Abstract:
Embodiments of the invention described herein thus provide systems and methods for ear restoration surgery. Certain embodiments provide an improved framework that provides enhanced cooperation between an ear base and a rim.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application Ser. No. 62/025,919, filed Jul. 17, 2014, titled “Support for Ear Base,” the entire contents of which are hereby incorporated by reference. 
     
    
     FIELD OF THE DISCLOSURE 
       [0002]    Embodiments of the present disclosure relate generally to a support for an ear base that is used in ear restoration and reconstruction. 
       BACKGROUND 
       [0003]    Surgical reconstruction of an external ear often uses a framework implant. The framework implant can be used to support the patient&#39;s overlying skin and generally provides a cartilage-like support structure, providing predictable aesthetic results. Porous polyethylene ear implants have been used for many years as a framework material. This material generally has good biocompatibility for reconstruction of ear malformations. Due to its porous structure, the material can promote revascularization at the implantation site. However, there are some drawbacks with currently available frameworks, and improvements are desired. 
       BRIEF SUMMARY 
       [0004]    Embodiments of the invention described herein thus provide systems and methods for ear restoration surgery. Certain embodiments provide an improved framework that provides enhanced cooperation between an ear base and a rim. 
         [0005]    Certain examples provide an ear base for an ear implant restoration, which has an ear base body comprising an antihelix rib and a rearwardly extending flange; and a support tab extending from the ear base. The support tab may extend from a point between the anti-helix rib and the rearwardly extending flange. The support tab may extend from a location where the inferior crus and superior crus of the ear base meet. The ear base and the support tab may comprise porous polyethylene. Exemplary polyethylenes include but are not limited to high density polyethylene or ultra high molecular weight polyethylene (UHMWPE). The ear base and the support tab may comprise polyether ether ketone (PEEK), polyethylene terephthalate (PETE), nylon, polypropylene, or any polymer of aliphatic hydrocarbons containing one or more double bonds, or any combination thereof. In one example, the support tab may have a reinforcing support rib. In another example, the support tab may be a thickened tab. The support tab can have a rectangular-like shape, or any other appropriate shape. Further examples provide an ear implant restoration device, which has a flexible rim, an ear base body, and a support tab extending from the ear base body. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]      FIG. 1  shows a side perspective view of a rim and an ear base according to embodiments described herein. 
           [0007]      FIG. 2  shows a side perspective view of rim and an ease base in cooperation with one another. 
           [0008]      FIG. 3  shows a rear perspective view of an ear base, illustrating the rear flange and one example of a potential extension location for the support tab. 
           [0009]      FIG. 4  shows a front perspective view of the ear base of  FIG. 3 . 
           [0010]      FIG. 5  shows a side perspective view of the ear base of  FIG. 3 . 
           [0011]      FIG. 6A  shows a rear perspective view of an alternate ear base, which has two support tabs. 
           [0012]      FIG. 6B  shows a front perspective view of the ear base of  FIG. 6A . 
       
    
    
