CN117257458A

CN117257458A - Headstock assembly

Info

Publication number: CN117257458A
Application number: CN202311416470.1A
Authority: CN
Inventors: 屈龙; 文平; 何文
Original assignee: Shenzhen Painuova Medical Technology Co ltd
Current assignee: Shenzhen Painuova Medical Technology Co ltd
Priority date: 2023-10-27
Filing date: 2023-10-27
Publication date: 2023-12-22

Abstract

The present invention relates to a headgear assembly comprising: a base configured for fixation on a brain of a patient, the base comprising a bracket, a plurality of biocompatible screws mounted on the bracket, and a visualization ring, wherein the visualization ring is provided with visualization ring zero scale points, the visualization ring and the visualization ring zero scale points being identifiable by CT or MRI imaging techniques; a headgear, the headgear comprising: a support frame; a planar rotary ring rotatably mounted on the support frame; an upper cover mounted on the plane rotary ring and having a dial for displaying the rotation angle phi; a swing lever constituted by a horizontal axis and a vertical axis, the swing lever being mounted so as to be capable of controlled swing at a swing angle θ and to be capable of controlled rotation at a rotation angle Φ together with the planar rotary ring; wherein the longitudinal axis is axially hollow defining a puncture path into which the puncture needle is removably inserted; wherein, the headstock is detachably fixed on the base.

Description

Headstock assembly

Technical Field

The invention relates to the field of innovative medical instruments, in particular to an innovative three-dimensional space orientation system for cranium brain surgery and a headstock assembly.

Background

Intracranial lesions vary in disease, lesions vary in location, and symptoms vary. The clinical symptoms of intracranial lesions are numerous, so that very precise targeting of the location and angle of penetration is required during intracranial surgery. The cerebral hemorrhage hematoma drainage, intracranial lesion biopsy, epileptic focus destruction, ventricular puncture external drainage, DBS electrode implantation and the like need to accurately position and adjust intracranial targets, and are common indications for stereotactic operations.

CN116327334a discloses a precise targeting positioning device for intracranial lesions, which comprises a cylindrical connecting rod, wherein the surface of the connecting rod is sleeved with a rotatable sleeve, the surface of the sleeve is integrally connected with a base, one surface of the base, which is far away from the sleeve, is rotationally connected with a gear disc through a rolling bearing, a guide tube is fixed on the gear disc, a fixed block is welded on one side of the gear disc on the surface of the base, a transverse shaft is inserted in the middle part of the fixed block, one end of the transverse shaft is fixedly connected with a pressing plate, the pressing plate is meshed with the surface of the gear disc, and two ends of the connecting rod are fixedly connected with spring clamping plates; according to the invention, the upper and lower angle directions of the guide tube can be adjusted by rotating the sleeve on the surface of the connecting rod, and the left and right directions of the guide tube can be adjusted by rotating the gear disc on the base, so that the device is convenient to adjust and operate, and the accurate targeting positioning of the puncture needle is ensured.

CN112022353a discloses a surgical robot surgical instrument locating component, belong to sand screening device technical field, its technical scheme main points include operation control panel and fixed bolster, the lower terminal surface fixedly connected with of fixed bolster adjusts servo motor, the automatically controlled expansion joint of preceding terminal surface of two fixed plates, the left and right sides of two fly leaves all is provided with first stop nut with first movable round pin axle assorted, the left and right sides of connecting jaw all is provided with the second stop nut with second movable round pin axle assorted, X drive lead screw is located the place ahead of connecting axle, Y drive lead screw is located the rear of connecting axle, the middle part of X drive seat is provided with the drive slider, the up end fixedly connected with fine adjustment servo motor of drive slider, the lower terminal surface of drive slider is provided with flexible art sword connecting rod, the surgical instrument realizes X, Y and the drive of three direction of Z, make the nimble and the convenient performance improvement of surgical instrument, the accurate drive location of surgical instrument of being convenient for makes the surgical instrument satisfy the precision requirement of wound.

CN112089481a discloses an automatic guiding device for a CT puncture needle, which comprises a first driving rod and a second driving rod, wherein the first driving rod is connected with a first toothed plate meshed with a first gear, the second driving rod is provided with a second toothed plate meshed with a second gear, a guiding sleeve for the puncture needle to pass through is slidingly connected with a first long sliding hole, so as to guide the puncture needle, and the lower end of the guiding sleeve passes through a second long sliding hole and is slidingly connected with the second long sliding hole. The invention has the following beneficial effects: the first driving rod and the second driving rod respectively control the first guide frame and the second guide frame to rotate, and the guide sleeve respectively moves along the first long sliding hole and the second long sliding hole so as to change the angle of the guide sleeve for guiding the puncture needle in a three-dimensional way, thereby realizing the automatic guiding of the puncture needle to puncture the angle and accurately positioning the puncture angle.

CN116602742a discloses a puncture auxiliary device for ventricular puncture drainage operation, which comprises a reference piece and a puncture needle ring fastener, wherein the reference piece and the puncture needle ring fastener are both in a sheet structure with a central opening, the reference piece is fixed on the head, and the puncture needle ring fastener axially coincides with the central opening of the reference piece and has a diameter difference smaller than 1mm. The puncture needle ring firmware extends out of an extension part with a bending structure, the reference part is provided with a groove matched with the extension part, and a fixing structure is formed after the extension part is matched with the groove to connect and fix the reference part and the puncture needle ring firmware. The reference piece can be fixed according to the puncture position, the puncture needle ring firmware can adjust the angle to assist in puncture after the hole is opened, and the puncture needle ring firmware ensures the stability of puncture. The puncture needle ring firmware can be matched with the skull tapping drill ring firmware to ensure the bacteria isolation effect in the puncture drainage process and avoid intracranial infection.

In the above prior art solutions, there are a number of problems and drawbacks, such as: the product has a plurality of parts, is heavy, is inconvenient to assemble and has long operation preparation time; the puncture angle is complicated to calculate, and the precision of the puncture angle depends on the experience of an operator; the marker is applied to the scalp, the position of the marker is not strictly fixed, and the precision is affected; the adjusting joint is too sensitive and inconvenient for adjustment; the whole equipment has complex structure, high manufacturing cost and high price.

Thus, there is a need in the art for innovative new three-dimensional spatial orientation systems for cranium surgery to alleviate or even overcome the deficiencies of the prior art and to achieve further beneficial technical effects and advances.

The information included in this background section of the specification of the present invention, including any references cited herein and any descriptions or discussions thereof, is included solely for the purpose of technical reference and is not to be construed as a subject matter that would limit the scope of the present invention.

Disclosure of Invention

The present invention has been made in view of the above and other further ideas.

With the progress of computer processing speed and imaging technology, the inventor of the patent creatively proposes a three-dimensional space positioning system/means based on the combination of medical imaging reconstruction calculation and three-dimensional stereotactic headstock/nerve navigation and other technologies according to the current state of the art and characteristics of the brain cranium surgery field, so as to serve as an improved intracranial focus target point (sometimes interchangeably called as a focus) for clinical application. The three-dimensional space orientation system of the present invention and its various components and associated methods may also be used for more purposes including, but not limited to, pre-operative analysis, simulation and training, teaching, training, research and development by medical college students and practitioners, and the like.

The concept according to one aspect of the present invention aims to provide an innovative three-dimensional spatial orientation system that can be used for cranium surgery. The three-dimensional space orientation system includes: the base is configured to be fixed on the brain of a patient in a position-unchanged manner and comprises a bracket and a developing ring arranged on the bracket, wherein the developing ring is provided with developing ring zero scale points, and the developing ring zero scale points can be identified by CT or MRI imaging technology; a headgear mounted on the base, wherein the headgear comprises: the headstock is detachably and fixedly arranged on the base through the support frame; a planar rotating ring mounted on the support frame; the upper cover is fixed on the support frame and is pressed above the plane rotating ring, so that the plane rotating ring is controllably and rotatably arranged between the support frame and the upper cover; the transverse shaft of the swinging rod is arranged in the diameter direction of the plane rotating ring and can rotate along with the plane rotating ring in a controlled way by a rotation angle phi; the longitudinal axis is mounted to be capable of controlled oscillation at an oscillation angle θ, wherein the longitudinal axis defines a puncture path for insertion of a puncture needle; the magnetic ring is embedded on the plane rotating ring; an image processing system configured to: three-dimensional reconstruction is carried out on CT/MRI scanned images of the brain and the base of the patient, a developing ring plane in the CT/MRI scanned images is determined to be a base plane, and a focus target point T in the brain of the patient is determined; mapping a head frame plane according to the base plane and the height h of the head frame, and thereby establishing a three-dimensional rectangular coordinate system (x, y, z); calculating the length r of a straight line from the origin o of a three-dimensional rectangular coordinate system (x, y, z) to a focus target T, and calculating to obtain a rotation angle phi and a swing angle theta; establishing a three-dimensional polar coordinate system based on an origin o of a three-dimensional rectangular coordinate system (x, y, z), and obtaining a polar coordinate of a focus target T in the three-dimensional polar coordinate system as (r, theta, phi); wherein the crossing center point of the transverse axis and the longitudinal axis of the swinging rod coincides with the origin o of the three-dimensional rectangular coordinate system (x, y, z).

According to one embodiment, an image processing system includes a control display module configured to send a calibration command and display a current angular state of a headgear in real time; and

the image processing system is configured to further plan a penetration path of the penetration needle based on the polar coordinates (r, θ, φ) data of the lesion target point T.

According to an embodiment, the base further comprises a plurality of biocompatible screws disposed along the developing ring.

According to one embodiment, the headgear further includes an angle detection control circuit secured at the upper cover.

According to an embodiment, the angle detection control circuit is internally provided with a rotation angle sensor and a body posture sensor, wherein the rotation angle sensor is installed tangentially to the magnetic ring.

According to one embodiment, the three-dimensional spatial orientation system further comprises an angle console operatively connected to the headgear.

According to one embodiment, an angle console includes: a fixing bracket for fixing the head frame so as not to deviate; a transmission having one end operatively connected to the motor and the other end operatively connected to the head and configured to operate the head to automatically adjust the rotation angle phi and the swing angle theta; and the computer is configured to send a control instruction to the control circuit through the serial port, and the control circuit receives the control instruction from the computer to control the rotation of the motor.

According to an embodiment, the transmission is configured to be able to automatically adjust the penetration depth of the puncture needle, such that the distance r can be automatically adjusted.

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

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

According to an embodiment, the support frame is further provided with a locking screw therein.

According to one embodiment, the three-dimensional space orientation system calibrates the swing angle θ by a six-sided calibration algorithm.

According to an embodiment, the image processing system is configured to: image data identified by CT or MRI imaging techniques is acquired and processed.

According to one embodiment, the manual adjustment upper cover is provided with a cavity surface for fixing the angle detection control circuit.

