Holding device for sterilized products, sterilized products, and method for monitoring sterilized product cycles

Abstract

The present invention relates to a holding device (1) for sterile products, in particular for sterile product containers or flexible packaging, which is provided to hold medical products to be sterilized during a preparation process and which comprises communication means (2, 5, 6, 8), part of which is designed for a frequency range so that when the sterile product is closed, said part supplies information about the medical products to the environment of the sterile product. The present invention further relates to a sterile product and a method (10) for monitoring the sterile product cycle.

Description

[Technical Field]

[0001] The present invention relates to a holding device for sterile products, in particular a holding device for sterile product containers or flexible packaging, and a method for monitoring a sterile product cycle, where sterile product also means a sterile container with an inserted screen basket and a screen basket in a flexible packaging. The holding device may be provided, inter alia, for holding at least one sterilizable medical product, in particular during a preparation process (including ultrasonic cleaning, cleaning and disinfection, maintenance such as application of lubricant, and / or sterilization), and for storing the medical product before and / or after the preparation process. [Background technology]

[0002] The detection of sterilization product cycles for medical products, for example medical industrial products such as tools (application parts, tools, etc.), surgical instruments, or handpieces, is mostly based on documenting or checking when the preparation cycle is completed. The problem with this is that it does not reliably account for how pre-cleaning, cleaning and disinfection, maintenance, and sterilization were performed. While manual records may produce valid data, this approach is prone to errors. Furthermore, the usage time of electrical, pneumatic, or hydraulic products cannot be recorded in a way that is relevant to the product (at the individual product level). A further problem is the lack of identification of individual products and detection of their lifespan, i.e., the catchword traceability.

[0003] There is no way to detect the entire sterilization product cycle during use. The acquisition of sensor and transponder data is limited to the holder associated with the product. Little data is acquired about the medical product (e.g., motor, handpiece, surgical instrument, etc.), limiting the possibilities for evaluation and initiating further processes such as service, delivery of replacement, etc.

[0004] A holding device of this type is provided, inter alia, for cleaning and holding surgical handpieces and is described, inter alia, in DE 10 2010 017 624. The holder is arranged, in particular, with the medical product placed therein in a medical cleaning device, such as a sterilizer or rinsing plant. Furthermore, the holder may be arranged in and used with a sterile product container, which ensures that the medical product is efficiently prevented from becoming newly contaminated after sterilization.

[0005] Furthermore, for example, it is common for reusable implants to be reprocessed in the same manner as the medical products described above. Frequent reprocessing of these multiple reprocessable implants, especially when they are made of titanium, can lead to a loss of quality in the medical product. In the case of titanium screws, for example, the frequent use of aggressive cleaning substances can reduce the thickness of the oxide layer that protects the titanium screw from corrosion and biofilm formation. Reprocessable implants are often used in sets, and they are usually subjected to a preparation process together, regardless of whether the individual elements of the set are actually used.

[0006] For example, from the state of the art to which the present application relates, holders of the above-mentioned type are known, which holders accompany medical products that are held in the holder throughout the entire cleaning and preparation process. Such holders are known, for example, from DE 10 2010 017 624.

[0007] To enable tracking of how often a medical product has been reprocessed during its lifetime, it is known to provide, for example, a temperature sensor integrated with an energy supply unit or energy harvesting unit in the motor of the medical product, which detects the temperature during the preparation process and stores it in a data memory of the motor. A motor including a memory suitable for this purpose is described, for example, in DE 10 2011 050 192. However, such a solution has the particular disadvantage of taking up a relatively large amount of installation space within the medical product and increasing the weight of the medical product. These disadvantages are unacceptable, especially for medical products applied in the field of neurosurgery or minimally invasive methods.

[0008] In medical product surveillance, Preferably, changes in the volume and / or weight of the medical product itself are avoided; individual medical products can be monitored; I realized that this is important.

[0009] moreover, The acquired data can be read wirelessly. be able to provide the data obtained for evaluation, Access to data worldwide It is desirable that: Summary of the Invention [Problem to be solved by the invention]

[0010] It is therefore an object of the present invention to avoid or at least mitigate the drawbacks of the state of the art. In particular, the sterilization product cycle should be improved with regard to traceability and documentation of the lifespan of medical products. [Means for solving the problem]

[0011] According to the present disclosure, this object is solved by providing a holding device for a medical product, the medical product being attached to the holding device during a sterilization product cycle, the holding device comprising a plurality of sensors arranged and designed to acquire data of process steps of the sterilization product cycle.

[0012] In a general device, this object is preferably solved by the invention in which a holding device is provided for / in a sterile product, and in particular in which a holding device is provided for / in a sterile product container, for / in a sterile product screen, or for / in a flexible packaging. The holding device is provided to hold the medical product to be sterilized in / in a holder and / or in the sterile product screen throughout the preparation process / cycle. The holding device comprises communication means. For example, some of the communication means, such as the communication module described further below, are designed for a certain frequency range and provide data about the medical product to the environment outside the sterile product container when the sterilization container is closed.

