Abstract:
The invention relates to a system and a method for marking any non-living or living objects, in particular medical instruments, implants, structural parts, e.g. tools, machines, items of clothing, jewelry, and many others, and to a marking element and the use of same for marking any objects, in particular for object control and object management. For this purpose, a marking system is proposed that comprises a holding device for the object ( 82 ) that is to be marked, a marking element ( 70 ) with a round, oval or polygonal cross-sectional shape, and a drill device with which a receiving bore for the marking element is formed in the object that is to be marked, wherein the receiving bore has a cross-sectional shape corresponding to the cross-sectional shape of the marking element and has a cross-sectional surface area that is smaller than the cross-sectional surface area of the marking element, and a pressing device for pressing the marking element into the bore.

Description:
TECHNICAL FIELD OF THE INVENTION 
       [0001]    The invention concerns a system and a method for marking any non-living or living objects, in particular medical instruments, implants, components such as tools, machines, pieces of clothing, pieces of jewelry and many others, as well as a marking element and the use of the same for marking any objects, in particular for object control and object management. 
       BACKGROUND OF THE INVENTION 
       [0002]    For various reasons that will be explained in the following it may be desirable to mark living or non-living objects such as animals, instruments, implants, tools, machines, pieces of clothing, pieces of jewelry and many others with a marking that is e.g. colored. For this purpose, WO 2007/090378 A2 discloses a method for marking medical instruments in which onto the instrument to be marked a layer of a mixture of polymerizable acrylates or methacrylates or of a solid partially polymerized mixture of polymerizable acrylates or methacrylates is applied, whereupon the polymerization of the mixture is initiated and the mixture is cured on the instrument wherein the aforementioned applied layer itself is colored or is at least light-permeable such that it appears colored as a result of an underlying colored layer. 
         [0003]    This method that is distinguished inter alia in that markings generated therewith stand great stress, for example, autoclave treatment, without being damaged has proven successful in practice. However, the application of the marking requires a certain know-how so that up to now usually this is done such that the manufactures of corresponding instruments transport them to a company that deals with marking of the instruments. This requires extra logistic expenditure that is undesirable for reasons of expenses as well as environmental concerns. 
         [0004]    DE 100 14 542 C2 discloses to provide surgical instruments with a non-removable memory device in which an identification that individually identifies the respective instrument is saved wherein the memory device comprises a sender by which an electromagnetic wave field can be emitted for reading out the saved identification. However, it has been found that in practice it is extremely difficult to attach the appropriate memory device permanently to the surgical instrument. 
         [0005]    In addition, it is known from a plurality of applications to provide wireless readable electronic components, so-called RFID chips, on an object to be marked which has the advantage that on the chip a plurality of information can be saved and utilized advantageously when a control of the object is done and the chip is read out. The greatest problem relating to this technology is however the attachment of the corresponding chip that, on the one hand, may not be completely shielded electromagnetically so that it can be read out at all and optionally also can be written on anew; on the other hand, it must protected from various loads, for example, dirt, sweat, dust, liquids etc. 
       SUMMARY OF THE INVENTION 
       [0006]    The invention has the object to provide a device and a method for marking of the aforementioned kind which device and method make it possible to provide the object to be marked, i.e., for example a medical instrument, a medical implant, a tool or the like (wherein the term “object” in the following is meant to encompass all kinds of living or non-living objects, including animals and humans) in a simple and easily applied way, with regard to the manufacturer of an object to be marked, in particular however also on the part of the user of a corresponding object, so that a robust marking is applied that also withstands loads, for example, an autoclave treatment of a medical instrument. In an advantageous configuration or embodiment it should also be possible to introduce special information into a marking element that is employed for marking which information surpasses by far the information contained in a pure color marking and, for example, can be read out by means of special reading devices, for example, a barcode or data matrix code reader, in particular however also by means of a RFID chip reader, and enables automated object control and automated object management. A further aspect of the invention is the automatic object control and object management enabled by means of such a marking element. 
         [0007]    The object is solved by a device with the features of claim  1  and a method with the features of claim  33 . The secondary claim  27  concerns a marking element for marking an object. The secondary claim  57  concerns a correspondingly marked object. Advantageous embodiments and further developments are the subject matter of the corresponding dependent claims. 
