FACE MASK ADAPTED FOR USE WITH NEBULIZER

Abstract

A face mask for use with a nebulizer having a frame structure with a central portion having a view port, a bottom portion extending from a bottom side of the central portion and having an opening for receiving the nebulizer, side portions extending from sides of the central portion and having an openings over which filters can be mounted, and elastic bands for mounting the frame structure to the patient's face. The elastic bands may be positioned around the back of the patient's neck, over the patient's nose, and under the patient's chin. A bendable nose wire on the elastic band positioned over the patient's nose. Providing a nebulizer treatment to a patient wearing the face mask,

Claims

1. Face mask for use with a nebulizer, comprising: a sheet of material constituting a frame structure having: a central portion; a left side portion extending from a left side of the central portion; a right side portion extending from a right side of the central portion; and a bottom portion extending from a bottom side of the central portion.

2. The face mask of claim 1, wherein: the material of the frame structure comprises polyethylene, has a thickness of approximately 1.5 mm, and is sufficiently flexible to allow the frame structure to conform to a contour of a patient's face.

3. The face mask of claim 1, wherein: a width and height of the frame structure is sufficient to span a lower portion of a patient's face, from chin-to-nose.

4. The face mask of claim 1, wherein: the central portion has an opening functioning as a view port; the left side portion has an opening over which a filter is mounted; and the right side portion has an opening over which a filter is mounted.

5. The face mask of claim 1, wherein: the bottom portion is elongate and has an opening for receiving a nebulizer, or a portion of a nebulizing apparatus; and a distal end portion of the bottom portion forming a chin support.

6. The face mask of claim 1, further comprising: a fold line between the left side portion and the central portion; a fold line between the right side portion and the central portion; and a fold line between the bottom portion and the central portion.

7. The face mask of claim 1, further comprising: a first elastic band (mask mounting elastic) secured at one end to the left side portion, and secured at its other end to the right side portion for mounting the frame structure to a patient's face by positioning the band around the back of the patient's neck.

8. The face mask of claim 1, further comprising: a second elastic band (nose elastic) secured at one end to the left side portion, and secured at its other end to the right side portion for mounting the frame structure to a patient's face by extending over the patient's nose.

9. The face mask of claim 8, further comprising: a bendable nose wire (malleable metal strip) disposed on a central portion of the second elastic band for securing the second elastic band to the patient's nose.

10. The face mask of claim 1, further comprising: a third elastic band (chin elastic strap) secured at one end to the left side portion, and secured at its other end to the right side portion for mounting the frame structure to a patient's face by being positioned under the patient's chin and supporting the weight of a nebulizer and associated tubing.

11. The face mask of claim 1, further comprising: a first elastic band (mask mounting elastic) secured at one end to the left side portion, and secured at its other end to the right side portion for mounting the frame structure to a patient's face by positioning the band around the back of the patient's neck; a second elastic band (nose elastic) secured at one end to the left side portion, and secured at its other end to the right side portion for mounting the frame structure to a patient's face by extending over the patient's nose; and a third elastic band (chin elastic strap) secured at one end to the left side portion, and secured at its other end to the right side portion for mounting the frame structure to a patient's face by being positioned under the patient's chin and supporting the weight of a nebulizer and associated tubing.

12. The face mask of claim 11, wherein: the third elastic band (chin elastic strap) is stiffer than the second elastic band (nose elastic) in order to support the weight of a nebulizer and associated tubing mounted to the opening in the bottom portion.

13. Method of providing a nebulizer treatment to a patient, comprising: providing a face mask comprising a frame structure having a central portion with a view port, a bottom portion extending from a bottom side of the central portion and having an opening for receiving a nebulizer, or a portion of a nebulizing apparatus, and elastic bands for mounting the frame structure to the patient's face; mounting the face mask on the patient's face; connecting the nebulizer, or a portion of a nebulizing apparatus to the face mask; and performing the treatment.

14. The method of claim 13, wherein the frame structure further comprises: at least one side portion extending from a side of the central portion of the frame structure and having an opening over which a filter can be mounted.

15. The method of claim 13, wherein: a first elastic band extends around the back of the patient's neck; a second elastic band extends over the patient's nose; and a third elastic band is positioned under the patient's chin.

16. The method of claim 15, wherein: the third elastic band is stiffer than the second elastic band and supports the weight of the nebulizer, or a portion of a nebulizing apparatus mounted to the opening in the bottom portion.

17. The method of claim 15, further comprising: a bendable nose wire (malleable metal strip) disposed on the second elastic band for securing the second elastic band to the patient's nose.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Reference will be made in detail to embodiments of the disclosure, non-limiting examples of which may be illustrated in the accompanying drawing figures (FIGs). The figures may generally be in the form of diagrams. Some elements in the figures may be stylized, simplified or exaggerated, others may be omitted, for illustrative clarity. Some figures, such as FIGs. #A and #B may be referred to collectively as FIG. #.

[0064] Although the invention is generally described in the context of various exemplary embodiments, it should be understood that it is not intended to limit the invention to these particular embodiments, and individual features of various embodiments may be combined with one another. Any text (legends, notes, reference numerals and the like) appearing on the drawings are incorporated by reference herein.

[0065] Some appendices (Appendix 1, Appendix 2) were included with the priority filings (provisional US patent applications), and may be cross-referenced herein.

[0066] Appendix 3 is the drawings (24 sheets of drawings containing FIGS. 1-17) as originally filed with the parent application (Ser. No. 17/324,455). Some of the drawing figures were objected to and were either eliminated or redrawn, and thirteen (13) Replacement Sheets, containing FIGS. 1-8 were filed.

[0067] This application is being filed with the aforementioned thirteen (13) Replacement Sheets, containing FIGS. 1-8, and with newly presented FIGS. 9A,B (sheet 14) which correspond with Appendix 4.

[0068] FIG. 1A (Appendix 1, page 1) is a perspective view of the dental mask, mounted to a patient, according to an embodiment of the invention.

[0069] FIG. 1B (Appendix 1, page 1) is a side view of the dental mask, mounted to a patient, according to an embodiment of the invention.

[0070] FIG. 2A (Appendix 1, page 3) is a diagram illustrating a first step (Step 1) in the process of manufacturing the mask, according to an embodiment of the invention.

[0071] FIG. 2B (Appendix 1, page 3) is a diagram illustrating a next step (Step 2) in the process of manufacturing the mask, according to an embodiment of the invention.

[0072] FIG. 2C (Appendix 1, page 4) is a diagram illustrating a first step (Step 3) in the process of manufacturing the mask, according to an embodiment of the invention.

[0073] FIG. 2D (Appendix 1, page 4) is a diagram illustrating a next step (Step 4) in the process of manufacturing the mask, according to an embodiment of the invention.

[0074] FIG. 2E Appendix 1, (page 5) is a diagram illustrating a first step (Step 5) in the process of manufacturing the mask, according to an embodiment of the invention.

[0075] FIG. 2F (Appendix 1, page 5) is a diagram illustrating a next step (Step 6) in the process of manufacturing the mask, according to an embodiment of the invention.

[0076] FIG. 2G (Appendix 1, page 6) is a diagram illustrating a first step (Step 7) in the process of manufacturing the mask, according to an embodiment of the invention.

[0077] FIG. 2H (2H-1, 2H-2) (Appendix 1, page 6) is a diagram illustrating a next step (Step 8) in the process of manufacturing the mask, according to an embodiment of the invention.

[0078] FIGS. 3A,B (Appendix 1, page 7) are front and back side views, respectively, of a completed mask (oral flex cab), such as may have been manufactured as described in the Steps shown in FIGS. 3A-3H, according to an embodiment of the invention.

[0079] FIG. 4A (Appendix 1, page 8) is a photograph showing an optional forming or shaping feature, such as a malleable metal strip, incorporated at a nose portion of the mask to ensure a better (more snug, more airtight) fit of the mask over the patient's nose, according to an embodiment of the invention.

[0080] FIG. 5A, B (Appendix 1, page 9) are sketches (frontal view) showing the mask on a patient's face, and an optional Instrument Port Deflector feature, according to an embodiment of the invention.

[0081] FIG. 5C, D (Appendix 1, page 9) are diagrams (plan view) showing details of the optional Instrument Port Deflector feature shown in FIGS. 7A,B, according to an embodiment of the invention.

[0082] FIG. 6 is a diagram of an adapter for connecting a nebulizer (or the like) to the face mask, according to an embodiment of the invention.

[0083] FIGS. 6A,B are diagrams (illustrations) of a patient wearing a mask and receiving a nebulizer treatment, according to some embodiments of the invention.

[0084] FIG. 7 is a diagram (side view) a tapered-tube type mask, generally, according to an embodiment of the invention.

[0085] FIGS. 7A-F are photographs of a mask, using a tapered (very thin) plastic tube (aka bag) as the mask substrate (MS), as may be suitable for some of the mask embodiments disclosed herein, according to an embodiment of the invention.

[0086] FIG. 8 is a schematic illustration (cross-section, partially exploded) of a basic embodiment of a mask, such as a dental mask, according to an embodiment of the invention.

[0087] FIG. 8A is a schematic illustration (plan view) of a malleable metal nose strip (MM) integrated with a face conforming elastic (CE), on a generic (basic) face mask, according to an embodiment of the invention.

