Robot-assisted navigation system and surgical system for hip replacement surgery

Abstract

The present application provides a robot-assisted navigation system and a surgical system for hip replacement surgery. Among them, the robot-assisted navigation system includes: a preoperative planning module, which is used to obtain a three-dimensional model of the bone according to the collected medical images, perform surgical planning and determine a surgical plan; an intraoperative registration module, which is used to register the patient's bone with the three-dimensional model of the bone according to the patient's spatial position determined by the navigation positioning device; an intraoperative execution module, which is used to control the execution of hip joint reconstruction according to the surgical plan, and adjust the acetabular anteversion angle according to the set combined anteversion angle and the measured femoral anteversion angle during the reconstruction process, and further update the surgical plan. By measuring the femoral anteversion angle in the intraoperative execution module and then adjusting the acetabular anteversion angle, the surgical plan is adjusted during the operation, improving the applicability of the robot-assisted navigation system and helping to improve the surgical effect of robot-assisted hip replacement surgery.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a robot-assisted navigation system and a surgical system for hip replacement surgery. Background Art

[0002] Hip replacement is to fix an artificial prosthesis on the normal bone structure of a patient to replace the diseased hip joint, thereby reconstructing the normal function of the patient's hip joint. Hip replacement is one of the most important and effective surgeries for treating end-stage lesions of diseases such as avascular necrosis of the femoral head, hip dysplasia, degenerative hip osteoarthritis, and rheumatoid arthritis.

[0003] In hip replacement surgery, the implantation position, implantation angle, and force line after implanting the prosthesis of the artificial prosthesis are important factors affecting the function of the prosthesis. If the implantation position of the acetabular prosthesis or femoral prosthesis is not good during the surgery, the probability of prosthesis collision, edge wear, prosthesis dislocation, and repeated revision after the surgery will increase greatly.

[0004] Using the traditional "manual operation" mode for hip replacement surgery, its surgical effect depends too much on the experience of the surgeon; the large incision and high radiation dose used during the surgery increase the surgical risk; moreover, the accuracy and stability of the surgery need to be improved. For hip replacement surgery, robot-assisted technology can accurately achieve the anatomy and reconstruction of the surgical site, thereby achieving relatively ideal postoperative parameters such as soft tissue balance and accurate force line, which is beneficial to the joint to recover its normal kinetic characteristics. Summary of the Invention

[0005] In view of the problem that the existing robot-assisted navigation system cannot adjust the preoperative planning scheme based on the physiological structure of the patient during the surgery, resulting in some adverse problems in the patient's postoperative recovery, this application provides a robot-assisted navigation system and a surgical system for hip replacement surgery. Among them, the robot-assisted navigation system includes:

[0006] A robot-assisted navigation system for hip replacement surgery, characterized by including:

[0007] A preoperative planning module, configured to perform surgical planning and determine a surgical plan after obtaining a three-dimensional bone model based on the collected medical images;

[0008] An intraoperative registration module, configured to register the patient's bones with the three-dimensional bone model according to the patient's spatial position determined by the navigation positioning device;

[0009] An intraoperative execution module, configured to perform hip joint reconstruction according to the surgical plan, and adjust the acetabular anteversion angle during the reconstruction according to the combined anteversion angle and femoral anteversion angle, and then update the surgical plan.

[0010] According to some embodiments of the present application, performing hip joint reconstruction includes:

[0011] The surgical robot drives the end tool, and after moving the end tool to a specified position according to the navigation instruction, performs acetabular reconstruction or femoral and acetabular reconstruction; or

[0012] The end tool held by hand performs the acetabular reconstruction or the femoral and acetabular reconstruction according to the position information obtained by the navigation positioning device.

[0013] According to some embodiments of the present application, the surgical robot driving the end tool includes:

[0014] The end tool is guided to move within a defined range through a guide installed on the end tool.

[0015] According to some embodiments of the present application, the guide ensures positioning accuracy through structural design and does not require calibration.

[0016] According to some embodiments of the present application, performing hip joint reconstruction further includes:

[0017] The movement range of the surgical robot is defined by a set three-dimensional safety boundary.

[0018] According to some embodiments of the present application, defining the movement range of the surgical robot by a set three-dimensional safety boundary includes:

[0019] When the end tool approaches the three-dimensional safety boundary, a gradually increasing robot operating force is fed back to the operator; or

[0020] When the end tool exceeds the three-dimensional safety boundary, the power supply of the end tool is automatically cut off.

[0021] According to some embodiments of the present application, the preoperative planning module is further used for:

[0022] According to the lengths of the two lower limbs in the medical image, performing the surgical planning according to the standard of equal lengths of the two lower limbs, so as to obtain the differences in the lengths of the lower limbs after surgery relative to the lengths of the lower limbs before surgery and the lengths of the contralateral lower limbs before surgery.

[0023] According to some embodiments of the present application, the intraoperative execution module is further used for:

[0024] Evaluating the range of joint movement and the collision situation within the range of joint movement after surgery according to the three-dimensional bone model and the surgical plan, and adjusting the surgical plan according to the collision situation.

[0025] According to some embodiments of the present application, the measurement of the femoral anteversion angle includes:

[0026] The femoral anteversion angle is determined by the transepicondylar line or the posterior condylar line obtained by the navigation positioning device and the femoral neck axis obtained by the femoral stem probe.

[0027] According to some embodiments of the present application, the intraoperative execution module further includes:

[0028] An interactive adjustment sub-module, configured to adjust the surgical plan according to the interactive input information.

