Identification and tracking tool and kit and medical navigation system comprising the same

Abstract

An identification and tracking tool, a kit and a medical navigation system are provided. The identification and tracking tool comprises a tracking array and a pattern (3), the tracking array comprises a support (1) and a plurality of tracking elements (2) arranged on the support (1), the plurality of tracking elements can be tracked by an optical camera; the pattern can be identified to identify the identification and tracking tool. The utility model realizes the function of self-identification by the pattern such as a two-dimensional code which has stronger self-identification capability. The tracking array only needs to meet the tracking requirement. Thus, the defect that the self-identification of an optical tracker needs to be met by the arrangement of tracking elements in the prior art is eliminated, and the limitation on the number of array designs is broken. The production cost and the purchase cost of users are reduced, and the operation of users can be simplified, the operation accuracy and the operation efficiency are improved.

Description

[0001] This utility model claims priority to Chinese invention patent application filed on September 9, 2025, with application number 2025112849366, entitled "Identification and Tracking Tool and Kit Including the Same, Medical Navigation System and Method for Identifying and Tracking Identified Objects Using the Same". Technical Field

[0002] This utility model relates to the field of medical device technology, and in particular to an identification and tracking tool, a kit including the same, and a medical navigation system. Background Technology

[0003] In recent years, optical navigation technology has been widely used in surgical procedures. Compared to non-navigation surgery, this technology offers substantial clinical benefits in reducing patient radiation exposure during surgery and improving the precision and repeatability of surgical procedures. Furthermore, its widespread application has promoted minimally invasive surgery and gained acceptance among clinical users.

[0004] Its basic principle is: A. Via optical camera 11 (see prior art) Figure 1 ( ) Takes a series of photographs, including the real-time position in space of an array of reflective spheres 121 (an example of a tracer element) of the optical tracer 12; B. By analyzing images with a computer, the array of optical tracers can be identified. C. Calculate the real-time position of the optical tracer in space; D. Based on the location information obtained in C and the size information of the surgical tools / equipment that are rigidly connected to the optical tracer 12, the computer 13 of the navigation system calculates the real-time spatial position of the surgical tools / equipment and displays it on the navigation screen 14 as data or image information for navigation.

[0005] In practical clinical applications, each surgery requires multiple surgical tools or devices that need navigation. To ensure the continuity of the surgical procedure, theoretically, a unique optical tracer array needs to be designed for each tool or device, allowing these optical tracers to be identified and distinguished in step B above. In actual product design, to meet the diverse needs of the navigated tools while also considering versatility, navigation device manufacturers design several optical tracers (forming kits, such as sold as tracer toolboxes) for multiple surgical tools, based on the optical camera manufacturer's requirements regarding the distance, shape, and asymmetric arrangement of each tracer element in the optical tracer array. These tracers are used alternately during navigation surgery. Therefore, navigation device manufacturers need to design and produce different models of optical tracer products, resulting in high production costs. Furthermore, users need to purchase multiple (e.g., complete sets) optical tracers, further increasing the purchase cost.

[0006] Moreover, this design approach, due to its underlying limitations (optical camera manufacturers require that the distance and / or shape of each tracer element in the optical tracer array differ and that it must be an asymmetrical shape due to the requirements of the recognition mechanism), limits the number of array designs (i.e., the number of optical tracer designs) that can be produced for the same size. In navigation surgery, the navigation technician pre-sets a correspondence between each optical tracer and the surgical tool according to the type and number of tools to be navigated and inputs this information into the navigation system. This method of relying entirely on pre-set pairings presents the following challenges and potential risks: (1) If the pre-set correspondence is not strictly followed during the operation, the inaccurate navigation information displayed on the navigation screen at this time may lead to misjudgment by the doctor and bring clinical risks.

[0007] (2). Once the number of surgical tools requiring navigation exceeds the number of optical tracers, the navigation technician needs to manually re-enter the matching relationship on-site, which reduces the efficiency of navigation surgery and increases the probability of (1) occurring.

[0008] Although navigation device manufacturers try to mitigate the risks associated with Challenge 1 by designing surgical instruments to be navigated to be of uniform length, in practice, considering that some instruments may require attachments of different sizes or implants of varying models at their ends, it is impossible to guarantee that all instruments will ultimately have the same actual length. Furthermore, any manual operation inherently carries the possibility of error, which is unacceptable in high-risk surgeries (which often require navigation technology for the greatest extent possible).

