Intelligent positioning device and system for orthopedic implant hole

Abstract

The application discloses an intelligent positioning device and system for an orthopedic implant channel, and relates to the technical field of orthopedic surgery positioning technology. The intelligent positioning device for the orthopedic implant channel comprises a laser module, a dynamic compensation module and a laser module. The laser module comprises two laser emission units and is used for projecting a laser beam to a target area on a patient's body surface to form a dynamic laser grid. The dynamic compensation module is used for detecting bone movement information of the patient through a sensor, determining a dynamic compensation control signal according to the bone offset information when detecting that the bone has deviated, and sending the dynamic compensation control signal to the laser module. The laser module adjusts the laser beam according to the received control signal to correct the laser grid. Furthermore, the application also provides an orthopedic navigation positioning system comprising the foregoing device, which can not only greatly reduce the number of fluoroscopy in surgery, but also significantly improve the positioning accuracy, operation efficiency and safety and reliability.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of orthopedic surgery positioning, in particular to an intelligent positioning device and system for an orthopedic implant hole. BACKGROUND

[0002] The accurate placement of implants in orthopedic surgery is one of the key factors for the success of the surgery, and the positioning technology of the hole (such as a nail hole) is directly related to the stability of the implant and the effect of the surgery. Medical imaging is the basis for accurately positioning the hole position. In traditional orthopedic surgery, a two-dimensional C-arm machine (i.e., a C-arm X-ray machine, referred to as a C-arm) is usually used to directly position the intramedullary nail hole channel under fluoroscopy. The surgery time is long, and the X-ray pictures need to be taken multiple times during the surgery for positioning, which will result in a high cumulative radiation dose for both the doctor and the patient, and there is a certain safety hazard. At the same time, the doctor needs to rely on operating experience to repeatedly adjust the position of the C-arm machine, the position and angle of the Kirschner wire, etc., which is highly dependent on the doctor's operating experience.

[0003] In view of the above problems, the prior art has proposed solutions from multiple aspects.

[0004] On the one hand, a C-arm machine assisted positioning system based on laser projection is proposed, which reduces the number of fluoroscopy through laser positioning technology. As an example, Chinese patent ZL202110611173.7 discloses a positioning device for an orthopedic implant nail hole intramedullary channel, which is used for a C-arm X-ray machine or a G-arm X-ray machine, comprising: two laser emitters and a binding belt, the binding belt is bound to the image intensifier of the C-arm X-ray machine or the G-arm X-ray machine; the two laser emitters are arranged on the binding belt and can move along the binding belt; during the operation, the two laser emitters can realize simultaneous positioning, which reduces the number of fluoroscopy, simplifies the operation method, and reduces the radiation damage. The core of the existing C-arm machine assisted positioning system based on laser projection is to integrate a laser positioning device on the C-arm machine, such as 2-4 groups of linear laser emitters which are symmetrically installed on the inside of the ring-shaped machine frame of the C-arm machine. These lasers realize manual adjustment of the laser plane angle within ±15° through a precision universal adjusting support, and the adjustment accuracy can reach ±0.5°. Through multiple laser beams, a cross projection grid can be formed in the surgical area to provide a visual reference for surgical navigation. The positioning principle is as follows: the cross intersection point projected on the patient's body surface based on the laser beam is used as an anatomical reference point, and through real-time registration with the C-arm machine fluoroscopy image (which is a reference image obtained by first fluoroscopy before the operation), a spatial coordinate system is established. Experimental data shows that the calibration error of the system can be controlled within 1.2 mm. This technical solution combining optical projection with medical imaging not only retains the advantages of C-arm machine imaging, but also significantly improves the intuitiveness and operation convenience of surgical positioning.

[0005] However, while C-arm integrated laser positioning systems provide crucial technical support for orthopedic surgical navigation, they still suffer from several drawbacks: 1) These systems typically employ static calibration, which is ineffective in addressing common intraoperative bone micro-movement issues. When intramedullary nail implantation causes a 3-5° torsional shift, manual correction by the surgeon's experience is still necessary, a time-consuming process (over 2.5 minutes) that can increase positioning errors to over 3mm. 2) Operation still heavily relies on multiple fluoroscopic verifications. A single surgery may require 15-30 fluoroscopic examinations (re-fluoroscopic correction is needed when shifts are detected), resulting in cumulative radiation doses for both doctors and patients far exceeding safety limits. 3) In deep tissue positioning, the traditional system's positioning accuracy is limited by two-dimensional imaging, failing to break the 1.2mm bottleneck and meeting the sub-millimeter precision requirements of modern orthopedic surgery. 4) The system demands a high level of skill from the operating surgeon, requiring mastery of complex laser-image spatial mapping techniques. Young surgeons typically require 6-12 months of training to become proficient, resulting in a lengthy learning period.

