Modular detection system for monitoring sterilization circuits and method for monitoring sterilization material circuits

Abstract

The present invention relates to a modular detection system for insertion into a strainer basket (1) for detecting, monitoring and tracking sterilized material (2) within a sterilization circuit, the modular detection system being provided as a strainer basket insert (3) that can be inserted directly into the strainer basket (2) or placed on a base plate (4) and designed to do so, and having the following individually and optionally electrically connectable modules: a central electronic unit (5); a defined or freely selectable number of slots (6) for mounting and / or connecting a predetermined number of retainer systems (7) for holding the sterilized material (2), in each case provided with and designed therewith at least one antenna system (8) for reading transponders in the sterilized material (2); and a preferably defined number of conductive tracks (9) provided and designed to electrically connect the slots (6) and / or retainer systems (7) to each other and / or to the central electronic unit (5).

Description

Technical Field

[0001] The present disclosure relates to a modular detection system for insertion into a sieve basket, a holder system, a sieve basket system, and a method for monitoring a sterilization cycle comprising at least one modular detection system for detecting, monitoring, and tracking sterilized items.

Background Art

[0002] For the monitoring and traceability of sterilized items, it should be possible to determine whether medical / surgical instruments and / or devices / apparatus and / or motor systems and / or medical products have successfully undergone all reprocessing procedures and whether all necessary maintenance steps have been performed. Sensors may sometimes be exclusively housed in larger sterilized items, thus giving rise to the problem that the feasibility of monitoring, especially with regard to medical / surgical instruments, is completely absent. Another problem is the connection of smart holder systems, i.e., holders equipped with sensor electronics, which are carried out in sieve baskets not specifically designed for this purpose.

[0003] Current types of holder devices are generally provided, among other things, for cleaning and holding motors, handpieces, surgical instruments, and medical products. The holders are arranged / used / utilized together with medical products arranged in holders within medical cleaning facilities, especially sterilizers, cleaning and disinfection facilities (WD, washing facilities), etc. In addition, the holders can also be used together with sterilization containers or flexible packaging, and by being placed therein, it is also possible to ensure that new contamination of the medical products is effectively prevented after sterilization of the medical products.

[0004] Prior art describes a retainer system for a medical motor system comprising a sensor, a communication module, and a data processing unit. In this context, US2008 / 142605A1 describes a storage location and / or transport container for medical devices comprising a mat of sterilizable material, and a marking device comprising a marking element that can be wirelessly read and stores electronic information relating to characteristic parameters of the medical devices and transport containers stored in the storage location and / or transported. Here, an RFID tag is used as the marking element that stores information relating to, for example, a sterilization process, sterilization time, and / or other characteristic parameters of the medical devices and / or transport containers housed in the storage location.

[0005] DE102011050333A1 relates to a surgical container detection system that can easily and reliably identify the contents of a sterile container and includes a container contents sensor device for placement inside or on a sterile container, wherein the container contents sensor device comprises a transport platform and at least one sensor placed on or formed on the transport platform for detecting identification elements placed on or formed on goods stored in a sterile container for identification.

[0006] EP2416298A4 discloses a portable container inventory control system that uses RFID technology to automatically monitor the removal and return of items such as tools, weapons, jewelry, surgical instruments, etc., from one or more containers within a portable container in order to maintain records of the status and operation of each element.

[0007] EP2914195B1 relates to various systems and methods for marking and tracking surgical devices / instruments using RFID tags that enable tracking of surgical devices during their distribution and sterilization. In one embodiment, the system includes a tray configured to hold a plurality of surgical devices, the tray having a top-level RFID tag attached to it that contains and / or facilitates access to information about the tray and each of the surgical devices placed therein. Each surgical device placed in the instrument tray may have a top-level RFID tag attached thereto that contains and / or facilitates access to such information about the surgical device.

[0008] WO2009 / 003231A1 describes a system for identifying articles undergoing sterilization, comprising a container for holding articles equipped with RFID tags capable of withstanding the sterilization process. The container has one or more internal antennas. The system also includes a container caller / calling device for querying the tags of the articles via the container's internal antennas, in which case the caller / calling device is detachably coupled to the container.

[0009] DE102015108264A1 describes a surgical or medical container contents detection system having container contents sensor means for placement inside a sterile container, wherein the container contents sensor means comprises a transport platform and at least one sensor disposed or formed on the transport platform for detecting at least one identification element disposed or formed on an article stored inside the sterile container for its identification. The transport platform module disposed on the transport platform has a detection device for detecting at least one detected identification element and is configured to wirelessly transmit information about the article identified by the detected identification element outside the sterile container.

