Patent Publication Number: US-2017354478-A1

Title: Medical device identification system

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. provisional application Ser. No. 62/347,149 filed Jun. 8, 2016, which is hereby incorporated herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to a medical device identification system. 
     BACKGROUND 
     Because of the need to trace materials and manufacturing processes, and generally have a complete history of the life of a medical device, various ways of providing identifying indicia for the medical device have been used. These may include, for example, etching or engraving a device with a lot number, a serial number, or some other identifying label. Although this system of identification and labeling has been successfully used for larger medical devices, very small medical devices have typically been identified by a lot or batch number only, and each individual device did not carry with it its own unique identifier. Examples of these small medical devices include tissue fasteners, such as bone screws, and small bone plates used to repair bone fractures. These small devices are typically not large enough to engrave or etch, or to otherwise label in such a way that the identifying information will remain with them until they are implanted. Therefore, a need exists for a system for medical device identification that can be effectively used with small devices. 
     SUMMARY 
     At least some embodiments described herein may include a medical device identification system that includes an attachment feature including a plurality of spaced-apart elongate members configured for removable attachment to a medical device. The system may also include an identification feature connected to the attachment feature and including a surface for receiving identifying indicia related to the medical device. 
     In at least some embodiments, the attachment feature may include two or more of the elongate members, where each of the elongate members forms a portion of a cylindrical or other-shaped housing configured to receive a tissue fastener. The attachment feature may further include a release feature configured to cooperate with a tool for attaching the tissue fastener to tissue, such that inserting the tool into the tissue fastener when the tissue fastener is disposed in the housing actuates the release feature to release the tissue fastener from the housing. In at least some embodiments, the attachment feature may include two of the elongate members, each of the elongate members including a clip transversely extending outward therefrom. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a perspective view of a medical device identification system in accordance with embodiments described herein; 
         FIG. 2  shows a cross-sectional view of the medical device identification system shown in  FIG. 1 ; 
         FIG. 3  shows the medical device identification system of  FIG. 1  including a bone screw and a driver attached to the screw; 
         FIG. 4  shows a perspective view of a medical device identification system in accordance with embodiments described herein; 
         FIG. 5  shows the medical device identification system of  FIG. 4  attached to a bone plate; and 
         FIG. 6  shows a cross-sectional view of the medical device identification system and bone plate illustrated in  FIG. 5 . 
     
    
    
