Sterile container with NFC module
By integrating NFC modules and sensors into sterile containers, the problem of the inability to monitor sterile containers throughout the entire process in existing technologies is solved. This enables automatic, container-specific data collection and process identification, ensuring complete monitoring of sterile containers during transportation, storage, and sterilization.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- AESCULAP AG
- Filing Date
- 2021-01-20
- Publication Date
- 2026-05-19
AI Technical Summary
Existing technologies cannot achieve full-process, reliable, simple, and container-specific automatic monitoring of sterile containers, especially during transportation, storage, and sterilization, where data cannot be fully collected and sterilization process and parameter curves cannot be identified.
The system employs a sterile container with an NFC module, equipped with sensors and a data logger to detect and store parameter data related to sterility and sterilization, including temperature, pressure, humidity, and acceleration. It communicates with the reading unit via the NFC module to achieve full-process monitoring.
It enables full, automated, and container-specific monitoring of sterile containers throughout their entire lifecycle, identifying damage during transport, storage conditions, and the sterilization process, and simplifying data reading and management.
Smart Images
Figure CN115003338B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to a sterile container for sterilizable medical technical articles, having a containing space for the medical technical articles and a data detection unit for detecting parameter data affecting the sterile container. The invention also relates to a method for monitoring such a sterile container. Background Technology
[0002] Sterilizable medical technology articles, such as medical technology instrument sets, typically undergo repeated use cycles, which include sterilization, storage, and use, for example, within the scope of surgery (OP). For quality assurance purposes, it is advantageous to monitor and record such use cycles as comprehensively as possible. This involves monitoring, on the one hand, the actual sterilization performed, i.e., determining whether sterilization was successfully carried out and the frequency of sterilization. On the other hand, it also involves monitoring transportation and storage to ensure, for example, that no (invisible or nearly invisible) damage is caused to the articles during transportation and / or that temperature limits are adhered to at all times when storing articles at critical temperatures.
[0003] Systems and methods are now known that either monitor / record actual sterilization in a sterilization apparatus, or monitor / record transportation and / or storage after sterilization. The latter system / method, according to the prior art, primarily involves pure transportation monitoring. Here, parameters such as the acceleration, tumbling, and position of the sterile container are detected. The monitoring device used for this is mechanically designed in its simplest form, but may also include electronic systems capable of communicating with the cloud. According to the prior art, storage conditions are primarily monitored via a central measuring unit that monitors the entire storage chamber and is not fixedly assigned to specific sterile containers. To monitor actual sterilization, in the prior art, either sensors for the sterilization autoclave are used, or, in some cases, manual temperature recorders capable of recording temperature profiles are used.
[0004] Known systems and methods for monitoring / recording sterile containers have a number of drawbacks. Of particular note in this context is the lack of complete monitoring of the entire usage cycle / cycle of sterile articles, i.e., the absence of systems / methods for monitoring and recording transportation, as well as monitoring and recording storage and sterilization. Another drawback is the lack of individual, and especially offline, complete data collection available for the transportation, storage, and sterilization of certain sterile containers or instrument groups. Furthermore, monitoring is not container-specific, i.e., it is not configured for a completely defined container. A further drawback associated with complete monitoring is the inability to automatically identify sterilization cycles and correct parameter profiles (e.g., pressure and / or temperature), and the inability to use programmable parameter limits or variation curves. Summary of the Invention
[0005] In this context, the objective of the present invention is to reduce the aforementioned disadvantages of the prior art, and in particular to achieve complete, reliable, simple, and sterile container-specific automatic monitoring of sterile containers (e.g., sterile boxes, baskets, or outer packaging) throughout their entire lifespan, that is, to achieve automatic monitoring of transportation, storage, sterilization, etc.
[0006] This task is solved by a sterile container according to the invention, namely a sterile container for sterilizable medical technical articles, the sterile container having a containing space for the medical technical articles and a data detection unit for detecting parameter data of influence parameters acting on the sterile container, wherein the sterile container has an NFC module, the NFC module having at least one sensor for detecting data related to sterility and / or sterilization and a data logger for receiving and storing the sensor data in a receiving interval. Furthermore, this task is solved by a method according to the invention.