[0006] On the other hand, with the increasing demand for precision medicine, 3D C-arm technology has developed rapidly, and orthopedic surgical navigation systems are undergoing a paradigm shift from experience-driven to data-driven. 3D C-arms, with their superior stereoscopic imaging capabilities, provide an ideal technical platform for locating orthopedic implant channels. They can rapidly generate transverse, sagittal, and coronal tomographic images, as well as 3D stereoscopic images, during surgery for 3D navigation. This comprehensive stereoscopic perspective significantly improves the accuracy of surgical navigation. Taking pelvic fracture surgery as an example, 3D reconstruction technology can clearly present the three-dimensional structure and spatial extent of the bone bridge, providing surgeons with intuitive anatomical references. Modern 3D C-arms have achieved significant breakthroughs in imaging speed; some 3D C-arm products can complete 3D data acquisition in just 30 seconds. This efficient imaging capability, combined with robotic systems, is driving orthopedic surgery towards a closed-loop model encompassing preoperative simulation, intraoperative navigation, and postoperative evaluation. Meanwhile, by employing advanced technologies such as iterative reconstruction algorithms, the new generation of 3D C-arm machines has achieved a significant reduction in radiation dose, decreasing it by 62.5% compared to traditional CT. This technological breakthrough has been validated in delicate surgical applications such as 3D printing of maxillofacial bones, maintaining excellent image quality while ensuring low radiation dose. It can be seen that 3D C-arm machines can effectively solve the problems of excessive fluoroscopy and insufficient positioning accuracy during surgery, but they still struggle to address the issue of implant displacement caused by intraoperative bone micromovement. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of existing technologies and provide an intelligent positioning device and system for orthopedic implant channels. The intelligent positioning device for orthopedic implant channels provided by this invention includes a dynamic compensation module corresponding to the laser module. This module detects micro-movements in the patient's bones (such as minor bone movements caused by the patient's breathing or limb movements). When micro-movements are detected, dynamic compensation adjustments are made based on bone offset information to correct the laser grid position in real time and offset the deviations caused by bone micro-movements. Furthermore, an orthopedic navigation and positioning system including the aforementioned device is also provided, which not only significantly reduces the number of fluoroscopy sessions during surgery but also significantly improves positioning accuracy, operational efficiency, and safety and reliability.

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] A smart positioning device for orthopedic implant channels, the device comprising:

[0010] The laser module includes two laser emitting units for projecting laser beams onto a target area on the patient's body surface to form a dynamic laser grid.

[0011] The dynamic compensation module is used to detect the patient's bone movement information through sensors. When bone displacement is detected, a dynamic compensation control signal is determined based on the bone displacement information, and the dynamic compensation control signal is sent to the laser module.

[0012] The laser module adjusts the laser beam according to the received control signal to correct the laser grid.

[0013] Furthermore, the dynamic compensation module includes a sensor, a main controller, and an optical encoder:

[0014] The sensor is used to detect bone movement information in real time. When the angle change Δθ of the bone is detected to exceed the preset angle threshold, it is determined that an offset has occurred and the angle offset signal is sent to the main controller.

[0015] The main controller is used to receive the angle offset signal sent by the sensor, calculate the compensation angle Δφ required for the current angle offset; and send a pulse width modulation (PWM) control signal to the laser module according to the calculated compensation angle; the laser module can control the operation of the laser emitting unit according to the aforementioned PWM control signal to adjust the direction of the laser beam directed toward the target area;

[0016] The optical encoder is used to verify the actual deflection angle of the laser and feed it back to the main controller.

[0017] Furthermore, the sensor is a MEMS sensor. When the angle change Δθ detected by the MEMS sensor does not exceed the preset angle threshold, it is determined that no offset has occurred, and the device maintains the current operating parameters.

[0018] The compensation angle Δφ is equal to the product of the angle change Δθ and the calibration coefficient K, the value of which is preset by the system or the user.

