Abstract:
A type of multilayered glove consisting of an inner layer, an outer layer, and pigments between the layers is disclosed. The layers can be made of the same or different materials to incorporate desired barrier properties such as oil or chemical resistance to a glove. The layers can also be made of the same or different colors. The glove can have the same physical barrier protection as wearing two gloves, but without the discomfort of wearing two gloves. The glove enhances barrier protection and allows users to detect any breach of the outer layer during the surgical procedure, which enables the user to execute corrective actions before cross contamination occurs.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
     U.S. PATENT DOCUMENTS  
       [0001]    
       
         
               
               
               
               
             
           
               
                   
                   
               
               
                   
                   
               
             
             
               
                   
                 4,935,260 
                 6/1990 
                 Shlenker 
               
               
                   
                 5,357,636 
                 10/1994  
                 Dresdner, Jr. et al. 
               
               
                   
                 5,411,034 
                 5/1995 
                 Beck et al. 
               
               
                   
                 5,679,399 
                 10/1997  
                 Shlenker et al. 
               
               
                   
                 5,911,848 
                 6/1999 
                 Haber et al. 
               
               
                   
                 5,965,276 
                 10/1999  
                 Shlenker et al. 
               
               
                   
                 6,145,130 
                 11/2000  
                 Haber et al. 
               
               
                   
                 6,618,861 
                 9/2003 
                 Saks et al. 
               
               
                   
                   
               
             
          
         
       
     
     
    
     OTHER PUBLICATIONS  
       [0002]     1. Glove Materials and Their Uses, F. B. Chen and R. Tuck, International Latex Conference at Akron, 2002.  
         [0003]     2. Macrolex® Fluorescent Red G, Bayer Product Information, Product: 72325, October, 1996.  
         [0004]     3. Macrolex® Green G Gran, Bayer Product Information, Product: 72612, March, 1999.  
         [0005]     4. Macrolex® Violet 3R Gran, Bayer Product Information, Product: 72404, October, 1996.  
         [0006]     5. Macrolex® Blue RR Gran, Bayer Product Information, Product: 72513, March, 1999.  
         [0007]     6. Standard Specification for Rubber Examination Gloves, ASTM D 3578, January, 2002.  
         [0008]     7. Standard Specification for Rubber Surgical Gloves, ASTM D 3577, January, 2002.  
       BACKGROUND OF THE INVENTION  
       [0009]     1. Field of the Invention  
         [0010]     The present invention discloses a type of multilayered glove that can have the same physical barrier protection as wearing two gloves, but without the discomfort of wearing two gloves. The invention has enhanced barrier protection on the glove and allows users to detect any breach of the outer layer during the surgical procedure, which enables the users to execute corrective actions before cross contamination occurs.  
         [0011]     2. Description of the Related Art  
         [0012]     Surgical and examination gloves are worn during a medical procedure to provide physical barriers between patients and health care professionals. However, 1˜3 percent of these gloves produced continue to contain hole defects and fail to serve their basic intended purpose of forming an impermeable physical barrier. Despite the significant effort that has been put forth by glove manufacturers, reducing hole defect to zero among gloves in mass production is still a distant dream. At the same time, diseases caused by infectious pathogens such as human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), and hepatitis B virus (HBV), accelerate with increased human contact. Such infections have created urgency for health care professionals (users) to take extra precautions. Donning two gloves is a recommended practice to reduce the chances of infectious pathogens from passing through glove hole defects in any high-risk procedure.  
         [0013]     Traditionally, users don two gloves of the same size or don the inner glove with one size smaller than the outer glove. In either case, the outer glove is not bound together with the inner glove. To don the outer glove over the inner glove, the outside surface of the inner glove is often treated with chlorine, polymer coating or FDA-approved absorbable powder. These processes produce a less tacky outer surface and permit the outer glove to don over the inner glove with ease. However, they create slippery issues for the outer glove by causing it to be more difficult to hold in place during procedures, and they also tend to cause sagging and easy-to-roll-down issues from repeated hand manipulation. Slippery, sagging and roll-down issues during procedures consequently interfere with surgical procedures.  
         [0014]     U.S. Pat. No. 5,357,636 discloses a glove comprising a thin inner layer, a thin outer layer and a compartment between the layers. The outer glove layer is slipped over the inner glove on the hand mold. After applying the antiseptic composition, the layers are sealed to create compartments. There is no contemplation of creating color contrast between the layers and adding pigments in the interface to amplify the breach of the outer layer. The process to make the glove disclosed in the prior art is tedious and labor intensive.  
         [0015]     U.S. Pat. No. 5,411,034 discloses a condom device consisting of two layers of material with a sandwiched layer that has an air sensitive, colorless agent between the two layers. In the event that the colorless agent is exposed to air, it changes color to alert the user that the integrity of the condom is compromised. The air sensitive color agent must be inserted between the first and third layers in an oxygen free environment, such as a chamber of carbon dioxide or nitrogen. There is no contemplation of preparing the condom in normal air environment.  
         [0016]     U.S. Pat. Nos. 5,911,848 and 6,145,130 disclose a visual indicator for a surgical glove to alert the user when the integrity of the glove is compromised. The glove includes outer and inner layers that have a space between the layers and a vacuum established within the space. There is no contemplation of creating color contrast and adding pigments in the interface to amplify the breach of the outer layer.  
         [0017]     U.S. Pat. No. 6,618,861 discloses a glove with two distinct portions, one portion clear and the other opaque. The glove allows wearers to see through the transparent wrist portion and tell time with the gloves on. There is no contemplation of creating color contrast between the layers and adding pigments in the interface to amplify the breach of the outer layer.  
         [0018]     U.S. Pat. Nos. 4,935,260, 5,679,399, and 5,965,276 describe a multilayered glove body comprising a latex outer layer, an intermediate layer containing lubricant, biocide, spermicide, or indicators, and a latex inner layer. The glove has discrete inner, intermediate, or outer layers. There is no contemplation of creating color contrast between the layers, adding pigments in the interface to amplify the breach of the outer layer, and linking all the layers together.  
       SUMMARY OF THE INVENTION  
       [0019]     The present invention is to provide a novel approach to produce a type of multilayered glove with enhanced barrier protection. The layers can be made of different materials to incorporate desired barrier properties such as oil or chemical resistance to a glove. Dipping a coagulant over the outer layer surface is directed toward eliminating hole defect. Making color differences in layers shows color contrast, and adding pigments between these layers creates a glaring visual indication to users when the outer layer is breached.  
         [0020]     The object of this invention is to make a type of multilayered glove, particularly a surgical or an examination glove, that can provide users with the same protection as wearing two gloves. At the same time, the invention will eliminate the uncomfortable feeling of wearing two gloves and provide enhanced optical effect to indicate the breach of the outer layer during the procedure. 
     
