A headgear assembly

Abstract

This invention relates to a head frame assembly, comprising: a base configured for fixation to a patient's skull, the base including a support, a plurality of biocompatible screws mounted on the support, and a radiopaque ring, wherein the radiopaque ring has a zero-scale point, and the radiopaque ring and the zero-scale point are identifiable by CT or MRI imaging technology; a head frame including: a support frame; a planar rotating ring rotatably mounted on the support frame; a top cover mounted on the planar rotating ring and having a dial displaying a rotation angle φ; a swing arm consisting of a horizontal axis and a vertical axis, the swing arm being configured to swing controllably by a swing angle θ and to rotate controllably with the planar rotating ring by a rotation angle φ; wherein the vertical axis is axially hollow, defining a puncture channel for removable insertion of a puncture needle; wherein the head frame is removably fixed to the base.

Description

Technical Field

[0001] This invention relates to the field of innovative medical devices, specifically to an innovative three-dimensional spatial orientation system and head frame assembly for neurosurgical procedures. Background Technology

[0002] Different intracranial lesions, located in different areas, present with varying symptoms. The clinical symptoms of intracranial lesions are numerous, necessitating highly precise targeting and localization of the puncture site during intracranial surgery. Procedures such as hematoma drainage for cerebral hemorrhage, intracranial lesion biopsy, epileptic focus ablation, ventricular puncture and external drainage, and DBS electrode implantation require precise localization and adjustment of intracranial targets, making them common indications for stereotactic surgery.

[0003] CN116327334A discloses a precise targeting and positioning device for intracranial lesions, including a cylindrical connecting rod. A rotatable sleeve is fitted onto the surface of the connecting rod, and a base is integrally connected to the surface of the sleeve. A gear disk is rotatably connected to the side of the base away from the sleeve via a rolling bearing. A guide tube is fixed to the gear disk. A fixing block is welded to the surface of the base on one side of the gear disk, and a horizontal shaft is inserted through the middle of the fixing block. A pressure plate is fixedly connected to one end of the horizontal shaft, and the pressure plate meshes with the surface of the gear disk. Spring clamps are fixedly connected to both ends of the connecting rod. This invention allows for adjustment of the vertical angle of the guide tube by rotating the sleeve on the surface of the connecting rod, and for adjustment of the horizontal direction of the guide tube by rotating the gear disk on the base. This facilitates adjustment, is easy to operate, and ensures precise targeting and positioning of the puncture needle.

[0004] CN112022353A discloses a surgical instrument positioning component for a surgical robot, belonging to the technical field of sand screening devices. Key technical features include an operation control panel and a fixed support. An adjustment servo motor is fixedly connected to the lower end face of the fixed support. Electrically controlled telescopic devices are fixedly connected to the front ends of both fixed plates. First limiting nuts matching the first movable pins are provided on the left and right sides of both movable plates. Second limiting nuts matching the second movable pins are provided on the left and right sides of the connecting claw. An X-drive screw is located in front of the connecting shaft, and a Y-drive screw is located behind the connecting shaft. A drive slider is provided in the middle of the X-drive seat. A micro-adjustment servo motor is fixedly connected to the upper end face of the drive slider, and a telescopic scalpel connecting rod is provided on the lower end face of the drive slider. The surgical instrument achieves drive in the X, Y, and Z directions, improving the flexibility and convenience of the surgical instrument, facilitating accurate drive and positioning, and ensuring the surgical instrument meets the precision requirements of the wound.

[0005] CN112089481A discloses an automatic guide device for CT puncture needles. The key technical features include a first drive rod and a second drive rod. The first drive rod is connected to a first toothed plate meshing with a first gear. The second drive rod is equipped with a second toothed plate meshing with a second gear. A guide sleeve for the puncture needle to pass through is slidably connected to a first long sliding hole to guide the puncture needle. The lower end of the guide sleeve passes through a second long sliding hole and is slidably connected to it. This invention has the following advantages: the first and second drive rods respectively control the rotation of the first and second guide frames, and the guide sleeve moves along both the first and second long sliding holes to three-dimensionally change the angle at which the guide sleeve guides the puncture needle, thereby automatically guiding the puncture needle to the insertion angle for precise positioning.

[0006] CN116602742A discloses a puncture assistance device for ventricular puncture and drainage, including a reference component and a puncture needle ring fastener. Both the reference component and the puncture needle ring fastener are sheet-like structures with a central opening. The reference component is fixed to the head, and the puncture needle ring fastener and the central opening of the reference component are axially aligned with each other with a diameter difference of less than 1 mm. The puncture needle ring fastener extends into a curved extension, and the reference component has a groove that matches the extension. The extension and the groove form a fixing structure that connects and secures the reference component and the puncture needle ring fastener. The reference component can be fixed according to the puncture position, and the puncture needle ring fastener can be adjusted at an angle after the opening is completed to assist puncture, ensuring puncture stability. The puncture needle ring fastener can also be used in conjunction with a skull opening drill ring fastener to ensure a sterile environment during the puncture and drainage process and prevent intracranial infection.

[0007] The existing solutions described above have many problems and defects, such as: the product has many parts, is bulky, inconvenient to assemble, and requires a long surgical preparation time; the calculation of the puncture angle is complicated, and its accuracy depends on the surgeon's experience; the marker is applied to the scalp, but its position is not strictly fixed, affecting accuracy; the adjustment connector is too sensitive, making adjustment inconvenient; the entire device has a complex structure, high manufacturing cost, and high price.

[0008] Therefore, the industry needs innovative three-dimensional spatial orientation systems for neurosurgical procedures to mitigate or even overcome the shortcomings of existing technologies and achieve more beneficial technical effects and advancements.

[0009] The information included in this background section of the present invention specification, including any references cited herein and any descriptions or discussions thereof, is included for technical reference purposes only and is not intended to limit the scope of the invention. Summary of the Invention

[0010] The present invention is proposed in view of the foregoing and other further ideas.

[0011] With advancements in computer processing speed and imaging technology, the inventors of this patent have creatively proposed a three-dimensional spatial localization system / method for improving intracranial lesion target locations (sometimes interchangeably referred to as "lesions") based on the current technological status and characteristics of the field of neurosurgical procedures. This system combines medical imaging reconstruction calculations with three-dimensional stereotactic head frames / neuronavigation technologies. The three-dimensional spatial orientation system, its components, and related methods of this invention can also be used for many other purposes, not limited to surgery, including preoperative analysis, simulation and training, teaching and training of medical students and interns, research and development, etc.

[0012] According to one aspect of the invention, an innovative three-dimensional spatial orientation system for use in neurosurgical procedures is provided. This three-dimensional spatial orientation system includes: a base configured to be fixed to the patient's skull in a position-invariant manner; the base includes a support and a contrast ring mounted on the support, wherein the contrast ring has a zero-scale point, and the contrast ring and the zero-scale point can be identified by CT or MRI imaging technology; a head frame mounted on the base, wherein the head frame includes: a support frame, the head frame being detachably fixed to the base via the support frame; a planar rotation ring mounted on the support frame; a top cover fixed to the support frame and pressed against the planar rotation ring, thereby allowing the planar rotation ring to be rotatably mounted between the support frame and the top cover; a swing rod consisting of a horizontal axis and a vertical axis, the horizontal axis of the swing rod being mounted in the diametrical direction of the planar rotation ring and rotatably controlled with the planar rotation ring by a rotation angle φ; and a vertical axis mounted to be rotatably controlled by a swing angle θ, wherein the vertical axis defines a puncture needle insertion point. The system includes: an insertion puncture channel; a magnetic ring embedded in a planar rotating ring; and an image processing system configured to: perform three-dimensional reconstruction of CT / MRI scans of the patient's skull and base, determine the plane of the imaging ring in the CT / MRI scan as the base plane, and determine the lesion target T within the patient's skull; map a head frame plane based on the base plane and the height h of the head frame, and establish a three-dimensional rectangular coordinate system (x, y, z); calculate the length r of the straight line from the origin o of the three-dimensional rectangular coordinate system (x, y, z) to the lesion target T, and calculate the rotation angle φ and the swing angle θ; establish a three-dimensional polar coordinate system based on the origin o of the three-dimensional rectangular coordinate system (x, y, z), and obtain the polar coordinates (r, θ, φ) of the lesion target T in the three-dimensional polar coordinate system; wherein the center point of the intersection of the horizontal and vertical axes of the swing rod coincides with the origin o of the three-dimensional rectangular coordinate system (x, y, z).

[0013] According to one embodiment, the image processing system includes a control display module configured to send calibration commands and display the current angle status of the headgear in real time; and

[0014] The image processing system is configured to further plan the puncture path of the puncture needle based on the polar coordinates (r, θ, φ) of the lesion target point T.

[0015] According to one embodiment, the base further includes a plurality of biocompatible screws disposed along the imaging ring.

[0016] According to one embodiment, the headframe further includes an angle detection and control circuit fixed to the top cover.

[0017] According to one embodiment, the angle detection control circuit has a built-in rotation angle sensor and a body posture sensor, wherein the rotation angle sensor is mounted tangent to the magnetic ring.

[0018] According to one embodiment, the three-dimensional spatial orientation system further includes an angle control console operatively connected to the headframe.

[0019] According to one embodiment, the angle control console includes: a fixed bracket for fixing the headstock and preventing it from shifting; a transmission device, one end of which is operably connected to a motor and the other end of which is operably connected to the headstock, and configured to manipulate the headstock to automatically adjust the rotation angle φ and the swing angle θ; and a computer configured to send control commands to a control circuit via a serial port, the control circuit receiving the control commands from the computer to control the rotation of the motor.

[0020] According to one embodiment, the transmission device is configured to automatically adjust the puncture depth of the puncture needle, thereby enabling automatic adjustment of the distance r.

[0021] According to one embodiment, an image processing software of an image processing system is installed in a computer.

[0022] According to one embodiment, the rotation angle sensor is an off-axis magnetically encoded angle sensor.

[0023] According to one embodiment, the support frame is further provided with locking screws.

[0024] According to one embodiment, the three-dimensional spatial orientation system calibrates the swing angle θ using a six-sided calibration algorithm.

[0025] According to one embodiment, the image processing system is configured to acquire and process image data identified by CT or MRI imaging techniques.

[0026] According to one embodiment, the manual adjustment cover is provided with a cavity surface for a fixed angle detection control circuit.

[0027] According to one embodiment, the horizontal axis and the vertical axis are integrally formed, so that the T-shaped swing arm is T-shaped.

[0028] According to one embodiment, the puncture needle is fixed in the puncture channel by a locking buckle and a locking screw, wherein the puncture needle is used to limit the puncture depth by the locking buckle.

[0029] According to one embodiment, the image processing system includes image processing software, which is configured in a three-dimensional spatial orientation system or installed in a separate computer outside the three-dimensional spatial orientation system.

[0030] According to one embodiment, the motor is a high-precision servo motor, and the transmission device is a transmission shaft mounted through the central longitudinal axis of the headframe.

[0031] According to one embodiment, the origin o coincides substantially with the center of the planar rotation ring.

[0032] According to one embodiment, 0 ≤ φ < 360°, -45° < θ < 45°.

[0033] According to another aspect of the invention, a head frame assembly is provided, comprising: a base configured for fixation to a patient's skull, the base including a support, a plurality of biocompatible screws mounted on the support, and a radiopaque ring, wherein the radiopaque ring has a zero-scale point, and the radiopaque ring and the zero-scale point are identifiable by CT or MRI imaging techniques; and a head frame including: a support frame; a planar rotating ring rotatably mounted on the support frame; a top cover mounted on the planar rotating ring and having a dial displaying a rotation angle φ; and a swing arm consisting of a horizontal axis and a vertical axis, the swing arm being configured to swing controllably by a swing angle θ and to rotate controllably with the planar rotating ring by a rotation angle φ; wherein the vertical axis is axially hollow, defining a puncture channel for removable insertion of a puncture needle; and wherein the head frame is removably fixed to the base.

