A craniocerebral puncture guiding device and an implementation method thereof

Abstract

The application provides a craniopuncture guiding device and an implementation method thereof, and belongs to the technical field of medical equipment.The craniopuncture guiding device comprises a main puncture guiding rod, a first adjustable connecting rod, a first adjustable positioning rod, a second adjustable connecting rod, a second adjustable positioning rod and a locking part, is a craniopuncture guiding device for non-invasive positioning and eliminating scalp deformation error by relying on a skull rigid reference, is entirely made of a pure mechanical structure and does not contain electronic elements and a laser positioning assembly, is not provided with a stereoscopic directional frame and does not need large-scale automatic equipment, and in an application process, parameter full-automatic calculation is realized by relying on a thin layer CT image, DICOM data, 3D Slicer software and a Python automatic script.The Python automatic script can be independently transplanted and operated, the whole preparation time before operation is not more than 10 minutes, and a calculation error is less than or equal to 1 mm.Meanwhile, the device structure is simplified, the purchase and use costs are reduced, and the craniopuncture guiding device is convenient for popularization and application in primary hospitals and emergency scenes.

Description

Technical Field

[0001] This invention relates to the field of minimally invasive medical device technology, and in particular to a cranial puncture guide device and its implementation method. Background Technology

[0002] Currently, the mainstream techniques used in clinical stereotactic cranial puncture mainly include frame-based stereotactic instruments, stereotactic surgical robots, and laser-assisted positioning devices. These are often used in conjunction with the 3D Slicer open-source imaging software for image analysis. However, all of these techniques have significant drawbacks: 1. Frame-type stereotactic instrument: It requires the metal frame to be invasively fixed to the patient's head. The device relies on a rigid frame as a coordinate reference. The frame must be physically fixed to the skull, which inevitably causes damage to the scalp. Therefore, it is routinely used in conjunction with general anesthesia in clinical practice. The anesthesia risk is high and the medical cost is high. At the same time, due to the complicated equipment assembly and coordinate calibration process, the preoperative preparation time is long, which cannot meet the needs of rapid treatment of craniocerebral emergencies.

[0003] 2. Stereotactic surgical robot: The equipment integrates a high-precision robotic arm and a complex registration algorithm. The hardware and process are highly complex, and the equipment is expensive and bulky, making it difficult for primary hospitals to configure. Before the operation, multiple procedures need to be completed, such as head frame installation, frame-based CT scan, image registration, and robotic arm calibration. A single preoperative preparation takes 40 to 90 minutes, making it poorly applicable to emergency scenarios. It is also often used in conjunction with general anesthesia.

[0004] 3. Laser-assisted positioning device: This device relies on a laser beam to determine the puncture direction, making it susceptible to interference from operating room lighting and obstructions, resulting in poor positioning stability. The laser emits slight radiation, posing a potential impact on medical staff and patients. Furthermore, the entire process relies on manual parameter calculation, leading to significant measurement errors. Therefore, this type of device is limited by its optical positioning principle, and environmental changes directly affect its effectiveness.

[0005] 4. Using only 3D Slicer software: This software can realize three-dimensional reconstruction of cranial images, target marking and manual ranging, but it is a general imaging tool. It does not have a dedicated automated script for cranial puncture, and it cannot automatically load geometric constraints or batch output positioning parameters. It can only be used as an image viewing tool and cannot directly guide intraoperative mechanical positioning. Manual operation is inefficient and has large errors.

[0006] 5. Most existing simple cranial puncture navigation devices use elastic scalp tissue as the sole positioning reference. The scalp soft tissue has significant elastic deformation characteristics, resulting in poor stability of the positioning reference and making it easy for the puncture path to deviate. The positioning accuracy cannot meet the standards of clinical surgery.

[0007] In summary, existing cranial puncture localization techniques generally suffer from many drawbacks, such as invasive fixation, reliance on general anesthesia, high equipment costs, long preoperative preparation periods, weak localization resistance to interference, large human error, and insufficient localization accuracy. Currently, there is an urgent clinical need for an integrated cranial puncture guidance solution that is non-invasive, low-cost, quick to deploy, can be performed under local anesthesia, has high localization accuracy, and is suitable for primary hospitals and emergency scenarios. Summary of the Invention

[0008] The technical problem to be solved by the present invention is to provide a cranial puncture guidance device.

[0009] Another technical problem to be solved by the present invention is to provide a method for implementing the above-mentioned craniotomy guidance device.

[0010] The technical solution adopted in this invention is: A cranial puncture guidance device includes a main puncture guide rod 1, a first adjustable connecting rod 2, a first adjustable positioning rod 3, a second adjustable connecting rod 4, a second adjustable positioning rod 5, and a locking component 6. The main puncture guide rod 1 is a hollow, through-type rod, with its hollow inner cavity serving as a through-type puncture guide channel for the puncture needle to travel linearly along the channel to accurately reach the intracranial surgical target. One end of the first adjustable connecting rod 2 and the second adjustable connecting rod 4 are respectively hinged to the side wall of the main puncture guide rod 1 via the locking component 6. The locking components 6 of the two sets of connecting rods are arranged in an orthogonal staggered manner (the hinged channels are orthogonal to each other, and the hinged installation positions are staggered vertically along the axial direction of the main puncture guide rod), and the adjustment process is independent and does not interfere with each other. The other end of the first adjustable connecting rod 2 is hinged to the first adjustable positioning rod 3 via the locking component 6, and the other end of the second adjustable connecting rod 4 is hinged to the second adjustable positioning rod 5 via the locking component 6.

[0011] Preferably, in the above-mentioned craniotomy puncture guide device, the locking component 6 is a threaded locking structure (locked and fixed by bolts and nuts) or a snap-locking structure. The main puncture guide rod 1, the first adjustable connecting rod 2, the first adjustable positioning rod 3, the second adjustable connecting rod 4, and the second adjustable positioning rod 5 are all provided with hinged channels for mounting the locking component 6. The locking component 6 is placed within the hinged channels, achieving axial connection between the first adjustable connecting rod 2 and the main puncture guide rod 1, the second adjustable connecting rod 4 and the main puncture guide rod 1, the first adjustable connecting rod 2 and the first adjustable positioning rod 3, and the second adjustable connecting rod 4 and the second adjustable positioning rod 5. The locking component locks and fixes the relative angles and extension of each rod, ensuring the overall stability of the device during the operation, with no displacement or angular deviation. The first adjustable connecting rod 2 and the second adjustable connecting rod 4 are set at adjustable angles, cooperating with the main puncture guide rod 1 and the first and second adjustable positioning rods 3 and 5 to achieve mechanical positioning.

[0012] Preferably, in the above-mentioned craniotomy puncture guidance device, the side wall of the main puncture guide rod 1 is provided with an auxiliary support rod 7. The auxiliary support rod 7 is used to conform to the surface of the patient's skull during the operation, to establish a rigid support positioning benchmark, and to avoid positioning errors caused by elastic deformation of the scalp from the source. More preferably, the main puncture guide rod 1 and the auxiliary support rod 7 are integrally formed structures.

