An intramedullary nail distal positioning system and method

Abstract

The application relates to the technical field of medical devices, and discloses an intramedullary nail far-end positioning system and method, which comprises an intelligent electric rotating device, an electromagnetic field generator and an intramedullary nail fixing frame; the intramedullary nail fixing frame is rigidly connected with a first electromagnetic sensor, and the intramedullary nail fixing frame is rigidly connected with an intramedullary nail in a target area; the intelligent electric rotating device comprises an electric rotating body, an electric rotating head and a second electromagnetic sensor; the second electromagnetic sensor is rigidly connected with the electric rotating body; and the application improves the positioning precision of the intramedullary nail far end.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an intramedullary nail distal positioning system and method. Background Technology

[0002] Intramedullary nailing is one of the most common and effective treatments for long bone fractures (especially fractures of the femur and tibia), offering advantages such as minimal trauma, high stability, and rapid early postoperative functional rehabilitation. During intramedullary fixation surgery, locking screws are inserted at both the distal and proximal ends of the intramedullary nail to ensure its anti-rotational and anti-shear stability. Compared to proximal locking screws, distal locking screws present a significant challenge due to the deep embedding of the intramedullary nail within the bone and the difficulty in visually identifying the screw holes. Summary of the Invention

[0003] This invention provides a system and method for locating the distal end of an intramedullary nail to solve the problem of difficulty in locating the distal end of an intramedullary nail.

[0004] In a first aspect, the present invention provides a distal positioning system for an intramedullary nail, the system comprising: an intelligent electro-rotation device, an electromagnetic field generator, and an intramedullary nail fixation frame; the intramedullary nail fixation frame is rigidly connected to a first electromagnetic sensor, and the intramedullary nail fixation frame is rigidly connected to an intramedullary nail within a target area; the intelligent electro-rotation device comprises an electro-rotation body, an electro-rotation head, and a second electromagnetic sensor; the second electromagnetic sensor is rigidly connected to the electro-rotation body; Electromagnetic field generator, used to establish an electromagnetic field environment within a target area; The first electromagnetic sensor is used to acquire position data of the distal nail hole of the intramedullary nail in an electromagnetic field environment. The second electromagnetic sensor is used to acquire the position data of the electric rotary head in an electromagnetic field environment, and to determine the positioning deviation data based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head, and to perform distal positioning of the intramedullary nail based on the positioning deviation data.

[0005] This invention provides a distal intramedullary nail positioning system. Since distal intramedullary nail locking surgery primarily relies on X-ray fluoroscopy, posing a high risk of radiation exposure, this invention incorporates an electromagnetic field generator and rigidly connects a first electromagnetic sensor to the intramedullary nail fixation frame and a second electromagnetic sensor to the electro-rotator body. Through the integration of electromagnetic field and sensor technology, dependence on X-rays is avoided, significantly reducing radiation exposure for both the surgeon and patient. Furthermore, the rigid connection of the first electromagnetic sensor to the intramedullary nail fixation frame eliminates positioning reference drift caused by assembly gaps in the mechanical aiming frame, operational vibrations, and intramedullary nail deformation. The rigid connection of the second electromagnetic sensor to the electro-rotator body eliminates positioning failures caused by sensor displacement or loosening during electro-rotation. The rigid configuration of the first and second electromagnetic sensors ensures the fixation of the relative positions of the first electromagnetic sensor and the distal nail hole of the intramedullary nail, as well as the relative positions of the second electromagnetic sensor and the electro-rotator head, thereby improving the accuracy of distal intramedullary nail positioning.

[0006] In one alternative implementation, the second electromagnetic sensor includes: The package includes a housing, a rigid mounting base connected to the housing, and a coil core frame, a multi-turn coil winding, a front-end circuit board, and an indicator light disposed within the housing. The coil core frame provides skeletal support for the multi-turn coil winding. The multi-turn coil winding is connected to the front-end circuit board. The front-end circuit board is connected to the indicator light.

[0007] In one optional embodiment, the intelligent electro-electric device further includes: The device includes a display screen, an electric rotary motor, a motor drive board, and an electric rotary trigger. The display screen is located on the side of the electric rotary handle. The electric rotary motor is located at the front end of the electric rotary handle. The motor drive board is connected to the second electromagnetic sensor, the display screen, the electric rotary motor, and the electric rotary trigger. The electric rotary trigger is connected to the motor drive board.

[0008] In one optional embodiment, the intelligent electro-electric device further includes: The rotary chuck is located at the front end of the output shaft of the electric rotary motor and rigidly clamps the electric rotary head.

[0009] In one optional embodiment, the intelligent electro-electric device further includes: The power management module is connected to the second electromagnetic sensor, the display screen, the electric rotary motor, the motor drive board, and the electric rotary trigger.

[0010] In a second aspect, the present invention provides a method for distal intramedullary nail positioning, applied to the distal intramedullary nail positioning system of the first aspect or any corresponding embodiment thereof, the method comprising: An electromagnetic field environment is established within the target area using an electromagnetic field generator; The location data of the distal nail hole of the intramedullary nail is obtained by the first electromagnetic sensor in an electromagnetic field environment. The position data of the electric rotary head is acquired in an electromagnetic field environment by a second electromagnetic sensor, and the positioning deviation data is determined based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head. The distal positioning of the intramedullary nail is then performed based on the positioning deviation data.

[0011] This invention provides a method for distal intramedullary nail positioning. An electromagnetic field generator establishes a unified electromagnetic field environment within the target area, providing a stable spatial positioning reference for the first and second electromagnetic sensors. This avoids accumulated errors caused by multiple reference switching or coordinate system transformations, ensuring the accuracy of position calculations for the distal nail hole and the electrosurgical head, significantly improving positioning reliability. Furthermore, the first electromagnetic sensor acquires the distal nail hole position data, and the second electromagnetic sensor acquires the electrosurgical head position data. The positioning reference and the operating terminal are independent, ensuring that the nail hole position reference is not disturbed by surgical operations while simultaneously tracking the electrosurgical head's dynamics in real time. This gives the positioning system both stability and real-time performance, effectively overcoming the shortcomings of single-sensor positioning schemes where the reference is prone to drift. Moreover, using the distal nail hole position data as the target and the electrosurgical head position data as the actual pose, positioning deviation data is directly calculated. This provides a real-time, accurate, and intuitive reflection of the alignment between the electrosurgical head and the nail hole, offering a reliable basis for intraoperative navigation and operational guidance, and achieving precise positioning of the distal intramedullary nail.

[0012] In one optional implementation, position data of the electric rotary head is acquired in an electromagnetic field environment using a second electromagnetic sensor, and positioning deviation data is determined based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head. Distal positioning of the intramedullary nail is then performed based on the positioning deviation data, including: The magnetic field strength and direction are sensed in an electromagnetic field environment by multi-turn coil windings, and the magnetic field strength and direction are converted into position data of the electric rotary head. The positioning deviation data is calculated by the front-end circuit board based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head, and a control signal is generated based on the positioning deviation data. The indicator light shows the alignment status of the electric rotary head and the distal screw hole of the intramedullary nail based on the control signal.

[0013] In one optional implementation, a magnetic field strength and direction are induced in an electromagnetic field environment through a multi-turn coil winding, and the magnetic field strength and direction are converted into position data of the electric rotary head, including: The multi-turn coil winding determines the global pose data of the second electromagnetic sensor based on the magnetic field strength and direction; The multi-turn coil winding acquires the relative position vector of the second electromagnetic sensor and the electric rotary head. Based on the relative position vector of the second electromagnetic sensor and the electric rotary head, as well as the global pose data of the second electromagnetic sensor, the position data of the electric rotary head is calculated.

[0014] In one optional implementation, the position data of the electric rotary head is acquired in an electromagnetic field environment by a second electromagnetic sensor, and positioning deviation data is determined based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head. The distal positioning of the intramedullary nail is then performed based on the positioning deviation data. The method further includes: Based on the positioning deviation data, the distal positioning image of the intramedullary nail is updated in real time on the display screen, and the operation status of the electric rotary motor is controlled by the motor drive board.

