CN117918911A

CN117918911A - Intelligent operation system suitable for tibia high osteotomy and control system thereof

Info

Publication number: CN117918911A
Application number: CN202410177173.4A
Authority: CN
Inventors: 王树新; 马信龙; 韩佳奇; 关佳奇; 王铭智; 谭景文; 周伊广; 吕奕欧; 石羽萌; 张鑫鹏
Original assignee: Institute Of Medical Robot And Intelligent System Tianjin University
Current assignee: Institute Of Medical Robot And Intelligent System Tianjin University
Priority date: 2024-02-08
Filing date: 2024-02-08
Publication date: 2024-04-26

Abstract

The present disclosure provides an intelligent surgical system suitable for high tibial osteotomies and a control system thereof, the intelligent surgical system comprising: an operating table configured to support a patient; an operation unit including: a first carriage; the mechanical arm is arranged on the trolley; and a surgical instrument configured to be mounted to a distal end of the robotic arm, the surgical instrument comprising: the expanding device comprises a moving mechanism and a maintaining mechanism, and the moving mechanism and the maintaining mechanism are kept to be matched in the process that the expanding device is inserted into a bone fracture to expand two bone cutting surfaces; after the two osteotomy faces are propped up by the prop-up device, the moving mechanism and the maintaining mechanism are separated through operation, and the maintaining mechanism is configured to enable the two osteotomy faces to keep in a prop-up state so as to install the fixing plate in the prop-up state; and a control section configured to control the operation section to complete the surgical operation.

Description

Intelligent operation system suitable for tibia high osteotomy and control system thereof

Technical Field

The disclosure relates to the technical field of tibial high osteotomies, in particular to an intelligent surgical system suitable for tibial high osteotomies and a control system thereof.

Background

High tibial osteotomies are an important surgical modality for the treatment of early and mid-knee osteoarthritis. The lower limb force line can be transferred from the affected side compartment to the normal compartment through the proximal tibia osteotomy mode, so that the purposes of relieving the pain of the knee joint and improving the function of the knee joint can be achieved. The related tibia high osteotomy has high requirements on the experience of doctors, and has the defects of lower efficiency, lower precision and lower safety.

Disclosure of Invention

To at least partially overcome at least one of the above-mentioned technical drawbacks of the other inventions, at least one embodiment of the present disclosure provides an intelligent surgical system and control system thereof suitable for high tibial osteotomies, which may improve the safety and accuracy of the high tibial osteotomies.

In view of this, an embodiment of the present disclosure provides an intelligent surgical system suitable for high tibial osteotomies, comprising: an operating table configured to support a patient; an operation unit including: a first carriage; the mechanical arm is arranged on the trolley; and a surgical instrument configured to be mounted to a distal end of the robotic arm, the surgical instrument comprising: the expanding device comprises a moving mechanism and a maintaining mechanism, and the moving mechanism and the maintaining mechanism are kept to be matched in the process that the expanding device is inserted into a bone gap to expand two bone cutting surfaces; after the spreader spreads the two osteotomies, the moving mechanism and the maintaining mechanism are separated by operation, and the maintaining mechanism is configured to keep the two osteotomies in a spread state, so as to mount a fixing plate in the spread state; and a control section configured to control the operation section to complete a surgical operation.

Optionally, the control part includes: a second trolley; a plurality of tracer tools disposed at the distal end of the robotic arm and the leg of the patient, respectively; an optical positioner mounted on the second trolley, the optical positioner configured to determine a position of the distal end of the robotic arm and a position of the target surgical site based on the optical signals reflected by the tracer tool; and the upper computer is installed on the second trolley and controls the operation part to finish operation based on the position of the tail end of the mechanical arm and the position of the target operation part.

Optionally, the opening device further includes: a base configured to be mounted to a distal end of the mechanical arm; the driving mechanism is arranged on the base; and a locking assembly mounted on the movement mechanism, the locking assembly configured to allow the movement mechanism and the maintenance mechanism to be engaged or disengaged; wherein, the mobile mechanism includes: a positioning moving part which is arranged on the base; the first end of the movable moving part is rotatably arranged at the first end of the positioning moving part through a first pivot; the maintenance mechanism includes: a positioning maintaining portion, a first end of which is configured to cooperate with a second end of the positioning moving portion to form a positioning-and-expanding mechanism; and a movable maintaining part, wherein the first end of the movable maintaining part is rotatably installed at the second end of the positioning maintaining part through a second pivot, the second end of the movable maintaining part is configured to be matched with the second end of the movable moving part to form a movable opening mechanism, and the driving mechanism is configured to drive the movable opening mechanism to rotate relative to the positioning opening mechanism.

Optionally, the maintenance mechanism further comprises: a support portion comprising: a first support provided on the positioning maintaining portion; a second support provided on the movable maintenance part; one end of the third support piece is connected with the second support piece, and the other end of the third support piece slides along the through hole of the first support piece in the process of expanding the two bone cutting surfaces; and the fixing part is in threaded connection with the third supporting piece, and after the two osteotomies are expanded by the expanding device, the two osteotomies are kept in an expanded state by rotating the fixing part from a state of abutting against the movable maintaining part to a state of abutting against the positioning maintaining part, so that the two osteotomies are kept in an expanded state after the moving mechanism and the maintaining mechanism are separated.

The embodiment of the disclosure also provides a control system suitable for the tibial high osteotomy system, comprising: a preoperative planning module, comprising: the two-dimensional planning unit is suitable for carrying out preoperative two-dimensional planning according to the two-dimensional images of the legs of the patient; the three-dimensional planning unit is suitable for carrying out preoperative three-dimensional planning according to the three-dimensional model of the leg of the patient and the preoperative two-dimensional planning; the layout planning unit is suitable for simulating an operation scene based on the preoperative three-dimensional planning; the preoperative preparation module is suitable for determining the pose of a target surgical site in the surgical operation process based on the three-dimensional model; and an operation control module adapted to control an operation of the operation portion on the target operation site based on the preoperative three-dimensional planning.

Optionally, the preoperative preparation module includes: a preliminary positioning optimization unit adapted to adjust the pose of the optical positioner based on the pose of a tracer tool mounted to the leg of the patient; and the spatial registration unit is suitable for registering the characteristic points on the three-dimensional model and the characteristic positions of the legs of the patient on the operating table to obtain a solid model of the legs, and determining the pose of the target operation part in the actual operation space based on the solid model and the preoperative three-dimensional planning.

Optionally, the preoperative preparation module further comprises: the automatic positioning optimizing unit is suitable for adjusting the positioning of the first trolley after the space registration unit completes registration operation until the tail end of the mechanical arm meets the condition of moving to the target operation position, and is suitable for adjusting the positioning of the optical positioning instrument on the second trolley until the optical positioning instrument on the second trolley meets the condition of simultaneously tracking a plurality of tracer tools.

Optionally, the preoperative preparation module includes: the mechanical arm initial pose optimization unit is suitable for determining the final pose of the mechanical arm based on the pose of the target operation position, determining the evaluation parameter of the current pose based on the final pose of the mechanical arm, and determining the initial target pose of the mechanical arm based on the evaluation parameter; the mechanical arm movement path optimizing unit is suitable for generating a plurality of movement paths of the mechanical arm based on the initial target gesture and the final gesture of the mechanical arm, determining the dexterity of the mechanical arm corresponding to each interpolation point in each path based on a plurality of interpolation points on each movement path, and determining the path with the minimum average value of the dexterity as the target movement path of the mechanical arm in the plurality of paths.

Optionally, the preoperative two-dimensional planning includes: determining two-dimensional related mechanical information, determining an osteotomy line, determining a two-dimensional target force line position, and two-dimensional simulation of orthopedics.

Optionally, the preoperative three-dimensional planning includes: determining three-dimensional related mechanical information, determining an osteotomy plane, determining a three-dimensional target force line position, three-dimensional simulation orthopedics, determining a mounting position of a fixing plate, determining a spatial position of a nail channel, determining length information of a locking screw and determining a surgical safety area.

According to the embodiment of the disclosure, the opening device is provided with the moving mechanism and the maintaining mechanism which can be separated and matched, the osteotomy face can be opened in the matched state, and the moving mechanism can be far away from the osteotomy face by separating the moving mechanism from the maintaining mechanism after the osteotomy face is opened. The maintaining mechanism can enable the two osteotomies to keep in an opening state, so that the fixing plate can be installed in the opening state of the two osteotomies, and the interference of the moving mechanism can be avoided in the process of installing the fixing plate, so that the safety and the accuracy of the tibial high-level osteotomies can be improved.

Drawings

Fig. 1 is a perspective view of a tibial plateau osteotomy system in accordance with an exemplary embodiment of the present disclosure.