         [0008]    Further details and advantages of the invention may be taken from the following purely exemplary and non-limiting description in connection with the drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  shows a first embodiment of the marking element according to the invention in a side view. 
           [0010]      FIG. 2  shows the marking element according to  FIG. 1  in a plan view of the bottom side. 
           [0011]      FIG. 3  shows a section of a receiving bore according to the invention in an object to be marked. 
           [0012]      FIG. 4  shows a section of the bore according to  FIG. 3  with inserted marking element according to  FIG. 1 . 
           [0013]      FIG. 5  shows a greatly simplified schematic illustration of a drill according to the invention for introducing a receiving bore into an object to be marked. 
           [0014]      FIG. 6  shows a schematic side view of a second embodiment of a marking element with introduced RFID chip wherein the position of the RFID chip is indicated by a dashed line. 
           [0015]      FIG. 7  shows the marking element according to  FIG. 6  in longitudinal section at the center according to the line VII-VII of  FIG. 6 . 
           [0016]      FIG. 8  shows a plan view of the bottom side of the marking element according to  FIG. 6 . 
           [0017]      FIG. 9  shows a section of an object with a receiving bore into which a marking element according to  FIGS. 6 to 8  has been inserted. 
           [0018]      FIG. 10  shows a section along the line X-X of the object according to  FIG. 9 . 
           [0019]      FIG. 11  shows a third embodiment of a marking element in longitudinal section at the center. 
           [0020]      FIG. 12  shows a basic schematic of a vacuum holder for a marking element in which a marking element can be secured for the purpose of pressing it into an object to be marked. 
           [0021]      FIG. 13  shows a basic schematic of the vacuum holder according to  FIG. 12  with inserted marking element. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0022]    In  FIGS. 1 and 2  a first embodiment of a marking element according to the invention, referenced as a whole by  10 , is illustrated respectively in a side view ( FIG. 1 ) and in a plan view of the bottom side ( 52 ), i.e., that side which in the proper mounting state faces the bottom of a receiving bore introduced into an object to be marked. 
         [0023]    This embodiment of a marking element concerns a substantially circular-cylindrical component with an outer wall surface  12  and two end faces  14  and  16  wherein the outer wall surface  14  that is facing the bottom of a marking bore in the proper mounting state is beveled, i.e., a conical section, the so-called bevel  18 , is formed at the transition area between the outer wall surface  12  and the end face  14 . It should be noted in this connection that instead of circular-cylindrical marking elements also marking elements with other cross-sectional shapes, for example, oval or polygonal shapes, can be used. As a result of the simple configuration of the corresponding receiving bore however marking elements of circular cylindrical shape are preferred. 
         [0024]    The bevel  18  facilitates on the one hand introduction of the marking elements into the receiving bore, serves as a centering aid and indicates on the other hand to the user which of the end faces is to face the bottom of the receiving bore. 
         [0025]    The marking plug  10  is produced of a colored (including white or black), transparent or translucent plastic material. In particular, it can be of a multi-color configuration. In this connection it is possible to design the end face that is to face the bottom of the receiving bore in a color different than the remainder of the marking element and to mark it in this way so that an operator that operates a press for pressing in the marking element into a bore is able to orient the marking element in the correct way relative to the bore. 
         [0026]    The marking element is comprised preferably of a plastic material whose thermal expansion coefficient is greater than the thermal expansion coefficient of the object to be marked, in particular greater than the thermal expansion coefficient of steel or stainless steel for titanium so that even when the marked object is exposed to a heat treatment, for example, a treatment in an autoclave, a safe pressfit of the marking element in the corresponding receiving bore is ensured. In this connection, it has been found, by the way, to be advantageous when the marking element is subjected to a heat treatment before introduction into the receiving bore. 
         [0027]    The marking element can be comprised of polyether ether ketone (PEEK) or a polymerizable acrylate or methacrylate or a mixture of polymerizable acrylates and methacrylates. In particular, the marking plug can be comprised of a plastic material that can be cured by light, in particular UV light, or cured by pressure and/or temperature. 