[0088] FIG. 9A is a diagram of a frame structure for a nebulizer supporting (face) mask, according to an embodiment of the invention.

[0089] FIG. 9B is a diagram of the frame structure of FIG. 9A, with additional components (elements) attached thereto, according to an embodiment of the invention.

[0090] The frame structure of FIGS. 9A,B may be referred to simply as frame, or as structure. Whereas the previous embodiments involved primarily a plasic sheet, in this embodiment some plastic sheet is involved, such as in the viewing port and elsewhere, and the flimsy plastic sheet is supported by a robust frame, as described in further detail hereinbelow.

ABBREVIATIONS

[0091] Some of the following abbreviations may be used, in the text and/or drawings, in lieu of or in addition to reference numerals. [0092] M overall mask (aka flex cab FC) [0093] DM a dental mask (mask specific for performing dental procedures) [0094] MS mask substrate, typically a very flexible sheet of plastic material [0095] CE contour elastic extending around a periphery of the mask substrate [0096] MM a malleable metal strip for conforming the mask to the patient's nose [0097] FE fastening elastic for securing the mask to the patient's head (face) [0098] VP view port, which is an opening at the front of the mask [0099] FP front (or face) plate, which is a rigid element disposed at the front of the mask [0100] VW viewing window (a transparent front plate), disposed over the view port [0101] P a port (i.e., opening in the MS or in the VW) for inserting something into the mask [0102] IP instrument port, which is a specific type of port for inserting an instrument [0103] TD a door disposed over a port for exposing (opening) or blocking (closing) the port [0104] F filter, which may be mounted either on the MS or on the VW [0105] NA nebulizer adapter which may be mounted on the mask to receive a nebulizer

DESCRIPTION

[0106] Various embodiments (or examples) may be described to illustrate teachings of the invention(s), and should be construed as illustrative rather than limiting. It should be understood that it is not intended to limit the invention(s) to these particular embodiments. It should be understood that some individual features of various embodiments may be combined in different ways than shown, with one another. Reference herein to one embodiment, an embodiment, or similar formulations, may mean that a particular feature, structure, operation, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Some embodiments may not be explicitly designated as such (an embodiment).

[0107] Some dimensions may be set forth herein. These are meant to be exemplary, not limiting, and are intended to convey a sense of scale, and may highlight the relative sizes of different elements (i.e., some larger than others, for example). Some exemplary materials may be set forth herein.

[0108] The facemask (or simply mask) disclosed herein solves both dental and medical needs for the containment of aerosol generated in procedures that require access and visibility into the oral (and nasal) cavity. Such procedures may include, but are not limited to tongue lacerations, tooth and Peritonsillar abscess drainageall dental procedures (including cleaning), oral exam throat inspection (say ahhh), swabbing throat or nose for viral testing, and intubation procedures. Masks for other purposes are also disclosed herein.

[0109] Facemasks for oxygen and nebulizing typically have a semi-rigid formed structure and are made of compliant material that somewhat conform to facial contours. They have no features that provide access and visibility into the oral cavity.

[0110] Some of the mask embodiments disclosed herein have a viewing window allowing the user (e.g., dentist) to see clearly into a patient's oral cavity while providing access to insert instruments (drills, mirrors, ultrasonic scalers and swabs, etc.) and flexibility to manipulate these instruments without impeding or limiting the user's (i.e., dentist's) motion or visibility. These masks may be referred to as dental masks.

[0111] The dental mask disclosed herein provides a barrier to aerosol generated by the instrumentation (such as during dental procedures) or expelled by the patient (such as coughing), restricting (substantially reducing) aerosol propagation to the environment, thereby reducing the exposure to healthcare providers (dentists, doctors, etc.). These may be referred to as dental masks. The dental mask (and some of the other masks disclosed herein) may or may not cover the patient's nose.

[0112] Other embodiments may have one or more ports for inserting instruments (such as swabs, an endoscope, etc.), through the mask, and generally do not require a clear view into the patient's mouth at all times. These masks may be referred to as scope/instrument masks.

[0113] For a scope/instrument mask, the mask's visibility clarity is not a big concern since once the scope/instrument is in the nasal or oral cavity the user (doctor) may be watching a scope camera. Therefore, the viewing window of a dental mask is not required. The overall mask (mask substrate) may be formed of a clear plastic material which allows sufficient visibility for initial penetration and subsequent extraction of a tool (such as an endoscope).

[0114] Generally, all of the embodiments disclosed herein may have: [0115] a flexible mask substrate which forms the overall mask (flex cab); [0116] straps (such as elastic bands) for (i) shaping the mask substrate and for (ii) securely and comfortably holding the mask on a patient's face; and [0117] one or more ports for allowing a user (doctor) to introduce a device or instrument through the mask into a patient's oral or nasal orifices, to perform a procedure. In some cases, the port(s) may initially be closed (such as with a trap door), and subsequently the port may be opened by the user either manually, or automatically by the user inserting an instrument or device into/through the port. [0118] The dental mask embodiment has a transparent viewing window (VW, which may be a transparent font plate FP) positioned in front of the patient's mouth (when the mask is being worn) to allow the dentist to see well into the patient's mouth during performing a dental procedure.

[0119] Filters may be incorporated into the mask substrate, or on the viewing window (or the likei.e., on a front plate which is not a viewing window), to facilitate patient breathing, and to balance pressures between the inside of the mask and the environment to avoid separation of contact of the mask with the patient's facial features. (Pressure imbalance may occur when nebulizer treatment or oxygen is introduced into the mask, also due to patient speaking, sneezing, or coughing, etc.)

[0120] Means may be provided to accommodate medical devices such as nebulizers, for example, a nebulizer adapter providing treatment to the patient via the mask (flex cab). Means, such as a headband or eyeglasses, external to the mask itself, may be provided to support such devices, since the overall mask (flex cab) is very flexible and otherwise not able to support the device. Handheld devices, such as mouthpiece (peace pipe) nebulizers, may be used to provide the treatment, without the external means.

Descriptions of the Figures (FIGS.)

[0121] Some appendices (Appendix 1, Appendix 2) were filed with some of the priority documents (i.e., US provisional patent applications), and are expressly incorporated by reference herein.

[0122] Some of the figures presented in the Appendices may be reproduced as stand-alone figures herein. The correspondence between some of the figures presented herein, and some of the figures in the Appendices, may be noted in some of the description(s) set forth herein.

Dental Mask

[0123] FIGS. 1A,B illustrate an embodiment of a dental mask 100, mounted to (fitted to, worn by) a patient, according to an embodiment of the invention. See also Appendix 1, page 1.

[0124] FIGS. 2A,B,C show the mask, which may be referred to as Oral Flex Cab, in use. See also Appendix 1, page 2.

[0125] The following elements are shown: [0126] 100 mask M (aka flex cab) [0127] 102 mask substrate MS [0128] 104 fastening elastic FE [0129] 106 (face) contour elastic CE [0130] 110 view port VP, typically disposed under the viewing window VW [0131] 112 viewing window VW, typically disposed over the view port VP [0132] 114 instrument ports IP

[0133] A dental mask 100 may comprise the following elements or components: [0134] a mask substrate 102 comprising a very thin, very flexible plastic sheet (such as a 1 or 2 mil poly) [0135] preferably (but not necessarily) of clear materialabout 10 long and 9 wide. This will form a very flexible cabinet (which may be referred to as a flex cab) in front of the patient's mouth to capture particles coming from the patient's mouth; [0136] a thicker (more rigid), very clear plastic sheet (such as 7 mil vinyl) about 3.5 5.5 which will be mounted over a slightly smaller (such as 35) opening 110 in the mask substrate to form a viewing window 112 (the viewing window may sometimes be referred to herein as a view port); [0137] The viewing window 112 may be disposed over the opening 110 and may be attached (preferably in an air-tight manner) to the mask substrate 102 around the periphery of the opening, by any suitable means (for attaching) such as, but not limited to an adhesive, heat, tape, or ultrasonic welding, etc.; [0138] one or more holes/openings 114 (which may be referred to herein as instrument ports) may be provided in the mask substrate to permit the user to introduce tools into the patient's oral cavity, for performing a desired treatment. These ports may simply be slits in the mask substrate material, with markings indicating where they are, and they need not be very airtight. [0139] There may be one (or more) instrument ports IP), one located on one side of the viewing window (VW), another located on the other (opposite) side of the viewing window (VW). Alternatively, two instrument ports (IP) could be provided on the same side of the viewing window (VW). Alternatively, the mask may be provided without instrument ports, allowing the user to simply poke instruments through the thin mask substrate (MS), piercing it, to create instrument port hole(s) at desired locations for specialized proceduressuch as abscess drainage, where the abscess could require approach from unique angles. [0140] a first, face contour elastic band 106 (CE) or the like, disposed around a peripheral portion of the mask substrate (MS) to deform (partially collapse) and hold the otherwise flat and flexible mask substrate around the patient's facial contours, thereby forming a face-conforming portion (or end) of the mask; [0141] additional fastening elastic bands 104 (FE) or the like to secure (mount, install) the mask to the patient's face by extending around the patient's neck or ears. [0142] The face contour elastic band and additional fastening elastic bands may be integrated to be formed out of a single elastic band, but are discussed separately to provide for description clarity. They may be claimed as at least one elastic band for performing the various functions disclosed herein.

