Abstract:
A semi-disposable face mask has a shaped molded base composed of silicone and/or TPE and molded forming a face seal, a filter media and a support structure that houses the shaped molded base and filter media in fluid communication allowing airflow from an environment through the filter media to the face seal.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of International Application No. PCT/US13/38820 filed Apr. 30, 2013, which claims the benefit of U.S. Provisional Patent Application No. 61/640,515 filed Apr. 30, 2012, the contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates generally to semi-disposable face masks with improved face seal compositions and characteristics useful in protective equipment for emergency personnel or industrial work. 
       SUMMARY OF THE PRESENT INVENTION 
       [0003]    A semi-disposable face mask has a shaped molded base composed of silicone and/or TPE and molded forming a face seal, a filter media and a support structure that houses the shaped molded base and filter media in fluid communication allowing airflow from an environment through the filter media to the face seal. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0004]    The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate exemplary embodiments of the invention, and together with the description above, serve to explain further features of the invention. 
           [0005]      FIG. 1  illustrates a mask of the invention having a base, filter, framing member and support member; 
           [0006]      FIG. 2  illustrates an expanded view of the mask shown in  FIG. 1 ; 
           [0007]      FIG. 3  illustrates a mask of the invention having a base, filter and support member; 
           [0008]      FIG. 4  illustrates an expanded view of the mask shown in  FIG. 3 ; 
           [0009]      FIGS. 5-7  illustrate construction and use of a mask of the invention having a base/support structure and filter; 
           [0010]      FIGS. 8-9  illustrate an embodiment of the invention; 
           [0011]      FIGS. 10-13  illustrate improvements in replaceable and washable filter media; 
           [0012]      FIGS. 14-16  illustrate improvements in adaptive fit; 
           [0013]      FIGS. 17-20  illustrate various improvements of the invention; 
           [0014]      FIGS. 21-24  illustrate improvements in the composition of the invention; and, 
           [0015]      FIGS. 25-29  illustrate PAPR adaptations combined with the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0016]    The invention includes improvements in mask wear and decontamination. Referring to  FIGS. 1 and 2 , a hybrid disposable mask  100  includes a shaped molded base  20  forming a face seal  22  with a sealing edge  24  for contact with the wearer&#39;s face. The shaped molded base  20 , face seal  22  and sealing edge  24  preferably have a composition of silicone, thermoplastic elastomer (TPE) or combination thereof. Silicone and TPE materials include any appropriate silicone rubber or thermoplastic rubbers having thermoplastic and elastomeric properties appropriate for facial contact and filter support. The sealing edge  24  of the face seal  22  provides a comfortable fit and wear of the mask  100  to the wearer. Generally the molded sealing edge  24  includes a rounded and/or textured edge for a comfortable facial contact to increase the area of contact with the wearer&#39;s face for extended times of use, although various seal profile options may be used in the face seal  22  design. Representative examples of the face seal  22  include, without limitation, a flat seal, reverse reflex, standard reflex and other like configurations for facial comfort. The face seal  22  is preferably configured to allow a single size to fit most personnel using the device which is enhanced with the elastic composition of the silicone or TPE material allowing a very flexible arrangement and fitting. The face seal  22  provides an improved mass or physical wear features for long term use of the mask  100 . 
         [0017]    As additionally seen in  FIGS. 1 and 2 , a filter media  30  may be combined with the shaped molded base  20  in the hybrid disposable mask  100 . The filter media  30  includes any appropriately constructed filter for a given use. Representative examples include, without limitation, pleated, sheet, molded, layered, or other planar formed filter media fixable within a framing structure. The filter media  30  may include the general form of a relatively flat or contoured face panels. Shapes include oval, rectangular, curved, pentagonal, etc. with the shape matching a framing structure and the shaped molded base  20  effectively to ensure an airtight seal of the mask  100 . Typically, a pleated filter may provide a feel and texture similar to a fabric and allows the body of the face mask to expand outwardly and generally conform to the wearer&#39;s face so as to loosely cover the nose and mouth of a wearer. Filters  30  may be single, layered, or preferably comprise a sandwich of several layers, such as an outer facing layer, an intermediate filter media layer, and an inner facing layer. The filter media  30  may include an inner and outer layer with a binder material to impart stiffness to the sheet during use. The filter media  30  may include a replaceable filter media or washable filter media. In one preferred embodiment, the filter media  30  includes a high efficiency filtering media typically used in the medical or research field. 
