Three-dimensional spatial orientation system for brain cranial surgery

Abstract

The present application relates to a three-dimensional spatial orientation system for brain craniotomy. The three-dimensional spatial orientation system comprises: a base configured to be fixed on a patient's brain in a position-invariant manner; a head frame mounted on the base, the head frame comprising: a support frame, the head frame being detachably fixedly mounted on the base through the support frame; a plane rotation ring; an upper cover; a swing rod, a transverse axis of the swing rod being controllably rotatable with the plane rotation ring at a rotation angle phi; a longitudinal axis being controllably swingable at a swing angle theta; a magnetic ring; an image processing system configured to: perform three-dimensional reconstruction, determine a developed ring plane as a base plane; map a head frame plane and establish a three-dimensional rectangular coordinate system (x, y, z); calculate a straight line length r from an origin o of the three-dimensional rectangular coordinate system (x, y, z) to a lesion target point T, and calculate the rotation angle phi and the swing angle theta; and obtain polar coordinates (r, theta, phi) of the lesion target point T in a three-dimensional polar coordinate system.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of innovative medical devices, in particular to an innovative three-dimensional spatial orientation system for brain craniotomy. BACKGROUND

[0002] Intracranial lesions are different, the lesion site is different, and the symptoms are also different. The clinical symptoms of intracranial lesions are many, so the position and angle of puncture need to be accurately targeted during intracranial surgery. Brain hemorrhage drainage, intracranial lesion biopsy, epileptic lesion destruction, ventricular puncture external drainage, DBS electrode implantation, etc. need to accurately position and adjust the intracranial target point, which is a common indication of stereotactic surgery.

[0003] CN116327334A discloses an intracranial lesion accurate targeting positioning device, which comprises a cylindrical connecting rod, a rotatable sleeve is sleeved on the surface of the connecting rod, and a base is integrally connected to the surface of the sleeve, and a gear disc is rotatably connected to the side of the base away from the sleeve through a rolling bearing. The gear disc is fixed with a guide pipe, a fixed block is welded on one side of the surface of the base, a horizontal shaft is inserted into the middle part of the fixed block, one end of the horizontal shaft is fixedly connected with a pressing plate, and the pressing plate is engaged with the surface of the gear disc. Both ends of the connecting rod are fixedly connected with spring clamping plates; the sleeve can adjust the up-down angle direction of the guide pipe by rotating on the surface of the connecting rod, and the gear disc can adjust the left-right direction of the guide pipe by rotating on the base, which is convenient to adjust, easy to operate, and ensures the accurate targeting positioning of the puncture needle.

[0004] CN112022353A discloses a surgical robot surgical instrument positioning assembly, which belongs to the technical field of sand screening devices. The technical solution comprises an operation control panel and a fixed support. The lower end surface of the fixed support is fixedly connected with an adjusting servo motor. The front end surfaces of the two fixed plates are fixedly connected with electric control stretchers. The left and right sides of the two movable plates are provided with first limiting nuts matched with first movable pins. The left and right sides of the connecting claws are provided with second limiting nuts matched with second movable pins. An X drive screw is located in front of the connecting shaft, and a Y drive screw is located behind the connecting shaft. The middle part of the X drive seat is provided with a drive sliding block. The upper end surface of the drive sliding block is fixedly connected with a micro-adjusting servo motor. The lower end surface of the drive sliding block is provided with a stretchable surgical knife connecting rod. The surgical instrument realizes X, Y and Z direction driving, improves the flexibility and convenience of the surgical instrument, accurately drives and positions the surgical instrument, and meets the precision requirements of the surgical incision.

[0005] CN112089481A discloses a CT puncture needle automatic guiding device, and the technical scheme points are that the first driving rod is connected with the first gear engaged with the first toothed plate, the second driving rod is provided with the second toothed plate engaged with the second gear, the first long sliding hole is slidably connected with the guide sleeve for the puncture needle to pass through to guide the puncture needle, and the lower end of the guide sleeve passes through the second long sliding hole and is slidably connected with the second long sliding hole. The first driving rod and the second driving rod control the rotation of the first guide frame and the second guide frame respectively, the guide sleeve moves in two directions along the first long sliding hole and the second long sliding hole respectively, the angle of the guide sleeve guiding the puncture needle is changed stereoscopically, and the angle of the puncture needle automatically guided to be pierced is realized, so that the angle of the puncture needle is accurately positioned.

[0006] CN116602742A discloses a ventricle puncture and drainage puncture auxiliary device, comprising a reference element and a puncture needle ring fixing element, the reference element and the puncture needle ring fixing element are both center-opening sheet structures, the reference element is fixed on the head, the puncture needle ring fixing element is axially coincident with the center opening of the reference element and the diameter difference is less than 1mm. The puncture needle ring fixing element extends out an extension having a curved structure, the reference element is provided with a groove matching the extension, and the extension and the groove form a fixed structure connection after matching to fix the reference element and the puncture needle ring fixing element. The reference element can be fixed according to the puncture position, the angle of the puncture needle ring fixing element is adjusted after the opening to assist puncture, and the puncture needle ring fixing element ensures the stability of puncture. The puncture needle ring fixing element can also cooperate with the skull opening drill ring fixing element to ensure the bacteria isolation effect in the puncture and drainage process and avoid intracranial infection.

[0007] The above-mentioned prior art scheme has many problems and defects, for example: the product has many parts, is heavy and inconvenient to assemble, the operation preparation time is long; the puncture angle calculation is complicated, and its accuracy depends on the experience of the surgeon; the marker is attached to the scalp, and its position is not strictly fixed, which affects the accuracy; the adjusting joint is too sensitive, which is inconvenient to adjust; the whole device structure is complex, the manufacturing cost is high, and the price is high.

[0008] Therefore, the industry needs a new three-dimensional space orientation system for brain craniotomy to reduce or even overcome the defects of the prior art and achieve more beneficial technical effects and technical progress.

[0009] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be construed as subject matter limiting of the invention. SUMMARY

[0010] The present application is proposed in view of the above and other more ideas.

[0011] With the progress of computer processing speed and imaging technology, the inventors of the present patent, based on the current technical status and characteristics in the field of brain craniotomy, creatively propose a three-dimensional spatial orientation system for clinical use, which is improved in the three-dimensional spatial positioning of intracranial lesion targets (sometimes interchangeably referred to as "lesions") based on the combination of medical imaging reconstruction calculation and three-dimensional stereoscopic directional head frame / neural navigation technology. The three-dimensional spatial orientation system and its individual components can also be used for more purposes beyond surgical operations, including preoperative analysis, simulation and training, teaching, training of medical students and interns, research and development, etc.

[0012] According to the idea of one aspect of the present application, an innovative three-dimensional spatial orientation system for brain craniotomy is provided. The three-dimensional spatial orientation system comprises: a base configured to be fixed on a patient's brain in a position-invariant manner, the base comprising a support and a developing ring mounted on the support, wherein the developing ring is provided with a developing ring zero scale point, and the developing ring and the developing ring zero scale point can be identified by CT or MRI imaging technology; a head frame mounted on the base, wherein the head frame comprises: a support frame, the head frame being detachably fixedly mounted on the base through the support frame; a planar rotating ring mounted on the support frame; an upper cover fixed to the support frame and pressed above the planar rotating ring, thereby enabling the planar rotating ring to be controllably rotatable between the support frame and the upper cover; a swing rod composed of a horizontal shaft and a vertical shaft, the horizontal shaft of the swing rod being mounted in a diameter direction of the planar rotating ring and being controllably rotatable with the planar rotating ring at a rotation angle φ; the vertical shaft being controllably swingable at a swing angle θ, wherein the vertical shaft defines a puncture path for insertion of a puncture needle; a magnetic ring embedded on the planar rotating ring; an image processing system configured to: perform three-dimensional reconstruction on images of CT / MRI scanning of the patient's brain and the base, determine a developing ring plane in the images of CT / MRI scanning as a base plane, and determine a lesion target T in the patient's head; map a head frame plane according to the base plane and a height h of the head frame, and thereby establish a three-dimensional rectangular coordinate system (x, y, z); calculate a length r of a straight line between an origin o of the three-dimensional rectangular coordinate system (x, y, z) and the lesion target T, and calculate the rotation angle φ and the swing angle θ; establish a three-dimensional polar coordinate system based on the origin o of the three-dimensional rectangular coordinate system (x, y, z), and obtain polar coordinates (r, θ, φ) of the lesion target T in the three-dimensional polar coordinate system; wherein a center point of intersection of the horizontal shaft and the vertical shaft of the swing rod coincides with the origin o of the three-dimensional rectangular coordinate system (x, y, z).

[0013] According to an embodiment, the image processing system comprises a control display module configured to send a calibration command and display a current angle state of the head frame in real time; and

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

[0015] According to an embodiment, the base further comprises a plurality of biocompatible screws arranged along the developing ring.

[0016] According to an embodiment, the head frame further comprises an angle detection control circuit fixed to the upper cover.

[0017] According to an embodiment, the angle detection control circuit is built-in with a rotation angle sensor and a body posture sensor, wherein the rotation angle sensor is installed tangentially to the magnetic ring.

[0018] According to an embodiment, the three-dimensional space orientation system further comprises an angle control console, which is operatively connected to the head frame.

[0019] According to an embodiment, the angle control console comprises a fixing support for fixing the head frame and preventing it from deviating, a transmission device, one end of which is operatively connected to the motor and the other end of which is operatively connected to the head frame and is configured to be able to manipulate the head frame to automatically adjust the rotation angle φ and the swing angle θ, and a computer configured to send control instructions to the control circuit through a serial port, the control circuit receiving the control instructions from the computer to control the rotation of the motor.

[0020] According to an embodiment, the transmission device is configured to be able to automatically adjust the puncture depth of the puncture needle, so that the distance r can be automatically adjusted.