Fig. 2 is a perspective view of a distracting device in a mated state in accordance with an exemplary embodiment of the present disclosure.

Fig. 3 is a perspective view of a distracting device in a separated state according to an exemplary embodiment of the present disclosure.

Fig. 4 is another angular perspective view of a distracting device in a distracted state according to an exemplary embodiment of the disclosure.

Fig. 5 is a perspective view of a movement mechanism according to an exemplary embodiment of the present disclosure.

Fig. 6 is a perspective view of a maintenance mechanism according to an exemplary embodiment of the present disclosure.

Fig. 7 is a perspective view of a movable part according to an exemplary embodiment of the present disclosure.

Fig. 8 is a perspective view of a positioning moving part according to an exemplary embodiment of the present disclosure.

Fig. 9 is a perspective view of an activity maintenance portion according to an exemplary embodiment of the present disclosure.

Fig. 10 is a perspective view of a positioning maintenance portion according to an exemplary embodiment of the present disclosure.

Fig. 11 is a perspective view of a connection plate and adjustment assembly according to an exemplary embodiment of the present disclosure.

Fig. 12 is an enlarged view at a in fig. 3.

Fig. 13 is a block diagram of a control system according to an exemplary embodiment of the present disclosure.

Fig. 14 is a block diagram of a pre-operative planning module according to an illustrative embodiment of the present disclosure.

Fig. 15 is a block diagram of a preoperative preparation module according to an illustrative embodiment of the present disclosure.

Fig. 16 is a perspective view of a tracer according to an illustrative embodiment of the disclosure.

Fig. 17 is a schematic diagram of a field of view of an optical positioner according to an illustrative embodiment of the present disclosure.

Fig. 18 is a schematic diagram of the angles formed by the normal direction of the tracer face of the tracer tool and the normal direction of the center of the optical locator according to an exemplary embodiment of the disclosure.

Fig. 19 is a perspective view of an osteotomy pendulum saw in accordance with an illustrative embodiment of the present disclosure.

FIG. 20 is a perspective view of an osteotomy guide according to an illustrative embodiment of the present disclosure.

Fig. 21 is a perspective view of a planar probe according to an exemplary embodiment of the present disclosure.

FIG. 22 is a perspective view of a staple channel guide according to an exemplary embodiment of the present disclosure.

In the drawings, the reference numerals specifically have the following meanings:

1. an operating table;

2. An operation unit;

21. A first carriage;

22. A mechanical arm;

23. A surgical instrument;

231. a spreader device;

2311. a moving mechanism;

23111. a positioning moving part; 23112. a movable part; 4. folding edges;

23113. A first pivot;

2312. a maintenance mechanism;

23121. a positioning maintaining part; 23122. an activity maintaining unit; 23123. a second pivot;

23124. A support part;

51. A first support; 52. a second support; 53. a third support; 54. a fixing part;

23125. An insertion hole;

2313. a base;

23131. A fixing seat;

2314. a driving mechanism;

23141. A driving motor;

23142. A screw rod;

23143. A guide rod;

23144. A driving block;

23145. A connecting plate;

23146. an adjustment assembly;

61. An adjusting block;

7. A chute;

62. A positioning button;

63. a third pivot;

2315. A locking assembly;

23151. a mounting base;

23152. a rotating plate;

8. a receiving groove;

23153. a fourth pivot; 23154. a locking button;

2316. A boss;

2317. a groove;

232. a bone cutting guide plate;

2321. A guide plate main body;

2322. A first guide groove;

2323. a second guide groove;

233. A planar probe;

2331. a measuring plate;

234. Bone cutting swing saw;

2341. Saw blade

2342. A compacting structure;

2343. A swinging structure;

2344. A saw body moving structure;

2345. A handle;

2346. A connection station;

2347. a temperature sensor;

235. a lane guide;

2351. A guide body;

2352. A guide hole;

3. a control unit;

31. A second trolley;

32. A tracer tool;

321. A tracer;

3211. A reflective ball;

3212. A tracer surface;

3213. A first link;

3214. a second link;

3215. A slide block;

3216. Bone needles;

3217. a knob;

33. An optical positioner;

34. an upper computer;

35. A cantilever;

900. A control system;

910. a preoperative planning module;

911. A two-dimensional planning unit;

912. a three-dimensional planning unit;

913. A layout planning unit;

920. A preoperative preparation module;

921. A preliminary positioning optimizing unit;

922. a spatial registration unit;

923. An automatic positioning optimizing unit;

924. The mechanical arm initial pose optimizing unit;

925. A mechanical arm movement path optimizing unit;

930. And an operation control module.

Detailed Description

For the purposes of promoting an understanding of the principles and advantages of the disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same.

It should be understood that the description is only exemplary and is not intended to limit the scope of the present disclosure. In the following detailed description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the embodiments of the present disclosure. It may be evident, however, that one or more embodiments may be practiced without these specific details. In addition, in the following description, descriptions of well-known techniques are omitted so as not to unnecessarily obscure the concepts of the present disclosure.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The term "comprising" as used herein indicates the presence of a feature, step, operation, but does not preclude the presence or addition of one or more other features.

Where a convention analogous to "at least one of A, B and C, etc." is used, in general such a convention should be interpreted in accordance with the meaning of one of skill in the art having generally understood the convention (e.g., "a system having at least one of A, B and C" would include, but not be limited to, systems having a alone, B alone, C alone, a and B together, a and C together, B and C together, and/or A, B, C together, etc.). Where a formulation similar to at least one of "A, B or C, etc." is used, in general such a formulation should be interpreted in accordance with the ordinary understanding of one skilled in the art (e.g. "a system with at least one of A, B or C" would include but not be limited to systems with a alone, B alone, C alone, a and B together, a and C together, B and C together, and/or A, B, C together, etc.).

Fig. 1 is a perspective view of a smart surgical system suitable for high tibial osteotomies in accordance with an exemplary embodiment of the present disclosure. Fig. 2 is a perspective view of a distracting device in a mated state in accordance with an exemplary embodiment of the present disclosure. Fig. 3 is a perspective view of a distracting device in a separated state according to an exemplary embodiment of the present disclosure. Fig. 4 is another angular perspective view of a distracting device in a distracted state according to an exemplary embodiment of the disclosure.

As shown in fig. 1-4, embodiments of the present disclosure provide an intelligent surgical system suitable for high tibial osteotomies. The intelligent surgical system may include an operating table 1, an operating section 2, and a control section 3.

In particular, the operating table 1 may be used to support a patient. The operation section 2 may be used to perform a surgical operation. The surgical operation may include an osteotomy operation, a distraction operation, and a fixation plate installation operation. The control section 3 may be used to control the operation section 2 to complete a surgical operation.

In detail, the operating part 2 may include a first carriage 21, a robot arm 22, and a surgical instrument 23. The robot arm 22 may be provided on the first carriage 21. The surgical instrument 23 may be mounted at the end of the robotic arm 22. The surgical instrument 23 may include a variety of devices for surgery. For example, the surgical instrument 23 may include an osteotomy guide, a staple channel guide, an osteotomy pendulum saw, an distractor, and the like. The osteotomy pendulum saw can be used for osteotomy procedures to form a bone seam at a target surgical site. After the bone gap is formed, the distraction device 231 can be used to distract the two osteotomies to install the fixation plate with the two osteotomies in a distracted state.

Further, the distraction device 231 can include a movement mechanism 2311 and a maintenance mechanism 2312. The movement mechanism 2311 and the maintenance mechanism 2312 can be kept engaged by operating during the insertion of the distraction device 231 into the bone slot to distract the two osteotomies. After the distraction device 231 distracts the two osteotomies, the movement mechanism 2311 and the maintenance mechanism 2312 can be separated by operation. After the movement mechanism 2311 and the maintenance mechanism 2312 are separated, the maintenance mechanism 2312 may be used to keep the two osteotomies in a distracted state to mount the fixing plate in a distracted state.

According to the embodiment of the present disclosure, the distraction device 231 can distract the osteotomy face in the engaged state by providing the distraction device 231 as a moving mechanism 2311 and a maintaining mechanism 2312 that can be separated and engaged. After the osteotomy face is distracted, the movement mechanism 2311 can be moved away from the osteotomy face by separating the movement mechanism 2311 and the maintenance mechanism 2312. The maintenance mechanism 2312 can keep the two osteotomies in an expanded state, so that the fixing plate can be installed in the expanded state of the two osteotomies, and the fixing plate cannot be interfered by the moving mechanism 2311 in the process of installing the fixing plate, so that the safety and the accuracy of the tibial high-level osteotomies can be improved.