[0007] Advantageous embodiments of the present invention are described in more detail below.
[0008] The general concept of this invention lies in using an NFC module for data detection and, preferably, for forwarding data to a reading unit, such as a smart device. Because the sterile container (which may in particular be a sterile container, basket, or outer packaging) has an NFC module, a persistent, stable, and fixed connection / association between the sterile container and the NFC module is achieved. Therefore, this invention can advantageously achieve complete, sterile container-specific, and automatic monitoring of the sterile container (e.g., sterile container, basket, or outer packaging) throughout its entire lifespan. This means that such monitoring occurs not only during transportation but also during storage and sterilization / cleaning.
[0009] One or more sensors in the NFC module are configured to continuously / persistently, or at defined measurement points or intervals (reception intervals), particularly through excitation by a data logger, detect data / parameters important for sterility and / or for sterilization. These are particularly used to detect the current primary conditions experienced by the sterile container. Such data / parameters are present not only during sterilization but also during the transport and / or storage of the sterile container. These data / parameters include, for example, temperature and / or pressure and / or humidity and / or pH and / or acceleration and / or position values. Evaluation of the detected sensor data / parameters can provide information about the environment and / or conditions experienced by the sterile container, both currently and over a longer period. The various parameters and their effects are listed in the table below:
[0010] Damage during transport Storage clean sterilization temperature Unrelated important Very important Very important pressure Unrelated Unrelated Unrelated important air humidity Unrelated important important important pH value Unrelated Unrelated important Related acceleration Very important Unrelated Unrelated Unrelated gas Unrelated Unrelated Unrelated important
[0011] This invention includes different embodiments in which different amounts of different data / parameters are collected. Therefore, in a basic variation, for example, only temperature and acceleration data may be detected to enable counting sterilization and detection of drops. Within the scope of this invention, it is feasible to pre-install additional data detection schemes, but the detection and processing of said additional data must first be enabled.
[0012] Within the scope of this invention, the temperature experienced by the sterile container can be either an external temperature, i.e., the temperature of the environment surrounding the sterile container, such as the temperature in a sterilization device, autoclave, etc., or, within the scope of this invention, the internal temperature of the sterile container. This invention also includes embodiments that detect / measure both external and internal temperatures. Within the scope of this invention, data / parameters can be measured either continuously or at defined intervals.
[0013] In order to identify transport damage, it is necessary to specify a limit value / limit parameter within the acceleration range that has been proven not to cause any significant damage to the sterile container and the instruments contained therein. Any deviation from such a limit value / limit parameter, for example, caused by rapid tipping or dropping with high acceleration, is detected in a simple and reliable manner by this invention and signaled as potential damage.
[0014] To ensure the quality of testing under the correct storage conditions, according to embodiments of the present invention, limit values / limit parameters that should not be below or above the temperature and / or humidity and / or pressure can be determined.
[0015] According to the present invention, cleaning and sterilization in a cleaning and disinfection device (RDG) are monitored in a simple and reliable manner by detecting at least one temperature. Air humidity and / or pressure and / or pH are additional data that can be evaluated within the scope of the present invention. By standardizing the internal process, the measured values used for comparison can be compared with parametric curves. If these are consistent with established tolerances, the process can be validated. After validation, the number of sterilization cycles performed can be stored. A feature of the present invention is that the cleaning and sterilization process can also be automatically identified throughout the entire usage cycle.
[0016] According to embodiments of the present invention, the NFC module can be specifically configured to automatically and specifically detect sterilization cycles performed by means of a sterile container by means of the sterile container, wherein: a temperature measuring device provided to the sterile container detects the temperature acting on the sterile container, the temperature measuring device detects the temperature at a defined first time interval, the detected temperature value is stored in a memory after exceeding a predetermined first limit temperature, the stored temperature value is set after falling below a predetermined second limit temperature or after exceeding the first limit temperature for a predetermined duration, the stored temperature value is compared with a reference temperature value, wherein the deviation between the temperature value and the reference temperature value is determined, and in the case of deviation, a counting device and / or a display device are operated within a predetermined tolerance range. The first limit temperature and / or the second limit temperature can be adapted as needed to cover and take into account different environmental conditions. By selecting two limit temperatures, a region can be defined in which the sterilization process takes place.
