Strapless Face Mask With and Without Access Ports

Abstract

A strapless face mask having a housing and an interior seal made of a soft material that creates an air-tight seal within the mask and has sufficient adhesive properties to ensure the mask adheres to the wearer's face. The strapless face mask further includes one or more access ports that are made of a self-sealing material that allow medical equipment to be inserted into the face mask to access the wearer's face without interrupting the air-tight seal of the mask.

Claims

1. A strapless face mask comprising: a housing configured to be disposed on a wearer's face to cover the mouth and nose; a seal of pliable material disposed on the inside perimeter of the housing to create a fully occlusive air-tight seal for the mask, wherein the seal is made of material that temporarily adheres to the wearer's face to hold the mask in place without the need for straps: and wherein further an air-tight interior space is created between the wearer's face and the housing when the housing is disposed on the wearer's face.

2. The strapless face mask of claim 1 wherein the housing is made from a semi-rigid and pliable fibrous filtration material.

3. The strapless face mask of claim 2 further comprising: at least one access port to allow access to the air-tight interior space between the mask and the face, without breaking the air-tight seal of the mask.

4. The strapless face mask of claim 3 wherein the at least one access port is configured to allow the introduction of medical equipment into the air-tight interior space.

5. The strapless face mask of claim 3 wherein the at least one access port is oriented so that the wearer's nose can be accessed.

6. The strapless face mask of claim 3 where the at least one access port is oriented so that the wearer's mouth can be accessed.

7. The strapless face mask of claim 2 wherein the seal is made of a soft silicon that provides an airtight seal and is sufficiently sticky to fully adhere the housing to the wearer's face.

8. The strapless face mask of claim 7 wherein the seal is made from a soft silicon with an adhesive strength of between 4 and 7 newtons.

9. The strapless face mask of claim 4 wherein the at least one access port is made from a soft and pliable silicon material that forms around the medical instrument to create an air-tight seal to ensure that the interior air-tight seal is not broken.

10. The strapless face mask of claim 9 wherein the access port includes a pre-cut access opening that self-seals, and that seals around the inserted medical instrument.

11. The strapless face mask of claim 8 wherein the access port is sufficiently thick such that the access port material on the outside moves to allow the entrance of medical equipment, but opening is still closed below to ensure the airtight seal, and the soft material adheres around the medical equipment as it is introduced to ensure the continuation of the airtight seal.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1A is a front view of the face mask.

[0017] FIG. 1B is a side view of the face mask.

[0018] FIG. 2 is a view of the inside of the face mask.

[0019] FIG. 3A is a view of a single access port within the access region.

[0020] FIG. 3B is a view of multiple access ports within the access region.

[0021] FIG. 3C is a view of multiple and varied access ports within the access region.

[0022] FIG. 3D is a view of a single access point on an access port.

[0023] FIG. 3E is a view of a slit as an access port.

[0024] FIG. 4A is a side exploded view of one coupling mechanism, and FIG. 4B shows the coupling mechanism attached.

[0025] FIG. 5 is a cross-section view of one access component.

[0026] FIG. 6 is a cross-section view of a connector.

[0027] FIG. 7 is a cross-section view of one embodiment of the septum.

[0028] FIG. 8 is a cross-section view of a second embodiment of the septum.

[0029] FIG. 9 is a cross-section view of an access component coupled to a receiving portion.

[0030] FIG. 10 is a side view of an access component.

[0031] FIG. 11 is a front view of an access component with a small access hole.

[0032] FIG. 12 is a front view of an access component with an access slit.

[0033] FIG. 13 is a front view of an access component with an offset access slit.

DETAILED DESCRIPTION OF THE INVENTION

[0034] Detailed embodiments of the present invention are disclosed herein. It is to be understood that the disclosed embodiments are merely exemplary of the invention, and that there may be a variety of other alternate embodiments. The figures are not necessarily to scale, and some features may be exaggerated or minimized to show details of particular components. Therefore, specified structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for teaching one skilled in the art to employ the varying embodiments of the present invention.