[0029] According to some embodiments of the present application, the robot-assisted navigation system further includes:

[0030] A postoperative summary module, configured to record the information of the surgical plan and provide a data reference for postoperative recovery.

[0031] According to another aspect of the present application, there is also provided a robot-assisted surgical system for hip replacement surgery, the surgical system including:

[0032] A navigation positioning device;

[0033] The above-mentioned robot-assisted navigation system communicates with the navigation positioning device;

[0034] A surgical robot, configured to assist in executing the surgical plan under the guidance of the robot-assisted navigation system.

[0035] According to some embodiments of the present application, the robot-assisted surgical system further includes:

[0036] A guide, fixed to the end of the surgical robot.

[0037] The robot-assisted navigation system and surgical system for hip replacement surgery provided by the present application adjust the surgical plan by measuring the femoral anteversion angle and then adjusting the acetabular anteversion angle in the intraoperative execution module, further improving the applicability of the robot-assisted navigation system and helping to improve the surgical effect of robot-assisted hip replacement surgery. The robot-assisted navigation system for hip replacement surgery provided by the present application can be operated by an operator holding the end tool, or can be operated by the surgical robot driving the end tool within the range of the guide, improving the safety of the execution process. During the acetabular reconstruction process, the safety of the acetabular reconstruction process is improved by establishing a safety margin. By providing the function of measuring the change in the length of the lower limb before and after surgery, the surgical plan is adjusted using the measured data, reducing the probability of postoperative lower limb length inequality in patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] To more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the accompanying drawings required for the description of the embodiments. Obviously, the accompanying drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, other accompanying drawings can also be obtained based on these drawings without exceeding the scope of protection required by the present application.

[0039] Figure 1 Show a block diagram of a robot-assisted navigation system according to a first exemplary embodiment of the present application;

[0040] Figure 2 Show a block diagram of a preoperative planning module according to an exemplary embodiment of the present application;

[0041] Figure 3 Show a block diagram of an intraoperative registration module according to an exemplary embodiment of the present application;

[0042] Figure 4 Show a block diagram of an intraoperative execution module according to an exemplary embodiment of the present application;

[0043] Figure 5 Show a block diagram of a robot-assisted navigation system according to a second exemplary embodiment of the present application;

[0044] Figure 6 Show a schematic diagram of the working process of a robot-assisted navigation system according to an exemplary embodiment of the present application;

[0045] Figure 7 Show a schematic diagram of a robot-assisted surgical system according to an exemplary embodiment of the present application. Detailed implementation manners

[0046] The following will clearly and completely describe the technical solutions in the embodiments of the present application in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative efforts fall within the scope of protection of the present application.

[0047] The terms "first", "second", etc. in the present application are used to distinguish different objects, rather than to describe a predetermined order. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device that includes a series of steps or units is not limited to the listed steps or units, but optionally further includes steps or units not listed, or optionally further includes other steps or units inherent to these processes, methods, products or devices.

[0048] Reference to "embodiments" in this document means that the predefined features, structures, or characteristics described in conjunction with the embodiments may be included in at least one embodiment of this application. The phrase appears at various positions in the specification and does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0049] Existing robot-assisted hip replacement surgery navigation systems have reduced the complexity of hip replacement surgeries and saved surgical time. However, during the surgery, the preoperative planning surgical plan formulated based on the patient's images is entirely executed by the robot, and the preoperative planning plan is not adjusted based on the patient's anatomical structure during the surgery, resulting in some adverse problems during the patient's postoperative recovery. Therefore, in order to improve the applicability of existing robot-assisted hip replacement surgery navigation systems, this application provides a robot-assisted hip replacement surgery navigation system with more complete functions, simpler operations, and capable of adjusting the surgical plan in combination with the intraoperative data of the patient, thereby improving the surgical effect of robot-assisted hip replacement surgery.

[0050] Figure 1 Shows a block diagram of the composition of a robot-assisted navigation system according to the first exemplary embodiment of the present application.

[0051] As Figure 1 shown, the robot-assisted navigation system 1000 for hip replacement surgery provided by this application includes a preoperative planning module 100, an intraoperative registration module 200, and an intraoperative execution module 300. Among them, the preoperative planning module 100 can be used to obtain a three-dimensional model of the bone after collecting medical images, perform surgical planning, and determine the surgical plan. The intraoperative registration module 200 can be used to register the patient's bone with the three-dimensional bone model according to the patient's spatial position determined by the navigation positioning device. The intraoperative execution module 300 can be used to control the robot to perform acetabular reconstruction or femoral reconstruction and acetabular reconstruction according to the surgical plan, and adjust the acetabular anteversion angle according to the set combined anteversion angle and the measured femoral anteversion angle during the reconstruction process, thereby updating the surgical plan.

[0052] According to some embodiments of the present application, the preoperative planning module 100 can perform image segmentation and three-dimensional reconstruction based on the acquired patient medical images (such as CT images or magnetic resonance images of the pelvis at the femur and hip joint), so as to obtain the three-dimensional model of the pelvis at the patient's hip joint and the three-dimensional model of the femur. Based on the three-dimensional model of the pelvis at the hip joint and the three-dimensional model of the femur, preoperative planning can be performed for the patient according to the specific situation of the patient to obtain a surgical plan. According to some embodiments of the present application, the preoperative planning module 100 can include a data import sub-module 110, an image processing sub-module 120, and a surgical planning sub-module 130, as Figure 2 shown.

