Oxygen mask with bite block and monitoring means

Abstract

The oxygen mask has a convex shell with upper and lower portions defining a chamber, a rim at least partially around the chamber, a nasal access port in the upper portion, and an oral access port in the lower portion. The nasal access port may be pierceable and / or puncturable to allow access to the chamber, and the oral access port may include a bite block with a lumen and a valve in the lumen. The oxygen mask may have an inlet to the chamber, an outlet from the chamber, and a sample collection port in communication with the chamber. The oxygen mask may have at least one fold or crease configured to allow the bite block to tilt relative to a horizontal axis and / or translate along a vertical axis.

Description

[Technical field]

[0001] The present invention relates generally to face masks, and more particularly to oxygen face masks having integral bite-blocks and / or monitoring means.

[0002] [Citation to Related Applications] This application claims priority to U.S. Provisional Patent Application No. 63 / 189,763, filed May 18, 2021, the disclosure of which is incorporated by reference in its entirety. [Background technology]

[0003] In various procedures, the patient often needs to be oxygenated to avoid hypoxia (low oxygen pressure in the blood and tissues), which can be critical if the patient is not breathing adequately to maintain oxygen pressure, as prolonged periods of low oxygen pressure can lead to abnormal heartbeats, cardiac arrest, and / or respiratory arrest. Endoscopic procedures may additionally require access to the patient's mouth or nose for insertion of instruments. Summary of the Invention [Problem to be solved by the invention]

[0004] Overview The inventors have recognized that there is a need for an improvement in the art to address the inefficiencies of current face masks in providing oxygen delivery or access to the mouth or nose. The inventors have also recognized that there is a need for an improved fit to ensure access to the mouth and / or nose, taking into account variability in facial structure and shape. Additional improvements of the present invention compared to the current state of the art can be readily recognized in the disclosure provided herein. [Means for solving the problem]

[0005] Thus, a first aspect of the invention relates to a mask having a convex shell with upper and lower portions and defining a chamber, a rim at least partially around the chamber, a nasal access port in the upper portion and an oral access port in the lower portion. The nasal access port may be pierceable and / or puncturable to allow access to the chamber, and the oral access port may include a bite block with a lumen and a valve in the lumen.

[0006] A second aspect of the invention relates to a mask having a convex shell with upper and lower portions and defining a chamber, a rim at least partially around the chamber, an inlet to the chamber, an outlet from the chamber, a sample collection port in communication with the chamber, a nasal access port in the upper portion, and an oral access port in the lower portion. The nasal access port may be pierceable and / or puncturable to allow access to the chamber, and the oral access port may include a bite block with a lumen and a duckbill valve disposed within the lumen.

[0007] A third aspect of the invention relates to a mask having a convex shell with upper and lower portions and defining a chamber, a rim at least partially around the chamber, an oral access port in the lower portion, and at least one fold or crease. The oral access port may include a bite block with a lumen and a valve in the lumen, and the at least one crease or crease may be configured to allow the bite block to tilt relative to a horizontal axis and / or translate along a vertical axis.

[0008] Some embodiments of the mask further include an inlet to the chamber and an outlet from the chamber. In some embodiments, the outlet comprises a plurality of holes disposed around the post. In some embodiments, the mask further includes a sample collection port in communication with the chamber. In some embodiments, the mask further includes at least one post disposed on the upper portion and configured to secure the nose clip. In some embodiments, the nasal access port has one or more flaps with edges forming a plurality of lines. In some embodiments, the plurality of lines includes a first line and a second line connected at a first node, and a third line and a fourth line connected at a second node. In some embodiments, the plurality of lines includes at least two lines connected to each other at an angle in a non-vertical orientation. In some embodiments, the plurality of lines includes a first line and a second line connected to form a first "V" shape. In some embodiments, the plurality of lines includes a third line and a fourth line connected to form a second "V" shape. In some embodiments, the second line and the third line are joined to form a "W" shape. In some embodiments, the one or more flaps are connected by one or more weakened portions along at least a portion of the edge. In some embodiments, the valve is a duckbill valve. In some embodiments, the bite block extends at an acute angle relative to a horizontal axis of the mask. In some embodiments, the mask further comprises at least one crease or fold configured to allow the bite block to tilt relative to the horizontal axis and / or translate along a vertical axis. In some embodiments, the at least one crease or fold is configured to allow the bite block to tilt relative to the horizontal axis and / or translate along a vertical axis. In some embodiments, the at least one crease or fold extends above and / or below the oral access port. In some embodiments, the at least one crease or fold laterally overlaps the bite block.In some embodiments, the at least one crease or fold extends circumferentially around the bite block. In some embodiments, the mask further comprises a membrane forming the at least one crease or fold. In some embodiments, the at least one crease or fold comprises a plurality of creases or folds. In some embodiments, the plurality of creases or folds extend laterally between the first side portion and the second side portion.

