Guiding stents, usage methods, and detection methods for breast lesion biopsy

Abstract

This invention provides a guide frame, method of use, and testing method for breast lesion biopsy, belonging to the field of medical auxiliary device technology. It includes a breast positioning support component and a movable guide component. The breast positioning support component is placed on the scanning bed and has a scale plate with grid markings for stable support of the breast and quantification of lesion coordinates and height. The movable guide component is slidably disposed on the side of the scanning bed and includes a lifting adjustment mechanism, an angle adjustment guide frame, and a puncture guide with guide grooves, enabling multi-degree-of-freedom precise adjustment and locking of the puncture path. This invention is made of magnetically compatible materials, eliminating artifact interference; it achieves millimeter-level precise positioning through three-dimensional quantification of coordinates, height, and angle; it can be used in conjunction with a physical breast model for preoperative simulation, significantly improving the success rate and safety of puncture. The structure is simple and the cost is low, making it suitable for large-scale clinical application.

Description

Technical Field

[0001] This invention relates to the field of medical auxiliary device technology, specifically to a puncture biopsy guide stent system suitable for magnetic resonance imaging (MRI) guidance for small-volume hard breast lesions in Asian and Chinese women, and more particularly to a guide stent for puncture biopsy of breast lesions, its usage method, and its detection method. Background Technology

[0002] Breast MRI has become a key tool for breast cancer screening and diagnosis due to its high sensitivity. However, for lesions detected by MRI but difficult to visualize by ultrasound / mammography, MRI-guided biopsy is required for definitive diagnosis. Current MRI breast biopsy techniques face two major bottlenecks: firstly, traditional techniques all employ a prone position, referring to… Figures 1a-1c As shown, this method is only suitable for large breasts. However, the small, firm breasts of Asian and Chinese women cannot be naturally suspended and fixed, resulting in significant stereotactic deviations and extremely poor clinical adaptability. Furthermore, the narrow operating space in the prone position further exacerbates the difficulty of localization. Secondly, there is a lack of magnetically compatible and low-cost dedicated biopsy guidance devices. Non-metallic instruments present significant puncture resistance, and non-magnetic metal needle artifacts interfere with localization. Moreover, the high cost of a single set of equipment hinders clinical adoption. Domestic research in this area is mostly limited to small-sample testing, lacking device innovation and technological implementation. Clinical research has encountered several bottlenecks in breast fixation methods, lesion localization methods, and the selection of instruments and consumables, restricting its application and promotion. Addressing these pain points is urgently needed to promote the widespread adoption of MRI breast diagnosis and treatment technology. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention provides a guiding stent for breast lesion puncture biopsy, its usage method, and its detection method.

[0004] According to the present invention, a guiding stent for breast lesion biopsy, its usage method, and its detection method are as follows: In a first aspect, a guiding stent for puncture biopsy of breast lesions is provided, the guiding stent comprising: a breast positioning support component and a movable guiding component; The breast positioning support component, placed on the scanning bed, supports the breast from the side of the patient and enables calibrated positioning of the lesion. The breast positioning support component is made of magnetically compatible material. A movable guide assembly is slidably disposed on the side of the scanning bed, the movable guide assembly including a multi-degree-of-freedom adjustment mechanism and a puncture guide disposed at its end; The breast positioning support component is used in conjunction with the movable guide component to guide the puncture needle to the lesion in the breast placed on the breast positioning support component when the patient is in a lateral decubitus position.

[0005] Preferably, the breast positioning support assembly includes: a positioning scale plate, lifting support legs, locking buckles, and a grid positioning area; The positioning scale plate is movably mounted on the lifting support leg to support the breast when the patient is in a lateral decubitus position, and is locked and fixed by a locking buckle; the grid positioning area is set on the surface of the positioning scale plate to mark the location of the lesion in the magnetic resonance image.

[0006] Preferably, the positioning scale plate is made of carbon fiber, the grid of the grid positioning area is a square scale, each grid is marked with a coordinate number, and gadolinium contrast agent is injected into the scale lines of the grid positioning area to mark the location of lesions in the MRI image.

[0007] Preferably, there are multiple lifting support legs, and a reinforcing plate is provided between the lifting support legs.

[0008] Preferably, the multi-degree-of-freedom adjustment mechanism includes: a lifting adjustment mechanism and an angle adjustment guide frame, wherein the angle adjustment guide frame is mounted on the lifting adjustment mechanism; The lifting and adjusting mechanism includes a fixed base, a lifting column, and a control knob; The bottom of the fixed base is provided with a slide rail, which is used to slide and engage with the slide groove on the side of the scanning bed. The fixed base is also provided with a fixing component for locking. The lifting column is installed on a fixed base, and the lifting column is driven to move up and down along the axis of the fixed base by a control knob.