[0053] Among them, the data import sub-module 110 is used to check the acquired patient medical image data and import the image data that meets the surgical standards into the preoperative planning module 100. The image processing sub-module 120 is used to perform image segmentation and three-dimensional reconstruction based on the imported patient medical image data, so as to obtain the three-dimensional model of the patient's pelvis and the three-dimensional model of the femur. The surgical planning sub-module 130 is used to plan the surgical plan according to the three-dimensional model of the patient's pelvis and the three-dimensional model of the femur. For example, according to the pelvic central axis, acetabular rotation center, acetabular diameter, femoral head rotation center, femoral mechanical axis, femoral anatomical axis, femoral transepicondylar line or posterior condylar line in the three-dimensional model of the pelvis and the three-dimensional model of the femur, and in combination with the lower limb length and combined offset before and after osteotomy, determine the type, size, implantation position and angle of the implanted prosthesis. After the preoperative planning is completed, a data packet of the surgical plan that can be executed can be obtained.

[0054] According to some embodiments of the present application, the preoperative planning sub-module of the present application performs surgical planning according to the lengths of the two lower limbs in the patient medical image according to the standard of equal length of the two lower limbs. For example, the lengths of the bilateral lower limbs can be measured from the patient's preoperative images, and surgical planning can be performed according to the standard of equal length of the bilateral lower limbs after surgery, so as to obtain the difference in the length of the affected lower limb after surgery relative to before surgery and relative to the contralateral side. By providing the function of measuring the change in the length of the lower limb before and after surgery, adjusting the surgical plan using the measured data can reduce the probability of unequal lengths of the two lower limbs in the patient after surgery.

[0055] According to some embodiments of the present application, the intraoperative registration module 200 is used to establish the correspondence between the patient's spatial position and the image space, and then convert the surgical plan planned in the image space into an executable plan in the patient space. According to some embodiments of the present application, the intraoperative registration module 200 can include a plan import sub-module 210, a navigation positioning sub-module 220, and an image registration sub-module 230, as Figure 3 shown.

[0056] Among them, the solution import sub-module 210 is used to import the surgical plan generated by the preoperative planning module, such as a surgical planning package. The navigation positioning sub-module 230 is used to determine the spatial position of the patient according to the navigation positioning device. For example, the navigation positioning device may include a first tracker, a second tracker, a third tracker, a fourth tracker, and a fifth tracker. The first tracker is used to determine the pelvic spatial position of the patient; the second tracker is used to determine the femoral spatial position of the patient; the third tracker is used to determine the spatial position of the surgical robot; the fourth tracker is used to collect the spatial positions of the bony landmark points of the patient; the fifth tracker is used to determine the spatial position of the end effector tool. Within the effective range of the navigation positioning device, the relative spatial position relationships of the patient's pelvis, femur, robot, and end effector tool can be determined by the first tracker, the second tracker, the third tracker, the fourth tracker, and the fifth tracker. The image registration sub-module 230 is used to establish the correspondence between the three-dimensional model of the patient's preoperative medical image and the bony structure of the patient through a series of coordinate transformations (such as rotation, offset, scaling, etc.), so that the corresponding points on the three-dimensional model and the patient's bony structure are completely consistent in spatial position and anatomical structure.

[0057] According to an exemplary embodiment of the present application, the image registration method adopted in the present application performs a translation transformation according to the fitted acetabular rotation center, and then performs a rotation transformation according to the reference vector composed of the significantly featured anterior superior iliac spine and the acetabular rotation center, thereby completing the coordinate transformation process of image registration. The image registration method may include the following steps:

[0058] Step 1, perform a translation transformation according to the coordinates of the first acetabular rotation center fitted in the image space and the second acetabular rotation center fitted in the patient space. The hip joint has a special structure, and the acetabular articular surface (i.e., the acetabular fossa) has a spherical feature. Therefore, based on the spherical feature of the acetabular articular surface, the acetabular rotation center and the acetabular rotation radius can be fitted through a certain number of acquisition points randomly selected on the spherical surface. For example, a certain number of points are collected along the acetabular articular surface to form a set of acquisition points C i , i = 1, 2... m. The coordinates of the acquisition point C i can be expressed as C i = (Cx i , Cy i , Cz i ). According to a set of randomly selected acquisition points C i on the acetabular articular surface of the hip joint, using the least squares method, the acetabular rotation center C0 can be fitted through the following formula, and at the same time, the acetabular rotation radius r can also be fitted.

[0059]

[0060] The first acetabular rotation center C is respectively fitted in the image spaceP0 , fit the second acetabular rotation center C in the patient space Q0 , and then the second acetabular rotation center C Q0 and the first acetabular rotation center C P0 's coordinate difference is used as the translation component T of the translation transformation, which can be expressed as: T = {C Q0 x - C P0 x, C Q0 y - C P0 y, C Q0 z - C P0 z}.