[0021] According to an embodiment, the computer is installed with image processing software of the image processing system.

[0022] According to an embodiment, the rotation angle sensor is an off-axis magnetic encoding angle sensor.

[0023] According to an embodiment, the support frame is further provided with a locking screw.

[0024] According to an embodiment, the three-dimensional space orientation system calibrates the swing angle θ through a six-face calibration algorithm.

[0025] According to an embodiment, the image processing system is configured to collect and process image data identified through CT or MRI imaging technology.

[0026] According to an embodiment, the upper cover is provided with a cavity surface for fixing the angle detection control circuit.

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

[0028] According to an embodiment, the puncture needle is fixed in the puncture channel by a clamping buckle and a clamping screw, wherein the puncture needle defines the puncture depth by the clamping buckle.

[0029] According to an embodiment, the image processing system comprises image processing software, which is configured in the three-dimensional space orientation system or in a separate computer outside the three-dimensional space orientation system.

[0030] According to an embodiment, the motor is a high-precision servo motor, and the transmission device is a transmission shaft installed through the center longitudinal axis of the head frame.

[0031] According to an embodiment, the origin O is substantially coincident with the center of the plane rotating ring.

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

[0033] According to another aspect of the present application, a method for manually adjusting the space orientation of a three-dimensional space orientation system is provided, which comprises the following steps: S1: fixing the base of the three-dimensional space orientation system to the skull of a patient; S2: allowing the patient to wear the base to perform CT / MRI scanning; S3: the image processing system of the three-dimensional space orientation system acquires and processes the images of the base and the lesion of the patient; S4: the image processing system three-dimensionally reconstructs and simulates the head frame of the three-dimensional space orientation system, and obtains the coordinate relationship between the lesion target T and the base and the head frame; S5: path optimization calculation obtains the swing angle θ and the rotation angle φ of the swing rod of the head frame, as well as the puncture depth L data; S6: the head frame receives the swing angle θ and the rotation angle φ data, as well as the puncture depth L data; S7: fixing the head frame to the base; and S8: manually adjusting the swing angle and the rotation angle of the swing rod according to the swing angle θ and the rotation angle φ data, so that they respectively reach the target angles θ and φ.

[0034] According to an embodiment, before step S7, the head frame is in an initial position state.

[0035] According to an embodiment, before step S7, the head frame is calibrated.

[0036] According to an embodiment, the calibration is manually performed by a calibration jig or automatically performed by the angle control console of the three-dimensional space orientation system.

[0037] According to an embodiment, in step S6, the head frame wirelessly receives the swing angle θ and the rotation angle φ data, as well as the puncture depth L data through the angle detection control circuit.

[0038] According to an embodiment, the above method further comprises step S9: manually moving the clamping buckle of the puncture needle to the target scale position of the puncture needle according to the puncture depth L data, and then fixing it by the clamping screw, so as to reach the target puncture depth.

[0039] According to an embodiment, the method further comprises a step S10 of puncturing a puncture needle through the puncture channel to the lesion target T.

[0040] According to an embodiment, in step S8, the position of the swing lever is locked after the target angle is reached.

[0041] According to an embodiment, the position of the swing lever is locked by tightening the rotation locking screw and the swing locking screw of the head holder.

[0042] According to an embodiment, the method is applied to at least one of the following: brain surgery; preoperative simulation; preoperative training; medical explanation; medical demonstration; medical teaching; medical training; and medical research and development.

[0043] According to the concept of another aspect of the present application, a method for automatically adjusting the spatial orientation of a three-dimensional spatial orientation system is provided, comprising the following steps: S1: fixing the base of the three-dimensional spatial orientation system to the skull of a patient; S2: having the patient wear the base for CT / MRI scanning; S3: the image processing system of the three-dimensional spatial orientation system acquires and processes images of the base and the patient's lesion; S4: the image processing system three-dimensionally reconstructs and simulates the head holder of the three-dimensional spatial orientation system, and obtains the coordinate relationship between the lesion target T and the base and the head holder; S5: path optimization calculation obtains the swing angle θ and the rotation angle φ of the swing lever of the head holder, as well as the puncture depth L data; S6: the angle console of the three-dimensional spatial orientation system receives the swing angle θ and the rotation angle φ data, as well as the puncture depth L data; S7: fixing the head holder to the angle console, and automatically completing the position zero calibration; and S8: the angle console automatically adjusts the swing angle θ and the rotation angle φ of the swing lever according to the swing angle θ and the rotation angle φ data, so that the target angle is reached.

[0044] According to an embodiment, before step S8, the head holder is in an initial position state.

[0045] According to an embodiment, before step S8, the head holder is automatically calibrated by the angle console.

[0046] According to an embodiment, in step S8, the position of the swing lever is locked after the target angle is reached.

[0047] According to an embodiment, in step S6, the head holder receives the swing angle θ and the rotation angle φ data, as well as the puncture depth L data, through the control circuit (419) of the angle console.

[0048] According to an embodiment, the method further comprises a step S9 of automatically adjusting the clamping buckle of the puncture needle inserted into the puncture channel of the swing lever to reach the target puncture depth according to the puncture depth L data.

[0049] According to an embodiment, the method further comprises a step S10 of removing the head holder and the puncture needle, and mounting the head holder to the base.

[0050] According to an embodiment, the method further comprises a step S11 of puncturing the puncture needle to the target T through the puncture path.

[0051] According to an embodiment, the step of locking the position of the swing lever is performed by tightening the rotation locking screw and the swing locking screw of the head holder.

[0052] According to an embodiment, the method is applied to at least one of the following: brain surgery; preoperative simulation; preoperative training; medical explanation; medical demonstration; medical teaching; medical training; and medical research and development.

[0053] According to an embodiment of the present application, there is provided a base, comprising: a support having a ring-shaped body, the ring-shaped body of the support defining an outer periphery and an inner periphery; a plurality of biocompatible screws arranged along the outer periphery of the support and spaced apart from each other.

[0054] According to an embodiment, the base further comprises a radiopaque ring disposed on the ring-shaped body and proximate to the inner periphery, wherein the radiopaque ring is disposed concentrically with the support.

[0055] According to an embodiment, the radiopaque ring is a metal ring embedded on the ring-shaped body, or a contrast ring mark directly coated on the upper surface of the ring-shaped body, wherein the radiopaque ring is provided with a radiopaque ring zero mark and matches the ring-shaped body into a unique assembly position relationship.

[0056] According to an embodiment, the plane of the radiopaque ring is flush with the plane of the upper surface of the ring-shaped body.

[0057] According to an embodiment, the upper surface of the ring-shaped body is flat.

[0058] According to an embodiment, the plurality of biocompatible screws are at least 3 titanium screws evenly spaced apart from each other along the outer periphery of the support.

[0059] According to an embodiment, the radiopaque ring is a titanium metal ring.

[0060] According to an embodiment, the radiopaque ring zero mark is a notch on the radiopaque ring.

[0061] According to an embodiment, a plurality of detent posts are provided on the ring-shaped body of the support.

[0062] According to an embodiment, the radial dimension of the substantially annular support of the base, i.e. the outer diameter of the annulus of the support, can be designed to be less than or equal to about 40 mm. Such a design can help miniaturize the base, thereby helping to reduce the weight of the headstock and to improve the positioning accuracy, and to some extent to optimize the manufacturing and assembly tolerances of the headstock and the base.

[0063] According to an embodiment, the plurality of detent posts are three detent posts arranged on the upper surface of the annular body and spaced apart from each other in the circumferential direction.

[0064] According to another aspect of the present application, there is provided a headstock, comprising: a support frame comprising a support ring body and a plurality of support posts arranged on the support ring body and extending axially upward and spaced apart from each other in the circumferential direction; a planar rotary ring rotatably mounted on the support frame; an upper cover fixed to the planar rotary ring, such that the planar rotary ring is controllably rotatable mounted between the support frame and the upper cover; and a swing lever comprising a transverse axis and a longitudinal axis, the swing lever being mounted such that the longitudinal axis is controllably swingable at a swing angle θ; wherein the transverse axis is mounted in the diametrical direction within the planar rotary ring and is controllably rotatable together with the planar rotary ring at a rotation angle φ; wherein the longitudinal axis is perpendicular to the transverse axis, and the longitudinal axis is axially hollow, defining a piercing channel; wherein the support ring body, the planar rotary ring and the upper cover are coaxially arranged.

[0065] According to an embodiment, a magnetic ring that rotates together with the planar rotary ring is coaxially arranged on the planar rotary ring.

[0066] According to an embodiment, the swing lever is a T-shaped swing lever, and the intersection center point of the transverse axis and the longitudinal axis is concentric with the planar rotary ring.

[0067] According to an embodiment, the inner periphery of the planar rotary ring is provided with two transverse bearing seats opposite in the diametrical direction, and the two ends of the transverse axis are rotatably mounted in the two transverse bearing seats, respectively, such that the longitudinal axis is swingable.

[0068] According to an embodiment, the headstock is provided with a swing locking screw for locking the swing lever so as to be unable to swing.

[0069] According to an embodiment, a swing angle sensor for detecting the swing angle θ of the swing lever is provided at the top end of the longitudinal axis of the swing lever or in the vicinity thereof, wherein the swing angle sensor is an acceleration sensor.

[0070] According to an embodiment, a rotation locking hole and a corresponding rotation locking screw are provided on each support post.

[0071] According to an embodiment, a plurality of positioning holes spaced apart in the circumferential direction are further provided on the support ring body.

[0072] According to an embodiment, the upper cover is integrally disc-shaped and has a handle and a scale disc.

[0073] According to an embodiment, the upper cover is integrally disc-shaped and has a handle and a scale disc.

[0074] According to an embodiment, the upper cover is provided with an angle detection control circuit.

