WO2023116076A1

WO2023116076A1 - Robot-assisted navigation system for hip replacement surgery, and surgical system

Info

Publication number: WO2023116076A1
Application number: PCT/CN2022/118692
Authority: WO
Inventors: 贾英杰; 孙巍; 邓明明; 王宝杰; 张胜锋; 姜丽丽
Original assignee: 北京天智航医疗科技股份有限公司
Priority date: 2021-12-24
Filing date: 2022-09-14
Publication date: 2023-06-29
Also published as: CN116327360A

Abstract

A robot-assisted navigation system (1000) for a hip replacement surgery, and a surgical system (7000). The robot-assisted navigation system (1000) comprises: a preoperative planning module (100), configured to perform surgical planning and determine a surgical scheme after obtaining a bone three-dimensional model according to a collected medical image; an intraoperative registration module (200), configured to register a bone of a patient and the bone three-dimensional model according to a patient spatial position that is determined by a navigation positioning apparatus (2000); and an intraoperative execution module (300), configured to control, according to the surgical scheme, to execute hip part reconstruction, and during reconstruction, adjust an acetabulum anteversion angle according to a set joint anteversion angle and a measured femur anteversion angle so as to update the surgical scheme. The femur anteversion angle is measured by means of the intraoperative execution module (300) so as to adjust the acetabulum anteversion angle, and the surgical scheme is adjusted during a surgery, thereby improving the applicability of the robot-assisted navigation system (1000), and helping to improve the surgical effect of a robot-assisted hip replacement surgery.

Description

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

technical field

The present application relates to the field of medical equipment, in particular to a robot-assisted navigation system and a surgical system for hip joint replacement surgery.

Background technique

Hip replacement is to fix the artificial prosthesis on the patient's normal bone structure 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 the treatment of end-stage diseases such as femoral head necrosis, hip dysplasia, degenerative hip osteoarthritis, and rheumatoid arthritis.

In hip replacement surgery, the implantation position, implantation angle, and line of force after implantation of the artificial prosthesis are important factors that affect the function of the prosthesis. If the implantation position of the acetabular prosthesis or femoral prosthesis is not good during the operation, the probability of prosthesis collision, edge wear, prosthesis dislocation, and repeated revision will be greatly increased after surgery.

Using the traditional "hands-on" mode for hip replacement surgery, the surgical effect is too dependent on the experience of the surgeon; the large incision and high radiation dose used in the operation lead to increased surgical risks; and the accuracy and stability of the operation need to be improved. For hip replacement surgery, robot-assisted technology can accurately realize the anatomy and reconstruction of the surgical site, so as to achieve ideal soft tissue balance, precise line of force and other postoperative parameters, which is conducive to the restoration of normal dynamic characteristics of the joint.

Contents of the invention

In view of the fact that the existing robot-assisted navigation system cannot adjust the preoperative planning scheme based on the physiological structure of the patient during the operation, which leads to some adverse problems in the postoperative recovery of the patient, this application provides a system for hip joint replacement surgery Robot-assisted navigation system and surgical system. Wherein, the robot-aided navigation system includes:

A robot-assisted navigation system for hip replacement surgery, characterized by comprising:

The preoperative planning module is used to perform surgical planning and determine the surgical plan after obtaining the three-dimensional bone model according to the collected medical images;

An intraoperative registration module, configured to register the patient's skeleton with the three-dimensional model of the skeleton according to the patient's spatial position determined by the navigation and positioning device;

The intraoperative execution module is configured to perform reconstruction of the hip joint according to the operation plan, and adjust the acetabular anteversion angle according to the joint anteversion angle and the femoral anteversion angle during the reconstruction process, and then update the operation plan.

According to some embodiments of the present application, the performing hip reconstruction includes:

The surgical robot drives the end tool, moves the end tool to the designated position according to the navigation instructions, and performs acetabular reconstruction or femoral and acetabular reconstruction; or

The acetabular reconstruction or the femoral and acetabular reconstruction is performed according to the position information acquired by the navigation and positioning device with the hand-held end tool.

According to some embodiments of the present application, the surgical robot drives an end tool, including:

The end tool is guided to move within a limited range by a guide installed on the end tool.

According to some embodiments of the present application, the guider ensures positioning accuracy through structural design without calibration.

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

The range of motion of the surgical robot is limited by the set three-dimensional safety boundary.

According to some embodiments of the present application, the range of motion of the surgical robot is limited by the set three-dimensional safety boundary, including:

When the end tool is close to the three-dimensional safety boundary, feeding back the 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.

