Abstract:
A reusable surgical implement is provided that is formed of a core positioned within an enclosure. The core is formed of a suitable rigid, and optionally flexible material to enable the implant to conform to the desired use for the implement in a surgical procedure. The material forming the enclosure is also stretchable and flexible to accommodate the configuration and/or any flexing of the core, and is biologically inert to enable the implant to be sterilized after use for use in subsequent surgical procedures while protecting the material forming the core. The enclosure can be molded around the core in separate portions or components using multiple molding steps to form an enclosure with the desired attributes.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority from U.S. Provisional Patent Application Ser. No. 61/993,383, filed on May 15, 2014, the entirety of which is expressly incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to items used in surgical procedures, and more particularly to a process for molding exterior coatings on those items and the items formed by the molding process. 
       BACKGROUND OF THE INVENTION 
       [0003]    There are many types of devices that are used in surgical procedures. The devices enable a physician to perform the multitude of tasks required to successfully complete the procedure. Oftentimes, the procedure that the physician needs to perform requires the use of items, implements or other tools that require a certain amount of rigidity in the tool in order for the tool to effective in its particular use in the procedure. As such, many of these items or tools are formed of a generally rigid material, such as a metal, that provides the desired amount of rigidity. 
         [0004]    However, with these tools formed at least partially of metal, the nature of the metal creates problems with regard to the re-use of the tool. The reason for this is that the metal, as well as any coating applied to the exterior of the metal, such as an anodized coating which is necessary for implements that are formed of titanium, must be sterilized after each use. With certain metals and coatings, the sterilization process can be problematic, as the metals and/or coating can become brittle or otherwise damaged upon sterilization after an initial use. Any damage done to the metal and/or coating can cause issues with the stability or integrity of the implement during subsequent uses which consequently can endanger the patient. 
         [0005]    Thus, it is desirable to develop implements that are formed of metal and a material that enables the implement/tool incorporating the metal to be sterilized and reused in multiple procedures without detrimentally affecting the tool and/or the metal component(s) of the tool. 
       SUMMARY OF THE INVENTION 
       [0006]    Briefly described, one aspect of the present disclosure provides an implement or tool formed of a substantially rigid, but optionally somewhat flexible core material that is enclosed within an inert material. The inert material provide a protective barrier around the core material and is capable of being sterilized after use without degrading the protective properties of the inert material to enable the implement to be reused. The inert material is molded over the core material to conform to the shape of the actual implement to provide the appropriate size and shape for the implement or tool when used by a physician in the procedure. Once used, the implement can be removed and subsequently sterilized, such as in an autoclave, for additional uses. 
         [0007]    According to another aspect of the present disclosure, the inert material is flexible and stretchable to accommodate any required flexibility of the core material while maintaining the core enclosed within the inert material. Thus, the implement can be bent in order to accurately conform to the proper location and configuration of for the implement when positioned within the body of the patient during the procedure and the inert material will maintain its conformance with the shape of the core. 
         [0008]    Numerous other aspects, features, and advantages of the present invention will be made apparent from the following detailed description together with the drawings figures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The drawings illustrate the best mode currently contemplated of practicing the present invention. 
           [0010]    In the drawings: 
           [0011]      FIG. 1  is an isometric view of one embodiment of an implement core constructed according to the present disclosure; 
           [0012]      FIG. 2  is a side elevation view of the core of  FIG. 1 ; 
           [0013]      FIG. 3  is a cross-sectional view of the core of  FIG. 2 ; 
           [0014]      FIG. 4  is an isometric view of the core of  FIG. 1  after a first molding step; 
           [0015]      FIG. 5  is a side elevation view of the core of  FIG. 4 ; 
           [0016]      FIG. 6  is a cross-sectional view of the core of  FIG. 5 ; 
           [0017]      FIG. 7  is an isometric view of the core/implement of  FIG. 1  after a second molding step; 
           [0018]      FIG. 8  is a side elevation view of the core/implement of  FIG. 7 ; 
           [0019]      FIG. 9  is a cross-sectional view of the core/implement of  FIG. 8 ; 
           [0020]      FIG. 10  is an isometric view of a second embodiment of an implement core constructed according to the present disclosure; 
           [0021]      FIG. 11  is a side elevation view of the implement core of  FIG. 10 ; 
           [0022]      FIG. 12  is an isometric view of the implement core of  FIG. 10  after a first molding step; 
           [0023]      FIG. 13  is a side elevation view of the implement core of  FIG. 12 ; 
           [0024]      FIG. 14  is an isometric view of the implement core of  FIG. 10  after a second molding step; 
           [0025]      FIG. 15  is a side elevation view of the implement core of  FIG. 14 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    Referring now in detail to the drawing figures, wherein like reference numerals represent like parts throughout the several views, one exemplary embodiment of an implement constructed according to the present disclosure is illustrated generally at  100  in  FIG. 7 . As best shown in  FIGS. 1-9 , the illustrated exemplary embodiment of the implement  100  is formed as a rod template having a central core  12  and an enclosure  14  disposed around the core  12  formed of a first component or portion(s)  16  and a second component or portion(s)  18 . In the illustrated exemplary embodiment, the rod template  100  is formed to be generally straight, though other curved, looped or other configurations for the rod template  100  are also contemplated as being within the scope of the disclosure of the present invention. 
         [0027]    Though any suitable shape for the core  12  can be utilized, in the illustrated embodiment the core  12  is formed with a generally flat rectangular or cylindrical cross-sectional shape with a first end  20  and a second end  22  joined by opposed sides  24 , though any suitable cross-sectional shape can be utilized to impart the desired amount of flexibility to the core  12 . The core  12  is shaped in any suitable machine and/or process to provide the desired shape for the core  12 , which may include apertures or other features therein, as desired. 