[0075] 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.

[0076] According to an embodiment, the rotation angle sensor is positioned at a tangent position of the edge of the magnetic ring.

[0077] According to another aspect of the present application, a method for automatically detecting and verifying the angle of a head holder by an angle detection control circuit is provided, the angle detection control circuit being configured with a rotation angle sensor, a signal processing circuit, an acceleration sensor, and a main control MCU, the method comprising the following steps: S1: calibrating the rotation angle sensor with the head holder at a calibrated initial zero position; S2: collecting the magnetic field strength of the magnetic ring of the head holder by the rotation angle sensor in real time, and performing amplification and filtering processing on the magnetic field strength data by the signal processing circuit, and outputting the data to the main control MCU; S3: obtaining the angle of rotation of the magnetic ring by the main control MCU through algorithm processing, the angle serving as the rotation angle φ of the swing lever of the head holder; S4: collecting the data of the acceleration sensor and the sensor data on the swing lever or the puncture needle by the main control MCU; S5: obtaining the swing angle θ and the rotation angle φ of the swing lever by the main control MCU through algorithm processing based on the data in steps S4 and S5; S6: sending the data of the rotation angle φ and the swing angle θ to the image processing system by the main control MCU in real time, and comparing with the target angle calculated by the image processing system; and S7: when the rotation angle φ and the swing angle θ are consistent with the corresponding target angle, prompting verification success.

[0078] According to an embodiment, the head holder is as described above; and in step S4, the sensor data on the swing lever or the puncture needle is acceleration sensor data.

[0079] According to the concept of another aspect of the present application, there is provided a head holder assembly, comprising: a base configured to be fixed on a skull of a patient, the base comprising a support, a plurality of biocompatible screws mounted on the support, and a radiopaque ring, wherein the radiopaque ring is provided with a radiopaque ring zero scale point, and the radiopaque ring and the radiopaque ring zero scale point are identifiable by CT or MRI imaging technology; a head holder, comprising: a support frame; a planar rotating ring rotatably mounted on the support frame; an upper cover mounted on the planar rotating ring and provided with a scale disc showing a rotation angle φ; and a swing rod composed of a horizontal shaft and a vertical shaft, the swing rod being mounted to be controllably swingable at a swing angle θ and controllably rotatable with the planar rotating ring at the rotation angle φ; wherein the vertical shaft is axially hollow to define a puncture channel for detachable insertion of a puncture needle; and the head holder is detachably fixedly mounted on the base.

[0080] According to an embodiment, the support is a support of a ring-shaped body, the plurality of biocompatible screws are arranged at intervals along an outer periphery of the ring-shaped body, and the radiopaque ring is concentrically arranged on the ring-shaped body close to an inner periphery thereof; the support frame comprises a support ring body and a plurality of support columns arranged at intervals on the support ring body and extending axially upward; a magnetic ring is coaxially arranged on the planar rotating ring and rotatable with the planar rotating ring; the upper cover is disc-shaped as a whole and is provided with a handle; the vertical shaft of the swing rod is controllably swingable at the swing angle θ, and the horizontal shaft is mounted in a diametric direction within the planar rotating ring to be controllably rotatable with the planar rotating ring at the rotation angle φ; the vertical shaft is perpendicular to the horizontal shaft; and the support ring body, the planar rotating ring, the magnetic ring, and the upper cover are coaxially arranged.

[0081] According to an embodiment, the swing rod is a T-shaped swing rod, and a center point of intersection of the horizontal shaft and the vertical shaft is concentric with the planar rotating ring.

[0082] According to an embodiment, an inner periphery of the planar rotating ring is provided with two horizontal bearing seats opposite in a diametric direction, and two ends of the horizontal shaft are rotatably mounted in the two horizontal bearing seats, respectively, so that the vertical shaft is swingable.

[0083] According to an embodiment, the head holder assembly further comprises the puncture needle configured to be detachably inserted into the puncture channel.

[0084] According to an embodiment, a swing angle sensor for detecting the swing angle θ is arranged on the swing rod or the puncture needle; and an angle detection control circuit is arranged on the head holder and is provided with a rotation angle sensor for detecting the rotation angle φ.

[0085] According to an embodiment, a rotation locking hole and a corresponding rotation locking screw are arranged on each support column.

[0086] According to an embodiment, a plurality of positioning holes are circumferentially spaced apart on the support ring body, and a plurality of clamping columns are provided on the annular main body of the support, and the headrest is detachably fixed on the base by cooperation between the plurality of positioning holes and the plurality of clamping columns.

[0087] According to an embodiment, a zero scale point of the developing ring is marked on the developing ring, and a rotation angle mark and a calibration zero scale point are marked on the dial.

[0088] According to an embodiment, in the initial state or the calibration state of the headrest assembly, the zero scale point of the developing ring is aligned with the calibration zero scale point.

[0089] According to an embodiment, the zero scale point of the developing ring is in the form of a notch.

[0090] According to an embodiment, a rotation angle mark and a calibration zero scale point are marked on the dial; and in the calibration state of the headrest assembly, the cross bearing seat is aligned with the zero scale point of the developing ring and the calibration zero scale point.

[0091] According to an embodiment, the puncture needle is provided with a clamping buckle and a clamping screw.

[0092] According to an embodiment, a scale mark is provided on the puncture needle.

[0093] According to an embodiment, the headrest assembly is configured as a three-dimensional spatial orientation system for brain craniotomy.

[0094] According to the concept of another aspect of the present application, there is provided an angle console for automatically adjusting the angle of a headrest, the headrest being provided with a planar rotating ring rotatable at a rotation angle (φ) relative to the headrest, and a swing lever mounted on the planar rotating ring and rotatable therewith, wherein the swing lever is mounted to be swingable at a swing angle (θ) relative to the planar rotating ring, the angle console comprising: a rotation driving assembly configured to drive the headrest to rotate; a swing driving assembly configured to drive the headrest to swing; a transmission mechanical arm operatively connected to both the rotation driving assembly and the swing driving assembly; a control circuit configured to control the rotation driving assembly and the swing driving assembly; a computer configured to calculate the rotation angle (φ) and the swing angle (θ) and send a command to the control circuit; and a headrest clamping mechanism for clamping the headrest; wherein the rotation driving assembly and the swing driving assembly are configured to receive the control command from the computer and / or the control circuit to drive and control the components of the headrest by means of the transmission mechanical arm, thereby performing the automatic control and adjustment of the rotation angle and the swing angle of the headrest.

[0095] According to an embodiment, the transmission mechanical arm is configured to operatively connect and manipulate the swing lever to be rotatable and swingable under control, thereby performing the automatic control and adjustment of the rotation angle and the swing angle.

[0096] According to an embodiment, the transmission mechanical arm comprises a mechanical claw connector, a mechanical claw detachably connected to the mechanical claw connector, and a coil spring sleeved on the mechanical claw.

[0097] According to an embodiment, the swing rod is a T-shaped swing rod composed of a longitudinal axis and a transverse axis, and the mechanical claw of the transmission mechanical arm is configured to be capable of gripping or clamping on the longitudinal axis of the T-shaped swing rod.

[0098] According to an embodiment, the rotation driving assembly comprises a rotation driving motor mounted on the motor bracket, and a rotation reduction gear and a rotation transmission gear operatively connected to the rotation driving motor.

[0099] According to an embodiment, the rotation driving assembly further comprises a rotation encoder, and the rotation encoder and the control circuit are configured to have a control accuracy of the rotation transmission gear up to 0.02°.

[0100] According to an embodiment, the swing driving assembly comprises a swing driving motor mounted on the motor bracket, and a swing reduction gear and a swing transmission device operatively connected to the swing driving motor.

[0101] According to an embodiment, the swing driving assembly further comprises a swing encoder, and the swing encoder and the control circuit are configured to have a control accuracy of the swing transmission device up to 0.02°.

[0102] According to an embodiment, the transmission mechanical arm automatically controls and adjusts the swing angle by controlling the swing of the longitudinal axis, and automatically controls and adjusts the rotation angle by controlling the rotation of the longitudinal axis and the plane rotation ring.

[0103] According to an embodiment, the head holder clamping mechanism comprises a clamping flap, a clamping screw, and a clamping base.

[0104] According to an embodiment, the angle control console is configured to be capable of automatically calibrating the angle of the head holder.

[0105] According to the concept of another aspect of the present application, a method for automatically adjusting the angle of the head holder is provided, the method is performed by the angle control console, and the method comprises the following steps: fixing the head holder on the angle control console; operatively connecting one end of a transmission mechanical arm of the angle control console to both a rotation driving assembly and a swing driving assembly, and operatively connecting the other end to the head holder; sending a control command by an operator through a computer or a control circuit; receiving the control command by the rotation driving assembly and the swing driving assembly, and driving the transmission mechanical arm to operate corresponding components of the head holder to perform automatic control and adjustment of the rotation angle and the swing angle of the head holder.

[0106] According to an embodiment, the transmission mechanical arm performs automatic control and adjustment of the rotation angle and the swing angle by operating the swing rod of the head holder.

[0107] According to an embodiment, the above method is performed by the angle console as described above.