[0009] Currently, the method of identifying tool models by capturing image features such as shape, outline, and material of the tool using optical cameras and image recognition algorithms cannot meet actual clinical needs for the following reasons: (1) This solution often places additional high demands on image quality and interference information in the image.

[0010] (2) The shape, outline, materials and other imaging features of surgical tools often have high similarity.

[0011] The above reasons often result in the solution failing to meet reliability and robustness requirements in actual clinical applications. It still requires navigation technicians to manually input the matching relationship between the navigated tool and the optical tracer on-site. Utility Model Content

[0012] The purpose of this utility model is to solve at least one of the above-mentioned problems and defects in the prior art, as well as other technical problems.

[0013] According to one aspect of the present invention, an identification and tracking tool is provided, comprising a tracking array and a pattern, wherein the tracking array includes a support and a plurality of tracking elements disposed on the support, the plurality of tracking elements being trackable by an optical camera, and the pattern being recognizable to identify the identification and tracking tool.

[0014] In this invention, the identification and tracking tool includes not only multiple trackable tracking elements but also a uniquely identifiable pattern. The "self-identification" function is handled by a pattern with stronger "self-identification" capabilities, such as a QR code. The tracking array only needs to meet the "tracking" requirement. This eliminates the shortcomings of existing technologies that require the arrangement of tracking elements to achieve self-identification in optical trackers, and overcomes the limitation on the number of arrays of optical trackers of the same size.

[0015] According to one example, the pattern is disposed on the support. Since self-identification is achieved through the pattern, it allows multiple identifiers and tracer tools to have identical tracer arrays, while the patterns of the multiple identifiers and tracer tools are different. With this approach, manufacturers of identifiers and tracer tools can reduce the design combinations of tracer arrays; for example, only one model of tracer array needs to be designed for the same size, and only the pattern on the support needs to be changed. This reduces the number of similar products, focuses the design and production of a single model, and lowers production costs.

[0016] In one example, the pattern is separate from the support. With this approach, users can purchase only a single kit containing one tracer array and multiple QR codes, reducing overall costs. Alternatively, to simplify operation and reduce the frequency of assembling and disassembling the tracer array, users can purchase more than one tracer array, allowing multiple arrays to be attached to different surgical instruments. For manufacturers, this reduces the number of tracer array designs, requiring only the production of a single model, thus decreasing the quantity of similar products and concentrating production on a single model, thereby reducing production costs through economies of scale.

[0017] According to one example, the pattern is constructed as a QR code.

[0018] According to another aspect of the present invention, a kit is provided, the kit comprising a plurality of marking and tracking tools, each marking and tracking tool comprising a tracking array and a pattern, the tracking array comprising a support and a plurality of tracking elements disposed on the support, the plurality of tracking elements being trackable by an optical camera; the pattern disposed on the support, the pattern being identifiable to identify the marking and tracking tool; wherein each tracking array of each marking and tracking tool in the kit has the same construction, and the patterns of the plurality of markings and tracking tools are all different.

[0019] According to another aspect of the present invention, a kit is provided comprising at least one tracer array and a plurality of identifiable patterns, wherein each tracer array includes a support and a plurality of tracer elements disposed on the support, the plurality of tracer elements being trackable by an optical camera; wherein each pattern is disposed separately from the support, the plurality of patterns are different, and the patterns are adapted to be applied to an object to be identified. As described above, users can purchase a kit comprising only one tracer array to save costs.

[0020] According to one example, the kit also includes multiple medical devices as the objects to be identified, wherein the patterns are integrated onto the corresponding medical devices. The kit directly and uniquely identifies the medical device with a pattern, allowing users to use the device directly without needing to establish a correspondence between the identifier and the tracing tool and the navigated tool. This improves surgical efficiency and reduces the error rate caused by manual operation.

[0021] According to one example, the pattern is configured to be attached by a user to the object to be identified. This solution more flexibly meets the user's needs, allowing the user to attach the QR code to the surgical tool based on the correspondence between the pattern and the surgical tool provided by the manufacturer (e.g., the corresponding serial numbers).

[0022] According to one example, the kit includes only one tracer array. As described above, since the pattern itself has self-identifying capabilities, the tracer array that enables the tracking function can be installed on any navigation tool / device, thus enabling the navigation system to automatically identify more than one navigation tool / device using a single optical tracer array.

