Optimized tracking system and tracking method in sterile article cycle, and computer readable storage medium
By embedding detection units and counters in medical products, and using ultrasonic screens and general adapters for data reading and writing, the problem of difficult to trace the service life of medical products and the number of cycles of sterile items is solved, and the guaranteed availability and safety of medical products is achieved.
Patent Information
- Application Number
- CN202380074290.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-10-24
- Filing Date
- 2023-10-23
- Publication Date
- 2025-05-30
AI Technical Summary
The prior art is difficult to trace the service life of medical products and the number of cycles of sterile items, resulting in manufacturers not being able to ensure the availability and safety of medical products.
By embedding detection units and counters in medical products, and using ultrasonic screens and general-purpose adapters for data reading and writing, tracking and recording of the cycle experience of sterile items in medical products can be achieved.
Ensures guaranteed availability of medical products, reduces delays and interruptions in surgery, improves safety of surgery, and reduces costs.
Smart Images
Figure CN120077445A_ABST
Abstract
Description
Technical Field
[0001] The present disclosure relates to a computer-implemented tracking method for tracking the sterile cycle history of medical products, in particular instruments or medical devices having a motor system. Furthermore, the invention also relates to a tracking system, a universal adapter for tracking the sterile cycle history, an ultrasonic sieve, a computer-readable storage medium, and a computer program according to the preambles of the dependent claims. Background Art
[0002] Generally, medical products (such as surgical instruments or surgical devices) have to meet processing, maintenance, and sterilization requirements that must be strictly adhered to. Here, they go through a so-called sterile item cycle / sterile item period.
[0003] Such a sterile item cycle for medical products / pharmaceutical products (such as surgical instruments or devices having a motor system) in particular has the following process steps or consists of the following process steps:
[0004] First process step: Manually or mechanically pre-clean the medical product, in particular by means of ultrasound;
[0005] Second process step: Disinfect the medical product;
[0006] Third process step: Maintain or service the medical product, in particular lubricate medical products having an integrated motor or motor system;
[0007] Fourth process step: Sterilize the medical product; and, finally
[0008] Fifth process step: Medical use or actual use of the medical product, in particular in a surgical operation.
[0009] Such a sterile item cycle / sterile item period is repeated until the medical product is defective or has exceeded its predetermined service life and must be replaced.
[0010] According to the current state of the art, medical products are usually used partially until they no longer have functional capabilities (i.e., are defective) or reach their maintenance intervals according to regulations or are subjectively evaluated by the user as no longer having functional capabilities.
[0011] So far, there has been no possibility, especially on the part of manufacturers of medical products, to retrospectively determine the service life of medical devices or to collect data on the medical products used, in particular on the experiences of the sterile item cycle Data on the number of times. Therefore, manufacturers rely on the good cooperation and honesty of customers to obtain the corresponding data on medical products. In addition, there are the following problems: It cannot be ensured to the greatest extent that customers actually collect data for each medical product, especially data at the serial number level, to reliably trace or track individual medical products separately. Summary of the Invention
[0012] Therefore, the object of the present invention is to avoid or at least reduce the disadvantages in the prior art, and in particular to provide a tracking method, a tracking system, a universal adapter, an ultrasonic sieve, a computer-readable storage medium, and a computer program, which allow the efficient and effective tracking of the experience of the sterile item cycle, more precisely, especially at the level of individual medical products, which have a uniquely defined identifier (ID), especially a one-to-one serial number. Another sub-task is to ensure the guaranteed availability of medical products in the sterile item cycle (preferably in the operating room) to prevent surgical delays and surgical interruptions and thereby improve the safety of surgery and also minimize costs.
[0013] These tasks are solved according to the present invention in terms of the tracking method by the features of claim 1, in terms of the tracking system by the features of claim 9, in terms of the universal adapter by the features of claim 10, in terms of the ultrasonic sieve by the features of claim 12, in terms of the computer-readable storage medium by the features of claim 13, and in terms of the computer program by the features of claim 14.
[0014] Thus, the basic idea of the present disclosure provides that in the sterile article cycle, “data points” or process steps that have the greatest impact on the lifespan of medical products and thus on their usability are used to ultimately ensure “guaranteed usability”, that is, to maintain medical products for medical interventions that still have a sufficient or adequate service life so that these medical products are defect-free in use. The mechanical pre-cleaning and product maintenance by means of ultrasound, especially oiling of medical products, have been identified as important relevant data points that have a significant impact on product quality, especially on the motor systems of medical products. By identifying this process step, an incremental counter (Counter) of the corresponding medical product can be incrementally (plus one) increased step by step, especially by means of an antenna, especially in the corresponding handpiece. If a medical product detects whether one or more medical products have undergone these process steps (in addition to the serial number / serial number), statements can be made about the service life based on the data collected. Based on the data already collected and based on a prediction model, statements can be made about future usability and (if necessary) failures, for example, by means of historical data on the service life of medical products. From this, a warning message can be output or an automated recovery process can be initiated. For example, the automatic repair of an automatic repair device for a medical product can be started. Supplementary ordering or repair can also trigger further actions fully automatically to eliminate shortages. Therefore, minimum requirements for the service life of medical products are defined to guarantee and ensure guaranteed usability for customers in the hospital. Thus, usability of more than 90% can be achieved.
