Stereotactic biopsy puncture device, system and method for low-point focus of mammary gland

Through the use of the stereotactic biopsy puncture device, the problem of puncture at low breast lesions is solved, and efficient and accurate breast biopsy is achieved, reducing the number of breast adjustments and patient pain.

CN119949979APending Publication Date: 2025-05-09SINO MEDICAL DEVICE TECH
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Patent Information

Application Number
CN202510298625.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-13
Publication Date
2025-05-09

AI Technical Summary

Technical Problem

Existing breast puncture devices are difficult to accurately puncture the low breast lesions, resulting in low puncture efficiency, frequent breast adjustments and pain in the patient.

Method used

A stereotactic biopsy puncture device, including a display control device and a positioning puncture device, is adopted to achieve accurate puncture for the low point lesions of the breast through coordinate positioning and puncture direction positioning.

Benefits of technology

It reduces the number of breast adjustments, improves puncture efficiency, reduces the patient's pain, and can perform horizontal puncture when the lesion is at a low point, avoiding the risk of blind spots of vertical puncture.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention provides a stereotactic biopsy puncture device, system and method for low-point lesions of mammary glands, the stereotactic biopsy puncture device comprises a display control device and a positioning puncture device which are electrically connected, and the display control device is used for determining a target area of the lesions of the mammary glands and presetting a puncture path; the driving device is used for respectively driving the plurality of coordinate positioning components in different axial directions to move according to the control signal so as to move the puncture needle to a target needle inserting position, and driving the puncture direction positioning component to rotate so as to rotate the puncture needle to a target puncture direction; the low-point movement protection device is used for detecting a lowest-point state signal of the puncture needle and realizing low-point movement protection of the puncture needle according to the signal; and the display control device is used for controlling the positioning device to lock the biopsy puncture task in the specific direction according to the direction signal. The puncture mode is adjusted through the positioning biopsy puncture device to achieve biopsy puncture of low-point focuses, and the effects of reducing the breast adjusting frequency and greatly improving the puncture efficiency are achieved.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a stereoscopic biopsy puncture device, system and method for low-point breast lesions. Background Art

[0002] Breast cancer is a common malignant tumor worldwide, and its incidence rate is showing a slow but steady upward trend. Early manifestations of breast cancer include breast diseases such as breast hyperplasia, mastitis, mastalgia, and breast fibroids. These breast diseases are often the main causes of breast cancer. If these breast diseases can be detected, diagnosed, and treated early, the probability of death from the disease can be greatly reduced and the survival rate of patients can be improved. The existing inspection plan is to obtain lesion samples through breast X-ray photography and biopsy puncture, and then conduct pathological analysis to further confirm the type of breast disease.

[0003] Existing breast puncture devices mainly use ordinary compression biopsy puncture and stereotactic vertical biopsy puncture. The puncture direction is vertical puncture. However, due to the different locations of breast lesions in patients, the patient's breast often needs to be positioned at multiple angles and multiple times to the upper position in order to obtain a more accurate position for biopsy. Repeated movement and adjustment of the breast causes the patient to endure the pain caused by multiple breast pulling and compression. At the same time, multiple position adjustments require repositioning of the puncture device, which increases the technical difficulty of detection, and frequent and repeated operations also greatly reduce the efficiency of biopsy puncture.

[0004] In addition, since most biopsy needles have an ineffective biopsy area of ​​5 mm or more at the front end, the existing vertical puncture device has a puncture blind spot. In this case, if the lesion is located at a lower position such as below the breast or on the left and right sides, there is a risk of puncturing or damaging the photography platform below during puncture. To avoid this risk, the existing puncture method still requires the above-mentioned multi-angle and multiple lesion positioning until the lesion area is placed in an upper position to meet the safe vertical puncture position.