[0017] Furthermore, the NFC module can be configured to compare stored temperature values with reference temperature values within the cleaning / sterilization monitoring range and determine the deviation between the temperature values and the reference temperature values. This can be performed continuously in real time during temperature measurement or after the temperature has fallen below a second temperature limit or a time limit. In particular, the detected values can be compared with a preset temperature-time curve and evaluated within tolerances.
[0018] In essence, cleaning / sterilization monitoring offers the possibility of both basic / coarse monitoring and sterilization / fine monitoring. Within the scope of basic / coarse monitoring, temperature detection occurs within a first time interval, i.e., at a time interval determined / defined by the first time interval. Within the scope of sterilization / fine monitoring, temperature detection occurs within a second time interval, i.e., at a time interval determined / defined by the second time interval. By appropriately selecting the lengths of the first and second time intervals, coarse and fine monitoring can be adapted as best as possible to the respective situations.
[0019] This allows for coarse monitoring, particularly continuous or long-term monitoring of sterile containers for cleaning / sterilization. For example, sterile containers can be monitored throughout the entire timeframe between two inspection cycles. The initial time interval can be chosen to be relatively long, so that even when stored at the temperature values being tested, such as within quality assurance limits, the amount of data collected during continuous monitoring over extended periods will not become excessive. Continuous and comprehensive monitoring can be performed almost throughout the entire service life and / or lifespan of the sterile container.
[0020] Within the range of fine monitoring triggered by exceeding the first limit temperature, particularly fine monitoring of cleaning / sterilization cycles, or any possible cleaning / sterilization cycles, is possible. The second time interval can be selected to be relatively short, i.e., shorter than the first time interval, enabling particularly fine / precise monitoring of the sterile container after exceeding the first limit temperature. The large amount of data generated during fine monitoring is relatively insignificant because fine monitoring is typically performed only over a relatively short period, until the temperature drops below the second limit temperature and the set temperature value is recorded. Therefore, the cleaning / sterilization process can be monitored with exceptional precision.
[0021] A particular advantage is that the transition from coarse to fine monitoring is automatic, triggered by exceeding a first limit temperature. Similarly, the switch from fine to coarse monitoring is automatic, triggered by falling below a second limit temperature. This advantageously enables automatic identification of sterilization cycles and / or detection of temperature change curves, measurement at defined time intervals, and comparison with preset temperature / temperature change curves. Furthermore, automatic switching between measurement intervals is possible.
[0022] Furthermore, within the scope of cleaning / sterilization monitoring, the deviation between the temperature value and the reference temperature value can be determined. If the deviation is within a predetermined tolerance range, it is considered that an actual sterilization process / cycle has occurred, and a counting device, especially an incremental cycle counter, is used to record the sterilization process performed using aseptic containers. Therefore, it is advantageous to achieve automatic detection and display of sterilization cycles performed using aseptic containers.
[0023] The present invention is characterized in that the NFC module has an energy storage unit. This energy storage unit can be rechargeable, particularly by means of NFC or energy harvesting. Alternatively or additionally, the NFC module can have an energy storage unit in the form of a battery or accumulator, particularly a high-temperature button cell. Furthermore, the NFC module can have an energy generating unit, particularly in the form of a Peltier element, a solar cell, particularly an indoor solar cell, or a turbine. Such a turbine is preferably operable by means of media loading via an RDG cleaning hose.
[0024] In another implementation, the NFC module may have a control unit, particularly a microcontroller. The microcontroller may be configured to have a data storage device for autonomously detecting, storing, and evaluating parameters.
[0025] Advantageously, the NFC module can have a fluid-sealed housing / enclosure. This housing can, in particular, be made of epoxy resin. Preferably, the housing has a flat design. Furthermore, the NFC module can have thermally insulating portions, and in particular, uses highly efficient insulating materials such as aerogel, silicone, or epoxy resin.
