KR20180114438A - System for Designing and Making Implant for Spinal Deformation Calibration with Patient customization and Controlling Method for the Same - Google Patents

Abstract

The present invention provides a patient-customized implant designing and manufacturing system for correction of spinal deformity. The system comprises: a first module for extracting a three-dimensional model from a CT image of a spinal patient under control of a control module and selecting a virtual implant model as a plurality of candidate groups on the basis of the extracted three-dimensional model; a second module for performing a fine model modeling in a three-dimensional manner according to spinal curvature of a patient on the basis of a virtual implant model selected by a clinician among the virtual implant models of the candidate groups; a third module for analyzing a three-dimensional implant model optimally designed by the second module by using a finite element scheme under control of the control module, simulating the analyzed three-dimensional implant model, and continuously correcting an error part to analyze a final implant model so that an actual implant has an optimal curve or an optimal curvature; and a fourth module for actually manufacturing a spinal deformity correction implant including a spiral rod and threads customized for an actual spinal patient while having a final virtual implant model analyzed by the third module under control of the control module. According to the present invention, an optimized implant corresponding to a surgical site of each vertebral patient is designed and manufactured to be provided to a surgeon. The present invention significantly reduces a spinal deformity error and a trial-and-error process which a surgeon may be faced by, thereby significantly reducing a time for a spinal correction operation.

Description

TECHNICAL FIELD The present invention relates to a system and a control method for a patient-customized spinal deformation correction implant,

The present invention relates to a system and method for designing and manufacturing implantable orthodontic prostheses for orthodontic patients, and more particularly, by designing and manufacturing an optimized implant corresponding to a surgical site of each spinal patient through a three-dimensional applied implant design and manufacturing system, The present invention relates to a system and method for designing and manufacturing a patient-tailored orthodontic orthodontic prosthesis that reduces the vertebral deformity error and trial-and-error process that a surgeon can face.

In general, the human spine is the body organs located centrally in the center of the body, centered on the dorsum of the body, 7 cervical, 12 thoracic, 5 lumbar, cartilaginous; And the spine is connected to the pelvis to support the upper head, and the lower part is connected to the pelvis to transmit weight to the lower body. A fibrous cartilaginous intervertebral disc (disc) is formed between the vertebrae and a strong ligament and muscle To support the body and maintain equilibrium. However, such vertebrae can be caused by a variety of causes, such as erroneous posture, excessive exercise or spinal degenerative diseases such as degenerative spondylolisthesis, fracture spine, thoracic lumbar spine, various acute and chronic instability anomalies of the spine. Therefore, in order to correct such vertebral deformities, a surgical operation is usually performed. Such surgery is performed by using a biocompatible material such as titanium, stainless steel, chromium cobalt or the like to fix and assist the deformed vertebrae to improve stability. Spinal fixation using a pedicle screw fixation system is widely used (Arthit Sitiso, John Wagner, and Frank Bailly, "Polyaxial pedicle screw system", US 20040158247 A1, 2004). The conventional pedicle screw fixation system is composed of a screw, a hook, a rod, a connector, a surgical instrument, etc. Each element has a shape, a diameter, a length And a set of components of various types and sizes according to the size of the patient are packaged in a single set, and one set of operations for the spinal fixation is provided to the surgeon and the operation is performed.

Referring to FIG. 1, a method for fixing a vertebra using a conventional pedicle screw fixation system as described above,

A first step (200) in which a surgeon selects an appropriate part for spinal surgery by referring to a patient's X-ray, CT image,

Using the part selected by the first step 200, the surgeon selects a screw having a diameter and a length suitable for the patient's spine, selects a rod that can be roughly used for the scope of surgery and curvature of the curved vertebra, A second step (210) of executing the first step (210);

A third step in which the surgeon manipulates the bar in accordance with the operation of the patient using the surgical instrument and performs the operation on the patient in the case that the parts selected by the second step 210 and used for the change are changed during the course of the actual operation (220).

Hereinafter, the spinal deformity fixing method using the conventional pedicle screw fixation system will be described in more detail. First, the surgeon selects a suitable part for spinal surgery by referring to the CT image of the patient during the preparation period. Then, the surgeon selects a screw having a diameter and a length suitable for the patient's spine using the selected parts in the above procedure, and performs a surgery by selecting a rod that can roughly be used for the operation range and the curved vertebra curvature. At this time, the surgeon will perform surgery on the patient after the surgeon manipulates the rod using the surgical equipment to match the operation patient, in case the parts that are scheduled to be used are changed during the actual operation progress. That is, since the curvature of the vertebrae of the operation patient is different for each individual, the uniformly produced rod must be bent according to the patient's surgical equipment to perform the operation.