[0009] In order that the invention may be readily understood, aspects of the invention are shown by way of example in the accompanying drawings. [Brief description of the drawings]

[0010] [Figure 1] 1 is an illustrative front isometric view of a first embodiment of an oxygen mask of the present invention. FIG. [Diagram 2] FIG. 2 is a front view of the oxygen mask of FIG. 1. [Diagram 3] FIG. 3 is an exemplary rear isometric view of the oxygen mask of FIGS. 1 and 2. [Figure 4] FIG. 4 is an exemplary rear view of a bite block of the oxygen mask of FIGS. 1-3. [Diagram 5] FIG. 5 is a partial front view of an example of the oxygen mask of FIGS. [Figure 6] FIG. 6 is an exemplary side cross-sectional partial view of the oxygen mask of FIGS. 1-5. [Figure 7] FIG. 7 illustrates a first exemplary assembly including the oxygen mask of FIGS. 1-6. [Figure 8] FIG. 7 illustrates a second exemplary assembly including the oxygen mask of FIGS. 1-6. [Figure 9] FIG. 2 is an exemplary front view of a second embodiment of the oxygen mask of the present invention. [Figure 10] 10 is an exemplary cross-sectional side view of the oxygen mask of FIG. 9. [Figure 11] FIG. 13 is an exemplary rear view of a third embodiment of the oxygen mask of the present invention. [Figure 12] 12 is an exemplary side cross-sectional partial view of the oxygen mask of FIG. 11. [Figure 13] FIG. 13 is an exemplary front view of a fourth embodiment of the oxygen mask of the present invention. [Figure 14] 14 is an exemplary side cross-sectional view of the oxygen mask of FIG. 13. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The present invention relates to a multi-access ported oxygen mask with an integrated oral bite block that can be used as a non-rebreathing mask. The oxygen mask can be worn as a standard oxygen mask during conventional oxygen therapy and can be readily converted into an intubation mask. Thus, the oxygen mask can selectively allow access to the patient's mouth and / or nose for insertion of an instrument (e.g., catheter, endoscope, and / or probe) during oxygen delivery. A duckbill valve can be configured in-line and incorporated into the bite block to prevent gas from exiting through the oral access port. When an instrument is inserted through the oral access port, the duckbill valve can flex open under pressure from the instrument, and when the instrument is removed, it can be biased to a closed configuration. When oxygen supply to the patient is insufficient or interrupted, the duckbill valve can also serve as a safety valve that opens under negative pressure in the face mask to allow ambient room air to enter the face mask during an inhalation cycle. The nasal access port can have one or more flaps with edges that form multiple nodes that are pierced and / or perforated. The nodes may be positioned in line with the nasal cavities to allow selective access to each nasal cavity. The clinician may use the integrated bite block as an entry point for various procedures, including manually piercing and / or drilling the nasal diaphragm and / or instruments introduced nasally or orally, without compromising the current benefits of increased oxygen saturation and / or continuous monitoring of exhaled gases. In some embodiments, the bite block is configured to tilt (or pivot) and / or translate to match the relative position of the patient's mouth by attaching at least one fold or crease and / or flexible membrane. In some embodiments, the bite block is configured to tilt vertically at least about 5-8° relative to the horizontal axis of the mask. In some embodiments, the bite block is configured to tilt vertically at least about 11-15° relative to the horizontal axis of the mask.In some embodiments, the bite block is configured to tilt vertically at least about 25° relative to a horizontal axis of the mask. In some embodiments, the mask is configured to maintain adjustment (pivot angle and / or translation distance) without immediately returning to its original configuration, such that the bite block can be adjusted prior to application to the patient. The oxygen mask may further include a multiple entry port with an oxygen tubing connector attachable to a reservoir bag, a carbon dioxide sample collection port, an exhaust port, and / or a nose clip.

[0012] As used herein, the term "upper" or "upper" refers to a portion of the mask or a component thereof that is located near the top of the patient's head during intended use. As used herein, the term "lower" or "lower" refers to a portion of the mask or a component thereof that is located near the patient's chin during intended use. As used herein, the term "vertical" refers to an axis extending along or parallel to the patient's median or sagittal plane that extends between the chin and head during intended use. As used herein, the term "lateral" or "horizontal" refers to the relative portion of the mask or a component thereof that is extending along or parallel to the patient's horizontal or transverse plane during intended use.

[0013] 1-6 show an oxygen face mask 100 according to a first exemplary embodiment of the present invention. FIG. 7 shows a first oxygen system 500 including the oxygen mask 100, and FIG. 8 shows a second oxygen system 500' including the oxygen mask 100. The oxygen mask 100 may have a convex shell with an upper portion 102 and a lower portion 104 and defining a chamber 101 that fits over a patient's face. The upper portion 102 may have a convex nature that fits over the patient's nose and provides sufficient space for comfort. The lower portion 104 may be configured to fit over the patient's mouth. A rim 106 may extend at least partially (e.g., completely) around the upper portion 102 and the lower portion 104. In use, the rim 106 may rest against the patient's face to form an airtight seal when the oxygen mask 100 generally encases the patient's nose and mouth within the chamber 101. The oxygen mask 100 may have one or more inlets and / or outlets in communication with the chamber 101 for delivering oxygen-enriched air to the patient. For example, the oxygen mask 100 may have an oxygen supply port 120 leading to an inlet to the chamber 101, a sample take port 122 leading to an outlet to the chamber 101, and an exhalation port 124 leading to an outlet to the chamber 101, which are further described below with reference to Figures 7 and 8.