According to one embodiment, the transverse and longitudinal axes are integrally formed such that the T-shaped swing arm is T-shaped.

According to one embodiment, the puncture needle is fixed in the puncture track by means of a snap-in lock and a snap-in screw, wherein the puncture needle defines the puncture depth by means of the snap-in lock.

According to an embodiment, the image processing system comprises image processing software configured in the three-dimensional spatial orientation system or installed in a separate computer outside the three-dimensional spatial orientation system.

According to one embodiment, the motor is a high precision servo motor and the drive means is a drive shaft mounted through the central longitudinal axis of the head frame.

According to an embodiment, the origin o substantially coincides with the centre of the plane rotation ring.

According to one embodiment, 0.ltoreq.φ < 360 DEG, -45 DEG < θ < 45 deg.

According to another aspect of the present invention, there is provided a headgear assembly comprising: a base configured for fixation on a brain of a patient, the base comprising a bracket, a plurality of biocompatible screws mounted on the bracket, and a visualization ring, wherein the visualization ring is provided with visualization ring zero scale points, the visualization ring and the visualization ring zero scale points being identifiable by CT or MRI imaging techniques; a headgear, the headgear comprising: a support frame; a planar rotary ring rotatably mounted on the support frame; an upper cover mounted on the plane rotary ring and having a dial for displaying the rotation angle phi; a swing lever constituted by a horizontal axis and a vertical axis, the swing lever being mounted so as to be capable of controlled swing at a swing angle θ and to be capable of controlled rotation at a rotation angle Φ together with the planar rotary ring; wherein the longitudinal axis is axially hollow defining a puncture path into which the puncture needle is removably inserted; wherein, the headstock is detachably fixed on the base.

According to an embodiment, the holder is a holder of an annular body, the plurality of biocompatible screws are arranged spaced apart from each other along an outer periphery of the annular body, and the developing ring is concentrically disposed on the annular body near an inner periphery thereof; the support frame comprises a support ring body and a plurality of support columns which are arranged on the support ring body, extend upwards in the axial direction and are circumferentially spaced; a magnetic ring which rotates together with the plane rotating ring is also coaxially arranged on the plane rotating ring; the upper cover is disc-shaped as a whole and is provided with a handle; the vertical axis of the swinging rod can swing in a controlled manner at a swinging angle theta, and the horizontal axis is arranged in the diameter direction of the plane rotating ring and can rotate in a controlled manner along with the plane rotating ring at a rotating angle phi; the vertical axis is perpendicular to the horizontal axis; wherein the support ring body, the planar rotating ring, the magnetic ring and the upper cover are coaxially arranged.

According to one embodiment, the rocking beam is a T-shaped rocking beam, and the intersection center point of the transverse axis and the longitudinal axis is concentric with the planar rotary ring.

According to an embodiment, the inner circumference of the planar rotary ring is provided with two diametrically opposed lateral bearing seats, and both ends of the lateral shaft are rotatably mounted in the two lateral bearing seats, respectively, so that the longitudinal shaft can oscillate.

According to one embodiment, the headgear assembly further includes a puncture needle configured to be removably inserted into the puncture track.

According to an embodiment, a swing angle sensor for detecting a swing angle θ is provided on the swing lever or the puncture needle; the headstock is provided with an angle detection control circuit which is provided with a rotation angle sensor for detecting the rotation angle phi.

According to one embodiment, a rotational locking hole and corresponding rotational capture screw are provided on each support post.

According to an embodiment, a plurality of circumferentially spaced apart positioning holes are also provided in the support ring, a corresponding plurality of detent posts are provided in the annular body of the bracket, and the headgear is removably secured to the base by means of cooperation between the plurality of positioning holes and the plurality of detent posts.

According to one embodiment, the developing ring is marked with developing ring zero scale points, and the dial is marked with rotation angle marks and calibration zero scale points.

According to one embodiment, in an initial or calibration state of the headgear assembly, the developing ring zero-scale points are aligned with the calibration zero-scale points.

According to one embodiment, the developing ring zero scale points are in the form of notches.

According to one embodiment, the dial is marked with a rotation angle mark and a calibration zero scale point; in the calibration state of the headstock assembly, the transverse bearing seat is aligned with the developing ring zero-scale point and the calibration zero-scale point.

According to one embodiment, the puncture needle is provided with a click button and a click screw.

According to one embodiment, the puncture needle is provided with scale marks.

According to one embodiment, the headgear assembly is configured as a three-dimensional spatial orientation system for cranium surgery.

According to a further aspect of the present invention there is provided a method of manually adjusting the spatial orientation of a three-dimensional spatial orientation system, the method comprising the steps of: s1: fixing the base of the three-dimensional spatial orientation system to the skull of the patient; s2: allowing the patient to wear the base for CT/MRI scanning; s3: an image processing system of the three-dimensional space orientation system acquires and processes images of the base and the patient focus; s4: the image processing system reconstructs and simulates a headstock of the three-dimensional space orientation system in a three-dimensional way, and obtains the coordinate relation between a focus target T and the headstock and between the base; s5: the path optimization calculation is carried out to obtain the swing angle theta and the rotation angle phi of the swing rod of the headstock and the puncture depth L data; s6: the headstock receives the swing angle theta and the rotation angle phi and puncture depth L data; s7: fixing the headstock to the base; and S8: according to the data of the swinging angle theta and the rotating angle phi, the swinging angle and the rotating angle of the swinging rod are manually adjusted to respectively reach the target angles theta and phi.

According to one embodiment, the headstock is placed in an initial position prior to step S7.

According to one embodiment, the head rest is calibrated prior to step S7.

According to an embodiment, the calibration is performed manually by a calibration jig or automatically by an angle console of a three-dimensional spatial orientation system.

According to one embodiment, in step S6, the headgear wirelessly receives swing angle θ and rotation angle Φ and penetration depth L data via the angle detection control circuit.

According to an embodiment, the method further includes step S9: according to the puncture depth L data, the clamping buckle of the puncture needle is manually moved to the target scale position of the puncture needle, and then is fixed by the clamping screw, so that the puncture depth L reaches the target puncture depth.

According to an embodiment, the method further includes step S10: the puncture needle is punctured to a focus target point T through a puncture path.

According to an embodiment, in step S8, after the target angle is reached, the position of the swing lever is locked.

According to an embodiment, locking the position of the swing lever is performed by adjusting a rotation lock screw and a swing lock screw of the head frame.

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

According to another aspect of the present invention, there is provided a method of automatically adjusting the spatial orientation of a three-dimensional spatial orientation system, the method comprising the steps of: s1: fixing the base of the three-dimensional spatial orientation system to the skull of the patient; s2: allowing the patient to wear the base for CT/MRI scanning; s3: an image processing system of the three-dimensional space orientation system acquires and processes images of the base and the patient focus; s4: the image processing system reconstructs and simulates a headstock of the three-dimensional space orientation system in a three-dimensional way, and obtains the coordinate relation between a focus target T and the headstock and between the base; s5: the path optimization calculation is carried out to obtain the swing angle theta and the rotation angle phi of the swing rod of the headstock and the puncture depth L data; s6: the angle control console of the three-dimensional space orientation system receives the swing angle theta and the rotation angle phi and puncture depth L data; s7: fixing the headstock on an angle control console and automatically completing position zeroing; and S8: and the angle control console automatically adjusts the swing angle theta and the rotation angle phi of the swing rod according to the swing angle theta and the rotation angle phi data so as to enable the swing angle theta and the rotation angle phi to reach a target angle.

According to one embodiment, the headstock is placed in an initial position prior to step S8.

According to one embodiment, the headstock is automatically calibrated by means of an angle control console prior to step S8.

According to one embodiment, in step S6, the headgear receives swing angle θ and rotation angle φ and penetration depth L data via control circuitry (419) of the angle console.

According to an embodiment, the method further includes step S9: the angle control console automatically adjusts the clamping buckle of the puncture needle inserted into the puncture channel of the swing rod according to the puncture depth L data so as to achieve the target puncture depth.

According to an embodiment, the method further includes step S10: and taking down the headstock and the puncture needle with the target puncture depth automatically adjusted to reach the target angle, and mounting the headstock on the base.

According to an embodiment, the method further includes step S11: the puncture needle is punctured to a focus target point T through a puncture path.

According to another aspect of the present invention, there is provided a susceptor including: a stent having an annular body, the annular body of the stent defining an outer perimeter and an inner perimeter; a plurality of biocompatible screws disposed spaced apart from one another along an outer periphery of the stent.

According to an embodiment, the base further comprises a developing ring disposed on the annular body proximate the inner periphery, wherein the developing ring is disposed concentric with the support.

According to an embodiment, the developing ring is a metal ring embedded on the annular body or is a contrast agent annular mark directly coated on the upper surface of the annular body, wherein the developing ring is provided with developing ring zero scale points and is matched with the annular body in a unique assembly position relationship.

According to one embodiment, the plane of the developing ring is disposed flush with the plane of the upper surface of the annular body.

According to an embodiment, the upper surface of the annular body is flat.

According to an embodiment, the plurality of biocompatible screws is at least 3 titanium screws arranged evenly spaced apart from each other along the outer periphery of the stent.

According to one embodiment, the developing ring is a titanium metal ring.

According to one embodiment, the developing ring zero scale point is a notch on the developing ring.

According to one embodiment, a plurality of clamping columns are arranged on the annular main body of the bracket.

According to an embodiment, the radial dimension of the generally annular support of the base, i.e. the outer diameter of the annular ring of the support, may be designed to be less than or equal to about 40mm. Such a design may facilitate miniaturization of the base, thereby helping to reduce the weight of the headgear and improve positioning accuracy, and to some extent, to optimize manufacturing and assembly tolerances of the headgear and base.

According to an embodiment, the plurality of detent posts are 3 detent posts disposed on the upper surface of the annular body and arranged spaced apart from each other in the circumferential direction.

According to another aspect of the present invention, there is provided a headgear comprising: the support frame comprises a support ring body and a plurality of support columns which are arranged on the support ring body, extend upwards axially and are circumferentially spaced; a planar rotary ring rotatably mounted on the support frame; the upper cover is fixed on the plane rotating ring, so that the plane rotating ring is controllably and rotatably arranged between the support frame and the upper cover; and a swing lever constituted by a lateral axis and a longitudinal axis, the swing lever being mounted so that the longitudinal axis can be controllably swung at a swing angle θ; wherein the transverse axis is mounted in the diameter direction within the planar rotating ring and is capable of controlled rotation with the planar rotating ring at a rotation angle phi; wherein the longitudinal axis is perpendicular to the transverse axis and the longitudinal axis is axially hollow defining a puncture; wherein the support ring body, the planar rotary ring and the upper cover are coaxially arranged.