[0026] Preferably, the NFC module is mounted or integrated on or within the sterile container. According to a particularly advantageous and robust embodiment, the NFC module is integrated / injected into the container baffle or filter cap of the sterile container. Alternatively, the NFC module can be mounted on a basket or outer packaging. Thus, the NFC module can be fixedly attached to a specific sterile container and reliably and clearly identify the sterile articles contained therein. In the case of the sterile container, its damage and sterilization cycles can be detected and stored in a data logger and optionally in management software. In the case of the basket, data regarding the group of instruments contained therein can be stored. Therefore, in the case of constant installation, cycle counts for each instrument can also be detected and stored. Communication via mobile reading units or during installation in the ZSVA with a management system for data evaluation and reading of warnings during surgery is also within the scope of this invention.
[0027] Another embodiment of the invention is characterized in that the NFC module has a temperature sensor and / or an acceleration sensor and / or a pressure sensor and / or a humidity sensor and / or a pH sensor and / or a gas sensor. In this way, the NFC module is suitable for detecting and processing a large number of different data / parameters that sterile containers may suffer. Preferably, sensor values are detected at defined intervals / spaces, in addition to detecting transport damage. In this way, energy consumption for continuous monitoring can be kept particularly low, ensuring the safe and long-lasting functionality of the NFC module. For this purpose, in particular, a passive acceleration sensor triggered from a defined limit can be used.
[0028] Another embodiment of the invention features an NFC module with an NFC interface configured for data communication with a reading unit / programming unit. Preferably, this interface is a smartphone-compatible NFC interface. This allows for the storage of updated or adapted parameters without requiring physical access to the module or damaging its housing / insulation. Furthermore, additional functions can be enabled or programmed in a particularly simple and user-friendly manner.
[0029] Alternatively, the present invention includes an autonomous module / autonomous NFC data logger that can be used for monitoring transportation, storage, and sterilization using various sensors. The module / data logger can be mounted in different locations on or within sterile containers, baskets, or outer packaging to allow for precise configuration of collected data, and is preferably thermally insulated and / or tightly sealed. Its power supply can be achieved using replaceable batteries or energy harvesting, which can generate energy not only for sterilization but also for cleaning or storage. The invention may include the use of sensors (particularly for temperature, pressure, air humidity, pH, gas, acceleration) to detect cleaning, sterilization, and potential damage. Comparing sensor values with stored preset curves and defined tolerances to verify sterilization, cleaning, or proper storage is particularly advantageous. Energy consumption can be minimized by interval measurement and the use of a passive accelerometer. In this case, by means of the present invention, continuous use can be maximized by using energy harvesting during cleaning, sterilization, and storage.
[0030] The embodiments of the present invention can achieve the following advantages in particular:
[0031] Monitoring of sterile containers such as sterile boxes, baskets, and outer packaging, as well as the devices / implants contained within them, especially long-term / life-cycle monitoring.
[0032] Detect sensor values used to monitor environmental parameters
[0033] Successful sterilization and / or cleaning is automatically identified by comparing sensor values with preset target values / target value change curves, especially temperature (and pressure) curves.
[0034] Automatic storage and transportation events (drop, rollover, excessive temperature or humidity).
[0035] Data / parameters and / or programming can be easily read via a reader or smartphone using NFC.
[0036] The NFC recorder can be directly and permanently mounted on sterile containers, baskets, shipping boxes, or outer packaging.
[0037] Energy is supplied through energy harvesting (Peltier elements, solar cells, turbines) or batteries.
[0038] The cycle (cleaning, sterilization) and storage conditions are reliably detected by comparing sensor values with stored parameter curves and tolerance ranges. Thus, compared to bimetallic sensors, multiple data values are detected and compared with rated values during the process in an energy-efficient manner, preventing erroneous indications.
[0039] Potential transport damage can be reversibly detected using accelerometers. Unlike accelerometer indicators, these accelerometers can be reset and automatically read using a scanner.
