CN111084675A - Preparation method of personalized customized craniomaxillofacial bone surgical repair and reconstruction implant - Google Patents

Preparation method of personalized customized craniomaxillofacial bone surgical repair and reconstruction implant Download PDF

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CN111084675A
CN111084675A CN201910968258.3A CN201910968258A CN111084675A CN 111084675 A CN111084675 A CN 111084675A CN 201910968258 A CN201910968258 A CN 201910968258A CN 111084675 A CN111084675 A CN 111084675A
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dimensional
data
reconstruction
bone
software
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康柱
郑力铭
佘淮滨
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Shaanxi Hengtong Intelligent Machine Co Ltd
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Xi'an Kezhi Bone Medical Devices Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T17/00Three dimensional [3D] modelling, e.g. data description of 3D objects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30952Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/3097Designing or manufacturing processes using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30971Laminates, i.e. layered products
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]

Abstract

The invention discloses a preparation method of a personalized customized craniomaxillofacial bone surgery repairing and reconstructing implant, which is based on CT image design and prosthesis assembly of a patient; is characterized in that: the computer stored with medical image control system software and reverse design software carries out data segmentation on the tomogram, then a three-dimensional prototype of the head of a patient is reconstructed, a prosthesis of a defect part is designed according to the three-dimensional prototype, 3D printing equipment obtains three-dimensional solid model data, and layering processing is carried out on the solid three-dimensional model data by using layering software to obtain layer slice data; and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.

Description

Preparation method of personalized customized craniomaxillofacial bone surgical repair and reconstruction implant
Technical Field
The invention relates to a method for preparing an artificial prosthesis for replacing defective bones of cranio-maxillofacial bones, in particular to a method for preparing a personalized and customized cranio-maxillofacial bone surgical repair and reconstruction implant.
Background
The traditional repair methods mainly comprise prosthesis, implant prosthesis, surgical repair of skin flap and bone flap transplantation, craniomaxillofacial bone traction technology and the like. The above various repair methods have certain disadvantages in the form and function after operation, and cannot achieve form repair and function recovery. The fundamental reason is that the individual complete matching between the restoration and the patient can not be achieved, the restoration accuracy is low, and too many human factors exist in the design and manufacture of the restoration, such as the great relation with the experience and aesthetic viewpoint of the operator. Surgeons often need to bend, twist or cut the implant in the operation site to adapt to the shape and size of bones of different patients, which brings trouble to the operation process. While autologous bone grafting entails new injuries in the donor area of the patient. Therefore, providing a customized and personalized restoration for a patient is a fundamental way to improve the restoration accuracy, and a new manufacturing means must be found for achieving the purpose.
A few manufacturers internationally adopt a numerical control processing method to provide individually customized metal bone substitutes for patients, but are limited by the size of a cutter, are only suitable for manufacturing artificial prostheses with simple shapes, have long production period, for example, the artificial hip joint developed by the German ALDLNGER company takes CAD/CAM as a core technology and mainly comprises image processing, three-dimensional reconstruction, matching design, CAM and other series of unit technologies, and the processing means mainly adopts the numerical control processing method and generally needs about one month for delivery. In China, units also adopt a numerical control processing-based method to manufacture personalized prostheses, but according to the knowledge of people, the manufacturing method only ensures that the size and the trend of the main skeleton are matched with the original skeleton of a patient, but cannot completely ensure that the outline of the skeleton is completely matched with the outline of the original skeleton of the patient. For complex shapes, particularly prostheses having a concave configuration, numerical control machining methods are often overwhelming.
