Patent Publication Number: US-2021193306-A1

Title: Sterile implant tracking device and method

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to and is a continuation of U.S. Nonprovisional patent application Ser. No. 16/550,815 filed Aug. 26, 2019, now U.S. Pat. No. 10,741,281, which is a continuation of U.S. Nonprovisional patent application Ser. No. 16/160,185 filed Oct. 15, 2018, now U.S. Pat. No. 10,395,768, which is a continuation of U.S. Nonprovisional patent application Ser. No. 15/165,201 filed May 26, 2016, and issued as U.S. Pat. No. 10,102,339, which is a continuation of U.S. Nonprovisional patent application Ser. No. 13/964,308 filed Aug. 12, 2013 and issued as U.S. Pat. No. 9,355,289, which is a continuation-in-part of U.S. Nonprovisional patent application Ser. No. 13/710,591 filed Dec. 11, 2012 entitled “Sterile Implant Tracking Device and Method” and issued as U.S. Pat. No. 8,651,385, which is a continuation of U.S. Nonprovisional patent application Ser. No. 13/437,161 filed Apr. 2, 2012 entitled “Sterile Implant Tracking Device and Method” and issued as U.S. Pat. No. 8,430,320, which is a continuation-in-part of U.S. Nonprovisional patent application Ser. No. 13/271,343 filed Oct. 12, 2011, and issued as U.S. Pat. No. 8,146,825, which claims the benefit of U.S. Provisional Patent Application No. 61/512,978 filed Jul. 29, 2011 and U.S. Provisional Patent Application No. 61/492,177 filed Jun. 1, 2011, the entire content of each application is incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to an implant tracking system using an optical-based identification technique. 
     2. Description of the Related Art 
     Tracking and managing orthopedic implant replacements is an important health issue. Typically each implant contains a unique identification number, such as, for example, a manufacturer&#39;s identification and/or serial number. Whenever an implant is placed, this number is recorded as a permanent record in a database. In the future, this number can be referenced to track the age of the implant, the manufacturer for purposes of recall and adjustment, and can be used postmortem to identify a person having the implant. 
     The unique identification number may be tracked by identifiers, such as unique labels or other indicia, applied to the product and/or packaging, and the labels may remain associated with the implant until the implant is used. In some cases, product labels include adhesive portions that can be applied to a chart or file of a patient to conveniently associate the medical device with a particular patient. 
     The numerical values and ranges in this disclosure are exemplary and therefore can be adjusted to include lower or higher values and ranges as necessary to provide the intended operation of the various embodiments of the sterile implant tracking device and method. 
     Identifiers may be any graphic that is capable of retaining identifying information. In some embodiments, the identifier is a one or two dimensional bar code suitable for scanning by an optical scanner such as a bar code reader. The identifier may be a two dimensional (2D) etched matrix of 2 millimeters (mm) by 2 mm (2×2 mm) or 1.4 mm by 1.4 mm (1.4×1.4 mm). The identifier may also be a radio frequency identification tag that is readable through radio frequency transmission generated by an independently powered RFID device. The identifier may also be an RFID tag that includes a transponder and is readable in response to a radio frequency signal transmitted to the RFID device. In some embodiments, the identifier is a human readable visual and/or tactile graphic such as alphanumeric characters that can be manually recorded in a database or chart. 
     It would be beneficial if physicians were able to obtain additional information about an implant and/or a patient from an implant identifier such as the manufacturer and model number of the device, the serial number of the device, the treating physician&#39;s name and contact information, and the patient&#39;s name, contact information, medical condition and treatment, among other relevant information. 
     Currently, difficulty arises in tracking medical implants. For example, medical implants are difficult to track because the implants generally do not have adequate surface area for applying marks. Thus, in many instances, implants are not tracked beyond their manufacturing facility, and may only be counted when reconciled for payment as one of many products that were not returned to a manufacturer for replenishment. 
     There is a strong and growing need to not only track medical implants but to do so efficiently while maintaining a sterile operating environment. Therefore, if the tracking system involves a reader, such as a barcode scanner or RFID reader, then the reader itself needs to be sterile so as not to contaminate the medical implant of which it is reading or the personnel operating the reader. 
     Medical equipment may be sterilized by the use of chemical or physical agents, for example using hot steam, gas or gamma rays sterilization. However, these means may not be appropriate for more delicate medical equipment, such as a reader. 
     There exists a need for a sterile interface for use with a reader that allows for the efficient use of the reader in a sterile operating room environment. 
     SUMMARY 
     In an embodiment, the invention is an assembly for tracking implants comprising a (i) reader, (ii) medical drape, and (iii) computer. The reader comprises a (a) scanner, (b) housing structure comprising a cover and base, and optionally (c) transparent sterile sheath having a top surface and side walls and encases the cover of the housing structure. The cover has an aperture through the top surface of the cover. The medical drape is attached to the side walls of the transparent sterile sheath. The computer is in communication with the reader. 
     In an embodiment, the invention is a reader comprising a scanner, a scanner mounting structure supporting the scanner, a housing structure comprising a cover and base, and an optional transparent sterile sheath encasing the cover of the housing structure. The base comprises a top surface to receive the scanner mounting structure, an inset groove to receive the cover, an inset channel extending radially from the cover to the edge of the top surface of the base, and a removable channel cover. The scanner mounting structure is attached to the base, and both the scanner and mounting structure are enclosed in the housing structure. 
     In an embodiment, the invention is a method of using a reader comprising the steps of providing a reader, placing an implant having an identifier onto the top surface of the transparent sterile sheath above the aperture, and scanning the identifier of the implant to electronically record the stored data. 
     In an embodiment, the invention is a tracking assembly comprising a reader comprising, a housing structure that includes a base and a cover, a scanner having a scanner housing, where the scanner housing is at least partially positioned in a cavity provided in the base; and an aperture provided in the cover, where the cover is configured to receive a transparent sterile sheath to at least partially encase the cover. 
     In an embodiment, the invention is a tracking assembly comprising, a reader comprising, a scanner; a scanner mounting structure supporting the scanner; a housing structure that includes a cover with an aperture on a top surface of the cover and a base secured to the cover, where the housing structure is configured to receive a one or more coverings to at least partially enclose the housing structure, where the scanner mounting structure is secured to the base, and where the scanner and scanner mounting structure are substantially enclosed in the housing structure. 
     In an embodiment, the invention is a method of using a tracking assembly comprising the steps of: providing a tracking assembly comprising a reader that includes a scanner and a housing structure with a cover having an aperture on a top surface; covering the cover with a transparent sterile sheath; placing an implant having an identifier over the aperture; and scanning the identifier of the implant to electronically record the implant data. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is described generally with reference to the drawings for the purpose of illustrating certain embodiments only, and not for the purpose of limiting the scope of the invention. In the drawings, like numerals are used to designate like parts throughout the same. 
         FIG. 1  is a schematic of an assembly of an embodiment of the invention including a reader and medical drape. 