[0013] Preferably, in the above-mentioned cranial puncture guidance device, the first set of double-section positioning arms, composed of the first adjustable connecting rod 2 and the first adjustable positioning rod 3, has the same structure as the second set of double-section positioning arms, composed of the second adjustable connecting rod 4 and the second adjustable positioning rod 5. A locking component 6 is provided at the connection point for free angle adjustment and locking fixation. The hinge channels of each of the two sets of double-section positioning arms are orthogonally arranged to the central axis of the main puncture guide rod 1. The auxiliary support rod 7 is parallel to the axis of the puncture guide channel inside the main puncture guide rod 1. This structure as a whole forms a multi-dimensional spatial geometric constraint system; by adjusting the spatial posture of the two sets of double-section positioning arms to adapt to the spatial coordinates of the surface marker points, a high-precision puncture reference axis can be uniquely determined.

[0014] Preferably, in the above-mentioned cranial puncture guiding device, the main puncture guide rod 1, the first adjustable connecting rod 2, the first adjustable positioning rod 3, the second adjustable connecting rod 4, and the second adjustable positioning rod 5 are made of medical stainless steel, medical plastic, or medical titanium alloy.

[0015] The method for implementing the above-mentioned cranial puncture guidance device includes the following steps: (1) Layout of surface markings: Select an area of ​​the patient's scalp that is undamaged and free of hair obstruction, set the scalp puncture reference point C, and set two surface positioning points A and B with the puncture reference point C as the vertex. The three points form a triangular positioning reference. Place X-ray-proof markings on points A, B and C respectively. (2) Image acquisition: Thin-slice (slice thickness ≤ 1 mm) spiral CT was used to scan the patient’s brain and to acquire complete tomographic image data including body surface markers, scalp, skull and intracranial lesions, and to export standard DICOM data. (3) 3D Reconstruction: Import DICOM data into 3D Slicer software and run Python automated script (the Python automated script is independently developed based on the built-in Python environment of 3D Slicer and can be independently ported to any 3D Slicer client for operation without relying on dedicated hardware devices). The functions of the Python automated script include: automatic identification of the 3D coordinates of radiopaque markers, forced loading of six-point collinear geometric constraints, and batch automatic calculation and output of spatial geometric positioning parameters. The entire process is automated and no manual measurement or calculation is required. The Python automated script automatically completes the loading of image volume data and the construction of spatial coordinate system. Through threshold segmentation combined with region growing algorithm, it realizes the partitioning and 3D solid model reconstruction of scalp, skull, intracranial lesions, and body surface markers. (4) Coordinate recognition: Obtain the three-dimensional spatial coordinates of the first body surface positioning marker A, the second body surface positioning marker B, and the scalp puncture point C; (5) Constraint loading: The intracranial puncture target point D is manually selected and its coordinates are locked. The intracranial puncture target point D is the location of the lesion target point inside the skull. The Python automated script forces the loading of six collinear geometric constraints on the puncture path: the top point K of the main puncture guide rod, the hinge point L between the main puncture guide rod and the first adjustable connecting rod, the hinge point M between the main puncture guide rod and the second adjustable connecting rod, the puncture reference point R at the bottom of the main puncture guide rod, the scalp puncture point C, and the intracranial puncture target point D. The tips of the two sets of double-section positioning arms are matched with points A and B, respectively. (6) Parameter calculation: The Python automated script automatically calculates and outputs five distance parameters, namely: the assembly length of the first double-section positioning arm AQ, the assembly length of the second double-section positioning arm BS, the standard puncture needle depth DK, the distance from skull support point I to point A IA, and the distance from skull support point I to point B IB. (7) Device mechanical posture adjustment: According to the five core parameters output by the script, first adjust the extension of the two sets of double-section positioning arms according to AQ and BS, and then adjust the rotation angle of the two sets of double-section positioning arms and the main puncture guide rod 1 according to IA and IB. After each adjustment, lock the posture of all related connecting rods through the locking component 6. (8) Positioning and fixing: Make a small incision in the scalp with the scalp puncture point C as the center to expose the skull; attach the end of the first adjustable positioning rod 3 to the first body surface positioning mark point A, attach the end of the second adjustable positioning rod 5 to the second body surface positioning mark point B, and attach the end of the auxiliary support rod 7 to the skull. This support point is point I. At this time, the hollow inner cavity axis of the main puncture guide rod 1 is the precise puncture axis. (9) Minimally invasive puncture surgery procedure: Insert the puncture needle through the through-type puncture guide channel of the main puncture guide rod to reach the intracranial puncture target point and complete the puncture operation.

[0016] The above-mentioned method for implementing the cranial puncture guide device, in step (9), strictly controls the needle insertion stroke according to the puncture depth DK, so that the puncture needle accurately reaches the intracranial puncture target point and completes various minimally invasive cranial puncture surgical operations such as hematoma aspiration, abscess drainage, and intracranial biopsy.

[0017] Preferably, in the above-mentioned method for implementing the cranial puncture guidance device, the thin-slice spiral CT can identify radiopaque markers, and the radiopaque markers are lead markers, contrast markers, or medical metal contrast stickers.

[0018] Preferably, in the above-mentioned method for implementing the cranial puncture guidance device, step (4) uses two optional methods to obtain the three-dimensional spatial coordinates of the first surface positioning marker A, the second surface positioning marker B, and the scalp puncture point C: Method 1, Automatic Recognition by Computer Script: This method uses a Python automated script to automatically identify markers within the image. By calculating the center point of the contact surface between the marker and the scalp, the three-dimensional spatial coordinates of three points—the first surface positioning marker A, the second surface positioning marker B, and the scalp puncture point C—are extracted. Method 2, manual marking and picking: The operator manually clicks the center point of the contact surface between the marker and the scalp in the 3D view to pick the three-dimensional spatial coordinates of the first body surface positioning marker point A, the second body surface positioning marker point B, and the scalp puncture point C.

