阅读说明：本技术 一种关节假体的制造方法及其试模的制造方法 (Manufacturing method of joint prosthesis and manufacturing method of test mold thereof ) 是由 陈扬 于 2019-10-15 设计创作，主要内容包括：本发明公开了一种关节假体的制造方法及其试模的制造方法,其特征在于：包括以下步骤,1)基于患者关节的医学影像数据建立股骨和胫骨的三维模型；2)使用软件对步骤1)中获得的股骨和胫骨的三维模型进行模拟截骨；3)根据步骤2)中的截骨量以及步骤1)中获得的股骨和胫骨的三维模型设计股骨假体和胫骨假体、半月板假体的三维模型；4)根据步骤3)中设计的股骨假体和胫骨假体、半月板假体的三维模型设计股骨试模和胫骨试模、半月板试模；5)根据步骤3)中设计的假体以及步骤4)中设计的试模的三维模型加工出相对应的部件。对置换的关节假体以及与关节假体相对应的试模进行设计,使试模与关节假体、关节假体与患者达到最佳匹配。(The invention discloses a manufacturing method of a joint prosthesis and a manufacturing method of a test mold thereof, which are characterized in that: the method comprises the following steps of 1) establishing a three-dimensional model of the femur and the tibia based on medical image data of the joint of a patient; 2) performing simulated osteotomy on the three-dimensional models of the femur and the tibia obtained in the step 1) by using software; 3) designing three-dimensional models of a femoral prosthesis, a tibial prosthesis and a meniscus prosthesis according to the osteotomy amount in the step 2) and the three-dimensional models of the femur and the tibia obtained in the step 1); 4) designing a femur test model, a tibia test model and a meniscus test model according to the three-dimensional models of the femur prosthesis, the tibia prosthesis and the meniscus prosthesis designed in the step 3); 5) and processing corresponding parts according to the prosthesis designed in the step 3) and the three-dimensional model of the test mould designed in the step 4). The replaced joint prosthesis and the test model corresponding to the joint prosthesis are designed, so that the test model and the joint prosthesis, and the joint prosthesis and a patient can be optimally matched.)

1. A method for manufacturing a joint prosthesis and a method for manufacturing a trial mold thereof are characterized in that: comprises the following steps of (a) carrying out,

1) establishing a three-dimensional model of the femur and the tibia based on medical image data of the joint of the patient;

2) performing simulated osteotomy on the three-dimensional models of the femur and the tibia obtained in the step 1) by using software;

3) designing three-dimensional models of a femoral prosthesis, a tibial prosthesis and a meniscus prosthesis according to the osteotomy amount in the step 2) and the three-dimensional models of the femur and the tibia obtained in the step 1);

4) designing a femur test model, a tibia test model and a meniscus test model according to the three-dimensional models of the femur prosthesis, the tibia prosthesis and the meniscus prosthesis designed in the step 3);

5) and processing corresponding parts according to the prosthesis designed in the step 3) and the three-dimensional model of the test mould designed in the step 4).

2. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 1, wherein: in the step 1), the image data of the femur and the tibia can be acquired by imaging technologies such as CT scanning, MRI scanning or micro-CT scanning.

3. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 1, wherein: in the step 1), the adopted three-dimensional reconstruction software is Mimics, Simpleware or 3D-docctor, and the format of the three-dimensional model storage file is STL format.

4. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 1, wherein: in the step 3), designing the femoral prosthesis and the tibial prosthesis according to the shape of the marrow cavity.

5. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 4, wherein: in the step 4), through holes for positioning the positions of the drilled holes are designed on the femur test model and the tibia test model according to the shape and the position of the section of the nailed object.

6. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 1, wherein: in the step 5), the processing mode of the prosthesis and the test mold is 3D printing.

7. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 6, wherein: in the step 5), the processing mode of the prosthesis and the test mold is a selective laser melting technology.

8. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 1, wherein: in step 4), additional mechanical features are provided on the femoral prosthesis and the tibial prosthesis.

9. The method for manufacturing a joint prosthesis and the method for manufacturing a trial mold therefor according to claim 8, wherein: in the step 4), the mechanical feature structure is a honeycomb type three-dimensional communicated porous structure.

Technical Field

The invention relates to the technical field of medical instruments, in particular to a manufacturing method of a joint prosthesis and a manufacturing method of a test mold of the joint prosthesis.

Background

Total knee replacement is a common orthopedic procedure for patients with severely damaged limbs due to arthritis or injury. During surgery, the fractured or damaged parts are fixed internally by means of suitable implants or are replaced by the most suitable available prosthesis.

Knee joint replacement is widely applied to clinic at present, is a mature operation technology in the field of joint surgery, and has absolute operation curative effect on relieving pain and deformity of knee joints of old patients.

