Intelligent surgical system suitable for high tibial osteotomy and control system thereof

Abstract

The present disclosure provides an intelligent surgery system and a control system thereof suitable for high tibial osteotomy, the intelligent surgery system comprising: a surgery table configured to support a patient; an operation part comprising: a first trolley; a mechanical arm arranged on the trolley; and a surgery instrument configured to be installed at the end of the mechanical arm, the surgery instrument comprising: a distraction device comprising a moving mechanism and a maintaining mechanism, the moving mechanism and the maintaining mechanism being kept in cooperation during the process of inserting the distraction device into a bone gap to distract two osteotomy surfaces; after the distraction device distracts the two osteotomy surfaces, the moving mechanism and the maintaining mechanism are separated by operation, and the maintaining mechanism is configured to keep the two osteotomy surfaces in a distracted state to install a fixation plate in the distracted state; and a control part configured to control the operation part to complete a surgery operation.

Description

Technical Field

[0001] This disclosure relates to the field of high tibial osteotomy surgery, and more particularly to an intelligent surgical system and its control system suitable for high tibial osteotomy. Background Technology

[0002] High tibial osteotomy is an important surgical procedure for treating early to mid-stage knee osteoarthritis. By repositioning the proximal tibia, the lower limb alignment is shifted from the affected compartment to the normal compartment, thereby relieving knee pain and improving knee function. However, high tibial osteotomy requires a high level of surgical experience and has drawbacks such as lower efficiency, lower precision, and lower safety. Summary of the Invention

[0003] To at least partially overcome the technical defects of at least one or other inventions mentioned above, at least one embodiment of this disclosure provides an intelligent surgical system and its control system suitable for high tibial osteotomy, which can improve the safety and accuracy of high tibial osteotomy surgery.

[0004] In view of this, the present disclosure provides an intelligent surgical system suitable for high tibial osteotomy, characterized in that it includes: an operating table configured to support a patient; an operating unit including: a first carriage; a robotic arm disposed on the carriage; and surgical instruments configured to be mounted at the end of the robotic arm, the surgical instruments including: a spreading device including a moving mechanism and a maintaining mechanism, wherein the moving mechanism and the maintaining mechanism cooperate during the process of the spreading device inserting into the bone suture to spread two osteotomy surfaces; after the spreading device spreads the two osteotomy surfaces, the moving mechanism and the maintaining mechanism are separated by operation, the maintaining mechanism being configured to keep the two osteotomy surfaces in a spread state for mounting a fixation plate in the spread state; and a control unit configured to control the operating unit to complete the surgical operation.

[0005] Optionally, the control unit includes: a second vehicle; multiple tracer tools respectively disposed at the end of the robotic arm and the patient's leg; an optical locator mounted on the second vehicle, the optical locator being configured to determine the position of the end of the robotic arm and the position of the target surgical site based on the light signals reflected by the tracer tools; and a host computer mounted on the second vehicle, the host computer controlling the operation unit to complete the surgical operation based on the position of the end of the robotic arm and the position of the target surgical site.

[0006] Optionally, the spreading device further includes: a base configured to be mounted on the end of a robotic arm; a drive mechanism mounted on the base; and a locking assembly mounted on the moving mechanism, the locking assembly being configured to allow the moving mechanism and the holding mechanism to engage or disengage; wherein the moving mechanism includes: a positioning moving part mounted on the base; and a movable moving part, a first end of which is rotatably mounted to the first end of the positioning moving part via a first pivot; the holding mechanism includes: a positioning holding part, a first end of which is configured to engage with a second end of the positioning moving part to form a positioning spreading mechanism; and a movable holding part, a first end of which is rotatably mounted to the second end of the positioning holding part via a second pivot, the second end of which is configured to engage with the second end of the movable moving part to form a movable spreading mechanism; the drive mechanism is configured to drive the movable spreading mechanism to rotate relative to the positioning spreading mechanism.

[0007] Optionally, the maintaining mechanism further includes: a support portion, comprising: a first support member disposed on the positioning maintaining portion; a second support member disposed on the movable maintaining portion; a third support member, one end of which is connected to the second support member, and the other end of which slides along the through hole of the first support member during the process of opening the two osteotomy surfaces; and a fixing portion threadedly connected to the third support member, wherein after the opening device opens the two osteotomy surfaces, the fixing portion is rotated from a state of abutting against the movable maintaining portion to a state of abutting against the positioning maintaining portion, thereby continuing to keep the two osteotomy surfaces in an open state after the moving mechanism and the maintaining mechanism are separated.

[0008] This disclosure also provides a control system applicable to the above-described high tibial osteotomy surgical system, comprising: a preoperative planning module, including: a two-dimensional planning unit adapted to perform preoperative two-dimensional planning based on a two-dimensional image of the patient's leg; a three-dimensional planning unit adapted to perform preoperative three-dimensional planning based on a three-dimensional model of the patient's leg and the preoperative two-dimensional planning; and a layout planning unit adapted to simulate the surgical scene based on the preoperative three-dimensional planning; a preoperative preparation module adapted to determine the pose of the target surgical site during the surgical operation based on the three-dimensional model; and an operation control module adapted to control the operation unit to perform surgical operations on the target surgical site based on the preoperative three-dimensional planning.

[0009] Optionally, the preoperative preparation module includes: a preliminary positioning optimization unit, adapted to adjust the pose of the optical positioning device based on the pose of the tracer installed on the patient's leg; and a spatial registration unit, adapted to register feature points on the three-dimensional model with feature positions of the patient's leg on the operating table to obtain a solid model of the leg, and determine the pose of the target surgical site in the actual surgical space based on the solid model and the preoperative three-dimensional planning.

[0010] Optionally, the preoperative preparation module further includes: an automatic positioning optimization unit, which is suitable for adjusting the positioning of the first vehicle after the spatial registration unit completes the registration operation, until the end of the robotic arm meets the conditions for moving to the target surgical site, and is also suitable for adjusting the positioning of the optical positioning device on the second vehicle, until the optical positioning device on the second vehicle meets the conditions for simultaneously tracking multiple tracking tools.

[0011] Optionally, the preoperative preparation module includes: a robotic arm initial pose optimization unit, adapted to determine the final pose of the robotic arm based on the pose of the target surgical site, determine the evaluation parameters of the current pose based on the final pose of the robotic arm, and determine the initial target pose of the robotic arm based on the evaluation parameters; and a robotic arm motion path optimization unit, adapted to generate multiple motion paths of the robotic arm based on the initial target pose and the final pose of the robotic arm, determine the dexterity of the robotic arm corresponding to each interpolation point in each path based on multiple interpolation points in each path, and determine the path with the minimum average dexterity among the multiple paths as the target motion path of the robotic arm.

[0012] Optionally, the preoperative two-dimensional planning includes: determining two-dimensional relevant mechanical information, determining the osteotomy line, determining the location of the two-dimensional target force line, and two-dimensional simulation correction.

[0013] Optionally, the preoperative three-dimensional planning includes: determining three-dimensional related mechanical information, determining the osteotomy surface, determining the position of the three-dimensional target force line, three-dimensional simulation correction, determining the installation position of the fixation plate, determining the spatial position of the screw track and determining the length information of the locking screw, and determining the surgical safety zone.

[0014] According to embodiments of this disclosure, by configuring the spreading device as a movable mechanism and a maintaining mechanism that can be separated and engaged, the osteotomy surface can be spread apart in the engaged state. After the osteotomy surface is spread apart, the movable mechanism and the maintaining mechanism can be separated, allowing the movable mechanism to move away from the osteotomy surface. The maintaining mechanism keeps the two osteotomy surfaces in a spread state, thereby allowing the fixation plate to be installed while the two osteotomy surfaces are spread apart. Furthermore, the installation of the fixation plate is not interfered with by the movable mechanism, thus improving the safety and accuracy of high tibial osteotomy surgery. Attached Figure Description

[0015] Figure 1 This is a perspective view of a high tibial osteotomy surgical system according to an illustrative embodiment of the present disclosure.

[0016] Figure 2 This is a perspective view of the opening device in a mating state according to an illustrative embodiment of the present disclosure.

[0017] Figure 3 This is a perspective view of the opening device in a separated state according to an illustrative embodiment of the present disclosure.

[0018] Figure 4 This is a perspective view from another angle showing the opening device in a separated state according to an illustrative embodiment of the present disclosure.

[0019] Figure 5 This is a perspective view of a moving mechanism according to an illustrative embodiment of the present disclosure.

[0020] Figure 6 This is a perspective view of a holding mechanism according to an illustrative embodiment of the present disclosure.

[0021] Figure 7 This is a perspective view of the movable part according to an illustrative embodiment of the present disclosure.

[0022] Figure 8 This is a perspective view of the positioning and moving part according to an illustrative embodiment of the present disclosure.

[0023] Figure 9 This is a perspective view of the activity maintenance unit according to an illustrative embodiment of the present disclosure.

[0024] Figure 10 This is a perspective view of the positioning and maintaining part according to an illustrative embodiment of the present disclosure.