However, since the spinal deformity fixing method using the conventional pedicle screw fixation system as described above is a method in which the surgeon selects only the medical image of the patient and selects the part based on his own experience and estimates the degree of bending of the rod, It is very likely that unexpected errors will occur depending on the actual conditions, and the operation time is often delayed due to a change in the operation plan or an error in the bending process of the bar. In addition, And a time delay may have a large effect on the surgical result, which may lead to a wrong result to the patient.

SUMMARY OF THE INVENTION The present invention has been made in order to solve the problems of the prior art as described above, and it is an object of the present invention to provide a computer simulation method using computational mechanics such as a finite element method, , And the procedure is designed to search, design, and produce implants that fit the spine of the patient through the simulation results. The patient-specific vertebra, which provides the patient and the surgeon with stability and convenience, And to provide a deformation-correcting implant designing and manufacturing system and a control method thereof.

According to another aspect of the present invention, there is provided a method for designing an implant for vertebroplasty, the method comprising: constructing a three-dimensional virtual implant model; and;

Under the control of the control module, a three-dimensional model is extracted from the X-ray and CT image of the spine patient, and based on the extracted three-dimensional model of the spine patient, the virtual implant model is classified into various candidates A first module for selecting the first module;

And designing the spiral load according to the vertebral curvature of the patient under the control of the function of the control module based on the virtual implant model selected by the clinician among the virtual implant models of the plurality of candidate groups selected by the first module, A second module for modeling;

The three-dimensional implant model designed by the second module is analyzed by the finite element method under the control of the control module, and the analyzed three-dimensional implant model is simulated and the error part is continuously corrected. A third module for interpreting the final implant model to obtain a curve or optimal curvature;

A fourth module for actually fabricating a vertebral deformation correcting implant having a final virtual implant model interpreted by a third module under the control of the control module and including spinal patient alignment screws and spiral rods; Provides a system for design and manufacture of vertebral deformation correction implants.

Another feature of the present invention is that the control module of the implant design and manufacturing system extracts a three-dimensional model from a CT image of a spinal patient through a first module, and based on the extracted three-dimensional model of the spine patient, And selecting each of the candidate groups as a candidate group;

The control module may design the spiral load according to the vertebral flexion of the patient through the second module based on the virtual implant model selected by the clinician among the virtual implant models of the plurality of candidate groups selected by the first module of the first process A second step of three-dimensionally finely modeling the object;

The control module analyzes the three-dimensional implant model designed by the second module of the second process using the finite element method through the third module, simulates the analyzed three-dimensional implant model, and continuously corrects the error portion A third step of analyzing the final implant model so that the actual implant has an optimal curve or an optimal curvature;

The fourth module is a fourth virtual module for verifying the final virtual implant model analyzed by the third module of the third process, and the fourth module for actually verifying the vertebrae orthodontic implant including the spinal- The present invention provides a control method of a system for designing and manufacturing a patient-customized vertebrae orthodontic prosthesis.

According to the present invention, the optimized implant corresponding to the surgical site of each spinal patient is designed and manufactured through the three-dimensional applied implant designing and manufacturing system, and provided to the surgeon. Thus, It is possible to significantly reduce the vertebral deformity error and the trial-and-error process that the doctor can face, thereby significantly shortening the time of the chiropractic operation.

In addition, according to the present invention as described above, the optimized implant that is hardly affected by the proficiency of the surgeon can be implanted in the patient, thereby providing a safe and successful operation to the surgeon as well as the patient.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an explanatory diagram illustrating an example of a method of fixing a spinal deformity using a conventional pedicle screw fixation system.
FIG. 2 is an explanatory view illustrating a system for designing and manufacturing a patient-customized spinal deformation correction implant according to the present invention; FIG.
FIG. 3 is an explanatory view for explaining a model completed from a three-dimensional model to a detailed modification step by extracting only a desired portion using the system of the present invention. FIG.
FIG. 4 is an explanatory diagram showing three-dimensional modeling of a virtual implant model among various candidate groups of a virtual implant model selected by the system of the present invention; FIG.
FIG. 5 is an explanatory diagram showing a virtual implant model inserted into a three-dimensional model of a spinal patient using the system of the present invention; FIG.
FIG. 6 is an explanatory view showing a stress distribution of each part after analyzing the three-dimensional model of a vertebral patient having a virtual implant model inserted using the system of the present invention by setting the contact condition and the boundary condition, and analyzing them by the finite element method.
FIG. 7 is an explanatory view showing a final implant manufactured after a simulation using the system of the present invention. FIG.
8 is a flowchart of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments of a patient-customized vertebra deformational implant designing and manufacturing system according to the present invention will be described with reference to the accompanying drawings.