     DETAILED DESCRIPTION 
       [0013]    An ear implant made of porous polyethylene or other porous material can provide a porous structure that allows tissue ingrowth. The material may be easily moldable, such that scalpels or heating can design and form structure interoperatively. Embodiments described herein provide improved cooperation between various components of ear implants. 
         [0014]    Embodiments of the present invention provide a support for an ear base that is used in ear restoration. A framework ear implant  10  generally includes two main components—the ear base  12  and a rim  14 . The ear base  12  is generally shaped to resemble a patient&#39;s outer ear. It includes an antihelix rib  16 , an inferior crus  18 , a superior crus  20 , a tragus element  22 , and an antiragus element  24 . A lower portion of the ear base also features a lobule  26 , which forms the ear lobe. An implant flange  28  extends rearwardly from the antihelix rib  16 . The implant flange  28  can help assist with implant placement in use. 
         [0015]    Referring now to the rim  14 , the rim  14  is designed to resemble the outer curvature of the ear, called the helix. It is generally a flexible element that can be twisted as desired. The rim  14  is formed as an elongated element with a hollow interior  30 , which resembles a C-shape in cross-section. The rim  14  also has an upper curve  32 , which forms the upper and outer portion of the ear helix. The rim  14  may help adjust the size of the ear that is reconstructed by sliding along the antihelix rib  16  of the ear base, and then be secured thereto at the appropriate position, once the appropriate ear size and shape has been formed.  FIG. 2  illustrates an exemplary cooperation between the ear base  12  and the rim  14 . As shown, there are generally two connection points between the ear base  12  and the rim  14 , illustrated as P 1  and P 2 . Once positioned as desired, the components  12 ,  14  may be bound together by heating with a point welding or cautery device or suturing. The general goal is for the contours to match as closely as possible so that a mirror image of the healthy ear may be formed. 
         [0016]    However, the present inventor has found that during implant surgery, it may be the case that the rim  14  and the ear base  12  are not easily attached in the desired position. It may also be the case that connection points P 1  and P 2  are insufficient for the desired securement. Accordingly, there is provided a support tab  40  extending away from the ear base  12 . The support tab  40  may provide at least a third connection point, P 3 , between the ear base  12  and the rim  14 . In use, the support tab  40  may provide at least one additional point of attachment between the ear base  12  and the rim  14 . As described in more detail below, it is possible to provide more than one support tab  40 . 
         [0017]    In one example, the support tab  40  may be attached to or otherwise cooperate with the antihelix rib  16 . As is shown in  FIGS. 3 and 4 , the support tab  40  may extend from a cooperation point  42  between the antihelix rib  16  and the flange  28 . This position can prevent interruption of the shape of the antihelix rib  16  (such that it shows through the repositioned, overlying skin) while providing an appropriate cooperation point with the rim  14 . In other words, the support tab  40  is positioned somewhat behind the antihelix rib  16  so as not to interfere therewith. One example of this position is illustrated by  FIG. 5 . 
         [0018]    The support tab  40  may extend from the ear base  12  from the location  44  at which the inferior crus  18  and superior crus  20  meet. In another example, the support tab  40  may extend from the ear base  12  at a point superior to location  44 . In a further example, the support tab  40  may extend from the ear base  12  at a point inferior to location  44 , between the inferior crus  18  and the lobule  26 . Additionally, multiple support tabs  40  may be provided in various positions along the antihelix rib  16 . One example of this embodiment is shown by  FIGS. 6A and 6B .  FIG. 6A  illustrates a rear perspective view of an ear base  12  having a first support tab  40   a  and a second support tab  40   b.    FIG. 6A  shows a front perspective view. Although two support tabs  40   a  and  40   b  are shown in these figures, it should be understood that more support tabs may be provided. It may be desirable to provide three support tabs, four support tabs, five support tabs, or more. It may also be possible to provide an elongated support tab that runs the edge of the ear base. 
         [0019]    In one example, the support tab  40  may be provided with a support rib  46 . The support rib  46  is shown as generally extending along a central portion of a rearward surface  48  of the support tab  40 . The support rib  46  may be provided as a raised protrusion, which may provide additional support to the support tab  40  in use. In another example, the support tab  40  may have its entire body provided as a thickened tab. The support tab may have a rectangular-like shape, a square-like shape, an oval-like shape (such that its non-connected end is curved), a pyramidal shape, a circular shape, or any other appropriate shape. The support tab  40  may have curved edges. The general goal is for the support tab to provide a support face  50  along which the rim  14  can rest. 
         [0020]    In one example, the support tab may be about 0.85 mm thick. In other examples, it may have a thickness of about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 4.0 mm, about 5.0 mm, about 5.5 mm, about 6.0 mm, about 6.5 mm, about 7.0 mm, or about 8 mm. This list is provided for exemplary purposes only and it should be understood that other thicknesses within these ranges as well as outside these ranges are possible and considered within the scope of this disclosure. Potential ranges for the projection length of the support tab include but are not limited to from about 3.0 mm to about 15.0 mm. For example, the support tab may project from the ear base about 3.0 mm, about 4.0 mm, about 5.0 mm, about 6.0 mm, about 7.0 mm, about 8.0 mm, about 9.0 mm, about 10.0 mm, about 11.0 mm, about 12.0 mm, about 13.0 mm, about 14.0 mm, or about 15 mm. This list is provided for exemplary purposes only and it should be understood that other projection lengths within these ranges as well as outside these ranges are possible and considered within the scope of this disclosure. In one specific example, the support tab  40  may be about 5 mm wide and about 5 mm in length/projection. 
         [0021]    In use, the rim  14  overlays the support tab  40  and rests along the support face  50 . Once the surgeon has located the rim  14  with respect to the ear base  12  at the desired position, s/he may heat weld or suture or otherwise secure the rim  14  to the support tab  40 . In one specific embodiment, it is possible for the surgeon to trim any excess material of the support tab  40  that may extend beyond the rim  14 . This trimming step is not required, however, particularly if the tab is provided as a thickened tab that is not easily trimmed or otherwise cut or shaped. 
         [0022]    The support tab  40  may be formed integrally with the ear base  12 , such that the particles forming the implant  10  are all sintered in the same mold. It is also possible for the support tab  40  to be welded or otherwise attached to the ear base  12  subsequent to formation of the ear base  12 . 
         [0023]    Although the support tab  40  has been described for use in connection with a porous polyethylene implant, it should be understood that the ear base  12  may be any known or future developed ear base. It is generally expected that the support tab  40  will be formed as having the same material as the ear base. However, it should be understood that it is possible for the support tab to be formed from a different material instead. In one example, the ear base  12  and the support tab  40  may be constructed from a high density polyethylene that either has an inter-connected pore structure or a smooth nonporous structure. One potential polyethylene is high density polyethylene or ultra high molecular weight polyethylene (UHMWPE). Other potential materials include but are not limited to polyether ether ketone (PEEK), polyethylene terephthalate (PETE), nylon, polypropylene, or any polymer of aliphatic hydrocarbons containing one or more double bonds, and allow the implant to be at least partially pliable. Other materials are also possible and considered within the scope of this disclosure. Combinations of these and other materials are also possible. 
         [0024]    Changes and modifications, additions and deletions may be made to the structures and methods recited above and shown in the drawings without departing from the scope or spirit of the disclosure or the following claims.