Abstract:
An orthopedic fixation system includes a sterile packaged implant kit and a sterile packaged instrument kit. The sterile packaged implant kit includes at least one surgical implant, an insertion device, and an implant package adapted to receive the at least one surgical implant and the insertion device therein. The implant package maintains the at least one surgical implant and the insertion device sterile after sterilization of the sterile packaged implant kit. The sterile packaged instrument kit includes one or more instruments necessary to use the sterile packaged implant kit and an instrument package adapted to receive the one or more instruments therein. The instrument package maintains the one or more instruments sterile after sterilization of the sterile packaged instrument kit.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of patent application Ser. No. 13/385,387, which was filed Feb. 16, 2012. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to an orthopedic fixation system consisting of a sterile packaged implant kit and a sterile packaged instrument kit. 
     2. Description of the Related Art 
     Bone fusion and healing in orthopedics often involves metallic implants being attached to bones in some way to fixate them together during the healing process. There are many forms of bone fixation devices including intramedullary devices, pins, screws, plates, and staples. Implants made from shape memory materials, such as nitinol, are a popular material for fixation because their shape memory and superelastic properties allow the device to create compression that can augment healing. 
     Many orthopedic implants are delivered to hospitals in a non-sterile form, and sterilized prior to surgery at the hospital. This is easier for the medical device manufacturer, since the implant requires less preparation than one that is sterile-packaged, however it places an onus on the hospital to insure sterility at the time of surgery. Frequently these implants are delivered in caddies, and the implants that are not used in surgery have to be re-sterilized before any subsequent surgical procedure. 
     Many other orthopedic implants are delivered to hospitals in a sterile packaged form. While this is more difficult and expensive for the medical device manufacturer, it is easier for the hospital to simply provide the implant at the time of surgery. 
     Finally, orthopedic instruments are generally provided as part of an instrument tray. The tray needs to be sterilized prior to surgical use. Furthermore, after surgery the tray needs to be properly cleaned, and then subsequently re-sterilized prior to the next use. 
     While there are numerous combinations of sterile and nonsterile orthopedic implants on the market, they all use an instrument tray that requires cleaning and sterilization. 
     The process of cleaning and sterilization at hospitals is known in the literature to periodically result in a phenomenon known as Hospital Acquired Infection. In this situation, patients are exposed to an infectious agent due to improperly cleaned or improperly sterilized equipment. Preventing and treating these infections is costly to hospitals. 
     Accordingly, a system is described herein for providing a sterile packaged implant kit mounted on an insertion device, and a complementary sterile packaged instrument kit. Methods of packaging the system, and delivering and using the system, are also presented. 
     SUMMARY OF THE INVENTION 
     The invention herein consists of a sterile packaged implant kit and a complementary sterile packaged instrument kit and methods for use and packaging thereof. 
     The sterile packaged implant kit includes an implant mounted on an insertion device and a drill guide. The sterile packaged implant kit further includes an implant tray shaped to hold the at least one surgical implant, the insertion device, and the drill guide therein, an implant outer cover insertable over the implant tray, and an implant seal securable over the implant outer cover. The implant seal encloses the implant outer cover such that the implant, the insertion device, and the drill guide remain sterile within the implant tray and implant outer cover after sterilization of the sterile packaged implant kit. 
     The sterile packaged instrument kit includes a drill bit, locating pins, an instrument handle, and an implant tamp. The sterile packaged instrument kit includes an instrument tray shaped to hold the drill bit, locating pins, instrument handle, and implant tamp therein, an instrument outer cover insertable over the instrument tray, and an instrument seal securable over the instrument outer cover. The instrument seal encloses the instrument outer cover such that the drill bit, locating pins, instrument handle, and implant tamp remain sterile within the instrument tray and instrument outer cover after sterilization of the sterile packaged instrument kit. 