         FIG. 2A  is a sectional view of the assembly of  FIG. 1 . 
         FIG. 2B  is a sectional view of an embodiment of the assembly of  FIG. 1 . 
         FIG. 3A  is an exploded view of the reader of  FIG. 1 . 
         FIG. 3B  is an exploded view of an embodiment of the assembly of  FIG. 1 . 
         FIG. 4  is an exploded view of the reader of  FIG. 3A  without the cover. 
         FIG. 5  is a bottom view of the removable channel cover. 
         FIG. 6  is a sectional view of the reader of  FIG. 2A . 
         FIG. 7  is a sectional view of  FIG. 6 . 
         FIG. 8  is a sectional view of  FIG. 6 . 
         FIG. 9  is a top view of the scanner in  FIG. 1 . 
         FIG. 10  is a sectional view of  FIG. 9 . 
         FIG. 11  is a schematic of a handheld reader and cradle of an embodiment of the invention. 
         FIG. 12  is a schematic of the handheld reader and a base structure. 
         FIG. 13A  is a schematic of the handheld reader enclosed within a medical drape. 
         FIG. 13B  is a schematic of the handheld reader and hand of a user enclosed within a medical drape. 
         FIG. 14  is a schematic of the reader of  FIG. 12  enclosed within the housing structure of the assembly of  FIG. 1 . 
         FIG. 15  is a schematic of another embodiment of the implant tracking assembly that includes a reader, a sheath, and a medical drape. 
         FIG. 16  is a perspective view of the reader and sheath of  FIG. 15 . 
         FIG. 17  is an exploded perspective view of  FIG. 16 . 
         FIG. 18  is an exploded perspective view of various portions of the reader of  FIG. 15 . 
         FIG. 19  is a sectional side view taken at line  19 - 19  of  FIG. 16 . 
         FIG. 20  is a schematic of an embodiment of the implant tracking assembly. 
         FIG. 21  is a perspective view of an embodiment of the sheath and drape of  FIG. 20 . 
         FIG. 22  is a side view of the sheath and drape of  FIG. 21 . 
         FIG. 23  is a perspective view of another embodiment of the sheath and drape of  FIG. 20 . 
         FIG. 24  is a side view of the sheath and drape of  FIG. 23 . 
         FIG. 25  is a perspective view of the sheath and drape of  FIG. 20 , in an exemplary folded configuration. 
         FIG. 26  is a sectional side view taken at line  26 - 26  of  FIG. 25 . 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure provides a system for tracking implants (e.g., screws, plates, cages, nuts, rods, etc.). An advantage of the present method for tracking an implant is a vast improvement in sterility and efficiency over current tracking methods. Typically, in an operating room, the patient to receive the implant is lying on an operating table in the center of the room. There is a sterile field extending two to three feet radially from the operating table. The present assembly comprising a reader assembled with transparent sterile sheath and sterile medical drape may be inside the sterile field. A computer, in communication with the reader, is typically outside the sterile field and, in certain instances, operated by a person outside the sterile field. The operator of the computer can log into the software which is password protected as the surgery is beginning and input certain information such as the patient&#39;s name, etc., to save time. 
     The present method increases efficiency in the operating room by decreasing the time spent during operation on scanning and tracking every implant going into the patient while maintaining a sterile environment. For example, during spinal surgery, the surgeon requests numerous screws, plates, hooks, and cages, and each implant must be tracked by recording its manufacturer&#39;s information, lot number, serial number, etc., in addition to where that screw is implanted in the spine. Using the present assembly, the surgeon would request a screw, for example, having an identifier on its surface. The assistant would take the screw out of the sterile package and set the screw down on top of the transparent sterile sheath above an aperture on the reader. The reader would beep to indicate a successful scan of the identifier, and the assistant would hand the screw to the surgeon for implantation. The information (manufacturer&#39;s information, lot number, serial number, etc.) obtained from the identifier by the reader is transferred to the computer and the user of the computer can input data that indicates where the screw was implanted according to the surgeon&#39;s instruction. The location data of where the implant is placed in the patient may be aided by the software, which pulls up an anatomical image where the user of the computer can then just select visually where the implant was inserted. 
     Table Top Implant Tracking Assembly 
       FIG. 1  depicts an embodiment of an implant tracking assembly  10  which includes reader  20  and medical drape  24 .  FIG. 1  shows reader  20  comprising an optional transparent sterile sheath  22  that fits, preferably snugly, over the top surface of reader  20 . Assembly  10  includes medical drape  24  which is temporarily attached to and extends radially from the side walls of the transparent sterile sheath  22  to cover the remaining elements of the reader, such as possible electrical cords and control panels, among other things. Assembly  10  includes a computer  25  (not shown) in communication with reader  20 . Although  FIG. 1  shows reader  20  placed on a table, the table is not part of the assembly  10 . The reader device in assembly  10  may be a table top reader, a handheld reader, or a table top-handheld reader. The implant tracking assembly  10  can include one or more coverings to provide limitation of contaminants to and/or from reader  20 , where the one or more coverings can include the transparent sterile sheath  22  and medical drape  24 . 
     Table Top Reader 
       FIG. 2A  is a sectional view of reader  20 . Reader  20  includes scanner  26 , scanner mounting structure  30 , and housing structure  32  including cover  33  and base  34 . As seen in  FIGS. 2A-4 , base  34  of housing structure  32  includes a base top surface  36  to receive the scanner mounting structure  30 , and inset groove  38  to receive the bottom edge of cover  33 . One or more vertical pins  40  may extend up from the bottom of the base through the inset groove  38 . The shape of the base may be circular as shown in  FIG. 1 , but as one skilled in the art would understand, the disclosure is not limited to a circular base. In addition, in at least some embodiments, base  34  includes a diameter DI that extends between about 6 inches to about 10 inches. Further, base  34  can weigh between about one pound to about four pounds.  FIG. 2A  shows an embodiment where the base has a track creating a lip or shelf that allows for easy transport or mobility of the reader by a user inserting their fingers into the track and picking up the reader. Further, cover  33  and base  34  can be integrally formed, although the separability of cover  33  and base  34  can allow for insertion/installation of various components inside housing structure  32 , in at least some embodiments, an alternate access may be provided to facilitate access for insertion of one or more components therein if cover  33  and base  34  are integrally formed. 
       FIG. 3A  is an exploded view of housing structure  32  and transparent sterile sheath  22 . Housing structure  32  further includes cover  33 . Cover  33  includes cover top surface  46  and side wall  48 , as seen in  FIG. 3A . In an embodiment, cover top surface  46  is circular and thus the side wall  48  is in the shape of a cylinder. Alternatively, cover top surface  46  may be square or rectangular, yielding four side walls  48 . Side wall  48  may have at least one radial pin  52  extending radially out from the side wall  48 . The cover top surface  46  has an aperture  54  that may be circular, oblong, square, or any other shape that allows the reader device to properly scan a medical implant placed above aperture  54 . Side wall  48  may have at least one pin hole extending vertically into side wall  48  to receive vertical pin  40 . Equivalents of pins are screws, bolts, nails, etc. In an embodiment, cover  33  is engaged with inset groove  38  of base  34  and vertical pin  40  is engaged with pin hole  50  of cover  33 , securing cover  33  from any lateral movement. Cover  33  may sit in the center of base  34  or, more preferably, off center. 