[0010] Conventional and known retainer systems have several drawbacks. On the one hand, individual retainer systems cannot communicate with each other, so each retainer system requires complete sensor and communication electronics as well as an independent antenna. On the other hand, a control unit / electronic unit is required for each retainer system. [Overview of the Initiative] [Problems that the invention aims to solve]

[0011] Therefore, an object of this disclosure is to provide a system that eliminates or at least improves upon the shortcomings of the prior art. Furthermore, an object of the present invention is to reduce manufacturing costs, particularly when there are a large number of units.

[0012] This objective is achieved by a modular detection system having the mechanism of claim 1, or by a retainer system or sieve basket system having at least one such modular detection system, or by a method for monitoring a sterilization cycle with at least one such modular detection system. Advantageous embodiments and further developments of the present invention are the subject of the dependent claims. [Means for solving the problem]

[0013] Accordingly, this disclosure relates to a modular detection system for insertion into a sieve basket to detect, monitor, and track sterilized items, particularly surgical instruments, and / or motor systems, and / or medical supplies, within a sterilization cycle. The modular detection system is provided and configured as a sieve basket insert, which can be inserted directly into the sieve basket or placed on a base plate. The modular detection system is provided and configured with the following modules, which can be electrically coupled individually and optionally: That is, a central electronic unit comprising, in particular, at least one sensor, an energy storage unit, a data processing unit and preferably a write and read unit via NFC; a (predetermined) number of slots for connecting and / or coupling a (predetermined) number of retainer systems provided and configured to hold sterilized material, each having at least one antenna system for reading a transponder, preferably an NFC transponder of the sterilized material; and a (fixed) number of conductive tracks, in particular data lines and antenna lines, and / or connections, provided and configured to electrically connect the slots and / or retainer systems to each other and / or to the central electronic unit.

[0014] In other words, the present disclosure relates to a modular detection system for sterilized items prepared for insertion into a sieve basket for a sterilization cycle, comprising the following modules, individually and optionally electrically connectable: a central electronic unit; an electrical line assembly connectable to the electronic unit and having several free-connecting terminals / slots; and several, preferably varyingly sized, sterilized item holders / supports for individually holding sterilized items, each having at least one connector compatible with a free-connecting terminal and at least one antenna unit, in which case the at least one antenna unit is electrically connected to at least one connector via an internal line / conductive track of the sterilized item holder / support.

[0015] Generally, this disclosure enables modular connection of multiple antenna systems to a central electronic unit. Here, the entire detection system is configured to function as an insert in a sheave basket, which can be directly mounted therein or implemented via a removable insert. One advantage of using such inserts, or each of them, a base plate with data lines and antenna lines and individual retainer systems, is that it eliminates the need to manufacture a specially adapted printed circuit board.

[0016] In other words, the module of the central electronic unit / control unit preferably has an energy source, preferably a rechargeable energy storage device, a data processing unit, a communication module, preferably a Bluetooth® or WiFi® communication module, or other wireless technology, and optionally an RFID reader with write capabilities, or preferably an NFC reader. The conductive track module, preferably a data connection section and an antenna connection section, preferably has a fixed number of conductive tracks connected to / connectable to the data connection unit and antenna interface of the central electronic unit. Each conductive track terminates at a preferably fixed number of contacts that form a slot provided for receiving at least one retainer system. The module of an individual retainer system means a retainer adapted to various sterilized items, in particular instruments and / or motor systems and / or medical products, and is understood to preferably have a simple sensor system with an energy storage device and a simple data processing unit. Furthermore, at least one retainer system has at least one data and antenna interface. To read RFID or preferably NFC transponders provided on individual sterilized items, at least one holder system has an antenna system, which has one or more antennas, and the antennas are connected to a central electronic unit either directly or via another multiplexer.

[0017] Therefore, it is possible to provide a system that can connect numerous antenna systems to a single / strictly single central control unit / electronic unit. Thus, individual retainer / support systems only need to have minimal electronics. Minimal electronics means that the retainer system is equipped with simple sensors, in particular temperature sensors, pressure sensors, humidity sensors, vibration sensors, tilt sensors, motion sensors and pH sensors, as well as a rechargeable energy source / energy storage unit. This allows process steps, in particular sterilization process steps, sterilization time and other sterilization cycle parameters to be detected and sensor values ​​to be temporarily stored. Here, if possible, complete monitoring of the sterilization cycle is an objective of this disclosure. Therefore, it is advantageous to implement a basic sensor system in one or more instrument retainers that is provided and configured to enable the detection and temporary storage of data. A complete sterilization cycle includes, but is not limited to, the following stages / process steps: namely, ultrasonic cleaning or manual pre-cleaning, cleaning in a WD (washing-disinfecting device), maintenance (e.g., oil spraying), and sterilization.