[0005] Therefore, there is an urgent need for a stereotactic biopsy puncture device, system and method for low-point breast lesions. Summary of the invention

[0006] The stereotactic biopsy puncture device, system and method for low-point breast lesions provided by the present invention are mainly used to solve the problems that existing vertical puncture devices are unable to puncture low lesions, have low puncture efficiency, and cause discomfort and pain due to repeated adjustments of the breast, thereby achieving the effect of being able to be used for stereotactic biopsy puncture of low-point breast lesions, reducing the number of breast adjustments and greatly improving the puncture efficiency.

[0007] The present invention achieves the above-mentioned purpose through the following technical solutions:

[0008] A stereoscopic biopsy puncture device for low-point breast lesions includes a display control device and a positioning puncture control device that establish electrical connections. The display control device is used to determine the target area of ​​the breast lesion and predetermine the puncture path, and output a control signal to the positioning puncture device to move the puncture needle to the target needle insertion position. The positioning puncture device includes a positioning device, on which a needle holding device is installed, and the needle holding device is used to install the puncture needle; the positioning device includes a driving device, a plurality of coordinate positioning components and a puncture direction positioning component, and the driving device is used to drive the coordinate positioning components of multiple different axes to move according to the control signal so that the puncture needle moves to the target needle insertion position, and drives the puncture direction positioning component to rotate so that the puncture needle turns to the target puncture direction; wherein, a low point movement protection device is provided on the coordinate positioning component, and the low point movement protection device is used to detect the lowest point state signal of the puncture needle and realize the low point movement protection of the puncture needle according to the signal; the puncture direction positioning component is also used to detect the current puncture direction and feed back the direction signal to the display control device, and the display control device is used to control the positioning device to lock the biopsy puncture task in a specific direction according to the direction signal.

[0009] A further solution is that the coordinate positioning component includes an X-axis moving unit, a Y-axis moving unit and a Z-axis moving unit, and the driving device is connected to the above-mentioned moving units respectively, and is used to drive the corresponding moving units to move in the X-axis, Y-axis and Z-axis directions; wherein the stroke of the X-axis moving unit is 240mm, the stroke of the Y-axis moving unit is 66mm, and the stroke of the Z-axis moving unit is 100mm.

[0010] A further solution is that the X-axis moving unit is horizontally arranged with the photographic platform and vertically arranged with the Z-axis moving unit, and its upper surface is connected to the bottom of the Z-axis moving unit through a track; the Y-axis moving unit is arranged perpendicular to the side of the Z-axis moving unit, and its movable end parallel to the photographic platform is connected to the side of the Z-axis through a track, and the fixed end is used to install the puncture direction positioning component.

[0011] A further solution is that the puncture direction positioning component includes a needle holder, an adjustment mechanism and a needle support seat. The needle holder is provided with a plurality of mounting holes for adjusting the mounting position of the needle holder on the Y-axis moving unit according to the required puncture direction; the adjustment mechanism and the needle support seat are fixedly installed on the needle holder in sequence according to the mounting direction of the puncture needle, and the adjustment mechanism adopts a push-type spring self-locking structure for locking and unlocking the position of the puncture needle; the needle support seat is provided with a T-shaped slot for clamping the needle holding device.

[0012] A further solution is that the adjustment mechanism is provided with a gear adjustment device, and the gear adjustment device is used to perform position compensation on the puncture needle according to the depth of the lesion position, and the gear adjustment range is 0-70mm.

[0013] A further solution is that the needle holding device includes a needle holder and a guide needle ring installed thereon, the guide needle ring being provided with a guide hole and a corresponding puncture needle specification mark for inserting a puncture needle of corresponding specifications into the needle holder through the guide hole; a needle identification device and an in-place detection device are provided in the needle holder, the needle identification device being used to automatically detect and identify the puncture needle specification mark, and feed back the puncture needle specification information to the display control device; the in-place detection device being used to detect an in-place status signal of the puncture needle and feed back the signal to the display control device.