     Housing structure  32  is made of an opaque material such as from a dense molded plastic, preferably a dark color, more preferably black. Utilizing a darker color can serve to reduce light noise, such as reflections of light, which can hinder the reader&#39;s ability to provide effective scans. Although in at least some embodiments, one or more portions of housing structure  32  can be comprised of materials other than plastic, as well as lighter colors. 
       FIG. 4  is an exploded view of base  34 , scanner mounting structure  30 , and scanner  26 . In an embodiment, scanning mounting structure  30  is bolted or otherwise securely fastened to a top surface of removable channel cover  44 . Alternatively, scanning mounting structure  30  is bolted to base top surface  36  of base  34 . Scanner  26  is housed in scanner housing  55 , which is attached to scanning mounting structure  30  by screws that are received into receptacles  56  of scanner housing  55  (see  FIG. 10 ). The position of scanner  26  is locked on the focal point of scanner  26 , which is 1-3 millimeters (mm), preferably 1-2 mm, above the top surface of cover  33  in the area above aperture  54 . When reader  20  comprises transparent sterile sheath  22 , the focal point is on the surface of transparent sterile sheath  22  in the area above aperture  54 . Alternatively, scanner  26  may be manufactured with adjustable knobs to allow a user to manually adjust the position of the scanner for an optimal read, as shown in  FIGS. 2B and 3B . 
     Base  34  includes an inset channel  42  extending radially from the scanner mounting structure  30  to the edge of base  34  where the electrical cords from scanner  26  lie in inset channel  42  and extend out to a power source, control panel, or other appropriate source, as shown in  FIG. 3B . Preferably, as shown in  FIG. 4 , inset channel  42  houses circuit board  58  which is in communication with scanner  26  and computer  25 , typically, via electrical cords or wirelessly. In an embodiment, circuit board  58  is equivalent to the circuit board found in Motorola Symbol DS6707-DP. 
     Circuit board  58  is securely positioned in inset channel  42  in circuit board mold  60 . Circuit board mold  60  is designed such that the outer surface matches the shape of inset channel  42  and the inner surface matches that of the shape of circuit board  58 . Circuit board mold  60  is secured to base  34  by screws or pins and removable channel cover  44  is secured to circuit board mold  60  by screws or pins. In an embodiment, circuit board  58  comprises button  62 , which activates scanner  26  to take a scan upon depressing button  62 . The inner surface of circuit board mold  60  is designed such that when circuit board  58  is positioned in circuit board mold  60 , button  62  is constantly depressed into the “on” position, which can be seen in  FIG. 7 . 
     Removable channel cover  44  is designed such that when in place it is merely a part of the top surface of the base. Removable channel cover  44  may be removed and slid, snapped, or placed back into place covering inset channel  42 .  FIG. 5  is a bottom view of an embodiment of removable channel cover  44 . Removable channel cover  44  has two perpendicular slats  66 , which engage with the inner surface of circuit board mold  60 .  FIG. 8  is a sectional of  FIG. 6  that shows removable channel cover  44  further secured in place by screws which extend into circuit board mold  60 .  FIG. 6  also shows perpendicular slats  66  of removable channel cover  44  engaged with the inner surface of circuit board mold  60 . 
       FIG. 6  is a sectional view of  FIG. 2 . In an embodiment, magnet  64  is positioned inside cover  33  and is attached to base  34  or scanner housing  55 . Most preferably, magnet  64  is built into base  34 . Base  34  has a cut out specifically for magnet  64  to be placed into such that magnet  64  is flush with the base top surface  36 . Magnet  64  is positioned off center and closest to the side of button  62 . Magnet  64  has sufficient strength to allow scanner  26  to take a scan only when a user places a scannable object in the focal point of scanner  26 . 
       FIG. 9  is a top view of scanner  26 . Scanner  26  has conical walls  68  inside scanner housing  55 . Scanner housing  55  includes shield  70 , which extends beyond conical walls  68 . Preferably, shield  70  comprises shield wings  72 , which extend further on two opposite sides (see  FIG. 4 ). 
     In an embodiment, scanner  26  is capable of reading identifiers such as conventional barcodes, etched matrixes, or any other optical indicator on an implant. In an embodiment, scanner  26  is equivalent to the scanner in Motorola Symbol DS6707-DP. In an embodiment, the reader further comprises a light emitting diode (LED)  28  for enhancing the visual indication of scanner  26 , as shown in  FIGS. 2B and 3B . 
     In an embodiment, reader  20  comprises an optional transparent sterile sheath  22  as shown in  FIGS. 3A and 3B  which encases cover  33  of reader  20 . Transparent sterile sheath  22  can be partially or completely transparent, while in at least some embodiments, transparent sterile sheath  22  can be provided without transparent portions, provided that scanner  126  includes the capability to scan identifiers through the level of transparency provided by transparent sterile sheath  22 . In at least some embodiments, sterile sheath  22  can be at least partially opaque, with the exception of at least a portion that covers aperture  54 . Transparent sterile sheath  22  has sheath top surface  75  and sheath side wall  76 . Preferably, sheath top surface  75  is slightly convex to deflect ambient light. In at least some embodiments, the convex portion of sheath top surface  75  can be substantially limited to the portion covering aperture  54 . The degree of convexity is such that the transparent sheath reflects ambient light that interferes with the reader. Ambient light is background light typically present in an operating room. In an embodiment, sheath side wall  76  has at least one radial pin slot  77  designed to receive radial pin  52  of cover  33 .  FIG. 3A  shows an embodiment in which two radial pin slots  77  are in an inverted “L” shape, such that when radial pin  52  of cover  33  engages with the radial pin slots  77  and the transparent sterile sheath  22  is twisted, it temporarily locks the transparent sterile sheath  22  in place by hindering vertical movement. One skilled in the art would understand the transparent sterile sheath could be temporarily locked into place over cover  33  in various manners. Alternatively, transparent sterile sheath  22  may just rest over cover  33  without any mechanism to lock the sheath in place. 
     Transparent sterile sheath  22  is designed such that when transparent sterile sheath  22  is engaged with housing structure  32  the area of sheath top surface  75  directly above aperture  54  of housing structure  32  is at the focal point of scanner  26 . Placement of an implant with an indicator directly on the sheath top surface  75  directly above aperture  54  allows for the scanner to read the indicator without an operator having to hover the implant device over aperture  54  and search for the focal point of the scanner  26 . 
     In an embodiment, transparent sterile sheath  22  is formed of a single piece of rigid transparent plastic. In an embodiment, transparent sterile sheath  22  is formed of a non-conductive, flexible, easily distortable, resilient material, which can be sterilized. Preferably, transparent sterile sheath  22  is disposable, such that transparent sterile sheath  22  is disposed of after identifiers have been received for all the medical implants implanted in a single patient during an operation. 
     The thickness of transparent sterile sheath  22  is such that does not interfere with the reader device&#39;s ability to obtain data from an identifier on a medical implant. Transparent sterile sheath  22  may be made of one or more of an elastomer, plastic, rubber, polyethylene, or polypropylene, among other materials that result in a functioning transparent sterile sheath  22  of the invention. In an embodiment, transparent sterile sheath  22  is made of a rigid, transparent plastic such as polycarbonate. 
     Transparent sterile sheath  22  may have additional properties that enhance the reader device&#39;s abilities. For example, in an embodiment, the sheath top surface  75  has magnifying abilities to allow a reader device to gather information from a smaller identifier such as a barcode or a 2D-grid or matrix the size of 2 millimeters (mm) by 2 mm, and even 1.4 mm by 1.4 mm. In an embodiment, the transparent sterile sheath  22  adheres to reader  20  such that the seal between transparent sterile sheath  22  and cover top surface  46  creates a vacuum between transparent sterile sheath  22  and the reader device. A vacuum between reader  20  and transparent sterile sheath  22  allows for improved reading of reader  20 . 