[0015] In other words, a computer-implemented tracking method is provided for tracking the sterile cycle history of medical products, especially instruments or medical devices having a motor system. The tracking method has the following steps: detecting the one-to-one identification of a medical product by a detection unit, especially detecting the identification number stored in the transponder of the medical product by a transponder reading and writing device; reading in a counter of the sterile cycle history associated with the medical product having the identification; detecting the ultrasonic treatment of the medical product and / or the maintenance of the medical product, especially oiling, and incrementing (i.e., plus one) the counter of the sterile cycle history associated with the medical product; storing the counter in a storage unit, especially storing the counter in the transponder of the medical product by a transponder reading and writing device; and when the counter exceeds a predefined limit value associated with the medical product, determining that the medical product is in a warning zone and outputting a warning message to the user by a visual presentation device and / or initiating an automated recovery process to restore the functional ability of the medical product. In this way, an optimized tracking method in the sterile article cycle can be said to be provided. This detection of process steps especially occurs in at least one of the following process steps, especially all process steps: ultrasonic bath, cleaning and disinfection and / or maintenance (servicing).
[0016] All these measures contribute to the guaranteed availability of medical products and result in the hospital being able to maintain its processes without interruption, where the manufacturer can also obtain an overview of the medical products and their status.
[0017] The advantageous embodiments are claimed in the dependent claims and are explained in particular below.
[0018] According to a preferred embodiment, in the case of a medical product with a transponder, in the step of reading in the counter of the aseptic cycle history, in addition to reading in (reading out) the identification number from the transponder, the counter stored in the transponder is also read in; and in the step of storing the counter, the counter is stored in the transponder associated with the medical product. In this way, in addition to the identification, the counter associated with the medical product is also directly stored in the medical product. The counter stored in the transponder can be read out by various transponder reading devices, for example, before or after surgery, in order to, for example, perform sampling inspections or determine the status of the medical product.
[0019] In particular, the tracking method can be adapted to read in, in the reading-in step, the counter of the aseptic cycle history associated with the medical product stored on a central server in a storage unit; and in the step of storing the counter, store the incrementally increased counter together with the identification in the storage unit of the central server for the medical product, in order to provide central data management of the aseptic item history of the medical product, especially for a plurality of different medical products. Thus, if a central database is saved for each individually manufactured medical product, where each database entry includes at least one identification number, the associated counter, and a predefined limit value for the counter, then the experience of the aseptic item cycle of each medical product can be detected by the associated counter, and a warning message can be output or a recovery process can be initiated if the counter is greater than or equal to the limit value.
[0020] In particular, the predefined limit value can be defined as the service life associated with the medical product that is less than a certain number of aseptic item cycles, such that a warning message is output to the user and / or an automated recovery process is initiated before the end of the service life is reached. Thereby, the user has sufficient preparation stages or time to prepare the medical product and restore its functional capabilities, or replace the medical product with a new one, for example, in an automated logistics with pre-prepared medical products.
[0021] According to one embodiment, for a medical product, an ultrasonic counter is stored as a first counter and a maintenance counter is stored as a second counter; and, in the case where ultrasonic treatment of the medical product and maintenance of the medical product are detected, the counters are incremented by one respectively; or, if ultrasonic treatment is detected, only the ultrasonic counter is incremented accordingly, and if maintenance is detected, only the maintenance counter is incremented accordingly; and, if at least one counter exceeds a predefined limit value, it is determined that the medical product is in a warning zone. For this purpose, for a medical product or a category of medical products (such as a surgical scalpel), on the one hand, a (first) predefined limit value regarding ultrasonic waves and a (second) predefined limit value regarding maintenance can be saved. In this way, it can be more accurately determined when a medical product enters the warning zone, for example when these steps do not have to be performed simultaneously compulsorily. Alternatively, a sum of the ultrasonic counter and the maintenance counter can also be created, and when this sum exceeds a predefined limit value, it is determined that there is a warning zone.
[0022] In particular, in the case where ultrasonic treatment of the medical product and maintenance of the medical product are detected, the counters can be incremented by only one. This can ensure that the counters are also incremented by only one in one experience. Alternatively, in the case where readout and / or write steps are also performed by a multi-reader in addition to ultrasonic treatment and maintenance, the counters can be incremented precisely by one. Similarly, exactly one experience is detected here and the counters are incremented accordingly.
[0023] According to another embodiment, in the step of detecting ultrasonic treatment, ultrasonic treatment can be detected by a sensor that is adapted to detect contact with a fluid and / or detect ultrasonic waves. In other words, for example, immersion into an ultrasonic bath can be detected by a water sensor, and / or ultrasonic waves can be detected by an ultrasonic sensor, such that based on this, it can be determined that ultrasonic treatment has been performed. At the same time, quality assurance can also be ensured during the duration.
