Component arrangement for x-ray treatment components, x-ray treatment system and method for operating an x-ray treatment system
By using a dual RFID transponder system in the X-ray therapy system, the safety and accuracy issues of handling sterile components in the non-sterilized area were resolved, enabling the effective execution of treatment plans and the management of component reuse.
Patent Information
- Application Number
- CN202280071915.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2021-11-15
- Filing Date
- 2022-11-14
- Publication Date
- 2025-11-25
- Estimated Expiration
- 2042-11-14
AI Technical Summary
In X-ray therapy, existing technologies lack effective solutions for the handling of sterile components within the scope of treatment planning and preparation, especially when handling plastic components in non-sterilized areas, which may lead to performance loss and safety risks.
A dual RFID transponder system is adopted, with one RFID transponder placed in the sterile primary packaging and the other RFID transponder placed in the non-sterilized secondary packaging. Data is read and written separately through the operating device to ensure the accuracy and safety of the operation of components and treatment plans in the non-sterilized area.
It enables aseptic processing of X-ray therapy components within a non-sterilized area, ensuring the accuracy and safety of treatment plans, avoiding component performance loss and safety risks due to repeated use, and supporting the reuse and management of components.
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Figure CN118234449B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a component arrangement for an X-ray therapy component, an X-ray therapy system, and a method for operating the X-ray therapy system. Background Technology
[0002] Regarding components used in X-ray therapy, it is important to know whether they have been previously used, as repeated use, such as in different systems and / or different locations, can pose risks to patients. Generally, components made of plastic have limited tolerance to ionizing radiation; that is, these components may lose reliable performance when the applied dose is exceeded. Furthermore, components with given performance must be provided within the scope of treatment planning and preparation. The practice of tagging medical components with radio frequency identification (RFID) transponders (RFID tags) to allow for unique identification of these components is known.
[0003] WO 2009 / 052048 A1 discloses a system and method for providing radiotherapy to a patient. The system includes at least one component equipped with an RFID tag, such as a patient positioning device used when a patient intends to receive radiotherapy. This at least one component is specifically selected for patient use. The RFID tag contains patient-related information. The RFID tag is queried by a reader to generate a signal used by a relevant computer system to verify the location and presence of the patient and the components in the room where treatment is intended to be performed. The system and method allow for the determination of the location of each patient, selected facility staff, and all components used to treat a specific patient. Furthermore, the system and method are capable of determining the time spent by the patient and / or staff and / or components at a specific location for specific treatment.
[0004] WO 2014 / 071337 A1 discloses systems and methods for tagging and tracking surgical devices using radio frequency identification (RFID) tags. Generally, these systems and methods enable the tracking of surgical devices throughout their dispensing and sterilization process. In one example, the system includes an instrument tray configured to hold multiple surgical devices and affixed with a supervising RFID tag containing information about the tray and each surgical device and / or enabling access to that information. Each surgical device located in the instrument tray may be affixed with an auxiliary RFID tag containing information about that surgical device and / or enabling access to that information.
[0005] DE 102020104628 B3 discloses an applicator for intraoperative radiotherapy. The applicator includes a housing for receiving a radiation detector and an insertion opening for inserting the radiation detector into the housing. The insertion opening is sealed by a seal. Furthermore, a first machine-readable information storage unit is present, at least partially disposed at the seal, such that removing or damaging the seal renders the information storage unit unreadable.
[0006] Within the scope of X-ray therapy, the problem of handling sterile components (e.g., applicators) in non-sterilized areas within the scope of treatment planning and preparation has only unsatisfactory solutions. Summary of the Invention
[0007] This invention is based on the aim of improving the treatment of sterile components for X-ray therapy in terms of treatment planning and preparation.
[0008] According to the invention, this objective is achieved by a component arrangement for X-ray therapy having the features of claim 1, an X-ray therapy system having the features of claim 6, and a method for operating the X-ray therapy system having the features of claim 8. The advantageous configurations of the invention are apparent from the dependent claims.