     Assembly  10  comprising table top reader  20  further increases the efficiency of implant tracking by allowing a user to place the implant having the identifier on the surface of a transparent sheath for an accurate, automatic scan of the identifier. The user is not having to spend precious time waving/hovering the implant in front of a handheld reader to find the focal point of the scanner to obtain a scan during surgery. The inventive structure of reader  20  provides an efficient and sterile implant tracking device. 
     Handheld Reader 
       FIGS. 11-14  are embodiments of an assembly comprising handheld reader  80  including reader lens  82  and handle  84 . Handheld reader  80  contains an optical scanner. In an embodiment, the optical scanner is equivalent to that found in Motorola Symbol DS6707-DP.  FIG. 11  is an embodiment of an assembly comprising a handheld reader  80  positioned in cradle  86 , wherein handheld reader  80  is detachably connected to the cradle. Handheld reader  80  further comprises transparent sterile lens cover  88  which allows for an implant bearing an identifier to come into close proximity to the lens cover  88  for scanning without compromising the implant&#39;s sterility. Transparent sterile lens cover  88  may have magnifying abilities to allow the reader device to gather information from a smaller barcode or a 2D-grid or matrix the size of 2 millimeters (mm) by 2 mm, and even 1.4 mm by 1.4 mm. The focal point of the scanner is just above (1-2 mm) the surface of transparent sterile lens cover  88 . 
       FIG. 12  shows an embodiment of handheld reader  80  further comprising base structure  90  built off of handle  84  of the handheld reader that allows the user to place handheld reader  80  on a flat surface and operate handheld reader  80  without holding onto it.  FIG. 12  shows transparent sterile lens cover  88  engaged with reader lens  82 . In an embodiment, transparent sterile lens cover  88  releasably attaches to reader lens  82  to temporarily fix transparent sterile lens cover  88  in place over reader lens  82  of handheld reader  80 . In an embodiment, transparent sterile lens cover  88  snaps into place over reader lens  82  with the application of minor force. 
     Table Top-Handheld Reader 
     In an embodiment shown in  FIG. 14 , handheld reader  80  is placed inside housing structure  32  of  FIG. 1  by replacing scanner  26  and scanner mounting structure  30 . Handheld reader  80  may be positioned in cradle  86  which is secured and/or mounted to base  34 . In an embodiment, handheld reader  80  does not contain handle  84 . Alternatively, handheld reader  80  may comprise base structure  90  which is mounted to base  34 . Reader lens  82  is positioned below aperture  54  which is covered by transparent sterile sheath  22  such that the focal point of handheld reader  80  is on or right above the surface of transparent sterile sheath  22  in the area above aperture  54 . As a typical handheld reader is operated by a trigger on handle  84 , a scanner switch  92  may be positioned on base  34  outside of cover  33  which allows the user to press to activate handheld reader  80 . Alternatively, magnet  64  may be positioned near handheld reader  80  to keep handheld reader  80  activated and continually taking scans when an implant having an identifier is placed on the focal point. The handheld reader  80  may or may not include transparent sterile lens cover  88 . Any of the transparent sterile sheath  22 , transparent sterile lens cover  88  and reader lens  82  may have magnifying abilities that are compatible with each other. 
     Medical Drape 
     Assembly  10  further comprises a medical drape. Medical drape  24  may be made of conventional medical drape material. Alternatively, medical drape  24  is transparent and flexible to enable use of a control panel on a reader device. Medical drape  24  may allow for the manipulation of buttons, calibrating dials, and adjusting knobs frequently associated with reader  20 . 
     As shown in  FIGS. 1, 2A, and 2B , medical drape  24  temporarily attaches to side wall  76  of transparent sterile sheath  22  and extends out radially to maintain a sterile environment. Medical drape  24  may comprise an elastic band to attach to sheath side wall  76 . Alternatively, medical drape  24  may clip onto sheath side wall  76  for attachment. Any attachment mechanism may be used to attach medical drape  24  to sheath side wall  76 . In at least some embodiments, medical drape  24  can be permanently adhered to sheath side wall  76  prior to installation on reader  20 . 
       FIGS. 13A and 13B  show an embodiment in which medical drape  24  is attached to transparent sterile lens cover  88  of handheld reader  80 . Medical drape  24  unrolls from lens cover  88  and creates a barrier between the reader device and the sterile environment. In the situation depicted in  FIG. 13A , the user, usually wearing a sterile glove, would generally operate handheld reader  80  by holding reader  80  on top of medical drape  24 . Alternatively, as shown in  FIG. 13B , the medical drape is designed to fit over the user&#39;s hand. 
     Medical drape  24  may be made of conventional medical drape material, although various other materials can be utilized alone or in combination. Alternatively, medical drape  24  is transparent and flexible to enable use of a control panel on a reader device. Medical drape  24  may allow for the manipulation of buttons, calibrating dials, and adjusting knobs frequently associated with reader  80 . 
     Computer 
     Assembly  10  comprises computer  25  in communication with reader  20 . 
     Computer  25  is equipped with software that allows recording and manipulation of input data from reader  20 . The software is designed to receive information (manufacturer&#39;s information, lot number, serial number, etc.) obtained from the identifier upon being scanned by the reader. The software further allows the user of the computer to input data that indicates where the screw was implanted according to the surgeon&#39;s instruction. The location data of where the implant is placed in the patient may be aided by the software, which pulls up an anatomical image where the user of the computer can then just select visually where the implant was inserted. Computer  25  is usually outside the sterile field. Alternatively, the computer may be part of the same assembly as the reader. The term computer is meant to encompass desktop computers, laptops, tablets, and pads, among others, as well as various other devices capable of receiving and storing data. 
     Additional Components 
     Assembly  10  may further include additional components such as a keyboard, mouse, stylus, printer, display screen or other interface that allows a user to interact with the system such as to input information, issue commands, power the device on and off, perform file management, upgrade software and database information, monitor output, receive feedback and perform other administrative and non-administrative tasks. 
     Implant Tracking Method 
     The present disclosure provides a method of tracking a medical implant including providing a reader as described above, placing a transparent sterile sheath over the housing structure of the reader device, placing an implant device having an identifier on the top surface of the transparent sterile sheath above the aperture of the housing structure, and scanning the identifier of the implant device to record the stored data. 
     An advantage of the present disclosure is a method of tracking an implant that allows for greater efficiency and ease of use by the operator, while maintaining a sterile environment. By using the implant tracking method of the present disclosure, the user does not have to hand record the implant identifying information, which allows a faster operating procedure. Nor does the user need to spend time finding the focal point of the scanner to obtain an accurate read of the identifier. The method of the present disclosure is designed to allow a user to place the implant with the identifier onto its top surface to obtain an accurate scan of the identifier and then quickly pass the implant to the surgeon for implantation, all while not compromising the sterility of the implant or surgical field. The scanner takes a scan automatically when the identifier is placed on the top surface of the transparent sheath above the aperture. Thus, the user does not have to bother with a button to activate the scanner to take a scan while handling in the implant. 