[0009] Preferably, the lifting column includes an inner column and an outer column that are nested together. The control knob is located on the side wall of the outer column. The inner column and the outer column are connected by a male and female thread. Rotating the control knob enables the lifting column to move axially up and down. The side wall of the inner column is also provided with a height scale mark.

[0010] Preferably, the angle adjustment guide frame includes: a rotating rod, an arc-shaped bracket, and an angle locking component; The rotating rod is installed on the top of the lifting column and can rotate horizontally and slide horizontally along the axis. Its position and angle are locked by the angle locking component. The arc-shaped support and the rotating rod are fixedly connected to the end facing the scanning bed. The rotating rod and the arc-shaped support work together to achieve three-dimensional adjustment of forward and backward movement and rotation. Both the rotating rod and the arc-shaped support are marked with scale markings to indicate the scale of forward and backward movement and the angle of rotation. The puncture guide is slidably mounted on the arc-shaped support and locked by the guide locking member to guide the puncture needle toward the lesion.

[0011] Preferably, the puncture guide has a puncture needle guide groove on its sidewall along the axial direction, the arc-shaped bracket is a 1 / 4 arc, and the axis of the puncture needle guide groove is set to be able to coincide with the virtual center of the arc-shaped bracket by adjustment, so as to point to the lesion.

[0012] Secondly, a method for using a guiding stent for breast lesion biopsy is provided, the guiding stent for breast lesion biopsy comprising: Patient positioning steps: Place the breast positioning support component on the scanning table. The patient lies on their side on one side of the component, facing the positioning scale plate. Place the breast with the lesion in the grid positioning area of ​​the positioning scale plate. Adjust the height of the scale plate by raising and lowering the support legs and locking buckles to ensure that the breast is stably attached. MRI scan localization steps: Start the MRI equipment to scan the patient's breast, determine the grid coordinates and vertical height of the lesion based on the MRI image, and record the lesion location parameters; Guide support adjustment steps: Insert the slide rail at the bottom of the movable guide assembly into the slide groove on the side of the scanning bed. Adjust the lifting mechanism by rotating the control knob according to the vertical height of the lesion and lock the height of the lifting column. Adjust the horizontal position and rotation angle of the rotating rod according to the grid coordinates of the lesion and the puncture requirements so that the axis of the puncture needle guide groove of the puncture guide component coincides with the lesion, i.e., the virtual sphere center. Lock all adjustment structures. Puncture procedure steps: Insert the puncture needle into the puncture needle guide groove, adjust the puncture needle depth to the lesion area, and lock the puncture needle; under real-time MRI guidance, complete the puncture biopsy along the preset path, and complete multi-point sampling and obstacle avoidance by moving the puncture guide and adjusting the angle of the rotating rod and the arc support.

[0013] Thirdly, a method for puncture biopsy of breast lesions is provided, based on a guiding stent for the puncture biopsy of the breast lesion, comprising: Step 1: Collect breast MRI image data of the target patient, construct a three-dimensional breast model including breast shape, lesion location and blood vessel distribution, and use self-healing polymer material to cast a solid breast model to replicate the appearance and skin texture of the human breast, and embed lesion and blood vessel simulation objects that can be visualized by magnetic resonance. Step 2: Simulate the patient's lateral decubitus position, place the solid breast model on the positioning scale plate, perform MRI scanning to obtain the grid coordinates and vertical height of the lesion, and use the movable guide component to complete the pre-puncture drill to optimize the puncture angle, depth and path; Step 3: The patient assumes a lateral decubitus position, places the breast on the affected side on the positioning scale plate, adjusts the height of the scale plate, and fixes the position; Step 4: Perform an MRI scan of the breast to obtain the grid coordinates and vertical height of the lesion on the scale plate, and compare it with the pre-puncture data to confirm the positioning parameters; Step 5: Embed the slide rail of the movable guide component into the slide groove on the side of the scanning bed, adjust the lifting column according to the vertical height of the lesion, and then adjust the angle between the rotating rod and the arc-shaped support so that the puncture needle guide groove of the puncture guide component accurately points to the lesion, i.e., the virtual sphere center, and lock each adjustment structure. Step 6: Insert the puncture needle into the puncture needle guide groove, adjust the needle tip to the lesion area and fix it, and complete the biopsy sampling under real-time MRI guidance; if multiple sampling is required, repeat the sampling after fine-tuning the path of the movable guide component.