[0108] According to the concept of another aspect of the present application, a method for three-dimensional reconstruction and spatial positioning of a head holder assembly is provided, the head holder assembly comprising a base with a visible ring and a head holder mounted on the base, the head holder comprising: a planar rotating ring rotatably mounted on a support frame; a swing rod composed of a horizontal shaft and a vertical shaft, the swing rod being controllably swingable at a swing angle θ, the horizontal shaft being mounted in a diametric direction within the planar rotating ring and being controllably rotatable with the planar rotating ring at a rotation angle φ, a center point of intersection (206) of the horizontal shaft and the vertical shaft being concentric with the planar rotating ring, and a vertical height of the visible ring to the center point of intersection (206) being h; the method comprising the following steps: fixing the base on a patient's head, and performing CT / MRI scanning; performing three-dimensional reconstruction on images of the CT / MRI scanning, wherein a plane of the visible ring in the images of the CT / MRI scanning is defined as a base plane (502), and a target point T of a lesion in the patient's head is determined according to the images of the CT / MRI scanning; mapping a head holder plane (501) parallel to the base plane (502) at a height h above the base plane (502), and establishing a three-dimensional rectangular coordinate system (x, y, z) with the head holder plane (501) as a reference, wherein an (x, y) plane of the three-dimensional rectangular coordinate system coincides with the head holder plane (501), an origin o of the three-dimensional rectangular coordinate system coincides with the center point of intersection (206), and a z axis of the three-dimensional rectangular coordinate system passes through the origin o and is perpendicular to the head holder plane (501); mapping a lesion plane (503) parallel to the base plane (502) below the base plane (502), so that the target point T of the lesion is located in the lesion plane (503), an origin o' of the lesion plane is located at the origin o, and an x' axis of the lesion plane is parallel to the x axis of the three-dimensional rectangular coordinate system; calculating a length r of a straight line between the origin o and the target point T of the lesion according to the images of the CT / MRI scanning; calculating an included angle ∠Too' between the straight line (r) and the z axis, the included angle ∠Too' being equal to the swing angle θ; calculating an included angle ∠To'x' formed by a To' connecting line between the target point T of the lesion and the origin o' in the lesion plane (503) relative to the x' axis, the included angle ∠To'x' being equal to the rotation angle φ; and obtaining polar coordinates of the target point T of the lesion in a three-dimensional spherical polar coordinate system established with the origin o, the polar coordinates being (r, θ, φ).

[0109] According to an embodiment, the above method comprises adjusting the head holder angle according to the parameters of the polar coordinates (r, θ, φ).

[0110] According to an embodiment, the above method further comprises mounting the head holder on the base, and setting the head holder assembly in an initial state or performing zero calibration.

[0111] According to an embodiment, the zero calibration includes aligning a zero calibration point on the head frame with a zero calibration point on the swing ring.

[0112] According to an embodiment, the zero calibration includes aligning a zero calibration point on the head frame with a zero calibration point on the swing ring.

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

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

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

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

[0117] According to an embodiment, the method includes correcting and / or verifying the head frame plane (501) and the three-dimensional orthogonal coordinate system according to the image of the plane rotation ring in the image of the CT / MRI scan.

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

[0119] To enable, for example, neurosurgeons to perform brain surgery or preoperative training and simulation more safely and accurately, thereby improving the success rate of surgery and reducing the risk rate of surgery;

[0120] To solve the problems of improving positioning accuracy and simplifying operation process by optimizing the positioning coordinate system of the lesion target point to the puncture channel;

[0121] To solve the problem of reducing the weight of the head frame by optimizing the design of the head frame structure and selecting medical-grade PTFE as the main material;

[0122] In the optimization design of the head frame structure, such as by making the base and the head frame separable, by using a T-shaped swing rod to adjust the angles of two different dimensions from two different directions in cooperation with the rotation ring, thereby realizing the miniaturization of the head frame volume, which helps to solve the problems of reducing the weight of the head frame and improving the positioning accuracy from another aspect;

[0123] To solve the problem of simplifying the operation process by modularizing the structure, reducing the number of parts, automatically calculating the angle by the image processing system, automatically adjusting the angle by the angle control console, and optimizing the transmission mode;

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

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

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

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

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

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

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

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

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

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

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

[0135] FIG. 8 is a schematic view of a headgear and how it rotates of the headgear assembly shown in FIGS. 5-6

[0136] FIG. 9 is a schematic view of a headgear and how it swivels of the headgear assembly shown in FIGS. 5-6

[0137] FIG. 10 is a schematic view of the angle detection control circuit of the three-dimensional spatial orientation system shown in FIG. 1

[0138] FIG. 11 is a schematic view of the angle detection control circuit of the three-dimensional spatial orientation system shown in FIG. 1

[0139] FIG. 12 is a schematic view of the base of the headgear assembly of the three-dimensional spatial orientation system shown in FIG. 1

[0140] FIG. 13A is a schematic perspective view of the assembled headgear assembly shown in FIG. 2

[0141] FIG. 13B is a schematic perspective view of the assembled headgear assembly shown in FIG. 13A

[0142] FIG. 14A is a schematic view of the assembled headgear and calibration jig of the three-dimensional spatial orientation system shown in FIG. 1

[0143] FIG. 14B is a schematic exploded view of the headgear and calibration jig shown in FIG. 14A

[0144] FIG. 15A is a schematic front view of the angle console of the three-dimensional spatial orientation system shown in FIG. 1

[0145] FIG. 15B is a schematic block diagram of the motor connection and control of the angle console of the three-dimensional spatial orientation system shown in FIG. 1 ​​​​​​​​​​​

[0146] FIG. 16 is a schematic diagram of a 2-motor combination and mounting for an angle console according to an embodiment of the present application. FIG. 1 is a side view schematic diagram of an angle console of a three-dimensional space orientation system shown in

[0147] FIG. 17 is a schematic diagram of a 2-motor combination and mounting for an angle console according to an embodiment of the present application.

[0148] FIG. 18A is a schematic diagram of an assembled partial longitudinal section of a transmission mechanical arm device for a degree console transmission according to an embodiment of the present application.

[0149] FIG. 18B is an exploded schematic diagram of the transmission mechanical arm device shown in 18A.

[0150] FIG. 19 is a schematic diagram of a head holder clamping mechanism device for a head holder according to an embodiment of the present application.

[0151] FIG. 20 is a schematic diagram of a three-dimensional polar coordinate system established between a head holder and a base of a three-dimensional space orientation system shown in FIG. 1

[0152] is a schematic diagram of a three-dimensional polar coordinate system model for establishing a coordinate relationship between a head holder, a base and a lesion shown in FIG. 21 FIG. 20 is a schematic diagram of a flow of image processing system simulation calculation of a lesion polar coordinate of a three-dimensional space orientation system shown in

[0153] FIG. 22 FIG. 1 is a schematic diagram of a general content of manual operation of a three-dimensional space orientation system shown in

[0154] FIG. 23 is a schematic diagram of a flow of manual implementation operation of a three-dimensional space orientation system shown in FIG. 1

[0155] FIG. 24 is a schematic diagram of a general content of automated implementation operation of a three-dimensional space orientation system shown in FIG. 1

[0156] FIG. 25 is a schematic diagram of a flow of automated implementation operation of a three-dimensional space orientation system shown in FIG. 1

[0157] FIG. 26 is a schematic diagram of a flow of automated implementation operation of a three-dimensional space orientation system shown in FIG. 1 ​​​​​System automation implementation process of the illustrated three-dimensional space orientation system.

[0158] Reference numerals:

[0159] 100-needle; 200A-head frame; 200B-base; 400-angle control console; 500-image processing system; 600-calibration jig; 101-needle shaft; 102-needle clamping buckle; 103-needle scale; 104-acceleration sensor; 105-clamping screw; 201-support frame; 201A-support ring body; 201B-support column; 202-plane rotation ring; 203-magnetic ring; 204-T-shaped swing rod; 205-acceleration sensor; 208-upper cover; 207-piercing channel; 209-angle detection control circuit; 210-calibration zero scale point; 225-positioning hole; 206-head frame origin o; 211-horizontal bearing seat; 212-horizontal shaft; 213-vertical shaft; 224-vertical shaft length r1; 214-plane rotation ring initial position; 215-plane rotation ring position after rotation; 216-rotation angle (φ); 217-plane rotation ring rotation direction; 218-swing angle (θ); 219-T-shaped swing rod position after swing; 220-T-shaped swing rod initial position; 221-T-shaped swing rod swing direction; 226-rotation angle sensor; 227-signal processing circuit; 228-acceleration sensor; 229-master control MCU; 230-LED indicator light; 231-rotation locking hole; 231A-rotation locking screw; 231B-swing locking screw; 232-PCB; 301-titanium screw; 302-bracket; 303-developing ring zero scale point s'; 304-developing ring; 305-base origin o'; 306-clamping column; 222-head frame rotation angle calibration point s (horizontal bearing seat aligns with zero point position); 223-head frame zero scale and base zero scale horizontally coincide; 601-clamping clamp; 602-positioning column; 603-zero scale point; 401A-rotation motor assembly; 401-rotation drive motor; 402-rotation reduction gear; 403-rotation encoder; 404-rotation transmission gear; 405-motor bracket; 406A-swing motor assembly; 406-swing drive motor; 407-swing reduction gear; 408-swing transmission device; 409-swing encoder; 410-computer; 411-transmission mechanical arm; 412-head frame clamping mechanism; 413-mechanical gripper; 414-spring; 415-mechanical gripper connecting piece; 416-clamping flap; 417-clamping screw; 418-clamping base; 419-control circuit; 420-fixing bracket; 501-head frame plane; 502-base plane; 503-lesion plane; 504-three-dimensional coordinate system xyz; 505-head frame rotation starting point s. DETAILED DESCRIPTION

[0160] The details of one or more embodiments of the application are set forth in the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

[0161] It is to be understood that the embodiments illustrated and described are not intended to be limited to the details shown, since the techniques expressly provide for variations and modifications. Rather, the scope of the various embodiments is to be accorded the broadest interpretation of the various claims so as to encompass all such modifications and equivalent structures and functions. In brief, the various embodiments of the application are directed to a system and method for providing a three-dimensional spatial orientation system for brain surgery.

[0162] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the term "comprises", "comprising", or "includes" and variations thereof are intended to cover and encompass items or components that are open-ended, i.e., "comprises one of", "comprising one of", or "including one of", and equivalents thereof are also encompassed.

