Registration device and method for bone model

By using the bone model registration device of femoral positioning component, tibial positioning component and probe component in the anterior cruciate ligament reconstruction surgery, the problem of inaccurate registration in the prior art is solved, and the bone coordinate system and image coordinate system are realized. Accurate fit improves the accuracy of the surgery.

CN119257681AInactive Publication Date: 2025-01-07BEIJING NATONG MEDICAL ROBOT TECH CO LTD
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Patent Information

Application Number
CN202411270577.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-09-11
Publication Date
2025-01-07
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

In the reconstruction surgery of anterior cruciate ligament, the registration conditions of existing registration tools for the surgical site are not high, and the movement of the leg bone during the operation affects the registration accuracy, making it difficult to accurately fit the bone coordinate system and the image coordinate system.

Method used

Using a bone model registration device including a femoral positioning component, a tibial positioning component and a probe component, emitting and receiving light through the camera, using a tracer to determine the position of the bone, the computer is converted into spatial coordinates, and fitted with the preoperative image coordinates. Dynamically monitor leg bone position to improve registration accuracy.

Benefits of technology

The precise registration of the knee joint bone surface platform is achieved, the accuracy of fitting the bone coordinate system and image coordinate system during the operation is improved, the error caused by leg bone movement is reduced, and the accuracy of the operation is enhanced.

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Abstract

The invention relates to the technical field of navigation systems for anterior cruciate ligament reconstruction surgeries, in particular to a bone model registration device and method.The bone model registration device comprises a thighbone positioning assembly, a tibia positioning assembly, a probe assembly, a camera and a computer, and the thighbone positioning assembly is used for determining the spatial position of a thighbone; the tibia positioning assembly is used for determining the spatial position of the tibia; the probe assembly is used for determining the spatial position of the knee joint bone surface platform; the camera emits incident light and receives reflected light, reflected by the thighbone positioning assembly, the tibia positioning assembly and the probe assembly, of the incident light at the same time; the computer is electrically connected with the camera, collects azimuth information of reflected light, converts the azimuth information into space coordinates, and fits the space coordinates with leg image coordinates obtained before an operation. Due to the fact that the thighbone positioning assembly and the position between the thighbone positioning assembly and the probe assembly are relatively fixed, a computer can convert reflected light into space coordinates, the space coordinates are fitted with leg image coordinates obtained before an operation, and the registration result is more accurate.
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Description

Technical Field

[0001] The present application relates to the technical field of navigation systems for anterior cruciate ligament reconstruction surgery, and in particular to a bone model registration device and method thereof. Background Art

[0002] In the navigation system of anterior cruciate ligament reconstruction surgery, the femur and tibia of the operated leg need to be registered so that the system can identify the coordinate system of the femur and tibia in space and realize the fitting of the bone coordinate system and the image (CT & MRI) coordinate system. The fitting of the bone coordinate system and the image coordinate system is an important step in positioning the patient's knee joint.

[0003] Common devices and methods for registering surgical sites using registration tools with tracers do not have high surgical operating conditions, and such surgeries are not minimally invasive. At the same time, during registration, it is necessary to consider the impact of leg bone movement on registration accuracy during surgery. Summary of the invention

[0004] In order to solve the above technical problem or at least partially solve the above technical problem, the present application provides a bone model registration device and method.

[0005] On the one hand, the present application provides a bone model alignment device, including a femoral positioning component, a tibial positioning component, a probe component, a camera and a computer, wherein the femoral positioning component is used to determine the spatial position of the femur; the tibial positioning component is used to determine the spatial position of the tibia; the probe component is used to determine the spatial position of the knee joint bone surface platform; the camera emits incident light and simultaneously receives reflected light after the incident light is reflected by the femoral positioning component, the tibial positioning component and the probe component; the computer is electrically connected to the camera, collects the orientation information of the reflected light, converts it into spatial coordinates, and fits the spatial coordinates with the leg image coordinates obtained before the operation.

[0006] Optionally, the probe assembly includes multiple probes, each of which includes multiple first tracers, and the positions of the multiple first tracers can determine a plane, and the first tracers are used to reflect the incident light emitted by the camera.

[0007] Optionally, the probe assembly includes a double-sided probe, a pointed probe, a blunt probe and / or a ball probe.

[0008] Optionally, the double-sided probe includes at least six of the first tracers, and the first tracers are divided into two groups. The positions of the first tracers in each group can determine a plane, and the two planes are perpendicular to each other.

[0009] Optionally, the needle tip of the double-sided probe is tilted, and the plane where the needle tip of the double-sided probe and the probe rod of the double-sided probe are located and the plane where each group of the first tracers are located are all at an angle of 45 degrees.

[0010] Optionally, the femoral positioning assembly includes a femoral positioner, a femoral clamp and a femoral guide, the femoral positioner is mounted on the femoral clamp, and the femoral positioner is used to reflect the incident light emitted by the camera;

[0011] The femoral bone pin is inserted into the femoral guide and guided by the femoral guide to be fixed to the femur. The femoral clamp is sleeved on the femoral bone pin and abuts against the femoral guide.

[0012] Optionally, the femoral locator includes a plurality of second tracers, the positions of the plurality of second tracers can determine a plane, and the second tracers are used to reflect the incident light emitted by the camera.

