic obstructive pulmonary disease (COPD), or any combination thereof.

[0152] In some embodiments, the pressurized gas tank reservoir is disposable, hand-held, self-managed and mounted onto the mask. In such embodiments the volume is of about 50-500 mL and total weight under about 300 g.

[0153] In some embodiments, the pressurized gas tank reservoir is designed for multi-use, refillable and may be connected indirectly onto the mask. At such embodiments, a volume is of about 1-20 L is capable of being placed/mounted onto a wheelchair or any other transportation device supporting SCI or other neuromuscular deficient patients.

[0154] In some embodiments, the pressurized gas may be selected from, but not limited to: oxygen (O.sub.2), nitrogen (N.sub.2), carbon dioxide (CO.sub.2), Aragon (Ar), Helium (He), air or any combination thereof. Each possibility is a separate embodiment. In some embodiments, the pressurized gas may be stored in a tank (container), as detailed above. In some embodiments, the tank stores a positively pressurized gas. In some embodiments, the gas pressure in the reservoir is about 10-30 atm, not more than about 50 atm. In some embodiments, the gas pressure in the reservoir is about 50-250 atm/not more than about 300 atm.

[0155] In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 5-300 atm, or any subranges thereof. In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 5-270 atm. In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 10-250 atm. In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 10-50 atm. In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 25-300 atm. In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 30-280 atm. In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 40-260 atm. In some embodiments, the gas pressure in the gas reservoir (in the container/tank) is about 50-250 atm.

[0156] As detailed above, on average, healthy subjects, capable of coughing effectively has a FVC of 4-5 L, a FEV1 of 3-4 L/s and a FRV of 1-2 L. SCI patients with tetraplegia (high injury, associated with higher risk and incidence of respiratory infections) has a 40-70% of the FVC, 45-75% of the FEV1 and 110-160% of the FRV of an uninjured patient. Essentially, this means that an SCI patient exhale approximately 17% the air volume of a healthy patient (0.5 L in comparison to the 3 L exhaled by an uninjured subject) at a much lower speed, producing a significantly lower shear-force on pulmonary disturbances and producing an ineffective cough. Even patients with paraplegia, which has better pulmonary functions, fall as low as 70% FVC and FEV1 and up to 150% FRV exhaling less than a half than an uninjured subject would, at a lower speed, producing an insufficient or ineffective cough. Therefore, the disclosed devices and systems can by adjusted to function on the range of volume and pressure parameters of an SCI patient and an uninjured patient described herein in order to accomplish optimal coughing based on these parameters. In addition, in some embodiments these parameters may be adjusted manually based on the optimal results and preference of the patient. In some embodiments, the parameters of the individual patient can be diagnosed/determined automatically by the devices and systems (platforms), by introducing pressure and volume sensors or response elements as is known in the art to automatically readjust the parameters of pressure and volume for inhalation of air into the lungs and/or the rapid exhalation of air to induce cough.

[0157] According to some embodiments, utilizing the platforms disclosed herein (including, devices, systems, kits, valve-units, and the like), allows the advantageous delivery of continuous fluid (air) flow, in particular, even if large volumes are delivered. For example, the volumes may be in the range of about, 0.25-5 L, or any subranges thereof. For example, the volumes may be in the range of about, 0.5-4 L, or any subranges thereof. For example, the volumes may be in the range of about, 0.75-3 L, or any subranges thereof. For example, the volumes may be in the range of about, 1-2 L, and any subranges thereof.

[0158] In one embodiment, the drug may be administered to the subject in the form of an aerosol. In some embodiments, the mask (for example, face mask and/or pharyngeal mask) is disposable and configured for a single use.

[0159] According to some embodiments, a face mask is provided for delivering pressurized gas (for example air) to a subject, the mask comprising: a cup member having a peripheral edge for placement against the face of the subject, said cup member is configured to fluidly connect to a pressurized gas tank; and a valve configured to controllably fluidly connect the gas tank to said cup member, wherein, when said mask is placed on the subject's face and the gas tank is connected to the cup member, inhalation by the subject causes said valve to open and gas to be released from the gas tank and forced into the cup member and into the subject's mouth.