[0024] Preferably, the tracking method can further have the following steps: creating a record, in particular by a camera and / or a lidar device (Light detection and ranging; LADAR) of a multi-reader; determining the state of the medical product based on the record, in particular determining the state of the cutting edge quality and / or the cutting edge geometry of a surgical instrument; and, in the case of an insufficient state, outputting a warning message to the user through a visual presentation device and / or initiating an automated recovery process of the functional ability of the medical product. Thereby, an additional safety mechanism is provided, which prevents the medical product from being prepared for a surgical operation when the state of the medical product requires replacement. Therefore, the service life aspects (such as cutting edge quality and cutting edge geometry) can be evaluated.
[0025] Preferably, the tracking method further has the following steps in the step of determining the state: transmitting the record to a trained artificial intelligence system (AI system) of the central server, the artificial intelligence system being trained with the cutting edge quality of the surgical instrument as input data and with state determination, in particular binary state determination "sufficient" - "insufficient" (1 - 0; good state - insufficient state), and performing the determination of the state by the trained artificial intelligence system; wherein, preferably, the determined state is also transmitted to a multi-reader / multi-writer device.
[0026] Before the maintenance process step, in the sterile goods cycle, the medical product is preferably visually inspected by an employee of the central sterile goods supply department (ZSVA). Here, the functional ability of the medical product can also be evaluated.
[0027] The detection of data can preferably also be carried out at the customer of the medical product. In particular, this can be achieved (in addition to or in addition to manual handwriting and subsequent digitization in order to be able to use the data) by direct detection and storage (recording) in a computer environment (using a suitable computer program) so that the data can be used subsequently. The prerequisite here is that the data points are recorded / generated by the customer and must be provided to the manufacturer in order to derive actions based on this. Thereby, guaranteed availability can be obtained as a service. This shows the minimum requirements for detecting data at the customer.
[0028] According to another embodiment of the extended variant, a partially automated tracking method can be used, which (automatically) detects a part of the process steps of the sterile goods cycle, in particular all process steps, with the aid of different electronic components.
[0029] In a tracking system for tracking the aseptic cycle history of medical products, especially instruments or medical devices having a motor system, the task is solved in that the tracking system has: a detection unit adapted to detect the unique identification of a medical product, in particular by means of a transponder reading and writing device or by means of a camera, the identification number stored in the transponder of the medical product and the two-dimensional code integrated in the medical product; a sensor adapted to detect the ultrasonic treatment of the medical product and / or the maintenance of the medical product, in particular lubrication; and a control unit adapted to increment (by 1) a counter of the aseptic cycle history associated with the medical product and store the counter in a storage unit, in particular store the counter in the transponder of the medical product by means of a transponder reading and writing device; and, when the counter exceeds a predefined limit value associated with the medical product, output a warning message to the user via a visual presentation device and / or initiate an automated recovery process of the functional capabilities of the medical product. In this way, the tracking system can record and track the experience of individual medical products and, when needed (i.e., when entering the warning area), can allow the output of a corresponding warning or the execution of a recovery process, more precisely, especially early enough so that the required medical products with sufficient service life for a surgical operation are available again. In this way, the guaranteed availability of one or more medical products can be ensured.
[0030] In particular, the tracking system can include a medical product with a transponder, wherein the control unit is adapted to read out the counter from the transponder of the medical product by means of a transponder reading and writing device and (also again) store it in the transponder of the medical product by means of a transponder reading and writing device after the increment.
[0031] Preferably, the tracking system can have a sensor adapted to detect contact with a fluid and / or detect ultrasound to detect ultrasonic treatment. Then, when ultrasonic treatment is detected, the counter can be incremented accordingly.
[0032] According to one embodiment, the tracking system can have a multi-reader with a camera and / or a lidar device. In particular, the tracking system can also have a trained artificial intelligence system that is trained with the cutting edge quality of a surgical instrument as input data and a state determination, in particular a binary state determination of "sufficient" - "insufficient", and the control unit can be adapted to transmit the record to the trained artificial intelligence system and, after the state is determined by the trained artificial intelligence system, in the case of an insufficient state, output a warning message to the user via a visual presentation device and / or initiate an automated recovery process of the functional capabilities of the medical product.
[0033] In terms of a general adapter / tracing adapter for coupling an antenna for tracing the aseptic cycle history of a medical product, the task is solved in the following way: The general adapter has: an adapter housing with antenna contacts, the antenna contacts having two electrically conductive surfaces spaced apart from each other, arranged on the upper side and exposed towards the outside of the adapter housing, in particular having exactly two electrically conductive surfaces, for a standardized coupling structure for a wired connection of the antenna in terms of signal technology; a fastening section of the adapter housing, in particular in the form of a ring, for fastening the general adapter to an object, in particular an ultrasonic sieve; and a wired signal interface, in particular a high-frequency coaxial cable, which is conductively connected to the antenna contacts for forwarding signals, in particular high-frequency signals (HF signals). Thus, an extension cable for connecting an antenna for reading out a transponder is provided, but it has a defined connection point (a kind of plug), such that the antenna (e.g., a bracket with an antenna) can be easily and reliably coupled (e.g., plugged in or inserted) by plug-and-play. The general adapter has such a signal interface that is exactly suitable for transmitting the high-frequency signals of the antenna for reading and writing the transponder, such that the antenna is arranged near the medical product with the transponder and can be read in the near field. Preferably, direct current, for example 3V, 5V or 12V direct current, can also be additionally transmitted through the antenna contacts to provide a power supply, for example for the medical product coupled in the antenna area. That is, a standardized interface is provided to provide at least one signal line to the transponder of the medical product through simple and quick coupling.