[0015] In one alternative implementation, before acquiring the location data of the distal nail hole of the intramedullary nail in an electromagnetic field environment via a first electromagnetic sensor, the method further includes: Position calibration is performed using a first electromagnetic sensor and a second electromagnetic sensor in an electromagnetic field environment. Attached Figure Description

[0016] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the structure of an intramedullary nail distal positioning system according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the structure of the second electromagnetic sensor according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of an intelligent electro-electric conversion device according to an embodiment of the present invention; Figure 4 This is a schematic diagram of the first step of a method for distal positioning of an intramedullary nail according to an embodiment of the present invention; Figure 5 This is a schematic diagram of the second process of an intramedullary nail distal positioning method according to an embodiment of the present invention. Detailed Implementation

[0018] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] It is understood that before using the technical solutions disclosed in the various embodiments of the present invention, users should be informed of the types, scope of use, and usage scenarios of the personal information involved in the present invention and their authorization should be obtained in accordance with relevant laws and regulations through appropriate means.

[0020] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0021] The relevant methods for distal locking of intramedullary nails mainly rely on "manual or aiming frame positioning of the distal nail hole" under C-arm perspective. This method has the following significant problems: (1) The need for repeated fluoroscopic positioning during the operation can easily lead to cumulative X-ray radiation exposure for both doctors and patients, increasing the radiation risk for both the surgeon and the patient; (2) The operation is difficult and the positioning time is long, especially for surgeons with insufficient experience. Positioning the distal nail hole is a time-consuming and unstable process. (3) Multiple drilling increases the risk of damage to the bone cortex microstructure, reduces the holding force of the locking screw, and may prolong the operation time, thus increasing the surgical risk; (4) The aiming frame of the relevant intramedullary nailing device is usually a rigid structure, which cannot effectively compensate for the displacement or deformation of the intramedullary nail caused by bending or torsion when the intramedullary nail is inserted into the medullary cavity.

[0022] (5) The positioning frame itself may undergo mechanical displacement under the influence of factors such as weight, surgical force load, and the strength of the operator, which may further reduce the positioning accuracy, especially when the medullary canal of long bones (such as femur and tibia) is more curved.

[0023] Therefore, reducing radiation exposure, improving surgical efficiency and precision, and reducing surgical risks have become the core issues that urgently need to be addressed in intramedullary nail distal locking technology.

[0024] In summary, existing intramedullary nail distal locking techniques rely on two-dimensional imaging, which introduces positioning errors, especially in complex fractures and deep keyhole positioning. This embodiment aims to achieve three-dimensional real-time positioning by combining electromagnetic tracking technology with an intelligent electro-rotation system, significantly improving positioning accuracy, reducing physician operational errors, and increasing the success rate of surgery.

[0025] This embodiment provides a distal positioning system for intramedullary nails, such as... Figure 1 As shown, it includes: an intelligent electro-rotation device 101, an electromagnetic field generator 102, and an intramedullary nail fixation frame 103; the intramedullary nail fixation frame 103 is rigidly connected to a first electromagnetic sensor 104, and the intramedullary nail fixation frame 103 is rigidly connected to the proximal end of the intramedullary nail in the target area; the intelligent electro-rotation device 101 includes an electro-rotation body 1011, an electro-rotation head 1012, and a second electromagnetic sensor 1013; the second electromagnetic sensor 1013 is rigidly connected to the electro-rotation body 1011; Electromagnetic field generator 102 is used to establish an electromagnetic field environment in a target area.

[0026] Specifically, the electromagnetic field generator 102 is installed above or to the side of the surgical area to cover the surgical area and ensure that the instruments being operated are within the range of magnetic field induction.

[0027] Furthermore, the electromagnetic field generator 102 provides a stable electromagnetic field environment for the entire intramedullary nail distal positioning system, enabling accurate positioning and tracking. That is, the electromagnetic field generator 102 generates a stable electromagnetic field around the surgical area. The electromagnetic field generator 102 can use a set of electromagnets to create a magnetic field of specific intensity and direction in space through current control. The electromagnetic field environment is not only used to provide positioning information for the sensors, but also to reduce external interference through the adjustment of specific frequency and intensity.

[0028] Furthermore, an appropriate electromagnetic field environment is set by an external electromagnetic field generator 102, which provides a reference coordinate system so that the magnetic field sensor can accurately identify the target position.

[0029] The first electromagnetic sensor 104 is used to acquire position data of the distal nail hole of the intramedullary nail in an electromagnetic field environment.

[0030] Specifically, the first electromagnetic sensor 104 is installed on the intramedullary nail fixation frame 103 to monitor the direction of the intramedullary nail in real time and sense the positional changes of the proximal and distal nail holes of the intramedullary nail.

[0031] Furthermore, a first electromagnetic sensor 104 is placed on the intramedullary nail fixation frame. Since the first electromagnetic sensor 104 and the intramedullary nail fixation frame 103 are rigidly fixed and cannot move, they can be regarded as an integral structure. The first electromagnetic sensor 104 can display the positional relationship in the electromagnetic field environment. Since it is rigidly connected to the intramedullary nail, it can be regarded as an integral structure. After the relevant information such as the length, thickness, and model of the intramedullary nail is determined, the position and orientation of the intramedullary nail and the nail hole can be accurately determined. Therefore, when the positional relationship of the first electromagnetic sensor 104 is determined in the electromagnetic field environment, the computer simulation program can accurately calculate the positional relationship of the intramedullary nail and the nail hole on the intramedullary nail to accurately determine the orientation of the nail hole. When the intramedullary nail moves, the first electromagnetic sensor 104 will also move accordingly, so that the movement positional relationship between the two can be located in real time in the magnetic field (because the two are rigidly connected, they can be regarded as an integral structure).

[0032] Furthermore, based on the input information about the length and model of the intramedullary nail, combined with the electrical and magnetic field data, the orientation of the nail hole is confirmed, and the matching calibration with the electromagnetic field environment is automatically completed.

[0033] For example, the electromagnetic field generator 102 generates stable coordinates. That is, the electromagnetic field generator 102 is fixed at any position next to the operating table and generates a precise magnetic field range of 50cm×50cm. This is the stable coordinate. The intramedullary nail and the electric rotary instrument are equipped with magnetic field sensors, so when they move within this range, the changes in position can be captured by the magnetic field, reflecting the positional relationship.

[0034] The second electromagnetic sensor 1013 is used to acquire position data of the electric rotary head 1012 in an electromagnetic field environment, and determine positioning deviation data based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head 1012, and perform distal positioning of the intramedullary nail based on the positioning deviation data.

[0035] Specifically, the intelligent electro-rotator 101 is equipped with a second electromagnetic sensor 1013, which can sense the position and orientation of the electro-rotator head 1012 in real time and interact with the electromagnetic field environment to accurately display the electro-rotator position and the intramedullary nail positioning relationship. At the same time, the intelligent electro-rotator 101 is equipped with an intelligent prompting system to accurately align the drilling and lock the nail in the correct position. Specifically, since the second electromagnetic sensor 1013 is rigidly fixed on the electro-rotator body 1011 and they are an integral structure, the electro-rotator will display its positional relationship in the magnetic field. The positional relationship of the entire electro-rotator in the electromagnetic field environment is determined by computer simulation. The magnetic field always exists, and the second electromagnetic sensor 1013 is always receiving magnetic field signals, so it can reflect the positional change relationship of the electro-rotator head 1012 in real time.

[0036] This embodiment provides an intramedullary nail distal positioning system. Since distal intramedullary nail locking surgery primarily relies on X-ray fluoroscopy, posing a high risk of radiation exposure, this invention incorporates an electromagnetic field generator and rigidly connects a first electromagnetic sensor to the intramedullary nail fixation frame and a second electromagnetic sensor to the electro-rotator body. Through electromagnetic field and sensor integration technology, dependence on X-rays is avoided, significantly reducing radiation exposure for both the surgeon and patient. Furthermore, the rigid connection of the first electromagnetic sensor to the intramedullary nail fixation frame eliminates positioning reference drift caused by assembly gaps in the mechanical aiming frame, operational vibrations, and intramedullary nail deformation. The rigid connection of the second electromagnetic sensor to the electro-rotator body eliminates positioning failures caused by sensor displacement or loosening during electro-rotation. The rigid configuration of the first and second electromagnetic sensors ensures the fixation of the relative positions of the first electromagnetic sensor and the distal nail hole of the intramedullary nail, as well as the relative positions of the second electromagnetic sensor and the electro-rotator head, thus improving the accuracy of distal intramedullary nail positioning.