However, the present invention may be embodied in other forms without being limited to the embodiments of the implantable prosthetic implant design and fabrication system according to the present invention described herein. Rather, the embodiments disclosed herein are provided so that the disclosure can be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like reference numerals designate like elements throughout the specification. It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In the present specification, the singular form includes plural forms unless otherwise specified in the specification. The term " comprises " And / or "comprising" does not exclude the presence or addition of one or more other elements, steps, operations, and / or elements.

Example

FIG. 2 is an explanatory view illustrating a system for designing and manufacturing a patient-customized vertebra deformational correction according to the present invention. FIG. 3 is a view for explaining a model completed from a three- FIG. 4 is an explanatory diagram showing three-dimensional modeling of a virtual implant model among several candidate groups of a virtual implant model selected by the system of the present invention. FIG. 6 is an explanatory view showing insertion of a virtual implant model into a three-dimensional model. FIG. 6 is a view illustrating a three-dimensional model in which a virtual implant model is inserted using a system of the present invention. FIG. 7 is a view showing a stress distribution of each part after the present invention system FIG. 8 is a flowchart of the present invention. FIG. 8 is a flowchart illustrating the final implant according to the present invention.

2 to 7, a three-dimensional applied implant designing and manufacturing system according to an embodiment of the present invention includes:

A control module 1 for designing, managing and controlling the whole process of actually manufacturing the vertebrae deformation correction implant 8 using the three-dimensional virtual implant model 2;

A three-dimensional model is extracted from the X-ray or CT image of the vertebrae under the control of the control module 1, and based on the extracted three-dimensional model of the spine patient, A first module (3) for classifying a plurality of candidate groups into a plurality of candidate groups;

The spiral load 7 is placed under the control of the control module 1 on the basis of the virtual implant model 2 selected by the clinician among the plurality of candidate implant virtual models 2 selected by the first module 3, A second module (4) for precisely modeling in three dimensions including designing in accordance with the vertebral curvature of the vertebra;

Dimensional implant model 2 designed optimally by the second module 4 is analyzed using the finite element method under the control of the function of the control module 1 and then the simulated three-dimensional implant model 2 is simulated and an error A third module (5) for interpreting the final implant model (2) so that the actual implant is the optimal curve or the optimal curvature,

With the final virtual implant model (2) interpreted by the third module (5) under the control of the function of the control module (1), the vertebrae deformations comprising the actual vertebrae tailoring screws (6) and the spiral rods (7) And a fourth module (9) for actually manufacturing the orthodontic implant (8).

As shown in FIG. 3, the first module 3 designates an expected range of operation in an X-ray or a CT image of a spinal patient and extracts a sophisticated spinal three-dimensional finite element model using a program such as Mimics Based on the three-dimensional model (12) of the extracted vertebral patients, the virtual implant model (2) is selected for the candidates of various surgical methods suitable for the patient.

Also, the second module (4) designs various types of system sets by selecting candidates such as screws and rods of various dimensions necessary for each virtual implant candidate group selected by the first module (3) When selecting the implant candidate group, the patient's physical information, for example, skeleton, bone density, and curvature of the vertebrae are considered.

Furthermore, the second module 4 inserts each of the virtual implant candidates selected by the first module 3 into a three-dimensional model and extracts the patient model. At this time, in the insertion process, In the case of the spiral load (7: or rod), it is not designed to model the conventional product in the existing market, but to the patient's vertebral flexion And model it according to the curvature.

That is, in the second module 4, as shown in FIG. 4, the virtual implant model 2 is selected as a case or candidate group so that a clinician can optimally select an implant when performing a spinal patient procedure.

5 to 6, the third module 5 also analyzes the virtual implant model 2 modeled as described above by the finite element method to calculate the respective result information. During the process of calculating the result information, the third module 5 of the implant designing and manufacturing system 10 calculates the result of the inserted three-dimensional model 12 using a finite element analysis program such as Ansys or Abaqus Especially, if more accurate result information is needed, the patient's micro CT image is obtained and the analysis is performed by three-dimensional modeling to the inside of a sophisticated cancellous bone. At this time, the third module 5 also executes the simulation of the three-dimensional virtual implant model 2 interpreted using the finite element method as described above, and continuously corrects the error part, so that the actual implant 8 is optimized The final virtual implant model (2) is calculated to obtain a curve or optimal curvature.