[0035] The present invention is a containment device to prevent the spread or transmission of airborne diseases and the inhalation of airborne particulate matter. In the primary embodiment the invention is a face mask that includes an adhesive-like material around the edges of the mask where it rests against the face of a wearer to create a seal. The primary embodiment also includes an access region with an access port, which allows access to the wearers face while maintaining the seal to prevent the transmission of air borne pathogens.

[0036] Embodiments of the present technology provide a mask-like structure for the containment of droplets, viruses, or other pathogens, and which will protect individuals from the same, and also other particulates or harmful substances, depending on the qualities of the masking material. Such mask-like containment structures can be easily deployed in any procedure room, endoscopy suite, and hospital operating room, ICU, patient room, field hospital, or ambulance or in an ambulatory surgery setting, or can be used in any non-medical setting as Personal Protective Equipment.

[0037] In some embodiments, a mask-like containment system as described herein can be suitable for outpatient office use, in which the patient is breathing on her own. For example, the system can allow upper airway endoscopic procedures to be performed while allowing the patient to breathe and while containing, within a microenvironment, any aerosolized virus or droplet spread from the patient into the surrounding environment. Such a mask-like containment system may permit endoscopies to be performed safely while minimizing risk to surgeons and other medical providers, even in the case of infected patients. Likewise, individuals could use the technology to allow insertion of straws and other instruments into the containment filed for provision of sustenance, without taking the mask off and risking exposure to pathogens, or other harmful materials.

[0038] FIG. 1a is a front view of a mask or containment system 100 in accordance with embodiments of the present technology, FIG. 1b is a side view thereof, and FIG. 2 is a view of the inside of the containment system/mask. The mask/containment system 100 can include a housing 101 configured to be placed adjacent a surface of the patient's body such that the patient surface and the housing 101 together define a containment volume 103. In operation, the containment system 100 can inhibit the spread of particles from within the containment volume 103 into the surrounding environment. For example, aerosolized or airborne pathogens, virus particles, microorganisms, fungi, water droplets, bone or tissue debris, or other such contaminants may be contained within the containment volume 103, thereby protecting clinicians (e.g., operating surgeons, nurses, etc.) from contamination by the patient.

[0039] As shown in FIG. 1, the housing 101 is coupled to the patient to define the containment volume 103 therebetween. A seal 105, as best seen in FIG. 2, can be disposed at the junction(s) of the housing 101 and the patient, and can be configured to provide an impermeable barrier such that air-borne particles cannot escape the containment volume at the junction of the housing 101 and the patient. In some embodiments, at least a portion of the housing 101 can be semi-permeable so that a patient can breathe therethrough. For example, a suitable filter (e.g., as in an N-95 mask) can be carried by the housing 101 such that the patient may breathe through the filter. It is also within the conception of the invention for the housing 101 to be made of this pliable fabric filtration material, such as N-95 or N-96 filtration material.

[0040] The housing 101 can be partially or fully transparent, so as to permit an operator to view the interior region therethrough. In some embodiments, the housing 101 can be a rigid or semi-rigid structure, for example being configured to stand off from the patient and maintain the containment volume 103 (e.g., the housing 101 can be at least partially rigid or otherwise configured to resist collapsing into contact with the patient's body). As described in more detail below, the particular size, shape, and configuration of the housing 101 can be tailored to particular procedures and/or particular body parts to which the housing 101 is to be coupled. For example, as described in more detail below, the housing 101 can take the shape and form of a mask or other wearable structure configured to be worn over a user's nose and mouth. In various embodiments, the housing 101 can be fully or partially made of a polymer, glass, gel, plastic, or other structural composite. It can also be made, as noted, from standard filtration material such as N-95 or N-96 material. The housing 101 may be disposable (e.g., configured for single use) and/or may be re-usable (e.g., configured to be cleansed and re-used among multiple patients). As described in more detail below, the housing 101 can also include or be coupled to other structural elements configured to retain the containment system 100 in place, for example straps, bands, ties, or any other suitable fasteners.