         [0028]    When the marking plug is comprised of a polymerizable acrylate or methacrylate or a mixture of polymerizable acrylates and methacrylates, the acrylates or methacrylates are preferably monomers with at least two acrylate or methacrylate groups, in particular difunctional or trifunctional methacrylates. In this connection, the monomers can be selected from a group that is formed of monomers forming tetraethylene glycol dimethacrylate, diethylene glycol dimethacrylate, ethylene glycol dimethacrylate, polyethylene glycol dimethacrylate; of monomers forming butanediol dimethacrylate, hexanediol dimethacrylate, decanediol dimethacrylate, dodecanediol dimethacrylate, bisphenol-A-dimethacrylate, trimethylol propane trimethacrylate, tetraethylene glycol diacrylate, diethylene glycol diacrylate, ethylene glycol diacrylate, polyethylene glycol diacrylate; butanediol diacrylate, hexanediol diacrylate, decanediol diacrylate, dodecanediol diacrylate, bisphenol-A-diacrylate, trimethylol propane triacrylate, their derivatives, and mixtures of these compounds. 
         [0029]    The monomers may comprise also urethane dimethacrylate and/or tetraethylene glycol dimethacrylate or may be selected from the group that is formed of BIS-GMA and TEDMA, mixtures of these compounds and mixtures of these compounds with monomers selected according to claim  18 . 
         [0030]    Such a mixture moreover may comprise a preferably non-crystalline filler, in particular a filler selected from quartz sand, crystal-free highly dispersed silicon dioxide, aluminum oxide, ceramic, glass, silanized glass powder, glass ceramic, barium glass, and mixtures of these fillers. 
         [0031]    Such a mixture may then comprise 70 to 90% by weight, preferably 79% by weight, BIS-GMA; 10 to 30% by weight, preferably 20% by weight, TEDMA; and 0 to 3% by weight, preferably 1% by weight, crystal-free highly dispersed silicon dioxide such that the sum of the components of the mixture is 100% by weight. Moreover, the mixture may be polymerized by a photoinitiator, in particular a photoinitiator that has an activation wavelength of 400 to 500 nm, preferably 470 nm. 
         [0032]    The aforementioned photoinitiator is preferably selected from the group that is formed of benzophenone, benzoin, an alpha-diketone, acyl phosphine oxide, camphor quinone and their derivatives as well as mixtures of these photoinitiators. 
         [0033]    Alternatively, the mixture can be at least partially polymerized at a pressure above 1 bar, in particular above 2 bar, and a temperature above 100° C. 
         [0034]    In  FIG. 3  a section in the area of a receiving bore  24  of an object  22  that is only schematically indicated, i.e., by a rectangular contour  20 , is shown. 
         [0035]    It can be seen clearly that the receiving bore  24  at the bottom has two conical sections with different slant relative to the center axis of the bore that are produced as a result of use of the special drill for introducing the bore indicated schematically in  FIG. 5 . This per se unusual shape of the bottom that, as can be seen in  FIG. 4 , is unnecessary per se for introducing the marking plug serves as an identification and quality insuring means: size and depth of the bore are matched to the marking plug according to the invention in such a way that the cross-sectional surface of the bore is somewhat smaller than the cross-sectional surface of the employed marking element. 
         [0036]    In order to prevent that between the inner wall of the bore and the outer wall of the marking element, for example, bacteria or the like can settle, a precision manufacture of the bore is required. Since appropriate precision drills are more expensive than a simple drill, some users may be inclined to employ simple drills for introducing the receiving bore. As a result of the special shape of the bottom it is then easily possible to determine in case of any complaints whether a precision drill that is part of the marking system has been employed for introducing the receiving bore. 
         [0037]    In  FIG. 4  a section of the object  22  in the area of the receiving bore with inserted marking element  10  is illustrated. The marking element has a certain elasticity and typically a diameter that is approximately 1 to 20, preferably approximately 2 to 10%, even more preferred approximately 2.5 to 4%, greater than the diameter of the receiving bore, wherein in one embodiment the diameter of the cross-sectional surface, when pressed into the receiving bore, is reduced correspondingly by compression of the marking element. 