[0034] According to one embodiment, the support is a ring-shaped body support, with multiple biocompatible screws arranged spaced apart from each other along the outer periphery of the ring-shaped body, and a radiopaque ring concentrically disposed on the ring-shaped body and close to its inner periphery; the support frame includes a support ring body and multiple support columns disposed on the support ring body, extending axially upward and spaced apart circumferentially; a magnetic ring is also coaxially arranged on the planar rotating ring and rotates together with the planar rotating ring; the top cover is generally disc-shaped and has a handle; the longitudinal axis of the swing rod can swing controllably at a swing angle θ, and the transverse axis is mounted in the diametrical direction within the planar rotating ring and can rotate controllably with the planar rotating ring at a rotation angle φ; the longitudinal axis is perpendicular to the transverse axis; wherein, the support ring body, the planar rotating ring, the magnetic ring, and the top cover are arranged coaxially.

[0035] According to one embodiment, the swing arm is a T-shaped swing arm, and the center point of the intersection of the horizontal axis and the vertical axis is concentric with the planar rotation ring.

[0036] According to one embodiment, the inner circumference of the planar rotating ring is provided with two horizontal bearing seats opposite each other in the diametrical direction, and the two ends of the horizontal shaft are rotatably mounted in the two horizontal bearing seats respectively, so that the vertical shaft can swing.

[0037] According to one embodiment, the head frame assembly also includes a puncture needle configured to be detachably inserted into a puncture channel.

[0038] According to one embodiment, a swing angle sensor for detecting the swing angle θ is provided on the swing rod or the puncture needle; an angle detection control circuit is provided on the head frame, and the angle detection control circuit is equipped with a rotation angle sensor for detecting the rotation angle φ.

[0039] According to one embodiment, each support column is provided with a rotary locking hole and a corresponding rotary locking screw.

[0040] According to one embodiment, the support ring body is further provided with a plurality of circumferentially spaced positioning holes, and the annular body of the bracket is provided with a plurality of corresponding locking posts. The head frame is detachably fixed to the base by means of the cooperation between the plurality of positioning holes and the plurality of locking posts.

[0041] According to one embodiment, the developing ring is marked with a developing ring zero mark, and the dial is marked with a rotation angle indicator and a calibration zero mark.

[0042] According to one embodiment, in the initial or calibration state of the head frame assembly, the zero mark of the developing ring is aligned with the zero mark of the calibration.

[0043] According to one embodiment, the zero mark of the developing ring is in the form of a notch.

[0044] According to one embodiment, the dial is marked with rotation angle indicators and a calibration zero mark; in the calibration state of the head assembly, the horizontal bearing seat is aligned with the zero mark of the developing ring and the calibration zero mark.

[0045] According to one embodiment, the puncture needle is equipped with a locking buckle and a locking screw.

[0046] According to one embodiment, the puncture needle is provided with graduation markings.

[0047] According to one embodiment, the headframe assembly is configured as a three-dimensional spatial orientation system for neurosurgical procedures.

[0048] According to another aspect of the present invention, a method for manually adjusting the spatial orientation of a three-dimensional spatial orientation system is provided, the method comprising the following steps: S1: fixing the base of the three-dimensional spatial orientation system to the patient's skull; S2: having the patient wear the base for CT / MRI scanning; S3: the image processing system of the three-dimensional spatial orientation system acquiring and processing images of the base and the patient's lesion; S4: the image processing system reconstructing and simulating the head frame of the three-dimensional spatial orientation system in three dimensions, and obtaining the coordinate relationship between the lesion target point T and the base and the head frame; S5: path optimization calculation obtaining the swing angle θ and rotation angle φ of the swing arm of the head frame and the puncture depth L data; S6: the head frame receiving the swing angle θ, rotation angle φ and puncture depth L data; S7: fixing the head frame to the base; and S8: manually adjusting the swing angle and rotation angle of the swing arm according to the swing angle θ and rotation angle φ data, so that they respectively reach the target angles θ and φ.

[0049] According to one embodiment, the headframe is in its initial position state before step S7.

[0050] According to one embodiment, the headframe is calibrated before step S7.

[0051] According to one embodiment, calibration is performed manually using a calibration fixture or automatically via an angle control console of a three-dimensional spatial orientation system.

[0052] According to one embodiment, in step S6, the head frame wirelessly receives swing angle θ, rotation angle φ, and puncture depth L data through an angle detection control circuit.

[0053] According to one embodiment, the above method further includes step S9: manually moving the locking buckle of the puncture needle to the target scale position of the puncture needle according to the puncture depth L data, and then fixing it with the locking screw to achieve the target puncture depth.

[0054] According to one embodiment, the above method further includes step S10: inserting the puncture needle through the puncture channel to the lesion target point T.

[0055] According to one embodiment, in step S8, after the target angle is reached, the position of the swing arm is locked.

[0056] According to one embodiment, locking the position of the swing arm is performed by tightening the rotating locking screw and the swing locking screw of the headstock.

[0057] According to one embodiment, the above method is applied to at least one of the following: brain surgery; preoperative simulation; preoperative training; medical explanation; medical demonstration; medical teaching; medical training; and medical research and development.

[0058] According to another aspect of the present invention, a method for automatically adjusting the spatial orientation of a three-dimensional spatial orientation system is provided, the method comprising the following steps: S1: fixing the base of the three-dimensional spatial orientation system to the patient's skull; S2: having the patient wear the base for CT / MRI scanning; S3: the image processing system of the three-dimensional spatial orientation system acquiring and processing images of the base and the patient's lesion; S4: the image processing system reconstructing and simulating the head frame of the three-dimensional spatial orientation system in three dimensions, and obtaining the coordinate relationship between the lesion target point T and the base and head frame; S5: path optimization calculation obtaining the swing angle θ and rotation angle φ of the swing arm of the head frame and the puncture depth L data; S6: the angle control console of the three-dimensional spatial orientation system receiving the swing angle θ, rotation angle φ and puncture depth L data; S7: fixing the head frame to the angle control console and automatically completing position zeroing; and S8: the angle control console automatically adjusting the swing angle θ and rotation angle φ of the swing arm according to the swing angle θ and rotation angle φ data, so that it reaches the target angle.

[0059] According to one embodiment, the headframe is in its initial position state before step S8.

[0060] According to one embodiment, before step S8, the headframe is automatically calibrated via an angle control console.

[0061] According to one embodiment, in step S8, after the target angle is reached, the position of the swing arm is locked.

[0062] According to one embodiment, in step S6, the head frame receives swing angle θ, rotation angle φ, and puncture depth L data via the control circuit (419) of the angle control console.

[0063] According to one embodiment, the above method further includes step S9: the angle control console automatically adjusts the locking buckle of the puncture needle in the puncture channel of the inserted swing rod according to the puncture depth L data, so that it reaches the target puncture depth.

[0064] According to one embodiment, the above method further includes step S10: removing the head frame that is automatically adjusted to the target angle and the puncture needle that is adjusted to the target puncture depth, and installing the head frame onto the base.

[0065] According to one embodiment, the above method further includes step S11: inserting the puncture needle through the puncture channel to the lesion target point T.

[0066] According to one embodiment, locking the position of the swing arm is performed by tightening the rotating locking screw and the swing locking screw of the headstock.

[0067] According to one embodiment, the above method is applied to at least one of the following: brain surgery; preoperative simulation; preoperative training; medical explanation; medical demonstration; medical teaching; medical training; and medical research and development.

[0068] According to another aspect of the invention, a base is provided, comprising: a support having an annular body defining an outer periphery and an inner periphery; and a plurality of biocompatible screws arranged spaced apart from each other along the outer periphery of the support.

[0069] According to one embodiment, the base further includes a developing ring disposed on the annular body and near the inner periphery, wherein the developing ring is concentrically disposed with the support.

[0070] According to one embodiment, the developing ring is a metal ring embedded in the annular body, or a contrast agent ring mark directly coated on the upper surface of the annular body, wherein the developing ring has a developing ring zero scale point and is matched with the annular body to form a unique assembly position relationship.

[0071] According to one embodiment, the plane of the developing ring is configured to be flush with the plane of the upper surface of the annular body.

[0072] According to one embodiment, the upper surface of the annular body is flat.

[0073] According to one embodiment, the plurality of biocompatible screws are at least three titanium screws arranged at uniform intervals from each other along the outer periphery of the scaffold.

[0074] According to one embodiment, the developing ring is a titanium ring.

[0075] According to one embodiment, the zero mark of the developing ring is a notch on the developing ring.

[0076] According to one embodiment, a plurality of locking posts are provided on the annular body of the bracket.

[0077] According to one embodiment, the radial dimension of the generally annular support of the base, i.e., the outer diameter of the annulus of the support, can be designed to be less than or equal to approximately 40 mm. Such a design can help to miniaturize the base, thereby helping to reduce the weight of the headframe and improve positioning accuracy, and to some extent helps to optimize the manufacturing and assembly tolerances of the headframe and base.

[0078] According to one embodiment, the plurality of locking posts are three locking posts disposed on the upper surface of the annular body and arranged circumferentially spaced apart from each other.

[0079] According to another aspect of the invention, a head frame is provided, comprising: a support frame including a support ring body and a plurality of support columns disposed on the support ring body, extending axially upward and spaced circumferentially; a planar rotating ring rotatably mounted on the support frame; a top cover fixed to the planar rotating ring, such that the planar rotating ring is controllably rotatably mounted between the support frame and the top cover; and a swing rod consisting of a horizontal axis and a vertical axis, the swing rod being mounted such that the vertical axis can swing controllably at a swing angle θ; wherein the horizontal axis is mounted in the diametrical direction within the planar rotating ring and can rotate controllably with the planar rotating ring at a rotation angle φ; wherein the vertical axis is perpendicular to the horizontal axis and is axially hollow, defining a puncture path; wherein the support ring body, the planar rotating ring, and the top cover are coaxially arranged.

[0080] According to one embodiment, a magnetic ring that rotates together with the planar rotating ring is also arranged coaxially on the planar rotating ring.

[0081] According to one embodiment, the swing arm is a T-shaped swing arm, and the center point of the intersection of the horizontal axis and the vertical axis is concentric with the planar rotation ring.

[0082] According to one embodiment, the inner circumference of the planar rotating ring is provided with two horizontal bearing seats opposite each other in the diametrical direction, and the two ends of the horizontal shaft are rotatably mounted in the two horizontal bearing seats respectively, so that the vertical shaft can swing.

[0083] According to one embodiment, the head frame is provided with a swing locking screw for locking the swing arm so that it cannot swing.

[0084] According to one embodiment, a swing angle sensor for detecting the swing angle θ of the swing arm is provided at or near the top of the longitudinal axis of the swing arm, wherein the swing angle sensor is an acceleration sensor.

[0085] According to one embodiment, each support column is provided with a rotary locking hole and a corresponding rotary locking screw.

[0086] According to one embodiment, the support ring body is further provided with a plurality of positioning holes spaced apart circumferentially.

[0087] According to one embodiment, the top cover is integrally disc-shaped and has a handle and a dial.

[0088] According to one embodiment, the top cover is generally disc-shaped and has a handle and a dial for displaying the rotation angle.

[0089] According to one embodiment, the top cover is provided with an angle detection and control circuit.