[0014] A stereoscopic positioning biopsy puncture system for breast low-point lesions comprises a photographic platform, the stereoscopic positioning biopsy puncture device for breast low-point lesions and a detection device. The photographic platform is used to collect lesion images and reconstruct a three-dimensional model of a breast in a compressed state, and to mark the coordinate information of the lesion and output it to a display control device; the display control device is used to determine the target area and predetermine the puncture path according to the coordinate information of the lesion, and output a control signal to the positioning puncture device to move the puncture needle to the target needle insertion position, and control the insertion depth of the puncture needle after locking the puncture direction; the detection device is used to monitor the needle tip trajectory of the puncture needle in real time and feed it back to the system control platform.

[0015] Wherein, when the lesion is in a low-point puncture state, the puncture direction positioning component is adjusted to make the puncture needle parallel to the photographic platform so as to achieve low-point horizontal puncture.

[0016] A further solution is that it also includes a coordinate calibration device, which includes a calibrator and a calibration needle. The calibrator is placed on a photographic platform and is provided with three calibrator needles corresponding to X, Y, and Z axis coordinates according to the coordinate information of the lesion. The calibration needle is inserted into the stereotactic biopsy device, and simulated punctures are performed on the lesion positions of the three coordinate axes in turn according to the predetermined puncture path. The tip position coordinates of the calibration needle and the calibrator needle are compared to see whether they are within the allowable deviation range. If exceeded, the lesion coordinates are calibrated according to the deviation value.

[0017] A stereotactic biopsy puncture method for breast low-point lesions, applied to the stereotactic biopsy puncture system, comprises:

[0018] S1: The stereotactic biopsy puncture device performs self-inspection and returns to the coordinate zero position.

[0019] S2: Determine a puncture method according to the estimated location of the breast lesion, wherein the puncture method includes vertical biopsy puncture, right horizontal biopsy puncture and left horizontal biopsy puncture.

[0020] S3: adjusting the puncture direction positioning component according to the puncture method, and the display control device locks the biopsy puncture task in this direction.

[0021] S4: Setting a coordinate calibration device and calibrating the stereotactic biopsy puncture device.

[0022] S5: The breast lesion image is acquired through the photographic platform and its center coordinates are calculated. The display control device is used to determine the target area and predetermine the puncture path according to the coordinate information of the lesion, and output a control signal to the positioning puncture device to move the puncture needle to the target needle insertion position for puncture.

[0023] S6: Obtain lesion samples and lesion images for pathological analysis.

[0024] A further solution is that step 5 also includes:

[0025] S51: Setting the minimum safe distance from the puncture needle to the photography platform.

[0026] S52: During the puncture process, the low point movement protection device detects the distance between the puncture needle and the photographic platform in real time, and detects the distance to determine whether it is close to or exceeds the minimum safety distance. If so, the low point movement protection is activated.

[0027] It can be seen that the present invention adjusts the puncture method through the stereotactic biopsy puncture device of the low-point lesion, so that there is no need to specifically position the lesion point to the upper position for puncture. Even if the lesion point is below or close to the photographic platform, biopsy puncture can be performed, thereby achieving the effect of reducing the number of breast adjustments and greatly improving the puncture efficiency.

[0028] The present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 Schematic diagram of a stereotactic biopsy puncture device in an embodiment of the present invention.

[0030] Figure 2 Schematic diagrams of three biopsy puncture methods in an embodiment of the present invention, wherein Figure (a) is a vertical biopsy puncture, Figure (b) is a right horizontal biopsy puncture, and Figure (c) is a left horizontal biopsy puncture.

[0031] Figure 3 Schematic diagram of a positioning puncture device in an embodiment of the present invention.

[0032] Figure 4Schematic diagram of the operation of the stereotactic biopsy puncture device in the embodiment of the present invention using a vertical biopsy puncture method.

[0033] Figure 5 1 is a schematic diagram of the operation of the stereotactic biopsy puncture device in the embodiment of the present invention using a right horizontal biopsy puncture method.

[0034] Figure 6 Schematic diagram of a stereotactic biopsy puncture system in an embodiment of the present invention.