[0014] The oxygen mask 100 may include a nasal access port 130 disposed in the upper portion 102. The nasal access port 130 may be pierceable and / or puncturable. For example, as shown, the nasal access port 130 may include one or more flaps 132 connected along at least a portion of the edges of such flaps 132 by one or more weakened portions 134. The one or more weakened portions 134 may be normally intact such that the one or more flaps 132 are joined together to seal the nasal access port 130, thereby preventing the escape of gas therethrough. The one or more weakened portions 134 may be made of a different material (e.g., a softer or weaker material) and / or may have reduced material strength provided by a reduced thickness as compared to the one or more flaps 132 and / or shell of the oxygen mask 100. In some embodiments, the one or more weakened portions 134 may be adhesive or welded that connect the one or more flaps 132 together. The one or more weakened portions 134 may be selectively torn or broken to separate the one or more flaps 132 and provide one or more access openings to the nasal cavity for insertion of an instrument (e.g., a catheter, endoscope, and / or probe). The one or more flaps 132 may be biased to a closed configuration in a natural state. Thus, the one or more flaps 132 may be flexible enough to conform to a shape around an inserted instrument to ensure that the chamber 101 is sealed and to return to the closed configuration after the instrument is removed. As further shown, the one or more weakened portions 134 and / or edges of the flaps 132 may form first and second lines that extend perpendicular to each other and intersect at a single node to form a "+" or "X" shape. A portion of each of the lines may be separately perforated and / or drilled, while another portion of the same line remains intact or in a similar state to reduce oxygen escape.

[0015] In some embodiments including one or more weakened portions 134, the nasal access port 130 may have a continuous flexible, modifiable membrane formed by one or more flaps 132 when the one or more weakened portions 134 are intact, and one or more customized instrument access openings may be manually configured from such membrane to access either or both of the patient's left and right nasal cavities when and where needed by piercing one or more lengths of the one or more weakened portions 134. In some embodiments, the one or more flaps 132 and / or the one or more weakened portions 134 may be made of the same material as the shell of the oxygen mask 100 and may be integrally formed therewith, for example, by injection molding with the oxygen mask 100.

[0016] In some embodiments, one or more of the weakened portions 134 may be omitted, so that the edges of one or more of the flaps 132 can be brought closer together to narrow the gap, thereby providing a sufficient seal to reduce gas leakage. Although the formation of a narrow gap between one or more of the flaps 132 and the inserted appliance results in a small amount of gas leakage into and out of the oxygen mask 100, the gas leakage through the narrow gap is insignificant when compared to the oxygen available to the patient through the oxygen delivery port 120. The narrow gap between one or more of the flaps 132 may form a line having the same orientation as the one or more weakened portions 134. Alternatively, the weakened portions 134 may be formed just at the nodes, so that one or more of the flaps 132 can be connected together to maintain the shape of the nasal access port 130 during shipping and storage.

[0017] In some embodiments, one or more of the flaps 132 may be omitted and the membrane covering the nasal access port 130 may be a single continuous weakened portion 134 (not shown) allowing for a fully customizable access opening of any size and shape through the weakened portion 134.

[0018] The oxygen mask 100 may further include a mouth access port 140 in the lower portion 104. The mouth access port 140 may include a lumen 142 in communication with the chamber 101 and a bite block 144 extending around the lumen 142. The bite block 144 may include a tube extending inwardly from the center of the lower portion 104 into the chamber 101 such that the bite block 144 is positioned in line with the patient's mouth. The tube of the bite block 144 may be rigid enough to prevent collapsing when bitten down to prevent damage to instruments inserted through the lumen 142. In that sense, the tube of the bite block 144 may be made of a harder material than the material of the shells of the upper and lower portions 102, 104. The bite block 144 may have an upper portion 146 configured to engage the patient's upper teeth and a lower portion 148 configured to engage the patient's lower teeth. The upper and lower portions 146, 148 may be separated on each lateral side by a channel 150 that is in communication with the lumen 142 and the chamber 101. Each of the upper and lower portions 146, 148 may have a slight curvature to facilitate insertion of instruments with minimal interference. The bite block 144 may have a rigid flange 152 disposed about the lumen 142 and welded or bonded to the shell of the lower portion 104.

[0019] The bite block 144 may be adjustable to fit men, women, and / or children with various facial sizes and shapes. The adjustability may be provided by at least one fold or crease 180, each encircling a well 182. The at least one fold or crease 180 may be compressible or flexible to allow the bite block 144 to tilt or pivot vertically at an angle α relative to a horizontal axis (as shown in FIG. 6) and / or translate along the vertical and / or lateral axes of the oxygen mask 100. The at least one fold or crease 180 may be provided in the shell to allow the bite block to tilt or pivot vertically up to an angle of about 5-8° relative to the horizontal axis to fit various facial sizes and shapes. Thus, the bite block 144 may extend at an acute angle α relative to the horizontal axis. Additionally or alternatively, the at least one fold or crease 180 may be compressible along a vertical and / or lateral axis to allow the bite block to translate along the vertical and / or lateral directions to further adjust the oxygen mask 100 to various facial sizes and shapes. The at least one fold or crease 180 and the enclosing well 182 may have a substantially U-shaped or V-shaped cross section. In some embodiments, the at least one fold or crease 180 may be inelastic to maintain the adjustment (pivot angle and / or translation distance) without immediately returning to its original configuration, thus allowing the bite block 144 to be adjusted prior to application to the patient. However, in some embodiments, the at least one fold or crease 180 may be elastic to return the bite block 144 to its original configuration, but still provide flexibility to allow adjustment.