[0013] Optionally, the femoral guide includes two first guide sleeves, the femoral bone pin is inserted into the first guide sleeves and guided by the first guide sleeves, and the ends of the two first guide sleeves are against the femur.

[0014] Optionally, the tibial positioning assembly comprises a tibial positioner, a tibial clamp and a tibial guide, the tibial positioner is mounted on the tibial clamp, and the tibial positioner is used to reflect the incident light emitted by the camera;

[0015] The tibial bone pin is inserted into the tibial guide and guided by the tibial guide to be fixed to the tibia. The tibial clamp is sleeved on the tibial bone pin and abuts against the tibial guide.

[0016] Optionally, the tibial locator includes a plurality of third tracers, the positions of the plurality of third tracers can determine a plane, and the third tracers are used to reflect the incident light emitted by the camera.

[0017] Optionally, the tibial guide includes two second guide sleeves, the tibial bone pin is inserted into and guided by the second guide sleeves, and the ends of the two second guide sleeves abut against the tibia.

[0018] Optionally, it further comprises a reference frame, wherein the reference frame comprises a frame body and a plurality of fourth tracers, wherein the plurality of fourth tracers are arranged on the frame body, and the positions of the plurality of fourth tracers can determine a plane;

[0019] The frame is provided with a check point, and the check point is used to place the needle of the probe to check the probe.

[0020] The bone model registration device provided by the present application emits incident light through a camera, and the femoral positioning component, the tibial positioning component and the probe component are capable of reflecting the light source to obtain reflected light. At this time, the camera collects the reflected light and transmits the collected data of the reflected light to a computer, and the computer collects the information of the reflected light. Since the positions between the femoral positioning component, the femoral positioning component and the probe component are relatively fixed, the computer can convert the reflected light into coordinates. The calculated spatial coordinates are combined with the leg image coordinates obtained before the operation to make the registration result more accurate.

[0021] On the other hand, the present application provides a bone model registration method, comprising:

[0022] Femoral positioning: fix the femur by the femoral positioning assembly, emit incident light through the camera, and the incident light is reflected by the femoral positioning assembly and then received by the camera;

[0023] Tibia positioning: fix the tibia through the tibia positioning component, emit incident light through the camera, and the incident light is reflected by the tibia positioning component and then received by the camera;

[0024] Positioning of the knee joint bone surface platform: the camera emits incident light, which is then reflected by the probe assembly and then received by the camera;

[0025] Coordinate fitting: The computer collects the position information of the reflected light from the femoral positioning component, the tibial positioning component and the probe component, and converts it into spatial coordinates. The spatial coordinates are then fitted with the leg image coordinates obtained before the operation to achieve registration of the knee joint bone surface platform.

[0026] Optionally, it also includes the calibration of the probe assembly;

[0027] placing the needle tip of the probe in the probe assembly within a checkpoint of the reference frame, wherein the coordinates at the checkpoint are standard coordinates;

[0028] Calculate the actual coordinates of the needle tip of the probe by using the camera and the computer;

[0029] If the difference between the standard coordinates and the actual coordinates is within the preset value, the verification is passed; if the difference between the standard coordinates and the actual coordinates exceeds the preset value, a warning is issued.

[0030] Optionally, a ball-tipped probe may be used to align the knee joint bone surface platform.

[0031] Optionally, when positioning the knee joint bone surface platform at multiple angles, positioning is performed using two sets of first tracers of the double-sided probe;

[0032] And / or, when the knee joint bone surface platform is covered by soft tissue and blocks the bone surface, a pointed probe is used to penetrate the residual soft tissue and directly reach the bone surface to confirm the registration point;

[0033] And / or, when there is no soft tissue residue at the registration point of the knee joint bone surface platform, a blunt probe is used to make the end of the blunt probe directly touch the bone surface to confirm the registration point.

[0034] The bone model registration method provided in the present application, the femoral positioning component 1 and the tibial positioning component 3 can dynamically monitor the positions of the femur 2 and the tibia 4, and update the coordinates of the leg bones in real time. Since the leg image coordinates obtained before the operation are two-dimensional coordinates, and the spatial coordinates converted by the computer from the orientation information of the reflected light are calculated coordinates, the actual two-dimensional coordinates and the calculated spatial coordinates are fitted, that is, the spatial coordinates are fitted with the leg image coordinates obtained before the operation, so that the registration result is more accurate. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0036] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0037] Figure 1 A schematic diagram of a first viewing angle of a registration device for a bone model according to an embodiment of the present application;

[0038] Figure 2 A schematic diagram of a second viewing angle of a registration device for a bone model according to an embodiment of the present application;

[0039] Figure 3 A schematic diagram of a femoral positioning assembly, a tibial positioning assembly and a probe assembly in use according to an embodiment of the present application;

[0040] Figure 4 A schematic diagram of a femoral positioning assembly and a tibial positioning assembly in use according to an embodiment of the present application;

[0041] Figure 5 A schematic diagram of the structure of a double-sided probe according to an embodiment of the present application;

[0042] Figure 6 This is a schematic diagram of the structure of a pointed probe according to an embodiment of the present application;