[0014] Compared with the prior art, the present invention has the following beneficial effects: 1. Innovative positioning to suit Asian women's breasts: The innovative lateral decubitus position replaces the traditional prone position, perfectly suited to the small volume and firm breasts of Asian and Chinese women. It solves the core pain points of breasts not being able to hang naturally and large positioning deviations in the prone position, thus expanding the clinically applicable population.

[0015] 2. Highly efficient and safe operation: The lateral decubitus position provides a more open operating space, making it easier for medical staff to operate; the multi-degree-of-freedom adjustment structure supports multi-point sampling, improving the accuracy and comprehensiveness of biopsy samples; the locking device ensures the stability of the needle and stent during puncture, reducing the risk of puncture complications.

[0016] 3. Precise positioning and quantitative adjustment: Through the scale plate grid coordinates, the height scale of the lifting column, and the angle scale of the rotating rod and the arc-shaped support, the lesion location can be quantitatively positioned throughout the entire process, avoiding subjective judgment errors and significantly improving positioning accuracy; the multi-dimensional adjustment structure can flexibly avoid anatomical structures such as ribs and nipples, and plan the optimal puncture path.

[0017] 4. Magnetic compatibility, no artifact interference: The core components are made of magnetically compatible materials such as carbon fiber and medical polymer resin, which avoids artifact interference from MRI equipment, ensures the accuracy of lesion localization and puncture operation, and solves the technical bottleneck of artifact interference of existing non-magnetic metal instruments.

[0018] 5. Simplified structure and low cost: It abandons complex magnetically compatible components, adopts a modular design for the overall structure, and has a simple operation process, allowing medical staff to quickly complete positioning and adjustment; the cost of a single system is far lower than that of existing non-magnetic equipment, making it economically feasible for large-scale clinical promotion.

[0019] Other beneficial effects of the present invention will be explained in detail through the introduction of specific technical features and technical solutions in specific embodiments. Those skilled in the art should be able to understand the beneficial technical effects brought about by these technical features and technical solutions through the introduction of these technical features and technical solutions. Attached Figure Description

[0020] Other features, objects, and advantages of the present invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings: Figures 1a-1c This is a schematic diagram of the traditional prone position for breast biopsy. Figure 2 This is a schematic diagram of the overall structure of the mobile guidance component of the present invention; Figure 3 This is a schematic diagram of the overall structure of the breast positioning support component of the present invention.

[0021] Reference numerals: 1. Movable guide assembly; 2. Breast positioning support assembly; 21. Positioning scale plate; 22. Lifting support leg; 23. Locking buckle; 24. Grid positioning area; 25. Reinforcing plate; 3. Lifting adjustment mechanism; 31. Fixed base; 32. Lifting column; 321. Inner column; 322. Outer column; 33. Control knob; 4. Angle adjustment guide frame; 41. Rotating rod; 42. Arc-shaped bracket; 43. Angle locking component; 44. Puncture guide component; 45. Guide component locking component; 5. Fixing component; 6. Protective cover; 7. Inside the arc-shaped track; 8. Puncture needle guide groove. Detailed Implementation

[0022] The present invention will now be described in detail with reference to specific embodiments. These embodiments will help those skilled in the art to further understand the present invention, but do not limit the invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present invention. These all fall within the protection scope of the present invention.