[0025] Figure 11 This is a perspective view of the connecting plate and adjustment assembly according to an illustrative embodiment of the present disclosure.

[0026] Figure 12 yes Figure 3 Enlarged view of point A in the middle.

[0027] Figure 13 This is a block diagram of a control system according to an illustrative embodiment of the present disclosure.

[0028] Figure 14 This is a block diagram of a preoperative planning module according to an illustrative embodiment of the present disclosure.

[0029] Figure 15 This is a block diagram of a preoperative preparation module according to an illustrative embodiment of the present disclosure.

[0030] Figure 16 This is a perspective view of a tracer according to an illustrative embodiment of the present disclosure.

[0031] Figure 17 This is a schematic diagram of the field of view of an optical positioning device according to an illustrative embodiment of the present disclosure.

[0032] Figure 18 This is a schematic diagram illustrating the angle between the normal direction of the tracing surface of the tracing tool and the normal direction of the center of the optical positioning instrument, according to an illustrative embodiment of the present disclosure.

[0033] Figure 19 This is a perspective view of an osteotomy oscillating saw according to an illustrative embodiment of the present disclosure.

[0034] Figure 20 This is a perspective view of an osteotomy guide plate according to an illustrative embodiment of the present disclosure.

[0035] Figure 21 This is a perspective view of a planar probe according to an illustrative embodiment of the present disclosure.

[0036] Figure 22 This is a perspective view of a spike guide according to an illustrative embodiment of the present disclosure.

[0037] The meanings of the reference numerals in the above figures are as follows:

[0038] 1. Operating table;

[0039] 2. Operations section;

[0040] 21. The first car;

[0041] 22. Robotic arm;

[0042] 23. Surgical instruments;

[0043] 231. Spreading device;

[0044] 2311. Moving mechanism;

[0045] 23111. Positioning and moving part; 23112. Movable moving part; 4. Folded edge;

[0046] 23113, First Pivot;

[0047] 2312. Maintenance mechanism;

[0048] 23121. Positioning maintenance unit; 23122. Movement maintenance unit; 23123. Second pivot;

[0049] 23124. Support section;

[0050] 51. First support member; 52. Second support member; 53. Third support member; 54. Fixing part;

[0051] 23125. Embedded hole;

[0052] 2313. Base;

[0053] 23131. Fixture;

[0054] 2314. Drive mechanism;

[0055] 23141. Drive motor;

[0056] 23142, Lead screw;

[0057] 23143, Guide rod;

[0058] 23144, Driver Block;

[0059] 23145. Connecting plate;

[0060] 23146. Adjustment components;

[0061] 61. Adjusting block;

[0062] 7. Slide groove;

[0063] 62. Positioning button;

[0064] 63. The Third Pivot;

[0065] 2315. Locking assembly;

[0066] 23151. Mounting bracket;

[0067] 23152. Rotating plate;

[0068] 8. Receiving tank;

[0069] 23153, Fourth Pivot; 23154, Locking Button;

[0070] 2316. Boss;

[0071] 2317. Groove;

[0072] 232. Osteotomy guide plate;

[0073] 2321. Guide plate body;

[0074] 2322, First guide groove;

[0075] 2323, Second guide groove;

[0076] 233. Planar probe;

[0077] 2331. Measuring plate;

[0078] 234. Osteotomy oscillating saw;

[0079] 2341. Saw blade

[0080] 2342. Compression structure;

[0081] 2343. Oscillating structure;

[0082] 2344. Saw body moving structure;

[0083] 2345. Handle;

[0084] 2346. Connecting platform;

[0085] 2347. Temperature sensor;

[0086] 235. Spike guide;

[0087] 2351. Guide body;

[0088] 2352, Guide hole;

[0089] 3. Control Department;

[0090] 31. The second vehicle;

[0091] 32. Tracing tools;

[0092] 321. Tracer;

[0093] 3211, Reflective sphere;

[0094] 3212. Tracer surface;

[0095] 3213, First Link;

[0096] 3214, Second Link;

[0097] 3215, slider;

[0098] 3216. Bone needles;

[0099] 3217. Knob;

[0100] 33. Optical positioning device;

[0101] 34. Host computer;

[0102] 35. Cantilever;

[0103] 900. Control system;

[0104] 910. Preoperative planning module;

[0105] 911. Two-dimensional programming unit;

[0106] 912. Three-dimensional planning unit;

[0107] 913. Layout planning unit;

[0108] 920. Preoperative preparation module;

[0109] 921. Preliminary placement optimization unit;

[0110] 922. Spatial registration unit;

[0111] 923. Automatic placement optimization unit;

[0112] 924. Initial pose optimization unit for robotic arm;

[0113] 925. Robotic arm motion path optimization unit;

[0114] 930. Operation control module. Detailed Implementation

[0115] To make the objectives, technical solutions, and advantages of this disclosure clearer, the following detailed description is provided in conjunction with specific embodiments and the accompanying drawings.

[0116] However, it should be understood that these descriptions are exemplary only and are not intended to limit the scope of this disclosure. In the following detailed description, numerous specific details are set forth to provide a thorough understanding of embodiments of this disclosure for ease of explanation. However, it will be apparent that one or more embodiments may be practiced without these specific details. Furthermore, descriptions of well-known technologies are omitted in the following description to avoid unnecessarily obscuring the concepts of this disclosure.

[0117] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit this disclosure. The term "comprising" as used herein indicates the presence of features, steps, or operations, but does not exclude the presence or addition of one or more other features.

[0118] When using expressions such as "at least one of A, B, and C," the expression should generally be interpreted in accordance with the meaning commonly understood by a person skilled in the art (e.g., "a system having at least one of A, B, and C" should include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B, having A and C, having B and C, and / or having A, B, and C, etc.). Similarly, when using expressions such as "at least one of A, B, or C," the expression should generally be interpreted in accordance with the meaning commonly understood by a person skilled in the art (e.g., "a system having at least one of A, B, or C" should include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B, having A and C, having B and C, and / or having A, B, and C, etc.).

[0119] Figure 1 This is a perspective view of an intelligent surgical system for high tibial osteotomy according to an illustrative embodiment of the present disclosure. Figure 2 This is a perspective view of the opening device in a mating state according to an illustrative embodiment of the present disclosure. Figure 3 This is a perspective view of the opening device in a separated state according to an illustrative embodiment of the present disclosure. Figure 4 This is a perspective view from another angle showing the opening device in a separated state according to an illustrative embodiment of the present disclosure.

[0120] like Figures 1 to 4 As shown, embodiments of this disclosure provide an intelligent surgical system suitable for high tibial osteotomy. The intelligent surgical system may include an operating table 1, an operating unit 2, and a control unit 3.

[0121] Specifically, the operating table 1 can be used to support the patient. The operating unit 2 can be used to perform surgical procedures. Surgical procedures may include osteotomy, dislocation, and fixation plate installation. The control unit 3 can be used to control the operating unit 2 to complete the surgical procedures.

[0122] In detail, the operating unit 2 may include a first carriage 21, a robotic arm 22, and surgical instruments 23. The robotic arm 22 may be mounted on the first carriage 21. The surgical instruments 23 may be mounted on the end of the robotic arm 22. The surgical instruments 23 may include various devices for surgery. For example, the surgical instruments 23 may include osteotomy guides, pin guides, osteotomy oscillating saws, and retraction devices. The osteotomy oscillating saw can be used for osteotomy operations to create a bone suture at the target surgical site. After the bone suture is formed, the retraction device 231 can be used to open the two osteotomy surfaces to install a fixation plate while the two osteotomy surfaces are in an open state.

[0123] Furthermore, the spreading device 231 may include a moving mechanism 2311 and a maintaining mechanism 2312. During the process of the spreading device 231 inserting into the bone suture to spread the two osteotomy surfaces, the moving mechanism 2311 and the maintaining mechanism 2312 can be operated to maintain their engagement. After the spreading device 231 has spread the two osteotomy surfaces, the moving mechanism 2311 and the maintaining mechanism 2312 can be operated to separate them. After the moving mechanism 2311 and the maintaining mechanism 2312 are separated, the maintaining mechanism 2312 can be used to keep the two osteotomy surfaces in a spread state so that the fixation plate can be installed while the two osteotomy surfaces are in a spread state.

[0124] According to embodiments of this disclosure, by configuring the spreading device 231 as a movable mechanism 2311 and a maintaining mechanism 2312 that can be separated and engaged, the spreading device 231 can spread the osteotomy surface when engaged. After spreading the osteotomy surface, by separating the movable mechanism 2311 and the maintaining mechanism 2312, the movable mechanism 2311 can be moved away from the osteotomy surface. The maintaining mechanism 2312 can keep the two osteotomy surfaces in a spread state, thereby allowing the fixation plate to be installed while the two osteotomy surfaces are spread, and the installation of the fixation plate will not be interfered with by the movable mechanism 2311, thereby improving the safety and accuracy of high tibial osteotomy surgery.