[0019] The beneficial effects of this invention are: The aforementioned cranial puncture guidance device is a cranial puncture guidance device that does not require invasive skull fixation using a stereotactic frame and relies on the rigidity of the skull to eliminate scalp deformation errors. It is entirely mechanical, containing no electronic components or laser positioning components, and requires no stereotactic frame or large automated equipment. It is suitable for minimally invasive stereotactic cranial puncture surgeries under local anesthesia, including procedures such as hematoma aspiration, brain abscess drainage, ventricular puncture, and intracranial lesion biopsy. During application, it utilizes thin-slice CT images, DICOM data, and 3D... The Slicer software and Python automation scripts enable fully automated parameter calculation. The Python automation scripts are independently developed and can be ported and run independently. The device relies on imaging software and Python scripts to automatically calculate positioning parameters, shortening preoperative preparation time and reducing human error. It is mainly used in minimally invasive craniocerebral puncture and treatment surgeries such as cerebral hemorrhage, brain abscess, and ventricular puncture. It can be used in emergency surgeries and routine local anesthesia craniocerebral puncture procedures in hospitals at all levels, effectively solving the problems of traditional equipment being invasive, having long preoperative preparation times, relying on general anesthesia and lasers, being costly, and having large human errors. The entire process requires no stereotactic frame or laser positioning, achieving non-invasive positioning, local anesthesia surgery, rapid preoperative preparation, and fully automated parameter calculation. The overall preoperative preparation time does not exceed 10 minutes, and the calculation error is ≤1mm. At the same time, it simplifies the equipment structure, reduces procurement and usage costs, and facilitates its promotion and application in primary hospitals and emergency settings. Specifically: 1. Simple structure and low cost: The whole structure is a pure mechanical structure, eliminating the need for stereoscopic frames, laser modules and large robotic equipment. The equipment has a simplified structure, low cost and simple maintenance, making it suitable for widespread use in primary hospitals and township hospitals.

[0020] 2. Surface positioning without frameless skull fixation pin insertion trauma eliminates frame trauma, laser interference, and radiation problems; only surface marking is done, and local anesthesia is used throughout the procedure, reducing surgical trauma and medical risks associated with general anesthesia, and significantly reducing medical costs.

[0021] 3. Fast preoperative preparation: The entire preoperative preparation time is reduced to less than 10 minutes, which is far better than the 40-90 minutes preparation time of traditional robots, and can quickly deal with intracranial emergencies such as cerebral hemorrhage.

[0022] 4. Fully automated calculation and high positioning accuracy: The Python script automatically completes 3D reconstruction, coordinate recognition, constraint loading, and parameter calculation. The entire process is automated, requiring no manual measurement. The calculation error is ≤1mm, eliminating human error and ensuring good positioning repeatability.

[0023] 5. Strong anti-interference ability: It adopts the principle of pure distance geometric positioning. The hinge channels of two sets of double-section positioning arms are arranged orthogonally to the central axis of the main puncture guide rod. The mechanical structure locks the puncture axis with three-point body surface marking and six-point collinearity double geometric constraints. The puncture path is unique, the positioning stability is strong, and the positioning accuracy and uniqueness are guaranteed. It does not rely on the laser light path and is not affected by the light in the operating room or obstructions. It has strong working stability and no laser radiation hazards.

[0024] 6. Simple operation and strong versatility: The entire operation can be completed by a single person, and the process is simple and easy to learn; it can be adapted to a variety of minimally invasive craniocerebral surgeries such as cerebral hemorrhage, brain abscess, and ventricular puncture, and has a wide range of applications. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the cranial puncture guidance device of the present invention.

[0026] In the diagram: 1-Main puncture guide rod, 2-First adjustable connecting rod, 3-First adjustable positioning rod, 4-Second adjustable connecting rod, 5-Second adjustable positioning rod, 6-Locking component, 7-Auxiliary support rod.

[0027] Figure 2 This is a visualization diagram of three-dimensional marker points, geometric auxiliary points, and puncture axes in the 3D Slicer software.

[0028] In the picture: X: X direction is the lateral orientation of point B relative to point A on the cranial puncture guide device; Y: Y direction is the opposite side of point A to point R on the cranial puncture guide device; A: First surface positioning marker; B: Second surface positioning marker; C: Scalp puncture reference point; D: Intracranial puncture target point; I: Skull support point; J: Auxiliary support rod apex; K: Top point of main puncture guide rod; L: Hinge point between main puncture guide rod and first adjustable connecting rod; M: Hinge point between main puncture guide rod and second adjustable connecting rod; R: Bottom puncture reference point of main puncture guide rod; O: Hinge point between first adjustable connecting rod and first adjustable positioning rod; N: Hinge point between second adjustable connecting rod and second adjustable positioning rod; E: Point C is offset by 1 / 2 the width of the main support rod along the vertical line perpendicular to plane ACD in the X direction. Point E is determined by the reference line segment CE. F: Point E is offset by 1 / 2 the width of the main support rod along the perpendicular line to plane CDE in the Y direction. Point F is determined by the reference line segment EF. G: Point D is offset by 1 / 2 the width of the main support rod along the vertical line perpendicular to plane ACD in the X direction. Point G is determined by the line segment DG reference. H: Point G is offset by 1 / 2 the width of the main support rod along the perpendicular line to plane CDG in the Y direction; point H is determined by the line segment GH reference. P: Line segment OL extends towards end L to the center point of the end of the first adjustable connecting rod to form point P; Q: Point P is offset by 1 / 2 the width of the first adjustable connecting rod along the vertical line perpendicular to plane OPK in the X direction. Point Q is determined by the reference line segment PQ, that is, the point at the end of the side of the first adjustable connecting rod. T: Line segment NM extends toward end M to the center point of the end of the second adjustable connecting rod to form point T; S: Point T is offset by 1 / 2 the width of the second adjustable connecting rod along the vertical line perpendicular to plane NTK in the X direction. Point S is determined by the reference line segment TS, that is, the point at the end of the side of the second adjustable connecting rod. Detailed Implementation

[0029] To enable those skilled in the art to clearly understand the technical solution of the present invention, the technical solution will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0030] Example 1 like Figure 1 As shown, the cranial puncture guide device includes a main puncture guide rod 1, a first adjustable connecting rod 2, a first adjustable positioning rod 3, a second adjustable connecting rod 4, a second adjustable positioning rod 5, a locking component 6, and an auxiliary support rod 7. The main puncture guide rod, the first adjustable connecting rod, the first adjustable positioning rod, the second adjustable connecting rod, and the second adjustable positioning rod are made of medical-grade titanium alloy (medical-grade stainless steel or medical-grade plastic can also be used), meeting the requirements for surgical sterility. The main puncture guide rod 1 is a hollow through rod, with the internal cavity serving as a puncture guide channel (i.e., a through-type puncture guide channel). An auxiliary support rod 7 is integrally formed at the bottom of the side wall of the main puncture guide rod, with a pointed support head at the end. During the operation, it can stably conform to the surface of the skull, constructing a rigid support positioning benchmark and completely eliminating positioning deviations caused by elastic deformation of the scalp.