[0013] This has the advantage of improved monitoring of the entire sterilized product cycle.

[0014] Flexible packaging may be used as an alternative to or a supplement to sterile product containers. Flexible packaging may be a screen wrapped in a particular paper, where the screen forms a retaining device.

[0015] A sterile product container may also refer to a sterile product container with an inserted screen basket, such as a sterile product screen. A sterile product screen may also refer to a screen basket within flexible packaging.

[0016] Specifically, frequencies capable of penetrating lossily through an all-metal container, such as a sterile product container, may be provided. The sterile product container may be sealed, for example, during use. Specific frequencies may be, for example, 2.4 GHz and 5 GHz. For Bluetooth®, a frequency range of 2.402 GHz to 2.480 GHz may be provided. For WLAN, a frequency range of 2.412 GHz to 2.484 GHz and / or a frequency range of 5.18 GHz to 5.825 GHz may be provided. This may correspond to the 802.11b / g / n standard or the 802.11a / h / j / n / ac standard.

[0017] The communication means should be broadly interpreted and may comprise a sensor, as further explained below. This may include any form of communication and / or interface. In particular, the communication means may transmit received / transmitted / sensor signals to a communicatively connected unit, which may be an evaluation unit / data processing unit, as further explained below.

[0018] Advantageous embodiments are set out in the subclaims and are explained in more detail below.

[0019] The holding device may in particular be a screen in the sterile product / sterilized product container, e.g., a sterile product screen. The screen may therefore include individual elements such as communication means. The screen may be in the form of a basket, i.e., a screen basket. This screen basket may include a holder for insertion into the sterile product / sterilized product container, or may have a fine mesh so that the medical product to be sterilized is held therein without falling or sliding through the mesh.

[0020] The external environment of the sterile product container (container) may in particular be a relatively close environment. The environment may be, for example, in a range of up to 8 meters or up to 4 meters. In other words, the environment corresponds to the range mentioned above (the range in which the receiving unit must be placed). It is also sufficient to define the environment as a radius of 1 meter around the sterile product (sterile container / screen). The signal strength of the corresponding communication means may be adapted accordingly.

[0021] The holding device may comprise a data processing device and an energy supply unit, for example the data processing device being designed to minimize the energy supply for the communication means of the holding device with respect to the data processing device provided by the energy supply unit between process steps of the preparation process.

[0022] The data processing device and / or the communication means may further comprise a separator enclosing them together or individually, which separator provides thermal and / or watertight separation.

[0023] Furthermore, the communication means may comprise an NFC read / write device provided in the holding device, which enables NFC communication with a complementary NFC antenna on the medical product to be sterilized when the medical product to be sterilized is inserted into the holding device.

[0024] The retaining device may be modular, thus allowing removal of individual elements of the retaining device.

[0025] The above object is also achieved by a container such as a sterile product container or flexible packaging. In a closed state, the sterile product container, and possibly also the flexible packaging, forms a metallic Faraday cage. The metal may be a non-ferromagnetic metal. The metal layer of the sterile product container may be sheet metal and has a penetration depth (obviously) smaller than the penetration depth of the current induced therein by the alternating magnetic field between the internal transponder and the external receiver.

[0026] In advantageous embodiments of the present disclosure, which may be combined with other features or may be separate, sensors are provided redundantly.

[0027] In an advantageous embodiment of the present disclosure, which may be combined with other features or may be separate, the holding device comprises multiple antennas and a read / write unit, the multiple antennas being connected to the read / write unit via an electronic distribution system (multiplexer).

[0028] In advantageous embodiments of the present disclosure, which may be combined with other features or may be separate, the retention device is modular, allowing for removal of individual elements of the retention device.

[0029] In advantageous embodiments of the present disclosure, which may be combined with other features or may be separate, the evaluation unit compares each individual process step with predetermined parameters and increments a respective counter if the evaluation unit determines that the process step was successfully executed.

[0030] In an advantageous embodiment of the present disclosure, which may be combined with other features or may be separate, the holding device (1) comprises a signal transmitter that indicates information about the process step to the user by optical, acoustic and / or tactile signals.

[0031] In advantageous embodiments of the present disclosure, which may be combined with other features or may be separate, the signal transmitter indicates the location of the medical product to the user by optical, acoustic, and / or tactile signals.

[0032] The above object is also achieved by a method for monitoring a sterilization product cycle, the method comprising: providing a retaining device within a sterile product case, such as a sterile product container, a sterile product screen, or flexible packaging; providing a medical product to be sterilized in a sterile product container and closing the sterile product container in an all-metal manner; performing a sterile wash in a sterile product container; monitoring the medical product during the performance of the sterile cleaning with parameter data representative of the sterile cleaning obtained by at least one of the plurality of sensors of the retaining device / holder.

