WO2022161161A1 - Procédé et dispositif de conception de plaque de guidage intelligente pour arthroplastie totale du genou - Google Patents

Procédé et dispositif de conception de plaque de guidage intelligente pour arthroplastie totale du genou Download PDF

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WO2022161161A1
WO2022161161A1 PCT/CN2022/071414 CN2022071414W WO2022161161A1 WO 2022161161 A1 WO2022161161 A1 WO 2022161161A1 CN 2022071414 W CN2022071414 W CN 2022071414W WO 2022161161 A1 WO2022161161 A1 WO 2022161161A1
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Prior art keywords
guide plate
osteotomy
tibial
femoral
file
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PCT/CN2022/071414
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English (en)
Chinese (zh)
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张逸凌
刘星宇
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北京长木谷医疗科技有限公司
张逸凌
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Publication of WO2022161161A1 publication Critical patent/WO2022161161A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14—Surgical saws ; Accessories therefor
    • A61B17/15—Guides therefor
    • A61B17/154—Guides therefor for preparing bone for knee prosthesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1732—Guides or aligning means for drills, mills, pins or wires for bone breaking devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00—Data acquisition or data processing for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/102—Modelling of surgical devices, implants or prosthesis
    • A61B2034/104—Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4687—Mechanical guides for implantation instruments

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to a method and device for designing an intelligent guide plate for total knee replacement surgery.
  • 3D printing osteotomy guide plate PSI
  • TKA total knee arthroplasty
  • TKA depends on the positioning, clearance and soft tissue balance of the knee joint, and all three depend on the correct position of the prosthesis.
  • the application of 3D printing PSI can take into account minor deformities or osteophytes through preoperative design and drills , and the size, position and rotation of the prosthesis can be determined in advance, which is conducive to adjusting the lower limb force line, making the lower limb force line close to the neutral position, and making the position of the prosthesis more accurate; with the assistance of 3D printing PSI, the distal end of the femur can be adjusted.
  • the osteotomy of the proximal tibia and the proximal tibia can obtain an accurate osteotomy amount, which has better surgical results and accuracy compared with traditional surgery and computer-guided surgery.
  • the existing PSI design method requires professionals to take CT or Magnetic Resonance Imaging (MRI) images, create computer aided design (CAD) design components, and further convert them into medical digital imaging and communication .
  • CAD computer aided design
  • the present application provides an intelligent guide plate design method and device for total knee arthroplasty, which are used to solve the defects of the related art that the guide plate used in total knee arthroplasty has a long design cycle and relies on professional designers, and reduces the difficulty of guide plate design. , The purpose of shortening the design cycle of the guide plate.
  • the present application provides an intelligent guide plate design method for total knee replacement surgery.
  • the method includes the following steps: determining a corresponding three-dimensional image based on medical image data of a target site, and selecting a suitable three-dimensional image in a pre-stored prosthesis database.
  • Prosthesis model matched with the prosthesis model generate a guide plate file adapted to the prosthesis model; place the guide plate model corresponding to the guide plate file on the target site for bone surface fitting, and obtain guide plate design data for the processing of the guide plate manufacture.
  • the intelligent guide plate design method before obtaining the guide plate design data, further comprising: adjusting the position parameters of the guide plate in the guide plate file based on the bone surface fitting result; after obtaining the guide plate design data, further comprising: : Export the guide plate design data and save it.
  • the corresponding three-dimensional image is determined based on the medical image data of the target part, and in the pre-stored prosthesis database, selecting a suitable prosthesis model includes: based on the medical image of the target part data, obtain a three-dimensional image through data processing; mark key anatomical parameters on the three-dimensional image; select a matching prosthetic model based on the key anatomical parameters.
  • the design of the guide plate file adapted to the prosthesis model includes: planning a plurality of osteotomy surfaces of the target site based on the three-dimensional image and the prosthesis model; According to the alignment principle of the osteotomy surface, the guide plate file is generated; based on the osteotomy instrument, the position of the positioning hole of the osteotomy surface guide plate is determined.
  • the guide files include: a femoral side guide file and a tibial side guide file.