[0037] In some alternative implementations, such as Figure 2 As shown, the second electromagnetic sensor 1013 includes: The package includes a housing 10131, a rigid mounting base 10132 connected to the housing 10131, and a coil core frame 10133, a multi-turn coil winding 10134, a front-end circuit board 10135, and an indicator light 10136 disposed within the housing 10131. The coil core frame 10133 provides skeletal support for the multi-turn coil winding 10134. The multi-turn coil winding 10134 is connected to the front-end circuit board 10135. The front-end circuit board 10135 is connected to the indicator light 10136.

[0038] Specifically, the multi-turn coil winding 10134 is composed of multi-turn triaxial orthogonal coils, which can simultaneously sense the magnetic field strength and direction of the external magnetic field in the X, Y, and Z axes, and convert the magnetic field signal into induced electromotive force to obtain position / attitude data.

[0039] Furthermore, the coil core frame 10133 provides a precise installation reference for the multi-turn coil winding 10134, ensuring that the position, angle, and number of turns of the coil winding strictly meet the design requirements and avoid magnetic field induction errors caused by coil deformation. Among them, the coil core frame 10133 uses a soft magnetic material with high permeability (such as ferrite) to guide the magnetic flux to concentrate, enhance the coil's sensitivity to external magnetic fields, and improve the signal acquisition accuracy in weak magnetic field environments.

[0040] Furthermore, the front-end circuit board 10135 integrates a low-noise amplifier circuit, a filter circuit, a synchronous sampling unit, and a posture sensing control board. The low-noise amplifier circuit amplifies the weak induced electromotive force output by the multi-turn coil winding 10134 with low noise, amplifying the millivolt-level signal to a processable volt level, thus improving the signal-to-noise ratio. The filter circuit filters out environmental electromagnetic interference and high-frequency noise through low-pass and band-pass filters, retaining the effective magnetic field signal and avoiding positioning drift caused by interference. The synchronous sampling unit synchronously acquires the magnetic field data of the three-axis coil at a sampling frequency of ≥100Hz, ensuring the real-time performance of the position / attitude data and meeting the needs of dynamic surgical tracking. The posture sensing control board completes the calculation of the magnetic field data into three-dimensional coordinates and attitude angles, and simultaneously outputs control signals to drive the indicator light 10136, realizing the alignment feedback between the electric rotary head and the nail hole.

[0041] Furthermore, the encapsulation shell 10131 provides rigid support for internal components such as coils and circuit boards, ensuring that the relative positions of each component remain constant, preventing internal structural displacement caused by vibration or collision during surgical operations, and ensuring positioning accuracy.

[0042] Furthermore, the rigid mounting base 10132 can be made of high-strength medical-grade metal / carbon fiber material to achieve a gapless rigid fixation between the second electromagnetic sensor 1013 and the electro-drill body 1011, ensuring that the relative position and angle between the sensor and the tip of the electro-drill remain constant throughout the operation, which is the core guarantee for the positioning accuracy of the electro-drill.

[0043] This embodiment provides an intramedullary nail distal positioning system. A rigid mounting base is used to achieve rigid fixation to the electro-rotator body, eliminating installation gaps and vibration errors, and improving positioning accuracy. The coil core skeleton stably supports the multi-turn coil winding, ensuring magnetic field induction sensitivity and signal consistency. The multi-turn coil is directly connected to the front-end circuit board, shortening the signal path and enhancing anti-interference capabilities. The front-end circuit board integrates signal processing and deviation calculation, enabling rapid on-site data resolution. Indicator lights are directly driven by the circuit board, providing real-time feedback on the positioning status, facilitating physician operation and judgment.

[0044] In some alternative implementations, such as Figure 3 As shown, the intelligent electric transfer device 101 also includes: The device includes a display screen 1014, an electric rotary motor 1015, a motor drive board 1016, and an electric rotary trigger 1017. The display screen 1014 is located on the side of the electric rotary handle. The electric rotary motor 1015 is located at the front end of the electric rotary handle. The motor drive board 1016 is connected to the second electromagnetic sensor 1013, the display screen 1014, the electric rotary motor 1015, and the electric rotary trigger 1017. The electric rotary trigger 1017 is connected to the motor drive board 1016.

[0045] Specifically, the motor drive board 1016 receives the operation signal from the electric rotary trigger 1017 and the positioning data from the electromagnetic sensor, generates motor drive control commands, and precisely controls the start, stop, speed, and torque of the electric rotary motor 1015 to achieve closed-loop control of the drilling process. Furthermore, based on the positioning deviation data generated by the second electromagnetic sensor 1013, the motor drive board 1016 locks the electric rotary motor 1015 drive and prohibits drilling operations when the alignment between the electric rotary trigger and the nail hole does not meet the requirements. When the drilling depth or torque exceeds the threshold, the power of the electric rotary motor 1015 is automatically cut off to avoid surgical risks.

[0046] Furthermore, the electric rotary motor 1015 provides rotational power to the electric rotary head 1012, driving the electric rotary head 1012 to complete the drilling operation of the distal nail hole of the intramedullary nail. That is, it receives the control signal from the motor drive board 1016 and automatically matches the speed and torque according to the specifications (length, thickness and model) of the intramedullary nail to adapt to the drilling needs of different surgical scenarios.

[0047] Furthermore, if the position and direction of the electric rotary head 1012 are inconsistent with the position of the distal screw hole of the intramedullary nail, the indicator light 10136 will be red. At this time, the user will adjust the electric rotary direction according to the color of the indicator light 10136 and the position data of the electric rotary head 1012 displayed on the display screen 1014. When the electric rotary head is adjusted to the correct direction, the indicator light 10136 will be green.

[0048] Alternatively, indicator lights 10136 can be configured with more than two. For example, with two indicator lights, when the physician adjusts the direction of the electrical rotation, the system uses the first indicator light to provide feedback on whether the direction is correct. That is, when the direction of the electrical rotation is consistent with the entrance position of the distal screw hole of the intramedullary nail, the first light is green; if they are inconsistent, the light is red, prompting the physician to adjust the direction. After the electrical rotation is adjusted to the correct direction, the second indicator light confirms whether the direction is appropriate. If it is appropriate, the second light is green; if it is not appropriate, the light is red, prompting the physician to further adjust the direction of the electrical rotation. When the direction of the electrical rotation is confirmed to be correct and the second green light is on, the physician can slowly drill the hole using the electrical rotation and begin driving in the locking screw.

[0049] This embodiment provides an intramedullary nail distal positioning system. The display screen is positioned to the side of the electric rotary handle, ensuring unobstructed surgical vision and facilitating real-time observation of navigation information by the physician. The electric rotary motor is located at the front end of the handle, featuring a rational structural layout, high transmission efficiency, and stable operation. The motor drive board centrally connects the second electromagnetic sensor, display screen, electric rotary motor, and electric rotary trigger, achieving unified signal processing and control linkage. The electric rotary trigger is directly connected to the drive board, enabling motor safety interlock control based on positioning deviations. Drilling is only permitted when alignment is correct, effectively preventing misoperation and significantly improving surgical safety and positioning accuracy.

[0050] In some alternative embodiments, the smart electro-electric device 101 further includes: The needle chuck 1018 is located at the front end of the output shaft of the electric rotary motor 1015 and rigidly clamps the electric rotary head 1012.

[0051] Specifically, the rotary chuck 1018 precisely transmits the rotational power of the electric rotary motor 1015 to the electric rotary head 1012, ensuring that the electric rotary head 1012 is coaxial and synchronous with the motor spindle without relative displacement, thus guaranteeing drilling accuracy.

