Disposable Comprising A Security Element, Security Element and Method for Protecting, by the Manufacturer, Permissible Usage

Abstract

The present disclosure relates to disposables for a usage application of a consumable in a medical apparatus, comprising a security element to protect against tampering or misuse by unauthorised third parties, wherein the security element has a first identification marking which materially forms a first manufacturer's identification code; the first identification marking is connected in a non-detachable manner to the disposable and is configured for uniquely identifying the disposable, such as with regard to a product type and/or product usage property, and is partially or completely concealed with a concealing means which is detachable in a non-destructive-free manner. Furthermore, methods for marking a disposable, methods for enabling a disposable in an associated consumption device, and methods for system-control of both aforementioned methods are proposed. Furthermore, the disclosure relates to associated control systems or associated computer programs for performing an aforementioned method, and to security elements.

Claims

1-19. (canceled)

20. A disposable for usage in a medical apparatus, the disposable comprising a security element to protect against tampering or misuse by unauthorised third parties, wherein: the security element has a first identification marking which materially forms a first identification code, and the first identification marking is connected in a non-detachable manner to the disposable and is configured for uniquely identifying the disposable, and wherein the first identification marking is partially or completely concealed with a concealing means which is detachable in a non-destructive-free manner.

21. The disposable of claim 20, further comprising: a second identification marking which materially forms a second identification code, wherein the second identification marking is unconcealed, clearly visible, and is used for at least temporary logistical use tracking, and wherein the second identification marking is part of the concealing means.

22. A method for marking a disposable for usage in a medical apparatus to protect against tampering or misuse by unauthorised third parties, the method comprising: generating, using information technology, a first identification code and storing, by a manufacturer, the consumable; marking the disposable with a first identification marking which materially forms the first identification code; allocating, using information technology, a product type and/or product usage property of the disposable to the first identification code to form a first data relation and storing by the manufacturer; and concealing the first identification marking with a concealing means, wherein: the first identification marking is partially or completely concealed; and the concealing means is applied in such a manner that it can be detached in a non-destructive free manner from the first identification marking.

23. The method of claim 22, further comprising: generating, using information technology, a second identification code and storing by the manufacturer; marking the disposable with a second identification marking which materially forms the second identification code, wherein the second identification marking is applied in an unconcealed manner; and allocating, using information technology, the second identification code to the first identification code to form a second data relation and storing by the manufacturer.

24. The method of claim 23, wherein the second identification marking for marking the disposable is part of the concealing means and is thus also used for partially or completely concealing the first identification marking.

25. The method of claim 23, wherein the concealing with the concealing means and/or the marking with the second identification marking is performed: by means of a connection which can be detached in a destructive-free manner for the first identification marking; and/or by means of reversible surface methods and/or multiple layer methods, by means of applying an adhesive cover layer, a cover layer which can be scratched off, an intermediate separation layer, a detachable adhesion layer, and/or by means of printing with reversible printing ink; and/or in a quality control stage of the production of the disposable; and/or in a packaging stage of the production of the disposable; and/or in-line directly following on from and/or in an integral method stage with the step of marking with the first identification marking; and/or on respective additional packaging of the packaging unit; and/or in a clearly visible manner under transparent respective additional packaging of the packaging unit; and/or wherein the second identification marking is in the form of a label which can be used for logistics purposes as a label configured for storing a transaction chain.

26. The method of claim 23, wherein the concealing means do not coincide with the second identification marking, and wherein the second identification marking is on a large pack including a plurality of disposables.

27. The method of claim 22, wherein the marking with the first identification marking is performed: by means of a connection which can be detached in a non-destructive-free manner; and/or by means of punching, lasing, printing, embossing, plating, coating, inlay methods, fixed adhesion, 3D printing, and/or sealing; and/or in a quality control stage of the production of the disposable; and/or in a packaging stage of the production of the disposable; and/or on respective additional packaging of the packaging unit; and/or in a clearly visible manner under transparent respective additional packaging of the packaging unit; and/or by means of a connection which is non-detachable at least in an originally packaged and/or originally closed state of the disposable; and/or in a region of the disposable which is concealed at least in the originally packaged and/or originally closed state and/or is not externally accessible.

28. The method of claim 22, further comprising: removing the concealing means from the disposable at a usage location, wherein the first identification marking is exposed in a recognisable, clearly visible manner; and authorising the usage and/or a respectively associated usage purpose of the disposable, wherein at least the first identification code is recognised.