[0019] Furthermore, the laser emitting unit includes a laser diode, a collimating lens group, a galvanometer system, and a reflecting mirror group;

[0020] The laser diode is used to emit a linear laser beam of a preset wavelength;

[0021] The collimating lens group is used to receive the laser beam emitted by the laser diode and control the laser beam divergence angle within a preset accuracy range.

[0022] The galvanometer system includes an X-axis galvanometer, a Y-axis galvanometer, and a galvanometer drive mechanism, used to adjust the laser angle of the laser beam output from the collimating lens group according to a control signal;

[0023] The reflector group is used to reflect the laser output from the galvanometer system so as to project the laser beam onto the aforementioned target area;

[0024] At this time, after calculating the compensation angle, the main controller of the dynamic compensation module sends a PWM control signal corresponding to the aforementioned compensation angle to the aforementioned galvanometer system.

[0025] After receiving the aforementioned PWM control signal, the galvanometer system controls the galvanometer drive mechanism to operate and control the corresponding galvanometer deflection, so that the galvanometer deflects the received laser light.

[0026] Furthermore, the main controller includes a MEMS interface circuit, a galvanometer driving circuit, and an optical encoder interface, wherein the optical encoder is a 24-bit absolute encoder;

[0027] The MEMS interface circuit uses an SPI bus to connect to the MEMS sensor.

[0028] The galvanometer driving circuit is based on a motor driving chip and sends control signals to the galvanometer system.

[0029] The optical encoder interface communicates with the 24-bit absolute encoder via the SSI protocol.

[0030] Furthermore, the laser module also includes a projection control unit, which controls the two laser emitting units to project dual laser beams onto the target area on the patient's body surface, forming a dynamically adjustable cross-projection grid on the patient's body surface;

[0031] The laser beam is a linear laser with a wavelength of 650nm.

[0032] The present invention also provides an orthopedic navigation and positioning system, including a main control computer, a three-dimensional imaging device and a projection positioning device, wherein the main control computer is communicatively connected to the three-dimensional imaging device and the projection positioning device and is used to control the operation of the three-dimensional imaging device and the projection positioning device;

[0033] The three-dimensional imaging device is used to generate a preoperative three-dimensional image as a reference image in a single fluoroscopic scan, and transmit the reference image to the main control computer.

[0034] The projection positioning device is the aforementioned device, used to project a laser beam onto a target area on the patient's body surface, and to dynamically compensate and adjust according to the detected bone movement information to counteract the deviation caused by bone movement.

[0035] Furthermore, it also includes a display terminal, wherein the main control computer is configured as follows:

[0036] Based on the reference image, spatial calibration of the image is performed using a calibration module; according to the calibration results, a spatial reference system for laser projection is set, and the projection position is matched with the region where the target bone is located; and...

[0037] A dynamic laser grid is projected onto the target area via a laser module, forming visual positioning marks on the target bone surface; the dynamic compensation module's sensors detect bone movement in real time, triggering dynamic compensation adjustments when bone displacement is detected, and correcting the laser grid position in real time based on the adjustment results; and,

[0038] The navigation module fuses the laser projection coordinates with the three-dimensional reference image in real time, then combines the implant parameters to form the implant planning path, and sends the path planning information to the aforementioned display terminal for display.

[0039] Furthermore, the three-dimensional imaging device is a three-dimensional C-arm machine, and the calibration module performs virtual calibration on a single perspective image based on a deep learning algorithm;

[0040] The calibration module is configured to: acquire a single perspective image from a 3D C-arm camera; preprocess the image; extract skeletal features using a deep convolutional neural network algorithm; after successful feature extraction, detect the skeletal edges; calculate the 3D spatial coordinates; and verify the accuracy of the calculated spatial coordinates and laser parameters. When the accuracy verification meets the standard, establish a mapping relationship between the laser projection coordinate system and the image coordinate system, and the calibration is completed. When the accuracy verification fails, return to execute the aforementioned 3D spatial coordinate calculation and perform accuracy verification based on the calculation results. This process continues until the accuracy verification meets the standard.

[0041] Furthermore, the system also includes an implant verification module, which is configured to: acquire bone image data after the implant is placed, compare the implant position in the bone image data with the planned implant position, obtain the implant position error value, and determine whether the error value is within a preset error allowable range.

[0042] Compared with the prior art, the present invention has the following advantages and positive effects, as an example: The intelligent positioning device for orthopedic implant channels provided by the present invention has a dynamic compensation module corresponding to the laser module. The dynamic compensation module detects the patient's bone micro-movements (such as the patient's breathing, limb micro-movements, etc.). When bone micro-movements are detected, dynamic compensation adjustments can be made according to the bone offset information to correct the laser grid position in real time, offset the deviation caused by bone micro-movements, and realize fully automatic closed-loop adjustment from bone micro-movement detection to laser dynamic compensation.