Pressing a titanium mesh after rapid molding to form: the Chinese invention patents 03156843.2 and 200410074339.2 disclose a method for preparing a titanium alloy cranio-maxillofacial bone prosthesis, which comprises the steps of carrying out three-dimensional reconstruction on a cranio-maxillofacial bone defect image scanned by CT, then utilizing a rapid prototyping system to manufacture a prosthesis model, and finally pressing a titanium mesh prosthesis according to the model. Although the method can manufacture a more accurate prosthesis model, because the titanium mesh is pressed to manufacture the prosthesis according to the prosthesis model, the bonded prosthesis is difficult to manufacture for the defect with a complex structure, and meanwhile, if the defect is a large defect surface or a part with higher mechanical requirement, the strength of the titanium mesh cannot meet the requirement, and the method cannot be used for repairing the defect of the large cranio-maxillofacial bone or the part with higher mechanical requirement.
Disclosure of Invention
The invention aims to solve the problems in the processing of the restoration, and provides a preparation method of a personalized and customized cranio-maxillofacial bone surgery restoration and reconstruction implant.
The technical scheme is as follows:
a preparation method of a personalized customized craniomaxillofacial bone surgery repairing and reconstructing implant comprises the following steps:
the method comprises the following steps: acquiring three-dimensional data of a craniomaxillofacial bone prototype: acquiring cranio-maxillofacial bone image data of a patient by utilizing an X-ray film or CT scanning, recording the data into an optical disc file for storage by using a standard DICOM format, and reading the cranio-maxillofacial bone image data from a storage medium by storing the data into a computer of general medical image control system software;
step two: three-dimensional reconstruction of a cranio-maxillofacial bone prototype, processing cranio-maxillofacial bone tomographic image data in a CT image, wherein the three-dimensional reconstruction comprises filtering, roughness reduction, gray level image binarization, contour extraction, vectorization three-dimensional modeling and outputting three-dimensional model data of the cranio-maxillofacial bone prototype in an STL format;
step three: designing a three-dimensional entity restoration body of a defect part according to a craniomaxillofacial bone prototype:
(1) firstly, fixing a point within 2cm of a bone defect edge on a reconstructed three-dimensional image to obtain a boundary contour point of an area to be repaired;
(2) triangulation is carried out on the contour points by using reverse software in a computer to form transition surface model data;
(3) the reverse solving software carries out surface reconstruction on the transition surface data, wherein the surface reconstruction comprises curve fitting, surface splicing and characteristic modeling, and NURBS surface model data is output in an IGES format;
(4) performing three-dimensional entity reconstruction on the NURBS curved surface model data through CAD/CAM software, wherein the three-dimensional entity reconstruction comprises curve repair, curved surface repair and three-dimensional entity modeling, and outputting three-dimensional entity model data in an STL format;
step four: the 3D printing equipment acquires three-dimensional entity model data, and layering the entity three-dimensional model data by using layering software to obtain layer data;
step five: and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.
And further, designing the fixing holes of the repairing part in the third step, wherein the specific process comprises the steps of firstly referring to clinical opinions in the design process, calibrating the position of each hole, further analyzing the mechanical characteristics of the hole-added repairing part, properly adjusting the positions of the holes, considering the clinical adaptability, and repeatedly adjusting for many times, so that the positions of the fixing holes not only meet the clinical requirements, but also can ensure the mechanical characteristics of the repairing part.
Further, the material used by the 3D printer in the fifth step may be any one of cobalt-chromium alloy, stainless steel, titanium alloy, high-temperature alloy, and grinding tool steel.
Compared with the prior art: in the design step of the repair part, a reverse design method is adopted, the repair part designed by a computer can completely cover various complex defect parts and perfectly fit with the periphery of the defect parts by adopting the technology, the repair part is directly implanted and fixed without shaping in the operation, the surface of the titanium alloy repair part is smooth, and the curvature and the edge are well matched with the defect area; the method comprises the steps of obtaining three-dimensional solid model data through 3D printing equipment, carrying out layering processing on the solid three-dimensional model data through layering software to obtain lamina data, carrying out reverse engineering manufacturing according to the lamina data through control software, wherein the reverse engineering includes lamina printing and lamina accumulation, and finally obtaining the metal prosthesis.
