Patent Document

RELATED APPLICATIONS 
       [0001]    This application claims the benefit of the filing date of U.S. patent application Ser. No. 13/590,377, filed Aug. 21, 2012, which is incorporated herein by reference in its entirety; U.S. patent application Ser. No. 14/483,155, filed Sep. 11, 2014, which is incorporated herein by reference in its entirety; and U.S. patent application Ser. No. 14/515,468, filed Oct. 15, 2014, which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention generally relates to disposable, biodegradable items and more specifically to disposable masks and tubing made from bioplastic resins. 
         [0003]    Environment and sustainability have become increasingly important factors in the design and specification of medical items and their safe disposal after use. Due to higher social responsibility and environmental concerns, corporations are being driven to produce more sustainable and environmentally safe products through government regulations, by institutional investors, and through consumer demand. 
         [0004]    Bioplastic resins include Polylactic acid (PLA), cellulose based PH, polybutylene adipate terephthalate (PBT) and polycaprolate (PCL), from corn and cellulose; green polyethylene, (GPE) and green polyethylene terephthalate (GPET also known as GPETE) from sugarcane; and Poly3-hydoxybutrate-3-hydroxyhexxanate (PHBH) from a fermentation process using glucose and propionic acid as the carbon source for Alcaligenes eutrophus. PHA polyhydroxyalkanoate) is derived by plant fermentation. Poly L lactide (PLLA) and poly D lactide (PDLA) are forms or homo-polymers of PLA. PLA, PDLA, and PLLA are especially compostable and can be degraded to make eco-friendly compost or humus. Bioplastic resins include PLA, PHA, PCL, PH, PBT, GPE, GPET, PHBH, PDLA, and PLLA. 
         [0005]    Bioplastic resins may have advantages over plastic and glass. Bioplastic has a smaller carbon footprint than plastic or glass, and also uses less energy to form an article like a biodegradable medical device. Bioplastics are biodegradable in an industrial composting unit. Bioplastic resins are from a plant source, and when plants are grown they absorb carbon dioxide, thus decreasing carbon dioxide in the atmosphere. These advantages, namely small carbon foot prints, absorbing carbon dioxide and using less energy, are up-stream advantages and the biodegradable and compostable advantages are downstream advantages. Plastic and glass disposable items have a higher carbon footprint than items made of other materials. Plastic and glass items enter the waste stream when they are disposed of, and may need incineration a process that causes release of hydrocarbons and toxins into the atmosphere and creates fly ash that ends up in landfills. 
         [0006]    Items made from bioplastic resin such as PLA, PHA, PH, PCL PCH are all biodegradable. Compostable items may be sterilized and then shredded and composted. PLA derived polymers namely PLLA and PDLA offer higher heat distortion properties can also be used. This will allows them to be diverted from land field. Some bio resins, such as GPE and GPET, may be made from plant sources even thought they might not be fully biodegradable or compostable. 
         [0007]    The use of face masks to apply inhalation agents (gases) is appropriate for anesthesia and in supporting ventilation for medical treatment of patients needing ventilation support or who suffer from sleep apnea. These same masks and tubing can also be used to treat patients with respiratory distress from respiratory illness like asthma and chronic obstructive pulmonary disease, having an exacerbation and need a breathing treatment, to deliver aerosolized inhalants to the lungs. For the administration of general anesthesia (GA) it is common to ventilate a patient with oxygen during the pre-intubation stage (induction) using a mask coupled to a suitable supply, using flexible breathing tubing. Sometimes it is necessary to continue to use mask ventilation during surgery when a patient cannot be intubated with an endotracheal tube, or during procedures of relatively brief duration. On other occasions, it may be desirable to provide supplemental anesthesia using various anesthesia inhalation agents in the form of a gas selected, for example, from the group consisting of desflurane, sevoflurane, isoflurane, or so nitrous oxide, or combinations thereof. Patients with sleep apnea may need positive ventilation support each night or during sleep, on a temporary basis. Oxygen or the inhalation gases selected by the anesthesiologist typically are applied to a patient using an inhalation face mask connected to a flexible tube or tubes which in turn is connected to a suitable gas supply. The fresh gas forces expired carbon dioxide (CO2) out of the mask to provide a breathing circuit. Generally, once a patient is ventilated and then intubated with an endotracheal tube or the like, the mask is set aside until the end of the procedure when the endotracheal tube is removed and the patient briefly is ventilated with the mask. 
         [0008]    It would be desirable to provide bioplastic or compostable devices such as medical face masks. 