According to an embodiment, a magnetic ring rotating together with the planar rotary ring is also coaxially arranged on the planar rotary ring.

According to one embodiment, the head frame is provided with a swing lock screw for locking the swing lever against swinging.

According to an embodiment, a swing angle sensor for detecting a swing angle θ of the swing lever is provided at or near the tip end of the longitudinal axis of the swing lever, wherein the swing angle sensor is an acceleration sensor.

According to an embodiment, a plurality of circumferentially spaced apart locating holes are also provided on the support ring body.

According to one embodiment, the upper cover is integrally disc-shaped and carries a handle and a dial.

According to one embodiment, the upper cover is generally disc-shaped and carries a handle and a dial for displaying the angle of rotation.

According to one embodiment, the upper cover is provided with an angle detection control circuit.

According to an 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.

According to an embodiment, the rotation angle sensor is positioned at a position tangential to an edge of the magnetic ring.

According to another aspect of the present invention, there is provided a method of automatically detecting and verifying an angle of a head frame by an angle detection control circuit configured with a rotation angle sensor, a signal processing circuit, an acceleration sensor, and a main control MCU, the method comprising the steps of: s1: the headstock is positioned at a calibrated initial zero position, and a rotation angle sensor is calibrated; s2: the magnetic field intensity of the magnetic ring of the headstock is acquired in real time through the rotation angle sensor, and the magnetic field intensity data is amplified and filtered through the signal processing circuit and transmitted to the main control MCU; s3: the main control MCU obtains the rotating angle of the magnetic ring through algorithm processing, and the angle serves as the rotating angle phi of the swinging rod of the headstock; s4: the main control MCU collects data of an acceleration sensor and sensor data on the swinging rod or the puncture needle; s5: the main control MCU obtains the swinging angle theta and the rotating angle phi of the swinging rod through algorithm processing according to the data in the steps S4 and S5; s6: the main control MCU sends data of the rotation angle phi and the swing angle theta to the image processing system in real time and compares the data with a target angle calculated by the image processing system; and S7: when the rotation angle phi and the swing angle theta are consistent with the corresponding target angles, prompt verification to pass.

According to one embodiment, the headgear is a headgear as described above; in step S4, the sensor data on the rocking beam or the puncture needle is acceleration sensor data.

According to another aspect of the present invention, there is provided an angle control console for automatically adjusting an angle of a head frame provided with a planar rotation ring rotatable at a rotation angle (Φ) with respect to the head frame, and a swing lever mounted on the planar rotation ring to be rotatable therewith, wherein the swing lever is mounted to be swingable at a swing angle (θ) with respect to the planar rotation ring, the angle control console comprising: a rotation drive assembly configured to drive rotation of the headgear; a swing drive assembly configured to drive the headgear to swing; a transmission robotic arm operatively connected to both the rotary drive assembly and the swing drive assembly; a control circuit configured to control the rotary drive assembly and the swing drive assembly; a computer configured to calculate a rotation angle (phi) and a swing angle (theta) and send commands to the control circuit; and a head holding mechanism for holding the fixed head; wherein the rotary drive assembly and the swing drive assembly are configured to receive control commands from the computer and/or control circuitry to drive and control components of the headgear by means of the transfer robot arm to perform automated control and adjustment of the angle of rotation and the angle of swing of the headgear.

According to one embodiment, the drive robotic arm is configured to operatively connect and manipulate the swing lever to controllably rotate and swing to perform automated control and adjustment of the rotation angle and swing angle.

According to one embodiment, the driving mechanical arm comprises a mechanical claw connecting piece, a mechanical claw detachably connected to the mechanical claw connecting piece and a spiral spring sleeved on the mechanical claw.

According to an embodiment, the oscillating bar is a T-shaped oscillating bar consisting of a longitudinal axis and a transverse axis, and the gripper of the driving robot is configured to grip or clamp onto the longitudinal axis of the T-shaped oscillating bar.

According to one embodiment, the rotary drive assembly includes a rotary drive motor mounted on a motor mount, and a rotary reduction gear and a rotary transmission gear operatively connected to the rotary drive motor.

According to an embodiment, the rotary drive assembly further comprises a rotary encoder, the rotary encoder and the control circuit being configured such that the control accuracy of the rotary transmission gear is up to 0.02 °.

According to one embodiment, the swing drive assembly includes a swing drive motor mounted on a motor mount, and a swing reduction gear and a swing transmission operatively connected to the swing drive motor.

According to an embodiment, the wobble drive assembly further comprises a wobble encoder, the wobble encoder and the control circuit being configured such that the control accuracy of the wobble transmission is up to 0.02 °.

According to an embodiment, the driving robot arm automatically controls and adjusts the swing angle by controlling the swing of the longitudinal axis, and the rotation angle by controlling the rotation of the longitudinal axis and the planar rotation ring.

According to one embodiment, a headgear clamping mechanism includes a clamping flap, a clamping screw, and a clamping base.

According to an embodiment, the angle console is configured to enable automated angle calibration of the head rest.

According to another aspect of the present invention, there is provided a method of automatically adjusting an angle of a head frame, the method being performed by an angle console, the method comprising the steps of: fixing the headstock on an angle control desk; one end of a transmission mechanical arm of the angle control console is operatively connected with both the rotary driving assembly and the swinging driving assembly, and the other end of the transmission mechanical arm of the angle control console is operatively connected with the headstock; an operator sends a control command through a computer or a control circuit; the rotary driving assembly and the swinging driving assembly receive control commands and drive the transmission mechanical arm to control corresponding parts of the headstock to execute automatic control and adjustment on the rotation angle and the swinging angle of the headstock.

According to an embodiment, the transmission robot arm performs automated control and adjustment of the rotation angle and the swing angle by manipulating the swing lever of the head frame.

According to one embodiment, the above method is performed by an angle console as described above.

In accordance with another aspect of the present invention, there is provided a method of three-dimensional reconstruction and spatial positioning of a headgear assembly including a base with a developer ring and a headgear mounted on the base, the headgear comprising: a planar rotary ring rotatably mounted on the support frame; a swing lever constituted by a horizontal axis and a vertical axis, the swing lever being capable of controlled swing at a swing angle θ, the horizontal axis being mounted in a diameter direction within the planar rotary ring and being capable of controlled rotation together with the planar rotary ring at a rotation angle Φ, a crossing center point (206) of the horizontal axis and the vertical axis being concentric with the planar rotary ring, and a vertical height from the developing ring to the crossing center point (206) being h; the method comprises the following steps: fixing the base on the skull of a patient, and performing CT/MRI scanning; three-dimensional reconstruction is carried out on the CT/MRI scanned image, wherein the plane of a developing ring in the CT/MRI scanned image is defined as a base plane (502), and a focus target T in the skull of the patient is determined according to the CT/MRI scanned image; mapping a headstock plane (501) parallel to the base plane (502) at a height h above the base plane and establishing a three-dimensional rectangular coordinate system (x, y, z) by taking the headstock plane (501) as a reference, wherein the (x, y) plane of the three-dimensional rectangular coordinate system coincides with the headstock plane (501), an origin o of the three-dimensional rectangular coordinate system coincides with a crossed central point (206), and a z-axis of the three-dimensional rectangular coordinate system passes through the origin o and is perpendicular to the headstock plane (501); mapping a focus plane (503) parallel to the base plane (502) below the base plane, so that a focus target point T is positioned in the focus plane (503), the origin of the focus plane is o ', and the x' axis of the focus plane is parallel to the x axis of a three-dimensional rectangular coordinate system; calculating the length r of a straight line from an origin o to a focus target T according to the CT/MRI scanned image; calculating an included angle Too 'between the straight line (r) and the z-axis, wherein the included angle Too' is equal to the swing angle theta; calculating an included angle To ' x ' formed by a To ' connecting line between a focus target point T and an origin o ' in a focus plane (503) relative To an x ' axis, wherein the included angle To ' x ' is equal To a rotation angle phi; and obtaining the polar coordinates of the focus target T in a three-dimensional spherical polar coordinate system established by the origin o, wherein the polar coordinates are (r, theta, phi).

According to an embodiment, the method includes: and the angle of the headstock is adjusted according to the parameters of polar coordinates (r, theta, phi).

According to an embodiment, the method further comprises: the headgear is mounted on the base with the headgear assembly in an initial state or zero scale calibration.

According to one embodiment, zero scale calibration includes aligning a developer ring zero scale point on the developer ring with a calibrated zero scale point on the head frame.

According to one embodiment, zero scale calibration includes aligning a transverse axis with a developing ring zero scale point on a developing ring or a calibrated zero scale point on a head frame.

According to an embodiment, the method includes: and adjusting the rotation angle and the swing angle of the swing rod according to the angle parameters of polar coordinates (r, theta, phi).

According to an embodiment, the method includes: after the rotation angle and the swing angle are adjusted, the position of the swing lever is locked.

According to an embodiment, the method includes: the puncture needle is inserted into the puncture channel of the swing rod, and the puncture depth L of the puncture needle is adjusted and fixed according to the parameter r of polar coordinates (r, theta, phi).

According to one embodiment, the penetration 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 oscillating bar.

According to an embodiment, the method includes: the gantry plane (501) and the three-dimensional rectangular coordinate system are corrected and/or verified based on the image of the planar rotating ring in the image of the CT/MRI scan.

Technical problems addressed by one or more aspects and embodiments of the present invention include, but are not limited to, the following:

for example, a neurosurgeon can perform brain surgery or preoperative training and simulation more safely and accurately, so that the success rate of the surgery is improved and the risk rate of the surgery is reduced;

the problems of improving the positioning precision and simplifying the operation flow are solved by optimizing the positioning coordinate system from the focus target point to the puncture path;

the problem of weight reduction of the headstock is solved by optimizing the headstock structural design and selecting medical grade PTFE as a main material;

in the optimization design of the headstock structure, for example, the base and the headstock are designed to be separable, and the angle of two different dimensions is adjusted from 2 different directions by adopting the T-shaped swinging rod to be matched with the rotating ring, so that the miniaturization of the headstock volume is realized, and the problems of reducing the headstock weight and improving the positioning precision are solved on the other hand;

the problems of few structural modularized parts, automatic path searching calculation of angles by an image processing system, automatic angle adjustment by an angle control console and optimization of a transmission mode are solved so as to simplify the operation flow;

The device is fixed on the skull through a base, and a high-precision attitude sensor such as an acceleration sensor, an algorithm calibration angle and an image processing system are adopted to calculate the angle so as to solve the problem of improving the positioning precision; and

the purpose of reducing the practical cost is achieved by means of controllable consumable cost and canceling large-scale expensive equipment.

Still other embodiments of the present invention are capable of achieving other advantageous effects not listed one by one and as such may be described in part below and as would be expected and appreciated by one skilled in the art upon reading the present invention.