As shown in fig. 1, in some embodiments, the control section 3 may include a second cart 31, a plurality of tracer tools 32, an optical locator 33, and an upper computer 34. Specifically, a plurality of tracer tools 32 can be disposed at the end of the robotic arm 22 and the patient's leg, respectively. The optical positioner 33 may be mounted on the second trolley 31. The optical locator 33 may be used to determine the position of the distal end of the robotic arm 22 and the position of the target surgical site based on the optical signals reflected by the tracer tool 32. The upper computer 34 may be mounted on the second carriage 31. The upper computer 34 controls the operation unit 2 to complete the operation based on the position of the distal end of the robot arm 22 and the position of the target operation site.

Fig. 5 is a perspective view of a movement mechanism according to an exemplary embodiment of the present disclosure. Fig. 6 is a perspective view of a maintenance mechanism according to an exemplary embodiment of the present disclosure. Fig. 7 is a perspective view of a movable part according to an exemplary embodiment of the present disclosure. Fig. 8 is a perspective view of a positioning moving part according to an exemplary embodiment of the present disclosure.

As shown in fig. 2-8, in some embodiments, the distraction device 231 can further include a base 2313, a drive mechanism 2314, and a locking assembly 2315. The base 2313 may be mounted at the end of the robot arm 22. The drive mechanism 2314 may be mounted on the base 2313. Locking assembly 2315 may be mounted to movement mechanism 2311. Locking assembly 2315 may be used to allow movement mechanism 2311 and maintenance mechanism 2312 to be mated or separated. Further, the movement mechanism 2311 and the maintenance mechanism 2312 can be maintained in engagement during insertion of the distraction device 231 into the bone fracture to distract the two osteotomies by operating the locking assembly 2315. After distraction device 231 distracts the two osteotomies, movement mechanism 2311 and maintenance mechanism 2312 can be separated by operating locking assembly 2315.

Further, the movement mechanism 2311 may include a positioning movement portion 23111 and a movable movement portion 23112. The positioning moving portion 23111 may be mounted on the base 2313. A first end of the movable portion 23112 (a left end of the movable portion 23112 shown in fig. 5) may be rotatably mounted to a first end of the positioning portion 23111 (a left end of the positioning portion 23111 shown in fig. 5) through a first pivot 23113.

Fig. 9 is a perspective view of an activity maintenance portion according to an exemplary embodiment of the present disclosure. Fig. 10 is a perspective view of a positioning maintenance portion according to an exemplary embodiment of the present disclosure.

As shown in fig. 5-10, in some embodiments, the maintenance mechanism 2312 includes a positioning maintenance portion 23121 and an activity maintenance portion 23122. A first end of the positioning maintaining portion 23121 (a direction toward the paper surface of the positioning maintaining portion 23121 shown in fig. 6) may be engaged with a second end of the positioning moving portion 23111 (a direction toward the paper surface of the positioning moving portion 23111 shown in fig. 5) to form a positioning-expanding mechanism, for example, by engaging the boss 2316 and the groove 2317 with a shape matching. A first end of the movable maintaining portion 23122 (a right end of the movable maintaining portion 23122 shown in fig. 6) is rotatably mounted to a second end of the positioning maintaining portion 23121 (a right end of the positioning maintaining portion 23121 shown in fig. 6) through a second pivot 23123. The second pivot 23123 may be parallel to the first pivot 23113. A second end of the movable maintenance portion 23122 (a direction of the movable maintenance portion 23122 toward the paper surface as shown in fig. 6) may be used to mate with a second end of the movable movement portion 23112 (a direction of the movable movement portion 23112 toward the paper surface as shown in fig. 5) to form a movable spreading mechanism, for example, by a shape-matched boss 2316 and recess 2317. The driving mechanism 2314 is configured to drive the movable spreader mechanism to rotate relative to the positioning spreader mechanism, so that the movable spreader mechanism and the positioning spreader mechanism are driven to form a certain angle.

Fig. 11 is a perspective view of a connection plate and adjustment assembly according to an exemplary embodiment of the present disclosure. Fig. 12 is an enlarged view at a in fig. 3.

As shown in fig. 3-12, the drive mechanism 2314 may include a drive motor 23141, a lead screw 23142, a guide bar 23143, a drive block 23144, a connection plate 23145, and an adjustment assembly 23146. The drive motor 23141 may be mounted on the mount 23131 of the base 2313. The screw 23142 extends in a direction perpendicular to the positioning moving portion 23111, is rotatably mounted on the fixing seat 23131 of the base 2313, and is rotated by the driving motor 23141 to drive the driving block 23144 to move. Guide bar 23143 is mounted to base 2313 and parallel to lead screw 23142 to guide movement of driving segment 23144. The connection plate 23145 is slidably mounted on the driving block 23144 through a slide rail in a direction parallel to the positioning moving portion 23111. The adjustment assembly 23146 may include an adjustment block 61, a positioning knob 62, and a third pivot 63. An adjustment assembly 23146 is rotatably mounted to an end of connecting plate 23145 by a third pivot 63. The third pivot 63 is parallel to the first pivot 23113. The adjusting component 23146 is detachably mounted at the edge folding 4 on the positioning moving part 23111, so as to drive the movable opening mechanism to rotate and open relative to the positioning opening mechanism to form an included angle along with the movement of the driving block 23144.

Further, the adjustment block 61 is provided with a chute 7. The chute 7 is configured to allow the flange 4 on the positioning moving portion 23111 to extend into the chute 7 to slide, so as to adjust the position of the adjustment block 61 at the flange 4. The positioning knob 62 is screwed to the adjusting block 61 and is configured to rotate to extend into the chute 7 and engage with the movable portion 23112 to prevent the adjusting block 61 from sliding relative to the movable portion 23112.

According to an embodiment of the present disclosure, the driving motor 23141 is started during the process that the driving mechanism 2314 drives the movable spreader mechanism to rotate away from the positioning spreader mechanism. The driving motor 23141 rotates the screw 23142, and the guide rod 23143 guides the driving block 23144 so that the driving block 23144 reciprocates along the screw 23142. In the process that the driving block 23144 moves away from the positioning and expanding mechanism, the connecting plate 23145 moves along with the driving block 23144 in the direction away from the positioning and expanding mechanism, and the connecting plate 23145 slides relative to the driving block 23144 in the direction parallel to the positioning and moving portion 23111, at this time, the adjusting assembly 23146 rotates around the third pivot 63 to drive the movable and expanding mechanism to rotate and expand relative to the positioning and moving portion 23111 along with the movement of the driving block 23144 to form an included angle, so that the outer walls of the positioning and expanding mechanism and the movable and expanding mechanism are respectively attached to the inner walls of the bone seams, and the using convenience can be improved.

As shown in fig. 12, locking assembly 2315 includes a mounting bracket 23151, a rotation plate 23152, a fourth pivot 23153 and a locking knob 23154 according to an embodiment of the present disclosure. The rotation plate 23152 is formed with a receiving groove 8. The number of locking assemblies 2315 may be two. The locking assembly 2315 may be mounted to an end of the positioning moving part 23111 and an end of the movable moving part 23112 of the moving mechanism 2311 based on the mounting seats 23151, respectively. The fourth pivot 23153 is perpendicular to the positioning moving part 23111 or the movable moving part 23112. The pivoting plate 23152 is pivotally coupled to the mount 23151 by a fourth pivot 23153. The rotation plate 23152 has a locked state rotated to be close to the positioning maintaining portion 23121 to allow the positioning maintaining portion 23121 to be inserted into the accommodation groove 8 so that the positioning moving portion 23111 and the positioning maintaining portion 23121 are maintained at the same plane, and an unlocked state rotated to be far from the positioning maintaining portion 23121 to allow the positioning moving portion 23111 to be separated with respect to the positioning maintaining portion 23121. The rotation plate 23152 has a locked state rotated to be close to the movable maintenance portion 23122 to allow the movable maintenance portion 23122 to be inserted into the accommodation groove 8 so that the movable movement portion 23112 and the movable maintenance portion 23122 are maintained in the same plane, and an unlocked state rotated to be far from the movable maintenance portion 23122 to allow the movable movement portion 23112 to be separated with respect to the movable maintenance portion 23122.

Further, the locking knob 23154 may be a knob 3217, which is not limited herein. The locking knob 23154 may be threadably coupled to the rotation plate 23152. The lock button 23154 is configured to rotate to extend into the receiving groove 8 and into the insertion hole 23125 of the positioning maintaining portion 23121 or the movable maintaining portion 23122 to prevent the movable portion 23112 from being separated with respect to the movable maintaining portion 23122 and/or the positioning moving portion 23111 from being separated with respect to the positioning maintaining portion 23121.