[0031] One end of the first adjustable connecting rod 2 and the second adjustable connecting rod 4 are respectively hinged to the side wall of the main puncture guide rod 1 via locking components 6. The locking components 6 of the two sets of connecting rods are arranged in an orthogonal staggered manner, specifically, the hinge channels are orthogonal to each other, and the hinge installation positions are staggered vertically along the axial direction of the main puncture guide rod. The adjustment process is independent and does not interfere with each other. The other end of the first adjustable connecting rod 2 is hinged to the first adjustable positioning rod 3 via locking components 6, and the other end of the second adjustable connecting rod 4 is hinged to the second adjustable positioning rod 5 via locking components 6. Specifically, the locking components 6 are threaded locking structures, which are locked and fixed by hexagonal threaded locking bolts and nuts. The main puncture guide rod 1, the first adjustable connecting rod 2, the first adjustable positioning rod 3, the second adjustable connecting rod 4, and the second adjustable positioning rod 5 are all provided with hinge channels for setting the locking components 6, and the locking components 6 are placed in the hinge channels. The device internally achieves axial connection between the first adjustable connecting rod 2 and the main puncture guide rod 1, the second adjustable connecting rod 4 and the main puncture guide rod 1, the first adjustable connecting rod 2 and the first adjustable positioning rod 3, and the second adjustable connecting rod 4 and the second adjustable positioning rod 5. The movable connection between the first adjustable connecting rod 2 and the second adjustable connecting rod 4 and the main puncture guide rod 1, and the axial connection between the first adjustable connecting rod 2 and the second adjustable connecting rod 4 and the corresponding first adjustable positioning rod 3 and the second adjustable positioning rod 5, adopts a pin-type hinge method. The locking component locks and fixes the relative angle and extension of each rod. After tightening, the rotation and displacement freedom of the rod can be completely locked, ensuring the overall posture stability of the device during the operation, without displacement or angular deviation. The first adjustable connecting rod 2 and the second adjustable connecting rod 4 are set at adjustable angles, and work with the main puncture guide rod 1 and the first adjustable positioning rod 3 and the second adjustable positioning rod 5 to achieve mechanical positioning.

[0032] The aforementioned cranial puncture guide device comprises a first set of double-section positioning arms consisting of a first adjustable connecting rod 2 and a first adjustable positioning rod 3, and a second set of double-section positioning arms consisting of a second adjustable connecting rod 4 and a second adjustable positioning rod 5. The hinge channels of both sets of double-section positioning arms are orthogonally arranged to the central axis of the main puncture guide rod 1. Locking components 6 are provided at each connection point, allowing for free angle adjustment and locking. The auxiliary support rod 7 is parallel to the axis of the puncture guide channel inside the main puncture guide rod 1. This structure forms a multi-dimensional spatial geometric constraint system. By adjusting the spatial posture of the two sets of double-section positioning arms to match the spatial coordinates of the surface marker points, a unique high-precision puncture reference axis can be determined. Specifically, the upper sidewall of the main puncture guide rod 1 is provided with two sets of staggered hinge mounting positions. The higher hinge position is hinged to the first adjustable connecting rod, and the lower hinge position is hinged to the second adjustable connecting rod. The two sets of hinge channels are orthogonal to each other, and the angle adjustment actions of the two sets of connecting rods are independent and without interference. The outer end of the first adjustable connecting rod is hinged to the first adjustable positioning rod, enabling 180° spatial axial adjustment. With the help of the locking bolt, the angle is precisely fixed. The two together form the first set of double-section positioning arms. The second adjustable connecting rod is hinged to the second adjustable positioning rod to form the second set of double-section positioning arms. The two sets of positioning arms have the same structural parameters and can independently complete spatial posture adjustment to accurately match the spatial position of the body surface marker points.

[0033] The above-mentioned cranial puncture guidance device achieves frameless cranial puncture guidance function through the following method: (1) Three surface reference markers were placed in the visible area of ​​the patient's scalp. After the markers were placed, a thin-slice spiral CT scan with a slice thickness of ≤1mm was performed on the patient's skull to collect complete CT tomographic images including scalp markers, skull, and intracranial lesions.

[0034] (2) Import and process the image data: Import the head CT DICOM standard sequence images obtained from the scan into the 3DSlicer three-dimensional visualization processing software.

[0035] (3) Segmentation and reconstruction of the three-dimensional model of the skull: retrieve the CT bone window tomographic sequence image, run the Python automated script to use threshold segmentation and region growth segmentation algorithms to segment the skull scalp tissue, bony tissue, intracranial lesions and three markers: the first body surface positioning marker A, the second body surface positioning marker B and the scalp puncture reference point C, and establish a complete three-dimensional spatial coordinate system of intracranial anatomy.

[0036] (4) The computer script automatically performs coordinate recognition. Relying on the software image recognition function, it automatically identifies and extracts the precise coordinate parameters of the reference markers on the scalp surface in three-dimensional space: The Python automated script automatically identifies the markers in the image and extracts the three-dimensional spatial coordinates of points A, B, and C by calculating the center point of the contact surface between the marker and the scalp.

[0037] For step (4), manual marking can also be used: the operator manually selects the center of the scalp contact surface of the marker on the three-dimensional visualization interface and picks the three-dimensional spatial coordinates of points A, B, and C.

[0038] (5) Marking intracranial lesion target points: In the reconstructed intracranial three-dimensional anatomical model, locate the geometric center of the intracranial lesion, set the intracranial puncture target point D at the center, the intracranial puncture target point D is the target point of the lesion inside the skull, and mark the target point to lock the three-dimensional spatial coordinates of the target point.

[0039] (6) Constraint loading: The intracranial puncture target point D and three marker points A, B and C are manually selected. The Python automated script forces the loading of six collinear geometric constraints: the top point K of the main puncture guide rod, the hinge point L between the main puncture guide rod and the first adjustable connecting rod, the hinge point M between the puncture guide rod and the second adjustable connecting rod, the puncture reference point R at the bottom of the main puncture guide rod, the scalp puncture reference point C, and the intracranial puncture target point D. The tips of the two sets of double-section positioning arms are matched with points A and B respectively.

[0040] (7) Parameter calculation: The Python automated script automatically calculates and outputs five distance parameters, namely: the assembly length of the first double-section positioning arm AQ, the assembly length of the second double-section positioning arm BS, the standard puncture needle depth DK, the distance from skull support point I to point A IA, and the distance from skull support point I to point B IB. (8) Device positioning: Adjust and fix each axial joint in sequence according to the five distance parameters. First, adjust the angle between the first adjustable positioning rod 3 and the first adjustable connecting rod 2 according to the distance AQ between the end of the first adjustable positioning rod 3 and the end point of the side of the first adjustable connecting rod 2, and fix the angle with locking component 6. Then, adjust the angle between the second adjustable positioning rod 5 and the second adjustable connecting rod 4 according to the distance BS between the end of the second adjustable positioning rod 5 and the end point of the side of the second adjustable connecting rod 4, and fix the angle with locking component 6. Then, adjust the angle between the first adjustable connecting rod 2 and the main puncture guide rod 1 according to the distance IA between the end of the first adjustable positioning rod 3 and the support point of the main puncture guide rod 1, and fix the angle with locking component 6. Then, adjust the angle between the second adjustable connecting rod 4 and the main puncture guide rod 1 according to the distance IB between the end of the second adjustable positioning rod 5 and the support point of the main puncture guide rod 1, and fix the angle with locking component 6. Finally, attach the ends of the first adjustable positioning rod 3 and the second adjustable positioning rod 5 to A and B. After the two positioning points are established, the tip support point I of the auxiliary support rod 7 is placed against the skull; the axis of the internal cavity of the main puncture guide rod is the puncture axis.

