Abstract:
The present invention is a covering for the nipple/areola area of the human breast. In one embodiment, the invention is a cover for the nipple and areola. In a second embodiment, the covering is a nipple prosthesis including an artificial nipple and areola. The covering is preferably fabricated from silicone having self adhering properties that enable the covering to be worn at the end of the breast without additional adhesive. As a nipple cover, the covering includes a concavity placed over the nipple to accommodate the nipple when the covering is worn. As a nipple prosthesis, in one embodiment, the covering includes a pocket or bubble positioned directly under the nipple portion of the prosthesis. After placing the prosthesis on the breast, the air in the pocket and or concavity is released to form a vacuum to allow the prosthesis to be held on the breast without the use of additional adhesive material.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates generally to the field of prostheses, more specifically to the field of breast prostheses, and still more specifically to the field of breast covers and nipple prostheses. 
       BACKGROUND OF THE INVENTION 
       [0002]    After breast surgery, such as partial or complete mastectomies, women are often faced with additional surgeries in the form of reconstructive procedures. Included in reconstructive surgery is the use of breast prostheses that attempt to impart the natural look that provides assurance to women as they proceed through a surgical program. 
         [0003]    Problems exist with breast prostheses found in the prior art in that they often give an unnatural appearance to the bust line. In addition, prostheses are often made from materials that are stiff or hard and uncomfortable to wear for prolonged periods of time. Moreover, in the case of temporary, reusable prostheses, adhesives, glues, and/or tapes are often required to be reapplied to a reusable prosthesis which can lead to skin irritation and a lack of comfort. 
         [0004]    U.S. Pat. No. 5,171,321 to Davis discloses a nipple prosthesis fabricated from polyvinylchloride, silicone, or other resilient materials and molded into the shape of a human nipple and areola. The &#39;321 patent discloses the need for an adhesive on the back (contact) surface of the prosthesis. U.S. Patent Application Publication No. 2004/0010311 to Reynolds, et al. discloses an integrated nipple and areola prosthesis used in conjunction with a breast prosthesis. The prosthesis disclosed in the &#39;311 publication comprises zones of cured gel that are built onto one another to form the shape of the nipple and surrounding areola. It is designed to become a permanent component of an external breast prosthesis. 
         [0005]    U.S. Patent Application Publication No. 2004/0143325 to Holmes discloses an artificial nipple prosthetic device attachable to a human breast that has undergone breast reconstruction surgery. The prosthesis has a concave shape with a layer of water—resistant adhesive used to hold the prosthesis on to the breast. U.S. Pat. No. 6,497,609 to Cobbs discloses a device placed between a breast and an article of clothing that covers the breast. The device is designed to enhance the appearance of the breast and nipple. Although the &#39;609 device does not utilize an adhesive, it explicitly requires that the clothing conform closely to the shape of the breast in order to hold the device in position. In addition, in contrast to other prosthetic devices, the &#39;609 device is sized to cover a major portion of the breast, not just the nipple-areola area. 
         [0006]    A related problem exists in which a woman may want to cover one or both breasts without revealing the outline of a nipple. Even though the user of such a pad or cover may want to conceal the outline of the nipple, the same requirements regarding materials and comfort remain. Typical of the prior art is U.S. Pat. No. 6,200,195 to Furuno, et al. which discloses an adhesive pad that can be molded to the shape of a particular body part such as an elbow, knee, or breast. Although it may be molded to cover a breast and conceal the nipple outline, it relies on an adhesive to hold the pad in place on the particular body part, including the breast. Therefore, it makes no disclosure or suggestion of a device or method of wearing a breast cover or pad without using an adhesive that may irritate the skin. 
         [0007]    Therefore, there exists a need in the field for a temporary nipple/areola prosthesis that does not require an adhesive, provides a look and feel that is similar to the appearance and feel of a natural human breast, is comfortable to wear for prolonged periods, and can be worn with any type of clothing. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention broadly comprises a temporary, reusable covering for a human breast that includes a device ranging in diameter or width from about 3 to about 9 cm. and having an outer surface and an inner surface with the device gradually increasing in thickness or height from less than 1 mm at the edge of the device to about 2 mm-1 cm toward the center of the device. The inner surface forms a generally concave arch or concavity extending from or close to the edge. The covering is fabricated from a form of silicone possessing self-adhering or sticky qualities that enables the cover to adhere to a forward end of a human breast. In an alternate embodiment, the inner surface may incorporate a layer of washable, reusable, sticky or adhesive silicone. The covering is temporary in that it is removable and may be used more than one time. In another embodiment, the present invention also includes a protrusion in the form of a human breast nipple formed from the outer surface and is configured so that the protrusion extends up to about 2.0 cm. as measured vertically from the edge of the prosthesis and is up to about 1.5 cm in diameter. In a more preferred embodiment of the invention, the covering also includes a suction bubble formed from the inner surface under the protrusion. 
