A design method for fracture internal fixation system based on bone morphology big data

Abstract

The present invention provides a design method for a fracture internal fixation system based on bone morphology big data, which can complete the design of an overall solution for an internal fixation system for a specific bone part of a target population. The present invention is based on CT scan bone digitization data of a large sample of real cases, and based on verified three-dimensional measurement technology and measurement schemes, reliable and repeatable measurements are performed on a large sample of digitized cases, and internal fixation design is performed based on the obtained large sample anatomical morphological parameters. By establishing an image screening operation platform, a large sample matching degree detection can be performed on the designed internal fixation system in a relatively short time, and improvements can be made based on the matching results, saving a lot of economic and time costs.

Description

Technical Field

[0001] The present invention relates to the field of fracture internal fixation devices, and in particular to a design method for a fracture internal fixation system based on bone morphology big data. Background Art

[0002] Epidemiological studies show that the annual incidence of fractures in the world is 9.0-22.8 / 1000. With the accelerated pace of urbanization and the complexity of urban traffic, various types of fractures have a tendency to increase. Regarding the treatment of fractures, the general principles proposed by the International Association for the Study of Internal Fixation (AO / ASIF) are: anatomical reduction, strong internal fixation, and early functional exercise. Therefore, the internal fixation system plays an important role in the treatment of fractures.

[0003] There are many deficiencies in the existing internal fixation systems. Orthopedic internal fixation devices are mainly divided into two categories: intramedullary and extramedullary fixation. As for the intramedullary system, the external design of the existing intramedullary system, such as the angle between components, cross-sectional shape, length, etc., does not conform to the anatomical characteristics of the medullary cavity of a specific population, resulting in poor matching between the intramedullary nail and the bone medullary cavity, leading to difficulty in insertion, the end protruding from the bone, causing iatrogenic fractures, irritation of surrounding soft tissues, and long-term pain, which affects the surgical efficacy and patient life; in addition, the existing intramedullary nail system does not take into account the differences between different types of fractures or different types of fractures of the same type, and thus does not design corresponding internal fixation components, making it difficult to achieve the best reduction and fixation effect. As far as the extramedullary system is concerned, many domestic internal fixation device manufacturers mainly imitate the appearance of the same series of foreign steel plates. However, the shapes of the steel plates developed and produced by foreign manufacturers are all designed for European and American people. Therefore, in clinical applications, the adhesion to the bone surface is poor, and large gaps are easily generated, leading to complications such as congestion and infection. In addition, due to the difficulty in placement, a lot of time is required to confirm the position during the operation, and there are high requirements for the surgeon's operating experience and the degree of mastery of bone morphology. Secondly, the number, position and direction of the Kirschner wire and screw openings of the existing steel plates are not reasonable, which makes the fixation operation difficult during the operation, and even makes it difficult to achieve stable and effective fixation.

[0004] The main reason for the many defects in the existing internal fixation system is that the internal fixation research and development model is unreasonable and imperfect, and there are the following defects:

[0005] First, there is a lack of a unified, complete, and reliable internal fixation design and development process for any skeletal area of ​​all people;

[0006] Second, many important design details of the internal fixation system, such as the shape and size of the internal fixation system, the size, direction, and number of holes for screws and Kirschner wires, rely on a large number of morphological quantitative indicators. However, due to technical bottlenecks, the research and development of internal fixation systems often lacks the support of large-sample skeletal anatomical parameters.

[0007] Third, after the preliminary design of internal fixation is completed, it needs to be matched with the real data of a large sample, and the design details need to be improved and perfected. However, due to the lack of necessary technical support, the existing internal fixation design lacks the necessary reliable and repeatable verification methods, and can only be gradually modified through clinical use, which is not only costly and time-consuming, but also not conducive to patient recovery. An effective solution is urgently needed to deal with the above problems. Summary of the invention

[0008] In view of the above problems existing in the prior art, a design method for a fracture internal fixation system based on bone morphology big data is provided, as follows:

[0009] A design method for a fracture internal fixation system based on bone morphology big data includes the following steps:

