A handheld orthopedic surgical navigation device, navigation method and system

Abstract

The application discloses a handheld orthopedic surgery navigation device, a navigation method and a system, the navigation device comprises an operating handle and an execution part connected based on a Stewart control platform, the execution part clamps a surgical instrument, and the execution part is fixedly connected with an instrument positioning array; the Stewart control platform comprises a Stewart frame and a controller, a driver and a driving motor connected in sequence, the controller is used for receiving a navigation control instruction in an orthopedic surgery process, and the corresponding driving motor is controlled to drive the telescopic struts of the Stewart frame to move cooperatively, so that the end of the surgical instrument moves in six degrees of freedom directions of front and back, left and back, up and down, pitch, yaw and roll, and is aligned with a surgical site, so that the surgical instrument is driven by the navigation module and the six-axis parallel Stewart platform to actively complete a complex surgical operation action, the precision is high, the error is small, the structure is compact, the operation is flexible, and the operation efficiency and the accuracy of the orthopedic surgery are improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a handheld orthopedic surgical navigation device, navigation method, and system. Background Technology

[0002] In traditional orthopedic surgery, the operation of surgical instruments relies heavily on the surgeon's personal experience and feel. In critical steps such as osteotomy and drilling, it is difficult to standardize and control the precision of the operation. This is especially true in complex anatomical structures or minimally invasive procedures, where human error can easily lead to risks such as nerve and blood vessel damage, uneven osteotomy surfaces, and misplacement of prostheses, affecting surgical outcomes and patient recovery.

[0003] Current optical or electromagnetic navigation systems used in surgical procedures can display the positional relationship between surgical instruments and bones in real time and assist surgeons through visual or auditory signals. However, these systems are essentially "passive" guides, only providing warnings or prompts. The actual manipulation of instruments still depends entirely on the surgeon's manual operation. The system cannot actively correct the instrument trajectory, and the precision of the operation is still limited by the surgeon's own stability.

[0004] Other mainstream orthopedic robotic systems, such as MAKO, ROBODOC, and Think Surgical, utilize multi-axis robotic arms to hold instruments or guides, enabling active motion control and significantly improving operational precision. However, their drawbacks are also significant, including large system size, high cost, cumbersome preoperative planning and intraoperative registration processes, and limitations imposed by the robotic arm structure on operational flexibility and surgeon's feel, restricting their application in confined spaces or surgeries with unusual patient positions. Furthermore, the robotic arm's own configuration also constrains its workspace and operational flexibility. Summary of the Invention

[0005] This invention provides a handheld orthopedic surgical navigation device, navigation method, and system, which solves the technical problems mentioned above.

[0006] A first aspect of the present invention provides a handheld orthopedic surgical navigation device, including an operating handle and an execution unit connected to a Stewart control platform. The execution unit holds a surgical instrument and is fixedly connected to an instrument positioning array, which is used to identify the real-time instrument position of the surgical instrument end during orthopedic surgery. The Stewart control platform includes a Stewart frame and a controller, a driver, and a drive motor connected in sequence. The controller is located inside the operating handle and is used to receive navigation control commands during orthopedic surgery and control the corresponding drive motor to drive the telescopic struts of the Stewart frame to move in coordination, so as to drive the end of the surgical instrument to move in six degrees of freedom: forward and backward, left and back, up and down, pitch, yaw, and roll, and to align with the surgical site.

[0007] A second aspect of the present invention provides an orthopedic surgical navigation method, comprising the following steps: Step 1: Collect the patient's preoperative examination data and generate initial surgical information based on the preoperative examination data; Step 2: Based on the initial surgical information, guide the target object to set up a bone positioning array at the patient's surgical site, and perform registration based on preset bony landmarks, so as to collect the current bone pose of the corresponding points in real time through the bone positioning array; Step 3: Obtain the patient's current surgical status parameters, and optimize the initial surgical information based on the current surgical status parameters to generate target surgical information; Step 4: Guide the navigation device to the target operating area, and obtain the current instrument pose of the surgical instrument end in real time through the preset optical camera and the instrument positioning array; Step 5: Calculate the target adjustment amount of the surgical instrument based on the target surgical information, the current bone pose and the current instrument pose, and generate navigation control commands for the Stewart control platform based on the target adjustment amount; The initial surgical information includes the surgical type, surgical steps, and the surgical site, surgical path, and / or surgical action corresponding to each surgical step.