Drawings

The above-mentioned and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the invention will be better understood by reference to the following description taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a schematic diagram of a three-dimensional spatial orientation system usable for cranium surgery according to one embodiment of the invention, illustrating the general overall configuration of the three-dimensional spatial orientation system embodiment.

Fig. 2 is a schematic diagram of a headgear assembly that may be used with the three-dimensional spatial orientation system of fig. 1, illustrating its general overall configuration and construction, according to an embodiment of the present invention.

FIG. 3 is a schematic view of a lancet assembly that may be used in the three-dimensional spatial orientation system of FIG. 1 according to one embodiment of the present invention.

FIG. 4 is a schematic view of a lancet scale line according to what can be used with the lancet assembly shown in FIG. 3.

Fig. 5 is an exploded schematic view of a headgear assembly that may be used with the headgear assembly of fig. 2 according to an embodiment of the present invention.

Fig. 6 is an overall schematic of the headgear of fig. 5 assembled from a top plan view.

Fig. 7 is an exploded view of the headgear T-swing stem and planar rotation ring of the headgear assembly of fig. 5-6 prior to assembly.

Fig. 8 is a schematic view illustrating a headgear of the headgear assembly of fig. 5-6 and how it rotates.

Fig. 9 is a schematic view of the headgear assembly of fig. 5-6 and how it oscillates.

Fig. 10 is a schematic diagram of an angle detection control circuit that may be used in the three-dimensional spatial orientation system of fig. 1 in accordance with one embodiment of the present invention.

Fig. 11 is a schematic view of a rotational angle sensor installation that may be used in the angle detection control circuit of the three-dimensional spatial orientation system of fig. 1 according to an embodiment of the present invention.

Fig. 12 is a schematic view of a base of a headgear assembly that may be used with the three-dimensional spatial orientation system of fig. 1 according to an embodiment of the invention.

Fig. 13A is a schematic perspective view of an assembled view of the headgear assembly of fig. 2, showing a planar alignment of the headgear, according to an embodiment of the present invention.

Fig. 13B is a schematic perspective view of the headgear assembly of fig. 13A from another perspective with the swing rod removed, showing a planar alignment of the headgear, according to an embodiment of the present invention.

FIG. 14A is an overall schematic of an assembled headgear and calibration jig that may be used with the three-dimensional spatial orientation system of FIG. 1 according to an embodiment of the invention.

Fig. 14B is an exploded view of the headgear and alignment jig of fig. 14A, showing the headgear assembly and alignment jig assembled therewith.

FIG. 15A is a schematic front view of an angle console that may be used in the three-dimensional spatial orientation system of FIG. 1, according to one embodiment of the invention.

FIG. 15B is a schematic block diagram of motor connections and control for an angle console that may be used in the three-dimensional spatial orientation system of FIG. 1, according to one embodiment of the invention.

FIG. 16 is a schematic side view of an angle console that may be used with the three-dimensional spatial orientation system of FIG. 1, according to one embodiment of the invention.

Fig. 17 is a schematic diagram of 2 motor combinations and installations that may be used for an angle console according to an embodiment of the invention.

FIG. 18A is a schematic view, partially in longitudinal section, of an assembled drive robot assembly usable for a degree console drive, according to one embodiment of the present invention.

Fig. 18B is an exploded view of the transfer robot device shown in fig. 18A.

Fig. 19 is a schematic view of a headgear clamping mechanism apparatus for clamping a headgear according to an embodiment of the invention.

FIG. 20 is a schematic view of a three-dimensional polar coordinate system established between a head and a base that may be used with the three-dimensional spatial orientation system of FIG. 1.

Fig. 21 is a schematic diagram of the three-dimensional polar coordinate system model of fig. 20 for establishing a coordinate relationship between a head, a base, and a lesion.

Fig. 22 is a schematic diagram of a process flow for simulating calculation of lesion polar coordinates by an image processing system usable in the three-dimensional spatial orientation system of fig. 1 according to an embodiment of the present invention.

FIG. 23 is a schematic diagram of the general content of a manual operation that may be used with the three-dimensional spatial orientation system of FIG. 1, in accordance with one embodiment of the present invention.

FIG. 24 is a schematic diagram of a manually implemented operational flow that may be used with the three-dimensional spatial orientation system of FIG. 1, according to one embodiment of the invention.

FIG. 25 is a schematic diagram of general content that may be used in the automated implementation of the three-dimensional spatial orientation system of FIG. 1 in accordance with one embodiment of the invention.

FIG. 26 is a schematic diagram of a system automation implementation process that may be used with the three-dimensional spatial orientation system of FIG. 1, in accordance with one embodiment of the present invention.

Reference numerals illustrate:

100-puncture needle; 200A-headstock; 200B-base; 400-angle console; 500-an image processing system; 600-calibrating the jig; 101-a lancet needle shaft; 102-a puncture needle clamping buckle; 103-puncture needle graduation; 104-an acceleration sensor; 105-clamping screws; 201-supporting frames; 201A-a support ring; 201B-support posts; 202-a planar rotating ring; 203-a magnetic ring; 204-T-shaped swing lever; 205-acceleration sensor; 208-upper cover; 207-puncture; 209-an angle detection control circuit; 210-calibrating zero scale points; 225-positioning holes; 206-headstock origin o; 211-a transverse bearing seat; 212-horizontal axis; 213-vertical axis; 224-longitudinal axis length r1; 214-a planar rotary ring initial position; 215-a post-rotation position of the planar rotating ring; 216—rotation angle (Φ); 217-direction of rotation of the planar rotating ring; 218-swing angle (θ); 219-T type swing rod swing back position; 220-T type swing lever initial position; 221-T type swinging direction of the swinging rod; 226—a rotation angle sensor; 227-a signal processing circuit; 228-an acceleration sensor; 229-master MCU;230-LED indicator lights; 231-a rotation locking hole; 231A-rotating the capture screw; 231B-swinging the capture screw; 232-PCB; 301-titanium screw; 302-a stent; 303-developing ring zero scale point s'; 304-a developing ring; 305-base origin o'; 306-a clamping column; 222-headstock rotation angle calibration point s (transverse bearing seat alignment zero position); 223-the headstock zero scale coincides with the base zero scale horizontally; 601-clamping clamp; 602-positioning columns; 603-zero scale points; 401A-a rotating electrical machine assembly; 401-a rotary drive motor; 402-rotating a reduction gear; 403-a rotary encoder; 404-rotating a transmission gear; 405-motor bracket; 406A-a swing motor assembly; 406-a swing drive motor; 407-oscillating a reduction gear; 408-a wobble transmission; 409-wobble encoder; 410-a computer; 411-driving mechanical arm; 412-a headgear clamping mechanism; 413—a gripper; 414-a spring; 415-a gripper connection; 416-grip flip; 417-clamping screws; 418-clamping the base; 419-control circuitry; 420-fixing a bracket; 501-a headstock plane; 502-a base plane; 503-focal plane; 504—three-dimensional coordinate system xyz; 505-headstock rotation start point s.

Detailed Description

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

It is to be understood that the illustrated and described embodiments are not limited in application to the details of construction and the arrangement of 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. Examples are provided by way of explanation, not 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 various 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 can be used with another embodiment to yield still a further embodiment. Accordingly, the present disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

The invention will be described in more detail below with reference to a number of specific embodiments thereof and with reference to the drawings accompanying the specification.

Three-dimensional space orientation system

As shown in fig. 1, an embodiment of the three-dimensional spatial orientation system may include a headgear assembly that may include a base 200B and a headgear 200A mounted on the base 200B. The headgear assembly may also include a lancet 100, the lancet 100 being mounted on the headgear 200A, such as by insertion into a T-shaped wobble bar mounted on the headgear 200A, as described in more detail below. The headgear assembly enables calibration and adjustment of the penetration path, penetration angle, and penetration depth of a lesion target T, as described in detail below.

In one example of the three-dimensional spatial orientation system of the present invention, the penetration path, including penetration angle and penetration depth, of a surgical device such as the needle 100 may be automatically adjusted. In this case, an angle console 400 is required, as shown in fig. 1.

Of course, in one example of the three-dimensional spatial orientation system of the present invention, the penetration path of the needle 100, including the penetration angle and penetration depth, can be manually adjusted by, for example, an operator such as a physician. In this case, those skilled in the art will appreciate that calibration and adjustment of the surgical device, such as the needle 100, may still be accomplished without the angle console 400 and the hardware and configuration associated therewith.

Embodiments of the three-dimensional spatial orientation system may also include an image processing system 500 (schematically represented by the cranium images processed therewith in FIG. 1) and a calibration jig 600, as schematically illustrated. The image processing system 500 may be used to perform data extraction, three-dimensional reconstruction, lesion path planning, angle calculation, and control display, among others. The calibration jig 600 may be used to determine an initial position of the rotation angle sensor and/or the acceleration sensor.

A general overview of the composition and configuration of a three-dimensional spatial orientation system is provided below, as is detailed below.

(1) Image processing system

The image processing system may be installed in a computer, for example, located in a doctor's office or operating room, or integrated into an angle console. One example of an image processing system may include a plurality of processing modules, such as data extraction, three-dimensional reconstruction, lesion path planning, angle calculation and control display modules, and so forth. The data extraction module can read the DICOM-format image data, and analyze and extract corresponding patient information. The three-dimensional reconstruction module can perform operations such as volume and surface drawing on the extracted data to realize three-dimensional reconstruction and simulate the origin plane of the headstock. The focus path planning module can plan a puncture path according to the focus and headstock model information reconstructed in three dimensions. The angle calculation module can perform image processing measurement according to the planned puncture path, and measure the plane rotation angle, the longitudinal axis swing angle and the depth from the focus target point to the origin of the headstock. The control display module can send calibration commands of the headstock and the sensor and display the current headstock angle state in real time.

(2) Angle control console

One example of an angle console may include a computer, a stationary bracket, a high precision motor, a transmission, and a control circuit. The computer may install the image processing system and send control commands to the control circuit via the serial port. The fixing bracket can fix the headstock. The high-precision motor can receive the driving of the control circuit to realize high-precision angle adjustment, and positioning accuracy is ensured. The control circuit can be connected with a computer, receives the control command and drives the high-precision motor to rotate. The transmission device can be connected with a high-precision motor and can rotate along with the motor to realize the automatic angle adjustment of the headstock.

(3) Base seat

One example of a base may include a developer ring, a bracket, and a biocompatible screw such as a titanium screw. The developing ring can be embedded in the bracket, so that CT/MRI identification is facilitated, and a coordinate system is established. The bracket can be used for fixing the head frame and establishing a coordinate tie relationship between the head frame and a focus of a patient. The titanium screw can be used for fixing the bracket and the patient, and is identified by CT/MRI together with the developing ring to establish a coordinate system.