29. The method of claim 28, wherein the second identification code is also recognised in advance of and/or at the same time as the recognition of the first identification code.

30. The method of claim 28, wherein at least the first identification code is read visually by a user or is recognised by means of a separate code reading apparatus and is transmitted to the consumption device and/or is automatically recognised by the consumption device.

31. The method of claim 28, wherein a connection of the concealing means to the disposable also serves to effect the removal of the concealing means during usage of the disposable.

32. The method of claim 28, further comprising disabling the disposable for usage after: refusal of or failure to acquire authorisation relating to the non-compliance with a permissible usage purpose previously stored for a user, on the basis of a verification of a product type and/or product usage property of the disposable; and/or an upper time limit allocated to the disposable on the basis of a shelf-life, and/or a time window after arriving at the usage location and/or after recognition of the first identification code; and/or a compatibility of technical requirements relating to the correct usage of the disposable with the technical data of the consumption device, wherein, in the event of a disabling action, information relating to an initiating reason and/or solution to a problem is also provided by the manufacturer.

33. The method of claim 28, wherein authorising is performed by comparing, using information technology, the first identification code recognised at the usage location with the first identification code which is generated and is stored by the manufacturer, the comparing comprising: comparing with a copy of the generated first identification code previously stored in the consumption device; and/or comparing with a copy of the generated first identification code previously stored with a user; and/or comparing with a copy of the generated first identification code previously stored in a decentralised database of an authorised further participant; and/or comparing and/or transmitting a previously stored copy of the generated first identification code by means of remote communication via an interface to a database of the manufacturer for managing at least the first identification code.

34. The method of claim 33, wherein authorising includes an information-technology use of a second data relation for taking into account information and/or a transaction chain collected as far the usage location.

35. The method of claim 33, wherein authorising includes an information-technology use of a first data relation for taking into account the product type and/or product usage property of the disposable.

36. The method of claim 35, wherein the information-technology use includes processing and/or storing in at least one block chain with linked transactions in a database management control system configured for guaranteeing documentation security between a plurality of distributed participants, the information-technology use comprising: code-generating; storing, by the manufacturer, data from production and/or logistics; allocating to form the first data relation, allocating to form a second data relation; authorising; comparing; verifying; using the first data relation, using a second data relation; and disabling action; and/or outputting information.

37. A control system which is configured to perform a method as claimed in claim 33, the control system comprising: a control apparatus; and a marking device configured to simultaneously and/or separately apply at least the first identification marking and/or the concealing means at a location of the manufacturer; and/or a consumption device for usage of the consumable at the usage location of the user.

38. A computer program, loaded into a digital memory of a computer, which performs a method as claimed in claim 22.

39. A security element configured to be applied to a disposable for a usage application of a consumable and arranged for protecting the disposable against being tampered with or misused by unauthorised third parties, comprising: a combination of a first identification marking, which materially forms a first identification code, and a second identification marking, which materially forms a second identification code, wherein the first identification marking is arranged to form a non-detachable connection to the disposable and to provide a unique identification of the disposable in terms of a product type and/or product usage property of the disposable; the first identification marking is partially or completely concealed with a concealing means which can be detached in a non-destructive-free manner; the second identification marking is detachable and is configured for temporary use and logistical traceability; and the second identification marking is identical to the concealing means.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0058] In the following detailed description of the figures, exemplified embodiments, which are to be understood to be non-limiting, together with the features and further advantages thereof will be discussed with the aid of the drawing. In the drawing:

[0059] FIG. 1 shows a side view of a disposable marked with a first identification marking;

[0060] FIG. 2 shows a side view of a disposable;

[0061] FIG. 3 shows a side view of a disposable according to an exemplified embodiment;

[0062] FIG. 4 shows a flow diagram illustrating steps of an exemplified embodiment of a method for marking;

[0063] FIG. 5 shows a flow diagram illustrating steps of an exemplified embodiment of a method for enabling;

[0064] FIG. 6 shows a schematic view of a control system according to an exemplified embodiment comprising a disposable according to the exemplified embodiment;

[0065] FIG. 7 shows a side view of a consumable in secondary packaging comprising a plurality of disposables according to a further exemplified embodiment.