As shown in fig. 3-10, in some embodiments, the maintenance mechanism 2312 further includes a support 23124. The support 23124 may include a first support 51, a second support 52, a third support 53, and a fixing portion 54. The fixing portion 54 may include two fixing members. The two fasteners may be two nuts. The diameter of the through hole of the first support 51 is larger than the outer diameter of the third support 53. The first support 51 may be disposed on the positioning maintaining part 23121. The first mounting axis of the first support 51 and the positioning maintaining portion 23121 may be parallel to the first pivot 23113. The first support 51 is rotatable about a first mounting axis. The second support 52 may be provided on the activity maintaining portion 23122. The second mounting axis of the second support 52 and the movable maintenance portion 23122 may be parallel to the first pivot 23113. The second support 52 is rotatable about a second mounting axis. One end of the third support 53 (an upper end of the third support 53 as shown in fig. 6) is connected to the second support 52. The other end of the third support 53 (the lower end of the third support 53 as shown in fig. 6) is penetrated in the through hole of the first support 51. During the distraction of the two osteotomy faces, the second support 52 slides along the through hole of the first support 51. The fixing member may be screw-coupled with the third supporting member 53. After the distraction device 231 distracts the two osteotomies, the fixed portion 54 is rotated from the state of abutting against the movable maintaining portion 23122 to the state of abutting against the positioning maintaining portion 23121, so that the two osteotomies are kept in the distracted state after the moving mechanism 2311 and the maintaining mechanism 2312 are separated.

Fig. 13 is a block diagram of a control system according to an exemplary embodiment of the present disclosure. Fig. 14 is a block diagram of a pre-operative planning module according to an illustrative embodiment of the present disclosure. Fig. 15 is a block diagram of a preoperative preparation module according to an illustrative embodiment of the present disclosure.

The present disclosure also provides a control system 900 suitable for use in the tibial plateau osteotomy system shown above. The control system 900 may include a preoperative planning module 910, a preoperative preparation module 920, and an operational control module 930. The functions of control system 900 may be implemented using a host computer 34 in a tibial high osteotomy system. Further, the upper computer 34 in the operating room can be connected to the client of the expert doctor at the far end by using the 5G communication technology, and the real-time transmission of the image data, the audio and video signals and the control signals can be realized, so that the functions of remote consultation, remote teaching, operation planning, navigation positioning and the like can be completed. The client of the expert doctor can be a mobile phone, a computer, a tablet and the like of the expert doctor.

The pre-operation 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 adapted to perform a pre-operative two-dimensional planning from two-dimensional images of the legs of the patient. The three-dimensional planning unit 912 is adapted for pre-operative three-dimensional planning from a three-dimensional model of the leg of the patient and the pre-operative two-dimensional planning. The layout planning unit 913 is adapted to simulate a surgical scenario based on a pre-operative three-dimensional planning. The preoperative preparation module 920 is adapted to determine a pose of the target surgical site during the surgical procedure based on the three-dimensional model. The operation control module 930 is adapted to control the operation unit 2 to perform a surgical operation on the target surgical site based on the preoperative three-dimensional planning.

The two-dimensional image may be generated based on a patient weight-bearing dual lower extremity full length X-ray film. The doctor can select the operation side based on the patient weight-bearing position double-lower limb full-length X-ray film, so that the preoperative two-dimensional planning is performed on the operation side corresponding to the two-dimensional image. For example, left or right leg is selected for surgery.

Further, the preoperative two-dimensional planning may include: determining two-dimensional related mechanical information, determining an osteotomy line, determining a two-dimensional target force line position, and two-dimensional simulation of orthopedics. The determining of the two-dimensional related mechanical information may be obtaining a plurality of point information corresponding to the leg of the patient in the two-dimensional image by using the trained two-dimensional force line key point recognition model. The plurality of line information may be generated by the plurality of point information. The plurality of distance information and angle information can be acquired through the plurality of line information, and two-dimensional related mechanical information of the legs of the patient can be determined. The point information may include position information of a femoral head center, a femoral tuberosity highest point, a femoral distal tangent outer point, a femoral distal tangent inner point, a tibial proximal tangent outer point, a tibial proximal tangent inner point, a tibial distal tangent outer point, and a tibial distal tangent inner point in a two-dimensional image. The line information can comprise the position information of a lower limb mechanical shaft, a femur mechanical shaft, a tibia mechanical shaft, a line connecting the femoral head center and the highest point of the femur tuberosity, a medial condyle tangent line at the distal end of the femur, a medial condyle tangent line at the lateral side of the tibia plateau, and a distal tibia tangent line in a two-dimensional image. The distance information may include distance and position information of the double lower limb length, the mechanical axis offset in the two-dimensional image. The angle information may include angle and position information of the mechanical axis offset, the mechanical femur proximal outside angle, the mechanical femur distal outside angle, the mechanical tibia proximal inside angle, the mechanical tibia distal outside angle, and the mechanical tibia femoral articular line intersection angle in a two-dimensional image. Further, the doctor can comprehensively judge according to the obtained two-dimensional related mechanical information, and select the type of operation suitable for the patient. The two-dimensional force line key point identification model can be obtained through training a two-dimensional X-ray film image sample, and key points can be marked on the sample.

The step of determining the osteotomy line can be to obtain the osteotomy point and the hinge point by using a trained two-dimensional force line key point identification model according to the operation type, and generate the osteotomy line in the two-dimensional image. The connection line between the osteotomy point and the hinge point can be an osteotomy line. Taking the medial open wedge tibial plateau as an example, the hinge point may be set about 1.5cm below the lateral tibial plateau and the osteotomy point may be set about 4cm below the medial tibial plateau.

The two-dimensional target force line position can be determined by dividing the connecting line of the tibia platform in the two-dimensional image into a plurality of parts, a doctor can set the relative position of the lower limb force line passing through the tibia platform in the two-dimensional image according to the abrasion degree of the knee joint cartilage of the patient, the inner side of the tibia platform is 0%, the outer side of the tibia platform is 100%, and the two-dimensional target position can be set to be a Fujisawa point, namely, a position of 62.5% from inside to outside.

The two-dimensional simulation correction can be to calculate an osteotomy correction angle through Miniaci method, rotate the tibia far end by taking the hinge point as the center, and when the lower limb force line passes through the two-dimensional target position on the tibia platform, the rotation angle of the tibia far end is the osteotomy correction angle, and generate the correction distance. By training the two-dimensional force line key point recognition model, a doctor can be assisted to complete preoperative two-dimensional planning, so that the operation preparation efficiency is improved.

In some embodiments, the preoperative three-dimensional planning may include: determining three-dimensional related mechanical information, determining an osteotomy plane, determining a three-dimensional target force line position, three-dimensional simulation orthopedics, determining a mounting position of a fixing plate, determining a spatial position of a nail channel, determining length information of a locking screw and determining a surgical safety area.

Furthermore, based on CT scanning data, image segmentation and three-dimensional reconstruction can be carried out on the femur, tibia, fibula, patella and other parts in the CT scanning data, so as to obtain a double-lower-limb three-dimensional model of the patient. The surgical side in the preoperative three-dimensional plan is determined based on the surgical side determined in the preoperative two-dimensional plan.

The three-dimensional related mechanical information is determined by selecting related anatomical landmark points in a three-dimensional model by utilizing a trained three-dimensional force line key point identification model, and generating angle information and position information of the length of a double lower limb, the offset of a mechanical shaft, the proximal outer angle of a mechanical femur, the distal outer angle of a mechanical femur, the proximal inner angle of a mechanical tibia, the distal outer angle of a mechanical tibia, the intersection angle of a mechanical tibia and a femur joint line, and the back dip angle of a tibia platform in a three-dimensional image. The three-dimensional force line key point recognition model can be obtained based on three-dimensional model image sample training, and key points can be marked on the sample. The doctor can also carry out preoperative two-dimensional planning and preoperative three-dimensional planning on the display screen panel of the upper computer in a manual point selection mode, and carry out preoperative two-dimensional planning and preoperative three-dimensional planning on the two-dimensional image three-dimensional image by clicking the screen panel.

Determining the osteotomy plane may include obtaining a spatial coordinate relationship between the X-ray slice and the three-dimensional model based on the data of the X-ray slice and the data of the three-dimensional model using a two-dimensional three-dimensional image registration algorithm to achieve two-dimensional and three-dimensional registration. Thus, the osteotomy face can be automatically generated by the osteotomy line determined in the preoperative two-dimensional planning. By two-dimensional and three-dimensional registration, the osteotomy plane can be determined relatively quickly.

The three-dimensional target force line position can be determined by dividing the connecting line of the tibia platform in the three-dimensional model into a plurality of parts, a doctor can set the relative position of the lower limb force line passing through the tibia platform in the three-dimensional model according to the abrasion degree of the knee joint cartilage of a patient, the inner side of the tibia platform is 0%, the outer side of the tibia platform is 100%, and the three-dimensional target position can be set to be a Fujisawa point, namely a 62.5% position from inside to outside.