[0009] One of the basic ideas of this invention is to arrange a (second) RFID transponder, in addition to arranging a (first) RFID transponder (which may also be referred to as an RFID tag) on or within the sterile component, also within or on the unsterilized secondary packaging. The sterile component is located within the primary packaging. In this case, the primary packaging and the sterile component can be moved independently of the secondary packaging and handled within the scope of treatment planning and preparation. Specifically, in the manufacturer-supplied state, it is provided that the sterile component is arranged in the primary packaging and the primary packaging is arranged in the unsterilized secondary packaging. For treatment planning, the (second) RFID transponder on the secondary packaging can be read by a (second) RFID reader. This is achieved at the operating device of the X-ray treatment system, which is specifically located in the unsterilized area of the operating room. Since the component continues to remain sterile in the primary packaging, no sterility issues arise. The treatment plan is implemented, for example, by a medical physicist or any other expert at the operating device. The primary packaging can then be removed from the secondary packaging, and the sterile component moved to the sterile area of the operating room. There, a (first) RFID transponder arranged on or in a component is read by a (first) RFID reader arranged on the X-ray therapy device of the X-ray therapy system, for example to indicate permission for X-ray source or X-ray radiation and / or to remove the blocking status of X-ray source or X-ray radiation.
[0010] Specifically, a component arrangement for an X-ray therapy component has been developed, comprising an X-ray therapy component having a first RFID transponder, a primary package in which the component is aseptically packaged, and a secondary package having a second RFID transponder disposed in and / or on the secondary package, and the component packaged in the primary package being arranged in the secondary package.
[0011] Furthermore, particularly, an X-ray therapy system has been developed, comprising: an X-ray therapy apparatus having a holding device configured to hold and / or position at least one component within and / or on a patient; and an operating device configured to control the X-ray therapy apparatus, wherein the X-ray therapy apparatus includes at least one first RFID reader configured to read data from and / or write data to the first RFID transponder disposed on or in the at least one component, and wherein the operating device includes at least one second RFID reader configured to read data from and / or write data to the second RFID transponder disposed in and / or on a secondary package.
[0012] Furthermore, a method for operating an X-ray therapy system is specifically provided, wherein configuring the X-ray therapy system for each of at least one component includes: using a second RFID reader of the operating device of the X-ray therapy system to read data from and / or write data to a second RFID transponder disposed in and / or on a secondary package of the component; removing the component sterilely packaged in a primary package from the primary package; and using a first RFID reader of the X-ray therapy device of the X-ray therapy system to read data from a first RFID transponder of the component and / or write data to the first RFID transponder.
[0013] This component arrangement, X-ray therapy system, and method improve the handling of X-ray therapy components within the scope of treatment planning and preparation. The use of two RFID transponders on or within the secondary packaging, and particularly on or within the component, also solves the problem that, under given conditions, it is often impossible to read RFID transponders arranged on or within the component when it is in the packaged state due to the large distance between the RFID transponder and the RFID reader. Furthermore, the secondary packaging can be spatially separated from the primary packaging and sterile components, allowing treatment planning and / or preparation to be performed on the (unsterilized) operating device of the X-ray therapy system without the need for the sterile components themselves.
[0014] Specifically, the component is an X-ray therapy component. For example, the component may be an applicator that is placed on an X-ray source during treatment and is used for targeted application and shielding of X-ray radiation.
[0015] Specifically, the operating device is formed separately from the X-ray therapy device. However, the operating device and the X-ray therapy device are signal-connected to each other. Specifically, the operating device includes a control device for controlling the treatment of the patient using the X-ray therapy device. Data read from the second RFID transponder is evaluated, particularly within the operating device, and especially by the control device, for treatment planning purposes. Specifically, the read data can be used as a starting point to create configuration parameters for the X-ray therapy device.
[0016] Data read from and / or written to an RFID transponder may include, for example, the following: usage status (e.g., used / unused / sterile), number of uses, date and time of the procedure, dose applied (units, Gry / min), hospital name, doctor's name, medical physicist's name, etc.
[0017] Components of the operating devices and / or X-ray therapy apparatus, particularly one or more control devices, can be designed individually or together as a combination of hardware and software, such as program code designed to execute on a microcontroller or microprocessor. Alternatively, the components can be provided individually or together as application-specific integrated circuits (ASICs) and / or field-programmable gate arrays (FPGAs).