       SUMMARY OF THE INVENTION 
       [0009]    In one aspect of the present invention, a disposable device includes a biodegradable resin selected from the group consisting of polylactic acid (PLA), cellulose based PH, polycaprolate (PCL), polybutyleneadipatetetephathalate (PBT), polyhydroxyalkanoate (PHA), green polyethylene (GPE), green polyethylene terephthalate (GPET), Poly3-hydoxybutrate-3-hydroxyhexxanate (PHBH), poly-D-lactide (PDLA), and poly-L-lactide (PLLA); a plasticizer intermixed with the resin to provide a generally homogenous bioplastic; and a medical mask that includes a shell substantially made of the bioplastic and a biodegradable cushion attached to an edge of the shell. 
         [0010]    In another aspect of the present invention, a medical mask includes a biodegradable resin selected from the group consisting of polylactic acid (PLA), cellulose based PH, polycaprolate (PCL), polybutyleneadipatetetephathalate (PBT), polyhydroxyalkanoate (PHA), green polyethylene (GPE), green polyethylene terephthalate (GPET), Poly3-hydoxybutrate-3-hydroxyhexxanate (PHBH), poly-D-lactide (PDLA), and poly-L-lactide (PLLA); a plasticizer intermixed with the resin to provide a generally homogenous bioplastic; a shell substantially made of the bioplastic, having an interior cavity and an edge, the shell having a nasal portion with a first width, a mouth portion with a second width greater than the first width, and a chin portion with a third width greater than the second width; an input port that provides gas to the interior cavity of the shell; an output port that expels gas from the interior cavity of the shell; and a biodegradable cushion attached to the edge of the shell. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a perspective view of an embodiment of a mask and tubing assembly according to the present invention; 
           [0012]      FIG. 2  is a view of an embodiment of a disposable anesthesia mask according to the present invention, in position on a patient&#39;s face; 
           [0013]      FIG. 3  is a top plan view of the mask of  FIG. 2 ; 
           [0014]      FIG. 3A  is a top plan view of the mask of  FIG. 2  depicting zones; 
           [0015]      FIG. 4  is a side elevation view of the face mask of  FIG. 2 ; 
           [0016]      FIG. 5  is a cross-sectional view of a mask with pneumatic cushion according to the present invention; 
           [0017]      FIG. 5A  is an enlarged view of a portion of the mask of  FIG. 5 ; 
           [0018]      FIG. 6  is an exploded view of the mask of  FIG. 5 ; 
           [0019]      FIG. 7  is a fragmentary perspective view of a portion of the mask of  FIG. 5 ; 
           [0020]      FIG. 8  is a bottom plan view of the mask of  FIG. 5 ; and 
           [0021]      FIG. 9  is a schematic diagram showing a mask and tubing assembly with a breathing circuit and a CO2 monitor according to the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0022]    The preferred embodiment and other embodiments, which can be used in industry and include the best mode now known of carrying out the invention, are hereby described in detail with reference to the drawings. Further embodiments, features and advantages will become apparent from the ensuing description, or may be learned without undue experimentation. The figures are not necessarily drawn to scale, except where otherwise indicated. The following description of embodiments, even if phrased in terms of “the invention” or what the embodiment “is,” is not to be taken in a limiting sense, but describes the manner and process of making and using the invention. The coverage of this patent will be described in the claims. The order in which steps are listed in the claims does not necessarily indicate that the steps must be performed in that order. 
         [0023]    Disposable plastic articles used in medical offices, hospitals and healthcare industries may be made from sustainable, environmentally friendly bioplastic resins and may be safely disposed without further environmental impact. Embodiments of disposable articles may be made from bioplastic resin, which include PLA (including PLLA and PDLA), PHA, PCH, PCL, PH, PBT, GPE, GPET, and PHBH. Embodiments of disposable articles may include a plasticizer intermixed with the resin to provide a generally homogenous bioplastic. Embodiments may include a disposable mask and tubing. 
         [0024]    An embodiment of the present invention may include a medical mask such as a disposable anesthesia face mask, ventilation mask, sleep apnea mask or respiratory mask (a “medical mask”). The mask may include a cup-like shell or receptacle member terminating at a peripheral edge with a circumferential flange, and an annular donut-shaped hollow cushion or seal member affixed or otherwise permanently attached to the flange. The seal member may be inflatable. 
         [0025]    The shell or shell member may preferably be transparent to permit viewing therethrough. The shell member may be shaped suitably to define a nose reception portion, a mouth reception portion, and a chin reception portion. The shell member may include a first passageway extending from the shell member from in a direction opposite to the flange for coupling to a breathing circuit, and a second passageway that may extend in a direction opposite to the flange for output. Embodiments of an anesthesia or ventilation mask may be connect the output passageway to a flexible tube which, in turn, is adapted to be connected to a CO2 monitoring machine or capnograph. 