[0143] Since the viewing window (VW) is made of stiffer plastic than the mask substrate (MS) which is very flexible, when the mask is in place on a patient's face, the viewing window resists bending and therefore pushes back on the thinner mask substrate to create a chamber (i.e., an empty volume) at the front of the mask, in front of the patient's face (particularly mouth) which will allow the user (e.g., dentist) to comfortably manipulate tools inserted through the instrument port(s).

[0144] As may be more relevant to some other embodiments, the viewing window may be moved around (back and forth, up and down) relative the patient's face, while the flex cab remains in a fixed position on the patient's face, in which case the viewing window may not need to be transparent, but nevertheless it is provides a rigid platform upon which to mount other things, such as a filter, a trap door, a nebulizer adapter, and the like.

[0145] It is apparent, for example in the side view of FIG. 1B, that the viewing window (VW) may be an inch or two (2-5 cm) in front of the patient's mouth. In this, and some other figures, various elements may be designated, and may conform to the description set forth above (FIG. 1A).

[0146] Because the mask substrate will become wrinkled at the Face Conforming end (or at the face cab), it may acquire a cumulative stiffness which will supports the viewing window and suspends it in front of the patient's oral cavity.

[0147] Instruments are easily passed through the instrument port(s) into the oral cavity, while the clear viewing window may be easily nudged (moved slightly) in any direction to permit access and view from various orientations.

[0148] In other words, the mask is essentially a very flexible chamber extending from the patient's face, sealed (more or less) around the patients cheeks and jaw, with a window allowing the user to view the patient's oral cavity while permitting tools to be introduced into the oral cavity to perform procedures.

Manufacturing the Mask (Oral Flex Cab)

[0149] The mask disclosed herein may be fabricated of simple inexpensive components, it can be manufactured in high volume, and it can be single-use disposable.

[0150] FIGS. 2A-H show an exemplary sequence of steps to fabricate the mask (aka flex cab). See also Appendix 1, pages 3-6.

[0151] FIG. 2A shows Step 1flex cab preparation.

[0152] FIG. 2B shows Step 2view port attachment.

[0153] FIG. 2A shows a rectangular (or substantially rectangular) sheet of plastic material, such as polyethylene may be prepared measuring, for example, 1-2 mils thick, 9 wide and 10 high (2225 mm), and may be referred to as the mask substrate (or cut sheet) 102 (may be referred to as 302). [0154] (a) a relatively large opening 120 (view port cutout) is prepared in the sheet. This will be the view port 110, and is where the viewing window 112 will be mounted, in the next step. This opening may rectangular, and may be centrally located on the cut sheet. The opening may measure, for example, 3 (7.5 cm) wide and 5 (12.5 cm) high, and: [0155] a top edge of the opening 120 may be disposed at a desired distance from the top edge of the cut sheet, representing a given distance from the patient's upper lip. [0156] a bottom edge of the opening 120 may be disposed at a desired distance from the bottom edge of the cut sheet, representing a given distance from the patient's lower jaw [0157] a left edge of the opening 120 may be disposed at a desired distance from the left edge of the cut sheet, representing a given distance from the patient's left cheek. [0158] a right edge of the opening 120 may be disposed at a desired distance from the right edge of the cut sheet, representing a given distance from the patient's right cheek. [0159] (b) cutout openings 124 may be provided on opposite sides of the cut sheet, at approximately halfway between the top and bottom edges of the cut sheet. These cutout openings will provide for instrument access ports 114 on the left and right sides of the finished mask (flex cab), as will become evident in a subsequent step. These are shown as small V-shaped notches extending into the substrate from the left and right (as viewed) side edges thereof. A fold line (not shown) may extend between the instrument access ports on the left and right sides of the mask substrate. (Step 3 describes folding over.)

[0160] It should be understood that the mask substrate may be other than rectangular in that it may have sides that are not straight, tapering towards the top or bottom, etc.

[0161] As illustrated by FIG. 2B (Step 2) A viewing window 112 (VW) may be prepared, and may be a rectangular (or generally rectangular, or substantially rectangular) sheet of vinyl measuring, for example, 7 mil thick, 3.5 wide and 5.5 high. The viewing window (112, VW), which is somewhat larger than the view port (110, VP) opening (or cut out) may then be mounted to the mask substrate 102 (MS) over (or under) the view port 110 (VP) with adhesive around the edge of the view port cutout. Alternatively, the viewing window may be welded to the mask substrate using ultrasonic energy or heat. Additionally, the view port cutout window may be of the same or larger dimensions than the view port sheet and glue tape may be used to connect the two component and cover over any gaps between the two components.

[0162] It should be understood that the mask substrate (MS) and the viewing window (VW) may be other than rectangular, such as having rounded corners, being oval, etc. The shape of the and corresponding hole in the mask substrate should be substantially the same shape as the viewing window.

[0163] It is also not necessary that the viewing window be larger than and overlap the corresponding hole in the mask substrate. When the viewing window is attached to the mask substrate with an adhesive tape, it may indeed be slightly smaller than the corresponding hole in the mask substrate.

[0164] FIG. 2c shows Step 3Folding

[0165] FIG. 2D shows Step 4connecting side edges [0166] The resulting assembly of mask substrate and viewing window (from Step 2) may now be bent (folded over), and the side edges thereof seamed (via heating, or with an adhesive) to create a bag (which may be referred to herein as a Flex Cab) having one closed end (the folded end), two sides which are joined together, and one open end. This folding should be done carefully, to avoid creasing the viewing window (View Port).

[0167] FIG. 2C shows the mask substrate (cut sheet) 102 (MS) with instrument access ports on the side edges thereof and with the viewing window (view port) mounted thereto may be folded over, as shown, so that the left and right side edges are substantially aligned with one another and the top and bottom (face conforming) edges are substantially aligned with one another. This step of folding over should be performed by gently bending the substrate and view port, paying particular attention to not creasing or forming a bend line in the view port which would detract from the clarity of the view port. The following features are noted: [0168] 312 bend location [0169] 314 side edges are aligned [0170] 316 face conforming edges are aligned

[0171] FIG. 2D shows that the side edges of the mask substrate may be connected (seamed) together, with either heat or an adhesive. Seaming stops about (1 cm) from the face conforming (peripheral) edges of the substrate to facilitate attachment of face-forming elastic (Steps 5,6). Note that the fold (Step 3) occurred between the left and right side instrument access ports which, when the mask substrate is folded over may become more circular. [0172] 312 bend location [0173] 318 side edges are seamed together [0174] 320 seaming stops about (1.25 cm) from the face conforming edges to facilitate attachment of face conforming elastic (CE, not shown).

[0175] The top and bottom edges which, as a result of folding over, may also be seamed together, with either heat or an adhesive. However, this seaming may occur a small distance, such as inward of the top and bottom edges so that face conforming end portions of the top and bottom edges remain free (loose, dangling) to facilitate incorporating a face conforming elastic into the mask, in a subsequent step.

[0176] Alternatively, the left and right side edges could be seamed together through the entire length and then face conforming end can be folded like a sleeve over the elastic band.

[0177] As mentioned above, a bag having three closed sides and an open end may be substituted for a folded over mask substrate with side edges seamed together. The process of bag fabrication could also be utilized where a die and heat sealing punch is lowered over two layers of the mask substrate sheets to attach and cut the sheets where needed, to generate the mask in a single operation.

[0178] FIG. 2E (Step 5) shows that a face conforming elastic band 106 may be stretched over the folded substrate 102, extending from side-to-side, just above (inboard of) the free end portions of the top and bottom (as viewed) edges.

[0179] FIG. 2F (Step 6) shows that the free end portions 322 of the folded over top and bottom edges of the mask substrate (both shown at the bottom of the folded substrate) are folded upward (as viewed), towards the fold line 312, so that they extend over the face conforming elastic band 106, in preparation for being captured by folded-over edges of the mask substrate 102.

[0180] FIG. 2G (Step 7) shows that the folded over free end portions of the top and bottom edges, with the face conforming elastic disposed therebetween, are seamed (with adhesive or heat) to capture (secure) the face conforming elastic band 106 (CE) in the mask substrate 102 (MS). The mask substrate is still folded over, in this and the next step.

[0181] The purpose of the face conforming elastic band 106 (CE), which is now integral within the facemask, is to provide a force maintaining a relatively secure fit of the facemask on the patient's lower face, including jaw, when the facemask is installed on the patient's face. Separate fastening elastic bands (Step 8) may be incorporated into the facemask to mount the facemask on the patient's face. One elastic band may be used as the face conforming elastic band and the fastening elastic band(s). [0182] An elastic (or rubber) band (which may be referred to herein as face conforming elastic) may be mounted to the open end of the folded over mask substrate & viewing window (Steps 3,4) so that the open side of the bag (Flex Cab) is flexible with the elasticsuch as for head capsand becomes Face Conforming. [0183] As illustrated, the Face Conforming Elastic is stretched over the Flex Cab at the end of the side seams, and the Face Conforming ends are folded over the elastic. Then the face conforming ends of the mask substrate may be seamed to capture the face conforming elastic in a tunnel extending along the periphery of the mask substrate.