[0018] The X-ray therapy apparatus includes a holding device, which is formed, for example, as a support or includes a support. However, in principle, the holding device can have different embodiments and, for example, be formed, as a holding arm or include a holding arm. For example, such a holding arm can be positioned on a patient's bed. Further, the X-ray therapy apparatus specifically includes an X-ray source disposed on the holding device, particularly at the (distal) end of the support or holding arm. An (X-ray) applicator can be disposed as a component on the X-ray source. Before treatment is administered via X-ray radiation from the X-ray source, it is specifically established whether a first RFID transponder of the component contemplated for treatment (e.g., the applicator disposed on the X-ray source) is registered by a first RFID reader. In principle, the presence of another given component (e.g., a holding plate, etc.) can be monitored and / or verified. Treatment authorization is given only when the presence of the component is detected, for example, by authorizing the X-ray source using an authorization signal or by releasing a blocking signal. The first RFID transponder and the first RFID reader form an interlock, specifically for monitoring and ensuring the operation of the X-ray source.
[0019] Specifically, primary packaging uses a sterile barrier (e.g.) A sealed welded sleeve (peel pouch) or blister pack, in which sterile components are arranged.
[0020] Specifically, the secondary packaging is an unsterilized package made of cardboard and / or paperboard. Specifically, the secondary packaging is in the form of a box or a collapsible box. For example, a second RFID transponder is arranged as a tag on the inside or outside of the secondary packaging, for example, glued thereto. Specifically, the primary packaging arranged within the secondary packaging contains only one component. In other words, each component is specifically allocated both primary and secondary packaging.
[0021] The embodiments provide a first RFID transponder and / or a second RFID transponder to provide component unique identification data. Specifically, this can be a unique serial number, particularly a UID (Unique Identifier). This results in the explicit identification of the component. Specifically, the component unique identification data is stored in the memory of the corresponding RFID transponder and can be retrieved from it by an RFID reader. For example, additional information about at least one component can be retrieved from a database using the component unique identification data.
[0022] The embodiments provide that the first RFID transponder is biocompatible. As a result, the first RFID transponder can come into contact with the patient's tissue without causing damage. For this purpose, the first RFID transponder is, for example, embedded in glass or a suitable plastic.
[0023] The embodiment provides that the first RFID transponder can be sterilized by a sterilization method. As a result, a component having the first RFID transponder can be resterilized after a single use and thus reused. For example, the sterilization method may include steam sterilization and / or gamma radiation.
[0024] The table below lists examples of RFID transponders that can be used:
[0025]
[0026] The embodiments provide components that are applicators for X-ray therapy. The applicator is arranged at or on the X-ray source of the X-ray therapy system. In particular, the applicator is used to position the tissue to be irradiated at a given distance from the initial point of X-ray radiation (i.e., from the target) and to protect unirradiated tissue.
[0027] The embodiment provides at least one first RFID reader arranged on a holding device, such as on a bracket, located in a connection area, wherein at least one component is arranged on or can be arranged on the holding device for use purposes. This allows a communication link to the first RFID transponder, especially when the transmission power of the first RFID reader is limited. The arrangement of the first RFID reader and the limitation of its transmission power can ensure that the component is registered only when it is arranged in the connection area. In particular, this allows for interlocking, wherein the X-ray source and X-ray radiation are permitted only when designated components (or multiple designated components) are arranged in the connection area. For example, it can be provided that the X-ray source is permitted to operate only when an applicator is arranged on the X-ray source. In this case, the connection area and the transmission power of the first RFID reader are selected such that the distance between the first RFID transponder and the first RFID reader is small enough to allow a communication link to be established therebetween and to allow data to be read from the first RFID transponder when the applicator is arranged in the area of the connection area on the X-ray source.