     A method of using an orthopedic fixation system is as follows. A sterile packaged implant kit is opened to access an implant, insertion device, and drill guide. A sterile packaged instrument kit is opened to access a drill bit and tamp. The drill guide and the drill bit are used to drill holes in bone. The insertion device is used to insert the implant. The insertion device is also used to release and activate the implant. The tamp is used to push the implant flush with bone. The foregoing method may also include the use of a sizing wheel to determine the proper implant selection. 
     A method of packaging an orthopedic fixation system is as follows. An implant is inserted into an insertion device, and the insertion device is inserted into an implant tray. A drill guide is inserted into the implant tray. The implant tray is enclosed by inserting an implant outer cover over the implant tray and securing an implant seal over the implant outer cover. A drill bit is inserted into an instrument tray. An implant tamp is inserted into the instrument tray. One or more locating pins are inserted into the instrument tray. An instrument handle is inserted into the instrument tray. The instrument tray is enclosed by inserting an instrument outer cover over the instrument tray and securing an instrument seal over the instrument outer cover. The enclosed implant tray and the implant, the insertion device, and the drill guide therein are sterilized. The enclosed instrument tray and the drill bit, the implant tamp, the one or more locating pins, and the instrument handle therein are sterilized. 
     It is an object of the present invention to present the surgeon with an implant ready for implantation, pre-mounted on an insertion device. 
     It is a further object of the present invention to provide the implant and insertion in a sterile packaged format. 
     It is still further an object of the present invention to provide all the instruments needed for use with this implant in sterile packaged format. 
     Still other objects, features, and advantages of the present invention will become evident to those of ordinary skill in the art in light of the following. Also, it should be understood that the scope of this invention is intended to be broad, and any combination of any subset of the features, elements, or steps described herein is part of the intended scope of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  provides an isometric view of an orthopedic fixation system. 
         FIG. 1B  provides a plan view of an orthopedic fixation system. 
         FIG. 2A  provides an isometric view of an insertion device being used to insert an implant into bones. 
         FIG. 2B  provides an isometric view of an implant being released from an insertion stick into bones. 
         FIG. 3A  provides an exploded isometric view of a sterile-packaged implant kit. 
         FIG. 3B  provides an assembled isometric view of a sterile-packaged implant kit. 
         FIG. 4A  provides an exploded isometric view of a sterile-packaged instrument kit. 
         FIG. 4B  provides an assembled isometric view of a sterile-packaged instrument kit. 
         FIG. 5A  provides an exploded view of a drill guide and an instrument handle. 
         FIG. 5B  provides an assembled isometric view of a drill guide system. 
         FIG. 6  provides an alternative embodiment of an orthopedic fixation system that includes a sizing guide. 
         FIG. 7  provides a plan view of a sizing guide. 
         FIGS. 8A-8J  provide a sequence of images showing the use of an orthopedic fixation system. 
         FIG. 9  provides a method for using a sterile orthopedic fixation system. 
         FIG. 10  provides a method for packaging a sterile orthopedic fixation system. 
         FIG. 11  provides a method for using an orthopedic sizing guide to select the proper implant. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. It is further to be understood that the figures are not necessarily to scale, and some features may be exaggerated to show details of particular components or steps. 
     In this invention, a method and system for a sterile packaged implant and complementary sterile packaged instrument kit are described. As shown in  FIGS. 1A and 1B , an orthopedic fixation system  100  consists of one or more sterile packaged implant kits  200 ,  201 , and  202 , and a sterile packaged instrument kit  300 . Implant kits  200 ,  201 , and  202  are identical, except that the implants maybe sized differently as required by the physician. 
     The orthopedic fixation implant is shown in  FIG. 2A . The fixation implant  205  consists of an implant made from a shape-memory or superelastic material such as nitinol. Implant  205  has two legs,  206  and  207 , that are designed to swing inward. Implant  205  is mounted on disposable insertion device  220 . The insertion device  220  holds the implant  205  such that implants legs  206  and  207  are held mechanically in a parallel position for easier insertion into bone.  FIG. 2A  shows the implant  205  being inserted into two bones  208  and  209 . Insertion device  220  can be twisted of implant  205 , as shown in  FIG. 2B , releasing the implant to squeeze bones  208  and  209 . 