[0163] The application will be described in greater detail with reference to the figures attached herein.

[0164] Three-dimensional spatial orientation system

[0165] FIG. 1 is a schematic view of a three-dimensional spatial orientation system for brain surgery according to an embodiment of the application, showing the general configuration of the three-dimensional spatial orientation system embodiment.

[0166] As shown in FIG. 1 , the three-dimensional spatial orientation system embodiment can include a headgear assembly, which can include a base 200B and a headgear 200A mounted on the base 200B. The headgear assembly can further include a puncture needle 100 mounted on the headgear 200A, for example inserted into a T-shaped swing lever of the headgear 200A, as detailed below. The headgear assembly can enable calibration and adjustment of the puncture path, puncture angle, and puncture depth of a lesion target T, as detailed below.

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

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

[0169] The embodiment of the three-dimensional spatial orientation system can further include an image processing system 500 (schematically shown in FIG. 1) and a calibration jig 600 (schematically shown in FIG. 2) for processing brain images and determining the initial position of the rotation angle sensor and / or the acceleration sensor, respectively. FIG. 1

[0170] The general composition and configuration of the three-dimensional spatial orientation system is summarized as follows, and the detailed description is provided later.

[0171] (1) Image processing system

[0172] The image processing system can be installed in a computer located in a doctor's office or an operating room, for example, or integrated in the angle control console. One example of the image processing system can include a plurality of processing modules, such as a data extraction module, a three-dimensional reconstruction module, a lesion path planning module, an angle calculation module, and a control display module, etc. The data extraction module can read the image data in DICOM format and parse and extract the corresponding patient information. The three-dimensional reconstruction module can perform volume rendering and surface rendering on the extracted data to achieve three-dimensional reconstruction and simulate the head holder origin plane. The lesion path planning module can plan the puncture path according to the three-dimensional reconstructed lesion and head holder model information. The angle calculation module can measure the plane rotation angle, the longitudinal axis swing angle, and the depth from the lesion target point to the head holder origin plane according to the planned puncture path. The control display module can send the calibration command of the head holder and the sensor, and display the current head holder angle state in real time.

[0173] (2) Angle control console

[0174] One example of the angle control console can include a computer, a fixed support, a high-precision motor, a transmission device, and a control circuit. The computer can install the image processing system and send control commands to the control circuit through a serial port. The fixed support can fix the head holder. The high-precision motor can receive the drive of the control circuit to achieve high-precision angle adjustment and ensure accurate positioning. The control circuit can be connected to the computer, receive its control commands, and drive the high-precision motor to rotate. The transmission device can be connected to the high-precision motor and rotate with it to achieve automatic adjustment of the angle of the head holder.

[0175] (3) Base​

[0176] One example of the base can include a radiopaque ring, a bracket, and a biocompatible screw such as a titanium screw. The radiopaque ring can be embedded in the bracket to facilitate CT / MRI recognition and to establish a coordinate system. The bracket can be used to fix the head frame and to establish a coordinate relationship between the head frame and the patient's lesion. The titanium screw can be used to fix the bracket to the patient, and together with the radiopaque ring, it can be recognized by CT / MRI to establish a coordinate system.

[0177] (4) Head frame

[0178] One example of the head frame can include a support frame, a planar rotating ring, a magnetic ring, a swing rod, an acceleration sensor, an origin, a puncture channel, an upper cover, and an angle detection control circuit. The support frame can be fixed to the base and provide a stable rotating environment for the planar rotating ring, which can have a rotating locking screw inside to prevent the planar rotating ring from moving. The planar rotating ring can be rotatably installed on the support frame and pressed by the upper cover to achieve flexible rotation. The magnetic ring can be embedded in the planar rotating ring to provide a basis for angle measurement for the angle detection circuit. The swing rod can be fixed to the planar rotating ring and can swing along the longitudinal axis, with a puncture channel inside. The swing rod can have a swing locking screw inside, which can be locked during non-working periods and cannot swing, but can be loosened to allow the swing rod to swing when needed. After adjusting to the desired swing angle, the swing locking screw can be tightened again to lock the swing rod at that angle. The sensor can be fixed above the swing rod or above the puncture needle to detect the swing angle, which can be omitted in the automatic adjustment implementation. The origin, for example, can be the center of the planar rotating ring, which, together with the vertical plane of the planar rotating ring, establishes a spatial coordinate system. The puncture channel can be the longitudinal central lumen of the swing rod, which can have different specifications according to the diameter of the puncture needle. The upper cover can be fixed to the support frame to ensure the rotating environment of the planar rotating ring. Depending on the implementation steps, the upper cover can be divided into automatic adjustment and manual adjustment. The manual adjustment upper cover can increase the cavity surface for fixing the angle detection control circuit in the case of automatic adjustment technology. The angle detection control circuit can be fixed to the manual adjustment upper cover, with a rotation angle sensor and a body posture sensor such as an acceleration sensor inside. The rotation angle sensor can be tangentially arranged along the edge of the magnetic ring.

[0179] (5) Puncture needle

[0180] One example of the puncture needle can include a locking buckle and a puncture needle. The locking buckle can have flexibility and can freely move on the puncture needle and be firmly locked on the puncture needle after adjusting to the predetermined length. The puncture needle can have different sizes according to different surgeries, with a scale inside to move smoothly in the puncture channel. Further, a locking screw that can cooperate with the locking buckle can be provided to fix the puncture length (e.g., adjusted to the position).

[0181] The three-dimensional space orientation system and its components, as well as its operation and calibration, etc. are described in detail below in conjunction with the accompanying drawings and examples.

[0182] Headgear assembly

[0183] As FIGS. 2-9 shown, FIG. 2 is a schematic view of a headgear assembly 200 according to an embodiment of the present application that can be used in a three-dimensional space orientation system as shown in FIG. 1 is a schematic view of a headgear assembly 200 according to an embodiment of the present application that can be used in a three-dimensional space orientation system as shown in FIG. 5 is an exploded schematic view of a headgear 200A of the headgear assembly 200 as shown in FIG. 2 is an exploded schematic view of a headgear 200A of the headgear assembly 200 as shown in FIG. 6 is a top-down assembled overall schematic view of the headgear assembly 200 as shown in FIG. 5 is a top-down assembled overall schematic view of the headgear assembly 200 as shown in FIG. 7 is an exploded schematic view of a T-shaped swing bar 204 and a planar rotation ring 202 of the headgear 200A of the headgear assembly 200 as shown in FIGS. 5-6 is an exploded schematic view of a T-shaped swing bar 204 and a planar rotation ring 202 of the headgear 200A of the headgear assembly 200 as shown in FIG. 8 is a schematic view showing the headgear 200A of the headgear assembly 200 as shown in FIGS. 5-6 is a schematic view showing the headgear 200A of the headgear assembly 200 as shown in FIG. 9 is a schematic view showing the headgear 200A of the headgear assembly 200 as shown in FIGS. 5-6 is a schematic view showing the headgear 200A of the headgear assembly 200 as shown in

[0184] According to one example, the headgear assembly 200 can include a headgear 200A and a base 200B, and optionally other components.

[0185] Headgear

[0186] In one example, the headgear 200A can be composed of a support frame 201, a planar rotation ring 202, a magnetic ring 203, a T-shaped swing bar 204, an acceleration sensor 205, and an upper cover 208, etc. The planar rotation ring 202 can be fixedly mounted on the support frame 201. The magnetic ring 203 can be sleeved on the planar rotation ring 202, for example, substantially flushly nested on an inwardly-retracted step at the top of the planar rotation ring 202. The upper cover 208 is disposed above the magnetic ring 203 and the planar rotation ring 202. The T-shaped swing bar 204 can be circumferentially rotatably and swingably mounted in the headgear 200A, and the acceleration sensor 205 can be provided at or near the top end of the T-shaped swing bar 204, as shown in FIGS. 2-6 .

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

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

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

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

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

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

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

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

[0195] Base

[0196] According to one example, for example as shown in FIG. 12 The base 200B can be composed of a generally circular annular support 302, a developing ring 304, and a plurality of, for example, 3 titanium screws 301 arranged on the outer circumference of the support 302. FIG. 12 The 3 titanium screws 301, for example, arranged equidistantly along the circumference, are used to fix the annular support 302 (and the base 200B and the headrest 200A fixed on the base 200B) on the skull of the patient, and to ensure that the reference point does not shift during use, and to establish a fixed coordinate relationship between the headrest 200A and the patient's lesion. According to one example, the circular annular support 302 of the base 200B can be designed such that the outer diameter of the support 302 circular ring is less than or equal to about 40 mm, and the other components of the base 200B are designed to be compatible with it, which helps to miniaturize the base 200B and the headrest.

[0197] The developing ring 304 can be generally concentrically embedded in the circular annular support 302, for example, arranged around the inner circumference and located radially inside it, and absolutely flush with the plane of the support 302. The developing ring 304, for example, can be a metal ring that can be recognized by CT / MRI, facilitating CT / MRI recognition and establishing a coordinate system. A notch can be provided at the zero mark point on the developing ring 304, as shown in FIG. 12 The notch is the developing ring zero mark point s' 303. When the base 200B and the headrest 200A are aligned and installed in place, the physical installation position of the developing ring zero mark point s' 303 can be aligned / aligned with the position of the calibration zero mark point 210 on the headrest 200A, for the image processing system to recognize the starting point / zero mark point.