[0090] According to one embodiment, the angle detection control circuit is configured with a rotation angle sensor, a signal processing circuit, an acceleration sensor, and a main control MCU.

[0091] According to one embodiment, the rotation angle sensor is positioned tangent to the edge of the magnetic ring.

[0092] According to another aspect of the present invention, a method for automatically detecting and verifying the angle of a headframe using an angle detection control circuit is provided. The angle detection control circuit is configured with a rotation angle sensor, a signal processing circuit, an accelerometer, and a main control MCU. The method includes the following steps: S1: Positioning the headframe at the initial zero point of calibration and calibrating the rotation angle sensor; S2: Real-time acquisition of the magnetic field strength of the magnetic ring of the headframe using the rotation angle sensor, amplifying and filtering the magnetic field strength data through the signal processing circuit, and transmitting it to the main control MCU; S3: The main control MCU obtains the rotation angle of the magnetic ring through algorithm processing, which serves as the rotation angle φ of the headframe's swing arm; S4: The main control MCU acquires data from the accelerometer and sensor data from the swing arm or the puncture needle; S5: The main control MCU obtains the swing angle θ and rotation angle φ of the swing arm through algorithm processing based on the data from steps S4 and S5; S6: The main control MCU sends the rotation angle φ and swing angle θ data to the image processing system in real time and compares them with the target angle calculated by the image processing system; and S7: When the rotation angle φ and swing angle θ match the corresponding target angle, a verification success message is displayed.

[0093] According to one embodiment, the head frame is the head frame as described above; and in step S4, the sensor data on the swing arm or the puncture needle is acceleration sensor data.

[0094] According to another aspect of the invention, an angle control console for automatically adjusting the angle of a headframe is provided. The headframe has a planar rotating ring rotatable relative to the headframe by a rotation angle (φ), and a swing arm mounted on the planar rotating ring rotatable therewith. The swing arm is mounted to swing relative to the planar rotating ring by a swing angle (θ). The angle control console includes: a rotation drive assembly configured to drive the headframe to rotate; a swing drive assembly configured to drive the headframe to swing; a transmission manipulator operably connected to both the rotation drive assembly and the swing drive assembly; a control circuit configured to control the rotation drive assembly and the swing drive assembly; a computer configured to calculate the rotation angle (φ) and the swing angle (θ) and send commands to the control circuit; and a headframe clamping mechanism for clamping and fixing the headframe. The rotation drive assembly and the swing drive assembly are configured to receive control commands from the computer and / or the control circuit and drive and control the components of the headframe by means of the transmission manipulator to perform automated control and adjustment of the rotation angle and the swing angle of the headframe.

[0095] According to one embodiment, a transmission robotic arm is configured to operatively connect to and manipulate a swing arm to rotate and swing in a controlled manner to perform automated control and adjustment of the rotation angle and the swing angle.

[0096] According to one embodiment, the transmission robotic arm includes a robotic claw connector, a robotic claw detachably connected to the robotic claw connector, and a helical spring sleeved on the robotic claw.

[0097] According to one embodiment, the swing arm is a T-shaped swing arm consisting of a longitudinal axis and a transverse axis, and the mechanical claw of the transmission robotic arm is configured to grip or clamp onto the longitudinal axis of the T-shaped swing arm.

[0098] According to one embodiment, the rotary drive assembly includes a rotary drive motor mounted on a motor bracket, and a rotary reduction gear and a rotary transmission gear operably connected to the rotary drive motor.

[0099] According to one embodiment, the rotary drive assembly further includes a rotary encoder, and the rotary encoder and control circuitry are configured to enable the control accuracy of the rotary drive gear to be up to 0.02°.

[0100] According to one embodiment, the swing drive assembly includes a swing drive motor mounted on a motor bracket, and a swing reduction gear and a swing transmission device operably connected to the swing drive motor.

[0101] According to one embodiment, the oscillation drive assembly further includes an oscillation encoder, and the oscillation encoder and control circuitry are configured to enable the control accuracy of the oscillation drive to be up to 0.02°.

[0102] According to one embodiment, the transmission robotic arm automatically controls and adjusts the swing angle by controlling the swing of the longitudinal axis, and automatically controls and adjusts the rotation angle by controlling the rotation of the longitudinal axis and the planar rotating ring.

[0103] According to one embodiment, the headstock clamping mechanism includes a clamping flip cover, a clamping screw, and a clamping base.

[0104] According to one embodiment, the angle control console is configured to perform automated angle calibration of the headframe.

[0105] According to another aspect of the present invention, a method for automatically adjusting the headframe angle is provided, the method being performed via an angle control console, the method comprising the following steps: fixing the headframe to the angle control console; operably connecting one end of the transmission robotic arm of the angle control console to both a rotary drive assembly and a swing drive assembly, and operably connecting the other end to the headframe; the operator sending control commands via a computer or control circuit; the rotary drive assembly and the swing drive assembly receiving the control commands and driving the transmission robotic arm to manipulate corresponding components of the headframe to perform automated control and adjustment of the headframe's rotation and swing angles.

[0106] According to one embodiment, the transmission robotic arm performs automated control and adjustment of rotation and swing angles by manipulating the swing arm of the headstock.

[0107] According to one embodiment, the above method is executed via the angle console described above.

[0108] According to another aspect of the present invention, a method for three-dimensional reconstruction and spatial positioning of a head frame assembly is provided. The head frame assembly includes a base with a developing ring and a head frame mounted on the base. The head frame includes: a planar rotating ring rotatably mounted on a support frame; and a swing rod consisting of a horizontal axis and a vertical axis, the swing rod being controllably swingable at a swing angle θ. The horizontal axis is mounted in the diametrical direction within the planar rotating ring and can be controllably rotated together with the planar rotating ring at a rotation angle φ. The intersection point (206) of the horizontal axis and the vertical axis is concentric with the planar rotating ring. The vertical height from the imaging ring to the center point of the intersection (206) is h; the method includes the following steps: fixing the base to the patient's skull and performing a CT / MRI scan; performing three-dimensional reconstruction of the CT / MRI scan image, wherein the plane of the imaging ring in the CT / MRI scan image is defined as the base plane (502), and the lesion target point T in the patient's skull is determined according to the CT / MRI scan image; mapping a head frame plane (501) parallel to it at a height h above the base plane (502) and using the head frame plane (501) as the reference. A three-dimensional rectangular coordinate system (x, y, z) is established as a reference. The (x, y) plane of the three-dimensional rectangular coordinate system coincides with the head frame plane (501), the origin o of the three-dimensional rectangular coordinate system coincides with the intersection center point (206), and the z-axis of the three-dimensional rectangular coordinate system passes through the origin o and is perpendicular to the head frame plane (501). A lesion plane (503) parallel to the base plane (502) is mapped below it, so that the lesion target point T is located in the lesion plane (503). The origin of the lesion plane is o', and the x' axis of the lesion plane is parallel to the three-dimensional rectangular coordinate system. The x-axis of the reference system is defined; based on the CT / MRI scan images, the length r of the straight line from the origin o to the lesion target point T is calculated; the angle ∠Too' between the straight line (r) and the z-axis is calculated, and the angle ∠Too' is equal to the swing angle θ; the angle ∠To'x' formed by the line To' connecting the lesion target point T and the origin o' in the lesion plane (503) relative to the x' axis is calculated, and the angle ∠To'x' is equal to the rotation angle φ; the polar coordinates of the lesion target point T in the three-dimensional spherical polar coordinate system established with the origin o are obtained, and the polar coordinates are (r, θ, φ).

[0109] According to one embodiment, the above method includes: adjusting the headframe angle according to parameters of polar coordinates (r, θ, φ).

[0110] According to one embodiment, the method further includes: mounting the headframe on the base and calibrating the headframe assembly to its initial state or to zero scale.

[0111] According to one embodiment, zero-scale calibration includes aligning the zero-scale point on the developing ring with the calibration zero-scale point on the headstock.

[0112] According to one embodiment, zero-scale calibration includes aligning the horizontal axis with the zero-scale point on the developing ring or the calibration zero-scale point on the headstock.

[0113] According to one embodiment, the above method includes: adjusting the rotation angle and swing angle of the swing arm according to the angle parameters of polar coordinates (r, θ, φ).

[0114] According to one embodiment, the method includes locking the position of the swing arm after adjusting the rotation angle and the swing angle.

[0115] According to one embodiment, the method includes: inserting a puncture needle into the puncture channel of a swing rod, and adjusting and fixing the puncture depth L of the puncture needle according to the parameter r of polar coordinates (r, θ, φ).

[0116] According to one embodiment, the puncture depth L is calculated according to the following formula: L = r + r1, where r is the parameter r in polar coordinates (r, θ, φ), and r1 is the length of the longitudinal axis of the swing rod.

[0117] According to one embodiment, the above method includes: correcting and / or verifying the head frame plane (501) and the three-dimensional rectangular coordinate system based on the image of the planar rotation ring in the CT / MRI scan.

[0118] The technical problems solved by one or more aspects and embodiments of the present invention include, but are not limited to, the following:

[0119] This allows neurosurgeons to perform brain surgery more safely and precisely, or to conduct preoperative training and simulations, thereby improving the success rate of surgery and reducing the surgical risk rate.

[0120] By optimizing the positioning coordinate system from the lesion target point to the puncture channel, the problems of improving positioning accuracy and simplifying the operation process can be solved.

[0121] By optimizing the headrest structure design and using medical-grade PTFE as the main material, the problem of reducing the weight of the headrest is solved;

[0122] In the optimized design of the headframe structure, for example, by making the base and headframe separable, and by using a T-shaped swing rod in conjunction with a rotating ring to adjust the angles in two different dimensions from two different directions, the size of the headframe can be reduced, which helps to solve the problems of reducing the weight of the headframe and improving positioning accuracy from another perspective.

[0123] The operation process is simplified by using a modular structure with fewer parts, an image processing system that automatically finds paths and calculates angles, an angle control console that automatically adjusts angles, and an optimized transmission method.

[0124] The problem of improving positioning accuracy is addressed by fixing a base to the skull, employing high-precision attitude sensors such as accelerometers, using algorithms to calibrate angles, and using image processing systems to calculate angles; and

[0125] The goal is to reduce practical costs by controlling consumable costs and eliminating large, expensive equipment.

[0126] Further embodiments of the present invention can achieve other advantageous technical effects not listed hereon, which may be partially described below and will be expected and understood by those skilled in the art after reading the present invention. Attached Figure Description

[0127] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, will become more apparent and the embodiments of the invention will be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0128] Figure 1 This is a schematic diagram of a three-dimensional spatial orientation system for use in neurosurgical procedures according to an embodiment of the present invention, illustrating the general overall configuration of the embodiment of the three-dimensional spatial orientation system.

[0129] Figure 2 It is applicable to an embodiment of the present invention. Figure 1 The schematic diagram of the headframe assembly of the three-dimensional spatial orientation system shown illustrates its general overall configuration and construction.

[0130] Figure 3 It is applicable to an embodiment of the present invention. Figure 1 A schematic diagram of the puncture needle assembly of the three-dimensional spatial orientation system is shown.

[0131] Figure 4 It is based on what can be used Figure 3 A schematic diagram of the puncture needle scale lines of the puncture needle assembly shown.

[0132] Figure 5 It is applicable to an embodiment of the present invention. Figure 2 The diagram shows an exploded view of the headframe assembly.

[0133] Figure 6 yes Figure 5 The diagram shows the assembled headframe as viewed from above.

[0134] Figure 7 yes Figure 5-6 The diagram shows an exploded view of the headframe T-shaped swing rod and the planar rotating ring of the headframe assembly before assembly.