         [0028]    The material forming the core  12  is selected to be a generally rigid, but flexible material that can be altered in shape by applying a physical force to the core  12 . Once the force is removed, the core  12  remains in the shape to which it was altered by the applied force. In one exemplary embodiment of the core  12 , the core  12  is formed of a shape memory material, such as a shape memory metal alloy, including the materials marketed under the trade name Nitinol® by Nitinol Devices &amp; Components, Inc. of Fremont, Calif. 
         [0029]    The enclosure  14  is disposed around the core  12  and each portion  16  and  18  joined together to form the enclosure  14  is formed of a biologically inert and flexible material that can conform to the shape of the core  12  in any configuration for the core  12 . in one embodiment, the material forming the portions  16  and  18  of the enclosure  14  is a silicone, such as a silicone rubber, including a high consistence rubber (HCR). 
         [0030]    The portions  16  and  18  of the enclosure  14  are formed with any features (not shown) desired to enhance the utility of the implement  100  when utilized within the body of the patient. The features can include apertures  110 , notches (not shown), raised or depressed tactile portions, or printed indicia, among others. The apertures can extend completely through the respective portions  16  and  18  without intersecting the core  12 , thereby preserving the integrity of the enclosure  14  around the core  12 . Further, the shape of the portions  16  and  18  forming the enclosure  14  can be shaped as desired. Also, the shape of the portions  16  and  18  can be selected independently of the shape of the core  12  to facilitate the operation or use of the implement  100 , or to conform to the shape of the core  12 , as desired. 
         [0031]    In one embodiment, the implement  100  is formed by initially forming the core  12  of the desired material in any suitable manner, such as by extruding or molding the material into the desired shape for the core  12 , as shown in  FIGS. 1-3 . The core  12  is then placed within a suitable mold (not shown) to enable the material selected to form the first portion  16  to be introduced into the mold containing the core  12  and form a portion of the enclosure  14  on or over the core  12  that contains the desired features within the portion  16 . Any suitable molding process can be utilized to form the first portion  16  around the core  12 , such as those shown in commonly owned U.S. Pat. No. 8,641,955 and its related applications, each of which are expressly incorporated by reference herein in their entirety. In the illustrated embodiment best shown in  FIGS. 4-6 , the first portion  16  constitutes a number of spaced sections  102  disposed along the length of the core  12 . 
         [0032]    Subsequently, the core  12  and the first portion  16  that has been molded onto or over the core  12  are removed or transferred from the first mold and placed within a separate or second mold (not shown) used to form the other of the second portion  18  on or over the core  12  in connection with the first portion  16  and with the desired features. The material selected to form the second portion  18  can be selected to be the same or different in one or more respects or attributes than the material used to form the first portion  16 , in order to provide the desired attributes to the enclosure  14  and the implement  100 , so long as the materials forming the first portion  16  and second portion  18  are capable of mating, co-mingling or otherwise joining to one another in the molding process used to form the enclosure  14  around the core  12 , which can be the same or different that the process used to form the first section  16 . Additionally, suitable materials can be applied to one or both of the portions  16  and/or  18  to properly affix the portions  16  and  18  to one another, either during molding of the portions  16  and  18  to one another, or when affixing pre-molded portions  16  and  18  to one another around the core  12 . 
         [0033]    In alternative exemplary embodiments, the portions  16  and  18  can be formed subsequently or simultaneously within a single mold in any suitable molding process. In the illustrated embodiment, the second portion  18  includes a number of spaced sections  104  disposed along the length of the core  12  and joining the sections  102  to form the enclosure  14 . In this embodiment, as shown in  FIGS. 7-9 , the sections  102  and  104  form a seamless enclosure  14  around the core  12  complete with end caps  106  disposed over each end  20 , 22  of the core  12 . The seamless enclosure  14  moves, stretches and/or flexes with the core  12  to retain the core  12  encased within the enclosure  14 , such that the sterilization of the implement  100  does not contact the core  12 . 
         [0034]    In a second embodiment of the implement  200  shown in  FIGS. 10-15  illustrates the implement  200  as a flex driver. The implement  200  includes a suitably shaped core  212  with a pair of opposed ends  220  and  222 . The ends  220  and  222  define a central section  224  therebetween, as best shown in  FIGS. 10-13 . In the embodiment shown in  FIGS. 12 and 13 , the first portion  216 , which can be formed similarly to the first portion  16  in the prior embodiment, is molded onto the core  212  in a first mold (not shown) in a first molding step over at least approximately one half of the central section  224  in a suitable process, such as those cited as examples for the molding of the first portion  16  in the prior embodiment. In this process, however, the ends  220  and  222  can function as stops for the flow of the material forming the first portion  216  at each end  220  and  222 . 
         [0035]    Subsequently, the core  212  can be removed from the first mold for positioning in a second mold (not shown), or simply rotated within the first mold to expose the uncovered portion  226  of the central section  224  within the second mold. Once properly positioned, the second portion  218  can be formed over the uncovered section  226  to form the enclosure  214  over the central section  224  with the first portion  216  and without end caps, leaving the ends  220 , 222  exposed. 
         [0036]    In alternative exemplary embodiments for either embodiment of the implement  100 ,  200 , the process for molding the first portion  16 , 216  and/or second portion  18 , 218  can be performed in any number of separate molding steps in order to form the enclosure  14 ,  214  on the core  12 , 212  with the desired appearance, attributes or other characteristics with any desired number and/or types of different materials forming the portions  16 , 216  and/or  18 , 218 . 
         [0037]    Various other embodiments of the present disclosure are contemplated as being within the scope of the filed claims particularly pointing out and distinctly claiming the subject matter regarded as the invention.