Abstract:
A reusable, washable breast shield for use by lactating women. The shield comprises a plurality of laminated silicone compound membranes; the outer laminate of a generally higher durometer than the inner laminate. The shield is placed against the breast of the user and may be held in place with an article of clothing or may be used without supporting clothing. The shield may also be incorporated into an article of clothing. The shield is thin and translucent and is relatively unnoticeable under clothing. The shield may be manufactured in decorative shapes and colors.

Description:
DESCRIPTION OF THE RELATED ART  
       [0001]     The related art is described in PCT Patent Application US2002/018976 which is hereby incorporated in its entirety by reference. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     The present invention relates to an apparatus for controlling leakage of lactating fluid in human females. Specifically, this invention is a thin, multi-layered silicone compound based membrane that conforms to the shape of the breast and provides pressure against the nipple.  
       SUMMARY OF THE INVENTION  
       [0003]     The present invention is a device for controlling breast milk leakage in lactating human females. It is known that pressure to the nipple will prevent leakage, and this device operates by maintaining pressure on the nipple. The device is self contained in that it does not need the support of an ancillary garment such as a bra to hold it in place or provide the pressure necessary to prevent let-down. The device comprises a thin, flexible and breathable, liquid impervious multi-layered shield that conforms to the shape of a human breast and is self adhesive. The device can be used in conjunction with a bra to assist in shaping the shield and providing additional pressure against the nipple of the user. However, the device is designed to maintain the necessary pressure on the nipple so that it does not require the use of ancillary clothing to perform it&#39;s function.  
         [0004]     The shield comprises a plurality of silicon rubber compound layers laminated together. In general the layers are formed and cured independently of each other. There is no cross linking or merging of the separate layers. Generally, the innermost layer is formed and cured first. Subsequent layers are added on top of the innermost layer and then cured. In a preferred embodiment, the outermost layer is a silicon compound with a higher durometer than the inner layer. The outer layer provides rigidity and shape to the shield, and supports the layer or layers of low durometer compound. The silicon compounds are sufficiently stretchy in any direction so that a moderate pressure forces the present invention to conform to the shape of a human breast. Silicon has been chosen as the preferred material for an application of the invention that a user would have on the skin for extended periods of time. Silicon compounds have an inherent breathability or gas permeability which prevents irritation of the skin of the wearer. The present invention may also be made of other materials such as polymer gels. Although polymer gels do not have the gas permeability of silicon compounds, polymer gels would be suitable for applications such as use in fashion where the invention would not be worn for long periods of time.  
         [0005]     The present invention has a low durometer silicon compound that forms the innermost layer next to the skin. Generally, a silicon compound known in the art as a silicon gel is used for the innermost surface. The inherent adhesive properties of a silicon gel provide a tacky inner surface. The tackiness of the gel allows it to remain in position without the use of adhesives or having to be attached to an ancillary garment such as a bra. The tackiness of the gel in conjunction with the moderate stiffness of the outer layer or layers provides a device that stays in place on the breast, and imparts pressure to the nipple, preventing let down.  
         [0006]     In a preferred embodiment, the present invention is pre-formed to present an elliptical surface in cross section, enabling it to conform to the shape of a human breast. In other embodiments it is anticipated that the invention could pre-formed as to more closely match the shape of a particular breast. The adhesive properties of the silicon gel material allow the shield to keep pressure on the depressed nipple and depress the nipple of the wearer. The pressure on the nipple is an effect inherent in the shield because of its shape and its adhesive qualities. The shield material is sufficiently translucent as to be almost invisible underneath clothing. The thickness of the shield is such that virtually no additional bulk is added to the breast profile of the wearer.  
         [0007]     Three embodiments of the invention are presented herein: All three designs have the same basic structure: A design comprising an outer frame laminated to an inner membrane wherein the inner membrane is a silicon rubber compound sufficiently low in durometer to allow adherence to the skin, the outer frame providing support and shape for the device. This basic structure and design is the subject of PCT Patent Application US2002/018976 which is hereby incorporated by reference. The first embodiment includes an inwardly protruding dimple situated to press against the human nipple. The second embodiment includes an area of stiffer silicon rubber situated in the inner shield to press against the human nipple. The third embodiment includes a thicker section of the outer shield situated to press against the human nipple, while maintaining continuity of the inner shield. The present invention is also directed toward a method of controlling leakage that utilizes the shield with a brasserie as described in PCT US2002/018976. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0008]      FIG. 1  is a cross sectional view of the invention having an inwardly protruding dimple.  
         [0009]      FIG. 2  is a cross sectional view of the invention and the mold used in production.  
         [0010]      FIG. 2   a  is a cross sectional view of a mold used to produce the invention.  
         [0011]      FIG. 3  is a cross sectional view of the invention shown in  FIG. 1  with a continuous inner layer over the dimple.  
         [0012]      FIG. 3  is a cross section view of the invention having a thicker section of the outer shield situated to press against the nipple with a continuous inner layer.  
         [0013]      FIG. 5  is a cross sectional view of the present invention having a tapered profile as it approaches the edge.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0014]     Referring to  FIG. 1 , an embodiment of the present invention, a breast shield, can be seen generally at  10 . In this embodiment, the shield  10  is a duel durometer laminated structure; the individual layers are manufactured from silicon rubber compounds of differing durometer and laminated together. In general, the shield  10  has an outer layer  11 ; a higher durometer silicone compound which provides a shell or frame for the shield  10 ; and an inner layer  12  of a lower durometer silicone compound or silicon gel, which provides the adhesive quality necessary for the shield to adhere to the human body. The shield  10  may take any shape that is suitable for conforming to the human breast. In one embodiment of the shield  10 , it is formed to have an elliptical curve to the outer layer, but other shapes or curves can be imposed upon the shield  10 .  