[0061] Step 2, perform the first rotation transformation according to the angle between the first reference vector formed by the first anterior superior iliac spine and the first acetabular rotation center in the image space and the second reference vector formed by the second anterior superior iliac spine and the second acetabular rotation center in the patient space. The anterior superior iliac spine is a characteristic point with significant features in the hip joint. In the patient space, although the anterior superior iliac spine is not exposed, the muscle tissue wrapping it is relatively thin, and this characteristic point can be accurately located by touch and used as the second anterior superior iliac spine S Q . Similarly, in the image space, the anterior superior iliac spine also has very obvious features and can be accurately picked up in the image by judgment (for example, the operator can easily obtain it by clicking the mouse) and used as the first anterior superior iliac spine S P . In the image space, the first acetabular rotation center C P0 and the first anterior superior iliac spine S P form the first reference vector B P , which can be expressed as: B P = C P0 – S P . In the patient space, the second acetabular rotation center C Q0 and the first anterior superior iliac spine S Q form the second reference vector B Q , which can be expressed as B Q = C Q0 – S Q .

[0062] After the translation transformation in step 1, the second acetabular rotation center C of the acetabular joint surface in the patient space Q0 coincides with the first acetabular rotation center C in the image space P0 , which can be defined as C0. The axis of the first reference vector B P and the second reference vector B Q is A B , which can be expressed as:

[0063]

[0064] Furthermore, the first reference vector BP To B Q The position of needs to rotate around A B Rotation angle θ B , which can be expressed as:

[0065]

[0066] Thus, the first rotation component R1 of the patient space and the image space can be obtained by the Rodrigues rotation formula and is expressed as:

[0067] R1 = B P + sinθ B (A B × B P ) + (1 - cosθ B )A B × (A B × B P )

[0068] Step 3: Perform a second rotation transformation based on the rotation angle of a set of point pairs composed of points selected on both sides of the first reference vector in the image space and the corresponding points in the patient space, and then complete the image registration. After the first rotation transformation, the second reference vector B in the patient space Q rotates to coincide with the first reference vector B in the image space P , which can be defined as the first reference vector B. Here, the rotation angle of a set of point pairs selected on both sides of the first reference vector B in the image space and the patient space around the first reference vector B can be used as the second rotation component. The number of point pairs can be 1 pair or more.

[0069] For example, in the image space, two points are taken on the acetabular joint surface on both sides of the first reference vector B, which can be expressed as P i , P j . Correspondingly, in the patient space, the points Q i , Q j corresponding to P i , P j are selected. Project the point pairs P i -Q i , P j -Q j onto the plane O passing through the first acetabular rotation center C0 and perpendicular to the first reference vector B to obtain the projected point pairs P i ’-Q i ’, P j ’-Q j ’. The rotation angle φ i from point P i ’ to point Q i , point P jTransform to point Q j Rotation angle φ of j . In theory, the rotation angle φ can be obtained through a set of point pairs. For the case of multiple sets of point pairs, the final rotation angle φ can be determined according to the obtained multiple rotation angles (such as φ i , φ j ) according to statistical estimations (such as the average value, the maximum value, etc.).

[0070] Thus, the second rotation transformation R2 can be expressed as: under the coordinate system formed by the plane O and the first reference vector B, a rotation transformation with the first acetabular rotation center C0 as the rotation center and the first reference vector B as the rotation axis. The specific representation is as follows:

[0071]

[0072] Through the above translation transformation, the first rotation transformation, and the second rotation transformation, the registration from the patient space to the image space can be achieved through the transformation matrix M = T × R1 × R2.

[0073] The above registration method improves the accuracy of the translation transformation by fitting the acetabular rotation center; through the reference vector composed of the significantly featured anterior superior iliac spine and the acetabular rotation center for rotation transformation, the accuracy of the rotation transformation is further improved, thereby improving the accuracy of registration.

[0074] According to some embodiments of the present application, the intraoperative execution module 300 is mainly used to adjust the surgical plan according to the intraoperative anatomical structure of the patient during the operation, generate an execution program based on the determined surgical plan and the registration relationship between the patient's pelvis, femur and the three-dimensional model determined by the navigation positioning device, and control the surgical robot and the end effector to run to the patient's surgical area to complete the surgical operations on the acetabular side and the femoral side. For example, it is used to perform hip joint reconstruction according to the surgical plan, and adjust the acetabular anteversion angle according to the combined anteversion angle and the femoral anteversion angle during the reconstruction, and then update the surgical plan. According to some embodiments of the present application, the intraoperative execution module 300 includes an interactive adjustment sub-module 310, an execution control sub-module 320, a femoral reconstruction sub-module 330, and an acetabular reconstruction sub-module 340, as Figure 4 shown.

[0075] Among them, the interactive adjustment sub-module 310 can be used to adjust the surgical plan according to the interactive input information. For example, the determined surgical plan is presented through an interactive page for browsing, and an interactive instruction is received to adjust parameters in the surgical plan such as the prosthesis model, size, placement position, placement angle, etc., so that the surgical plan better conforms to the actual situation of the surgical patient.

[0076] The execution control sub-module 320 is used to control the execution of hip joint reconstruction, including separate acetabular reconstruction or sequential reconstruction of the femur and acetabulum. For example, based on the surgical plan output by the preoperative planning module and the relative position relationship between the patient, the robotic arm of the robot, and the end tool determined by the navigation positioning sub-module, the robotic arm of the surgical robot is controlled to move to the planned position in the planned posture, and the spatial positions of the robotic arm and the patient are obtained in real time through the navigation positioning sub-module during this process.