[0135] Figure 8 It is a demonstration Figure 5-6 A schematic view of the headframe assembly shown and how it rotates.

[0136] Figure 9 yes Figure 5-6 A schematic view of the headframe assembly shown and how it swings.

[0137] Figure 10 It is applicable to an embodiment of the present invention. Figure 1 A schematic view of the angle detection and control circuit of the three-dimensional spatial orientation system shown.

[0138] Figure 11 It is applicable to an embodiment of the present invention. Figure 1 A schematic view showing the installation of a rotation angle sensor in the angle detection and control circuit of the three-dimensional spatial orientation system.

[0139] Figure 12 It is applicable to an embodiment of the present invention. Figure 1 A schematic diagram of the base of the headframe assembly of the three-dimensional spatial orientation system shown.

[0140] Figure 13A According to an embodiment of the present invention Figure 2 The schematic perspective view of the assembled headframe assembly shows the headframe plane alignment.

[0141] Figure 13B According to an embodiment of the present invention Figure 13A The schematic perspective view of the headframe assembly after the swing arm has been removed shows the headframe plane alignment.

[0142] Figure 14A It is applicable to an embodiment of the present invention. Figure 1 The diagram shows the overall assembly of the headframe and calibration fixture for the three-dimensional spatial orientation system.

[0143] Figure 14B yes Figure 14A The exploded view of the headframe and calibration fixture shown illustrates the headframe assembly and the calibration fixture used in conjunction with it.

[0144] Figure 15A It is applicable to an embodiment of the present invention. Figure 1 The diagram shows a front view of the angle control console of the three-dimensional spatial orientation system.

[0145] Figure 15BIt is applicable to an embodiment of the present invention. Figure 1 The diagram shows a schematic block diagram of the motor connection and control of the angle control console of the three-dimensional spatial orientation system.

[0146] Figure 16 It is applicable to an embodiment of the present invention. Figure 1 The diagram shows a side view of the angle control console of the three-dimensional spatial orientation system.

[0147] Figure 17 This is a schematic diagram of the combination and installation of two motors that can be used in an angle control console according to an embodiment of the present invention.

[0148] Figure 18A This is a schematic diagram showing a portion of the assembled longitudinal section of a transmission robotic arm device that can be used for control console transmission according to an embodiment of the present invention.

[0149] Figure 18B This is an exploded view of the transmission robotic arm device shown in 18A.

[0150] Figure 19 This is a schematic diagram of a headframe clamping mechanism device for clamping a headframe according to an embodiment of the present invention.

[0151] Figure 20 It can be used Figure 1 A schematic diagram of the three-dimensional polar coordinate system established between the headframe and the base of the three-dimensional spatial orientation system shown.

[0152] Figure 21 yes Figure 20 The three-dimensional polar coordinate system model shown is a schematic diagram used to establish the coordinate relationship between the head frame, base and lesion.

[0153] Figure 22 It is applicable to an embodiment of the present invention. Figure 1 The diagram shows a schematic of the process by which the image processing system of the three-dimensional spatial orientation system simulates the calculation of the polar coordinates of the lesion.

[0154] Figure 23 It is applicable to an embodiment of the present invention. Figure 1 A schematic diagram illustrating the general aspects of manual operation of the three-dimensional spatial orientation system.

[0155] Figure 24 It is applicable to an embodiment of the present invention. Figure 1 The diagram shows a manual operation procedure for the three-dimensional spatial orientation system.

[0156] Figure 25 It is applicable to an embodiment of the present invention. Figure 1 The diagram illustrates the general aspects of the automated operation of a three-dimensional spatial orientation system.

[0157] Figure 26 It is applicable to an embodiment of the present invention. Figure 1 The diagram shows the automated implementation process of the three-dimensional spatial orientation system.

[0158] Explanation of reference numerals in the attached figures:

[0159] 100-Puncture needle; 200A-Head frame; 200B-Base; 400-Angle control console; 500-Image processing system; 600-Calibration fixture; 101-Puncture needle shaft; 102-Puncture needle locking buckle; 103-Puncture needle scale; 104-Acceleration sensor; 105-Locking screw; 201-Support frame; 201A-Support ring body; 201B-Support column; 202-Plane rotating ring; 203-Magnetic ring; 204-T-shaped swing rod; 205-Acceleration sensor; 208-Top cover; 207-Puncture channel; 209-Angle detection control circuit; 210-Calibration zero scale point; 225-Positioning hole; 206 - Headstock origin o; 211 - Horizontal bearing seat; 212 - Horizontal axis; 213 - Vertical axis; 224 - Vertical axis length r1; 214 - Initial position of the planar rotating ring; 215 - Position of the planar rotating ring after rotation; 216 - Rotation angle (φ); 217 - Rotation direction of the planar rotating ring; 218 - Swing angle (θ); 219 - Position of the T-shaped swing rod after swing; 220 - Initial position of the T-shaped swing rod; 221 - Swing direction of the T-shaped swing rod; 226 - Rotation angle sensor; 227 - Signal processing circuit; 228 - Accelerometer sensor; 229 - Main control MCU; 230 - LED indicator; 231 - Rotation lock Hole; 231A - Rotary locking screw; 231B - Swing locking screw; 232 - PCB; 301 - Titanium screw; 302 - Bracket; 303 - Zero scale point s' of developing ring; 304 - Developing ring; 305 - Origin point o' of base; 306 - Positioning post; 222 - Headstock rotation angle calibration point s (horizontal bearing seat aligned with zero point position); 223 - Headstock zero scale and base zero scale horizontally coincide; 601 - Positioning clamp; 602 - Positioning post; 603 - Zero scale point; 401A - Rotary motor assembly; 401 - Rotary drive motor; 402 - Rotary reduction gear; 403 - Rotary encoder; 404 - Rotary transmission gear; 405-Motor bracket; 406A-Oscillating motor assembly; 406-Oscillating drive motor; 407-Oscillating reduction gear; 408-Oscillating transmission device; 409-Oscillating encoder; 410-Computer; 411-Transmission robotic arm; 412-Headstock clamping mechanism; 413-Mechanical claw; 414-Spring; 415-Mechanical claw connector; 416-Clamping flip cover; 417-Clamping screw; 418-Clamping base; 419-Control circuit; 420-Fixed bracket; 501-Headstock plane; 502-Base plane; 503-Lesion plane; 504-Three-dimensional coordinate system xyz; 505-Headstock rotation starting point s. Detailed Implementation

[0160] In the following description of the accompanying drawings and detailed embodiments, details of one or more embodiments of the invention will be set forth. Other features, objects, and advantages of the invention will become apparent from these descriptions, drawings, and claims.

[0161] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the invention without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0162] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and additional items.

[0163] The present invention will now be described in more detail with reference to several specific embodiments and the accompanying drawings.

[0164] Three-dimensional spatial orientation system

[0165] Figure 1 This is a schematic diagram of a three-dimensional spatial orientation system for use in neurosurgical procedures according to an embodiment of the present invention, illustrating the general overall configuration of the embodiment of the three-dimensional spatial orientation system.

[0166] like Figure 1 As shown, an embodiment of this three-dimensional spatial orientation system may include a headframe assembly, which may include a base 200B and a headframe 200A mounted on the base 200B. The headframe assembly may also include a puncture needle 100 mounted on the headframe 200A, for example, inserted into a T-shaped swing arm mounted on the headframe 200A, as detailed below. This headframe assembly enables calibration and adjustment of the puncture path, puncture angle, and puncture depth at the lesion target point T, as detailed below.

[0167] In one example of the three-dimensional spatial orientation system of the present invention, the puncture path of a surgical device such as a puncture needle 100 can be automatically adjusted, including the puncture angle and puncture depth. In this case, an angle control console 400 is required, such as... Figure 1 As shown.

[0168] Of course, in one example of the three-dimensional spatial orientation system of the present invention, the puncture path of the puncture needle 100, including the puncture angle and puncture depth, can be manually adjusted by, for example, an operator such as a doctor. In this case, those skilled in the art will understand that calibration and adjustment of the surgical device such as the puncture needle 100 can still be achieved without the angle control console 400 and its associated hardware and configuration.

[0169] Embodiments of the three-dimensional spatial orientation system may also include an image processing system 500. Figure 1 The image processing system 500 (illustrated representation of a brain image processed by the system) and calibration fixture 600 are shown schematically in the figure. The image processing system 500 can be used for data extraction, 3D reconstruction, lesion path planning, angle calculation, and display control, etc. The calibration fixture 600 can be used to determine the initial positions of the rotation angle sensor and / or accelerometer.

[0170] The general composition and configuration of a three-dimensional spatial orientation system are summarized below, with detailed descriptions provided later.

[0171] (1) Image processing system

[0172] The image processing system can be installed in a computer, for example, located in a doctor's office or operating room, or integrated into an angle control console. An example of an image processing system may include multiple processing modules, such as data extraction, 3D reconstruction, lesion path planning, angle calculation, and control display modules, etc. The data extraction module can read DICOM format image data, parse it, and extract relevant patient information. The 3D reconstruction module can perform volume and surface drawing operations on the extracted data to achieve 3D reconstruction and simulate the head frame origin plane. The lesion path planning module can plan the puncture path based on the 3D reconstructed lesion and head frame model information. The angle calculation module can perform image processing measurements based on the planned puncture path, measuring the plane rotation angle, longitudinal axis swing angle, and depth from the lesion target point to the head frame origin. The control display module can send calibration commands to the head frame and sensors, and display the current head frame angle status in real time.

[0173] (2) Angle Control Console

[0174] An example of an angle control console may include a computer, a fixed bracket, a high-precision motor, a transmission mechanism, and control circuitry. The computer may be equipped with an image processing system and send control commands to the control circuitry via a serial port. The fixed bracket secures the headstock. The high-precision motor receives drive from the control circuitry to achieve high-precision angle adjustments, ensuring accurate positioning. The control circuitry can be connected to the computer, receive its control commands, and drive the high-precision motor to rotate. The transmission mechanism can be connected to the high-precision motor and rotates with it to automatically adjust the headstock angle.

[0175] (3) Base

[0176] An example of a base may include a radiopaque ring, a scaffold, and biocompatible screws such as titanium screws. The radiopaque ring can be embedded within the scaffold for easy identification by CT / MRI and establishment of a coordinate system. The scaffold can be used to fix the head frame, establishing a coordinate link between the head frame and the patient's lesion. The titanium screws can be used to fix the scaffold to the patient and, together with the radiopaque ring, are identified by CT / MRI to establish a coordinate system.

[0177] (4) Head frame

[0178] An example of a head frame may include a support frame, a planar rotating ring, a magnetic ring, a swing arm, an accelerometer, an origin, a puncture channel, a top cover, and an angle detection and control circuit. The support frame can be fixed to a base, providing a stable rotational environment for the planar rotating ring. It may contain a rotation locking screw to prevent the planar rotating ring from moving. The planar rotating ring is rotatably mounted on the support frame and pressed together by the top cover, allowing for flexible rotation. The magnetic ring may be embedded in the planar rotating ring, providing the angle measurement basis for the angle detection circuit. The swing arm can be fixed to the planar rotating ring and can swing along its longitudinal axis, containing a puncture channel. The swing arm may contain a swing locking screw, which can be locked in place when not in use, preventing swinging. When needed, the swing locking screw can be loosened to allow the swing arm to swing. After adjusting to the desired swing angle, the swing locking screw is retightened to lock the swing arm to that swing angle. The sensor can be fixed above the swing arm or above the puncture needle to detect its swing angle; it can be omitted in an automatic adjustment implementation. The origin can be, for example, the center of the planar rotating ring, establishing a spatial coordinate system together with the planar rotating ring and its perpendicular plane. The puncture channel can be the longitudinal center cavity of the swing rod, and can have different specifications depending on the diameter of the puncture needle. The top cover can be fixed to the support frame, ensuring the rotational environment of the planar rotating ring. Depending on the implementation steps, it can be divided into automatically adjusted top cover and manually adjusted top cover. In the case of using automatic adjustment technology, the manually adjusted top cover can add a cavity surface for fixing the angle detection control circuit. The angle detection control circuit can be fixed to the manually adjusted top cover, and has a built-in rotation angle sensor and body posture sensor such as an accelerometer, wherein the rotation angle sensor can be arranged tangentially to the edge of the magnetic ring.