[0041] The calculation logic of the Python automation script used above is as follows: The accompanying Python automation script is independently developed based on the built-in Python environment of 3DSlicer, supports cross-device portability, and can automatically complete image data processing and positioning parameter calculation. The specific calculation steps are as follows: (1) Three-dimensional model segmentation and reconstruction: Threshold segmentation combined with region growing algorithm is used to complete the three-dimensional entity segmentation and model reconstruction of scalp, skull, intracranial lesions and body surface markers in sequence, and a unified spatial coordinate system is constructed.

[0042] (2) Automatic coordinate extraction: The script automatically identifies three radiopaque markers in the CT image: the first body surface positioning marker A, the second body surface positioning marker B, and the scalp puncture reference point C, and accurately extracts the three-dimensional spatial coordinates of the center point of each marker and the scalp contact surface.

[0043] (3) Target coordinate locking: The geometric center of the intracranial lesion selected by the individual is received as the intracranial puncture target point D. The intracranial puncture target point D is the target point location of the lesion inside the skull. The three-dimensional spatial coordinates of the target point are fixed. The six points of the intracranial puncture target point D, the scalp puncture reference point C, the puncture reference point R at the bottom of the main puncture guide rod, the hinge point L between the main puncture guide rod and the first adjustable connecting rod, the hinge point M between the main puncture guide rod and the second adjustable connecting rod, and the top point K of the main puncture guide rod are geometrically constrained to be collinear, forming the puncture reference line. The tips of the two sets of double-section positioning arms are matched with the corresponding points A and B at the ends of the first and second adjustable positioning rods, respectively.

[0044] (4) Solving for the reference points of the auxiliary support main line: such as Figure 2As shown, point C is offset by 1 / 2 the width of the main support rod in the X direction along a perpendicular line to plane ACD, and point E is determined by line segment CE as the reference. Point E is offset by 1 / 2 the width of the main support rod in the Y direction along a perpendicular line to plane CDE, and point F is determined by line segment EF as the reference. Point D is offset by 1 / 2 the width of the main support rod in the X direction along a perpendicular line to plane ACD, and point G is determined by line segment DG as the reference. Point G is offset by 1 / 2 the width of the main support rod in the Y direction along a perpendicular line to plane CDG, and point H is determined by line segment GH as the reference. Points F and H form the main line of the auxiliary support rod.

[0045] (5) Location of skull support point: Solve the three-dimensional intersection of the main support line FH and the outer surface of the skull to accurately determine the intraoperative skull support point I.

[0046] (6) Calculation of basic distance parameters: Accurately calculate the straight distances IA and IB from the skull support point I to the first body surface positioning mark A and the second body surface positioning mark B, which serve as the basic parameters for adjusting the angles of the two sets of double-section positioning arms and the main puncture guide rod.

[0047] (7) Solving the puncture depth parameter: Extend the puncture baseline to mark the top point K of the main puncture guide rod, calculate the length of the line segment from the intracranial puncture target point D to the top point K of the main puncture guide rod, which is the standard puncture needle insertion depth DK.

[0048] (8) Hinge point generation: The top point K of the main puncture guide rod is precisely offset by a fixed distance along the puncture axis to generate two sets of positioning arm hinge points L and M, and the spatial coordinates of the hinge points are fixed.

[0049] (9) Calculation of positioning arm length: Based on the spatial triangle geometric constraints and combined with the fixed dimension parameters of the rod, the standard assembly lengths AQ and BS of the two sets of double-section positioning arms are calculated respectively.

[0050] (10) Batch output of parameters: Automatically summarize five core adjustment parameters and visualize the output parameter results for precise adjustment of instruments during the operation. The five core adjustment parameters are: the first group of double-section positioning arm assembly length AQ, the second group of double-section positioning arm assembly length BS, the standard puncture needle depth DK, the distance from skull support point I to point A IA, and the distance from skull support point I to point B IB.

[0051] The aforementioned Python automation script possesses three unique functions: ① Automatically identifies the coordinates of surface marker points; ② Enforces collinear geometric constraints on six points; ③ Batch calculates and outputs distance parameters. This Python automation script is standalone and portable.

[0052] Application Example 1 The procedure for puncture site localization in stereotactic cranial puncture surgery using the cranial puncture guidance device described in Example 1 includes surface marking → CT scan → DICOM import → automatic calculation by Python script → mechanical adjustment of puncture. Specifically: Reference points (fixed dimensions, uniform parameters): The bottom end of the main puncture guide rod 1 is the puncture reference point R at the bottom of the main puncture guide rod, corresponding to the scalp puncture reference point C. The top end of the rod is the top point K of the main puncture guide rod. Point K is located a fixed dimension downward from the puncture reference point R at the bottom of the main puncture guide rod, where the main puncture guide rod and the first adjustable connecting rod hinge point L are located. Point L is located a fixed dimension downward from the second adjustable connecting rod, where the main puncture guide rod and the second adjustable connecting rod hinge point M are located. An auxiliary support rod 7 extends from the side of the rod. The end of the auxiliary support rod 7 is the skull support point I. The position of point I is lower than the scalp puncture reference point C, and it is used for intraoperative skull support.

[0053] The hinge point is the location where the locking mechanism is installed. The first adjustable connecting rod 2 and the first adjustable positioning rod 3 are hinged at hinge point O between the first adjustable connecting rod and the first adjustable positioning rod. The second adjustable connecting rod 4 and the second adjustable positioning rod 5 are hinged at hinge point N between the second adjustable connecting rod and the second adjustable positioning rod. The hinge channels of the first adjustable connecting rod 2 and the second adjustable connecting rod 4 are perpendicular to the direction of the main puncture guide rod at 90°, and can rotate axially around the corresponding hinge point. The first adjustable positioning rod 3 and the second adjustable positioning rod 5 can also rotate axially around their corresponding hinge points. The center point of the end of the first adjustable connecting rod 2 at the hinge point with the main puncture guide rod 1 is point P, which is fixed relative to the position of line segment OL. The side end of the first adjustable connecting rod 2 at the hinge point with the main puncture guide rod 1 is point Q, which is fixed relative to the position of point P. The center point of the end of the second adjustable connecting rod 4 at the hinge point with the main puncture guide rod 1 is point T, which is fixed relative to the position of line segment NM; the side end of the second adjustable connecting rod 4 at the hinge point with the main puncture guide rod 1 is point S, which is fixed relative to the position of point T.

[0054] Geometric constraints: During the puncture procedure, the following six points are forcibly collinear: the puncture reference point R at the bottom of the main puncture guide rod, the puncture reference point K at the top of the main puncture guide rod, the hinge point L between the main puncture guide rod and the first adjustable connecting rod, the hinge point M between the main puncture guide rod and the second adjustable connecting rod, the intracranial puncture target point D, and the scalp puncture reference point C. This straight line is the only puncture axis. The tips of the two sets of double-section positioning arms are respectively matched with the corresponding points A and B at the ends of the first and second adjustable positioning rods.