[0023] This invention provides a guiding stent, method of use, and detection method for breast lesion biopsy. It aims to provide a magnetically compatible, low-cost guiding stent system for MRI-guided breast lesion biopsy in the lateral decubitus position, suitable for small, firm breasts in Asian and Chinese women, offering precise positioning and convenient operation. This system overcomes the bottlenecks of existing technologies, such as poor compatibility in the prone position, large positioning deviations, equipment incompatibility, and difficulties in widespread adoption, thereby enabling the clinical popularization and precise application of MRI breast biopsy technology. (Refer to...) Figure 2 and Figure 3 As shown, it includes two parts: a movable guiding component 1 and a breast positioning support component 2. The two work together to achieve precise lesion positioning, puncture path optimization, and puncture operation guidance. The specific structure and functions are as follows: The movable guide component 1 is used to realize the dynamic adjustment and locking of the puncture angle and depth, ensuring that the puncture needle is accurately pointed to the lesion area and adapts to the MRI magnetic environment and operating space limitations. Specifically, it includes a multi-degree-of-freedom adjustment mechanism and a puncture guide 44 set at its end. The multi-degree-of-freedom adjustment mechanism includes a lifting adjustment mechanism 3 and an angle adjustment guide frame 4, with the angle adjustment guide frame 4 mounted on the lifting adjustment mechanism 3. Furthermore, the lifting and adjusting mechanism 3 includes a fixed base 31, a lifting column 32, and a control knob 33; The bottom of the fixed base 31 is equipped with a slide rail that slides into a groove on the side of the scanning bed, thereby enabling the position adjustment of the entire movable guide assembly 1 along the length of the bed. To improve sliding stability, the slide rail is preferably designed with a trapezoidal cross-section, and the groove forms a trapezoidal fit with it, which can effectively suppress lateral swaying and ensure the positioning accuracy of the support during adjustment and puncture. The fixed base 31 is also equipped with a fixing component 5 (such as a locking screw) for fixing. After the support is moved to the target position, tightening the fixing component 5 will firmly lock the base to the side of the scanning bed.

[0024] The lifting column 32 is mounted on the fixed base 31 and can move up and down along the axial direction of the fixed base 31. The lifting column 32 includes an inner column 321 and an outer column 322 that are nested together. The inner column 321 and the outer column 322 are connected by a male and female thread. A control knob 33 is provided on the side wall of the outer column 322. Rotating the control knob 33 drives the inner column 321 to spirally rise and fall relative to the outer column 322, thereby realizing stepless adjustment of the overall height of the lifting column 32. To facilitate precise height control by the operator, a height scale is provided on the side wall of the inner column 321 along the axial direction. The scale accuracy can reach the millimeter level. Combined with the fine adjustment capability of the control knob 33, precise alignment of the vertical height of the lesion can be achieved.

[0025] The outer column 322 is also provided with a protective cover 6 around the control knob 33. The protective cover 6 can effectively prevent accidental touch of the control knob 33 during operation, which may cause unexpected changes in height and improve the reliability and safety of operation.

[0026] The angle adjustment guide frame 4 includes a rotating rod 41, an arc-shaped bracket 42, and an angle locking component 43; The rotating rod 41 passes horizontally through the top of the lifting column 32 and is fixedly connected to the lifting column 32. The rotating rod 41 can move horizontally left and right relative to the lifting column 32 (i.e., extend and retract along its own axis) and rotate 360° horizontally. The rotating rod 41 can be locked at any position and angle by the angle locking component 43 (e.g., locking screw). This design allows the operator to flexibly adjust the extension length and orientation of the rotating rod 41 according to the grid coordinates of the lesion, and initially determine the planar position of the puncture path.

[0027] The arc-shaped support 42 is fixedly connected to the end of the rotating rod 41 facing the scanning bed. The arc-shaped support 42 is a quarter-circle arc (i.e., an arc segment with a central angle of 90°). The rotating rod 41 works in conjunction with the arc-shaped support 42 to achieve multi-degree-of-freedom adjustment of forward and backward movement (by extending and retracting the rotating rod) and rotation (by rotating the rotating rod horizontally), ensuring that the virtual center of the arc-shaped support 42 can accurately point to the lesion location. To facilitate quantitative adjustment, both the rotating rod 41 and the arc-shaped support 42 have scale markings on their surfaces, indicating the extension distance and rotation angle, respectively, allowing the operator to perform standardized and repeatable adjustments according to the lesion parameters obtained from the MRI scan.

[0028] The puncture guide 44 is embedded in the arc-shaped track 7 on the side wall of the arc-shaped support 42 and can slide smoothly along the track. A puncture needle guide groove 8 is axially formed on the side wall of the puncture guide 44, and the axis of this guide groove 8 always points to the virtual center of the arc-shaped support 42. When the virtual center of the arc-shaped support 42 coincides with the lesion, the puncture needle can be inserted along the guide groove 8 to accurately hit the lesion. After the puncture guide 44 is adjusted to a suitable angle, it is fixed by the guide locking member 45 (e.g., a locking nut or an eccentric handle) provided on the puncture guide 44. The angle scale on the arc-shaped support 42, in conjunction with the locking member, can precisely lock the insertion angle of the puncture needle.