[0160] According to some embodiments, a system is provided for insufflation and exsufflation of pressurized gas to a subject, the system comprising: a face mask comprising a cup member having a peripheral edge for placement against the face of the subject, said cup member is configured to fluidly connect to a pressurized gas tank via an insufflation port and to a venturi-based device via an exsufflation port; and a embedded sensor functionally associated with a regulator configured to trigger, upon the beginning of inhalation of the subject, insufflation of pressurized gas from the pressurized gas tank via the insufflation port and to the cup member, wherein the system is further configured to induce exsufflation after a predetermined time or upon exhalation (coughing) detected by the embedded sensor of a volume of the pressurized gas by directing the gas flow to the venturi-based device.

[0161] According to some embodiments, the mask may further include a membrane located between the mouth and the valve when said mask is worn, and wherein inhalation by the subject, causes deformation of said membrane, which causes said valve to open. The mask may further include a mouthpiece for securing said mask to said mouth. The mouthpiece may include a bite surface for securing said mask by the teeth of the subject.

[0162] According to some embodiments, the pressurized gas may include a drug (e.g., aerosolized drug). The drug may be configured for administration to the respiratory system of the subject. The drug may be used for treating respiratory infections, excessive secretions, asthma, bronchospasm, bronchiectasis, chronic obstructive pulmonary disease (COPD), lung cancer or other abnormal pulmonary conditions, or any combination thereof. The drug may be selected from a group consisting of: an anti-inflammatory drug, a corticosteroid, a respiratory drug, a cough inducing drug, an anti-microbial drug, an anti-viral drug, an anti-fungi drug, cannabinoids, immunotherapy, chemotherapy or any other substances that may be delivered via the pulmonary route and any combination thereof. According to some embodiments, the drug may include capsaicin or any other cough inducing agent. According to some embodiments, the drug may be used for inducing coughing in a subject. According to some embodiments, the mask (e.g., for administering a drug) may be used for inducing coughing in a subject suffering from spinal cord injury (SCI). According to some embodiments, the mask may be configured to stop drug delivery once a cough is induced. According to some embodiments, the mask may include a pressure and/or volume sensor or responding elements and a regulator. The sensor/response element may be configured to activate the regulator upon inhalation to allow gas flow from the gas tank to the mouthpiece during inhalation. According to some embodiments, the mask may further include a chamber, wherein the cup member is configured to fluidly connect to the pressurized gas tank via said chamber, and wherein said chamber is configured to facilitate pressure equilibration.

[0163] According to some embodiments, the valve may include a positive expiratory pressure (PEP) one-way valve configured to prevent backflow and thus to facilitate deeper drug delivery into the lungs and/or to increase hyperinflation capacity of the lungs.

[0164] According to some embodiments, the mask may further include a chin support assembly to facilitate self-mounting of the mask on the subject's face with minimal hand-assistance.

[0165] According to some embodiments, the mask may further include a nose bridge for sealing the nose when said mask is worn.

[0166] According to some embodiments, the mask may include an elastic material. According to some embodiments, the mask is disposable and/or recyclable.

[0167] According to some embodiments, there is provided a face mask for delivering pressurized gas (such as air) to a subject, the mask comprising: a cup member having a peripheral edge for placement against the face of the subject, said cup member is configured to fluidly connect to a pressurized gas container (tank); and a valve configured to controllably fluidly connect the gas container to said cup member, wherein, when said mask is placed on the subject's face and the gas tank is connected to the cup member, inhalation by the subject causes said valve to open and gas to be released from the fluid tank and forced into the cup member and into the subject's mouth.

[0168] According to some embodiments, the mask may further include a membrane located between the mouth and the valve when said mask is worn, and wherein inhalation by the subject, causes deformation of said membrane, which causes said valve to open. In some embodiments, the mask may further include a mouthpiece for securing said mask to said mouth. In some embodiments, the mouthpiece includes a bite surface for securing said mask by the teeth of the subject.