     In an embodiment, the identifier is a conventional 4×4 millimeter (mm) matrix, or a non-conventional 2×2 mm, or 1.4×1.4 mm matrix laser etched directly onto the implant device. By having the identifier etched directly into the surface of the medical implant, the user does not have to bother with scanning external tags to the medical device and removing the tag prior to the implant procedure, thus allowing for a more efficient method of tracking. 
     The method further includes positioning a medical drape to cover the remaining portions of a reader device. In an embodiment, the positioning of the medical drape to cover the remaining portions of a reader device includes unrolling the medical drape from the transparent lens cover to extend around the remaining portions of the reader device. In an embodiment, the positioning of the medical drape to cover the remaining portions of a reader device further includes unrolling the medical drape to extend around the remaining portions of the reader as well as the user&#39;s arm operating the reader device. 
     Referring to  FIGS. 15-19 , an exemplary embodiment of implant tracking assembly  110  is provided that includes various components that are similar in form and/or function to various components described above with respect to implant tracking assembly  10 . It shall be understood that various components described below, with like names to those described above, can include one or more of the aforementioned features, such as shapes, dimensions, materials, configuration, uses, etc., as described above. 
       FIG. 15  provides a perspective view of implant tracking assembly  110  with reader  120 , transparent sterile sheath  122 , and medical drape  124 .  FIG. 16  provides a perspective view of reader  120  and transparent sterile sheath  122 . Reader  120  includes housing structure  132  having cover  133  and base  134 . Referring to  FIG. 17 , an exploded perspective view of reader  120  and transparent sterile sheath  122  is provided. Base  134  includes base top surface  136  having inset groove  138  formed therein. Inset groove  138  is sized and shaped to fittingly receive planar cover bottom surface  135  of cover  133 . Base pin holes  141  are provided, which pass through inset groove  138  to allow vertical pins  140  to pass therethrough and secure to pin holes  150  in cover  133 . In this regard, cover  133  can be secured to base  134  without the need for protruding fasteners. In addition, base  134  includes cavity  139 , which extends from base top surface  136  towards base bottom  143 . Cavity  139  is configured to receive scanner  126 , such that at least a portion of scanner  126  is recessed below base top surface  136 . In at least some embodiments, cavity  139  forms a rectangular shape sized to accommodate scanner  126 , while in other embodiments, cavity  139  is sized and shaped to accommodate various other types, sizes, and shapes of scanners. 
     As seen in  FIG. 17 , transparent sterile sheath  122  includes generally circular sheath top surface  175  and cylindrical sheath side wall  176  that extends perpendicularly downward from sheath top surface  175  to sheath bottom surface  147 . As discussed above, in at least some embodiments, sheath top surface  75  is slightly convex to deflect ambient light. In addition, transparent sterile sheath  122  includes one or more radial pin slots  177 , which are configured to engage one or more radial pins  152  on cover  133  to provide securement of transparent sterile sheath  122  to reader  120 . Transparent sterile sheath  122  is sized and shaped to fit over cover  133 . More particularly, cover  133  includes generally circular cover top surface  146  and cylindrical side wall  148  that extends substantially perpendicularly downward from cover top surface  146  to flange  151 . Flange  151  includes a flange top surface  153 , which is configured to receive sheath bottom surface  147  when transparent sterile sheath  122  is installed. Flange side wall  181  extends downward towards base  134  and includes cover bottom surface  135 , which is configured to rest on the inset groove  138  when cover  133  is installed on base  134 . Although transparent sterile sheath  122  is intended to fit over cover  133 , one or both of transparent sterile sheath  122  and cover  133  can vary in shape to provide greater or fewer conforming surfaces. 
     Cover  133  further includes aperture  154  having an aperture perimeter  159 , where aperture  154  allows scanner  126  to obtain information from exemplary object  161  (see  FIG. 19 ) when positioned over the aperture  154 . Aperture  154  may be positioned in one of various locations about the cover  133  to provide suitable access to a user and to accommodate the field of view of the scanner  126 . In addition, if scanner  126  is configured to sense identifier  111  having a non-optical component (e.g., RFID), then the aperture  154  may be omitted entirely and the cover  133  comprised of a material that allows signal-based communication therethrough, or the cover  133  may include a portion of the cover material that is capable of allowing signal-based communication therethrough. 
     Referring to  FIG. 18 , an exploded perspective view of reader  120  with cover  133  removed is provided. As shown, scanner  126  includes scanner housing  155  that is secured to scanner mounting structure  130  by one or more scanner fasteners  163 . Scanner mounting structure  130  is shaped to provide a suitable angle for scanner  126  to read identifiers  111  through aperture  154 . Scanner  126  is connected to plug  165  at one end of cord  167 . Plug  165  provides a removable connection between cord  167  and scanner  126 . Cord  167  connects scanner  126  to another device, such as computer  125 , as discussed above. Base  134  includes mount passages  169  configured to receive mount fasteners  171  that are inserted through mount passages  169  and secured to scanner mounting structure  130 . In this manner, scanner  126  can be installed in reader  120  by securing scanner  126  to scanner mounting structure  130 , plugging in plug  165 , and inserting both into cavity  139  and securing to base  134 . Base  134  further includes cord passage  173  that extends from cavity  139  to outside base  134  to provide an outlet for cord  167 . 
     Referring to  FIG. 19 , a sectional side view taken at line  19 - 19  of  FIG. 16  is provided. For illustrative purposes, although medical drape  124  was not shown in  FIG. 16 , it has been included on  FIG. 19 . As shown in  FIG. 19 , scanner  126  includes lens assembly  178  extending from scanner housing  155  and directed towards aperture  154 . Lens assembly  178  includes front surface  189 , where front surface  189  extends to aperture  154  along a distance D, where distance D is between about 3 inches to about 5 inches. In at least some embodiments, scanner  126  is a Model No. DataMan  500  barcode reader, as manufactured by COGNEX located in Natick, Mass. However, in at least some other embodiments, other models, types, and brands of scanners can be provided. The DataMan  500  model, as well as other types of scanners can be modified from their original manufactured form. For example, the original scanner housing can be reduced in size to fit accordingly in cavity  139 , such as by removing portions of the scanner housing without damaging or otherwise rendering other necessary portions or components non-functional. Scanner  126  is configured to read identifier  111 , which is located on object  161 , such as a medical implant, as discussed above. Identifier  111  is communicated to computer  125  for recordation and/or display. It shall be understood that various components described below with like names to those described above, can include similar functions and features, such as shapes, dimensions, materials, configuration, uses, etc., as described above. 
     Referring to  FIG. 20 , implant tracking assembly  210  is illustrated, which includes reader  120  enclosed by sheath  222  and drape  224 . As shown, implant tracking assembly  210  is positioned on table  108 , which is representative of one of many types of support surfaces that implant tracking assembly  210  can be situated on during a medical procedure. Additionally, in at least some embodiments, sheath  222  is similar or identical to transparent sterile sheath  22  and transparent sterile sheath  122 . As shown, drape  224  extends from sheath  222 , over reader  120 , and over one or more cords  267  connected to reader  120 . Drape  224  is secured to sheath  222  in one of a temporary or permanent manner, as discussed further below. 