[0040] Extend service life by using energy harvesting modules
[0041] The sterilization cycle is monitored to control a specified "lifespan". If this "lifespan" is exceeded, a maintenance notification can be output. If an alternative cycle needs to be started, this can be programmed into the data logger or management system without replacing the hardware.
[0042] Further features and advantages of the invention will become apparent from the following exemplary and non-limiting description with reference to the accompanying drawings. These drawings are merely illustrative and are intended only to understand the invention. Attached Figure Description
[0043] This is shown here:
[0044] Figure 1 Two stereoscopic views, taken from different perspectives, illustrate an implementation of an NFC module with a battery.
[0045] Figure 2 Two perspective views, taken from different viewing angles, illustrate an implementation of an NFC module with Peltier elements.
[0046] Figure 3 An embodiment of an NFC module with a solar cell is illustrated in a 3D view.
[0047] Figure 4 An implementation of an NFC module with a turbine is shown in a 3D view.
[0048] Figure 5 An NFC module integrated into the container baffle is shown, and
[0049] Figure 6 An NFC module for mounting on the basket is shown, integrated into the housing.
[0050] Wherein: 1: NFC module; 2: Circuit; 3: Power supply unit; 4: Circuit board; 5: Housing; 6: Battery, storage battery; 7: Peltier element; 8: Solar cell; 9: Turbine; 10: Inlet; 11: Outlet; 12: Sterile container baffle; 13: Thermal insulation part, aerogel insulation part; 14: Shell, outer cover. Detailed Implementation
[0051] Figures 1 to 4The NFC module 1 includes electronic circuitry 2 and a power supply unit 3. Circuitry 2 is mounted on a circuit board 4 and includes (not shown in more detail in the figure) a data logger, particularly a transmit / receive circuit in the form of an NFC interface, a storage unit, and a microcontroller. The power supply unit 3 provides power to the electronic circuitry. For example, especially in… Figure 6 As shown, the NFC module 1 is housed in the housing 5. The housing tightly seals / fluid-tightly surrounds the NFC module 1.
[0052] exist Figure 1 In this embodiment, the energy supply unit is implemented in the form of a miniature button cell battery 6. This can be configured as a rechargeable battery 6, which can be charged, in particular, via near-field communication (wireless charging). In the case of battery 6, the housing 5 is accessible to allow for battery replacement. Furthermore, the housing 5 is thermally insulated, thereby protecting battery 6 or rechargeable battery 6 from harmful temperatures that may occur, for example, in the sterilization range.
[0053] exist Figure 2 In one embodiment, the energy supply unit is implemented as a Peltier element 7 disposed on the underside of the circuit board 4, which is electrically connected to the circuit 2. In this embodiment, the housing 5 can be constructed in a tightly sealed manner to prevent entry, but the housing is insulated only in a way that allows the process heat of the cleaning or sterilization process to act on the Peltier element 7 and to supply energy to the circuit 2.
[0054] exist Figure 3 In one embodiment, at least a portion of the circuit board 4 is configured as an indoor solar cell 8 electrically connected to the circuit 2. In this case, the housing 5 is transparent at least in the area of the solar cell 8.
[0055] Figure 4 One embodiment has a turbine 9 as an energy supply unit 3, which is arranged on a circuit board 4 at the edge and electrically connected to the circuit 2. The turbine 9 is either arranged outside the housing 5 or is externally accessible at its inlet 10 and outlet 11.
[0056] The NFC module 1 allows for particularly simple, specific, and persistent monitoring of sterile items, especially for counting sterilization and detecting potential damage. Its small, flat design makes it particularly easy to mount on sterile containers, baskets, or outer packaging.