[0035] Figure 7 Schematic diagram of the operation of the coordinate calibration device in an embodiment of the present invention.

[0036] Figure 8 1 is a flow chart of a stereotactic biopsy puncture method in an embodiment of the present invention. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical solution and advantages of the embodiment of the present invention clearer, the technical solution of the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings of the embodiment of the present invention. Obviously, the described embodiment is a part of the embodiment of the present invention, not all of the embodiments. Based on the described embodiment of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] Embodiment of a stereotactic biopsy puncture device for breast low-point lesions

[0039] See also Figure 1The stereoscopic positioning biopsy puncture device for low-point breast lesions involved in the present invention includes a display control device 10 and a positioning puncture device 20 that establish an electrical connection. The display control device 10 is used to determine the target area of ​​the breast lesion and predetermine the puncture path, and output a control signal to the positioning puncture device 20 to move the puncture needle 30 to the target needle insertion position. The positioning puncture device 20 includes a positioning device, on which a needle holding device is installed, and the needle holding device is used to install the puncture needle 30; the positioning device includes a driving device, a plurality of coordinate positioning components 21 and a puncture direction positioning component 22, and the driving device is used to drive a plurality of coordinate positioning components 21 in different axes to move according to the control signal so that the puncture needle 30 moves to the target needle insertion position, and drives the puncture direction positioning component 22 to rotate so that the puncture needle 30 turns to the target puncture direction; wherein a low point movement protection device is provided on the coordinate positioning component 21, and the low point movement protection device is used to detect the lowest point state signal of the puncture needle 30 and realize the low point movement protection of the puncture needle 30 according to the signal; the puncture direction positioning component 22 is also used to detect the current puncture direction and feed back the direction signal to the display control device 10, and the display control device 10 is used to control the positioning device to lock the biopsy puncture task in a specific direction according to the direction signal.

[0040] Specifically, the display control device 10 of this embodiment is provided with an intelligent path planning system and a display device constituting an interactive visual platform. The intelligent path planning system integrates a multi-objective optimization model with an intelligent algorithm, generates a plurality of puncture paths according to the three-dimensional coordinates of the lesion, performs human-computer interaction through the display device, and manually selects the best puncture path and confirms its execution.

[0041] Among them, the multi-objective optimization model designs the objective function and constraint matrix according to the breast and lesion conditions. When designing the objective function, it is necessary to optimize multiple indicators at the same time, including path length, safety distance and resistance damage risk. For example, the path length needs to be dynamically adjusted according to the lesion depth; the constraints include the safety boundary value from the blood vessel, the angle limit value to reduce the deviation of the needle tip, and avoiding important organs.

[0042] Among them, the appropriate intelligent algorithm can be selected according to actual needs. For example, if fast obstacle avoidance and support for dynamic update are required, the RRT* path planning algorithm can be selected; if multiple objectives need to be optimized, a hybrid algorithm can be used, such as the hybrid RRT*-NSGA-II algorithm.

[0043] Specifically, the above-mentioned display control device 10 in this embodiment is only exemplary and not the only way. Any system that can be used for path planning can be used in this device.

[0044] See also Figure 2-5In this embodiment, the coordinate positioning component 21 includes an X-axis moving unit, a Y-axis moving unit and a Z-axis moving unit, and the driving devices are respectively connected to the above-mentioned moving units to drive the corresponding moving units to move in the X-axis, Y-axis and Z-axis directions; wherein the stroke of the X-axis moving unit is 240mm, the stroke of the Y-axis moving unit is 66mm, and the stroke of the Z-axis moving unit is 100mm.

[0045] In this embodiment, the X-axis moving unit is horizontally arranged with the photographic platform 101 and vertically arranged with the Z-axis moving unit, and its upper surface is connected to the bottom of the Z-axis moving unit via a track. The Y-axis moving unit is arranged perpendicular to the side of the Z-axis moving unit, and its movable end parallel to the photographic platform 101 is connected to the side of the Z-axis via a track, and the fixed end is used to install the puncture direction positioning component 22.