     Referring to  FIGS. 21 and 22 , a perspective and side view of sheath  222  and drape  224  are illustrated. As shown, sheath  222  includes generally circular sheath top surface  275  and cylindrical sheath side wall  276  that extends perpendicularly downward from sheath top surface  275  to sheath bottom surface  247 . In at least some embodiments, sheath top surface  275  may be slightly convex to deflect ambient light. In at least some embodiments, sheath  222  includes an interlocking engagement, such as one or more radial pin slots  277 , which are configured to engage one or more radial pins  152  on cover  133  to provide securement of sheath  222  to reader  120 . In other embodiments, sheath  222  may be positioned over cover  133  without an interlocking engagement. 
     The sheath  222  is sized and shaped to fit over cover  133 , as such, although sheath  222  is illustrated as cylindrical, other shapes, such as rectangular, pyramidal, etc. may be utilized sheath  222  to accommodate various cover  133  shapes. Similar to transparent sterile sheaths  22  and  122 , sheath  222  may be transparent, partially transparent or include varied levels of transparency. In addition, sheath  222  can vary in signal-based transparency as well as optical transparency, wherein signal-based transparency allows for transmission of a non-optical scanning signal (not optically dependent) between reader  120  and identifier  111  ( FIG. 19 ) of an object  161 , and therefore, may be independent of the level of optical transparency or sheath coloring. 
     As discussed above, cover  133  includes aperture  154  having an aperture perimeter  159 , wherein aperture  154  allows scanner  126  to obtain information from object  161  (see  FIG. 19 ) when positioned over aperture  154 . As sheath  222  covers cover  133 , the scan will also pass through sheath  222 . To accommodate scanning therethrough, sheath  222  is comprised of a material that is completely or at least partially optically transparent or signal-based transparent. For example, sheath  222  may be substantially opaque, but include a window (not shown) that is positionable over at least aperture  154  to allow scanner  126  to view or otherwise communicated with identifier  111  of object  161 . 
     Referring to  FIGS. 21 and 22 , sheath  222  is shown with drape  224 . The drape  224  includes drape upper portion  283  and drape lower portion  285 , where the drape upper portion  283  includes a first end  291  of drape  224  and drape lower portion  285  includes a second end  287  of the drape  224 . The drape  224  is secured to and extends radially from sheath side wall  276  to enclose reader  120 , and various related components, such as electrical cords and control panels, among other things. 
     As shown, first end  291  of drape  224  is secured to sheath side wall  276  along securement band  293 , which encircles sheath side wall  276 . The securement can be one of temporary or permanent and in at least some embodiments, provides an airtight seal. In a temporary configuration, drape  224  may be held to sheath  222  by a fastener, such as a rubber band or clip. Any attachment mechanism may be used to attach drape  224  to sheath side wall  276 , although in the present embodiment, first end  291  is permanently secured to sheath  222 . A permanent securement may be performed in one of various manners, such as heat welding, heat sealing, chemical adhesives, etc. Drape  224  may be comprised of conventional medical drape material or another suitable material, such as vinyl, that is sterilizable and able to provide a sufficient sterile barrier to limit or prevent contamination between reader  120  and the surrounding environment. Drape  224  may be configured with one or more of various levels of transparency, and may be flexible enough to enable use of a control panel on reader  120 . More particularly, drape  224  may include sufficient flexibility to allow for the manipulation of buttons, calibrating dials, and adjusting knobs that may be associated with reader  120 . 
       FIGS. 21 and 22  provide an embodiment of drape  224  that includes a generally pyramidal-shaped drape upper portion  283 , which extends from sheath side wall  276  to the drape lower portion  285 . The drape lower portion  285  then extends in a linear manner (i.e., parallel sidewalls) along drape sides  294 .  FIGS. 23 and 24  provide an embodiment of drape  224  that includes a generally conical-shaped drape upper portion  283  that extends from sheath side wall  276  to the drape lower portion  285 . The drape lower portion  285  then extends in a cylindrical manner (i.e., parallel sidewalls) along drape sides  294 . Although drape lower portion  285  is shown and described as extending linearly and cylindrically, drape lower portion  285  may extend in other manners with varied sizes and shapes, and may include a closure (not shown), such as a drawstring, elastic band, etc. at the second end  287 . 
     As shown in  FIG. 20 , drape lower portion  285  extends over reader  120  and a length of cord(s)  267 . In this manner, drape  224  can provide a sterile barrier that extends for several feet, for example six feet, to allow reader  120  to be situated adjacent to a patient during an implant procedure. In at least some embodiments, drape  224  may extend to cover additional components connected to reader  120 . Fasteners, such as tie strap  299 , can be used to secure the drape lower portion  285 , which can substantially limit or prevent air exchange between reader  120  and environmental air outside sheath  222  and drape  224 , as shown in  FIG. 20 . The extended drape lower portion  285  allows for positioning of reader  120  adjacent to the patient, which allows an assistant to scan objects  161  (i.e., implants) and pass them directly to a surgeon for implantation as quickly and efficiently as possible, and without leaving the near proximity of the surgeon. 
     Referring to  FIGS. 25 and 26 ,  FIG. 25  illustrates a perspective view of sheath  222  and medical drape  224  of  FIG. 20 , in a rolled configuration, and  FIG. 26  illustrates a sectional side view taken at line  25 - 25  of  FIG. 25 . Prior to installation of sheath  222  and drape  224 , drape  224  is situated in a folded configuration, such as a telescopic fold, to facilitate convenient and efficient installation of over reader  120  and cord(s)  267 . To install sheath  222  and drape  224 , the user places the sheath  222  and the folded drape  224  over reader  120  to position the sheath  222  onto cover  133 . The sheath  222  is interlocked with cover  133  and the drape  224  is then unfolded over the reader  120  and the cord(s)  267 . In  FIG. 25 , drape  224  is shown in a folded configuration having circular shape. Depending on the shape of the drape  224 , particularly, the drape lower portion  285 , the drape  224  may have a non-circular or partially circular shape when folded, such as in a square configuration. 
     As one skilled in the art would understand, a medical implant of the present disclosure includes implants, such as artificial joints, spinal implants, active medical device implants such as cardiac defibrillators, cardiac pacemakers, gastrointestinal pace makers, and arterial stents, as well as other passive or active implantable medical devices. In addition to implants, tracking assembly  10 ,  110 , and  210  can be utilized to scan other medical devices and/or instruments that may be used during surgery, such as a clamp, a scalpel, etc. 
     The present disclosure includes the following embodiments: 
     An assembly for tracking implants comprising
         a reader comprising:
           a scanner,   a housing structure comprising
               a cover comprising
                   an aperture on a top surface of the cover, and   
                   a base comprising
                   an inset groove to receive the cover, and   
                   optionally a transparent sterile sheath having a top surface and side walls,   wherein the transparent sterile sheath encases the cover of the housing structure,   wherein the scanner is positioned to form a focal point above the aperture,   wherein the scanner is enclosed in the housing structure;   
               
