Abstract:
An improved post-operative dressing for providing both breast and, notably, nipple reconstruction and which in particular establishes custom lateral supporting of the nipple annulus. A body is constructed of a medical grade silicone and exhibits a three dimensional shape adapted for placement over the reconstructed breast and an aperture defined by an inner rim configured within the body is adapted to seat therethrough an associated nipple graft in a laterally supporting and non-pressure applied fashion. A number of secondary advantages incorporated into the body include each of apertures for breathability, suction/adherence properties, and impregnation or entrainment within the body inner surface of any form of anti-infection medicine.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This Application claims the benefit of U.S. Provisional Application 61/237,383 filed on Aug. 27, 2009. 
    
    
     FIELD OF THE INVENTION 
     The present invention discloses a one-piece silicone gel dressing for post operative use in breast and nipple reconstruction surgeries, and exhibiting a generally arcuate and variable thickness consistency and which is generally shaped to correspond to the contour of the female breast mound. More specifically, the present invention teaches such a device in which a center cutout and aperture defined portion, in combination with the concave surface of the device, provides a desired minor degree of gentle pressure to the surrounding areola, while concurrently providing lateral support but no direct pressure to the reconstructed nipple and which is permitted to project through the center aperture. 
     BACKGROUND OF THE INVENTION 
     The prior art is documented with examples of breast reconstruction devices, such as following mastectomy or other breast related surgeries and which are typically geared toward shaping of the breast. A shortcoming of such prior art devices is in the shaping of the reconstructed nipple, with such known applications including clips, collar devices and the like which typically attach directly to the areola, in surrounding fashion to a reconstructed nipple graft. Shortcomings include both discomfort to the wearer, as well as the evident nature of the device when worn under clothing. 
     An example of one known nipple reconstruction device is set forth in US Patent Application Publication No. 2006/0106329, to Hammer et al., and which including a padded component  12 , a core component  14  and an attaching component  16 . In relevant part, the core  14  contains a hollow opening  18  for permitting insertion of the reconstructed nipple, however establishes no lateral supporting or other reconstructive aspects not related to the underlying breast mound. 
     Imonti, U.S. Pat. No. 4,870,977 teaches a surgical protector for raised wounds and which includes an aereola/nipple surface wound protector exhibiting a cone shape. Becker, U.S. Pat. No. 4,790,309 discloses a tissue expander stent for nipple reconstruction and which defines a frusto-conical shaped segment with a short cylindrical tubular element extending outwardly and which encompasses a rigid ring. In application, the conical segment is forced downwardly onto the breast, following which the nipple is sutured to the stent in order that the resiliency of the conical segment maintains the sutures under tension and tends to pull the nipple upwardly during healing. 
     SUMMARY OF THE INVENTION 
     The present invention discloses an improved post-operative dressing for providing both breast and, notably, nipple reconstruction which is an improvement over the prior art and which in particular establishes custom lateral supporting of the nipple annulus, combined with a series of secondary advantages including, most notably, invisibility when worn under clothing and, alternatively or accumulatively, each of breathability, suction/adherence, and impregnation or entrainment of any form of anti-biotic (anti-infection) medicine. The body is constructed of a medical grade silicone and exhibits a three dimensional shape adapted for placement over the reconstructed breast and an aperture defined by an inner rim configured within the body is adapted to seat therethrough an associated nipple graft in a laterally supporting and non-pressure applied fashion. 
     In one non-limiting variant, the outer perimeter of the body is selected from any of including a rounded, oval or ellipsoidal shape and further such that the body exhibits a narrow most and tapered outer profile increasing in dimension to a most thickened interior corresponding to location of the aperture defining inner rim. A tacky adhesive may be applied to an inner concave surface associated with the body to enhance surface gripping onto the surrounding skin. Other features include the adhesive exhibited by a gentle paper tape. 
     Additional features include a gripping pattern formed into an outer radial edge portion of an inner concave surface of the body and providing additional gripping support against the wearer&#39;s skin and about the outer perimeter of the dressing. Pluralities of surface perforations are formed through the body and accessible to a surface in order to improve air permeability. Additionally, the body may include interior molded channels communicating interior located apertures with the wearer&#39;s skin, with outer located baffles permitting fresh air to pass through the dressing body to the breast and for generated body warmth to escape through the baffles. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Reference will now be made to the attached drawing, when read in combination with the following detailed description, wherein like reference numerals refer to like parts throughout the several views, and in which: 
         FIG. 1  is a perspective view of the dressing device according to one potential embodiment of the present invention; 
         FIG. 2  is a top view of the device shown in  FIG. 1 ; 
         FIG. 3  is an inverted bottom or inside view of the device; 
         FIGS. 4A-4G  are a progression of views detailing a breast and nipple reconstruction, followed by post surgical application of the post nipple reconstruction dressing/scar reduction and nipple protector device according to the present invention and further showing the variable thickness of the dressing device including a greatest thickness at a center location corresponding to the reconstructed nipple seating through the center aperture; 
         FIGS. 5A-5E  illustrate a succession of views of the dressing in  FIG. 4  and, with particular reference to the side views of  FIGS. 5B-5E , the provision of dressings of varying thicknesses and radii; 
         FIG. 5F  is a partial perimeter edge view of a selected dressing and further showing an additional gripping pattern formed into the outer radial edge portion of the inner concave surface; 
         FIGS. 6A-D  illustrate a further variant of reconstruction dressing incorporating a plurality of surface perforations to improve air permeability; 
         FIGS. 7A-7C  illustrate a yet further variant of reconstruction dressing in which interiorly configured aperture patterns are combined with interior defined channels with outer baffles, and in order to facilitate ventilation of the wearer&#39;s skin; 
         FIG. 8  is a use illustration in which the reconstruction dressing is worn invisibly underneath a dress, shirt or blouse. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     With reference to the several illustrations described below, the present invention discloses a one-piece, three dimensional shaped and medical grade silicone gel dressing  10  for post operative use in breast/nipple reconstruction surgeries. As will be described in more detail, the dressing provides a number of improvements not evident in the prior art, including notably provision of a suitable one piece dressing for providing reconstructed breast support in combination with being properly sized for laterally supporting (but not pinching or deforming) the sensitive reconstructed nipple, such dressing further capable of being worn in a virtually invisible nature underneath any normal feminine garment. 