According to some embodiments of the present application, the preoperative planning module is also used for:

According to the length of both lower limbs in the medical image, the surgical planning is performed according to the standard of equal length of both lower limbs, so as to obtain the difference between the postoperative lower limb length and the preoperative lower limb length, and the preoperative contralateral lower limb length.

According to some embodiments of the present application, the intraoperative execution module is also used for:

Evaluate the postoperative range of motion of the joint and the collision situation in the range of motion of the joint according to the three-dimensional model of the skeleton and the operation plan, and adjust the operation plan according to the collision situation.

According to some embodiments of the present application, the measurement of described femoral anteversion comprises:

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

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

The interactive adjustment sub-module is used to adjust the operation plan according to the interactive input information.

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

The postoperative summary module is used to record the information of the operation plan and provide data reference for postoperative recovery.

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

Navigation and positioning device;

The robot-aided navigation system communicates with the navigation and positioning device;

A surgical robot assists in performing a surgical plan under the guidance of the robot-assisted navigation system.

According to some embodiments of the present application, the robot-assisted surgery system further includes:

a guide fixed to the end of the surgical robot.

In the robot-assisted navigation system and surgical system for hip replacement surgery provided by this application, the intraoperative execution module measures the anteversion angle of the femur, and then adjusts the acetabular anteversion angle, adjusts the surgical plan, and further improves the robot-assisted navigation system. applicability to help improve surgical outcomes in robot-assisted hip replacement surgery. The robot-assisted navigation system for hip replacement surgery provided by the present application can be operated by the operator holding the terminal tool, or the surgical robot can drive the terminal tool to operate within the range of the guide, which improves the safety of the execution process. In the process of acetabular reconstruction, the safety of the acetabular reconstruction process can be improved by establishing a safety margin. By providing the function of measuring the length change of the lower limbs before and after the operation, the measured data can be used to adjust the operation plan and reduce the probability of unequal length of the lower limbs after the operation.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings that need to be used in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application. Those skilled in the art can also obtain other drawings based on these drawings without going beyond the protection scope of the present application.

Fig. 1 shows a composition block diagram of a robot-assisted navigation system according to a first exemplary embodiment of the present application;

Fig. 2 shows a block diagram of a preoperative planning module according to an exemplary embodiment of the present application;

Fig. 3 shows a composition block diagram of an intraoperative registration module according to an exemplary embodiment of the present application;

FIG. 4 shows a block diagram of intraoperative execution modules according to an exemplary embodiment of the present application;

Fig. 5 shows a composition block diagram of a robot-assisted navigation system according to a second exemplary embodiment of the present application;

FIG. 6 shows a schematic diagram of a workflow of a robot-assisted navigation system according to an exemplary embodiment of the present application;

Fig. 7 shows a schematic diagram of a robot-assisted surgery system according to an exemplary embodiment of the present application.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without making creative efforts belong to the scope of protection of this application.

The terms "first", "second", etc. in the present application are used to distinguish different objects, not to describe a predetermined order. Furthermore, the terms "include" and "have", as well as any variations thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, system, product or device comprising a series of steps or units is not limited to the listed steps or units, but optionally also includes unlisted steps or units, or optionally further includes For other steps or units inherent in these processes, methods, products or apparatuses.

Reference herein to an "embodiment" means that a predetermined feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present application. The occurrences of this phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. It is understood explicitly and implicitly by those skilled in the art that the embodiments described herein can be combined with other embodiments.

The existing robot-assisted hip replacement surgery navigation system reduces the cumbersomeness of hip replacement surgery and saves surgery time. However, during the operation, the preoperative planning plan based on the patient's image is completely executed by the robot, and the preoperative planning plan is not adjusted based on the patient's anatomical structure during the operation, which leads to some adverse problems in the postoperative recovery of the patient. . Therefore, in order to improve the applicability of the existing navigation system for robot-assisted hip replacement surgery, this application provides a robot-assisted hip joint with more complete functions, simpler operation, and the ability to adjust the surgical plan based on the patient's intraoperative data. Replacement surgery navigation system to improve surgical outcomes in robot-assisted hip replacement surgery.

Fig. 1 shows a block diagram of a robot-assisted navigation system according to a first exemplary embodiment of the present application.

As shown in FIG. 1 , the robot-assisted navigation system 1000 for hip replacement surgery provided by the present 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 perform surgical planning and determine the surgical plan after obtaining the three-dimensional bone model according to the collected medical images. The intraoperative registration module 200 can be used to register the patient's bone with the bone three-dimensional model according to the patient's spatial position determined by the navigation and 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 operation plan, and during the reconstruction process according to the set joint anteversion angle and the measured femoral anteversion angle Adjust the acetabular anteversion, and then update the operation plan.

