Patent Application
20210360996
This invention relates to a flexible face mask, adapted to be worn by a patient, covering the patient's nose and mouth area, while allowing a user (doctor, dentist) to perform a dental or medical procedure involving (interacting with) the patient's mouth or nose. This may include a dental mask, a nasal swab mask, an oral swab mask, an instrument mask, a scope mask, a sinus mask, bronchoscopy and GI endoscopy masks, and also a mask configured for administering nebulizer and breathing treatments.
Medical facemasks for delivering oxygen or nebulized treatments to patients are known, and some medical facemasks have filters incorporated therein. For example U.S. Pat. No. 7,559,323 (Hacke, et al.; Jul. 14, 2009; Respan Products, Inc.) discloses a disposable mask assembly with exhaust filter wherein:
Such medical facemasks are generally semi-rigid, having a contoured shape “out-of-the-box”. Some teachings of prior art facemasks may be incorporated into the present invention, such as methods of attaching the facemask to the patient.
The invention(s) disclosed herein may be useful in conjunction with micro-abrasive blasting devices powered by a pressurized-gas source for use with dental procedures, an example of which may be found in U.S. Pat. No. 9,050,156 (2015 Jun. 9; Groman). As noted therein various methods for reducing the overspray of the abrasive are known for such devices. See, for example: U.S. Pat. No. 5,356,292 (1994 Oct. 18; Ho); U.S. Pat. No. 5,197,876 (1993 Mar. 30; Coston); U.S. Pat. No. 6,024,566 (2000 Feb. 15; Bruns et al.). These may disclose add-on splatter guard and collector attachments to air abrasion devices.
In the 2020 Coronavirus pandemic, dental treatments which generate aerosol were halted until evacuation and other aerosol reducing precautions (PPE) were implemented. Treatment options for patients with shortness of breath were limited due to the fear that first line and hospital personnel would be exposed to aerosolized viral particles expelled by patients into the environment. The invention(s) disclosed herein address some of these concerns.
It is an overall object of the invention to provide an improved facemask (face mask) to be worn by a patient when a user (dentist or doctor) is performing a procedure requiring access to the patient's mouth or nose, while protecting the user from aerosols or particles which are a byproduct of the procedure and/or which are expelled (such as exhaled) by the patient.
It is an object of the invention to provide techniques, including methods and apparatus, for shielding a user (doctor, dentist) from aerosolized particles and the like which may be emitted by a patient during an intraoral procedure such as, but not limited to, micro-abrasive blasting.
Of course, the user can wear a face shield to protect themselves from aerosolized particles and the like which may be emitted by a patient during such an intraoral procedure. However, there are also risks related to the patient “polluting” the immediate environment when such a procedure is being performed as an inevitable direct result of the procedure (such as detritus being spread around) or as a collateral indirect result such as the patient coughing or sneezing. Some hospitals and dental clinics have implemented negative pressure rooms and evacuation devices to draw, collect, and filter the contaminated air in the environment. The facemasks disclosed herein address some of these issues.
The facemask of the present invention is generally a thin, optionally transparent, very flexible mask substrate (or portion) which can easily be deformed to be fitted around the patient's lower face, including nose and jaw. A fastening elastic secures the mask to the patient's face, while a face contour elastic conforms the mask substrate to the contour of the patient's face so that the mask “hugs” the patient's face. The resulting mask may be referred to as a “flex cab”.
Various additional elements may be provided on the mask, such as:
In some embodiments, the mask may have two main portions:
In the main, hereinafter, a dental mask may be described, which has a transparent viewing window disposed on the front surface of the mask substrate. A dental mask may have instrument ports located on either side of the viewing window (in this case, the ports are not located on the viewing window, but rather on the mask substrate). For other (non-dental) uses of the mask, the viewing window may not be required, and may be eliminated or replaced by other features, such as a trap door for selectively allowing a user to access the patient's covered face, instrument ports, and the like.