         [0038]    In another currently especially preferred embodiment the marking element is, with respect to the diameter, again somewhat greater than the receiving bore but upon pressing into the receiving bore is not at all or only minimally compressed by the conical (beveled) centering surface at the transition area between an end face and the outer wall surface. Instead, excess material upon introduction of the marking element is sheared off at the top edge of the receiving bore so that an especially tight and stable pressfit results. A marking element that is provided for such a pressfit has preferably a substantially circular-cylindrical shape so that upon introduction of the marking element no alignment work must be done as would be the case for a marking element with oval or polygonal cross-section. 
         [0039]    In  FIG. 5  in greatly simplified illustration a drill, referenced as a whole by  26 , embodied according to the invention is shown for introducing round receiving bores into an object to be marked wherein only the outer contours but not the individual cutting surfaces of the drill are illustrated. 
         [0040]    The area of the tip of the drill that is marked by the dashed circle  28  is illustrated enlarged in the dash-dotted circle  30 . It can be clearly seen that the tip of the drill has two sections  32  and  34  that are slanted differently relative to the center axis of the drill and that effect the embodiment of the bottom of a corresponding bore as described in connection with  FIG. 3 . The slants are selectable at will. In particular, the first area can be slanted more toward the center axis, i.e., relative to the center axis of the drill can have a smaller angle than the second area. Also, more than two areas with different slants can be provided. 
         [0041]    It is understood that already by colored marking elements a marking that is satisfactory for many applications can be effected. For example, a dentist who has several treatment rooms may mark the instrumentation sets that are to be at his disposal in the individual rooms with different colors. 
         [0042]    In this connection, completely or partially transparent marking elements may be used wherein then into the receiving bore a colored element or a colored layer is applied before pressing in the marking element. This element or this layer may even be comprised of a thermochromic color with irreversible color change. 
         [0043]    An especially preferred embodiment of the invention however provides that in the marking elements an information element, in particular a company logo, a barcode, a data matrix code, an RFID chip or a combination of the aforementioned elements is introduced, for example, by potting. 
         [0044]    In  FIGS. 6 ,  7  and  8  an embodiment of a marking plug  40  according to the invention is illustrated in which such an information element, here in the form of an RFID chip, is provided. 
         [0045]    The marking element  40  also has, like the marking element  10 , a substantially cylindrical shape with an outer wall surface  42  and  2  end faces  44  and  46  wherein the lower outer wall surface  44 , i.e., the one that in the proper mounting state is facing the bottom of a corresponding receiving bore, is also provided with a bevel  40 . 
         [0046]    As indicated in  FIG. 6  by the dashed line, into the marking element  40  an RFID chip  50  has been introduced which in this embodiment is potted in the marking element. However, it is also advantageously possible to arrange such an RFID chip in various other ways in a marking element according to the invention; this will be explained in the following. 
         [0047]    The marking element in this embodiment is somewhat taller than the marking element shown in  FIG. 1  so that, as shown in  FIGS. 9 and 10 , upon introduction into a bore that corresponds to the one shown in  FIG. 3 , it projects slightly from the object  52  to be marked. This is desired in this embodiment in order to improve the sending properties of the RFID chip, i.e., to improve its readability by appropriate reading devices. However, it should be noted in this context that, depending on the configuration, in particular the size of receiving bore and marking element, it is indeed possible to arrange the RFID chip such in the marking element that it is located entirely within the receiving bore and, despite of this, can still be read out so that the marking element must not project from the receiving bore but, as shown in  FIG. 4 , is flush with the upper edge of the receiving bore. 
         [0048]    For improving the sending properties, as illustrated in  FIG. 11 , into the marking element in the proper mounting state below, i.e., closer to the bottom of a receiving bore, a sending amplification element, in particular, a ferrite lamella  54  can be provided. In other respects, the marking element  56  illustrated in  FIG. 11  corresponds to the marking element illustrated in  FIGS. 6 through 8 . 
         [0049]    The use of the aforementioned information element in the marking element makes it possible, in addition to a pure color marking, to store and easily automatically retrieve a plurality of information, in particular when using RFID chips. In this way, a counting control of the instruments in the operation theater is possible before as well as after surgery. In addition, the information element may have saved therein information that relates to or contains, for example: operating manuals; medical risk classification of the instrument; cleaning and disinfection instructions; sterilization instructions; cleaning, disinfection and sterilization data, for example, information in regard to date and time of the cleaning/disinfection/sterilization performed last, frequency of use and expiration date of the instrument, repair instructions, and repair data as well as, naturally, certain manufacturer information including, for example, in case of implants, information about the date and location of implantation, of the attending doctor or further patient-specific data. 