[0043] Figure 7This is a schematic diagram of the structure of a blunt-tip probe according to an embodiment of the present application;

[0044] Figure 8 This is a schematic diagram of the structure of a ball-tip probe according to an embodiment of the present application;

[0045] Fig. 9 A schematic diagram of the structure of a femoral positioner according to an embodiment of the present application;

[0046] Fig.10 It is a schematic diagram of the structure of a femoral clamp and a tibial clamp according to an embodiment of the present application;

[0047] Fig.11 A cross-sectional view of a femoral clamp and a tibial clamp according to an embodiment of the present application;

[0048] Fig.12 This is a schematic structural diagram of a first guide according to an embodiment of the present application;

[0049] Fig.13 A schematic diagram of the structure of a tibial locator according to an embodiment of the present application;

[0050] Fig.14 A schematic diagram of the structure of a second guide according to an embodiment of the present application;

[0051] Fig.15 A schematic diagram of the structure of a reference frame according to an embodiment of the present application;

[0052] Fig.16 A side view of a reference frame according to an embodiment of the present application;

[0053] Fig.17 A schematic diagram of a reference frame calibrating a double-sided probe when applied to a right leg according to an embodiment of the present application;

[0054] Fig.18 This is a schematic diagram of a reference frame calibrating a double-sided probe applied to a left leg in an embodiment of the present application;

[0055] Fig.19 This is a schematic diagram of calibrating a pointed probe in an embodiment of the present application;

[0056] Fig. 20 This is a schematic diagram of calibrating a blunt-tip probe in an embodiment of the present application;

[0057] Fig.21 This is a schematic diagram of calibrating a ball-tip probe in an embodiment of the present application;

[0058] Fig. 22 This is an operation flow chart of an embodiment of the present application.

[0059] The reference numerals in the specific implementation manner are as follows:

[0060] 1. Femoral positioning assembly; 11. Femoral locator; 111. Second tracer; 12. Femoral clamp; 13. Femoral guide; 131. First guide sleeve; 2. Femur; 3. Tibial positioning assembly; 31. Tibial locator; 311. Third tracer; 32. Tibial clamp; 33. Tibial guide; 331. Second guide sleeve; 4. Tibia; 5. Probe assembly; 51. Probe; 511. Double-sided probe; 512. Pointed probe; 513. Blunt probe; 514. Ball probe; 52. First tracer; 6. Camera; 7. Operating table; 8. Femoral bone needle; 9. Tibial bone needle; 10. Reference frame; 101. Frame body; 102. Fourth tracer; 103. Verification point. DETAILED DESCRIPTION

[0061] In order to more clearly understand the above-mentioned purposes, features and advantages of the present application, the scheme of the present application will be further described below. It should be noted that the embodiments of the present application and the features in the embodiments can be combined with each other without conflict.

[0062] In the following description, many specific details are set forth to facilitate a full understanding of the present application, but the present application may also be implemented in other ways different from those described herein; obviously, the embodiments in the specification are only part of the embodiments of the present application, rather than all of the embodiments.

[0063] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by technicians in the technical field to which this application belongs; the terms used herein are only for the purpose of describing specific embodiments and are not intended to limit this application; the terms "including" and "having" in the specification and claims of this application and the above-mentioned figure descriptions and any variations thereof are intended to cover non-exclusive inclusions.

[0064] In the description of the embodiments of the present application, "multiple" and "several" mean more than two (including two), unless otherwise clearly and specifically defined.

[0065] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0066] According to some embodiments of the present application, referring to Figure 1 and Figure 2The bone model registration device of the embodiment of the present application includes: a femoral positioning component 1, a tibial positioning component 3, a probe component 5, a camera 6 and a computer, wherein the femoral positioning component 1 is used to determine the spatial position of the femur 2; the tibial positioning component 3 is used to determine the spatial position of the tibia 4; the probe component 5 is used to determine the spatial position of the knee joint bone surface platform; the camera 6 emits incident light and simultaneously receives reflected light after the incident light is reflected by the femoral positioning component 1, the tibial positioning component 3 and the probe component 5; the computer is electrically connected to the camera 6, collects the orientation information of the reflected light, converts it into spatial coordinates, and fits the spatial coordinates with the leg image coordinates obtained before the operation.

[0067] Femoral positioning assembly 1 is used to determine the spatial position of femur 2, tibial positioning assembly 3 is used to determine the spatial position of tibia 4, and probe assembly 5 is used to determine the spatial position of knee joint bone surface platform. Camera 6 can emit incident light and simultaneously receive the reflected light after the incident light is reflected by femoral positioning assembly 1, tibial positioning assembly 3 and probe assembly 5. At this time, camera 6 collects the reflected light. Since the positions between femoral positioning assembly 1, tibial positioning assembly 3 and probe assembly 5 are relatively fixed, the computer can convert the reflected light into coordinates. At the same time, camera 6 transmits the data of the reflected light collected to the computer, and the computer is electrically connected to camera 6. The computer collects the azimuth information of the reflected light and converts it into spatial coordinates. During the operation, the leg bone will move. At this time, the position of femur 2 and tibia 4 can be dynamically monitored by femoral positioning assembly 1 and tibial positioning assembly 3, and the coordinates of the leg bone can be updated in real time. Since the coordinates of the leg image obtained before the operation are two-dimensional coordinates, and the spatial coordinates converted by a computer from the orientation information of the reflected light are calculated coordinates, the actual two-dimensional coordinates and the calculated spatial coordinates are fitted, that is, the spatial coordinates are fitted with the coordinates of the leg image obtained before the operation, so that the registration result is more accurate.