[0077] According to some embodiments of the present application, the execution control sub-module 320 can control the surgical robot to drive the end tool and move the end tool to a specified position according to the navigation instruction. After the end tool is driven to the specified position, femoral reconstruction and / or acetabular reconstruction are performed; it can also control the end tool held by hand to perform acetabular reconstruction, or femoral and acetabular reconstruction according to the position information obtained by the navigation positioning device. For example, the robot can be controlled by the navigation positioning sub-module and the execution control module to drive the end tool to automatically move to a specified position relative to the patient's acetabulum and / or femur, and perform the surgical operations on the femur and acetabulum in the manual mode; the operator can also hold the end tool and, under the positioning of the navigation positioning sub-module, detect the position and posture of the end tool in real time to perform the surgical operation.

[0078] According to some embodiments of the present application, when the surgical robot drives the end tool to move and performs surgical operations in the automatic mode, a guide installed on the end tool is used to guide the end tool to move within a limited range, thereby improving the safety of surgical operations. The guide installed at the end of the robotic arm is suitable for operations such as femoral neck osteotomy guidance, acetabular directional grinding and filing, and directional insertion of acetabular cup prostheses. Moreover, it can be quickly installed on the end tool, and the positioning accuracy is ensured through the structural design. The positioning accuracy can be ensured without calibration, thereby simplifying the surgical operation process.

[0079] The femoral reconstruction sub-module 330 is used to complete operations such as femoral neck osteotomy, femoral medullary cavity shaping, and installation of femoral side prostheses. According to some embodiments of the present application, during femoral reconstruction, when performing femoral medullary cavity shaping and prosthesis installation, the intraoperative execution module adjusts the acetabular anteversion angle in the surgical plan according to the combined anteversion angle and the femoral anteversion angle measured during the operation, and then updates the surgical plan. For example, the femoral anteversion angle can be measured by the navigation positioning device, and the surgical plan is adjusted according to the measured value of the femoral anteversion angle with the combined anteversion angle as a constraint, so that the surgical plan is more consistent with the physiological structural characteristics of the patient, more conducive to the patient's postoperative recovery, and reduces postoperative complications. The combined anteversion angle is equal to the sum of the femoral anteversion angle and the acetabular anteversion angle. Generally, according to surgical experience, the combined anteversion angle is usually set to 40 degrees, or the combined anteversion angle on the surgical side is set according to the combined anteversion angle on the contralateral side of the patient's surgical side.

[0080] According to some embodiments of the present application, the femoral reconstruction sub-module 330 determines the femoral anteversion angle based on the position and orientation obtained by the femoral stem probe and the second tracker (femoral tracker) in the navigation positioning sub-module, as well as the transepicondylar line or posterior condylar line determined on the patient's image. The femoral stem probe can be adapted to different models of femoral stem prostheses and can be coaxially mounted (the sleeve on the femoral stem probe is coaxial with the axis of the femoral neck) on the femoral neck prosthesis. The spatial position of the axis of the femoral neck is measured by the femoral stem probe. The spatial position of the patient's femur is obtained by the second tracker (femoral tracker) in the navigation positioning sub-module. According to the known spatial position of the transepicondylar line or posterior condylar line of the patient's operative side, the femoral anteversion angle can be determined by the axis of the femoral neck and the transepicondylar line or posterior condylar line.

[0081] The acetabular reconstruction sub-module 340 can be used to complete operations such as acetabular rasping and acetabular prosthesis implantation. For example, when performing acetabular rasping, the appropriate size of the acetabular rasp and the pose of the end tool can be selected according to the surgical plan. According to some embodiments of the present application, during the acetabular reconstruction process, the movement range of the robot is limited by the set three-dimensional safety boundary, so as to avoid the harm caused to the patient by the error of the surgical plan and further improve the safety of the operation of the robot-assisted navigation system. The three-dimensional safety boundary can be set according to surgical experience or surgical position requirements, and the present application does not limit this.

[0082] For example, under the combined action of the navigation positioning sub-module and the execution control sub-module, when the robot and the end tool acetabular rasp move to the planned position, the three-dimensional safety boundary is activated. The navigation positioning sub-module real-time detects the pose of the acetabular rasp. Within the three-dimensional safety boundary, the program can be executed to perform operations such as acetabular rasping; when the acetabular rasp approaches the three-dimensional safety boundary, a gradually increasing robot operating force is feedback to the operator, so that the operator can clearly perceive the three-dimensional safety boundary and receive a safety reminder. When the acetabular rasp exceeds the set three-dimensional safety boundary, the power supply of the acetabular rasp is automatically cut off to ensure the safety of the operation.

[0083] According to some embodiments of the present application, during the process of performing acetabular rasping, different sizes of acetabular rasps are allowed to be used to adapt to different surgical plans. In addition, the intraoperative execution module 300 real-time displays the difference between the current acetabular morphology and the planned acetabular morphology in the surgical plan in three-dimensional space, thereby providing guidance for the execution of acetabular rasping.

[0084] According to some other embodiments of the present application, the intraoperative execution module is also used to control the robot to automatically run to the planned position according to the acetabular anteversion angle and acetabular abduction angle determined in the surgical plan, and complete the operation of implanting the acetabular prosthesis through the acetabular cup inserter connected to the end. When implanting the acetabular prosthesis, the intraoperative execution module real-time displays the depth information of the acetabular cup insertion, so as to ensure the safety during the operation process.

[0085] According to other embodiments of the present application, the intraoperative execution module is also used to virtually evaluate the range of joint motion on the surgical side after hip replacement, as well as collision conditions within the range of joint motion, such as collisions between the prosthesis and the bony structure, and between prostheses. Joint motion includes flexion or extension, internal rotation or external rotation, abduction or adduction, etc. of the hip joint. Based on the collision conditions within the evaluated range of joint motion, the position and angle of the prosthesis in the surgical plan can be further adjusted.