[0029] Through the aforementioned multi-dimensional adjustment structure, the operator can flexibly plan the optimal needle insertion route based on the lesion location and breast anatomy (such as ribs, nipples, and chest wall), effectively avoiding obstacles and preventing damage to important tissues. Simultaneously, the combination of scale markings and locking mechanisms enables quantitative positioning and locking throughout the entire process, completely preventing puncture deviations caused by changes in body position or manual operation errors. Furthermore, this structure supports rapid switching of the guide slider position without the need for repositioning, thereby efficiently completing multi-point sampling and significantly improving biopsy efficiency and sample representativeness.

[0030] The breast positioning support component 2 is used to achieve stable support for the patient's breast and calibrated positioning of lesions. It is made entirely of magnetically compatible materials (such as carbon fiber and medical polymer resin) to ensure that no artifacts are generated in the MRI magnetic field and that image quality is not affected. Specifically, it includes the following components: a positioning scale plate 21, lifting support legs 22, locking buckles 23, a grid positioning area 24, and a reinforcing plate 25.

[0031] The positioning scale plate 21 is made of carbon fiber, which has excellent magnetic compatibility and mechanical strength, and is free from artifact interference. A grid positioning area 24 is located in the central region of the plate. This grid consists of square scale units, each marked with a unique coordinate number (e.g., X1-Xn, Y1-Yn). During manufacturing, gadolinium contrast agent is precisely injected within the scale lines, allowing the positioning scale plate to be clearly visualized in MRI scans, thus accurately corresponding to the location of lesions on the grid.

[0032] The positioning scale plate 21 is mounted on two vertical lifting support legs 22 on both sides, allowing it to move up and down along the legs to adjust its height. It is quickly locked in place by locking buckles 23 on both sides of the legs. This adjustable design allows the positioning scale plate to adapt to breasts of different sizes: for smaller breasts, the scale plate can be raised to ensure full contact between the breast and the plate; for larger breasts, the scale plate height can be appropriately lowered to avoid excessive compression and deformation. To enhance the overall structural stability, a reinforcing plate 25 connects the two lifting support legs 22 to prevent swaying when the patient leans against it or during puncture procedures.

[0033] Instructions for use: The patient lies on their side on the scanning bed, facing the breast positioning support component 2, and naturally places the breast with the lesion on the grid positioning area 24 of the positioning scale plate 21. Due to the lateral decubitus position, the breast naturally adheres to the scale plate surface under its own weight, achieving stable support and avoiding the problem of breast compression and deformation in the traditional prone position. Through MRI scanning, the grid coordinates (e.g., X8, Y12) corresponding to the lesion and the vertical distance (i.e., vertical height) from the lesion to the scale plate surface can be accurately obtained. These parameters will provide precise quantitative basis for subsequent adjustment of the movable guide component 1.

[0034] Case 1: For a female patient with a breast volume of approximately 200 cm³ (MRI detected 5 types of lesions, but ultrasound did not show them), the patient was positioned according to the above principles. MRI scans determined the grid coordinates (X8, Y12) corresponding to the lesions, with a vertical height of 4 cm from the scale plate. The height of the lifting column was adjusted to 4 cm, and the rotation angle was adjusted so that the distance between the rotating rod and the lesion was 10 cm (the radius of the virtual sphere was 10 cm). The angle of the arc-shaped support was set to 90° horizontally, ensuring that the guide hole of the puncture needle pointed towards the virtual sphere. A 2.7 mm biopsy gun was inserted, and the needle tip depth was adjusted to the sphere's center position. The puncture needle was then locked. The biopsy gun was fired to complete the biopsy. There was no change in the patient's position during the sampling process, the lesion was accurately located, the puncture path avoided the ribs, and there were no postoperative complications such as bleeding or infection. The pathological results confirmed breast cancer, consistent with the preoperative imaging assessment.

[0035] Case 2: The difference from Case 1 is that the positioning scale plate has an adjustment range of 0-12cm, the arc-shaped support has a radius of 12cm, and the puncture needle guide hole has a diameter of 2mm. It is suitable for patients with smaller breast volume (about 150cm³) and meets the precise puncture needs of Asian women with small breasts. The rest of the structure and working principle are the same as Case 1.

[0036] This invention also provides a method for using a guiding stent for breast lesion biopsy, specifically including the following: Patient positioning steps: Place the breast positioning support component 2 on the scanning table, with the patient lying on their side facing the positioning scale plate 21. Place the breast with the lesion in the grid positioning area 24 of the positioning scale plate 21. Adjust the height of the positioning scale plate 21 by using the lifting support leg 22 and locking buckle 23 to ensure stable breast fit.