[0010] Step s1, constructing a digital bone image database provided with digital bone data and an image fusion screening operation platform, wherein the image fusion screening operation platform is connected to the digital bone image database, and the image fusion screening operation platform is provided with an internal fixation digital model import program;

[0011] Step s2, establishing a three-dimensional measurement system for anatomical parameters of a specific part, and further completing the digital three-dimensional measurement of anatomical parameters of a large sample on the basis of good reliability and repeatability test results of the digital three-dimensional measurement system for anatomical parameters, and obtaining the digital three-dimensional measurement results of anatomical parameters of the large sample;

[0012] Step s3, establishing a fracture internal fixation system according to the digital three-dimensional measurement results of the anatomical parameters, generating a preliminary digital model of the internal fixation components, and importing the preliminary digital model of the internal fixation components into the image fusion screening operation platform;

[0013] Step s4, generating a digital three-dimensional bone image based on the digitized bone data and performing morphological matching detection and adjustment on the preliminary digital model of the internal fixation component until the expected matching degree is reached, further performing physical matching verification and adjustment on the physical object of the internal fixation component obtained based on the preliminary digital model of the internal fixation component and the three-dimensional printed bone model, until the expected matching degree is reached and the expected computational biomechanics and biomechanical performance requirements are met, thereby obtaining the fracture internal fixation system with the adjusted digital model of the internal fixation component.

[0014] Preferably, the step s1 further includes simultaneously carrying out computational biomechanics modeling and test scheme design, physical mechanical properties test scheme design and determining the system sample size.

[0015] Preferably, the fracture internal fixation system includes an intramedullary fixation system and an extramedullary fixation system, the intramedullary fixation system includes an intramedullary nail system, the extramedullary fixation system includes a compression plate, a support plate, a bridging plate and a tension band plate, and the internal fixation component parameters include angles, curvatures, cross-sectional shapes and lengths between components.

[0016] Preferably, the digitized bone image database provided with the digitized bone data stores data in DICOM 3.0 format.

[0017] Preferably, the step s2 further comprises:

[0018] Step s21, designing the anatomical parameter three-dimensional measurement system according to the morphological characteristics of a specific bone, wherein the bone anatomical parameters at least include bone length, angle, curvature and area;

[0019] Step s22, by repeatedly measuring the skeletal anatomical parameters and applying statistical methods, verifying the reliability and repeatability of the anatomical parameter three-dimensional measurement system;

[0020] Step s23, performing anatomical digital three-dimensional measurement according to the system sample volume.

[0021] Preferably, the step s3 further comprises:

[0022] Step s31, establishing the fracture internal fixation system based on the digital three-dimensional measurement results of the anatomical parameters, and making the preliminary digital model of the internal fixation components;

[0023] Step s32, importing the preliminary digital model of the internal fixation component into the image fusion screening operation platform.

[0024] Preferably, the step s4 further comprises:

[0025] Step s41, detecting and adjusting the matching degree of the preliminary internal fixation digital bone morphology, completing the adjustment of the internal fixation parameters according to the matching degree detection result, and performing matching degree detection again after each adjustment;

[0026] Step s42, selecting the digitized bone data of the target sample to print out a first three-dimensional printed model, placing the internal fixation component in the first three-dimensional printed model, and re-verifying the reliability of the internal fixation matching detection method based on the digital three-dimensional bone image by comparing the matching detection result of the proportional physical model of the first three-dimensional printed model and the digitized three-dimensional bone image, and at the same time, making adjustments again based on the matching detection result of the proportional physical model of the first three-dimensional printed model;

[0027] Step s43, performing computational biomechanics testing on the fracture internal fixation system according to the computational biomechanics modeling and testing scheme, and adjusting existing defects;

[0028] Step s44, performing a physical mechanical property test on the fracture internal fixation system according to the physical mechanical property test plan.

[0029] Preferably, the physical mechanical properties test of the fracture internal fixation system in step s44 adopts a simulation test, and the reliability of the computational biomechanical testing mode method based on the fracture internal fixation system is verified by comparing the physical mechanical properties test of the fracture internal fixation system and the computational biomechanical testing results of the fracture internal fixation system. At the same time, based on the physical mechanical properties test results of the fracture internal fixation system, the fracture internal fixation system is adjusted again until it passes the physical mechanical properties test.