(4) Headstock

One example of a headgear may include a support frame, a planar rotating ring, a magnetic ring, a swing rod, an acceleration sensor, an origin, a puncture, a cap, an angle detection control circuit. The support frame can be fixed on the base, and simultaneously provides a stable rotating environment for the plane rotating ring, and a rotating locking screw can be arranged in the support frame, so that the plane rotating ring can not move. The plane rotary ring is rotatably arranged on the support frame and pressed by the upper cover, so that the purpose of flexible rotation is achieved. The magnetic ring can be embedded on the plane rotating ring to provide a measuring angle basis for the angle detection circuit. The swinging rod can be fixed on the plane rotating ring and can swing along the longitudinal axis, and a puncture path is arranged in the swinging rod. The swing rod can be internally provided with a swing locking screw which can be locked by a clamping position in a non-working period and cannot swing, and the swing locking screw can be loosened when required so that the swing rod can swing, and after the swing rod is regulated to a required swing angle, the swing locking screw is re-screwed to lock the swing rod to the swing angle. The sensor may be fixed above the swing lever or above the puncture needle to detect its swing angle, which may be omitted in the case of an automatic adjustment embodiment. The origin may be, for example, the center of a plane rotation ring, and a space coordinate system is established together with the plane rotation ring and its vertical plane. The puncture path can be a longitudinal central cavity of the swing rod, and can have different specifications according to the diameter of the puncture needle. The upper cover can be fixed on the support frame, and meanwhile, the rotating environment of the plane rotating ring is guaranteed. According to the implementation steps, the method can be divided into automatic adjustment of the upper cover and manual adjustment of the upper cover. The manual adjustment of the upper cover can increase the cavity surface for fixing the angle detection control circuit under the condition of adopting an automatic adjustment technology. The angle detection control circuit can be fixed on the manual adjustment upper cover, and a built-in rotation angle sensor and a body posture sensor such as an acceleration sensor are arranged, wherein the rotation angle sensor can be tangential to the edge of the magnetic ring.

(5) Puncture needle

One example of a puncture needle may include a clip and a puncture needle. The clip can have flexibility, can freely move on the puncture needle, and is firmly clipped on the puncture needle after being adjusted to a predetermined length. The puncture needle can have different dimensions according to different operations, scales are arranged in the puncture needle, and the puncture needle can stably move in a puncture path. A detent screw may be further provided that is engageable with the detent button to fix (e.g., adjust in place) the penetration length.

The three-dimensional space orientation system and its components, and its operation and calibration, etc. are described in detail below with reference to the accompanying drawings and examples.

Headstock assembly

2-9, FIG. 2 is a schematic diagram of a headgear assembly 200 that may be used with the three-dimensional spatial orientation system of FIG. 1, illustrating its general overall configuration and construction, according to one embodiment of the invention. Fig. 5 is an exploded view of a headgear 200A that may be used with the headgear assembly 200 shown in fig. 2 according to an embodiment of the present invention. Fig. 6 is a top plan view of the assembled overall schematic of the headgear assembly 200 of fig. 5. Fig. 7 is an exploded view of the T-wobble bar 204 and the planar rotation ring 202 of the headgear 200A of the headgear assembly 200 of fig. 5-6 prior to assembly. Fig. 8 is a schematic view illustrating a headgear 200A of the headgear assembly 200 of fig. 5-6 and how it rotates. Fig. 9 is a schematic view of the headgear 200A of the headgear assembly 200 of fig. 5-6 and how it swings.

According to one example, headgear assembly 200 may include headgear 200A and base 200B, and optionally other components.

Headstock

In one example, headgear 200A may be comprised of a support frame 201, a planar rotating ring 202, a magnetic ring 203, a T-shaped swing rod 204, an acceleration sensor 205, and an upper cover 208, among others. The planar rotary ring 202 may be fixedly mounted on the support frame 201. The magnetic ring 203 may be sleeved on the planar rotary ring 202, for example, nested substantially flush on an inwardly-received step at the top of the planar rotary ring 202. The upper cover 208 is disposed above the magnetic ring 203 and the planar rotation ring 202. The T-shaped swing lever 204 is rotatably and swingably mounted in the head frame 200A, and an acceleration sensor 205 may be provided at or near the tip of the T-shaped swing lever 204, as shown in fig. 2 to 6.

The support frame 201 has a support ring 201A in the shape of a circular ring or a hollow cylinder as a whole, and a plurality of (3 are shown in fig. 5 to 9) support columns 201B provided on the support ring 201A and circumferentially spaced apart. As shown in fig. 8-9, the planar rotary ring 202 (and other components thereon) of the headgear 200A rests against the support ring 201A and is rotatably nested radially inward of the 3 support posts 201B, whereby the 3 support posts 201B will provide circumferential limits and constraints for the mounting and rotational movement of the planar rotary ring 202 so that it can be reliably and rotatably mounted and held on the support frame 201. In addition, the 3 support columns 201B may also provide structural strength and support to the support frame 201 itself and other components mounted thereon, if any.

As shown in fig. 5-9, a plurality of, for example, 3 rotation locking holes 231 may also be provided on the support ring 201A, and more particularly, 3 support columns 201b—one radially extending rotation locking hole 231 is provided on each support column 201B, and the 3 rotation locking holes 231 may be used to selectively lock the planar rotation ring 202 from rotation relative to the support frame 201 when desired. A rotation lock screw 231A which can be screwed for radial adjustment is arranged in each rotation locking hole 231, and when the rotation lock screw 231A is screwed and adjusted to extend radially inwards, the plane rotation ring 202 is radially restrained and locked by the rotation lock screw 231A and cannot rotate freely (the rotation angle is adjusted); when the turn-down rotation lock screw 231A is turned back to extend radially outward, the planar rotation ring 202 will no longer be radially constrained by the rotation lock screw 231A, thereby being free to rotate (adjust) along with other headgear components thereon, such as the magnetic ring 203, the T-turn bar 204, the acceleration sensor 205, the upper cover 208, and the like.

The support ring 201A of the support frame 201 may also be provided with a plurality of, e.g., three, circumferentially spaced apart locating holes 225 (shown in fig. 6 and 8-9) for securing the headgear 200A to the base 200B, while also providing a relatively rotatable support base for the planar rotation ring 202 rotatably mounted on the support ring 201A.

As above, the magnetic ring 203 is embedded on the planar rotation ring 202, thereby ensuring that the magnetic ring 203 also rotates along with the planar rotation ring 202 when it rotates. The planar rotary ring 202 may further be provided with 2 cross bearing blocks 211 for mounting the T-shaped swing lever 204, which 2 cross bearing blocks 211 are used for rotatably mounting the T-shaped swing lever 204, in particular the cross shaft 212 of the T-shaped swing lever, so that the T-shaped swing lever 204, in particular the cross shaft 212 of the T-shaped swing lever, after mounting, can be pivoted relative to the 2 cross bearing blocks 211, which pivoting makes the entire T-shaped swing lever 204, in particular the longitudinal shaft 213 of the T-shaped swing lever, appear to be in a swinging motion. The planar rotation ring 202 is relatively rotatable so that the entire T-shaped wobble bar 204 can also be rotated along with the planar rotation ring 202, and thus can be used to adjust the angle of rotation of the head 200A.

The magnetic ring 203 may be a neodymium-iron-boron magnetic ring capable of being radially magnetized, which may provide a measurement basis for the rotation angle sensor 226.

According to one example, the T-shaped swing lever 204 may be formed from a transverse axis 212 and a longitudinal axis 213, which together form a generally T-shape. The intersection center point 206 of the horizontal axis 212 and the vertical axis 213 may be set as the headstock origin o 206. The T-shaped swing rod 204 is used to adjust the swing angle of the head 200A, where the head origin o 206 may be set as the positioning origin of the three-dimensional spatial orientation system.

The acceleration sensor 205 provided on the T-shaped swing rod 204 may be used to detect the swing angle of the head frame 200A, and may be fixed at or near the upper end of the longitudinal axis 213, but is not limited to being mounted at this position, and may be mounted on a puncture needle or other accessory as long as the relative position of the T-shaped swing rod 204 is kept constant during operation.

A disc-shaped upper cover 208 with a handle (shown in fig. 5-8) may be used to secure the headgear 200A and maintain the planar rotation ring 202 in rotation in the same plane during the rotational movement without shifting up and down. The upper cover 208 may be provided with (e.g., printed or engraved with) a dial for displaying the rotation angle of the planar rotary ring 202, with zero points of the dial being calibration zero scale points 210. An angle detection control circuit 209 may be selectively installed below or above the right handle of the upper cover 208 (as shown in fig. 5-6). 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 MCU229. The rotation angle sensor 226 may be an off-axis magnetic sensor that may be mounted at a location tangential to the edge of the magnetic ring 203, such as shown in fig. 11. Because the magnetic field intensity at each position of the magnetic ring 203 is different, the rotation angle sensor 226 can detect the relative rotation angle by detecting the magnetic field intensity change before and after the rotation of the magnetic ring 203, and then transmitting the detected magnetic field intensity change to the main control MCU229 through the signal processing circuit 227.

Base seat

According to one example, as shown in fig. 12, for example, the base 200B may be composed of a generally annular bracket 302, a developing ring 304, and a plurality of, for example, 3 titanium screws 301 arranged on the outer circumference of the bracket 302. 3 titanium screws 301, e.g. equally spaced circumferentially, as shown in fig. 12, are used to fix the ring-like mount 302 (as well as the base 200B and the head 200A fixed to the base 200B) to the skull of the patient, and to ensure that the reference point does not shift during use and that a fixed coordinate relationship is established between the head 200A and the patient's lesion. According to an example, the annular shaped cradle 302 of the base 200B may be designed such that the outer diameter of the cradle 302 annulus is less than or equal to about 40mm, and other components of the base 200B are sized to fit with such a design, which facilitates miniaturization of the base 200B and headgear design.

The developer ring 304 may be substantially concentrically embedded on the annular frame 302, for example, disposed about its inner circumference and radially inward thereof, and absolutely flush with the plane of the frame 302. The visualization ring 304 may be, for example, a metal ring that can be identified by CT/MRI, facilitating CT/MRI identification, and establishing a coordinate system. A notch may be provided at the zero mark point on the developer ring 304 as shown in fig. 12, i.e., developer ring zero mark point s'303. When base 200B is aligned with head 200A and mounted in place, the physical mounting locations of developer ring zero scale points s'303 may be aligned with each other with the locations of calibration zero scale points 210 on head 200A for the image processing system to identify the starting/zero scale points.