         [0018]    The filter media  30  is positioned within and a framing member  40  to maximize the filter media  30  area and to ensure optimum efficiency of the filter during use. This framing member  40  is attachable/detachable to a support structure  50  when in use. The framing member  40  preferably matches the perimeter of the filter media  30  and the support structure  50 , allowing for the filter media  30  to remain as expanded as possible. The framing member  40  may be attached to the support structure through any appropriate locking mechanism, such as without limitation, latches, fictional contact, overhangs, pivot surfaces, twist insertions and the like, with fictional contact preferred. The framing member  40  provides a rigid structure to retain the filter media  30  in a given shape while allowing attachment to the support structure  50  without significant distortions of the shape. 
         [0019]    The shaped molded base  20  attaches to the support structure  50 , to maximize the area of the shaped molded base  20  and comfort of the user. The perimeter of the support structure  50  is generally similar to the perimeter of the shaped molded base  20 , and the framing member  40  containing the filter media  30 . 
         [0020]    In operation, the assembled mask  100  is used within a work environment. After use the mask  100  is disassembled by detaching the framing member  40  (holding the filter media  30 ) from the support structure  50 . The filter media  30  is removed from the framing member  40  and decontaminated or disposed of, as appropriate. The shaped molded base  20  is removed from the support structure  50 , allowing both the shaped molded base  20  and support structure  50  to be thoroughly decontaminated. Additionally, the framing member  40 , without the filter media  30  present, is decontaminated. Once decontaminated, the shaped molded base  20 , framing member  40  and support structure  50  are reassembled into the mask  100  with either the decontaminated filter media  30  or new filter media  30 . As such the invention provides a reuse and repeated disinfection durability, low breathing resistance as it includes a large area filter, improved protection and respirator fit. 
         [0021]    In an alternative embodiment, shown in  FIGS. 3 and 4 , the invention includes the shaped molded base  20  attached to the support structure  50  with the filter media  30  therebetween. The filter media  30  is combined to the user&#39;s side of the support structure  50 , and the shaped molded base  20  is then applied. In operation, the assembled mask  100  is used within a work environment. After use the mask  100  is disassembled by detaching the support structure  50  (holding the filter media  30 ) from the shaped molded base  20 . The filter media  30  is removed from the support structure  50  and decontaminated or disposed of, as appropriate. The shaped molded base  20 , being removed from the support structure  50 , allows both the shaped molded base  20  and support structure  50  to be thoroughly decontaminated. Once decontaminated, the shaped molded base  20  and support structure  50  are reassembled into the mask  100  with either the decontaminated filter media  30  or new filter media  30 . 
         [0022]    In an alternative embodiment, shown in  FIGS. 5-7 , the invention includes the shaped molded base  20  forming the support structure  50  with the filter media  30  inserted into a ridge  66  in the shaped molded base  20 /support structure  50  as seen in  FIG. 6 . The filter media  30 , once inserted, is held in place over the user&#39;s  200  nose and mouth with a strap  60 , shown in  FIG. 7 . In operation, the assembled mask  100  is used within a work environment. After use the mask  100  is disassembled by detaching the filter media  30  from the shaped molded base  20 /support structure  50 . Removed filter media  30  is decontaminated or disposed of, as appropriate. The shaped molded base  20 /support structure  50  is thoroughly decontaminated. Once decontaminated, the shaped molded base  20 /support structure  50  is reassembled into the mask  100  with the insertion of either the decontaminated filter media  30  or new filter media  30 . 
         [0023]    In the embodiment of the invention shown in  FIGS. 8 and 9 , the mask  100  includes filter media  30  that is preferably a replaceable and washable synthetic media having low breathing resistance filter pleating and media. The mask  100  includes an easy check and negative fit checking with hands as known by those skilled in the respirator arts. Additionally, a flexible and one size fits all head cradle  60  is readily cleaned, along with co-molded seal materials, smooth profile translucent oronasal  26 . The mask  100  includes a downward facing exhale valve  72  and light weight assembly. In operation, the assembled mask  100  is used within a work environment. After use the mask  100  is disassembled by detaching the filter media  30 ) from the shaped molded base  20 . The filter media  30  is removed and decontaminated or disposed of, as appropriate. The shaped molded base  20  is thoroughly decontaminated. Once decontaminated, the shaped molded base  20  is reassembled into the mask  100  with either the decontaminated filter media  30  or new filter media  30 . As such the invention provides the mask  100  with easy disinfection, reuse and repeated disinfection durability, while additionally having a smooth external profile, improved breathing resistance, improved gauging fit, improved visual field, improved facial pressure using co-molded seal materials, improved air exchange having downward facing exhalation, improved mass or physical wear features, and improved facial visualization. 