According to some embodiments of the present application, the preoperative planning module 100 can perform image segmentation and three-dimensional reconstruction according to the collected medical images of the patient (such as CT images or MRI images of the pelvis at the femur and the hip joint), so that the patient's hip joint can be obtained. 3D model of pelvis and 3D model of femur. Based on the three-dimensional model of the pelvis and the three-dimensional model of the femur at the hip joint, preoperative planning can be carried out for the patient according to the specific conditions of the patient, and the surgical plan can be obtained. According to some embodiments of the present application, the preoperative planning module 100 may include a data import submodule 110 , an image processing submodule 120 and an operation planning submodule 130 , as shown in FIG. 2 .

Among them, the data importing sub-module 110 is used for checking the acquired medical image data of the patient, and importing the image data meeting the operation standard into the pre-operative planning module 100 . The image processing sub-module 120 is used to perform image segmentation and three-dimensional reconstruction according to the imported medical image data of the patient, so as to obtain the three-dimensional model of the patient's pelvis and femur. The operation planning sub-module 130 is used to plan an operation plan according to the patient's three-dimensional model of the pelvis and the three-dimensional model of the femur. For example, according to the three-dimensional model of the pelvis, the central axis of the pelvis in the three-dimensional model of the femur, the center of rotation of the acetabulum, the diameter of the acetabulum, the center of rotation of the femoral head, the mechanical axis of the femur, the anatomical axis of the femur, the femoral condylar line or the posterior condylar line, and the joint section The length of the lower extremity and the joint offset of the bone before and after determine the type, size, position and angle of the implanted prosthesis. After the preoperative planning is completed, a data package of available surgical plans can be obtained.

According to some embodiments of the present application, the preoperative planning submodule of the present application performs operation planning according to the length of both lower limbs in the patient's medical image and the standard of equal length of both lower limbs. For example, the length of the bilateral lower limbs can be measured from the preoperative images of the patient, and the surgical planning can be carried out according to the standard of equal length of the bilateral lower limbs after operation, so as to obtain the difference between the length of the affected side's postoperative lower limbs compared with the preoperative and the contralateral side value. By providing the function of measuring the length change of the lower limbs before and after the operation, the measured data can be used to adjust the operation planning and reduce the probability of the patients' lower limbs being unequal in length after operation.

According to some embodiments of the present application, the intraoperative registration module 200 is used to establish a corresponding relationship 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 may include a scheme import submodule 210 , a navigation positioning submodule 220 and an image registration submodule 230 , as shown in FIG. 3 .

Wherein, the plan importing sub-module 210 is used to import the operation plan generated by the preoperative planning module, such as the operation planning package. The navigation and positioning sub-module 230 is configured to determine the spatial position of the patient according to the navigation and positioning device. For example, the navigation and 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 spatial position of the patient's pelvis; the second tracker is used to determine the spatial position of the patient's femur; the third tracker is used to determine the spatial position of the surgical robot; the fourth tracker is used to collect the spatial position of the patient's bony landmarks ; The fifth tracker is used to determine the spatial position of the end effector. Within the effective range of the navigation and positioning device, the relative space of the patient's pelvis, femur, robot, and end-effector can be determined through the first tracker, second tracker, third tracker, fourth tracker, and fifth tracker Positional relationship. The image registration sub-module 230 is used to establish the corresponding relationship between the three-dimensional model of the patient's preoperative medical image and the patient's bone structure through a series of coordinate transformations (such as rotation, offset, scaling, etc.), so that the three-dimensional model is consistent with the patient's bone structure. The corresponding points on the sexual structure are completely consistent in spatial position and anatomical structure.

According to the exemplary embodiment of the present application, the image registration method used in the present application performs translation transformation according to the fitted acetabular rotation center, and then performs rotation transformation according to the reference vector composed of the prominent anterior superior iliac spine and the acetabular rotation center , so as to complete the coordinate transformation process of image registration. The image registration method may include the following steps:

Step 1: Perform 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 in which the articular surface of the acetabulum (ie, the acetabular fossa) has spherical characteristics. Therefore, based on the spherical characteristics of the acetabular articular surface, the acetabular center of rotation and the acetabular radius of rotation can be fitted by randomly selecting a certain number of collection points on the spherical surface. For example, a certain number of points are collected along the acetabular articular surface to form a group of collection points C _i , i=1, 2...m. The coordinates of the collection point C _i can be expressed as C _i =( _Cxi , Cy _i , _Czi ). According to a group of collection points C _i randomly selected on the acetabular articular surface of the hip joint, using the least square method, the acetabular rotation center C ₀ can be fitted by the following formula, and the acetabular rotation radius r can also be fitted .