[0020] At least one crease or fold 180 may extend circumferentially about the longitudinal axis of bite block 144 to permit tilting and / or translation. Thus, at least one crease or fold 180 may extend above and below oral access port 140 and overlap laterally with oral access port 140. Depending on the circumferential configuration, at least one crease or fold 180 may be a single crease or fold 180 that defines a single well 182 that permits tilting and translation of bite block 144 in the vertical and lateral directions. Rigid flange 152 of bite block 144 may be recessed within circumferential crease or fold 180.

[0021] The bite block 144 may have a one-way valve 160 disposed across the lumen 142 and defining an open and closed configuration. In the open configuration, the one-way valve 160 may allow passage of an instrument from the lumen 142 into the chamber 101. In the closed configuration, the one-way valve 160 may seal the lumen 142 and the chamber 101 in a substantially air-tight manner. The one-way valve 160 may be a duckbill valve formed of multiple valve members 162 (e.g., four valve members 162 as shown) that engage with one another or are biased into a closed configuration in close contact with one another. The duckbill valve 160 may be incorporated into the bite block 144 and may provide a robust self-sealing mechanism that does not require a valve seat. Each of the valve members 162 may be formed with two substantially flat portions 164 that converge to an apex 166 (as shown in FIG. 4). The valve 160 may be provided between the patient's face and the shell of the lower portion 104 and inside the lumen 142 of the bite block 144 to avoid interference from the patient's teeth. Additionally, in the event of insufficient or interrupted oxygen supply to the patient, the valve 160 may also serve as a safety valve that opens under negative pressure within the face mask to allow ambient room air to enter the face mask 100 during the inhalation cycle.

[0022] The oxygen mask 100 may have a number of holes 108 in the rim 106 for securing one or more straps 502, as shown in Figures 7 and 8. The straps 502 may be elastic and may be wrapped around the patient's head to secure the oxygen mask 100 over the patient's nose and mouth. For example, two straps 502 may each be separately threaded through a pair of holes 108, as shown in Figures 7 and 8, such that each of the straps 502 may be tightened to secure the oxygen mask 100 to the patient in a sealing manner.

[0023] As further shown in the systems 500, 500' of Figures 7 and 8, the oxygen supply port 120 may be coupled to a supply adapter 504 for supplying oxygen. The oxygen supply port 120 may be integrated into the shell of the oxygen mask 100 within a peripheral sidewall on a first side of the upper portion 102. The oxygen supply port 120 may be an open tubular member having a larger diameter than the supply adapter 504, which may be configured to receive the supply adapter 504 in an interference fit. For example, as shown in the embodiment of Figure 7, the supply adapter 504 may be coupled to an oxygen supply line 506, which may be configured for a medium concentration oxygen flow. Figure 8 shows an embodiment having a supply adapter 504' coupled to an oxygen supply line 506 and a reservoir bag 508 configured for a high concentration oxygen flow or non-rebreathing mask. The supply adapter 504' may fit radially around a fitting on the reservoir bag 508. The oxygen supply line 506 of either system 500 , 500 ′ may have a fitting 507 to be connected to an oxygen tank (not shown) for the supply of regulated oxygen to the chamber 101 .

[0024] The sample collection port 122 may be positioned on the front surface of the upper portion 102 and in communication with the chamber 101. The sample collection port 122 may be configured to allow sampling of the air within the chamber 101 to determine carbon dioxide levels during use. The sample collection port 122 may have a diameter ranging from about 2.5 mm to about 3.7 mm. In some embodiments, the sample collection port 122 may be covered by a cap 510.

[0025] The exhale port 124 may be incorporated into the shell of the oxygen mask 100 at a peripheral sidewall on a second side of the upper portion 102 laterally opposite the oxygen delivery port 120. The exhale port 124 may be circular in shape with a number of holes 126 (e.g., six holes 126 as shown) located along the periphery. The holes 126 allow exhaled air rich in carbon dioxide to exit the oxygen mask 100. When configured as a non-rebreathing mask, the exhale port 124 may include a flap valve (not shown) to inhibit room / ambient air from entering the oxygen mask 100. The flap valve may be circular to cover the hole 126 and may flex away from the hole 126 under pressure from the chamber 101, thereby allowing exhaled air rich in carbon dioxide to exit the oxygen mask 100. The flap valve may be supported and held centered by providing a central hole that receives the post 128 of the inhalation port 124. When configured for medium or high oxygen flow, the inhalation port 124 may be left open without the flap valve. Thus, the inhalation port 124 allows the ambient room air inhalation to mix with the oxygen inhalation from the oxygen delivery port 120 to provide the entire inhalation flow for the patient.

[0026] The system 500, 500' may further include a nose clip 520 securable to the upper portion 102. The nose clip 520 may be substantially "U" shaped. The nose clip 520 may be crimpable and / or spring loaded to compress the upper portion 102 around the patient's nose. An end of the nose clip 520 may be provided with an opening configured to receive a post 170 embedded in the upper portion 102, thereby securing the nose clip 520 to the oxygen mask 100. Although the system 500, 500' is illustrated with the oxygen mask 100, the system 500, 500' may alternatively include an oxygen mask 200, 300, as described further below.