[0008] A third aspect of the present invention provides an orthopedic surgical navigation system, including a navigation module and the navigation device, wherein the navigation module includes: The first data acquisition unit is used to collect the patient's preoperative examination data and generate initial surgical information based on the preoperative examination data. The registration unit is used to guide the target object to set up a bone positioning array at the surgical site of the patient based on the initial surgical information, and to perform registration based on preset bony landmarks, so as to collect the current bone pose of the corresponding point in real time through the bone positioning array. The second data acquisition unit is used to acquire the patient's current surgical status parameters and optimize the initial surgical information based on the current surgical status parameters to generate target surgical information; The instrument pose acquisition unit is used to guide the navigation device to the target operation area and to acquire the current instrument pose of the surgical instrument end in real time through a preset optical camera and the instrument positioning array. The navigation unit is used to calculate the target adjustment amount of the surgical instruments based on the target surgical information, the current bone pose and the current instrument pose, and to generate navigation control commands for the Stewart control platform based on the target adjustment amount.

[0009] The beneficial effects of this invention are as follows: This invention provides a handheld orthopedic surgical navigation device, navigation method and system. During the operation, the surgeon only needs to hold the orthopedic surgical navigation device and move it forward. At the same time, the navigation module and the six-axis parallel Stewart platform drive the surgical instruments to actively complete complex surgical operations. It is not only highly accurate and has small errors, but also has a compact structure and flexible operation, which improves the efficiency and accuracy of orthopedic surgery.

[0010] To make the above-mentioned objects, features and advantages of the invention more apparent and understandable, preferred embodiments of the invention are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0011] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0012] Figure 1 This is a schematic diagram of the handheld orthopedic surgical navigation device provided in Example 1; Figure 2 This is a flowchart illustrating the orthopedic surgical navigation method provided in Example 2; Figure 3 This is a schematic diagram of the orthopedic surgical navigation system provided in Example 3. Detailed Implementation

[0013] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without inventive effort are within the scope of protection of this invention.

[0014] It should be noted that, unless otherwise specified, the various features in the embodiments of this invention can be combined with each other, all of which are within the protection scope of this invention. Furthermore, although functional modules are divided in the device schematic diagram and a logical order is shown in the flowchart, in some cases, the steps shown or described can be executed in a different order than the module division in the device or the order in the flowchart. Moreover, the terms "first," "second," and "third" used in this invention do not limit the data or execution order, but only distinguish identical or similar items with essentially the same function and effect.

[0015] Figure 1 This is a schematic diagram of the handheld orthopedic surgical navigation device provided in Embodiment 1, as shown below. Figure 1 As shown, it includes an operating handle 1 and an actuator 2 connected to the Stewart control platform. The actuator 2 holds a surgical instrument 3 and is fixedly connected to an instrument positioning array 4. The instrument positioning array 4 is used to identify the real-time instrument position of the surgical instrument tip during orthopedic surgery. The Stewart control platform includes a Stewart frame 5 and a controller 6, a driver, and a drive motor connected in sequence. The controller 6 is located inside the operating handle and is used to receive navigation control commands during orthopedic surgery and control the corresponding drive motor to drive the telescopic struts of the Stewart frame to move in coordination, so as to drive the end of the surgical instrument 3 to move in six degrees of freedom: front-back, left-back, up-down, pitch, yaw, and roll, and to align with the surgical site.

[0016] Unlike other orthopedic robot designs, the above technical solution uses a six-axis parallel Stewart platform control actuator, which has the following advantages: (1) High rigidity and strong load-bearing capacity. Each drive rod mainly bears axial tension / compression, resulting in good structural stress distribution, enabling high load and resistance to deformation. (2) High precision and no cumulative error. The parallel structure averages the error of each rod, unlike the problem of progressively amplified error in a series mechanism. (3) Fast dynamic response. The moving parts are lightweight and have low inertia, enabling high-speed and high-acceleration motion. (4) High load-to-weight ratio and compact structure. Under the same weight, it can bear a much greater weight than a series mechanism, facilitating tool miniaturization and weight reduction. Therefore, compared with existing technologies, it enables the actuator and the operating handle to move in six degrees of freedom: forward and backward, left and right, up and down, pitch, yaw and roll. Specifically, the operating direction of the actuator is first confirmed and input, including plane, line and point positioning, etc., and then the surgeon is precisely guided to perform osteotomy, pin placement, marking and other operations. When the target bone tissue moves or the doctor's hand shakes, it is recognized in real time and corrected in real time with optical navigation to ensure accurate operation position.