[0179] (5) Puncture needle

[0180] An example of a puncture needle may include a retaining clip and a puncture needle. The retaining clip may be flexible, allowing free movement on the puncture needle, and securely locking onto it after adjustment to a predetermined length. The puncture needle may be available in different sizes for different procedures, and has internal graduations for smooth movement within the puncture channel. A retaining screw that mates with the retaining clip may also be provided to secure (e.g., to the adjusted puncture length).

[0181] The following describes in detail the three-dimensional spatial orientation system, its components, its operation and calibration, etc., with reference to the accompanying drawings and embodiments.

[0182] Headframe assembly

[0183] like Figures 2-9 As shown, Figure 2 It is applicable to an embodiment of the present invention. Figure 1 The schematic diagram of the headframe assembly 200 of the three-dimensional spatial orientation system shown illustrates its general overall configuration and construction. Figure 5 It is applicable to an embodiment of the present invention. Figure 2 An exploded view of the headframe 200A of the headframe assembly 200 shown. Figure 6 yes Figure 5 The diagram shows a top-down view of the assembled headframe assembly 200. Figure 7 yes Figure 5-6 An exploded view of the T-shaped swing rod 204 and the planar rotating ring 202 of the head frame 200A of the head frame assembly 200 before assembly. Figure 8 It is a demonstration Figure 5-6 A schematic view of the headframe 200A of the headframe assembly 200 and how it rotates. Figure 9 yes Figure 5-6 A schematic view of the headframe 200A of the headframe assembly 200 and how it swings.

[0184] According to one example, headframe assembly 200 may include headframe 200A and base 200B, as well as other optional components.

[0185] Headframe

[0186] In one example, the headframe 200A may consist of a support frame 201, a planar rotating ring 202, a magnetic ring 203, a T-shaped swing arm 204, an acceleration sensor 205, and a top cover 208, etc. The planar rotating ring 202 may be fixedly mounted on the support frame 201. The magnetic ring 203 may be fitted onto the planar rotating ring 202, for example, nested substantially flush with the inwardly recessed step at the top of the planar rotating ring 202. The top cover 208 is positioned above the magnetic ring 203 and the planar rotating ring 202. The T-shaped swing arm 204 is rotatably and swingably mounted within the headframe 200A, and an acceleration sensor 205 may be located at or near the top of the T-shaped swing arm 204, such as... Figure 2-6 As shown.

[0187] The support frame 201 has a support ring body 201A that is generally circular or hollow cylindrical in shape, and a plurality of ( ) arranged on the support ring body 201A and circumferentially spaced apart. Figure 5-9 (As shown in the image, there are 3) support columns 201B. Figure 8-9 As shown, the planar rotating ring 202 of the head frame 200A (and other components thereon) abuts against the support ring body 201A and is rotatably nested within the radially inner side of the three support columns 201B. Thus, the three support columns 201B provide circumferential boundaries and constraints for the installation and rotational movement of the planar rotating ring 202, ensuring that it can be reliably and rotatably installed and held on the support frame 201. Furthermore, the three support columns 201B also provide structural strength and support for the support frame 201 itself and other components (if any) mounted thereon.

[0188] like Figure 5-9 As shown, the support ring 201A, specifically the three support posts 201B, may also have multiple, for example, three rotary locking holes 231 – each support post 201B has a radially extending rotary locking hole 231, which can be used to selectively lock the planar rotating ring 202 when needed so that it cannot rotate relative to the support frame 201. Each rotary locking hole 231 is provided with a rotary locking screw 231A that can be turned for radial adjustment. When the rotary locking screw 231A is turned and tightened to extend radially inward, the planar rotating ring 202 will be radially constrained and locked by the rotary locking screw 231A and cannot rotate freely (adjust the rotation angle). When the rotary locking screw 231A is turned and loosened to extend radially outward, the planar rotating ring 202 will no longer be radially constrained by the rotary locking screw 231A, and can thus rotate freely (adjust) together with other head frame components, such as magnetic ring 203, T-shaped swing arm 204, acceleration sensor 205 and top cover 208.

[0189] The support ring 201A of the support frame 201 may also be provided with a plurality of circumferentially spaced positioning holes 225, such as three. Figure 6 and Figure 8-9 As shown, it is used to fix the head frame 200A to the base 200B, and at the same time it can also provide a support base for the planar rotating ring 202 that is rotatably mounted on the support ring body 201A for relative rotation.

[0190] As described above, a magnetic ring 203 is embedded in the planar rotating ring 202, ensuring that the magnetic ring 203 rotates along with the planar rotating ring 202 when it rotates. The planar rotating ring 202 may also be provided with two horizontal bearing seats 211 for mounting the T-shaped swing arm 204. These two horizontal bearing seats 211 are used to rotatably mount the T-shaped swing arm 204 (specifically, the horizontal axis 212 of the T-shaped swing arm), so that after installation, the T-shaped swing arm 204 (specifically, the horizontal axis 212 of the T-shaped swing arm) can pivot relative to these two horizontal bearing seats 211. This pivoting makes the entire T-shaped swing arm 204 (specifically, the vertical axis 213 of the T-shaped swing arm) appear to be swinging. The planar rotating ring 202 is relatively rotatable, allowing the entire T-shaped swing arm 204 to rotate along with the planar rotating ring 202, thus enabling adjustment of the headframe 200A's rotation angle.

[0191] The magnetic ring 203 can be a neodymium iron boron magnetic ring that can be radially magnetized, which can provide measurement data for the rotation angle sensor 226.

[0192] According to one example, the T-shaped swing arm 204 can be composed of a horizontal axis 212 and a vertical axis 213, which together form a general T-shape. The intersection point 206 of the horizontal axis 212 and the vertical axis 213 can be set as the headframe origin o 206. The T-shaped swing arm 204 is used to adjust the swing angle of the headframe 200A, in which case the headframe origin o 206 can be set as the positioning origin of the three-dimensional spatial orientation system.

[0193] The acceleration sensor 205, which is mounted on the T-shaped swing arm 204, can be used to detect the swing angle of the head frame 200A. It can be fixed at the upper end of the longitudinal axis 213 or at its vicinity, but is not limited to this position. It can also be mounted on the puncture needle or other accessories, as long as its relative position with the T-shaped swing arm 204 remains constant during operation.

[0194] With handle ( Figure 5-8 The disc-shaped top cover 208 (as shown) can be used to fix the headstock 200A and keep the planar rotating ring 202 rotating in the same plane during rotational movement without vertical displacement. The top cover 208 may be provided with (e.g., printed or engraved) a scale to display the rotation angle of the planar rotating ring 202; the zero point of the scale is the calibration zero mark 210. On the right handle of the top cover 208 (e.g., ... Figure 5-6 An angle detection control circuit 209 may be selectively installed below or above (as shown). The angle detection control circuit 209 may be configured with a rotation angle sensor 226, a signal processing circuit 227, an acceleration sensor 228, and a main control MCU 229. The rotation angle sensor 226 may be an off-axis magnetic sensor, which can be installed at a position tangent to the edge of the magnetic ring 203, for example... Figure 11As shown. Since the magnetic field strength is different at different positions of the magnetic ring 203, the rotation angle sensor 226 can detect the change in magnetic field strength before and after the magnetic ring 203 rotates, and then transmit the signal to the main control MCU 229 after passing through the signal processing circuit 227, so as to detect the relative rotation angle.

[0195] base

[0196] Based on an example, such as Figure 12 As shown, the base 200B may consist of a generally annular support 302, a developing ring 304, and a plurality of, for example, three titanium screws 301 arranged on the outer circumference of the support 302. Figure 12 The three titanium screws 301, arranged circumferentially at equal intervals, are used to fix the annular support 302 (along with the base 200B and the head frame 200A fixed to the base 200B) to the patient's skull, ensuring that the reference point does not shift during use and establishing a fixed coordinate relationship between the head frame 200A and the patient's lesion. According to one example, the annular support 302 of the base 200B can be designed such that the outer diameter of the annulus of the support 302 is less than or equal to approximately 40 mm, and the dimensions of other components of the base 200B are designed to fit this. This design contributes to the miniaturization of the base 200B and the head frame design.

[0197] The imaging ring 304 can be substantially concentrically embedded in the annular support 302, for example, arranged around its inner circumference and located radially inside it, and perfectly flush with the plane of the support 302. The imaging ring 304 can, for example, be a metal ring recognizable by CT / MRI, facilitating CT / MRI identification and the establishment of a coordinate system. A notch can be provided at the zero mark on the imaging ring 304, such as... Figure 12 As shown, the zero mark s'303 of the developing ring. When the base 200B is aligned with and installed in place with the headstock 200A, the physical installation position of the zero mark s'303 of the developing ring can be aligned with the position of the calibration zero mark 210 on the headstock 200A, for the image processing system to identify the starting point / zero mark.

[0198] As described above, the developing ring 304 shares a common center with the support 302, which is the base origin o'305. The support 302 may have multiple, for example, three, locking posts 306 embedded in its circumference. When the headstock 200A is assembled onto the base 200B, the locking posts 306 need to be aligned with the positioning holes 225 to ensure that the zero-scale point s'303 of the developing ring on the base 200B is aligned with the calibration zero-scale point 210 of the headstock 200A. Figure 13A and 13B As shown, the headstock rotation angle calibration point s (the horizontal bearing housing is aligned with the zero point) 222 is displayed, and the position indication 223 of the headstock zero scale and the base zero scale being horizontally aligned is also displayed. Figure 13A According to one embodiment Figure 2 A schematic perspective view of the assembled headframe assembly 200 from one angle. Figure 13B yes Figure 13A The schematic perspective view of the headframe assembly 200 after the swing arm 204 has been removed shows headframe plane alignment.

[0199] Angle detection and control

[0200] Combining, for example Figure 10 As shown, an angle detection and control circuit 209, a signal processing circuit 227, a main control MCU 229, an LED indicator 230, etc., can be arranged on, for example, a PCB (printed circuit board) 232. An embodiment of using a headgear 200A with the angle detection and control circuit 209 for angle detection and verification steps is as follows:

[0201] 1) Position the headstock 200A at the initial zero point of calibration and calibrate the rotation angle sensor 226;

[0202] 2) The rotation angle sensor 226 collects the magnetic field strength of the magnetic ring in real time, and after the signal processing circuit 227 amplifies and filters the collected data, it is transmitted to the main control MCU 229.

[0203] 3) The main control MCU229 processes the algorithm to obtain the precise angle information after the magnetic ring rotates, which is the rotation angle of the head frame;

[0204] 4) The main control MCU229 receives data from the accelerometer (104, 205, or one of other accessories);

[0205] 5) The main control MCU229 acquires data from the acceleration sensor 228 on the angle detection and control circuit;

[0206] 6) The main control MCU229 uses data from two accelerometers and processes it with an algorithm to obtain the precise swing angle of the T-shaped swing arm 204 relative to the head frame 200A;

[0207] 7) The main control MCU229 sends the current angle information of the headframe 200A to the image processing system in real time, and compares it with the target angle calculated by the image processing system; and

[0208] 8) When the headstock is adjusted to an angle close to or consistent with the target angle, the operator and the angle control panel 400 can be alerted by LED indicator 230.