Drawings
FIG. 1 is a flow chart of a method for preparing a customized craniomaxillofacial bone surgical repairing and reconstructing implant according to the present invention;
FIG. 2 is a block diagram of the post-treatment process of a metal prosthesis of a method for preparing a personalized and customized cranio-maxillofacial bone surgical repairing and reconstructing implant according to the present invention;
FIG. 3 is a flow chart of the design of the fixing holes of the repair part for the method for preparing the personalized and customized cranio-maxillofacial bone surgical repair and reconstruction implant according to the invention;
FIG. 4 is a flow chart of three-dimensional reconstruction software for a method for preparing a customized craniomaxillofacial bone surgical repairing and reconstructing implant according to the present invention;
FIG. 5 is a three-dimensional view of a right half-defective mandible according to example 1 of the present invention;
FIG. 6 is a three-dimensional view of a left half defective mandible of example 2 of the present invention;
FIG. 7 is a three-dimensional view of a defective left maxilla according to example 3 of the present invention;
fig. 8 is a three-dimensional view of a defective frontal bone according to example 4 of the present invention.
Detailed Description
The invention is further described below with reference to the accompanying drawings.
Referring to fig. 1, 2, 3 and 4, the invention specifically discloses a preparation method of a personalized customized craniomaxillofacial bone surgery repairing and reconstructing implant, which comprises the following steps:
the method comprises the following steps: acquiring three-dimensional data of a craniomaxillofacial bone prototype: acquiring cranio-maxillofacial bone image data of a patient by utilizing an X-ray film or CT scanning, recording the data into an optical disc file for storage by using a standard DICOM format, and reading the cranio-maxillofacial bone image data from a storage medium by storing the data into a computer of general medical image control system software;
step two: three-dimensional reconstruction of a cranio-maxillofacial bone prototype, processing cranio-maxillofacial bone tomographic image data in a CT image, wherein the three-dimensional reconstruction comprises filtering, roughness reduction, gray level image binarization, contour extraction, vectorization three-dimensional modeling and outputting three-dimensional model data of the cranio-maxillofacial bone prototype in an STL format;
step three: designing a three-dimensional entity prosthesis of a defect part according to a mandible prototype:
(1) firstly, fixing a point within 2cm of a bone defect edge on a reconstructed three-dimensional image to obtain a boundary contour point of an area to be repaired;
(2) triangulation is carried out on the contour points by using reverse software in a computer to form transition surface model data;
(3) the reverse solving software carries out surface reconstruction on the transition surface data, wherein the surface reconstruction comprises curve fitting, surface splicing and characteristic modeling, and NURBS surface model data is output in an IGES format;
(4) performing three-dimensional entity reconstruction on the NURBS curved surface model data through CAD/CAM software, wherein the three-dimensional entity reconstruction comprises curve repair, curved surface repair and three-dimensional entity modeling, and outputting three-dimensional entity model data in an STL format;
step four: the 3D printing equipment acquires three-dimensional entity model data, and layering the entity three-dimensional model data by using layering software to obtain layer data;
step five: and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.
And the obtained metal prosthesis is subjected to polishing, ultrasonic cleaning and decontamination, laser marking, inspection, packaging and sealing, and then is put in storage.
The third step also comprises the design of the fixing holes of the repairing parts, and the specific process is that the clinical opinions are firstly referred in the design process, the position of each hole is calibrated, the mechanical characteristics of the repairing parts with holes are further analyzed, the positions of the holes are properly adjusted, the clinical adaptability is considered, and the positions of the fixing holes can meet the clinical requirements and can also ensure the mechanical characteristics of the repairing parts after repeated adjustment.
And fifthly, the material used by the 3D printer can be any one of cobalt nameplate alloy, stainless steel, titanium alloy, high-temperature alloy and grinding tool steel.