[0037] MRI scan localization steps: Start the MRI equipment to scan the patient's breast, identify the visible grid lines and lesions in the MRI image, determine the grid coordinates (such as X8, Y12) and vertical height (e.g., 4cm from the scale plate) corresponding to the lesion, and record the above lesion location parameters in detail. Guided support adjustment steps: Insert the slide rail at the bottom of the movable guide assembly 1 into the slide groove on the side of the scanning bed, move it to the appropriate position, and lock it with the fixing piece 5. Adjust the height of the lifting column 32 by rotating the control knob 33 according to the vertical height of the lesion (e.g., 4cm), so that the virtual center of the arc-shaped support 42 is located on the horizontal plane of the lesion; adjust the horizontal extension length and rotation angle of the rotating rod 41 according to the lesion grid coordinates and puncture requirements, and at the same time slide the puncture guide 44 along the arc-shaped track 7 until the axis of the puncture needle guide groove 8 is precisely pointed to the lesion (i.e., the virtual center of the sphere). Lock the angle locking piece 43 and the guide locking piece 45 in sequence to complete all adjustments.

[0038] Puncture procedure: Insert the puncture needle (e.g., a 2.7mm biopsy gun) into the puncture needle guide groove 8, adjust the needle depth so that the needle tip reaches the lesion area (i.e., within the radius r of the virtual sphere center), and lock the puncture needle using the built-in locking device or an external clamp. Under real-time MRI guidance, fire the biopsy gun along the preset path to complete the puncture sampling. For multiple sampling points, the puncture guide 44 can be moved or the angle of the rotating rod 41 and the arc-shaped support 42 can be finely adjusted to quickly switch to the next sampling point, while flexibly avoiding obstacles such as ribs and nipples. Throughout the entire operation, the support remains stable, the puncture needle does not deviate, and the risk of postoperative complications is significantly reduced.

[0039] This invention also provides a magnetic resonance-guided breast lesion biopsy method, using the aforementioned magnetic resonance-guided breast lesion biopsy guide stent, and specifically adding a preoperative simulation verification step to achieve closed-loop control of the entire process from preoperative planning to intraoperative execution. The method includes the following steps: Step 1: 3D Modeling and Solid Model Casting. Breast MRI images of the target patient are acquired, and a 3D breast model including breast shape, lesion location, and blood vessel distribution is constructed using medical image processing software. A solid breast model is cast using a self-healing polymer material (such as silicone-based biomimetic material). This model accurately replicates the external contour, skin texture, and internal hardness distribution of a human breast, and incorporates MRI-detectable lesion and blood vessel simulators. This material has the characteristic of automatic needle tract closure and repair after puncture, supporting multiple repeated puncture rehearsals.

[0040] Step 2: Pre-puncture rehearsal. Place the solid breast model on the positioning scale plate 21, simulate the patient's lateral decubitus position, and perform MRI scan to obtain the grid coordinates and vertical height of the lesion. Use the movable guide component 1 to complete the pre-puncture rehearsal. Based on the model feedback (such as whether the puncture needle hits the lesion simulation object or whether it accidentally damages the blood vessel simulation object), repeatedly optimize the puncture angle, depth, and path until the optimal puncture plan is obtained.

[0041] Step 3: Position the patient. The patient should be in a lateral decubitus position. Place the breast on the side of the lesion on the positioning scale plate 21, adjust the height of the scale plate and fix the position to ensure that it is consistent with the posture during the model simulation.

[0042] Step 4: Compare positioning parameters. Perform an MRI scan on the patient's breast to obtain the grid coordinates and vertical height of the lesion on the scale plate. Compare these coordinates with the pre-puncture data (model lesion coordinates) obtained in Step 2 to confirm the consistency of the positioning parameters. If there is any deviation, it can be corrected in time.

[0043] Step 5: Adjust the guide support. Embed the slide rail of the movable guide assembly 1 into the side groove of the scanning bed. Adjust the lifting column 32 according to the vertical height of the lesion, and then adjust the angle between the rotating rod 41 and the arc-shaped support 42 so that the puncture needle guide groove 8 of the puncture guide 44 accurately points to the lesion (virtual center). Lock all adjustment structures. This step can be completed quickly by referring to the optimized parameters from the pre-rehearsal, greatly shortening the intraoperative adjustment time.

[0044] Step 6: Biopsy sampling. Place the puncture needle into the puncture needle guide groove 8, adjust the needle tip to the lesion area and fix it. Complete the biopsy sampling under real-time MRI guidance. If multiple sampling points are required, repeat the sampling after fine-tuning the path of the movable guide component 1.