The three-dimensional simulation orthopedics can be to rotate the tibia far end by taking a hinge line as a center, and when the lower limb force line passes through a three-dimensional target position on a tibia platform, the rotation angle of the tibia far end is the osteotomy orthopedics angle. The doctor can adjust parameters such as the inclination angle between the osteotomy faces, the orthopedic angle between the osteotomy faces and the like according to the change of the information such as the back inclination angle of the tibial plateau and the like, so that the three-dimensional tibial model after the orthopedic is obtained.

Determining the mounting location of the fixation plate may be based on an orthopaedic three-dimensional tibial model, selecting the type of fixation plate. The fixing plate may be a locking steel plate. The type of the fixing plate can be determined from a registered model of the locking steel plate. At the orthopedic bone seam, the length information and the spatial position of the locking screw for fixing the fixing plate are determined based on the type of the fixing plate selected and the placement position of the fixing plate.

The determination of the surgical safe area may be based on an osteotomy plane, and the design of the personalized surgical safe area may include an osteotomy area and a safety restraint boundary according to the bony structures of different patients. Taking the medial open wedge tibial plateau osteotomy as an example. The osteotomies may include a horizontal osteotomies and an ascending osteotomies. The angle between the ascending osteotomy face and the horizontal osteotomy face is about 110 deg.. Can be used for generating an operation safety area for horizontal osteotomy operation according to the requirements of the horizontal osteotomy on retaining an osseous hinge with the outer side of 1cm, protecting rear vascular nerves and the like. The surgical safe area for the upstream osteotomy can be generated according to the requirements that the upstream osteotomy should be careful to avoid the patellar ligament, the proper tibial tuberosity width is kept to be at least 1.5cm, and the like. By determining the safe area for surgery, the safety in subsequent surgery can be improved.

According to the embodiment of the disclosure, based on the layout planning unit 913, a doctor can realize layout simulation of hardware equipment and motion simulation of an execution process, so that the doctor has clear knowledge of the operation process and is more fully prepared for the operation. The layout planning unit 913 may be a digital simulation system. Specifically, based on the layout planning unit 913, the doctor can simulate the pose of the tip of the robot arm 22, the pose of the optical positioner 33, the positions of the first carriage 21, the second carriage 31, and the operating table 1 according to the preoperative three-dimensional plan. Based on the layout planning unit 913, the doctor can simulate the motion state of the robot arm 22 during the operation according to the preoperative three-dimensional plan.

In some embodiments, the physician may first place the hardware device in layout. For example, the patient may be placed in a supine position on the operating table 1. The first trolley 21 is located on the right side of the patient and the doctor is located on the right side of the first trolley 21 to facilitate the handling of the robot arm 22. The second trolley 31 is positioned to the left of the patient, adjusting the field of view of the optical positioner 33 towards the target surgical site. Further, the inner side of the second trolley 31 may be disposed at 30cm from the operating table in the horizontal direction, and the lower side of the second trolley 31 may be disposed at 40cm from the lower side of the operating table 1 in the vertical direction, so as to facilitate the operation of the upper computer 34 by the assistant doctor. The inner side of the first carriage 21 may be set to be 100cm from the operating table in the horizontal direction, and the lower side of the first carriage 21 is set to be 40cm from the lower side of the operating table 1 in the vertical direction, so as to avoid affecting the doctor of the main knife to perform the subsequent spatial registration operation. Further, the first carriage 21 and the upper second carriage 31 may be mounted with a driving device, a laser radar sensor, and other detection devices. The preoperative preparation module 920 may detect the positional relationship among the position operating table 1, the first carriage 21 and the upper second carriage 31 through the laser radar sensor, and calculate a second position satisfying the above positional relationship, so that the first carriage 21 and the second carriage 31 may be moved from the first position to the second position by using the driving device, and thus the automatic movement function of the first carriage 21 and the second carriage 31 may be realized. The first position is characterized as a daily storage position of the first carriage 21 and the second carriage 31.

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

In some embodiments, the optical locator 33 may be used to obtain the spatial pose of the mating tracer tool 32. The tracer tool 32 can include a femoral tracer 321, a tibial tracer 321, a point probe, a planar probe 233, and the like. A plurality of reflective balls 3211 may be mounted on the tracer 32. The optical locator 33 may identify the spatial position information of the reflective ball 3211 based on the light reflected by the reflective ball and send the tracer 32 information to the preliminary placement optimization unit 921.

Fig. 16 is a perspective view of a tracer according to an illustrative embodiment of the disclosure. Fig. 17 is a schematic diagram of a field of view of an optical positioner according to an illustrative embodiment of the present disclosure.

As shown in fig. 16, the tracer 321 may include a light reflecting ball 3211, a tracing 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 mounted on the femur and tibia of the leg. The surgeon may mount the tracer 321 on the femur and tibia, respectively. The tracer surface 3212 may be positioned within the effective recognition range of the optical positioner 33 by adjusting the angles of the first and second links 3213, 3214 during installation of the tracer 321, and the tracer surface 3212 may be substantially perpendicular to the field of view of the optical positioner 33. Further, since the field of view area (as shown in fig. 17) of the optical positioner 33 is limited and there is a difference in recognition accuracy of different positions of the field of view area, the actual installation position and orientation of the tracer 321 affect the operation accuracy of the surgery, the pose of the optical positioner 33 can be adjusted by the preliminary positioning optimization unit 921 to improve the surgery accuracy.

The optical positioner 33 may be disposed on the second trolley 31 by means of a cantilever 35. The preliminary positioning optimization unit 921 can communicate with the second carriage 31, the optical positioner 33, and the cantilever 35. By mounting the tracer 32 on the leg, the optical locator 33 can determine the pose of the tracer 32 based on the light signals reflected by the reflective ball 3211 on the tracer 32. The preliminary localization optimization unit 921 may determine a target pose of the optical localizer 33 based on the pose of the tracer tool 32. The pose of the optical positioner 33 can be flexibly adjusted by controlling the arms of the cantilever 35. The lidar sensor may acquire current position information of the second carriage 31 in the operating room and environmental data of the operating room. The preliminary positioning optimizing unit 921 can adjust the pose of the optical positioner 33 by sending a movement instruction to the second carriage 31 and the cantilever 35.

Further, when adjusting the pose of the optical positioner 33, a distance constraint condition and an angle constraint condition may be set to optimize the recognition accuracy of the optical positioner 33 on the femoral tracer 321 and the tibial tracer 321, and meanwhile, avoid the phenomena of shielding and interference between the tracer surfaces 3212, and prevent potential safety hazards caused by the recognition loss of the tracer surfaces 3212. The distance constraint may be that the sum of the distances from the center of the plurality of tracer facets 3212 to the center of the field of view of the optical locator 33 is a minimum. The angle constraint condition may be that the included angle between the normal direction of the tracing surface 3212 and the normal direction of the optical positioner 33 is the minimum value, and the included angle between the connecting lines of the centers of any two tracing surfaces 3212 and the center of the optical positioner 33 is greater than or equal to n/6.

In some embodiments, the first trolley 21 may further be provided with a sudden stop device, a base, a pedal, a driving device, a laser radar sensor, and other detection devices. The control system 900 may be used to control the movement of the robotic arm 22 to move the surgical instrument 23 coupled to the distal end of the robotic arm 22 to a position in real surgical space corresponding to the preoperative three-dimensional plan, thereby assisting the surgeon in performing the surgical procedure. By mounting the tracer 32 at the end of the robotic arm 22, a plurality of reflective balls 3211 are mounted on the tracer 32. During the operation, the tracer 32 is located in the field of view of the optical positioner 33, and the optical positioner 33 can acquire the position information of the surgical instrument 23 connected to the end of the mechanical arm 22 in real time through the tracer 32 at the end of the mechanical arm 22. The relative positions of the robotic arm 22, the surgical instrument 23, and the patient may be displayed in real time on the host computer 34. A physician may control the control system 900 using a foot pedal to allow the physician to interact with the control system 900 while being remote from the host computer 34. The lidar sensor is capable of acquiring current position information of the first carriage 21 in the operating room and environmental data of the operating room.

According to the disclosed embodiment, the spatial registration unit 922 is adapted to register the feature points on the three-dimensional model and the feature positions of the legs of the patient on the operating table 1 to obtain a solid model of the legs, and determine the pose of the target surgical site in the actual surgical space based on the solid model and the preoperative three-dimensional plan, i.e. the spatial registration between the actual surgical space and the computer virtual space can be achieved. The characteristic positions of the legs comprise a hip joint center, a femur distal lateral condyle, a femur distal medial condyle, a tibia proximal medial, a tibia proximal lateral, a ankle medial, a ankle lateral and a ankle joint center.