DETAILED DESCRIPTION

[0066] FIGS. 1 and 2 each show a side view of a disposable item for use in a medical-technical apparatus, e.g., in the form of a dialysis module D (dialyser, tube kit, etc.) which is to be used for a patient on a dialysis apparatus. The dialysis module D has a multi-row bar code imprint ID-1-Label printed on it with permanent printing ink as a first identification marking, and a side view of a dialysis module D as described herein having a security element 110 which is adhered such that it can be pulled off. The graphical illustration of the multi-row bar code imprint ID-1-Label corresponds on an information-technology side to a manufacturer's control system 400 (not shown), in which the associated numerical data code ID-1-Code is generated and also stored under a consecutive serial number as a master data information type. As can be seen in FIG. 2, the multi-row bar code ID-1-Label, with the exception of its first row, is visually concealed with a pull-off, neutrally configured sticker 150 having a square pull-off tab, thus forming the security element 110. The security element protects the masked part of the bar code ID-1-Label from being read-out or scanned. The first unconcealed row can be read-out and used in a conventional manner just like a single-row bar code, e.g., at quality-control and dispatch. As soon as the sticker 150 is removed, the state of the dialysis module then corresponds to the state prior to the concealing, as shown in FIG. 1. Then, the complete bar code ID-1-Label, i.e. all of its rows, can be read-out in a bar code scanner and can be used for identifying the individual dialysis module D.

[0067] Both of FIGS. 1 and 2 likewise illustrate two production stages of a method for marking, as described below schematically with reference to FIG. 4, wherein FIG. 1 shows a semi-finished intermediate stage and FIG. 2 shows a dialysis module D comprising a security element 110.

[0068] FIG. 3 shows a side view of a dialysis module D according to an exemplified embodiment. The sticker 150 illustrated in FIG. 2 contains a second multi-row bar code imprint ID-2-Label as a second identification marking. The second multi-row bar code imprint ID-2-Label is clearly visible externally on the dialysis module D and therefore can be scanned-in and used by anyone.

[0069] FIG. 4 and FIG. 5 each show a flow diagram which illustrates steps S101-S107 of an exemplified embodiment of a method for marking a disposable (not illustrated) for a usage application of a consumable (FIG. 4) and steps S108-S111 of a method for enabling the same (FIG. 5). Both methods serve to safeguard an identity given to an individual disposable in the form of a first identification marking ID-1-Label against tampering or misuse by unauthorised third parties. By means of the method illustrated in FIG. 4, the disposable is initially protected by a manufacturer's security element at a manufacturer's site. And after the disposable has been transported to a usage location, the method, illustrated in FIG. 5, for enabling said disposable for correct and appropriate usage for an authorised person, is performed. With regard to the schematic form of illustration, it is noted that the essential steps are represented in respective small boxes bordered by continuous lines (on the left in FIG. 4: S101, S103, S104 and S107: at the top in FIG. 5: S108 and S109). In contrast, the merely optional steps are illustrated by boxes in broken lines, insofar as they apply to some embodiments (on the right in FIG. 4: S102, S105 and S106; at the bottom in FIG. 5: S110 and S111).

[0070] The method for marking a disposable, as schematised by the flow diagram in FIG. 4, comprises the steps S101, S103. S104 and S107 which are essential: in a first step S101, a first identification code ID-1-Code is generated using information technology or is produced using computer technology and is stored by a manufacturer of the consumable. In a subsequent step S103, the disposable is marked with a first identification marking ID-1-Label which materially forms the first identification code ID-1-Code. In parallel with step S103, a product type and/or product usage property of the disposable is allocated S104, at an information-technology level, to the first identification code ID-1-Code, whereby a first data relation ID-1-Code/Type is formed. The step S104 or the first data relation ID-1-Code/Type is stored by the manufacturer. In a further step S107, the first identification marking ID-1-Label is concealed with a concealing means 150. Concealing S107 is effected partially or completely, e.g., visually, and by means of a concealing means 150 which is detachable from the first identification marking ID-1-Label.

[0071] Furthermore, the method for marking can comprise optional steps: generating S102, using information-technology, a second identification code ID-2-Code and storing by the manufacturer; marking S105 the disposable with an unconcealed second identification marking ID-2-Label; and allocating S106, using information technology, the second identification code ID-2-Code to the first identification code ID-1-Code to form a second data relation ID-1-Code/ID-2-Code and storing by the manufacturer. The double arrow, indicated in broken lines, between step S104 and step S106 illustrates that by means of the first identification code ID-1-Code, it is possible to link the first data relation ID-1-Code/Type and the second data relation ID-1-Code/ID-2-Code, whereby the second identification code ID-2-Code and the product type Type and/or product usage property are indirectly related to one another in terms of information technology. The double arrow, indicated in broken lines, between step S107 and step S105 again illustrates that, in an embodiment, the concealing means 150 and the second identification marking ID-2-Label are identical or coincide.