[0034] In particular, the general adapter can have at least one magnet to provide a force-locking and releasable coupling with the general adapter, in particular for a corresponding adapter complementary to the general adapter, wherein the general adapter preferably has two magnets spaced apart from each other, which are oriented parallel to each other but have opposite magnetic poles to ensure a one-to-one alignment of the connection part with the corresponding adapter having a complementary arrangement of magnets.
[0035] In particular, the general adapter can have asymmetrically arranged protrusions on its upper side to ensure a one-to-one alignment of the corresponding adapter. Similar to a USB-A port, the general adapter and the corresponding adapter can only be coupled to each other in one orientation. This is particularly important for direct current transmission.
[0036] In particular, the signal interface can have a shielded coaxial cable for transmitting HF signals.
[0037] Preferably, the universal adapter can be configured to be waterproof, in particular having a fluid-tight housing that encloses the internal space and only the electrical contacts are open to the outside, so as to further ensure the function even during or after immersion in an ultrasonic bath. In particular, immersion in the ultrasonic bath can be detected by means of an antenna contact with two contact surfaces, since a short circuit of these two contact surfaces is thereby established and the electrical conductivity of the circuit can be considered as a parameter.
[0038] In the case of an ultrasonic sieve for receiving medical products and immersing them in an ultrasonic bath, the task is solved in such a way that the ultrasonic sieve has at least one universal adapter according to the present disclosure, which is fastened to the ultrasonic sieve, in particular to the bottom of the sieve bowl, by means of its fastening section and is connected to a central communication unit via its signal interface, such that an antenna that can be connected via the antenna contact is used for reading and / or writing the transponder of the medical product. Thus, the universal adapter, as an extension with a defined interface, connects the connection part of the communication unit to the antenna for reading the transponder. In this way, the medical products can be arranged in the sieve basket at different positions, and the antenna for reading and / or writing is placed near them and simply connected via the universal adapter. Since HF signals are also transmitted, the cumbersome screwing of antenna cables, such as the antenna of a holder, is dispensed with, and the antenna can be connected by plug and play.
[0039] According to one embodiment, the ultrasonic sieve can also have a holder with an antenna, wherein the holder is adapted to receive and hold, in particular fix, a plurality of medical products, and the holder has a corresponding adapter that is complementary to the universal adapter to centrally connect the holder to the universal adapter. Thus, with only one universal adapter, the corresponding transponders can be read and / or written in a plurality of medical products (such as a handpiece with a motor system). In particular, an antenna can be mounted on the holder, and medical products equipped with RFID can be arranged or placed on the holder. Special electronic devices (such as an antenna) can be mounted under the handpiece, and this special electronic device can be adapted by means of the contact system of the universal adapter and thus by plug and play. This can reliably transmit high-frequency signals / HF signals and can work properly especially underwater.
[0040] In particular, in addition to this signal, direct current (DC) can also be transmitted via the signal interface in order to supply electrical energy to the medical product.
[0041] As another variant, the ultrasonic sieve can be equipped with an electronic module / electronic device that is adapted to be able to detect or reveal at least one of the following characteristics:
[0042] - Detecting the ultrasonic bath by means of an ultrasonic sensor;
[0043] -Detecting cleaning and disinfection by means of a temperature sensor and / or a pressure sensor;
[0044] -A communication module, in particular for wireless data transmission by means of Bluetooth, particularly preferably by means of low energy Bluetooth (BLE), wireless local area network (WLAN) and similar transmission modalities, in order to be able to communicate with a reading and / or writing device (in particular a multi-reader); and / or
[0045] -Detecting maintenance with oil by means of a temperature and / or a pressure sensor.
[0046] An ultrasonic sieve can be provided which does not completely undergo the cycle of sterile articles and thus does not need to withstand the high temperature and high pressure phases of sterilization, so that the electronic device of the ultrasonic sieve is correspondingly suitable. In other words, the ultrasonic sieve can in particular have an ultrasonic sensor for detecting an ultrasonic bath. The ultrasonic sieve can also include a temperature sensor and / or a pressure sensor for detecting cleaning, disinfection or maintenance. The ultrasonic sieve can also have a communication module of a communication unit for wireless transmission of data.
[0047] In one embodiment, the ultrasonic sieve can be equipped with an electronic device or a detector which is suitable for detecting the immersion of the ultrasonic sieve into an ultrasonic bath and the ultrasonic operation itself.
[0048] In particular, the ultrasonic sieve in combination with a universal adapter or a universal interface can perform additional functions, that is, an antenna can be contacted thereby and data (such as a counter) can thus be written into a transponder (such as an RFID glass tag). In the process step of oiling, the handpiece is simultaneously sprayed with oil. The ultrasonic sieve can also identify this process step in the ultrasonic bath and write data into a medical product, in particular a handpiece, by means of a universal adapter and an antenna connected to a bracket.