[0043] Furthermore, an orthopedic navigation and positioning system including the aforementioned device is provided, which can not only significantly reduce the number of fluoroscopy sessions during surgery, but also significantly improve positioning accuracy, operational efficiency, and safety and reliability.

[0044] On the other hand, the calibration algorithm was improved, and a deep learning-based virtual calibration algorithm was proposed, which can complete accurate spatial registration with only a single fluoroscopy, further reducing the number of fluoroscopy sessions per surgery. Through collaborative work with a 3D C-arm machine, the system can achieve displacement monitoring accuracy at the 0.1mm level, providing precise navigation support for deep tissue surgery. Attached Figure Description

[0045] Figure 1 A schematic diagram of the module structure of the intelligent positioning device for orthopedic implant channels provided in an embodiment of the present invention.

[0046] Figure 2 This is a schematic diagram of the module structure of the laser emitting unit of the laser module provided in an embodiment of the present invention.

[0047] Figure 3 The information transmission logic diagram of the dynamic compensation module provided in the embodiment of the present invention is shown.

[0048] Figure 4 This is a logic diagram of information interaction between the laser module and the dynamic compensation module provided in an embodiment of the present invention.

[0049] Figure 5 This is a schematic diagram of the module structure of the orthopedic navigation and positioning system provided in an embodiment of the present invention.

[0050] Figure 6 The positioning and navigation flowchart of the orthopedic navigation and positioning system provided in the embodiment of the present invention.

[0051] Figure 7 A flowchart of a single-perspective calibration model provided in an embodiment of the present invention. Detailed Implementation

[0052] The intelligent positioning device and system for orthopedic implant channels disclosed in this invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be considered isolated; they can be combined with each other to achieve better technical effects. In the accompanying drawings of the following embodiments, the same reference numerals appearing in each drawing represent the same features or components, which can be applied to different embodiments. Therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0053] It should be noted that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes and to aid those skilled in the art in understanding and reading the invention. They are not intended to limit the conditions under which the invention can be implemented. Any modifications to the structure, changes in proportions, or adjustments to size, provided they do not affect the effectiveness or purpose of the invention, should fall within the scope of the technical content disclosed in the invention. The scope of the preferred embodiments of the present invention includes other implementations, wherein functions may be performed not in the order stated or discussed, including substantially simultaneously or in reverse order, depending on the functions involved. This should be understood by those skilled in the art to which the embodiments of the present invention pertain.

[0054] Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and apparatus should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. Example

[0055] See Figure 1 As shown, this invention provides an intelligent positioning device for orthopedic implant channels, the device comprising a laser module and a dynamic compensation module.

[0056] The laser module includes two laser emitting units for projecting laser beams onto a target area on the patient's body surface to form a dynamic laser grid.

[0057] The laser module, serving as the optical system of this device, is used for projection calibration. In specific implementation, the laser module employs a dual-laser dynamic cross-projection design, comprising two independent 650nm laser emitting units. This wavelength selection ensures both good tissue penetration and meets human eye safety standards. A projection control unit is provided for each laser emitting unit to control the two laser emitting units to project dual laser beams onto the target area on the patient's body surface, forming a dynamically adjustable cross-projection grid on the patient's body surface.

[0058] Each laser emitting unit comprises multiple precision components, including a laser diode, a collimating lens group, a galvanometer system, and a reflector group. The laser diode emits a linear laser beam of a preset wavelength. The collimating lens group receives the laser beam emitted by the laser diode and controls the laser beam divergence angle within a preset accuracy range. The galvanometer system includes an X-axis galvanometer, a Y-axis galvanometer, and a galvanometer drive mechanism, used to adjust the laser angle of the laser beam output from the collimating lens group according to a control signal. The reflector group reflects the laser beam output from the galvanometer system to project the laser beam onto the aforementioned target area.

[0059] As a preferred option for a typical approach, see [link to relevant documentation]. Figure 2 As shown, the laser diode can be a 5mW output diode (compliant with Class 3R safety standards), capable of outputting a safe 650nm laser beam, coupled with a collimating lens group that can precisely control the laser beam divergence angle to an accuracy of 0.5mrad. The preferred galvanometer system is the Sintec GVS012 series high-precision Galvo galvanometer system, which features a deflection accuracy of 0.5mrad and a fast response time of less than 1ms. Through dynamic galvanometer operation (±15° deflection, 0.8ms response), sub-millimeter-level real-time positioning of the implant during surgery can be achieved.