Here, the analysis process of the third module 5 will be described in more detail. After the load condition and the support condition are set, the third module 5 performs simulation on four kinds of physical motions. At this time, the third module (5) has a self load (self load) in which only the body weight of the patient acts as a load, a flexion load which is a load action when the patient bends the waist forward, Extension load of the case, torsion load when the waist is rotated, and so on. In addition, the third module 5 performs the above-described analysis in four kinds of analyzes such as linear analysis, nonlinear analysis, dynamics analysis, and fracture analysis, 16 kinds of analysis results are derived. At this time, the third module 5 analyzes the three types of drawings such as total deformation, equivalent elastic strain, and equivalent stress, which are output results after each analysis is completed Check the maximum stress and maximum displacement acting on the screw system and bones. Here, the third module 5 determines, based on the analysis information, the influence of the load and the screw system (or implant) on the part most vulnerable to the screw system (or implant) after the physical exercise and the bone of the patient do.

The fourth module 9, on the other hand, has a final virtual implant model 2 interpreted by the third module 5 as shown in Fig. 7, and the screw 6 and the spiral rod 7) to make a vertebrae orthodontic implant (8). That is, the fourth module 9 can be manufactured by bending the spiral rod 7 in accordance with the curvature of the patient's vertebra, for example, and a set of all-manufactured patient-customized vertebra correction implants 8, The equipment is packaged in a packaging set that is easy for the surgeon to use.

In addition, the fourth module (9) further includes a set of preliminary patient-adapted vertebra correction orthodontic appliances (8) to be used when an emergency occurs during surgery and the set of patient-customized vertebrae orthodontic appliances (8) to provide.

Here, the three-dimensional applied implant designing and manufacturing system 10 further includes storage means 11, monitoring means 13, wire / wireless transmitting / receiving means 14, and a key panel.

Next, the control method of the present invention having the above-described configuration will be described.

8, in the initial state S1, the control module extracts a three-dimensional model from a medical image of a spinal patient through a first module and generates a virtual image based on the extracted three- A first step (S2) of classifying the implant model into various candidates by classifying the implant model according to the surgical method and each dimension;

Based on the virtual implant model selected by the clinician among the virtual implant models of various candidates selected by the first module in the first step S2, the control module controls the spiral load through the second module according to the curvature of the vertebra of the patient A second step (S3) of precise modeling in three dimensions including designing as a three-dimensional model;

The control module analyzes the three-dimensional implant model designed by the second module of the second process (S3) using the finite element method through the third module, simulates the interpreted three-dimensional implant model, (S4) of analyzing the final implant model so that the actual implant has an optimal curve or an optimal curvature;

The final virtual implant model analyzed by the third module of the third step S4 is used to actually make the vertebrae correction orthodontic implant in which the control module includes actual spinal patient fitting screws and spiral rods through the fourth module (Step S5).

In addition, the first step S2 further includes a three-dimensional model processing step of processing a sophisticated spinal three-dimensional finite element model using a program such as Mimics, for example.

In the first step S2, various sets of system sets are selected by selecting candidates of screws, spiral rods (or rods, etc.) having various dimensions required for each virtual implant candidate group selected by the first module 3 And further includes a step of considering precision patient information in consideration of the patient's body information, for example, skeleton, bone density, vertebral curvature, etc., when selecting each virtual implant candidate group.

In addition, in the second step S3, the second module 4 inserts each of the virtual implant candidates selected by the first module into the extracted patient model by three-dimensionally modeling the virtual implant candidates. At this time, works, and Inventor. In particular, the spiral load (or rod) is not a model of a conventional product seen in the existing market, but a curvature due to the curvature of the patient's vertebrae And further includes a spinal curvature application step to model properly.

That is, in the second step (S3), a virtual implant model is selected by the second module as a case or candidate group so that a clinician can optimally select an implant for a spinal patient.

In the third step S4, an analysis result information calculation step of analyzing the virtual implant model modeled by the third module by the finite element method and calculating each result information is further included. During the analysis result information calculation step, the results of the three-dimensional model of the patient in which the third module of the implant design and production system is inserted are calculated using a finite element analysis program such as Ansys or Abaqus, Dimensional precision modeling step of obtaining a micro CT image of a patient and performing a three-dimensional modeling into a sophisticated cancellous bone to perform an analysis if the result information needs to be obtained. At this time, during the analysis result information calculation step, the third module executes the simulation of the three-dimensional virtual implant model analyzed by using the finite element method, and continuously corrects the error part, so that the actual implant becomes the optimum curve or the optimum curvature And a final implant model calculation step of calculating a final virtual implant model. Further, in the third step (S4), the third module performs simulation of four kinds of physical motions after setting the load condition and the support condition, and the simulation is performed in which the weight of the patient, Self load, Flexion load which is the load action when the patient bends forward, Extension load when backward bending, Torsion load when the waist is rotated, etc. And a precise motion analysis step in which the analysis of the four types of motion is performed. In the third step S4, the third module is analyzed by four kinds of analysis such as linear analysis, nonlinear analysis, dynamics analysis, and fracture analysis. And a concrete analysis execution step in which 16 kinds of analysis results are derived. At this time, in the concrete analysis execution step, there are three kinds of drawings such as total deformation, equivalent elastic strain, and equivalent stress, which are output results of the third module after each analysis is completed And analyzing the result of the analysis to confirm the maximum stress and maximum displacement value acting on the screw system and the bone part.