[0030] The present invention provides a design method for a fracture internal fixation system based on bone morphology big data. Aiming at the problem that the traditional internal fixation system research and development design lacks the support of large-sample bone anatomical parameters, the present invention can obtain the anatomical parameters of specific bone parts of the target sample in a relatively short time through an image fusion screening operation platform. Different from the problem of lack of cadaver specimens and unreliable two-dimensional measurement mode in traditional measurement, the present invention is based on the CT scan digitized data of large-sample real cases, and based on the verified three-dimensional measurement technology and measurement scheme, it can measure the large-sample digital cases reliably and repeatably; different from the problem that the traditional internal fixation design lacks the necessary verification steps and technical means, the present invention matches the internal fixation system with a large sample through an image fusion screening operation platform and a digital model database, and makes improvements based on the matching results, saving a lot of economic and time costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a basic flow chart of the present invention;

[0032] Figure 2 This is a schematic diagram of the process of step s2 of the present invention;

[0033] Figure 3 This is a schematic diagram of the process of step s3 of the present invention;

[0034] Figure 4 This is a schematic diagram of the process of step s4 of the present invention. DETAILED DESCRIPTION

[0035] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0036] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0037] The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments, but they are not intended to limit the present invention.

[0038] In view of the above problems existing in the prior art, a design method for a fracture internal fixation system based on bone morphology big data is provided. Figure 1 As shown, the details are as follows:

[0039] Step s1, constructing a digital bone image database provided with digital bone data and an image fusion screening operation platform, the image fusion screening operation platform is connected to the digital bone image database, and the image fusion screening operation platform is provided with an internal fixation digital model import program;

[0040] Step s2, establishing a three-dimensional measurement system for anatomical parameters of a specific part, and further completing the digital three-dimensional measurement of anatomical parameters of a large sample on the basis of good reliability and repeatability test results of the digital three-dimensional measurement system for anatomical parameters, and obtaining the digital three-dimensional measurement results of anatomical parameters of a large sample;

[0041] Step s3, establishing a fracture internal fixation system based on the digital three-dimensional measurement results of the anatomical parameters, generating a preliminary digital model of the internal fixation components, and importing the preliminary digital model of the internal fixation components into the image fusion screening operation platform;

[0042] Step s4, generating a digital three-dimensional bone image based on the digitized bone data and performing morphological matching detection and adjustment on the preliminary digital model of the internal fixation component until the expected matching degree is reached, further performing physical matching verification and adjustment on the preliminary obtained physical internal fixation component and the 3D printed bone model, until the expected matching degree is reached and the expected computational biomechanics and biomechanical performance requirements are met, and then a fracture internal fixation system with the adjusted digital model of the internal fixation component is obtained.

[0043] As a preferred embodiment, step s1 further includes simultaneously carrying out computational biomechanics modeling and test scheme design, physical mechanical properties test scheme design, and calculating the target population to be studied and determining the system sample size.

[0044] As a preferred embodiment, the internal fixation digital model import program can uniformly encode, name and group the high-precision ".stl" format data generated by computer-aided design software modeling, and set the coordinate system, screw hole direction, color matching, etc. of the internal fixation system through a dedicated software operation window, so as to quickly call and match the image in the image fusion screening operation platform; the digital bone image database stores DICOM 3.0 format data including CT, magnetic resonance, etc., and can automatically read image information for unified naming, grouping and other settings, so it can be quickly retrieved; the image fusion screening operation platform can freely rotate, scale and move the reconstructed three-dimensional image, can quickly and accurately segment the bony structure in the image, and can hide non-target bones. The image fusion screening operation platform is also used to match and fuse the internal fixation system with the three-dimensional reconstructed image of the bone, that is, display them in the same window and further match the internal fixation system with the three-dimensional reconstructed image of the bone by rotation, translation, etc., and can save the fused and registered image data to facilitate further operations such as data review and secondary adjustment.