[0028] The embodiment provides that X-ray therapy authorization is granted if data from a first RFID transponder of at least one component includes at least one specified piece of information. This ensures that at least one component possesses specified characteristics (e.g., usage status, number of uses, specified type). This can prevent misoperation and / or incorrect use. For example, it can be provided that if at least one piece of information is not found after a read from the first RFID transponder, use of the X-ray therapy device can be prevented. For example, the at least one piece of information may include a serial number and / or type number, particularly a UID (Unique Identifier). For example, before using a component, it can be verified whether the component has already been used (usage status) by reading and verifying the corresponding information. Accordingly, after each use, information indicating that the component has been used (or not used) can be stored in the memory of the first RFID transponder (see the embodiments below). Further, for example, it can be verified whether the maximum number of uses has been reached (number of uses). To this end, after a read, for example, the number of uses stored in the memory of the first RFID transponder can be compared with a maximum value. Taking into account the comparison result, an authorization signal for the X-ray source and / or treatment is created or not created.
[0029] The embodiment provides storing information in a first RFID transponder after the use of at least one component, the information marking the at least one component as used and / or including the number of times the at least one component has been used. Thus, at least one component can be directly marked as used. Then, before using the component, it can be verified whether the component has been used by reading and verifying the corresponding information. Further, for example, it can be verified whether the maximum number of uses has been reached. For this purpose, after reading, for example, the number of uses can be compared with a maximum value. Based on the comparison result, a permit signal for the X-ray source and / or treatment is created or not created.
[0030] The embodiment provides that the first RFID transponder becomes unusable after use and / or once a given number of uses has been reached. The first RFID transponder can be irreversibly tagged in this way. This may limit the overall number of uses of the component. For example, this is necessary once the material of the component (e.g., plastic) reaches the maximum permissible total dose of ionizing radiation. Irreversible destruction can be implemented, for example, by generating a transmit pulse with a given power above a suitable threshold, which causes thermal damage (severing and / or short-circuiting) to the wires in the first RFID transponder due to the total amount of energy coupled into the input. Subsequently, the first RFID transponder ceases to function and can no longer be read.
[0031] The embodiments provide that at least one component is sterilized after a single use. Thus, at least one component can be reused. In this case, a first RFID transponder has a sterilizable embodiment and undergoes sterilization together with the component. For example, the component and the first RFID transponder can be arranged in a sterilization tray (or instrument tray) or a peel bag, and then can undergo a sterilization method (e.g., steam sterilization or gamma ray sterilization). Before being arranged in the sterilization tray or peel bag, the component is reset to an "unused" state by appropriately writing to the first RFID transponder, for example by changing the bits provided for this purpose. The secondary packaging remains outside the tray or peel bag, resulting in a second RFID transponder that can still be read and / or written at the operating device for preparation and / or planning purposes. It can be configured that after a single use and subsequent cleaning, the component is stored in an unsterilized state in the secondary packaging and sterilized only when needed again. However, in principle, the process in this case is as described above. In particular, the component is only marked as "unused" before it is arranged in the tray or peel bag. Attached Figure Description
[0032] The invention will now be described in more detail with reference to the accompanying drawings, based on preferred exemplary embodiments. In the drawings:
[0033] Figure 1 A schematic diagram of an embodiment of a component arrangement for X-ray therapy is shown;
[0034] Figure 2 A schematic diagram of an embodiment of an X-ray therapy system is shown;
[0035] Figure 3 A schematic flowchart illustrating an embodiment of a method for operating an X-ray therapy system is shown. Detailed Implementation
[0036] Figure 1 A schematic diagram of an embodiment of the component arrangement 1 for X-ray therapy component 2 is shown.
[0037] The component arrangement 1 includes an X-ray therapy component 2 having a first RFID transponder 3. The first RFID transponder 3 is arranged in or on the component 2. Specifically, the component 2 is designed as an applicator 20, which can be connected to an X-ray source (see [link to application]) in a connection area 21. Figure 2 Specifically, the first RFID transponder 3 is arranged in or near the connection area 21, such that the first RFID transponder 3 can be read and / or written by an RFID reader arranged on the X-ray source.
[0038] Component arrangement 1 also includes a primary package 4 in which component 2 is aseptically packaged. For example, the primary package 4 may be a peel-off bag or a package using a sterile barrier (e.g., A blister pack sealed with a thin film.