  • the femoral side guide file includes a femoral side guide body, and the femoral side guide body is provided with: a determination part for the osteotomy surface of the distal end of the femur, a part for determining the anterior condyle osteotomy surface, and a femoral side guide body.
  • Distal osteotomy positioning hole, posterior femoral condyle osteotomy positioning hole and femoral guide plate fitting area Distal osteotomy positioning hole, posterior femoral condyle osteotomy positioning hole and femoral guide plate fitting area.
  • the determination part of the osteotomy surface of the distal femur is aligned with the osteotomy surface of the distal femur determined based on the three-dimensional image and the prosthesis model; Align with the anterior condyle osteotomy surface determined by the prosthesis model; the positioning hole of the distal femoral osteotomy is aligned with the distal femoral osteotomy according to the positioning hole of the distal femoral osteotomy instrument adapted to the prosthesis model The relative position between the surfaces is determined; the positioning hole of the posterior femoral condyle osteotomy is determined according to the relative position between the positioning hole of the posterior femoral condyle osteotomy instrument adapted to the prosthesis model and the surface of the posterior femoral condyle osteotomy; And, the femoral guide plate fitting area fits different femoral bone surfaces based on different guide plates.
  • the tibial side guide plate file includes a tibial side guide plate body, and the tibial side guide plate body is provided with: a tibial osteotomy surface determination part, a tibial osteotomy positioning hole, and a force line rod insertion hole and tibial guide fitting area.
  • the tibial osteotomy surface determination part is aligned with the tibial osteotomy surface determined based on the three-dimensional image and the prosthesis model; The relative position between the positioning hole and the tibial osteotomy surface is determined; the force line rod insertion hole is used to simulate the recovery of the tibial force line after osteotomy using the tibial side guide body, and the sagittal plane is parallel to the tibial force line. Bone surface; and, the tibial guide plate fitting area fits different tibial bone surfaces based on different guide plates.
  • obtaining a three-dimensional image corresponding to the target part through data processing includes: segmenting the medical image data of the target part through a preset algorithm to obtain a segmentation result , wherein the segmentation result is the bone structure related to the knee joint; and according to the segmentation result, three-dimensional reconstruction is performed to obtain a three-dimensional image corresponding to the target part.
  • placing the guide plate model corresponding to the guide plate file on the target site for bone surface fitting including: judging whether the fitting area needs to be adjusted, and if no adjustment is required, exporting the guide plate file , print; if adjustment is required, adjust the position parameters of the guide plate and re-fit until the fitting area conforms to the preset fitting rules.
  • the application also provides an intelligent guide plate design device for total knee replacement surgery, the device includes: a prosthesis selection module, a guide plate adaptation module and a design data acquisition module.
  • the prosthesis selection module is configured to determine the corresponding three-dimensional image based on the medical image data of the target site, and select the adapted prosthesis model in the pre-stored prosthesis database;
  • the guide plate adaptation module is configured to generate the corresponding three-dimensional image.
  • the design data obtaining module is configured to place the guide plate model corresponding to the guide plate file on the target site for bone surface fitting, and obtain guide plate design data for the processing and manufacture of the guide plate.
  • the design data obtaining module before obtaining the guide plate design data, is further configured to adjust the position parameters of the guide plate in the guide plate file based on the bone surface fitting result; After obtaining the guide plate design data, it is also configured to: export the guide plate design data and save it.
  • the prosthesis selection module includes: a three-dimensional image acquisition unit, configured to obtain a three-dimensional image through data processing based on the medical image data of the target site; a marking unit, configured to The key anatomical parameters are marked on the three-dimensional image; the selection unit is configured to select a matching prosthesis model based on the key anatomical parameters.
  • the guide plate adaptation module includes: an osteotomy plane planning unit configured to plan multiple osteotomies of the target site based on the three-dimensional image and the prosthesis model
  • the guide plate files include: a femoral side guide file and a tibial side guide file.
  • the femoral side guide file includes a femoral side guide body, and the femoral side guide body is provided with: a distal femoral osteotomy surface determination portion; wherein, the distal femoral osteotomy The surface determination part is aligned with the osteotomy surface of the distal femur determined based on the three-dimensional image and the prosthesis model; the anterior condyle osteotomy surface determination part; wherein, the anterior condyle osteotomy surface determination part is aligned with the osteotomy surface based on the three-dimensional The image is aligned with the osteotomy surface of the anterior condyle determined by the prosthesis model; the positioning hole of the distal femur osteotomy; wherein, the positioning hole of the distal femur osteotomy is cut according to the distal femoral cut that fits with the prosthesis model.