[0049] In particular, the ultrasonic sieve can include a self-sufficient energy source, and in particular the power supply of the electronic device in the ultrasonic sieve can be solved by a primary battery or by a storage battery which can be inductively charged during the process or can be charged by means of energy harvesting in corresponding steps.
[0050] In particular, the tracking system according to the present disclosure can have a universal adapter and / or an ultrasonic sieve according to the present disclosure.
[0051] In particular, the tracking system can also have a medical oil spraying device for spraying oil onto a medical product (with a motor system), wherein the oil spraying device / oil sprayer has a universal adapter according to the present disclosure.
[0052] In particular, multi-write / read devices / multi-readers can be used to identify medical products. This can be achieved in particular by means of data matrix codes (such as QR codes) and / or barcodes and / or transponders (such as RFID chips). Similarly, a camera system can also be given an important function here, both for identifying data matrix codes (QR codes) and preferably (in other steps) for evaluating the cutting edge quality of medical products, such as cutting instruments. This evaluation is preferably used in combination with an AI algorithm to determine the remaining service life. Then, a universal adapter or port itself also reads out each hand-held piece and enters the data as an interface into a database, such as the cloud, directly into the corresponding cloud database. Thus, data transfer can be achieved at the multi-reader itself by means of communication (such as BLE, WLAN, etc.). Then, via the multi-reader, the data can be entered into a server or the cloud or other programs, and thereby the service life of each individual medical product can be recorded.
[0053] The multi-reader can also have a universal adapter to batch-read medical products with transponders on brackets and holding brackets.
[0054] In terms of a computer-readable storage medium or a computer program, the task is solved in the following way: the computer-readable storage medium or the computer program includes instructions which, when executed by a computer, cause the computer to execute the method steps of the tracking method according to the current embodiment.
[0055] The universal adapter as a contact system can be adjusted in terms of shape and size, wherein the geometric dimensions in terms of length / width / height can in particular be 30 mm / 12 mm / 7 mm and can thus be implemented very small so as to be able to be arranged, for example, at different parts of an ultrasonic sieve or an injector.
[0056] The disclosure regarding the tracking method of the present disclosure is equally applicable to the tracking system, the universal adapter and the ultrasonic sieve of the present disclosure, and vice versa. Description of the Drawings
[0057] Below, the present disclosure will be explained in more detail with reference to the accompanying drawings by means of preferred embodiments. It is shown:
[0058] Figure 1a A schematic diagram of a sterile item cycle, in which a tracking method of a preferred embodiment is applied, wherein the experience of the sterile item cycle is detected at two stations;
[0059] Figure 1b A flowchart of a tracking method according to a first preferred embodiment, which is applied to Figure 1a the sterile item cycle in
[0060] Figure 2Schematic diagram of a sterile article cycle of another variant together with a tracking method, wherein the detection of the experience is carried out at three stations;
[0061] Figure 3 Perspective view of an ultrasonic sieve according to a preferred embodiment, the ultrasonic sieve having a central communication unit and two connected universal adapters for contactlessly connecting instruments, in particular for a tracking system according to a preferred embodiment;
[0062] Figure 4 Figure 3 Perspective view of the sterilization basket in [reference], the sterilization basket having two brackets in which instruments and handpieces are received, wherein the antennas are in contact with the universal adapters respectively;
[0063] Figure 5 Perspective view of a universal adapter according to a preferred embodiment;
[0064] Figure 6 Figure 5 Longitudinal sectional view of the universal adapter in [reference];
[0065] Figure 7 Perspective view of a multi-reader (reading and writing device) according to a preferred embodiment, the multi-reader having a centrally arranged universal adapter for contactless connection for reading and writing;
[0066] Figure 8 Perspective view of an injector with a universal adapter; and
[0067] Figure 9 Viewed from below Figure 8 Another more detailed partial perspective view of the injector in [reference].
[0068] The drawings are essentially schematic and should only be used for understanding the present invention. The same elements are denoted by the same reference numerals. The features of different embodiments may be interchanged. Detailed description of the preferred embodiments
[0069] FIG. 1 shows a schematic sterile article cycle, in which a computer-implemented tracking method for tracking the sterile cycle history of a medical product 1 (e.g., in the form of a surgical instrument or handpiece having a motor system) is applied.
[0070] This sterile article cycle has five stations or process steps:
[0071] First process step: Manually or mechanically pre-clean the medical product 1, in particular by means of ultrasound;
[0072] Second process step: Disinfect the medical product 1;
[0073] Third process step: servicing or maintenance of the medical product 1, in particular lubricating a medical product 1 having an integrated motor or motor system (for example, a handpiece having a motor);
[0074] Fourth process step: sterilizing the medical product 1; and, finally
[0075] Fifth process step: medical or actual use of the medical product 1, in particular during a surgical operation.
[0076] Currently, at the pre-cleaning stations in the form of ultrasonic treatment and lubrication, the medical product 1 is examined for its experience of the sterile goods cycle. These two stations are the stations that are most significantly related to the service life of the medical product 1.
[0077] Specifically, this is achieved by Figure 1b implementing.