[0068] According to some embodiments of the present application, reference Figure 1 and Figure 2 As shown, the probe assembly 5 includes multiple probes 51 , each probe 51 includes multiple first tracers 52 , and the positions of the multiple first tracers 52 can determine a plane. The first tracers 52 are used to reflect the incident light emitted by the camera 6 .

[0069] The number of the first tracers 52 is at least three, because three points can determine a plane. Each first tracer 52 includes a reflective ball, which is used to reflect the incident light emitted by the camera 6. The reflective ball of the first tracer 52 can fully reflect the incident light emitted by the reflective camera 6, so that the camera 6 can accurately capture the position information of the first tracer 52.

[0070] According to some embodiments of the present application, reference Figures 3 to 8As shown, the probe assembly includes a double-sided probe 511, a pointed probe 512, a blunt probe 513 and / or a ball probe 514. The double-sided probe 511 includes at least six first tracers 52, and the first tracers 52 are divided into two groups. The positions of each group of first tracers 52 can determine a plane, and the two planes are perpendicular to each other. The needle tip of the double-sided probe 511 is tilted, and the plane where the needle tip of the double-sided probe 511 and the probe rod of the double-sided probe 511 are located and the plane where each group of first tracers 52 are located are all at an angle of 45 degrees.

[0071] Specifically, the multiple first tracers 52 in the double-sided probe 511 are divided into two groups, each of which includes at least three first tracers 52. The planes where the two groups of first tracers 52 are located are perpendicular to each other. The needle tip of the double-sided probe 511 is tilted, so the needle tip of the double-sided probe 511 and the probe rod of the double-sided probe 511 can form a plane, and the plane where the needle tip of the double-sided probe 511 and the probe rod of the double-sided probe 511 are located and the plane where each group of first tracers 52 is located are all at an angle of 45 degrees.

[0072] When using the double-sided probe 511, the double-sided probe hook can be inserted into the skin incision opening of the knee joint bone surface platform and contact the registration point of the knee joint bone surface platform to complete the registration. The needle tip of the double-sided probe 511 is tilted, so that the needle tip is easy to insert into the bone surface platform, which is convenient for aligning the cartilage surfaces on both sides of the bone surface platform. At the same time, the tilted needle tip is easy to avoid muscles and soft tissues when in use, so as to avoid damaging the original human tissue structure. The multiple first tracers 52 in the double-sided probe 511 are divided into two groups, and the planes where the first tracers 52 are located are perpendicular to each other. The position of the needle tip of the double-sided probe 511 can be confirmed from two sets of coordinate systems, which is conducive to accurate positioning. Furthermore, when the cartilage surfaces on both sides of the knee joint bone surface platform are aligned respectively, or when the left and right legs are aligned, the setting of the two groups of first tracers 52 can make the needle tip of the double-sided probe 511 be located at any place, and the first tracer 52 can reflect the light source, so that when the left and right legs are changed in position, the camera 6 can recognize the first tracer 52, thereby reducing the measurement error caused by insufficient reflected light during use. At the same time, the plane where the needle tip of the double-sided probe 511 and the probe rod of the double-sided probe 511 are located and the plane where each group of first tracers 52 are located are all at an angle of 45 degrees, so that the double-sided probe 511 can conveniently receive and reflect the incident light emitted by the camera 6 when it is aligned to the left leg or the right leg.

[0073] In addition, when registering the knee joint bone surface platform, since the surgery is minimally invasive, the registration tool needs to be inserted into the patient's knee joint tissue from the tibial skin incision opening. The limited registration operation space makes it impossible to complete the collection of all registration points with one tool. Therefore, in this embodiment, multiple probes 51 can be used, specifically including: a pointed probe 512, a blunt probe 513, and a ball probe 514.

[0074] Among them, the blunt-tip probe 513 is suitable for touching the registration point from both the left and right approaches under normal conditions, and the first tracer 52 in the blunt-tip probe 513 can be registered by the camera 6 under visual conditions. Because the blunt-tip probe 513 will not damage the cartilage, but it is required that there should be no soft tissue residue at the registration point. When the non-load-bearing area of ​​the intercondylar fossa is covered with soft tissue (such as ligament stumps) to block the bone surface, it is advisable to use a pointed probe 512. At this time, the pointed probe 512 is used to penetrate the residual soft tissue and directly reach the bone surface to confirm the registration point. Furthermore, the ball-tip probe 514 is a more convenient and accurate registration tool. Because the needle tip of the ball-tip probe 514 is spherical, the relative position of any point in the sphere to the center of the sphere can be calculated.