[0045] As a preferred embodiment, Figure 2 As shown, step s2 further comprises:

[0046] Step s21, designing a three-dimensional measurement system of anatomical parameters according to the morphological characteristics of a specific bone, wherein the anatomical parameters of the bone include parameters such as bone length, angle, arc and area. Specifically, referring to the anatomical theories in previous literature, designing a three-dimensional measurement system of anatomical parameters as complete and comprehensive as possible according to the morphological characteristics of the specific bone;

[0047] Step s22, by repeatedly measuring the parameters and applying statistical methods, verify the reliability and repeatability of the anatomical parameter three-dimensional measurement system, including whether the selected anatomical landmarks are unique, whether the measured indicators can fully present the morphological characteristics of the bone, and modify and improve according to the test results;

[0048] Step s23, performs anatomical digital three-dimensional measurement based on the calculated system sample size, adopts a digital bone morphology three-dimensional measurement mode, can freely rotate, segment, and partially hide the generated bone three-dimensional CT image, and applies a three-dimensional measurement technology that combines the four elements of point, line, plane, and surface to perform high-precision measurement of relevant indicators.

[0049] As a preferred embodiment, Figure 3 As shown, step s3 further includes:

[0050] Step s31, combining the anatomical parameter measurement results, designing a fracture internal fixation system suitable for the target population, and making a preliminary digital model of the internal fixation components;

[0051] Step s32, importing the preliminary digital model of the internal fixation component into the image fusion screening operation platform.

[0052] As a preferred embodiment, Figure 4 As shown, step s4 further comprises:

[0053] Step s41, detecting and adjusting the matching degree of the internal fixation digital bone morphology, completing the adjustment of the internal fixation parameters according to the matching degree detection result, and performing matching degree detection again after each adjustment;

[0054] Step s42, placing the internal fixation object into the 3D printed physical model, and verifying the reliability of the internal fixation matching detection method based on the digital three-dimensional bone image by comparing the matching detection results of the 3D printed proportional physical model and the digital three-dimensional bone image. At the same time, adjustment is made again based on the matching detection results of the 3D printed proportional physical model;

[0055] Step s43, performing computational biomechanics testing on the fracture internal fixation system according to the computational biomechanics modeling and testing scheme, and adjusting the existing defects;

[0056] Step s44, performing a physical mechanical property test on the fracture internal fixation system according to a physical mechanical property test plan.

[0057] As a preferred embodiment, the part of the readjustment of the fracture internal fixation system in step s43 does not involve structures related to bone matching and does not affect the completed matching test results.

[0058] As a preferred embodiment, the physical mechanical properties test of the fracture internal fixation system in step s44 simulates the mechanical environment of the real fracture internal fixation system in the human body. By comparing the physical mechanical properties test of the internal fixation and the computational biomechanical test results of the internal fixation, the reliability of the computational biomechanical test mode method based on the internal fixation is verified. At the same time, based on the physical mechanical properties test results of the internal fixation, the fracture internal fixation system is adjusted again until it passes the physical mechanical properties test.

[0059] In summary, the present invention provides a design method for a fracture internal fixation system based on bone morphology big data. Aiming at the problem that the traditional fracture internal fixation system research and development design lacks the support of large-sample bone anatomical parameters, the present invention can obtain large-sample anatomical parameters of specific bone parts of the target population in a relatively short time through an image fusion screening operation platform. Different from the problems of lack of cadaver specimens and unreliable two-dimensional measurement mode in traditional measurements, the present invention is based on the CT scan digitized data of large-sample real cases, and based on verified three-dimensional measurement technology and measurement scheme, reliable and repeatable measurement of large-sample digital cases; different from the problem that traditional internal fixation design lacks necessary verification steps and technical means, the present invention matches large samples of fracture internal fixation systems through an image fusion screening operation platform and a digital model database of internal fixation systems, and makes improvements based on the matching results, saving a lot of economic and time costs.