[0060] In addition, the laser module is equipped with a professional reflector group coated with a high-reflectivity medium film (reflectivity exceeding 99.5%) to ensure the accuracy of laser projection and system stability.

[0061] The dynamic compensation module is used to detect the patient's bone movement information through sensors. When bone displacement is detected, it determines a dynamic compensation control signal based on the bone displacement information and sends the dynamic compensation control signal to the laser module.

[0062] The laser module adjusts the laser beam according to the received control signal to correct the laser grid, thereby eliminating the deviation caused by the aforementioned bone micro-movement.

[0063] In this embodiment, the dynamic compensation module may include a sensor, a main controller, and an optical encoder.

[0064] The sensor is used to detect bone movement information in real time. When the angle change Δθ of the bone exceeds the preset angle threshold, it determines that an offset has occurred and sends the angle offset signal to the main controller.

[0065] Preferably, the sensor is a MEMS sensor, such as the ADXL356 model MEMS sensor. When the angle change Δθ detected by the MEMS sensor does not exceed a preset angle threshold, it is determined that no offset has occurred, and the device maintains the current operating parameters.

[0066] The main controller receives the angle offset signal sent by the sensor, calculates the compensation angle Δφ required for the current angle offset, and sends a pulse width modulation (PWM) control signal to the laser module based on the calculated compensation angle. The laser module can control the laser emitting unit to adjust the direction of the laser beam directed towards the target area according to the aforementioned PWM control signal. Specifically, after receiving the aforementioned PWM control signal, the galvanometer system of the laser module controls the galvanometer drive mechanism to deflect the corresponding galvanometer. The galvanometer deflects the received laser light, thereby adjusting the direction of the laser beam directed towards the target area.

[0067] In this embodiment, the compensation angle Δφ is equal to the product of the angle change Δθ and the calibration coefficient K. The value of the calibration coefficient K can be preset by the system or the user.

[0068] The optical encoder is used to verify the actual deflection angle of the laser and feed it back to the main controller. Preferably, the optical encoder is a 24-bit absolute encoder.

[0069] Specifically, the dynamic compensation module can use an STM32H743 controller as the main controller. Its key sub-circuits include a MEMS interface circuit, a galvanometer drive circuit, and an optical encoder interface. The information transmission logic process is described in [reference needed]. Figure 3 As shown. In this embodiment, the MEMS interface circuit can be connected to the ADXL356 via an SPI bus, with a sampling rate configured to 1kHz. The galvanometer driving circuit can be based on the DRV8837 motor driver chip, supporting a peak current of 4A. The optical encoder interface preferably uses a 24-bit absolute encoder, communicating via the SSI protocol.

[0070] As an example, and not a limitation, when the preset angle threshold is configured to 2°, the dynamic compensation process is as follows: See Figure 4As shown, when the MEMS sensor (ADXL356) detects an angle change Δθ ≥ 2°, it determines that a deviation has occurred. At this point, the main controller first calculates the required compensation angle Δφ = K•Δθ based on the angle change value. Then, the main controller sends a PWM control signal corresponding to the compensation angle to the Galvo galvanometer to adjust the direction (angle) of the laser beam directed towards the target area. Subsequently, the optical encoder can detect the actual deflection angle and feed it back to the main controller for verification, forming a closed-loop control. This process can be completed within 200ms, which is hundreds of times faster than the traditional manual adjustment time (average time 2.5 minutes).

[0071] Another embodiment of the present invention provides an orthopedic navigation and positioning system, including a main control computer, a three-dimensional imaging device, and a projection positioning device. The main control computer is communicatively connected to the three-dimensional imaging device and the projection positioning device and is used to control the operation of the three-dimensional imaging device and the projection positioning device.

[0072] The three-dimensional imaging device is used to generate a preoperative three-dimensional image as a reference image in a single fluoroscopic scan, and transmits the reference image to the main control computer. In this embodiment, the three-dimensional imaging device is preferably a three-dimensional C-arm machine, see [link to documentation]. Figure 5 As shown, it is connected to the main control computer via Ethernet.