     With reference initially to  FIG. 1 , the dressing is provided as a body  10 , again typically constructed of a medical grade silicone but also contemplating the inclusion of other suitable materials. The body exhibits a generally arcuate and variable thickness consistency and which is generally shaped to correspond to the contour of the female breast mound. As shown, the device  10  exhibits a generally tapered and narrowest thickness associated with its outermost and perimeter defined edge, at  12 , and which can adopt any of a generally round, oval or ellipsoidal shape depending upon the overall contour of the reconstructed breast to which it is applied. 
     As further shown in  FIGS. 4A-4F  is a progression of views detailing a breast and nipple reconstruction, followed by post surgical application of the post nipple reconstruction dressing/scar reduction and nipple protector device according to the present invention and further showing the variable thickness of the dressing device including a greatest thickness at a center location corresponding to the reconstructed nipple seating through the center aperture. The thickness of the device increases to a maximum dimension (such as ½″ in one desired variant) at a generally central location corresponding further to an aperture (see inner annular rim  14  in each of  FIGS. 4D-4F ). 
     As is known, and following a mastectomy procedure (see again  FIGS. 4A-4C ), a complete breast reconstruction includes recreating the breast mound  2 , the nipple  6  and areola complex (NAC)  4 , such that the breasts are symmetric with regard to pigmentation, shape, size, projection and position. This is a multi-stage process, with the NAC reconstruction often considered to be the final stage. 
     The center cutout and aperture defined rim  14 , in combination with the overall (inner facing) concave surface of the device (see further at  16  in  FIG. 4E ), is custom designed in order to provide adequate lateral supporting aspect around the entire periphery of the reconstructed nipple, this further defined as a desired minor degree of gentle pressure when applied to a breast  2 , specifically to a surrounding areola  4  associated with a central projecting reconstructed nipple  6  which comfortably seats through the central aperture and is gently and laterally supported by its rim  14 ). 
     In this fashion, the dressing  10  provides a desired degree of lateral support to the outer edges of the nipple  6 , such as occurring without application of any direct pressure to the reconstructed nipple, which is permitted to project through the rim  14  defined center aperture. Adherence of the device to the breast is further facilitated by the use of any tacky surfacing material (such as a gentle paper tape a portion of which is representatively designated at  13  in  FIG. 3 ), as well as any compound or ingredient applied to a corresponding inner concave surface  16  of the body, this including a non-residue application of a material upon the inner surface  16  which provides a requisite degree of continual adhering support to the breast mound and areola. It is further envisioned that the molecular composition of the silicone material, combined with a desired texturing (or roughening) of the inner concave surface  16  and natural contact forces of adhesion generated by the body heat of the wearer, can to a large degree establish the requisite degree of holding forces between the device and the reconstructed breast mound, and without the need for separate adhesive materials. 
     The device  10  is constructed, as previously described in one preferred embodiment, of a medical grade silicone given its durable, cushioning and flexible nature, with its outer perimeter, dimensions, and variable thicknesses being largely dictated by the dimensions and contours of the reconstructed breast. As is further known, medical grade silicone is a material which is clinically proven to reduce scarring of tissue and is known to be sold in sheet from for such a purpose. This is particular value in the present application, given the existence of an incision scar associated with the breast reconstruction, the appearance of which is progressively minimized at a faster rate as a result of the application of the post surgical and reconstructive silicone dressing device. 
     Given this, it is desired that the silicone cushioned device can be customized (or produced in a wide range of varying shapes, sizes and configurations, to comfortably seat the reconstructed breast and nipple graft of the wearer. It is further envisioned and understood that other suitable materials, such as drawn from other types of polymeric and/or rubberized based materials can be substituted which provide similar cushioning to the breast and areola, with concurrent lateral and non-pressurized support to the wearer&#39;s reconstructed nipple. 