[0055] Device Assembly: Before the operation, distance parameters are calculated using imaging. During the operation, the angles of the first adjustable connecting rod 2, the first adjustable positioning rod 3, the second adjustable connecting rod 4, and the second adjustable positioning rod 5 are adjusted first. Then, the angles of the first adjustable connecting rod 2, the second adjustable connecting rod 4, and the main puncture guide rod are adjusted. Each adjustment is fixed by locking component 6. Then, the ends of the first and second adjustable positioning rods are brought against the surface markings A and B, respectively. At the same time, the main rod support point is brought against the surface of the patient's skull, which is the skull support point I. At this time, the posture of the entire device is uniquely locked, forcing the scalp puncture reference point C, the intracranial puncture target point D, the puncture reference point R at the bottom of the main puncture guide rod, the hinge point M between the main puncture guide rod and the second adjustable connecting rod, the hinge point L between the main puncture guide rod and the first adjustable connecting rod, and the top point K of the main puncture guide rod to be collinear, thereby fixing the spatial posture of the device. The hollow channel is the precise puncture path.

[0056] The overall operation steps are as follows: 1. Preoperative surface marking and head CT image acquisition steps Surface reference point placement procedure: Three surface reference points are placed in the visible area of ​​the patient's scalp, which are defined as the first surface positioning point A, the second surface positioning point B, and the scalp puncture reference point C, respectively; after the marking is completed, a thin-section fine CT scan of the skull is performed on the patient to fully acquire CT tomographic image data including scalp reference points, scalp, skull, and intracranial lesions.

[0057] 2. Import of 3D images and reconstruction of 3D models of scalp, skull, intracranial lesions, and surface markers. The DICOM standard tomographic image sequence obtained from the preoperative cranial CT scan was imported into the 3D Slicer three-dimensional visualization processing software. First, the original CT tomographic sequence was retrieved, and based on the software's threshold segmentation and region growing segmentation algorithms, accurate three-dimensional segmentation and solid model reconstruction of surface localization markers were completed first. On this basis, the scalp soft tissue, skull bony structures, and intracranial lesion areas were sequentially processed for layered image segmentation.

[0058] Based on the bone window CT sequence, the bony contour of the skull is segmented to construct a complete three-dimensional solid model of the skull and establish a standardized three-dimensional spatial coordinate system for intracranial anatomy. Simultaneously, the homologous image segmentation method is used to reconstruct the three-dimensional solid models of the scalp soft tissue and intracranial lesions, respectively, to achieve accurate registration and fusion display of the three-dimensional anatomical models of multiple structures, including the scalp, skull, lesions, and surface markers.

[0059] 3. Automated extraction steps of three-dimensional coordinates of body surface reference points Based on the completion of the 3D model reconstruction of the marker, the interface between the marker and the scalp is automatically fitted using a Python automated calculation script. The precise 3D spatial coordinate parameters of the reference marker points A, B, and C on the scalp surface are calculated and obtained, providing standardized 3D coordinate data support for subsequent spatial positioning and surgical area planning.

[0060] 4. Three-dimensional localization steps for intracranial puncture target Intracranial lesion target identification: In the reconstructed three-dimensional intracranial anatomical model, locate the geometric center of the intracranial lesion, set the intracranial puncture target at the center, mark it as target point D, and lock the three-dimensional spatial coordinates of target point D.

[0061] 5. Solve for the 3D coordinates of point F using a Python automated script: (1) Point C is offset by 1 / 2 the width of the main support rod along the perpendicular line to plane ACD in the X direction, and point E is determined by the reference line segment CE; (2) Point E is offset by 1 / 2 the width of the main support rod along the perpendicular line to plane CDE in the Y direction, and point F is determined by the reference line segment EF.

[0062] 6. Solve for the 3D coordinates of point H using a Python automated script: (1) Point D is offset by 1 / 2 the width of the main support rod along the vertical line perpendicular to plane ACD in the X direction, and point G is determined by the reference line segment DG; (2) Point G is offset by 1 / 2 the width of the main support rod along the perpendicular line to the plane CDG in the Y direction, and point H is determined by the line segment GH reference; points F and H form two points on the main support line.

[0063] 7. Use a Python automated script to determine the skull support point I. Connect auxiliary points F and H to generate a straight line FH, which is the main support line of the puncture positioning device; solve for the spatial intersection point of the straight line FH with the outer surface of the three-dimensional model of the skull, which is the skull support point I.

[0064] 8. Calculate the positioning distance parameter of the support foot using a Python automated script. Line segments IA from skull support point I to body surface reference point A and IB from skull support point I to body surface reference point B are constructed respectively. The spatial straight line lengths of line segments IA and IB are calculated by three-dimensional spatial coordinate difference calculation, and used as matching calibration parameters between the support point and the positioning points on both sides.

[0065] 9. Solve for the vertex J of the support line and the length of the support line using a Python automated script. Extend the auxiliary support rod linearly outward from the main support line HI, and mark the end point of the extension as the vertex J of the auxiliary support rod; connect the points H and J to form the auxiliary support rod line segment HJ, and calculate the length of the line segment HJ.

[0066] 10. Use Python automated scripts to perform three-dimensional localization of the reference apex point K of the puncture channel and determine the puncture path. The puncture channel is calibrated at the top. A three-dimensional spatial plane DHJ is constructed using the intracranial puncture target point D, the apex J of the auxiliary support rod, and point H (the bottom end of the auxiliary support rod). First, the spatial length of the line segment DC between the scalp puncture reference point C and point D is measured. Starting from point D, the line segment HJ is extended along the direction from point D to point C, with the extension ending at point K, which is the top point K of the main puncture guide rod. The length of line segment DK is calculated as the reference length parameter of the puncture channel.

[0067] 11. Use Python automated scripts to calibrate the offset of the hinged positioning points L and M of the main puncture guide rod. The articulation point is offset and positioned in segments, and the point is offset sequentially along the line segment KD pointing from the top point K of the main puncture guide rod to the intracranial puncture target point D: (1) Move a fixed distance from point K along line segment KD toward point D to generate the hinge point L between the main piercing guide rod and the first adjustable connecting rod; (2) The hinge point L between the autonomous puncture guide rod and the first adjustable connecting rod moves a fixed distance along the KD line segment towards point D to generate the hinge point M between the main puncture guide rod and the second adjustable connecting rod.