[0125] like Figure 1 As shown, in some embodiments, the control unit 3 may include a second carriage 31, multiple tracking tools 32, an optical locator 33, and a host computer 34. Specifically, the multiple tracking tools 32 may be respectively disposed at the end of the robotic arm 22 and the patient's leg. The optical locator 33 may be mounted on the second carriage 31. The optical locator 33 can be used to determine the position of the end of the robotic arm 22 and the position of the target surgical site based on the light signals reflected by the tracking tools 32. The host computer 34 may be mounted on the second carriage 31. The host computer 34 controls the operation unit 2 to complete the surgical operation based on the position of the end of the robotic arm 22 and the position of the target surgical site.

[0126] Figure 5 This is a perspective view of a moving mechanism according to an illustrative embodiment of the present disclosure. Figure 6 This is a perspective view of a holding mechanism according to an illustrative embodiment of the present disclosure. Figure 7 This is a perspective view of the movable part according to an illustrative embodiment of the present disclosure. Figure 8 This is a perspective view of the positioning and moving part according to an illustrative embodiment of the present disclosure.

[0127] like Figures 2 to 8 As shown, in some embodiments, the spreading device 231 may further include a base 2313, a drive mechanism 2314, and a locking assembly 2315. The base 2313 may be mounted on the end of the robotic arm 22. The drive mechanism 2314 may be mounted on the base 2313. The locking assembly 2315 may be mounted on the moving mechanism 2311. The locking assembly 2315 may be used to allow the moving mechanism 2311 and the holding mechanism 2312 to engage or disengage. Further, by operating the locking assembly 2315, the moving mechanism 2311 and the holding mechanism 2312 can remain engaged during the process of the spreading device 231 inserting into the bone suture to spread the two osteotomy surfaces. After the spreading device 231 has spread the two osteotomy surfaces, the moving mechanism 2311 and the holding mechanism 2312 can be disengaged by operating the locking assembly 2315.

[0128] Furthermore, the moving mechanism 2311 may include a positioning moving part 23111 and a movable moving part 23112. The positioning moving part 23111 may be mounted on the base 2313. The first end of the movable moving part 23112 (e.g., Figure 5 The left end of the movable part 23112 shown can be rotatably mounted on the first end of the positioning part 23111 via the first pivot 23113 (e.g., the left end of the movable part 23112 shown). Figure 5 (The left end of the positioning and moving part 23111 shown).

[0129] Figure 9 This is a perspective view of the activity maintenance unit according to an illustrative embodiment of the present disclosure. Figure 10 This is a perspective view of the positioning and maintaining part according to an illustrative embodiment of the present disclosure.

[0130] like Figures 5 to 10 As shown, in some embodiments, the maintaining mechanism 2312 includes a positioning maintaining part 23121 and a moving maintaining part 23122. The first end of the positioning maintaining part 23121 (e.g., ...) Figure 6 The positioning holding part 23121 shown (in the direction facing the paper) can be connected to the second end of the positioning moving part 23111 (e.g., Figure 5 The positioning moving part 23111 shown (facing the paper) engages to form a positioning opening mechanism, for example, by engaging a shape-matching boss 2316 and a groove 2317. The first end of the movable holding part 23122 (as shown) Figure 6 The right end of the movable holding part 23122 shown is rotatably mounted to the second end of the positioning holding part 23121 via the second pivot 23123 (e.g., the right end of the movable holding part 23122 shown). Figure 6 The right end of the positioning holding part 23121 shown). The second pivot 23123 can be parallel to the first pivot 23113. The second end of the movable holding part 23122 (as shown) Figure 6 The direction of the movable holding part 23122 (as shown) towards the paper can be used with the movable moving part 23112 (such as... Figure 5 The second end of the movable part 23112 (facing the paper) is engaged to form a movable opening mechanism, for example, by engaging a boss 2316 and a groove 2317 with matching shapes. The drive mechanism 2314 is configured to drive the movable opening mechanism to rotate relative to the positioning opening mechanism so that the drive movable opening mechanism and the positioning opening mechanism form an angle.

[0131] Figure 11 This is a perspective view of the connecting plate and adjustment assembly according to an illustrative embodiment of the present disclosure. Figure 12 yes Figure 3 Enlarged view of point A in the middle.

[0132] like Figures 3 to 12As shown, the drive mechanism 2314 may include a drive motor 23141, a lead screw 23142, a guide rod 23143, a drive block 23144, a connecting plate 23145, and an adjustment assembly 23146. The drive motor 23141 can be mounted on a fixed seat 23131 of the base 2313. The lead screw 23142 extends in a direction perpendicular to the positioning moving part 23111, is rotatably mounted on the fixed seat 23131 of the base 2313, and rotates under the drive of the drive motor 23141 to drive the drive block 23144 to move. The guide rod 23143 is mounted on the base 2313 and parallel to the lead screw 23142 to guide the movement of the drive block 23144. The connecting plate 23145 is slidably mounted on the drive block 23144 via a slide rail in a direction parallel to the positioning moving part 23111. The adjustment assembly 23146 may include an adjustment block 61, a positioning knob 62, and a third pivot 63. The adjustment assembly 23146 is rotatably mounted to the end of the connecting plate 23145 via the third pivot 63. The third pivot 63 is parallel to the first pivot 23113. The adjustment assembly 23146 is detachably mounted to the flange 4 on the positioning moving part 23111, so that it drives the movable opening mechanism to rotate relative to the positioning opening mechanism and open at an included angle as the driving block 23144 moves.

[0133] Furthermore, the adjusting block 61 is provided with a slide groove 7. The slide groove 7 is configured to allow the flange 4 on the positioning moving part 23111 to slide into the slide groove 7 to adjust the position of the adjusting block 61 on the flange 4. The positioning button 62 is threaded to the adjusting block 61 and is configured to rotate into the slide groove 7 and engage with the movable moving part 23112 to prevent the adjusting block 61 from sliding relative to the movable moving part 23112.

[0134] According to an embodiment of this disclosure, during the process of the drive mechanism 2314 driving the movable opening mechanism to rotate away from the positioning opening mechanism, the drive motor 23141 is activated. The drive motor 23141 drives the lead screw 23142 to rotate, and the guide rod 23143 guides the drive block 23144, causing the drive block 23144 to reciprocate along the lead screw 23142. During the process of the drive block 23144 moving away from the positioning opening mechanism, the connecting plate 23145 moves with the drive block 23144 in the direction away from the positioning opening mechanism, and the connecting plate 23145 slides relative to the drive block 23144 in a direction parallel to the positioning moving part 23111. At this time, the adjusting component 23146 rotates around the third pivot 63, so as to drive the movable opening mechanism to rotate relative to the positioning moving part 23111 and open at an angle with the movement of the drive block 23144, so that the outer walls of the positioning opening mechanism and the movable opening mechanism respectively fit against the inner wall of the bone suture, which can improve the convenience of use.

[0135] like Figure 12As shown, according to an embodiment of this disclosure, the locking assembly 2315 includes a mounting base 23151, a rotating plate 23152, a fourth pivot 23153, and a locking button 23154. The rotating plate 23152 has a receiving groove 8. There can be two locking assemblies 2315. The locking assemblies 2315 can be mounted on the end of the positioning moving part 23111 and the end of the movable moving part 23112 of the moving mechanism 2311, respectively, based on the mounting base 23151. The fourth pivot 23153 is perpendicular to either the positioning moving part 23111 or the movable moving part 23112. The rotating plate 23152 is rotatably connected to the mounting base 23151 via the fourth pivot 23153. The rotating plate 23152 has a locked state in which it rotates to be close to the positioning holding part 23121 to allow the positioning holding part 23121 to extend into the receiving groove 8, thereby keeping the positioning moving part 23111 and the positioning holding part 23121 in the same plane, and an unlocked state in which it rotates away from the positioning holding part 23121 to allow the positioning moving part 23111 to separate relative to the positioning holding part 23121. The rotating plate 23152 also has a locked state in which it rotates to be close to the movable holding part 23122 to allow the movable holding part 23122 to extend into the receiving groove 8, thereby keeping the movable moving part 23112 and the movable holding part 23122 in the same plane, and an unlocked state in which it rotates away from the movable holding part 23122 to allow the movable moving part 23112 to separate relative to the movable holding part 23122.

[0136] Furthermore, the locking button 23154 can be a knob 3217, which is not limited here. The locking button 23154 can be threadedly connected to the rotating plate 23152. The locking button 23154 is configured to rotate into the receiving groove 8 and into the insertion hole 23125 of the positioning holding part 23121 or the movable holding part 23122 to prevent the movable moving part 23112 from separating from the movable holding part 23122 and / or the positioning moving part 23111 from the positioning holding part 23121.

