Patent Application
20240306739
Not Applicable
Not Applicable
Not Applicable
The present invention relates to a protective face mask, and more particularly to a face mask that can be securely attached to the face of a wearer without the need for straps. The strapless face mask is also configured to operate with access ports to allow a clinician to access the wearer's face, nose, and mouth.
The present technology relates to equipment, such as a face mask, for protecting clinicians from aerosolized pathogens while performing medical procedures. The device can also be used in a non-medical setting by the general public, first responders, military, skilled workers among others for personal protection from aerosolized pathogens and other entities (e.g. organic molecules, particulates, etc.) which may be harmful to the individual, if inhaled.
More specifically, this invention relates to a device, particularly a face mask, that is designed to prevent the transmission of pathogens, particularly during medical procedures. It is designed to protect the wearer of the facemask from environmental exposure or particulate matter and/or pathogens and protects people around the wearer from aerosol exposure released from the wearer. In one embodiment the invention is a face mask with a sealing material to ensure a complete seal of the mask on the face. In another embodiment the seal is sufficiently strong and secure to eliminate the need for straps on the face mask. In another embodiment the face mask includes one or more access regions that allow a clinician access to a wearers face, including mouth, nose and eyes, to perform medical procedures with the mast in place, and without pathogens passing the seal of the mask. In another embodiment, the face mask is made of a material which prevents passage of pathogens and particulate matter through the body of the mask.
Operating surgeons and other clinicians risk exposure to aerosolized or airborne pathogens while performing medical procedures, particularly those involving the patient's ear, nose, and/or throat. Most recently, the SARS and SAR-COV-2 (Covid-19 disease) pandemics have increased the risk of inflicting high viral loads during on clinicians who perform medical procedures on infected patients. Accordingly, there remains a need to provide protect medical personnel from aerosolized or airborne pathogens. Likewise as the pandemic has evolved, and other pathogens (e.g., influenza and respiratory syncytial virus) have become more of a threat to the general public, there is a need to protect the general public from all these potential pathogens. Of particular importance is that it has become clear that cloth and paper masks provide minimal protection to the individual, and that N-95 and similar (e.g., KN-95) masks only provide optimal protection, if properly fit to the individual and worn in such a manner as to provide a tight seal around the face. Most people do not wear their masks properly, so there is not a tight seal around the face, so it is always possible for pathogens to enter in the gaps, particularly at the bridge of the nose and under the submental area and neck. As a result there is a need for a mask which provides an occlusive seal, without requiring the user to be professionally fit to the mask, and minimizes the potential to break the seal around the face. Also, skilled workers, laborers, first responders, military and other peoples' working in environments containing particulate matter, dust, known and unknown pathogens and gasses require protection from inhalable articles.
The use of face masks became common and ubiquitous during the worldwide COVID-19 pandemic that began in late 2019. Many people began to wear face masks in an attempt to protect themselves from the spread of this airborne disease. When face masks were not easily available, many people made their own masks out of fabric. While this may prevent some aerosol droplets, and in particular prevent a wearer from spreading droplets through a sneeze, it is virtually useless to protect the wearer. In the early stages of the pandemic standard blue surgical face masks became very common. These masks are typically made from woven polypropylene and were typically worn to prevent the wearer, such as a surgeon, from transmitting diseases into an otherwise sterile environment. It provides a minimal amount of filtration to the exhalation from the mouth and nose of the wearer. Because these masks are ill-fitting and poorly sealed, they provide very minimal protection to the wearer. A better option, which became more common later in the pandemic, was the standard N-95 mask. This mask is slightly fitted, with a peak at the nose, and often a thin strip of a metallic material to form the top of the mask around the nose. The material of the N-96 mask, which is somewhat soft and pliable, is typically made from a woven polypropylene with fiber melded together in a process called “melt blow extrusion.” These masks are referred to as N-95 because the fibers are woven tightly enough so that they prevent 95% of airborne microbes cannot penetrate the mask. The problem is, however, that these masks are frequently worn improperly so that there are gaps in areas between the mask and the wearer's face, which means that there is not an airtight seal around the mask, so airborne pathogens can get in and out. A recent study has found that it is very common for N-95 masks to be ill-fitted, and for the fit to degrade during lengthy use. Results showed that the most common “tri-fold” N-95 mask had a “fit failure” of 61.3%, while the dome-style mask had a 25.8%“fit Failure.” See, Wang R C, Degesys N F, Fahimi J, et al. Incidence of Fit Test Failure During N95 Respirator Reuse and Extended Use. JAMA Netw Open. 2024; 7(1):e2353631. doi:10.1001/jamanetworkopen.2023.53631. There is a need, therefore, for a simple mask that is easily fitted and sealable, and that includes a seal that ensures that the air-tight seal of the mask does not degrade through extended use.