[0017] As those skilled in the art will know, the Stewart frame consists of upper and lower platforms connected to six telescopic struts via ball joints or Hooke joints, possessing technical advantages such as high rigidity, strong load-bearing capacity, and fast dynamic response. In specific implementation, the upper platform connects to the actuator, and the lower platform connects to the operating handle. Specific navigation control commands include: The first navigation control command is used to control the coordinated extension and retraction of the six telescopic struts, driving the upper platform to adjust its pitch attitude relative to the lower platform, so as to adjust the spatial tilt angle of the actuator end relative to the bone surface, so that the actuator end remains perpendicular to the target osteotomy surface or maintains a preset angle. The second navigation control command is used to control the coordinated extension and retraction of the six telescopic struts, driving the upper platform to adjust its rolling posture relative to the lower platform in order to compensate for local changes in the curvature of the bone surface and maintain the alignment of the end of the actuator with the normal direction of the target osteotomy surface. The third navigation control command is used to control the coordinated extension and retraction of the six telescopic struts, driving the upper platform to generate a feed displacement relative to the lower platform along the target osteotomy direction, so as to control the cutting depth at the end of the actuator and realize a progressive osteotomy from the superficial to the deep. The fourth navigation control command is used to control the coordinated extension and retraction of the six telescopic support rods, driving the upper platform to move relative to the lower platform along the first translation direction, so as to guide the end of the actuator to make lateral position adjustments along the preset osteotomy trajectory; The fifth navigation control command is used to control the coordinated extension and retraction of the six telescopic support rods, driving the upper platform to move relative to the lower platform along the second translation direction, so as to guide the end of the actuator to adjust its longitudinal position along the preset osteotomy trajectory; The sixth navigation control command is used to control the coordinated extension and retraction of the six telescopic support rods, driving the upper platform to rotate relative to the lower platform around a preset axis, so as to adjust the azimuth angle of the end of the actuator and / or achieve a composite adjustment of position and attitude in conjunction with the aforementioned navigation control command.

[0018] In a preferred embodiment, such as Figure 1 As shown, the operating handle has a built-in posture sensor 7, which is used to acquire posture change data of the operating handle during orthopedic surgery to identify the hand tremor or inertial motion state of the target object. The posture sensor includes a linear accelerometer, a rotary encoder, and / or a gyroscope. Specifically, when the surgeon holds this orthopedic surgical navigation device during surgery, such as during osteotomy, the surgeon's hand may shake or tremble, or there may be inertial deviation when the surgeon's hand moves forward. At this time, the posture sensor can detect the position and posture changes of the operating handle in real time, thereby identifying these states and compensating for the posture adjustment of the surgical instrument end effector during subsequent navigation to counteract hand movements and further improve the accuracy of operation.

[0019] In a preferred embodiment, the operating handle is equipped with a display screen and a control panel on its outer side. The control panel is used to generate operating instructions in response to the interactive actions of the target object. These operating instructions include instructions for modifying surgical parameters, changing surgical instruments, adjusting the end-effector posture, optimizing surgical steps, and / or optimizing surgical paths, etc. Specifically, during the surgical planning and execution phases, the target object, i.e., the surgeon, can interact with the control panel, for example, by using touch selection, foot pedals, or voice commands to directly modify current surgical information, including surgical parameters, surgical steps, and surgical paths, such as osteotomy depth, osteotomy angle, and prosthesis placement. This allows for direct modification of the surgical process without interrupting the surgery, exiting navigation, or re-registering, further improving surgical efficiency.

[0020] The display screen is used to display surgical scene information in real time. The surgical scene information includes the planned / current pose of the surgical site, the planned / current pose of the surgical instruments, and surgical information, which are modeled in 3D. This allows the surgeon to view the surgical status in real time and intuitively, identify problems in a timely manner, and adjust surgical parameters.

[0021] The above embodiments provide a handheld orthopedic surgical navigation device. During the operation, the surgeon only needs to hold the orthopedic surgical navigation device and move it forward. At the same time, the navigation module and the six-axis parallel Stewart platform drive the surgical instruments to actively complete complex surgical operations. It is not only highly accurate and has small errors, but also has a compact structure and flexible operation, which improves the efficiency and accuracy of orthopedic surgery.