     In use, the overall configuration of the device  10 , combined with its generally gentle sloping convex outer surface  18  (opposite the inner concave surface  16  as shown in  FIGS. 4E and 4F ) provides a dressing which can be easily and invisibly concealed underneath a surgical bra or other garment and held in place by any disclosed adhesive (again such as a gentle paper tape as well as any other non-residue and tacky promoting application to the inner concave surface  16  as well as also possibly including a vacuum sealing aspect as will be subsequently described). Additional advantages of the device  10  include its wash-ability, as well of the central and aperture defined rim  14  facilitating evacuation of moisture or perspiration building up along the inside contact surface between the breast mound and areola and the inner concave surface  16  of the device. 
     Referring now to  FIGS. 5A-5E , illustrated are a succession of views of the dressing in  FIG. 4  and, with particular reference to the side views of  FIGS. 5B-5E , better illustrates the range and variety of dressings which can be provided according to varying thicknesses and radii. In each instance, the sizing or scalability of the dressing body  10  increases progressively, with the inner nipple seating aperture concurrently incrementing from an original diameter  14  in  FIG. 5B , to  14 ′ in  FIG. 5C ,  14 ″ in FIGS.  5 D and  14 ′″ in  FIG. 5E . One variant of the invention further contemplates providing a plurality of bodies  10  of varying size and nipple aperture (this contemplated as including additional to consistent scalable sizes the inclusion of smaller sized bodies with larger aperture nipple seating locations and vice versa). 
     Proceeding to  FIG. 5F , a partial perimeter edge view is shown of an inner perimeter surface extending and non-linear (or undulating) pattern, see concave depictions  20 , of a selected dressing and which further illustrates an additional gripping pattern formed into the outer radial edge portion of the inner concave surface, this providing additional gripping (such as warmth induced gripping or other vacuum retaining) support against the wearer&#39;s skin and about the outer perimeter of the dressing away form the central and nipple sensitive location. 
     The concave depictions  20 , as well as any location along the smooth inner adhering surface  16  of the dressing, may also include any type of anti-infection or anti-microbial application, this including any form of chemical impregnation either formed into the body of the dressing or (as representatively depicted at  21 ) possible inlaid within the concave depressions in order to deliver anti-inflammatory or anti-infection compounds at the particular areas desired. It is also envisioned that the concave depictions  20  can be substituted by any other pattern, scheme or depiction calculated to enhance gripping aspects with or without the inclusion of other adhesive retention support. 
     Referring now to  FIGS. 6A-D , illustrated are further variants of a reconstruction dressing, see generally at  22  in each of the front and side cutaway views of  FIGS. 6A and 6B , respectively. The dressing body  22  incorporates pluralities of surface perforations or apertures, at  24 ,  26 ,  28 , et. seq. in a generally outermost to inner extending pattern formed through the surface of the dressing and in order to improve air permeability. 
     As further best shown in the enlarged partial cutaway views of  FIGS. 6C and 6D  (taken from  FIG. 6B ), illustrated are enlarged partial views of the pattern of the apertures is again shown, as is the formation of additional mini-concave pockets, see as depicted at  30  in a first pattern in  FIG. 6C  and which is similar to that depicted at  20  in  FIG. 5F , and further at  31  in a second and non-limiting alternate pattern in  FIG. 6D  which is again defined along the interior concave surface of the dressing. 
     With reference to  FIGS. 7A-7C , a series of perspective, side cutaway and enlarged partial cutaway illustrations are progressively shown of a yet further variant  32  of reconstruction dressing, and in which any desired pattern or arrangement of interiorly communicating apertures, such as selected from any combination of apertures and including those in positions as also depicted at  26  and  28  in  FIG. 6A . As further shown in  FIGS. 7B and 7C , the apertures  26  and  28  are internally communicated by channels  34 , and which are in turn also communicated with outer baffles (including apertures  36  over which are positioned partially obstructing and projecting covering elements  38 ), this in order to facilitate a degree of controlled ventilation of the wearer&#39;s skin. In operation, the detail shown of the channel ( FIG. 7C ) allows fresh air to pass through the body (see directional arrows  40 ), while allowing the warmth of the body to escape (additional directional arrows  42 ). In this manner, it is envisioned that the skin surface of the wearer can be ventilated with a dressing incorporating the interior configured (e.g. molded) channels  34  and outer communicating baffle channels  36 . 
     Finally,  FIG. 8  is a use illustration, generally at  44 , in which the reconstruction dressing, such as previously shown at  10 , is illustrated being worn invisibly underneath a dress  46 , and which can be equally applicable to being worn underneath a shirt, blouse or any other female upper body garment. The ability to provide a contour establishing and invisible post operative dressing, suitably worn with existing clothing, has been found to be a desirable improvement over cumbersome prior art dressings. 
     Having described my invention, other and additional preferred embodiments will become apparent to those skilled in the art to which it pertains, and without deviating from the scope of the appended claims. This can include the use of any material composition within the dressing body, including again but not limited to medical grade silicone, as well as the construction or addition of any adhering, ventilating, medicating or supporting features to correspond and support the provision of the desirably dimensioned and laterally supporting central aperture for seating the reconstructed nipple therethrough.