[0086] According to other embodiments of the present application, during acetabular reamer and acetabular cup placement, the navigation and positioning submodule determines robot motion control instructions based on the first tracker (pelvis tracker), the third tracker (robot tracker), and the fifth tracker (end tool tracker). This allows real-time tracking of movements in the patient's pelvis to ensure the correct placement angle.

[0087] According to other embodiments of the present application, after the prosthesis is implanted, the intraoperative execution module is further used to measure the acetabular abduction angle, acetabular anteversion angle, lower limb length difference relative to the preoperative and contralateral sides, and joint offset.

[0088] Figure 5 A block diagram showing the composition of a robot-assisted navigation system according to a second exemplary embodiment of the present application is shown.

[0089] According to another example embodiment of the present application, the robot-assisted navigation system 1000 provided in the present application may further include a postoperative summary module 400. The postoperative summary module 400 may be used to record information about the surgical plan and provide a data reference for postoperative recovery. For example, through the postoperative summary module 400, all information related to the operation is summarized, including the patient's basic information, preoperative images, the surgical plan planned before the operation, the surgical plan adjusted during the operation, the type and size of the prosthesis, key clinical technical indicators, etc. The key clinical technical indicators may include the femoral anteversion angle, acetabular abduction angle, acetabular anteversion angle, the difference in lower limb length and joint offset relative to the preoperative and contralateral sides after the prosthesis is implanted. Through the postoperative summary, not only can guidance be provided for the patient's postoperative recovery, but it can also facilitate the surgeon's optimization of the surgical plan and provide data accumulation for further improving the surgical execution plan.

[0090] Figure 6 A schematic diagram of the workflow of a robot-assisted navigation system according to an exemplary embodiment of the present application is shown.

[0091] The use process of the total hip replacement surgery execution system provided by this application is as follows: Figure 6 As shown, the following steps are included:

[0092] Step S600: Acquiring patient images. For example, CT equipment or magnetic resonance imaging can be used to acquire images of the patient's femur and pelvis at the hip joint.

[0093] Step S610: Image segmentation and reconstruction. Based on the acquired images of the patient's femur and pelvis at the hip joint, the images of the femur and pelvis can be segmented through an image processing algorithm and the three-dimensional models of the femur and pelvis can be reconstructed.

[0094] Step S620: Preoperative plan formulation. Based on the reconstructed three-dimensional models of the femur and pelvis, surgical planning is carried out to determine a surgical plan that includes information such as the type, size, and position of the prosthesis.

[0095] Step S630: Import of the surgical plan, including importing the surgical plan of the patient generated by preoperative planning.

[0096] Step S640: Image registration. Establish the correspondence between the patient's spatial position and the image space, and then convert the surgical plan planned in the image space into an executable plan in the patient space.

[0097] Step S650: Femur reconstruction. Operations such as femoral neck osteotomy, femoral medullary cavity shaping, and prosthesis implantation are performed, and the acetabular anteversion angle is adjusted according to the set combined anteversion angle and the intraoperatively measured femoral anteversion angle, thereby updating the surgical plan.

[0098] Step S660: Acetabulum reconstruction. Operations such as acetabular rasping and acetabular prosthesis placement are performed, and the movement range of the robot is limited by the set three-dimensional safety boundary, so as to avoid the harm brought to the patient by the error of the surgical plan and further improve the safety of the operation of the robot-assisted navigation system.

[0099] Step S670: Prosthesis implantation. When the acetabular cup is implanted, the navigation positioning sub-module determines the motion control instructions of the robot according to the first tracker (pelvis tracker), the third tracker (robot tracker), and the fifth tracker (end tool tracker). When the position of the patient's pelvis moves, it can be tracked in real time to ensure the correct implantation angle.

[0100] Step S680: Measurement of clinical indicators. Measure indicators such as the femoral anteversion angle, acetabular abduction angle, acetabular anteversion angle, lower limb length difference relative to the preoperative and contralateral sides, and combined offset of the patient.

[0101] Step S690: Postoperative evaluation and summary. Record and summarize the information related to the surgery, including the basic information of the patient, preoperative images, the surgical plan planned before surgery, the surgically adjusted surgical plan, the type and size of the prosthesis, key clinical technical indicators, etc., to provide data reference for postoperative recovery.

[0102] Figure 7 Shows a schematic diagram of a robot-assisted surgical system according to an exemplary embodiment of the present application.

[0103] According to another aspect of the present application, a robotic assisted surgical system 7000 for hip replacement surgery is further provided, as Figure 7 shown. The robotic assisted surgical system 7000 includes the above-mentioned robotic assisted navigation system 1000, navigation positioning device 2000 and robot 3000. The robotic assisted navigation system 2000 communicates with the navigation positioning device to obtain the actual spatial positions of the patient's surgical site, the robot, and the surgical end tool; the robot 3000 assists in executing the surgical plan under the guidance of the robotic assisted navigation system.

[0104] The robotic assisted navigation system 1000 includes an upper controller 1100 and a human-machine interaction device 1200. The navigation positioning device 2000 includes a navigation camera 2100, a patient tracker 2200, a robot end tracker 2300, an end tool tracker 2400, and a scanning probe 2500. The upper controller 1100 is respectively communicatively connected to the human-machine interaction device 1200, the robot 3000, and the navigation camera 2100, receives the information transmitted by the human-machine interaction device 1200 and the navigation camera 2100, and sends relevant information or instructions to the human-machine interaction device 1200, the robot 3000, and the navigation camera 2100.