[0023] According to another aspect of the present invention, a medical navigation system is also provided, comprising an identification and tracking tool or a kit as described in any of the foregoing examples, an optical camera and a scanning device, wherein the optical camera is configured to track a tracking element in the identification and tracking tool or the kit; and the scanning device is configured to scan a pattern in the identification and tracking tool or the kit.

[0024] According to one example, the optical camera and the scanning device are integrated into a single unit, simplifying the structure of the navigation system.

[0025] In one example, the optical camera and the scanning device are arranged separately.

[0026] According to one example, the scanning device is an RGB camera.

[0027] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit the scope of protection of this utility model. Attached Figure Description

[0028] The above and other features and advantages of the present invention will become more apparent from the following detailed description of exemplary embodiments with reference to the accompanying drawings.

[0029] Figure 1 An exemplary schematic diagram of an optical navigation system that utilizes an optical tracer in the prior art for navigation is shown.

[0030] Figure 2 A schematic diagram of the identification and tracing tool according to the first embodiment and the corresponding optical navigation camera (integrating an optical camera and an RGB camera) is shown.

[0031] Figure 3 A schematic diagram of the identification and tracing tool according to the second embodiment and the corresponding optical navigation camera (integrating an optical camera and an RGB camera) is shown. Detailed Implementation

[0032] The technical solution of this utility model will be further described in detail below through embodiments and in conjunction with the accompanying drawings. The following description of the embodiments of this utility model with reference to the accompanying drawings is intended to explain the overall concept of this utility model and should not be construed as limiting this utility model.

[0033] The following specific embodiments describe the specific structure of the identification and tracking tool, the specific structure of the kit, and the medical system of this utility model. Furthermore, methods for identifying and tracking identified objects using the identification and tracking tool are also described. In the following detailed description, numerous specific details and steps are set forth in a highly specific and detailed manner to provide a comprehensive understanding of this embodiment. However, it should be understood that one or more other embodiments may be implemented without these specific details and steps.

[0034] As the background art reveals, existing optical tracer arrays simultaneously perform two functions: "tracking" and "self-identification" (i.e., distinguishing them from other optical tracers used concurrently during surgery to differentiate them from identified objects such as surgical instruments or equipment connected to each tracer). This necessitates that the array, while meeting size requirements, also accommodate shape variations. Consequently, as mentioned in the background art, only a limited number of array designs are possible for optical tracers of the same size.

[0035] In this invention, a marking and tracing tool is provided to replace existing optical tracers. This marking and tracing tool includes a tracer array and a pattern 3, such as... Figure 2 As shown, the tracking array may include a support 1 and multiple tracking elements 2 disposed on the support 1. These tracking elements 2 can be tracked by an optical camera, and together they form an array of the identifier and tracking tool. The pattern 3 can be identified to achieve a unique identifier. The tool pattern 3 can be a QR code, which can be scanned and identified, for example, by an RGB camera. Therefore, according to this invention, the function of "self-identification" is implemented by a pattern with stronger "self-identification" capabilities, such as a QR code. Because a QR code can carry various information including characters, numbers, and even Chinese characters, the tracking array only needs to meet the "tracking" requirement. This eliminates the deficiency in the prior art that requires the arrangement of tracking elements to meet the self-identification of the optical tracker, and breaks through the limitation on the number of array design elements.

[0036] A QR code, also known as a 2D barcode, is a type of barcode technology. Based on its structure, QR codes can be divided into row-based QR codes and matrix QR codes. Row-based QR codes can be considered as multiple stacked 1D codes, while matrix QR codes arrange regular modules in a symbolic graphic (usually a matrix), using dark and light modules to represent binary "1" and "0" respectively, carrying related encoded information. Common QR codes include PDF417 barcodes, Data Matrix codes, QR codes (Quick Response Matrix codes), and Hanxin codes.

[0037] The tracking element 2 in the marking and tracking tool can be a reflective sphere (in) Figure 3 As can be seen in the examples), it can also be a black and white grid (in... Figure 2 (As can be seen in the example). The navigation system includes an optical camera that acquires images of the tracer array and its spatial information to track the marker and the tracer. The optical camera can be an infrared camera or a visible light camera. The scanning device used to scan and identify pattern 3, such as an RGB camera, can be separate from the optical camera or integrated into it (e.g., Figure 2 , 3 (As shown).