  • the relative position between the positioning hole of the bone instrument and the osteotomy surface of the distal end of the femur is determined; the positioning hole of the posterior femoral condyle osteotomy; wherein, the positioning hole of the posterior femoral condyle osteotomy is based on the posterior femoral condyle adapted to the prosthesis model. determining the relative position between the positioning hole of the condyle osteotomy instrument and the osteotomy surface of the posterior condyle of the femur; and a femoral guide plate fitting area; wherein the femoral guide plate fitting area fits different femoral bone surfaces based on different guide plates.
  • the tibial side guide file includes a tibial side guide body, and the tibial side guide body is provided with: a tibial osteotomy surface determination part, and a tibial side guide based on the three-dimensional image and the prosthesis
  • the tibial osteotomy surface determined by the model is aligned; the tibial osteotomy positioning hole; wherein, the tibial osteotomy positioning hole is based on the positioning hole of the tibial osteotomy instrument adapted to the prosthesis model and the tibial osteotomy surface.
  • the relative position is determined; the force line rod insertion hole; wherein, the force line rod insertion hole is used to simulate the recovery of the tibial force line after osteotomy using the tibial side guide body, and is parallel to the osteotomy plane in the sagittal plane; and a tibial guide plate fitting area; wherein the tibial guide plate fitting area fits different tibial bone surfaces based on different guide plates.
  • the three-dimensional image acquisition unit includes: a medical image segmentation subunit, configured to segment the medical image data of the target part by a preset algorithm to obtain a segmentation result, wherein, The segmentation result is the skeletal structure related to the knee joint; and a three-dimensional image reconstruction subunit is configured to perform three-dimensional reconstruction according to the segmentation result to obtain a three-dimensional image corresponding to the target part.
  • the design data obtaining module includes: a fitting area judgment unit, configured to judge whether the fitting area needs to be adjusted, and if no adjustment is required, export the guide plate file for printing;
  • the fitting area adjustment unit is configured to adjust the position parameter of the guide plate if adjustment is required, and re-fit until the fitting area conforms to the preset fitting rule.
  • the present application also provides an electronic device, including a memory, a processor, and a computer program stored in the memory and runnable on the processor, when the processor executes the program, any one of the above-mentioned applications for a total knee joint is implemented. Steps of a smart guide design method for replacement surgery.
  • the present application also provides a non-transitory computer-readable storage medium on which a computer program is stored, and when the computer program is executed by a processor, implements the steps of any of the above-mentioned intelligent guide plate design methods for total knee replacement surgery .
  • a prosthesis model corresponding to the medical image of the target site is selected from a plurality of preset prosthetic model databases, and based on the prosthetic model, a prosthesis model is generated.
  • a guide file for the fabrication of guides that guide osteotomies in total knee replacement surgery is generated.
  • Fig. 1 is one of the schematic flow charts of the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • FIG. 2 is a schematic flowchart of steps for performing prosthetic model matching based on a three-dimensional image corresponding to a medical image of a target site in an intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • Fig. 3a is a schematic diagram of a prosthesis model adapted to the three-dimensional images of the femur and the tibia in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • Fig. 3b is one of the schematic diagrams of the guide plate generated according to the plan provided by the present application.
  • 3c is the second schematic diagram of the guide plate generated according to the plan provided by the present application.
  • FIG. 4 is a schematic flowchart of the steps of generating a guide plate file in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • 5a is a schematic diagram of the guide plate for the distal femur osteotomy surface and the guide plate for the anterior condyle osteotomy surface in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • Figure 5b is a schematic diagram of the positioning hole on the osteotomy surface of the distal femur in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • Figure 5c is a schematic diagram of the positioning hole on the osteotomy surface of the posterior femoral condyle in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • Fig. 5d is a schematic diagram of the fitting area of the femoral guide plate in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • 6a is a schematic diagram of the tibial osteotomy surface guide plate and the positioning hole of the tibial osteotomy surface in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • 6b is a schematic diagram of a force line rod jack in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • Fig. 6c is a schematic diagram of the fitting area of the tibial guide plate in the intelligent guide plate design method for total knee replacement surgery provided by the present application;
  • FIG. 7 is the second schematic flow chart of the intelligent guide plate design method for total knee replacement surgery provided by the present application.