[0027] 9 and 10 show an oxygen face mask 200 as a second exemplary embodiment of the present invention. The oxygen mask 200 is a variation of the oxygen mask 100, and thus embodies many of the features of the oxygen mask 100 as described herein and designated by the reference numeral having the same last two digits. Thus, the disclosure of the oxygen mask 100 is incorporated herein with respect to the oxygen mask 200, unless expressly specified otherwise.

[0028] For example, as further described above, the oxygen mask 200 may have an upper portion 202 and a lower portion 204 defining a chamber 201 that fits over the patient's face to provide oxygen-enriched air. The upper portion 202 may have a convex shape that fits over the patient's nose with sufficient clearance for comfort. The lower portion 204 may be configured to fit over the patient's mouth. A rim 206 may extend at least partially (e.g., completely) around the upper and lower portions 202 and 204. In use, the rim 206 may rest against the patient's face to form an airtight seal when the oxygen mask 200 generally encases the patient's nose and mouth within the chamber 201. The rim 206 may have a number of holes 208 for securing one or more straps 502 (as shown in FIGS. 7 and 8) to sealingly secure the oxygen mask 200 to the patient. The mask 200 may further include a post 270 incorporated into the upper portion 202 for securing the nose clip 520 to the oxygen mask 200. The oxygen mask 200 may include one or more inlets and / or outlets in communication with the chamber 201 for delivering oxygen-enriched air to the patient. For example, the oxygen mask 200 may include an oxygen supply port 220 for inletting the chamber 201, a sample collection port 222 for outletting the chamber 201, and an exhalation port 224 for outletting the chamber 201, which are substantially the same as those described above with reference to Figures 7 and 8.

[0029] The oxygen mask 200 may include a nasal access port 230 disposed in the upper portion 202. The nasal access port 230 may be pierceable and / or puncturable. For example, as shown, the nasal access port 230 may include one or more flaps 232 connected along at least a portion of the edges of such flaps 232 by one or more weakened portions 234. The one or more weakened portions 234 may be normally intact such that the one or more flaps 232 are joined together to seal the nasal access port 230, thereby preventing the escape of gas therethrough. The one or more weakened portions 234 may be made of a different material (e.g., a softer or weaker material) and / or may have reduced material strength provided by a reduced thickness as compared to the one or more flaps 232 and / or shell of the oxygen mask 200. In some embodiments, the one or more weakened portions 234 may be adhesive or welds connecting the one or more flaps 232 together. The one or more weakened portions 234 may be selectively torn or broken to separate the one or more flaps 232 and provide one or more access openings to the nasal cavity for insertion of an instrument (e.g., a catheter, endoscope, and / or probe). The one or more flaps 232 may be biased to a closed configuration in a natural state. Thus, the one or more flaps 232 may be flexible enough to conform to a shape around an inserted instrument to ensure that the chamber 201 is sealed and to return to the closed configuration after the instrument is removed. As further shown, the one or more weakened portions 234 and / or edges of the flaps 232 may form a plurality of lines. The multiple lines may be connected to one another at an angle in a non-vertical orientation and may include at least two lines extending at acute and / or obtuse angles relative to one another (e.g., in a non-"+" or non-"X" shape). The multiple lines may be laterally spaced apart and joined by multiple nodes, one or more of which may provide access to each nasal cavity.For example, the multiple lines may include a first line and a second line joined at a first node (e.g., forming a first "V" shape) that is in-line with and allows access to the right nostril, and a third line and a fourth line joined at a second node (e.g., forming a second "V" shape) that is in-line with and allows access to the left nostril. The second and third lines may optionally be joined at a third node that joins the first and second "V" shapes to form a "W" or zigzag shape. It is also contemplated that the nodes may be rounded to form a "U" shape and / or a sinusoidal shape. Additional lines may extend vertically (upward or downward) from each of the nodes to facilitate opening of the nodes and insertion of the device. Furthermore, this configuration allows the first and second nodes of the nasal access port 230 to be pierced and / or punched independently or separately, thereby allowing separate access to either the right or left nasal cavity. The first node may be pierced and / or punched to access the right nasal cavity, while the second node may remain intact or in a similar state to prevent oxygen from escaping. Alternatively, the second node may be pierced and / or punched to access the left nasal cavity, while the first node may remain intact or in a similar state to prevent oxygen from escaping. Furthermore, each portion of the line may be pierced and / or punched separately, while another portion of the same line may remain intact or in a similar state.

[0030] In some embodiments including one or more weakened portions 234, the nasal access port 230 may have a continuous, flexible, modifiable membrane formed by one or more flaps 232 when the one or more weakened portions 234 are intact, and one or more customized instrument access openings may be manually constructed from such membrane by piercing one or more lengths of the one or more weakened portions 234 to access either or both of the patient's left and right nasal cavities, when and as needed.

[0031] In some embodiments, one or more of the weakened portions 234 may be omitted, so that the edges of one or more flaps 232 can be brought closer together to narrow the gap, thereby providing a sufficient seal to reduce gas leakage. Although the formation of a narrow gap between one or more flaps 232 and the inserted appliance results in a small amount of gas leakage into and out of the oxygen mask 200, the gas leakage through the narrow gap is insignificant when compared to the oxygen available to the patient through the oxygen delivery port 220. The narrow gap between one or more flaps 232 may form a line having the same orientation as the one or more weakened portions 234. In some embodiments, one or more flaps 232 may be omitted, and the membrane covering the nasal access port 230 may be a single continuous weakened portion 234 (not shown) that allows for the realization of a fully customizable access opening of any size and shape through the weakened portion 234. Alternatively, weakened portions 234 may be formed just at one or more (all) of the nodes, allowing one or more flaps 232 to be connected together to maintain the shape of the nasal access port 230 during shipping and storage.