Example 1 (design of right-side defective mandible substitute 5)
The method comprises the following steps:
the method comprises the following steps: obtaining three-dimensional data of a mandible prototype: acquiring the data of the patient's mandible tomographic image by X-ray film or CT scanning, recording the data into an optical disc file for storage in a standard DICOM format, and reading the data of the mandible tomographic image from a storage medium by a computer stored in a universal medical image control system software;
step two: three-dimensional reconstruction of a mandible prototype, namely preprocessing mandible tomographic image data in a CT image, wherein the preprocessing comprises image filtering, image smoothing and image denoising; binarizing the preprocessed gray level image, wherein the purpose is to segment the image, mainly to segment bone tissues and soft tissues; carrying out the processing to obtain a single-value region of the target contour, extracting and tracking the contour of the single-value region to obtain an external contour value of the target contour, carrying out vectorization three-dimensional modeling on the obtained contour value, and outputting three-dimensional model data of a craniomaxillofacial bone prototype in an STL format;
step three: designing a three-dimensional entity prosthesis of a defect part according to a mandible prototype:
(1) firstly, fixing a point within 2cm of a bone defect edge on a reconstructed three-dimensional image to obtain a boundary contour point of an area to be repaired;
(2) triangulation is carried out on the contour points by using reverse software in a computer to form transition surface model data;
(3) the reverse solving software carries out surface reconstruction on the transition surface data, wherein the surface reconstruction comprises curve fitting, surface splicing and characteristic modeling, and NURBS surface model data is output in an IGES format;
(4) performing three-dimensional entity reconstruction on the NURBS curved surface model data through CAD/CAM software, wherein the three-dimensional entity reconstruction comprises curve repair, curved surface repair and three-dimensional entity modeling, and outputting three-dimensional entity model data in an STL format;
step four: the 3D printing equipment acquires three-dimensional entity model data, and layering the entity three-dimensional model data by using layering software to obtain layer data;
step five: and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.
And the obtained metal prosthesis is subjected to polishing, ultrasonic cleaning and decontamination, laser marking, inspection, packaging and sealing, and then is put in storage.
The third step also includes the design of the fixing holes of the repairing part and the extending fixing plate, the specific process is that referring to the clinical suggestion in the design process, the upper end of the repairing part of the mandible defect position is inosculated with the mandible support, the lower end is inosculated with the mandible of the healthy side, because the repairing part is lack of the supporting part after being implanted, the upper end of the repairing part is fixed with the mandible support of the patient through the upper left extending fixing plate and the fixing bolt, the lower end of the repairing part is fixed with the mandible of the healthy side of the patient through the lower right extending fixing plate and the fixing bolt, the shape and the size of the upper left extending fixing plate and the lower right extending fixing plate and the position of each fixing hole on the repairing part are calibrated, the mechanical characteristics of the repairing part with holes are analyzed, the position of the holes is properly adjusted, and the size and the shape of the upper left, and then the clinical adaptability is considered, and the positions of the fixing holes are repeatedly adjusted for many times, so that the clinical requirements are met, and the mechanical properties of the repair piece, the upper left extending fixing plate and the lower right extending fixing plate can be ensured.
The thickness of the upper left extending fixing plate and the lower right extending fixing plate is 0.8 mm-2 mm.