         [0050]    The use of RFID chips as information element has several great advantages that are expressly encompassed and claimed by the invention. In contrast to information elements that work “at sight”, for example, barcodes or data matrix codes that, in case of soiled objects, for example, surgical instruments after their use in surgery, can possibly only be read after cleaning, the RFID chips are readable independent of the degree of soiling of the object and, moreover, readable completely automatically. Also, the chips are resistant, for example, with respect to manipulations often performed during repair work or manipulations performed thereon would be immediately apparent. For example, in case of repair of certain surgical instruments it is conventional to grind them and to therefore also remove certain manufacturer information. The repaired instruments can then however no longer be differentiated with regard to manufacturers because sometimes, with regard to their shape, they are exactly identical. With marking elements provided with RFID chips it is now possible to exactly follow the “career” of an instrument or other object. An especially important use is the subject matter of claim  67 . In addition to the known counting control (completeness of the instrument set) it is possible for the first time to make a differentiation which instruments have been actually used so that in case of future operations instruments that have been rarely or never used but belong to the standard instrument set no longer must be automatically made available on a so-called support screen and after the operation, independent of whether they have been used or not, must no longer be sterilized in a complex process. Instead, such instruments can be separately packaged and may be unpacked only if needed; this is an important economic advantage. 
         [0051]    The described marking elements and the described drill form parts of a marking system that moreover comprises a holding device, not illustrated here, for an object to be marked, a drilling device for introducing the receiving bore for the marking element into the object to be marked by means of the illustrated drill, and a pressing device for pressing the marking element into the receiving bore. In this way, it is possible to provide manufacturers or users, for example, hospitals, with a system that makes it possible for them to mark the respective objects themselves in a reliable fashion. When marking elements with RFID chips are used, an appropriate device for reading out and/or writing on the RFID chips completes the system. 
         [0052]    In  FIGS. 12 and 13  a holder, referenced as a whole by  60 , for a marking element is illustrated, for example, for a marking element  50  as illustrated in  FIG. 6 . The holder has a section  62  that is designed such that the holder can be inserted into a conventional receptacle for a drill. In this way, the holder  60 , after a bore has been produced in an object to be marked, can be inserted into the drilling device, usually comprising means for movement of the object to be marked relative to the drill, in exchange for the drill so that then after insertion of the marking element into the holder, the holder can be moved relative to the object to be marked so that the marking element is pressed into the bore previously introduced into the object to be marked. This has the advantage that the object to be marked that has already been aligned relative to the drilling device must not be changed.  FIG. 13  shows the situation where the holder  60  has been lowered onto an object  64  to be marked after prior insertion of a marking element  50  into the holder  60  and, in this way, the marking element  50  is pressed into the object. 
         [0053]    The holder that has been illustrated in  FIGS. 12 and 13  comprises advantageously a passage  66  indicated by dashed lines that is connectable to means, not illustrated in detail here, for generating a vacuum, so that a marking element that has been introduced into the holder  60  can be secured in the holder by applying a vacuum. In a preferred embodiment, the receptacle that is formed in the holder  60  for a marking element is designed such that the pressure that is applied by the holder onto the marking element upon pressing into an object to be marked is limited substantially to the edge areas of the marking element so that an information element that is possibly contained in the marking element, thus in particular an RFID chip, upon pressing of the marking element into the object to be marked will not be damaged. 
         [0054]      FIG. 14  shows the two parts  72  and  78  insertable into one another of an especially preferred embodiment of a marking element according to the invention in different illustrations that are self-explanatory to a person skilled in the art. In the upper half of  FIG. 14  the part  72  that is arranged substantially in the interior of the part  78  in the proper mounting state is illustrated in a perspective illustration (a), in plan view of the top side (b), in side view (c), and in section along the line A-A (d). Easily recognizable is a receptacle  78  in the upper area of the part  72  which receptacle is cylindrical in this embodiment into which upon mounting of the marking element an information element, in particular an RFID chip, may be inserted. 