         [0009]    An object of the invention is to provide a temporary nipple cover that is both comfortable and reusable. 
         [0010]    A second object of the invention is to supply a temporary nipple cover that adheres to the breast without the use of adhesives. 
         [0011]    A third object of the invention is to present a temporary nipple cover that is similar in appearance and feel to a natural human breast. 
         [0012]    Another object of the invention is to provide a temporary nipple prosthesis that is both comfortable and reusable. 
         [0013]    An additional object of the invention is to supply a temporary nipple prosthesis that adheres to the breast without the use of adhesives. 
         [0014]    A further object of the invention is to present a temporary nipple prosthesis that is similar in appearance and feel to the nipple of a natural human breast. 
         [0015]    An added object of the invention is to provide a removable breast covering or areola/nipple covering capable of decoration and receiving ornamentation. 
     
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0016]    The nature and mode of the operation of the present invention will now be more fully described in the following detailed description of the invention taken with the accompanying drawing Figures, in which: 
           [0017]      FIG. 1  is a side perspective view of a pair of breasts for which use of the breast cover and nipple prosthesis of the present invention is appropriate; 
           [0018]      FIG. 2  is a top view of the nipple prosthesis of the present invention; 
           [0019]      FIG. 3  is a side view of the nipple prosthesis of the present invention; 
           [0020]      FIG. 4   a  is a cross section of a small size nipple prosthesis of the present invention taken generally along line  4 - 4  in  FIG. 2 ; 
           [0021]      FIG. 4   b  is a cross section of a medium size nipple prosthesis of the present invention taken generally along line  4 - 4  in  FIG. 2 ; 
           [0022]      FIG. 4   c  is a cross section of a large size nipple prosthesis of the present invention taken generally along line  4 - 4  in  FIG. 2 ; 
           [0023]      FIG. 5  is a bottom view of the nipple prosthesis of the present invention; 
           [0024]      FIG. 6  depicts the side perspective view of  FIG. 1  showing the placement of the nipple prosthesis on the left and right breasts; 
           [0025]      FIG. 7  shows the nipple prosthesis in place on the left breast with the nipple and areola of the prosthesis in a natural position when compared to the natural nipple and areola on the right breast; 
           [0026]      FIG. 8  depicts the same side perspective view of  FIG. 1  except both the right breast and left breast possess natural nipples and areolas; 
           [0027]      FIG. 9  is a top view of the nipple cover of the present invention; 
           [0028]      FIG. 10  is a side view of the nipple cover of the present invention; 
           [0029]      FIG. 11   a  is a cross section of a small size of the nipple cover of the present invention taken generally along line  11 - 11  of  FIG. 9 ; 
           [0030]      FIG. 11   b  is a cross section of a medium size of the nipple cover of the present invention taken generally along line  11 - 11  of  FIG. 9 ; 
           [0031]      FIG. 11   c  is a cross section of a large size of the nipple cover of the present invention taken generally along line  11 - 11  of  FIG. 9 ; 
           [0032]      FIG. 12  is a bottom view of the nipple cover of the present invention; 
           [0033]      FIG. 13  depicts the side perspective view seen in  FIG. 8  in which the nipple cover is applied to the right breast and is aligned for placement over the nipple and areola of the left breast; 
           [0034]      FIG. 14  shows each of the nipple/areolar regions covered by the nipple cover of the present invention; 
           [0035]      FIG. 15  is a top perspective view of an alternate embodiment of the nipple prosthesis of the present invention in which the top surface includes a “rough surface” comprising pimples, ridges, grooves and/or other features commonly found on the surface of a natural breast, areola, and nipple; 
           [0036]      FIG. 16   a  is a cross section of an alternate embodiment of a small size nipple prosthesis of the present invention taken generally along line  16 - 16  in  FIG. 15 ; 
           [0037]      FIG. 16   b  is a cross section of an alternate embodiment of a medium size nipple prosthesis of the present invention taken generally along line  16 - 16  in  FIG. 15 ; 