[0022] Figure 2 This is a flowchart illustrating an orthopedic surgical navigation method provided in Example 2. Figure 2 As shown, it includes the following steps: Step 1: Collect the patient's preoperative examination data and generate initial surgical information based on the preoperative examination data. The preoperative examination data includes the patient's CT, MRI, X-ray, etc. Based on the CT, a bone tissue model of the patient can be reconstructed and displayed on the screen in real time. The initial surgical information includes the surgical type, surgical steps, and the surgical site, surgical path, and / or surgical actions corresponding to each surgical step, etc. During the operation, this surgical information can also be displayed in conjunction with the patient's 3D bone tissue model on the screen.

[0023] Step 2: Based on the initial surgical information, guide the target object to set up a bone positioning array at the patient's surgical site, such as the femur, tibia, pelvis, spinous process, etc., and perform registration based on preset bony landmarks to acquire the current bone pose of the corresponding bone structure in real time through the bone positioning array. For example, a bone positioning array can be installed on the tibia, and several points on the tibia surface can be marked by probes and fitted and registered with preoperative CT images. This allows the calculation of the spatial coordinate relationship between the installed bone positioning array and the tibia during surgery. In this way, no matter how the tibia moves in space, its spatial pose can be calculated by tracking the bone positioning array installed on the tibia. Specific pose calculation methods can use triangulation, etc., to achieve sub-millimeter-level real-time tracking of pose changes at the surgical site. Triangulation is already maturely applied in related fields, and its specific calculation process will not be elaborated here.

[0024] Step 3: Obtain the patient's current surgical status parameters, such as soft tissue tension and bone gaps, and optimize the initial surgical information based on the current surgical status parameters. The specific optimization process can be actively optimized by the surgeon through the control panel, or automatically optimized by the system. For example, it can simulate each surgical action performed by the surgical instruments in each surgical step, identify control parameters that exceed the safety control range in each surgical action, and adjust the surgical parameters, actions, paths and / or steps to generate target surgical information.

[0025] Step 4: Place the surgical instrument in the field of view of the preset optical camera, automatically identify the instrument positioning array and calibrate its geometric relationship with the end of the surgical instrument, register the instrument, and then guide the surgeon to place the navigation device in the target operating area. The current instrument pose of the end of the surgical instrument is obtained in real time through the preset optical camera and the instrument positioning array. The specific pose calculation method is not described in detail.

[0026] Step 5: Calculate the target adjustment amount of the surgical instruments based on the target surgical information, current bone pose, and current instrument pose, and generate navigation control commands for the Stewart control platform based on the target adjustment amount. Specifically, the target instrument pose and target bone pose for each surgical action can be obtained based on the target surgical information. The target adjustment amount of the surgical instruments can then be calculated based on the current bone pose and current instrument pose. During the calculation process, the target adjustment amount is compensated and corrected based on real-time hand tremor data collected by the handle pose sensor, thereby obtaining accurate navigation control commands. This ensures that operations such as osteotomy, screw placement, and grinding are performed within the planned surface, line, and point range, and controls the operation depth to avoid tissue damage.

[0027] Furthermore, during the surgery, the surgeon can make parameter adjustments through the control panel, recalculate the surgical path and control parameters based on the new parameters, and generate and send new navigation control commands to the execution unit to drive the surgical execution unit to adjust to the new operating position.

[0028] The above embodiments provide a method for orthopedic surgical navigation. During the operation, the surgeon only needs to hold the orthopedic surgical navigation device and move it forward. At the same time, the navigation module and the six-axis parallel Stewart platform drive the surgical instruments to actively complete complex surgical operations. It is not only highly accurate and has small errors, but also has a compact structure and flexible operation, which improves the efficiency and accuracy of orthopedic surgery.

[0029] The above method will be explained in detail below through two specific implementation processes.

[0030] One embodiment is a total knee replacement surgery, which includes the following steps: 1. Preoperative planning is conducted based on the patient's CT, MRI, X-ray, etc., including the size and location of the prosthesis, the amount of bone to be removed, etc. 2. Intraoperative registration: After the knee joint is opened and fully exposed, bone positioning arrays are installed on the femoral and tibial sides respectively, and probes are used for registration to register the spatial coordinates of the femur and tibia. 3. Device registration: Place the handheld navigation device within the field of view of the binocular depth vision navigation system to automatically identify and calibrate the spatial pose of the actuator; 4. Data import: Measure the maximum spread gap and soft tissue tension to further plan the osteotomy volume of the femur and tibia; 5. Activation and Positioning: The surgeon positions the handheld navigation device within the distal femur or tibial plateau osteotomy area and presses the operation button to trigger the guidance and correction functions. (Depending on the status of the execution unit:) (1) If the execution unit is a pin placement system, then the positioning navigation is performed to guide the two positioning pins to be placed, and then the osteotomy guide plate is installed and the osteotomy is performed using a conventional oscillating saw; (2) If the execution unit is a oscillating saw, then it performs fixed-plane and depth-limited navigation, corrects hand tremors in real time, and ensures the osteotomy plane and depth.