[0072] The method for enabling a disposable, as schematised by the flow diagram in FIG. 5, comprises the steps S108 and S109 which are essential: removing S108 the concealing means from the disposable at a usage location and authorising S109 the usage and/or a respectively associated usage purpose of the disposable. In the removing step S108, the first identification marking ID-1-Label is exposed in an (again) recognisable, e.g., clearly visible manner by removing the concealing means. The removal can be configured, e.g., as part of the procedure of opening a closure cap. For authorisation S109, at least the first identification code ID-1-Code is recognised. By means of the first identification code and the associated first data relation, it is possible for the product type and/or product usage property of the disposable, which are stored and saved in a manner previously allocated by the manufacturer, to be used as information in an enabling control element. Furthermore, the method for enabling can optionally comprise the steps of triggering or initiating a blocking action S110 and/or outputting information S111 (e.g., via a use intended without authorisation).

[0073] FIG. 6 shows a schematic view of a control system 400 (with a memory, not illustrated) according to an exemplified embodiment for the misuse-proof usage of an embodiment of the dialysis module D of FIG. 3 in an associated dialysis apparatus 200 as an associated consumption device, i.e., for a prescribed dialysis treatment of a patient 2 under the supervision of a doctor 3. For this purpose, the control system implements an embodiment of the method for marking (cf. FIG. 4) dialysis modules D in combination with the subsequent implementation of an embodiment of the method for enabling (cf. FIG. 5) the dialysis modules D for respectively authorised usage. The method for marking is performed in an area of influence, located at the top in FIG. 6, of a manufacturer 1 of dialysis modules D using a marking device 199. The method for enabling is performed in an area of influence, located at the bottom in FIG. 6, of the patient 2 or the doctor 3.

[0074] Furthermore, a computer-based entity of a health coordination center 4 is schematically illustrated in the center on the right in FIG. 4 as a further decentralised participant, which is configured to operate a distributed database management control system 300 (with a memory, not illustrated). The database management control system 300 is distributed, e.g., between the computer-based entities of the participants (manufacturer 1, patient 2, user 3 and coordination center 4). The database management control system 300 is part of the control system 400, with which it forms an overlapping region. The four locally distributed areas of influences of the distributed participants 1, 2, 3 and 4 are graphically indicated in the form of domains or subunits in broken lines. Broken-line arrows relating to the control system 400 with the database management control system 300 of the coordination center 4 symbolise the respective participation of the other three distributed participants 1, 2 and 3.