[0198] As mentioned above, the developing ring 304 can be concentric with the support 302, and the center of the circle is the base origin o' 305. The circumference of the support 302 can be embedded with a plurality of, for example, 3 detent posts 306, which need to be aligned and positioned with the positioning holes 225 when the headrest 200A is assembled onto the base 200B, to ensure that the developing ring zero mark point s' 303 of the base 200B is aligned with the calibration zero mark point 210 of the headrest 200A. As shown in FIG. 13A and 13B The headrest rotation angle calibration point s (cross bearing seat alignment zero point position) 222 is shown, and the position indication 223 where the headrest zero mark and the base zero mark are horizontally overlapped is shown.FIG. 13A is an assembled headrest assembly 200 according to an embodiment FIG. 2 is a schematic perspective view of one view of the assembled headrest assembly 200 according to an embodiment. FIG. 13B is FIG. 13A is a schematic perspective view of another view of the headrest assembly 200 according to an embodiment, showing headrest plane calibration.

[0199] Angular detection and control

[0200] In conjunction with, for example FIG. 10 may be arranged on, for example, a PCB (printed circuit board) 232, signal processing circuit 227, master MCU 229, LED indicator 230, etc. One embodiment of the angle detection and verification steps using headrest 200A with angle detection control circuit 209 is as follows:

[0201] 1) Calibrate the rotation angle sensor 226 with the headrest 200A at the calibrated initial zero position;

[0202] 2) The rotation angle sensor 226 collects the magnetic ring magnetic field strength in real time, and after signal processing circuit 227 amplification and filtering processing, the collected data is transmitted to the master MCU 229;

[0203] 3) The master MCU 229 obtains the accurate angle information of the magnetic ring after rotation, that is, the headrest rotation angle, through algorithm processing;

[0204] 4) The master MCU 229 receives the acceleration sensor (104, 205 or one of the other accessories) data;

[0205] 5) The master MCU 229 collects the acceleration sensor 228 data on the angle detection control circuit;

[0206] 6) The master MCU 229 obtains the accurate T-shaped swing rod 204 swing angle relative to the headrest 200A through algorithm processing of the data of the two acceleration sensors;

[0207] 7) The master MCU 229 transmits the current angle information of the headrest 200A to the image processing system in real time, and compares it with the target angle calculated by the image processing system; and

[0208] 8) When the adjusted angle of the headrest is close to and consistent with the target angle, the operator and the angle console 400 can be reminded by the LED indicator 230.

[0209] Another embodiment of the angle detection and control steps of the headrest 200A (the headrest does not contain the angle detection control circuit) is as follows:

[0210] 1) Install the head frame 200A on the base 200B through a plurality of, for example, 3 positioning holes 225;

[0211] 2) Loosen the swing locking screw on the horizontal bearing seat 211 on the head frame 200A, so that the longitudinal axis 213 of the T-shaped swing rod 204 can swing left and right, for example, as shown by the dotted arrow in FIG. 9 , until the swing angle reaches the desired angle, and then stop, and then tighten the swing locking screw again to lock the T-shaped swing rod in place; and

[0212] 3) Loosen the rotation locking screw 231A in the rotation locking hole 231 on the head frame 200A, so that the plane rotation ring 202 (and thus the magnetic ring 203 and the T-shaped swing rod 204) can be freely rotated (adjusted) in the plane rotation ring rotation direction 217 in the plane rotation ring, for example, as shown by the dotted arrow 217 in FIG. 8 , until the rotation angle reaches the desired angle, and then stop, and then tighten the rotation locking screw 231A in the rotation locking hole 231 again to lock the plane rotation ring 202 in place.

[0213] Calibration jig and calibration method

[0214] FIG. 14A is a schematic diagram of the head frame and calibration jig 600 that can be used in the assembly of the three-dimensional space orientation system shown in FIG. 1 . FIG. 14B is an exploded view of the head frame and calibration jig 600 shown in FIG. 14A , showing the head frame assembly and the calibration jig 600 that is assembled and used in conjunction therewith.

[0215] For example, as shown in FIGS. 14A-14B , the structure and clamping groove at the top of the calibration jig 600 can be similar to the support of the base 200B, and can be designed to match the head frame 200A very precisely. For example, as shown in FIG. 14A and 14B , three positioning columns 602 and a zero scale point 603 can also be provided on the circumference thereof, for alignment, positioning and calibration. In addition, the calibration jig 600 can also be provided with, for example, two clamping jigs 601, to ensure that the T-shaped swing rod 204 of the head frame 200A is perpendicular to the plane in which the calibration jig 600 is located (parallel to the plane in which the plane rotation ring 202 is located) when calibration is performed, thereby improving the positioning accuracy.

[0216] One example of sensor calibration can include initial position determination and sensor software calibration.

[0217] The operation steps in one embodiment of calibration using the calibration jig 600 can include the following:

[0218] 1) Mount the head holder 200A on the calibration jig 600 through the locating hole 225;

[0219] 2) Align the 3 circumferentially spaced locating holes 225 of the head holder 200A with the 3 circumferentially spaced locating posts 602 of the calibration jig 600, thereby ensuring the zero scale of the head holder 200A is aligned with the zero scale point 603 of the calibration jig 600, as shown in FIGS. 14A-14B

[0220] 3) Operate the clamping fixture 601 on the calibration jig 600 to make the longitudinal axis 213 of the T-shaped swing lever 204 perpendicular to the plane on which the calibration jig 600 lies;

[0221] 4) Lock the head holder 200A by, for example, rotating the locking screw and the swing locking screw, so that the T-shaped swing lever 204 and the planar swing ring 202 are fixed in the initial position;

[0222] 5) The above calibration steps can be performed before the product leaves the factory, thereby reducing the surgical preparation time and the learning time of the doctor (of course, it can also be performed after the product leaves the factory);

[0223] 6) Remove the head holder 200A from the calibration jig 600;

[0224] 7) Mount the head holder 200A on the base 200B, send the calibration command via the computer / image processing system, and perform software calibration of the acceleration sensor 228 and the angle sensor 226 by the master control MCU 229.

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

[0226] Angular control console

[0227] As shown in FIGS. 15-19, an example of the angle control console 400 can include a rotation driving motor 401, a rotation reduction gear 402, a rotation encoder 403, a rotation transmission gear 404, a motor support 405, a swing driving motor 406, a swing reduction gear 407, a swing transmission device 408, a swing encoder 409, a computer 410, a control circuit 419, a transmission mechanical arm 411, and a head holder clamping mechanism 412. The head holder clamping mechanism 412 can be used to clamp the head holder 200A. The motor support 405 can have any suitable configuration, such as L-shaped, U-shaped, or H-shaped, for example, as shown in FIG. 15A and FIGS. 16-17 ​An exemplary configuration is shown, which can be used to fix / mount the swing motor assembly 406A on one hand, and to mount the rotation motor assembly 401A on the other hand, for example to connect the rotation transmission gear 404. The transmission mechanical arm 411 can be used to drive the head holder clamping mechanism 412, so that the head holder 400A can realize the movement in both rotation and swing directions. As shown, one end of the transmission mechanical arm 411 can be connected to the swing transmission device 408, and the other end can be connected to the head holder clamping mechanism 412. The head holder clamping mechanism 412 can be composed of the mechanical claw 413, the spring 414, the mechanical claw connecting piece 415, etc. For example, as shown in FIG. 19 As shown, the fixing support 420 can be composed of the clamping cover 416, the clamping screw 417, the clamping base 418, etc., which together with the head holder clamping mechanism 412 can be used to fix the head holder 200A and can make it in the physical zero position. According to the instructions sent by the operator such as the surgeon through the computer 410, the rotation drive motor 401, the rotation reduction gear 402, the rotation encoder 403, the rotation transmission gear 404, the transmission mechanical arm 411, and the head holder clamping mechanism 412, etc. of the angle console 400 automatically drive / adjust the planar rotation ring 202 of the head holder 200A on the angle console 400 (together with the magnetic ring 203 and the T-shaped swing rod 204) to rotate in the rotation plane defined by the planar rotation ring 202 along the planar rotation ring rotation direction 217 according to the required rotation angle, so as to adjust the rotation angle of the head holder 200A in the rotation plane.

[0228] According to the instructions sent by the operator such as the surgeon through the computer 410, the swing drive motor 406, the swing reduction gear 407, the swing transmission device 408, the swing encoder 409, the transmission mechanical arm 411, and the head holder clamping mechanism 412, etc. of the angle console 400 mounted on the motor support 405 automatically drive / adjust the T-shaped swing rod 204 of the head holder 200A on the angle console 400 to swing according to the required swing angle, so as to adjust the swing angle of the longitudinal axis 213 of the head holder 200A.

[0229] As shown in FIGS. 15A-15B and FIGS. 18A-18B The transmission mechanical arm 411 can be composed of the mechanical claw 413, the spring 414, and the mechanical claw connecting piece 415, etc. The mechanical claw 413 can grip and drive the T-shaped swing rod 204 of the head holder 200A, for example, to automatically adjust the angles of the head holder 200A in two directions, i.e. the rotation direction and the swing direction.

[0230] As shown in FIGS. 16-17 and FIG. 19As shown, the head clamp mechanism 412 cooperates with the transmission mechanical arm 411 to fix the head 200A on the angle console 400 without deviation and to fix the rotation part at the calibration position. The head clamp mechanism 412 may, for example, mainly consist of a clamp cover 416, a clamp screw 417 and a clamp base 418. The clamp cover 416 and the clamp base 418 each have a circular / oblong mounting hole, and the mounting position formed by the clamp cover 416 and the clamp base 418 when clamped in place is suitable for clamping a head 200A of corresponding shape and size.

[0231] One example of the angle console 400 can include a computer 410 configured to install an image processing system and configured to send control commands to the control circuit 419 through a serial port. The control circuit 419 is configured to be connected in communication with or integrated with the computer 410, to receive control commands therefrom and to drive the high-precision drive motor to rotate.

[0232] According to one example, the rotation drive motor 401 and the swing drive motor 406 can be high-precision motors configured to receive drive signals from the computer 410 (for example, through the control circuit 419) to operate to achieve high-precision angle adjustment or calibration, ensuring accurate positioning.

