Precise double-needle positioning method and system for total ankle joint operation based on optical guidance

Abstract

The embodiment of the invention provides a total ankle joint surgery precise double-needle positioning method and system based on optical guidance, and belongs to the technical field of medical instruments.The method comprises the steps that after ankle joint surgery space registration is completed, a surgery planning system determines double-needle implantation parameters and the position of a needle guiding device based on the ankle joint surgery space registration; dragging the mechanical arm to be near the position, capturing information of the needle guide device by the optical tracker, calculating the accurate position of the needle guide device by the system according to the information and instructing the mechanical arm to adjust; after the needle guide device is in place, double needles are implanted along the Y axis, and then the osteotomy plate is positioned and mounted based on the double needles to complete osteotomy. According to the method, optical guidance and mechanical arm accuracy are fused, and the operation accuracy is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a precise double-needle positioning method and system for total ankle joint surgery under optical guidance. Background Art

[0002] In traditional surgery, high-precision positioning relies on X-ray imaging. A single operation can last up to 4-5 hours and requires multiple positionings. The cumulative shooting frequency is as high as 40-100 times. The single radiation dose is 0.2-0.5mSv, and the cumulative amount far exceeds the effective dose limit of 1mSv per year, posing a great threat to health.

[0003] While 3D-printed personalized guide technology offers a new path for precision surgery, it faces significant bottlenecks. Preoperative guide preparation can take as long as 48-72 hours, and data errors or design modifications can extend this time to 5-7 days, severely hindering surgical progress. Furthermore, the surgical plan must be determined preoperatively, leaving minimal room for intraoperative adjustments. This makes it difficult to address individual patient anatomical variations and the resulting changes in mechanical balance caused by dynamic intraoperative changes such as soft tissue traction and bone displacement.

[0004] Optical guidance technology holds great potential in surgical navigation due to its real-time guidance, lack of radiation, and support for intraoperative adjustments. However, traditional optical positioning solutions are difficult to apply to ankle surgery. Ankle surgery requires a confined operating space, and installing trackers on osteotomy plates or surgical tools presents spatial limitations. Additional light spheres can interfere with the procedure. Furthermore, the use of robotically controlled instruments significantly increases the risk of collision within confined spaces. These challenges require urgent solutions. Summary of the Invention

[0005] In view of this, an embodiment of the present invention provides a method and system for precise double-needle positioning in total ankle surgery under optical guidance, which at least partially solves the problems existing in the prior art.

[0006] In a first aspect, an embodiment of the present invention provides a method for precise double-needle positioning in total ankle surgery under optical guidance, comprising the following steps:

[0007] After completing the spatial registration for ankle surgery, the surgical planning system automatically determines the double-needle implantation parameter information based on the spatial registration results, completing the surgical planning and determining the precise position of the needle guide;

[0008] During the initial positioning, the robotic arm is dragged to the vicinity of the double needle implantation position determined based on the above double needle implantation parameter information. During the position tracking phase, the optical tracker captures the position and posture information of the optical tracking ball on the needle guide in real time.

[0009] The surgical navigation system automatically calculates the precise position of the needle guide based on the position and posture information of the tracking ball, combined with the relative positional relationship between the robotic arm, the needle guide, and the osteotomy site. This precise position of the needle guide is then commanded to the robotic arm through the control system. The robotic arm then makes slight movements and rotations at the end of the robotic arm based on the deviation.

[0010] After the needle guide reaches the specified precise position, the double needles are implanted along the Y-axis direction. Based on the positioning of the double needles, the osteotomy plate is installed and the osteotomy surgery is completed.

[0011] According to a specific implementation method of an embodiment of the present invention, during the surgical preparation stage, an optical tracking ball is installed on the needle guide, and the double needle implantation hole positions are pre-set; during the operation, the navigation system relies on real-time tracking of the position of the optical tracking ball to accurately calculate the position of the needle guide, providing precise guidance for subsequent operations.

[0012] According to a specific implementation of an embodiment of the present invention, the double-needle implantation parameter information is generated by surgical planning navigation software, and instructions are issued to the control system, and the robotic arm moves precisely to the specified position according to the instructions.

[0013] According to a specific implementation method of an embodiment of the present invention, a double-needle needle guide is fixed at the end of the robotic arm, and the needle guide is positioned using precise self-positioning technology. After the needle guide guides the double needle positioning, the doctor performs a manual double-needle implantation operation.