     The representative sterile packaged implant kit  200  is shown in more detail in exploded view  FIG. 3A  and assembly  FIG. 3B . Implant kit  200  includes the aforementioned implant  205  and insertion device  220 . Implant kit  200  also includes a drill guide  230 . The purpose of drill guide  230  is to allow a surgeon to drill parallel holes into hone with the proper separation distance to match implant  205  and parallel legs  206  and  207 . Drill guide  230  has a universal mating shaft  231  that can be used to attach to a handle. The entire assembly, consisting of implant  205  mounted to insertion device  220  and matching drill guide  230  are placed into an implant package  210  suitable to house implant  205 , insertion device  220 , and matching drill guide  230  and maintain implant  205 , insertion device  220 , and matching drill guide  230  sterile. In particular, implant  205 , insertion device  220 , and matching drill guide  230  are placed into an implant tray  240 . Implant tray  240  could be made from thermoformed plastic or a similar material, and is shaped to hold and secure insertion device  220  and drill guide  230 . While implant tray  240  in the preferred embodiment is shaped to hold insertion device  220  with implant  205  mounted, one of ordinary skill in the art will recognize that implant tray  240  could hold insertion device  220  and implant  205  separately. Implant tray  240  fits into implant outer cover  245 , which protects all of the contents. Both implant tray  240  and implant outer cover  245  can be made from transparent plastic so that implant  205  is visible from outside. An implant seal  250  secures over and encloses implant outer cover  245  using any suitable means such as a heat and pressure activated adhesive. Implant seal  250  is made from a suitable material for insuring sterility while still allowing air passage. After sealing the system with implant seal  250 , implant kit  200  can be sterilized by any common sterilization method such as gas, radiation, or another type. All of the components of implant kit  200  can be made from disposable materials such as injection molded plastic, metal, or other suitable materials, with the exception of implant  205  which is made from a superelastic or shape-memory material. It is an objective of implant kit  200  to be packaged and then sterilized to simplify the surgical implantation of implant  205 , and then allow all of the other components to be discarded after surgery. 
     Instrument kit  300  is displayed in exploded view  FIG. 4A  and assembly  FIG. 4B . Instrument kit  300  is sterile-packaged and designed to work in conjunction with one or more implant kits  200 ,  201 , or  202 , or any combination of implant kits. In this embodiment, the instrument kit  300  includes multiple instruments needed by the surgeon for the implant kit. Instrument kit  300  consists of a handle  310  that mates with previously mentioned drill guide  230 . Instrument kit  300  also consists of one or more locating pins  320 , drill bit  330 , and tamp  340 . Locating pins  320  are used to fit inside drill guide  230 . Drill bit  330  also fits inside drill guide  230  and can drill a hole in bone. Tamp  340  is used to press down on implant  205  to push it flush to bone. The handle  310 , one or more locating pins  320 , drill bit  330 , and tamp  340  all fit into instrument package  305  suitable to house handle  310 , one or more locating pins  320 , drill bit  330 , and tamp  340  and maintain handle  310 , one or more locating pins  320 , drill bit  330 , and tamp  340  sterile. In particular, the handle  310 , one or more locating pins  320 , drill bit  330 , and tamp  340  all fit into instrument tray  350 . Instrument tray  350  is made from a thermoformed plastic or similar material that is shaped to conform and hold each instrument; namely, handle  310 , one or more locating pins  320 , drill bit  330 , and tamp  340 . Instrument tray  350  fits inside instrument outer cover  360 . Both instrument tray  350  and instrument outer cover  360  can be made from transparent plastic so that each instrument is visible from outside. An instrument seal  370  secures over and encloses instrument outer cover  360  using any suitable means such as a heat and pressure activated adhesive. Instrument seal  370  is made from a suitable material for insuring sterility while still allowing air passage. Instrument seal  370  adheres to instrument outer tray  360  to allow instruments  310 ,  320 ,  330 , and  340  to be sterilized and then maintain sterility. Instrument kit  300  is sterilized by any common method of sterilization such as gas or radiation. 