[0105] The upper controller 1100 is also communicatively connected to the scanning probe 2500, the robot end tracker 2300, the patient tracker 2200, the end tool tracker 2400, etc., for example, controlling the activation of these components. The patient tracker 2200 includes an acetabular side tracker and a femoral side tracker, which are respectively fixed to the patient's pelvis and femur, and are used to determine the spatial positions of the patient's acetabulum and femur during the operation.

[0106] The robot end tracker 2300 is installed at the end of the robot and is used to determine the spatial position of the robot end. The end tool tracker 2400 includes an acetabular rasp tracker 2410 and an acetabular cup prosthesis insertion tracker (not shown in the figure), which are respectively fixed to the acetabular rasp connecting rod and the acetabular cup prosthesis driver connecting rod, and are used to determine the spatial positions of the acetabular rasp and the acetabular cup prosthesis. The scanning probe 2500 includes a probe 2510 for collecting the patient's bone landmark points and a probe 2520 for measuring the anteversion angle of the femoral prosthesis.

[0107] The navigation camera 2100 receives the signals of the robot end tracker 2300, the patient tracker 2200, and the end tool tracker 2400, and determines the relative spatial position relationship between the robot, the end tool, and the patient's pelvis and femur in the same spatial coordinate system. On the premise that the spatial position relationship among the patient's pelvis, femur, robot, and end tool is determined, the navigation camera 2100 receives the signal of the scanning probe 2510 to complete the collection of the patient's acetabulum and femur bone landmark points, and receives the signal of the scanning probe 2520 to complete the collection of the anteversion angle of the femoral prosthesis.

[0108] According to some other embodiments of the present application, the robotic-assisted surgical system 7000 further includes a guide 4000, which is fixed to the end of the robot 3000 to perform femoral neck osteotomy, acetabular rasping, and acetabular cup prosthesis implantation under the guidance of the robot.

[0109] The basic workflow of the robotic-assisted surgical system 7000 for hip replacement surgery provided by the present application is as follows:

[0110] Complete the computer tomography (CT) or magnetic resonance imaging (MRI) image datasets of the patient's hip and knee according to the technical parameters specified by the preoperative imaging scanning protocol. Import the patient's image data into the upper controller 1100, set the regions of interest (ROIs) in the hip joint and the knee joint respectively, and use the AI image intelligent segmentation algorithm to achieve the segmentation and reconstruction of the patient's pelvis and femur, and obtain the three-dimensional models of the patient's pelvis and femur.

[0111] In the preoperative planning stage, select bony landmark points on the three-dimensional models of the patient's pelvis and femur, and establish the pelvis and femur coordinate systems according to the selected bony landmark points respectively. Complete the image rotation according to the established coordinate systems. Select the marked points with bony landmarks on the patient's three-dimensional model as the basis for intraoperative registration and verification. Measure and obtain the pelvic midline, acetabular rotation center, acetabular diameter, femoral head rotation center, femoral mechanical axis, femoral anatomical axis, femoral epicondylar line, and posterior condylar line on the patient's three-dimensional model, and then obtain the lower limb length and combined offset. Determine the type, size, and position of the prosthesis based on the above data, and complete the preoperative planning of the surgical plan. The surgical plan obtained from the preoperative planning may include prosthesis data such as the prosthesis type, as well as the preliminary osteotomy and rasping plan, etc. The prosthesis data further includes the three-dimensional model data of the joint prosthesis and its corresponding spatial definition in human anatomy.

[0112] In the intraoperative execution stage, first import the surgical plan completed in the preoperative planning stage into the upper controller 1100. Under the unified spatial coordinate system established by the navigation camera 2100, use the scanning probe 2510 to collect the marked points on the patient's acetabular side and femoral side, and the navigation camera 2100 receives the data of the scanning probe 2510 to obtain the spatial position data of the current marked points. Repeat the marked point collection work until a sufficient number of marked points are collected, and complete the registration of the patient's image with the patient's pelvis and femur through the image registration algorithm.

[0113] After image registration, the corresponding relationship between the preoperative image space and the intraoperative patient space is established. Based on the orientation and angle of femoral neck osteotomy and the orientation and angle of acetabular rasping determined by the preoperative planned surgical plan, the upper controller 1100 controls the robot 3000 to move to the designated position according to the planned orientation and angle. The movement position of the robot 3000 is obtained by the navigation camera 2100 collecting the data of the end tracker 2200 of the robot in real time. After the robot 3000 moves to the designated position, the guide 4000 installed at the end of the robot provides physical guidance for femoral neck osteotomy, acetabular rasping, and insertion of the acetabular cup prosthesis.

[0114] After the femoral prosthesis and the acetabular prosthesis are implanted, the scanning probe 2520 is used to measure the anteversion angle of the femoral neck, and the scanning probe 2510 is used to measure the anteversion angle and abduction angle of the acetabular cup, as well as data such as the length change of the patient's affected lower limb relative to the preoperative state and relative to the contralateral side, so as to obtain clinical indicators such as combined offset, combined anteversion angle, and difference in length between the two lower limbs.