[0038] Figure 2 A first embodiment of the marking and tracing tool is shown, wherein pattern 3 is disposed on a bracket 1, which can be integrated onto the bracket 1 (as one piece with the bracket), for example, by direct laser printing onto it; or it can be disposed on the bracket 1 by a fixing connection device. This utility model does not limit this.

[0039] In this embodiment, pattern 3 uniquely identifies the marker and tracking tool, thereby uniquely identifying the tracked object (or identified object) of the marker and tracking tool. Through the tracking element 2 on the bracket 1, the marker and tracking tool are tracked and positioned by the optical camera, thus realizing the tracking of the specific tracked object.

[0040] Accordingly, this invention provides a kit comprising multiple such identification and tracking tools. Each identification and tracking tool includes a tracking array and a uniquely identifiable pattern 3 mounted on a support 1. The tracking array includes the support 1 and multiple tracking elements 2 mounted on the support 1, which can be tracked by an optical camera. Since self-identification is achieved through the pattern 3, the tracking arrays of each identification and tracking tool in this kit can have the same structure, while the patterns 3 are different for each. Through this solution, manufacturers of identification and tracking tools can reduce the design combinations of tracking arrays; for example, only one model of tracking array needs to be designed for the same size, and only the pattern 3 on the support 1 needs to be changed. This reduces the number of similar products, focuses the design and production of a single model, and lowers production costs. When using this kit, users attach different identification and tracking tools to surgical equipment (e.g., a C-arm machine) or surgical instruments, enabling them to identify and track each surgical device (e.g., a C-arm machine) or surgical instrument and navigate to it.

[0041] According to another embodiment of the present invention, pattern 3 and bracket 1 can also be set separately. Figure 3A second embodiment of the identification and tracking tool is shown, in which pattern 3 is separate from support 1. Pattern 3 can be directly integrated into the corresponding medical device 6 (the object to be identified), such as a surgical instrument, during manufacturing, thereby uniquely identifying the medical device during the user's surgical procedure. As another example, the pattern can be configured to be attached by the user to the object to be identified; for example, pattern 3 can be disposed on a body 4, which can be fixedly connected to the object to be identified via a quick-release structure. That is, it is attached to the object to be identified by the user only during use. In this example, the object to be identified suitable for attachment to the body 4 can be a surgical instrument or a medical device such as a C-arm machine. In the case of a surgical instrument, the user can connect and fix the QR code to the surgical instrument based on the correspondence between the QR code provided by the manufacturer and the surgical instrument (e.g., the corresponding serial number). Thus, when a scanning device such as an RGB camera scans the QR code, the processor of the navigation system loads the model of the corresponding tool onto the navigation view based on the identified QR code. For example, when the object to be identified is a C-arm CT scanner, the user can use the pre-calibration process provided by the navigation system software to calculate the spatial relationship between the optical tracer and the C-arm CT scanner's field of vision (FOV). Then, the user establishes a correspondence between this parameter (e.g., the FOV position transformation matrix used for registration calculation) and the QR code, and stores it in the navigation system. Subsequently, during the acquisition of intraoperative images of the patient using the C-arm CT scanner, the optical camera locates the C-arm CT scanner's FOV spatial position through the optical tracer. Simultaneously, when the scanning device scans the QR code, the navigation system automatically loads the C-arm CT scanner's parameters (e.g., the aforementioned FOV position transformation matrix) for registration calculation.

[0042] Corresponding to the scheme where pattern 3 and tracer array are separate, this invention also provides a kit that may include only one tracer array while simultaneously including multiple identifiable patterns 3. After purchasing the kit, the user attaches each pattern 3 to the surgical tool or device (such as a C-arm machine) to be used during surgery. During the surgical procedure, the user only needs to fix the tracer array to the surgical tool or device that requires navigation. This allows the user to purchase only one array to track and identify multiple navigation tools or devices, reducing the user's purchase cost. Of course, to further facilitate user use and reduce the number of times the tracer array needs to be installed and removed, the kit may also include more than one tracer array, allowing multiple tracer arrays to be fixed to different surgical tools or devices. For manufacturers, this reduces the design combinations of tracer arrays, requiring only the production of one model of tracer array, reducing the number of similar products, concentrating products on a single model, and reducing production costs through economies of scale.

[0043] As another example, the kit may also include multiple medical devices, such as multiple surgical instruments, that are the objects to be identified. That is, the kit directly includes the object to be identified, and pattern 3 is already integrated onto the corresponding medical device (see...). Figure 3 Users can use it directly.