The number and frequency of global infectious pandemics is increasing. Most recently, aerosolization or droplet spread from SARS and SARS-COV-2 (Covid-19 disease) pandemics have exposed containment inadequacies in medical systems globally. Evidence from the Chinese and Italian experiences with both of these pandemics indicates that medical personnel who perform procedures, endoscopies and open upper airway surgery are at greater risk for high viral load exposure. Operating room intubation, ICU intubation, patient management in the intensive care unit (ICU), patient management on the routine floor and performing airway and tissue management in the trauma field and in military settings greatly increased risk of not only becoming infected with Covid-19, but having severe infections due to inoculation of very high viral loads. Beyond SARS-COV-2, droplets containing aerosolized bacterial, viral, fungal, and tissue/bone debris and other pathogens can spread with high density during manipulation of the upper aerodigestive tract, sinuses, ears, nose and/or mouth. Currently, the ability to contain aerosolized droplets, viral particles and other particulate matter remains inadequate. As such, developing methods to minimize droplet-mediated aerosolized virus spread during airway, digestive tract and temporal bone manipulation thought bone drilling, soft tissue removal, endoscope insertion in clinics, procedural suites, and operating rooms is imperative. As the Covid-19 pandemic has evolved, and has been complicated by other pathogens (e.g. influenza and RSV), it is clear that current Personal Protective Equipment can be improved by providing a better occlusive fit and access for eating and drinking (such as on a prolonged airline flight, or even in a restaurant or bar, whereby taking a mask off to consume food and drink increases the exposure to pathogens to the individual. Skilled laborers, first responders, military personnel and other workers who are exposed to unknown aerosolized particles and pathogens would benefit from an occlusive mask described herein as well. A mask of this type would provide wearers with protection with minimal interference with eyeglass and hearing aid use. This mask can also be used by the general public in situations where they want to maximize protection while retaining the ability to drink liquids through the access port.
Embodiments of the present technology provide a mask-like structure for the containment of droplets, viruses, other pathogens and various forms of airborne particulate matter. The present invention can also 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 medical or surgical 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.
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.
The mask of the present invention will include a sealing material disposed inside the mask on the entire perimeter of the inside mask surface. This will allow the mask to adhere to the wearer's face to create an airtight seal, and thus create an air-tight interior airspace between the mask and the wearer's face. This will create a fully occlusive and complete seal to completely prevent pathogens from entering the contained space within the mask and contains aerosolized particles from the wearer preventing spread to the surrounding environment. In one embodiment the seal material is made from Liquid Silicon Rubber (LSR) that is adhered to the inside perimeter of the mask, and that creates a thorough, air-tight seal around the entire perimeter of the mask. In one embodiment the LSR has adhesive properties that allow the mask to be securely attached to the wearers face without straps.
The mask of the present invention will also include an access region disposed on the mask. The access region allows a medical clinician to insert a medical device, such as an endoscope, into the mask to perform a procedure on the patient. The access region is made from a material, such as LSR, that is sufficiently flexible so that it will form around the inserted medical device to ensure a seal on the device to prevent pathogens from entering the contained space within the mask. This will allow the medical clinician to perform a procedure on a patient while ensuring that the patient is not exposed to pathogens within a room, but equally important, it will allow medical personnel to perform procedures on an infected patient without the risk of pathogens spreading from the patient to the medical personnel. This access region can also potentially be used in non-medical situations, such as on an airplane, or even in a crowded social setting like a party or a bar, to allow the individual wearing the mask to drink liquids through a straw without removing the mask, while ensuring that the individual is not exposed to pathogens in the surrounding environment.
The strapless face mask comprises 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 mask 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. In the strapless face mask, the housing can be made from a semi-rigid and pliable fibrous filtration material. The strapless face mask further includes 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. These access ports are configured to allow the introduction of medical equipment into the air-tight interior space, and can be aligned so that the that the wearer's nose or mouth can be accessed. The seal of the strapless face mask can be made of a soft silicon that provides an airtight seal and is sufficiently sticky to fully adhere the housing to the wearer's face, and the seal can be made from a soft silicon with an adhesive strength of between 4 and 7 newtons. The access ports can be 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. The access port can also include a pre-cut access opening that self-seals, and that seals around the inserted medical instrument. The access port can be 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.
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.
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.
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.
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.
As shown in
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.
The seal 105, as shown in
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.
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.
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
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.
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.
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.
Non-limiting examples of different access regions 115 are shown in
In some embodiments, a single access region 115 comprises a single port 250, as shown in
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.
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.
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.
As shown in
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.
As shown in
As depicted in
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.
This application claims priority to U.S. provisional application Ser. No. 63/443,186, filed on Feb. 3, 2023, and incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63443186 | Feb 2023 | US |