  • FIG 8 is the third schematic flow chart of the method for designing an intelligent guide plate for total knee replacement surgery provided by the present application.
  • FIG. 9 is a schematic structural diagram of an intelligent guide plate design device for total knee replacement surgery provided by the present application.
  • FIG. 10 is a schematic structural diagram of an electronic device provided by the present application.
  • the guide plate in the intelligent guide plate design method provided in this embodiment is used for total knee replacement surgery, and the method includes the following steps:
  • Step S110 determining the corresponding three-dimensional image based on the medical image data of the target site, and selecting a suitable prosthesis model in the pre-stored prosthesis database;
  • Step S120 generating a guide plate file adapted to the prosthesis model.
  • step S130 the guide model corresponding to the guide file is placed on the target site to perform bone surface fitting, and personalized guide design data is obtained, which is used for the processing and manufacturing of the guide.
  • the method provided by the present application does not require professional technicians to create design components through CAD to design and manufacture the personalized guide plate, which reduces the design difficulty of the guide plate, shortens the design cycle of the guide plate, and makes The reliance of the guide plate on the professional level of the designer is also greatly reduced, which significantly improves the production efficiency of the total knee replacement guide plate, assists the operator to complete the operation more accurately and efficiently, and improves the clinical effect of the operation.
  • step S110 the corresponding three-dimensional image is determined based on the medical image data of the target site, and a suitable prosthesis model is selected from the pre-stored prosthesis database.
  • the medical image data of the target part can be understood as CT data, MRI data, etc. of the relevant parts of the knee joint.
  • the matching of the prosthesis model can be performed through the step flow chart shown in FIG. 2 :
  • Step S1101 based on the medical image data of the target part, obtain a three-dimensional image corresponding to the target part through data processing;
  • data processing includes image segmentation and three-dimensional reconstruction.
  • other skeletal structures such as femur and tibia related to the knee joint (for example, fibula, patella, and sesamoids).
  • three-dimensional reconstruction is performed to obtain a three-dimensional image of the target site, such as a three-dimensional image of the femur or a three-dimensional image of the tibia.
  • Three-dimensional reconstruction can refer to related technologies.
  • 3D reconstruction technology depicts real scenes into mathematical models that conform to computer logic through processes such as depth data acquisition, preprocessing, point cloud registration and fusion, and surface generation, including passive 3D reconstruction technology and active 3D reconstruction.
  • reconstruction techniques include texture recovery shape method, shadow recovery shape method and stereo vision method.
  • Active 3D reconstruction technology refers to the use of light sources or energy sources such as lasers, sound waves, and electromagnetic waves to transmit to the target object, and to obtain the depth information of the object by receiving the returned light waves. and triangulation method.
  • Step S1102 marks key anatomical parameters on the three-dimensional image
  • the key anatomical parameters may include at least one of key points, key axes, and key angles.
  • the key points include the center point on different levels of the femoral medullary canal, the lowest point of the distal femur, the apex of the femoral intercondylar fossa, the concave point of the medial femoral condyle, the highest point of the lateral femoral condyle, the center point of the different levels of the tibia medullary canal, and the lowest tibial plateau. point, the medial border of the tibia, the lateral border of the tibia, the medial border of the tibial tubercle, the midpoint of the insertion point of the posterior cruciate ligament, etc.
  • Key axes include femoral anatomical axis, femoral mechanical axis, tibial anatomical axis, tibial mechanical axis, transcondylar line, etc.
  • the tibial anatomical axis and the tibial mechanical axis are the same axis.
  • Key angles include tibiofemoral angle, distal femoral angle, etc.
  • the above-mentioned key anatomical parameter information can be identified and marked by the AI (artificial intelligence) algorithm identification mark in the prior art.
  • Step S1103 selecting a matched prosthetic model based on key anatomical parameters.