           a medical drape attached to the side walls of the transparent sterile sheath; and   a computer in communication with the reader.       

     The assembly wherein the reader further comprises an LED and a scanner mounting structure supporting the scanner and LED device wherein the scanner mounting structure is attached to the base. 
     An assembly for tracking implants comprising
         a handheld reader;   a housing structure comprising
           a cover comprising
               an aperture on a top surface of the cover, and   
               a base comprising
               an inset groove to receive the cover;   
               
           optionally a transparent sterile sheath having a top surface and side walls,
           wherein the transparent sterile sheath encases the cover of the housing structure,   wherein the handheld reader is secured to the base to form a focal point above the aperture,   wherein the handheld reader is enclosed in the housing structure;   
           a medical drape attached to the side walls of the transparent sterile sheath; and a computer in communication with the handheld reader.       

     A reader comprising:
         a scanner;   an LED;   a scanner mounting structure supporting the scanner and LED;   a housing structure comprising
           a cover comprising
               an aperture on a top surface of the cover, and   
               a base comprising
               a top surface to receive the scanner mounting structure,   an inset groove to receive the housing structure; and   
               
           an optional transparent sterile sheath encasing the cover of the housing structure,   wherein the scanner mounting structure is attached to the base   wherein the scanner and LED are positioned to form a focal point above the aperture,   wherein the scanner, LED and mounting structure are enclosed in the housing structure.       

     The reader wherein the cover further comprises at least one radial pin extending from a side surface of the cover. 
     The reader wherein the cover further comprises at least one pin hole in the side of the cover to receive a vertical pin. 
     The reader wherein the base further comprises at least one vertical pin extending up through the inset groove. 
     The reader of claim  4  wherein the base further comprises an inset channel extending radially from the scanner mounting structure to the edge of the top surface of the base, and a removable channel cover. 
     The reader having a transparent sterile sheath covering the cover of the reader. 
     The reader having a transparent sterile sheath covering the cover of the reader wherein the transparent sterile sheath further comprises at least one radial pin slot to receive the radial pin from the cover. 
     The reader wherein the scanner is capable of scanning 2×2 mil etched identifiers. 
     The reader wherein the top surface of the transparent sheath in the area above the aperture of the cover corresponds with the focal point of the scanner and LED. 
     The reader further comprising a medical drape wherein the medical drape does not obstruct the aperture of the housing structure and wherein the medical drape extends radially out from the side surface of the housing structure. 
     The reader wherein the transparent sterile sheath has magnifying abilities. 
     The reader wherein the transparent sterile sheath is formed of a single piece of transparent plastic. 
     The reader wherein the transparent sterile sheath is disposable. 
     A method of using a reader comprising the steps of: 
     providing a reader comprising:
         a scanner;   an LED;   a scanner mounting structure supporting the scanner and LED device; and   a housing structure comprising
           a cover comprising   an aperture on a top surface of the cover, and   a base comprising   a top surface to receive the scanner mounting structure,   an inset groove to receive the housing structure,   
           wherein the scanner mounting structure is attached to the base   wherein the scanner and LED are positioned to form a focal point above the aperture,   wherein the scanner, LED and mounting structure are enclosed in the housing structure;   placing a transparent sterile sheath over the housing structure of the reader;   placing an implant having an identifier onto the top surface of the transparent sterile sheath above the aperture; and   scanning the identifier of the implant to electronically record the stored data.       

     The method further comprising the step of positioning a medical drape to cover the remaining portions of a reader. 
     The method wherein the identifier on the implant is an etched 2×2 matrix containing data regarding the implant. 
     The method wherein positioning the medical drape to cover the remaining portions of a reader device comprises unrolling the medical drape from the transparent sterile sheath to extend the medical drape around the remaining portions of the reader device. 
     A tracking assembly comprising:
         a reader comprising:
           a housing structure that includes a base and a cover;   a scanner having a scanner housing, where the scanner housing is at least partially positioned in a cavity provided in the base; and   an aperture provided in the cover, where the cover is configured to receive a transparent sterile sheath to at least partially encase the cover.   
               

     The assembly further comprising a transparent sterile sheath positioned over the cover. 
     The assembly further comprising a medical drape attached to a side wall of the transparent sterile sheath. 
     The assembly where the medical drape extends radially and downwardly from the transparent sterile sheath. 
     The assembly where the medical drape is removably secured to the transparent sterile sheath by an elastic band. 
     The assembly where the medical drape is permanently secured to the transparent sterile sheath. 
     The assembly where the combination of the transparent sterile sheath and the medical drape substantially cover the housing structure to substantially limit exposure of the housing structure to the atmosphere. 
     The assembly where the scanner is positioned in the base to form a focal point on a top surface of the transparent sterile sheath above the aperture. 
     The assembly where the reader further comprises a scanner mounting structure supporting the scanner wherein the scanner mounting structure is positioned substantially in the cavity and secured to the base. 
     The assembly where the scanner is in communication with a computer device located apart from the reader, where the computer device is capable of receiving and storing information obtained from the identifier upon being scanned by the reader. 
     The assembly where the scanner is capable of scanning 2×2 mm etched identifiers. 
     A tracking assembly comprising:
         a reader comprising:
           a scanner;   a scanner mounting structure supporting the scanner;   a housing structure that includes a cover with an aperture on a top surface of the cover and a base secured to the cover,   where the housing structure is configured to receive a one or more coverings to at least partially enclose the housing structure,   where the scanner mounting structure is secured to the base, and   where the scanner and scanner mounting structure are substantially enclosed in the housing structure.   
               

