Method for evaluating performance of spinal medical device using computer simulation

Abstract

The present invention relates to a method for evaluating the performance of a spinal medical device using computer simulation and a computer-readable recording medium having recorded thereon a program for executing same. A 3-dimensional spinal surgery model is constructed by constructing a 3-dimensional spine model and a 3-dimensional spinal medical device model by using a 3-dimensional modeling method to replace performance verification (evaluation) of an existing spinal medical device using a cadaver, and performing a virtual spinal surgery computer simulation process of combining the 3-dimensional spine model and the 3-dimensional spinal medical device model, thereby not only effectively reducing time and costs required for a conventional cadaveric experiment but also contributing to predicting and improving the performance of a spinal medical device which has been developed or is being developed.

Description

A method for evaluating the performance of spinal medical devices using computer simulation

[0001] The present invention relates to a method for evaluating the performance of a spinal medical device using computer simulation and a computer-readable recording medium recording a program for executing the same.

[0002] In general, new spinal medical devices used in orthopedics or neurosurgery are developed and released to the market every year, both domestically and internationally, for various reasons (e.g., development of medical devices for newly developed treatment methods, performance improvement of existing medical devices, development of new medical substances, etc.).

[0003] Figure 1 is a conceptual diagram explaining the development process of a conventional spinal medical device.

[0004] Referring to Figure 1, the development of a spinal medical device generally goes through the following processes. That is, the process proceeds sequentially as follows: idea, spinal medical device concept design, spinal medical device detailed design, prototype development, performance verification (performance analysis) of the spinal medical device using animal testing and cadaver testing, design supplementation, prototype production, performance verification test (performance test) based on the relevant spinal medical device licensing regulations, spinal medical device licensing based on the test report, and spinal medical device market launch (product launch).

[0005] However, in the development process of conventional spinal medical devices, cadaver experiments for performance verification (evaluation) of spinal medical devices at home and abroad require a lot of cost.

[0006] For example, it costs 5.5 million won per cadaver at a domestic university hospital, and in order to derive meaningful experimental results, experiments utilizing multiple cadavers and statistical analysis are required due to the nature of cadaver experiments.

[0007] Therefore, securing meaningful cadaveric experimental results incurs significant costs. For example, statistical performance evaluation of lumbar medical devices requires at least 10 cadavers, with costs as follows:

[0008] Material cost: Price per corpse (5.5 million won) * 10 corpses = 55 million won

[0009] Labor costs: Labor costs per person (KRW 2 million) * 2 people * 12 months = KRW 48 million

[0010] (Calculating labor costs per person: Labor costs 4 million won / month * Participation rate 50% = 2 million won)

[0011] As mentioned above, there is a problem of severe waste of manpower and cost in statistical performance evaluation of lumbar medical devices.

[0012] The present invention has been made to solve the above-mentioned problems, and the purpose of the present invention is to provide a method for evaluating the performance of a spinal medical device using a computer simulation, which uses a three-dimensional modeling method to construct a three-dimensional spinal model and a spinal medical device model, and performs a virtual spinal surgery computer simulation process that combines them to construct a three-dimensional spinal surgery model, thereby effectively reducing the time and cost required for a conventional cadaver experiment, and contributing to improving the performance of a spinal medical device that has been developed or is under development by predicting it in advance, and a computer-readable recording medium storing a program for executing the same.

[0013] In order to achieve the above-described object, a first aspect of the present invention is a method for evaluating the performance of a spinal medical device using a computer simulation device operated by at least one processor, comprising: (a) a step of constructing a three-dimensional normal or degenerative spinal model using human body information of a plurality of normal or abnormal vertebrae constituting the human spine and soft tissues contributing to the stability of the spine; (b) a step of constructing a three-dimensional spinal medical device model based on information about a spinal medical device developed to be inserted into a body during spinal surgery for a degenerative spinal disease of the human body to assist in recovery of the body or to restore and reproduce functions by replacing the role of a human joint; (c) a step of constructing a three-dimensional spinal surgery model by performing a virtual spinal surgery simulation process based on information about the three-dimensional normal or degenerative spinal model constructed in step (a) and information about the three-dimensional spinal medical device model constructed in step (b) so that the three-dimensional spinal medical device model is applied to the corresponding three-dimensional normal or degenerative spinal model according to a predetermined spinal surgery method; And (d) a method for evaluating the performance of a spinal medical device using a computer simulation, including a step of adding a preset specific load from the top to the bottom of the spinal surgery model of the three-dimensional shape constructed in the above step (c), and evaluating the movement of the entire spine and the movement of each spinal motion segment under the added specific load.

[0014] Here, in the step (a), it is preferable that the human body information of a plurality of normal or abnormal vertebrae constituting the human spine include bone shape information of the normal / abnormal spine, bone alignment information of the normal / abnormal spine, and bone property information of the normal / abnormal spine.

[0015] Preferably, in the above step (a), the human body information of soft tissues contributing to the stability of the spine may include material property information of ligaments, cartilage, and intervertebral discs so that the same role can be performed mechanically by taking into account anatomical characteristics.

[0016] Preferably, the spinal medical device applied in the above step (b) may include a spinal fixation prosthesis inserted into a damaged and removed intervertebral disc portion in an abnormal degenerative spine model, a pedicle screw inserted and fixed into a vertebra, and a connecting rod fixed between the inserted pedicle screw and the screw.