[0057] Figure 5A variant is shown in which an NFC module 1, with or without a housing 5, is implemented (injected here) into a baffle 12 of a sterile container (not shown). Here, the NFC module 1, which includes a microcontroller, a temperature sensor, and a passive accelerometer, is encased in an aerogel insulation portion 13. To protect these from pressure variations, the housing 5 is constructed in the form of a sleeve 14 made of epoxy resin. The NFC module 1 is then injected into the container baffle. During the transport of the sterile container, it is possible to easily monitor whether a critical load of potential damage to the sterile container and / or the sterile articles contained therein occurs. This is caused by a passive accelerometer that sends a signal to the microcontroller from a defined (boundary) acceleration. Therefore, collisions, drops, and overturns that may damage the container and / or sterile articles can be reliably identified. Such incidents can be displayed to the user via an NFC interface and / or by means of optical or acoustic signal output devices, if necessary. The user can then perform additional optical control over the sterile container and / or sterile articles. Subsequently, the warning can be reset using an NFC-enabled device.
[0058] To identify sterilization or cleaning in the RDG (Refrigerant Container Group), the NFC module measures ambient temperature at defined intervals using a data logger. The interval can be selected to minimize energy consumption while still allowing for the detection of significant temperature increases. If a specified limit / extreme temperature is exceeded, temperature data can be detected at shorter intervals. Successful cleaning or sterilization is determined by comparing the data with a predefined temperature profile and tolerance range. Because these two processes are distinctly different, they can be distinguished using a microcontroller. In the case of successful sterilization, an internal counter increments. This counter records all sterilization counts detected to date and is therefore used to control the frequency of use of the container or its associated instrument group. After cleaning / sterilization, the NFC module 1 can again detect temperature at larger intervals and detect erroneous accelerations. Data, such as the number of sterilizations, potential damage, and / or identification codes, can be read using a reading unit, for example, at the packaging location in the ZSVA, and the data is transmitted to the management system.
Claims
1. A sterile container for a sterilizable medical technical article, the sterile container having a containing space for the medical technical article and a data detection unit for detecting parameter data that affects the sterile container. Its features are, The sterile container has a near-field communication module (1) and an acceleration sensor for detecting drops, wherein the near-field communication module has a temperature sensor for detecting and recording temperature data at preset intervals and a data logger for receiving and storing the temperature data of the temperature sensor at receiving intervals, and wherein the near-field communication module is configured to compare the temperature data with a preset temperature curve and tolerance range to determine that the sterilization of the sterile container is complete.
2. The sterile container according to claim 1, characterized in that, The sterile container is a sterile box, basket, or outer packaging.
3. The sterile container according to claim 1 or 2, characterized in that, The near-field communication module (1) has an energy storage device (3, 6, 7), which is rechargeable by means of near-field communication or energy harvesting and / or has an energy storage device in the form of a battery or accumulator and / or has an energy generation unit.
4. The sterile container according to claim 1, characterized in that, The near-field communication module (1) has a control unit and is configured to autonomously detect, store and evaluate data detected by means of the temperature sensor.
5. The sterile container according to claim 1, characterized in that, The near-field communication module (1) includes a fluid-sealed outer casing (5, 14) and / or a thermally insulating part.
6. The sterile container according to claim 1, characterized in that, The near-field communication module (1) is injected into the container baffle (12).
7. The sterile container according to claim 1, characterized in that, The near-field communication module (1) also has a pressure sensor and / or a humidity sensor and / or a pH sensor and / or a gas sensor.
8. The sterile container according to claim 1, characterized in that, The near-field communication module (1) has a near-field communication interface, which is configured to communicate with the reading unit / programming unit in terms of data technology.
9. A method for automatically and specifically monitoring a sterile container according to any one of claims 1 to 8, characterized in that, The accelerometer monitors acceleration and sends data to the near-field communication module starting from an acceleration that meets a preset boundary. It also retrieves temperature data from the temperature sensor at predetermined time intervals via the data logger, and / or continuously retrieves temperature data from the temperature sensor. The temperature data on the data logger is stored, and the temperature data is compared with a preset temperature curve and tolerance range to determine whether sterilization of the sterile container is complete.
10. The method according to claim 9, characterized in that, Further data related to sterility and / or sterilization, retrieved by means of the data logger, are pressure values and / or humidity values and / or pH values, and / or continuously retrieved data related to sterility and / or sterilization are acceleration values.