           [0038]      FIG. 16   c  is a cross section of an alternate embodiment of a large size nipple prosthesis of the present invention taken generally along line  16 - 16  in  FIG. 15 ; 
           [0039]      FIG. 17  is a top perspective view of an alternate embodiment of the breast cover of the present invention in which the top surface includes a “rough surface” comprising pimples, ridges, grooves and other features commonly found on the surface of a natural human breast; 
           [0040]      FIG. 18   a  is a cross section of an alternate embodiment of a small size of the nipple cover of the present invention taken generally along line  18 - 18  of  FIG. 17 ; 
           [0041]      FIG. 18   b  is a cross section of an alternate embodiment of a medium size of the nipple cover of the present invention taken generally along line  18 - 18  of  FIG. 1.7 ; 
           [0042]      FIG. 18   c  is a cross section of an alternate embodiment of a large size of the nipple cover of the present invention taken generally along line  18 - 18  of  FIG. 17 ; and; 
           [0043]      FIG. 19  is a front view of two nipple prostheses of the present invention including embodiments of ornamentation and designs applied or attached to the prostheses. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0044]    At the outset, it should be appreciated that like drawing numbers on different drawing views identify identical structural elements of the invention. 
         [0045]    While the present invention is described with respect to what is presently considered to be the preferred embodiments, it is understood that the invention is not limited to the disclosed embodiments. The present invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. 
         [0046]    Adverting to the drawings,  FIG. 1  is a side perspective view of a pair of breasts for which use of the breast cover and nipple prosthesis of the present invention is appropriate. Right breast R includes a nipple N and areola A while left breast L lacks a nipple and areola. 
         [0047]      FIG. 2  is a top view of the nipple prosthesis  10  (“prosthesis 10”) of the present invention. Outer surface  16  of prosthesis  10  includes prosthetic nipple  14  (“nipple 14”) and areolar region  12  (“areola 12”) which surrounds nipple  14 . Nipple  14  is in the form of a protrusion and is preferably located in the center of prosthesis  10  although it may be located in an off-center position if desired for an individual patient or particularly desired visual effect. Prosthesis  10  can range in size (width or diameter) from about 3-9 cm as measured by the gap between lines a and a′. Prosthesis  10  can be made from any number of plastics or fabrics designed to enable it to be washable and reusable. In a preferred embodiment, prosthesis  10  is fabricated from silicone in the form of liquid silicone rubber (LSR/LIM) or heat cured rubber (HCR/HCE) as this material provides both an appearance and feel nearly indistinguishable from the look and feel of a natural nipple and areola. Specific types of silicone for molding include, but are not limited to GE LIM 6010, GE CLS 2020 CLR, GE LIM 6030, GE LIM 6040, GE LIM 6050-D2, Wacker 3003/20, Wacker 3003/30, Shin Etsu KE1950-10 and Shin Etsu X-34-1784 and their equivalents. Although prosthesis  10  is shown as having a circular shape, it will be recognized by those having skill in the art that it may be formed into other shapes to fit a particular need including noncircular, nonsymmetrical, or irregular shapes. By irregular is meant a shape that is uneven. 
         [0048]      FIG. 3  is a side view of prosthesis  10 . Nipple  14  is seen as a protrusion formed from outer surface  16  and possessing sloping sides. In an alternate embodiment, nipple  14  may be cylindrically shaped with the cylindrical wall somewhat more perpendicular to outer surface  16 . In one embodiment, nipple  14  may be up to approximately 2 cm in length as measured by the gap between arrows b and b′ in  FIG. 3  and up to about 1.5 cm in diameter. In alternate embodiments, nipple  14  may be of any desired length as described below. Edge  18  of prosthesis  10  is a micro edge preferably less than 1 mm in thickness around the perimeter of prosthesis  10 . Because edge  18  is a thin micro edge, it is difficult to exactly ascertain where the supporting breast and edge  18  meet when prosthesis  10  is applied to a breast. In a more preferred embodiment, edge  18  measures about 0.38 mm in thickness. This advantage provides a more natural look and feel to prosthesis  10 , especially at edge  18  where it intersects with the natural breast giving prosthesis  10  the appearance and feel of a natural nipple and areola. 