[0137] like Figures 3 to 10As shown, in some embodiments, the holding mechanism 2312 further includes a support portion 23124. The support portion 23124 may include a first support member 51, a second support member 52, a third support member 53, and a fixing portion 54. The fixing portion 54 may include two fixing members. The two fixing members may be two nuts. The diameter of the through hole of the first support member 51 is larger than the outer diameter of the third support member 53. The first support member 51 may be disposed on the positioning holding portion 23121. The first mounting axis of the first support member 51 and the positioning holding portion 23121 may be parallel to the first pivot 23113. The first support member 51 may rotate about the first mounting axis. The second support member 52 may be disposed on the movable holding portion 23122. The second mounting axis of the second support member 52 and the movable holding portion 23122 may be parallel to the first pivot 23113. The second support member 52 may rotate about the second mounting axis. One end of the third support member 53 (e.g. Figure 6 The upper end of the third support member 53 (as shown) is connected to the second support member 52. The other end of the third support member 53 (as shown) Figure 6 The lower end of the third support member 53 shown passes through the through hole of the first support member 51. During the process of opening the two osteotomy surfaces, the second support member 52 slides along the through hole of the first support member 51. The fixing member can be threadedly connected to the third support member 53. After the opening device 231 opens the two osteotomy surfaces, by rotating the fixing part 54 from a state of abutting against the movable holding part 23122 to a state of abutting against the positioning holding part 23121, the two osteotomy surfaces continue to be kept in the opened state after the moving mechanism 2311 and the holding mechanism 2312 separate.

[0138] Figure 13 This is a block diagram of a control system according to an illustrative embodiment of the present disclosure. Figure 14 This is a block diagram of a preoperative planning module according to an illustrative embodiment of the present disclosure. Figure 15 This is a block diagram of a preoperative preparation module according to an illustrative embodiment of the present disclosure.

[0139] This disclosure also provides a control system 900 applicable to the high tibial osteotomy surgical system described above. The control system 900 may include a preoperative planning module 910, a preoperative preparation module 920, and an operation control module 930. The functions of the control system 900 can be implemented using a host computer 34 within the high tibial osteotomy surgical system. Furthermore, 5G communication technology can be used to connect the host computer 34 in the operating room to a remote expert physician's client, enabling real-time transmission of image data, audio / video, and control signals, thereby facilitating remote consultation, remote teaching, surgical planning, and navigation positioning. The expert physician's client can be a mobile phone, computer, or tablet, etc.

[0140] The preoperative planning module 910 may include a two-dimensional planning unit 911, a three-dimensional planning unit 912, and a layout planning unit 913. The two-dimensional planning unit 911 is suitable for performing preoperative two-dimensional planning based on a two-dimensional image of the patient's leg. The three-dimensional planning unit 912 is suitable for performing preoperative three-dimensional planning based on a three-dimensional model of the patient's leg and the preoperative two-dimensional planning. The layout planning unit 913 is suitable for simulating the surgical scenario based on the preoperative three-dimensional planning. The preoperative preparation module 920 is suitable for determining the pose of the target surgical site during the surgical operation based on the three-dimensional model. The operation control module 930 is suitable for controlling the operation unit 2 to perform surgical operations on the target surgical site based on the preoperative three-dimensional planning.

[0141] Two-dimensional images can be generated based on full-length X-ray images of both lower limbs in a weight-bearing position. Based on these images, surgeons can select the surgical side and perform preoperative two-dimensional planning on the corresponding side of the two-dimensional image. For example, choosing either the left or right leg for surgery.

[0142] Furthermore, preoperative two-dimensional planning can include: determining two-dimensional relevant biomechanical information, determining the osteotomy line, determining the location of the two-dimensional target force line, and two-dimensional simulation of orthopedics. Determining two-dimensional relevant biomechanical information involves using a trained two-dimensional force line key point recognition model to obtain multiple point information corresponding to the patient's leg in the two-dimensional image. Multiple point information can generate multiple line information. Multiple line information can obtain multiple distance and angle information, thus determining the two-dimensional relevant biomechanical information of the patient's leg. Point information can include the location information of the femoral head center, the highest point of the greater trochanter of the femur, the lateral point of the distal femoral tangent, the medial point of the distal femoral tangent, the lateral point of the proximal tibial tangent, the medial point of the proximal tibial tangent, the lateral point of the distal tibial tangent, and the medial point of the distal tibial tangent in the two-dimensional image. Line information can include the location information of the lower limb mechanical axis, the femoral mechanical axis, the tibial mechanical axis, the line connecting the femoral head center and the highest point of the greater trochanter of the femur, the tangents of the medial and lateral distal femoral condyles, the medial and lateral tibial plateau tangents, and the tangent of the distal tibial region in the two-dimensional image. Distance information can include the length of both lower limbs and the distance and position of the mechanical axis offset in the two-dimensional image. Angle information can include the angle and position of the mechanical axis offset, the proximal lateral angle of the mechanical femur, the distal lateral angle of the mechanical femur, the proximal medial angle of the mechanical tibia, the distal lateral angle of the mechanical tibia, and the angle between the mechanical tibiofemoral joint lines in the two-dimensional image. Furthermore, doctors can comprehensively judge based on the obtained two-dimensional related biomechanical information and select the appropriate surgical type for the patient. The two-dimensional force line key point recognition model can be trained using two-dimensional X-ray image samples, on which key points can be labeled.

[0143] Determining the osteotomy line involves using a trained 2D force line key point recognition model to obtain the osteotomy point and hinge point based on the surgical type, and then generating the osteotomy line in the 2D image. The line connecting the osteotomy point and the hinge point constitutes the osteotomy line. Taking a medial open wedge tibial high osteotomy as an example, the hinge point can be set approximately 1.5 cm below the lateral tibial plateau, and the osteotomy point can be set approximately 4 cm below the medial tibial plateau.

[0144] Determining the position of the two-dimensional target force line can be achieved by dividing the line connecting the tibial plateau in the two-dimensional image into multiple parts. Doctors can set the relative position of the lower limb force line passing through the tibial plateau in the two-dimensional image according to the degree of wear and tear of the patient's knee cartilage. The medial side of the tibial plateau is 0%, and the lateral side is 100%. The two-dimensional target position can be set as the Fujisawa point, which is the position at 62.5% from the inside to the outside.

[0145] Two-dimensional simulation orthopedics can calculate the osteotomy correction angle using the Miniaci method. Centered on the hinge point, the distal tibia is rotated. When the lower limb force line passes through the two-dimensional target position on the tibial plateau, the angle of rotation of the distal tibia is the osteotomy correction angle, and the correction distance is generated. By training a two-dimensional force line key point recognition model, it can assist doctors in completing preoperative two-dimensional planning, thereby improving surgical preparation efficiency.

[0146] In some embodiments, preoperative three-dimensional planning may include: determining three-dimensional related mechanical information, determining the osteotomy surface, determining the position of the three-dimensional target force line, three-dimensional simulation of correction, determining the installation position of the fixation plate, determining the spatial position of the pin track and determining the length information of the locking screw, and determining the surgical safety zone.

[0147] Furthermore, based on CT scan data, image segmentation and three-dimensional reconstruction can be performed on the femur, tibia, fibula, patella, and other parts of the CT scan data to obtain a three-dimensional model of the patient's two lower limbs. The surgical side in the preoperative three-dimensional planning is determined based on the surgical side determined in the preoperative two-dimensional planning.

[0148] Determining the relevant three-dimensional mechanical information allows for the selection of relevant anatomical landmarks in the three-dimensional model using a trained three-dimensional force line key point recognition model. This generates angular and positional information in the three-dimensional image, including the length of both lower limbs, mechanical axis offset, and angles and positions of the proximal lateral angle of the mechanical femur, the distal lateral angle of the mechanical femur, the proximal medial angle of the mechanical tibia, the distal lateral angle of the mechanical tibia, the angle between the mechanical tibia and femoral joint lines, and the posterior tilt angle of the tibial plateau. The three-dimensional force line key point recognition model can be trained based on three-dimensional model image samples, which can be labeled with key points. Doctors can also perform preoperative two-dimensional and three-dimensional planning on the display panel of the host computer by manually selecting points and clicking on the screen panel to perform preoperative two-dimensional and three-dimensional planning on the two-dimensional and three-dimensional images.

[0149] Determining the osteotomy surface can involve using 2D / 3D image registration algorithms. Based on X-ray data and 3D model data, the spatial coordinate relationship between the X-ray image and the 3D model is obtained, achieving 2D / 3D registration. This allows the osteotomy surface to be automatically generated from the osteotomy line determined in the preoperative 2D planning. Through 2D / 3D registration, the osteotomy surface can be determined relatively quickly.

[0150] Determining the position of the three-dimensional target force line can be achieved by dividing the line connecting the tibial plateau in the three-dimensional model into multiple parts. Doctors can set the relative position of the lower limb force line passing through the tibial plateau in the three-dimensional model according to the degree of wear and tear of the patient's knee cartilage. The inner side of the tibial plateau is 0%, and the outer side is 100%. The three-dimensional target position can be set as the Fujisawa point, which is the position at 62.5% from the inside to the outside.

[0151] Three-dimensional simulation orthopedics involves rotating the distal tibia around the hinge line. When the lower limb force line passes through the three-dimensional target position on the tibial plateau, the angle of rotation of the distal tibia is the osteotomy orthopedic angle. Surgeons can adjust parameters such as the tilt angle between osteotomy surfaces and the orthopedic angle between them based on changes in information such as the posterior tilt angle of the tibial plateau, thereby obtaining a three-dimensional model of the orthopedic tibia after correction.