[0018] In the central electronic unit, at least one distribution module / multiplexer is provided and configured to drive at least two retainer systems via their respective antenna systems, and each distribution module is configured to communicate via analog and digital inputs. A distribution module or multiplexer is a selection circuit in analog and digital electronic equipment that can be used to select from several input signals and pass them to outputs. This enables a large number of antenna systems, each antenna system may have one or more antennas connected to the central electronic unit and to communicate with the central electronic unit. The distribution module has an antenna interface and thus represents a contact / connection between the central electronic unit and antenna connections and data connections, or between one retainer system or a conductive track with connected antennas or antenna systems of multiple retainer systems. By using such distribution modules, a large number of antennas can be driven without the need to accommodate a large number of lines in a sheave basket.

[0019] Furthermore, it is preferable that the numerous distribution modules are provided and configured in such a manner that they are sequentially connected to / connectable to a central electronic unit in order to sequentially control each distribution module in order to read sterilized items placed on at least one of each antenna systems, thereby switching between at least one of each antenna systems.

[0020] Preferably, each antenna system of at least one of a predetermined number of retainer systems is provided and configured as an NFC antenna. The use of an NFC antenna has the advantage that it is essential that the sterilized items are in direct proximity to the antenna, and thus the error rate or incorrect inventory count is likely to be reduced. Alternatively, the use of an RFID antenna is also possible.

[0021] In one advantageous embodiment of the present invention, a predetermined number of retainer systems are configured, each equipped with a sensor system for detecting and temporarily storing data, the sensor system comprising at least one sensor, a data processing unit, a communication unit, a temporary memory, and a rechargeable energy storage unit. The temporary memory is a memory for storing data / information or similar over a limited period, and this data is further processed by the same or a different program. In this case, process steps and sensor values ​​detected by the sensor system are temporarily stored and transmitted to the central electronic unit as soon as each retainer system is connected to the central electronic unit. Preferably, the energy storage unit is charged in parallel with the data exchange.

[0022] The central electronic unit is provided and configured to detect and temporarily store data, and is preferably communicated with the sensor systems of a predetermined number of retainer systems and / or with the sterilized items held within the predetermined number of retainer systems.

[0023] The data processing unit is provided to detect data and write it to a predetermined number of retainer systems and / or to sterile objects held by the predetermined number of retainer systems, and is advantageous when adapted in this manner.

[0024] In other words, the data processing unit can write and temporarily store identified cleanliness information / data, detected, for example, via the environment, to the data memory of the holder device or to the RFID tag of the sterilized object held by the holder system. Thus, a communication connection is established with the data processing unit, and since the data processing unit has internal data memory, after processing the output signal, the data processing unit can write the cycle information of the sterilization cycle to the internal data memory of the holder device or the sterilized object, respectively. This has the advantage that the electronic unit is provided as a buffer / temporary memory for temporarily storing data, for example, when the corresponding holder device or sterilized object for this data is unavailable. The detection system can then write the data to the corresponding holder device or sterilized object when the corresponding holder device or sterilized object becomes available again at some point within a predetermined time. In this method, it is possible to deviate from permanent network connections or cloud solutions, respectively.

[0025] In summary, the use of a single sensor system within the holding system allows for the detection of process steps without the need to connect the entire electronic unit. This also has the advantage of allowing for individual cleaning.

[0026] Advantageously, the modular detection system is provided and configured to communicate and exchange data with at least one other modular detection system. In this way, it is possible to have at least two independent modular detection systems, each having a central electronic unit and communicating with each other and exchanging data via these central electronic units. This is preferably done via any optional wireless technology via a proprietary protocol. Thus, the entire mesh / network of modular detection systems or each electronic unit of the modular detection system can each build a so-called independent company mesh / network, which provides complete information transparency. The proprietary protocol is a protocol that strictly limits rights and reuse possibilities and continued use as well as changes and adaptations by users and third parties.

[0027] Furthermore, it is preferred that the central electronic unit is provided and configured to read at least one respective antenna system of a fixed number of holder systems via at least one distribution module / multiplexer and transmit the received data and / or information to an external unit such as, preferably, a smartphone and / or an application and / or a control device, and the external unit is provided and configured to visually output the received data and / or information, preferably the item number, serial number, location of the antenna, position and / or processing cycle.

[0028] Furthermore, it is advantageous if the mounted electronic device is protected against temperature, detergents, especially moisture and alkaline detergents. Here, a simple housing with an insulator / isolation body to overcome a high-temperature phase above 130 °C for approximately 10 minutes in the sterilization device is basic. Such protection can be achieved by a thick insulating layer in the housing and a coating on the electronic device itself. Encapsulation of the electronic device is also conceivable.