[0039] Furthermore, component arrangement 1 includes a secondary package 5, in which and / or on which a second RFID transponder 6 is arranged. Component 2, which is contained in the primary package 4 and the aseptic package, is arranged within the secondary package 5. For example, the secondary package is in the form of a box or collapsible box made of cardboard or hardboard. The secondary package 5 is unsterilized and is used to handle the aseptic component 2 in the primary package 4, provide transport protection for the aseptic component in the primary package, and store the aseptic component.
[0040] A first RFID transponder 3 and / or a second RFID transponder 6 may provide component unique identification data 25. Component unique identification data 25 specifically includes a unique serial number (e.g., a unique identifier, UID). In this case, component unique identification data 25 is stored in the memory of the RFID transponders 3 and 6, and can be retrieved from them and become available when needed.
[0041] The first RFID transponder 3 can be configured to be biocompatible. This allows the first RFID transponder 3 to come into contact with biological tissue. For this purpose, the RFID transponder 3 can be encapsulated in, for example, (bio)glass or a suitable plastic.
[0042] The first RFID transponder 3 can be sterilized by sterilization methods. The RFID transponder 3 suitable for this purpose has been described above.
[0043] Figure 2 A schematic diagram of an embodiment of an X-ray therapy system 10 is shown. The X-ray therapy system 10 includes an X-ray therapy apparatus 11 having a holding device 12 configured to hold and / or position at least one component 2 within and / or on a patient. For example, the holding device 12 is in the form of a support or includes a support. The X-ray therapy system 10 also includes an operating device 13 configured to control the X-ray therapy apparatus 11.
[0044] At least a portion of the holding device 12, particularly the portion on which at least one component 2 is disposed or can be disposed, is located in the sterile area 30 of the operating room. The remainder of the X-ray treatment system 10, particularly the operating device 13, is located in an unsterilized area outside the sterile area 30, and is accordingly easier to manage.
[0045] The X-ray therapy apparatus 11 includes a first RFID reader 14 configured to read data from and / or write data to a first RFID transponder 3 disposed on or in at least one component 2. Specifically, at least one first RFID reader 14 is provided disposed on a holding device 12 in a connection region 17, in which at least one component 2 is disposed on or can be disposed on the holding device 12 for use purposes. Specifically, the RFID transponder 3 is disposed in the connection region 17, and the component 2, particularly the applicator 20, is disposed on or can be disposed on an X-ray source 15 in the connection region, which is disposed on the holding device 12.
[0046] The operating device 13 includes a second RFID reader 16, which is configured to read data from and / or write data to a second RFID transponder 6 disposed in and / or on the secondary package 5.
[0047] Both the X-ray therapy apparatus 11 and the operating device 13 include corresponding control units (not shown), each control unit having a computing device and a memory. For example, each computing device includes a microprocessor and is configured to execute program code stored in the memory. Specifically, the control units are configured to control communication between the corresponding RFID readers 14, 16 and the RFID transponders 3, 6, and to read and evaluate data, particularly component unique identification data 25, from the corresponding RFID transponders 3, 6, and / or write data to the RFID transponders. In particular, the control unit of the X-ray therapy apparatus 11 provides an interlocking function in such a way that the X-ray therapy apparatus 11 can only be operated or treatment can only be permitted when at least one designated component 2 is correctly arranged and unused (sterile). In particular, this ensures that the applicator 20 (unused / sterile) is arranged on the X-ray source 15 before the X-ray source 15 is activated. Furthermore, the functionality of other components of the X-ray therapy apparatus 11 (e.g., a holding device 12 for holding the X-ray source 15 and the applicator 20) may also be blocked or permitted based on the presence of the applicator 20 on the X-ray source 15. This prevents the placement of a used / unsterilized applicator 20 on or inside the patient.
[0048] Figure 3 A schematic flowchart illustrating an embodiment of a method for operating an X-ray therapy system is shown. In addition... Figure 3 The following text also references Figure 2 .
[0049] To set up the X-ray therapy system 10, the following measures are performed for each of at least one component 2. However, these measures are described herein with respect to only one component 2. However, in principle, the method can be implemented in the same manner for the other components 2. In particular, component 2 is an applicator 20, which is arranged on the X-ray source 15 of the X-ray therapy apparatus 11 during X-ray therapy.