[0068] 12. Using Python automated scripts, solve for the three-dimensional coordinates and calculate the support arm parameters of the first set of double-section positioning arms. Solve for the spatial configuration of the first set of double-section positioning arms: (1) Solve the problem by spatial triangle constraint at the hinge point O between the first adjustable connecting rod 2 and the first adjustable positioning rod 3: Construct a constraint triangle △OAL with the hinge point L between the main puncture guide rod 1 and the first adjustable connecting rod 2 and the first body surface positioning mark point A. Set the fixed side length constraint conditions for the fixed lengths OA and OL of the components, and limit the point O to be solved to be located in the three-dimensional plane to which the triangle ALK belongs. Solve the three-dimensional coordinates of point O by spatial geometric constraint equation. (2) Generation of auxiliary positioning point P: The line segment OL is extended towards the L end to the center point of the end of the first adjustable connecting rod 2 to generate point P; (3) Generate the positioning point Q of the outer end of the first adjustable connecting rod 2: Point P is offset by 1 / 2 of the width of the first adjustable connecting rod along the vertical line perpendicular to the plane OPK in the X direction. Point Q is determined by the reference line segment PQ to obtain the positioning point Q of the outer end of the first adjustable connecting rod 2. (4) Calculation of the length of the first double-section positioning arm: Connect the reference point A on the body surface and the positioning point Q at the outer end to form a line segment AQ. Calculate the spatial length of the line segment AQ as the fixed assembly dimension parameter of the first double-section positioning arm.

[0069] 13. Using Python automated scripts to solve the three-dimensional coordinates and calculate the support arm parameters of the second set of double-section positioning arms, and to solve the spatial configuration of the second set of double-section positioning arms: (1) Solve the problem by spatial triangle constraint at the hinge point N between the second adjustable connecting rod 4 and the second adjustable positioning rod 5: Construct a constraint triangle △NBM with the hinge point M between the main puncture guide rod and the second adjustable connecting rod and the second body surface positioning mark point B, set the fixed side length constraint conditions for the fixed lengths NB and NM of the components, and limit the point N to be solved to be located in the three-dimensional plane to which the triangle BMK belongs. Solve the three-dimensional coordinates of point N through the spatial geometric constraint equation. (2) Generation of auxiliary positioning point T: The line segment NM is extended towards the M end to the center point of the end of the second adjustable connecting rod 4 to generate point T; (3) Generate the positioning point S at the outer end of the second adjustable connecting rod 4: Point T is offset by 1 / 2 of the width of the second adjustable connecting rod along the vertical line perpendicular to the plane NTK in the X direction, and point S is determined by the reference line segment TS; (4) Calculation of the length of the second double-section positioning arm: Connect the second body surface positioning mark point B and the outer end positioning point S to form a line segment BS, calculate the spatial length of the line segment BS, and use it as the fixed assembly dimension parameter of the second double-section positioning arm.

[0070] 14. Use Python automation scripts to batch output standardized parameters. Summary output of geometric parameters: All key geometric parameters for device assembly and calibration are output in batches. The parameters include: the length of the first group of double-section positioning arms AQ, the length of the second group of double-section positioning arms BS, the standard puncture path length DK, and the matching lengths IA and IB between the support point and the positioning points of the two adjustable positioning rods.

[0071] 15. Adjust the angles of each connecting rod and positioning rod in the cranial puncture guide device according to the data, so that the positioning points at the bottom of the two positioning rods abut against the surface marking points A and B and the support point fit against the skull, and the puncture can be completed.

[0072] Taking emergency puncture and aspiration surgery for cerebral hemorrhage as an example, the application process of the cranial puncture guidance device described in this invention will be explained in detail: The first step is surface marking and CT scanning. A smooth area of ​​the patient's scalp without hair or damage is selected, and the scalp puncture reference point C is determined. The first surface positioning mark point A and the second surface positioning mark point B are set, and medical lead contrast markers are affixed to the three points. After marking, a 1mm thin-slice spiral CT scan is performed on the patient's brain to acquire complete brain tomographic images and export them as DICOM format files.

[0073] The second step is 3D reconstruction and automated parameter calculation. The DICOM image file is imported into the 3D Slicer software, and a customized Python automated script is run. The software automatically completes image segmentation and 3D model reconstruction. The coordinates of points A, B, and C on the body surface can be obtained either automatically by the script or manually by the operator by marking the center point of the contact surface between the marker and the scalp. The intracranial puncture target point D is calibrated; D is the location of the lesion target point inside the skull. Target point matching and geometric parameter calculation are completed, and five instrument adjustment parameters (AQ, BS, DK, IA, and IB) are quickly output.

[0074] The third step is precise adjustment and fixation of the device. Medical staff adjust the extension and spatial angle of the two sets of double-section positioning arms according to the parameters output by the script. After adjusting to the standard parameters, they tighten all the nuts and locking bolts to lock the overall posture of the rods and ensure that the device structure is stable and free from loosening or displacement.

[0075] The fourth step is intraoperative positioning and puncture. Local infiltration anesthesia is administered to the scalp in the puncture area. A small incision is made in the scalp, centered at the puncture reference point C. After retracting the scalp, a hole is drilled in the skull, and the dura mater is electrocoagulated and incised. The ends of two sets of double-segment positioning rods are respectively attached to points A and B, and the end of the auxiliary support rod 7 is attached to the skull support point I, locking the precise puncture axis. The puncture needle is inserted along the internal cavity of the main puncture guide rod 1, and the needle stroke is precisely controlled according to the preset insertion depth DK, ensuring the puncture needle reaches the center of the hematoma, completing the hematoma aspiration procedure.

[0076] In this embodiment, the entire preoperative preparation time is only 9 minutes, which fully meets the needs of rapid treatment of emergency and critical illnesses; the puncture positioning calculation error is only 0.66mm, with excellent positioning accuracy; the entire operation does not require general anesthesia, invasive fixation of the skull, or laser radiation interference, resulting in minimal trauma to the patient, high surgical safety, and rapid postoperative recovery.

[0077] As can be seen, the cranial puncture guidance device of the present invention automatically completes three-dimensional reconstruction, coordinate recognition, geometric constraint loading, and distance parameter calculation with the help of 3D Slicer software and Python automated scripts. During the operation, the mechanical device is adjusted according to the parameters so that the positioning rod abuts against the body surface marker point and the support point fits against the skull, thereby positioning and completing the puncture. No stereotactic frame or laser equipment is required. Local anesthesia is used, the preoperative preparation time is ≤10 minutes, the calculation error is ≤1mm, the parameter calculation is automated and highly accurate, the device has a simple structure, low cost, convenient operation, and strong resistance to environmental interference. It is suitable for minimally invasive cranial puncture surgeries such as cerebral hemorrhage, brain abscess, and ventricular puncture, and can be widely used in various minimally invasive cranial puncture surgeries in emergency and primary hospitals.