As above, the developing ring 304 may be concentric with the frame 302, and the center is the origin o'305 of the base. The circumference of the bracket 302 may be embedded with a plurality of, for example, 3, detent posts 306, for example, and when the head frame 200A is assembled to the base 200B, the detent posts 306 need to be mounted in alignment with the positioning holes 225 to ensure that the developing ring zero scale points s'303 of the base 200B are aligned with the calibration zero scale points 210 of the head frame 200A. As shown in fig. 13A and 13B, a head rotation angle calibration point s (transverse bearing alignment zero position) 222 is shown, and a position indication 223 of the head frame zero scale horizontally coincident with the base zero scale is shown. Fig. 13A is a schematic perspective view of one perspective of the assembled headgear assembly 200 shown in fig. 2 according to an embodiment. Fig. 13B is a schematic perspective view of the headgear assembly 200 of fig. 13A from another perspective, with the wobble bar 204 removed, showing a planar alignment of the headgear.

Angle detection and control

In connection with, for example, fig. 10, the angle detection control circuit 209, the signal processing circuit 227, the main control MCU229, the LED indicator light 230, etc. may be arranged on, for example, a PCB (printed circuit board) 232. An example of the angle detection and verification step using the headgear 200A with the angle detection control circuit 209 is as follows:

1) Calibrating the headstock 200A at a calibrated initial zero position and the rotation angle sensor 226;

2) The rotation angle sensor 226 collects the magnetic field intensity of the magnetic ring in real time, and the collected data is amplified and filtered by the signal processing circuit 227 and then transmitted to the main control MCU229;

3) The main control MCU229 obtains accurate angle information after the magnetic ring rotates, namely the headstock rotation angle through algorithm processing;

4) The main control MCU229 receives acceleration sensor (104, 205 or one of the other accessories) data;

5) The main control MCU229 collects data of the acceleration sensor 228 on the angle detection control circuit;

6) The main control MCU229 obtains the accurate swinging angle of the T-shaped swinging rod 204 relative to the headstock 200A through the algorithm processing of 2 acceleration sensor data;

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

8) The angle of the headstock adjustment is similar to or consistent with the target angle, and the operator and the angle console 400 can be alerted by the LED indicator light 230.

Another embodiment of the angle detection and control step for headgear 200A (headgear does not include angle detection control circuitry) is as follows:

1) Headgear 200A is mounted to base 200B through a plurality of, for example, 3 positioning holes 225 as shown;

2) Loosening the swing locking screw on the transverse bearing seat 211 on the headstock 200A to enable the longitudinal axis 213 of the T-shaped swing rod 204 to swing left and right, for example, as shown by a dotted arrow in fig. 9, until the swing angle reaches a desired angle, stopping, and re-tightening the swing locking screw to fix the T-shaped swing rod locking position; and

3) Loosening the rotation lock screw 231A in the rotation lock hole 231 on the head frame 200A, so that the plane rotation ring 202 (thereby driving the magnetic ring 203 and the T-shaped swing rod 204) can freely rotate (adjust) along the plane rotation ring rotation direction 217 in the rotation plane, as indicated by a dotted arrow 217 in fig. 8, until the rotation angle reaches a desired angle, stopping, and re-tightening the rotation lock screw 231A in the rotation lock hole 231 to lock the plane rotation ring 202.

Calibration jig and calibration method

Fig. 14A is an overall schematic diagram of an assembled headgear and calibration jig 600 that may be used in the three-dimensional spatial orientation system of fig. 1 according to an embodiment of the invention. Fig. 14B is an exploded view of the headgear and calibration jig 600 of fig. 14A, showing the headgear assembly and the calibration jig 600 assembled therewith.

For example, as shown in fig. 14A-14B, the structure and slots at the top of the calibration jig 600 may be similar to the brackets of the base 200B, and may be configured to very precisely mate with the headgear 200A. For example, as shown in fig. 14A and 14B, 3 positioning posts 602 and zero scale points 603 may also be provided on the circumference for alignment and calibration. In addition, the calibration fixture 600 may be further provided with two clamping clips 601, for example, to ensure that the T-shaped swing rod 204 of the headstock 200A is perpendicular to the plane of the calibration fixture 600 (parallel to the plane of the plane rotating ring 202) when the headstock 200A is calibrated, so as to improve positioning accuracy.

One example of sensor calibration may include: initial position determination and sensor software calibration.

The operation steps in one embodiment of performing calibration using the calibration jig 600 may include the following:

1) The headstock 200A is mounted on the calibration jig 600 through the positioning hole 225;

2) Aligning the 3 circumferentially spaced locating holes 225 of the headgear 200A and the 3 circumferentially spaced locating posts 602 of the calibration jig 600 with one another, thereby ensuring that the zero scale of the headgear 200A is aligned with the zero scale points 603 of the calibration jig 600, as shown in fig. 14A-14B;

3) Operating the clamping clamp 601 on the calibration jig 600 to enable the longitudinal axis 213 of the T-shaped swing rod 204 to be perpendicular to the plane of the calibration jig 600;

4) Locking the head frame 200A by, for example, rotating the lock screw and swinging the lock screw, the T-shaped swing lever 204 and the planar rotary ring 202 are immobilized in the initial position;

5) The above calibration steps can be performed before shipment, so that the operation preparation time and the doctor learning time can be reduced (of course, the calibration steps can also be performed after shipment);

6) Removing the headgear 200A from the calibration jig 600;

7) Headgear 200A is mounted on base 200B, and a calibration command is sent via a computer/image processing system, software calibration of acceleration sensor 228 and angle sensor 226 is performed by master MCU 229.

As an alternative example, steps 1) -5) above may also be accomplished by an angle console mounting bracket 420.

Angle control console

As shown in fig. 15-19, one example of an angle console 400 may include a rotary drive motor 401, a rotary reduction gear 402, a rotary encoder 403, a rotary drive gear 404, a motor mount 405, a swing drive motor 406, a swing reduction gear 407, a swing drive 408, a swing encoder 409, a computer 410, a control circuit 419, a drive robot 411, and a headgear clamping mechanism 412. Headgear clamping mechanism 412 may be used to clamp headgear 200A. The motor mount 405 may have any suitable configuration, such as an L-shape, U-shape, or H-shape, for example, as shown in fig. 15A and 16-17 for one exemplary configuration that may be used to secure/mount the swing motor assembly 406A on the one hand, and the rotary motor assembly 401A on the other hand, such as may be coupled to the rotary drive gear 404. The drive arm 411 may be used to drive the headgear clamping mechanism 412 such that the headgear 400A may achieve 2-directional movement in rotation and oscillation. As shown, one end of the drive arm 411 may be coupled to the swing drive 408 and the other end may be coupled to the headgear clamping mechanism 412. Head clamp mechanism 412 may be comprised of 413 a gripper, spring 414, gripper attachment 415, and the like. For example, as shown in fig. 19, the mounting bracket 420 may be comprised of a clamp flip 416, clamp screw 417, clamp mount 418, etc., which, along with the headgear clamp mechanism 412, may be used to mount the headgear 200A and may be placed in a physical zero position. According to an instruction sent by an operator such as a surgeon through, for example, a computer 410, the components of the rotation driving motor 401, the rotation reduction gear 402, the rotation encoder 403, the rotation transmission gear 404, the transmission mechanical arm 411, and the head holding mechanism 412 of the angle control console 400 automatically drive/adjust the planar rotation ring 202 of the head 200A on the angle control console 400 (thereby driving the magnet ring 203 and the T-shaped swing lever 204 together) to perform a rotation movement (adjustment) in a rotation plane defined by the planar rotation ring 202 along the planar rotation ring rotation direction 217 by a desired rotation angle, and thus can be used to adjust the rotation angle of the head 200A in the rotation plane.

According to instructions sent by an operator such as a surgeon or the like through, for example, a computer 410, components of the swing drive motor 406, the swing reduction gear 407, the swing transmission 408, the swing encoder 409, the transmission robot 411, and the head holding mechanism 412 mounted on the motor bracket 405 of the angle control console 400 automatically drive/adjust the T-shaped swing lever 204 of the head 200A on the angle control console 400 to perform a swing motion (adjustment) at a desired swing angle, and thus can be used to adjust the swing angle of the longitudinal axis 213 of the head 200A.

As shown in fig. 15A-15B and fig. 18A-18B, the driving robot 411 may be composed of, for example, a gripper 413, a spring 414, a gripper connection 415, and the like. The gripper 413 can grasp and drive, for example, the T-shaped swing lever 204 of the head 200A, thereby automatically adjusting the angles of the 2 directions of the head 200A, i.e., the rotational direction and the swing direction.

As shown in fig. 16-17 and 19, the headgear clamping mechanism 412 cooperates with the drive robotic arm 411 to secure the headgear 200A to the angle console 400 without deflection and to place the rotational components in the calibration position. The headgear clamping mechanism 412 may be comprised primarily of, for example, a clamping flip 416, a clamping screw 417, and a clamping base 418. The circular/oblong mounting holes of the clamp flip 416 and clamp mount 418, respectively, form mounting locations that facilitate clamping of a correspondingly shaped and sized headgear 200A when clamped in place.

One example of an angle console 400 may include a computer 410 configured to mount an image processing system and to send control commands to control circuitry 419 via a serial port. The control circuit 419 is configured to be communicatively coupled to or integrated with the computer 410, receive control commands thereof, and drive the high-precision drive motor.

According to one example, the rotary drive motor 401 and the wobble drive motor 406 may be high precision motors configured to receive drive signals from the computer 410 (e.g., by means of the control circuit 419) to operate to achieve high precision angular adjustment or calibration, ensuring accurate positioning.

The rotary motor assembly 401A may include, for example, a rotary drive motor 401 mounted on a stationary bracket or other stationary location, a rotary reduction gear 402 and a rotary drive gear 404 operatively connected to the rotary drive motor 401, and may include a rotary encoder 403. The control circuit 419 can drive the motor 401 to drive the reduction gear 402 and the transmission gear 404 to rotate, the encoder 403 can detect the rotation angle and feed back the rotation angle to the control circuit 419, and the control circuit 419 can be configured to precisely control the rotation angle through an algorithm, such as a PID algorithm, for example, so as to realize high-precision motor control and driving, and control precision of the rotation transmission gear can reach 0.02 degrees. The rotating motor assembly 401A rotates the motor bracket 405, and the motor bracket 405 rotates together with the swing motor assembly 406A with the driving mechanical arm 411 until the target rotation angle is reached.

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 408 operatively connected to the swing drive motor 406. The wobble drive 408 can, for example, have drive teeth, for example in the form of segments of a partial drive gear. Also, the swing motor assembly 406A may further include a swing encoder 409. The wobble encoder 409 may detect the wobble angle and feed it back to the control circuit 419. The control circuit 419 may be configured to precisely control the wobble angle, for example by means of an algorithm, such as a PID algorithm, to achieve high precision motor control and driving, enabling a control accuracy of the wobble transmission of up to 0.02 °. The swing motor assembly 406A swings the driving mechanical arm 411 through the swing driving device 408 until the target swing angle is reached.