Fit the first acetabular rotation center C _P0 in the image space and the second acetabular rotation center C _Q0 in the patient space, and then the second acetabular rotation center C _Q0 can be compared with the first acetabular rotation The coordinate difference of the center C _P0 is taken as the translation component T of the translation transformation, which can be expressed as: T={C _Q0 xC _P0 x, C _Q0 yC _P0 y, C _Q0 zC _P0 z}.

Step 2, according to 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 Vector of angles to perform the first rotation transformation on. The anterior superior iliac spine is a distinctive feature point in the hip joint. In the patient space, although the anterior superior iliac spine is not exposed, the muscular tissue surrounding it is relatively thin, and this feature point can be accurately located by touching it as the second anterior superior iliac spine S _Q . Similarly, in the image space, the anterior superior iliac spine also has very obvious features, which can be accurately picked up in the image through judgment (for example, the operator can easily obtain it by clicking the mouse), 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 constitute 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 constitute a second reference vector B _Q , which can be expressed as B _Q =C _Q0 −S _Q .

After the translation transformation in step 1, the second acetabular rotation center C _Q0 of the acetabular articular surface in the patient space coincides with the first acetabular rotation center C _P0 in the image space, which can be defined as C ₀ . The axis of the first reference vector B _P and the second reference vector B _Q is A _B , which can be expressed as:

Furthermore, the positions of the first reference vectors B _P to B _Q need to be rotated around A _B by an angle θ _B , which can be expressed as:

Therefore, the first rotation component _R1 of patient space and image space can be obtained by Rodrigue’s rotation formula, expressed as:

R ₁ ＝B _P +sinθ _B (A _B ×B _P )+(1-cosθ _B )A _B ×(A _B ×B _P )

Step 3: According to the rotation angle around the first reference vector of a set of points selected on both sides of the first reference vector in the image space and the corresponding points in the patient space, perform the second rotation transformation, and then complete the image registration . After the first rotation transformation, the rotation of the second reference vector B _Q in the patient space coincides with the first reference vector B _P in the image space, which can be defined as the first reference vector B. Here, the rotation angle around the first reference vector B of a group of point pairs located on both sides of the first reference vector B selected in the image space and the patient space can be used as the second rotation component. The number of point pairs can be 1 pair or more.

For example, in the image space, two points are respectively taken on the acetabular articular surface on both sides of the first reference vector B, which can be expressed as P _i and P _j . Correspondingly, in the patient space, 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 that passes through the first acetabular rotation center C ₀ and is perpendicular to the first reference vector B, and obtains the projected point pairs P _i '-Q _i ', _Pj' - _Qj '. The point P _i ' is transformed into the rotation angle φ _i of the point Q _i ', and the point P _j ' is transformed into the rotation angle φ _j of the point Q _j '. Theoretically, 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 statistical estimates (eg, average value, maximum value, etc.) according to the obtained multiple rotation angles (eg, φ _i , φ _j ).

Therefore, the second rotation transformation _R2 can be expressed as: under the coordinate system composed of the plane O and the first reference vector B, with the first acetabular rotation center _C0 as the rotation center and the first reference vector B as the rotation axis Rotation transformation. The specific expression is as follows:

After the above-mentioned translation transformation, first rotation transformation and second rotation transformation, the registration from the patient space to the image space can be realized through the transformation matrix M=T×R ₁ ×R ₂ .

The above registration method improves the accuracy of translation transformation through the fitted acetabular rotation center; through the reference vector composed of the prominent anterior superior iliac spine and the acetabular rotation center, the rotation transformation is further improved, thereby improving the accuracy of the rotation transformation. the registration accuracy.

According to some embodiments of the present application, the intraoperative execution module 300 is mainly used to adjust the surgical plan according to the anatomical structure of the patient during the operation, according to the determined surgical plan and the patient's pelvis, femur and bone determined by the navigation and positioning device. The registration relationship between the three-dimensional models generates an execution program, controls the surgical robot and the end-effector tool to run to the patient's surgical area, and completes the surgical operation on the acetabular side and the femoral side. For example, it is used to perform reconstruction of the hip joint according to the operation 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 operation plan. According to some embodiments of the present application, the intraoperative execution module 300 includes an interactive adjustment submodule 310 , an execution control submodule 320 , a femoral reconstruction submodule 330 and an acetabular reconstruction submodule 340 , as shown in FIG. 4 .

Wherein, the interactive adjustment sub-module 310 may be used to adjust the surgical plan according to the interactive input information. For example, through the interactive page, the determined surgical plan is presented for browsing, and the parameters in the surgical plan such as the model, size, placement position, and placement angle of the prosthesis are adjusted by receiving interactive instructions, so that the surgical plan is more in line with the needs of the surgical patient. The true situation.