Example 2 (left half of the defect mandibular bone substitute exemplary Structure 6)
The method comprises the following steps:
the method comprises the following steps: obtaining three-dimensional data of a mandible prototype: acquiring the data of the patient's mandible tomographic image by X-ray film or CT scanning, recording the data into an optical disc file for storage in a standard DICOM format, and reading the data of the mandible tomographic image from a storage medium by a computer stored in a universal medical image control system software;
step two: three-dimensional reconstruction of a mandible prototype, namely preprocessing mandible tomographic image data in a CT image, wherein the preprocessing comprises image filtering, image smoothing and image denoising; binarizing the preprocessed gray level graph, wherein the purpose is to segment the image, mainly the bone tissue and the soft tissue; carrying out the processing to obtain a single-value region of the target contour, extracting and tracking the contour of the single-value region to obtain an external contour value of the target contour, carrying out vectorization three-dimensional modeling on the obtained contour value, and outputting three-dimensional model data of a craniomaxillofacial bone prototype in an STL format;
step three: designing a three-dimensional entity restoration body of a defect part according to a craniomaxillofacial bone prototype:
(1) firstly, fixing a point within 2cm of a bone defect edge on a reconstructed three-dimensional image to obtain a boundary contour point of an area to be repaired;
(2) triangulation is carried out on the contour points by using reverse software in a computer to form transition surface model data;
(3) the reverse solving software carries out surface reconstruction on the transition surface data, wherein the surface reconstruction comprises curve fitting, surface splicing and characteristic modeling, and NURBS surface model data is output in an IGES format;
(4) performing three-dimensional entity reconstruction on the NURBS curved surface model data through CAD/CAM software, wherein the three-dimensional entity reconstruction comprises curve repair, curved surface repair and three-dimensional entity modeling, and outputting three-dimensional entity model data in an STL format;
step four: the 3D printing equipment acquires three-dimensional entity model data, and layering the entity three-dimensional model data by using layering software to obtain layer data;
step five: and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.
And the obtained metal prosthesis is subjected to polishing, ultrasonic cleaning and decontamination, laser marking, inspection, packaging and sealing, and then is put in storage.
The third step also includes the design of the fixing hole of the repair part and the extending fixing plate, the specific process is that the lower end of the repair part of the mandible defect part is matched with the healthy mandible with reference to the clinical opinion in the design process, because the prosthesis is lack of a supporting piece after being implanted, the lower end of the prosthesis is fixed with the mandible of the patient on the healthy side by a fixing bolt through a left lower extension fixing plate and a right lower extension fixing plate, the shape and the size of the left lower fixing plate, the position of each fixing hole on the left lower fixing plate and the position of each fixing hole on the repairing piece are calibrated, the mechanical properties of the perforated repairing piece are analyzed, the position of the hole is properly adjusted, the size and the shape of the left and the right extension fixing plates are properly adjusted, the clinical adaptability is considered, and after repeated adjustment, the position of the fixing hole meets the clinical requirement, and the mechanical characteristics of the repair part and the left and right extension fixing plates can be ensured.
The thickness of the left lower extension fixing plate is 0.8 mm-0.2 mm.
Example 3 (left defective maxillary substitute exemplary Structure 7)
One side of the skull of a patient is defective, the other side of the skull of the patient is intact, a mirror image method can be adopted, and health data of the other side are utilized, and the method comprises the following steps:
the method comprises the following steps: obtaining three-dimensional data of a maxilla prototype: acquiring the data of the lower jaw tomographic image of a patient by using an X-ray film or CT scanning, recording the data into an optical disc file for storage by using a standard DICOM format, and reading the data of the upper jaw tomographic image from a storage medium by storing the data into a computer of a universal medical image control system software;
step two: performing maxilla prototype three-dimensional reconstruction, namely preprocessing maxilla tomographic image data in the CT image, including image filtering, image smoothing and image denoising; binarizing the preprocessed gray level graph, wherein the purpose is to segment the image, mainly the bone tissue and the soft tissue; carrying out the processing to obtain a single-value region of the target contour, extracting and tracking the contour of the single-value region to obtain an external contour value of the target contour, carrying out vectorization three-dimensional modeling on the obtained contour value, and outputting three-dimensional model data of a craniomaxillofacial bone prototype in an STL format;