One example of assembly and operation of the running operation of the high precision motor is as follows:

1) The computer 410 sends a control command to the control circuit 419, and the control circuit 419 drives the rotary driving motor 401 to rotate the rotary reduction gear 402, so as to increase torque and control resolution, thereby providing a basis for controlling the motor 401 to rotate with high precision, and simultaneously, no revolution is generated in the stop state of the motor 401.

2) The rotation reduction gear 402 may drive the rotation transmission gear 404, and the rotation transmission gear 404 may be connected to the motor support 405 and the rotation encoder 403, for example, in equal proportion, and the rotation encoder 403 detects the rotation angle and feeds back to the control circuit 419, and the control circuit 419 may precisely control the rotation angle through an algorithm (for example, PID algorithm). In this way, the rotary encoder 403 can detect, for example, the rotational speed, i.e., the rotational angle of the load, and the angle control console 400 can thereby reduce the accuracy error generated between the rotary reduction gear 402 and the rotary transmission gear 404.

3) Rotary encoder 403 may be a type of non-contact absolute encoder, for example, of 17bit resolution, that measures the rotational position of rotary drive motor 401 with an effective control accuracy of 14 bits, such that rotary drive motor 401 can be controlled to an accuracy of about 0.02.

The motor operation of the swing drive motor 406 may be substantially identical to that of the rotary drive motor 401, for example, similar to that described above, and thus will not be described in detail herein.

An example of the operation of the angle console 400 is as follows:

1) The clamp flip 416 is flipped open, and the head frame 200A is placed on the clamp base 418;

2) Clamping mount 418 may be configured similar to cradle 302 of base 200B to hold headstock 200A in a calibrated position;

3) The driving mechanical arm 411 makes the T-shaped swinging rod 204 perpendicular to the plane of the headstock 200A;

4) Tightening clamp screw 417, causing headstock 200A to be very firmly mounted on angle control cabinet 400 and remain in the calibrated position;

5) The operations of the rotation driving motor 401 and the swing driving motor 406 may be as described above, control thereof may be performed by a control circuit 419, and an image processing system/software may be installed in the computer 410.

Puncture needle

The needle 100 is configured to be inserted and mounted into and secured to the hollow lumen of the T-shaped rocking beam 204, i.e., the puncture 207.

As shown in fig. 1-4, the lancet 100 may be provided with a scale 103 and may be provided with a detent 102 so that the penetration depth of the lancet 100 may be adjusted according to the scale shown. The latch 102 is mountable and configured to have a certain positional flexibility, to be freely movable and positionable on the lancet 100, and to securely latch the latch 102 to the lancet 100 after the lancet 100 is adjusted to a predetermined length. The acceleration sensor 104 may be mounted at or near the tip (upper end, or proximal end, as shown) of the needle 100, as opposed to the distal or surgical end, as shown in fig. 2-3, for example, and may be used to measure an angular parameter during lancing.

The needle 100 may have a variety of different dimensions and may be smoothly moved, inserted or withdrawn within the track 207 depending on the application or procedure.

Three-dimensional polar coordinate system and spatial localization

FIG. 20 is a schematic diagram of a three-dimensional polar coordinate system established between headgear 200A and base 200B that may be used with the three-dimensional spatial orientation system shown in FIG. 1. Fig. 21 is a schematic diagram of the three-dimensional polar coordinate system model of fig. 20 that may be used to establish a coordinate relationship between the head 200A, the base 200B, and the lesion target T.

The space polar coordinate, also called spherical polar coordinate system, is a kind of three-dimensional polar coordinate system, which is extended from two-dimensional polar coordinate system to determine the position of the point, line, plane and body in three-dimensional space, and is composed of azimuth angle, elevation angle and distance by taking the origin of coordinates as the reference point, as shown in fig. 20-21, for example. The nature of the manner in which polar coordinates work in two dimensions is: points in three-dimensional space may be specified by giving directions and distances. Spherical coordinates can function by defining directions and distances: in three dimensions, two angles are required to define the direction, such as the rotation angle phi (equivalent to phi in the figures, used interchangeably herein) and the swing angle theta as shown in fig. 20-21. 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 convention, and the other axis is "vertical" corresponding to "+z" in three-dimensional Cartesian convention.

Headgear plane 501 refers to a plane established with reference to origin o 206 of headgear 200A. On this plane, the plane rotation ring 202 is concentric with the headstock origin o 206, thereby forming a fixed plane. The plane is made up of numerous concentric circles, each of which has a different radius, but which are centered about the origin o of the head 200A.

As shown in fig. 20-21, 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 reference to the headgear plane 501 (e.g., the plane defined by the planar rotating ring 202). The origin o 206 of the head 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 rotating 90 ° clockwise around the origin o in the head plane 501, and the axis perpendicular to the head plane 501 passing down through the origin o 206 is the z-axis.

The base plane 502 refers to a plane established with reference to the developer ring 304 of the base 200B, which is parallel to the head plane 501.

Focal plane 503 refers to a plane modeled with reference to a focal target T, which is disposed parallel to base plane 502, and from which a two-dimensional coordinate system x 'y' is established. The origin (center) o ' of the two-dimensional coordinate system (x ', y ') is the point where the origin o of the headstock 200A maps into the focal plane 503 along the z-axis of the three-dimensional rectangular coordinate system (x, y, z) 504, where the x ' -axis is the mapping of the x-axis of the three-dimensional rectangular coordinate system (x, y, z) 504 to the focal plane 503 and the y ' -axis is the mapping of the y-axis of the three-dimensional rectangular coordinate system (x, y, z) 504 to the focal plane 503.

Fig. 22 is a schematic diagram of a process for simulating calculation of polar coordinates of a lesion target T by an image processing system usable in the three-dimensional spatial orientation system of fig. 1 according to an embodiment of the present invention.

As shown in fig. 22, one example of a procedure for simulation calculation of polar coordinates of a lesion target T is as follows:

the patient wears the fixing base 200B on the skull and then carries out CT/MRI scanning;

acquiring the position relation, position parameters and/or images between the focus target point in the head of the patient and the developing ring 304 of the base 200B;

a head frame plane 501 parallel to the developing ring 304 is mapped at a height h above the plane (i.e., the base plane 502), and a three-dimensional rectangular coordinate system (x, y, z) 504 with an origin o is established with reference to the head frame plane 501;

a plane parallel to the developing ring 304 (i.e. focal plane 503 with origin o') is mapped downwards by the plane of the developing ring 304, so that the focal target T is located in the plane, and the coordinate and the positional relationship thereof are shown in fig. 21;

calculating the length of a straight line between a focus target T and an origin o as r, calculating an included angle Too 'formed between r and a z axis as theta (corresponding To a swinging angle theta), and calculating an included angle To' x 'formed between a To' connecting line and an x 'axis in a focus plane 503 as phi' (corresponding To a rotating angle phi), as shown in fig. 21;

The lesion target T is mapped to a point T 'in the head plane 501, at which point the angle phi' is equal to the corresponding angle phi in the head plane 501.

The image processing system of the three-dimensional spatial orientation system may reconstruct the coordinate positional relationship of fig. 20-21 in accordance with, for example, the flow simulation of fig. 22. Wherein the diameter of the developing ring 304 is d, the height h of the head 200A, then in a three-dimensional rectangular coordinate system (x, y, z) 504 with the origin o established based on the head plane 501, the point s coordinate is (d/2,0,0), the point s 'coordinate is (d/2, 0, h), the point o' coordinate is (0, h, 0), and the focus target T coordinate isThe coordinate of the mapping point T' corresponding to the focus target point T isIf represented by a three-dimensional spherical polar coordinate system established by the origin o, the polar coordinates of the focus target T are (r, θ, Φ).

According to fig. 21, the puncture depth of the puncture needle 100 and the rotation angle phi and the swing angle theta of the head frame 200A are adjusted, so that the position of the focus target T can be accurately punctured.

The penetration depth L of the penetration needle 100 is the sum of the penetration path oT length (r) and the length r1 of the longitudinal axis 213, i.e., l=r+r1.

As shown in fig. 20-21, the angle phi is the angle at which the headgear 200A rotates in the headgear plane 501, i.e., the rotation angle 216, as shown in fig. 8.

As shown in fig. 20-21, angle θ is the angle at which the longitudinal axis 213 of the T-shaped swing rod of the head 200A swings, i.e., the swing angle 218, as shown in fig. 9.

Manual operation of three-dimensional space orientation system

FIG. 23 is a schematic diagram of the general content of a manual operation that may be used with the three-dimensional spatial orientation system of FIG. 1, in accordance with one embodiment of the present invention. The general content of this manual operation may include: performing CT/MRI scanning by wearing the base 200B on the brain of a patient, performing three-dimensional image reconstruction by using an image processing system, and calculating the coordinate relation between a focus target T and the base (and the headstock), thereby obtaining and providing angle data (theta and phi) and puncture depth data (L); the initial position of the head frame 200A is determined by using a calibration jig, and the head frame 200A is disassembled after being fixed by a locking screw after the initial position is determined; head 200A is secured to base 200B by mating alignment holes 225 and detent posts 306, or alternatively, may be secured to base 200B by, for example, screws; manually operating and adjusting the headstock 200A according to the corresponding angle data and the puncture depth data to enable the headstock to reach a target angle; manually adjusting the clamping buckle of the puncture needle 100 to the target position and locking; the puncture needle 100 is installed and adjusted to puncture the lesion target T position by the puncture path 207.

FIG. 24 is a schematic diagram of a manually implemented operational flow that may be used with the three-dimensional spatial orientation system of FIG. 1, according to one embodiment of the invention. One example of a flow of this manually-implemented operation may include (the operation is not limited by the order of precedence described herein):

locking (immobilizing) the support of the base 200B on the skull of the patient through a titanium screw;

allowing the patient to wear the base 200B for CT/MRI scanning;

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

the image processing system reconstructs and simulates the position of the headstock in a three-dimensional way, and obtains the coordinate relation between a focus target T and a base (and the headstock);

the path optimization calculation obtains corresponding angle (theta and phi) data and puncture depth (L) data;

the angle detection control circuit 209 of the head frame 200A receives the angle (θ and Φ) and penetration depth (L) data calculated by the image processing system through wireless communication;

the headstock 200A is placed in an initial position state (can be set at the time of delivery), or the initial position of the headstock 200A can be determined by using a calibration jig;

securing headgear 200A to base 200B via, for example, 3 clamp posts 306;

calibrating the sensor on the head frame 200A by, for example, an image processing system (image processing software);

According to the angle data, loosening the rotary locking screw 231A, manually rotating the T-shaped swing rod of the headstock 200A to enable the T-shaped swing rod to rotate to reach a target rotation angle phi, and tightening the rotary locking screw 231A to enable the plane rotating ring 202 to be unable to rotate;

according to the angle data, loosening the swing lock screw 231B, manually rotating the T-shaped swing rod 204 of the headstock 200A to swing to a target swing angle theta, and tightening the swing lock screw 231B to enable the swing rod 204 not to swing;

manually adjusting the clamping buckle of the puncture needle 100 according to the puncture depth data to enable the puncture needle to reach the target puncture depth and lock the puncture depth; and

the puncture needle 100 is operated to puncture through the puncture path 207 of the T-shaped swing lever 204.