[0115] The robot-assisted navigation system and surgical system for hip replacement surgery provided by this application adjust the surgical plan by measuring the anteversion angle of the femur during the intraoperative execution module, and then adjusting the anteversion angle of the acetabulum, which further improves the applicability of the robot-assisted navigation system and helps to improve the surgical effect of robot-assisted hip replacement surgery. The robot-assisted navigation system for hip replacement surgery provided by this application can be operated by an operator holding the end tool, or can be operated by the surgical robot driving the end tool within the range of the guide, which improves the safety of the execution process. In addition, the guide ensures the positioning accuracy through its structural design, and can ensure the positioning accuracy without calibration, thus simplifying the operation process of the surgery. During acetabular reconstruction, the safety of the acetabular reconstruction process is enhanced through the three-dimensional safety boundary. By providing the function of measuring the length change of the lower limb before and after surgery, the surgical plan is adjusted using the measured data to reduce the probability of unequal lengths of the two lower limbs in the patient after surgery. The information of the surgical plan is recorded through the postoperative summary module, providing a data reference for postoperative recovery.

[0116] The embodiments of this application have been introduced in detail above. Specific examples are used in this article to elaborate on the principle and implementation manner of this application. The description of the above embodiments is only used to help understand the method and its core idea of this application. At the same time, any changes or deformations made by those skilled in the art based on the idea of this application, within the specific implementation manner and application scope of this application, all belong to the protection scope of this application. In summary, the content of this specification should not be construed as a limitation of this application.

Claims

1. A robot-assisted navigation system for hip replacement surgery, characterized in that: include: Preoperative planning module, which is used to obtain a 3D bone model based on the collected medical images, and then perform surgical planning and determine the surgical plan; An intraoperative registration module, configured to register the patient's skeleton with the three-dimensional skeleton model according to the patient's spatial position determined by the navigation and positioning device; an intraoperative execution module, configured to perform hip joint reconstruction according to the surgical plan, and adjust the acetabular anteversion angle according to the joint anteversion angle and the femoral anteversion angle during the reconstruction process, thereby updating the surgical plan; The intraoperative registration module performs translation transformation according to the coordinates of the first acetabulum rotation center fitted in the image space and the second acetabulum rotation center fitted in the patient space; The intraoperative registration module performs a first rotation transformation based on an angle between a first reference vector formed by the first anterior superior iliac spine and the first acetabulum rotation center in the image space and a second reference vector formed by the second anterior superior iliac spine and the second acetabulum rotation center in the patient space; The intraoperative registration module performs a second rotation transformation on a set of points consisting of points selected along both sides of the first reference vector in the image space and corresponding points in the patient space according to the rotation angle around the first reference vector, thereby completing the image registration.

2. The robot-assisted navigation system according to claim 1, characterized in that The hip reconstruction is performed, including: The surgical robot drives the end tool, moves the end tool to a designated position according to the navigation instruction, and performs acetabulum reconstruction or femur and acetabulum reconstruction; or The handheld end tool performs the acetabulum reconstruction or the femur and acetabulum reconstruction according to the position information acquired by the navigation and positioning device.

3. The robot-assisted navigation system according to claim 2, characterized in that: The surgical robot drives the end tool, including: The end tool is guided to move within a limited range by a guide installed on the end tool.

4. The robot-assisted navigation system according to claim 3, characterized in that: The guide ensures positioning accuracy through structural design and does not require calibration.

5. The robot-assisted navigation system according to claim 2, characterized in that: The performing of hip joint reconstruction further comprises: The motion range of the surgical robot is limited by the set three-dimensional safety boundary.

6. The robot-assisted navigation system according to claim 5, characterized in that: The motion range of the surgical robot is limited by setting a three-dimensional safety boundary, including: When the end tool approaches the three-dimensional safety boundary, feeding back gradually increasing robot operating force to the operator; or When the end tool exceeds the three-dimensional safety boundary, the power supply of the end tool is automatically cut off.

7. The robot-assisted navigation system according to claim 1, characterized in that: The preoperative planning module is further configured to: The surgical planning is performed according to the lengths of both lower limbs in the medical image and the standard of equal length of both lower limbs, thereby obtaining the difference between the postoperative lower limb length and the preoperative lower limb length and the preoperative contralateral lower limb length.

8. The robot-assisted navigation system according to claim 1, wherein: The intraoperative execution module is further configured to: The postoperative range of joint motion and collision conditions within the range of joint motion are evaluated based on the three-dimensional bone model and the surgical plan, and the surgical plan is adjusted based on the collision conditions.

9. The robot-assisted navigation system according to claim 1, characterized in that: The measurement of the femoral anteversion angle includes: The femoral anteversion angle is determined by the condylar line or the posterior condylar line obtained by the navigation positioning device and the femoral neck axis obtained by the femoral stem probe.

10. The robot-assisted navigation system according to claim 1, characterized in that: The intraoperative execution module further includes: The interactive adjustment submodule is used to adjust the surgical plan according to the interactive input information.

11. The robot-assisted navigation system according to claim 1, wherein: Also includes: The postoperative summary module is used to record the information of the surgical plan and provide data reference for postoperative recovery.

12. A robot-assisted surgical system for hip replacement surgery, characterized in that: include: Navigation and positioning device; The robot-assisted navigation system according to any one of claims 1 to 11, communicating with the navigation and positioning device; The surgical robot assists in executing the surgical plan under the guidance of the robot-assisted navigation system.

13. The robot-assisted surgery system according to claim 12, wherein: include: The guide is fixed to the end of the surgical robot.

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