[0209] Another embodiment of the angle detection and control steps for the headframe 200A (headframe does not include angle detection and control circuitry) is as follows:

[0210] 1) Mount the head frame 200A onto the base 200B through multiple, for example, the three positioning holes 225 shown in the figure;

[0211] 2) Loosen the swing locking screw on the horizontal bearing seat 211 of the headstock 200A so that the longitudinal axis 213 of the T-shaped swing rod 204 can swing left and right, for example... Figure 9 As indicated by the dotted arrow, continue swinging until the desired angle is reached, then tighten the swing locking screw to lock the T-shaped swing arm in place.

[0212] 3) Loosen the rotary locking screw 231A in the rotary locking hole 231 on the headstock 200A, so that the planar rotating ring 202 (thereby driving the magnetic ring 203 and the T-shaped swing rod 204) can rotate freely in the rotation plane along the rotation direction 217 of the planar rotating ring (adjustment), such as Figure 8 The rotation is continued in the direction indicated by the dashed arrow 217 until the expected angle is reached, and then the rotation locking screw 231A in the rotation locking hole 231 is tightened to lock the planar rotating ring 202 in place.

[0213] Calibration fixtures and calibration methods

[0214] Figure 14A It is applicable to an embodiment of the present invention. Figure 1 The diagram shows the overall assembly of the headframe and calibration fixture 600 of the three-dimensional spatial orientation system. Figure 14B yes Figure 14A The exploded view of the headframe and calibration fixture 600 shown illustrates the headframe assembly and the calibration fixture 600 used in conjunction with it.

[0215] For example, such as Figures 14A-14B As shown, the structure and slots at the top of the calibration fixture 600 are similar to the support of the base 200B, and can both be configured to match the headstock 200A with very high precision. For example, as Figure 14A and 14B As shown, the circumference of the fixture may also be provided with three positioning posts 602 and a zero mark 603 for alignment, positioning and calibration. In addition, the calibration fixture 600 may also be provided with, for example, two clamping clips 601 to ensure that the T-shaped swing arm 204 of the headstock 200A is perpendicular to the plane of the calibration fixture 600 (parallel to the plane of the planar rotating ring 202) during calibration, thereby improving positioning accuracy.

[0216] An example of sensor calibration may include initial position determination and sensor software calibration.

[0217] The operational steps in one embodiment of performing calibration using calibration fixture 600 may include the following:

[0218] 1) Mount the headstock 200A onto the calibration fixture 600 through the positioning hole 225;

[0219] 2) Align the three circumferentially spaced positioning holes 225 of the headstock 200A and the three circumferentially spaced positioning posts 602 of the calibration fixture 600 with each other to ensure that the zero mark of the headstock 200A is aligned with the zero mark point 603 of the calibration fixture 600. Figures 14A-14B As shown;

[0220] 3) Operate the clamping clip 601 on the calibration fixture 600 so that the longitudinal axis 213 of the T-shaped swing rod 204 is perpendicular to the plane of the calibration fixture 600;

[0221] 4) The head frame 200A is locked by, for example, rotating the locking screw and swinging the locking screw, so that the T-shaped swing rod 204 and the planar rotating ring 202 are fixed in the initial position;

[0222] 5) The above calibration steps can be performed before leaving the factory, which can reduce surgical preparation time and doctor's learning time (of course, they can also be performed after leaving the factory).

[0223] 6) Remove the headstock 200A from the calibration fixture 600;

[0224] 7) Mount the headgear 200A on the base 200B, send a calibration command via the computer / image processing system, and perform software calibration on the accelerometer 228 and angle sensor 226 via the main control MCU 229.

[0225] As an alternative example, steps 1)-5) above can also be completed by fixing bracket 420 using the angle control console.

[0226] Angle console

[0227] As shown in Figures 15-19, one example of an angle control console 400 may include a rotary drive motor 401, a rotary reduction gear 402, a rotary encoder 403, a rotary transmission gear 404, a motor bracket 405, a swing drive motor 406, a swing reduction gear 407, a swing transmission device 408, a swing encoder 409, a computer 410, a control circuit 419, a transmission robotic arm 411, and a headstock clamping mechanism 412. The headstock clamping mechanism 412 can be used to clamp the headstock 200A. The motor bracket 405 may have any suitable configuration, such as L-shaped, U-shaped, or H-shaped, for example... Figure 15A and Figure 16-17An exemplary configuration is shown, which can be used to fix / install the swing motor assembly 406A on one hand, and simultaneously install the rotary motor assembly 401A on the other hand, for example, it can be connected to the rotary transmission gear 404. The transmission robotic arm 411 can be used to drive the headstock clamping mechanism 412, so that the headstock 400A can realize rotational and swinging movements. As shown, one end of the transmission robotic arm 411 can be connected to the swing transmission device 408, and the other end can be connected to the headstock clamping mechanism 412. The headstock clamping mechanism 412 can be composed of a mechanical claw 413, a spring 414, a mechanical claw connector 415, etc. For example, Figure 19 As shown, the fixing bracket 420 can be composed of a clamping flip cover 416, a clamping screw 417, a clamping base 418, etc., and together with the head frame clamping mechanism 412, it can be used to fix the head frame 200A and place it at the physical zero point position. According to the instructions sent by the operator, such as the surgeon, through, for example, a computer 410, the rotary drive motor 401, rotary reduction gear 402, rotary encoder 403, rotary transmission gear 404, transmission robotic arm 411, and head frame clamping mechanism 412 of the angle control console 400 automatically drive / adjust the planar rotating ring 202 of the head frame 200A on the angle control console 400 (thereby driving the magnetic ring 203 and the T-shaped swing rod 204 together) to rotate (adjust) within the rotation plane defined by the planar rotating ring 202 along the rotation direction 217 of the planar rotating ring according to the required rotation angle. Therefore, it can be used to adjust the rotation angle of the head frame 200A in the rotation plane.

[0228] According to instructions sent by operators such as surgeons via, for example, computer 410, the components of the angle control console 400, such as the swing drive motor 406, swing reduction gear 407, swing transmission device 408, swing encoder 409, transmission robotic arm 411, and headstock clamping mechanism 412 mounted on the motor bracket 405, automatically drive / adjust the T-shaped swing arm 204 of the headstock 200A on the angle control console 400 to swing (adjust) according to the required swing angle, so it can be used to adjust the swing angle of the longitudinal axis 213 of the headstock 200A.

[0229] like Figures 15A-15B and Figures 18A-18B As shown, the transmission robotic arm 411 may be composed of, for example, a robotic gripper 413, a spring 414, and a robotic gripper connector 415. The robotic gripper 413 can grasp and drive, for example, a T-shaped swing arm 204 of the head frame 200A, thereby automatically adjusting the angles of the head frame 200A in two directions, namely the rotation direction and the swing direction.

[0230] like Figure 16-17 and Figure 19As shown, the headstock clamping mechanism 412, in conjunction with the transmission robotic arm 411, fixes the headstock 200A on the angle control console 400 without deviation and keeps the rotating components in the calibration position. The headstock clamping mechanism 412 may primarily consist of a clamping flip cover 416, clamping screws 417, and a clamping base 418. The circular / oblong mounting holes of the clamping flip cover 416 and the clamping base 418, when in position, form mounting positions that facilitate clamping the headstock 200A of the corresponding shape and size.

[0231] An example of the angle control console 400 may include a computer 410 configured to install an image processing system and send control commands to a control circuit 419 via a serial port. The control circuit 419 is configured to communicate with or be integrated with the computer 410, receive its control commands, and drive a high-precision drive motor to rotate.

[0232] According to one example, the rotary drive motor 401 and the oscillating drive motor 406 can be high-precision motors configured to operate in response to drive signals from the computer 410 (e.g., via control circuitry 419) to achieve high-precision angle adjustments or calibrations, ensuring accurate positioning.

[0233] The rotary motor assembly 401A may include, for example, a rotary drive motor 401 mounted on a fixed bracket or other fixed position, a rotary reduction gear 402 and a rotary transmission gear 404 operably connected to the rotary drive motor 401, and may include a rotary encoder 403. A control circuit 419 can drive the motor 401 to rotate the reduction gear 402 and transmission gear 404. The encoder 403 can detect the rotation angle and feed it back to the control circuit 419. The control circuit 419 can be configured to precisely control the rotation angle, for example, through an algorithm such as a PID algorithm, thereby achieving high-precision motor control and drive, enabling the control accuracy of the rotary transmission gear to reach up to 0.02°. The rotary motor assembly 401A drives the motor bracket 405 to rotate, and the motor bracket 405, together with the swing motor assembly 406A, rotates the transmission robotic arm 411 until the target rotation angle is reached.

[0234] The swing motor assembly 406A may include a swing drive motor 406 mounted on a motor bracket 405, and a swing reduction gear 407 and a swing transmission device 408 operably connected to the swing drive motor 406. The swing transmission device 408 may, for example, have transmission teeth, such as in the form of a sector of a partial transmission gear. Furthermore, the swing motor assembly 406A may also include a swing encoder 409. The swing encoder 409 can detect the swing angle and feed it back to a control circuit 419, which can be configured to precisely control the swing angle, for example, through an algorithm such as a PID algorithm, thereby achieving high-precision motor control and drive, enabling the control accuracy of the swing transmission device to reach up to 0.02°. The swing motor assembly 406A drives the transmission robotic arm 411 to swing via the swing transmission device 408 until the target swing angle is reached.

[0235] An assembly and operation example of a high-precision motor is shown below:

[0236] 1) The computer 410 sends control commands to the control circuit 419. The control circuit 419 drives the rotary drive motor 401 to rotate the rotary reduction gear 402, thereby increasing the torque and control resolution, providing a basis for controlling the high-precision rotation of the motor 401, and at the same time, no rotation will occur when the motor 401 is stopped.

[0237] 2) The rotary reduction gear 402 can drive the rotary transmission gear 404. The rotary transmission gear 404 can be proportionally connected to the motor bracket 405 and the rotary encoder 403 respectively. The rotary encoder 403 detects the rotation angle and feeds it back to the control circuit 419. The control circuit 419 can precisely control the rotation angle through an algorithm (e.g., PID algorithm). In this way, the rotary encoder 403 can detect, for example, the rotation angle of the load, such as the rotation speed. The angle control console 400 can thereby reduce the accuracy error between the rotary reduction gear 402 and the rotary transmission gear 404.

[0238] 3) The rotary encoder 403 can be a non-contact absolute encoder with a resolution of 17 bits that can measure the rotational position of the rotary drive motor 401. Its effective control accuracy is 14 bits, so the control accuracy of the rotary drive motor 401 can reach approximately 0.02°.

[0239] The operation of the oscillating drive motor 406 can be basically the same as that of the rotary drive motor 401, for example, it can be operated in a similar manner as described above, so it will not be described in detail here.

[0240] An example of operation on the Angle Console 400 is as follows:

[0241] 1) Open the clamping cover 416 and place the headstock 200A on the clamping base 418;

[0242] 2) The structure of the clamping base 418 can be similar to the bracket 302 of the base 200B, which allows the head frame 200A to be in the calibration position;

[0243] 3) The transmission mechanical arm 411 makes the T-shaped swing rod 204 perpendicular to the plane of the head frame 200A;

[0244] 4) Tighten the clamping screws 417 to secure the headstock 200A firmly on the angle control console 400 and keep it in the calibration position;

[0245] 5) The operation of the rotary drive motor 401 and the swing drive motor 406 can be as described above, and their control can be completed by the control circuit 419. The computer 410 can be equipped with an image processing system / software.