[0073] The projection positioning device is the aforementioned device, comprising a laser module and a dynamic compensation module. This device projects a laser beam onto a target area on the patient's body surface and performs dynamic compensation adjustments based on detected bone movement information to counteract deviations caused by bone movement.

[0074] See also Figure 5 As shown, the system also includes at least one display terminal. The main control computer can synchronously control the laser module (galvanometer drive) and the dynamic compensation module MEMS sensor, and output the real-time data fusion to the display terminal. The spacing between the devices is set within a preset communication distance (e.g., less than 1.5m) to better achieve signal synchronization.

[0075] The main control computer is configured to: perform spatial calibration of the image based on the reference image using a calibration module; set a spatial reference system for laser projection according to the calibration results, with the projection position matching the area where the target bone is located; project a dynamic laser grid onto the target area through a laser module to form a visual positioning mark on the surface of the target bone; detect bone movement in real time through the sensors of the dynamic compensation module, trigger dynamic compensation adjustment when bone displacement is detected, and correct the laser grid position in real time according to the adjustment results; and fuse the laser projection coordinates with the three-dimensional reference image in real time through a navigation module, then combine the implant parameters to form an implant planning path, and send the path planning information to the aforementioned display terminal for display.

[0076] The system provided in this embodiment includes a main control computer, a three-dimensional imaging device, a laser module, a dynamic compensation module, and a calibration module (for spatial calibration). During operation, before surgery, the system first acquires a baseline image through a single C-arm fluoroscopic scan, and then quickly completes spatial calibration using the calibration module. During surgery, a dynamically adjustable cross-projection grid (adjustable from 30-90°) is formed on the patient's surface using dual laser beams. When the MEMS sensor detects a slight shift in bone movement (≥2°), the Galvo galvanometer system automatically adjusts the laser angle within 200ms to achieve real-time compensation. Finally, the laser projection coordinates are fused with the C-arm three-dimensional image to output pinhole positioning and navigation information with an accuracy of 0.1mm.

[0077] The following is in conjunction with reference to [see also] Figure 6 Describe a typical navigation and positioning process.

[0078] Preoperative preparation steps: fix the patient's position, disinfect, and ensure that the equipment (3D C-arm, laser system, etc.) is in normal operation.

[0079] 3D C-arm scanning steps: Scan the bones at the surgical site to generate a 3D model, which serves as an "anatomical map" for localization.

[0080] Single-view fluoroscopy virtual calibration steps: Use X-ray fluoroscopy to calibrate the coordinate system of the equipment and the position of the patient's bones to eliminate spatial deviations.

[0081] Steps to establish a laser projection coordinate system: Based on the calibration results, set a spatial reference system for laser projection to ensure that the projection position matches the skeleton.

[0082] Dual-laser dynamic mesh projection procedure: A dynamic laser mesh is projected onto the surgical area to form a visual positioning mark on the bone surface.

[0083] MEMS sensor detection of bone micro-movement steps: Use sensors to detect whether there is any slight movement in the bones (such as patient breathing, limb micro-movement); if it is determined to be yes, enter the dynamic compensation adjustment mode; if it is determined not to be yes, you can directly enter the real-time navigation display mode.

[0084] Dynamic compensation adjustment step (when a micro-motion of the preset standard is detected): In dynamic compensation adjustment mode, the laser grid position is corrected in real time to offset the deviation caused by the micro-motion of the bone.

[0085] Real-time navigation displays steps: bone model, laser grid, implant planning path, assisting doctors in operation.

[0086] Implant placement steps: The doctor places the implant (such as screws or prostheses) according to the navigation and confirms that the position is correct.

[0087] Postoperative 3D verification steps: Scan the bone again, compare it with the preoperative plan, and confirm that the implant position error is within the safe range (≤1mm).

[0088] Postoperative verification can be achieved through an implant verification module, which is configured to: acquire bone image data after implant placement, compare the implant position in the bone image data with the planned implant position, obtain the implant position error value, and determine whether the error value is within a preset error allowable range.