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

[0234] The swing motor assembly 406A can include a swing drive motor 406 mounted on the motor bracket 405, and a swing reduction gear 407 and a swing transmission 408 operatively connected with the swing drive motor 406. The swing transmission 408 can be, for example, a belt transmission gear, such as in the form of a sector of a partial transmission gear. Also, the swing motor assembly 406A can further include a swing encoder 409. The swing encoder 409 can detect the swing angle and feed back to the control circuit 419, which can be configured to precisely control the swing angle, for example, by an algorithm, such as a PID algorithm, to achieve high-precision motor control and driving, so that the control accuracy of the swing transmission can be as high as 0.02°. The swing motor assembly 406A drives the swing transmission 408 to drive the transmission mechanical arm 411 to swing until the target swing angle is reached.

[0235] An example of the assembly and operation of the high-precision motor operation is as follows:

[0236] 1) The computer 410 sends a control command to the control circuit 419, which drives the rotation drive motor 401 to drive the rotation reduction gear 402 to rotate to increase the torque and control resolution, to provide a basis for high-precision rotation of the motor 401, while not generating a rotation in the stopped state of the motor 401.

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

[0238] 3) The rotation encoder 403 can be a non-contact absolute value encoder with, for example, 17-bit resolution, which can measure the rotation position of the rotation drive motor 401, and the effective control accuracy is 14-bit, so that the control accuracy of the rotation drive motor 401 can reach about 0.02°.

[0239] The motor operation mode of the swing drive motor 406 can be basically the same as that of the rotation drive motor 401, for example, operated similarly as above, and thus is not described here.

[0240] An example of the operation of the angle control console 400 is as follows:

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

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

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

[0244] 4) Tighten the clamping screw 417, so that the head frame 200A is very stably installed on the angle console 400 and kept in the calibration position;

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

[0246] Piercing needle

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

[0248] As shown in FIGS. 1-4 , the puncture needle 100 can be provided with a scale 103, and can be provided with a clamping buckle 102, so that the puncture depth of the puncture needle 100 can be adjusted according to the displayed scale. The clamping buckle 102 can be installed and configured to have a certain position flexibility, and can be freely positioned on the puncture needle 100, and after the puncture needle 100 is adjusted to a predetermined length, the clamping buckle 102 is stably clamped on the puncture needle 100. The acceleration sensor 104 can be installed at the top end (the upper end shown in the figure, or the proximal end, which is opposite to the distal end or surgical end of the puncture needle 100) or its vicinity as shown in FIGS. 2-3 , which can be used to measure the angle parameter during puncture.

[0249] The puncture needle 100 can have various sizes according to different uses or operations, and can be smoothly moved, inserted or withdrawn in the puncture channel 207.

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

[0251] FIG. 20 is a schematic diagram of a three-dimensional polar coordinate system established between the head frame 200A and the base 200B, which can be used for the three-dimensional space orientation system shown in FIG. 1 . FIG. 21 is a schematic diagram of a three-dimensional polar coordinate system model shown in FIG. 20 , which can be used to establish a coordinate relationship between the head frame 200A, the base 200B and the lesion target T.

[0252] Spherical polar coordinates, also known as spherical polar coordinate system, is a kind of three-dimensional polar coordinate system, which is extended from two-dimensional polar coordinate system, and is used to determine the position of points, lines, surfaces and bodies in three-dimensional space. It takes the coordinate origin as the reference point, and is composed of azimuth angle, elevation angle and distance, for example, as shown in FIGS. 20-21 The essence of the working mode of polar coordinates in two dimensions is that a point in three-dimensional space can be specified by giving a direction and a distance. Spherical coordinates can work by defining a direction and a distance: in three dimensions, defining a direction requires two angles, for example, the rotation angle φ (identical to φ in the drawing, used interchangeably in this text) and the wobble angle θ, as shown in FIGS. 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.

[0253] The head frame plane 501 refers to a plane established with the origin o 206 of the head frame 200A as the reference. On this plane, the head frame origin o 206 is taken as the center, and the plane rotation ring 202 is taken as a concentric circle therein, thereby forming a fixed plane. The plane is composed of an infinite number of concentric circles, each with a different radius, but all with the origin o of the head frame 200A as the center.

[0254] As shown in FIGS. 20-21 In the three-dimensional space orientation system of the present application, the three-dimensional rectangular coordinate system (x, y, z) 504 refers to a coordinate system established with the head frame plane 501 (for example, the plane defined by the plane rotation ring 202) as the reference. The origin o 206 of the head frame 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 the os rotates 90° clockwise around the origin o in the head frame plane 501, and the z-axis is the axis perpendicular to the head frame plane 501 and downward through the origin o 206.

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

[0256] The lesion plane 503 refers to a plane simulated with the lesion target point T as the reference, which is set to be parallel to the base plane 502, and a two-dimensional coordinate system x'y' is established according to the plane. The origin (center) o' of the two-dimensional coordinate system (x', y') is the point where the origin o of the head frame 200A is mapped to the lesion plane 503 along the z-axis of the three-dimensional rectangular coordinate system (x, y, z) 504, wherein the x'-axis is the mapping of the x-axis of the three-dimensional rectangular coordinate system (x, y, z) 504 in the lesion plane 503, and the y'-axis is the mapping of the y-axis of the three-dimensional rectangular coordinate system (x, y, z) 504 in the lesion plane 503.

[0257] FIG. 22is a three-dimensional space orientation system according to an embodiment of the present application FIG. 1 Fig. 1 is a schematic diagram of a three-dimensional space orientation system according to an embodiment of the present application.

[0258] As shown in Fig. 2, the three-dimensional space orientation system comprises a head support 200A and a base 200B. FIG. 22 As shown in Fig. 3, one example of the process of simulating and calculating the polar coordinates of the lesion target T is as follows:

[0259] The patient wears the base 200B on his head and then performs CT / MRI scanning.

[0260] The position relationship, position parameters and / or images between the lesion target in the patient's head and the developing ring 304 of the base 200B are obtained.

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

[0262] A lesion plane 503 parallel to the plane of the developing ring 304 is mapped downward from the plane of the developing ring 304, so that the lesion target T is located in the lesion plane 503, and the coordinates and position relationship are as shown in Fig. 5. FIG. 21

[0263] The length of the straight line between the lesion target T and the origin o is calculated as r, the included angle between r and the z-axis is calculated as θ (corresponding to the swing angle θ), and the included angle between the To' connecting line in the lesion plane 503 and the x' axis is calculated as φ' (corresponding to the rotation angle φ), as shown in Fig. 6. FIG. 21

[0264] The lesion target T is mapped in the headrest plane 501 to obtain a point T', at this time, the angle φ' is equal to the corresponding angle φ in the headrest plane 501.

[0265] The image processing system of the three-dimensional space orientation system can simulate and reconstruct the coordinate position relationship of Fig. 7 according to the process of Fig. 8, for example. FIG. 22 FIGS. 20-21 In the three-dimensional rectangular coordinate system (x, y, z) 504 with the origin o established based on the headrest plane 501, the coordinates of the point s are (d / 2, 0, 0), the coordinates of the point s' are (d / 2, 0, h), the coordinates of the point o' are (0, h, 0), the coordinates of the lesion target T are (r*cosθ, ), and the coordinates of the mapping point T' corresponding to the lesion target T are (r*cosθ, 0). If a three-dimensional spherical polar coordinate system is established with the origin o, the polar coordinates of the lesion target T can be obtained as (r, θ, φ).​​​

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

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

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

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

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

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

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

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

[0274] Let the patient wear the base 200B to perform CT / MRI scanning;

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

[0276] The image processing system three-dimensionally reconstructs and simulates the position of the head holder, and obtains the coordinate relationship between the lesion target point T and the base (and the head holder);

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

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

[0279] The head holder 200A is in an initial position state (which can be set at the factory), or the initial position of the head holder 200A can be determined using a calibration jig;

[0280] The head holder 200A is fixed to the base 200B by, for example, three clamping columns 306;

[0281] The sensor on the head holder 200A is calibrated by, for example, the image processing system (image processing software);

[0282] According to the angle data, loosen the rotation locking screw 231A, manually rotate the T-shaped swing rod of the head holder 200A to the target rotation angle φ, and tighten the rotation locking screw 231A to prevent the plane rotation ring 202 from rotating;

[0283] According to the angle data, loosen the swing locking screw 231B, manually rotate the T-shaped swing rod 204 of the head holder 200A to the target swing angle θ, and tighten the swing locking screw 231B to prevent the swing rod 204 from swinging;

[0284] According to the puncture depth data, manually adjust the clamping buckle of the puncture needle 100 to reach the target puncture depth and lock it; and

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

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

[0287] FIG. 25 According to an embodiment of the present application, which can be used FIG. 1The general content of the automatic operation of the three-dimensional space orientation system is shown. The general content of the automatic operation can include: CT / MRI scanning by wearing the base 200B on the patient's brain, three-dimensional image reconstruction by using the image processing system, and calculation of the coordinate relationship between the lesion target T and the base (and the head frame), thereby obtaining and providing angle data (θ and φ) and puncture depth data (L); mounting the head frame 200A (which can not contain sensors and control circuits, for example) on the fixed support 420 of the angle console 400 through the positioning hole 225; using the angle console 400 to automatically calibrate the head frame 200A, and automatically adjusting to the target angle (θ and φ) and automatically fixing with the locking screw according to the corresponding angle data (θ and φ) and puncture depth data (L) after the automatic calibration; and automatically adjusting the clamping buckle on the puncture needle 100 to the target depth (L) and locking; dismounting the head frame 200A, fixing it on the base 200B through the positioning hole 225 and the clamping column 306, or fixing it on the base 200B through, for example, a screw; mounting the adjusted puncture needle 100 to perform puncture through the puncture path 207, so that the puncture needle 100 punctures to the lesion target T position.