[0075] Therefore, the ball-tip probe 514 uses the center of the needle tip as the coordinate origin, and the camera 6 can identify the spatial coordinates of the center of the needle tip and the first tracer 52. Even when the ball-tip probe 514 stops at any position in space, the vertical distance from the center of the sphere to the registration point can be derived according to the coordinates of the first tracer 52, so that any position on the spherical surface can contact the registration point and the registration can be completed. Using the ball-tip probe 514 for registration can solve the problem that when registering in a minimally invasive environment, the coordinate origin and the registration point of other probes 51 are difficult to coincide, thereby affecting the registration accuracy, and greatly improves the convenience and accuracy of registration.

[0076] It is worth noting that the arrangement of the first tracer 52 in the pointed probe 512, the blunt probe 513 and the ball probe 514 is different. The camera 6 emits incident light and simultaneously receives reflected light after the incident light is reflected by the probe assembly 5. If the arrangement of the first tracer 52 is different, the type of probe 51 used can be determined based on the relative position of the collected reflected light.

[0077] According to some embodiments of the present application, reference Figure 3 , Figure 4 as well as Figures 9 to 12 As shown, the femoral positioning assembly 1 includes a femoral positioner 11, a femoral clamp 12 and a femoral guide 13. The femoral positioner 11 is mounted on the femoral clamp 12. The femoral positioner 11 is used to reflect the incident light emitted by the camera 6. The femoral bone needle 8 is inserted into the femoral guide 13 and guided by the femoral guide 13 to be fixed to the femur 2. The femoral clamp 12 is sleeved on the femoral bone needle 8 and abuts against the femoral guide 13. The femoral positioner 11 includes a plurality of second tracers 111. The positions of the plurality of second tracers 111 can determine a plane. The second tracers 111 are used to reflect the incident light emitted by the camera 6. The femoral guide 13 includes two first guide sleeves 131. The femoral bone needle 8 is inserted into the first guide sleeve 131 and guided by the first guide sleeve 131. The ends of the two first guide sleeves 131 abut against the femur 2.

[0078] The femoral spicule 8 is inserted into the femoral guide 13, and the femoral spicule 8 penetrates into the femur 2 to fix the position of the femur 2. The femoral guide 13 includes two first guide sleeves 131, and the distance between the two first guide sleeves 131 is relatively constant, which can ensure the distance between the two femoral spicules 8. The femoral positioner 11 is installed on the femoral clamp 12, and the femoral clamp 12 is sleeved on the femoral spicule 8 and abuts against the femoral guide 13. At this time, the femoral guide 13 also plays a role in limiting the movement of the femoral clamp 12 on the femoral spicule 8. The femoral positioner 11 includes a plurality of second tracers 111, and the plurality of second tracers 111 are used to reflect the incident light emitted by the camera 6. The computer collects the azimuth information of the reflected light and converts it into spatial coordinates to determine the position of the femur 2.

[0079] According to some embodiments of the present application, reference Figure 10 to Figure 11 as well as Figure 13 to Figure 14 The tibial positioning assembly 3 includes a tibial positioning device 31, a tibial clamp 32 and a tibial guide 33. The tibial positioning device 31 is mounted on the tibial clamp 32. The tibial positioning device 31 is used to reflect the incident light emitted by the camera 6. The tibial bone pin 9 is inserted into the tibial guide 33 and guided by the tibial guide 33 to be fixed to the tibia 4. The tibial clamp 32 is sleeved on the tibial bone pin 9 and abuts against the tibial guide 33. The tibial positioning device 31 includes a plurality of third tracers 311. The positions of the plurality of third tracers 311 can determine a plane. The third tracers 311 are used to reflect the incident light emitted by the camera 6. The tibial guide 33 includes two second guide sleeves 331. The tibial bone pin 9 is inserted into the second guide sleeve 331 and guided by the second guide sleeve 331. The ends of the two second guide sleeves 331 abut against the tibia 4.

[0080] The tibial pin 9 is inserted into the tibial guide 33, and the tibial pin 9 penetrates into the tibia 4 to fix the position of the tibia 4. The tibial guide 33 includes two second guide sleeves 331, and the distance between the two second guide sleeves 331 is relatively constant, which can ensure the distance between the two tibial pins 9. The tibial positioner 31 is installed on the tibial clamp 32, and the tibial clamp 32 is sleeved on the tibial pin 9 and abuts against the tibial guide 33. At this time, the tibial guide 33 also plays a role in limiting the movement of the tibial clamp 32 on the tibial pin 9. The tibial positioner 31 includes a plurality of third tracers 311, and the plurality of third tracers 311 are used to reflect the incident light emitted by the camera 6. The computer collects the azimuth information of the reflected light and converts it into spatial coordinates to determine the position of the tibia 4.

[0081] It should be noted that the femoral clamp 12 and the tibial clamp 32 have the same structure. The second guide sleeve 331 of the tibial guide 33 is shorter than the first guide sleeve 131 of the femoral guide 13. Because the guide sleeves are both against the leg bones, and in the human body, the thigh is thicker than the calf, so in order to make the guide sleeves against the leg bones, the first guide sleeve 131 needs to be longer than the second guide sleeve 331.

[0082] In addition, the arrangement of the second tracer 111 on the femoral locator 11 is different from the arrangement of the third tracer 311 on the tibial locator 31. The camera 6 emits incident light and simultaneously receives reflected light after the incident light is reflected by the femoral positioning component 1 and the tibial positioning component 3. If the arrangement of the second tracer 111 and the third tracer 311 is different, the model of the locator used can be determined based on the relative position of the collected reflected light.