[0089] In this embodiment, the calibration module performs virtual calibration on a single perspective image based on a deep learning algorithm. Specifically, the calibration module is configured to: acquire a single perspective image from a 3D C-arm machine; preprocess the image—such as image denoising and enhancement; extract skeletal features using a deep convolutional neural network (DCNN) algorithm; preferably, an improved DCNN network model is used, which incorporates a residual module to increase feature extraction accuracy; and after successful feature extraction, detect skeletal edges and calculate the 3D spatial coordinates—for example, using the SolvePnP algorithm to calculate the 3D spatial coordinates; verify the accuracy of the calculated spatial coordinates and laser parameters; when the accuracy verification meets the standard, establish a mapping relationship between the laser projection coordinate system and the image coordinate system, and the calibration is completed; when the accuracy verification does not meet the standard, perform automatic iterative optimization, i.e., return to execute the aforementioned 3D spatial coordinate calculation and verify the accuracy based on the calculation result, and so on, until the accuracy verification meets the standard. See [link to documentation]. Figure 7 As shown.

[0090] Furthermore, the calibration module is also equipped with a manual intervention mode, which can be triggered to obtain the user's intervention instructions when the aforementioned feature extraction operation fails.

[0091] The accuracy verification standard can be configured by the system or the user according to factors such as the actual operation site and surgical needs. For example, for the positioning of the distal keyhole of the intramedullary nail and the implantation of the spinal pedicle screw, the accuracy standard can be configured to a threshold of 0.1 mm.

[0092] The virtual calibration scheme based on single-viewing can significantly reduce the spatial calibration time (traditional optical calibration takes about 15 minutes) from the traditional 15 minutes to 30 seconds, and the accuracy can reach 0.1mm.

[0093] Other technical features are described in the previous embodiments and will not be repeated here.

[0094] The above-mentioned solution provided in this embodiment, on the one hand, effectively overcomes the shortcomings of traditional laser positioning in handling intraoperative bone micro-movements through the dual-laser dynamic cross-compensation design; on the other hand, in terms of system calibration, it proposes an intelligent calibration algorithm based on single fluoroscopy, which significantly reduces the number of intraoperative fluoroscopy attempts by combining deep learning feature extraction and spatial solution technology; in addition, the system adopts optical and image data fusion technology, and through real-time verification by a high-precision encoder, it achieves accurate matching between laser projection coordinates and three-dimensional images, thus constructing a high-precision dynamic navigation and positioning system, which can significantly improve the accuracy and efficiency of orthopedic surgical navigation.

[0095] This system works in deep collaboration with a 3D C-arm machine, optimizing radiation dose through standardized interface protocols and data fusion rules. It is particularly suitable for clinical scenarios such as distal keyhole positioning of intramedullary nails and pedicle screw implantation in the spine, achieving precise surgical navigation.

[0096] In the above description, the disclosure of this invention is not intended to limit itself to these aspects. Rather, within the scope of the objectives of this disclosure, components can be selectively and operationally combined in any number. Furthermore, terms such as “comprising,” “encompassing,” and “having” should be interpreted by default as inclusive or open-ended, rather than exclusive or closed, unless explicitly defined as such. All technical, scientific, or other terms are to be understood by those skilled in the art, unless defined as such. Public terms found in dictionaries should not be interpreted in the context of the relevant technical documents in an overly idealistic or impractical manner, unless explicitly defined as such in this disclosure. Any modifications or alterations made by those skilled in the art based on the foregoing disclosure are within the scope of the claims.

Claims

1. An intelligent positioning device for orthopedic implant channels, characterized in that... include: The laser module includes two laser emitting units for projecting laser beams onto a target area on the patient's body surface to form a dynamic laser grid. The dynamic compensation module is used to detect the patient's bone movement information through sensors. When bone displacement is detected, a dynamic compensation control signal is determined based on the bone movement information, and the dynamic compensation control signal is sent to the laser module. The laser module adjusts the laser beam according to the received control signal to correct the laser grid. The dynamic compensation module includes a sensor, a main controller, and an optical encoder. The sensor is used to detect bone movement information in real time. When the angle change Δθ of the bone is detected to exceed the preset angle threshold, it is determined that an offset has occurred and the angle offset signal is sent to the main controller. The main controller is used to receive the angle offset signal sent by the sensor, calculate the compensation angle Δφ required for the current angle offset; and send a pulse width modulation (PWM) control signal to the laser module according to the calculated compensation angle; the laser module can control the operation of the laser emitting unit according to the aforementioned PWM control signal to adjust the direction of the laser beam directed toward the target area; The optical encoder is used to verify the actual deflection angle of the laser and feed it back to the main controller.

2. The apparatus according to claim 1, characterized in that, The sensor is a MEMS sensor. When the angle change Δθ detected by the MEMS sensor does not exceed the preset angle threshold, it is determined that no offset has occurred, and the device maintains the current operating parameters. The compensation angle Δφ is equal to the product of the angle change Δθ and the calibration coefficient K, the value of which is preset by the system or the user.