[0029] Furthermore, the present invention relates to a holder system for holding sterilized articles, especially surgical instruments and / or motor systems and / or medical products. In this regard, it is realized that the holder system comprises a sensor system for detecting process steps in a self - contained manner, where the holder system is provided and configured to be connected to a modular detection system according to one of the aforementioned aspects.

[0030] Furthermore, put another way, various holder systems for instruments and motor systems can be arranged on this insert for a sieve basket, which are connected to an existing interface. These holder systems have an implemented NFC antenna that can read NFC transponders on medical products / sterilized articles. Furthermore, each of the holder systems has a sensor unit / sensor system, which has sensors, a data processing unit, a temporary memory, and a rechargeable energy storage device. When two or more antennas are used, the central electronic unit also includes at least one multiplexer.

[0031] Furthermore, the present invention relates to a sieve basket system for monitoring and tracking sterilized articles, especially surgical instruments and / or motor systems and / or medical products, within a complete sterilization cycle. Thus, a first at least one further sieve basket is preferably provided and configured in a stacking / stackable manner into which a modular detection system according to one of the aforementioned aspects can be inserted / is insertable, where only the modular detection system of the first sieve basket has a central electronic unit, which is preferably connected / connectable via another distribution module / multiplexer to the modular detection system of at least one further sieve basket without a module of the central electronic unit.

[0032] In other words, several sheaves / sheave baskets are always provided together in a composite manner and can be stacked. Here, however, only the first sheave basket, also called the main sheave, is realized to contain the central electronic unit. Connections to other sheaves / sheave baskets and their respective antennas or antenna systems can then be established via contacts / interfaces and distribution modules.

[0033] Furthermore, the present invention relates to a method for monitoring a sterilization cycle using at least one modular detection system according to one of the embodiments described above, the method comprising the following steps: namely, detecting and temporarily storing process steps and / or sensor values ​​of at least one retainer system; connecting / coupling at least one retainer system to a central electronic unit of the modular detection system via at least one data and antenna interface; transmitting data, particularly process steps and sensor values, of the at least one retainer system to a data processing unit of the modular detection system; charging an energy storage device; analyzing and evaluating the data in the data processing unit of the modular detection system; reading an instrument ID for comparison with a stored list relating to at least one connected / coupled retainer system; and, in the case of a negative match result, outputting information.

[0034] In other words, once at least one retainer system is connected to the central electronic unit, the collected data is transmitted and the energy storage device is charged. The data is then further analyzed and evaluated by a valid data processing unit. Another objective here is to check the precise placement of the instruments. This is done by reading the placement of the individual instruments within the retainer system or the retainer system itself.

[0035] In summary, the present invention relates to an insert for a sieve basket having a central electronic unit having a sensor, an energy storage device, a communication module, and an NFC write / read unit. Furthermore, the insert has data connection and antenna connection sections connected to a specified number of slots, to which an intelligent / smart retainer system having an NFC antenna is selectively connected. In addition, each retainer system has a simple sensor unit that can temporarily store and transmit data. Thus, the sieves / sieve basket and their sterilized items / products can be checked in real time and interact with each other through real time recognition. The corresponding sterilized items / products can be immediately reported to the user in terms of serial number and service life. The removal of sterilized items / products is thus detected and logged / recorded accordingly.

[0036] The system uses existing sensors to monitor the environment and automatically detect whether maintenance or sterilization is being performed, such as ultrasonic cleaning, cleaning in a WD, or oil spraying. In this case, it is possible to extend the range of another sensor system. If the retainer system is detached from the sieve basket, the sensor unit attached to the retainer system stores the data and, upon reconnection, passes the data to the central electronic unit in the sieve basket for evaluation. Furthermore, it is possible to check at any time whether the instrument is placed in the correct retainer system, and this can be done in real time. For this purpose, the transponder attached to the sterilized object is read and compared to a stored list. The retainer system is identified by the attached data processing unit. Evaluation can be performed by the central data processing unit or via Bluetooth®, WiFi®, or any other wireless standard, and transmitted to an external computing unit for evaluation. [Brief explanation of the drawing]