[0031] Specifically, the surgeon places the handheld navigation device in the operating area where the femoral four-in-one osteotomy guide plate is installed, presses the operation button to trigger the guidance and correction functions, the execution unit guides the implantation of two positioning screws, then installs the four-in-one osteotomy guide plate, and uses a traditional oscillating saw to perform osteotomy.

[0032] During the above operations, the positions of the bones and instruments are acquired in real time, the required adjustment amount is calculated, and then predictive compensation is performed to counteract hand movements. Navigation control commands for the Stewart platform are generated, and the six motors of the Stewart platform are controlled to perform correction in six degrees of freedom, ensuring that the osteotomy operation is within the planned area of ​​planes, lines, and points, and controlling the operation depth in the anterior-posterior direction to avoid tissue damage.

[0033] 6. Real-time adjustment: During the operation, the surgeon can propose adjustments to the osteotomy plan through the control panel, recalculate the target path and control parameters based on the new parameters, and send new target instructions to the execution unit to update the latest position of the surgical instruments.

[0034] Another embodiment is spinal pedicle screw implantation, which specifically includes the following steps: 1. Preoperative planning is carried out based on the patient's CT, MRI, X-ray, etc., including the implantation direction and depth of the pedicle screws; 2. Intraoperative registration: After fully exposing the spinous process, lamina, and articular processes, a skeletal positioning array is installed on the spinous process of the target vertebra, and a probe is used for registration to register the spatial coordinates of the target vertebra. 3. Device registration: Place the handheld navigation device within the field of view of the binocular depth vision navigation system to automatically identify and calibrate the spatial pose of the actuator; 4. Data import: Further optimize the direction and depth of pedicle screw implantation; 5. Initiation and Positioning: The surgeon places the handheld navigation device within the pin placement area, presses the operation button to trigger the guidance and correction functions, and performs alignment navigation to guide the placement of the pin. The navigation system acquires the bone and instrument pose in real time, calculates the required relative adjustment, and then performs predictive compensation to counteract hand movements. It generates motor control commands to control the six motors of the Stewart platform to perform correction in six degrees of freedom, ensuring the operation stays within the planned path and controlling the depth of operation to avoid tissue damage.

[0035] 6. Real-time adjustment: During the operation, the doctor can propose adjustments to the screw placement plan or change the screw placement target through the control panel. Based on the new parameters, the target path and control parameters are recalculated, and instructions containing the new target are sent to the execution unit to update the latest position of the surgical instruments.

[0036] For example, in a preferred embodiment, an automatic correction step is further included, comprising: S601, during orthopedic surgery, uses a pose sensor to collect continuous pose change data of the operating handle; S602, obtain jitter recognition conditions, determine whether the continuous pose change data meets the jitter recognition conditions, and generate the current jitter state based on the judgment result; S603, if the operating handle is in a jittering state, then the preset jitter compensation scheme is invoked to optimize the target adjustment amount, and a first navigation adjustment command is generated based on the optimization result; If the operating handle is not in a shaking state, the historical inertial offset data corresponding to the target object under the current surgical type is obtained, and the target adjustment amount is optimized based on the historical inertial offset data. A second navigation adjustment command is generated according to the optimization result. In the above preferred embodiment, the historical inertial offset data is used to correct hand tremors and swaying during the operation and the different operating habits of each surgeon in advance, thereby further improving the operational accuracy of orthopedic surgery.

[0037] In a further preferred embodiment, a fault warning step is also included, comprising: S701, generate the desired pose of the upper platform relative to the lower platform according to the target adjustment amount corresponding to each surgical action, and calculate the target adjustment angle and / or target adjustment length of the telescopic support rod based on the desired pose; S702, Obtain the initial working range of the Stewart control platform, and optimize the initial working range according to the current surgical type to generate a target working range; S703, determine whether the target adjustment angle and / or target adjustment length are within the target working range, and generate a corresponding warning result based on the current surgical stage.