  • the prosthesis model includes a femoral prosthesis model and a tibial prosthesis model.
  • Fig. 3a is a prosthesis model matching the distal end of the femur and the proximal end of the tibia in an embodiment of the application.
  • the first row is a simulation schematic diagram of three different angles after adding a femoral prosthesis model to one end of the femur;
  • the second row is a simulation schematic diagram of three different angles after adding a tibial prosthesis model to one end of the tibia.
  • the prosthesis database pre-stores many product models of existing prostheses (also called prosthesis models), and the types and models of the prosthesis models are different.
  • CT scans of normal human joints can be performed, and digital technology can be used to measure the joint shape and the shape after osteotomy, and then a digital joint model database can be established to provide morphological data for joint prosthesis design.
  • FIGS. 3b and 3c one and two schematic views of the plan-generated guides are shown. As can be seen from these two figures, the guide plate is generated according to the plan.
  • Step S120 will be described below.
  • Step S120 generating a guide plate file adapted to the prosthesis model, in one embodiment, may include the steps shown in Figure 4:
  • Step S1201 planning multiple osteotomy surfaces of the target site based on the three-dimensional image of the target site and the prosthesis model.
  • the built-in AI (artificial intelligence) algorithm can be used to segment other skeletal structures such as the femur and tibia related to the knee joint by using the medical image data of the target site, and then, through three-dimensional reconstruction technology, The three-dimensional image of the target part is obtained, and the key points, key axes, key angles and other parameter information are identified and marked by AI recognition markers. Through this information, multiple osteotomy surfaces at the target part can be planned.
  • AI artificial intelligence
  • Step S1202 obtaining a corresponding guide plate file according to the alignment principle of the osteotomy surface.
  • Step S1203 based on the osteotomy instrument, determine the position of the positioning hole of the osteotomy surface guide plate.
  • the osteotomy operation can be performed.
  • the guide files include a femoral side guide file and a tibial side guide file.
  • the femoral side guide file includes:
  • the distal femoral osteotomy surface guide plate wherein, the distal femoral osteotomy surface guide plate is aligned with the distal femoral osteotomy surface determined based on the three-dimensional image;
  • anterior condyle osteotomy surface guide plate wherein the anterior condyle osteotomy surface guide plate is aligned with the femoral anterior condyle osteotomy surface determined based on the three-dimensional image
  • FIGS. 5 a to 5 d it is a schematic diagram of the generation of each guide plate and positioning hole on the femoral side.
  • 1 is the schematic guide plate of the distal femoral osteotomy surface
  • 2 is the schematic guide plate of the anterior condyle osteotomy surface
  • 3 is the schematic positioning hole of the distal femoral osteotomy surface
  • 4 is the schematic positioning hole of the posterior femoral condyle osteotomy surface
  • 5 are the indicated fitting area of the femoral guide plate.
  • Distal Osteotomy Plane Automatically aligns the preoperatively planned distal femur osteotomy surface.
  • Anterior condyle osteotomy surface guide automatically aligns the preoperatively planned femoral anterior condyle osteotomy surface.
  • Locating holes on the osteotomy surface of the distal femur (2) According to the relative position between the locating hole and the osteotomy surface of the distal femoral osteotomy instrument suitable for the planned prosthesis, when the osteotomy surface at the distal end of the guide plate is determined to automatically generate two positioning holes for the distal osteotomy of the femoral side guide.
  • Posterior femoral condyle osteotomy surface positioning holes (2) According to the relative position between the positioning hole and the osteotomy surface of the posterior femoral condyle osteotomy instrument for the planned prosthesis, when the guide plate is determined by the posterior condyle osteotomy surface , automatically generate two positioning holes for the posterior condyle osteotomy of the lateral femoral guide.
  • Femoral guide plate fitting area Different series of guide plates fit different bone surfaces.
  • the tibial side guide file includes:
  • FIG. 6a to FIG. 6c it is a schematic diagram of generating each guide plate and positioning hole on the tibial side, respectively.
  • 1 is a schematic tibial osteotomy surface guide plate
  • 2 is a schematic tibial osteotomy surface positioning hole
  • 4 is a schematic force line rod insertion hole
  • 4 is a schematic tibial guide plate fitting area.