[0060] The above description is only a preferred embodiment of the present invention, and does not limit the implementation mode and protection scope of the present invention. For those skilled in the art, it should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A design method for a fracture internal fixation system based on bone morphology big data, characterized in that: The steps include: Step s1, constructing a digital bone image database provided with digital bone data and an image fusion screening operation platform, wherein the image fusion screening operation platform is connected to the digital bone image database, and the image fusion screening operation platform is provided with a digital model import program of an internal fixation component; Step s2, establishing a three-dimensional measurement system for anatomical parameters of a specific part, completing the digital three-dimensional measurement of anatomical parameters of a large sample, and obtaining the digital three-dimensional measurement results of anatomical parameters of a large sample; Step s3, establishing a fracture internal fixation system according to the digital three-dimensional measurement results of the anatomical parameters, generating a preliminary digital model of the internal fixation components, and importing the preliminary digital model of the internal fixation components into the image fusion screening operation platform; Step s4, generating a digitized three-dimensional bone image based on the digitized bone data, and performing a morphological matching test on the preliminary internal fixation component digital model and adjusting the internal fixation component digital model until an expected matching degree is achieved, performing a physical matching verification between the physical internal fixation component obtained based on the preliminary internal fixation component digital model and the three-dimensional printed bone model, and adjusting the internal fixation component digital model until an expected matching degree is achieved and the expected computational biomechanics and physical mechanical performance requirements are met, thereby obtaining the fracture internal fixation system having the adjusted internal fixation component digital model; The step s1 also includes simultaneously carrying out computational biomechanics modeling and test scheme design, physical mechanical properties test scheme design and determining the system sample size; The step s2 further comprises: Step s21, designing the anatomical parameter three-dimensional measurement system according to the morphological characteristics of a specific bone, wherein the bone anatomical parameters at least include bone length, angle, curvature and area; Step s22, by repeatedly measuring the skeletal anatomical parameters and applying statistical methods, verifying the reliability and repeatability of the anatomical parameter three-dimensional measurement system; Step s23, performing digital three-dimensional measurement of anatomical parameters according to the system sample volume; The step s4 further comprises: Step s41, detecting the matching degree of the preliminary internal fixation digital bone morphology and adjusting the internal fixation component digital model, completing the adjustment of the internal fixation component parameters according to the matching degree detection result, and performing matching degree detection again after each adjustment; Step s42, selecting the digitized bone data of the target sample to print out a first three-dimensional printed model, placing the physical internal fixation component into the first three-dimensional printed model, and re-verifying the reliability of the internal fixation matching detection method based on the digital three-dimensional bone image by comparing the matching detection result of the proportional physical model of the first three-dimensional printed model and the digital three-dimensional bone image, and at the same time, adjusting the digital model of the internal fixation component again based on the matching detection result of the proportional physical model of the first three-dimensional printed model; Step s43, performing computational biomechanics testing on the fracture internal fixation system according to the computational biomechanics modeling and testing scheme, and adjusting the digital model of the internal fixation component according to existing defects; Step s44, performing a physical mechanical property test on the fracture internal fixation system according to the physical mechanical property test plan.

2. The design method of the fracture internal fixation system based on bone morphology big data according to claim 1 is characterized in that: The fracture internal fixation system includes an intramedullary fixation system and an extramedullary fixation system. The intramedullary fixation system includes an intramedullary nail system. The extramedullary fixation system includes a compression plate, a support plate, a bridging plate and a tension band plate. The parameters of the internal fixation components include angles, curvatures, cross-sectional shapes and lengths between components.

3. The design method of the fracture internal fixation system based on bone morphology big data according to claim 1, characterized in that: The digitized bone image database provided with the digitized bone data stores DICOM 3.0 format data.

4. The design method of a fracture internal fixation system based on bone morphology big data according to claim 1, characterized in that: The physical mechanical properties test of the fracture internal fixation system in step s44 adopts a simulation test. By comparing the physical mechanical properties test of the fracture internal fixation system and the computational biomechanical test results of the fracture internal fixation system, the reliability of the computational biomechanical test mode method based on the fracture internal fixation system is verified. At the same time, based on the physical mechanical properties test results of the fracture internal fixation system, the fracture internal fixation system is adjusted again until it passes the physical mechanical properties test.

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