[0038] For example, if it is the surgical planning stage, and the target adjustment angle and / or target adjustment length corresponding to any surgical action exceeds the target working range, then the surgical path is replanned and the target surgical information is updated; If it is during the surgical stage, and the target adjustment angle and / or target adjustment length corresponding to the current surgical action exceeds the target working range, then according to the degree of exceeding the limit, options such as reducing speed, stopping the movement for manual adjustment, or stopping the movement to replan the surgical path are selected to further ensure the safety of the surgical process.

[0039] In a preferred embodiment, in order to better identify the risk of exceeding limits during the surgical planning stage, a Stewart simulation model corresponding to each surgical action can be constructed to characterize the overall telescopic length and angle of the six telescopic struts. By comparing the current configuration with the preset reference configuration, abnormal configurations of the Stewart simulation model can be identified, thereby providing a fault warning when abnormal configurations occur, further identifying surgical risks from an overall perspective, and improving surgical safety.

[0040] It should be understood that the sequence number of each step in the above embodiments does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present invention.

[0041] Figure 3 This is a schematic diagram of the orthopedic surgical navigation system provided in Example 3, as shown below. Figure 3 As shown, the system includes a navigation module 100 and the navigation device 200 described in the above embodiments. The navigation module 100 includes: The first data acquisition unit 101 is used to collect the patient's preoperative examination data and generate initial surgical information based on the preoperative examination data. The registration unit 102 is used to guide the target object to set up a bone positioning array at the surgical site of the patient according to the initial surgical information, and to perform registration based on preset bony landmarks, so as to collect the current bone pose of the corresponding point in real time through the bone positioning array. The second data acquisition unit 103 is used to acquire the patient's current surgical status parameters and optimize the initial surgical information based on the current surgical status parameters to generate target surgical information; The instrument pose acquisition unit 104 is used to guide the navigation device to the target operation area and to acquire the current instrument pose of the surgical instrument end in real time through a preset optical camera and the instrument positioning array. The navigation unit 105 is used to calculate the target adjustment amount of the surgical instrument based on the target surgical information, the current bone pose and the current instrument pose, and to generate navigation control instructions for the Stewart control platform based on the target adjustment amount.

[0042] The above embodiments provide an orthopedic surgical navigation system. During the operation, the surgeon only needs to hold the orthopedic surgical navigation device and move it forward. At the same time, the navigation module and the six-axis parallel Stewart platform drive the surgical instruments to actively complete complex surgical operations. It is not only highly accurate and has small errors, but also has a compact structure and flexible operation, which improves the efficiency and accuracy of orthopedic surgery.

[0043] like Figure 1 As shown, the handheld orthopedic surgical navigation device 200 also has a built-in wireless communication module 8, which enables communication with the navigation module 100, such as sending user control commands generated by the control panel or receiving navigation control commands generated by the navigation module 100.

[0044] like Figure 1 As shown, the handheld orthopedic surgical navigation device 200 also includes a power module 9 for supplying power to various control modules or sensors.

[0045] In a preferred embodiment, the navigation module 100 further includes an automatic correction unit 106, which specifically includes: The third data acquisition unit 1061 is used to acquire continuous pose change data of the operating handle through a pose sensor during orthopedic surgery. The jitter recognition unit 1062 is used to acquire jitter recognition conditions, determine whether the continuous pose change data meets the jitter recognition conditions, and generate the current jitter state based on the judgment result; The correction unit 1063 is used to optimize the target adjustment amount by calling a preset jitter compensation scheme when the operating handle is in a jitter state, and generate a first navigation adjustment command based on the optimization result; and to obtain the historical inertial offset data corresponding to the target object under the current surgical type when the operating handle is not in a jitter state, optimize the target adjustment amount based on the historical inertial offset data, and generate a second navigation adjustment command based on the optimization result.

[0046] In a preferred embodiment, the navigation module 100 further includes a fault warning unit 107, which specifically includes: The calculation unit 1071 is used to generate the desired pose of the upper platform relative to the lower platform according to the target adjustment amount corresponding to each surgical action, and to calculate the target adjustment angle and / or target adjustment length of the telescopic support rod based on the desired pose. Boundary acquisition unit 1072 is used to acquire the initial working range of the Stewart control platform and optimize the initial working range to generate a target working range according to the current surgical type; The early warning unit 1073 is used to determine whether the target adjustment angle and / or target adjustment length are within the target working range, and to generate a corresponding early warning result based on the current surgical stage.

[0047] It should be noted that the foregoing explanation of the embodiments of the orthopedic surgical navigation method also applies to the orthopedic surgical navigation system of the above embodiments, and will not be repeated here.