In the third step (S4), the third module analyzes the weakest part of the screw system after the physical exercise based on the analysis information, and the weak part confirming the influence of the load and the screw system on the bone of the patient .

Meanwhile, in the fourth step S5, the fourth module includes a final implant model analyzed by the third module, and a final implant preparation step in which the vertebrae correction orthodontic implant is actually manufactured . At this time, in the final implant manufacturing step, the fourth module is used, for example, to bend the spiral rod according to the curvature of the patient's vertebra or to make a 3D printer or the like, Surgical equipment is packaged in a packaging set for easy access by the surgeon.

In addition, in the fourth step S5, the fourth module further provides a set of preliminary patient-customized vertebra correction implants to be used when an emergency situation occurs during surgery and a set of patient-customized vertebrae correction implants is broken And a preliminary implant set providing step.

In other words, in order to use the three-dimensional applied implant designing and manufacturing system according to the present invention, the control module 1 first extracts the three-dimensional model 12 from the CT image of the spinal patient through the first module 3, Based on the three-dimensional model of the spine patient, the virtual implant model (2) is classified into various candidates by the surgical method and each dimension. In order to extract the elaborate spinal three-dimensional finite element model, . The control module 1 selects candidates of screws 6, spiral rods 7 (or rods, etc.) having various dimensions required for each virtual implant candidate group selected by the first module 3, The system set is designed, and the patient's physical information such as skeleton, bone density, and vertebral curvature are taken into consideration when selecting candidate virtual implant models.

After the candidate group selection process is completed, the control module 1 determines whether or not the virtual implant model 2 of the plurality of candidates selected by the first module 3 is the second virtual implant model 2, Through the module 4, the spiral rod 7 is specifically designed according to the patient's vertebral curvature and is precisely modeled on the other structures in three dimensions. Here, in the three-dimensional modeling process, the second module 4 inserts each of the virtual implant candidates 2 selected by the first module 3 into the extracted patient model 12 by three-dimensional modeling, In the insertion process, for example, a candidate group is designed as a specific virtual implant model 2 using a program such as Solid-works or Inventor, and in particular, a spiral load (7: rod) Instead of modeling, model the patient according to the curvature of the vertebral curvature. That is, the second module (4) selects a virtual implant model (2) as a case or candidate group so that a clinician can optimally select an implant when performing a spinal patient procedure.

When the three-dimensional implant model is designed to be optimized by the second module 4, the control module 1 performs the finite element method on the three-dimensional implant model 2 designed by the optimization through the third module 5 And then analyzes the analyzed three-dimensional implant model (2) and continuously analyzes the error part to analyze the final implant model (2) so that the actual implant has the optimal curve or the optimum curvature. Here, in the above-described analysis process, the third module 5 analyzes the modeled virtual implant model 2 by the finite element method, and then calculates each result information. That is, in this process, the third module 5 of the implant design and manufacturing system 10 calculates the results of the inserted patient's three-dimensional model using a finite element analysis program such as Ansys or Abaqus, If more accurate result information is needed, the patient's micro CT image is acquired and the analysis is performed by three-dimensional modeling to the inside of a sophisticated cancellous bone. At this time, during the analysis result information calculation step, the third module 5 executes simulation on the three-dimensional virtual implant model 2 interpreted by using the finite element method, and continues to correct the error part, so that the actual implant 8 The final virtual implant model (2) is calculated to obtain an optimal curve or optimal curvature. Furthermore, the third module 5 executes the simulation of four kinds of physical motions after setting the load condition and the support condition, that is, the self load, which is a state where only the weight of the patient acts as a load, Flexion load, which is the load action when the patient bends the waist forward, and extension load when bending backward, and torsion load when the waist is rotated. And a precise motion analysis to proceed with the analysis of the motion. In addition, the third module 5 performs four kinds of analyzes such as linear analysis, nonlinear analysis, dynamics analysis, and fracture analysis in precision motion analysis, The result of analysis of the kind is derived. In this case, during the execution of the specific analysis, the third module 5 is a result display after the completion of each analysis and includes three types of total deformation, equivalent elastic strain, and equivalent stress The maximum stress and maximum displacement values acting on the screw system and the bony part are analyzed by analyzing the drawing.