[0052] Furthermore, the rotating needle chuck 1018 and the second electromagnetic sensor 1013 maintain a fixed geometric positional relationship, ensuring that the pose data of the second electromagnetic sensor 1013 can be accurately mapped to the three-dimensional coordinates of the tip of the rotating head, thus eliminating installation errors between the chuck and the rotating head.

[0053] This embodiment provides an intramedullary nail distal positioning system in which a rotating needle clamp is rigidly positioned at the front end of the output shaft of an electric rotary motor. This rigidly clamps the rotary head, ensuring stable power transmission from the motor and preventing loosening, shaking, or radial runout of the rotary head during drilling. This effectively improves drilling coaxiality and positional accuracy. At the same time, the rigid clamping structure maintains a fixed relative position between the rotary head and the electric rotary body, providing a stable geometric reference for the pose calculation of the second electromagnetic sensor, further enhancing the distal positioning accuracy of the intramedullary nail and the reliability of the surgery.

[0054] In some alternative embodiments, the smart electro-electric device 101 further includes: The power management module 1019 is connected to the second electromagnetic sensor 1013, the display screen 1014, the electric rotary motor 1015, the motor drive board 1016, and the electric rotary trigger 1017.

[0055] Specifically, the power management module 1019 provides stable and safe DC power to all components such as the second electromagnetic sensor 1013, the display screen 1014, the electric rotary motor 1015, and the motor drive board 1016, ensuring that the intelligent electric rotary device 101 operates continuously and reliably throughout the entire surgical procedure.

[0056] Furthermore, the power management module 1019 monitors the battery power, voltage, and current in real time. When the power is insufficient, it issues a warning through the display screen 1014 and indicator light 10136 to avoid power interruption during surgery. It also has overcharge, over-discharge, overload, and short-circuit protection, which meets medical electrical safety standards.

[0057] This embodiment provides an intramedullary nail distal positioning system. The power management module centrally supplies power to all functional components, realizing global power control and energy distribution optimization, ensuring stable and reliable power supply to the system. Through centralized power management, it reduces line redundancy and fault points caused by decentralized power supply, and improves the overall integration and safety of the power supply. At the same time, it has voltage monitoring, overload protection, and undervoltage protection functions, effectively avoiding damage to components under abnormal operating conditions, ensuring continuous and stable operation, and improving the service life and clinical reliability of the equipment.

[0058] The following specific example illustrates the workflow of the intramedullary nail distal positioning system.

[0059] Example 1: The workflow of the intramedullary nail distal positioning system includes: Step 1: First, set up an appropriate electromagnetic field environment using an external electromagnetic field generator. This electromagnetic field environment provides a reference coordinate system, enabling the magnetic field sensor to accurately identify the target location.

[0060] Step 2: The system automatically starts the registration program and automatically corrects the positional relationship of the intramedullary nail positioning frame to ensure that the relative positional relationship between the magnetic field sensor and the intramedullary nail frame is accurately acquired, thereby determining the orientation of the intramedullary nail.

[0061] Step 3: Input the length, thickness, and model of the intramedullary nail into the electroporation system. The system will automatically match and calibrate the electroporation settings to ensure they are consistent with the specifications of the intramedullary nail. A few X-ray fluoroscopy scans will be used to correct for any deformation of the intramedullary nail after insertion into the femoral medullary cavity (the probability of deformation is small). The computer will then simulate automatic position correction. At this point, the system will compare the real-time data from the electroporation with the magnetic field sensor to confirm the direction of the nail hole and automatically generate corresponding directional guidance.

[0062] Step 4: Based on the input length and model information, combined with the electrical and magnetic field data, the system confirms the orientation of the intramedullary nail hole and automatically completes the matching calibration with the electromagnetic field environment.

[0063] Step 5: As needed for the surgery, input the number of the screw hole to be drilled into the electrosurgical unit via the system. The system displays the specific location of the screw hole and guides the surgeon to align the electrosurgical unit with that location.

[0064] Step 6: The auxiliary monitor screen will display real-time 3D model graphics of the intramedullary nail and electrocautery, which will be compared with the current position of the intramedullary nail in real time, providing intuitive assistance to the physician and helping to quickly and accurately locate the nail hole.

[0065] Step 7: When the physician adjusts the direction of the electrocautery, the system provides feedback on whether the direction is correct via the first indicator light. When the direction of the electrocautery matches the position of the screw hole entrance, the first light illuminates green; if they do not match, the light illuminates red, prompting the physician to adjust the direction.

[0066] Step 8: After the electrosurgical unit is adjusted to the correct direction, the system confirms whether the direction is appropriate through the second indicator light. If it is appropriate, the second light will light up green; if it is not appropriate, the second light will light up red, prompting the physician to further adjust the electrosurgical unit direction.

[0067] Step 9: When the direction of the electric drill is confirmed to be correct and the second green light is lit, the doctor can slowly drill a hole through the electric drill and begin to insert the locking nail. The intelligent electric drill device 101 will track its position in real time to ensure accurate drilling and lock the nail in the correct position.

[0068] Because related intramedullary nail distal locking techniques rely on two-dimensional imaging, which introduces positioning errors, especially in complex fractures and deep keyhole positioning, Embodiment 1 above combines electromagnetic tracking technology with an intelligent electro-rotation system to achieve three-dimensional real-time positioning, significantly improving the positioning accuracy of intramedullary nail distal locking, reducing physician operational errors, and increasing the success rate of the surgery. Furthermore, since related intramedullary nail distal locking procedures mainly rely on X-ray fluoroscopy, posing a high risk of radiation exposure, the adoption of electromagnetic field and sensor integration technology avoids reliance on X-rays, thereby greatly reducing radiation exposure for both the surgeon and patient. Real-time three-dimensional visualization and intelligent feedback not only improve surgical precision but also help physicians complete positioning operations more quickly and effectively, reducing the time spent on repeated fluoroscopy and positioning, thus improving overall surgical efficiency and shortening surgical time. Finally, the integration of artificial intelligence algorithms (such as image recognition and prediction algorithms) will be explored to provide intelligent auxiliary decision support based on preoperative data and real-time sensor information, helping physicians make optimal decisions during surgery and improving the personalization and precision of the procedure.

[0069] According to an embodiment of the present invention, an embodiment of a method for distal localization of an intramedullary nail is provided. It should be noted that the steps shown in the flowchart in the accompanying drawings can be executed in a computer system such as a set of computer-executable instructions. Furthermore, although a logical order is shown in the flowchart, in some cases the steps shown or described may be executed in a different order than that shown here.

[0070] This embodiment also provides a method for distal intramedullary nail positioning, which can be used in the aforementioned distal intramedullary nail positioning system. Figure 4 This is a flowchart of the distal localization method for intramedullary nails according to an embodiment of the present invention, as follows: Figure 4 As shown, the process includes the following steps: Step S401: Establish an electromagnetic field environment in the target area using an electromagnetic field generator.

[0071] Specifically, a reference coordinate system is constructed in the electromagnetic field environment. The reference coordinate system is a three-dimensional Cartesian coordinate system, that is, the three axes (X, Y, Z) are determined by the position of the magnetic field source. In the reference coordinate system, the positions of the first electromagnetic sensor and the second electromagnetic sensor relative to the magnetic field source are calculated by sensing the change in magnetic field strength.

[0072] Furthermore, in the reference coordinate system, the source point is located at the center of the electromagnetic field generator. The coordinates of the source point in three-dimensional space are determined through an initial calibration process, i.e., preliminary analysis of magnetic field strength and direction data, to ensure that the source point is the center of the magnetic field source location. In three-dimensional space, the coordinate axes must be orthogonal; therefore, the X-axis is set along the front-to-back direction of the operating table. In experiments, the X-axis is usually chosen to align with the patient's longitudinal direction, or adjusted as needed. If the location of the source point in the electromagnetic field environment is... Then the X-axis direction can be defined as: (1) In the above formula, The x-axis represents the first or second electromagnetic sensor. The lateral distance between the source point and either the first or second electromagnetic sensor is denoted as .