         [0049]      FIGS. 4   a - c  are cross sectional views of different sizes, small, medium, and large, respectively, of prosthesis  10  taken generally along line  4 - 4  in  FIG. 2 . In all three sizes, inner surface  20  is seen extending from the perimeter at edge  18  toward the center to form to center concavity  22 . Concavity  22  is in the general shape of a concave arch formed from inner surface  20 . Surface  20   a  is a continuation of inner surface  20  and forms the bottom surface of nipple  14  and the upper wall of concavity  22 . In one embodiment, adhesive layer  20   b  (described below) is applied to inner surface  20  and surface  20   a.  The center of concavity  22  is preferably positioned over the position on the breast where the natural nipple would be. It will be recognized that concavity  22  of prosthesis  10  may also be paced over the natural nipple N of a human breast. This is advantageous if the user desires to maintain a similar appearance for both breasts. In the embodiment shown, passage  24  is positioned between concavity  22  and suction bubble  26  (“bubble 26”). In one embodiment, passage  24  ranges from about 1.7 to 3.2 mm in width and bubble  26  has a spherical diameter ranging from about 3-9 mm. The total height or thickness of prosthesis  10  ranges from 10-17 mm as measured from the vertical height between edge  18  and the peak of nipple  14  as represented by the gap between lines b and b′ in  FIG. 3 , while the diameter ranges from about 40 to about 70 mm.  FIGS. 4   a - c  all depict the preferred embodiment in which prosthesis  10  gradually increases in thickness from the perimeter defined by edge  18  to nipple  14  (preferably located at the center of prosthesis  10 ). The diameter of the small, medium, and large prosthesis  10  is about 40 mm, 60 mm and 80 mm, respectively. In all three sizes, edge  18  measures about 0.38 mm in thickness. Persons of skill in the art will recognize that although three specific sizes of prosthesis  10  are shown and described, other embodiments of prosthesis  10  may have different diameters, heights, thicknesses, and shapes incorporated in the components of prosthesis  10 .  FIGS. 4   a - c  also show optional smooth layer  16   a  applied to outer surface  16 . Both layers  16   a  and  20   b  are shown in exaggerated form for clarity. Layer  16   a  is normally very thin to achieve the desired natural look and feel.  FIG. 5  is a bottom view of prosthesis  10 . Passage  24  is preferably positioned in the center of concavity  22 . 
         [0050]      FIG. 6  depicts the side perspective view of  FIG. 1  showing the placement of prosthesis  10  on left breast L and right breast R. It can be seen that a user may optionally place prosthesis  10  over a natural nipple N on right breast R as well as a breast without a nipple to attain the same or nearly the same look for both breasts L and R.  FIG. 7  shows prosthesis  10  in place on left breast L with nipple  14  and areola  12  in a natural position when compared to nipple N and areola A on right breast R. The silicone material used to fabricate prosthesis  10  can possess a self adhering quality that enables prosthesis  10  to attach to left breast L without the use of additional, conventional fasteners such as tapes or glue. In the embodiment shown in  FIGS. 4   a - c,  bubble  26  and/or concavity  22 , which is filled with air when placed on breast L, may be “burped” similar to a plastic container top, such as a TUPPERWARE® container, to remove a quantity of air from bubble  26  and/or concavity  22  thereby creating a vacuum. This vacuum acts to hold prosthesis  10  in place without additional adhesive agents. In a preferred embodiment, a sticky silicone layer, such as Wacker SILGEL 612 OR GE 1408-02-18 seen as layer  20   b  in  FIGS. 4   a - c,  may be applied to inner surface  20 , to provide additional clinging capacity to hold prosthesis  10  in place, if desired. In an even more preferred embodiment, smooth layer  16   a  may be applied to outer surface  16  using a smooth silicone material such as GE Top Coat to provide a natural feel to outer surface  16  of prosthesis  10  whether or not sticky silicone layer  20   b  is applied to inner surfaces  20  and  20   a.    