[0037] [Figure 1]This figure shows the modular detection system according to this disclosure. [Figure 2] This is a disassembled and assembled side view of the modular detection system described in this disclosure. [Figure 3] This is another exploded assembly diagram of the modular detection system described herein. [Figure 4] This figure shows a sieve basket equipped with the modular detection module according to the present disclosure, positioned on a base plate. [Figure 5] This figure shows the modular detection module according to the present disclosure, arranged on a base plate. [Figure 6] This figure shows the modular detection module according to the present disclosure, inserted directly into the sieve basket. [Figure 7] This figure shows the modular detection module according to the present disclosure. [Figure 8] This figure shows a modular detection module comprising a central electronic unit and conductive tracks according to the present disclosure. [Figure 9] This figure shows a modular detection module comprising a central electronic unit and conductive tracks arranged on a base plate according to the present disclosure. [Figure 10] This figure shows the underside of a modular detection module, which is arranged on a base plate and consists of a central electronic unit and conductive tracks according to this disclosure. [Figure 11] This figure shows a retainer system equipped with an antenna according to the present disclosure. [Figure 12] This figure shows the bottom view of the retainer system with an antenna and two antenna connectors according to the present disclosure. [Figure 13] This figure shows a retainer system equipped with an antenna system according to the present disclosure. [Figure 14] This figure shows the bottom view of the antenna system and the retainer system equipped with the antenna connection part according to the present disclosure. [Figure 15] This figure shows the system structure of the modular detection module according to this disclosure. [Figure 16] This figure shows a simplified system structure of a modular detection module and at least one external unit, which includes a distribution module as described herein. [Figure 17] This figure shows a simplified system structure of a modular detection module equipped with multiple distribution modules as disclosed herein. [Figure 18] This figure shows communication between two simple system structures of a modular detection module, each having a distribution module according to the present disclosure. [Figure 19] This figure shows a mesh network compared to a conventional network according to this disclosure. [Figure 20] This figure shows an example of temperature and pressure curves in a sterilization apparatus according to this disclosure. [Modes for carrying out the invention]

[0038] A preferred configuration of this disclosure is described below with reference to the accompanying drawings.

[0039] Figure 1 shows a modular detection system according to a first configuration example of the present disclosure. Figure 1 shows a modular detection system for insertion into a sieve basket 1 to detect, monitor, and track sterilized material 2. The modular detection system is provided and configured as a sieve basket insert 3, which is positioned on a base plate 4 and can be inserted directly into the sieve basket 1 according to a second configuration example of the present invention (see Figures 5 and 6) or according to a first configuration example (see Figures 1 to 4). Figure 1 shows a central electronic unit 5, a specified number of slots 6, a specified number of retainer systems 7 (here, two retainer systems) and a specified number of conductive tracks 9.

[0040] Figure 1 shows that a base plate 4, preferably having the same size and shape as the bottom region of the sieve basket 1, is inserted into / insertable to the sieve basket 1. A central electronic unit 5 is positioned on the base plate 4, which is connected to a conductive track 9, and the conductive track is connectable to / connected to at least one plate-shaped / substrate-shaped retainer system 7 via at least one antenna connection and a data connection 13. Figures 2 and 3 show the corresponding exploded assembly views of Figure 1, and Figure 4 substantially corresponds to Figure 1 without the sterilized material 2. Therefore, Figures 2 to 4 will not be further described.

[0041] Figure 1, in conjunction with Figures 8 and 9, shows a conductive track 9 connected to the central electronic unit 5, which is preferably intended to have the conductive track structure shown in the drawings. Conductive tracks 9b are realized by branching at right angles from conductive track 9a, which is directly connected to the central electronic unit 5. Each conductive track 9b terminates with an antenna connection and a data connection 13, in which case it is even more preferable that at least one other antenna connection and data connection 13 is provided on the conductive track 9b. Furthermore, it is preferable that there are exactly four conductive tracks 9b branching from conductive track 9a, in which case there may be fewer or more conductive tracks 9b.

[0042] Figure 1, in relation to Figures 11 to 14, shows a retainer system 7 mounted in slot 6, in which case the slot is defined by the required number of antenna and data connection points 13 depending on the retainer system 7. According to the current configuration example, two differently configured retainer systems 7 are provided in the sheave basket 1, in which case each retainer system 7 is configured to include a sensor unit 11, where data and sensor values ​​are detected and temporarily stored, and these are transmitted to the central electronic unit 5 after being connected.

[0043] According to Figures 11 and 12, a retainer system 7 is provided, which is formed with an antenna system 8 comprising an antenna.

[0044] Figure 11 shows the top surface of such a substrate-like retainer system 7, on which at least one sterilized object support structure (base / clamp) 15 is formed / positioned, into which the sterilized object 2 can be inserted according to Figure 1. Figure 12 shows the bottom surface of such a retainer system 7, where an antenna connector 14 is shown, which is compatible with the antenna connector and data connector 13 of a conductive track 9, known as a dual connector. Through this, the retainer system 7 can be attached to or fastened to the conductive structure of the antenna connector 14 (see Figures 12 and 14), which is compatible with the antenna connector and data connector 13. Figure 14 further shows that, in addition to the antenna connector 14, support means 16 are provided at each corner of the bottom surface of the retainer system 7, which are positioned on or preferably fastened to a base plate 4 or a sheave basket 1, respectively.