[0246] Puncture needle

[0247] The puncture needle 100 is configured to be inserted into and fixed in the hollow cavity of the T-shaped swing rod 204, i.e., the puncture channel 207.

[0248] like Figure 1-4 As shown, the puncture needle 100 may be provided with a scale 103 and may be equipped with a locking buckle 102, allowing the puncture depth of the puncture needle 100 to be adjusted according to the displayed scale. The locking buckle 102 may be configured to have a certain degree of positional flexibility, allowing it to move and position freely on the puncture needle 100, and to securely lock the locking buckle 102 onto the puncture needle 100 after the puncture needle 100 has been adjusted to a predetermined length. The acceleration sensor 104 may be mounted, for example... Figure 2-3 The tip shown (the upper end, or proximal end, shown in the figure, which is opposite to the distal end, or surgical end, of the puncture needle 100) or its vicinity can be used to measure the angular parameters during puncture.

[0249] The puncture needle 100 can be available in various sizes depending on the purpose or procedure, and can move smoothly within the puncture channel 207 for insertion or withdrawal.

[0250] Three-dimensional polar coordinate system and spatial positioning

[0251] Figure 20 It can be used Figure 1 A schematic diagram of the three-dimensional polar coordinate system established between the headframe 200A and the base 200B in the three-dimensional spatial orientation system shown. Figure 21 yes Figure 20 The three-dimensional polar coordinate system model shown is a schematic diagram for establishing the coordinate relationship between the head frame 200A, the base 200B and the lesion target point T.

[0252] Spatial polar coordinates, also known as spherical polar coordinates, are a type of three-dimensional polar coordinate system, extended from the two-dimensional polar coordinate system. They are used to determine the position of points, lines, surfaces, and volumes in three-dimensional space. They use the origin as a reference point and consist of azimuth, elevation, and distance. For example... Figure 20-21 As shown. The essence of how polar coordinates work in two dimensions is that a point in three-dimensional space can be specified by giving direction and distance. Spherical coordinates also function by defining direction and distance: in three dimensions, defining direction requires two angles, for example... Figure 20-21 The rotation angle φ (equivalent to φ in the attached figure, and used interchangeably in this document) and the oscillation angle θ are shown. The three-dimensional spherical space also has two polar axes: the first axis is "horizontal," corresponding to the polar axis in two-dimensional polar coordinates or +x in three-dimensional Cartesian conventions, and the other axis is "vertical," corresponding to "+z" in three-dimensional Cartesian conventions.

[0253] The headframe plane 501 refers to the plane established with the origin o 206 of the headframe 200A as the reference. On this plane, with the headframe origin o 206 as the center, the plane rotation ring 202 is a concentric circle within it, thus forming a fixed plane. This plane is composed of an infinite number of concentric circles, each with a different radius, but they all have the origin o of the headframe 200A as the center.

[0254] like Figure 20-21 As shown, in the three-dimensional spatial orientation system of the present invention, the three-dimensional rectangular coordinate system (x, y, z) 504 refers to a coordinate system established with the headframe plane 501 (e.g., the plane defined by the planar rotation ring 202) as the reference. The origin o 206 of the headframe 200A is the origin of the coordinate system, the axis in the os direction is the x-axis, the y-axis is the axis perpendicular to the x-axis after os has rotated 90° clockwise around the origin o in the headframe plane 501, and the axis perpendicular to the headframe plane 501 and downward through the origin o 206 is the z-axis.

[0255] The base plane 502 refers to the plane established with the developing ring 304 of the base 200B as a reference, which is parallel to the head frame plane 501.

[0256] The lesion plane 503 refers to a plane simulated based on the lesion target point T. This plane is set to be parallel to the base plane 502, and a two-dimensional coordinate system x'y' is established based on this plane. The origin (center) o' of this two-dimensional coordinate system (x', y') is the point mapped from the origin o of the head frame 200A along the z-axis of the three-dimensional rectangular coordinate system (x,y,z) 504 onto the lesion plane 503. Here, the x' axis is the mapping of the x-axis of the three-dimensional rectangular coordinate system (x,y,z) 504 onto the lesion plane 503, and the y' axis is the mapping of the y-axis of the three-dimensional rectangular coordinate system (x,y,z) 504 onto the lesion plane 503.

[0257] Figure 22It is applicable to an embodiment of the present invention. Figure 1 The diagram shows the process of simulating the calculation of the polar coordinates of the lesion target point T in the image processing system of the three-dimensional spatial orientation system.

[0258] like Figure 22 As shown, an example of the process for simulating the polar coordinates of the lesion target point T is as follows:

[0259] The patient's head was fitted with the 200B mounting and fixing base before a CT / MRI scan was performed.

[0260] Acquire the positional relationship, positional parameters, and / or images between the target lesion in the patient's skull and the imaging ring 304 of the base 200B;

[0261] Map a headstock plane 501 parallel to the plane of the developing ring 304 (i.e., the base plane 502) at a height h above it, and establish a three-dimensional rectangular coordinate system (x,y,z) 504 with the origin o based on the headstock plane 501.

[0262] A plane parallel to the plane of the imaging ring 304 is mapped downwards (i.e., the lesion plane 503 with its origin at o'), such that the lesion target point T lies within this plane, and its coordinates and positional relationship are as follows. Figure 21 As shown;

[0263] Calculate the length of the straight line between the lesion target point T and the origin o as r, calculate the angle ∠Too' formed between r and the z-axis as θ (corresponding to the swing angle θ), and calculate the angle ∠To'x' formed between the line connecting To' within the lesion plane 503 and the x' axis as φ' (corresponding to the rotation angle φ). Figure 21 As shown;

[0264] The lesion target point T is mapped onto the head frame plane 501 to obtain point T'. At this time, the angle φ' is equal to the corresponding angle φ in the head frame plane 501.

[0265] The image processing system of a three-dimensional spatial orientation system can be configured according to, for example... Figure 22 Process simulation reconstruction Figure 20-21 The coordinate relationships are as follows. The diameter of the imaging ring 304 is d, and the height of the head frame 200A is h. In a three-dimensional rectangular coordinate system (x, y, z) 504 established with the head frame plane 501 as the reference and the origin at o, the coordinates of point s are (d / 2, 0, 0), the coordinates of point s' are (d / 2, 0, h), the coordinates of point o' are (0, h, 0), and the coordinates of the lesion target point T are... The coordinates of the mapping point T' corresponding to the lesion target point T are: If we use a three-dimensional spherical polar coordinate system established at the origin o, then the polar coordinates of the lesion target point T can be obtained as (r, θ, φ).

[0266] in accordance with Figure 21 As shown, by adjusting the puncture depth of the puncture needle 100 and adjusting the rotation angle φ and swing angle θ of the head frame 200A, the lesion target point T can be accurately punctured.

[0267] The puncture depth L of the puncture needle 100 is the sum of the length (r) of the puncture path oT and the length r1 of the vertical axis 213, that is, L = r + r1.

[0268] like Figure 20-21 As shown, angle φ is the angle by which the headframe 200A rotates on the headframe plane 501, that is, the rotation angle is 216. Figure 8 As shown.

[0269] like Figure 20-21 As shown, angle θ is the angle of swing of the T-shaped swing rod of the head frame 200A along its longitudinal axis 213, that is, the swing angle 218. Figure 9 As shown.

[0270] Manual operation of three-dimensional spatial orientation system

[0271] Figure 23 It is applicable to an embodiment of the present invention. Figure 1 A schematic diagram illustrating the general aspects of manual operation of the three-dimensional spatial orientation system. The general content of this manual operation may include: performing a CT / MRI scan by wearing a base 200B on the patient's skull, reconstructing a three-dimensional image using an image processing system, and calculating the coordinate relationship between the lesion target point T and the base (and the head frame), thereby obtaining and providing angle data (θ and φ) and puncture depth data (L); determining the initial position of the head frame 200A using a calibration fixture, and then fixing it with locking screws before removing the head frame 200A; fixing the head frame 200A to the base 200B by matching the positioning hole 225 and the locking post 306, or by fixing it to the base 200B by, for example, screws; manually operating and adjusting the head frame 200A to achieve the target angle according to the corresponding angle data and puncture depth data; manually adjusting the locking buckle of the puncture needle 100 to the target position and locking it; installing and adjusting the puncture needle 100 and puncturing it through the puncture channel 207 to puncture the lesion target point T.

[0272] Figure 24 It is applicable to an embodiment of the present invention. Figure 1 The diagram illustrates the manual operation procedure for the three-dimensional spatial orientation system. An example of this manual operation procedure may include (the operations are not limited to the order described herein):

[0273] The 200B base bracket is locked (fixed) to the patient's skull using titanium screws;

[0274] The patient was instructed to wear the 200B base during a CT / MRI scan.

[0275] The image processing system acquires images of the base 200B and the patient's lesion;

[0276] The image processing system performs 3D reconstruction and simulation of the head frame position, and obtains the coordinate relationship between the lesion target point T and the base (and head frame);

[0277] The path optimization calculation yields the corresponding angle (θ and φ) data and puncture depth (L) data;

[0278] The angle detection and control circuit 209 of the head frame 200A receives angle (θ and φ) and puncture depth (L) data calculated by the image processing system via wireless communication;

[0279] The headstock 200A is placed in its initial position (which can be set at the factory), or the initial position of the headstock 200A can be determined using a calibration fixture;

[0280] The head frame 200A is fixed to the base 200B by, for example, three locking posts 306;

[0281] The sensors on the headgear 200A are calibrated using, for example, an image processing system (image processing software);

[0282] Based on the angle data, loosen the rotary locking screw 231A, manually rotate the T-shaped swing arm of the head frame 200A to rotate it to the target rotation angle φ, and tighten the rotary locking screw 231A to prevent the plane rotating ring 202 from rotating.

[0283] Based on the angle data, loosen the swing locking screw 231B, manually rotate the T-shaped swing rod 204 of the head frame 200A to make it swing to the target swing angle θ, and tighten the swing locking screw 231B to prevent the swing rod 204 from swinging.

[0284] Based on the puncture depth data, manually adjust the locking mechanism of the puncture needle 100 to achieve the target puncture depth and lock it in place; and

[0285] The puncture needle 100 is used for puncture through the puncture channel 207 of the T-shaped swing rod 204.

[0286] Automated operation of three-dimensional spatial orientation system

[0287] Figure 25 It is applicable to an embodiment of the present invention. Figure 1This diagram illustrates the general aspects of the automated operation of the three-dimensional spatial orientation system. The general aspects of this automated operation may include: performing a CT / MRI scan by wearing a base 200B on the patient's skull; reconstructing a three-dimensional image using an image processing system; calculating the coordinate relationship between the lesion target point T and the base (and the head frame); thereby obtaining and providing angle data (θ and φ) and puncture depth data (L); mounting the head frame 200A (e.g., without sensors and control circuitry) onto the fixing bracket 420 of the angle control console 400 through positioning holes 225; and automatically calibrating the head frame 200A using the angle control console 400, and performing automated calibration... After preparation, based on the corresponding angle data (θ and φ) and puncture depth data (L), the angle control console 400 automatically adjusts to the target angle (θ and φ) and automatically fixes it with locking screws; and automatically adjusts the locking buckle on the puncture needle 100 to the target depth (L) and locks it; the head frame 200A is removed and fixed to the base 200B by matching the positioning hole 225 and the locking post 306, or it can be fixed to the base 200B by, for example, screws; the installed and adjusted puncture needle 100 is punctured through the puncture channel 207, so that the puncture needle 100 punctures the lesion target point T.