[0046] In this embodiment, the puncture direction positioning component 22 includes a needle holder 223, an adjustment mechanism 222 and a needle support seat 221. The needle holder 223 is provided with a plurality of mounting holes for adjusting the mounting position of the needle holder 223 on the Y-axis moving unit according to the required puncture direction; the adjustment mechanism 222 and the needle support seat 221 are fixedly installed on the needle holder 223 in sequence according to the installation direction of the puncture needle 30, and the adjustment mechanism 222 adopts a push-type spring self-locking structure for locking and unlocking the position of the puncture needle 30; the needle support seat 221 is provided with a T-shaped slot for clamping the needle holding device.

[0047] In this embodiment, the adjustment mechanism 222 is provided with a gear adjustment device, which is used to perform position compensation on the puncture needle 30 according to the depth of the lesion position, and the gear adjustment range is 0-70 mm.

[0048] Specifically, in this embodiment, the front ends of the adjusting mechanism 222 and the needle support seat 221 are both provided with positioning marbles for prompting that the needle holding device is in place.

[0049] In this embodiment, the needle holding device includes a needle holder 42 and a guide needle ring 41 installed thereon, and the guide needle ring 41 is provided with a guide hole and a corresponding specification mark of the puncture needle 30, which is used to insert the puncture needle 30 of the corresponding specification into the needle holder 42 through the guide hole; a needle identification device and an in-place detection device are provided in the needle holder 42, and the needle identification device is used to automatically detect and identify the specification mark of the puncture needle 30, and feed back the specification information of the puncture needle 30 to the display control device 10; the in-place detection device is used to detect the in-place status signal of the puncture needle 30 and feed back the signal to the display control device 10.

[0050] Specifically, the front end 32 of the puncture needle in this embodiment is provided with a puncture needle sampling groove 31 .

[0051] Specifically, the opening of the guide needle ring 41 of this embodiment is provided with a guiding bevel, and the applicable needle diameter specification and the corresponding QR code of the needle diameter are engraved on the front and back surfaces thereof.

[0052] Specifically, in this embodiment, a two-dimensional code recognition sensor is built into the front of the needle holder 42. When the guide needle ring 41 is installed on the needle holder 42, the system automatically recognizes the guide needle ring 41. At this time, the two-dimensional code recognition sensor feeds back the detection signal to the display control device 10.

[0053] Specifically, the in-place detection device described in this embodiment uses a photoelectric sensor, and when the puncture needle 30 blocks the photoelectric sensor, a in-place state signal is detected and fed back.

[0054] Specifically, this embodiment adjusts the position of the needle holder 221 to achieve vertical biopsy puncture, right horizontal biopsy puncture and left horizontal biopsy puncture, and locks the puncture task corresponding to the puncture direction through the display control system. An angle tilt sensor is provided in the needle holder 42, and the angle tilt sensor is used to detect the tilt angle of the needle holder 42 and feedback the vertical direction signal, the left horizontal direction signal, and the right horizontal direction signal to the display control device 10. For example: when using vertical puncture, the angle tilt sensor defaults to the 0° state; when the needle holder is rotated to the right horizontal state, the angle tilt sensor will send a -90° feedback signal to the display control device, at which time only the right biopsy puncture is allowed; when the needle holder is rotated to the left horizontal state, the angle tilt sensor will send a +90° feedback signal to the display control device, at which time only the left biopsy puncture is allowed.

[0055] Embodiment of a stereotactic biopsy puncture system for breast low-point lesions

[0056] See also Figure 6 The stereoscopic positioning biopsy puncture system for breast low-point lesions involved in the present invention comprises a photographic platform 101, the stereoscopic positioning biopsy puncture device for breast low-point lesions and a detection device. The photographic platform 101 is used to collect lesion images and reconstruct a three-dimensional model of a breast in a compressed state, and mark the coordinate information of the lesion and output it to the display control device 10; the display control device 10 is used to determine the target area and predetermine the puncture path according to the coordinate information of the lesion, and output a control signal to the positioning puncture device 20 to move the puncture needle 30 to the target needle insertion position, and control the penetration depth of the puncture needle 30 after locking the puncture direction; the detection device is used to monitor the needle tip trajectory of the puncture needle 30 in real time and feed it back to the system control platform.