step three: designing a three-dimensional entity prosthesis of a defect part according to the maxilla prototype:
(1) reading in a skull three-dimensional prototype by a computer provided with general surface modeling software;
(2) adjusting the position of the three-dimensional prototype to ensure that the symmetry plane of the model is superposed with the YZ coordinate plane;
(3) copying a skull prototype along a YZ coordinate mirror image;
(4) according to the three-dimensional curve generation step of software, points on the edge of the skull defect part are sequentially taken by using mouse points to generate a space closed curve; then according to the biasing step of software, the generated closed curve is outwardly biased for 20mm to be used as the cutting boundary of the prosthesis;
(5) selecting extraction points according to a software frame, drawing a rectangular frame on the cutting boundary, and cutting off point data outside the frame;
(6) triangulation is carried out on the point cloud on the space closed curve by reverse solving software in a computer to form transition surface model data;
(7) the reverse solving software carries out surface reconstruction on the transition surface data, wherein the surface reconstruction comprises curve fitting, surface splicing and characteristic modeling, and NURBS surface model data is output in an IGES format;
(8) performing three-dimensional entity reconstruction on the NURBS curved surface model data through CAD/CAM software, wherein the three-dimensional entity reconstruction comprises curve repair, curved surface repair and three-dimensional entity modeling, and outputting three-dimensional entity model data in an STL format;
step four: the 3D printing equipment acquires three-dimensional entity model data, and layering the entity three-dimensional model data by using layering software to obtain layer data;
step five: and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.
And the obtained metal prosthesis is subjected to polishing, ultrasonic cleaning and decontamination, laser marking, inspection, packaging and sealing, and then is put in storage.
The method also comprises the step three, wherein the fixing holes of the repairing part are designed, the specific process is that clinical opinions are firstly referred in the design process, the position of each fixing hole on the repairing part is calibrated, the mechanical characteristics of the hole-added repairing part are further analyzed, the position of the hole is properly adjusted, the clinical adaptability is considered, and the positions of the fixing holes can meet the clinical requirements and can also ensure the mechanical characteristics of the repairing part and the left lower fixing plate after repeated adjustment.
Example 4 (typical Structure of frontal bone defect substitute 8)
The method comprises the following steps:
the method comprises the following steps: acquiring three-dimensional data of a frontal bone prototype: acquiring frontal bone image data of a patient by utilizing an X-ray film or CT scanning, recording the data into an optical disc file for storage by using a standard DICOM format, and reading the craniomaxillofacial bone image data from a storage medium by storing the data into a computer of general medical image control system software;
step two: the method comprises the steps of three-dimensional reconstruction of a frontal bone prototype, processing frontal bone tomographic image data in a CT image, and performing image filtering, image smoothing and image denoising; binarizing the preprocessed gray level graph, wherein the purpose is to segment the image, mainly the bone tissue and the soft tissue; carrying out the processing to obtain a single-value region of the target contour, extracting and tracking the contour of the single-value region to obtain an external contour value of the target contour, carrying out vectorization three-dimensional modeling on the obtained contour value, and outputting three-dimensional model data of a craniomaxillofacial bone prototype in an STL format;
step three: designing a three-dimensional entity restoration body of a defect part according to a frontal bone prototype:
(1) firstly, fixing a point within 2cm of a bone defect edge on a reconstructed three-dimensional image to obtain a boundary contour point of an area to be repaired;
(2) triangulation is carried out on the contour points by using reverse software in a computer to form transition surface model data;
(3) the reverse solving software carries out surface reconstruction on the transition surface data, wherein the surface reconstruction comprises curve fitting, surface splicing and characteristic modeling, and NURBS surface model data is output in an IGES format;
(4) performing three-dimensional entity reconstruction on the NURBS curved surface model data through CAD/CAM software, wherein the three-dimensional entity reconstruction comprises curve repair, curved surface repair and three-dimensional entity modeling, and outputting three-dimensional entity model data in an STL format;
step four: the 3D printing equipment acquires three-dimensional entity model data, and layering the entity three-dimensional model data by using layering software to obtain layer data;
step five: and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.