3. The apparatus according to claim 1 or 2, characterized in that, The laser emitting unit includes a laser diode, a collimating lens group, a galvanometer system, and a reflecting mirror group; The laser diode is used to emit a linear laser beam of a preset wavelength; The collimating lens group is used to receive the laser beam emitted by the laser diode and control the laser beam divergence angle within a preset accuracy range. The galvanometer system includes an X-axis galvanometer, a Y-axis galvanometer, and a galvanometer drive mechanism, used to adjust the laser angle of the laser beam output from the collimating lens group according to a control signal; The reflector group is used to reflect the laser output from the galvanometer system so as to project the laser beam onto the aforementioned target area; At this time, after calculating the compensation angle, the main controller of the dynamic compensation module sends a PWM control signal corresponding to the aforementioned compensation angle to the aforementioned galvanometer system. After receiving the aforementioned PWM control signal, the galvanometer system controls the galvanometer drive mechanism to operate and control the corresponding galvanometer deflection, so that the galvanometer deflects the received laser light.

4. The apparatus according to claim 3, characterized in that, The main controller includes a MEMS interface circuit, a galvanometer driving circuit, and an optical encoder interface. The optical encoder is a 24-bit absolute encoder. The MEMS interface circuit uses an SPI bus to connect to the MEMS sensor. The galvanometer driving circuit is based on a motor driving chip and sends control signals to the galvanometer system. The optical encoder interface communicates with the 24-bit absolute encoder via the SSI protocol.

5. The apparatus according to claim 3, characterized in that, The laser module also includes a projection control unit, which controls two laser emitting units to project dual laser beams onto the target area on the patient's body surface, forming a dynamically adjustable cross-projection grid on the patient's body surface. The laser beam is a linear laser with a wavelength of 650nm.

6. An orthopedic navigation and positioning system, characterized in that, It includes a main control computer, a three-dimensional imaging device, and a projection positioning device. The main control computer is communicatively connected to the three-dimensional imaging device and the projection positioning device and is used to control the operation of the three-dimensional imaging device and the projection positioning device. The three-dimensional imaging device is used to generate a preoperative three-dimensional image as a reference image in a single fluoroscopic scan, and transmit the reference image to the main control computer. The projection positioning device is an intelligent positioning device for orthopedic implant channels as described in any one of claims 1-5, used to project a laser beam onto a target area on the patient's body surface, and to make dynamic compensation adjustments based on detected bone movement information to counteract deviations caused by bone movement.

7. The system according to claim 6, characterized in that, It also includes a display terminal, and the main control computer is configured as follows: Based on the reference image, the spatial calibration of the image is completed using the calibration module; according to the calibration results, a spatial reference system for laser projection is set, and the projection position is matched with the area where the target bone is located; as well as, A dynamic laser grid is projected onto the target area via a laser module, forming visual positioning marks on the target bone surface; the dynamic compensation module's sensors detect bone movement in real time, triggering dynamic compensation adjustments when bone displacement is detected, and correcting the laser grid position in real time based on the adjustment results; and, The navigation module fuses the laser projection coordinates with the three-dimensional reference image in real time, then combines the implant parameters to form the implant planning path, and sends the path planning information to the aforementioned display terminal for display.

8. The system according to claim 7, characterized in that, The three-dimensional imaging device is a three-dimensional C-arm machine, and the calibration module performs virtual calibration on a single perspective image based on a deep learning algorithm. The calibration module is configured to: acquire a single-view perspective image from a 3D C-arm camera; preprocess the image; and then extract skeletal features using a deep convolutional neural network algorithm. After successful extraction, the bone edges are detected, the three-dimensional spatial coordinates are calculated, and the accuracy of the calculated spatial coordinates and laser parameters is verified. When the accuracy verification meets the standard, the mapping relationship between the laser projection coordinate system and the image coordinate system is established, and the calibration is completed. When the accuracy verification does not meet the standard, the process returns to the above-mentioned three-dimensional spatial coordinate calculation and the accuracy verification is performed based on the calculation results. This process is repeated until the accuracy verification meets the standard.

9. The system according to any one of claims 6-8, characterized in that, The system also includes an implant verification module, which is configured to: acquire bone image data after the implant is placed, compare the implant position in the bone image data with the planned implant position, acquire the implant position error value, and determine whether the error value is within a preset error allowable range.

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