[0057] When the lesion is in a low-point puncture state, the puncture direction positioning component 22 is adjusted to make the puncture needle 30 parallel to the photographic platform 101 so as to achieve low-point horizontal puncture.

[0058] Specifically, the detection device of this embodiment includes a detector 105 and a tube 106. The detector 105 is used to continuously monitor the puncture process and display the needle tip position and the changes of the surrounding tissues in real time; the tube 106 is used to generate X-rays for X-ray photography.

[0059] See also Figure 7 In this embodiment, a coordinate calibration device is also included, and the coordinate calibration device includes a calibrator 103 and a calibration needle 104. The calibrator 103 is placed on the photographic platform 101, and is provided with three calibrator needles 103 corresponding to the X-axis, Y-axis, and Z-axis coordinates according to the coordinate information of the lesion. The calibration needle 104 is inserted into the stereotactic biopsy device, and simulates punctures on the lesion positions of the three coordinate axes in turn according to the predetermined puncture path. The tip position coordinates of the calibration needle 104 and the calibrator needle 103 are compared to see whether they are within the allowable deviation range. If exceeded, the lesion coordinates are calibrated according to the deviation value.

[0060] Example of a stereotactic biopsy puncture method for low-point breast lesions

[0061] See also Figure 8 The stereotactic biopsy puncture method for low-point breast lesions of the present invention is applied to the stereotactic biopsy puncture system, comprising:

[0062] S1: The stereotactic biopsy puncture device performs self-inspection and returns to the coordinate zero position.

[0063] S2: Determine a puncture method according to the estimated location of the breast lesion, wherein the puncture method includes vertical biopsy puncture, right horizontal biopsy puncture and left horizontal biopsy puncture.

[0064] Specifically, this embodiment determines the approximate location of the lesion and selects the puncture method. For example, if the lesion point is judged to be in the lower right position, it is necessary to select the right horizontal biopsy puncture method, rotate the biopsy puncture device to the right, and install the horizontal needle holder and the guide needle ring. The display control system will prompt that the current status is the right horizontal biopsy puncture method and the data of the horizontal needle holder and the guide needle ring.

[0065] S3: adjusting the puncture direction positioning component 22 according to the puncture mode, and the display control device 10 locks the biopsy puncture task in this direction.

[0066] S4: Setting a coordinate calibration device and calibrating the stereotactic biopsy puncture device.

[0067] Specifically, this embodiment takes the right horizontal biopsy puncture calibration work as an example, places the calibrator on the photographic platform, and uses a compressor to appropriately compress it, and then selects through the workstation operation: two-dimensional positioning or three-dimensional positioning, calibration needle and needle specification data, and after the selection is completed, calibration is performed through the coordinate calibration device.

[0068] The calibration process includes: obtaining an image of the calibrator 103 through photographic exposure, and selecting the needle tip of the calibrator 103 on the workstation image interface, and the workstation calculates the target position of the needle tip of the calibrator 103, that is, the three-dimensional coordinate X, Y, and Z axis data; sending the calibration coordinate data to the display control device 10 of the stereotactic biopsy puncture device, and sending the operation control instruction through the display control device 10 to move the device to the predetermined target point; inserting the corresponding calibration needle 104, and comparing whether the tip of the calibration needle 104 and the needle tip of the calibrator 103 coincide with each other. If they coincide, the coordinate data is accurate; if they do not coincide, the display control device 10 is used to make a slight adjustment until they coincide); inputting the point coordinates of the other two calibrators 103 through the display control device, and verifying the relative coordinate position.