[0045] Based on the 3D modeling of the actual breast and the aforementioned puncture guidance stent system, a closed-loop operation is achieved from preoperative simulation verification and intraoperative precise positioning to postoperative quality control. It is especially suitable for small-volume hard breast lesions in Asian and Chinese women, solving the pain points of traditional prone biopsy, such as large positioning deviation, high operation difficulty, and inability to repeatedly verify.

[0046] This invention provides a guide frame, method of use, and testing method for breast lesion biopsy. It pioneers a lateral decubitus position operation mode, perfectly suited for MRI-guided biopsy of small, high-rigidity breasts in Asian and Chinese women. Through a grid positioning scale plate, a multi-degree-of-freedom adjustable frame, and full-process quantitative markings (coordinates, height, angle), it achieves millimeter-level precise positioning and puncture path planning. Simultaneously, the core components utilize magnetically compatible materials to ensure artifact-free imaging. The overall structure is simple and cost-effective, and can be combined with a physical breast model for preoperative simulation and verification, significantly improving the puncture success rate and reducing the risk of complications. It overcomes the bottlenecks of traditional prone position positioning (large deviations, limited operating space, and incompatible equipment), providing a practical solution for the clinical popularization of breast MRI diagnosis and treatment technology.

[0047] Those skilled in the art will understand that, besides implementing the system and its various devices, modules, and units provided by this invention in the form of purely computer-readable program code, the same functions can be achieved entirely through logical programming of the method steps, making the system and its various devices, modules, and units of this invention function in the form of logic gates, switches, application-specific integrated circuits, programmable logic controllers, and embedded microcontrollers. Therefore, the system and its various devices, modules, and units provided by this invention can be considered as a hardware component, and the devices, modules, and units included therein for implementing various functions can also be considered as structures within the hardware component; alternatively, the devices, modules, and units for implementing various functions can be considered as both software modules implementing the method and structures within the hardware component.

[0048] In the description of this application, it should be understood that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0049] Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various changes or modifications within the scope of the claims, which do not affect the essence of the present invention. Unless otherwise specified, the embodiments and features described in this application can be arbitrarily combined with each other.

Claims

1. A guiding stent for breast lesion biopsy, characterized in that, include: Breast positioning support assembly and movable guide assembly; The breast positioning support component, placed on the scanning bed, supports the breast from the side of the patient and enables calibrated positioning of the lesion. The breast positioning support component is made of magnetically compatible material. A movable guide assembly is slidably disposed on the side of the scanning bed, the movable guide assembly including a multi-degree-of-freedom adjustment mechanism and a puncture guide disposed at its end; The breast positioning support component is used in conjunction with the movable guide component to guide the puncture needle to the lesion in the breast placed on the breast positioning support component when the patient is in a lateral decubitus position.

2. The breast lesion punch biopsy guiding template according to claim 1, characterized in that The breast positioning support assembly includes: a positioning scale plate, lifting support legs, locking buckles, and a grid positioning area; The positioning scale plate is movably mounted on the lifting support leg to support the breast when the patient is in a lateral decubitus position, and is locked and fixed by a locking buckle; the grid positioning area is set on the surface of the positioning scale plate to mark the location of the lesion in the magnetic resonance image.

3. The guiding stent for breast lesion puncture biopsy according to claim 2, characterized in that, The positioning scale plate is made of carbon fiber, and the grid of the grid positioning area is a square scale. Each grid is marked with a coordinate number. Gadolinium contrast agent is injected into the scale lines of the grid positioning area to mark the location of lesions in the MRI image.

4. The guiding stent for breast lesion puncture biopsy according to claim 2, characterized in that, The lifting support legs are multiple in number, and a reinforcing plate is provided between the lifting support legs.

5. The guiding stent for breast lesion puncture biopsy according to claim 1, characterized in that, The multi-degree-of-freedom adjustment mechanism includes: a lifting adjustment mechanism and an angle adjustment guide frame, wherein the angle adjustment guide frame is mounted on the lifting adjustment mechanism; The lifting and adjusting mechanism includes a fixed base, a lifting column, and a control knob; The bottom of the fixed base is provided with a slide rail, which is used to slide and engage with the slide groove on the side of the scanning bed. The fixed base is also provided with a fixing component for locking. The lifting column is installed on a fixed base, and the lifting column is driven to move up and down along the axis of the fixed base by a control knob.