[0032] The oxygen mask 200 may further include an oral access port 240 located in the lower portion 204. The oral access port 240 may include a lumen 242 in communication with the chamber 201 and a bite block 244 extending around the lumen 242. The bite block 244 may be adjustable to fit various sizes and shapes of faces of men, women, and / or children. The adjustability may be provided by at least one fold or crease 280, each fold or crease 280 surrounding a well 282. The at least one fold or crease 280 may be compressible to allow the bite block 244 to tilt or pivot vertically at an angle α relative to a horizontal axis (as shown in FIG. 10) and / or to translate along the vertical and / or lateral axes of the oxygen mask 200. Thus, the bite block 244 may be adjusted at an acute angle α relative to the horizontal axis. Additionally or alternatively, the at least one fold or crease 280 may be compressible along a vertical and / or lateral axis to allow the bite block to translate along the vertical and / or lateral directions to further adjust the oxygen mask 200 to various facial sizes and shapes. The at least one fold or crease 280 and the enclosing well 282 may have a substantially U-shaped or V-shaped cross-section without any overlapping rib structure. The bite block 244 may have a one-way valve 260 disposed across the lumen 242 to define an open configuration and a closed configuration as described herein.

[0033] At least one fold or crease 280 may extend circumferentially about the longitudinal axis of bite block 244 to permit tilting (or pivoting) and / or translation. Thus, at least one fold or crease 280 may extend above and below oral access port 240 and may overlap oral access port 240 laterally. Depending on the circumferential configuration, at least one fold or crease 280 may be a single fold or crease 280 that defines a single well 282 that permits tilting and translation of bite block 244 in the vertical and lateral directions. At least one fold or crease 280 may be formed by a membrane 290 that connects the translatable end of bite block 244 to the shell of lower portion 204. Membrane 290 may be sufficiently flexible to permit increased adjustability of bite block 244 relative to the shell of lower portion 204. For example, the membrane 290 may be made of a material that is softer than the material of the shell of the lower portion 204 and / or has a thickness less than the thickness of the shell of the lower portion 204. The membrane may form at least one fold or crease 280 that allows the bite block to be tilted vertically at an angle α of up to about 25° relative to a horizontal axis to fit various facial sizes and shapes. The membrane 290 may be inelastic and rigid enough to hold the bite block 244 in place after adjustment without immediately returning to its original configuration, so that the bite block 244 can be adjusted prior to application to the patient. However, in some embodiments, the oxygen mask 200 may allow the bite block 244 to elastically return to its original configuration, but still provide flexibility to allow adjustment. The membrane 290 may have a radially outer surface welded to the lower section shell at a seam 292 and a radially inner surface welded to the bite block 244, each of which may be welded with a radio frequency (RF) weld, for example.

[0034] 11 and 12 show an oxygen mask 200' as a third exemplary embodiment of the present invention. The oxygen mask 200' is a variation of the oxygen mask 200 and thus embodies many of the features of the oxygen masks 100, 200 as described herein and indicated by the reference numerals of the oxygen mask 200. Thus, the disclosure of the oxygen masks 100, 200 is expressly incorporated herein with respect to the oxygen mask 200' unless expressly specified otherwise. For example, as further described above, the oxygen mask 200' may have an upper portion 202' and a lower portion 204' that define a chamber 201' that fits over the patient's face to provide oxygen-enriched air as described herein.

[0035] As further shown in FIG. 11, the oxygen mask 200′ may include one or more ribs 254′ extending radially across the well 282 of the at least one fold or crease 280 to inhibit vertical and / or lateral translation of the bite block 244. As shown in FIG. 11, the one or more ribs 254′ may include a pair of ribs 254′ extending laterally on opposite lateral sides of the bite block 244. The lateral positioning of the ribs 254′ (and the absence of the ribs 254′ in the vertical direction) may substantially fix the distal end of the bite block 244 laterally relative to the lower portion 204 while allowing the bite block 244 to tilt or pivot vertically up and down about the fixed attachment. The one or more ribs 254′ may increase the stability of the bite block 244 such that the bite block 244 maintains its position within the oral cavity after the oxygen mask 200′ is strapped to the patient. As further shown in FIG. 12, the periphery of membrane 290 may laterally overlap the shell at lower portion 204 and thereby be joined at lap joint 292', for example by RF welding.

[0036] 13 and 14 show an oxygen mask 300 as a fourth exemplary embodiment of the present invention. The oxygen mask 300 may embody many of the features of the oxygen masks 100, 200, and 200' as described herein and designated by reference numerals having the same last two digits. Thus, the disclosure of the oxygen masks 100, 200, and 200' is incorporated herein with respect to the oxygen mask 300 unless expressly specified otherwise.