[0288] Figure 26 It is applicable to an embodiment of the present invention. Figure 1 The diagram shows the automated implementation process of the three-dimensional spatial orientation system.

[0289] An example of the process for automating operations may include (the operations are not limited to the order described herein):

[0290] The 200B base bracket is locked (fixed) to the patient's skull using titanium screws;

[0291] The patient was instructed to wear the 200B base during a CT / MRI scan.

[0292] The image processing system acquires images of the base 200B and the patient's lesion;

[0293] The image processing system performs 3D reconstruction and simulation of the head frame position, and obtains the coordinate relationship between the lesion target point T and the base (and head frame);

[0294] The path optimization calculation yields the corresponding angle (θ and φ) data and puncture depth (L) data;

[0295] The control circuit 419 of the angle control console 400 receives angle (θ and φ) and puncture depth (L) data calculated by the image processing system;

[0296] Position the headstock 200A in its initial position (which can be set at the factory). Mount the headstock 200A on the fixed bracket 420 of the angle control console 400. Since the mechanical claw 413 of the headstock clamping mechanism 412 is tightly pressed against the horizontal axis 212 of the headstock 200A, the headstock 200A can be positioned in its initial position.

[0297] Click the calibration button on the operation display interface of the angle control console 400 to perform automatic calibration;

[0298] Based on the angle data, the angle control console 400 automatically adjusts the rotation angle φ of the T-shaped swing arm of the head frame 200A by driving the motor bracket 405 and the transmission mechanical arm 411 through the rotary motor assembly 401A, so that it reaches the target angle.

[0299] Lock the rotating part of the head frame 200A, which has been adjusted to the target angle, in place, for example by tightening the rotating locking screw 231A in the rotating locking hole 231 of the support frame 201 (for example, refer to the corresponding part above), so that the planar rotating ring 202 cannot rotate.

[0300] Based on the angle data, the angle control console 400 drives the transmission mechanical arm 411 through the swing motor assembly 406A to automatically adjust the swing angle θ of the T-shaped swing arm of the head frame 200A so that it reaches the target angle.

[0301] Lock the swinging part of the headstock 200A, which has been adjusted to the target angle, in place, for example, by tightening the swing locking screw 231B on the transverse bearing housing 211 (e.g. Figure 6 As shown (refer to the corresponding section above), this prevents the swing arm from swinging.

[0302] Based on the puncture depth data, the angle control console 400 can automatically adjust the locking buckle of the puncture needle 100 to achieve the target puncture depth and automatically lock it with the locking screw.

[0303] Remove the headgear 200A, which has been adjusted to the target angle, and install it onto the base 200B, which is fixed to the patient's skull; and

[0304] Remove the puncture needle 100 after adjusting the puncture depth, and perform the puncture operation through the puncture channel 207 of the T-shaped swing rod 204.

[0305] One or more embodiments of the innovative three-dimensional spatial orientation system of the present invention provide numerous technical advantages over the prior art, including but not limited to the following:

[0306] 1) By fixing a small base to the skull, a coordinate relationship between the lesion target and the base can be established. Since the base, serving as a reference, is directly fixed to the skull, the relative position of the head frame's internal structure to the base is fixed and definite, allowing those skilled in the art to more accurately determine the precise location between the head frame and the lesion target. This method helps surgeons to more accurately locate and manipulate the lesion during surgery, improving surgical positioning accuracy and ensuring the safety and precision of the procedure.

[0307] 2) The planar rotating ring and swing rod of the head frame are concentric, allowing for precise positioning within a plane. Combined with the length of the puncture needle, precise spatial positioning can be achieved.

[0308] 3) The separate design and detachable assembly of the headframe and base allow for automatic and manual angle adjustments, facilitating operation. Furthermore, in many steps and procedures, it is not necessary to install all or part of the headframe assembly on the patient. This effectively reduces the size and weight of the implanted brain tissue, making it more portable and alleviating the burden on the patient.

[0309] 4) The swing angle can be measured by installing high-precision sensors on the swing arm and / or puncture needle of the head frame. Simultaneously, algorithms such as the six-sided calibration algorithm can be used to improve measurement accuracy.

[0310] 5) The relative angle of rotation can be measured by embedding a magnetic ring inside the planar rotating ring and installing an off-axis magnetically encoded angle sensor at its tangent position. Furthermore, software calibration algorithms can be used to process the measurement data, enabling more accurate angle measurements and improving the performance and stability of the 3D spatial orientation system.

[0311] 6) Biocompatible screws can be made of titanium, a material with good biocompatibility and strength, which can be stably fixed in the patient's body tissue. The contrast ring can be a metal ring embedded in a ring-shaped body. Furthermore, the contrast ring can also be a ring-shaped marker provided by a contrast agent or a ring coated with a contrast agent, which can produce a clear mark in, for example, scanned images, helping to accurately locate and identify target areas. By combining the use of titanium screws and contrast rings, CT / MRI images can provide clearer and more accurate information, reducing reference coordinate system errors.

[0312] 7) The puncture angle and / or depth can be automatically adjusted via the angle control console, effectively improving the accuracy, repeatability, and convenience of the procedure. The automatic adjustment of the puncture angle using the angle control console, and the use of a compact, high-precision angle sensor to measure the angle, further simplifies system configuration and operation, improves positioning accuracy, and reduces the learning time for doctors to use the equipment.

[0313] 8) An angle control can be made more precise by using a drive motor, such as a stepper motor, to drive a reduction gear and by setting a high-precision encoder at the end of the reduction gear.

[0314] The foregoing description of several embodiments of the invention has been provided for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the invention to the precise steps and / or forms disclosed; clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A head frame assembly for a three-dimensional spatial orientation system in neurosurgical procedures, characterized in that, The headframe assembly includes: A base configured for fixation to a patient's skull, the base comprising a support having an annular body, a plurality of biocompatible screws mounted on the support, and a radiopaque ring, wherein the upper surface of the annular body of the support is flat, the radiopaque ring is concentrically disposed on the annular body and close to its inner periphery, the plane of the radiopaque ring being flush with the plane of the upper surface of the annular body, wherein the radiopaque ring is marked with a zero-scale point, the radiopaque ring and the zero-scale point being identifiable by CT or MRI imaging technology, the outer diameter of the annular support being less than or equal to 40 mm, and the annular body of the support having three circumferentially spaced locking posts; and A head frame, comprising: a support frame; a planar rotating ring rotatably mounted on the support frame; a top cover mounted on the planar rotating ring and having a dial displaying a rotation angle φ; and a T-shaped swing rod consisting of a horizontal axis and a vertical axis, the T-shaped swing rod being configured to swing controllably at a swing angle θ and to rotate controllably with the planar rotating ring at a rotation angle φ; wherein the vertical axis is axially hollow, defining a puncture channel for detachable insertion of a puncture needle, and the intersection point of the horizontal axis and the vertical axis is concentric with the planar rotating ring; A magnetic ring is coaxially arranged on the planar rotating ring and rotates together with it. An angle detection and control circuit is provided on the head frame. The angle detection and control circuit is equipped with a rotation angle sensor, an acceleration sensor, a signal processing circuit and a main control MCU. The rotation angle sensor is an off-axis magnetically encoded angle sensor. The rotation angle sensor is installed tangent to the edge of the magnetic ring and is used to detect the rotation angle φ. A swing angle sensor is provided at or near the top of the longitudinal axis of the T-shaped swing rod to detect the swing angle θ. The swing angle sensor is an acceleration sensor. The support frame includes a support ring body and three support columns that are disposed on the support ring body, extend axially upward and are circumferentially spaced apart. Each support column is provided with a rotation locking hole and a corresponding rotation locking screw. The support ring body, the planar rotating ring, the magnetic ring and the upper cover are arranged coaxially. The upper cover is mounted on the planar rotating ring. The upper cover is generally disc-shaped and has a handle. The upper cover is provided with a scale for displaying the rotation angle. The scale is marked with a rotation angle mark and a calibration zero mark. The support ring body is provided with three circumferentially spaced positioning holes. The head frame is detachably fixed to the base by means of the cooperation between the three positioning holes and the three locking posts, and forms a unique assembly position relationship, so that the zero scale point of the developing ring is aligned with the calibration zero scale point of the upper cover. In the calibration state of the head frame assembly, the horizontal bearing seat of the T-shaped swing rod is aligned with the zero mark of the developing ring and the zero mark of the calibration. The dial is marked with a rotation angle indicator and a calibration zero mark. In the initial or calibration state of the head assembly, the zero mark of the developing ring is aligned with the calibration zero mark, and the horizontal bearing seat is aligned with the zero mark of the developing ring and the calibration zero mark. The head frame assembly also includes a puncture needle, which is configured to be detachably inserted into the puncture channel. The puncture needle is equipped with a locking buckle and a locking screw, and the puncture needle is marked with scale markings.

2. The headframe assembly according to claim 1, characterized in that, The inner circumference of the planar rotating ring is provided with two horizontal bearing seats opposite each other in the diametrical direction. The two ends of the horizontal shaft are rotatably installed in the two horizontal bearing seats respectively, so that the vertical shaft can swing. The two horizontal bearing seats constitute the rotating locking hole.

3. The headframe assembly according to claim 1, characterized in that, The top end or near the longitudinal axis of the T-shaped swing rod is provided with a swing locking screw, which is used to lock the T-shaped swing rod so that it cannot swing.

4. The headframe assembly according to claim 1, characterized in that, The biocompatible screws are three titanium screws evenly spaced apart from each other along the outer periphery of the scaffold, and the imaging ring is a titanium metal ring.

5. The headframe assembly according to claim 1, characterized in that, The zero mark of the developing ring is in the form of a notch.

6. The headframe assembly according to claim 3, characterized in that, The headframe assembly uses a six-sided calibration algorithm to calibrate the swing angle θ.

7. The headframe assembly according to claim 1, characterized in that, The headframe assembly is configured to work in conjunction with the image processing system and the angle control console. The image processing system is configured to: perform three-dimensional reconstruction of CT / MRI scan images of the patient's skull and base; determine the imaging ring plane in the CT / MRI scan images as the base plane; and determine the lesion target point T within the patient's skull; map a head frame plane based on the base plane and the height h of the head frame, and thereby establish a three-dimensional rectangular coordinate system (x, y, z); calculate the length r of the straight line from the origin o of the three-dimensional rectangular coordinate system to the lesion target point T, and calculate the rotation angle φ and the swing angle θ; establish a three-dimensional polar coordinate system based on the origin o of the three-dimensional rectangular coordinate system, and obtain the polar coordinates (r, θ, φ) of the lesion target point T in the three-dimensional polar coordinate system; wherein the center point of the intersection of the horizontal and vertical axes of the T-shaped swing rod coincides with the origin o of the three-dimensional rectangular coordinate system; The angle control console includes: a fixed bracket for fixing the head frame and preventing it from shifting; a transmission device, one end of which is operably connected to a motor and the other end of which is operably connected to the head frame, and configured to manipulate the head frame to automatically adjust the rotation angle φ and the swing angle θ; a computer configured to send control commands to a control circuit via a serial port, the control circuit receiving control commands from the computer to control the rotation of the motor; wherein the transmission device is configured to automatically adjust the puncture depth of the puncture needle, thereby automatically adjusting the distance r.

8. The headframe assembly according to claim 1, characterized in that, The headframe assembly wirelessly receives data on the swing angle θ and rotation angle φ through the angle detection and control circuit.

Images