Patent Publication Number: US-2022221838-A1

Title: Process for producing individualized artificial nipple

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims the benefit of US Provisional Patent Application 63/122,014 filed Dec. 7, 2020, under 35 USC § 119(e). 
    
    
     BACKGROUND 
     There are numerous commercially available pacifiers and bottle nipples. Pacifiers, traditionally, are mimics of female nipples used to soothe a child. The importance of these items being effective is common knowledge; however, the benefit of highly effective, or structurally similar, pacifiers and bottle nipples can be more nuanced. Some of the more nuanced items might be reduction in Sudden Infant Death Syndrome (SIDS) and reduction in nipple confusion. Current medical literature suggests pacifiers reduce rates of SIDS. Unfortunately, not all babies will utilize a pacifier, or their adherence is not optimal. Nipple confusion is also a frequently debated, but can occur when introducing a pacifier, or when switching between breast and bottle feeding. Despite this knowledge, the commercially available variety of pacifiers and bottle nipples fail to replicate the exact shape, size, texture, and contour of mammalian anatomy. In addition, they are not individualized to replicate a specific female&#39;s anatomy (nipple, areola, or combination of nipple and areola). Some research suggests using various methods to create a more individualized pacifier or bottle nipple, such as using a mold or combining multiple images at different angles; however, none of these methods were found to be commercially available, and, regardless, would fail to create a highly precise replication of the desired human anatomy. In addition, the processes described were cumbersome, not readily available, and often required the assistance of an additional person(s) exposing sensitive anatomy. 
     SUMMARY 
     The present disclosure is directed to an individualized artificial nipple made by a process comprising the steps of capturing surface geometry of a mammalian nipple with a device configured for capturing depth data, transferring the depth data to an additive manufacturing device, using the depth data to create a file format used for additive manufacturing, and producing a replica of the mammalian nipple using additive manufacturing. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  depicts a diagrammatic view of components of an exemplary process, according to the present disclosure. 
         FIG. 2  depicts a flow diagram of the exemplary process of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Before the present methods, implementations, and systems are disclosed and described, it is to be understood that this invention is not limited to specific implementations, and as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular implementations only and is not intended to be limiting. 
     For the purposes of promoting an understanding of the principles of the invention and presenting its currently understood best mode of operation, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, with such alterations and further modifications in the illustrated device and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     Referring to  FIG. 1 , a process of producing an individualized artificial nipple is shown. A mammalian nipple is shown at  10  in  FIG. 1 . A device  12  for capturing depth data is used for capturing surface geometry of the mammalian nipple  10 . This surface geometry is, exported, or transferred, to an additive manufacturing device  14 . During the process, the surface geometry and/or depth data is used to create a file format  16  used for additive manufacturing. This file format  16  is ultimately used to produce an individualized replica of  18  or mold for the mammalian nipple using the additive manufacturing device  14 . 
     This process is described in more detail in  FIG. 2 , but continued reference to  FIG. 1  is also made. In  FIG. 2 , a process  30  for producing an individualized artificial nipple, or replica,  18  is illustrated. At a first step, at  32 , surface geometry of a mammalian nipple  10  is captured. This may be accomplished using light emitted from a device, such as, for example, TrueDepth (or similar dot projection) or Lidar, to obtain precise data of the desired mammalian anatomy. The utilized device  12 , for example, may be a handheld device. Using a handheld device, such as a smartphone, the required data may be readily available, efficient, and may eliminate unnecessary exposure of sensitive anatomy. 
     The data capture and export may both be accomplished using the same device, such as a mobile device, as described above. This data, including surface geometry, is ultimately transferred to an additive manufacturing device  14 , at  34 . At some point in the process, the surface geometry is used to create an additive manufacturing file format  16 , at  36 . At  38 , a replica ( 18 ) or mold for the mammalian nipple  10  is produced using additive manufacturing. 
     Materials for producing the individualized artificial nipple may include FDA approved materials, including, for example, an elastomer material. 
     This process will result in a precise, individualized pacifier or mold therefor made using 3-dimensional printing, which will result in a precise, individualized pacifier or bottle nipple. That is, the current process may be used to make an individual artificial nipple that replicates the size, texture and firmness of a mother&#39;s natural nipple.