[0075] The two aforementioned methods, i.e., the method for marking using the method steps S101-S107 (cf. FIG. 4) and the method for enabling using the method steps S108-S111 (cf. FIG. 5), are illustrated in small method block diagram boxes, bordered by bold lines, in their respectively associated areas of influence, and moreover, in the area of influence of the manufacturer 1 and in the area of influence of the patient 2 and/or doctor 3. The two aforementioned small method block diagram boxes are connected from top to bottom by a transition arrow marked in bold lines. The transition arrow symbolises the combination of the two above-mentioned methods relating to a superordinate method for system-control. In the case of the method for system-control, the method for enabling follows the method for marking. In this respect, the first method step of the method for enabling S108 (at the bottom) is subsequent to the last method step of marking for enabling. In other words, an output from the method for marking in the form of the finished dialysis module D as a disposable marked with a security element enters, as an input, the method for enabling. The last method step of marking for enabling corresponds, in the embodiment illustrated in FIG. 6, to the optional method steps S105 with S106 relating to the second identification marking ID-2-Label with code ID-2-Code. After intermediate transportation of the finished dialysis module D from the manufacturer 1 to the patient 2 or doctor 3, step S108 follows which serves to render visible or ‘discover’ the first identification marking ID-1-Label. This step S108 is graphically illustrated in greater detail at the bottom on the right in FIG. 6. As can be seen, the doctor 3 uses the pull-off tab to pull the sticker 150, which is provided with the second multi-row bar code imprint ID-2-Label, off the dialysis module D. As a result, the first multi-row bar code imprint ID-1-Label (in the left region of the cylindrical middle part of the dialysis module D) is undamaged and is exposed so as to be completely visible again. Next, the doctor uses a hand-held scanner 250 to scan in the first multi-row bar code imprint ID-1-Label, whereby the associated identification code ID-1-Code is transmitted using information technology to the connected dialysis apparatus 200, which communicates with the hand-held scanner 250 (via a cable connection or wirelessly). If, with the aid of the identification code ID-1-Code, it can be positively determined (control system 400, dialysis apparatus 200, step of authorising S109) that the dialysis module D read-out by the doctor 3 can perform a dialysis treatment which is prescribed or suitable for the patient 2 and that, furthermore, the dialysis apparatus 200 set up in the relevant treatment room is configured, in terms of its apparatus design or model type, in a harmonised or suitable manner for a dialysis operation with the dialysis module D as an apparatus system, the dialysis treatment is commenced with authorisation. In the other case of a negative determination, in step S111 information relating to solutions to problems can optionally be output on the display screen of the dialysis apparatus; e.g., a notification to the doctor 3 that a further dialysis apparatus corresponding to the read-out dialysis module D is located in another treatment room or that the shelf-life of the dialysis module D has been exceeded, etc. In the case of a positive determination or after the dialysis treatment has been performed, such information or a transaction can be relayed to the control system 400 or to the database management control system 300 for resolving further optional functionalities. FIG. 7 shows a side view of a consumable 100 in a cube-shaped dispatch box (outlines indicated in broken lines) as secondary packaging with nine dialysis modules D as disposables according to a further exemplified embodiment. Each of the nine dialysis modules D corresponds to the embodiment illustrated in FIG. 2 and comprises in this respect a security element 110 having a multi-row bar code imprint ID-1-Label which is masked except for the first row by a sticker 150. Irrespective of, e.g., the forwarding agent, a so-called “track-and-trace-label” ID-2-Label is attached, as a second identification marking, to the outside of the end face on the right of the dispatch carton for dispatching purposes, such as traceability. Upon arrival at the destination address, e.g., a dialysis center or a repeat-use dialysis patient, the dialysis modules D are removed individually from the dispatch carton and are sent for use in accordance with regulations.

[0076] Finally, it is noted that the description of the invention and the exemplified embodiments are fundamentally to be understood to be non-limiting with respect to a specific physical implementation. All features explained and illustrated in conjunction with individual embodiments of the invention can be provided in different combinations in the subject matter in accordance with the invention in order to achieve the advantageous effects thereof at the same time.

[0077] All the method steps can be implemented by devices which are suitable for carrying out the respective method step. All functions which are carried out by features can be a method step of a method. Furthermore, the components or means of the consumption device associated with the disposable, e.g., the medical apparatus, and the control system for performing a method can be distributed to a plurality of physical products or sub-assemblies.

[0078] The scope of protection of the present invention is set by the claims and is not limited by the features explained in the description or shown in the figures.

[0079] It is obvious to a person skilled in the art that the invention can be applied not only to protect dialysis methods, i.e., of medical usage applications in associated dialysis apparatuses against misuse and to safeguard against unauthorised use, but also to safeguard other technical system devices, in which appropriate disposables are used. Further examples of use of the proposed protection and monitoring against tampering or misuse by unauthorised third parties and auditing in system apparatuses for usage-relevant information (e.g., electronic health file) relate to the usage of membranes for reverse osmosis units. It is a basic concept of the invention, with regard to the disposables, for the manufacturer to provide a technical possibility, which is effective, specifically efficient and can also be used in a varied and flexible manner, for protecting the consumers or users and, where appropriate, the general public against the consequences of possible miscellaneous misuse and/or tampering and thus for the manufacturer to take further action to prevent such occurrences.

LIST OF REFERENCE SIGNS

[0080] 1 manufacturer [0081] 2 consumer [0082] 3 user [0083] 4 further participant [0084] 100 consumable [0085] 110 security element [0086] 150 concealing means [0087] 199 marking device [0088] 200 consumption device (e.g., medical apparatus) [0089] 250 code reading apparatus [0090] 300 database management control system [0091] 400 control system [0092] D disposable (e.g., dialysis module) [0093] ID-1-Code first identification code [0094] ID-1-Label first identification marking [0095] ID-2-Code second identification code [0096] ID-2-Label second identification marking [0097] Type product type/product usage property [0098] ID-1-Code/ [0099] Type [0100] first data relation [0101] ID-1-Code [0102] /ID-2-Code [0103] second data relation [0104] S101-S113 method steps