[0152] The installation position of the fixation plate can be determined based on the corrected 3D tibial model, selecting the type of fixation plate. The fixation plate can be a locking plate. The type of fixation plate can be determined based on a previously recorded model of a locking plate. After placing the fixation plate at the corrected suture site, the length and spatial position of the locking screws used to fix the fixation plate are determined based on the selected fixation plate type and placement position.

[0153] Determining the surgical safety zone can be based on the osteotomy plane and can be customized according to the individual patient's bony structure. This safety zone can include the osteotomy area and safety constraint boundaries. Taking a medial open wedge tibial high osteotomy as an example, the osteotomy plane can include a horizontal osteotomy plane and an ascending osteotomy plane. The angle between the ascending and horizontal osteotomy planes is approximately 110°. A surgical safety zone for horizontal osteotomy can be generated based on requirements such as preserving the lateral 1cm bony hinge and protecting posterior blood vessels and nerves. Similarly, a surgical safety zone for ascending osteotomy can be generated based on requirements such as avoiding the patellar ligament and preserving a suitable tibial tuberosity width of at least 1.5cm. Determining the surgical safety zone can improve the safety of subsequent surgeries.

[0154] According to embodiments of this disclosure, based on the layout planning unit 913, doctors can simulate the layout of hardware devices and the motion of the execution process, enabling them to have a clear understanding of the surgical procedure and better prepare for the surgery. The layout planning unit 913 can be a digital simulation system. Specifically, based on the layout planning unit 913, doctors can simulate the pose of the end effector of the robotic arm 22, the pose of the optical locator 33, and the positions of the first cart 21, the second cart 31, and the operating table 1 according to preoperative 3D planning. Based on the layout planning unit 913, doctors can simulate the motion state of the robotic arm 22 during the surgical procedure according to preoperative 3D planning.

[0155] In some embodiments, the doctor can first arrange the hardware equipment. For example, the patient can be placed in a supine position on the operating table 1. The first carriage 21 is located on the right side of the patient, and the doctor is located on the right side of the first carriage 21 to facilitate the operation of the robotic arm 22. The second carriage 31 is located on the left side of the patient, and the field of view of the optical positioning device 33 is adjusted to face the target surgical site. Furthermore, the inner side of the second carriage 31 can be set 30cm away from the operating table in the horizontal direction, and the lower side of the second carriage 31 can be set 40cm away from the lower side of the operating table 1 in the vertical direction to facilitate the assistant doctor's operation of the host computer 34. The inner side of the first carriage 21 can be set 100cm away from the operating table in the horizontal direction, and the lower side of the first carriage 21 can be set 40cm away from the lower side of the operating table 1 in the vertical direction to avoid affecting the surgeon's subsequent spatial registration operations. Furthermore, the first carriage 21 and the second carriage 31 can be equipped with detection devices such as drive devices and lidar sensors. The preoperative preparation module 920 can detect the positional relationship between the operating table 1, the first cart 21, and the second cart 31 using a lidar sensor, calculate a second position that satisfies the aforementioned positional relationship, and then use a drive device to move the first cart 21 and the second cart 31 from the first position to the second position, thereby realizing the automatic movement function of the first cart 21 and the second cart 31. The first position represents the daily storage location of the first cart 21 and the second cart 31.

[0156] In some embodiments, the preoperative preparation module 920 may include a preliminary positioning optimization unit 921 and a spatial registration unit 922. The preliminary positioning optimization unit 921 is adapted to adjust the pose of the optical locator 33 based on the pose of the tracer 32 mounted on the patient's leg.

[0157] In some embodiments, the optical locator 33 can be used to acquire the spatial pose of the accompanying tracer tool 32. The tracer tool 32 may include a femoral tracer 321, a tibial tracer 321, a point-taking probe, a planar probe 233, etc. Multiple reflective spheres 3211 may be mounted on the tracer tool 32. The optical locator 33 can identify the spatial position information of the reflective spheres 3211 based on the light reflected from the reflective spheres and send this tracer tool 32 information to the preliminary positioning optimization unit 921.

[0158] Figure 16 This is a perspective view of a tracer according to an illustrative embodiment of the present disclosure. Figure 17 This is a schematic diagram of the field of view of an optical positioning device according to an illustrative embodiment of the present disclosure.

[0159] like Figure 16 As shown, the tracer 321 may include a reflective ball 3211, a tracer surface 3212, a first link 3213, a second link 3214, a slider 3215, a bone needle 3216, and a knob 3217. The tracer tool 32 can be installed on the femur and tibia of the leg. Doctors can install the tracer 321 on the femur and tibia respectively. During the installation of the tracer 321, the angle of the first link 3213 and the second link 3214 can be adjusted so that the tracer surface 3212 is within the effective recognition range of the optical positioning device 33, and the tracer surface 3212 can be approximately perpendicular to the field of view of the optical positioning device 33. Furthermore, due to the field of view area of ​​the optical positioning device 33 (e.g., Figure 17 As shown, the recognition accuracy varies at different locations within the limited field of view. The actual installation position and orientation of the tracer 321 affect the operational accuracy of the surgery. The position and orientation of the optical positioning device 33 can be adjusted using the preliminary positioning optimization unit 921 to improve the surgical accuracy.

[0160] The optical positioning device 33 can be mounted on the second vehicle 31 via the cantilever 35. The preliminary positioning optimization unit 921 can communicate with the second vehicle 31, the optical positioning device 33, and the cantilever 35. By mounting the tracer tool 32 on the leg, the optical positioning device 33 can determine the pose of the tracer tool 32 based on the light signal reflected by the reflective ball 3211 on the tracer tool 32. The preliminary positioning optimization unit 921 can determine the target pose of the optical positioning device 33 based on the pose of the tracer tool 32. The pose of the optical positioning device 33 can be flexibly adjusted by controlling each arm of the cantilever 35. The lidar sensor can acquire the current position information of the second vehicle 31 in the operating room and the environmental data of the operating room. The preliminary positioning optimization unit 921 can adjust the pose of the optical positioning device 33 by sending motion commands to the second vehicle 31 and the cantilever 35.

[0161] Furthermore, when adjusting the pose of the optical positioning device 33, distance and angle constraints can be set to optimize the recognition accuracy of the femoral tracer 321 and the tibial tracer 321 by the optical positioning device 33, while avoiding occlusion and interference between the various tracer surfaces 3212, and preventing safety hazards caused by the loss of recognition of the tracer surfaces 3212. The distance constraint can be that the sum of the distances from the centers of multiple tracer surfaces 3212 to the center of the field of view of the optical positioning device 33 is minimized. The angle constraint can be that the angle between the normal direction of the tracer surface 3212 and the normal direction of the optical positioning device 33 is minimized, and the angle between the lines connecting the centers of any two tracer surfaces 3212 to the center of the optical positioning device 33 is greater than or equal to Π / 6.

[0162] In some embodiments, the first vehicle 21 may also be equipped with an emergency stop device, a base, foot pedals, a drive mechanism, and a lidar sensor, among other detection devices. The control system 900 can control the movement of the robotic arm 22, causing the surgical instrument 23 connected to the end of the robotic arm 22 to move to the position in the actual surgical space corresponding to the pre-operative three-dimensional plan, thereby assisting the surgeon in performing the operation. A tracer tool 32 with multiple reflective balls 3211 is installed at the end of the robotic arm 22. During the surgery, the tracer tool 32 is within the field of view of the optical positioning device 33, which can obtain the position information of the surgical instrument 23 connected to the end of the robotic arm 22 in real time through the tracer tool 32. The relative positions of the robotic arm 22, the surgical instrument 23, and the patient can be displayed in real time on the host computer 34. The surgeon can use the foot pedal to control the control system 900, allowing the surgeon to interact with the control system 900 while away from the host computer 34. The lidar sensor can obtain the current position information of the first vehicle 21 in the operating room and environmental data of the operating room.

[0163] According to embodiments of this disclosure, the spatial registration unit 922 is suitable for registering feature points on a three-dimensional model with feature positions of the patient's leg on the operating table 1 to obtain a solid model of the leg. Based on the solid model and preoperative three-dimensional planning, the pose of the target surgical site in the actual surgical space is determined, thus realizing spatial registration between the actual surgical space and the computer virtual space. The feature positions of the leg include the center of the hip joint, the lateral distal femoral condyle, the medial distal femoral condyle, the medial proximal tibia, the lateral proximal tibia, the medial ankle joint, the lateral ankle joint, and the center of the ankle joint.

[0164] In some embodiments, the spatial registration unit 922 can achieve spatial registration by using a point-taking probe. Specifically, feature points are set on the 3D model.

[0165] Feature points may include the virtual hip joint center, the virtual distal femoral lateral condyle, the virtual distal femoral medial condyle, the virtual proximal tibia medial side, the virtual proximal tibia lateral side, the virtual ankle joint medial side, the virtual ankle joint lateral side, and the virtual ankle joint center. During spatial registration, the doctor can support the patient's thigh and rock it around the hip joint center. The spatial registration unit 922 can fit and calculate the physical hip joint center based on the trajectory of the tracer 321 on the patient's leg during the doctor's rocking motion.