[0073] The left-right direction, perpendicular to the X-axis and parallel to the operating table, is set as the Y-axis. This means the Y-axis aligns with the transverse direction of the patient's body. By setting the Y-axis, the orthogonality of the reference coordinate system can be ensured. The direction of the Y-axis can be defined as follows: (2) In the above formula, The ordinate of the first electromagnetic sensor or the second electromagnetic sensor is denoted as . The longitudinal distance between the source point and the first electromagnetic sensor or the second electromagnetic sensor.

[0074] The direction perpendicular to the operating table surface is set as the Z-axis. The Z-axis direction vector typically represents the vertical direction of the patient's upper or lower limb, ensuring a complete coordinate system in three-dimensional space. The Z-axis direction can be defined as: (3) In the above formula, This represents the cross product, ensuring that the Z-axis is perpendicular to the X-axis and Y-axis.

[0075] Furthermore, to ensure high accuracy in real-time positioning, continuous calibration is required. Before each operation, automatic calibration is performed based on the initial relative position of the sensor and the magnetic field source. That is, before acquiring the position data of the distal nail hole of the intramedullary nail through the first electromagnetic sensor in the electromagnetic field environment, the position is calibrated in the electromagnetic field environment using the first and second electromagnetic sensors. In other words, before the start of the operation, the first and second electromagnetic sensors need to be calibrated to ensure the accuracy of their data. Based on the preoperative magnetic field strength and direction data, the initial position of the sensor is calculated, and the source point and axis direction of the reference coordinate system are set. The calibration process obtains the initial relative position by comparing the first and second electromagnetic sensors with the reference position of the magnetic field.

[0076] Furthermore, the first and second electromagnetic sensors are placed at known reference positions, triaxial magnetic field strength data are collected, a mapping model between the magnetic field signal and spatial coordinates is established, sensor zero drift and installation errors are eliminated, and initial registration is completed; wherein, based on the spatial position of the first electromagnetic sensor... The magnetic field strength and direction are determined by the direction of the magnetic field. The induced magnetic field data of the first electromagnetic sensor are: This corresponds to the components of the magnetic field on the X, Y, and Z axes.

[0077] Furthermore, the magnetic field strength is measured, and the magnetic field strength is related to the distance from the first electromagnetic sensor to the magnetic field source point, and the distance between the magnetic field source point and the first electromagnetic sensor is... The calculation formula is as follows: (4) Assuming the magnetic field strength generated by the electromagnetic field generator follows an inverse square law, its strength... With distance The magnetic field strength and direction are inversely proportional to the location of the magnetic field source. The model of the magnetic field source can be expressed as: (5) in, is the magnetic field source strength constant.

[0078] Furthermore, the components of each axis can be represented by the spatial relationship between the sensor and the source point and the strength of the magnetic field. The X-axis component, Y-axis component, and Z-axis component are calculated using the following formula: (6) (7) (8) Furthermore, by measuring the magnetic field strength and direction, the position of the target can be calculated in reverse, thus utilizing the known magnetic field components. The position of the first electromagnetic sensor (i.e., the distal nail hole of the intramedullary nail) in the reference coordinate system is calculated using the following formula: (9) Furthermore, magnetic field data is continuously collected during the operation and compared with the preset model. The sensor position is corrected through a reverse algorithm to eliminate coordinate drift caused by environmental interference and instrument displacement, and the terminal data is updated synchronously.

[0079] Furthermore, the system automatically initiates the registration process, automatically corrects the positional relationship of the intramedullary nail positioning frame, and ensures that the relative positional relationship between the magnetic field sensor and the intramedullary nail frame is accurately acquired, thereby determining the orientation of the intramedullary nail.

[0080] Furthermore, the length, thickness, and model of the intramedullary nail are input into the intelligent electro-rotation device. The system automatically calls up and matches the geometric parameters corresponding to the model of intramedullary nail to complete the initial setup and calibration of the intelligent electro-rotation device. This ensures that the positioning and guidance parameters of the intelligent electro-rotation device are consistent with the specifications of the intramedullary nail. A few X-ray fluoroscopy scans are used to correct whether the intramedullary nail has deformed after being inserted into the femoral medullary cavity (the probability of deformation is small), and the computer simulates automatic position correction. At this time, the direction of the nail hole is confirmed by comparing the real-time data of the electro-rotation with the magnetic field sensor (i.e., the first electromagnetic sensor and the second electromagnetic sensor), and the corresponding directional guidance is automatically generated.

[0081] Furthermore, the acquisition and calibration of information such as the length, thickness, and model of the intramedullary nail can be achieved using at least one of the following methods: (1) Preoperative three-dimensional scanning database construction method: Three-dimensional scanning of intramedullary nails from different manufacturers / specifications or a three-dimensional model database based on their CAD data is performed to obtain parameters including intramedullary nail length, diameter, locking hole position, hole axis direction, etc., and the above parameters are mapped to the corresponding models; after inputting the model during the operation, the corresponding parameters are read for calibration and positioning.

[0082] (2) Preoperative magnetic field simulation template method: In the electromagnetic field environment before surgery, an intelligent electro-rotation device equipped with electromagnetic sensors is used to simulate the alignment / rotation operation of the distal locking hole of the target intramedullary nail, so that the rotation pose of the intelligent electro-rotation device and the pose of the distal locking hole form a visualized three-dimensional relative positional relationship in the computer; based on this simulation process, the system generates and records template parameters for subsequent rapid calibration. The template parameters include at least: the relative pose relationship between the pose of the distal locking hole and the pose of the intelligent electro-rotation device in the electromagnetic field reference coordinate system; and / or, the relative pose relationship between the pose of the distal locking hole and the pose of the sensor on the intramedullary nail positioning frame / intramedullary nail in the electromagnetic field reference coordinate system.

[0083] The template parameters can be associated with the corresponding intramedullary nail model and stored in the database for quick access during surgery, enabling rapid preliminary calibration without repeated manual adjustments.

[0084] Furthermore, during the surgery, when the intramedullary nail is inserted into the femoral medullary cavity and manipulated to lock the distal femur, there is a small probability that additional operations may cause the intramedullary nail to deform or bend. Therefore, after the intramedullary nail is inserted and corrected with X-ray assistance, there is a small probability that the position of the intramedullary nail will deform. Correcting the deviation caused by the deformation of the intramedullary nail and the displacement of the positioning frame can dynamically track the positional relationship, but it cannot dynamically correct the deformation, because the deformation after the intramedullary nail is inserted may be too small to require correction. In addition, both the electrosurgical unit and the intramedullary nail have magnetic field sensors, which can represent the relative positional relationship between the two in the magnetic field. Therefore, mutual adjustment and registration can be performed, enabling real-time interaction of data between the two ends.

[0085] Furthermore, during the surgery, the magnetic field strength and direction data are collected in real time and compared with the preset model. If a deviation occurs, the direction of the electric rotary head is automatically calibrated, and the physician is prompted to adjust the angle or position through real-time feedback.

[0086] Furthermore, if the magnetic field strength or sensor position changes, the sensor position is corrected through a reverse algorithm, and the display is updated in real time.

[0087] Step S402: The position data of the distal nail hole of the intramedullary nail is acquired in an electromagnetic field environment by the first electromagnetic sensor.

[0088] Specifically, the first electromagnetic sensor receives information from the electromagnetic field environment at the initial moment and determines its spatial position relative to the magnetic field source by measuring the magnetic field strength and direction.

[0089] Furthermore, the steps for the first electromagnetic sensor and the second electromagnetic sensor to acquire their position data in the reference coordinate system are the same.

[0090] Step S403: The position data of the electric rotary head is acquired in the electromagnetic field environment by the second electromagnetic sensor, and the positioning deviation data is determined based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head. The distal positioning of the intramedullary nail is performed based on the positioning deviation data.

[0091] Specifically, the second electromagnetic sensor measures the magnetic field strength in the electromagnetic field environment and determines its relative position by the strength difference with a known reference magnetic field source. The magnetic field strength at different positions will vary depending on the distance from the magnetic field source. The second electromagnetic sensor matches the measured magnetic field strength value with the model of the known magnetic field source to identify the target position.