  • Tibial Osteotomy Surface Guide Automatically aligns the preoperatively planned tibial osteotomy surface.
  • Tibial osteotomy positioning holes (2) According to the relative position between the positioning hole of the tibial osteotomy instrument suitable for the planned prosthesis and the osteotomy surface, when the tibial osteotomy surface of the guide plate is determined, the tibial guide plate will be automatically generated. Two positioning holes.
  • the force line hole is parallel to the osteotomy plane in the sagittal plane. Inserting the force line bar in the jack can simulate the recovery of the tibial force line after osteotomy using the tibial guide plate.
  • the determining portion of the distal femoral osteotomy surface, the determining portion of the anterior condyle osteotomy surface guide plate, and the determining portion of the tibial osteotomy surface can be designed in the form of grooves.
  • step S130 the guide model corresponding to the guide file is placed on the target site for bone surface fitting, and the guide design data is obtained, which is used for the processing and manufacture of the guide.
  • the guide plate can be processed and manufactured by 3D printing.
  • this step can be optimized as follows:
  • a step of exporting and saving the personalized guide plate design data can also be set.
  • Fig. 7 is a flowchart of steps for obtaining guide plate design data in the intelligent guide plate design method for total knee replacement surgery provided by the application, including:
  • Step S1301 the guide plate model corresponding to the guide plate file is placed on the target site for bone surface fitting;
  • Step S1302 adjusting the position parameters in the guide plate file based on the bone surface fitting result
  • Step S1303 obtaining guide plate design data
  • Step S1304 export and save the personalized guide plate design data.
  • the modification of the fitting of the guide plate is added, so that the designed guide plate can better fit the target site and improve the clinical effect of the operation.
  • FIG. 8 is a schematic flowchart of a preferred embodiment of the guide plate generation method of the present application, including:
  • Step a inputting the medical image corresponding to the target part, constructing the corresponding three-dimensional image, and performing preoperative planning based on the three-dimensional image, including fitting the prosthesis model for the three-dimensional image;
  • Step b generating a guide plate based on the preoperatively planned prosthesis model
  • Step c1 generate the femoral lateral guide, including:
  • Step c11 the distal osteotomy surface of the guide plate and the anterior condyle osteotomy surface are automatically aligned, and the distal osteotomy surface and the anterior condyle osteotomy surface are planned before the operation;
  • Step c12 according to the osteotomy instrument, automatically determine the osteotomy positioning hole at the distal end of the guide plate and the posterior condyle osteotomy positioning hole;
  • Step c2 generate the tibial lateral guide, including:
  • Step c21 the osteotomy surface of the guide plate is automatically aligned with the preoperatively planned tibial osteotomy surface
  • Step c22 according to the osteotomy instrument, automatically determine the position of the osteotomy positioning hole of the tibial guide plate.
  • Step d place the guide plate determined in step c1 and step c2 on the target part for fitting;
  • Step e Determine whether the fitting area needs to be adjusted. If no adjustment is required, export the guide plate file for printing; if adjustment is required, manually adjust the position parameters of the guide plate and re-fit until the fitting area conforms to the preset fitting. rule.
  • an osteotomy guide is generated with one click, and the osteotomy plane of the control guide is automatically aligned with the preoperative planning osteotomy plane, placed in the corresponding position and displayed on the interface , according to the relative position of the osteotomy surface and the positioning hole on the planned prosthesis-fitted osteotomy instrument, the position of the positioning hole on the guide plate is automatically determined, and the fitting surface of the guide plate and the bone is manually checked.
  • the appropriate guide plate position is fine-tuned; after the guide plate fitting position is determined, one-click each guide plate together with the corresponding file of the positioning hole is used for 3D printing.
  • the smart guide plate design device provided by the present application is described below, and the smart guide plate design device described below and the smart guide plate design method described above can be referred to each other correspondingly.
  • the present application also provides an intelligent guide plate design device for total knee replacement surgery.
  • the device includes: a prosthesis selection module 90 , a guide plate adaptation module 92 and a design data acquisition module 94 .