[0050] In measure 100, the second RFID reader 16 of the operating device 13 of the X-ray therapy system 10 is used to read data from and / or write data to the second RFID transponder 6 arranged in and / or on the secondary package 5 of the component 2.
[0051] Specifically, a component unique identification data 25 (e.g., unique identifier, UID) is provided to be read from a second RFID transponder during the process. Treatment can be prepared on the operating device 13 by means of the read data. For example, the type and performance of the applicator 20 used for treatment planning can be stored in the X-ray treatment system 10. In principle, multiple similar components 2 of different types (e.g., applicators with different shapes) can also be stored, and the component 2 used can be selected from them before the specific treatment (e.g., the shape of the applicator 20 is selected according to the surgical procedure).
[0052] In measure 101, the aseptically packaged component 2, specifically the applicator 20, is removed from the primary packaging. If the primary packaging is arranged in a secondary packaging 5, the primary packaging, along with the component 2 arranged therein, is removed from the secondary packaging 5. In this case, the aseptically packaged component 2 is removed from the primary packaging in a manner that does not compromise the asepticity of the component 2 during the process.
[0053] In measure 102, the first RFID reader 14 of the X-ray therapy device 11 of the X-ray therapy system 10 is used to read data from the first RFID transponder 3 of the component 2 (particularly the applicator 20) and / or write data to the first RFID transponder 3. Specifically, it is provided to read component unique identification data 25 (e.g., unique identifier, UID) from the first RFID transponder 3 during this process. Further, it may also be provided to read data during this process, said data including information about whether the component 2 has been used.
[0054] It can be configured such that X-ray treatment is permitted in step 103 if the data from the first RFID transponder 3 of component 2 (specifically, applicator 20) includes at least one specified piece of information. Specifically, unique identifier data 25 (e.g., unique identifier, UID) of the component is provided for verification during this process. Alternatively, or further, if the data does not include the at least one specified piece of information, a blocking signal can be created. For example, the at least one specified piece of information may include a usage status explicitly indicating that component 2 must not be used. For example, a bit reserved accordingly for this purpose can be checked. If the bit contains the specified information (unused), treatment is permitted; otherwise, treatment is permitted.
[0055] Measure 104 can provide the use of component 2, particularly applicator 20, and then store information in a first RFID transponder 3, which marks component 2 as used and / or includes the number of times component 2 has been used. For this purpose, the corresponding data is written into the memory of the first RFID transponder 3.
[0056] Measure 105 may render the first RFID transponder 3 unusable after use and / or once a given number of uses has been reached. This may be implemented, for example, by coupling in a high transmit power (above a suitable threshold) that irreversibly damages the wires of the first RFID transponder 3 and / or short-circuits it by the influx of heat energy.
[0057] Measure 106 can provide sterilization of component 2, particularly applicator 20, after a single use. For this purpose, component 2 is arranged, for example, in a sterilization tray or peel bag. In this case, particularly after sterilization, the sterilization tray or peel bag forms primary packaging. Specifically, a first RFID transponder 3 is provided to be written with data and then immediately sterilized; said data includes information marking component 2 as unused and / or sterilized. For example, bits previously changed (i.e., after use) can be reset. Subsequently, the above measures can be repeated with the sterilized component 2.
[0058] The method described in this disclosure improves the handling of components in radiotherapy. In particular, it can facilitate preparation and work in both unsterilized and sterile areas. This improves, and in particular facilitates, treatment planning and preparation. Specifically, it improves the workflow because it enables the rapid and simple recording and / or writing of data related to at least one component, independently and easily, in both unsterilized and sterile areas of the operating room.