[0184] FIG. 2h (step 8) shows that two fastening elastics 104 (FE) for mounting the mask to the patient's face.

[0185] The left hand figure (FIG. 2H-1) shows a fastening elastic 104 (FE) which is for fastening the facemask via the patient's neck, attached at approximately the location of the side edges seamed intersection with the face conforming end.

[0186] The right-hand figure (FIG. 2H-1) shows two fastening elastics 104a, 104b which are ear loops attached at approximately the location of the side edges seamed intersection with the face conforming end.

[0187] These two elastics (neck and ears) may be used in conjunction with one another to secure the facemask to the patient's face. And, the aforementioned face-conforming elastic may ensure a good fit of the flat, flexible facemask around the contour of the patient's lower face and jaw.

[0188] A single elastic band may be arranged to perform both of the face-conforming and fastening functions of the two elastic bands (CE, FE). Rubber band (or Latex free elastic) may be utilized for contouring (106) to the facial features while softer textured elastic such as the elastic for N95 face masks may be utilized for the ear loops (104, 104a, b). These FE elastics may be installed on the mask substrate to hold the resulting flexible mask onto the patient's face, such as by extending around the patient's ears, or the back of their neck.

[0189] After fitting the components (view port, conforming/contour elastic, fastening elastics) to the mask substrate, the facemask may be unfolded and ready for use, as shown in FIGS. 4A,B.

The Completed Mask, and Some Optional Features

[0190] FIGS. 3A,B shows some photographs of the resulting facemask. FIG. 3A shows a view of the front-side of the mask. FIG. 3B shows a view of the back side of the mask.

[0191] In use, the face conforming elastic may be pulled to contour to the patient's face by stretching the elastic over patient's jaw/chin via an additional Fastening Elastic band that wraps around the patient's neck (or two additional bands each secures the patient's ears) to position the viewing window (View Port) in front of the patient's oral cavity.

Some Alternative Steps

[0192] Other fabrication steps and/or sequences may be employed to yield substantially the same outcome, such as: [0193] the viewing window can be attached to the mask substrate first, and then the mask substrate material may be removed to expose the View Port, instead of first making a cutout (view port) in the mask substrate. Additionally, the operation can be reversed where the mask substrate is attached to the viewing window. [0194] starting with a preformed poly bag or tube where the viewing window is mounted in a bend that conforms to the bag shape instead of mounting to a flat sheet (mask substrate) first. [0195] if a bag is utilized as the mask substrate, the two corners at the closed ends of the bag may be then cut to create the openings (instrument ports) for instrument access.

[0196] Some benefits of the mask disclosed herein may include: [0197] contact may be maintained with the patient's chin/lower jaw when mouth is open and closed, so that the patient can speak and be heard during the procedures; [0198] permits easy placement of instruments-such as suction devices-between face conforming elastic and patient's skin; [0199] facilitates easy poking of additional holes for procedures that require access of more than two hands (such as when an assistant is helping the dentist); [0200] permits the easy manipulation of the cheeks with user's fingers;

Some Optional/additional Features

[0201] For some applications it may be advantageous that the mask (flex cab) covers the patient's nose in addition to the oral cavity.

[0202] FIG. 4A (see Appendix 1, page 8) shows that a forming feature 504 may be added to the mask to ensure a better fit of the mask over the protrusion of the patients nose. The forming feature may be a malleable metal strip, such as is common in medical masks, to ensure a good fit onto the patient's nose.

[0203] FIGS. 5A,B,C,D show that an instrument port deflector feature 704 may be incorporated into the mask. FIG. 5A, B are similar to, and elaborate upon FIG. 1A. FIGS. 5B,C are similar to, and elaborate upon FIG. 2A, showing an exemplary manufacturing step.

[0204] Generally, the instrument port deflector feature 704 comprises some extensions (wings) of the viewing window extending to the left and right (as viewed) from the viewing window 112 (VW), in the direction of the nearby instrument ports 114 (IP) which are disposed to the left and right of the view port 110 (VP). The view port 110 may or may not be cut out (enlarged) to accommodate these wings. Rather, the wings may extend over the surface of the mask substrate (102), adjacent to (to either side of) the view port 110.

[0205] The viewing window 112 material is relatively rigid (in contrast with the very flexible mask substrate), and it tends to remain flat, thereby pushing the Flex Cab sheet (substrate) outward, thereby causing the nearby (closely adjacent to the wings of the viewing port) move forward, becoming more visible to the user for easy access.

[0206] FIG. 5A shows the deflector features 704 extending from the left and right (as viewed) side edges of the viewing window 112.

[0207] FIG. 5B shows (the curved arrows) how the deflector features 704 a, b will tend to pull the mask substrate 102 (flex cab) forward, to the left and right (as viewed) sides of the view port (110).

[0208] FIG. 5C shows the deflector features 704 a, b extending from the left and right side edges, respectively, of the viewing window 112, approximately midway (vertically, as shown) between the top and bottom edges of the mask substrate 102.

[0209] FIG. 5D shows the deflector features 704 a, b extending from the left and right side edges, respectively, of the viewing window 112. In this example. the deflector features 704a, b disposed closer to the bottom (as viewed) edge of the mask substrate 102.

[0210] FIGS. 5A,B,C,D (page 9 of Appendix 1) shows the mask (oral flex cab) mounted to a patient, with the addition of an instrument port deflector. The instrument port deflector may comprise two wing portions of the relatively stiff viewing window extending from the left and right sides of the otherwise rectangular viewing window towards the instrument ports located on the respective left and right sides of the relatively soft mask substrate. In use, this will cause the instrument ports to be forced forward a bit. The logic behind this is, as follows.

[0211] Testing of the mask has shown that it may be difficult at times to identify the Instrument Ports because they may collapse into and be concealed by the wrinkled portion of the very flexible mask substrate (bag).

[0212] It therefore may be useful to cause the Instrument Ports 114 to face substantially forward so that the user is able to easily find them and insert an instrument, and so that the ports snap back to that forward position once the instrument is retracted so the user is able to easily identify its location for instrument reinstatement. During user operation of the instrument, this feature should not impede the user's visibility into the oral cavity or interfere with the user's hand and/or instrumentation. That can be established by having a component that causes the mask substrate to expand yet not be in the way of the user, either visually, instrument, or fingers.

[0213] To avoid the introduction of new components and processes, the viewing window (View Port) plastic sheet area may be extended towards the Instrument Ports thereby providing a deflection force near the Instrument Ports thereby forcing the Instrument Ports forward. The Instrument Port Deflector segment(s) of the viewing window does not require a cutout in the mask substrate and is entirely secured to the mask substrate. The viewing window material's tendency is to remain flat thereby pushing the mask substrate sheet outwardly making the Instrument Ports move forward, becoming more visible to the user for easy access.

[0214] The overall purpose of the instrument port deflectors (wings) extending from the modified viewing window is to force (urge, distort) the mask substrate outward (away from the patient's face), when the mask is worn by a patient.

[0215] Alternatively, modifying the mask substrate itself was considered and tested. This involved creating inflation locations on the mask substrate surface to achieve the desired firmness in the selected areas, such as features on floaties, packing blisters. However, this solution was considered to be susceptible to failure if a sharp instrument were to pierce the inflated surface made of the thin poly material.

[0216] Some of the paragraphs herein may make reference to parent application Ser. No. 17/324,455, and reference some of the drawings as originally filed therewith.

Some Uses for the Mask

[0217] In the parent application, as originally filed, FIGS. 8A,B showed the dental mask, in use during a clinical examination (FIG. 8A) and during a prophylaxis procedure (FIG. 8B). See also Appendix 2, page 1, FIGS. 1A,B.

[0218] The mask of FIGS. 1-5 may be referred to as a dental mask, as it is intended primarily for use by a dentist, and is focused on clear visibility required for dental procedures, and includes a clear View Port enabling a user (e.g., dentist) to see well into the patient's mouth during the entirety of a procedure. In some embodiments the patient's nose is also enclosed with the mask (dental cab, flex cab).

[0219] Dentists use UV cure lights for curing bonding materials intra-orally, and they use special UV filtering glasses and protective guards. The mask disclosed herein may be fabricated of UV protection (UV blocking or filtering) plastic, which may eliminate the need for these protective devices to be worn by the dentist. Or, when UV protective plastic is used in conjunction with these devices, increased protection for the dentist may be provided.