In some embodiments, spatial registration unit 922 may achieve spatial registration by way of a point probe. Specifically, by setting feature points on the three-dimensional model.

The feature points may include a virtual hip joint center, a virtual femoral distal lateral condyle, a virtual femoral distal medial condyle, a virtual tibial proximal medial, a virtual tibial proximal lateral, a virtual ankle medial, a virtual ankle lateral, and a virtual ankle center. During spatial registration, the doctor may hand-hold the patient's thigh around the hip center, and spatial registration unit 922 may calculate the physical hip center from a trajectory fit of the tracer 321 of the patient's leg as the doctor is swaying.

Further, the doctor may select the distal lateral condyle of the femur and the distal medial condyle of the femur on the leg of the patient using the punctual probe according to experience, and the spatial registration unit 922 may generate the distal lateral condyle of the solid femur and the distal medial condyle of the solid femur by the optical signals reflected on the punctual probe.

Further, the doctor may select the proximal tibia side, the medial ankle side, and the lateral ankle side by using the point probe according to experience, and the spatial registration unit 922 may generate the distal condyle of the solid femur, the distal medial condyle of the solid femur, the medial ankle side of the solid ankle, and the lateral ankle side by using the optical signals reflected from the point probe, and determine the center of the solid ankle.

Further, the solid hip center, the solid distal condyle of the femur, the solid distal medial condyle of the femur, the solid proximal medial aspect of the tibia, the solid proximal lateral aspect of the tibia, the solid medial aspect of the ankle, the solid lateral aspect of the ankle, and the solid center of the ankle may be expressed as solid locations. By matching the feature points in the three-dimensional model with the above-described physical locations, the three-dimensional model can be converted into a physical model conforming to the actual operation space.

Further, the feature locations and feature points may be point cloud data. Taking the open tibia high osteotomy on the inner side of the left leg as an example, making a longitudinal incision on the inner lower side of the left knee joint of a patient, separating layer by layer, loosening part of the goose feet and the collateral ligaments on the inner side, and exposing the tibia tuberosity and the bone surface on the inner side behind the proximal tibia. A doctor can slide a point on the exposed bone surface by using a point probe to acquire point cloud data of the outline of the exposed bone surface, and the registration of an operation actual space and a virtual image space is completed by using a point cloud registration technology. In addition, the three-dimensional point cloud data of the exposed bone surface can be obtained by using the structured light scanner, so that a doctor can replace the process of manually taking points by using the point taking probe, the operation flow is quickened, and the operation difficulty is reduced.

In some embodiments, spatial registration unit 922 may utilize a two-dimensional C-arm to achieve spatial registration. Taking tibia registration as an example, the two-dimensional C-arm can be used for carrying out positive side shooting on the operation side, segmenting the tibia part of the positive side X-ray image, and carrying out two-dimensional and three-dimensional image registration with the three-dimensional model, so that space registration is realized. Specifically, the CT scan data may be used to obtain a digitally reconstructed radiological image, and the similarity measure function may be used to obtain a similarity degree between the digitally reconstructed radiological image and the X-ray image. And continuously transforming the position and the posture of the CT scanning data through an optimization algorithm until the similarity function reaches an extreme value, and outputting the position and posture parameters of the CT scanning data at the moment, so that the spatial registration is completed.

In some embodiments, spatial registration unit 922 may utilize cone-beam computed tomography to achieve spatial registration. Taking tibia registration as an example, the three-dimensional C-arm can be utilized to shoot the operation side, CBCT data containing tibia and tibia development characteristic points can be shot, and because the positions of the tibia development characteristic points under the coordinate system of the tibia tracer 321 are known, the CT image of the tibia before operation and the CBCT image of the tibia during operation are registered under the virtual space coordinate system, the positions of the tibia development characteristic points under the virtual space coordinate system are obtained, and therefore the space transformation relation between the coordinate system of the tibia tracer 321 and the computer virtual space coordinate system is obtained, and the space registration is completed.

In some embodiments, after the spatial registration is completed, the spatial registration unit 922 may automatically generate information of the lower limb force line, the relative position of the lower limb force line through the tibial plateau, the tibial plateau back-tilt angle, the limb length, and the like in the patient operation on the solid model based on the preoperative three-dimensional planning, and instruct the doctor to perform adjustment of the operation planning scheme in the operation according to the information. Because the current solid model is already matched with the human body in the actual operation space, the pose of the target operation position in the actual operation space can be determined, namely the pose of the information such as the osteotomy face in the target operation position in the actual operation space can be determined.

In some embodiments, the preoperative preparation module 920 further includes an auto-positioning optimization unit 923. Further, after spatial registration is completed, the robotic arm 22 may not be able to reach the target surgical site while performing the surgical procedure due to the relative position between the position of the first trolley 21 and the patient being too far. The automatic positioning optimizing unit 923 is adapted to adjust the positioning of the first trolley 21 after the spatial registration unit 922 completes the registration operation until the end of the mechanical arm 22 meets the condition of moving to the target operation site, so that the working space of the mechanical arm 22 can cover the target operation site, thereby improving the accuracy of the operation. The positioning of the first carriage 21 is adjusted so that the tracer 321 at the end of the arm 22 is positioned within the field of view of the optical positioner 33. Adjusting the positioning of the first trolley 21 may be determined according to the position of the target surgical site. Taking the left leg inside open wedge tibial high osteotomy as an example, the origin of the coordinate system of the base on 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 downward from the center of the target surgical site. The target surgical site may be an osteotomy region.

In some embodiments, the automatic positioning optimizing unit 923 is adapted to adjust the positioning of the optical positioners 33 on the second trolley 31 by using the cantilever until the optical positioners 33 on the second trolley 31 meet the conditions of simultaneous tracking of the plurality of tracer tools 32, the distance constraint condition and the angle constraint condition, so as to optimize the identification accuracy of the tracer 321 on the femur, the tracer 321 on the tibia and the tracer tools 32 on the tail end of the mechanical arm 22 by the optical positioners 33, and simultaneously avoid shielding between the tracer surfaces on each tracer tool 32, and prevent the potential safety hazard caused by loss of identification of the tracer surfaces. The distance constraint may be that the sum of the distances from the centers of the plurality of tracking surfaces to the center of the field of view of the optical positioner 33 is a minimum. The angle constraint condition may be that the included angle between the normal direction of the tracing surface 3212 and the normal direction of the optical positioner 33 is the minimum value, and the included angle between the connecting lines of the centers of any two tracing surfaces 3212 and the center of the optical positioner 33 is greater than or equal to n/6.

In some embodiments, the pre-operative 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 a final pose of the robotic arm 22 based on the pose of the target surgical site using inverse kinematics solution. The evaluation parameters of the current pose are determined based on the final pose of the robot arm 22. And determining an evaluation value based on the evaluation parameter under the pose optimization constraint condition. The posture of the robot arm 22 when the evaluation value is highest is determined as the initial target posture of the robot arm 22. The evaluation parameters include the mobility information m of the robot arm 22, the smart space information β of the robot arm 22, the view angle information γ of the optical positioner 33, and the view distance information l of the optical positioner 33. Pose optimization constraints may include sterility constraints and angle constraints.

According to an embodiment of the present disclosure, the sterility constraint may be to define a certain fixed interval as a sterility interval, and remove the posture beyond the sterility interval in the posture set of the mechanical arm 22, that is, ensure that each joint of the mechanical arm 22 is located in the sterility interval.

Further, the evaluation value f (x, y) can be expressed by the following formula:

Where x represents an abscissa of the distal joint end of the manipulator 22 in the current posture, y represents an ordinate of the distal joint end of the manipulator 22 in the current posture, and m _i represents the i-th mobility information in the mobility information set m of the manipulator 22 of the surgical robot in the current posture.

In the case where the robot arm includes 6 joints, the mobility information set m may be expressed by the following formula:

Where θ _i is the target angle of the ith joint, μ _i is the current angle of the ith joint in radians.

The smart spatial information β is determined by the flexibility of the mechanical arm 22 in the current posture, and the flexibility of the mechanical arm 22 in the current posture can be determined by the joint angles of six joints of the mechanical arm 22, which can be read by a demonstrator at the tail end of the mechanical arm 22, and the smart spatial information β is obtained by jacobian matrix calculation. The smart spatial information β can be expressed by the following formula:

Wherein σ _max and σ _min respectively represent the maximum singular value and the minimum singular value of the jacobian matrix obtained corresponding to six joint angles, and the smaller β represents the more flexible the manipulator 22 is in this pose.

The view angle information γ of the optical positioner 33 may be an angle epsilon (epsilon as shown in fig. 18) between the normal direction of the tracer 32 at the end of the robot arm 22 and the normal direction of the center of the optical positioner 33, and the angle epsilon may be read by a quaternion of the optical positioner 33.