[0048] Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the above-described division of functional units and modules is merely an example. In practical applications, the above functions can be assigned to different functional units and modules as needed, that is, the internal structure of the device can be divided into different functional units or modules to complete all or part of the functions described above. The functional units and modules in the embodiments can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or as a software functional unit. Furthermore, the specific names of the functional units and modules are only for easy differentiation and are not intended to limit the scope of protection of this application. The specific working process of the units and modules in the above system can be referred to the corresponding process in the foregoing method embodiments, and will not be repeated here.

[0049] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0050] Those skilled in the art will recognize that the units and method steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementations should not be considered beyond the scope of this invention.

[0051] In the embodiments provided by this invention, it should be understood that the disclosed apparatus / terminal devices and methods can be implemented in other ways. For example, the apparatus / terminal device embodiments described above are merely illustrative. For instance, the division of modules or units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between devices or units may be electrical, mechanical, or other forms.

[0052] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0053] Furthermore, the functional units in the various embodiments of the present invention can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or as a software functional unit.

[0054] The present invention is not limited to the description in the specification and embodiments, and thus other advantages and modifications can be readily realized by those skilled in the art. Therefore, the present invention is not limited to the specific details, representative devices and illustrated examples shown and described herein without departing from the spirit and scope of the general concept as defined by the claims and their equivalents.

Claims

1. A handheld orthopedic surgical navigation device, characterized in that, It includes an operating handle and an actuator connected to the Stewart control platform. The actuator holds a surgical instrument and is fixedly connected to an instrument positioning array, which is used to identify the real-time instrument position of the surgical instrument tip during orthopedic surgery. The Stewart control platform includes a Stewart frame and a controller, a driver, and a drive motor connected in sequence. The controller is located inside the operating handle and is used to receive navigation control commands during orthopedic surgery and control the corresponding drive motor to drive the telescopic struts of the Stewart frame to move in coordination, so as to drive the end of the surgical instrument to move in six degrees of freedom: forward and backward, left and back, up and down, pitch, yaw, and roll, and to align with the surgical site.

2. The handheld orthopedic surgical navigation device according to claim 1, characterized in that, The Stewart frame includes six telescopic struts positioned between the upper and lower platforms. The upper platform connects to the actuator, and the lower platform connects to the operating handle. The navigation control commands include: The first navigation control command is used to control the coordinated extension and retraction of the six telescopic struts, driving the upper platform to adjust its pitch attitude relative to the lower platform, so as to adjust the spatial tilt angle of the actuator end relative to the bone surface, so that the actuator end remains perpendicular to the target osteotomy surface or maintains a preset angle. The second navigation control command is used to control the coordinated extension and retraction of the six telescopic struts, driving the upper platform to adjust its rolling posture relative to the lower platform in order to compensate for local changes in the curvature of the bone surface and maintain the alignment of the end of the actuator with the normal direction of the target osteotomy surface. The third navigation control command is used to control the coordinated extension and retraction of the six telescopic struts, driving the upper platform to generate a feed displacement relative to the lower platform along the target osteotomy direction, so as to control the cutting depth at the end of the actuator and realize a progressive osteotomy from the superficial to the deep. The fourth navigation control command is used to control the coordinated extension and retraction of the six telescopic support rods, driving the upper platform to move relative to the lower platform along the first translation direction, so as to guide the end of the actuator to make lateral position adjustments along the preset osteotomy trajectory; The fifth navigation control command is used to control the coordinated extension and retraction of the six telescopic support rods, driving the upper platform to move relative to the lower platform along the second translation direction, so as to guide the end of the actuator to adjust its longitudinal position along the preset osteotomy trajectory; The sixth navigation control command is used to control the coordinated extension and retraction of the six telescopic support rods, driving the upper platform to rotate relative to the lower platform around a preset axis, so as to adjust the azimuth angle of the end of the actuator and / or achieve a composite adjustment of position and attitude in conjunction with the aforementioned navigation control command.

3. The handheld orthopedic surgical navigation device according to claim 1 or 2, characterized in that, The operating handle has a built-in posture sensor, which is used to acquire posture change data of the operating handle during orthopedic surgery to identify the hand tremor or inertial motion state of the target object.

4. The handheld orthopedic surgical navigation device according to claim 3, characterized in that, The pose sensor includes a linear accelerometer, a rotary encoder, and / or a gyroscope.