Some Variations and Optional/additional Items/Features

[0220] the instrument entry points (ports) could also be made as slits, or with elastic patches so they wrap tightly around the instruments to increase isolation (air-tightness); [0221] the opening (View Port) for the viewing window in the mask substrate (plastic sheet) does not have to be symmetrical with respect to the bend line; [0222] the View Port may be placed so that its edge is closer to the upper lip and more distant from the lower jaw thereby providing better visibility depending on patient-provider special positioning. [0223] the View Port positioning may favor one side versus the other (i.e. shifted toward right or left cheek) to accommodate specialized procedures. [0224] A forming feature, such as a nose strip, may be added to the mask to facilitates better contact with the nose contours. [0225] A low flow aeration of the viewing window may be provided to remove any condensation that may form on the View Port. [0226] A wiper feature may be provided to clean off the inside surface of the viewing window in case of water splatter or other fluids impede visibility during the procedure. [0227] Elastic band to secure the mask to the patient can be integral to the mask face conforming elastic, so one piece of elastic is used for face conforming and attachment around the patient's neck or ears. [0228] A filter can be incorporated into the mask to reduce bag inflation for procedures that generate increased air pressure in the mouth-such as air abrasive or air polishing procedures-or patient sneezing. [0229] A filter can be mounted to the mask to reduce bag collapse for procedures that generate decreased air pressure in the mouth-such as dental irrigation suctionfilter permits pressure equalization on both sides of the mask so there is no mask deformation. [0230] For nasal swabbing procedures, one or more instrument access ports(s) can be disposed in the mask substrate around the nasal cavity. [0231] For intubation type procedures, the instrument access port(s) in the mask may be positioned central to the oral cavity with the viewing window, or a plurality of viewing windows disposed on the mask substrate. These viewing windows may be located offset from the center of the mask. [0232] An empty balloon bag (like an oxygen mask reservoir bag) may be attached to the mask to capture high air flows due to sneezing thereby reducing the likelihood of aerosol spread through the instrument ports and face conforming end of the mask due to back pressure. Such balloon bags are standard equipment for oxygen masks. [0233] The mask may have an evacuation port for the attachment of aerosol capturing devices, such as air purifiers, evacuation and suction devices. [0234] The mask may be used as a containment chamber for aerosol supplied medications.

Some Benefits of the Mask May Include

[0235] because the mask substrate is very flexible (and oversized), the view port (viewing window) may be moved (shifted) around to different positions on the mask substrate, rather than centered thereon, to permit operation on a specific oral quadrant; [0236] Access via a specialized tool (intubation is a good example where the tool always has a specific orientation and handling yet requires visibility on a specific side of the oral cavity) [0237] The mask may accommodate a right-handed or left-handed healthcare provider [0238] The mask may accommodate specialized instrument holding (such as hygiene procedures) [0239] The mask may provide for coverage of the nose area when there is the potential of sneezing, such as when performing nose or throat swabbing.

Some Additional (Other) Mask Embodiments

[0240] Some other masks, similar in many respects to the dental mask described above, will now be described. Generally, many or all of the mask embodiments disclosed herein may utilize the basic flexible, preferably transparent mask substrate with face contour elastic and fastening elastic(s), as described with respect to the dental mask of FIGS. 1-8. Generally, in these additional (or other) mask embodiments, the view port and viewing window may not be needed, and other features may be incorporated into the mask to permit the user access to the patient's oral or nasal cavities for performing medical procedures such as swabbing, endoscopy, etc.

Nasal Swab Mask

[0241] In this embodiment, a trap door is disposed on the mask, rather then the aforementioned viewing window (of the Dental Mask embodiment).

[0242] In the parent application, as originally filed, FIGS. 9A,B,C showed a nasal swab mask, a key feature of which may be a so-called trap door 900 which can be opened and closed. The trap door may comprise a fixed component 902 with an opening (not visible in FIG. 9A, slightly visible in FIG. 9B) in it, and may be affixed to the mask substrate 102 in a manner akin to that of the viewing window (VW) in the dental mask. The fixed component may be formed of a rigid plastic material (e.g., PVC, polyethylene, polypropylene, nylon), and need not be transparent. See also Appendix 2, page 2, FIGS. 2A,B,C. The trap door may alternately be mounted to a flat plastic piece akin to the viewing window (VW).

[0243] The trap door further comprises a movable component 904 which may be situated and supported to slide back-and-forth over the fixed component 902, alternately exposing and concealing the opening in the fixed component. The movable component may comprise a portion which has an opening 906 in it, and another portion which does not have an opening in it. Actually, the trap door shown is more like a sliding door, than a trap door which may typically be a hinged door.

[0244] In a given (open) position of the movable component with respect to the fixed component, the opening in the movable component may line up with (be directly over) the opening in the fixed component so that a user has access to the patient's face, such as for obtaining a nasal swab.

[0245] In another (closed) position of the movable component with respect to the fixed component, the opening in the movable component is not lined up with the opening in the fixed component. Rather, the portion of the movable component without an opening blocks the opening in the fixed component so that aerosols and/or particles expelled or exhaled by the patient wearing the mask are contained within the mask.

[0246] A typical swab may be in the form of an elongated plastic member (a handle, or stick), having a mass of cotton or the like at its distal (far) end, in the manner of a Q-Tip(), only longer.

[0247] It may be noted that the openings in each of the fixed and movable components may be keyhole shaped, a major portion of the opening being round, and a small slot portion of the opening extending radially outward from the major portion.

[0248] In the parent application, as originally filed, FIG. 9A showed that the trap door may normally be closed, so the opening in the fixed component 902 is blocked by the porting of the moveable component 904 which does not have the opening 906 so that aerosol exhaled by the patient wearing the mask is contained within the mask prior to specimen collection.

[0249] In the parent application, as originally filed, FIG. 9B showed that the trap door may be opened to allow a swab tip to pass therethrough. The openings in the fixed and movable portions may be circular, having a diameter of approximately 1.5 inches (38 mm) to avoid contact with the swab tip when it is inserted or withdrawn (i.e., passes) through the trap door (i.e., the aligned openings in the movable and fixed components when the movable component is in the open position). FIG. 9B shows that a swab handle may fit into the slots in the openings in the fixed and movable components.

[0250] In the parent application, as originally filed, FIG. 9C showed that the trap door may be closed, during performing the desired procedure (e.g. swabbing the patient), with the smaller, radially extending portion of the opening being sufficiently large for the handle of the swab. This minimizes passage of air through the opening(s). In other words, the trap door is closed to create a secure fit over the swab handle for a tight seal during specimen collection.

[0251] In the parent application, as originally filed, FIGS. 9A,B,C described a sliding version of a trap door. It is within the scope of the invention that the fixed component has the aforementioned keyhole shaped opening, and that the movable component is simply a door (without an opening) which is hinged to the fixed component so that in the open position the opening in the fixed component is accessible, and in the closed position, it is not.

Oral Swab Mask

[0252] In the parent application, as originally filed, FIGS. 10A,B showed an Oral Swab Mask 1000 according to an embodiment of the invention. See also Appendix 2, page 3, FIGS. 3A,B.

[0253] This mask has two ports: [0254] a first port 1030 which may be a trap door, such as a hinged (rather than sliding) door, for inserting a Tongue Depressor; and [0255] a second port 1032 which may be an opening for inserting a swab.

[0256] Oral swabbing may be a two-handed procedure, one of the user's hands manipulating a tongue depressor and the other of the user's hands manipulating the swab. Protecting the user from aerosols/particles in the patient's exhalations are of paramount importance.

[0257] In the parent application, as originally filed, FIG. 10A showed the mask with the first port closed. Both ports are normally closed so that aerosol (patient's exhaled air) is contained, prior to specimen collection.

[0258] In the parent application, as originally filed, FIG. 10B showed the mask with the tongue depressor inserted into the first (trap door) port, and with the swab extending through the second port. Insertion of the tongue depressor opens swab port trap door so there is no contact with the swab.

Instrument Mask

[0259] In the parent application, as originally filed, FIGS. 11A,B showed an Instrument Mask 1100 according to an embodiment of the invention. See also Appendix 2, page 4, FIGS. 4A,B, now FIGS. 3A,B.

[0260] This embodiment is similar to the nasal swab mask shown in FIGS. 9A,B,C, in that is may be in the form of a sliding trap door. In this embodiment, there is a rubber flexible aperture 1002 with a small port (hole) 1004 (contrast the slot in the openings in the nasal swab mask), which may be selectively blocked or accessible using the trap door.

[0261] In the parent application, as originally filed, FIG. 11A showed the port is normally closed so that aerosol exhaled by the patient is contained within the mask, prior to specimen collection.

[0262] In the parent application, as originally filed, FIG. 11B showed that the trap door may be opened (lifted), exposing an instrument port.

Scope Masks (Endoscopy, Bronchoscopy and GI)

[0263] In the parent application, as originally filed, FIGS. 12A,B,C showed a Scope Mask, according to an embodiment of the invention. See also Appendix 2, page 5, FIGS. 5A,B,C. (see FIG. 4A)

[0264] This embodiment has a rubber port 1214 mounted to the mask substrate 1202 (alternatively to a separate plastic piece like the viewing window of the dental mask), for performing endoscopy procedures.

[0265] This endoscope type mask works with both the rigid scopes and flexible scopes where the instrument has a rubber interface (port) that wraps around the scope. (A finger cot or condom would also work.) The port may be covered, pre-use. The rubber port may optionally be pre-punctured to provide an entry start point for the instrument. The rubber is mounted to the inside of the mask and may be lubricated (with KY gel or other medical lubricant) for smooth movement of the scope through the port. The port has a seal over the port externally (not shown here) assuring that the gel does not dry or get contaminated pre-use. The port is located in vicinity of the nasal passages.