Automated operation of three-dimensional space orientation system

FIG. 25 is a schematic diagram of general content that may be used in the automated implementation of the three-dimensional spatial orientation system of FIG. 1 in accordance with one embodiment of the invention. The general content of the automation operation may include: performing CT/MRI scanning by wearing the base 200B on the brain of a patient, performing three-dimensional image reconstruction by using an image processing system, and calculating the coordinate relation between a focus target T and the base (and the headstock), thereby obtaining and providing angle data (theta and phi) and puncture depth data (L); headgear 200A (e.g., which may be sensor-free and control circuitry-free) is mounted to a mounting bracket 420 of angle console 400 via positioning hole 225; the head frame 200A is automatically calibrated by utilizing the angle control console 400, and after the automatic calibration, the head frame 200A is automatically adjusted to a target angle (theta and phi) by utilizing the angle control console 400 according to corresponding angle data (theta and phi) and puncture depth data (L) and is automatically fixed by using locking screws; and automatically adjusting the clip on the puncture needle 100 to a target depth (L) and locking; the headstock 200A is detached and fixed on the base 200B through the matching of the positioning hole 225 and the clamping post 306, or can be fixed on the base 200B through screws, for example; the puncture needle 100 is installed and adjusted to puncture the lesion target T position by the puncture path 207.

An example of a flow of this automated implementation operation may include (operation is not limited by the order described herein):

allowing the patient to wear the base 200B for CT/MRI scanning;

the control circuit 419 of the angle console 400 receives the angle (θ and Φ) and penetration depth (L) data calculated by the image processing system;

the headstock 200A is placed in an initial position state (which can be set at the time of shipment), the headstock 200A is mounted on the fixing bracket 420 of the angle console 400, and the headstock 200A can be placed in the initial position state due to the tight press-fit of the mechanical jaw 413 of the headstock clamping mechanism 412 and the transverse shaft 212 of the headstock 200A;

clicking a calibration button of an operation display interface of the angle console 400 to perform automatic calibration;

According to the angle data, the angle control console 400 drives the motor bracket 405 and the transmission mechanical arm 411 through the rotating motor assembly 401A so as to automatically adjust the rotation angle phi of the T-shaped swing rod of the headstock 200A to reach a target angle;

locking the rotation portion of the adjusted target angle head 200A in place, for example, by tightening the rotation lock screw 231A (e.g., the corresponding portion referred to above) in the rotation lock hole 231 of the support frame 201, the planar rotation ring 202 is prevented from rotating;

according to the angle data, the angle control console 400 drives the transmission mechanical arm 411 through the swing motor component 406A so as to automatically adjust the swing angle theta of the T-shaped swing rod of the headstock 200A to reach a target angle;

locking the swing portion of the adjusted target angle head 200A in place, for example, by tightening a swing lock screw 231B (e.g., fig. 6, which may participate in the corresponding portion of the previous description) on the lateral bearing 211, so that the swing lever cannot swing;

according to the puncture depth data, the angle control console 400 can automatically adjust the clamping buckle of the puncture needle 100 to achieve the target puncture depth and automatically lock with the clamping screw;

removing and mounting the head frame 200A with the adjusted target angle on a base 200B fixed to the skull of the patient; and

The puncture needle 100 with the puncture depth adjusted is removed, and the puncture operation is performed through the puncture path 207 of the T-shaped swing lever 204.

One or more embodiments of the inventive three-dimensional spatial orientation system of the present invention provide a number of technical advantages over the prior art, including, but not limited to, the following:

1) By fixing a small-sized base to the skull, a coordinate relationship between the lesion target and the base can be established. Since the base as a reference is directly fixed to the skull, the relative position of the internal structure of the head frame and the base is fixed and determined, so that the precise position between the head frame and the focus target can be determined more accurately by a person skilled in the art. The method can help doctors to more accurately position and operate in the operation process, improve the positioning precision of the operation and ensure the safety and the accuracy of the operation.

2) The accurate position can be determined in the plane through the concentric structure of the plane rotating ring of the headstock and the swinging rod. Simultaneously, the length of the puncture needle is combined, and the effect of accurate space positioning can be achieved.

3) The angle adjustment can be accomplished automatically and manually by discrete design and removable assembly of the headgear to the base, is convenient to operate, and does not require all or a portion of the headgear assembly to be mounted to the patient during numerous steps and procedures. In this way, the volume and weight of the cranium implantation part can be effectively reduced, so that the cranium implantation part is lighter and the burden of a patient is reduced.

4) The swing angle can be measured by mounting high precision sensors on the swing rod and/or the puncture needle of the head frame. Meanwhile, an algorithm such as a six-sided calibration algorithm may be used to improve measurement accuracy.

5) The relative angle of rotation can be measured by arranging a magnetic ring in the plane rotating ring and arranging an off-axis magnetic coding angle sensor at the tangent position of the magnetic ring. And the software calibration algorithm can be adopted to process the measurement data, so that more accurate angle measurement can be realized, and the performance and stability of the three-dimensional space orientation system are improved.

6) The biocompatible screw may be a titanium screw, which is a material having good biocompatibility and strength, and is stably fixed in the body tissue of the patient. The developing ring may be a metal ring embedded on the annular body. Also, the developing ring may be a ring-shaped marker provided with or coated with a contrast agent that can create a distinct mark in, for example, a scanned image, helping to accurately locate and identify the target area. By combining the application of the titanium screw and the developing ring, the CT/MRI image can provide clearer and more accurate information to reduce the reference coordinate system error.

7) The puncture angle and/or depth can be automatically adjusted through the angle control console, so that the accuracy, repeatability and convenience of operation can be effectively improved. The puncture angle is automatically adjusted by using the angle control console, and the angle is measured by using the small and exquisite high-precision angle sensor configuration, so that the system configuration and the using operation flow are further simplified, the positioning precision is further improved, and the learning time of using equipment by doctors is reduced.

8) The speed reducing gear can be driven by a driving motor in the form of a stepping motor, and a high-precision encoder can be arranged at the tail end of the speed reducing gear, so that the beneficial effect of more accurate angle control can be realized.

The foregoing description of several embodiments of the invention has been presented for the purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the invention to the precise steps and/or forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The scope of the invention and all equivalents are intended to be defined by the appended claims.

Claims

1. A headgear assembly, the headgear assembly comprising:

a base configured for fixation on a brain of a patient, the base comprising a bracket, a plurality of biocompatible screws mounted on the bracket, and a visualization ring, wherein the visualization ring is provided with visualization ring zero scale points, the visualization ring and the visualization ring zero scale points being identifiable by CT or MRI imaging techniques; and

A headgear, the headgear comprising: a support frame; a planar rotary ring rotatably mounted on the support frame; an upper cover mounted on the plane rotary ring and having a dial for displaying a rotation angle phi; a swing lever constituted by a horizontal axis and a vertical axis, the swing lever being mounted so as to be capable of controlled swing at a swing angle θ and to be capable of controlled rotation at a rotation angle Φ together with the planar rotary ring; wherein the longitudinal axis is axially hollow defining a puncture path into which a puncture needle is removably inserted;

wherein the headstock is detachably and fixedly mounted on the base.

2. The headgear assembly according to claim 1, wherein,

the holder is a holder of an annular body, the plurality of biocompatible screws are arranged spaced apart from each other along an outer periphery of the annular body, and the developing ring is concentrically disposed on the annular body near an inner periphery thereof;

the support frame comprises a support ring body and a plurality of support columns which are arranged on the support ring body, axially extend upwards and are circumferentially spaced;

a magnetic ring which rotates together with the plane rotating ring is also coaxially arranged on the plane rotating ring;

The upper cover is disc-shaped as a whole and is provided with a handle;

the longitudinal axis of the swinging rod can swing in a controlled manner by a swinging angle theta, and the transverse axis is arranged in the diameter direction of the plane rotating ring and can rotate in a controlled manner by a rotating angle phi along with the plane rotating ring; the longitudinal axis is perpendicular to the transverse axis;

wherein the support ring body, the planar rotary ring, the magnetic ring, and the upper cover are coaxially arranged.

3. The headgear assembly according to claim 2, wherein the wobble rod is a T-shaped wobble rod, and wherein the cross center point of the transverse axis and the longitudinal axis is concentric with the planar rotation ring.

4. The headgear assembly according to claim 2, wherein the inner periphery of the planar rotation ring is provided with two diametrically opposed cross bearing seats, and both ends of the cross shaft are rotatably mounted in the two cross bearing seats, respectively, such that the longitudinal axis is swingable.

5. The headgear assembly according to any one of claims 1-4, further comprising a puncture needle configured to be removably inserted into the puncture track.

6. The headgear assembly according to claim 5, wherein a swing angle sensor for detecting the swing angle θ is provided on the swing lever or the puncture needle; and is also provided with

An angle detection control circuit is arranged on the headstock, and the angle detection control circuit is provided with a rotation angle sensor for detecting the rotation angle phi.

7. The headgear assembly according to claim 2, wherein a rotational locking hole and corresponding rotational capture screw are provided on each support post.

8. The headgear assembly according to claim 2, wherein a plurality of circumferentially spaced apart locating holes are also provided on the support ring, a corresponding plurality of detent posts are provided on the annular body of the bracket, the headgear being removably secured to the base by means of cooperation between the plurality of locating holes and the plurality of detent posts.

9. The headgear assembly according to any one of claims 1-4, wherein a developing ring zero scale point is marked on the developing ring and a rotation angle identification and calibration zero scale point is marked on the dial.

10. The headgear assembly according to claim 9, wherein in an initial or calibration state of the headgear assembly, the developing ring zero scale points are aligned with the calibration zero scale points.

11. The headgear assembly according to claim 10, wherein the developing ring zero scale points are in the form of indentations.

12. The headgear assembly according to claim 4, wherein a rotation angle indicator and a calibration zero scale point are marked on the dial; and is also provided with

In the calibration state of the headgear assembly, the cross bearing seat aligns the developing ring zero scale point with the calibration zero scale point.

13. The headgear assembly according to claim 5 or 6, wherein the piercing needle is equipped with a detent button and a detent screw.

14. The headgear assembly according to claim 5 or 6, wherein the puncture needle is provided with scale markings.

15. The headgear assembly according to any one of the preceding claims, wherein the headgear assembly is configured as a three-dimensional spatial orientation system for cranium surgery.