The visual field distance information l of the optical positioner 33 can be expressed by the following formula:

Wherein x ₀,y₀,z₀ can be obtained by reading the three-dimensional coordinates of the optical positioner 33.

In some embodiments, the robotic arm motion path optimization unit 925 is adapted to generate multiple motion paths of the robotic arm 22 using interpolation methods, such as B-spline interpolation, based on the initial target pose and the final pose of the robotic arm 22. The same number of interpolation points are set on each motion path.

Under the path constraint condition, based on a plurality of interpolation points on each motion path, determining the dexterity of the mechanical arm 22 corresponding to each interpolation point in each path, and determining the path with the minimum average value of the dexterity in the paths as the target motion path of the mechanical arm 22. The interpolation points may represent the end position of the robotic arm 22 during motion.

The path constraint may include that each interpolation point on the motion path satisfies that the shortest distance between the surgical instrument 23 connected to the distal end of the robotic arm 22 and the tracer 321 of the leg is greater than a preset distance (for example, the preset distance may be 50 mm). The path constraint may include that the view angle γ between the tracer 32 at the end of the robot arm 22 and the optical positioner 33 corresponding to each interpolation point on the motion path is within a preset angle range (for example, the preset angle range may be greater than or equal to-n/3 and less than or equal to-n/3. The path constraint may include that the optical positioner 33 is capable of effectively identifying the tracer 32 at the end of the robot arm 22. The path constraint may include an angle constraint.

And respectively performing inverse kinematics calculation on a plurality of interpolation points on each motion path through the plurality of motion paths obtained by screening the path constraint conditions, solving six joint angles of the mechanical arm 22 corresponding to different interpolation points on each path, calculating the dexterity of the mechanical arm 22 corresponding to each interpolation point by utilizing the six joint angles of each interpolation point, and generating a dexterity change curve of the mechanical arm 22 under different motion paths. The maximum value of the dexterity does not exceed a certain set threshold value (for example, the threshold value may be set to 3.8), which is an effective motion path. And (3) averaging a plurality of obtained dexterity corresponding to a plurality of interpolation points of each motion path, wherein the motion path with the minimum dexterity average value is the target motion path of the mechanical arm 22. After the optimization process is completed, the motion conditions of the mechanical arm 22 in different operation stages can be simulated in a digital simulation system, so that the mechanical arm 22 is ensured not to collide with a patient, a tracer tool 32 on the patient and the like in the motion process. Meanwhile, the tracer tool 32 at the tail end of the mechanical arm 22 and the tracer tool 32 on the patient can be effectively identified by the optical positioner, and whether the mechanical arm 22 is positioned accurately or not is verified.

In some embodiments, different surgical instruments 23 may be required to be associated with different surgical phases. The tail end of the mechanical arm 22 can be provided with a quick-mounting tool, so that the quick replacement of different surgical instruments 23 can be realized, and the whole process coverage of the tibia high-level osteotomy is completed. Specifically, during the osteotomy phase, the surgical instrument 23 at the distal end of the robotic arm 22 is an osteotomy guide 232, an osteotomy pendulum saw 234, or a laser osteotomy device. In the distraction phase, the surgical instrument 23 at the distal end of the robotic arm 22 is a distractor 231. In the steel plate mounting stage, the surgical instrument 23 at the distal end of the robotic arm 22 is a staple guide 235.

Fig. 19 is a perspective view of an osteotomy pendulum saw in accordance with an illustrative embodiment of the present disclosure. FIG. 20 is a perspective view of an osteotomy guide according to an illustrative embodiment of the present disclosure. Fig. 21 is a perspective view of a planar probe according to an exemplary embodiment of the present disclosure.

Further, the osteotomy may be accomplished by different modes of operation during the osteotomy phase. Such as passive and semi-active modes of operation. In the passive mode of operation, the surgical instrument 23 may be an osteotomy guide 232, with the guide slot of the osteotomy guide 232 aligned with the osteotomy face of the target surgical site by controlling movement of the robotic arm 22, and the surgeon may perform an osteotomy procedure on the patient's leg along the guide slot by holding the osteotomy pendulum saw 234.

As shown in fig. 19, osteotomy pendulum saw 234 can include a blade 2341 compression structure 2342, a pendulum structure 2343, a saw body movement structure 2344, a handle 2345, a connection station 2346, and a temperature sensor 2347. Blade 2341 compression structure 2342 may be used to compress and relax blade 2341. Swing structure 2343 may be used to control the periodic swing of saw blade 2341. Saw body moving structure 2344 may be used to control the forward and backward movement of swing structure 2343 and blade 2341 compression structure 2342. The handle 2345 is convenient for a doctor to hold and operate, and is provided with a stepless speed regulating button, and the doctor can regulate the swinging frequency of the saw blade 2341 by pressing the switch. The attachment station 2346 may be used to attach the trace tool 32 in a passive mode of operation, and to mount on a quick-mount tool interface at the end of the robotic arm 22 in a semi-active mode of operation. The temperature sensor 2347 may be used to detect the cutting temperature during operation of the tool.

As shown in FIG. 20, osteotomy guide 232 includes a guide body 2321, a first guide slot 2322, and a second guide slot 2323. The first guide groove 2322 and the second guide groove 2323 are disposed at the same end of the guide plate body 2321 and intersect at an angle. The other end of the fence body 2321 may be connected with an interface provided by a quick-fit tool at the end of the robotic arm 22. The angle between first guide slot 2322 and second guide slot 2323 may be 110 °. The first guide slot 2322 and the second guide slot 2323 may guide the osteotomy swing saw 234 to perform positioning in two directions, so that the movement range of the mechanical arm 22 during switching of different osteotomy planes (such as a horizontal osteotomy plane and an uplink osteotomy plane) can be reduced, and thus the collision risk can be reduced. After positioning is completed, the doctor may insert the first guide groove 2322 or the second guide groove 2323 using the measuring plate 2331 of the planar probe 233, thereby determining the spatial position of the first guide groove 2322 or the second guide groove 2323. In this mode, the tracer tool 32 may be installed on the osteotomy pendulum saw 234, and the optical positioner 33 may acquire the position information of the osteotomy pendulum saw 234 in real time through the tracer 321 on the osteotomy pendulum saw 234, and display the relative position between the osteotomy pendulum saw 234 and the patient and the planned operation safety region on the upper computer 34 in real time.

In the semi-active mode of operation, the surgical instrument 23 may be an osteotomy pendulum saw 234 or a laser osteotomy device, and the plane of the saw blade 2341 of the osteotomy pendulum saw 234 or the emission source of the laser osteotomy device is aligned with the osteotomy surface of the target surgical site by controlling the movement of the mechanical arm 22, whereby the doctor may control the movement of the osteotomy pendulum saw 234 or the laser osteotomy device in cooperation with the mechanical arm 22 to complete the osteotomy of the leg of the patient. The relative position between the osteotomy pendulum saw 234 or laser osteotomy device and the patient and the planned surgical safe area can be displayed in real time on the host computer 34 in this mode using the tracer tool 32 at the distal end of the robotic arm 22. Compared with osteotomy data, the laser osteotomy device can perform more accurate osteotomy depth control according to a set operation safety area, vibration damage and thermal damage are generated to be small, and minimally invasive surgery is facilitated.

In some embodiments, the control system 900 may also be provided with multiple security protection mechanisms. The surgical safety zone constrains the motion area of the pendulum saw in real time during an osteotomy, the tip of the saw blade 2341 is about to exceed the planned osteotomy safety boundary, and the pendulum saw triggers movement of the saw body moving structure 2344 and alarm audible prompts. The end of the pendulum saw blade 2341 exceeds the planned osteotomy safety margin, the mechanical arm 22 triggers an emergency stop signal and the pendulum saw is power-off protected. The end of the robotic arm may be provided with an LED light that may flash to indicate when the end of saw blade 2341 is about to exceed the planned osteotomy safety boundary. The pendulum saw is provided with a force sensor and a temperature sensor 2347, and the working frequency of the pendulum saw is automatically adjusted according to the cutting force and the temperature in the operation process. And finishing the safety feedback of the fusion of the multiple information such as the position, the force, the temperature and the like.

