MEDICAL VENTILATION MASK

Abstract

An aerosol-proof ventilation mask which efficiently and safely collects and removes aerosol droplets. The medical ventilation mask comprising a gas opening, a mask frame having an internal portion and an external portion, an internal seal having an internal rim, an external seal having an external rim, and at least one vacuum outlet port connected to the mask frame to provide fluid communication with a vacuum line.

Claims

1-16. (canceled)

17. A medical ventilation mask having a central axis, the medical ventilation mask comprising, at least when the mask is ready for use: a gas opening configured to be connected, in fluid communication to a ventilation machine and defining a location of a reference plane perpendicular to the central axis; a mask frame having an internal portion and an external portion and accommodating the gas opening so as to provide fluid communication of the gas opening with the internal portion, the external portion overlaying said internal portion at least along a part of an extension thereof along the central axis and including an auxiliary space therebetween; an internal seal connected to said internal portion at one end of the seal and having an internal rim at another end thereof, and configured for contacting with the face of a subject so that the internal portion of the mask frame and the internal seal define with the face of a subject a ventilation cavity in fluid communication with the gas opening for delivering pressurized ventilation gas to the airways of the subject, said internal rim being spaced from the reference plane along the central axis to a first distance D1; an external seal connected to said external portion at one end of the seal and having an external rim at another end thereof, and configured for contacting with the face of the subject at a location spaced from the internal rim in a direction perpendicular to the central axis, so that said external portion of the mask frame with its auxiliary space and the external seal define with the face of a subject a vacuum cavity, said external rim being spaced from the reference plane along the central axis to a second distance D2 longer than the first distance; and at least one vacuum outlet port connected to the mask frame so as to provide fluid communication between said auxiliary space and a vacuum line, so as to provide aerosol clearance by applying vacuum to the vacuum cavity, simultaneously with, and without interrupting, the ventilation in the ventilation cavity.

18. The medical ventilation mask of claim 17, wherein the mask frame has an external wall and an internal wall spaced inwardly from the external wall in a direction perpendicular to the central axis, the external wall defining at least partially said external portion of the mask frame, and the internal wall defining at least partially said internal portion of the mask frame, and wherein the mask frame optionally further comprises a cap wall which accommodates the gas opening so that the opening is coaxial with the central axis, and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis, the internal portion being defined by the cap wall and the internal wall.

19. The medical ventilation mask of claim 17, wherein a ratio D1:D2 is at least 1:1.10.

20. The medical ventilation mask of claim 17, wherein said internal rim comprises a curved internal lip open towards an interior of the internal portion.

21. The medical ventilation mask of claim 17, wherein the external rim comprises a curved external lip.

22. The medical ventilation mask of claim 21, wherein said curved external lip is open away from the auxiliary space.

23. The medical ventilation mask of claim 21, wherein said curved external lip is open towards the auxiliary space.

24. The medical ventilation mask of claim 17, wherein the external portion has a nose bridge area.

25. The medical ventilation mask of claim 24, wherein the external portion comprises a chin area oppositely spaced from the nose bridge area along a direction perpendicular to the central axis.

26. The medical ventilation mask of claim 24, wherein said vacuum outlet port is positioned in proximity of the nose bridge area.

27. The medical ventilation mask of claim 25, further comprising a pressure regulating port located in proximity of the chin area and providing fluid communication between said external portion and an exterior of the mask.