[0014] According to a specific implementation method of an embodiment of the present invention, a three-dimensional spatial coordinate system is constructed with the osteotomy plane as a reference, wherein the Z axis is perpendicular to the osteotomy plane, the X axis corresponds to the left and right width directions of the osteotomy plane, the Y axis is perpendicular to the plane formed by the X axis and the Z axis, and the two needles are implanted in parallel along the Y axis direction, and the formed two-needle parallel plane maintains a perpendicular relationship with the Z axis.

[0015] According to a specific implementation method of an embodiment of the present invention, the length of the double needles is flexibly adjusted according to the specific situation of the patient, and the matching clearance between the double needle tips and the guide needle hole is strictly controlled to ≤0.1mm. The spacing between the double needle tips is fixed and the accuracy is maintained at ±0.2mm, which can accurately adapt to the guide needle hole distance of the needle guide and the positioning hole distance of the osteotomy plate.

[0016] According to a specific implementation method of an embodiment of the present invention, relying on professional surgical planning and navigation software, the optimal prosthesis position is accurately calculated, and the osteotomy surface position is gradually calculated and determined through the prosthesis position, and then the position of the double needles is determined. The spatial coordinates of the double needles are defined around the head to be cut, and the system strictly follows the principle of one-to-one correspondence between the prosthesis, osteotomy plate and needle guide.

[0017] According to a specific implementation of an embodiment of the present invention, when the prosthesis model needs to be changed or the prosthesis position needs to be adjusted during surgery, the relevant parameters of the osteotomy plate are automatically updated and the spatial position of the needle guide is recalculated.

[0018] According to a specific implementation of an embodiment of the present invention, the optical positioning system monitors and feeds back the posture information of the bones in real time, and feeds the data back to the system, thereby achieving high-precision positioning of the double needles.

[0019] In the second aspect, an embodiment of the present invention provides a precise double-needle positioning system for total ankle joint surgery under optical guidance, including an optical tracker, a robotic arm, a needle guide, double needles and an osteotomy plate, for implementing the method described in the first aspect or any implementation method of the first aspect.

[0020] The present invention has the following beneficial effects:

[0021] Through the real-time and precise capture of position information by the optical tracker, the end positioning accuracy of the robotic arm of ±0.3mm, and the strict coordination standards between the double needles, guide pin holes, and osteotomy plate positioning holes, the problem of insufficient osteotomy positioning accuracy in traditional surgery is effectively solved, ensuring the accuracy of the osteotomy plane, angle, and prosthesis installation, restoring the normal anatomical structure and biomechanical function of the ankle joint, and reducing the risks of postoperative pain, lameness, etc.

[0022] It gets rid of the reliance of traditional surgery on X-ray imaging, eliminates the need for multiple X-rays, avoids the harm of excessive cumulative radiation exposure to patients and doctors, and significantly reduces radiation-related health risks.

[0023] In view of the limited space required for ankle joint surgery, the double-needle design does not require the installation of a reference frame, and the robot and navigation system can be deployed remotely, reducing the occupancy of the surgical space; the human-machine collaboration mode and integrated needle guide design effectively avoid the risk of instrument collision and solve the problem of insufficient space in traditional operations.

[0024] The surgical planning and navigation software supports dynamic adjustments during surgery. When the prosthesis model needs to be changed or the position needs to be adjusted, the parameters can be quickly updated and the needle guide position can be recalculated. This overcomes the disadvantages of 3D printing guide technology, which has fixed preoperative plans and limited intraoperative adjustments, and adapts to individual differences in patients and changes in mechanical balance during surgery.

[0025] Robot-assisted double-needle positioning reduces the time consumed by manual repeated positioning, and each link is seamlessly connected. Compared with the 4-5 hours of traditional surgery, the operation time is greatly shortened and the efficiency of the surgical process is improved.

[0026] Precise positioning reduces damage to surrounding blood vessels, nerves, and soft tissues, and lowers the incidence of complications such as postoperative bleeding and muscle atrophy; at the same time, it ensures balanced force on the ankle joint, provides a good foundation for postoperative recovery, and improves the quality of patient rehabilitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0028] Figure 1 This is a schematic diagram of the precise double-needle positioning system for total ankle surgery under optical guidance;

[0029] Figure 2 This is a flow chart of the precise double-needle positioning system for total ankle surgery under optical guidance;

[0030] Figure 3 It is a schematic diagram of the positional relationship between the double needle, optical tracker, needle guide and robotic arm;

[0031] Figure 4 This is a schematic diagram of the structural design of a double-needle integrated end needle guide under optical guidance;

[0032] Figure 5 This is a schematic diagram of the relationship between the double-needle implantation direction and the spatial position of the osteotomy surface;

[0033] Figure 6 This is a schematic diagram of the position of double needles and osteotomy plates of different models. DETAILED DESCRIPTION

[0034] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0035] See also Figures 1-6 The present invention proposes a method and system for precise double-needle positioning in total ankle joint surgery under optical guidance. The system can achieve precise positioning guidance with the help of an optical tracker during total ankle joint surgery, and at the same time perform adaptive precise positioning operations with the assistance of a robot-assisted double needle, and then cooperate with the osteotomy plate to complete precise positioning in a small space before surgery, laying a solid foundation for subsequent osteotomy surgery.