  • the prosthesis selection module 90 is configured to determine the corresponding three-dimensional image based on the medical image data of the target site, and select a suitable prosthesis model from the pre-stored prosthesis database.
  • the template fitting module 92 is configured to generate a template file that fits the prosthesis model.
  • the design data obtaining module 94 is configured to place the guide model corresponding to the guide file on the target site to perform bone surface fitting to obtain guide design data for use in the fabrication of the guide.
  • the design data obtaining module 94 is further configured to adjust the position parameters in the guide plate file based on the bone surface fitting result; after obtaining the personalized guide plate design data After that, it is also configured to: export the personalized guide design data and save it.
  • the prosthesis selection module 90 includes: a three-dimensional image acquisition unit, a marking unit and a selection unit.
  • the three-dimensional image acquisition unit is configured to obtain a three-dimensional image through data processing based on the medical image data of the target site;
  • the marking unit is configured to mark key anatomical parameters on the three-dimensional image;
  • the selection unit is configured to select the key anatomical parameters based on the key anatomical parameters. Matching prosthetic model.
  • the guide plate adaptation module 92 includes: an osteotomy plane planning unit, a guide plate file generation unit and a position determination unit.
  • the osteotomy plane planning unit is configured to plan multiple osteotomy planes of the target site based on the three-dimensional image and the prosthesis model;
  • the guide plate file generation unit is configured to generate the guide plate file according to the alignment principle of the osteotomy planes;
  • the position determination unit is configured to determine the position of the positioning hole of the osteotomy surface guide based on the osteotomy instrument.
  • the guide files include: femoral side guide file and tibial side guide file.
  • the femoral side guide file includes the femoral side guide body, and the femoral side guide body is provided with: the determination part of the distal femoral osteotomy surface; wherein, the determination part of the distal femoral osteotomy surface and the femur determined based on the three-dimensional image and the prosthesis model Alignment of distal osteotomy surface; determination of anterior condyle osteotomy surface; wherein, the determination of anterior condyle osteotomy surface is aligned with the anterior condyle osteotomy surface determined based on 3D images and prosthetic models; positioning hole for distal femoral osteotomy ; Wherein, the positioning hole of the distal femoral osteotomy is determined according to the relative position between the positioning hole of the distal femoral osteotomy instrument matched with the prosthesis model and the osteotomy surface of the distal femur; the positioning hole of the posterior femoral condyle osteotomy; wherein , the positioning hole of the posterior
  • the tibial side guide file includes the tibial side guide body, and the tibial side guide body is provided with: a tibial osteotomy surface determination part, which is aligned with the tibial osteotomy surface determined based on the three-dimensional image and the prosthesis model; the tibial osteotomy positioning hole; wherein , the positioning hole of the tibial osteotomy is determined according to the relative position between the positioning hole of the tibial osteotomy instrument matched with the prosthesis model and the tibial osteotomy surface; the force line rod socket; wherein, the force line rod socket is used for simulation use
  • the 3D image acquisition unit includes: a medical image segmentation subunit and a 3D image reconstruction subunit.
  • the medical image segmentation sub-unit is configured to segment the medical image data of the target part through a preset algorithm to obtain a segmentation result, wherein the segmentation result is the bone structure related to the knee joint;
  • the three-dimensional image reconstruction sub-unit is configured to perform segmentation according to the segmentation As a result, three-dimensional reconstruction is performed to obtain a three-dimensional image corresponding to the target part.
  • the design data obtaining module 94 includes: a fitting area judging unit and a fitting area adjusting unit.
  • the fitting area judging unit is configured to judge whether the fitting area needs to be adjusted, and if no adjustment is required, export the guide plate file for printing;
  • the fitting area adjusting unit is configured to adjust the position parameter of the guide plate if adjustment is required , and re-fit until the fitting area conforms to the preset fitting rules.
  • FIG. 10 illustrates a schematic diagram of the physical structure of an electronic device.
  • the electronic device may include: a processor (processor) 1010, a communication interface (Communications Interface) 1020, a memory (memory) 1030 and a communication bus 1040,
  • the processor 1010 , the communication interface 1020 , and the memory 1030 communicate with each other through the communication bus 1040 .
  • the processor 1010 can call the logic instructions in the memory 1030 to execute a personalized intelligent guide plate design method for total knee arthroplasty.