6. The guiding stent for breast lesion puncture biopsy according to claim 5, characterized in that, The lifting column includes an inner column and an outer column that are nested together. The control knob is located on the side wall of the outer column. The inner column and the outer column are connected by a male and female thread. Rotating the control knob enables the lifting column to move axially up and down. The inner column side wall is also provided with a height scale mark.

7. The guiding stent for breast lesion puncture biopsy according to claim 5, characterized in that, The angle adjustment guide frame includes: a rotating rod, an arc-shaped bracket, and an angle locking component; The rotating rod is installed on the top of the lifting column and can rotate horizontally and slide horizontally along the axis. Its position and angle are locked by the angle locking component. The arc-shaped support and the rotating rod are fixedly connected to the end facing the scanning bed. The rotating rod and the arc-shaped support work together to achieve three-dimensional adjustment of forward and backward movement and rotation. Both the rotating rod and the arc-shaped support are marked with scale markings to indicate the scale of forward and backward movement and the angle of rotation. The puncture guide is slidably mounted on the arc-shaped support and locked by the guide locking member to guide the puncture needle toward the lesion.

8. The guiding stent for breast lesion biopsy according to claim 7, characterized in that, The puncture guide has a puncture needle guide groove on its side wall along the axial direction. The arc-shaped bracket is a 1 / 4 arc. The axis of the puncture needle guide groove is set to be able to coincide with the virtual center of the arc-shaped bracket by adjustment, so as to point to the lesion.

9. A method of using a guiding stent for breast lesion biopsy, based on the guiding stent for breast lesion biopsy according to any one of claims 1-8, characterized in that, include: Patient positioning steps: Place the breast positioning support component on the scanning table. The patient lies on their side on one side of the component, facing the positioning scale plate. Place the breast with the lesion in the grid positioning area of ​​the positioning scale plate. Adjust the height of the scale plate by raising and lowering the support legs and locking buckles to ensure that the breast is stably attached. MRI scan localization steps: Start the MRI equipment to scan the patient's breast, determine the grid coordinates and vertical height of the lesion based on the MRI image, and record the lesion location parameters; Guide support adjustment steps: Insert the slide rail at the bottom of the movable guide assembly into the slide groove on the side of the scanning bed. Adjust the lifting mechanism by rotating the control knob according to the vertical height of the lesion and lock the height of the lifting column. Adjust the horizontal position and rotation angle of the rotating rod according to the grid coordinates of the lesion and the puncture requirements so that the axis of the puncture needle guide groove of the puncture guide component coincides with the lesion, i.e., the virtual sphere center. Lock all adjustment structures. Puncture procedure steps: Insert the puncture needle into the puncture needle guide groove, adjust the puncture needle depth to the lesion area, and lock the puncture needle; under real-time MRI guidance, complete the puncture biopsy along the preset path, and complete multi-point sampling and obstacle avoidance by moving the puncture guide and adjusting the angle of the rotating rod and the arc support.

10. A method for puncture biopsy of breast lesions, based on the guiding stent for puncture biopsy of breast lesions as described in any one of claims 1-8, characterized in that, include: Step 1: Collect breast MRI image data of the target patient, construct a three-dimensional breast model including breast shape, lesion location and blood vessel distribution, and use self-healing polymer material to cast a solid breast model to replicate the appearance and skin texture of the human breast, and embed lesion and blood vessel simulation objects that can be visualized by magnetic resonance. Step 2: Simulate the patient's lateral decubitus position, place the solid breast model on the positioning scale plate, perform MRI scanning to obtain the grid coordinates and vertical height of the lesion, and use the movable guide component to complete the pre-puncture drill to optimize the puncture angle, depth and path; Step 3: The patient assumes a lateral decubitus position, places the breast on the affected side on the positioning scale plate, adjusts the height of the scale plate, and fixes the position; Step 4: Perform an MRI scan of the breast to obtain the grid coordinates and vertical height of the lesion on the scale plate, and compare it with the pre-puncture data to confirm the positioning parameters; Step 5: Embed the slide rail of the movable guide component into the slide groove on the side of the scanning bed, adjust the lifting column according to the vertical height of the lesion, and then adjust the angle between the rotating rod and the arc-shaped support so that the puncture needle guide groove of the puncture guide component accurately points to the lesion, i.e., the virtual sphere center, and lock each adjustment structure. Step 6: Insert the puncture needle into the puncture needle guide groove, adjust the needle tip to the lesion area and fix it, and complete the biopsy sampling under real-time MRI guidance; if multiple sampling is required, repeat the sampling after fine-tuning the path of the movable guide component.

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