[0092] Furthermore, the positioning of the second electromagnetic sensor can also be achieved through time synchronization and data fusion techniques (such as Kalman filtering, particle filtering, etc.). By processing the multiple measurement data of the second electromagnetic sensor, errors can be eliminated, positioning accuracy can be improved, and real-time updates of the target position can be ensured. By receiving data from different sensors in real time (such as feedback data from the electro-rotation system, sensor position data, etc.) and performing fusion calculations, a higher precision positioning result can be obtained.

[0093] The electro-rotation system, in conjunction with a magnetic field sensor, provides real-time spatial position data for instruments (such as electro-rotation heads). This position data typically includes X-axis, Y-axis, and Z-axis coordinates to represent the position of the electro-rotation head in three-dimensional space. These coordinates are usually relative to the magnetic field source or a reference coordinate system. The difference between the target position and the current instrument position helps physicians understand the deviation between the current instrument and the target pinhole position so that adjustments can be made.

[0094] The direction information of the rotary head is monitored in real time by a second electromagnetic field sensor. The feedback direction data usually includes: the azimuth angle of the rotary head: pitch angle, yaw angle and roll angle, to describe the attitude of the rotary head, that is, the spatial orientation of the rotary head relative to the operating table; the alignment degree with the target nail hole direction: the difference between the direction of the rotary head and the predetermined direction of the nail hole is calculated in real time to provide feedback on whether the alignment is correct.

[0095] Calculate operational errors and provide feedback on current error data to help physicians make adjustments: Error between the current position and the target nail hole position: usually expressed as a deviation value (e.g., in millimeters), used to show the relative positional difference between the surgical instrument and the target; Directional error: indicates the deviation between the current direction of head rotation and the direction of the target nail hole.

[0096] Electrosurgical status and operating mode data: Provides information on the system's operating status to ensure normal equipment operation: Current operating mode: such as whether it is in locked mode, positioning mode, or adjustment mode, to help physicians understand the current status of the system; Calibration completed: Displays whether the electrosurgical system has completed system calibration and initialization settings, ensuring that the system can accurately track the position and direction of the rotating head; Power status: Ensures that the electrosurgical system has sufficient power supply to ensure that the entire surgical procedure is not affected.

[0097] Intelligent electrosurgical units, combined with display devices (such as screens or surgical navigation systems), provide real-time visualization data: real-time images and 3D models: intelligent electrosurgical units can combine 3D imaging technology to display the 3D position and orientation of surgical instruments and target screw holes on the screen in real time, enabling physicians to clearly see the current operation status; graphical interface: the screen displays indicators to show the position alignment of the screw holes, directional errors, and any areas that need adjustment.

[0098] Operation prompts and guidance: Indicator lights or sound alerts provide feedback to the physician on the correctness of the operation: Green and red light prompts: These are usually used to indicate whether the rotating head is aligned with the target screw hole; a green light indicates accurate positioning, and a red light indicates that the direction needs to be adjusted; Sound prompts: Some electrosurgical systems will issue sound prompts so that the physician can make timely adjustments during the tense operation.

[0099] Real-time calibration data: During the operation, the intelligent electrosurgical unit ensures operational accuracy through real-time calibration: Calibration error range: Errors are detected and adjusted in real time to ensure a low error range throughout the operation; Automatic calibration status: If the system detects a deviation exceeding the set range, it will automatically start the calibration procedure and adjust it through feedback data.

[0100] Surgical progress and data recording: The intelligent electrosurgical device records the surgical progress and related data for postoperative analysis: Surgical step record: Records the time and location data of each step of the operation for easy postoperative review and analysis; Surgical completion status: Displays the current progress of the surgery and indicates whether the nail hole positioning or other related operations have been completed.

[0101] Furthermore, in the combined technology of intelligent electrosurgical unit and magnetic field induction, multiple sensors (such as electromagnetic field sensors, accelerometers, gyroscopes, etc.) are used to acquire the position and orientation information of surgical instruments (such as electrosurgical rotors, intramedullary nail positioning frames, etc.) in real time. To improve positioning accuracy and eliminate errors, data from different sensors needs to be fused and calculated. The following are the specific steps to achieve this data fusion. Common methods include Kalman filtering and particle filtering. For example, before the start of surgery, all sensors (such as electromagnetic field sensors, accelerometers, gyroscopes, etc.) need to be initialized to ensure that their output signals can accurately reflect their position and orientation. During initialization, the initial state of the sensors needs to be set, such as the initial position and initial orientation of the sensors. After initialization, data acquisition begins, including information such as magnetic field strength, angular velocity, and acceleration. Sensors continuously collect data during the procedure: a magnetic field sensor provides magnetic field strength and direction, used to measure the relative position of the sensor and the magnetic field source; an accelerometer measures three-dimensional acceleration, used to calculate the sensor's linear acceleration; and a gyroscope provides rotational angular velocity, used to calculate the sensor's angular change. These sensors continuously output data representing position, velocity, acceleration, and direction at different points in time. Each sensor's data typically contains some noise, therefore filtering is needed to remove unnecessary errors. Kalman filtering is a widely used recursive filtering algorithm for sensor data fusion, capable of estimating the sensor's state and updating the state estimate based on the sensor data.

[0102] Furthermore, in practical applications, data from multiple sensors (such as electromagnetic field sensors, accelerometers, and gyroscopes) are often fused to improve the positioning accuracy and robustness of the system. Each sensor provides data with different measurement and noise characteristics. Therefore, by using algorithms such as Kalman filtering, data from multiple sensors can be weighted and fused to eliminate data errors from a single sensor.

[0103] Furthermore, by calculating the relative position with surgical equipment (such as electrosurgical systems, positioning frames, etc.), the electromagnetic field sensor can update the relative position of the target instrument and the patient's anatomical structure in real time. As the surgical operation progresses, the sensor can provide real-time feedback on the current position change and compare it with the surgical target position to ensure accurate positioning.

[0104] The intramedullary nail distal positioning method provided in this embodiment establishes a unified electromagnetic field environment within the target area using an electromagnetic field generator. This provides a stable spatial positioning reference for the first and second electromagnetic sensors, avoiding cumulative errors caused by multiple reference switching or coordinate system transformation. This ensures the accuracy of position calculation between the distal nail hole and the electrosurgical head, significantly improving positioning reliability. Furthermore, the first electromagnetic sensor acquires the position data of the distal nail hole, and the second electromagnetic sensor acquires the position data of the electrosurgical head. The positioning reference and the operating terminal are independent of each other, ensuring that the nail hole position reference is not disturbed by surgical operations and that the electrosurgical head dynamics can be tracked in real time. This gives the positioning system both stability and real-time performance, effectively overcoming the shortcomings of single-sensor positioning schemes where the reference is prone to drift. Moreover, using the distal nail hole position data as the target and the electrosurgical head position data as the actual pose, the positioning deviation data is directly calculated. This can reflect the alignment degree between the electrosurgical head and the nail hole in real time, accurately and intuitively, providing a reliable basis for intraoperative navigation and operation guidance, and achieving precise positioning of the distal end of the intramedullary nail.

[0105] This embodiment provides a method for distal intramedullary nail positioning, which can be used in the aforementioned distal intramedullary nail positioning system. Figure 5 This is a flowchart of the distal localization method for intramedullary nails according to an embodiment of the present invention, as follows: Figure 5 As shown, the process includes the following steps: Step S501: Establish an electromagnetic field environment in the target area using an electromagnetic field generator. For details, please refer to [link to relevant documentation]. Figure 4 Step S401 of the illustrated embodiment will not be described again here.

[0106] Step S502: The position data of the distal nail hole of the intramedullary nail is acquired in an electromagnetic field environment by the first electromagnetic sensor.