28. A medical ventilation mask having a central axis, the medical ventilation mask comprising, at least when the mask is ready for use: a mask frame having an external wall and an internal wall spaced inwardly from the external wall at least along a majority of lengths of these walls along the central axis, the internal wall defining at least partially an internal portion of the mask frame, the external wall defining at least partially an external portion of the mask frame including an auxiliary space between the walls; a gas opening connectable to a ventilation machine to provide fluid communication therewith of the internal portion of the mask frame; an internal seal connected to said internal wall at one end thereof and having an internal rim at another end thereof at which the internal seal is configured for contacting with the face of a subject so that the internal portion and the internal seal define with the face of a subject a ventilation cavity in fluid communication with the gas opening for delivering pressurized ventilation gas to the airways of the subject; an external seal connected to said external wall at one end thereof and having an external rim at another end thereof at which the external seal is configured for contacting with the face of the subject at a location spaced from the internal rim at least in a direction perpendicular to the central axis, so that said external portion with its auxiliary space and the internal seal define with the face of a subject a vacuum cavity; at least one vacuum outlet port connected to the mask frame to provide fluid communication between said auxiliary space and a vacuum line so as to provide aerosol clearance by applying vacuum to the vacuum cavity, simultaneously with, and without interrupting, the ventilation in the ventilation cavity; and wherein the mask frame optionally further comprises a cap wall which accommodates the gas opening and to which the internal and external walls are connected at a location spaced from the gas opening along the central axis and along a direction perpendicular to the central axis, the internal portion being defined by the cap wall and the internal wall.

29. The medical ventilation mask of claim 28, wherein the internal rim is spaced from the reference plane along the central axis to a first distance D1 and the external rim is spaced from the reference plane along the central axis to a second distance D2 longer than the first distance.

30. The medical ventilation mask of claim 28, wherein at least one of the internal seal and external seal is detachably attachable to the respective internal and external wall of the mask frame.

31. The medical ventilation mask of claim 28, further comprising a structural reinforcement arrangement extending between the cap wall and outer surface of the external wall.

32. The medical ventilation mask of claim 31, wherein said structural reinforcement arrangement comprises a plurality of reinforcement elements radially spaced from each other about the central axis.

33. The medical ventilation mask of claim 30, wherein at least one of the internal seal or the external seal is detachably attachable to the respective internal and external wall of the mask frame by a quick-connection fitting and further optionally by snap fitting.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0094] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments of a ventilation mask will now be described, by way of non-limiting examples only, with reference to the accompanying drawings, in which, unless indicated specifically, the ventilation mask is shown in its state ready for use:

[0095] FIGS. 1A, 1B, 1C and 1D are, respectively, schematic front, perspective, longitudinal cross-sectional, and side view of a ventilation mask according to an exemplary embodiment of the presently disclosed subject matter.

[0096] FIGS. 2A, 2B, 2C and 2D are, respectively, schematic front, rear, upper and exploded view of a mask according to another exemplary embodiment of the presently disclosed subject matter.

[0097] FIGS. 3A, 3B, 3C, 3D and 3E are, respectively, schematic side, top, perspective, and two longitudinal cross-sectional view of a mask according to another exemplary embodiment of the presently disclosed subject matter.

[0098] FIG. 4 is a schematic side view of the mask shown in FIGS. 3A to 3E, when fitted onto a subject's face.

[0099] FIG. 5 is schematic side view of a ventilation mask according to a further exemplary embodiment of the presently disclosed subject matter.

[0100] FIG. 6 is schematic side view of a ventilation mask fitted onto the subject' face, according to still further exemplary embodiment of the presently disclosed subject matter.

[0101] FIG. 7 is schematic rear view of a mask, which can be any of the masks shown in the previous drawings.

[0102] FIG. 8 is a schematic enlarged side view of a portion of a mask, which any of the masks shown in the previous drawings can have, according to an exemplary embodiment of the presently disclosed subject matter.

[0103] FIGS. 9A-9C are, respectively, schematic upper, rear and perspective view of a ventilation mask according to a still further exemplary embodiment of the presently disclosed subject matter.