[0036] The design of this system fully takes into account the narrow space required for total ankle surgery. The optical tracker can capture the spatial information of the surgical area in real time and accurately, providing precise coordinate reference for positioning; the robot-assisted double-needle positioning uses its high-precision operating capabilities to achieve adaptive adjustment of the double needles, ensuring the accuracy and stability of positioning; and the use of the osteotomy plate further standardizes the positioning position and angle, making the entire positioning process more accurate and efficient, effectively improving the safety and success rate of total ankle surgery.

[0037] (1) System composition

[0038] The system mainly consists of: optical tracker, robotic arm, needle guide, double needle, osteotomy plate, software system, etc. Figure 1 Shown, including:

[0039] Optical tracker: used for intraoperative navigation in ankle surgery. Through advanced optical positioning technology, it can provide high-precision spatial positioning information, accurately read the position of the needle guide in real time, and transmit the acquired data to the surgical navigation system in a timely manner.

[0040] Robotic Arm: The robotic arm's end-of-arm positioning accuracy reaches ±0.3mm. The dual-needle guide is held by the end of the robotic arm, and its precise self-positioning function enables rapid and accurate positioning of the needle guide. Following software system instructions, the robotic arm precisely controls the needle guide, delivering it to the desired surgical location, significantly improving surgical accuracy and efficiency.

[0041] Needle Guide: As a key component connecting the robotic arm to the surgical procedure, the needle guide is fixed to the end of the robotic arm, its position precisely determined by the movement of the robotic arm. During surgery, the needle guide's primary task is to guide the placement of the locating needle, indicating the precise path and location for the needle.

[0042] Double Needle: Designed for the narrow space of the ankle joint, specifically for achieving precise positioning in this area.

[0043] Software system: This includes surgical planning and navigation software and control software. The latter fully plans and guides the surgical procedure. The control software precisely controls the robotic arm, adjusting its movements based on instructions from the software to ensure it completes the intended procedure.

[0044] 1. Robot-assisted double needle adaptive precise positioning

[0045] (1) The positioning parameters are generated by the surgical planning and navigation software, and instructions are given to the control system. The robotic arm moves precisely to the specified position according to the instructions.

[0046] (2) The positioning accuracy of the end of the robotic arm can reach ±0.3mm. By fixing the double-needle needle guide at the end of the robotic arm and using precise self-positioning technology to complete the positioning of the needle guide, the surgical accuracy and efficiency can be significantly improved.

[0047] (3) After the needle guide completes the double needle positioning, the doctor performs a manual double needle implantation operation, then installs the osteotomy plate and performs manual osteotomy.

[0048] (4) This human-machine collaboration model fully integrates the dual advantages of the robot's precise positioning and the doctor's flexible operation, effectively avoiding the risk of instrument collision, ensuring the safety of the operation while ensuring the high precision of the surgical operation. Compared with the disadvantages of traditional surgery that relies on the doctor's experience and two-dimensional images and is prone to cumulative errors after multiple positioning, this surgical system achieves precise positioning and real-time monitoring of the entire surgical process, providing a solid guarantee for the quality of the surgery.

[0049] 2. Optically guided double needle integrated end guide design

[0050] (1) During the surgical preparation phase, an optical tracking ball is installed on the needle guide and the double needle insertion hole positions are pre-set. During the operation, the navigation system can accurately calculate the position of the needle guide by real-time tracking of the optical tracking ball position, providing precise guidance for subsequent operations.

[0051] (2) During the operation, after the positioning of the needle guide is completed, the double needles on the needle guide hole can be easily implanted along the preset hole position, simplifying the surgical process.

[0052] (3) In terms of precision control, the clearance between the guide needle hole and the double needle is strictly controlled to ≤0.1mm, and the distance between the double needle tips is fixed and the accuracy is maintained at ±0.2mm. This strict standard ensures that the double needle can not only accurately adapt to the guide needle hole distance of the guide needle device, but also perfectly match the positioning hole distance of the osteotomy plate, greatly improving the high precision and stability of the surgical operation.