         [0015]     Referring again to  FIG. 1 , the shield  10  can be seen wherein it comprises a dimple  13  protruding through the inner layer  12 . The dimple  13  will generally be formed of a silicon compound with sufficient hardness or durometer to keep the human nipple depressed. In one embodiment of the shield  10 , the dimple  13  is made from a silicon compound with the same durometer as the outer layer  11 . The dimple  13  is located at the center of the shield  10 , but may be offset to accommodate various designs of the shield  10  and various breast shapes. The dimple  13  is appropriately sized both in diameter and height to depress the nipple of the wearer thereby preventing letdown and minimizing leakage.  
         [0016]     Referring to  FIG. 2 , and to  FIG. 2   a , the shield  10  and a mold  40  for manufacturing the shield  10  can be seen. In the manufacturing process using the mold  40 , the shield  10  is formed with a dimple  13 , created by a depression  13   a  in the mold  40 . Using the mold  40 , an uncured silicon compound is placed on the mold  40  in a quantity sufficient to form the inner layer  12 . The uncured silicon compound will become the inner layer  12 . The uncured silicon compound filling the depression  13   a  is displaced by suitable means. The inner layer  12  is then fully heat cured for the appropriate amount of time at the appropriate temperature. The cure times and temperatures for silicon compounds are well known in the art. After the inner layer  12  is cured, a second uncured silicon compound is placed on top of the inner layer  12  in sufficient quantity to form the outer layer  11 . The outer layer  11  is generally made from a silicon compound that is higher in durometer than the inner layer  12 . The shield  10  is then again heat cured at the appropriate temperature and for the appropriate time to fully cure the outer layer  11 . The silicon compound used to form the outer layer  11  fills in the depression  13   a  in the mold  40 , forming a dimple  13  made of the same silicon compound as the outer layer  11 . The same technique may be used to form other configurations of the invention, where the center section may be something other than an inwardly extending dimple. Various shapes of the mold  40  may be used to provide the desired shape for the shield  10 .  
         [0017]     In the above described method of manufacture, the silicon compounds are poured on top of the mold  40  shown in  FIG. 3 , and gravity spreads the silicon compounds out over the mold. The quantity and the viscosity or both of the silicon compounds used to form the inner layer  12  and the outer layer  11  are controlled so that the desired thickness of the layers results. In general, the inner layer  12  is much thinner than the outer layer  11 . In the method described above for manufacture of the present invention the relative thickness of the layers is proportionate the the viscosity of the uncured silicon compounds. The viscosity of the compounds or amount applied can be altered to give the desired thickness to the layers.  
         [0018]     The present invention, in all embodiments disclosed herein, may also be formed by compression molding. Using this method, the uncured silicon compound would be placed in one half of a mold, compressed by the second half of the mold, and heated to cure. Generally, the first compound in the mold would be the compound with the higher durometer number that would form the outer layer. The inner layer would generally be the silicon gel or compound of a lower durometer. The compound for the second layer would be placed in the mold over the already formed outer layer. The second half or top part of the mold would then compress the second compound. The second compound would then be heated to cure. The completed part would then be removed from the mold. This type of compression molding with heat curing is well known in the art.  
         [0019]     Referring to  FIG. 3 , a second embodiment of the shield may be seen at  20 , having an outer layer  21 , an inner layer  22 , and a inwardly extending dimple  23 . As in the previous embodiment, the inner layer  22  is of a low durometer silicon compound allowing the shield  20  to adhere to the skin of the wearer. The outer layer  21  is a silicon rubber compound with a durometer sufficiently high to give shape to the shield  20  and support the inner layer  22 . The shield  20  comprises an inwardly extending dimple  23 , centrally located in the shield  20  as in the first embodiment. The method of manufacture of the shield  20  is similar to that of the first embodiment. In this case however, the silicon compound comprising the inner layer  22  is not fully displaced before the silicon compound forming the outer layer  21  is poured onto the mold  40 . Since the silicon compound forming the inner layer  22  is not fully displaced, a thin skin of the uncured silicon compound covers the dimple formed when the harder silicon compound used for the outer layer  21  is placed over the cured inner layer  22 . This results in a finished product that has a continuous inner layer  22 . Displacement of the compound comprising the inner layer  22  may be done with any suitable mechanical means. Alternatively, the amount of the compound used to form the inner layer  22  may be less in the nipple area at the beginning of the curing process.  
         [0020]     Referring to  FIG. 4 , a third embodiment of the present invention may be seen at  30 . The structure of the shield  30  is similar to the previous embodiments, having an inner layer  32  of low durometer and an outer layer  31  of a higher durometer silicon compound. A centrally located reinforcement  33  is provided that provides additional pressure on the nipple of the wearer. In a preferred embodiment, the reinforcement  33  is a single layer of a silicon compound comprised of the same material as the outer layer  31 . This embodiment is manufactured in a manner similar to the methods discussed above.  
         [0021]     Referring to  FIG. 5 , a fourth embodiment of the shield may be seen at  50 . This embodiment of the invention is similar to all other embodiments with the difference that the thickness of the structure of the shield  50  narrows nears the edges. It has been found that making the shield  50  thinner as it approaches the edges does not detract from the ability of the shield  50  to adhere to the breast, nor does it detract from the ability of the shield  50  to put pressure on the nipple of the wearer to prevent let down. Narrowing the shield  50  makes it less noticeable underneath clothing and presents a more natural shape to an observer. The shield  50  may be manufactured as shown, or may be manufactured with a central reinforced area, or inwardly extending nipple, as in the other embodiments. The method of manufacture of the device as shown in  FIG. 5  is similar to the previously discussed methods.