And the obtained metal prosthesis is subjected to polishing, ultrasonic cleaning and decontamination, laser marking, inspection, packaging and sealing, and then is put in storage.
The third step also comprises the design of the fixing holes of the repairing parts, and the specific process is that the clinical opinions are firstly referred in the design process, the position of each hole is calibrated, the mechanical characteristics of the repairing parts with holes are further analyzed, the positions of the holes are properly adjusted, the clinical adaptability is considered, and the positions of the fixing holes can meet the clinical requirements and can also ensure the mechanical characteristics of the repairing parts after repeated adjustment.
In the above process, the reverse software is surface software, and the CAD/CAM software is Unigraphics software.
In the process, the 3D printing equipment is novel 3D printing equipment jointly researched by the national engineering research center of rapid manufacturing and western university of traffic, has a printing speed of 150/6 hours, can be used for printing twice a day, and is high in quality precision, and the product density is close to 100%.

Claims (3)

1. A preparation method of a personalized customized craniomaxillofacial bone surgery repairing and reconstructing implant is characterized by comprising the following steps:
the method comprises the following steps: acquiring three-dimensional data of a craniomaxillofacial bone prototype: acquiring cranio-maxillofacial bone image data of a patient by utilizing an X-ray film or CT scanning, recording the data into an optical disc file for storage by using a standard DICOM format, and reading the cranio-maxillofacial bone image data from a storage medium by storing the data into a computer of general medical image control system software;
step two: three-dimensional reconstruction of a cranio-maxillofacial bone prototype, processing cranio-maxillofacial bone tomographic image data in a CT image, wherein the three-dimensional reconstruction comprises filtering, roughness reduction, gray level image binarization, contour extraction, vectorization three-dimensional modeling and outputting three-dimensional model data of the cranio-maxillofacial bone prototype in an STL format;
step three: designing a three-dimensional entity restoration body of a defect part according to a craniomaxillofacial bone prototype:
(1) firstly, fixing a point within 2cm of a bone defect edge on a reconstructed three-dimensional image to obtain a boundary contour point of an area to be repaired;
(2) triangulation is carried out on the contour points by using reverse software in a computer to form transition surface model data;
(3) the reverse solving software carries out surface reconstruction on the transition surface data, wherein the surface reconstruction comprises curve fitting, surface splicing and characteristic modeling, and NURBS surface model data is output in an IGES format;
(4) performing three-dimensional entity reconstruction on the NURBS curved surface model data through CAD/CAM software, wherein the three-dimensional entity reconstruction comprises curve repair, curved surface repair and three-dimensional entity modeling, and outputting three-dimensional entity model data in an STL format;
step four: the 3D printing equipment acquires three-dimensional entity model data, and layering the entity three-dimensional model data by using layering software to obtain layer data;
step five: and 3D printing control software carries out reverse manufacturing according to the lamina data, including lamina printing and lamina stacking, and finally the metal prosthesis is obtained.
2. The method for preparing an implant for surgical reconstruction and repair of craniomaxillofacial bone according to claim 1, wherein the third step further comprises designing the fixing holes of the repair part, wherein the method comprises the steps of referring to clinical opinions during the design process, calibrating the position of each hole, analyzing the mechanical properties of the hole-added repair part, properly adjusting the position of the hole, considering the clinical adaptability, and repeatedly adjusting for many times, so that the position of the fixing hole can meet the clinical requirements and the mechanical properties of the repair part.
3. The method for preparing an implant for surgical restoration and reconstruction of craniomaxillofacial bone according to claim 1, wherein the material used by the 3D printer in the fifth step is any one of cobalt-chromium alloy, stainless steel, titanium alloy, high temperature alloy and grinding tool steel.
CN201910968258.3A 2019-10-12 2019-10-12 Preparation method of personalized customized craniomaxillofacial bone surgical repair and reconstruction implant Pending CN111084675A (en)

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