[0033] Similarly, during preparation for ultrasonic cleaning or the like, the holding device may be placed in a cleaning tank, particularly in the form of a screen basket, and at least one of the multiple sensors located on the holding device acquires parameter data representative of the ultrasonic cleaning.

[0034] Similarly, during maintenance using oil, the product may remain in the holder, and at least one of the multiple sensors arranged on the holding device may acquire parameter data representative of the oil maintenance. The same applies to the cleaning process, and at least one of the multiple sensors arranged on the holding device may acquire parameter data representative of the cleaning process. During maintenance processes using oil, the oil bottle used should be placed or held upright to ensure optimal oil flow. This may be ensured, for example, by a tilt sensor arranged in / on the holding device. Thus, the correct position of the oil bottle can be reliably tracked during the maintenance process.

[0035] In other words, the present disclosure preferably relates to monitoring of sterilization product cycles, and in particular to ultrasonic cleaning detection, tracking in closed systems enabled using Bluetooth and / or WiFi, environmental sensors, automatic detection of process steps, and / or product monitoring.

[0036] For example, devices (sensors) may be provided for temperature detection, for detection of preparation processes including cleaning, disinfection, maintenance, and / or sterilization. Furthermore, methods for providing products with radio frequency identification markers (transponders) may be described herein. Data may be stored on a server or in a cloud solution. The transponders may be read and / or written by the holding devices for the medical products described herein and / or elements thereof.

[0037] The present disclosure allows for comprehensive monitoring of a product's entire sterilization cycle. To this end, various sensors located in a single holding device can automatically detect different process steps, autonomously evaluate the data via an evaluation device in the single holding device, change the corresponding operating mode, and / or store the results while writing them to a product transponder. Furthermore, transponder and sensor data reading may be performed by an intelligent "module" installed, for example, in a holder / holding device (also called a tray) located on / in the screen basket and / or sterilization container. Optical, acoustic, or tactile transmitters may be used to communicate important information to the user.

[0038] Additionally, the present disclosure relates to the full detection and analysis of sterile product cycles (operating room use, ultrasonic cleaning, washer-disinfector cleaning, maintenance, e.g., with oil spray, and sterilization) and the provision of detailed data for the corresponding individual products. System and / or device components may be designed as holders themselves, such as the holding devices described herein, or as inserts for screen baskets, such as the holding devices described herein.

[0039] The sensors in the holding device capture data on the entire operation room, ultrasonic cleaning, cleaning in a washer-disinfector, maintenance such as oil spraying, and sterilization.

[0040] Depending on the frequency range used, there is no shielding from the metallic environment, so there is a relatively free choice of placement of the electronics (e.g. inside or under the screen basket), however it is preferred that the electronics are firmly connected to the holder, in particular the screen, but not to the container.

[0041] For the use of multiple antenna systems, slots may be included, allowing multiple antennas to be connected to the read / write unit via an electronic distribution system (multiplexer).

[0042] The system may further comprise a data evaluation unit (microcontroller), a communication module (e.g., Bluetooth or Wi-Fi in the 2.4-5.825 GHz range), an exchangeable energy supply (e.g., high-temperature battery, power cap), an RFID / NFC module (read / write module), and / or various sensors (temperature, humidity, pH, pressure, sound waves, flow rate, voltage, light, or vibration) and signal transmitters (acoustic, optical, or tactile). Energy harvesting may be used at least in part as the energy supply.

[0043] The system may furthermore be modular and built according to given requirements as desired. Thermal shielding (from moisture and chemicals) may be used to protect the electronics before cleaning and sterilization. Sensors may be positioned to ensure that individual process steps are detected. Energy supplies may be replaced at the end of their life or recharged at predetermined change intervals at predetermined process locations.

[0044] One of the aspects may include a smart tray or a smart screen, which may be for the holder itself, but also for the entire screen.

[0045] Another aspect may be the detection of ultrasonic cleaning, which may be performed by a suitable sensor system.

[0046] Yet another aspect may be product location. Bluetooth or Bluetooth Low Energy (BLE) and / or W-LAN may be used to track and detect products through sealed sterile product containers and screen baskets (Faraday cages). A signal may be emitted by the smart tray "module," which may emit a sound or vibrate. A major advantage is that the container does not need to be opened to locate the product. Once opened, the container is considered non-sterile even if unused and must be re-entered into the preparation process. This would be costly, but the present disclosure avoids this.

[0047] Yet another embodiment relates to data transmission through sealed sterile product containers using Bluetooth and W-LAN.

[0048] Unlike the state of the art, the present invention allows for holistic monitoring of the sterilization product cycle. Automatic detection and analysis of process steps allows for an evaluation of the entire process and allows for the calculation of the lifespan, damage, and usage behavior of individual products. A further improvement could be the separation of specific holding devices designed for one product type to a solution in which the screen basket is modified so that it can serve as a system for evaluating sensor data and reading / writing transponders.

[0049] A further difference is that automatic detection of ultrasonic cleaning is provided, which is very important for the hygiene of medical products.