Studies have shown that the anatomical morphology of the knee joint varies from patient to patient, and current knee prosthesis systems for total knee replacement are standardized, modular designs of several different types of prosthesis, such that the standardized prosthesis and the patient's individual knee joint morphology do not match. The mismatch between the prosthesis and the knee joint can cause the prosthesis to be under-covered or suspended, which further causes the clinical symptoms of the prosthesis, such as abrasion, shortened service life, knee joint pain and swelling after joint replacement, and even the possibility of prosthesis revision.

Currently, there are joint prostheses customized according to medical image data of a patient using 3D printing technology, but the customized joint prostheses may have poor suitability to a general trial mold, and holes drilled through the bone by the trial mold may not be perfectly matched with the positions of the implants of the joint prostheses.

Disclosure of Invention

The technical problem to be solved by the invention is as follows: a method for manufacturing a joint prosthesis and a method for manufacturing a trial mold therefor are provided, which are capable of manufacturing a dedicated joint prosthesis and a trial mold adapted to the joint prosthesis according to the bone form of a patient.

The solution of the invention for solving the technical problem is as follows:

a method for manufacturing a joint prosthesis and a method for manufacturing a trial mold thereof comprise the following steps,

1) establishing a three-dimensional model of the femur and the tibia based on medical image data of the joint of the patient;

2) performing simulated osteotomy on the three-dimensional models of the femur and the tibia obtained in the step 1) by using software;

3) designing three-dimensional models of a femoral prosthesis, a tibial prosthesis and a meniscus prosthesis according to the osteotomy amount in the step 2) and the three-dimensional models of the femur and the tibia obtained in the step 1);

4) designing a femur test model, a tibia test model and a meniscus test model according to the three-dimensional models of the femur prosthesis and the tibia prosthesis designed in the step 3);

5) and processing corresponding parts according to the prosthesis designed in the step 3) and the three-dimensional model of the test mould designed in the step 4).

As a further improvement of the above technical solution, in the step 1), the image data of the femur and the tibia may be acquired by an imaging technique such as CT scan, MRI scan, or micro-CT scan.

As a further improvement of the above technical solution, in the step 1), the three-dimensional reconstruction software is a Mimics, a Simpleware or a 3D-doctor, and the format of the three-dimensional model storage file is an STL format.

As a further improvement of the above technical solution, in step 3), the design of the femoral prosthesis and the tibial prosthesis also designs the nailing object according to the shape of the marrow cavity.

As a further improvement of the above technical solution, in the step 4), through holes for positioning the positions of the drilled holes are designed on the femur trial mold and the tibia trial mold according to the shape and the position of the cross section of the nailing object.

As a further improvement of the above technical solution, in the step 5), the processing mode of the prosthesis and the test mold is 3D printing.

As a further improvement of the above technical solution, in the step 5), the processing mode of the prosthesis and the test mold is a selective laser melting technology.

As a further improvement of the above technical solution, in step 4), additional mechanical features are provided on the femoral prosthesis and the tibial prosthesis.

As a further improvement of the above technical solution, in the step 4), the mechanical feature structure is a honeycomb type three-dimensional interconnected porous structure.

The invention has the beneficial effects that: based on the native bone morphology of a patient, the replaced joint prosthesis and the test model corresponding to the joint prosthesis are designed by combining the medical image data with the virtual osteotomy of the medical three-dimensional software, so that the test model and the joint prosthesis, and the joint prosthesis and the patient are optimally matched.

The invention is used in the technical field of medical instruments.

Drawings

In order to more clearly illustrate the technical solution in the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly described below. It is clear that the described figures are only some embodiments of the invention, not all embodiments, and that a person skilled in the art can also derive other designs and figures from them without inventive effort.

FIG. 1 is a schematic flow chart of the implementation of the present invention.

Detailed Description

The conception, the specific structure, and the technical effects produced by the present invention will be clearly and completely described below in conjunction with the embodiments and the accompanying drawings to fully understand the objects, the features, and the effects of the present invention. It is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments, and those skilled in the art can obtain other embodiments without inventive effort based on the embodiments of the present invention, and all embodiments are within the protection scope of the present invention. All technical characteristics in the invention can be interactively combined on the premise of not conflicting with each other.

As shown in fig. 1, the method for manufacturing a joint prosthesis and the method for manufacturing a trial mold thereof according to the present invention include the following steps:

1. establishing a three-dimensional model of the femur and the tibia based on medical image data of the knee joint of a patient:

① carrying out three-dimensional reconstruction on the tomographic image obtained by scanning to obtain a three-dimensional model of the femur by using medical imaging software Mimics, Simpleware or 3D-factor based on the tomographic image formed by imaging technologies such as CT scanning, MRI scanning or micro-CT scanning of the femur of the knee joint of the patient, and outputting the three-dimensional model as a file in STL format;

② three-dimensionally reconstructing the scanned tomographic image to obtain a three-dimensional model of the tibia based on the tomographic image formed by imaging technologies such as CT scanning, MRI scanning or micro-CT scanning of the tibia of the knee joint of the patient by using medical imaging software Mimics, Simpleware or 3D-factor, and outputting the three-dimensional model as a file in STL format.