[0037] For example, as further described above, the oxygen mask 300 may have an upper portion 302 and a lower portion 304 defining a chamber 301 that fits over the patient's face to provide oxygen-enriched air. The upper portion 302 may have a convex shape that fits over the patient's nose with sufficient clearance for comfort. The lower portion 304 may be configured to fit over the patient's mouth. A rim 306 may extend at least partially (e.g., completely) around the upper and lower portions 302, 304. In use, the rim 306 may rest against the patient's face to form an airtight seal when the oxygen mask 300 generally encases the patient's nose and mouth within the chamber 301. The rim 306 may have a number of holes 308 for securing one or more straps 502 (as shown in FIGS. 7 and 8) to sealingly secure the oxygen mask 300 to the patient. The mask 300 may further include a post 370 incorporated into the upper portion 302 for securing the nose clip 520 to the oxygen mask 300. The oxygen mask 300 may include one or more inlets and / or outlets in communication with the chamber 301 for delivering oxygen-enriched air to the patient. For example, the oxygen mask 300 may include an oxygen delivery port 320 for inletting the chamber 301, a sample collection port 322 for outletting the chamber 301, and an exhalation port 324 for outletting the chamber 301, which are substantially the same as those described above with reference to Figures 7 and 8.

[0038] The oxygen mask 300 may include a nasal access port 330 disposed in the upper portion 302. The nasal access port 330 may be pierceable and / or puncturable. For example, as shown, the nasal access port 330 may include one or more flaps 332 connected along at least a portion of the edges of such flaps 332 by one or more weakened portions 334. The one or more weakened portions 334 may be normally intact such that the one or more flaps 332 are joined together to seal the nasal access port 330, thereby preventing the escape of gas therethrough. The one or more weakened portions 334 may be made of a different material (e.g., a softer or weaker material) and / or may have reduced material strength provided by a reduced thickness as compared to the one or more flaps 332 and / or shell of the oxygen mask 300. In some embodiments, the one or more weakened portions 334 may be adhesive or welds connecting the one or more flaps 332 together. The one or more weakened portions 334 may be selectively torn or broken to separate the one or more flaps 332 and provide one or more access openings to the nasal cavity for insertion of an instrument (e.g., a catheter, endoscope, and / or probe). The one or more flaps 332 may be biased to a closed configuration in a natural state. Thus, the one or more flaps 332 may be flexible enough to conform to a shape around an inserted instrument to ensure that the chamber 301 is sealed and to return to the closed configuration after the instrument is removed. As further shown, the one or more weakened portions 334 and / or edges of the flaps 332 may form a plurality of lines. The multiple lines may be connected to one another at an angle in a non-vertical orientation and may include at least two lines (e.g., three or more lines) that extend at acute and / or obtuse angles relative to one another (e.g., in a non-"+" or non-"X" shape). The multiple lines may be laterally spaced apart and connected by multiple nodes, one or more of which may provide access to each nasal cavity.For example, the multiple lines may include a first line and a second line joined at a first node (e.g., forming a first "V" shape) that is in-line with and allows access to the right nostril, and a third line and a fourth line joined at a second node (e.g., forming a second "V" shape) that is in-line with and allows access to the left nostril. The second and third lines may optionally be joined at a third node that joins the first and second "V" shapes to form a "W" or zigzag shape. It is also contemplated that the nodes may be rounded to form a "U" shape and / or a sinusoidal shape. Additional lines may extend vertically (upward or downward) from each of the nodes to facilitate opening of the nodes and insertion of the device. Furthermore, this configuration allows the first and second nodes of the nasal access port 330 to be pierced and / or punched independently or separately, thereby allowing separate access to either the right or left nasal cavity. The first node may be pierced and / or punched to access the right nasal cavity, while the second node may remain intact or in a similar state to prevent oxygen from escaping. Alternatively, the second node may be pierced and / or punched to access the left nasal cavity, while the first node may remain intact or in a similar state to prevent oxygen from escaping. Furthermore, each portion of the line may be pierced and / or punched separately, while another portion of the same line may remain intact or in a similar state.

[0039] In some embodiments including one or more weakened portions 334, the nasal access port 330 may have a continuous, flexible, modifiable membrane formed by one or more flaps 332 when the one or more weakened portions 334 are intact, and one or more customized instrument access openings may be manually constructed from such membrane by piercing one or more lengths of the one or more weakened portions 334 to access either or both of the patient's left and right nasal cavities, when and as needed.

[0040] In some embodiments, one or more of the weakened portions 334 may be omitted, so that the edges of one or more of the flaps 332 can be brought closer together to narrow the gap, thereby providing a sufficient seal to reduce gas leakage. Although the formation of a narrow gap between one or more of the flaps 332 and the inserted appliance results in a small amount of gas leakage into and out of the oxygen mask 300, the gas leakage through the narrow gap is insignificant when compared to the oxygen available to the patient through the oxygen delivery port 320. The narrow gap between one or more of the flaps 332 may form a line having the same orientation as the one or more weakened portions 334. Alternatively, the weakened portions 334 may be formed just at one or more (all of the nodes) of the nodes, so that one or more of the flaps 332 can be connected together to maintain the shape of the nasal access port 330 during shipping and storage.

[0041] In some embodiments, one or more of the flaps 332 may be omitted and the membrane covering the nasal access port 330 may be a single continuous weakened portion 334 (not shown) allowing for a fully customizable access opening of any size and shape through the weakened portion 334.