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0021]     So that the present invention may be understood more readily, the following description is given, merely by way of example with reference to the accompanying drawings, in which:  
         [0022]      FIG. 1  is a blow-up of a schematic view of the present invention after the outer layer of the glove is formed to shape.  
         [0023]      FIG. 2  is a blow-up of a schematic view of the present invention after the glove sandwich layer is dipped.  
         [0024]      FIG. 3  is a blow-up of a schematic view of the present invention after the glove inner layer is formed to shape.  
         [0025]      FIG. 4  is a blow-up of a schematic view of the present invention after the glove is stripped off.  
         [0026]      FIG. 5  is a blow-up of schematic view of the cross section marked  41 - 43  in  FIG. 4 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0027]     As shown in  FIGS. 4 and 5 , the present invention relates to a type of multilayered medical glove  4 , comprising an outer layer  11 , an inner layer  13 , and a sandwich layer  12  between the outer layer  11  and the inner layer  13 . The outer layer has the longest length than all the other layers. The sandwich layer is the shortest. The inner layer is longer than the sandwich layer but shorter than the outer layer.  
         [0028]     Surgical gloves and examination gloves have different thickness requirements. Surgical glove thickness of the foregoing outer layer  11  and inner layer  13  is preferably 0.05 mm or more respectively in compliance with the regulations of ASTM D 3577 to achieve a minimum glove thickness of 0.10 mm. The sandwich layer  12  is designed to cover most portions of the inner layer from the finger tip to the wrist. The thickness is less than 0.01 mm. Examination glove thickness of the foregoing outer layer  11  and inner layer  13  is preferably 0.04 mm or more respectively in compliance with the regulations of ASTM D 3578 to achieve a minimum glove thickness of 0.08 mm.  
         [0029]     The actual production process to form a multilayered glove includes a series of dipping: coagulant, latex (outer layer dipping), coagulant/pigments, and latex (inner layer dipping). A glove-forming former is immersed in coagulant, dried, and then immersed in latex to form an outer layer  11  of glove  4  ( FIG. 1 ). It is then immersed in a mixture of coagulant, fluorescent pigments or color pigments, and dried to form a sandwich layer  12  of glove  4  ( FIG. 2 ). Then the former is immersed in latex to form an inner layer  13  and establish the linkages between the inner layer and the outer layer of glove  4  ( FIG. 3 ). Leaching and vulcanization follow and then the glove is stripped off the former. After stripping the glove, the inner layer  13  on the outside as shown in  FIG. 3  stays inside, and the outer layer  11  on the inside as shown in  FIG. 3  becomes outside. The resulted glove is shown as glove  4  in  FIG. 4 . Since the sandwich layer dipping consists of coagulant and pigments, during the dipping of the inner layer, the coagulant is dissolved and used completely to gel the latex and form an inner layer and physical linkages between the outer layer and the inner layer. The linkages between the inner layer and the outer layer are very dense through the entire area of the inner layer.  FIG. 5  is a schematic view of the cross section of  41 - 43  from  FIG. 4 . The inner layer and the outer layer are linked together and become inseparable. The pigments are embedded inside the linkages between the inner layer and the outer layer. The pigments are bound together inside the latex matrix. The present invention is completely different from U.S. Pat. No. 5,965,276. The prior art emphasizes distinct layers. There is no proven linkage between the distinct inner, intermediate, and outer layers.  
         [0030]     The materials used to form a medical glove should be flexible and should be capable of being made into a thin sheet. The latexes commonly used for dipping surgical and examination gloves are natural rubber latex, nitrile rubber latex, acrylonitrile-butadiene latex, butyl rubber latex, ethylene-propylene latex, styrene butadiene rubber latex, polyisoprene latex, polychloroprene latex, silicone rubber latex, polybutadiene latex, polyurethane latex, etc. All these latexes can be used to make the inner layer and the outer layer of the glove mentioned in the present invention. The inner layer and the outer layer can be made from different latexes to achieve a synergetic effect from respective material characteristics. Polychloroprene is more resistant to oil and body fat, nitrile rubber is more resistance to chemicals, polyisoprene is more flexible and easy for hand manipulation, and butyl rubber is more impermeable to gas. The selection of latex in making the inner layer and the outer layer is strictly dependent on the preferences of the end user for a finished glove.  