According to the invention, generally, a dental mask is provided for covering at least the patient's mouth while an oral procedure is being performed. More particularly, the mask may comprise:
According to the invention, generally, a dental mask (M) may comprise a very flexible mask substrate (MS) with a relatively rigid front plate (FP) which may be a viewing window (VW) causing the mask substrate to extend forward from a patient's face, forming a chamber in front of the patient's mouth. Instrument ports (IP) on the mask substrate or front plate (FP) allow instruments to be introduced through the mask into the patient's oral or nasal cavity to perform dental or medical procedures. A face-conforming elastic band (CE) on the mask substrate for conforming the mask to contours of the patient's face. A malleable metal strip (MM) for conforming the mask to the patient's nose. The conforming elastic (CE) may extend from opposite ends of the metal strip (MM). Methods of fabricating the mask are disclosed. The mask, and variations thereof, may be used to perform various treatments, including non-oral procedures. Means for using a nebulizer in conjunction with the mask is disclosed, wherein the nebulizer is supported independently of the mask.
According to some embodiments of the invention, a mask (M, FC) for performing medical or dental procedures on a patient may comprise: a relatively flexible mask substrate (MS); at least one elastic strap (CE; FE) for (i) shaping the mask substrate to the patient's face and for (ii) securely and comfortably holding the mask on the patient's face; a relatively rigid front plate (FP), which may be a transparent viewing window (VW) disposed on a front portion of the mask substrate; and one or more instrument ports (IP) extending through the mask substrate or front plate for allowing a user to introduce a device or instrument through the mask into the patient's oral or nasal orifices, to perform a procedure. The ports may be disposed on either side of the front plate (or viewing window).
The front plate may comprise a transparent viewing window positioned on the mask substrate to be located in front of the patient's mouth when the mask is being worn, to allow the user to see well into the patient's mouth during performing a procedure.
Filters (F) may be incorporated into the mask substrate or on the front plate to facilitate patient breathing and to balance pressures between the inside of the mask and the environment
A malleable metal strip (MM) having two opposite ends may be disposed across the mask substrate at a position corresponding with the patient's nose. Opposite ends of the conforming elastic (CE) may be attached to the respective two ends of the malleable metal strip.
Deflectors which are “wing” like extensions of the front plate may extend towards the instrument ports to urge the ports forward, making them more accessible.
A door (TD) may be disposed over a port for selectively exposing (opening) or blocking (closing) the port. The door may comprise a fixed component with an opening and a sliding component with an opening. The door may be initially closed (when the openings are not aligned with each other); and the door a may be capable of being opened (when the openings are aligned). A door may be opened either manually, or automatically by the user inserting an instrument or device into the port.
The mask substrate may be initially flat. The mask substrate may be initially in the form of a tapered tube.
The mask may be provided with an adapter for accepting a nebulizer.
The mask may be selected from the group consisting of dental mask (
According to some embodiments of the invention, a mask (M) for fitting onto a patient's face when performing oral or nasal procedures may comprise: a very flexible mask substrate (MS) having at least one instrument port (IP) in the mask substrate for allowing a user to insert instruments through the mask substrate; and at least one elastic band having a first face conforming portion (CE) for maintaining a relatively secure fit of the facemask on the patient's lower face, including jaw, and a fastening portion (FE) for mounting the mask to the patient's face. A view port (VP) and viewing window (VW) may be provided on the mask substrate for allowing the user to see into the patient's oral cavity. A nose strip (MM) may be provided for conforming the mask substrate to the patient's nose. At least one filter (F) may be attached to the mask substrate. A rigid front plate (FP) may be disposed on the mask substrate. At least one filter (F) may be attached to the rigid front plate, or to the flexible mask substrate. At least one instrument port (IP) in the mask substrate or front plate for allowing the user to insert instruments into the patient's oral cavity or to deliver medications to the patient wearing the mask.