Here, during the analysis process, the third module 5 further includes a process of confirming the influence of the load and the screw system on the parts most vulnerable to the screw system and the patient's bones after the physical exercise, based on the analysis information do.

After the above-described analysis process, the control module 1 has the final virtual implant model 2 interpreted by the third module 5 and the actual vertebrae-adapted screws 6 ) And a spiral rod (7) are actually manufactured. That is, the fourth module 9 actually includes the screw and rod of the actual vertebrae patient with the final implant model 2 interpreted by the third module 5 to actually make the vertebrae correction orthodontic implant 8 At this time, in the final implant manufacturing process, for example, the fourth module 9 is manufactured by bending the spiral rod 7 according to the curvature of the patient's vertebra, using a 3D printer or the like, A set of vertebrae orthodontic implants (8) and surgical surgical equipment are packaged in a packaging set that is easily accessible to the surgeon. In addition, the fourth module (9) adds a set of preliminary patient-adapted vertebra correction orthodontic implants (8) to be used when an emergency occurs during surgery and the set of patient-customized vertebrae orthodontic appliances (8) As shown in FIG.

Here, the three-dimensional applied implant designing and manufacturing system 10 of the present invention confirms the design and manufacturing process of the patient-customized vertebra deformation correction implant through the monitoring means 13, And can transmit and receive the processing data to the mobile phone 15 or wireless equipment by accessing the Internet, a local area network, or a mobile communication network through the wired / wireless transmitting / receiving unit 14.

Hereinafter, the method for designing and manufacturing the implant according to the present invention will be described in more detail. First, in extracting and selecting, a medical image such as X-ray and CT of a patient is acquired in order to extract a three-dimensional model. At this time, since the image image is most important for photographing the expected range of the patient's surgery and completing a more precise model, the photographing section is divided as much as possible and the image quality is improved. In addition, based on the medical image obtained in the above process, a program corresponding to the skeleton shown in the image is firstly extracted using a program (Mimics, etc.) for extracting a three-dimensional model from the image, and the remaining skeletal parts And extracts only the parts necessary for us as a three-dimensional model. In addition, since there are various parts that affect the behavior of the human body as well as the skeleton in the extraction process, the parts which can not be extracted from the medical image are directly produced by using the three-dimensional modeling program and added to the three-dimensional skeleton model. Here, since the model is used for finite element analysis later, the 3D model is finally finalized by making detailed modifications in the form optimized most for the analysis. FIG. 3 shows a model from a lumbar lumbar region to an ilium region, which is a model completed from a three-dimensional model obtained by extracting only a desired portion to a detailed correction process. Different colors are assigned to each part, and the disk between each lumbar vertebra and the ligament that restricts the movement between the skeletons are made to complete the three-dimensional model of the human body. In addition, we discussed with the surgeon various types of surgical methods appropriate for the patient, including the patient's skeleton, bone density, vertebral curvature, and so on, and subdivided the diameter and length of screws, rods, etc. into each candidate group We also classify several subordinate candidates. In addition, if the patient's bone density is significantly low, accurate interpretation is required, so internal images of cancellous bone are needed. This image can be photographed by Micro CT and extracted into the cancellous bone, completing a sophisticated three-dimensional model.

Particularly, in the second step (S3), a three-dimensional model of the human body is extracted and a virtual implant model (or a pedicle screw fixation system) to be inserted into the human body model is designed using a design program (Solid works, Inventor, . At this time, when setting a candidate group of the virtual implant model, many parts need to be modeled, and some representative items that are formalized are designed, and the three-dimensional model designed before the start of the operation plan is prepared in advance. Thereby modeling a plurality of parts. Then, the modeled parts are assembled according to the shape of each candidate group classified according to the operation method, and the candidate groups are classified into types. When modeling a virtual implant model as described above, it is important to design a spiral rod (or a rod) to construct a three-dimensional model based on the curvature value of the vertebral curvature, rather than making a conventional shaped product. 4 is a view showing a screw system of, for example, the S2AI screw, which is one of various candidates of the virtual implant model, by three-dimensional modeling. Models having various dimensions in the lower candidate group of the virtual implant model are formed in the shape as shown in the figure, and a large number of models of candidates of different types are generated. At this time, the curvature of the spiral rod was shaped along the curvature of the spine.

The 3D model and the selected virtual implant model (or pedicle screw fixation system) are combined as shown in FIG. 5 after the 3D modeling is performed through the above process. At this time, the three-dimensional model and the selected virtual implant model The system model of the spine model is located at a predetermined coordinate of the spine model and the system model is inserted by drilling a hole of the same size as the screw diameter in the spinal model in the same manner as the actual operation.