[0041] The seal 105, as shown in FIG. 2, can be a continuous seal around the perimeter of the housing 101 disposed at the junction of the housing 101 and the patient, or in some embodiments the seal 105 can include a plurality of discrete sealing elements that together effectively seal the containment volume 103 therein to create a fully occlusive air-tight interior space between the housing and the face. In some embodiments, the seal 105 can include an air-impermeable foam, air-filled balloon, or other compliant member fixedly coupled to the housing 101 and an adhesive (e.g., tape, gel, etc.) that releasably secures the compliant member against the patient's body. In some embodiments, the foam or other compliant member can conform to the surface of the patient's body around the perimeter of the housing 101, thereby providing a continuous and uninterrupted seal.

[0042] FIG. 1A is a front view of the primary embodiment of the invention and FIG. 1B is a side view of one embodiment of the invention. As seen in FIG. 1A and FIG. 1B, the face mask embodiment appears much like a common N-95 style face mask. In this embodiment the mask is made from an N-95, or N-96 material, which is an electrostatic non-woven polypropylene fiber material. While not fully rigid, standard N-95 material is, or can be configured to be, sturdy enough to hold its shape. In the embodiment shown in FIG. 1A and FIG. 1B, the access port sits over the wearer's nose, but it is within the conception of the invention to position the access port on any portion of the mask to correspond to the medical needs of the situation. FIG. 2, the interior view, shows a number of representative access ports 115, in various positions on the housing 101. In one non-medical embodiment, the access port is roughly in front of the mouth, which allows the access port to be used with a straw to allow the wearer to drink while wearing the mask while maintaining a complete seal from the outside environment.

[0043] In a preferred embodiment there will be a seal 105 on the inside perimeter of the mask, and in the preferred embodiment the seal 105 will be made from liquid silicon rubber (LSR). LSR is commonly used in medical settings. The hardness and softness, flexibility and rigidity of LSR depends upon the catalyst used. An LSR with a low durometer hardness is more flexible, and depending upon the polymer can be sticky and have adhesive properties. A very low durometer harness LSR will be soft and spongy, and will easily adhere and form to the skin of the mask wearer to create a continuous and air-tight seal around the edges of the mask. LSR is a low-viscosity material that flows easily during the molding process, depending upon how it is cured and what catalysts are added during the curing process. In the present invention the LSR used in the seal around the face mask is cured with a platinum catalyst that leaves the end product pliable and highly elastic. In this regard it is similar to SILPURAN?, which is a medical grade soft LSR.

[0044] Many of these medical grade LSRs are sticky and have adhesive properties but also have low adhesive strength of between 3 and 10 newtons per inch, though preferably near 5 newtons per inch. These are ideal for medical use because they do not adhere to the skin and therefore don't damage the skin when removed. The LSR can be adhered to the mask material when in liquid form, and will bond within the fibers of the material, and then when cured will be attached to the mask to form the seal. Because LSR can be in a liquid form before cured it adheres easily to cloth or other fibrous materials, and so a thin strip of pre-cured LSR can be placed around the edges of the mask, and then cured to harden. In its hardened form it will still be soft and malleable, and have a slight stickiness. In this embodiment the stickiness of the LSR seal around the inside perimeter of the mask will allow the mask to adhere to the wearers face. In a most preferred embodiment, this soft and sticky LSR will allow the mask to be securely attached to the face without straps, and will create a strapless face mask. In the preferred embodiment the LSR strip seal 105 will be around 10 mm wide or larger.

[0045] In use, in the most preferred embodiment, the housing 101 will be made of N-95 or N-96 semi-rigid woven polypropylene or comparable material that prevents most pathogens from transiting the material. The housing 101 will be configured to create a tri-fold style face mask with a peak for the nose. A bead of silicon sealant material will be disposed around inside perimeter of the mask 100 to create a complete seal 105, as shown in FIG. 2. In use, the wearer will place the mask 100 on their face, using the peak at the nose to properly align the mask 100.