[0266] In the parent application, as originally filed, FIG. 12A showed the mask, pre-procedure. The rubber port may be lubricated and covered pre-use.

[0267] In the parent application, as originally filed, FIG. 12B showed the mask, with an instrument inserted.

[0268] In the parent application, as originally filed, FIG. 12C is an instrument port view from the inside of the mask with the instrument inserted.

Sinus Mask

[0269] In the parent application, as originally filed, FIGS. 13A,B show a Sinus Mask, according to an embodiment of the invention. See also Appendix 2, page 6, FIGS. 6A,B.

[0270] An endoscopy procedure may be described. The mask has a port for inserting an endoscope. The port may be similar to or substantially the same as the previously described port (1214), but located on the mask substrate (1202) more appropriately to access the patient's nasal passage. Compare FIG. 12C in the application as originally filed.

[0271] In the parent application, as originally filed, FIG. 13A showed performing an endoscopy procedure using a rigid scope inserted through the port in the mask.

[0272] In the parent application, as originally filed, FIG. 13B showed performing an endoscopy procedure using a flexible scope inserted through the port in the mask.

Bronchoscopy and GI Endoscopy Masks

[0273] In the parent application, as originally filed, FIGS. 14A,B,D showed bronchoscopy and GI Endoscopy masks according to an embodiment of the invention. See also Appendix 2, page 7, FIGS. 7A,B,C. The bronchoscopy and GI endoscopy masks may be substantially similar, but may differ in the size of the port since the scopes are of different diameters.

[0274] This embodiment of a bronchoscopy and GI endoscopy type mask has the port near the patient's oral cavity and support a port 1414 similar to the port 1214. The port 1414 may be slightly larger in diameter (than the port 1214) to accommodate the wider scopes utilized for these procedures. Compare FIG. 12C of the application as originally filed

[0275] This embodiment shows filters (F) 1430a and 1430b on either side of the port 1414. The filters may be semicircular, as shown, having been cut from a standard circular filter, such as a B/V filter. The port and the filters are shown as being disposed on the mask substrate 1402. In this embodiment, there is no more rigid piece such as the viewing window (VW) mounted to the mask substrate (compare MS 102). The filter shape (semicircular) is a design choice so that the filters do not obscure the user's vision (i.e. up and down vision may be more important than left-right).

[0276] In the parent application, as originally filed, FIG. 14A showed a front view of the mask, pre-procedure.

[0277] In the parent application, as originally filed, FIG. 14B showed a side view of the mask, pre-procedure.

[0278] In the parent application, as originally filed, FIG. 14C showed the mask during a clinical procedure.

Nebulizer Embodiment(s)

[0279] The OralFlexCab (or mask) disclosed herein comprises a flexible covering for a patient's face, with bands for fitting the mask to the patient's face (contour elastic) and for securing the mask to the patient's head (fastening elastics), and, and is provided with openings for performing various procedures. FIGS. 1A,B (Appendix 1, page 1) are illustrative of a dental mask.

[0280] The dental mask may be adapted (modified) for Nebulizer and Oxygen treatments, in which case the view port and viewing window are not needed. The flexible mask substrate allows for automatically fitting the mask to the contour the facial features and, as described above, various ports may be provided in the mask to allow a user to perform medical procedures while protecting the user from aerosols or particles which may be exhaled by the patient wearing the mask.

[0281] It is an object of this embodiment of the invention to provide means for adapting the OralFlexCab mask for use with nebulizer and oxygen components. Because the OralFlexCab mask is made of thin plastic, external (additional) means such as glasses and a hanger are used for supporting the weight of the nebulizer and oxygen components.

[0282] Nebulizers, oxygen components, and the like, may have a mouthpiece that is inserted into the patient's mouth. A problem with this is that the patient may exhale air that bypasses the mouthpiece.

[0283] It is an object of this aspect of the invention to capture the patient's exhaled air by using a mask, such as the OralFlexCab disclosed herein.

[0284] According to an aspect of the invention, generally, separate means (i.e., separate from the mask itself) are provided for adapting a nebulizer or oxygen component, or any device having a mouthpiece, to be used with a flexible mask, such as the OralFlexCab disclosed herein. In the main, hereinafter, a nebulizer is described as an exemplary component to be used in conjunction with the mask.

[0285] FIG. 6 shows that a nebulizer adapter 1540 may be integrated into the mask substrate 1502, as an instrument port, instead of (for example) a viewing window or a trap door, to allow (accept) a nebulizer (or the like) to be used with the mask. The viewing window may be modified to function as a nebulizer adapter, and need not be transparent. Generally, in some of the embodiments disclosed herein, a relatively rigid front plate (which in some cases is a transparent viewing window) may be incorporated onto the front of the relatively flexible mask substrate. The advantages of such a hybrid arrangement include that the relatively rigid front plate can be moved around (shifted in position) relative to the patient's face, due to the flexibility of the mask substrate.

[0286] The adapter may simply be a tube, with a flange, that fits into an appropriately sized opening 1542 in the substrate (or modified viewing window), and may be glued or welded to the substrate (or modified viewing window). The adapter 1540 may be cylindrical piece of nylon, with a flange, and may be located on an opening 1542 in the mask substrate 1502 and attached (glued, welded) to either the exterior surface of the mask substrate 1502, or on an interior surface thereof (and extend through the opening 1542). Since the nebulizer is a relatively heavy instrument (as compared with the mask itself), separate support means 1550, such as eyeglasses or a headband may be provided to support the nebulizer. For a handheld nebulizer, a separate support means may not be required.

[0287] As shown in FIG. 15A of the application as originally filed, semi-circular filters (compare 1414a) can be fitted to the mask substrate on either side of the nebulizer adapter. These filters are readily available in circular form, and may be referred to as bacterial/viral (B/V) filters. (A B/V filter, as used herein, may resemble a coffee filter.)

[0288] In the parent application, as originally filed, FIG. 15A showed that a separate component (support means) such as glasses, goggles, a headband, a cap or the like may be provided, and worn by the patient with a mask, for supporting the nebulizer.

[0289] In the parent application, as originally filed, FIG. 15B showed that a hand-held nebulizer may be mounted to the mask, using the adapter, without requiring the separate support means such as was described in FIG. 15A. This may be referred to as NebShield.

[0290] In the parent application, as originally filed, FIG. 15C showed that a hand-held nebulizer may be mounted to the mask, using the adapter, without requiring the separate support means such as was described in FIG. 15A. This may be referred to as NebShield. The nebulizer instrument supplies aerosolized medication into the mask (flex cab).

[0291] In the parent application, as originally filed, FIG. 15D is a detailed (close-up) view of a portion of the NebShield, showing the contour elastic and the (malleable metal) nose strip.

[0292] In the parent application, as originally filed, FIG. 15E is a detailed (close-up) view of a portion of the NebShield, showing the contour elastic and fastening (ear loop) elastic.

[0293] FIG. 6A is an illustration (side view) of a nebulizer instrument supplying aerosolized medication into the mask (flex cab), via an instrument port which may be located in a modified viewing window. The window need not be transparent. A filter is also shown, mounted to the modified viewing window. (Compare FIG. 1B.) This does not require the external support (eyeglass, headband) as shown in FIG. 15A.

[0294] FIG. 6B is an illustration (side view) of a nebulizer instrument supplying aerosolized medication into the mask (flex cab), via an instrument port which may be located in a modified viewing window. The window need not be transparent. A filter is also shown, mounted to the modified viewing window. (Compare FIG. 1B.) This does not require the external support (eyeglass, headband) as shown in FIG. 15A.

[0295] In FIGS. 6A,B, the fastening elastic (FE) is shown as two separate ear loops may be provided (compare FIG. 2H-2). The two ear loops (fastening elastics) may wrap around the patient's ears. Alternatively, a single fastening elastic (FE) may extend from the mask around the back of the patient's head/neck. (compare FIG. 2H-1; also FIGS. 1A,B).

[0296] FIGS. 6A,B are shown with a nebulizer, which may be a handheld nebulizer, not requiring the external support (FIG. 15A of the application as originally filed). FIGS. 6A,B also show the malleable metal nose strip (MS) integrated into the mask. FIGS. 6A,B also show a filter disposed on the viewing window (VW, or view port VP), or relatively rigid front plate (FP). (A viewing window VW may be considered to be a transparent front plate FP.)

Nebshield Ports

[0297] The NebShield may be adapted for use with intubation tubes. The NebShield port (opening, instrument port) is made of a compliant plastic sheet that creates a good seal over a slightly oversized (i.e., slightly larger then the port) predetermined diameter smooth tubes such as nebulizer exhalation tubes.

[0298] For use with the i-Gel intubation tubes the NebShield port could be made oval to accept an oval i-Gel device. Since the NebShield port requires a predetermined tube diameter, devices (masks) with specific ports for each size of the i-Gel devices may be made and supplied. Alternatively, the port on the intubation device may be fitted with an elastic band so it fits snugly over (and complies with) various (a range of) sizes of i-Gel devices intubation tubes. Also, since an elastic port expands, it would also work with standard intubation tubes that have a flange at the front end.