         [0031]     Natural rubber latex, polychloroprene and polyisoprene are preferred materials for surgical gloves. Nitrile, polyurethane, thermoplastic rubbers, and vinyl gloves are dominant for examination gloves. Since the majority of glove dipping machines are equipped with one single dipping, the multilayered glove as disclosed in the present invention is a novel approach to have different layers of materials in a glove to enhance its performance.  
         [0032]     Coagulants used to dip gloves in the present invention should be multivalent cations: calcium chloride, calcium nitrate, aluminum chloride, aluminum sulfate, magnesium acetate, zinc nitrate, zinc chloride; organic and inorganic acids; and water-soluble organic solvents. Water and alcohol are common materials to dilute the coagulants. Surfactants are often added to smooth out the deposit of the coagulant.  
         [0033]     A pigment is a dry colorant, usually an insoluble powder. There are both natural and synthetic pigments, both organic and inorganic ones. Pigments work by selectively absorbing some parts of the visible spectrum whilst reflecting others. Pigments in the interface of the inner layer and the outer layer include color pigments, phosphorescent pigments or fluorescent pigments. The basic requirement for the pigments used in the present invention is that the pigments neither dissolve in water nor cause staining in leaching. Typical materials are: Macrolex® Fluorescent Red G, Macrolex® Fluorescent Yellow 10GN, Macrolex® Green G Gran, Macrolex® Violet 3R Gran, Macrolex® Blue RR Gran, chrome oxide green, iron oxide, antimony oxide, sodium silicofluoride, titanium dioxide, clay, zinc oxide, zinc carbonate, calcium carbonate, silica, mica, animal black, charcoal, lampblack, litharge, lead chromate, white lead, lead carbonate, Cadmium yellow, Ultramarine, ferric ferrocyanide, vermilion (mercuric sulfide), chlorophyll (green), xanthophyll (yellow), carotene, anthocyanin, etc.  
         [0034]     The glove  4  of the present invention can be comprised of completely different colors in the outer layer and the inner layer. The inner layer  13  is preferred to be very bright in color. The outer layer  11  is preferred to be dark in color to diffuse the light glaring in the operation room. The pigments sandwiched between the outer and the inner layers are preferred to be fluorescent in nature. Should breaching of the outer layer occur, the pigments between the layer will be exposed to the light source and reflect glaring to user&#39;s eyes. Also, the contrasting colors between the layers will prompt the user; therefore, the present invention is designed to warn the user of the breach to the outer layer.  
         [0035]     In a normal dipping, the outer layer is inadvertently produced with 1˜3% of hole defects. As described in  FIG. 2 , the coagulant is dipped over the outer layer and fills the voids in the outer layer. During the inner layer dipping, the latex will be destabilized by the coagulant and fills the voids. This process shall reduce the potential for hole defects in a finished glove.  
         [0036]     The process is also completely different from normal double dipping in the latex. Current common practice is to dip twice in sequence into the latex with no coagulant dipping between the two latex dips. In this case, the inner layer is significantly thinner than the outer layer. It could be as thin as one tenth of the thickness of the outer layer. This double dipping would reduce the hole defect compared to single latex dipping, but wouldn&#39;t be as effective as the process proposed in the present invention. The invention could produce an inner layer thicker than the outer layer. The efficiency of the thicker inner layer versus the normal double dipping to cover hole defect is obvious.  
         [0037]     The glove produced by the present invention could have the same thickness as one or two single layer gloves. Therefore the physical barrier from the present invention can be the same as wearing two gloves. The color contrast between the inner layer and the outer layer adds the feature to warn users when the outer layer is breached and the inner layer with a different color is exposed to the users. Pigments residing in the interface between the inner layer and the outer layer amplify the effects further. The outer layer and the inner layer can be made of different materials. The variety of compositing two different spectrum materials together in forming a glove enhances the resistance of the glove to oil or chemicals as demanded from users. Even though the discussion is focused on the glove, the present invention shall cover any device of which the intention is to form an impermeable film but not limited to the following: condoms, finger cots, sheaths, balloons, and tubes. The subject matter of the present invention has not been made obvious nor has it been suggested by the prior art.