DETAILED DESCRIPTION OF EMBODIMENTS

[0104] A schematic illustration of an aerosol-proof ventilation mask 100 of an exemplary embodiment of this disclosure is shown in FIGS. 1A-1D, wherein FIGS. 1A-1D show the mask in isolation in respective front, perspective longitudinal cross-section and side view. The mask 100 allows safe ventilation by collecting and removing aerosols exhaled by the subject during ventilation. When fitting the mask 100 onto the subject's face during ventilation, viral aerosols are scavenged to a vacuum port 124 that is connectable to a vacuum source (not shown). As best seen in FIG. 1C, the mask 100 has a mask frame 102 with cap wall 104 defining the front of the mask and having an opening 122 coaxial with a central axis 146 of the mask and defining a reference plane of the mask, at which a gas opening 122 is mounted, an internal wall 116 defining with the cap wall an internal portion 106 of the mask frame, an external wall 118 overlaying the internal wall 116 so as to leave an auxiliary space 126 therebetween, the external wall and the auxiliary space defining an external portion 107 of the mask frame. The internal and external walls merge with the cap wall at an area 105 spaced from the gas opening both along the central axis and in a direction perpendicular to the central axis.

[0105] The vacuum outlet port 124 is optionally positioned in proximity of the nose bridge area and may comprise a filter (not shown).

[0106] The mask 100 further comprises an external seal 112 connected to the external wall 118 at one end thereof and having an external rim 114 at the other end thereof, configured for contacting with the face of the subject so that the external portion of the mask frame with its auxiliary space 126 defines therewith a vacuum cavity (designated as 442 in FIG. 4).

[0107] The mask 100 further comprises an internal seal 108 connected to the internal wall 116 at one end thereof and having an internal rim 110 at the other end thereof configured for contacting with the face of a subject so as to define therewith a ventilation cavity (designated as 440 in FIG. 4) in fluid communication with the gas opening 122 for delivering pressurized ventilation gas to the airways of the subject. The gas opening 122 is at the front end of the cap wall 104 of the mask frame 102.

[0108] In other words, the mask 100 comprises two face-engaging rims: the internal rim 110 and the external rim 114, each configured to be tightly attached onto the facial skin of the subject creating together a gas-tight seal between the mask and the facial skin, which secures against release of potentially hazardous aerosol particles to the environment while allowing uninterrupted ventilation.

[0109] With reference to FIG. 4, during ventilation at the ventilation cavity, excess ventilation gas and exhaled breath leak from the ventilation cavity 440 into the vacuum cavity 442 via gaps created between the internal rim of the internal seal and the face of a subject due to the impossibility of ideal sealing therebetween (not shown).

[0110] The gas opening 122 is connectable to a ventilation machine and the vacuum port 124 is connectable to a vacuum line (not shown) Thus, in operation the ventilation cavity is subjected to a positive pressure for delivering pressurized ventilation gas to the airways of the subject, and the vacuum cavity is subjected to negative pressure to thereby evacuate excess ventilation gas and exhaled breath therefrom through the vacuum port 124.

[0111] Reverting to FIG. 1C, the internal rim 110 and the external rim 114 are spaced from the gas opening 122 defining the reference plane, along the central axis, to respective distances D1 150 and D2 152, the latter distance being longer than the former distance. The difference between D1 150 and D2 152 can suit the human face topography where a location at which the external rim 114 is to contact the face is further from the gas opening 122 or the reference plane, than a location at which the internal rim 110 is to contact the face. Since external rim 114 protrudes farther towards the face of the subject than the internal rim 110, potentially hazardous aerosol particles escaping the ventilation cavity with excess ventilation gas and exhaled breath are prevented by the external wall of the mask frame from reaching the external rim of the mask frame before they are removed from the vacuum cavity. Thereby, the mask 100 is a dual-seal mask having a sealed ventilation cavity and a sealed vacuum cavity upon fitting of the mask on the subject's face. The resulted dual-seal configuration allows environmentally safe aerosol scavenging during safe ventilation.

[0112] The internal wall 116 and the external wall 118 are formed as a unitary body with the cap wall 104. The internal seal 108 and external seal 112, can also be formed as a unitary body with the internal and external walls, but they can alternatively be connected to these walls integrally, e.g. by heat welding or by any mechanical means.

[0113] The mask 100 may further comprise structural reinforcement arrangement extending between the cap wall 104 and outer surface of the external wall 118. One example of such arrangement is shown in FIG. 5, where it is designated as 536, where it shown to comprise a plurality of reinforcement elements spaced from each other.