[0069] S5: The breast lesion image is acquired through the photographic platform 101 and its center coordinates are calculated. The display control device 10 is used to determine the target area and predetermine the puncture path according to the coordinate information of the lesion, and output a control signal to the positioning puncture device 20 to move the puncture needle 30 to the target needle insertion position for puncture.

[0070] Specifically, in this embodiment, the compression plate 102 is used to compress the patient's breast, and parameters such as two-dimensional positioning or three-dimensional positioning, puncture needle specifications, exposure data, etc. are selected at the workstation, and a lesion position state diagram is obtained through exposure photography; the center position of the lesion is selected according to the lesion position diagram to automatically calculate the center coordinates of the lesion, and the center coordinates are sent to the display control system 10, and the display control system 10 sends an operation control command to move the device to the predetermined target point, and then a biopsy puncture needle 30 is used for puncture.

[0071] S6: Obtain lesion samples and lesion images for pathological analysis.

[0072] In this embodiment, step 5 also includes:

[0073] S51: Setting the minimum safe distance between the puncture needle 30 and the imaging platform 101 .

[0074] S52: During the puncture process, the low point movement protection device detects the distance between the puncture needle 30 and the photographic platform 101 in real time, and detects the distance to determine whether it is close to or exceeds the minimum safety distance. If so, the low point movement protection is activated.

[0075] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.

Claims

1. A stereoscopic positioning biopsy puncture device for low-point breast lesions, comprising a display control device and a positioning puncture device that are electrically connected, wherein the display control device is used to determine the target area of ​​the breast lesion and predetermine the puncture path, and output a control signal to the positioning puncture device to move the puncture needle to the target needle insertion position, characterized in that: The positioning puncture device comprises: A positioning device, on which a needle holding device is installed, and the needle holding device is used to install the puncture needle; the positioning device includes a driving device, a plurality of coordinate positioning components and a puncture direction positioning component, and the driving device is used to drive the coordinate positioning components in a plurality of different axes to move according to the control signal so that the puncture needle moves to the target needle insertion position, and drives the puncture direction positioning component to rotate so that the puncture needle turns to the target puncture direction; wherein, a low point movement protection device is provided on the coordinate positioning component, and the low point movement protection device is used to detect the lowest point state signal of the puncture needle and realize the low point movement protection of the puncture needle according to the signal; the puncture direction positioning component is also used to detect the current puncture direction and feed back the direction signal to the display control device, and the display control device is used to control the positioning device to lock the biopsy puncture task in a specific direction according to the direction signal.

2. The stereotactic biopsy puncture device for low-point breast lesions according to claim 1, characterized in that: The coordinate positioning component includes an X-axis moving unit, a Y-axis moving unit and a Z-axis moving unit. The driving devices are respectively connected to the above-mentioned moving units to drive the corresponding moving units to move in the X-axis, Y-axis and Z-axis directions; wherein the stroke of the X-axis moving unit is 240mm, the stroke of the Y-axis moving unit is 66mm, and the stroke of the Z-axis moving unit is 100mm.

3. The stereotactic biopsy puncture device for low-point breast lesions according to claim 2, characterized in that: The X-axis moving unit is horizontally arranged with the photographic platform and vertically arranged with the Z-axis moving unit, and its upper surface is connected with the bottom of the Z-axis moving unit via a track. The Y-axis moving unit is arranged perpendicular to the side of the Z-axis moving unit, and its movable end parallel to the photographic platform is connected with the side of the Z-axis via a track, and the fixed end is used to install the puncture direction positioning component.

4. The stereotactic biopsy puncture device for low-point breast lesions according to claim 3, characterized in that: The puncture direction positioning component includes a needle holder, an adjustment mechanism and a needle support seat. The needle holder is provided with a plurality of mounting holes for adjusting the mounting position of the needle holder on the Y-axis moving unit according to the required puncture direction; the adjustment mechanism and the needle support seat are fixedly installed on the needle holder in sequence according to the mounting direction of the puncture needle, and the adjustment mechanism adopts a push-type spring self-locking structure for locking and unlocking the position of the puncture needle; the needle support seat is provided with a T-shaped slot for clamping the needle holding device.