       FIG. 5A  shows handle  310  and drill guide  230  being positioned for assembly. Shaft  235  of drill guide  230  slides into handle  310  to make a connection.  FIG. 5B  shows assembled drill guide assembly  390 , consisting of handle  310  and drill guide  23 . 
     In a second embodiment, shown in  FIG. 6 , the orthopedic fixation system now includes an additional component.  FIG. 6  shows fixation system  500  consisting of one or more implant kits  200 ,  201 , and  202 , instrument kit  300 , and sizing guide  400 . Implant kits  200 ,  201 , and  202  and instrument kit  300  functions the same as in the preferred embodiment. Sizing guide  400  is shown in more detail in  FIG. 7 . It is a sterile packaged device made from plastic or a similar disposable material, with incremental projections on the perimeter. Representative projections  410  and  411  are shown in  FIG. 7 , however, any number of projections could be situated on the perimeter. Projections  410  and  411  have a known separation distance corresponds to the previously described separation distance of legs  206  and  207  on implant  205 . The measurement  415  between projections  410  and  411  is shown on sizing guide  400 . 
       FIGS. 8A-8J  show a sequence of images illustrating the use of a sterile-packaged orthopedic fixation system.  FIG. 9  shows a method for using a sterile orthopedic fixation system that corresponds to  FIGS. 8A-8J .  FIG. 8A  and step  600  of  FIG. 9  show sizing guide  400  being used to determine the proper size of implant needed for bones  208  and  209 .  FIG. 8B  and step  610  of  FIG. 9  show drill guide assembly  390  being created from handle  310  and drill guide  230  by inserting shaft  235  into handle  310 .  FIG. 8C  and step  620  of  FIG. 9  show drill guide assembly  390  and drill bit  330  being used to drill a hole into bone  209 .  FIG. 8D  shows locating pin  320  positioned in drill guide assembly  390  and extending into the hole in bone  209 . Locating pin  320  secures the drill guide assembly  390  in place while drill bit  330  is used to drill a hole in bone  208 .  FIG. 8E  and step  630  of  FIG. 9  show drill guide assembly  390  with two locating pins  320  securing it to bone.  FIG. 8F  shows that the two locating pins  320  are left in bones  208  and  209 .  FIG. 8G  and step  640  of  FIG. 9  show implant  205  mounted to insertion device  220 , being positioned over bones  208  and  209 .  FIG. 8H  and step  650  of  FIG. 9  show insertion device  220  being twisted off implant  205  to release implant  205  into bones  208  and  209 .  FIG. 8I  and step  660  of  FIG. 9  show implant  205  being pressed flush against bones  208  and  209  by tamp  340 . Finally,  FIG. 8J  shows multiple implants  205  in position on bones  208  and  209 . 
       FIG. 10  shows a method for packaging a sterile orthopedic fixation system. Step  700  involves inserting the implant into an insertion device. In step  710 , the insertion device with implant and corresponding drill guide is placed into a storage tray. In step  720 , the components of an instrument kit, including drill bit, location pins, tamp, and instrument handle are placed into an instrument tray. In step  730  both trays are sealed with lids. Finally, in step  740  both trays are sterilized via gas, radiation or other sterilization method. 
       FIG. 11  shows a method for using a sizing guide to determine the appropriate implant size for an orthopedic surgical procedure. Step  800  describes exposing bones that require surgery. Step  810  describes using a sizing tool by rotating it&#39;s projections over the bones. Step  820  involves selecting the proper implant that best fits the bones. 
     Although the present invention has been described in terms of the foregoing embodiments, such description has been for exemplary purposes only and, as will be apparent to those of ordinary skill in the art, many alternatives, equivalents, and variations of varying degrees will fall within the scope of the present invention. That scope, accordingly, is not to be limited in any respect by the foregoing detailed description; rather, it is defined only by the claims that follow.