[0042] The oxygen mask 300 may have a bite block 344 that is adjustable to fit men, women, and / or children with different facial sizes and shapes. The adjustability may be provided by at least one fold or crease 380, each encircling a well 382. The at least one fold or crease 380 may be compressible to allow the bite block 344 to tilt or pivot vertically at an angle α relative to a horizontal axis (as shown in FIG. 14) and / or translate along the vertical and / or lateral axes of the oxygen mask 300. The at least one fold or crease 380 may allow the bite block to tilt vertically at an angle of about 11-15° relative to the horizontal axis to fit different facial sizes and shapes. Thus, the bite block 344 may extend at an acute angle α relative to the horizontal axis. Additionally or alternatively, the at least one fold or crease 380 may be compressible along a vertical and / or lateral axis to allow the bite block to translate along the vertical and / or lateral directions to further adjust the oxygen mask 300 to various facial sizes and shapes. The at least one fold or crease 380 and the enclosing well 382 may have a substantially U-shaped or V-shaped cross section. In some embodiments, the at least one fold or crease 380 may be inelastic to maintain the adjustment (pivot angle and / or translation distance) without immediately returning to its original configuration, so that the bite block 344 can be adjusted prior to fitting to the patient. However, in some embodiments, the mask 300 may be elastic to return the bite block 344 to its original configuration, but still provide flexibility to allow adjustment.

[0043] The at least one fold or crease 380 may include a plurality of folds or creases 380 forming an accordion-like and / or corrugated structure extending laterally from the first lateral portion to the second lateral portion. The plurality of folds or creases 380 may be stacked from below the mouth access port 340 to above the mouth access port 340, and the plurality of folds or creases 380 may extend inwardly and outwardly of the chamber 301 in an accordion fashion. Thus, the plurality of folds or creases 380 may include complete folds 380 above and below the mouth access port 360, extending from the first lateral portion to the second lateral portion, and folds or creases 380 interrupted laterally by the mouth access port 340. Thus, at least one fold or crease 380 may extend above and below and laterally overlap oral access port 340. The accordion-shaped and / or wavy folds or creases allow bite block 344 to tilt vertically about a horizontal axis and adjust along a vertical axis to accommodate variations in anatomy. Bite block 344 may have a one-way valve 360 ​​across lumen 242 that defines an open configuration and a closed configuration, as described herein.

[0044] The shell of the oxygen mask 100, 200, 200', 300 of the present invention may be molded in one piece from a transparent soft plastic material, such as polyvinyl chloride (PVC) or thermoplastic polyurethane (TPU), having a wall thickness of about 1.25 mm. The membrane 290, 290' may be made of a softer plastic material than the material of the shell, such as PVC or TPU made with a lower Shore durometer hardness. The bite block 144, 244, 244', 344 may be made of a stiffer, harder plastic material than the shell, such as polypropylene (PP) or acrylonitrile butadiene styrene (ABS), and attached by insert molding, adhesives, and / or welding.

[0045] The many features and advantages of the present invention will be apparent from the detailed description, and it is thus intended by the appended claims to cover all such features and advantages of the present invention which fall within the true spirit and scope of the invention. Moreover, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation as illustrated and described, and therefore, all suitable modifications and equivalents are to be embraced within the scope of the present invention.

Claims

1. A mask comprising: a convex shell having an upper portion and a lower portion and defining a chamber; a rim provided at least partially around the chamber; a nose access port provided in the upper portion and penetrable and / or pierceable to allow access to the chamber; a mouth access port provided in the lower portion, the mouth access port having a byte block with a lumen and a duckbill valve provided in the lumen; a mask including at least one crease or fold configured to tilt the byte block relative to a horizontal axis and / or translate it along a vertical axis.

2. The mask according to claim 1, further having an inlet to the chamber and an outlet from the chamber.

3. The mask according to claim 2, wherein the outlet includes a plurality of holes provided around a post.

4. The mask according to claim 1, wherein the nose access port has one or more flaps with edges forming a plurality of lines.

5. The mask according to claim 4, wherein the plurality of lines includes a first line and a second line joined at a first node, and a third line and a fourth line joined at a second node.

6. The mask according to claim 4, wherein the plurality of lines includes at least two lines joined at an angle in a non-vertical orientation.

7. The mask according to claim 4, wherein the plurality of lines includes a first line and a second line joined to form a first "V" shape.

8. The mask according to claim 7, wherein the plurality of lines includes a third line and a fourth line joined to form a second "V" shape.

9. The mask according to claim 8, wherein the second line and the third line are joined to form a "W" shape.

10. The mask according to claim 4, wherein the one or more flaps are connected by one or more weak portions along at least a part of the edge.

11. The mask according to any one of claims 1 to 10, further having a sample collection port in communication with the chamber.

12. The mask according to any one of claims 1 to 10, further comprising at least one post provided on the upper side portion and configured to fix the nose clip.

13. The mask according to any one of claims 1 to 10, wherein the bite block extends at an acute angle with respect to the horizontal axis of the mask.

14. The at least one fold or crease is configured to be able to tilt the bite block with respect to the horizontal axis or translate it along the vertical axis, extends above and / or below the mouth access port, laterally overlaps with the bite block, extends circumferentially around the bite block, and consists of a plurality of folds or creases, The mask according to claim 1.

15. The mask according to claim 14, wherein the plurality of folds or creases extend laterally between a first side portion and a second side portion.

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