     The assembly where the one or more coverings includes a transparent sterile sheath positioned over the cover. 
     The assembly where the one or more coverings further includes a medical drape attached to a side wall of the transparent sterile sheath. 
     The assembly further including a cavity positioned inside the base, where the scanner is substantially positioned inside the cavity. 
     The assembly where the scanner includes a scanner housing attached to the scanner mounting structure. 
     The assembly where the one or more coverings includes a transparent sterile sheath and a medical drape. 
     The assembly where the one or more coverings includes a transparent sterile sheath and a medical drape attached to a side wall of the transparent sterile sheath. 
     The assembly where the scanner is capable of scanning 2×2 mm etched identifiers. 
     The assembly where a top surface of the transparent sheath in an area above the aperture of the cover corresponds with the focal point of the scanner. 
     The assembly where the scanner housing has a lens secured thereto, where the lens includes a front surface, where the front surface is situated between about 3 inches to about 5 inches from the aperture of the cover. 
     The assembly where the transparent sterile sheath includes a sheath top surface having at least one of a convex portion and a magnifying portion. 
     The assembly where the transparent sterile sheath is formed of a single piece of transparent plastic. 
     The assembly where the transparent sterile sheath is disposed of after identifiers have been received for all the medical implants implanted in a single patient during an operation. 
     The assembly where the sheath is rigid and cylindrical in shape. 
     The assembly where the sheath is cylindrical in shape and includes a locking mechanism. 
     The assembly where the base of the reader includes a diameter that extends between about 6 inches to about 10 inches. 
     The assembly where the scanner is connected via a cord to a computer located outside the housing structure. 
     A method of using a tracking assembly comprising the steps of:
         providing a tracking assembly comprising:
           a reader comprising:
               a scanner;   a scanner mounting structure supporting the scanner;   a housing structure comprising:
                   a cover comprising:    an aperture on a top surface of the cover; and   a base secured to the cover, where the base includes a cavity;   
                   where the scanner mounting structure is positioned in the cavity of the base, and where the scanner and scanner mounting structure are substantially enclosed in the housing structure;   
               
           covering the cover with a transparent sterile sheath;   placing an implant having an identifier over the aperture; and   scanning the identifier of the implant to electronically record the implant data.       

     The method further including attaching a medical drape to the transparent sterile sheath. 
     The method where the identifier on the implant is an etched 1.4×1.4 mm matrix containing data regarding the implant. 
     The method further including sensing an implant having an identifier, when the implant is positioned above the aperture and automatically obtaining a scan of the identifier. 
     A tracking assembly comprising:
         a reader comprising:
           a housing structure that includes a base and a cover; and   a scanner positioned in the housing structure for scanning a medical implant;   
           a sterile sheath positioned on the cover; and   a sterile drape secured to the sterile sheath, where the sterile drape and the sterile sheath substantially enclose the housing structure.       

     The assembly where the sterile drape is permanently secured to the sterile sheath. 
     The assembly where the sterile drape includes a drape lower portion that at least partially encloses one or more cords extending from the housing structure. 
     The assembly where the sterile drape extends radially and downwardly from the sterile sheath. 
     The assembly where the sterile drape is removably secured to the sterile sheath. 
     The assembly where the permanent securement of the drape to the sterile sheath provides an airtight seal therebetween. 
     The assembly further comprising an aperture in the cover to allow optical signals to pass between the scanner and the medical implant. 
     The assembly where the scanner is positioned in the base to form a focal point on a top surface of the sterile sheath above the aperture. 
     The assembly where the base further comprises a cavity for at least partially receiving the scanner. 
     The assembly where the scanner is in communication with a computer device located apart from the reader, where the computer device is capable of receiving and storing information obtained from the medical implant upon being scanned by the reader. 
     The assembly where the sterile sheath is formed of a single piece of transparent plastic. 
     A tracking assembly comprising:
         a reader comprising:
           a scanner;   a scanner mounting structure supporting the scanner;   a housing structure that includes a cover with an aperture and a base secured to the cover,   a sheath positioned on the cover; and   a drape permanently secured to the sterile sheath, where the drape and sheath substantially enclose the housing structure,   where the scanner mounting structure is secured to the base, and   where the scanner and scanner mounting structure are substantially enclosed in the housing structure.   
               

     A tracking assembly comprising:
         a reader comprising:
           a scanner;   a scanner mounting structure supporting the scanner;   a housing structure that includes a cover with an aperture and a base secured to the cover,   a sheath positioned on the cover; and   a drape permanently secured to the sterile sheath along a securement band, where the drape and sheath substantially enclose the housing structure,   where the scanner mounting structure is secured to the base, and   where the scanner and scanner mounting structure are substantially enclosed in the housing structure.   
               

     The assembly where the drape is permanently secured to the sheath using heat to melt a portion of the drape and the sheath along the securement band to form a bond. 
     The assembly where the drape is permanently secured to the sheath using a chemical adhesive. 
     The assembly further including a cavity positioned inside the base, where the scanner is substantially positioned inside the cavity. 
     The assembly where the scanner includes a scanner housing attached to the scanner mounting structure. 
     The assembly where the scanner is capable of scanning 2×2 mm etched identifiers. 
     The assembly where the aperture of the cover corresponds with the focal point of the scanner. 
     The assembly where the sterile drape is comprised of at least one of elastomer, plastic, rubber, polyethylene, and polypropylene. 
     The assembly where an optically transparent portion of the sheath is situated in an area above the aperture of the cover. 
     The assembly where the scanner housing has a lens secured thereto, where the lens includes a front surface, where the front surface is situated between about 3 inches to about 5 inches from the aperture of the cover. 
     The assembly where the sterile sheath includes a sterile sheath top surface having at least one of a convex portion and a magnifying portion. 
     The assembly where the sterile sheath is formed of a single piece of transparent plastic. 
     The assembly where the sterile sheath is disposed of after identifiers have been received for all the medical implants implanted in a single patient during an operation. 
     The assembly where the reader is positionable adjacent to a patient during a surgical procedure. 
     The assembly where the scanner is connected via a cord to a computer located outside the housing structure. 
     A method of using a tracking assembly comprising the steps of:
         providing a tracking assembly comprising:
           a reader comprising:
               a scanner;   a scanner mounting structure supporting the scanner; and   a housing structure comprising:
                   a cover comprising:    an aperture in the cover; and    a base secured to the cover, where the base includes a cavity,   
                   where the scanner mounting structure is positioned in the cavity of the base, and where the scanner and scanner mounting structure are substantially enclosed in the housing structure;   
               
           covering the cover with a sterile sheath and further enclosing the reader with a drape secured to the sterile sheath;   positioning the reader adjacent to a surgical patient;   placing an implant having an identifier over the aperture; and   scanning the identifier of the implant to electronically record the implant data.       

     The method where the medical drape includes a drape upper portion and a drape lower portion, where the drape lower portion extends beyond the housing structure. 
     The method where further enclosing the reader with the drape further includes unfolding the drape over the housing structure and extending a lower portion over the drape to at least partially cover one or more cords extending from the housing structure. 
     The method further including enclosing the housing structure and all associated cords that extending therefrom, for a distance of at least four feet from the housing structure. 
     The method where the drape is in a telescopically folded configuration prior to unfolding over the housing structure. 
     Although the invention has been described with certain detail through the preceding description of the preferred embodiments, this detail is for the primary purpose of illustration. Many variations and modifications can be made by one skilled in the art without departing from the spirit and scope of the invention as described in the following claims.