5. The handheld orthopedic surgical navigation device according to claim 3, characterized in that, The operating handle is equipped with a display screen and a control panel on its outer side. The control panel is used to generate operation instructions in response to interactive actions of the target object. The operation instructions include surgical parameter modification instructions, surgical instrument replacement instructions, instrument end-effector posture adjustment instructions, surgical procedure optimization instructions, and / or surgical path optimization instructions. The display screen is used to display surgical scene information in real time. The surgical scene information includes the planned / current pose of the surgical site, the planned / current pose of the surgical instruments, and surgical information, all based on 3D modeling.

6. A method for orthopedic surgical navigation, based on the navigation device according to any one of claims 1-5, characterized in that, Includes the following steps: Step 1: Collect the patient's preoperative examination data and generate initial surgical information based on the preoperative examination data; Step 2: Based on the initial surgical information, guide the target object to set up a bone positioning array at the patient's surgical site, and perform registration based on preset bony landmarks, so as to collect the current bone pose of the corresponding points in real time through the bone positioning array; Step 3: Obtain the patient's current surgical status parameters, and optimize the initial surgical information based on the current surgical status parameters to generate target surgical information; Step 4: Guide the navigation device to the target operating area, and obtain the current instrument pose of the surgical instrument end in real time through the preset optical camera and the instrument positioning array; Step 5: Calculate the target adjustment amount of the surgical instrument based on the target surgical information, the current bone pose and the current instrument pose, and generate navigation control commands for the Stewart control platform based on the target adjustment amount; The initial surgical information includes the surgical type, surgical steps, and the surgical site, surgical path, and / or surgical action corresponding to each surgical step.

7. The orthopedic surgical navigation method according to claim 6, characterized in that, It also includes automatic correction steps, including: During orthopedic surgery, a pose sensor is used to collect continuous pose change data of the operating handle; Obtain jitter recognition conditions, determine whether the continuous pose change data meets the jitter recognition conditions, and generate the current jitter state based on the judgment result; If the control handle is in a jittering state, a preset jitter compensation scheme is invoked to optimize the target adjustment amount, and a first navigation adjustment command is generated based on the optimization result; If the operating handle is in a non-shaking state, the historical inertial offset data corresponding to the target object under the current surgical type is obtained, and the target adjustment amount is optimized based on the historical inertial offset data, and a second navigation adjustment command is generated according to the optimization result.

8. The orthopedic surgical navigation method according to claim 6, characterized in that, It also includes fault warning steps, including: The desired pose of the upper platform relative to the lower platform is generated based on the target adjustment amount corresponding to each surgical action, and the target adjustment angle and / or target adjustment length of the telescopic strut are calculated based on the desired pose. Obtain the initial working range of the Stewart control platform, and optimize the initial working range according to the current surgical type to generate a target working range; Determine whether the target adjustment angle and / or target adjustment length are within the target working range, and generate a corresponding warning result based on the current surgical stage.

9. The orthopedic surgical navigation method according to claim 8, characterized in that, If it is the surgical planning stage, and the target adjustment angle and / or target adjustment length corresponding to any surgical action exceeds the target working range, then the surgical path is replanned and the target surgical information is updated. If it is during the surgical stage, and the target adjustment angle and / or target adjustment length corresponding to the current surgical action exceeds the target working range, then the following options are selected based on the degree of exceeding the limit: reduce speed, stop movement for manual adjustment, or stop movement and replan the surgical path.

10. An orthopedic surgical navigation system, characterized in that, Includes a navigation module and the navigation device according to any one of claims 1-5, wherein the navigation module comprises: The first data acquisition unit is used to collect the patient's preoperative examination data and generate initial surgical information based on the preoperative examination data. The registration unit is used to guide the target object to set up a bone positioning array at the surgical site of the patient based on the initial surgical information, and to perform registration based on preset bony landmarks, so as to collect the current bone pose of the corresponding point in real time through the bone positioning array. The second data acquisition unit is used to acquire the patient's current surgical status parameters and optimize the initial surgical information based on the current surgical status parameters to generate target surgical information; The instrument pose acquisition unit is used to guide the navigation device to the target operation area and to acquire the current instrument pose of the surgical instrument end in real time through a preset optical camera and the instrument positioning array. The navigation unit is used to calculate the target adjustment amount of the surgical instrument based on the target surgical information, the current bone pose and the current instrument pose, and to generate navigation control instructions for the Stewart control platform based on the target adjustment amount. The initial surgical information includes the surgical type, surgical steps, and the surgical site, surgical path, and / or surgical action corresponding to each surgical step.

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