         [0051]    In a second embodiment, the present invention is in the form of a pad or nipple cover  30  (“cover  30 ”).  FIG. 8  depicts the same side perspective view of  FIG. 1  except both right breast R and left breast L possess natural nipple N and areola A. Cover  30  may be used, for example, to provide padding for the nipple area of the natural breast, to present a desired visual appearance in which nipple N is not distinctly visible, and/or to cover breast, nipple, and/or areola scarring after surgery. It should be recognized that these examples are not to be considered to apply limits to the uses for cover  30 . For example, cover  30  may be used if nipple N is not present. Persons of skill in the art will recognize that cover  30  may be fabricated from the same or equivalent materials as those used to produce prosthesis  10 . In a preferred embodiment, cover  30  may include the application of the sticky silicones described above to inner surface  38  forming a layered composite, similar to that discussed above with prosthesis  10 , to provide additional holding capacity to cover  30  when it is placed on a breast. In addition, a smooth silicone, such as GE Top Coat, may be applied to outer surface  34  of cover  30  whether or not adhesives are applied to inner surface  38 . Consequently, cover  30  may possess the same self adhering qualities as prosthesis  10 . 
         [0052]      FIG. 9  is a top view of cover  30  with outer surface  34  showing micro edge  32  bounding the perimeter of cover  30 . Similar to edge  18  of prosthesis  10 , edge  32  is less than 1 mm in thickness. In a preferred embodiment, edge  32  is about 0.38 mm in width or thickness Cover  30  can range in diameter or width from 30-90 mm (3-9 cm) as measured by the gap between lines c and c′. In one embodiment, cover  30  may be 8-9 cm in diameter or width. Center  36  of cover  30  is also shown in  FIG. 9 . Although cover  30  is shown as having a circular shape, it will be recognized by those having skill in the art that it may be formed into other shapes to fit a particular need including noncircular, nonsymmetrical, or irregular shapes. By noncircular is meant a shape that does not form a circle at its edge or perimeter. Examples of a noncircular shape include but are not limited to, oblongs and rectangles.  FIG. 10  is a side view of cover  30 . 
         [0053]      FIGS. 11   a - c  are cross sectional views of different sizes of cover  30  taken generally along line  11 - 11  of  FIG. 9 . Cover  30  increases in height from less than 1 mm at edge  32  to approximately 2 mm in the center as measured by the gap between lines d and d′ in  FIG. 10 .  FIGS. 11   a - c  depict small, medium, and large sizes, respectively, of cover  30 . In all three sizes, inner surface  38  is seen extending from edge  32  to center concavity  39 . Surface  38   a  is a continuation of inner surface  38  and forms the upper wall of concavity  39 . In the embodiments shown, surface  38   a  starts to extend from inner surface  38  at or near edge  32 . Adhesive layer  38   b  is shown applied to inner surfaces  38  and  38   a.  Through the three sizes, the preferred diameter of cover  30  ranges from about 30 to about 90 mm. In an alternate embodiment, the height of cover  30  ranges from about 10 to about 17 mm measured as the vertical height from edge  32  to the highest point of cover  30  (the gap between lines d and d′ in  FIG. 10 ). In the embodiments shown in  FIGS. 11   a - c,  the highest point is generally in the center  36  of cover  30 , but it will be understood that the highest point may be located elsewhere within the perimeter of cover  30 . Throughout the different sizes of cover  30 , edge  23  preferably measures about 0.38 mm in thickness. Smooth layer  34   a  is shown applied to outer surface  34 . As in  FIGS. 4   a - c  above, layers  34   a  and  38   b  are shown in exaggerated form for clarity. Layer  34   a  is normally very thin to achieve the desired natural look and feel. The circled areas W in each of  FIGS. 11   a - c  represents the thickest portion of cover  30 . Areas W range in thickness from 3-8 mm in the smallest to the largest sizes of cover  30 , respectively. 
         [0054]      FIG. 12  is a bottom view of cover  30 . Concavity  39  is again seen formed by inner surface  38   a.  Persons of skill in the art will recognize that although three specific sizes of cover  30  are show as described, other embodiments of cover  30  may have different diameters, heights, thicknesses, and shapes. 
         [0055]      FIG. 13  depicts the side perspective view seen in  FIG. 8  in which cover  30  is applied to right breast R and a second cover  30  is aligned to cover or conceal nipple N and areola A of left breast L. It can be seen in this view that covers  30  cover all of the nipple/areola regions of both breasts.  FIG. 14  shows both nipple/areola regions covered by cover  30 . 