[0046] The mask 100 will be pressed against the skin, starting at the nose to create a seal. The wearer will then proceed by pressing around the perimeter of the mask 100 down the cheeks to the jawline, then under the jaw on the upper throat to create a complete seal 105 on the mask 100. Masks 100 can be produced in multiple sizes to ensure adequate fit for people with different sized head. However, if the wearer is small and a small mask cannot be found, the seal can be competed by pinching the extra fabric to the sides of the jaw together to create a complete seal 102 around the mask. This allows a standard, inexpensive, disposable but fully protective face mask 100 to be easily donned. The stickiness of the LSR material allows the mask 100 to remain in place on the face without the need for ear straps, creates a complete seal, and allows the mask to remain in place for extended periods of time without the seal becoming degraded and breaking the fully occlusive air-tight seal.

[0047] In one possible embodiment the full facemask will be made of LSR material. This will allow the full mask to be largely translucent, if not fully transparent. In this embodiment, in addition to the access region there will need to be a filter to allow filtered air to enter the mask. The translucence of the mask will allow a clinician to see into the mask, which will improve the ability to perform procedures. In this embodiment some or all of the mask will be made from a more rigid LSR material, with a shore hardness of 30 to 60 durometer range.

[0048] The access regions describe in more detail below, will be, in preferred embodiments, made from LSR material, which will easily mold around the inserted medical device. A low durometer LSR opening will easily mold and fit around the inserted medical device. As previously mentioned, the containment systems 100 disclosed herein may include one or more access regions 115 configured to provide the clinician direct or indirect access to the interior region of the containment system 100, including access to the portion of the patient's body covered by the housing 101. The access region 115 may be integrated with the housing 101 (e.g., non-detachable from the housing 101), or may comprise a region of the housing 101 configured to be releasably coupled with one or more access components. Any of the containment systems 100 disclosed herein may include one or more integrated access regions 115 and/or one or more access regions 115 configured to receive an access component.

[0049] Non-limiting examples of different access regions 115 are shown in FIGS. 3A to 3E. As shown, the access regions 115 of the present technology can include one or more ports 250 that provide passage through the access region 115 and/or housing 101 to the clinician and/or medical instrumentation. Each port 250 can comprise a slit, a perforation, an opening, a channel, and/or other suitable means for providing access through the housing 101. The shape, size, and configuration of the port 250 can be tailored to a particular function. For example, a port 250 may comprise an instrument port configured to receive one or more medical instruments therethrough, a therapeutic agent port configured to facilitate administration of one or more therapeutic agents to the patient therethrough, and/or a caregiver port configured to receive a hand or arm of a clinician therethrough. Moreover, the shape, size, and configuration of the port 250 can be tailored to a particular medical instrument. For example, a port 250 configured to receive a medical instrument having a flatter end therethrough (such as an elevator, a forcep, the blade of a laryngoscope, etc.) may comprise a single slit (such as slit 281 in FIG. 3E) to provide a better seal during insertion and withdrawal, while a port 250 configured to receive an instrument having a more circular cross-sectional dimension (such as an aspiration tube or endoscope) may comprise a single perforation (such as perforation 280 in FIG. 3D). The port(s) 250 accommodate a multitude of endoscopes, suctions, and both powered and non-powered instrumentation.

[0050] In some embodiments, a single access region 115 comprises a single port 250, as shown in FIG. 3A, and in some embodiments a single access region 115 comprises a plurality of ports 250, as shown in FIGS. 3B and 3C. In those embodiments including multiple access regions 115, the different access regions 115 can have the same or a different arrangement of ports 250, the same of different types of ports, the same or different numbers of ports, the same or different shapes of ports, and/or the same or different shapes of ports. An access region 115 having ports 250 of different sizes is shown, for example, in FIG. 3C. In some embodiments, one or more of access regions 115 and/or ports 250 includes a valve. The valve, for example, may be a one-way or two-way valve.