         [0055]    Part  72  has in this embodiment at its bottom side a bore  76  that serves for improved handling of the part and in particular of the finish-mounted marking element. 
         [0056]    The part  78  shown in the lower area of  FIG. 14  is shown, analog to part  72 , in perspective illustration (a), in plan view onto the top side (b), in a side view (c), and in section along the line A-A (d). The part  78  is substantially formed like a cap into which the part  72  can be inserted. In this connection, the dimensions are such that upon insertion, more precisely, upon pressing in the part  72  into the part  78 , a secure seat is provided. 
         [0057]      FIG. 15  shows schematically the assembly of a marking element according to the invention comprising a part  72  with a receptacle  74  for an RFID chip  80  and a part  78 . It should be noted in this context that the parallelepipedal chip  80  in this embodiment, of course, can have also any other suitable shape in particular a cylindrical shape. As will be explained in the following, the cavity that remains after insertion of the chip  80  into the receptacle  74  can be filled out, for example with silicone; however, it has been found that this is not necessary in most cases. 
         [0058]      FIG. 16  shows a completely assembled marking element, as a whole referenced by  70 , in a side view (a) and in a section along the line A-A. 
         [0059]      FIG. 17  shows in a perspective view the situation shortly before marking any non-living object  82  into which a receiving bore  84  for receiving the marking element  70  is introduced. 
         [0060]      FIG. 18  shows in section at the center (a) and in perspective view (b) the situation after introduction of the marking element  70  into the object  82  to be marked in which it is safely held by pressfit in the receiving bore. 
         [0061]      FIGS. 19 to 24  show a further embodiment of a marking element according to the invention that is suitable especially for use as an industrial plagiarism protection. The marking element, referenced as a whole by  90 , is in this connection embodied like a screw and, as illustrated in the  FIGS. 23 and 24  schematically, can be screwed into any component  92  provided with an appropriate threaded bore. In this connection, the marking element embodied like the marking element illustrated in  FIG. 16  comprises a part  94  that in  FIG. 19  is shown in a side view (a), in section along the line A-A (b), and that is pressed into a part  96  that is shown in  FIG. 20  in a side view (a) and in section along line A-A (b). In this connection, the part  94  has again two receptacles or bores  98  and  100  of which one ( 100 ) serves for improved handling, the other ( 98 ) for receiving an RFID chip  102 . 
         [0062]      FIG. 25  shows a further embodiment of a marking element according to the invention that, as a whole is referenced by  110 , and is comprised of a part  112  and a part  114  that between them form a cavity for an information element, in particular an RFID chip  116 . In this embodiment, the essentially cylindrical part  114  has at two locations on its outer wall surface flattened portions  118  that enable an adhesive and sealing material, as in particular silicone, as can be seen in particular in  FIG. 26 , to escape from the marking element. Assembly of this embodiment is realized such that into the receptacle  122  formed in the part  114  a substance such as in particular silicone is filled in into which then the chip  116  is inserted. The substance in general is a substance that cures by drying or heat. When the substance is at least partially cured, onto the chip  116  a certain quantity of the substances is applied also whereupon the part  112  is placed onto the part  114  and pressed onto it. When doing so, the excess substance can then escape through the passages that are formed between the surfaces  118  and the inner walls of the part  112 . After curing of the substance, a marking element is formed in which the inserted information element is safely secured. 
       INDUSTRIAL APPLICABILITY 
       [0063]    In particular the marking element according to the invention enables numerous industrial applications not only for the described detection of information in case of medical instruments but also in particular in connection with protection against plagiarism. Marking elements according to the invention can be inserted in various ways into the objects that are to be marked. When the marking element is produced of suitable biocompatible material such as in particular certain plastic materials, it can also be used for marking living objects, for example, animals. Accordingly, the application implies also various new business methods, i.e., in particular the industrial marking of objects of various kinds with marking elements according to the invention, in particular with marking elements with wireless readable information elements such as in particular RFID chips. In this connection, the providers of such markings can also offer to their clients to introduce certain information that can be read out only by them into the information elements in order to ensure a high protection against piracy products. These methods are thus expressly encompassed by the invention and are claimed accordingly in those countries whose national laws permits this.