[0053] (4) In terms of specifications, the distance between the two needles is 12 mm, the length is 9 mm, the diameter is 2.0 mm, and the length of the male thread on the head is 2 mm and the diameter is 2.4 mm. In actual application, the length of the two needles can be flexibly adjusted according to the specific conditions of the patient.

[0054] Compared with traditional positioning methods, this design ensures the high precision and stability of double-needle positioning from the hardware structure level, laying a solid foundation for subsequent surgical operations.

[0055] 3. Double needle positioning method

[0056] (1) Osteotomy coordinate system: A three-dimensional coordinate system is constructed based on the osteotomy plane. The Z axis is perpendicular to the osteotomy plane and is the normal direction of the osteotomy surface, providing a vertical positioning reference for surgical operations. The X axis corresponds to the left and right widths of the osteotomy surface. This dimension is critical due to the limitations of the surgical space. Accurate positioning helps to ensure the accuracy of the osteotomy operation in a limited space. The Y axis is perpendicular to the plane formed by the X and Z axes, representing the osteotomy depth direction, and is also the direction of the tool path, providing guidance for the advancement of surgical instruments.

[0057] (2) Double-needle positioning mechanism: During the operation, the double needles are implanted in parallel along the Y-axis direction, and the double-needle parallel plane formed maintains a perpendicular relationship with the Z-axis. This perpendicular relationship ensures the precise positioning of the horizontal position of the osteotomy surface, so that the surgical operation can be accurately performed on the preset horizontal plane. The double-needle spacing adopts a fixed design, which can accurately control the left and right widths of the osteotomy surface to ensure that the osteotomy size meets the surgical expectations. Since the operating space in the Y-axis direction is relatively sufficient, when the guide needle is implanted along this direction, on the one hand, the operational safety is significantly improved, and on the other hand, there will be no additional restrictions on the osteotomy depth, providing doctors with flexible operating space.

[0058] (3) Positioning characteristics: Through the double-needle combination positioning method, the horizontal position and angle of the osteotomy surface can be precisely controlled to ensure the accuracy and standardization of the surgical operation. At the same time, this positioning mechanism does not limit the osteotomy depth. On the basis of providing precise guidance for surgical operations, it gives the doctor the flexibility to freely control the osteotomy depth, allowing the doctor to adjust according to actual surgical needs, thereby improving the adaptability and success rate of the operation.

[0059] (4) The robot and navigation system can be deployed at a location far away from the ankle joint surgery site (at least 20 cm away from the ankle joint surgery site, and the distance can be adjusted according to the actual length of the double needles), and the double needle implantation operation can be completed through remote guidance or automated procedures. During the operation, the doctor can adjust the needle insertion speed and depth in real time according to the actual situation, effectively ensuring the safety of the operation. In addition, since the double needle does not need to be installed with a reference frame, this design significantly reduces the occupation of the surgical space, successfully solving the clinical problem of narrow operating space for ankle joint surgery, and creating more favorable conditions for the smooth implementation of the operation.

[0060] 4. Method for determining the target position of osteotomy plate and double needle positioning

[0061] (1) This system relies on professional surgical planning and navigation software to accurately calculate the optimal prosthesis position. Based on the prosthesis position, the osteotomy surface position is gradually calculated and determined. Based on the osteotomy surface position, the position of the two needles is further determined. The spatial coordinates of the two needles are defined around the bone to be cut. The system strictly follows the principle of one-to-one correspondence between the prosthesis, osteotomy plate and needle guide. From prosthesis implantation to osteotomy operation, each link is seamlessly connected to ensure the precise execution of the surgical process.

[0062] (2) The surgical planning and navigation software has powerful dynamic adjustment capabilities during surgery. When the prosthesis model needs to be changed or the prosthesis position needs to be adjusted during surgery, the system can respond quickly, automatically update the relevant parameters of the osteotomy plate, and recalculate the spatial position of the needle guide, providing technical support for the flexible modification of the surgical plan and adapting to the complex and changing needs during surgery.

[0063] (3) At the same time, the optical positioning system monitors and feeds back the bone posture information in real time, and feeds the data back to the system, thereby achieving high-precision positioning of the double needles.

[0064] (4) The osteotomy plate is made of high-strength and biocompatible titanium alloy. The surface is treated with a special process to form a non-slip texture, which effectively enhances intraoperative stability. In view of the individual differences of patients, a variety of different models of prostheses (conventional 5 types) are designed. Each prosthesis corresponds to a dedicated osteotomy plate, and the position of the cut surface of each osteotomy plate varies depending on the prosthesis model. However, the double pinhole specifications of all osteotomy plates remain unified, so only one needle guide is required to adapt to different models of osteotomy plates, effectively reducing the cost of equipment and management complexity.

