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.
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.
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.
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.
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.
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.
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.
Further details and advantages of the invention may be taken from the following purely exemplary and non-limiting description in connection with the drawings.
In
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
In
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
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.
In
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.
In
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
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.
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.
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.
In
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.
As indicated in
The marking element in this embodiment is somewhat taller than the marking element shown in
For improving the sending properties, as illustrated in
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.
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.
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.
In
The holder that has been illustrated in
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.
The part 78 shown in the lower area of
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.
Number | Date | Country | Kind |
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10 2007 054 716.3 | Nov 2007 | DE | national |
10 2007 055 064.4 | Nov 2007 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2008/003771 | 11/13/2008 | WO | 00 | 7/4/2010 |