According to some embodiments of the invention, a method of performing a dental or medical procedure on a patient may comprise: mounting a mask on the patient's face, said mask having a very flexible mask substrate and elastics (FE, CE) for mounting and conforming the mask to the patient's face; and providing means, such as a headband or eyeglasses to be worn by the patient, external to the mask itself, to support devices such as a nebulizer.
According to some embodiments of the invention, a mask (M) for performing medical or dental procedures on a patient may comprise: a very flexible mask substrate (MS) portion which conform well to the contour of a patient's face; a relatively rigid portion (FP, VW) disposed at the front of the mask; and at least one instrument port (IP) extending through the relatively rigid portion or the flexible mask substrate portion; wherein: instrument ports (IP) are disposed on the relatively rigid portion; and the relatively rigid portion can be moved around by a user while the flexible mask substrate portion remains fixed in position on the patient's face.
According to some embodiments of the invention, a dental mask (M, DM) for covering at least a patient's mouth while an oral procedure is being performed by a user (dentist) may comprise: a mask substrate (MS) comprising a generally rectangular, flat sheet of a material that is big enough to fit over the patient's lower face and which is very flexible to allow the mask to conform well to the contour of the patient's face; a view port (VP) in the mask substrate; a viewing window (VW) on the view port, and comprising a transparent material which is more rigid than the mask substrate. one or more openings (instrument ports, IP) provided in the mask substrate to allow the user to introduce instruments into the patient's mouth, to perform the procedure; a face conforming elastic band (CE) incorporated into a peripheral portion of the mask substrate to help “contour” the mask substrate to the patient's face; and one or more fastening elastics (FE) for mounting the mask on the patient's face, said fastening elastics extending around the back of the patient's neck or around the patient's ears.
According to some embodiments of the invention, a mask for fitting onto a patient's face when performing oral procedures may comprise: a mask substrate having at least one opening for corresponding at least one viewing window; at least one viewing window installed over the at least one opening: at least one instrument port in the mask substrate for allowing a user to insert instruments through the mask into the patient's mouth; and at least one elastic band having a first face conforming portion for maintaining a relatively secure fit of the facemask on the patient's lower face, including jaw, and a fastening portion for mounting the mask to the patient's face.
According to some embodiments of the invention, a mask for fitting onto a patient's face when performing various procedures may comprise: a very flexible mask substrate portion; an elastic band for conforming the mask substrate to the contour of a patient's face; a relatively rigid viewing window providing a user with a view of the patient's facial features; and at least one instrument port in the mask substrate for allowing the user to insert instruments through the mask into the patient's facial orifices (nostrils and mouth). The mask may have at least one port enabling at least one of the following procedures to be performed by a user on a patient: nasal swabbing; oral swabbing; and Endoscopy, Bronchoscopy and GI.
According to some embodiments of the invention, a mask system may comprise: a flexible mask substrate adapted to be fitted to a patient's face; means (such as elastic bands) for mounting the mask on the patient's face and for maintaining a relatively secure (and airtight) fit of the mask on the patient's lower face, including jaw; and a port (opening for inserting external instrumentalities) in the mask substrate. The mask system may further comprise:
separate from the mask itself, means for supporting an external instrumentality such as a nebulizer in close proximity with the mask (such as in front of the mask), with a patient portion of the nebulizer extending through the port so that a treatment may be administered to the patient. The means for supporting may comprise glasses, goggles, a headband, a cap, or the like to support the nebulizer independently of the mask.
Some of the masks disclosed herein may be referred to as an “Oral Flex Cab” or “Flex Cab”, and it should be understood that the applicant may claim trademark rights to “Oral Flex Cab” or “Flex Cab”, whether or not these terms are used herein in quotation marks.
The terms “mask”, “face mask”, “dental mask”, “dental facemask”, and variations thereof may be used interchangeably herein. Generally, the finished product may be referred to as “mask”, or “facemask”, while the main component to which other components may be attached (incorporated into the finished mask) may be referred to as the “mask substrate”.