Bag Version

[0299] FIG. 7 shows a tapered-tube type mask, generally. The mask has a large opening at one end (Patient Side), for fitting to a patient's face, and a smaller opening at the other end (User side) for fitting a front plate, viewing window, instrument ports, trap door, etc. Filters may also be fitted to the mask. Only the mask substrate 1602 (MS) is shown in this figure, for illustrative clarity. Refer, for example, to FIG. 17A for examples of viewing window, instruments ports, filters, etc, disposed on the mask substrate (MS)

[0300] FIGS. 7 A-F show some examples, and further details, of masks made from a tapered plastic tube as the mask substrate (MS), as may be suitable for some of the mask embodiments disclosed herein. [0301] FIG. 7A is a side view of the mask, showing a tube port (at the small opening end) and a nose strip. Ear loops are shown. The large opening end of the tapered tube may be referred to as the face end. [0302] FIG. 7B is a rear view of the mask, and shows elastic bands disposed around the tube port and/or instrument ports. Ear loops are shown. [0303] FIG. 7C is a side view of the mask, and shows the small opening end of the tapered tube as an instrument port which fits elastically over an i-Gel device. Ear loops are shown. [0304] FIG. 7D is a front view of the mask, and shows the small opening end of the tapered tube as an instrument port which fits elastically over an i-Gel device. Ear loops are shown. [0305] FIG. 7E is a front view of the mask, and shows a flange (compare ...) disposed at the small opening end of the tapered tube, such as for receiving an intubation tube. [0306] FIG. 7F is a side view of the mask, and shows a flange (compare ...) disposed at the small opening end of the tapered tube, such as for receiving an intubation tube.

[0307] Rather than starting with a flat sheet for the mask substrate (MS), a tapered plastic sheet tube having a larger opening at one end and a smaller opening at the other end may be used at the starting material. An elastic band (i.e., contour elastic CE) may be disposed around the large opening of the tapered tube. A nose strip (MM) and ear loops (or fastening elastic FE) may also be incorporated at the large end of the tapered tube (near the larger opening end of the tube). The narrower end of the tapered tube (bag) may be provided an elastic band that fits over and creates a seal with intubation tubes. Filters could be added.

Basics

[0308] FIG. 8 shows a basic (simplified, for illustrative clarity)embodiment of a mask, such as a dental mask, comprising: [0309] a mask substrate (MS), formed of thin, flexible plastic, which may be transparent. Patient Side refers to an interior of the mask. User Side refers to the exterior of the mask. [0310] a view port (opening, VP)) in the mask substrate [0311] a viewing window (VW) disposed over the view port, on either side of the mask substrate, and formed of a more rigid, transparent plastic. (In some text and/or illustrations herein, the viewing window may be referred to as view port.) [0312] a fastening elastic (FE) for securing the mask substrate to the user's face [0313] a face contour elastic (CE) extending around a periphery of the mask substrate for forming the mask to the contour of the user's face. (This is akin to an old-fashioned shower cap-a piece of flexible plastic with an elastic around the edge/perimeter.) When disposed on the patient's face, the mask forms what may be referred to as a flex cab (i.e. flexible cabinet), completely closed from the environment by the mask substrate and the user's face. [0314] one of more instrument ports (IP), which are openings in the mask substrate, such as for allowing instruments to be inserted into the flex cab. [0315] one or more filters (F) may be disposed on or in the mask substrate (having a suitable opening for receiving the filter(s). The filters allow air to enter into or exit from the flex cab. [0316] optionally, a malleable metal nose strip (MM) disposed on the mask substrate for forming the mask to the patient's nose

[0317] In embodiments of the mask which cover the patient's nose, a malleable metal strip (MM) may be disposed on the mask substrate which can be deformed to secure the mask substrate to the patient's highly contoured nose. In these cases, the face conforming elastic (CE) may not extend completely around the periphery of the mask. Rather, the face conforming elastic may extend from opposite ends of the malleable metal strip, working together to ensure a reliable fit on the patient's face.

[0318] FIG. 8A shows an example of a mask substrate (MS) 1702 having a malleable metal nose-conforming strip (MM) 1707 integrated with the facial contour elastic (CE) 1706. The mask substrate is shown as rounded, and the concept disclosed herein may apply to either the substantially rectangular mask substrate (see, e.g., FIGS. 2A-H), or to the tapered-tubular mask substrate (FIGS. 7A-F).

[0319] The malleable metal strip (MM) 1707 is elongated, has two opposite ends, and extends horizontally (as shown) across the mask substrate (MS) at a location that will correspond with the patient's nose, when the mask is being worn. The facial contour elastic (CE) 1706 is elongated, having two ends, and is shown as a dashed line, disposed slightly inboard of the perimeter (periphery, circumference) of the mask substrate 1702. The two ends of the contour elastic (CE) are connected in any suitable manner to the respective two ends of the metal strip (MM).

[0320] This integrated arrangement of metal strip (MM) and contour elastic (CE) has some advantages. When the mask is worn, the contour elastic (CE) will be stretched over the contour of the patient's face, including nose (in examples of the mask which cover the nose, such as in FIGS. 15F,G). The nose, of course, is a significant (abrupt) protuberance from an otherwise gently contoured face. This is why it is advantageous to include the metal strip (MM), such as is commonly found on medical masks. If, for example, the face conforming elastic (CE) were to extend completely around the periphery of the mask (again, we are considering masks that cover the nose here), it would compete with the metal strip (MM) for keeping the mask securely mounted to the patient's face.

[0321] FIG. 8A also shows an exemplary front plate (FP) 712 disposed on the mask, which may be a viewing window (VW, compare FIG. 1A, 112) disposed over a view port (VP, compare FIG. 1A, 110) in the mask substrate (MS, compare FIG. 1A, 102). FIG. 17A also shows exemplary instrument ports 714 (IP, compare FIG. 1A, 114), and filters 718 (F, compare filters F in FIG. 15A) disposed on the front plate 712, or on the mask substrate near (adjacent, to either side of) the front plate (FP).

Comment(s)

[0322] Some differences between the mask(s) disclosed herein and prior art masks is the rigidity of the prior art masks vs. the highly flexible mask (FlexCab). Many prior art masks do not seal to facial features well, and prior art masks which are made of a more rigid material will tend to move when an instrument inserted therein and the instrument is manipulated, while the more flexible mask disclosed herein will comply as the port in the mask substrate is able to move without disturbing the contact surfaces of the mask with the patient's facial features. (Refer to prior art POM (Procedural Oxygen Mask) masks. https://proceduraloxygenmask.com/)

[0323] The masks disclosed herein have a very flexible mask substrate (flex cab), provided with elastics to aid in conforming the mask to the patients face, and more rigid elements (viewing window, ports, etc.) mounted to the mask substrate. In use, the user is able to move (reposition) the more rigid element(s) from their initial position without disturbing the fit or placement of the mask on the patient's face. Hence, the mask(s) disclosed herein are a kind of hybrid, combining some features of a flexible mask with some features of a rigid mask, while in some cases providing enhanced capability over either a purely flexible mask or a purely rigid mask.

Alternative Uses

[0324] It is contemplated that different (or modified) versions of the mask(s) disclosed herein could be used for some non-oral procedures, where access of instruments is required and containment of patient polluting fluids may be ejected. For example, incision & drainage procedures for abscess (pus surrounded by inflamed tissue) removal requires guarding of the user/doctor when it is drained. A modified version of the mask can be held to the skin by an elastic band, or a sticky media to prevent fluid splatter. Such modified versions of the mask would have a comparable relatively flexible mask substrate, a relatively stiff viewing window, instrument ports, and means for mounting the mask to the patient.

[0325] Traditional nebulizer masks are essentially hangers for the nebulizer with aerosol deflectors oriented towards the patient's nostrils. The face mask disclosed herein has a frame for supporting a nebulizer (aka mister), and also has elastic straps to create a seal with a patient's facial features and may be superior to the Faceplateimplementation with the standard nebulizer masks.

[0326] Reference may be made to US 2024/0017031 published 18 Jan. 2024, incorporated by reference herein, entitled ADJUSTABLE FACEPLATE FOR RESPIRATORY MASKS, which discloses: [0327] A relatively rigid, adjustable faceplate fitted over and working in conjunction with a relatively flexible respiratory facemask. The faceplate pushes (urges) the facemask against a user's (patient's) facial features to assure a better fit of the facemask to the patient's face. Straps are disposed on the faceplate, rather than on the facemask. The faceplate may provide or comprise: filter protection from user contact, strap locking features, cutouts for accommodating stick-on filters mounted to the facemask, and a nebulizer cutout. An upper portion of the faceplate is provided with a slider to allow the faceplate to achieve an effective fit when used with different size (adult, child, pediatric) facemasks by adjusting the distance between a nose pressure point and a chin pressure point of the faceplate. (Abstract)

[0328] Implementing a feature for accepting standard nebulizers (or misters) on a face mask, generally requires two things (or features)namely, (i) a support for the nebulizer and (ii) a connection of the nebulizer to the mask. In the embodiment(s) of a face mask disclosed herein, the support hangs off the mask and is implemented (constructed) as a portion of a thin structure (which may be referred to as a frame structure, or simply as a frame) that can be bent to form the mask structure and support the nebulizer. The frame is suitably made of polyethylene so that filtration media (filters) and a plastic view port can easily be welded to the mask. Face masks accepting filtration media and a having a view port have been described hereinabove, and features of those embodiments of a face mask may be incorporated into the present embodiment(s) which are specifically designed for use with a nebulizer (mister).