         [0024]    As seen in  FIGS. 10-13 , the invention includes the mask  100  with improved transmission reduction having single co-molded inhalation/exhalation filter  30 . Referring to  FIGS. 10-12 , the mask  100  includes replaceable and washable filter media  30  (with decontamination filter media  30  shown in  FIG. 13 ), that has a low breathing resistance filter media  30  installed into a low profile clear  26  silicone and/or TPE oronasal mask  100 . The shaped molded base  20  is permanently fixed within a support structure  50 , and the filter media  30  is placed, either permanently or temporarily, within the framing member  40 . 
         [0025]    In operation, the assembled mask  100  shown in to  FIGS. 10-12  is used within a work environment. After use the mask  100  is disassembled by detaching the framing member  40  (holding the filter media  30 ) from the support structure  50 . The filter media  30  may be removed from the framing member  40  if appropriate, or left intact within the framing member  40 , and decontaminated or disposed of, as appropriate. The shaped molded base  20  and support structure  50  are thoroughly decontaminated. Additionally, the framing member  40 , when the filter media  30  is removable, is decontaminated (shown in  FIG. 13 ). When the filter media  30  is not removable from the framing member  40 , it may be discarded for decontaminated when appropriate. Once decontaminated, the shaped molded base  20  and support structure  50  are reassembled into the mask  100  with either the decontaminated framing member  40  and filter media  30  or the decontaminated framing member  40  and new filter media  30 . As such the mask  100  includes reuse and repeated disinfection durability, and improvements in breathing resistance, fomite transmission with the use of filtered exhalation, gauging fit, visual field and facial visualization. 
         [0026]    As seen in  FIGS. 14-16 , the invention includes the mask  100  with improvements in adaptive fit having flexible and one size fits all head cradle  62  that is easily cleaned. The mask  100  includes a smooth profile oronasal with a shaped molded base  20  having a clear  28  front for good user recognition. The mask  100  has a downward facing exhale valve  72  and an easy check and negative fit checking with hands. Filter media  30  of the mask  100  is replaceable and washable. The mask  100  provides a light weight assembly. Flap valves  38  direct air over clear section for potential de-misting and in-mold wire for face formability. The mask  100  provides reuse and repeated disinfection durability and improvements in speech intelligibility, breathing resistance, visual field, protection and respirator fit or adaptive fit, and facial visualization. 
         [0027]    As seen in  FIG. 17 , the mask  100  includes improvements in fit accommodation and comfort having self adhesive seal  80  for difficult face forms. A protective sheet  82  may be peeled away from the adhesive seal  80  for application. Referring to  FIG. 18 , the mask  100  includes improvements in formable nasal strip for difficult nasal bridge issues. A collapsible support  84  within a nose section of the shaped molded base  20  is tightened with movement as shown in A-B, or expanded in the opposite direction of A-B. Referring to  FIG. 19 , the mask  100  includes improvements in gel based inserts  86  for seals and an additional formable part that allows user level fit issues and improved comfort and stability. Referring to  FIG. 20 , the mask  100  includes improvements in prolonged tolerability and improvements in facial pressure, and protection and respirator fit with the movement of an exoskeleton component  88  for fixing the placement of the shaped molded base  20 . Additionally, as seen in  FIGS. 21-24 , longitudinal and lateral flexibility of the shaped molded base  20  is shown with arrows A-B-C-D (shown in  FIGS. 21 and 22 ). Additionally, placement of the exhaust valve  72  and cover  74  with regard to the flexible shaped molded base  20  (shown in  FIGS. 23 and 24 ). 
         [0028]    As seen in  FIGS. 25-29 , the invention includes the mask  100  which may combine with PAPR  110  applications having lower physiological burdens, e.g., cooling effect of blower or the work of breathing with supplied air  112  (shown in  FIG. 25 ). Higher simulated workplace protection factor, such as an assigned Protection Factor (APF) of greater than 1000, swept back supply hose integration with lightweight and low profile for integration into health care worker personal protective ensembles  116  (shown in  FIG. 26 ), respirator facial pressure low, directed exhalation path incorporated into supply system to capture/direct from patient, single battery charge per shift, and smooth supply hose surface for disinfection between uses, rotates on ball joint  118  (shown in  FIG. 27 ) to move with wearer  200  (shown in  FIG. 28-29 ). The mask  100  provides improvements in comfort and prolonged tolerability, breathing resistance, visual field, and gauging fit. 
         [0029]    While certain embodiments of the disclosure have been described herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.