[0078] At the pre-cleaning station, in step S1, the unique identification of the medical product 1 is detected by the detection unit 2, in particular the identification number stored in the transponder 4 of the medical product 1 is detected by the transponder reading and writing device 6. Thus, the medical product can be uniquely identified and associated with the data stored related to the medical product 1.
[0079] In step S2, the counter of the sterile cycle history related to the medical product 1 having the identification is read in. Thus, after association with the relevant data, the significantly relevant counter is read in.
[0080] In step S3, the ultrasonic treatment of the medical product 1 is detected and, subsequently, the counter of the sterile cycle history related to the medical product 1 is incremented by one.
[0081] In the subsequent step S4, the incremented counter is now stored in the storage unit 8 by the transponder reading and writing device 6, in particular in the transponder 4 of the medical product 1 itself.
[0082] Finally, in step S5, it is determined that the medical product 1 is in the warning area, i.e., when the counter exceeds a predefined limit value related to the medical product (1). Thus, if the sterile goods cycle of an individual medical product 1 is experienced too frequently, the status of the medical product 1 can be switched from the "green" area to the "yellow" area before it reaches the "red" area where the medical product 1 is unusable. Currently, a warning in the "yellow" area has been recognized, i.e., the expected service life will soon be reached, and, in step S6a, a warning message is output to the user by a visual presentation device 10 (for example, in the form of a display).
[0083] Alternatively or additionally, in step S6b, an automated recovery process can also be initiated to restore the functional capabilities of the medical product 1.
[0084] The order of the above steps is carried out at the servicing station where the medical product is sprayed with oil. However, it is only confirmed here that the counter at the ultrasonic station has been incremented so that the counter will not be incremented incrementally at this station again.
[0085] Alternatively, it can also be set that the counter is incremented only when the medical product has passed through the pre-cleaning station and the servicing station. Further alternatively, the counter can also be incremented at each of the two stations, where, however, in this case a cumulative predefined limit value is also used to take this into account. Currently, the two critical stations are marked with asterisks respectively.
[0086] Figure 2 A schematic diagram of another cycle of sterile articles together with a tracking method showing another variant, where the detection of the passage is carried out at three stations; different from the sterile article cycle in FIG. 1, another station is also provided here at a so-called multi-reader. The multi-reader can also detect the passage and can be provided instead of or in addition to the other two stations (pre-cleaning and servicing).
[0087] Figures 3 to 6 An ultrasonic sieve 101 is shown having a central communication unit 102 and two connected universal adapters 12 for contactlessly connecting instruments, and, Figure 5 and Figure 6 the universal adapter 12 is shown separately therein, which is particularly for a tracking system with a control unit according to a preferred embodiment.
[0088] The ultrasonic sieve 101 (shown in Figure 3 without the medical product 1, shown in Figure 4 with a bracket and the medical product 1) is arranged and designed to receive the medical product 1 and immerse it in an ultrasonic bath.
[0089] For this purpose, according to a preferred embodiment, the ultrasonic sieve 101 has two universal adapters 12, which are respectively fastened to the sieve bowl base 102 by their fastening sections 24 and connected to the central communication unit 104. This communication unit 104 can wirelessly exchange data with a data interface via WLAN or Bluetooth to access the stored data about the medical product 1. As will be described later, a connectable antenna (14) can be used through the universal adapter 12 to read and / or write to the transponder (4) of the medical product (1). In particular, the ultrasonic sieve has an electronic module with a temperature sensor and an ultrasonic sensor to detect immersion and ultrasonic treatment.
[0090] Refer to Figure 5 and Figure 6, the general adapter 12 will be described more precisely. The general adapter 12 is used to couple the antenna 14 to track the aseptic cycle history of the medical product 1. For this purpose, it has an adapter housing 16 with antenna contacts 18, which have two electrically contacting surfaces 22 spaced apart from each other, arranged on the upper side 20 and exposed towards the outside of the adapter housing 16, in order to be able to manufacture a standardized coupling structure for a wired connection to the antenna in terms of signal technology. The general adapter also has a fastening section 24 in the form of a (screw-in / fastening) ring of the adapter housing 16 to fasten the general adapter 12 to the bottom 102 of the sieve bowl of the ultrasonic sieve 101.
[0091] In addition, the general adapter has a wired signal interface 26 in the form of a high-frequency coaxial cable, which is conductively connected to the antenna contacts 18 to forward high-frequency signals and thereby control the antenna 14.
[0092] In addition, the general adapter 12 includes magnets 28 to provide a force-locking detachable coupling with the general adapter 12, especially for a corresponding adapter 110 of a bracket 106 complementary to the general adapter 12. In this embodiment, the general adapter 12 has two magnets 28 spaced apart from each other, which are oriented parallel to each other but have opposite magnetic poles to ensure a one-to-one alignment of the connection, i.e., a one-to-one alignment of the connection with the corresponding adapter 110 having complementary arranged magnets. In addition, the general adapter 12 has three asymmetrically arranged protrusions 30, which prevent misalignment when connecting to the corresponding adapter 110.