In some of the embodiments disclosed herein, a relatively rigid “front plate” (FP, which in some cases is a transparent viewing window VW) may be incorporated onto the front of the relatively flexible mask substrate (MS), and may support other elements such as filters, ports, adapters, etc., and the front plate may not need to be transparent.
In embodiments of the mask which cover the patient's nose, a malleable metal strip 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 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.
Various embodiments of the invention may be described in greater detail in the discussion that follows (including any appendices that may be attached hereto, or in the priority documents). These may include the apparatus itself, method of manufacturing the apparatus, and methods of treatment which include using the apparatus. This may also include providing for the interaction of the mask with other instrumentalities, such as a nebulizer, which may be supported by independent (of the mask) means such as a headband or glasses worn by the user (of the mask—i.e., the patient). Alternatively, the nebulizer may be hand-held, not requiring the additional support.
Other objects, features and advantages of the invention(s) disclosed herein may become apparent in light of the following illustrations and descriptions thereof.
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. #”.
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.
Some appendices (Appendix 1, Appendix 2) are included with the priority filings (provisional US patent applications), and may be cross-referenced herein.
Some of the following abbreviations may be used, in the text and/or drawings, in lieu of or in addition to reference numerals.
M overall mask (aka “flex cab” FC)
DM a dental mask (mask specific for performing dental procedures)
MS mask substrate, typically a very flexible sheet of plastic material
CE contour elastic extending around a periphery of the mask substrate
MM a malleable metal strip for conforming the mask to the patient's nose
FE fastening elastic for securing the mask to the patient's head (face)
VP view port, which is an opening at the front of the mask
FP front (or face) plate, which is a rigid element disposed at the front of the mask
VW viewing window (a transparent front plate), disposed over the view port
P a port (i.e., opening in the MS or in the VW) for inserting something into the mask
IP instrument port, which is a specific type of port for inserting an instrument
TD a door disposed over a port for exposing (opening) or blocking (closing) the port
F filter, which may be mounted either on the MS or on the VW
NA nebulizer adapter which may be mounted on the mask to receive a nebulizer
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”).
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.
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 drainage—all 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.
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.
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”.
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.
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”.
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).
Generally, all of the embodiments disclosed herein may have:
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.
Filters may be incorporated into the mask substrate, or on the viewing window (or the like—i.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.)
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.
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.
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.
The following elements are shown:
A dental mask 100 may comprise the following elements or components:
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).
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.
It is apparent, for example in the side view of
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.
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.
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.
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.
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.
As illustrated by
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.
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.
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 ½″ 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.
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.
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.
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).
The left hand figure (
The right-hand figure (
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.
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.
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
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.
Other fabrication steps and/or sequences may be employed to yield substantially the same outcome, such as:
Some benefits of the mask disclosed herein may include:
For some applications it may be advantageous that the mask (flex cab) covers the patient's nose in addition to the oral cavity.
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.
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.
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).
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.
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.
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.
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.
The mask of
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 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
In this embodiment, a trap door is disposed on the mask, rather then the aforementioned viewing window (of the Dental Mask embodiment).
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.
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.
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.
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.
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.
This mask has two ports:
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.
This embodiment is similar to the nasal swab mask shown in
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.
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.
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
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
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).
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.
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.
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.
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.
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.
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.
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.
As shown in
In
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.
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.
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.
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.
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).
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
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/)
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.
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.
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.
Priority (filing date benefit) is claimed from the following, incorporated in their entirety (including any appendices) by reference herein. U.S. 63/154,673 filed 27 Feb. 2021U.S. 63/062,383 filed 6 Aug. 2020U.S. 63/026,730 filed 19 May 2020
| Number | Date | Country | |
|---|---|---|---|
| 63154673 | Feb 2021 | US | |
| 63062383 | Aug 2020 | US | |
| 63026730 | May 2020 | US |