[0059] List of reference numerals
[0060] 1. Component Arrangement
[0061] 2 components
[0062] 3 First RFID transponder
[0063] 4. Primary Packaging
[0064] 5 Secondary Packaging
[0065] 6 Second RFID transponder
[0066] 10 X-ray therapy systems
[0067] 11 X-ray therapy device
[0068] 12 Holding device
[0069] 13 Operating device
[0070] 14 First RFID Reader
[0071] 15 X-ray sources
[0072] 16 Second RFID reader
[0073] 17 Connecting Area
[0074] 20 Applicator
[0075] 21 Connecting Area
[0076] 25 Component Identification Data
[0077] 30. Aseptic Area
[0078] Measures of Methods 100-106
Claims
1. A component arrangement (1) for an X-ray therapy component (2), the component arrangement comprising: X-ray therapy component (2) with a first RFID transponder (3). Primary packaging (4), the component (2) is aseptically packaged in the primary packaging, An unsterilized secondary package (5) is provided with a second RFID transponder (6) which is readable in the unsterilized area for the treatment plan, and the primary package (4) and the component aseptically packaged in the primary package (4) are arranged in the secondary package such that the component (2) is assigned to a primary package and a secondary package, and the primary package and the sterile component are movable independently of the secondary package to move the sterile component to a sterile area.
2. The component arrangement (1) as described in claim 1, characterized in that, The first RFID transponder (3) and / or the second RFID transponder (6) provide component unique identification data (25).
3. The component arrangement (1) as described in claim 1 or 2, characterized in that, The first RFID transponder (3) is biocompatible.
4. The component arrangement (1) as described in claim 1 or 2, characterized in that, The first RFID transponder (3) can be sterilized by sterilization methods.
5. The component arrangement (1) as described in claim 1 or 2, characterized in that, The component (2) is the applicator (20) for X-ray therapy.
6. A method for operating an X-ray therapy system (10), in, Configuring the X-ray therapy system (10) for each of at least one component (2) present in the component arrangement (1) as described in any one of claims 1 to 5 includes: The second RFID reader (16) of the operating device (13) of the X-ray therapy system (10) reads data from and / or writes data to the second RFID transponder (6) arranged in and / or on the secondary package (5) of the component (2). Remove the component (2) that is aseptically packaged in the primary package (4) from the primary package (4), and The first RFID reader (14) of the X-ray therapy device (11) using the X-ray therapy system (10) reads data from the first RFID transponder (3) of the component (2) and / or writes data to the first RFID transponder (3).
7. The method as described in claim 6, characterized in that, If the data from the first RFID transponder (3) of the at least one component (2) includes at least one specified piece of information, then the X-ray treatment is authorized.
8. The method as described in claim 6 or 7, characterized in that, After using at least one component (2), information is stored in the first RFID transponder (3) that marks the at least one component (2) as used and / or includes the number of times the at least one component (2) has been used.
9. The method as described in claim 6 or 7, characterized in that, The first RFID transponder (3) becomes unusable after use and / or once the given number of uses has been reached.
10. The method as described in claim 6 or 7, characterized in that, The at least one component (2) is sterilized after each use.
11. An X-ray therapy system (10), comprising: An X-ray therapy device (11) having a holding device (12) configured to hold and / or position at least one component (2) of the component arrangement (1) as described in any one of claims 1 to 5 inside and / or on a patient. Operating device (13) configured to control the X-ray therapy device (11). The X-ray therapy device (11) includes at least one first RFID reader (14), which is configured to read data from and / or write data to a first RFID transponder (3) disposed on or in at least one component (2) of the component arrangement (1). The operating device (13) includes at least one second RFID reader (16), which is configured to read data from and / or write data to a second RFID transponder (6) disposed in and / or on the secondary package (5) of the component arrangement (1) as described in any one of claims 1 to 5. The X-ray therapy system (10) is configured according to the method described in any one of claims 6 to 10.
12. The X-ray therapy system (10) as described in claim 11, characterized in that, The at least one first RFID reader (14) is arranged on the holding device (12) in the connection area (17), in which the at least one component (2) is arranged on or can be arranged on the holding device (12) for use purposes.
Citation Information
Patent Citations
Applicator for intraoperative radiotherapy, radiotherapy device and method for ensuring the use of a proper applicator in a radiotherapy device
DE102020104628B3
RFID record and verification system and method of use for patient undergoing radiation therapy
WO2009052048A1
Systems and methods for tagging and tracking surgical devices and surgical accessories using radio frequency identification tags
WO2014071337A1
Method and apparatus to account for transponder tagged objects used during clinical procedures, employing a shielded receptacle
CN109561942A
Radiotherapy device, applicator and method for ensuring the use of a proper applicator in radiotherapy
EP3868441A1