The execution control sub-module 320 is used to control the execution of hip joint reconstruction, including acetabular reconstruction alone or femur and acetabular reconstruction in sequence. For example, based on the surgical plan output by the preoperative planning module and the relative positional relationship between the patient, the robotic arm of the robot, and the end tool determined by the navigation and positioning sub-module, the robotic arm of the surgical robot is controlled to move to the planned position with a planned posture, And in the process, the spatial position of the robot arm and the patient is obtained in real time through the navigation and positioning sub-module.

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

According to some embodiments of the present application, the surgical robot drives the terminal tool to move, and when the surgical operation is performed in the automatic mode, the guide installed on the terminal tool guides the terminal tool to move within a limited range to improve the safety of the surgical operation . The guide installed at the end of the robotic arm is suitable for femoral neck osteotomy guidance, acetabular directional rasp, directional acetabular cup prosthesis, etc., and can be quickly installed on the end tool, and the positioning accuracy is guaranteed through structural design. The positioning accuracy can be guaranteed without calibration, thereby simplifying the operation process of the operation.

The femoral reconstruction sub-module 330 is used to complete operations such as femoral neck osteotomy, femoral medullary canal shaping, and femoral side prosthesis installation. According to some embodiments of the present application, during femoral reconstruction, when performing femoral canal shaping and prosthesis installation, the intraoperative execution module adjusts the acetabulum in the surgical plan according to the combined anteversion angle and the femoral anteversion angle measured during the operation Anteversion angle, and then update the surgical plan. For example, the femoral anteversion angle can be measured by the navigation and positioning device, and the combined anteversion angle is used as a constraint to adjust the surgical plan according to the measured value of the femoral anteversion angle, so that the surgical plan is more in line with the patient's physiological structure characteristics, and it is more beneficial to the patient after surgery. recovery and reduce postoperative complications. The joint anteversion is equal to the sum of femoral anteversion and acetabular anteversion. Generally, according to surgical experience, the combined anteversion angle is usually set to 40 degrees, or the combined anteversion angle of the operative side is set according to the combined anteversion angle of the opposite side of the patient's operative side.

According to some embodiments of the present application, the femoral reconstruction submodule 330 obtains the position and attitude of the second tracker (femoral tracker) in the femoral handle probe and the navigation positioning submodule and the condyle line or posterior condyle determined on the patient's image. line to determine femoral anteversion. The femoral stem probe can be adapted to different types of femoral stem prosthesis, and can be installed coaxially (the sleeve on the femoral stem probe is coaxial with the axis of the femoral neck) on the femoral neck prosthesis. The axial spatial position of the femoral neck was obtained from femoral stem probe measurements. The spatial position of the patient's femur is obtained by the second tracker (femoral tracker) in the navigation and positioning submodule. According to the known spatial position of the patient's operative side through-condyle line or posterior condyle line, the femoral anteversion angle can be determined from the axis of the femoral neck and the through-condyle line or posterior condyle line.

The acetabular reconstruction sub-module 340 can be used to complete operations such as acetabular reaming and acetabular prosthesis placement. For example, when performing acetabular reaming, the size of the acetabular reamer and the posture of the end tool can be selected according to the surgical plan. According to some embodiments of the present application, in the process of acetabular reconstruction, the range of motion of the robot is limited by the set three-dimensional safety boundary, thereby avoiding the injury caused by the error of the surgical plan to the patient, and further improving 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 location requirements, which is not limited in this application.

For example, under the combined action of the navigation and positioning submodule and the execution control submodule, when the robot and the end tool acetabular reamer move to the planned position, the three-dimensional safety boundary is activated. The navigation and positioning sub-module detects the position and posture of the acetabular reamer in real time, and within the three-dimensional safety boundary, the program can be executed to perform operations such as acetabular reaming; when the acetabular reamer approaches the three-dimensional safety boundary, it will feed back the gradually increasing robot operation to the operator Force, so that the operator can clearly perceive the three-dimensional safety boundary, and carry out safety reminders. When the acetabular reamer exceeds the set three-dimensional safety boundary, the power supply of the acetabular reamer is automatically cut off, thereby ensuring surgical safety.

According to some embodiments of the present application, in performing acetabular reaming, it is allowed to use different sizes of acetabular reamers to adapt to different surgical plans. In addition, the intraoperative execution module 300 displays the difference in three-dimensional space between the current acetabular shape and the planned acetabular shape in the surgical plan in real time, so as to provide guidance for the execution of acetabular reaming.

According to 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 drive the robot into the acetabular cup through the end-connected acetabular cup. The device completes the acetabular prosthesis insertion operation. When the acetabular prosthesis is placed, the intraoperative execution module displays the depth information of the acetabular cup in real time, so as to ensure safety during the operation.