[0288] FIG. 26 The three-dimensional space orientation system according to an embodiment of the present application can be used for FIG. 1 The schematic diagram of the system automatic implementation process of the three-dimensional space orientation system is shown.

[0289] An example of the process of the automatic implementation operation can include (the order of the operation is not limited by the description here):

[0290] Locking (fixing) the base 200B support on the patient's brain skull through a titanium screw;

[0291] Let the patient wear the base 200B to perform CT / MRI scanning;

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

[0293] The image processing system three-dimensionally reconstructs and simulates the position of the head frame, and obtains the coordinate relationship between the lesion target T and the base (and the head frame);

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

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

[0296] The head frame 200A is in the initial position state (which can be set at the factory), and the head frame 200A is installed on the fixed support 420 of the angle console 400. Because the mechanical claw 413 of the head frame clamping mechanism 412 is tightly pressed with the horizontal shaft 212 of the head frame 200A, the head frame 200A can be in the initial position state;

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

[0298] According to the angle data, the angle console 400 drives the motor support 405 and the transmission mechanical arm 411 through the rotating motor assembly 401A to automatically adjust the rotation angle φ of the T-shaped swing rod of the head frame 200A, so that it reaches the target angle;

[0299] The rotating part of the head frame 200A with the target angle adjusted is locked, for example, the rotating lock hole 231 in the rotating lock screw 231A of the support frame 201 is tightened (for example, please refer to the corresponding part in the foregoing), so that the plane rotating ring 202 cannot rotate;

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

[0301] The swing part of the head frame 200A with the target angle adjusted is locked, for example, the swing lock screw 231B on the horizontal shaft bearing seat 211 is tightened (for example, please refer to the corresponding part in the foregoing), so that the swing rod cannot swing; FIG. 6

[0302] According to the puncture depth data, the angle console 400 can automatically adjust the clamping buckle of the puncture needle 100, so that it reaches the target puncture depth and is automatically locked with the clamping screw;

[0303] The head frame 200A with the target angle adjusted is removed and installed on the base 200B fixed to the skull of the patient; and

[0304] The puncture needle 100 with the target puncture depth adjusted is removed, and the puncture operation is performed through the puncture channel 207 of the T-shaped swing rod 204.

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

[0306] ​1) A small base can be fixed on the skull to establish the coordinate relationship between the lesion target and the base. Since the base as a reference is directly fixed on the skull, the relative position of the internal structure of the head frame and the base is fixed and determined, enabling the skilled person to more accurately determine the precise position between the head frame and the lesion target. This method can help doctors more accurately position and operate during surgery, improve the positioning accuracy of surgery, and ensure the safety and accuracy of surgery.

[0307] 2) The structure of the planar rotating ring and the swing rod of the head frame can be co-centered to determine the precise position in the plane. At the same time, combined with the length of the puncture needle, the effect of spatial precise positioning can be achieved.

[0308] 3) The separate design and detachable assembly of the head frame and the base can automatically and manually adjust the angle, facilitate operation, and do not need to install the entire or part of the head frame assembly on the patient in many steps and processes. In this way, the volume and weight of the brain implant part can be effectively reduced, making it more portable and reducing the burden on the patient.

[0309] 4) High-precision sensors can be installed on the swing rod of the head frame and / or the puncture needle to measure the swing angle. At the same time, algorithms such as six-face calibration algorithms can be used to improve measurement accuracy.

[0310] 5) A magnetic ring can be built-in in the planar rotating ring, and an off-axis magnetic coded angle sensor can be installed at the tangent position to measure the relative angle of rotation. Software calibration algorithms can be used to process the measurement data to achieve more accurate angle measurement and improve the performance and stability of the three-dimensional spatial orientation system.

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

[0312] 7) The angle control console can automatically adjust the puncture angle and / or depth, thereby effectively improving the accuracy, repeatability, and convenience of the surgery. The use of the angle control console to automatically adjust the puncture angle and the use of a small and high-precision angle sensor configuration to measure the angle further simplify the system configuration and operation process, further improve the positioning accuracy, and reduce the learning time of the doctor using the device.

[0313] 8) can be driven by a drive motor in the form of, for example, a stepper motor, and a high-precision encoder can be provided at the end of the reduction gear, so that the beneficial effect of more precise angle control can be achieved.

[0314] The foregoing description of several embodiments of the application has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the application to the precise steps and / or forms disclosed, and various modifications and variations are possible in light of the above teachings or can be acquired from practice of the application. The scope and spirit of the application are intended to be limited only by the claims that follow.

Claims

1. A three-dimensional spatial orientation system for brain craniotomy, comprising: a base configured to be fixed on a patient's brain in a position-invariant manner, the base comprising a support and a radiographic ring mounted on the support, wherein a radiographic ring zero scale point is provided on the radiographic ring, and the radiographic ring and the radiographic ring zero scale point are identifiable by CT or MRI imaging technology; a head frame mounted on the base, wherein the head frame comprises: a support frame, the head frame being detachably fixed to the base via the support frame; a planar rotation ring mounted on the support frame; an upper cover fixed to the support frame and clamped above the planar rotation ring, thereby enabling the planar rotation ring to be controllably rotated between the support frame and the upper cover; a swing rod comprising a transverse axis and a longitudinal axis, the transverse axis of the swing rod being mounted in a diametric direction of the planar rotation ring and being controllably rotatable with the planar rotation ring at a rotation angle Ф, and the longitudinal axis being controllably swingable at a swing angle θ, wherein the longitudinal axis defines a puncture path for a puncture needle to be inserted; and a magnetic ring embedded on the planar rotation ring; an image processing system configured to: perform three-dimensional reconstruction on images of CT / MRI scanning of the patient's brain and the base, determine a radiographic ring plane in the images of the CT / MRI scanning as a base plane, and determine a lesion target point T in the patient's brain; map a head frame plane according to the base plane and a height h of the head frame, and thereby establish a three-dimensional rectangular coordinate system (x, y, z); calculate a length r of a straight line between an origin o of the three-dimensional rectangular coordinate system (x, y, z) and the lesion target point T, and calculate the rotation angle Ф and the swing angle θ; establish a three-dimensional polar coordinate system based on the origin o of the three-dimensional rectangular coordinate system (x, y, z), and obtain polar coordinates (r, θ, Ф) of the lesion target point T in the three-dimensional polar coordinate system; wherein a center point of intersection of the transverse axis and the longitudinal axis of the swing rod coincides with the origin o of the three-dimensional rectangular coordinate system (x, y, z); wherein the image processing system comprises a control display module configured to send calibration commands and display a current angle state of the head frame in real time; the image processing system is further configured to plan a puncture path of a puncture needle according to the polar coordinates (r, θ, Ф) of the lesion target point T; wherein the head frame further comprises an angle detection control circuit fixed to the upper cover; and wherein the three-dimensional spatial orientation system further comprises an angle control console operatively connected to the head frame.

2. The three-dimensional spatial orientation system of claim 1, wherein, The base further comprises a plurality of biocompatible screws arranged along the radiographic ring.

3. The three-dimensional spatial orientation system of claim 1, wherein, The angle detection control circuit is internally provided with a rotation angle sensor and a body posture sensor, wherein the rotation angle sensor is mounted tangentially to the magnetic ring.

4. The three-dimensional spatial orientation system of claim 1, wherein, The angle control console comprises: a fixed support for fixing the head frame and preventing it from being deviated. a transmission device, one end of which is operatively connected to the motor and the other end of which is operatively connected to the head frame and configured to manipulate the head frame to automatically adjust the rotation angle Ф and the swing angle θ; a computer configured to send control instructions to the control circuit through a serial port, the control circuit receiving the control instructions from the computer to control the rotation of the motor.

5. The three-dimensional spatial orientation system of claim 4, wherein, The transmission device is configured to automatically adjust the puncture depth of the puncture needle, so that the length r can be automatically adjusted.

6. The three-dimensional spatial orientation system of claim 4, wherein, The image processing software of the image processing system is installed in the computer.

7. The three-dimensional spatial orientation system of claim 3, wherein, The rotation angle sensor is an off-axis magnetic encoding angle sensor.

8. The three-dimensional spatial orientation system of claim 1, wherein, The support frame is further provided with a locking screw.

9. The three-dimensional spatial orientation system of claim 1, wherein, The three-dimensional space orientation system further calibrates the swing angle θ through a six-surface calibration algorithm.

10. The three-dimensional spatial orientation system of claim 1, wherein, The image processing system is configured to: Collect and process image data identified by CT or MRI imaging technology.

11. The three-dimensional spatial orientation system of claim 1, wherein, A cavity surface for fixing the angle detection control circuit is arranged on the upper cover.

12. The three-dimensional spatial orientation system of claim 1, wherein, The horizontal axis and the vertical axis are integrally formed, so that the swing rod is T-shaped.

13. The three-dimensional spatial orientation system of claim 1, wherein, The puncture needle is fixed in the puncture channel by a clamping buckle and a clamping screw, wherein the puncture needle defines the puncture depth by the clamping buckle.

14. The three-dimensional spatial orientation system of claim 11, wherein, The image processing system includes image processing software, which is configured in the three-dimensional space orientation system or installed in a separate computer outside the three-dimensional space orientation system.

15. The three-dimensional spatial orientation system of claim 4, wherein, The motor is a high-precision servo motor, and the transmission device is a transmission shaft installed through the center vertical axis of the head frame.

16. The three-dimensional spatial orientation system of any one of claims 1-15, wherein, The origin o coincides with the center of the plane rotation ring.

17. The three-dimensional spatial orientation system of any one of claims 1-15, wherein, 0≤Ф<360°, -45°<θ<45°.

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