[0083] In other embodiments, reference Figures 15 to 21 As shown, it also includes a reference frame 10, which includes a frame body 101 and a plurality of fourth tracers 102. The plurality of fourth tracers 102 are arranged on the frame body 101, and the positions of the plurality of fourth tracers 102 can determine a plane; a check point 103 is provided on the frame body 101, and the check point 103 is used to place the needle of the probe 51 to check the probe 51.

[0084] Specifically, the check point 103 is in the shape of a hole, wherein the check point 103 is divided into a first check point and a second check point, the first check point is used to check the double-sided probe 511, the pointed probe 512 and the blunt probe 513, and the second check point is used to check the ball probe 514. Since the needle tip of the ball probe 514 is spherical and requires a larger space for placement, the hole of the second check point is larger than the hole of the first check point.

[0085] In the preoperative preparation stage, the above-mentioned instruments need to be calibrated to ensure that all instruments are in good condition to prevent collision and deformation during storage and transportation, which may lead to deviation in registration. Specifically, the tip of the probe 51 is placed in the calibration point 103. At this time, the reference frame 10 is a standard coordinate system. The position coordinates of the tip of the probe 51 can be calculated by a computer. If the difference between the two is within the preset value, it passes. If it exceeds the preset value, a warning is issued. Among them, when calibrating the double-sided probe 511, since the double-sided probe 511 has two groups of first tracers 52, and the two groups of first tracers 52 are located in two planes perpendicular to each other, the two groups of first tracers 52 in the two planes must be calibrated respectively. That is, the tip of the double-sided probe 511 is placed in the calibration point 103, and the probe rod of the double-sided probe 511 is parallel to the frame body 101, and calibration is performed in both directions.

[0086] In addition, the design of the reference frame 10 also takes into account the calibration of various drill bits, femoral drilling guide locators, tibial drilling guide locators and other tools used in bone tunnel preparation. This application only describes the alignment method, so the calibration of various drill bits and femoral\tibial drilling guide locators will not be elaborated.

[0087] According to some embodiments of the present application, referring to Figures 1 to 22 The bone model registration method of the embodiment of the present application comprises the following steps:

[0088] S1: Femoral positioning: fix the femur 2 through the femoral positioning component 1, emit incident light through the camera 6, and the incident light is reflected by the femoral positioning component 1 and then received by the camera 6.

[0089] Specifically, the femoral positioning assembly 1 is used to determine the spatial position of the femur 2, can dynamically monitor the position of the femur 2, and update the coordinates of the femur 2 in real time. The femoral positioning assembly 1 includes a femoral positioner 11, a femoral clamp 12, and a femoral guide 13. The femoral bone needle 8 is inserted into the femoral guide 13, and the femoral bone needle 8 penetrates into the femur 2 to fix the position of the femur 2. The femoral positioner 11 is installed on the femoral clamp 12, and the femoral clamp 12 is sleeved on the femoral bone needle 8 and abuts against the femoral guide 13. The femoral positioner 11 includes a plurality of second tracers 111, and the plurality of second tracers 111 are used to reflect the incident light emitted by the camera 6. The computer collects the azimuth information of the reflected light and converts it into spatial coordinates to determine the position of the femur 2.

[0090] S2: Tibia positioning: The tibia 4 is fixed by the tibia positioning component 3, and the incident light is emitted by the camera 6. The incident light is reflected by the tibia positioning component 3 and then received by the camera 6.

[0091] Specifically, the tibial positioning assembly 3 is used to determine the spatial position of the tibia 4, can dynamically monitor the position of the tibia 4, and update the coordinates of the tibia 4 in real time. The tibial positioning assembly 3 includes a tibial positioner 31, a tibial clamp 32 and a tibial guide 33, and the tibial bone pin 9 is inserted into the tibial guide 33, and the tibial bone pin 9 penetrates into the tibia 4 to fix the position of the tibia 4. The tibial positioner 31 is installed on the tibial clamp 32, and the tibial clamp 32 is sleeved on the tibial bone pin 9 and abuts against the tibial guide 33. The tibial positioner 31 includes a plurality of third tracers 311, and the plurality of third tracers 311 are used to reflect the incident light emitted by the camera 6. The computer collects the azimuth information of the reflected light and converts it into spatial coordinates to determine the position of the tibia 4.

[0092] S3: Positioning of the knee joint bone surface platform: The incident light is emitted by the camera 6 , and the incident light is reflected by the probe assembly 5 and then received by the camera 6 .

[0093] Specifically, the probe assembly 5 includes a plurality of probes 51 , each probe 51 includes a plurality of first tracers 52 , and the positions of the plurality of first tracers 52 can determine a plane, and the first tracers 52 are used to reflect incident light emitted by the camera 6 .