According to other embodiments of the present application, the intraoperative execution module is also used for virtual evaluation of the joint range of motion of the operated side after hip joint replacement and the collision situation within the range of joint motion, such as prosthesis Collisions with bony structures and between prosthesis and prosthesis. Joint activities include hip flexion or extension, internal rotation or external rotation, abduction or adduction, etc. The position and angle of the prosthesis in the surgical plan can be further adjusted based on the assessed collision in the range of motion of the joint.

According to other embodiments of the present application, during acetabular reaming and acetabular cup placement, the navigation and positioning submodule uses the first tracker (pelvis tracker), the third tracker (robot tracker) and the fifth tracker (End Tool Tracker) determines the motion control commands of the robot. When the patient's pelvic position moves, it can be tracked in real time to ensure the correct insertion angle.

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

Fig. 5 shows a block diagram of a robot-assisted navigation system according to a second exemplary embodiment of the present application.

According to another exemplary 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 can be used to record the information of the surgical plan and provide data reference for postoperative recovery. For example, through the postoperative summary module 400, all information related to the operation is summarized, including the basic information of the patient, preoperative images, the surgical plan planned before the operation, the adjusted surgical plan 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, lower extremity length difference and joint offset relative to preoperative and contralateral sides after prosthesis placement. Through the postoperative summary, it can not only provide guidance for the postoperative recovery of patients, but also facilitate the optimization of the surgical plan by the operator, and provide data accumulation for further improvement of the surgical execution plan.

Fig. 6 shows a schematic diagram of a workflow of a robot-assisted navigation system according to an exemplary embodiment of the present application.

The usage process of the total hip replacement operation execution system provided by this application is shown in Figure 6, including the following steps:

Step S600, patient image acquisition. 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.

Step S610, image segmentation and reconstruction. According to the obtained images of the patient's femur and pelvis at the hip joint, image processing algorithms can be used to segment the images of the femur and pelvis and reconstruct a three-dimensional model of the femur and a three-dimensional model of the pelvis.

Step S620, preoperative plan planning. Based on the reconstructed three-dimensional model of the femur and three-dimensional model of the pelvis, surgical planning is performed, and a surgical plan including information such as the type, size, and position of the prosthesis is determined.

Step S630, importing the surgical plan, including importing the patient's surgical plan generated by preoperative planning.

Step S640, image registration. The corresponding relationship between the patient's spatial position and the image space is established, and then the surgical plan planned in the image space is converted into an executable plan in the patient space.

Step S650, femoral reconstruction. Perform operations such as femoral neck osteotomy, femoral medullary canal shaping, prosthesis implantation, etc., and update the surgical plan by adjusting the acetabular anteversion according to the set joint anteversion and the femoral anteversion measured during the operation.

Step S660, acetabular reconstruction. Perform operations such as acetabular reaming and acetabular prosthesis placement, and limit the range of motion of the robot through the set three-dimensional safety boundary, thereby avoiding the injury caused by the error of the surgical plan to the patient, and further improving the safety of the robot-assisted navigation system operation sex.

Step S670, implanting the prosthesis. When the acetabular cup is placed, the navigation and positioning sub-module determines the motion control command of the robot according to the first tracker (pelvis tracker), the third tracker (robot tracker) and the fifth tracker (end tool tracker). When the patient's pelvic position moves, it can be tracked in real time to ensure the correct insertion angle.

Step S680, clinical index measurement. The femoral anteversion angle, acetabular abduction angle, acetabular anteversion angle, lower extremity length difference and joint offset relative to preoperative and contralateral sides were measured.

Step S690, postoperative evaluation summary. Record and summarize information related to the operation, including basic information of the patient, preoperative images, preoperatively planned surgical plan, intraoperatively adjusted surgical plan, type and size of the prosthesis, key clinical technical indicators, etc. Recovery provides data reference,

According to another aspect of the present application, a robot-assisted surgery system 7000 for hip replacement surgery is also provided, as shown in FIG. 7 . The robot-assisted surgery system 7000 includes the above-mentioned robot-assisted navigation system 1000 , a navigation and positioning device 2000 and a robot 3000 . The robot-assisted navigation system 2000 communicates with the navigation and positioning device to obtain the actual spatial position of the patient's surgical site, robot, and surgical end tools; the robot 3000 assists in the execution of the surgical plan under the guidance of the robot-assisted navigation system.

The robot-assisted navigation system 1000 includes a host controller 1100 and a human-computer interaction device 1200 . The navigation and 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 host controller 1100 communicates with the human-computer interaction device 1200, the robot 3000 and the navigation camera 2100 respectively, receives the information transmitted by the human-computer interaction device 1200 and the navigation camera 2100, and sends the information to the human-computer interaction device 1200, the robot 3000 and the navigation camera 2100. related information or instructions.