         [0056]    Similar to prosthesis  10 , cover  30  is placed over each nipple/areola region and is held in place by the inherent adhesive quality of the silicone used to fabricate cover  30 . Concavity  39  allows room for nipple N to fit comfortably under cover  30 . In an alternate embodiment, cover  30  may be held comfortably in place by a sticky silicone layer  38   b  applied to inner surface  38  and/or  38   a,  similar to that used with inner surface  20  of prosthesis  10 . In a preferred embodiment, a smooth silicone layer  34   a  is applied to outer surface  34  of cover  30 . This smooth silicone serves to reduce friction between cover  30  and clothing as well as to produce a desirable tactile feel to cover  30 . This layer may be made from GE Top Coat or equivalent material. 
         [0057]      FIG. 15  is a top perspective view of an alternate embodiment of the nipple prosthesis, nipple prosthesis  40  (“prosthesis 40”), in which top surface  42  comprises a “rough surface” comprising pimples, ridges, grooves and/or other features commonly found on the surface of a natural breast, areola, and nipple. Nipple  44  is seen as a protrusion formed from outer surface  46  and possessing sloping sides. In an alternate embodiment, nipple  44  may be cylindrically shaped with the cylindrical wall somewhat more perpendicular to outer surface  46 . In one embodiment, nipple  44  may be up to approximately 2 cm in length measured in a manner similar to that seen above using a gap analogous to the gap between arrows b and b′ in  FIG. 3 . The diameter of nipple  44  may be up to about 1.5 cm. In alternate embodiments, nipple  44  may be of any desired length as described below. Similar to prosthesis  10  and cover  30 , prosthesis  40  includes edge  48  which is a micro edge preferably less than 1 mm in thickness around the perimeter of prosthesis  40 . Because edge  48  is a thin micro edge, it is difficult to exactly ascertain where the supporting breast and edge  48  meet when prosthesis  40  is applied to a breast. In a more preferred embodiment, edge  48  measures about 0.38 mm in thickness. Areolar region  42  is seen on surface  46  of prosthesis  40 . 
         [0058]      FIGS. 16   a - c  are cross sectional views of different sizes, small, medium, and large, respectively, of prosthesis  40  taken generally along line  16 - 16  in  FIG. 15 . In all three sizes, inner surface  50  is seen extending from the perimeter at edge  48  toward the center to form to center concavity  52 . Concavity  52  is in the general shape of a concave arch formed from inner surface  50 . Surface  50   a  is a continuation of inner surface  50  and forms the bottom surface of nipple  44  and the upper wall of concavity  52 . In one embodiment, adhesive layer  50   b  (described below) is applied to inner surface  50  and surface  50   a.  Concavity  52  is preferably positioned over the position on the breast where the natural nipple would be. In the embodiment shown, passage  54  is positioned between concavity  52  and suction bubble  56  (“bubble 56”). In one embodiment, passage  54  ranges from about 1.7 to 3.2 mm in width and bubble  56  has a spherical diameter ranging from about 3-9 mm. The total height or thickness of prosthesis  40  ranges from 10-17 mm as measured from the vertical height between edge  48  and the peak of nipple  44  as analogous to the method described above utilizing the gap between lines b and b′ in  FIG. 3 . The diameter of nipple  44  ranges from about 40 to about 70 mm.  FIGS. 16   a - c  all depict the preferred embodiment in which prosthesis  40  gradually increases in height from the perimeter defined by edge  48  to nipple  44  (preferably located at the center of prosthesis  40 ). The diameter of the small, medium, and large prostheses  40  is about 40 mm, 60 mm and 80 mm, respectively. In all three sizes, edge  48  preferably measures about 0.038 mm in thickness. Persons of skill in the art will recognize that although three specific sizes of prosthesis  40  are shown and described, other embodiments of prosthesis  40  may have different diameters, heights, thicknesses, and shapes in the components of prosthesis  40 . A top coat  46   a  similar to that described above for prosthesis  10  and cover  30  may be applied to prosthesis  40 . Similar to prosthesis  10  discussed above, it will be recognized that a user may optionally place prosthesis  40  over a natural nipple N on right breast R as well as a breast without a nipple to attain the same or nearly the same look for both breasts L and R. 