[0050] Particular focus may be placed on detection of the entire sterilization product cycle. Additionally, the use of ultrasonic sensors (e.g., piezoelectric elements, radiometers, microphones) may be provided for detection of pre-cleaning by ultrasonic baths.

[0051] Ultrasonic cleaning is one of the key process steps in the sterilization product cycle. Whether ultrasonic cleaning has been performed can be detected by an ultrasonic sensor, such as a piezoelectric element, a radiometer, and / or a microphone, thereby achieving multiplex redundancy.

[0052] Applicable sensors may be extended to (temperature, pressure), humidity, pH value, sound waves, flow rate, voltage, light, and / or vibration.

[0053] In advantageous embodiments of the present disclosure, which may be combined with other features or may be separate, the sensors detect temperature, humidity, pH value, pressure, sound waves, voltage, and / or vibration.

[0054] Furthermore, the holding system may be extended to a screen basket with connections for an antenna and an evaluation unit.

[0055] Similarly, communications in the GHz frequency range (unshielded) may allow the electronics to be freely placed within a container or screened basket (Faraday cage).

[0056] For example, Bluetooth or WiFi (2.4-5.825GHz) may be used for tracking systems.

[0057] Additionally, product location may occur through a sealed sterile container and a sealed screen basket (Faraday cage).

[0058] Additionally, data transmission may occur through the sealed container using Bluetooth and W-LAN.

[0059] The present disclosure may, for example, implement continuous monitoring of medical products. The obtained data can be used to establish calculations regarding the lifespan and condition of the medical product. Furthermore, individual process steps can be detected autonomously by the device. By providing additional data, calculations of possible damage can be performed. For example, a user may be informed of the location, condition, and process step by a signal transmitter. A user can locate and identify the product through the sealed sterile container without opening the container, which would increase the cost of reprocessing. A customer can locate and identify the product through the sealed flexible packaging without opening the flexible packaging, which would increase the cost of reprocessing.

[0060] In an advantageous embodiment of the present disclosure, which may be combined with other features or separately, the holding device comprises an evaluation unit that infers the life and / or condition of the medical product from the data.

[0061] An exemplary case of the present disclosure described below is a holding device for a medical motor system. The medical motor system is equipped with an NFC transponder having a unique identification number that matches the motor system. Furthermore, the transponder is designed so that information regarding the number of pre-cleaning, cleaning, maintenance, sterilization, and use cycles (e.g., duration of current supply, etc.) can be stored, optionally along with detailed data.

[0062] The holding device is designed, for example, so that the sensor can be placed together with the protected evaluation unit and replaceable energy supply. The entire electronics is designed, for example, to be replaceable. Sensors for detecting temperature, humidity, pH, pressure, sound waves, voltage, position, and / or vibrations may be used. For example, at least one antenna is connected to the evaluation unit and mounted so that the transponder is always within range for reading and writing to the NFC transponder.

[0063] The sensors for detecting process steps are mounted to ensure optimal detection without interfering with operation, cleaning, or handling. To minimize the energy required by the module, only those systems that are needed are activated. Between two process steps, the module goes into energy-saving mode, where a check is made at defined intervals to see if a process step has started. Examples of this are temperature limits before cleaning, maintenance, and sterilization, and changes in light during opening or use before using ultrasound in pre-cleaning.

[0064] For example, piezoelectric elements may be used to detect ultrasonic cleaning. The detection of information about use and operating conditions can be performed by a control device provided, which stores the data in the individual handpieces. In a basic variant, a pair of temperature sensors may be used to detect cleaning, maintenance with oil spray, and sterilization. The sensors may in each case be designed to be redundant and / or automatically checked by self-check.

[0065] The evaluation unit, for example, analyzes the individual process steps and compares them with predetermined parameters. If a process step is completed with an acceptable deviation, the respective internal counter is incremented. The updated counter value and / or process data are then sent to the NFC transponder. A signal transmitter, which can emit optical, acoustic, or tactile signals, informs the user about the process steps and the exact duration of the oil spray process.

[0066] Signal transmitters can also be used to determine the location of relevant medical products, for example, within rigid or flexible sterile barrier systems (e.g., sterile containers, screens, flexible packaging). Here, a user can activate a search function using Bluetooth or Wi-Fi. The corresponding signal transmitter is then activated, resulting in a signal (sound, light, vibration) in the closer environment indicating the location of the product. For example, location can also be determined by triangulation or signal strength measurements, which are possible with wireless standards (e.g., Bluetooth, Wi-Fi).

[0067] A first evaluation of the sensor values ​​is performed, for example, by an integrated evaluation unit, which can then analyze the process. The data is further analyzed, for example, in an external evaluation unit (e.g., PC, tablet) or in a server-based solution (e.g., cloud, server), for the calculation of lifespan, possible damage, and other product-related predictions (predictive maintenance).