  • select a suitable prosthesis model generate a guide plate file suitable for the prosthesis model; place the guide plate model corresponding to the guide plate file on the target site for bone surface fitting to obtain a guide plate Design data for the fabrication of guide plates.
  • the above-mentioned logic instructions in the memory 1030 can be implemented in the form of software functional units and can be stored in a computer-readable storage medium when sold or used as an independent product.
  • the technical solution of the present application can be embodied in the form of a software product in essence, or the part that contributes to the prior art or the part of the technical solution.
  • the computer software product is stored in a storage medium, including Several instructions are used to cause a computer device (which may be a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the methods of the various embodiments of the present application.
  • the aforementioned storage medium includes: U disk, mobile hard disk, Read-Only Memory (ROM, Read-Only Memory), Random Access Memory (RAM, Random Access Memory), magnetic disk or optical disk and other media that can store program codes .
  • the present application also provides a computer program product
  • the computer program product includes a computer program stored on a non-transitory computer-readable storage medium
  • the computer program includes program instructions
  • the program instructions when executed by a computer, the computer can execute
  • the individualized intelligent guide plate design method for total knee arthroplasty includes: determining the corresponding three-dimensional image based on the medical image data of the target part, and selecting an appropriate three-dimensional image in the pre-stored prosthesis database.
  • Prosthesis model matched with the prosthesis model generate a guide plate file adapted to the prosthesis model; place the guide plate model corresponding to the guide plate file on the target site for bone surface fitting, and obtain guide plate design data for the processing of the guide plate manufacture.
  • the present application also provides a non-transitory computer-readable storage medium on which a computer program is stored, the computer program being implemented by a processor to execute each of the above-mentioned provided personalities for total knee arthroplasty
  • a method for designing an intelligent guide plate comprising: determining a corresponding three-dimensional image based on medical image data of a target site, selecting an adapted prosthesis model in a pre-stored prosthesis database; The guide plate file of the guide plate file; the guide plate model corresponding to the guide plate file is placed on the target site for bone surface fitting, and the guide plate design data is obtained, which is used for the processing and manufacture of the guide plate.
  • the device embodiments described above are only illustrative, wherein the units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place , or distributed to multiple network elements. Some or all of the modules may be selected according to actual needs to achieve the purpose of the solution in this embodiment. Those of ordinary skill in the art can understand and implement it without creative effort.
  • each embodiment can be implemented by means of software plus a necessary general hardware platform, and certainly can also be implemented by hardware.
  • the above-mentioned technical solutions can be embodied in the form of software products in essence or the parts that make contributions to the prior art, and the computer software products can be stored in computer-readable storage media, such as ROM/RAM, magnetic Disks, optical discs, etc., include instructions for causing a computer device (which may be a personal computer, server, or network device, etc.) to perform the methods of various embodiments or portions of embodiments.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
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  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dentistry (AREA)
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  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Robotics (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un procédé et un dispositif de conception de plaque de guidage intelligente pour une arthroplastie totale du genou. Le procédé consiste à : déterminer une image tridimensionnelle correspondante sur la base de données d'image médicale d'une partie cible, et sélectionner un modèle de prothèse adapté dans une base de données de prothèse pré-stockée (S110) ; générer un fichier de plaque de guidage adapté au modèle de prothèse (S120) ; et placer un modèle de plaque de guidage correspondant au fichier de plaque de guidage sur la partie cible pour un ajustement de surface osseuse, et obtenir des données de conception de plaque de guidage pour le traitement et la fabrication de la plaque de guidage (S130). Il n'est pas nécessaire qu'un technicien professionnel réalise la conception et la fabrication d'une plaque de guidage personnalisée en créant un composant de conception au moyen de CAD, de telle sorte que la difficulté de conception de la plaque de guidage est réduite, une période de conception de la plaque de guidage est raccourcie, et la dépendance de la plaque de guidage sur le degré professionnel d'un concepteur est fortement diminuée.
PCT/CN2022/071414 2021-01-29 2022-01-11 Procédé et dispositif de conception de plaque de guidage intelligente pour arthroplastie totale du genou WO2022161161A1 (fr)

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