5. The stereotactic biopsy puncture device for low-point breast lesions according to claim 4, characterized in that: The adjustment mechanism is provided with a gear adjustment device, and the gear adjustment device is used to perform position compensation on the puncture needle according to the depth of the lesion position, and the gear adjustment range is 0-70mm.

6. The stereotactic biopsy puncture device for low-point breast lesions according to any one of claims 1 to 5, characterized in that: The needle holding device includes a needle holder and a guide needle ring installed thereon, the guide needle ring is provided with a guide hole and a corresponding puncture needle specification mark, which is used to insert a puncture needle of corresponding specifications into the needle holder through the guide hole; the needle holder is provided with a needle identification device and an in-place detection device, the needle identification device is used to automatically detect and identify the puncture needle specification mark, and feed back the puncture needle specification information to the display control device; the in-place detection device is used to detect the in-place status signal of the puncture needle and feed back the signal to the display control device.

7. A stereotactic biopsy puncture system for low-point breast lesions, characterized in that: include: A photographic platform, a stereoscopic positioning biopsy puncture device for breast low-point lesions as described in any one of claims 1 to 7, and a detection device, wherein the photographic platform is used to collect lesion images and reconstruct a three-dimensional model of a breast in a compressed state, and to mark the coordinate information of the lesion and output it to a display control device; the display control device is used to determine the target area and predetermine the puncture path according to the coordinate information of the lesion, and output a control signal to the positioning puncture device to move the puncture needle to the target needle insertion position, and control the insertion depth of the puncture needle after locking the puncture direction; the detection device is used to monitor the needle tip trajectory of the puncture needle in real time and feed it back to the system control platform; Wherein, when the lesion is in a low-point puncture state, the puncture direction positioning component is adjusted to make the puncture needle parallel to the photographic platform so as to achieve low-point horizontal puncture.

8. The stereotactic biopsy puncture system for low-point breast lesions according to claim 7, characterized in that: It also includes a coordinate calibration device, which includes a calibrator and a calibration needle. The calibrator is placed on a photographic platform and is provided with three calibrator needles corresponding to X, Y, and Z axis coordinates according to the coordinate information of the lesion. The calibration needle is inserted into the stereotactic biopsy device, and simulated punctures are performed on the lesion positions of the three coordinate axes in turn according to the predetermined puncture path. The tip position coordinates of the calibration needle and the calibrator needle are compared to see whether they are within the allowable deviation range. If exceeded, the lesion coordinates are calibrated according to the deviation value.

9. A stereotactic biopsy puncture method for low-point breast lesions, characterized in that: A stereotactic biopsy puncture system as described in any one of claims 8 to 7, comprising: S1: The stereotactic biopsy puncture device performs self-check and returns to the coordinate zero position; S2: determining a puncture method according to the estimated location of the breast lesion, wherein the puncture method includes vertical biopsy puncture, right horizontal biopsy puncture and left horizontal biopsy puncture; S3: adjusting the puncture direction positioning component according to the puncture mode, and the display control device locks the biopsy puncture task in this direction; S4: Setting a coordinate calibration device and calibrating the stereotactic biopsy puncture device; S5: The breast lesion image is acquired through the photographic platform and its center coordinates are calculated. The display control device is used to determine the target area and predetermine the puncture path according to the coordinate information of the lesion, and output a control signal to the positioning puncture device to move the puncture needle to the target needle insertion position for puncture; S6: Obtain lesion samples and lesion images for pathological analysis.

10. The stereotactic biopsy puncture method for low-point breast lesions according to claim 9, characterized in that: Step 5 also includes: S51: Setting the minimum safe distance from the puncture needle to the photography platform; S52: During the puncture process, the low point movement protection device detects the distance between the puncture needle and the photographic platform in real time, and detects the distance to determine whether it is close to or exceeds the minimum safety distance. If so, the low point movement protection is activated.