[0093] Therefore, especially through Figures 3 to 6 the ultrasonic sieve 101 shown, a tracking system with a control unit (not shown) has been implemented according to a preferred embodiment. The detection unit is implemented by a transponder reading and writing device 6, which is adapted to detect the one-to-one identification of the medical product 1, especially the identification number stored in the transponder 4 of the medical product 1. The sensor adapted to detect the ultrasonic treatment of the medical product 1 is implemented by an electronic module having a temperature sensor and an ultrasonic sensor to detect immersion and ultrasonic treatment. The (not shown) control unit of the tracking system is adapted to increment (by 1) a counter related to the aseptic cycle history of the medical product 1 and store this counter in a storage unit, especially store this counter in the transponder 4 of the medical product 1 through the transponder reading and writing device; and, when the counter exceeds a predefined limit value related to the medical product 1, output a warning message to the user through a visual presentation device 10 and / or initiate an automated recovery process of the functional capabilities of the medical product 1.
[0094] Figure 7Shows a multi-reader for a tracking system, which has a universal adapter 12 in the middle of the base to be able to read out medical products 1 with antennas 14 arranged thereon, and these medical products are implemented similarly to the aforementioned ultrasonic sieve 101. Through the universal adapter 12, a defined standardized interface of the detection unit in the form of a transponder reading and writing device can be provided. Thus, the multi-reader is suitable for detecting the one-to-one identification of one medical product 1 or multiple medical products 1, and the identification is stored in the transponder 4 of the medical product 1 as an identification number.
[0095] The tracking system with the Figure 7 multi-reader according to a preferred embodiment also has a sensor, which is suitable for detecting the ultrasonic treatment of the medical product 1 and / or the maintenance of the medical product 1, especially lubrication (especially through a separate injector 108), as disclosed in the following Figure 8 and Figure 9 . A control unit (not shown), which can be arranged in the multi-reader, for example, is specifically suitable for incrementing (by 1) a counter of the aseptic cycle history related to the medical product 1 during detection and storing the counter in the transponder 4 of the medical product 1 through the transponder reading and writing device. In addition, the control unit is suitable for, when the counter exceeds a predefined limit value related to the medical product 1, outputting a warning message to the user through a visual presentation device (not shown here) and / or starting an automated recovery process of the functional ability of the medical product 1.
[0096] Figure 8 and Figure 9 shows an injector 108, which has a corresponding adapter 110 with a complementary structure to the universal adapter 12. Thus, at the maintenance site, coupling with the injector can be achieved through the universal adapter and the counter of the medical product can be incremented.
[0097] List of reference numerals
[0098] 1 Medical product
[0099] 2 Detection unit
[0100] 4 Transponder
[0101] 6 Transponder reading and writing device
[0102] 8 Storage unit
[0103] 10 Presentation device
[0104] 12 Universal adapter
[0105] 14 Antenna
[0106] 16 Adapter housing
[0107] 18 Antenna Contact
[0108] 20 Upper Side
[0109] 22 Contact Surface
[0110] 24 Fastening Section
[0111] 26 Signal Interface
[0112] 28 Magnet
[0113] 30 Protrusion
[0114] 101 Ultrasonic Sieve
[0115] 102 Sieve Bowl Bottom
[0116] 104 Communication Unit
[0117] 106 Bracket
[0118] 108 Injector
[0119] 110 Corresponding Adapter
[0120] S1 Step of Detecting the Identification of a Medical Product
[0121] S2 Step of Reading into the Counter
[0122] S3 Step of Detecting the Process Step
[0123] S4 Step of Storing the Altered Counter
[0124] S5 Step of Determining Whether the Medical Product is Located in the Warning Area
[0125] S6a Step of Outputting a Warning Message
[0126] S6b Step of Initiating the Recovery Process
Claims
1. A computer-implemented tracking method for tracking the aseptic cycle history of a medical product (1), in particular an instrument or medical device having a motor system, characterized in that it includes the following steps: detecting (S1) the unique identification of the medical product (1) by a detection unit (2), in particular detecting the identification number stored in the transponder (4) of the medical product (1) by a transponder reading and writing device (6); reading in (S2) a counter for the aseptic cycle history associated with the medical product (1) having the identification; detecting (S3) the ultrasonic treatment of the medical product (1) and / or the maintenance of the medical product (1), in particular greasing, and incrementing the counter for the aseptic cycle history associated with the medical product (1); storing (S4) the counter in a storage unit (8), in particular storing the counter in the transponder (4) of the medical product (1) by means of a transponder reading and writing device (6); and when the counter exceeds a predefined limit value associated with the medical product (1), determining (S5) that the medical product (1) is in a warning zone, and outputting a warning message (S6a) to the user by a visual presentation device (10) and / or initiating an automated recovery process (S6b) to restore the functional capacity of the medical product (1).
2. The computer-implemented tracking method according to claim 1, characterized in that in the case of a medical product (1) having a transponder (4), in the step of reading in the counter for the aseptic cycle history, in addition to reading in (reading out) the identification number from the transponder (4), the counter stored in the transponder (4) is also read in; and in the step of storing the counter, the counter is stored in the transponder (4) associated with the medical product (1).