[0114] As illustrated in FIG. 8, the internal rim 710 which can comprise a curved internal lip 738 and the external rim 714 which can comprise a curved external lip illustrated as 740. In this example, the inner curved lip 738 is open inwardly, i.e. into the interior of the ventilation cavity, and the external curved lip 740 is open outwardly, i.e. towards the exterior of the mask when the mask is in use. More detailed description of the internal and external lips is presented below in the detailed description of FIG. 8.

[0115] The external portion 107 of the mask frame can have a nose bridge area, and optionally a chin area oppositely spaced from the nose bridge area. The mask 100 may further comprise a pressure regulating port (not shown) providing fluid communication between the external portion 107 and an exterior of the mask, located in proximity of the chin area.

[0116] Mask 100 also includes mask engagement elements 134 that may be linked to straps for fixing the mask to the subject's face over the airways. The mask 100 may be configured for use in non-invasive ventilation (NIV), (CPAP) ventilation, or (BiPAP) ventilation, and may further comprise a UV purifier.

[0117] An exemplary embodiment of a mask 200 is shown schematically in FIGS. 2A-2B, which has the same elements as in the mask 100 described above.

[0118] In these figures like reference numerals shifted by 100 are used for elements of the mask 200 which are seen there and which function in the same way as those of the mask 100 described above with reference to FIGS. 1A-1D. The reader is referred to the description of these elements in the mask 100. For example, in FIGS. 2A-2C a mask frame 202 is shown with its internal portion 206 and external portion 207 comprising an auxiliary space 226, which are the same as the mask frame 102 with its internal portion 106 and external portion 107 with its auxiliary space 126.

[0119] As shown in FIG. 2C, the mask 200 further comprises an internal seal 208 having an internal rim 210 for contacting with the face of a subject so as to define therewith a ventilation cavity in fluid communication with the gas opening 222 for delivering pressurized ventilation gas to the airways of the subject, and external seal 212 connected to an external wall 218 of the mask frame and having an external rim 214 configured for contacting with the face of the subject for creating a vacuum cavity 232 in fluid communication with a vacuum port 224 for removing aerosols exhaled by the subject during ventilation and escaped with excess ventilation gas and exhaled breath leak from the ventilation cavity into the vacuum cavity.

[0120] FIG. 2D illustrates an exploded view of the mask 200, comprising the mask frame 202 with its cap wall 204, external wall 218, internal seal 208 to be connected to an internal wall of the mask frame (not seen in FIG. 2D), and external seal 212 configured to be connected to the external wall 216 by any suitable mechanical connection means, as explained above with reference to the mask 100 or as described below with respect to a mask 300.

[0121] A mask 300 is shown schematically in FIGS. 3A-3E and it has the same elements as the masks 100 and 200 described above. In these figures like reference numerals shifted by 200 are used for elements of the mask 300, which are seen in these figures and which function in the same way as those of the mask 100 described above with reference to FIGS. 1A-1D. The reader is referred to the above description of these elements in the mask 100.

[0122] FIG. 3E presents a longitudinal cross-sectional view of the mask 300 having a central axis 346 and comprising a mask frame 302 with a cap wall 304, external wall 318, internal wall 316, internal seal 308 and external seal 312. The cap wall is formed with an opening 322 configured for connecting a gas port thereto (not shown) and with a vacuum port 324 open into an auxiliary space 326.

[0123] The opening 322 lies in or defines a reference plane RP 348 perpendicular to the central axis 346. An internal rim 310 of the internal seal 312 is spaced from the reference plane RP along the central axis 346 to a first distance D1 350 and the external rim 314 of the external seal 308 is spaced from the reference plane RP along the central axis 346 to a second distance D2 352 longer than the first distance D1 350.

[0124] The internal and external walls merge with the cap wall at an area 305 spaced from the reference plane both along the central axis 346 and in a direction perpendicular to this axis. Each of the internal and external walls have a mounting end 346, 348 respectively, to which the internal and external seals are mountable.