[0329] In some prior masks, wherein a nebulizer is used in conjunction with the mask, the nebulizer is supported independently of the mask by a headband or eyeglasses worn by the patient. In the mask of the present invention, the nebulizer (or tubing associated with a nebulizer) is supported by the mask itself.

[0330] FIGS. 9A,B illustrate a frame structure for a face mask (facemask, or mask) particularly adapted for use with a nebulizer (or mister). Images of a frame structure and of a facemask incorporating the frame structure are shown in Appendix 4, incorporated by reference herein. More particularly: [0331] Page 1 shows two variations of a frame structure: the one on the left adapted in use to accept a nebulizer; the one on the right adapted in use to accept a nebulizer and filters and corresponds to the embodiment shown in FIGS. 9A,B. [0332] Page 2 shows the frame structure of FIG. 9A. [0333] Page 3 shows the frame structure of FIG. 9B. [0334] Page 4 shows three examples of a face mask incorporating the frame structure of FIGS. 9A,B.

[0335] FIG. 9A shows a frame structure (or simply frame) 900 of a facemask having four portions: [0336] a central portion 902 having two (left and right, as viewed) sides and a cutout (opening) 904 forming (functioning as) a view port which may be covered by a plastic sheet forming the aforementioned viewing window (View Port); [0337] a left (as viewed in the diagram; right, as worn by the patient) side portion 912 extending from a left side of the central portion; [0338] a right (as viewed in the diagram; left, as worn by the patient) side portion 922 extending from an opposite (right) side of the central portion; [0339] a bottom portion 932 extending from a bottom (as viewed) side of the central portion.

[0340] The frame structure may be formed of (from) a sheet of polyethylene having a thickness of approximately 1.5 mm. The material of the frame structure should be rigid, yet sufficiently flexible to allow the frame structure to conform well to a contour of a patient's face.

[0341] An overall width (w, as shown in the drawing) of the frame structure, exclusive of the extensions 916 and 926, may be approximately 190 mm. With the extensions 916 and 926 the overall width (not labeled in the drawing) may be approximately 250 mm.

[0342] An overall heght (h, as shown in the drawing) of the frame structure, exclusive of the bottom portion 932, may be approximately 90 mm. With the bottom portion 932 the overall height (not labeled in the drawing) may be approximately 156 mm.

[0343] The width and height of the frame structure should be sufficient to span a lower portion of a patient's face, from chin-to-nose. Different size frame structures for different size masks may be provided.

[0344] The central portion 902 is generally rectangular, and may have an overall size of approximately 83 mm (height)approximately 82 mm (width). The opening 904 may measure approximately 70 mm (height)approximately 75 mm (width).

[0345] The left side portion 912 may be formed integrally with the central portion 902, is generally round (circular or elliptical), and may have an overall size of approximately 90 mm (height)approximately 83 mm (width). An opening (filter cutout) 914 may measure approximately 80 mm (height)approximately 45 mm (width). An extension 916 of the left side portion may have a length of approximately 34.5 mm and is shown extending outward (to the left, as viewed) from a laterally outermost point of the left side portion, and may terminate in an enlarged portion having a small (such as 6.5 mm diameter) hole 918. A filter (not shown) may be mounted to the left side portion 912, over the opening 914.

[0346] The right side portion 922 may be formed integrally with the central portion 902, is generally round (circular or elliptical), and may have an overall size of approximately 90 mm (height)approximately 83 mm (width). An opening (filter cutout) 924 may measure approximately 80 mm (height)approximately 45 mm (width). An extension 926 of the right side portion may have a length of approximately 34.5 mm and is shown extending outward (to the right, as viewed) from a laterally outermost point of the right side portion, and may terminate in an enlarged portion having a small (such as 6.5 mm diameter) hole 928. A filter (not shown) may be mounted to the right side portion 922, over the opening 924.

[0347] The bottom portion 932 (or nebulizer support) may be formed integrally with the central portion 902, is generally elongate and may have an overall size of approximately 75 mm (height, or length). A width of a top (as viewed) portion 932a of the the bottom portion 932 where it joins with the central portion may have a width of approximately 37 mm. An opening (nebulizer connection cutout) 934 for receiving (connecting with) a nebulizer (not shown) or a portion of a nebulizing apparatus (not shown) is shown in the top portion 932a, may be round (circular), and may have a diameter of approximately 17.75 mm. An extension portion 936 of the bottom portion extends approximately 50 mm from a lower end of the top portion 932 a, and terminates in a nebulizer chin support portion 938 at a distal end of the bottom portion which may have a width of approximately 33.5 mm.

[0348] In use, a nebulizer (mister; not shown) may be press fit into the opening (nebulizer connection cutout) 934. A strap 956 (described hereinbelow with respect to FIG. 9B) will keep the nebulizer chin support portion 938 nebulizer support 932 in contact with the patient's chin so the nebulizer may be maintained in a desirable (vertical) orientation during use. When mounted to the patient's face, the strap 956 creates a continuous seal with the facial features.

[0349] A dashed line 942 (structure fold line) is shown between the left side portion 912 and the central portion 902, and represents an area where the material of the frame structure has been made thinner (such as 1.0 mm thinner) so that the dashed line portion of the frame structure can act like a living hinge, allowing the left side portion to fold (wrap) around the right side of the patient's face.

[0350] A dashed line 944 (structure fold line) is shown between the right side portion 922 and the central portion 902, and represents an area where the material of the frame structure has been made thinner (such as 1.0 mm thinner) so that the dashed line area can act like a living hinge, allowing the right side portion to fold (wrap) around the left side of the patient's face.

[0351] A dashed line 946 (structure fold line) is shown between the bottom portion 932 and the central portion 902, and represents an area where the material of the frame structure has been made thinner (such as 1.0 mm thinner) so that the dashed line area can act like a living hinge, allowing the bottom portion to fold (wrap) around the bottom (chin area) of the patient's face.

[0352] While the dashed-line hinges 942, 944, 946 allow the portions 912, 922 and 932 to fold (generally, only a few tens of degrees) with respect to the central portion 902, it will be undersood that each of the portions 902, 912, 922, 932 are themselves flexible and may be able to flex (bend) so as to conform well to the contour of the patient's face.

[0353] The breadth of the frame portions, shown for example as dimension b between a periphery of the right side portion 922 and the opening 924 of the right side portion 922 may measure approximately 5.0 mm, and is exemplary of the breadth of the various portions 902, 912, 922, 932 of the frame 900.

[0354] FIG. 9B shows the frame structure 900 of FIG. 9A, with the addition of three straps or elastic bands 952, 954, 956 for securing the frame structure 900 to the patient's face. Some reference numerals presented in FIG. 9A may be omitted, for illustrative clarity.

[0355] Each of the elastic bands 952, 954, 956 are elongate, and have two opposite ends. [0356] A first one 952 of the elastic bands (aka mask mounting elastic) may have a length (unstretched) of approximately 440 mm, may be releasably or adjustably or permanently secured at one end to the hole 918 in the extension 916 of the left side portion 912, and may be secured at its other end to the hole 928 in the extension 926 of the right side portion 922. In use, this band 952 may be positioned around the back of the patient's neck for the purpose of securing (mounting) the frame structure 900 (and the mask it supports) to the patient's face. The other two elastic bands 954 and 956 assist in securing the mask to the patient's face. [0357] A second one 954 of the elastic bands (aka nose elastic) may have a length (unstretched) of approximately 120 mm, may be releasably or adjustably or permanently secured at one end to the hole 918 in the extension 916 of the left side portion 912, and may be secured at its other end to the hole 928 in the extension 926 of the right side portion 922. In use, this band 954 may be positioned over the patient's nose. A bendable nose wire 960 (or malleable metal strip) may be disposed on (incorporated onto) the band 954, such as at a central portion thereof, for the purpose of securing (mounting) nose elastic 954 (and the frame structure 900 and the mask it supports) to the patient's face to the bridge of their nose. This element 960 may be similar to the malleable metal strip (MM) for conforming the mask to the patient's nose described above. The nose elastic with the bendable wire 960 is designed to be stiff enough to maintain contact with the facial feature (patient's nose) while allowing the bendable wire to remain formed around the patient's nose. [0358] A third one 956 of the elastic bands (aka chin elastic strap) may have a length (unstretched) of approximately 350 mm, may be releasably or adjustably or permanently secured at one end to the hole 918 in the extension 916 of the left side portion 912, and may be secured at its other end to the hole 928 in the extension 926 of the right side portion 922. In use, this band 956 may be positioned under the patient's chin for the purpose of securing (mounting) the frame structure 900 (and the mask it supports) to the patient's face.

[0359] The chin elastic strap 956 may be stiffer than the nose elastic 954 in order to support the weight of a nebulizer and associated tubing.

[0360] While the invention(s) may have been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention(s), but rather as examples of some of the embodiments of the invention(s). Those skilled in the art may envision other possible variations, modifications, and implementations that are also within the scope of the invention(s), and claims, based on the disclosure(s) set forth herein.