[0045] According to Figure 13, the retainer system 7 includes an antenna system 8 formed with three antennas 8a. The retainer system 7 also includes a sensor unit 11, which is formed with a distribution module 10 (not shown) to deal with each of the three antennas 8a.

[0046] Figures 5 to 7 show a modular detection module according to a second configuration example, which lacks the base plate 3 and otherwise basically matches the structure of the first configuration example described above. Repeated explanations are therefore omitted here.

[0047] Figures 9 and 10 show the top and bottom of a modular detection module, comprising a central electronic unit 5 and conductive tracks 9, arranged on a base plate 4, according to the present disclosure. Figure 10 further shows that additional support means (spacers / hook legs / etc.) 16 are provided on the underside of the base plate 4 for insertion into and preferably fastening within the sheave basket 1.

[0048] Figure 15 shows the system structure of a modular detection module according to the present disclosure. Figure 15 shows a central electronic unit 5 which contains an energy storage unit 17, a data processing unit 18, a communication module 19, and a reading unit 20. The central electronic unit 5 is connected to a number of retainer systems 7 via a distribution module 10. Here, the first retainer system 7a has a sensor system 11a and an additional distribution module 10a connected to an antenna system 8, in which case the antenna system 8 consists of a number of antennas 8a, each of which is handled by the distribution module 10a. Furthermore, a second retainer system 7b and a third retainer system 7c are provided, each having an antenna system with several antennas 8b or 8c and a sensor unit 11b or 11c, respectively, each of which is handled by the first distribution module 10. The number of retainer systems 7 and antenna systems or antennas 8 can be expanded as desired in the modular method.

[0049] Figure 16 shows a simplified system structure of a modular detection module comprising a distribution module 10 and at least one external unit 12 according to the present disclosure. Here, a central electronic unit 5 controls and reads each antenna 8a of the antenna system 8 via the distribution module 10. This information is further communicated to the external unit 12. In the shown case, the external unit 12 is an application on a smartphone that visually outputs information on a display 24 such as item number 21, serial number 22, antenna location 23, or respective storage location. Further data such as processing cycles may also be displayed. A preferred transmission means preferably configured to act in two directions is, in this case, Bluetooth® or any other wireless standard.

[0050] Figure 17 shows the system structure of a modular detection module with multiple distribution modules 10 according to the present disclosure. Figure 17 shows a central electronic unit 5 that sequentially controls three distribution modules 10a, 10b, and 10c. Each distribution module 10a, 10b, and 10c switches between antenna systems 8 having three antennas 8a, three antennas 8b, and three antennas 8c, respectively. This outputs that a sterilized item 2 (medical supplies or medical instruments and / or motor systems) is located on each of the three antennas 8a, each of the three antennas 8b, and each of the three antennas 8c. In this manner, extremely complex sieves / sieve baskets 1 can be inventoryed. Here, it is particularly preferable to benefit from tags that are in direct proximity to the antennas, thereby preventing inaccurate inventory searches.

[0051] Figure 18 shows communication between two simplified system structures of a modular detection module, each comprising a distribution module 10 according to the present disclosure. Figure 18 shows two central electronic units 5a and 5b, which can communicate with and exchange data with each other via a transmission means 25, preferably via Bluetooth®. Each central electronic unit 5a and 5b has a distribution module 10, which corresponds to / drives an antenna system 8 comprising three antennas 8a and 8b in each case.

[0052] Figure 19 shows a mesh network according to the present disclosure compared to a conventional network. The right side of Figure 19 shows a conventional network, where all detection systems, simply referred to here as electronic units 5, are concentrated in a central mediating means 26, and there is no direct communication between the electronic units 5. The left side of Figure 19 shows the mesh network according to the present disclosure, where direct communication between the electronic units 5 is possible, and therefore no intermediate mediating means are required.