[0125] Each of the internal and external seals has a mounting end designated as 342, and 344 respectively, opposite to the sealing rims of the seal, which is securely connected to the the corresponding internal and external wall of the mask frame. The connection can be permanent or detachable.

[0126] Reverting to FIG. 4, it illustrates the dual-seal function of each one of the masks 100, 200 and 300 described above, when the mask is fitted onto the subject's face with the internal and external rims of its seals in tight contact with the face of the subject, and with the gas port connected to a ventilation machine and the vacuum port being connected to a vacuum line (both not shown). The dual-seal function is provided by the following two cavities created by the mask with the subject's face once the mask is fitted thereto as described above: the ventilation cavity 440 in fluid communication with the gas opening for delivering pressurized ventilation gas to the airways of the subject, and the vacuum cavity 442 in fluid communication with the vacuum port for removing aerosols exhaled by the subject during the ventilation and escaped with excess ventilation gas and exhaled breath leak from the ventilation cavity into the vacuum cavity.

[0127] FIG. 5 illustrates a ventilation mask which can be any of the masks described above, having a structural reinforcement arrangement in the form of an array of silicon rims 536 on an outer surface of the external wall of the mask frame. Such reinforcement may be implemented in a single use mask that is comprised of an elastic material to support the dual-seal of the mask onto the subjects' face. The illustrated reinforcement arrangement enables safe and controlled tightening of the internal portion of the mask when pulling the straps connected to the engagement elements, thereby allowing a safe and secured dual-seal.

[0128] Any of the above-described masks can have two vacuum ports, as illustrated in FIG. 6, in which the right-pointing arrow illustrates incoming ventilation gas and the two left-pointing arrows represent suctioned aerosol and exhaled gas from two vacuum ports 554 and 556, the two vacuum ports are positioned in proximity to weak sealing spots beings nose bridge and chin areas of the mask.

[0129] FIG. 7 depicts a rear view of a mask which can be any of the masks 100, 200 and 300 described above, with arrows schematically representing exhaled breath flow pattern within the auxiliary space designated as 626 to the vacuum outlet port.

[0130] Reverting to FIG. 8, it depicts an enlarged view of a portion of any of the masks 100, 200 and 300, according to a non-limiting embodiment, which portion comprises a part of the internal and the external rim with the respective internal curved lip 738 and external curved lip 740. As seen in FIG. 8, each curved lip has an extremity and a rim edge at which the lip terminates, wherein internal curved lip 738 is open towards the interior of the mask or towards the ventilation cavity, when the mask is in use, and the external curved lip 740 is open towards the exterior of the mask or away from the ventilation and vacuum cavities, when the mask is in use. This means that the rim edge 760 of the internal curved lip is disposed within the interior of the mask or the ventilation cavity when the mask is in use, and the rim edge 764 of the external curved lip is disposed out of the any interior space of the mask and of the vacuum cavity when the mask is in use. The extremities 758 and 762 of the respective lips 738 and 740 are spaced from the reference plane of the mask (not shown in this figure) to respective distances D1 and D2 described above in the description of the masks 100 and 300.

[0131] A yet another exemplary embodiment of a mask 800 is shown schematically in FIGS. 9A-9C representing the upper, rear and perspective views of the mask, respectively. In these figures like reference numerals shifted by 700 are used for elements having a similar function to those of FIGS. 1A-1D. The reader is referred to the description of FIGS. 1A-1D, where needed, for explanation of their function. For example, reference numerals 108 and 808 are used to refer to the internal seals of the respective mask frames 100 and 800, and reference numerals 112 and 812 are used to refer to the external seals of these masks. In this embodiment, which is applicable to any of the masks described above, the mask 800 comprises a plurality of gas conduits 846 formed at the periphery of the auxiliary space 826 between the internal wall 816 and the external wall 818 of the mask frame 802 configured to function as described in the General Description part of the present specification.