[0051] In some cases it may be beneficial for the access region to be detachable so that different ports may be utilized without having to change out the entire housing. For example, an intubated patient may undergo several procedures, each calling for a different medical instrument that requires a different port or arrangement of ports. In some instances, the type or arrangement of ports may be the same from procedure to procedure, but a new port may be required to maintain a sterile environment. To address the foregoing challenges, the containment systems 100 of the present technology may include one or more access regions 115 that comprise a receiving portion at the housing 101 and one or more access components configured to be detachably coupled to the receiving portion. The individual access component(s) can include a connector for mating with the receiving portion, and one or more ports and/or a material configured to be penetrated by a medical instrument. The receiving portion can be configured to receive a variety of access components having different port arrangements so that the clinician can select the appropriate configuration for a given procedure.

[0052] The receiving portion may be a portion of the housing 101, such as an opening in the material of the housing 101, or may be a separate component fixed to the housing 101. In either case, the receiving portion 270 is configured to detachably couple to the access component 260 to secure the access component 260 to the housing 101. FIGS. 4A and 4B, for example, schematically depict different coupling mechanisms for the access components and receiving portions of the present technology. As shown in FIG. 4A, the containment system may include an access component 260 configured to be received at least partially within an opening of a receiving portion 270 disposed at the housing 101. For example, the receiving portion 270 may comprise a ring or other annular member having a threaded lumen, and the access component 260 may have a complementary cross-sectional shape with complementary threading around its exterior surface. The couple the access component to the receiving portion 270, the access component 260 may be screwed into the lumen of the receiving portion 270. Additionally or alternatively, the access component 260 may be coupled to the receiving portion 270 via other temporary fixation mechanisms, such as a snap fit, a friction fit, a ratcheted configuration, via the use of an adhesive or mechanical fasteners (such as a screw, a pin, etc.), and/or other suitable means.

[0053] According to several embodiments, the access component 260 is configured to rotate within the receiving portion 270, thereby allowing instruments to be manipulated through a broad range of trajectories. For example, the access component 260 may have an annular protrusion configured to slide within a complementary annular groove around the interior surface of the receiving portion 270. This way, the access component 260 can rotate relative to the receiving portion 270 but has limited longitudinal movement, if any at all.

[0054] FIG. 5 is an isolated, cross-sectional view of an access component 260 configured in accordance with several embodiments of the present technology. The access component 260 is configured to be coupled to a receiving portion 270 of a housing 101 (such as any of the housing embodiments described herein) such that a first side 260a of the access component 260 is outside of the operating environment and faces towards the caregiver, and a second side 260b of the access component 260 is within the operating environment inside the mask 103, or vice versa. According to some embodiments, for example as shown in FIG. 3, the access component 260 comprises a substantially planar disc. In some embodiments, the access component 260 has a non-circular shape, such as a triangle, a square, a rectangle, etc., and/or the access component 260 may be non-planar at one or both of the first and second sides 260a, 260b. The access component 260 can be made in multiple sizes to accommodate the instrumentation desired. In some embodiments, for example, the access component has a cross-sectional dimension of about 1 cm to about 4 cm. Other sizes are possible.

[0055] As shown in FIG. 5, the access component 260 may comprise an annular connector 262 configured to mate with the receiving portion 270, a septum 264 extending across the connector opening, and a port 250 extending through the thickness of the septum 264. Although only a single port 250 is shown in FIG. 5, the access component 260 may comprise multiple ports 250 (as described in greater detail below). According to several embodiments, the septum 264 does not include any pre-existing ports. In such embodiments, the septum 264 comprises a material configured to be penetrated through its thickness by a medical instrument. The connector 262 may comprise a metal, a plastic, a composite material, and other suitable materials.

[0056] The septum 264 may comprise one or more occlusive materials that inhibit fluid communication (liquid or gas) between the operating environment and the clinician's environment. In some embodiments, the septum 264 comprises a self-sealing and/or resilient material that can be penetrated by a medical instrument but collapses around the medical instrument while inserted, thereby providing a seal around the instrument. When the instrument is withdrawn, the self-sealing material fills in the space once occupied by the instrument. The self-sealing material may comprise a silicone or another deformable, biocompatible material. In some embodiments, the access region 115 comprises a material that enables repeated access using a non-coring needle, for example to enable infusion of medication or aspiration of blood. Additionally or alternatively, the septum 264 may comprise an anti-fogging material and/or an anti-viral/bacterial/fungal material, one or both of which may comprise a foam. Such materials may advantageously provide added protection against virus aerosol droplets that can spread as an endoscope (or other instrument) is placed through the septum 264.