3. The computer-implemented tracking method according to any one of the preceding claims, characterized in that in the reading-in step, the counter for the aseptic cycle history associated with the medical product (1) stored on a central server in a storage unit is read in; and in the step of storing the counter, the incremented counter together with the identification is stored in the storage unit of the central server for the medical product (1) to provide central data management of the aseptic item history of the medical product (1), in particular for a plurality of different medical products (1).
4. The computer-implemented tracking method according to any one of the preceding claims, characterized in that the predefined limit value is defined as less than the service life associated with the medical product (1) for a certain number of aseptic item cycles, such that a warning message is output to the user and / or the automated recovery process is initiated before the end of the service life is reached.
5. The computer-implemented tracking method according to any one of the preceding claims, characterized in that for the medical product (1), an ultrasonic counter is stored as a first counter and a maintenance counter is stored as a second counter, and In the case where ultrasonic treatment of the medical product (1) and maintenance of the medical product (1) are detected, the counters are each incremented by one, and if at least one counter exceeds a predefined limit value, it is determined that the medical product (1) is in the warning area.
6. The computer-implemented tracking method according to any one of the preceding claims, characterized in that in the step of detecting ultrasonic treatment, the ultrasonic treatment is detected by a sensor, the sensor being adapted to detect contact with a fluid and / or to detect ultrasonic waves.
7. The computer-implemented tracking method according to any one of the preceding claims, characterized in that the tracking method further has the following steps: creating a record, in particular by means of a multi-reader camera and / or a lidar device; determining the state of the medical product (1) based on the record, in particular determining the state of the cutting edge quality and / or the cutting edge geometry of a surgical instrument; and in the case of an insufficient state, outputting a warning message to the user via a visual presentation device and / or initiating an automated recovery process of the functional capabilities of the medical product (1).
8. The computer-implemented tracking method according to claim 7, characterized in that the tracking method further has the following steps in the step of determining the state: transmitting the record to a trained artificial intelligence system of a central server, the trained artificial intelligence system being trained with the cutting edge quality of a surgical instrument as input data and with a state determination, in particular a binary state determination "sufficient" - "insufficient", and performing the determination of the state by the trained artificial intelligence system; wherein, preferably, the determined state is also transmitted to the multi-reader.
9. A tracking system for tracking the aseptic cycle history of a medical product (1), in particular an instrument or a medical device having a motor system, characterized in that the tracking system has: a detection unit adapted to detect a one-to-one identification of the medical product, in particular to detect an identification number stored in a transponder (4) of the medical product (1) by means of a transponder reading and writing device; a sensor adapted to detect ultrasonic treatment of the medical product (1) and / or maintenance of the medical product (1), in particular oiling; a control unit adapted to increment a counter (increment by 1) of the aseptic cycle history associated with the medical product (1) and store the counter in a storage unit, in particular store the counter in the transponder (4) of the medical product (1) by means of a transponder reading and writing device; and, when the counter exceeds a predefined limit value associated with the medical product (1), outputting a warning message to the user via a visual presentation device and / or initiating an automated recovery process of the functional capabilities of the medical product (1).
10. A universal adapter (12) for coupling an antenna (14) for tracking the aseptic cycle history of a medical product (1), in particular in a computer-implemented tracking method according to any one of claims 1 to 8 or in a tracking system according to claim 9, the universal adapter having: an adapter housing (16) with antenna contacts (18), the antenna contacts having two electrically conductive surfaces (22) spaced apart from each other, arranged on the upper side (20) and exposed towards the outside of the adapter housing (16), in particular having exactly two electrically conductive surfaces, for a standardized coupling structure for a wired connection of the antenna (14) in terms of signal technology; a fastening section (24) of the adapter housing (16), in particular in the form of a ring, for fastening the universal adapter (12) to an object, in particular an ultrasonic sieve; and a wired signal interface (26), in particular a high-frequency coaxial cable, conductively connected to the antenna contacts (18) for forwarding signals, in particular high-frequency signals.
11. The universal adapter (12) according to claim 10, characterized in that the universal adapter (12) has at least one magnet (28) for providing a force-locking detachable coupling of the universal adapter (12), in particular for a corresponding adapter complementary to the universal adapter (12), wherein the universal adapter (12) preferably has two magnets (28) spaced apart from each other, which are oriented parallel to each other but have opposite magnetic poles, to ensure a one-to-one alignment of the connection part, in particular with a corresponding adapter having a complementary arrangement of magnets.
12. An ultrasonic sieve (101) for receiving a medical product (1) and immersing it in an ultrasonic bath, characterized in that the ultrasonic sieve (101) has at least one universal adapter (12) according to claim 10 or 11, the universal adapter being fastened to the sieve (101) via its fastening section, in particular to the bottom (102) of the sieve bowl, and being connected to a central communication unit (104) via its signal interface (26), such that an antenna (14) connectable via the antenna contacts (18) is used for reading and / or writing to a transponder (4) of the medical product (1).
13. A computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to perform the method steps according to any one of claims 1 to 8.
14. A computer program comprising instructions which, when executed by a computer, cause the computer to perform the method steps according to any one of claims 1 to 8.