The upper controller 1100 is also in communication with the scanning probe 2500 , the robot end tracker 2300 , the patient tracker 2200 , the end tool tracker 2400 , etc., for example to control 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 surgery.

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. End tool tracker 2400, including acetabular file tracker 2410 and acetabular cup prosthesis placement tracker (not shown in the figure), are respectively fixed on the connecting rod of acetabular file and the connecting rod of acetabular cup prosthesis driver above, used to determine the spatial position of the acetabular reamer and acetabular cup prosthesis. The scanning probe 2500 includes a probe 2510 for acquiring bony landmarks of the patient and a probe 2520 for measuring the anteversion of the femoral prosthesis.

The navigation camera 2100 receives signals from the robot end tracker 2300, the patient tracker 2200, and the end tool tracker 2400, and determines the relative spatial position relationship of the robot, the end tool, and the patient's pelvis and femur in the same space coordinate system. On the premise that the spatial relationship between the patient’s pelvis, femoral robot, and end tool is determined, the navigation camera 2100 receives the signal from the scanning probe 2510, completes the collection of bony marker points on the patient’s acetabulum and femur, receives the signal from the scanning probe 2520, and completes the Femoral prosthesis anteversion collection work.

According to some other embodiments of the present application, the robot-assisted surgery system 7000 also includes a guide 4000, which is fixed at the end of the robot 3000, so as to implement robot-guided femoral neck osteotomy, acetabular reaming, and acetabular cup prosthesis placement Work.

The basic workflow of the robot-assisted surgery system 7000 for hip replacement surgery provided by this application is:

Computed tomography (CT) or magnetic resonance imaging (MRI) image datasets of the patient's hip and knee joints were completed according to the technical parameters specified in the preoperative imaging scanning protocol. Import the patient’s image data into the host controller 1100, set the region of interest (ROI) at the hip joint and knee joint respectively, use the AI image intelligent segmentation algorithm to realize segmentation and reconstruction of the patient’s pelvis and femur, and obtain a 3D model based on the patient’s pelvis and femur .

In the preoperative planning stage, bony landmarks were selected on the three-dimensional model of the patient's pelvis and femur, and the coordinate systems of the pelvis and femur were respectively established according to the selected bony landmarks. The image is corrected according to the established coordinate system. Select marker points with bony landmarks on the patient's three-dimensional model as the basis for intraoperative registration and verification. Measure and obtain the pelvic central axis, acetabular rotation center, acetabular diameter, femoral head rotation center, femoral mechanical axis, femoral anatomical axis, femoral condylar line and posterior condylar line on the patient's three-dimensional model, and then obtain the lower limb length and joint deviation distance. Determine the model, 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 model of the prosthesis, as well as preliminary osteotomy and rasping plans. The prosthesis data further includes the three-dimensional model data of the joint prosthesis and its spatial definition corresponding to human anatomy.

In the intraoperative execution stage, the operation plan completed in the preoperative planning stage is first imported into the host controller 1100 . Under the unified spatial coordinate system established by the navigation camera 2100, the scanning probe 2510 is used to collect marker points on the patient's acetabular side and the femoral side, and the navigation camera 2100 receives the data of the scanning probe 2510 to obtain the spatial position data of the current marker point. Repeat the collection of marker points until a sufficient number of marker points are collected, and the registration of the patient's image with the patient's pelvis and femur is completed through the image registration algorithm.

After the image registration is completed, the corresponding relationship between the preoperative image space and the intraoperative patient space is established. Based on the position and angle of the femoral neck osteotomy and the position and angle of the acetabular reamer determined by the preoperatively planned surgical plan, the upper controller 1100 controls the robot 3000 to move in place according to the planned position and angle, and the moving position of the robot 3000 is determined by the navigation camera 2100 The data acquisition of the robot end tracker 2200 is collected in real time. After the robot 3000 moves into place, the guide 4000 installed at the end of the robot provides physical guidance for femoral neck osteotomy, acetabular reaming, and acetabular cup prosthesis placement.

After the femoral prosthesis and acetabular prosthesis are placed, use the scanning probe 2520 to measure the femoral neck anteversion angle, use the scanning probe 2510 to measure the acetabular cup anteversion angle and abduction angle, and measure the patient's lower limb on the operation side relative to the operation The data such as the length change of the anterior and relative to the contralateral side are used to obtain clinical indicators such as joint offset distance, joint anteversion angle, and length difference between the lower limbs.