[0068] Thus, in one example, the present disclosure relates to a holding system that can detect the entire sterilization product cycle of a medical product (e.g., surgical instruments, implants, etc.) and provide detailed sensor data offline and online. Because the ultrasonic pre-clean detection is performed by a sensor, more data is available. Furthermore, a product location system is integrated into, for example, a screen. Thus, the product location system is an integral element of the present disclosure that resides within the sealed container.

[0069] Additional embodiments are described below.

[0070] A holding device may be provided for holding at least one sterilizable medical product, in particular during the preparation process, and for storing the medical product before and / or after the preparation process. The data processing device is connected / connectable to at least one sensor for signal communication. The sensor may be, in particular, a temperature sensor for determining a temperature during the preparation process and / or a pressure sensor for determining a static and / or dynamic pressure of the cleaning liquid during the preparation process.

[0071] The data processing device, for example, processes the sensor signals into cleaning information and comprises a storage device and / or is / is connected in data communication with / connectable to a storage device in which the cleaning information is / is able to be stored, the cleaning information being retrievable / readable from the storage device by the evaluation unit, whereby the cleaning information can be used by the evaluation unit to determine a cleaning profile for the medical product.

[0072] Thus, the cleaning profile can be used to record the preparation process of the medical product without changing the volume and / or weight of the medical product. In particular, it is also provided that the sensor data history is a component of the cleaning profile. The signal transmission connection between the data processing device and the sensor may be established, for example, by a wired connection and / or a wireless connection.

[0073] In addition to determining the pressure and temperature of the cleaning agent, for example, one or more sensors can also determine the quantity of the cleaning oil, its pH value, its conductivity, etc. For all the data determined, the history, cycles, retention times, time course, etc. can also be detected.

[0074] By way of example, the data processing device may for example be a so-called SOC (System on a Chip). In order to be able to use the data processing device in a holder, i.e. in an area to be cleaned and / or sterilized, the data processing device is protected from environmental influences.

[0075] The evaluation unit may for example be a PC, a laptop, a tablet, etc. Furthermore, it is conceivable that the evaluation unit can be designed as a component of a further computer system, for example as a control device for a medical product.

[0076] In one embodiment, the holding device includes a supply line and at least one cleaning line branching off from the supply line, and the at least one cleaning line is connected to a rinse port, in particular for receiving medical products of the handpiece, and a cleaning agent can be introduced through the supply line, the cleaning line, and the rinse port, in particular to the part of the handpiece to be cleaned. The handpiece may refer, for example, to a surgical instrument having an internal or external drive and an inlet for a surgical tool.

[0077] The holding device may comprise a plurality of cleaning lines, each of which is assigned to a rinsing port, so that by monitoring the cleaning lines it is possible to deduce whether the preparation process has been carried out in accordance with predetermined parameters and whether the medical product, in particular the handpiece, placed in the rinsing port has been properly cleaned.

[0078] Temperature and / or pressure sensors are arranged, for example, in the supply lines, and / or the cleaning lines, and / or the rinse outlets. Due to the thermodynamic and hydraulic coupling between the supply lines, the cleaning lines and the rinse outlets, it is sufficient for each cleaning line to be equipped with a pressure sensor and the supply line with a temperature sensor to determine the cleaning profile.

[0079] The temperature determined in the supply line and the pressure in the cleaning line during the cleaning process define parameters that can be used to determine that the cleaning process has been performed on all medical products, especially handpieces, to ensure proper hygienic preparation.

[0080] In order to simplify the construction of the holding device, it is also conceivable that only the supply line may be equipped with both a pressure sensor and a temperature sensor, which is particularly advantageous when cleaning similar medical products, in particular handpieces, with similar levels of contamination.

[0081] In one embodiment, the data processing device is connected / connectable to a data storage device of the medical product, and the cleaning information is stored / storable in the data storage device. Thus, the data processing device writes the specified cleaning information to the data storage device of the medical product. In the case of a handpiece that is connected to an associated control device before use, the stored cleaning information can be read and / or displayed by the control device. Such data transmission may be performed, for example, via a wired connection or wirelessly.

[0082] In such an embodiment of the holding device, the association of cleaning information with each medical product is achieved by writing the cleaning information assigned to the medical product directly into the data store of the medical product.

[0083] For example, the holding device may comprise at least one identification feature operatively connected / adapted to a data processing device, which may identify a medical product placed in the holding device based on an identification feature, and which may associate the identification feature with cleaning information to create product information for the medical product. Such an embodiment of the present disclosure may transfer the processed cleaning information to the product information independently of the medical product, and is therefore also suitable for use in a range of external analyses, such as during inventory control, monitoring of usage intervals, etc.

[0084] For example, the identification arrangement may be, for example, a reader for reading an NFC chip, and the identification feature is an NFC chip placed on a medical product. An identification feature according to the inventive concept refers to any means suitable for identifying an object in an automatable manner and the identification information stored therein. When linking the cleaning information to the identification feature, the cleaning information is enriched by the identification information of the identification feature. The identification feature may be, in particular, an NFC chip, a resistive code, an EEPROM, a barcode, a machine-readable number sequence, etc. It is also conceivable that the identification arrangement may be partially or completely integrated into the data processing device.