[0057] As shown in FIG. 5, the septum 264 may have a thickness that is generally the same as a thickness of the connector 262. In some embodiments, the septum 264 may extend beyond the connector 262 at one or both sides 260a, 260b of the connector 262. In these and other embodiments, one or both broad surfaces of the septum 264 may lie below the plane of the connector ends at one or both sides 260a, 260a of the connector 262 (i.e., within the lumen of the connector), as shown in FIG. 6. All or a portion of the septum 264 may have a cross-sectional dimension that is less than the cross-sectional dimension of the connector 262 (as shown in FIG. 5), and all or a portion of the septum 264 may have a cross-sectional dimension that is greater than the cross-sectional dimension of the connector 262.

[0058] As depicted in FIG. 7, in some embodiments the septum 264 comprises at least two materials 264a, 264b with different properties. For example, the septum 264 may comprise a first material 264a comprising latex, silastic, nitrile, etc. at the clinician-facing side 260a and a second material 264b comprising an anti-fogging and/or anti-viral/bacterial/fungal material at the operating environment side 260b, or vice versa. The first and second materials 264a, 264b can be in direct contact with one another (as shown in FIG. 7), or may be spaced apart (as shown in FIG. 8) such that the access component 260 contains a gap 265 between the first and second materials 264a, 264b. In some embodiments, the access component 260 comprises a liquid or gas between the first and second materials 264a, 264b. In several embodiments, the septum 264 comprises more than two materials. As can be appreciated when viewing the cross sectional views of FIGS. 5, 6, 7, and 8,

[0059] FIG. 9 is a side cross-sectional view of an access component 260 coupled to a receiving portion 270 configured in accordance with embodiments of the present technology. As shown in FIG. 9, the material forming the housing 101 may have an opening, and the access component 260 comprises a first member 262a and a second member 262b that sandwich the housing 101 therebetween when secured to one another. In some embodiments, the first connector 262a has an annular extension that extends laterally away from the more tubular septum-containing portion of the first connector 262a. In FIG. 9 the access component is essentially a two-piece circular grommet that is attached to a hole in the housing 101 and snapped into place.

[0060] FIGS. 10 and 11 are side and top views, respectively, of an access component 260 configured in accordance with embodiments of the present technology. As shown, the access component 260 may include a connector 262, a first material 264a disposed at the exterior surface of the connector 262, and a second material 264b disposed at an interior (operative side facing) surface. The connector 262 may be configured to detachably couple to a receiving portion 270 of the housing 101, as discussed herein. The access component 260 may comprise a perforation 280 configured to receive instrumentation therethrough.

[0061] FIGS. 10 and 12 are side and top views, respectively, of an access component 260 configured in accordance with embodiments of the present technology. As shown, the access component may include a connector 262, a first material 264a disposed at the exterior surface of the connector 262, and a second material 264b disposed at an interior (operative side facing) surface. The connector 262 may be configured to detachably couple to a receiving portion 270 of the housing 101, as discussed herein. The access component 260 may comprise a perforation 280 and a slit 281 configured to receive instrumentation therethrough. The slit 281 may allow perforation of an instrument into the operative field, and then collapse upon withdrawal of the operating instrument. FIG. 12 show an access component with a central slit 281, and FIG. 13 shows an access component with a slit 281 that is offset from a central axis of the access component. In some embodiments, one or more of access components 260 and/or ports 250 includes a valve. The valve, for example, may be a one-way or two-way valve.

[0062] It will be appreciated that any of the access component configurations described herein can also be integrated with the housing 101 in a non-detachable manner. Likewise, any of the access regions configurations described herein can be incorporated into an access component 260 (i.e., made to be detachable from the housing 101). The access regions may also be employed in non-medical uses, such as passing common straws and/or specially modified instruments for consumption of liquid and non-liquid foodstuffs while wearing the occlusive masks.