[0166] Furthermore, based on experience, doctors can use a sampling probe to select the distal lateral femoral condyle and distal medial femoral condyle on the patient's leg. The spatial registration unit 922 can generate solid distal lateral femoral condyles and solid distal medial femoral condyles through the light signal reflected from the sampling probe.

[0167] Furthermore, based on experience, doctors can use the sampling probe to select the medial side of the proximal tibia, the lateral side of the proximal tibia, the medial side of the ankle joint, and the lateral side of the ankle joint. The spatial registration unit 922 can generate the solid lateral femoral condyle, the solid medial femoral condyle, the solid medial ankle joint, and the solid lateral ankle joint through the light signal reflected from the sampling probe, and determine the center of the solid ankle joint.

[0168] Furthermore, the solid hip joint center, solid distal femoral lateral condyle, solid distal femoral medial condyle, solid proximal tibia medial side, solid proximal tibia lateral side, solid ankle joint medial side, solid ankle joint lateral side, and solid ankle joint center can be represented as solid locations. By matching feature points in the 3D model with the above solid locations, the 3D model can be converted into a solid model that conforms to the actual surgical space.

[0169] Furthermore, feature locations and points can be represented as point cloud data. Taking an open high tibial osteotomy on the medial side of the left leg as an example, a longitudinal incision is made below the medial aspect of the patient's left knee joint. Layer by layer, the pes anserinus and medial collateral ligament are dissected, partially releasing the tibial tuberosity and the posteromedial aspect of the proximal tibia. The surgeon can use a sampling probe to slide and sample points on the exposed bone surface, acquiring point cloud data of the exposed bone surface contour. Point cloud registration technology is then used to register the actual surgical space with the virtual image space. In addition, a structured light scanner can be used to acquire three-dimensional point cloud data of the exposed bone surface, replacing the surgeon's manual sampling process with a sampling probe, thus accelerating the surgical procedure and reducing the difficulty of the operation.

[0170] In some embodiments, the spatial registration unit 922 can utilize a two-dimensional C-arm to achieve spatial registration. Taking tibial registration as an example, a two-dimensional C-arm can be used to perform anteroposterior and lateral imaging of the surgical side, segment the tibial portion of the anteroposterior and lateral X-ray images, and perform two-dimensional and three-dimensional image registration with the three-dimensional model, thereby achieving spatial registration. Specifically, CT scan data can be used to obtain digitally reconstructed radiographic images. Using a similarity measurement function, the degree of similarity between the digitally reconstructed radiographic images and the X-ray images can be obtained. By continuously changing the position and orientation of the CT scan data through an optimization algorithm until the similarity function reaches an extreme value, the position and orientation parameters of the CT scan data at this point are output, thus completing the spatial registration.

[0171] In some embodiments, the spatial registration unit 922 can utilize cone-beam computed tomography (CBCT) to achieve spatial registration. Taking tibial registration as an example, a three-dimensional C-arm can be used to capture images of the surgical side, obtaining CBCT data containing the tibia and tibial imaging feature points. Since the positions of the tibial imaging feature points in the tibial tracer 321 coordinate system are known, the preoperative CT image of the tibia and the intraoperative CBCT image of the tibia are registered in a virtual spatial coordinate system to obtain the positions of the tibial imaging feature points in the virtual spatial coordinate system. This yields the spatial transformation relationship between the tibial tracer 321 coordinate system and the computer virtual spatial coordinate system, thus completing the spatial registration.

[0172] In some embodiments, after spatial registration is completed, the spatial registration unit 922 can automatically generate information such as the patient's lower limb force line during surgery, the relative position of the lower limb force line through the tibial plateau, the posterior tilt angle of the tibial plateau, and limb length on the solid model based on preoperative 3D planning. This information guides the surgeon in adjusting the surgical plan during the operation. Since the solid model is now matched with the human body in the actual surgical space, the pose of the target surgical site in the actual surgical space can be determined, that is, the pose of information such as the osteotomy surface in the target surgical site in the actual surgical space can be determined.

[0173] In some embodiments, the preoperative preparation module 920 further includes an automatic positioning optimization unit 923. Further, after spatial registration, if the relative position of the first carriage 21 is too far from the patient, the robotic arm 22 may not be able to reach the target surgical site during the surgical procedure. The automatic positioning optimization unit 923 is adapted to adjust the positioning of the first carriage 21 after the spatial registration unit 922 completes the registration operation, until the end of the robotic arm 22 meets the conditions for moving to the target surgical site, so that the workspace of the robotic arm 22 can cover the target surgical site, thereby improving the accuracy of the surgical procedure. When adjusting the positioning of the first carriage 21, it is also necessary to ensure that the tracer 321 at the end of the robotic arm 22 is within the field of view of the optical positioning device 33. The positioning of the first carriage 21 can be determined according to the position of the target surgical site. Taking the open wedge tibial high osteotomy of the left medial leg as an example, the coordinate system origin of the base of the robotic arm 22 can be set to be 70cm horizontally from the center of the target surgical site, and the vertical distance is 15cm downwards from the center of the target surgical site. The target surgical site can be the osteotomy area.

[0174] In some embodiments, the automatic positioning optimization unit 923 is adapted to adjust the positioning of the optical positioning device 33 on the second vehicle 31 using a cantilever until the optical positioning device 33 on the second vehicle 31 meets the conditions for simultaneous tracking of multiple tracking tools 32, as well as distance and angle constraints. This optimizes the recognition accuracy of the optical positioning device 33 for the tracking devices 321 on the femur, tibia, and the tracking tools 32 at the end of the robotic arm 22, while preventing occlusion between the tracking surfaces of the various tracking tools 32 and avoiding safety hazards caused by lost tracking surface recognition. The distance constraint can be that the sum of the distances from the centers of multiple tracking surfaces to the center of the field of view of the optical positioning device 33 is minimized. The angle constraint can be that the angle between the normal direction of the tracking surface 3212 and the normal direction of the optical positioning device 33 is minimized, and the angle between the lines connecting the centers of any two tracking surfaces 3212 to the center of the optical positioning device 33 is greater than or equal to Π / 6.

[0175] In some embodiments, the preoperative preparation module 920 includes a robotic arm initial pose optimization unit 924 and a robotic arm motion path optimization unit 925. The robotic arm initial pose optimization unit 924 is adapted to determine the final pose of the robotic arm 22 using inverse kinematics based on the pose of the target surgical site. Evaluation parameters for the current pose are determined based on the final pose of the robotic arm 22. Under pose optimization constraints, an evaluation value is determined based on the evaluation parameters. The pose of the robotic arm 22 with the highest evaluation value is determined as the initial target pose of the robotic arm 22. The evaluation parameters include the motion information m of the robotic arm 22, the dexterity space information β of the robotic arm 22, the field of view angle information γ of the optical locator 33, and the field of view distance information l of the optical locator 33. The pose optimization constraints may include aseptic constraints and angular constraints.

[0176] According to embodiments of this disclosure, the aseptic constraint condition may be to define a certain fixed interval as the aseptic interval, and remove the postures that exceed the aseptic interval from the posture set of the robotic arm 22, that is, to ensure that each joint of the robotic arm 22 is within the aseptic interval.

[0177] Furthermore, the evaluation value f(x,y) can be expressed by the following formula:

[0178]

[0179] Where x represents the x-coordinate of the end effector joint of the robotic arm 22 in its current posture, y represents the y-coordinate of the end effector joint of the robotic arm 22 in its current posture, and m i This represents the i-th motion information in the motion information set m of the surgical robot arm 22 in its current posture.

[0180] When the robotic arm includes 6 joints, the set of dynamic information m can be represented by the following formula:

[0181]

[0182] Where, θ i Let μ be the target angle of the i-th joint. i This represents the current angle of the i-th joint, in radians.

[0183] The dexterity space information β is determined by the dexterity of the robotic arm 22 in the current posture. This dexterity can be determined by the joint angles of the six joints of the robotic arm 22. These joint angles can be read by the teach pendant at the end of the robotic arm 22, and the dexterity space information β can be calculated using the Jacobian matrix. The dexterity space information β can be expressed by the following formula:

[0184]

[0185] Where, σ maxand σ min These represent the maximum and minimum singular values ​​of the Jacobian matrix obtained for the six joint angles, respectively. The smaller β is, the more flexible the robotic arm 22 is in that pose.

[0186] Figure 18 This is a schematic diagram illustrating the angle between the normal direction of the tracing surface of the tracing tool and the normal direction of the center of the optical positioning instrument, according to an illustrative embodiment of the present disclosure.

[0187] The field of view angle information γ of the optical positioning device 33 can be the angle ε between the normal direction of the end effector 32 of the robotic arm 22 and the normal direction of the center of the optical positioning device 33 (e.g., Figure 18 As shown in the figure, the included angle ε can be read by the quaternion of the optical positioning instrument 33.