[0085] For example, the identification arrangement may be operatively connected to the data processing device both wired and wirelessly, the wireless connection being established by a wireless standard such as WLAN.

[0086] In another example, medical products are identified at least in part wirelessly. Identification of medical products according to the inventive concept particularly refers to which combination of identification structures and characteristics is used to identify the medical product. Wireless methods include both radio-based electronic methods and, for example, optical methods. Radio-based electronic methods include, for example, the use of RFID technology, WLAN, NFC, etc. Optical methods include, for example, the use of QR codes, bar codes, machine-readable number sequences, etc.

[0087] It is also conceivable to identify medical products at least in part by wire. In the wired method, a physical connection, in particular a wire connection, is established between the identification structure and the identification feature. Identification features that are particularly suitable for wired identification are, for example, resistive codes, EEPROMs, etc.

[0088] Furthermore, it is conceivable to use different identification means in parallel in order to provide redundancy in identifying the medical products, which in particular reduces the error rate in identifying the medical products and increases fail-safety.

[0089] In order to transmit cleaning information and / or product information directly from the data processing device to the evaluation unit, according to the present invention, the data processing device is operably connected / adapted to a transmission device, e.g. part of a communication means, so as to be able to transmit data, and the transmission device is adapted to establish / establish a data transmission connection between the data processing device and the evaluation unit, whereby the cleaning information and / or product information can be transmitted from the data processing device to the evaluation unit.

[0090] Such an embodiment of the holding device is particularly advantageous when the medical products to be cleaned do not have their own data storage, such as compressed air handpieces, reprocessable implants, tools, instruments, etc. The evaluation unit may be, for example, a PC, a tablet, a smartphone, etc. This embodiment is particularly advantageous as it allows, for example, the inspection of the contents of sterilization screens, trays, flexible packaging and / or sterilized product containers without opening them and breaking their seals.

[0091] Alternatively, the transmission device may be designed to establish a data transmission connection with the evaluation unit via a wireless standard, in particular a mobile communication standard, a WLAN standard, and / or a short-range wireless communication standard. The use of a wireless standard facilitates the connection of the evaluation unit to the data processing device via the transmission device, since standardized protocols can be used. However, it is also possible that a common wireless standard can be used to establish the connection.

[0092] The product information can be transmitted between the holding device and the evaluation unit either directly or indirectly. A direct connection can be designed both wirelessly and via a wired connection. An indirect connection can be established, in particular via a data storage device of the medical product. That is, the data storage device is first connected to the holding device, the product information is stored in the data storage device, and then the medical product together with the data storage device is connected to the evaluation unit, so that the product information can be read out from the data storage device by the evaluation unit.

[0093] In order that the evaluation unit can accurately assign product information to the medical product, the evaluation unit may comprise means for reading out information characteristics or product information stored in a data store of the medical product.

[0094] The evaluation unit may be operatively connected / adapted to an external storage medium, and cleaning information and / or product information may be transmitted from the data processing device to the external storage medium via the evaluation unit, thereby exporting the cleaning information and allowing it to be evaluated and / or stored in an external system, thus facilitating measures of quality assurance and hygiene monitoring for medical products.

[0095] The external storage medium may be a cloud storage. Storing the cleaning information in the cloud storage allows stakeholders, particularly surgeons, personnel in a central sterile product supply department, manufacturers, etc., to obtain information about the status of medical products regardless of their location. Furthermore, it allows manufacturers of medical products to centralize and perform and / or coordinate product updates, recall actions, etc. with less organizational effort.

[0096] It will be clear to those skilled in the art that the description herein may / can be implemented using hardware circuits, software means, or a combination thereof, which may relate to a programmed microprocessor or general-purpose computer, an ASIC (Application Specific Integrated Circuit), and / or a DSP (Digital Signal Processor).

[0097] The holding device, the sterile product / container, and / or their (structural) elements may be realized, for example, as a computer, logic circuit, FPGA (Field Programmable Gate Array), processor (including, for example, a microprocessor, microcontroller (μC), or vector processor) / core (which may be integrated with or used by a processor) / CPU (Central Processing Unit, potentially multiple processor cores), FPU (Floating Point Unit), NPU (Numeric Processing Unit), ALU (Arithmetic Logic Unit), coprocessor (additional microprocessor to support a Central Processing Unit (CPU)), GPGPU (General Purpose Computing with Graphics Processing Unit), parallel computer (especially for simultaneous execution of computing operations on multiple central processing units and / or graphics processors), or DSP.

[0098] Furthermore, it will be apparent to those skilled in the art that where details described herein are described with respect to a method, these details may also be implemented in a suitable apparatus, computer processor, or storage connected to the processor, the storage comprising one or more programs that, when executed by the processor, implement the method. Methods such as swapping and paging may also be used.