         [0059]      FIG. 17  is a top perspective view of breast cover  60  (“cover 50”) including an alternate embodiment in which outer surface  64  comprises a “rough surface” comprising pimples, ridges, grooves and/or other features commonly found on the surface of a natural breast. Cover  60  includes edge  62  which is a micro edge preferably less than 1 mm in thickness around the perimeter of cover  60 . Because edge  62  is a thin micro edge, it is difficult to exactly ascertain where the supporting breast and edge  62  meet when cover  60  is applied to a breast. In a more preferred embodiment, edge  62  measures about 0.38 mm in thickness. 
         [0060]    In one embodiment, cover  60  may be 8-9 cm in diameter or width. Center  66  of cover  60  is also shown in  FIG. 17 . Although cover  60  is shown as having a noncircular shape, it will be recognized by those having skill in the art that it may be formed into other shapes to fit a particular need including circular, nonsymmetrical, or irregular shapes. By noncircular is meant a shape whose perimeter does not form a circle. Examples of a noncircular shape include but are not limited to, oblongs and rectangles. 
         [0061]      FIGS. 18   a - c  are cross sectional views of different sizes of cover  60  taken along line  18 - 18  in  FIG. 17 . Cover  60  increases in height from less than 1 mm at edge  62  to approximately 2 mm in the center as measured analogous to the gap between lines d and d′ in  FIG. 10 .  FIGS. 18   a - c  depict small, medium, and large sizes, respectively, of cover  60 . In all three sizes, inner surface  68  is seen extending from edge  62  to center concavity  69 . Surface  68   a  is a continuation of inner surface  68  and forms the upper wall of concavity  69 . In the embodiments shown, surface  68   a  starts to extend from inner surface  68  at or near edge  62 . Adhesive layer  68   b  is shown applied to inner surfaces  68  and  68 a. Through the three sizes, the preferred diameter of cover  60  ranges from about 30 to about 90 mm. In an alternate embodiment, the height of cover  60  ranges from about 10 to about 17 mm measured as the vertical height from edge  62  to the highest point of cover  60  (analogous to the gap between lines d and d′ in  FIG. 10 ). In the embodiments shown in  FIGS. 18   a - c,  the highest point is generally in the center  66  of cover  60 , but it will be understood that the highest point may be located elsewhere within the perimeter of cover  60 . Throughout the different sizes of cover  60 , edge  62  measures about 0.38 mm in thickness. Adhesive layer  68   b  is shown applied to inner surface  68 . Persons of skill in the art will recognize that although three specific sizes of cover  60  are show as described, other embodiments of cover  60  may have different diameters, heights, thicknesses, and shapes. A smooth top coat  64   a  similar to that applied to cover  30  above may also be applied to cover  60 . The circled areas W in each of  FIGS. 11   a - c  represents the thickest portion of cover  30 . Areas W range in thickness from 3-8 mm in the smallest to the largest sizes of cover  60 . 
         [0062]    Both prostheses  10  and  40  and covers  30  and  60  may be fabricated by injection molding from liquid silicone rubber material. For prostheses  10  and  40 , nipples  14  and  44 , respectively, are formed as an integral part of prostheses  10  and  40 , respectively, in the molding process. The liquid silicone rubber may be injected and cured in a mold that will range in temperature from 250-400° F. and the curing cycle time will normally range from 20 seconds to 2 minutes. In an alternate embodiment, a post cure process for the molded device(s) may be desired. The post cure is a secondary process in which the molded prostheses  10  and  40  or covers  30  and  60  are placed in an air circulating oven for 30 minutes to  8  hours with an oven temperature of 150-400° F. Post curing may be desirable to drive residual volatiles from the silicone material. 
         [0063]    Alternative methods of molding prostheses  10  and  40  and covers  30  and  60  may include compression molding where the liquid silicone rubber or heat cured rubber is placed in compression molds and then molded in a compression vs. injection molding machine. Material is typically hand fed into these molds although automated feed dispensing equipment known to those skilled in the art may be used. Cycle times would normally range from  1 - 10  minutes and cure temperatures would be 250-400° F. Post cures may be applied as described above. 