[0188] The field-of-view distance information l of the optical positioning device 33 can be expressed by the following formula:

[0189]

[0190] Among them, x0, y0, and z0 can be obtained by reading the three-dimensional coordinates of the optical positioning instrument 33.

[0191] In some embodiments, the robotic arm motion path optimization unit 925 is adapted to generate multiple motion paths for the robotic arm 22 based on the initial target pose and final pose of the robotic arm 22 using an interpolation method, such as B-spline interpolation. Each motion path has the same number of interpolation points.

[0192] Under path constraints, based on multiple interpolation points on each motion path, the dexterity of the robotic arm 22 corresponding to each interpolation point in each path is determined. Among multiple paths, the path with the minimum average dexterity is determined as the target motion path of the robotic arm 22. The interpolation point can represent the end effector position of the robotic arm 22 during the motion.

[0193] Path constraints may include ensuring that the shortest distance between the surgical instrument 23 connected to the end of the robotic arm 22 and the tracer 321 on the leg is greater than a preset distance (e.g., the preset distance could be 50 mm) at each interpolation point on the motion path. Path constraints may also include ensuring that the field of view angle γ between the tracer 32 at the end of the robotic arm 22 and the optical locator 33 at each interpolation point on the motion path is within a preset angle range (e.g., the preset angle range could be greater than or equal to -π / 3 and less than or equal to π / 3). Path constraints may also include ensuring that the optical locator 33 can effectively identify the tracer 32 at the end of the robotic arm 22. Path constraints may also include angle constraints.

[0194] After filtering based on the aforementioned path constraints, multiple motion paths are obtained. Inverse kinematics calculations are performed on multiple interpolation points along each path to determine the six joint angles of the robotic arm 22 corresponding to different interpolation points on each path. Using these six joint angles, the dexterity of the robotic arm 22 at each interpolation point is calculated, generating dexterity variation curves for the robotic arm 22 under different motion paths. A valid motion path is defined as one where the maximum dexterity value does not exceed a predetermined threshold (e.g., 3.8). The average dexterity values ​​corresponding to multiple interpolation points for each obtained motion path are calculated, and the motion path with the smallest average dexterity value is the target motion path for the robotic arm 22. After completing the above optimization process, the motion of the robotic arm 22 at different operation stages can be simulated in a digital simulation system to ensure that the robotic arm 22 does not collide with the patient or the tracking tool 32 on the patient during movement. Meanwhile, the tracer tool 32 at the end of the robotic arm 22 and the tracer tool 32 on the patient can be effectively identified by the optical locator and the accuracy of the positioning of the robotic arm 22 can be verified.

[0195] In some embodiments, different surgical instruments 23 are required for different surgical stages. The end effector of the robotic arm 22 can be equipped with a quick-release tool, enabling rapid replacement of different surgical instruments 23, thereby completing the entire process of high tibial osteotomy. Specifically, in the osteotomy stage, the surgical instrument 23 at the end effector of the robotic arm 22 is an osteotomy guide plate 232, an osteotomy oscillating saw 234, or a laser osteotomy device. In the distraction stage, the surgical instrument 23 at the end effector of the robotic arm 22 is a distraction device 231. In the plate installation stage, the surgical instrument 23 at the end effector of the robotic arm 22 is a pin guide 235.

[0196] Figure 19 This is a perspective view of an osteotomy oscillating saw according to an illustrative embodiment of the present disclosure. Figure 20 This is a perspective view of an osteotomy guide plate according to an illustrative embodiment of the present disclosure. Figure 21 This is a perspective view of a planar probe according to an illustrative embodiment of the present disclosure.

[0197] Furthermore, osteotomy can be performed using different operating methods during the osteotomy stage. For example, there are passive and semi-active operating modes. In passive operating mode, the surgical instrument 23 can be an osteotomy guide plate 232. By controlling the movement of the robotic arm 22, the guide groove of the osteotomy guide plate 232 is aligned with the osteotomy surface of the target surgical site. The surgeon can then use a handheld osteotomy oscillating saw 234 to perform osteotomy on the patient's leg along the guide groove.

[0198] like Figure 19As shown, the osteotomy oscillating saw 234 may include a saw blade 2341 clamping structure 2342, an oscillating structure 2343, a saw body moving structure 2344, a handle 2345, a connecting platform 2346, and a temperature sensor 2347. The saw blade 2341 clamping structure 2342 can be used to clamp and release the saw blade 2341. The oscillating structure 2343 can be used to control the periodic oscillation of the saw blade 2341. The saw body moving structure 2344 can be used to control the forward and backward movement of the oscillating structure 2343 and the saw blade 2341 clamping structure 2342. The handle 2345 is convenient for doctors to hold and operate, and also has a stepless speed adjustment button, allowing doctors to adjust the oscillation frequency of the saw blade 2341 by pressing a switch. The connecting platform 2346 can be used to connect the tracer tool 32 in passive working mode, and to be mounted on the quick-release tool interface at the end of the robotic arm 22 in semi-active working mode. The temperature sensor 2347 can be used to detect the cutting temperature during the cutting process.

[0199] like Figure 20 As shown, the osteotomy guide plate 232 includes a guide plate body 2321, a first guide groove 2322, and a second guide groove 2323. The first guide groove 2322 and the second guide groove 2323 are located at the same end of the guide plate body 2321 and intersect at a certain angle. The other end of the guide plate body 2321 can be connected to the interface provided by the quick-release tool at the end of the robotic arm 22. The included angle between the first guide groove 2322 and the second guide groove 2323 can be 110°. The first guide groove 2322 and the second guide groove 2323 can guide the osteotomy oscillating saw 234 to be positioned in two directions, which can reduce the range of motion of the robotic arm 22 when switching between different osteotomy surfaces (such as horizontal osteotomy surface and ascending osteotomy surface), thereby reducing the risk of collision. After positioning, the doctor can use the measuring plate 2331 of the planar probe 233 to insert into the first guide groove 2322 or the second guide groove 2323 to determine the spatial position of the first guide groove 2322 or the second guide groove 2323. In this mode, a tracer tool 32 can be installed on the osteotomy oscillating saw 234. The optical locator 33 can obtain the position information of the osteotomy oscillating saw 234 in real time through the tracer 321 on the osteotomy oscillating saw 234, and display the relative position between the osteotomy oscillating saw 234 and the patient, as well as the planned surgical safety zone, on the host computer 34 in real time.

[0200] In the semi-active working mode, the surgical instrument 23 can be an osteotomy oscillating saw 234 or a laser osteotomy device. By controlling the movement of the robotic arm 22, the plane of the saw blade 2341 of the osteotomy oscillating saw 234 or the emission source of the laser osteotomy device is aligned with the osteotomy surface of the target surgical site. The surgeon can achieve motion control of the osteotomy oscillating saw 234 or the laser osteotomy device through coordinated operation with the robotic arm 22, thereby completing the osteotomy operation on the patient's leg. In this mode, the tracer tool 32 at the end of the robotic arm 22 can display the relative position between the osteotomy oscillating saw 234 or the laser osteotomy device and the patient, as well as the planned surgical safety zone, in real time on the host computer 34. Compared with the osteotomy oscillating saw, the laser osteotomy device can perform more precise osteotomy depth control according to the set surgical safety zone, resulting in less vibration and thermal damage, which is conducive to minimally invasive surgery.

[0201] In some embodiments, the control system 900 may also be equipped with multiple safety protection mechanisms. During osteotomy, the surgical safety zone constrains the movement area of ​​the oscillating saw in real time. When the end of the saw blade 2341 is about to exceed the planned osteotomy safety boundary, the oscillating saw will trigger the movement of the saw body moving structure 2344 and sound an alarm. If the end of the oscillating saw blade 2341 exceeds the planned osteotomy safety boundary, the robotic arm 22 will trigger an emergency stop signal and the oscillating saw will be powered off. An LED light may be installed at the end of the robotic arm. When the end of the saw blade 2341 is about to exceed the planned osteotomy safety boundary, the LED light will flash to indicate this. The oscillating saw is equipped with force sensors and temperature sensors 2347, which automatically adjust the working frequency of the oscillating saw according to the cutting force and temperature during the operation. This achieves safety feedback by fusing multiple information such as position, force, and temperature.

[0202] Furthermore, during the dislocation phase, the surgical safety zone can constrain the movement area of ​​the dislocation device 231, preventing excessive insertion depth that could lead to hinge fracture. During dislocation, the pressure sensor on the dislocation device 231 can measure the pressure generated in the bone suture in real time. By controlling the rotation speed of the drive motor 23141 to keep the pressure generated in the bone suture below a safe threshold, excessive dislocation speed can be prevented from causing hinge fracture. Furthermore, reflective balls 3211 can be installed on the positioning and holding parts 23121 and the movement and holding parts 23122, respectively. The positional changes between the reflective balls 3211, detected by the optical positioning device 33, can be used to measure the dislocation angle of the bone suture in real time. The dislocation angle information can be displayed in real time on the host computer 34. After the dislocation angle reaches the osteotomy and correction angle planned in the three-dimensional plan, the drive motor is stopped, maintaining the dislocation angle of the bone suture at the osteotomy and correction angle. Then, the moving mechanism 2311 and the holding mechanism 2312 are separated, and the moving mechanism 2311 is withdrawn.