[0044] This invention also provides a medical navigation system, which may include an optical camera, a scanning device, and the marking and tracing tools or kits described above. As described above, the optical camera is configured to track the tracing element 2 of the marking and tracing tool or the tracing element 2 in the kit described above. The scanning device is configured to scan pattern 3.

[0045] For the case where the object to be identified is a C-arm 3D machine, in existing technologies, considering that users may have different brands and models of 3D C-arm 3D machines that need to be used in conjunction with the navigation system, and that each C-arm 3D machine has two faces (left and right), 6-8 different arrays may be needed to meet all possible identification needs. However, considering that the arrays must be sufficiently diverse, the size of these 6-8 arrays may be large (this affects clinical use because they are prone to collisions with patients, fixation braces, or other operating table equipment), and the number of tracer elements, such as reflective balls, is also large. Since reflective balls are single-use consumables, this further increases the user's operating costs.

[0046] According to the present invention, spatial positioning is achieved through a tracer array, serving as a spatial reference position for the C-arm's field of view (FOV) for registration calculations by the robot / navigation system. The QR code serves two purposes: "identification" and "recall." "Identification" distinguishes between different C-arms or the left and right sides of the same C-arm. During pre-calibration, the robot / navigation system calculates the spatial positional relationship of the C-arm's FOV relative to the tracer array and binds this parameter to the unique QR code. Later, in actual clinical use, once the navigation system identifies a QR code, it automatically retrieves the parameters bound to that QR code (such as a calculation matrix) for the C-arm's registration calculations.

[0047] Other embodiments of the present invention will readily occur to those skilled in the art upon consideration of the specification and practice of the disclosure herein. This application is intended to cover any variations, uses, or adaptations of the present invention that follow the general principles of the present invention and include common knowledge or customary techniques in the art not disclosed herein. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of the present invention are indicated by the appended claims.

Claims

1. An identification and tracking tool, characterized in that, The identification and tracing tools include: The tracer array includes: The stent (1); and Multiple tracer elements (2) are disposed on the bracket (1), and the multiple tracer elements (2) can be tracked by an optical camera (51); as well as Pattern (3), which can be identified to identify the mark and the tracking tool.

2. The identification and tracing tool according to claim 1, characterized in that, The pattern (3) is set on the bracket (1).

3. The identification and tracing tool according to claim 1, characterized in that, The pattern (3) is set separately from the bracket (1).

4. The identification and tracing tool according to any one of claims 1-3, characterized in that, The pattern (3) is constructed as a QR code.

5. A kit, characterized in that, The kit includes multiple identification and tracing tools, each of which includes: Tracer array, wherein the array comprises: The stent (1); and Multiple tracer elements (2) are disposed on the bracket (1), and the multiple tracer elements (2) can be tracked by an optical camera; as well as The pattern (3) is set on the bracket (1), and the pattern (3) can be identified to identify the mark and the tracer; The respective tracer arrays of the respective identifiers and tracers in the kit have the same construction, and each pattern (3) of the plurality of identifiers and tracers is different.

6. A kit, characterized in that, The kit includes: At least one tracer array, wherein each tracer array comprises: The stent (1); and Multiple tracer elements (2) are disposed on the bracket (1), and the multiple tracer elements (2) can be tracked by an optical camera; as well as Multiple identifiable patterns (3), each pattern being separately set from the bracket (1), the multiple patterns (3) being different, and the patterns (3) being adapted to be set on the object to be identified.

7. The kit according to claim 6, characterized in that, The kit also includes: Multiple medical devices (6) are the objects to be identified, wherein the pattern (3) is integrated on the corresponding medical device.

8. The kit according to claim 6, characterized in that, The pattern is configured to be attached by a user to the object to be identified.

9. The kit according to any one of claims 6-8, characterized in that, The kit includes only one tracer array.

10. A medical navigation system, characterized in that, The medical navigation system includes: The identification and tracing tool according to any one of claims 1-4 or the kit according to any one of claims 5-9, An optical camera (51) configured to track the identification and tracking tool or the tracking element (2) in the kit; and A scanning device (52) is configured to scan the pattern (3) in the identification and tracing tool or the kit.

11. The medical navigation system according to claim 10, characterized in that, The optical camera and the scanning device are integrated into one unit.

12. The medical navigation system according to claim 10, characterized in that, The optical camera and the scanning device are set up separately.

13. The medical navigation system according to any one of claims 10-12, characterized in that, The scanning device is an RGB camera.

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