[0169] According to some embodiments, there is provided a one-way valve unit. In some embodiments, the one-way valve unit configured to controllably release pressurized gas from a closed pressurized fluid tank/reservoir, the valve unit comprising a deformable membrane configured to deform only upon inhalation by a subject, wherein upon deformation of the membrane, one or more gas passage(s) in the valve unit are at least partially opened, to allow the movement of the pressurized gas movement from to the pressurized gas tank; wherein the valve unit further comprises one or more resistance units, configured to resist the membrane deformation, and allow controlling the gas passages. In some embodiments, the resistance unit comprises one or more of: springs, dashpot, electrical resistant units, or any combination thereof. In some embodiments, the valve unit may be configured to maintain a constant change in the gas pressure, such that the difference between a peak expiratory airflow (PEF) and a peak inspiratory airflow (PIF) is over about 20 L/min and/or the ratio between the peak inspiratory airflow (PIF) and the peak expiratory airflow (PEF) is lower than about 0.9.

[0170] According to some embodiments, the platforms disclosed herein may be used to increase adherence for cough assisting, respiratory exercise or any combination thereof.

[0171] According to some embodiments, the platforms disclosed herein may be used to lower acute pulmonary infections rates, prevent acute pulmonary infections, lower acute pulmonary complication rates, prevent acute pulmonary complications, lower chronic pulmonary complication rates, prevent chronic pulmonary complications or any combination thereof.

[0172] According to some embodiments, the platforms disclosed herein may be used to treat acute pulmonary infections, shorten the duration of acute pulmonary infections, treat acute pulmonary complication, shorten the duration acute pulmonary complications, treat chronic pulmonary complication, shorten the duration chronic pulmonary complications or any combination thereof.

[0173] According to some embodiments, the platforms disclosed herein may be used at home, by the user (subject) alone, or with the help of a caregiver.

[0174] According to some embodiments, the platforms disclosed herein may be used in a clinical setting, by the user alone, or with the help of a caregiver/clinician.

[0175] According to some embodiments, the platforms disclosed herein may be stored, attached or mounted on a motion assisting device such as, but not limited to: walker, wheelchair, motorized chair, extra-skeleton or any combination thereof.

[0176] According to an aspect of some embodiments of the present disclosure, there is provided a kit for delivering pressurized gas to a subject. The kit comprises a face mask and a pressurized gas tank configured for use with the mask. The face mask includes a cup member and a valve.

[0177] According to some embodiments there is provided a kit for delivering pressurized gas to a subject, the kit comprising: a face mask; and a pressurized gas tank configured for use with said mask.

[0178] According to some embodiments, there is provided a method for delivering pressurized gas to a subject, the method includes: adjusting a face mask according to embodiments disclosed herein, to the subject's face and upon inhaling, triggering a release of pressurized gas from the gas tank such that the gas is forced into the cup member and into the subject's mouth.

[0179] In another embodiment, the present disclosure provides a method for delivering pressurized gas to a subject. The method comprises a step of adjusting a face mask to the subject face. The method comprises a step of opening the valve by inhaling, thereby releasing pressurized gas from the gas tank and forcing the gas into the cup member and into the subject's mouth.

[0180] In the description and claims of the application, the words “include” and “have”, and forms thereof, are not limited to members in a list with which the words may be associated.

[0181] As used herein, the term “about” may be used to specify a value of a quantity or parameter (e.g. the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, “about” may specify the value of a parameter to be between 80% and 120% of the given value. For example, the statement “the length of the element is equal to about 1 m” is equivalent to the statement “the length of the element is between 0.8 m and 1.2 m”. According to some embodiments, “about” may specify the value of a parameter to be between 90% and 110% of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 95% and 105% of the given value.

[0182] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

[0183] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0184] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described steps carried out in a different order. A method of the disclosure may include a few of the steps described or all of the steps described. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such.

[0185] Although the disclosure is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the disclosure embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

[0186] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.