2. The three-dimensional models of femur and tibia obtained in step 1 were subjected to simulated osteotomy using software:

① simulation osteotomy software uses Geomagicstudio, CopyCAD, Imageware or RapidForm to introduce STL files of the three-dimensional model of the femur into the software, firstly, the three-dimensional model of the femur is operated to establish a mechanical axis of the femur, then a surgical epicondyle line of the femur is found on a vertical plane of the mechanical axis, the mechanical axis of the femur is taken as a Z axis and the surgical epicondyle line is taken as an X axis, and a three-dimensional coordinate system is established according to the right-hand Cartesian coordinate system;

② operating the three-dimensional model of tibia to establish the mechanical axis of tibia, then establishing the three-dimensional coordinate system according to the right-handed cartesian coordinate system rule with the mechanical axis of tibia as the Z-axis and the surgical epicondyle line as the X-axis, tilting the tibia backwards by 5-10 degrees after the positioning of tibia is completed, simulating proximal osteotomy of tibia at the position of tibia close to the fibula by 10-14 mm, obtaining the osteotomy model and the remaining bone model of tibia, and exporting to STL format file.

3. Designing three-dimensional models of the femoral prosthesis and the tibial prosthesis according to the osteotomy amount in the step 2 and the three-dimensional models of the femur and the tibia obtained in the step 1:

① extracting the curved surface form of the distal end of the femur according to the cut bone model of the femur, keeping the curved surface form of the distal end of the femur unchanged, smoothing and optimizing to obtain the curved surface form of the femoral prosthesis, extracting the surface form characteristics of the cut and retained bone surface according to the retained bone model of the femur, designing the binding surface characteristics of the femoral prosthesis, designing the number and length of the nailed objects and the distribution mode of the nailed objects according to the shape of the medullary cavity of the femur, finally completing the shaping design of the femoral prosthesis, and outputting the shaping design to STL file format for storage.

② extracting the feature of the surface of the cut tibia according to the tibia retaining bone model, designing the joint surface feature of the tibia prosthesis, designing the nailing object on the tibia prosthesis according to the shape of the marrow cavity of the tibia to complete the design of the tibia prosthesis, designing the meniscus prosthesis according to the tibia cutting bone model, finally completing the shaping design of the tibia prosthesis and the meniscus prosthesis, and outputting the shape in STL file format for storage.

4. Designing a femur test model and a tibia test model according to the three-dimensional models of the femur prosthesis and the tibia prosthesis designed in the step 3:

① according to the three-dimensional model of the femoral prosthesis obtained by the above steps, removing the nailing object according to the outline of the femoral prosthesis, and opening a through hole for positioning the drilling hole at the position of the nailing object;

② removing the nailed objects according to the three-dimensional model of the tibial prosthesis obtained by the above steps and the outline of the tibial prosthesis, and opening through holes for positioning the drilled holes at the positions of the nailed objects;

③ according to the three-dimensional model of the meniscus prosthesis obtained by the above steps, the parts of both ends contacting with the femur prosthesis are kept according to the contour of the meniscus prosthesis, and the consumptive material is reduced.

5. Processing corresponding parts according to the prosthesis designed in the step 3 and the three-dimensional model of the test mold designed in the step 4:

①, importing the femoral prosthesis, the tibial prosthesis and the meniscal prosthesis obtained in the above steps and STL files of the femoral trial model, the tibial trial model and the meniscal trial model into preprocessing software matched with 3D printing equipment for support generation, or importing the STL files into general 3D printing preprocessing software for support printing;

② the false body and the test mould are made of titanium alloy with high strength, small density, good mechanical property, good toughness and corrosion resistance, the titanium alloy powder is heated by laser at high temperature through selective laser melting technology and is completely melted, the solid parts are piled layer by layer, the complex structure parts can be accurately formed, and the formed parts have compact structure and high precision;

③ the prosthesis is printed to have a honeycomb three-dimensional connected porous structure inside, and the density of the porous structure is adjustable, the structure has good matching performance with the human bone, and the combination of the bone and the prosthesis is more compact.

While the preferred embodiments of the present invention have been illustrated and described, it will be understood by those skilled in the art that the present invention is not limited to the details of the embodiments shown and described, but is capable of numerous equivalents and substitutions without departing from the spirit of the invention as set forth in the claims appended hereto.