         [0064]    Molds used to make the body of both of the prostheses and both of the covers may be made of aluminum or steel. The molds may contain from one cavity up to several hundred cavities. After prostheses  10  and  40  or covers  30  and  60  are molded, they may then be transferred to a secondary processing area where silicone adhesive and/or top coat may be applied. The silicone adhesive may be Wacker SILGEL 612, GE 1408-02-18 or equivalent material. In either case the adhesive material is supplied in 1:1 ratio of A and B components which are hand mixed and kept refrigerated once mixed to preserve shelf life using methods known to those skilled in the art. The material is then applied to prostheses  10  and  40  and/or covers  30  and  60  using either a paint roller, paint brush or spray equipment. It is important that the entire surface be covered evenly with adhesive to ensure maximum tackiness. The molded prostheses  10  and  40  and/or covers  30  and  60  with the layer of silicone adhesive is then passed through a convection oven set between 200-400° F. for a time period of 5-20 minutes. [ 0038 ] Should a top coat layer be desired on the outer surface of molded prostheses  10  and  40  or covers  30  and  60 , it may be applied before or after the above application of adhesive. The GE Top Coat material is also supplied in a 1:1 ratio (A and B components). This material is water like in viscosity and is also mixed by hand. The preferred method of application of the top coat is spraying but it may also be rolled or brushed on the desired molded product surface. This top coat layer is cured after application in a convection oven set at 200-400° F. for a time period of 2-10 minutes. Top coats are applied in a similar manner with smooth surface and “rough surface” embodiments. 
         [0065]    Preferably, during fabrication of both prostheses  10  and  40  and covers  30  and  60 , at least one pigment may be incorporated into the material to produce a color that blends with the natural breast/nipple/areola color(s) of the user. In an alternate embodiment, other colors may be used to produce a particular visual effect. Examples include, but are not limited to, fluorescent colors, “glow-in-the-dark” colors, pictures, drawings, simulated tattoos, and other designs limited only by the user&#39;s or manufacturer&#39;s imagination. Methods to incorporate pigments are well known to those skilled in the art. 
         [0066]    Similarly, both prostheses  10  and  40  and covers  30  and  60  may be manufactured with orifices designed to receive ornaments, including but not limited to, jewelry or piercings or they may be pierced by the user to hold such ornaments. This provides the advantages of avoiding both the pain of applying jewelry and similar ornamentation to the natural breast and/or nipple and possible medical complications, including but not limited to infection, that may result from such piercing operations.  FIG. 19  is a front view of two prostheses  10  which receive a piercing  81  and chain  82 . Also seen is design  83  applied to the areola or outer surface of prosthesis  10 . It will be recognized by those skilled in the art both that other articles may be applied to prostheses  40  and covers  30  and  60 , as well as prosthesis  10 . 
         [0067]    Thus it is seen that the objects of the invention are efficiently obtained, although changes and modifications to the invention should be readily apparent to those having ordinary skill in the art, which changes would not depart from the spirit and scope of the invention as claimed. 
       Parts List 
       [0000]    
       
         A areola 
         L left breast 
         N nipple 
         R right breast 
           10  nipple prosthesis 
           12  areola region of prosthesis 
           14  nipple of prosthesis  10   
           16  nipple prosthesis top surface 
           18  nipple prosthesis micro edge 
           20  bottom surface 
           20   a  bottom concavity surface 
           22  concavity 
           24  passage 
           26  air bubble 
           30  nipple cover 
           32  nipple cover micro edge 
           34  nipple cover top surface 
           36  nipple cover center 
           38  nipple cover bottom surface 
           38   a  concavity surface 
           39  nipple cover concavity 
           40  nipple prosthesis (“rough surface”) 
           42  areola region of prosthesis  40   
           44  nipple of prosthesis  40   
           46  outer surface of prosthesis  40   
           48  micro edge of prosthesis  40   
           50  inner surface of prosthesis  40   
           50   a  concavity surface 
           52  concavity of prosthesis  40   
           54  passage of prosthesis  40   
           56  suction bubble of prosthesis  40   
           60  nipple cover (“rough surface”) 
           62  micro edge of cover  60   
           64  outer surface of cover  60   
           66  center or peak of cover  60   
           68  inner surface of cover  60   
           68   a  inner surface of concavity of cover  60   
           69  concavity of cover  60   
           81  piercing 
           82  chain 
           83  design