[0107] Specifically, the first electromagnetic sensor is rigidly fixed to the intramedullary nail fixation frame and the intramedullary nail, with a constant relative position vector (determined by the type and length of the intramedullary nail). The first electromagnetic sensor calculates the global coordinates through magnetic field data and simultaneously calculates the attitude rotation matrix. Then, it calculates the position of the distal nail hole of the intramedullary nail through the relative position vector between the first electromagnetic sensor and the intramedullary nail and the attitude data of the first electromagnetic sensor.

[0108] Step S503: The position data of the electric rotary head is acquired in the electromagnetic field environment by the second electromagnetic sensor, and the positioning deviation data is determined based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head. The distal positioning of the intramedullary nail is performed based on the positioning deviation data.

[0109] Specifically, step S503 includes: Step S5031: The magnetic field strength and direction are sensed in the electromagnetic field environment through a multi-turn coil winding, and the magnetic field strength and direction are converted into position data of the electric rotary head.

[0110] In some optional implementations, step S5031 above includes: Step a1: The multi-turn coil winding determines the global pose data of the second electromagnetic sensor based on the magnetic field strength and direction.

[0111] Specifically, suppose the second electromagnetic sensor measures the magnetic field strength at a certain moment as follows: , The unit of magnetic field strength is the source strength constant of the magnetic field. The distance from the second electromagnetic sensor to the magnetic field source for: (10) Based on the model of magnetic field strength and magnetic field source, the distance between the second electromagnetic sensor and the magnetic field source is 4.47 meters. Assuming the relative position between the second electromagnetic sensor and the magnetic field source is known, calculate the specific coordinates of the second electromagnetic sensor in three-dimensional space based on its orientation and magnetic field strength. For example, the angle of the second electromagnetic sensor's position relative to the magnetic field source when it is located near the source point. Given that the three-dimensional coordinates of the second electromagnetic sensor are... for: (11) (12) (13) Furthermore, by measuring the direction of the magnetic field vector using the second electromagnetic sensor—that is, by measuring the direction of the magnetic field along its three axes (X, Y, and Z)—the second electromagnetic sensor can calculate the position coordinates of the second electromagnetic sensor in three-dimensional space based on the known magnetic field direction and intensity, by simultaneously measuring the intensity changes of the magnetic field in the three directions.

[0112] Furthermore, by using the magnetic field direction vector, the attitude (pitch angle, yaw angle, and roll angle) of the second electromagnetic sensor in the global coordinate system is calculated and converted into a rotation matrix, which is composed of the three-axis magnetic field components. The direction vector of the local coordinate system of the second electromagnetic sensor relative to the global coordinate system is obtained; the three attitude angles are solved using Euler angles or quaternion method, and then converted into a 3×3 rotation matrix for subsequent coordinate transformation; the gyroscope and accelerometer data are fused, and the attitude estimation is optimized by Kalman filtering to eliminate attitude drift caused by magnetic field noise.

[0113] Step a2: The multi-turn coil winding obtains the relative position vector of the second electromagnetic sensor and the electric rotary head. Based on the relative position vector of the second electromagnetic sensor and the electric rotary head, as well as the global pose data of the second electromagnetic sensor, the position data of the electric rotary head is calculated.

[0114] Specifically, after obtaining the global pose of the second electromagnetic sensor, the sensor coordinates are mapped to the global coordinates of the electric rotary head through rigid coordinate transformation.

[0115] Furthermore, assuming the relative positions of the rotary head and the second electromagnetic sensor are known data, i.e., the position of the second electromagnetic sensor relative to the rotary head is fixed, the relative position vector between the second electromagnetic sensor and the rotary head is: (14) Furthermore, the position of the second electromagnetic sensor in the global coordinate system is calculated based on the magnetic field data sensed by the second electromagnetic sensor. Then, the position of the electric rotary head is calculated using the known fixed positional relationship (the relative position of the second electromagnetic sensor to the electric rotary head). The position of the rotary head is determined by the following formula: (15) In the above formula, This indicates the absolute position of the second electromagnetic sensor.

[0116] Step S5032: The positioning deviation data is calculated by the front-end circuit board based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head, and a control signal is generated based on the positioning deviation data.

[0117] Specifically, whether the electric drill head has deviated is mainly determined by a comprehensive assessment of the error between its current position and the ideal position of the target nail hole. This includes: the positional deviation between the tip of the electric drill head and the target nail hole entry point corresponding to the distal nail hole of the intramedullary nail; the directional deviation between the electric drill drilling axis and the keyhole axis; the deviation of the shortest spatial distance between the two axes; and the dynamic stability deviation reflected by the error fluctuation within a continuous time window. At the same time, the reliability of the positioning result is evaluated by combining the residual measurement of the magnetic field sensor and the signal quality index. When the positional error, angle error, axis error, and dynamic stability are all below the preset threshold, and the magnetic field measurement residual is within the allowable range, the current electric drill state is determined to meet the drilling requirements; otherwise, it is determined that there is a deviation in the system, and the surgeon is guided to make adjustments through light, image, or numerical prompts.

[0118] Furthermore, the positional deviation is the spatial distance error between the current position of the rotary head and the entrance of the target nail hole. If the threshold is exceeded, it indicates that the rotary head is not aligned with the target nail hole inlet; assuming the target nail hole inlet is located at... The tip of the electric rotary head is Then the positional deviation The calculation formula is: (16) Furthermore, the directional deviation between the electric drill's entry axis and the keyhole axis... This refers to the angular error between the axis of the electric drill and the axis of the distal keyhole of the intramedullary nail. The closer the angle is to 0, the more consistent the direction. If the included angle error is large, even if the tip of the electric drill head is close to the target nail hole entrance, it may still result in rubbing, deviating, or failure to pass through the opposite locking hole after penetrating the bone cortex; the directional deviation between the electric drill entry axis and the locking hole axis. The calculation formula is as follows: (17) In the above formula, This represents the current axial unit vector of the electric drill bit. The unit vector representing the axis of the distal keyhole of the intramedullary nail.

[0119] Furthermore, the shortest spatial distance deviation between the electric drill bit axis and the keyhole axis reflects whether the entry point is off-center, whether the direction is parallel, and whether the actual drilling path can pass through the entire keyhole. The calculation formula is as follows: (18) Furthermore, the dynamic stability deviation reflected by error fluctuations within a continuous time window is defined as the deviation within the continuous time window. Error fluctuation within and , If it is too large, it indicates that the position is unstable. If it's too large, it means the direction is still fluctuating; even then... and Even if the threshold range is met momentarily, it cannot be determined as a stable state. and The calculation formula is: (19) (20) In the above formula, It represents the standard deviation.

[0120] Furthermore, the measurement residuals and signal quality indicators of the magnetic field sensor include: whether the magnetic field strength exceeds the calibration range, whether the triaxial magnetic field components change abruptly, whether the sensor output is saturated, whether the filter residual increases abnormally, and whether the registration error exceeds the limit; among these, the measurement residual is defined. for: (twenty one) In the above formula, These are actual measured values. To predict the measured values ​​for the model.

[0121] If the measurement residual is too large over a long period, it indicates that the current magnetic field identification result is unreliable, and it is determined that there is a measurement deviation rather than an operational deviation.

[0122] For example, if the following conditions are met simultaneously, the rotary head is determined to be aligned; otherwise, the rotary head is determined to be deviated: (twenty two) (twenty three) (twenty four) (25) (26) (27) In the above formula, Indicates the threshold. .

[0123] In step S5033, the indicator light indicates the alignment status of the electric rotary head and the distal screw hole of the intramedullary nail based on the control signal.

[0124] Specifically, the indicator lights are displayed in different colors according to different deviation levels; for example, if , This prompts the doctor to move to the target area, and the indicator light turns yellow; if , , If the indicator light transitions from yellow to green, it will indicate that the drilling is nearing completion; if , , If the position remains stable for 0.5-1 seconds and the signal residual is normal, drilling is permitted, indicated by a green indicator light and a red indicator light turning off.

[0125] Furthermore, based on the positioning deviation data, the distal positioning image of the intramedullary nail is updated in real time on the display screen, and the operation status of the electric rotary motor is controlled by the motor drive board.