Then, if the overall three-dimensional model is completed through the above-described process, the simulation proceeds through engineering analysis as shown in FIG. In this case, first, the contact condition of each part of the three-dimensional model should be set. For example, since there is no displacement between the lumbar spine and the disk, the condition is set in a state where the two parts are completely coupled. It can be set as the friction condition by inputting the friction coefficient or the like. Next, the boundary condition must be set up, and it can be divided into the load condition and the support condition. Here, the load conditions include a force, a pressure, and a moment, and the support conditions include a fix support, a friction support, and the like. The above-mentioned conditions are dynamically analyzed and applied according to the physical motion of the three-dimensional model, and different kinds of motion cases are set to derive the respective mechanical analysis results.

On the other hand, when the finite element analysis result is derived for each candidate group of the three-dimensional model in which the virtual implant model is combined as described above, various engineers and surgeons discuss the results and select the final candidate. At this time, the optimized model candidates are finally selected using the result information such as stress distribution, strain distribution, and deformation distribution according to various exercise conditions. Since there may be cases in which the applicability evaluation is not appropriate, a model of the second and third candidates is also selected.

Meanwhile, the virtual implant model selected as the final candidate through the above process is finally evaluated for the applicability to the actual patient. In the case of the surgical procedure and the patient's life after the operation, safety, economical efficiency, convenience And judges whether or not it is applicable. If it is judged that the applicability is judged to be applicable in this process, the process proceeds to the next step. If it is judged to be impossible, the model selected as the second candidate is re-evaluated and evaluated repeatedly until the conclusion can be obtained.

When a final virtual implant model (or a model of a pedicle screw fixation system) is selected via the above-described process, an actual product is manufactured as shown in FIG. 7. When a product such as a screw, a ring, The spiral rod (or bar) is manufactured in accordance with the dimension, and the 3D model through the fourth module is manufactured by using a 3D printer, or the bending is taken into a linear shape, and the curvature values of the three- Proceed in such a way that the bend of the shape of the model is given to the bar of the straight line.

If the final implant (or screw fixation system of the pedicle screw) is completed through the above process, the final implant is packed with the surgical instrument and is provided to the surgeon. And pack it in the system box. At this time, since there is a possibility of an emergency in the surgical procedure, a surgeon provides a set of preliminary systems including products of various sizes that are commercially available in the existing market and not subjected to the above simulation process to prepare for an emergency.

 Therefore, when the present invention as described above is applied, the results of various methods can be predicted by performing the simulation in the surgical preparation process, the optimal method suitable for the patient can be determined before the surgery, and the surgeon's quick judgment can be expected Thus, each simulation can reduce errors and shorten the operation time, providing stability, promptness, and convenience to the surgeon and patient and greatly reducing the burden on the operation.

1: Control module 2: Virtual implant model
3: first module 4: second module
5: Third module 6: Screw
7: Spiral load 8: Implant for correcting spinal deformity
9: Fourth module 10: Implant design and manufacturing system
11: storage means 12: three-dimensional model
13: Monitoring means 14: Wired / wireless transmission / reception means
15: Mobile phone

Claims (18)