[0099] Although some of the above aspects are described with respect to the holding device, these aspects may also be applied to the sterile product / sterile product container and the method. Similarly, the aspects described above with respect to the sterile product / sterile product container may also be applied to the method, holding device, and screen.

[0100] It should be noted that when an element is said to be "connected," "tied," or "accessing" another element, this may mean a direct connection or direct access, but may involve another intervening element. On the other hand, when an element is said to be "directly connected" or "accesses" another element, it means that no other element is available between the elements.

[0101] The present invention will be described below with reference to the drawings. [Brief explanation of the drawings]

[0102] [Figure 1] 1 is a schematic diagram of a retention system and its elements. [Figure 2] FIG. 1 is a schematic diagram of the system process. DETAILED DESCRIPTION OF THE INVENTION

[0103] The drawings are merely schematic in nature and serve only for the purpose of understanding the invention. Identical elements are provided with identical reference numerals. Features of the individual embodiments are interchangeable.

[0104] Additionally, spatial terms such as "lower-disposed," "below," "lower side," "upper-disposed," "above," "left," "right," and the like may be used to simply describe the relationship of an illustrated element or structure to one or more other elements or structures. Spatial terms are intended to encompass other orientations of elements during use or operation in addition to the orientation shown. The orientation of elements may be different (rotated 90 degrees or at another orientation), and spatial descriptions herein may be interpreted accordingly.

[0105] Embodiments describe a holding device, a method, and a sterile product, i.e., a sterile product container or a sterile product screen.

[0106] 1 shows a schematic diagram of a holding system 1 and its elements. In particular, the holding system 1 comprises a communication module 2, which is provided for the external communication of data. For this purpose, the data is provided by a microcontroller 3, which communicates directly with the communication module 2. The microcontroller 3 controls the energy supply provided by an energy supply unit 4. To this end, the microcontroller 3 can influence the energy supply so that the energy supply is gradually reduced and / or so that an energy saving mode is entered between process steps.

[0107] Furthermore, the microcontroller 3 directly communicates with the sensor 6. The type of sensor may be different and may be one or more of the types mentioned herein. Similarly, the microcontroller 3 may interface with the signal transmitter 5. Thus, the sensor 6 may interface with the signal transmitter 5 directly or indirectly via the microcontroller 3. The signal transmitter 5, such as an LED, a loudspeaker, or a wireless module, may inform the user, for example, where the medical product is currently located and / or which process step the system 1 is currently in. The system 1 further comprises an NFC reader / writer (if applicable) 8, which is connected to and / or operatively communicates with one or more NFC antennas 9 of different products 7. This may be implemented by placing the products 7 directly on one NFC reader / writer 8 and / or on multiple NFC reader / writer 8 devices.

[0108] Further details and aspects are described in relation to the embodiments described above or below. The embodiment shown in Figure 1 may include one or more optional additional features corresponding to one or more aspects mentioned in relation to the proposed concepts or embodiments described below with reference to Figure 2.

[0109] Figure 2 shows a schematic diagram of a possible system process 10. The system process 10 may begin at step S1, where a product is used, for example, during surgery. The user may then activate the product's search function at step X1. The signal transmitter 5 indicates the product's location (e.g., in a sealed container) to the user (see X2). Data regarding usage is written to the transponder by the control device / microcontroller 3 (see M1). The system 1 then enters energy-saving mode Sx.

[0110] When the energy-saving mode Sx ends, an ultrasonic pre-cleaning begins (see S2). The ultrasonic waves are detected by the sensor 6 and transmitted to the outside of the holder (i.e., the container or the flexible packaging) via the communication module 2, for example, and then analyzed in the evaluation unit (see M2). The system 1 then switches back to the energy-saving mode Sx.

[0111] When the energy-saving mode Sx ends, cleaning begins in the washer-disinfector (see S3). During this process, the temperature sensor 6 detects the temperature at use (and / or the internal temperature of the holder), which is analyzed in the evaluation unit 3 (see M3). Maintenance is then performed using an oil spray (see S4). The signal transmitter 5 indicates a sufficient spray duration (see X3). The temperature sensor 6 detects the spray and the evaluation unit detects the duration (see M4). Sterilization then takes place in an autoclave (not shown) (see S5). The temperature sensor detects the temperature at use (and / or the internal temperature of the holder and / or container), which is analyzed in the evaluation unit (see M5). The system 1 then switches back to energy-saving mode (see Sx).

[0112] If step M1, M2, M3 or M4 is successful, the respective counter is incremented (see X4) and / or signal transmitter 5 indicates the failure / success of the process step (see X5).