[0065] (5) The clearance between the positioning hole of the osteotomy plate and the double needle is strictly controlled to ≤0.1mm. Under the high-precision positioning guarantee of the double needle, the installation error of the osteotomy plate is ≤0.3mm and the angle error is ≤1°, ensuring that the osteotomy guide groove is highly consistent with the predetermined osteotomy path, which greatly improves the accuracy of the osteotomy operation.

[0066] (6) Compared with the traditional osteotomy plate positioning method, this system has significant advantages. The traditional method relies entirely on the doctor's subjective judgment and manual operation, which is greatly affected by the doctor's experience level. The positioning error is usually several millimeters, which is difficult to meet the high-precision requirements of complex ankle surgery.

[0067] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A precise double-needle positioning method for total ankle surgery under optical guidance, characterized in that: The following steps are involved: After completing the spatial registration for ankle surgery, the surgical planning system automatically determines the double-needle implantation parameter information based on the spatial registration results, completing the surgical planning and determining the precise position of the needle guide; During the initial positioning, the robotic arm is dragged to the vicinity of the double needle implantation position determined based on the above double needle implantation parameter information. During the position tracking phase, the optical tracker captures the position and posture information of the optical tracking ball on the needle guide in real time. The surgical navigation system automatically calculates the precise position of the needle guide based on the position and posture information of the tracking ball, combined with the relative positional relationship between the robotic arm, the needle guide, and the osteotomy site. This precise position of the needle guide is then commanded to the robotic arm through the control system. The robotic arm then makes slight movements and rotations at the end of the robotic arm based on the deviation. After the needle guide reaches the specified precise position, the double needles are implanted along the Y-axis direction. Based on the positioning of the double needles, the osteotomy plate is installed and the osteotomy surgery is completed.

2. The method according to claim 1, characterized in that During the surgical preparation stage, an optical tracking ball is installed on the needle guide and the double needle implantation hole positions are pre-set; during the operation, the navigation system accurately calculates the position of the needle guide by real-time tracking of the position of the optical tracking ball, providing precise guidance for subsequent operations.

3. The method according to claim 2, characterized in that The double-needle implantation parameter information is generated by surgical planning and navigation software, and instructions are sent to the control system. The robotic arm moves precisely to the specified position according to the instructions.

4. The method according to claim 3, characterized in that A double-needle needle guide is fixed at the end of the robotic arm, and the needle guide is positioned using precise self-positioning technology. After the needle guide guides the double needle positioning, the doctor performs manual double-needle implantation.

5. The method according to claim 4, characterized in that Taking the osteotomy plane as the reference, a three-dimensional coordinate system is constructed, in which the Z axis is perpendicular to the osteotomy plane, the X axis corresponds to the left and right width directions of the osteotomy surface, and the Y axis is perpendicular to the plane formed by the X axis and the Z axis. The two needles are implanted parallel to the Y axis, and the formed two-needle parallel plane maintains a perpendicular relationship with the Z axis.

6. The method according to claim 5, characterized in that The length of the double needles can be flexibly adjusted according to the patient's specific situation. The clearance between the double needle tips and the guide needle hole is strictly controlled to ≤0.1mm. The distance between the double needle tips is fixed and the accuracy is maintained at ±0.2mm, which can accurately adapt to the guide needle hole distance of the needle guide and the positioning hole distance of the osteotomy plate.

7. The method according to claim 6, characterized in that Relying on professional surgical planning and navigation software, the optimal prosthesis position is accurately calculated, and the osteotomy surface position is gradually calculated through the prosthesis position, and then the position of the double needles is determined. The spatial coordinates of the double needles are defined around the head to be cut, and the system strictly follows the principle of one-to-one correspondence between the prosthesis, osteotomy plate and needle guide.

8. The method according to claim 7, characterized in that When the prosthesis model needs to be changed or the prosthesis position needs to be adjusted during surgery, the relevant parameters of the osteotomy plate are automatically updated and the spatial position of the needle guide is recalculated.

9. The method according to claim 8, characterized in that The optical positioning system monitors and feeds back the bone posture information in real time, and feeds the data back to the system, thereby achieving high-precision positioning of the double needles.

10. A precise double-needle positioning system for total ankle surgery under optical guidance, characterized in that: The invention comprises an optical tracker, a robot arm, a needle guide, a double needle and an osteotomy plate, so as to implement the method according to any one of claims 1 to 9.

Images