[0203] Figure 22 This is a perspective view of a spike guide according to an illustrative embodiment of the present disclosure.

[0204] During the fixation plate installation phase, surgical instrument 23 can be a pin guide 235. The pin guide 235 may include a guide body 2351 and a guide hole 2352. At least two pin paths can be selected based on the actual surgical situation. Based on the spatial position information of the selected pin paths, the axis of the guide hole 2352 of the pin guide 235 can be aligned with the pin path to assist the surgeon in inserting Kirschner wires and positioning the fixation plate screw holes. The selected fixation plate is then placed, and locking screws in different hole positions are driven in accordingly.

[0205] In some embodiments, the control system 900 may also be equipped with an intelligent auxiliary evaluation system. This system monitors various patient indicators and parameters of the high tibial osteotomy surgical system during the operation, and tracks the patient's surgical outcome and recovery after the operation. Mathematical models and algorithms are established to quantitatively evaluate the effectiveness of the high tibial osteotomy surgical system, facilitating physician follow-up on the patient's condition.

[0206] The embodiments of this disclosure have been described in detail above with reference to the accompanying drawings. It should be noted that implementations not illustrated or described in the drawings or the main text of the specification are forms known to those skilled in the art and have not been described in detail. Furthermore, the definitions of the various components described above are not limited to the specific structures, shapes, or methods mentioned in the embodiments, and those skilled in the art can easily modify or substitute them.

[0207] It should also be noted that, in the specific embodiments of this disclosure, unless otherwise stated otherwise, the numerical parameters in this specification and the appended claims are approximate values ​​and can be changed according to the desired characteristics obtained from the content of this disclosure. Specifically, all numbers used in the specification and claims to indicate dimensions, range conditions, etc., of the composition should be understood to be modified by the term "about" in all cases. Generally, this means that there may be variations of ±10% in some embodiments, ±5% in some embodiments, ±1% in some embodiments, and ±0.5% in some embodiments.

[0208] Those skilled in the art will understand that the features described in the various embodiments and / or claims of this disclosure can be combined or combined in various ways, even if such combinations or combinations are not explicitly described in this disclosure. In particular, the features described in the various embodiments and / or claims of this disclosure can be combined or combined in various ways without departing from the spirit and teachings of this disclosure. All such combinations and / or combinations fall within the scope of this disclosure.

[0209] The above specific embodiments further illustrate the purpose, technical solutions and beneficial effects of this disclosure. It should be understood that the above are only specific embodiments of this disclosure and are not intended to limit this disclosure. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this disclosure should be included within the protection scope of this disclosure.

Claims

1. An intelligent surgical system suitable for high tibial osteotomy, characterized in that, include: The operating table was configured to support the patient. The operating unit includes: The first car; A robotic arm is mounted on the first vehicle; and Surgical instruments, configured to be mounted at the end of the robotic arm, the surgical instruments comprising: A dispersing device includes a moving mechanism and a maintaining mechanism. During the process of the dispersing device being inserted into the bone suture to dissipate the two osteotomy surfaces, the moving mechanism and the maintaining mechanism remain engaged. After the dispersing device dissipates the two osteotomy surfaces, the moving mechanism and the maintaining mechanism are separated by operation. The maintaining mechanism is configured to keep the two osteotomy surfaces in the dissipated state for mounting a fixation plate in the dissipated state. The dispersing device includes: The base is configured to be mounted at the end of the robotic arm; The drive mechanism is mounted on the base; and A locking assembly is mounted on the moving mechanism, the locking assembly being configured to allow the moving mechanism and the holding mechanism to engage or disengage; The moving mechanism includes: The positioning and moving part is mounted on the base; and A movable part, the first end of which is rotatably mounted to the first end of the positioning movable part via a first pivot; The maintenance mechanism includes: A positioning maintaining part, wherein a first end of the positioning maintaining part is configured to cooperate with a second end of the positioning moving part to form a positioning spreading mechanism; and A movable holding part, the first end of which is rotatably mounted to the second end of the positioning holding part via a second pivot, the second end of which is configured to cooperate with the second end of the movable moving part to form a movable spreading mechanism, and the driving mechanism being configured to drive the movable spreading mechanism to rotate relative to the positioning spreading mechanism; and A control unit, configured to control the operating unit to perform surgical operations, includes: Multiple tracer devices are respectively positioned at the end of the robotic arm and on the patient's leg; and An optical locator is configured to determine the position of the end effector of the robotic arm and the position of the target surgical site based on the light signal reflected by the tracer.

2. The intelligent surgical system according to claim 1, characterized in that, The control unit includes: The second vehicle, on which the optical positioning device is installed; A host computer is installed on the second vehicle. The host computer controls the operating unit to complete the surgical operation based on the position of the end of the robotic arm and the position of the target surgical site.

3. The intelligent surgical system according to claim 2, characterized in that, The maintenance mechanism also includes: Support components, including: A first support member is disposed on the positioning and maintaining part; A second support member is provided on the movable support part; A third support member, one end of which is connected to the second support member, and the other end of which slides along the through hole of the first support member during the process of opening the two osteotomy surfaces; and The fixing part is threadedly connected to the third support member. After the two osteotomy surfaces are opened by the opening device, the fixing part is rotated from a state of abutting against the movable holding part to a state of abutting against the positioning holding part, so that the two osteotomy surfaces continue to be kept in the opened state after the moving mechanism and the holding mechanism are separated.

4. A control system for the intelligent surgical system according to any one of claims 2 to 3, comprising: The preoperative planning module includes: Two-dimensional planning unit, suitable for preoperative two-dimensional planning based on two-dimensional images of the patient's legs; A three-dimensional planning unit is used to perform preoperative three-dimensional planning based on a three-dimensional model of the patient's leg and the preoperative two-dimensional planning, and to determine the osteotomy and correction angles; and The layout planning unit is suitable for simulating surgical scenarios based on the aforementioned preoperative three-dimensional planning. The preoperative preparation module is suitable for determining the pose of the target surgical site during the surgical procedure based on the aforementioned 3D model; and The operation control module is suitable for performing surgical operations on the target surgical site based on the preoperative three-dimensional planning control operation unit. During the process of opening the bone suture, the pressure generated by the bone suture can be measured in real time by the pressure sensor on the opening device. The rotation speed of the drive mechanism is controlled to keep the pressure generated by the bone suture below a safe threshold. Tracer tools are installed on the positioning maintenance unit and the movement maintenance unit respectively. The positional change between the tracer tools detected by the optical positioning instrument can measure the opening angle of the bone suture in real time. After the opening angle is adjusted to the osteotomy correction angle in the three-dimensional planning unit, the drive mechanism is controlled to stop rotating, so that the opening angle of the bone suture is maintained at the osteotomy correction angle. Then, the moving mechanism and the maintenance mechanism are separated, and the moving mechanism is withdrawn.

5. The control system according to claim 4, characterized in that, The preoperative preparation module includes: A preliminary positioning optimization unit is adapted to adjust the pose of the optical locator based on the pose of a tracer mounted on the patient's leg; and The spatial registration unit is suitable for registering feature points on the three-dimensional model with feature positions of the patient's leg on the operating table to obtain a solid model of the leg, and determining the pose of the target surgical site in the actual surgical space based on the solid model and the preoperative three-dimensional planning.

6. The control system according to claim 4, characterized in that, The preoperative preparation module also includes: The automatic positioning optimization unit is suitable for adjusting the positioning of the first vehicle after the spatial registration unit has completed the registration operation, until the end of the robotic arm meets the conditions for moving to the target surgical site, and is also suitable for adjusting the positioning of the optical positioning device on the second vehicle, until the optical positioning device on the second vehicle meets the conditions for simultaneously tracking multiple tracking tools.

7. The control system according to claim 4, characterized in that, The preoperative preparation module includes: The robotic arm initial pose optimization unit is suitable for determining the final pose of the robotic arm based on the pose of the target surgical site, determining the evaluation parameters of the current pose based on the final pose of the robotic arm, and determining the initial target pose of the robotic arm based on the evaluation parameters. The robotic arm motion path optimization unit is suitable for generating multiple motion paths for the robotic arm based on the initial target pose and final pose of the robotic arm. Based on multiple interpolation points on each motion path, it determines the dexterity of the robotic arm corresponding to each interpolation point in each path, and determines the path with the minimum average dexterity among the multiple paths as the target motion path of the robotic arm.

8. The control system according to claim 4, characterized in that, The preoperative two-dimensional planning includes: determining two-dimensional relevant mechanical information, determining the osteotomy line, determining the location of the two-dimensional target force line, and two-dimensional simulation of correction.

9. The control system according to claim 4, characterized in that, The preoperative three-dimensional planning includes: determining three-dimensional related mechanical information, determining the osteotomy surface, determining the position of the three-dimensional target force line, three-dimensional simulation of correction, determining the installation position of the fixation plate, determining the spatial position of the screw track and determining the length information of the locking screw, and determining the surgical safety zone.

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