         [0026]    The face mask nasal portion may have a first width, the face mask mouth portion may have a second width greater than the first width, and the face mask chin portion may have a third width greater than the second width, giving the face mask shell a characteristic pear-shaped configuration. The nasal, mouth and chin portions may be continuous and form the cup-like extent of the shell or receptacle component. 
         [0027]    Embodiments may include a headband. The mask may have lateral projections on the flange or two sides of the shell for accommodating a suitable elastic head strap that may adjustably be coupled to the projections to thereby retaining the strap to the mask. The tension in the elastic headband when attached may provide a stable suspension system securely maintaining the mask assembly in place before or during surgery and enabling anesthesia personnel to attend to other tasks using both hands free. This also applies if the mask and band are used for sleep apnea or during a breathing treatment. 
         [0028]    Embodiments of a mask may be adapted to be fitted to the patient&#39;s face with the chin portion of the face being received in a cavity near the bottom of the mask. T-shaped posts that hold the headband may be located on the flange member upwardly near the nose portion of the mask assembly. The lateral projections hold the strap to form a loop that holds the mask in place on the user&#39;s face. 
         [0029]    An embodiment of a face mask may be made from bio resins for environmental advantages, using a bioresin such as PLA (including PLLA and PDLA), PHA, PBT, PH, PCH, PH, GPE , GPET, or PHBH. A plasticizer intermixed with the resin to provide a generally homogenous bioplastic, and the device may be substantially made from the bioplastic. These polymers offer environmental advantages and can be in any combinations. For example, the mask can be made from PLA and the cushion can be from PCL GPE, or GPET. 
         [0030]    Embodiments of masks may include an anesthesia mask, ventilation mask, sleep apnea mask, or a respiratory therapy mask. Embodiments of masks may be disposable, made of transparent material, may have a strap or straps to hold the mask in place when desired. Embodiments may be of sufficient size to cover the patient&#39;s nose, mouth and chin. Embodiments may have a pneumatic sealing cushion, to promote patient comfort and to prevent leakage of air or gases once the mask is applied. Embodiments may include gas input ports or output ports. 
         [0031]    As depicted in  FIG. 1 , an embodiment of a mask assembly  10  may include facemask  11  and tubing  12 . Facemask  11 , tubing  12 , or both may be made substantially of biodegradable resin mixed with a plasticizer, and may provide compostable material. 
         [0032]    As depicted in  FIG. 2 , embodiments of face mask  11  may include a shell member  13  or other receptacle, and a cushion  14  that may be a pliable, or may be a flexible, pneumatically inflatable cushion. Embodiments of a shell member  13  may preferably be made of one-piece or unitary construction fabricated from bio resin. Shell member  13  may be transparent so that when face mask  11  is worn on the face of a patient, the portion of the patient&#39;s face covered or substantially worn by the mask is clearly visible at all times. Shell member  13  may have a first cylindrical hollow inlet member or port  15  that forms an input passageway  21 , and a second cylindrical hollow outlet member or port  16  that forms an output passageway  22 . Ports  15  and  16  may extend out from a top wall portion  17  that is opposite the user. In an embodiment, the location of ports  15  and  16  on the top wall portion  17  of shell member  13  may be such that when the mask  11  is suitably fitted to a patient&#39;s face, passageway  21  of inlet port  15  is located near the patient&#39;s nasal region, and passageway  22  of outlet port  16  is located near the mouth region of the patient. An input receptacle  20  may be adapted to attach tubes or tubing to the input port  15 . 
         [0033]    Embodiments of a mask  11  may be attached to the head of the patient using an elastic headband or strap member  39  selectively attachable to the mask shell  13  to adjust for different sizes. Strap member  39  may attached to mask  11  by way of a pair of protruding integral T-shaped posts  34 ,  35  extending from sides of the shell  13 . Embodiments of a strap member  39  may preferably include a series of spaced holes  37  which are adapted to engage with the T-shaped posts  34 ,  35 . 
         [0034]    As depicted in the embodiment of  FIG. 3 , the outer or top wall portion of shell member  13  may extend slopingly into a continuous sidewall portion  18  along a peripheral extent of the shell member. Embodiments may include a pair of protruding integral T-shaped posts  34 ,  35  extending from sides of the shell  13 . The T-shaped posts  34 ,  35  may fit into spaced holes in a headband or strap to hold the mask to the patient. Embodiments may include a gas input port  15 , and an output port  16 . 