[0126] Furthermore, a 3D model of the target screw hole is displayed on an auxiliary display screen, allowing the doctor to see the relative position of the screw hole and the rotating head, enabling precise operation. This involves converting the position and angle data of the sensors (i.e., the first and second electromagnetic sensors) into a 3D model. This involves establishing a 3D coordinate system and locating the target object within this system. The target object includes the screw hole for distal locking of the intramedullary nail, the position of surgical instruments, etc. Based on the spatial position data obtained from the sensors and the calculated angle data, a 3D point cloud is created through a geometric model, thus establishing the 3D model. Each collected sensor data represents a position and angle of the surgical instrument. Through data accumulation, a 3D model that changes over time is established, reflecting the real-time and relative position of the target instrument (such as the electro-rotating head or intramedullary nail) in space.

[0127] Furthermore, once the sensor's position is calculated, it is converted into a real-time 3D image and displayed on the surgical screen (i.e., the auxiliary display). Each time new magnetic field data is acquired, the position of the 3D model is updated in real time based on the current position and angle data. The real-time acquired data is continuously corrected for errors through data fusion algorithms (such as Kalman filtering) to ensure that each frame of data accurately reflects the current position of the target instrument. By visualizing the above-mentioned real-time updated data, the doctor can see the spatial relationship between the surgical instrument and the patient's bone structure on the 3D visualization interface, and adjust the angle and direction of the electro-rotation system as needed. Based on the feedback light prompts, the doctor is guided to adjust the rotation direction to ensure accurate locking of the screw holes.

[0128] Furthermore, real-time 3D images and dynamic tracking data help physicians adjust their operations based on real-time feedback, thereby achieving precise remote targeting.

[0129] The intramedullary nail distal positioning method provided in this embodiment utilizes dynamic registration and data fusion technology of electromagnetic field and sensor system to correct deviations in real time, ensuring high-precision positioning of the nail hole and improving the accuracy and safety of the surgery. The automated nail hole positioning and adjustment mechanism, and the high degree of integration between the electro-rotation system and the magnetic field sensor, enable the system to automatically calibrate the direction of electro-rotation based on real-time sensor data and match it with the nail hole direction in real time. Physicians do not need to rely on fixed mechanical devices and traditional aiming frames. The intelligent electro-rotation device automatically adjusts the direction based on real-time data, making the positioning process more automated and standardized, changing the habits and operation path of intramedullary nail locking surgery. Furthermore, X-ray fluoroscopy positioning is replaced with a low-radiation or radiation-free electromagnetic navigation system, thereby significantly reducing radiation risks. In addition, the combination of real-time three-dimensional image modeling and feedback mechanism can dynamically display the spatial relationship between surgical instruments and target positions in real time.

[0130] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of the embodiments of this application.

[0131] Those skilled in the art will understand that, for the sake of convenience and brevity, the specific working processes of the systems, devices, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0132] In the embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the displayed or discussed mutual couplings, direct couplings, or communication connections may be through some interfaces; indirect couplings or communication connections between devices or units may be electrical, mechanical, or other forms.

[0133] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0134] In addition, the functional units in the various embodiments of this application can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0135] If a function is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solutions of this application, essentially, or the parts that contribute to the prior art, or parts of the technical solutions, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0136] Although embodiments of the invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A distal positioning system for an intramedullary nail, characterized in that, The system includes: an intelligent electro-rotation device, an electromagnetic field generator, and an intramedullary nail fixation frame; the intramedullary nail fixation frame is rigidly connected to a first electromagnetic sensor, and the intramedullary nail fixation frame is rigidly connected to an intramedullary nail within the target area; the intelligent electro-rotation device includes an electro-rotation body, an electro-rotation head, and a second electromagnetic sensor; the second electromagnetic sensor is rigidly connected to the electro-rotation body; The electromagnetic field generator is used to establish an electromagnetic field environment within the target area; The first electromagnetic sensor is used to acquire position data of the distal nail hole of the intramedullary nail in the electromagnetic field environment; The second electromagnetic sensor is used to acquire position data of the electric rotary head in the electromagnetic field environment, and determine positioning deviation data based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head, and perform distal positioning of the intramedullary nail based on the positioning deviation data.

2. The system according to claim 1, characterized in that, The second electromagnetic sensor includes: The package includes a housing, a rigid mounting base connected to the housing, and a coil core skeleton, a multi-turn coil winding, a front-end circuit board, and an indicator light disposed within the housing; the coil core skeleton provides skeletal support for the multi-turn coil winding; the multi-turn coil winding is connected to the front-end circuit board; and the front-end circuit board is connected to the indicator light.

3. The system according to claim 1, characterized in that, The intelligent electro-electric device further includes: The device includes a display screen, an electric rotary motor, a motor drive board, and an electric rotary trigger. The display screen is located on the side of the electric rotary handle. The electric rotary motor is located at the front end of the electric rotary handle. The motor drive board is connected to the second electromagnetic sensor, the display screen, the electric rotary motor, and the electric rotary trigger. The electric rotary trigger is connected to the motor drive board.

4. The system according to claim 3, characterized in that, The intelligent electro-electric device further includes: A rotary chuck is located at the front end of the output shaft of the electric rotary motor and rigidly clamps the electric rotary head.

5. The system according to claim 3, characterized in that, The intelligent electro-electric device further includes: The power management module is connected to the second electromagnetic sensor, the display screen, the electric rotary motor, the motor drive board, and the electric rotary trigger, respectively.

6. A method for distal positioning of an intramedullary nail, characterized in that, The method, applied to the distal positioning system of an intramedullary nail as described in any one of claims 1 to 5, comprises: An electromagnetic field environment is established within the target area using an electromagnetic field generator; The location data of the distal nail hole of the intramedullary nail is obtained by the first electromagnetic sensor in the electromagnetic field environment. The second electromagnetic sensor acquires the position data of the electric rotary head in the electromagnetic field environment, and determines the positioning deviation data based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head, and performs distal positioning of the intramedullary nail based on the positioning deviation data.

7. The method according to claim 6, characterized in that, The step of acquiring position data of the electro-rotator head in the electromagnetic field environment via a second electromagnetic sensor, determining positioning deviation data based on the position data of the distal nail hole of the intramedullary nail and the position data of the electro-rotator head, and performing distal positioning of the intramedullary nail based on the positioning deviation data includes: The magnetic field strength and direction are sensed in the electromagnetic field environment by a multi-turn coil winding, and the magnetic field strength and direction are converted into position data of the electric rotary head. The front-end circuit board calculates positioning deviation data based on the position data of the distal nail hole of the intramedullary nail and the position data of the electric rotary head, and generates control signals based on the positioning deviation data; The indicator light indicates the alignment status of the electric rotary head and the distal screw hole of the intramedullary nail based on the control signal.

8. The method according to claim 7, characterized in that, The process of inducing magnetic field strength and direction in the electromagnetic field environment through a multi-turn coil winding, and converting the magnetic field strength and direction into position data of the electric rotary head, includes: The multi-turn coil winding determines the global pose data of the second electromagnetic sensor based on the magnetic field strength and the magnetic field direction; The multi-turn coil winding acquires the relative position vector of the second electromagnetic sensor and the electric rotary head, and calculates the position data of the electric rotary head based on the relative position vector of the second electromagnetic sensor and the electric rotary head, as well as the global pose data of the second electromagnetic sensor.

9. The method according to claim 7, characterized in that, The step of acquiring position data of the electro-rotator head in the electromagnetic field environment through a second electromagnetic sensor, determining positioning deviation data based on the position data of the distal nail hole of the intramedullary nail and the position data of the electro-rotator head, and performing distal positioning of the intramedullary nail based on the positioning deviation data further includes: Based on the positioning deviation data, the distal positioning image of the intramedullary nail is updated and displayed in real time on the display screen, and the operation status of the electric rotary motor is controlled by the motor drive board.

10. The method according to claim 6, characterized in that, Before acquiring the location data of the distal nail hole of the intramedullary nail in the electromagnetic field environment via the first electromagnetic sensor, the method further includes: In the electromagnetic field environment, position calibration is performed using the first electromagnetic sensor and the second electromagnetic sensor.

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