[0078] Based on the core technical solution of this invention, those skilled in the art can make various equivalent structural replacements and optimizations. The cranial puncture guide device can also adopt the following equivalent alternative implementation methods: (1) Material replacement: The device rods can be replaced with medical polypropylene (PP) sterile polymer plastic to prepare a disposable sterile puncture guide device, which is suitable for special infection surgery scenarios and completely avoids the risk of cross-infection; (2) Locking structure replacement: The threaded locking bolt can be replaced with a push-button quick-lock structure to further improve the efficiency of instrument adjustment and fixation and shorten the preoperative preparation time; (3) Rotary structure optimization: The rod hinge rotary joint can be replaced with a gear locking assembly to achieve precise angle adjustment in gear position, further improving the positioning adjustment accuracy and stability; (4) Replacement of markers: Lead markers or contrast markers can be replaced with medical radiographic gel stickers, which have better adhesion and comfort, are non-irritating to the scalp, and are suitable for surgical scenarios involving children and patients with sensitive constitutions.

[0079] The above-described embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A cranial puncture guidance device, characterized in that: The device includes a main puncture guide rod, a first adjustable connecting rod, a first adjustable positioning rod, a second adjustable connecting rod, a second adjustable positioning rod, and a locking component. The main puncture guide rod is a hollow, through-type rod, with its hollow inner cavity serving as a through-type puncture guide channel for the puncture needle to travel linearly along the channel to reach the intracranial surgical target. One end of each of the first and second adjustable connecting rods is hinged to the side wall of the main puncture guide rod via the locking component, and the locking components of the two sets of connecting rods are arranged in an orthogonal staggered configuration. The other end of the first adjustable connecting rod is hinged to the first adjustable positioning rod via the locking component, and the other end of the second adjustable connecting rod is hinged to the second adjustable positioning rod via the locking component.

2. The cranial puncture guide device according to claim 1, characterized in that: The locking component is a threaded locking structure or a snap-locking structure. The main puncture guide rod, the first adjustable connecting rod, the first adjustable positioning rod, the second adjustable connecting rod, and the second adjustable positioning rod are all provided with hinged channels for mounting the locking component. The locking component is placed within the hinged channels, achieving axial connection between the first adjustable connecting rod and the main puncture guide rod, the second adjustable connecting rod and the main puncture guide rod, the first adjustable connecting rod and the first adjustable positioning rod, and the second adjustable connecting rod and the second adjustable positioning rod. The first and second adjustable connecting rods are set at adjustable angles, cooperating with the main puncture guide rod and the first and second adjustable positioning rods to achieve mechanical positioning.

3. The cranial puncture guide device according to claim 1, characterized in that: The side wall of the main puncture guide rod is provided with an auxiliary support rod.

4. The cranial puncture guide device according to claim 3, characterized in that: The first set of double-section positioning arms, consisting of a first adjustable connecting rod and a first adjustable positioning rod, has the same structure as the second set of double-section positioning arms, consisting of a second adjustable connecting rod and a second adjustable positioning rod. The hinge channels of each of the two sets of double-section positioning arms are orthogonally arranged to the central axis of the main puncture guide rod. Locking components are provided at each connection point for free adjustment of the angle and locking and fixing. The auxiliary support rod is parallel to the axis of the puncture guide channel inside the main puncture guide rod.

5. The cranial puncture guide device according to claim 1, characterized in that: The main puncture guide rod, the first adjustable connecting rod, the first adjustable positioning rod, the second adjustable connecting rod, and the second adjustable positioning rod are made of medical-grade stainless steel, medical-grade plastic, or medical-grade titanium alloy.

6. A method for implementing the cranial puncture guidance device according to any one of claims 1-5, characterized in that: Includes the following steps: (1) Layout of surface markings: Set the scalp puncture reference point C, and with the puncture reference point C as the vertex, lay out two surface positioning points A and B, which form a triangular positioning reference; attach radiopaque markers to points A, B and C respectively; (2) Image acquisition: Thin-slice spiral CT was used to scan the patient's brain, and complete tomographic image data was acquired and standard DICOM data was exported; (3) Three-dimensional reconstruction: Import DICOM data into 3D Slicer software and run Python automated script. The Python automated script automatically completes the loading of image volume data and the construction of spatial coordinate system. Through threshold segmentation combined with region growing algorithm, it realizes the partitioning and reconstruction of scalp, skull, intracranial lesions and body surface markers and the reconstruction of three-dimensional solid models. (4) Coordinate recognition: Obtain the three-dimensional spatial coordinates of the first body surface positioning marker A, the second body surface positioning marker B, and the scalp puncture point C; (5) Constraint loading: The intracranial puncture target point D is manually selected and its coordinates are locked. The intracranial puncture target point D is the location of the lesion target point inside the skull. The Python automated script forces the loading of six collinear geometric constraints on the puncture path: the top point K of the main puncture guide rod, the hinge point L between the main puncture guide rod and the first adjustable connecting rod, the hinge point M between the main puncture guide rod and the second adjustable connecting rod, the puncture reference point R at the bottom of the main puncture guide rod, the scalp puncture point C, and the intracranial puncture target point D. The tips of the two sets of double-section positioning arms are matched with points A and B, respectively. (6) Parameter calculation: The Python automated script automatically calculates and outputs five distance parameters, namely: the assembly length of the first double-section positioning arm AQ, the assembly length of the second double-section positioning arm BS, the standard puncture needle depth DK, the distance from skull support point I to point A IA, and the distance from skull support point I to point B IB. (7) Device mechanical posture adjustment: According to the five core parameters output by the script, first adjust the extension of the two sets of double-section positioning arms according to AQ and BS, and then adjust the rotation angle of the two sets of double-section positioning arms and the main puncture guide rod according to IA and IB. After each adjustment, lock the posture of all related connecting rods through the locking component. (8) Positioning and fixing: With the scalp puncture point C as the center, the end of the first adjustable positioning rod is attached to the first body surface positioning mark point A, the end of the second adjustable positioning rod is attached to the second body surface positioning mark point B, and the end of the auxiliary support rod is attached to the skull. This support point is point I. At this time, the hollow inner cavity axis of the main puncture guide rod is the precise puncture axis. (9) Perform puncture: Insert the puncture needle through the through-type puncture guide channel of the main puncture guide rod to reach the intracranial puncture target point.

7. The method for implementing the cranial puncture guidance device according to claim 6, characterized in that: The radiopaque marker is a lead marker, a contrast marker, or a medical metal contrast sticker.

8. The method for implementing the cranial puncture guidance device according to claim 6, characterized in that: In step (4), two optional methods are used to obtain the three-dimensional spatial coordinates of the first body surface positioning marker A, the second body surface positioning marker B, and the scalp puncture point C: Method 1, Automatic Recognition by Computer Script: This method uses a Python automated script to automatically identify markers within the image. By calculating the center point of the contact surface between the marker and the scalp, the three-dimensional spatial coordinates of three points—the first surface positioning marker A, the second surface positioning marker B, and the scalp puncture point C—are extracted. Method 2, manual marking and picking: The operator manually clicks the center point of the contact surface between the marker and the scalp in the 3D view to pick the three-dimensional spatial coordinates of the first body surface positioning marker point A, the second body surface positioning marker point B, and the scalp puncture point C.

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