Further, during the distraction phase, the surgical safety area can restrict the movement area of the distraction device 231, avoiding the occurrence of fractures in the hinge due to excessive depth of extension. During the distraction process, the pressure generated by the bone fracture can be measured in real time by the pressure sensor on the distraction device 231. The pressure generated by the bone seam is lower than the safety threshold value by controlling the rotating speed of the driving motor 23141, so that the fracture of the hinge caused by the too high opening speed of the hinge can be avoided. Further, the reflective balls 3211 may be mounted on the positioning maintaining portion 23121 and the movable maintaining portion 23122, respectively, and the opening angle of the bone fracture may be measured in real time by the position change between the reflective balls 3211 detected by the optical positioner 33. The distraction angle information can be displayed in real time on the host computer 34. After the distraction angle is changed to the osteotomy orthopedic angle in the three-dimensional planning, the driving motor is controlled to stop rotating, so that the distraction angle of the bone seam is kept to be the osteotomy orthopedic angle, and then the moving mechanism 2311 and the maintaining mechanism 2312 are separated, and the moving mechanism 2311 is evacuated.

During the mounting of the fixation plate, the surgical instrument 23 may be a staple guide 235. The staple channel guide 235 can include a guide body 2351 and a guide bore 2352. The nail path of at least any two hole sites can be selected according to actual operation conditions. The axis of the guide hole 2352 of the lane guide 235 may be controlled to align with the lane path based on the spatial location information of the selected hole site lane to assist the physician in driving the k-wire to locate the fixation plate screw hole location. And placing the fixed plate with the selected model, and driving locking screws with different hole sites.

In some embodiments, the control system 900 may also be provided with an intelligent auxiliary evaluation system. Various indexes of a patient and various parameters in a tibial high-level osteotomy system are monitored in the operation process, the operation effect and the recovery condition of the patient are tracked after the operation, and a mathematical model and an algorithm are established to quantitatively evaluate the effect of the tibial high-level osteotomy system so as to facilitate a doctor to follow the condition of the patient.

Thus, embodiments of the present disclosure have been described in detail with reference to the accompanying drawings. It should be noted that, in the drawings or the text of the specification, implementations not shown or described are all forms known to those of ordinary skill in the art, and not described in detail. Furthermore, the above definitions of the components are not limited to the specific structures, shapes or modes mentioned in the embodiments, and may be simply modified or replaced by those of ordinary skill in the art.

It should also be noted that, in the specific embodiments of the disclosure, unless otherwise noted, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present disclosure. In particular, all numbers expressing dimensions, range conditions, and so forth, used in the specification and claims are to be understood as being modified in all instances by the term "about". In general, the meaning of expression is meant to include a variation of + -10% in some embodiments, a variation of + -5% in some embodiments, a variation of + -1% in some embodiments, and a variation of + -0.5% in some embodiments by a particular amount.

Those skilled in the art will appreciate that the features recited in the various embodiments of the disclosure and/or in the claims may be provided in a variety of combinations and/or combinations, even if such combinations or combinations are not explicitly recited in the disclosure. In particular, the features recited in the various embodiments of the present disclosure and/or the claims may be variously combined and/or combined without departing from the spirit and teachings of the present disclosure. All such combinations and/or combinations fall within the scope of the present disclosure.

The foregoing embodiments have been provided for the purpose of illustrating the general principles of the present disclosure, and are not meant to limit the disclosure to the particular embodiments disclosed, but to limit the scope of the disclosure to the particular embodiments disclosed.

Claims

1. An intelligent surgical system adapted for high tibial osteotomies, comprising:

An operating table configured to support a patient;

An operation unit including:

a first carriage;

the mechanical arm is arranged on the first trolley; and

A surgical instrument configured to be mounted to a distal end of the robotic arm, the surgical instrument comprising:

The expanding device comprises a moving mechanism and a maintaining mechanism, and the moving mechanism and the maintaining mechanism are kept to be matched in the process that the expanding device is inserted into a bone gap to expand two bone cutting surfaces; after the spreader spreads the two osteotomies, the moving mechanism and the maintaining mechanism are separated by operation, and the maintaining mechanism is configured to keep the two osteotomies in a spread state, so as to mount a fixing plate in the spread state; and

And a control section configured to control the operation section to complete a surgical operation.

2. The intelligent surgical system according to claim 1, wherein the control section includes:

a second trolley;

A plurality of tracer tools disposed at the distal end of the robotic arm and the leg of the patient, respectively;

an optical positioner mounted on the second trolley, the optical positioner configured to determine a position of the distal end of the robotic arm and a position of the target surgical site based on the optical signals reflected by the tracer tool;

And the upper computer is installed on the second trolley and controls the operation part to finish operation based on the position of the tail end of the mechanical arm and the position of the target operation part.

3. The intelligent surgical system according to claim 2, wherein the distracting device further comprises:

A base configured to be mounted to a distal end of the mechanical arm;

the driving mechanism is arranged on the base; and

A locking assembly mounted on the movement mechanism, the locking assembly configured to allow the movement mechanism and the maintenance mechanism to be mated or separated;

wherein, the mobile mechanism includes:

A positioning moving part which is arranged on the base; and

The first end of the movable moving part is rotatably arranged at the first end of the positioning moving part through a first pivot;

The maintenance mechanism includes:

A positioning maintaining portion, a first end of which is configured to cooperate with a second end of the positioning moving portion to form a positioning-and-expanding mechanism; and

The first end of the movable maintaining part is rotatably installed at the second end of the positioning maintaining part through a second pivot, the second end of the movable maintaining part is configured to be matched with the second end of the movable moving part to form a movable opening mechanism, and the driving mechanism is configured to drive the movable opening mechanism to rotate relative to the positioning opening mechanism.

4. The intelligent surgical system according to claim 3, wherein the maintenance mechanism further comprises:

a support portion comprising:

A first support provided on the positioning maintaining portion;

a second support provided on the movable maintenance part;

One end of the third support piece is connected with the second support piece, and the other end of the third support piece slides along the through hole of the first support piece in the process of expanding the two bone cutting surfaces; and

And the fixed part is in threaded connection with the third supporting piece, and after the two osteotomy faces are expanded by the expanding device, the two osteotomy faces are kept in an expanded state continuously after the moving mechanism and the maintaining mechanism are separated by rotating the fixed part from a state of abutting against the movable maintaining part to a state of abutting against the positioning maintaining part.

5. A control system adapted for use in the intelligent surgical system of claim 2, 3 or 4, comprising:

A preoperative planning module, comprising:

the two-dimensional planning unit is suitable for carrying out preoperative two-dimensional planning according to the two-dimensional images of the legs of the patient;

the three-dimensional planning unit is suitable for carrying out preoperative three-dimensional planning according to the three-dimensional model of the leg of the patient and the preoperative two-dimensional planning; and

The layout planning unit is suitable for simulating an operation scene based on the preoperative three-dimensional planning;

The preoperative preparation module is suitable for determining the pose of a target surgical site in the surgical operation process based on the three-dimensional model; and

And the operation control module is suitable for performing operation on the target operation part based on the preoperative three-dimensional planning control operation part.

6. The control system of claim 5, wherein the preoperative preparation module comprises:

A preliminary positioning optimization unit adapted to adjust the pose of the optical positioner based on the pose of a tracer tool mounted to the leg of the patient; and

The spatial registration unit is suitable for registering the characteristic points on the three-dimensional model and the characteristic positions of the legs of the patient on the operating table to obtain a solid model of the legs, and determining the pose of the target operation position in the actual operation space based on the solid model and the preoperative three-dimensional planning.

7. The control system of claim 5, wherein the preoperative preparation module further comprises:

The automatic positioning optimizing unit is suitable for adjusting the positioning of the first trolley after the space registration unit completes registration operation until the tail end of the mechanical arm meets the condition of moving to the target operation position, and is suitable for adjusting the positioning of the optical positioning instrument on the second trolley until the optical positioning instrument on the second trolley meets the condition of simultaneously tracking a plurality of tracer tools.

8. The control system of claim 5, wherein the preoperative preparation module comprises:

The mechanical arm initial pose optimization unit is suitable for determining the final pose of the mechanical arm based on the pose of the target operation position, determining the evaluation parameter of the current pose based on the final pose of the mechanical arm, and determining the initial target pose of the mechanical arm based on the evaluation parameter;

The mechanical arm movement path optimizing unit is suitable for generating a plurality of movement paths of the mechanical arm based on the initial target gesture and the final gesture of the mechanical arm, determining the dexterity of the mechanical arm corresponding to each interpolation point in each path based on a plurality of interpolation points on each movement path, and determining the path with the minimum average value of the dexterity as the target movement path of the mechanical arm in the plurality of paths.

9. The control system of claim 5, wherein the pre-operative two-dimensional planning comprises: determining two-dimensional related mechanical information, determining an osteotomy line, determining a two-dimensional target force line position, and two-dimensional simulation of orthopedics.

10. The control system of claim 5, wherein the preoperative three-dimensional planning comprises: determining three-dimensional related mechanical information, determining an osteotomy plane, determining a three-dimensional target force line position, three-dimensional simulation orthopedics, determining a mounting position of a fixing plate, determining a spatial position of a nail channel, determining length information of a locking screw and determining a surgical safety area.