In the robot-assisted navigation system and surgical system for hip replacement surgery provided by this application, the intraoperative execution module measures the anteversion angle of the femur, and then adjusts the acetabular anteversion angle, adjusts the surgical plan, and further improves the robot-assisted navigation system. applicability to help improve surgical outcomes in robot-assisted hip replacement surgery. The robot-assisted navigation system for hip replacement surgery provided by this application can be operated by the operator holding the terminal tool, or the surgical robot can drive the terminal tool to operate within the range of the guide, which improves the safety of the execution process. In addition, the guider ensures positioning accuracy through structural design, and can ensure positioning accuracy without calibration, thereby simplifying the operation process of the operation. In the process of acetabular reconstruction, the safety of the acetabular reconstruction process is improved through the three-dimensional safety boundary. By providing the function of measuring the length change of the lower limbs before and after the operation, the measured data can be used to adjust the operation plan and reduce the probability of unequal lengths of the lower limbs after the operation. The information of the surgical plan is recorded through the postoperative summary module, which provides data reference for postoperative recovery.

The above is a detailed introduction to the embodiments of the present application. In this paper, specific examples are used to illustrate the principles and implementation methods of the present application. The descriptions of the above embodiments are only used to help understand the methods and core ideas of the present application. At the same time, changes or deformations made by those skilled in the art based on the ideas of the application, specific implementation methods and application scopes of the application all belong to the scope of protection of the application. To sum up, the contents of this specification should not be understood as limiting the application.

Claims

A robot-assisted navigation system for hip replacement surgery, characterized in that it includes:

The preoperative planning module is used to perform surgical planning and determine the surgical plan after obtaining the three-dimensional bone model according to the collected medical images;

An intraoperative registration module, configured to register the patient's skeleton with the three-dimensional model of the skeleton according to the patient's spatial position determined by the navigation and positioning device;

The intraoperative execution module is configured to perform reconstruction of the hip joint according to the operation plan, and adjust the acetabular anteversion angle according to the joint anteversion angle and the femoral anteversion angle during the reconstruction process, and then update the operation plan.
The robot-assisted navigation system according to claim 1, wherein said performing reconstruction of the hip joint comprises:

The surgical robot drives the end tool, moves the end tool to a designated position according to the navigation instruction, and performs acetabular reconstruction or femoral and acetabular reconstruction; or

The acetabular reconstruction or the femoral and acetabular reconstruction is performed according to the position information acquired by the navigation and positioning device with the hand-held end tool.
The robot-aided navigation system according to claim 2, wherein the surgical robot drives an end tool, including:

The end tool is guided to move within a limited range by a guide installed on the end tool.
The robot-aided navigation system according to claim 3, wherein the guider ensures positioning accuracy through structural design without calibration.
The robot-aided navigation system according to claim 1, wherein said performing hip joint reconstruction further comprises:

The range of motion of the surgical robot is limited by the set three-dimensional safety boundary.
The robot-assisted navigation system according to claim 5, wherein the range of motion of the surgical robot is limited by the set three-dimensional safety boundary, including:

When the end tool is close to the three-dimensional safety boundary, feeding back the 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.
The robot-assisted navigation system according to claim 1, wherein the preoperative planning module is also used for:

According to the length of both lower limbs in the medical image, the surgical planning is performed according to the standard of equal length of both lower limbs, so as to obtain the difference between the postoperative lower limb length and the preoperative lower limb length, and the preoperative contralateral lower limb length.
The robot-assisted navigation system according to claim 1, wherein the intraoperative execution module is also used for:

Evaluate the postoperative range of motion of the joint and the collision situation within the range of motion of the joint according to the three-dimensional model of the bone and the operation plan, and adjust the operation plan according to the collision situation.
The robot-aided navigation system according to claim 1, wherein the measurement of the femoral anteversion angle comprises:

The femoral anteversion angle is determined by the condylar line or posterior condylar line obtained by the navigation positioning device and the femoral neck axis obtained by the femoral stem probe.
The robot-assisted navigation system according to claim 1, wherein the intraoperative execution module further comprises:

The interactive adjustment sub-module is used to adjust the operation plan according to the interactive input information.
The robot-aided navigation system according to claim 1, further comprising:

The postoperative summary module is used to record the information of the operation plan and provide data reference for postoperative recovery.
A robot-assisted surgical system for hip replacement surgery, characterized in that it includes:

Navigation and positioning device;

The robot-assisted navigation system according to any one of claims 1-11, which communicates with the navigation and positioning device;

A surgical robot assists in performing a surgical plan under the guidance of the robot-assisted navigation system.
The robot-assisted surgery system according to claim 12, characterized in that it comprises:

a guide fixed to the end of the surgical robot.