[0094] It should be pointed out that the ball-end probe 514 can be used for registration of the knee joint bone surface platform, and the double-sided probe 511 is used for positioning of the knee joint bone surface platform at multiple angles, and the two groups of first tracers 52 of the double-sided probe 511 are used for positioning; when the knee joint bone surface platform is covered by soft tissue blocking the bone surface, the pointed probe 512 is used to penetrate the residual soft tissue and directly reach the bone surface to confirm the registration point; when there is no soft tissue remaining at the registration point of the knee joint bone surface platform, the blunt-end probe 513 is used to make the end of the blunt-end probe directly reach the bone surface to confirm the registration point.

[0095] S4: Coordinate fitting: The computer collects the position information of the reflected light from the femoral positioning component 1, the tibial positioning component 3 and the probe component 5, and converts it into spatial coordinates. The spatial coordinates are then fitted with the leg image coordinates obtained before the operation to achieve the alignment of the knee joint bone surface platform.

[0096] It should be pointed out that the order of step S1 and step S2 can be interchanged and adjusted, and this application does not limit their order.

[0097] Before performing femoral positioning, the present application also includes a calibration of the probe assembly 5. Specifically, the needle tip of the probe 51 in the probe assembly 5 is placed in the calibration point 103 of the reference frame 10, and the coordinates at the calibration point 103 are the standard coordinates; the actual coordinates at the needle tip of the probe 51 are calculated by the camera 6 and the computer; if the difference between the standard coordinates and the actual coordinates is within the preset value, the calibration is passed; if the difference between the standard coordinates and the actual coordinates exceeds the preset value, a warning is issued and the probe assembly 5 is replaced or adjusted.

[0098] The working principle of the bone model registration device will be introduced in detail below.

[0099] After the patient is located on the operating table 7, the femur positioning assembly 1 is used to determine the spatial position of the femur 2, the tibial positioning assembly 3 is used to determine the spatial position of the tibia 4, and the probe assembly 5 is used to determine the spatial position of the knee joint bone surface platform. The camera 6 can emit incident light and simultaneously receive the reflected light after the incident light is reflected by the femur positioning assembly 1, the tibial positioning assembly 3 and the probe assembly 5. At this time, the camera 6 collects the reflected light, and since the position between the femur positioning assembly 1, the tibial positioning assembly 3 and the probe assembly 5 is relatively fixed, the computer can convert the reflected light into coordinates. At the same time, the camera 6 transmits the data of the reflected light collected to the computer, and the computer is electrically connected to the camera 6, and the computer collects the azimuth information of the reflected light and converts it into spatial coordinates. During the operation, the leg bone will move, and at this time, the femur positioning assembly 1 and the tibial positioning assembly 3 can dynamically monitor the position of the femur 2 and the tibia 4, and update the coordinates of the leg bone in real time. Since the leg image coordinates obtained before the operation are two-dimensional coordinates, and the spatial coordinates converted by the computer from the orientation information of the reflected light are calculated coordinates, the actual two-dimensional coordinates and the calculated spatial coordinates are fitted, that is, the spatial coordinates are fitted with the leg image coordinates obtained before the operation, so that the registration result is more accurate. It should be noted that it is necessary to select a suitable probe 51 according to the characteristics of the operating space of the probe 51. In addition, in the preoperative preparation stage, the above-mentioned instruments need to be calibrated to ensure that all instruments are in good condition to prevent collision and deformation during storage and transportation, resulting in deviations in the registration. The needle tip of the probe 51 is placed in the calibration point 103. At this time, the reference frame 10 is a standard coordinate system. The needle tip position coordinates of the probe 51 can be calculated by the computer. If the difference between the two is within the preset value, it passes. If it exceeds the preset value, a warning is issued.

[0100] The content of this application is not limited to the examples listed in the embodiments, and any equivalent changes made to the technical solution of this application by ordinary technicians in this field after reading the description of this application are covered by the claims of this application.

[0101] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them; although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should all be included in the scope of the claims and specification of the present application. In particular, as long as there is no structural conflict, the various technical features mentioned in the various embodiments can be combined in any way. The present application is not limited to the specific embodiments disclosed herein, but includes all technical solutions that fall within the scope of the claims.

Claims

1. A bone model registration device, characterized in that: include: A femoral positioning assembly (1), wherein the femoral positioning assembly (1) is used to determine the spatial position of a femur (2); A tibia positioning assembly (3), wherein the tibia positioning assembly (3) is used to determine the spatial position of the tibia (4); A probe assembly (5), the probe assembly (5) being used to determine the spatial position of a knee joint bone surface platform; A camera (6), wherein the camera (6) emits incident light and simultaneously receives reflected light after the incident light is reflected by the femoral positioning component (1), the tibial positioning component (3) and the probe component (5); A computer is electrically connected to the camera (6), collects the orientation information of the reflected light, converts it into spatial coordinates, and fits the spatial coordinates with the coordinates of the leg image obtained before the operation.

2. The bone model registration device according to claim 1, characterized in that: The probe assembly (5) includes a plurality of probes (51), each of the probes (51) includes a plurality of first tracers (52), and the positions of the plurality of first tracers (52) can determine a plane, and the first tracers (52) are used to reflect the incident light emitted by the camera (6).

3. The bone model registration device according to claim 2, characterized in that: The probe assembly includes a double-sided probe (511), a pointed probe (512), a blunt probe (513) and / or a ball probe (514).