     DETAILED DESCRIPTION 
     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 that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention. 
       FIG. 1  shows a medical device identification system  10  in accordance with at least some embodiments described herein. The identification system  10  is configured to allow identifying indicia to be associated with a small medical device, for example, to meet medical device tracking requirements, or to otherwise identify the medical device. As used herein, “medical device” may refer to an implantable device; however, it may also refer to external devices or associated instrumentation. The identification system  10  includes an attachment feature  12 , which, in this embodiment, includes a pair of spaced-apart elongate members  14 ,  16 . The elongate members  14 ,  16  are configured for removable attachment to a medical device, and in particular a tissue fastener such as a bone screw. In the embodiment shown in  FIG. 1 , the elongate members  14 ,  16  form a portion of a cylindrical housing  18  configured to receive a bone screw. In other embodiments, more than two elongate members may form a portion or all of a housing, which may or may not be cylindrical like the housing  18 . In the embodiment shown in  FIG. 1 , the elongate members  14 ,  16  are attached to each other at or near a proximal end  19  of the housing  18 , and are separated from each other at or near a distal end  21  of the housing  18 . In this embodiment, the elongate members  14 ,  16  are cantilevered from a base  23  disposed toward the proximal end  19  of the housing  18 . 
     The identification system  10  also includes an identification feature  20 , which is connected to the attachment feature  12  and includes a surface  22  for receiving identifying indicia related to the medical device. This may be, for example, a lot number, a serial number, some other identifying label, or a combination of any of these. The identifying indicia may be laser engraved, etched, or otherwise placed in or on the surface  22  so that it will be available until the associated medical device is used. In at least some embodiments, the identification system  10  can be molded as a single piece from a polymeric material, such as a polymer from the polyaryletherketone (PAEK) family. Polymers from this family may withstand repeated sterilization by autoclaving or other sterilizing processes. The identification system  10  may be made from other materials, for example, a heat-stabilized polypropylene, or any other material effective to provide the properties necessary for its intended uses. 
       FIG. 2  shows a cross-sectional view of the identification system  10  as viewed through the cut section  2 - 2  shown in  FIG. 1 . Shown in  FIG. 2  in phantom is a bone screw  24  captured by the elongate members  14 ,  16  of the attachment feature  12 . As shown in  FIG. 2 , the elongate members  14 ,  16  together form a generally trapezoidal shape  26  configured to closely resemble the cross section of a head  27  of the screw  24 . Also shown in  FIG. 2  is a release feature  28  made up of two ramped tabs  30 ,  32 . The tabs  30 ,  32  are disposed along the insides of their respective elongate members  14 ,  16 . The tabs  30 ,  32  may extend circumferentially around most or all of the inside portion of their respective elongate members  14 ,  16 , or alternatively may extend for a small portion only along the insides of the elongate members  14 ,  16 . 
     In practice, the screw  24  will be attached to the identification system  10  prior to sterilization, and then will be placed in a “caddy”, which is brought into the surgical suite to provide ready access to the devices by the surgeon. In order to remove the screw  24  from the identification system  10  and make it ready for use in a patient, a driver may be inserted into a proximal opening  34  at the top of the attachment feature  12 . The screw  24  and the identification system  10  may be positioned in a blind hole in the caddy so that as the driver is inserted through the proximal opening  34 , it contacts the two ramped tabs  30 ,  32  and pushes them outward as indicated by the directional arrows  36 ,  38 . To facilitate the outward movement, the tabs  30 ,  32  have surfaces  33 ,  35 , which are disposed at an oblique angle to an inside surface  37  of the housing  18 . Because it is in a blind hole in the caddy, the screw  24  will bottom-out as the elongate members  14 ,  16  release the screw. This allows the driver to be inserted into the head  27  of the screw  24 . 
     Identification systems, such as the identification system  10 , may be made in different sizes to accommodate various medical devices. In particular, a receiving portion, such as the trapezoidal-shaped portion  26 , may be sized to receive bone screws of different sizes—for example, bone screws having diameters of 2.5 millimeters (mm), 3 mm, 4 mm, 4.5 mm, etc. Then, to accommodate different sizes of drivers, a bore  39  may have an inside diameter that is dimensioned such that there is a close fit between the walls of the bore  39  and the outside diameter of the driver shaft. This allows the driver shaft to contact and actuate a release feature, such as the tabs  30 ,  32 , merely by inserting it into the bore  39 . 
     In at least some embodiments, a screw head, such as the screw head  27  may include a hexalobular socket—e.g., a “Torx” head—which facilitates a tight connection between the screw head and the driver. It is therefore possible for the surgeon to remove the screw from the hole in the caddy merely by removing the driver. This is illustrated in  FIG. 3 , which shows the screw  24  attached tightly to a driver  40 . As shown in  FIG. 3 , the driver  40  has caused the elongate members  14 ,  16  to separate far enough for the screw head  27  to be released. The depth of the hole in the caddy can be configured to allow a driver, such as the driver  40 , to contact and connect with the screw head at some predetermined distance from a distal end  42  of the identification system  10 . Once having implanted the screw  24  in a patient, the identification system  10  can be easily removed from the driver  40  and the identifying information provided on the identification feature  20  can be recorded. 
     Embodiments of the present invention may also be used with other types of medical devices.  FIG. 4  shows a medical identification system  44  in accordance with at least some embodiments described herein. The identification system  44  includes an attachment feature  46  and an identification feature  48 . The attachment feature  46  includes a plurality of spaced-apart elongate members  50 ,  52 . Each of the elongate members  50 ,  52  includes a respective clip  54 ,  56  transversely extending outwardly therefrom. The clips  54 ,  56  respectively include ramped portions  58 ,  60 , which, as explained in conjunction with  FIG. 5  and  FIG. 6 , facilitate insertion of the attachment feature  46  into a medical device, such as, for example, a bone plate. Similar to the identification system  10 , the identification feature  48  of the identification system  44  includes a surface  58  for receiving identifying information thereon. The identification system  44  may also be made from a PAEK polymer, or any other material effective for its intended uses. 
       FIG. 5  shows the identification system  44  attached to a bone plate  62 . Specifically, the elongate members  50 ,  52  are inserted into a hole  64  in the bone plate  62 . If the hole  64  will be used by the surgeon as part of the fixation, the identification system  44  may be removed before the bone plate  62  is implanted. As described above, the clips  54 ,  56  include ramped surfaces  58 ,  60 , which allow the identification system  44  to be pressed downward into the hole  64  without the need to separately press the elongate members  50 ,  52  toward each other. When the ramped surfaces  58 ,  60  contact the edges of the hole  64 , the elongate members  50 ,  52  will be automatically pushed inward, and will extend outward once the clips  54 ,  56  are past a distal surface  66  of the bone plate  62 —see  FIG. 6 . 
       FIG. 6  shows a cross-sectional view of the bone plate  62  and the identification system  44  as viewed through the cut section  6 - 6  shown in  FIG. 5 . In the embodiment shown in  FIG. 6 , the tabs  54 ,  56  are shown to extend beyond the distal surface  66  of the bone plate  62  by a dimension (D 1 ). In some embodiments, the dimension (D 1 ) may be approximately 0.9 mm, although it could be more or less depending on the size of the bone plate or other medical device to which the identification system  44  is attached. The thickness of the identification system  44  that extends above a proximal surface  68  of the bone plate  62  is shown by dimension (D 2 ). In some embodiments, the dimension (D 2 ) may be approximately 2 mm, although it could be more or less depending on the size of the bone plate or other medical device to which the identification system  44  is attached. Although the medical devices described and illustrated herein consist of a bone screw and a bone plate, identification systems in accordance with embodiments described herein may be configured to attach to other types of medical devices as well. 
     While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various implementing embodiments may be combined to form further embodiments of the invention.