[0053] Figure 20 shows an example of temperature and pressure curves inside a sterilizer according to this disclosure. Here, the upper curve represents the temperature curve (Y-axis) inside the sterilizer, and the lower curve represents the pressure curve over time (x-axis). This specification also discloses the following: (Item 1) A modular detection system for insertion into a sieve basket (1) to detect, monitor, and track sterilized items (2), in particular surgical instruments and / or motor systems and / or medical products, within a sterilization cycle, wherein the modular detection system is provided as a sieve basket insert (3) that can be inserted directly into the sieve basket (1) or placed on a base plate (4), and is configured to such effect, comprising modules that can be individually and optionally electrically coupled. The aforementioned module is A central electronic unit (5) is preferably configured to include at least one sensor, an energy storage unit (17), a data processing unit (18), a communication unit (19), and preferably a read and write unit (20) via NFC, A predetermined number or freely selectable number of slots (6) for connecting and / or coupling a predetermined number of holder systems (7), each provided and configured to hold a sterilized object (2), each comprising at least one antenna system (8) for reading a transponder, preferably an NFC transponder, of the sterilized object (2), Preferably a fixed number of conductive tracks (9), in particular data lines and antenna lines and / or connections, provided and configured to electrically connect the slots (6) and / or the retainer system (7) to each other and / or to the central electrical and electronic unit (5), the fixed number of conductive tracks (9), A modular detection system equipped with the following features. (Item 2) The modular detection system according to item 1, characterized in that, in the central electronic unit (5), at least one distribution module (10) is provided to drive at least two retainer systems (7) via the respective antenna systems (8), and is configured in this manner. (Item 3) A modular detection system according to item 1 or 2, characterized in that a plurality of distributed modules (10) are provided and configured in such a manner that they are sequentially connected to / connectable to the central electronic unit (5) in order to sequentially drive each of the distributed modules (10) to read the sterilized material (2) placed on each of the at least one antenna system (8), thereby switching between the at least one antenna system (8). (Item 4) A modular detection system according to any one of claims 1 to 3, characterized in that each of the at least one antenna system (8) of the predetermined number of retainer systems (7) is provided and configured as an NFC antenna. (Item 5) The modular detection system according to any one of claims 1 to 4, wherein each of the predetermined number of retainer systems (7) is provided with a sensor system (11) for detecting and temporarily storing data, and the sensor system (11) is characterized in that it has at least one sensor, a data processing unit, a temporary memory and a rechargeable energy storage unit. (Item 6) The modular detection system according to any one of claims 1 to 5, characterized in that the central electronic unit (5) is provided and configured to detect and temporarily store data, and communicates with the sensor system (11) of a predetermined number of retainer systems (7) and / or with the sterilized objects (2) held within the predetermined number of retainer systems (7). (Item 7) The modular detection system according to any one of claims 1 to 6, characterized in that the data processing unit (18) is provided and adapted to detect data and write it to a predetermined number of retainer systems (7) and / or the sterilized objects (2) held by the predetermined number of retainer systems (7). (Item 8) The modular detection system according to any one of claims 1 to 7, characterized in that the modular detection system is provided for and adapted to communicate with and exchange data with at least one other modular detection system. (Item 9) The modular detection system according to any one of claims 1 to 8, characterized in that the central electronic unit (5) is provided and configured to read each of the at least one antenna system (8) of the preferably fixed number of retainer systems (7) via the at least one distributed module (10), and to transmit the received data and / or information to an external unit (12), preferably such as a smartphone and / or application and / or control device, wherein the external unit is provided and configured to visually output the received data and / or information, preferably such as an item number, serial number, antenna location, position and / or information relating to a processing cycle. (Item 10) A retaining system (7) for holding sterilized items (2), in particular surgical instruments and / or motor systems and / or medical products, wherein the retaining system (7) comprises a sensor system (11) for autonomously detecting process steps, and the retaining system (7) is provided and configured to be connected to a modular detection system as described in any one of items 1 to 9. (Item 11) A sieve basket system for monitoring and tracking sterilized items (2), in particular surgical instruments and / or motor systems and / or medical supplies, within a sterilization cycle, wherein at least one other sieve basket (1) is provided and configured in a stackable manner into which a modular detection system described in any one of items 1 to 7 is inserted / insertable, A sieve basket system characterized in that only the modular detection system of the first sieve basket (1) comprises the central electronic unit (5), which is preferably connected to / connectable to the modular detection system of at least one other sieve basket (1) without a module of the central electronic unit (5) via another distribution module (10). (Item 12) A method for monitoring a sterilization cycle using at least one modular detection system as described in any one of items 1 to 9, comprising the following steps: A step of detecting and temporarily storing the process steps and / or sensor values ​​of at least one retainer system (7), The steps include connecting / coupling the at least one retainer system (7) to the central electronic unit (5) of the modular detection system via at least one data and antenna interface, A step of transmitting data from at least one retainer system (7), in particular the process step and the sensor value, to the central processing unit (5) of the modular detection system, in particular its data processing unit (18), The steps include charging the energy storage unit, The steps include analyzing and evaluating the data in the data processing unit (18) of the modular detection system, The steps include reading the instrument ID to match it with a list stored for at least one connected / coupled retainer system (7), A method including the step of outputting information in the case of a negative matching result. [Explanation of Symbols]