4. The bone model registration device according to claim 3, characterized in that: The double-sided probe (511) comprises at least six of the first tracers (52), and the first tracers (52) are divided into two groups. The positions of the first tracers (52) in each group can determine a plane, and the two planes are perpendicular to each other.

5. The bone model registration device according to claim 4, characterized in that: The needle tip of the double-sided probe (511) is tilted, and the plane where the needle tip of the double-sided probe (511) and the probe rod of the double-sided probe (511) are located and the plane where each group of the first tracers (52) are located are all at an angle of 45 degrees.

6. The bone model registration device according to claim 1, characterized in that: The femoral positioning assembly (1) comprises a femoral positioner (11), a femoral clamp (12) and a femoral guide (13), wherein the femoral positioner (11) is mounted on the femoral clamp (12), and the femoral positioner (11) is used to reflect the incident light emitted by the camera (6); The femoral bone needle (8) is inserted into the femoral guide (13) and guided by the femoral guide (13) to be fixed to the femur (2); the femoral clamp (12) is sleeved on the femoral bone needle (8) and abuts against the femoral guide (13).

7. The bone model registration device according to claim 6, characterized in that: The femoral locator (11) comprises a plurality of second tracers (111), the positions of the plurality of second tracers (111) can determine a plane, and the second tracers (111) are used to reflect the incident light emitted by the camera (6).

8. The bone model registration device according to claim 6, characterized in that: The femoral guide (13) comprises two first guide sleeves (131), the femoral bone needle (8) is inserted into the first guide sleeves (131) and guided by the first guide sleeves (131), and the ends of the two first guide sleeves (131) are against the femur (2).

9. The bone model registration device according to claim 1, characterized in that: The tibial positioning assembly (3) comprises a tibial positioning device (31), a tibial clamp (32) and a tibial guide (33), wherein the tibial positioning device (31) is mounted on the tibial clamp (32), and the tibial positioning device (31) is used to reflect the incident light emitted by the camera (6); The tibial bone pin (9) is inserted into the tibial guide (33) and guided by the tibial guide (33) to be fixed to the tibia (4). The tibial clamp (32) is sleeved on the tibial bone pin (9) and abuts against the tibial guide (33).

10. The bone model registration device according to claim 9, characterized in that: The tibia locator (31) includes a plurality of third tracers (311), the positions of the plurality of third tracers (311) can determine a plane, and the third tracers (311) are used to reflect the incident light emitted by the camera (6).

11. The bone model registration device according to claim 9, characterized in that: The tibial guide (33) comprises two second guide sleeves (331), the tibial bone needle (9) is inserted into the second guide sleeves (331) and guided by the second guide sleeves (331), and the ends of the two second guide sleeves (331) abut against the tibia (4).

12. The bone model registration device according to claim 1, characterized in that: It also includes a reference frame (10), the reference frame (10) including a frame body (101) and a plurality of fourth tracers (102), the plurality of fourth tracers (102) are arranged on the frame body (101), and the positions of the plurality of fourth tracers (102) can determine a plane; The frame body (101) is provided with a check point (103), and the check point (103) is used to place the needle of the probe (51) to check the probe (51).

13. A registration method using the bone model registration device according to any one of claims 1 to 12, characterized in that: The following steps are involved: Femoral positioning: the femur (2) is fixed by a femoral positioning component (1), incident light is emitted by a camera (6), and the incident light is reflected by the femoral positioning component (1) and then received by the camera (6); Tibia positioning: the tibia (4) is fixed by a tibia positioning component (3), incident light is emitted by a camera (6), and the incident light is reflected by the tibia positioning component (3) and then received by the camera (6); Positioning the knee joint bone surface platform: the camera (6) emits incident light, and the incident light is reflected by the probe assembly (5) and then received by the camera (6); Coordinate fitting: The computer collects the position information of the reflected light from the femoral positioning component (1), the tibial positioning component (3) and the probe component (5), converts it into spatial coordinates, and fits the spatial coordinates with the leg image coordinates obtained before the operation to achieve the alignment of the knee joint bone surface platform.

14. The bone model registration method according to claim 13, characterized in that: Also included is the calibration of the probe assembly (5); Placing the needle tip of the probe (51) in the probe assembly (5) in a checkpoint (103) of the reference frame (10), wherein the coordinates at the checkpoint (103) are standard coordinates; Calculating the actual coordinates of the needle tip of the probe (51) by using the camera (6) and the computer; If the difference between the standard coordinates and the actual coordinates is within the preset value, the verification is passed; if the difference between the standard coordinates and the actual coordinates exceeds the preset value, a warning is issued.

15. The bone model registration method according to claim 13, characterized in that: A ball-tipped probe (514) may be used to align the knee joint bone surface platform.

16. The bone model registration method according to claim 15, characterized in that: When positioning the knee joint bone surface platform at multiple angles, positioning is performed using two groups of first tracers (52) of the double-sided probe (511); and / or, when the knee joint bone surface platform is covered by soft tissue and blocks the bone surface, a pointed probe (512) is used to penetrate the remaining soft tissue and directly reach the bone surface to confirm the registration point; And / or, when there is no soft tissue residue at the registration point of the knee joint bone surface platform, a blunt probe (513) is used to make the end of the blunt probe directly touch the bone surface to confirm the registration point.

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