[0113] Further details and aspects are described in relation to the embodiments described above or below. The embodiment shown in Figure 2 may include any one or more additional features corresponding to the concepts proposed above or one or more aspects mentioned in relation to one or more of the embodiments described above (e.g., Figure 1). The following items are elements that are claimed in the international application: (Item 1) A holding device (1) for a medical product attached to the holding device during a sterilization product cycle, comprising: The holding device comprises a plurality of sensors arranged and designed to acquire parameters of a preparatory process step, preferably and more preferably parameters of all process steps of the entire sterile product cycle, each sensor designed to acquire different parameters representative of a different individual process step of the sterile product cycle so as to be able to identify the process step that has just been performed. (Item 2) The holding device (1) according to item 1, wherein the sensors of the holding device are designed to acquire all parameter data relating to the use of the medical product in an operating room, and / or ultrasonic cleaning, and / or cleaning in a washer-disinfector, and / or maintenance with lubricants, and / or sterilization thereof. (Item 3) 3. The holding device (1) according to item 1 or 2, wherein the sensors detect temperature, humidity, pH value, pressure, sound waves, voltage, and / or vibrations in general. (Item 4) 4. The holding device (1) according to item 3, wherein at least one sensor of the plurality of sensors is a piezoelectric element. (Item 5) 5. The holding device (1) according to item 3 or 4, wherein at least one sensor of the plurality of sensors is a radiometer. (Item 6) 6. The holding device (1) according to item 3, 4 or 5, wherein at least one sensor of the plurality of sensors is a microphone. (Item 7) 7. The holding device (1) according to any one of items 1 to 6, wherein the holding device comprises an electronic evaluation unit for deducing the life and / or condition of the medical product from the parameter data. (Item 8) The holding device (1) according to any one of items 1 to 7, wherein the sensors are designed to be redundant. (Item 9) The holding device (1) comprises a plurality of antennas and a read / write unit; The holding device (1) according to any one of items 1 to 8, wherein the antenna is connected to the read / write unit via an electronic distribution system (multiplexer). (Item 10) 10. A holding device (1) according to any one of items 1 to 9, wherein the holding device is of modular construction, allowing for the removal of individual elements (2, 3, 4, 5, 6, 8) of the holding device. (Item 11) 11. The holding device (1) according to any one of items 7 to 10, wherein the evaluation unit is designed to compare the individual parameter data representing a process step with predetermined parameters and to increment a respective counter if the evaluation unit determines that the process step has been executed successfully. (Item 12) 12. The holding device (1) according to any one of items 1 to 11, wherein the holding device (1) comprises a signal transmitter that indicates information about the process step to a user by optical, acoustic and / or tactile signals. (Item 13) 13. The holding device (1) according to any one of items 1 to 12, characterized in that the signal transmitter indicates the position of the medical product to the user by the optical signal, acoustic signal, and / or tactile signal. [Explanation of symbols]

[0114] 1 Retention System 2. Communication Module 3 Microcontrollers 4. Energy supply 5 Signal Transmitter 6 sensors 7 products 8 NFC reader / writer 9 NFC antenna 10 ways S1~S5, Sx operation X1~X5 Event M1~M5 sensor events

Claims

1. 1. A retainer for a medical product attached to the retainer during a sterilization product cycle, comprising: the holding device comprises a plurality of sensors disposed and designed to acquire parameters of a preparation process step, each sensor being designed to acquire a different parameter representative of a different process step of the sterile product cycle; the holding device comprises an evaluation unit provided and designed for the analysis of the parameters and which performs, based on the analysis, an identification of the process step that has just been carried out; The holding device, wherein the evaluation unit is designed to compare parameter data of each of the parameters representing a process step with predetermined parameters and to increment a respective counter if the evaluation unit determines that the process step has been successfully executed.

2. 2. The holding device according to claim 1, wherein the sensors of the holding device are designed to acquire the entire parameter data of the parameters related to the use of the medical product in an operating room, and / or ultrasonic cleaning, and / or cleaning in a washer-disinfector, and / or maintenance with lubricants, and / or sterilization.

3. 3. The holding device according to claim 1 or 2, wherein the sensors detect temperature, humidity, pH value, pressure, sound waves, voltage and / or vibrations in general.

4. The holding device of claim 3 , wherein at least one sensor of the plurality of sensors is a piezoelectric element.

5. 5. The holding device of claim 3 or claim 4, wherein at least one sensor of the plurality of sensors is a radiometer.

6. The holding device of claim 3 , 4 or 5 , wherein at least one sensor of the plurality of sensors is a microphone.

7. The holding device according to any one of claims 1 to 6, wherein the evaluation unit infers the life and / or condition of the medical product from the parameter data.

8. The holding device according to any one of claims 1 to 7, wherein the sensors are designed to be redundant.

9. A retaining device according to any one of claims 1 to 8, wherein the retaining device is of modular construction, allowing for removal of individual elements of the retaining device.

10. The holding device according to any one of claims 1 to 9, wherein the holding device comprises a signal transmitter for indicating information about the process step to a user by means of optical, acoustic and / or tactile signals.

11. The holding device according to any one of claims 1 to 9, wherein the holding device comprises a signal transmitter for indicating the location of the medical product to a user by means of an optical, acoustic and / or tactile signal.

12. 11. The holding device according to claim 10, wherein the signal transmitter indicates the location of the medical product to the user by means of the optical, acoustic and / or tactile signal.

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