         [0035]    As depicted in the embodiment of  FIG. 3A , a mask or shell may appear to be pear-shaped with a first transverse width or extent  28  at the front of the mask (top of the drawing) defining the nose reception region of the shell, a second or intermediate transverse width or extent  29  defining the mouth reception region of the shell, and a third transverse width or extent  30  at the rear defining the chin or jaw reception region of the shell, with the third extent  30  being greater than the intermediate extent  29  and the intermediate extent  29  being greater than the first transverse extent  28 . 
         [0036]    As depicted in the embodiment of  FIG. 4 , an outer or top wall portion  17  and continuous sidewall  18  of shell member  13  are concave defining a generally pear-shaped, cup-like receptacle having an interior cavity  19 . Pear-shaped interior cavity  19  may be suitably shaped and sized to receive the nose portion, mouth portion and chin portion of a patient&#39;s face when the face mask assembly is sealingly applied to that patient&#39;s face. Embodiments may include a continuous sidewall portion  18  of shell member  13  which extends along the peripheral extent of the shell and terminates in a cushion  14 . 
         [0037]    As depicted in the embodiment of  FIG. 5 , a hollow inlet member or port  15  defines a first passageway  21  opening into interior cavity  19  and a second outlet member or port  16  defines a second passageway  22  opening into interior cavity  19 . Port  15  may have an input receptacle  20 . Embodiments may include a continuous sidewall portion or top wall portion  17  of shell member  13  which extends along the entire peripheral extent of the shell member  13  and terminates in a radially outwardly extending flange member  31 . Embodiments may include a cushion inflation port  40  that allows a user to add or remove air from a pneumatic sealing cushion that attaches to the flange member  31 . 
         [0038]      FIG. 5A  is a close-up of the circled area of  FIG. 5 . As depicted in the embodiment of  FIG. 5A , the bottom of flange member  31  may be substantially flat so as to define a shell mounting surface  32 . A pneumatic sealing cushion  36  may have a flat top that defines a pneumatic sealing cushion mounting surface  33 . This allows embodiments to be made fabricated as by injection molding. A pneumatic sealing cushion  36  or cushion member preferably is formed with a somewhat thickened top wall portion defining a mounting foot, pad, or cushion mounting surface  33  which may be securely adhered to the mounting surface  32  of flange member  31  with an adhesive applied along the cushion mounting surface  33  surface of pad, the shell mounting surface  32 , or both. 
         [0039]    As depicted in the embodiment of  FIG. 6 , a shell member  13  with a flat lower surface may provide a shell mounting surface  32 , and a pneumatic sealing cushion  36  with a flat upper surface may provide a cushion mounting surface  33  or other flexible annular sealing cushion component. The shell member  13  may have a cushion inflation port  40 , that aligns with a cushion inflation conduit  41  in the pneumatic sealing cushion  36 . The two parts mate and are fixed together, possibly with adhesive, so that air in the cushion  36  can be adjusted with the inflation port. 
         [0040]    As depicted in the embodiment of  FIG. 7 , a flange member  31  on the shell has a lower shell mounting surface  32 , which corresponds to and mates with a pneumatic sealing cushion  36  that has an upper cushion mounting surface  33 . 
         [0041]    As depicted in the embodiment of  FIG. 8 , a pneumatic sealing cushion  36  includes a donut-shaped hollow annular member made of pliable flexible material, and can be inflatable. The pneumatic cushion member in  FIG. 8  is shown in broken lines to avoid obfuscation. The sealing cushion  36  may be attached to a flange member  31 , and may enable the shell member to be comfortably held to the face of the patient using an elastic headband or strap member selectively attachable to the mask shell via a pair of protruding  34 ,  35  integral T-shaped posts, 
         [0042]    As depicted in the embodiment of  FIG. 9 , a mask assembly may have a mask made substantially of biodegradable resin or compostable material, attached to a breathing circuit and to a capnograph (CO2 monitor) through a flexible tube. In an embodiment, input receptacle  20  may be suitably sized to receive in slide so as to provide a snug, sealing engagement with a tube nipple  38  at the end of a flexible breathing tube  23 . Flexible breathing tube  23  may attach to a breathing circuit  24  such that anesthesia gas or gases are adapted to pass from a source (not shown), through a branch of the breathing circuit  24 , then through input receptacle  20 , and into the interior cavity  19  of the facemask. The breathing circuit can be connected to a ventilator for ventilation support. For sleep, the breathing circuit may be connected to an apnea prevention machine or continuous positive airway pressure (CPAP) machine. The outside diameter of output port  16  may be suitably sized to snugly and sealingly fit on one end of a flexible CO2 tube  26  and the other end of the flexible CO2 tube  26  may be adapted connect to a conventional CO2 monitoring device  25  or capnograph. Embodiments of an outlet port  16  that provide CO2 may include a suitable screw-on type cap or closure member (not shown) when not being used.

Technology Category: a