[0054] 1: Seebasket 2: Sterilized items 3: Sheave basket insert 4: Base plate 5: Electronic Unit 6: Slot 7: Retainer System 8: Antenna System 9: Conductive Tracks 10: Distribution Module 11: Sensor System 12: External Unit 13: Antenna connection section and data connection section 14: Antenna connection section 15: Sterile object support structure 16: Support means 17: Energy Storage Unit 18: Data Processing Unit 19: Communication module 20: Reading Unit 21: Item Number 22: Serial number 23: Antenna location 24: Display 25: Transmission means 26: Intermediary means

Claims

1. A modular detection system for insertion into a sieve basket to detect, monitor, and track sterile surgical instruments and / or sterile medical motor systems, The modular detection system is configured as a sheave basket insert that can be directly inserted into the sheave basket or placed on a base plate. The modular detection system can be electrically coupled to the sheave basket. The central electronic unit, A holder system configured to hold surgical instruments and / or motor systems, and having at least one antenna system for reading data from or writing data to each transponder of the surgical instruments and / or motor systems, A specified or freely selectable number of slots for connecting and / or coupling the at least one retainer system, the at least one retainer system being mounted A plurality of conductive tracks that electrically connect the slots and / or the retainer system to each other, and / or the slots to the central electronic unit, Equipped with, Each of the at least one antenna systems of the aforementioned retainer system is configured as an RFID antenna. The at least one retainer system is provided with a sensor system for detecting and temporarily storing data, and the sensor system is a modular detection system having at least one sensor, a data processing unit, and a temporary memory.

2. The modular detection system according to claim 1, comprising at least two retainer systems, wherein in the central electronic unit, at least one distribution module is configured to drive the respective antenna systems of the at least two retainer systems.

3. The modular detection system according to claim 2, comprising a plurality of distribution modules, wherein the plurality of distribution modules are configured such that they are sequentially connected to / connectable to the central electronic unit in order to sequentially drive each of the distribution modules to read the respective transponders of the surgical instruments and / or motor systems placed on the at least two retainer systems, and to switch between the respective antenna systems of the at least two retainer systems.

4. The modular detection system according to claim 1, characterized in that the central electronic unit is configured to detect and temporarily store data, and communicates with the sensor system of the at least one retainer system and / or with the respective transponders of the surgical instruments held within the at least one retainer system and / or with the respective transponders of the motor system.

5. The modular detection system according to claim 4, characterized in that the data processing unit is provided and adapted to detect data, to read data from and / or write data to the temporary memory, and / or read data from and / or write data to each transponder of the surgical instrument and / or motor system held by the retainer system.

6. The modular detection system according to any one of claims 1 to 5, characterized in that the modular detection system is provided for and adapted to communicate with and exchange data with at least one other modular detection system.

7. The modular detection system according to any one of claims 2 to 6, characterized in that the central electronic unit is provided and configured to read the antenna systems of each of the at least two retainer systems via the at least one distribution module and to transmit the received data and / or information to an external unit, the external unit being configured to output the received data and / or information visually.

8. A sieve basket system for monitoring and tracking sterile surgical instruments and / or sterile medical motor systems, wherein a first sieve basket and at least one other sieve basket are provided and configured in a stacking / stackable manner, The aforementioned sieve basket system includes different types of modular detection systems, One of the different types of modular detection systems is the modular detection system described in any one of claims 1 to 7, wherein the modular detection system is inserted into a first sieve basket. Another of the different types of modular detection systems is a modular detection system according to any one of claims 1 to 7, wherein the central electronic unit is removed, and the modular detection system is inserted into at least one sheave basket separate from the first sheave basket. A sheave basket system in which the central electronic unit of the modular detection system inserted in the first sheave basket is connected to / connectable to the modular detection system inserted in the other at least one sheave basket.

9. A method for monitoring a surgical instrument and / or motor system using at least one modular detection system according to any one of claims 1 to 7, comprising the following steps: A step of detecting and temporarily storing the process steps and / or sensor values ​​of at least one retainer system, The steps include connecting / coupling the at least one retainer system to the central electronic unit of the modular detection system via at least one connection, The steps include transmitting data from at least one retainer system to the central electronic unit of the modular detection system, The data processing unit of the modular detection system performs the step of analyzing and evaluating the data, The steps include reading the instrument ID to match it with a stored list relating to the at least one connected / coupled retainer system, A method including the step of outputting information in the case of a negative matching result.

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