A control module for designing, managing, and controlling the entire process of actually manufacturing the vertebral deformation correction implant using the three-dimensional virtual implant model;
A first step of extracting a three-dimensional model from the medical image of the spinal patient under the control of the control module and selecting the virtual implant model as a candidate group by classifying the virtual implant model according to the surgical method and each dimension based on the extracted three- A module;
And designing the spiral load according to the vertebral curvature of the patient under the control of the function of the control module based on the virtual implant model selected by the clinician among the virtual implant models of the plurality of candidate groups selected by the first module, A second module for modeling;
The three-dimensional implant model designed by the second module is analyzed by the finite element method under the control of the control module, and the analyzed three-dimensional implant model is simulated and the error part is continuously corrected. A third module for interpreting the final implant model to obtain a curve or optimal curvature;
A fourth module for actually fabricating a vertebral deformation correcting implant having a final virtual implant model interpreted by a third module under the control of the control module and including spinal patient alignment screws and spiral rods; Implant design and fabrication system for orthodontic spine deformity. The method according to claim 1,
The second module designing various types of system sets including a screw of a plurality of dimensions and a candidate group of a spiral rod necessary for each virtual implant candidate group selected by the first module, Bone density, and vertebral curvature information of the patient, based on the body information of the patient. The method according to claim 1,
The second module is designed by inserting each of the virtual implant candidates selected by the first module into the extracted patient model by three-dimensionally modeling the virtual implant candidates, and using the Solid-works or Inventor program, Wherein the implantable prosthesis is designed with a specific virtual implant model. The method of claim 3,
Wherein the spiral load (or rod) is modeled according to the curvature of the patient's vertebral curvature in the insertion process. The method according to claim 1,
The third module analyzes the modeled virtual implant model using the finite element method, calculates each result information, and performs a three-dimensional modeling of the inside of the sophisticated cancellous bone using the patient's micro CT image to perform the analysis A system for the design and manufacture of patient - tailored orthodontic orthodontics. The method according to claim 1,
Wherein the third module performs a simulation on the interpreted three-dimensional virtual implant model and continues to correct the error portion to yield a final virtual implant model with a curve or curvature close to the actual implant. Deformation correction implant design and fabrication system. The method according to claim 1,
The third module includes a self load which is a state in which only the patient's body weight acts as a load, a flexion load which is a load action when the patient bends the front waist, an extension load when the patient bends back, wherein the simulations are carried out with a physical analysis of the four types of movements including the load and the torsion load when the waist is rotated. 8. The method of claim 7,
The third module has four kinds of analysis including simulation of linear analysis, nonlinear analysis, dynamics analysis, and fracture analysis, and 16 kinds of analysis result Wherein the implantable prosthesis comprises a plurality of implantable implantable prostheses. 8. The method of claim 7,
The third module analyzes the three types of diagrams of Total Deformation, Equivalent Elastic Strain, and Equivalent Stress, which are output results after each analysis, Wherein a maximum stress and a maximum displacement value acting on the vertebrae vertebrae are identified. 10. The method of claim 9,
The third module is based on the interpretation information, and it confirms the influence of the load and the screw system on the parts most vulnerable to the screw system after the physical exercise and the bones of the patient, and the patient-customized spine deformation correction implant design And production system. The method according to claim 1,
Wherein said fourth module further fabricates a set of preliminary patient-customized vertebra correction implants to be used when an emergency occurs during surgery and a set of patient-customized vertebrae correction implants is broken. ≪ RTI ID = 0.0 > Implant design and manufacturing system. The control module of the implant design and manufacturing system extracts the 3D model from the CT image of the spine patient through the first module and classifies the virtual implant model according to the surgical method and each dimension based on the extracted three- A first step of selecting a candidate group;
The control module may design the spiral load according to the vertebral flexion of the patient through the second module based on the virtual implant model selected by the clinician among the virtual implant models of the plurality of candidate groups selected by the first module of the first process A second step of three-dimensionally finely modeling the object;
The control module analyzes the three-dimensional implant model designed by the second module of the second process using the finite element method through the third module, simulates the analyzed three-dimensional implant model, and continuously corrects the error portion A third step of analyzing the final implant model so that the actual implant has an optimal curve or an optimal curvature;
The fourth module is a fourth virtual module for verifying the final virtual implant model analyzed by the third module of the third process, and the fourth module for actually verifying the vertebrae orthodontic implant including the spinal- A method for controlling a patient - customized spinal deformation correction implant design and manufacturing system including a method. 13. The method of claim 12,
The second step further includes a spinal curvature application step of modeling the spiral load (or rod) according to the curvature of the patient's vertebrae when designing the virtual implant model, and designing and manufacturing the patient-customized vertebra correction implant Method of controlling the system. 13. The method of claim 12,
In the third step, when the virtual implant model modeled by the third module is analyzed by the finite element method, a three-dimensional precision modeling step of performing three-dimensional modeling to a sophisticated cancellous bone based on the patient's micro CT image Wherein the implantable prosthesis comprises a plurality of implantable prostheses. 13. The method of claim 12,
In the third step, after the third module sets the load condition and the support condition, a simulation is performed on four kinds of physical motions. Self load, which is a state in which only the weight of the patient acts as a load, Physical analysis of four types of motion: flexion load (flexion load) when the waist is bent forward, extension load when bending backward, and torsion load when the waist is rotated. Further comprising a precise motion analysis step of performing a precise motion analysis of the spine deformation correction prosthesis. 13. The method of claim 12,
In the third step, the third module is analyzed by four types of analysis: linear analysis, nonlinear analysis, dynamics analysis, and fracture analysis. Further comprising a specific analysis execution step in which the analysis result is derived. 17. The method of claim 16,
In the concrete analysis execution step, three kinds of drawings including total deformation, equivalent elastic strain, and equivalent stress are shown as a result drawing after the completion of each analysis of the third module And analyzing the results of the analysis to determine the maximum stress and maximum displacement value acting on the screw system and the bones, and designing and preparing the patient-customized vertebral deformational correction implant Method of controlling the system. 13. The method of claim 12,
The final virtual implant model analyzed by the third module of the third process, and the control module actually manufactures the actual spiral load through the fourth module in the form of a virtual implant model through a device for giving a 3D printer or a bend Further comprising the step of: < RTI ID = 0.0 > - < / RTI >

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