[0017] Preferably, the step (d) may further include: (d-1) a step of attaching a virtual wire to the uppermost vertebra in a state where the sacrum, which is the lowest part of the 3D shape spinal surgery model in which the virtual spinal surgery has been completed in the step (c) is fixed based on the 3D shape spinal surgery model; (d-2) a step of connecting the virtual wire along each vertebra; (d-3) a step of applying a preset specific load from the top to the bottom of the 3D shape spinal surgery model in a state where the virtual wire is connected so as to apply a compressive load along the vertebra; and (d-4) a step of evaluating the movement of the entire spine and the movement of each spinal motion segment under the specific load applied in the step (d-3).

[0018] Preferably, before or after the step (d-4), a step of evaluating the pressure inside the intervertebral disc provided between each vertebra under the specific load added in the step (d-3) may be further included.

[0019] Preferably, before or after the step (d-4), a step of applying a preset moment value to the uppermost spine in at least one of bending, extension, lateral bending, and torsional states while the specific load added in the step (d-3) is applied may be further included, and then analyzing the behavior information of the spine.

[0020] Preferably, the behavior information of the spine analyzed above can be used to analyze the performance of the spine and the spinal medical device from a mechanical engineering perspective, such as the change in the rotation angle of each motion segment of the spine and the risk of damage to the spinal medical device inserted into the spine.

[0021] Preferably, in the step (c), the virtual spinal surgery may include a first step of removing a damaged intervertebral disc due to degeneration of the intervertebral disc of the spine, and then inserting a pre-prepared spinal fixation prosthesis into that location; a second step of inserting and fixing a pre-prepared pedicle screw into the vertebrae that contact the upper and lower surfaces of the intervertebral fixation prosthesis inserted in the first step, respectively; and a third step of fixing the pedicle screw inserted in the second step using a pre-prepared connecting rod of a predetermined length between the screws.

[0022] Before or after the above step (d-4), the step may further include analyzing at least one of information from among changes in the rotation angle of the surgical segment and the adjacent segment, stress applied to the inserted intervertebral fixation prosthesis and the surrounding vertebrae, direction and magnitude of force applied to the pedicle screw, and stress and strain information generated in the pedicle screw and the connecting rod, while the specific load added in the above step (d-3) is applied.

[0023] Preferably, the method may further include a step of predicting at least one possibility information among the possibility of accelerated degeneration of the intervertebral disc in an adjacent segment after performing spinal surgery, the possibility of damage to the spinal fixation prosthesis and the possibility of damage to the vertebrae in contact with the fixation prosthesis, the possibility of detachment of the pedicle screw, and the possibility of damage to the pedicle screw and connecting rod based on the result of the information analysis.

[0024] Preferably, in the step (d-4), at least one of a finite element analysis (FEA) model, a multi-body dynamics module, and a computer simulation model in the field of mechanical engineering is applied to the spinal surgery model of the three-dimensional shape to evaluate the movement of the entire spine and the movement of each spinal motion segment under the specific load.

[0025] Preferably, the normal or degenerative spine model of the three-dimensional shape constructed in the step (a) above has cartilage attached to the posterior joints of the vertebrae, and an intervertebral disc attached between the upper and lower vertebrae, wherein the intervertebral disc is composed of a cartilaginous endplate, a nucleus pulposus, and a ligament, and the ligament can be provided between each vertebra to connect each consecutive vertebra to each other.

[0026] Preferably, the ligament may be further provided between adjacent vertebrae so as to be connected to at least one adjacent vertebra among the N+2-th to N+M-th vertebrae (M is a natural number of 3 or more) adjacent to the N-th vertebrae (N is a natural number of 1 or more).

[0027] Preferably, the human body information of a plurality of normal or abnormal vertebrae constituting the human spine applied in the above step (a) may include three-dimensional shape information of the vertebrae obtained using at least one medical image data among X-ray image, computed tomography image (CT), and magnetic resonance imaging (MRI) data taken of the human spine.

[0028] Preferably, at least one of the steps (a) to (d) can be modeled or simulated using a user-friendly graphical user interface (GUI) service.

[0029] Preferably, the method may further include storing, in a separate data storage module, in a database (DB) format, at least one piece of information among information on a normal or degenerative spine model in a three-dimensional shape constructed in the step (a), information on a spinal medical device model in a three-dimensional shape constructed in the step (b), information on a virtual spinal surgery process and a three-dimensional spinal surgery model performed in the step (c), and information on evaluation information on the movement of the entire spine and the movement of each spinal segment or the pressure inside the intervertebral disc provided between each vertebra under a predetermined specific load based on the three-dimensional spinal surgery model in which the virtual spinal surgery is completed in the step (c).

[0030] Preferably, the method may further include a step of transmitting preset unique user identification information or device identification information to an external terminal or server via wired or wireless communication, together with at least one of information on a normal or degenerative spine model of a three-dimensional shape constructed in the step (a), information on a spinal medical device model of a three-dimensional shape constructed in the step (b), information on a virtual spinal surgery process and a three-dimensional spinal surgery model of a three-dimensional shape performed in the step (c), and information on evaluation information on the movement of the entire spine and the movement of each spinal segment or the pressure inside the intervertebral disc provided between each vertebra under a preset specific load based on the three-dimensional spinal surgery model of a virtual spinal surgery performed in the step (c).

[0031] Preferably, the external terminal or server may be provided with at least one piece of information from among information on a normal or degenerative spine model in a three-dimensional shape, information on a spinal medical device model in a three-dimensional shape, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and information on evaluation of the entire spine movement and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra, through a pre-installed spinal surgery-related application service, and may display on a display screen or output by voice at least one piece of information from among information on a normal or degenerative spine model in a three-dimensional shape, information on a spinal medical device model in a three-dimensional shape, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and information on evaluation of the entire spine movement and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra so that the user can visually or audibly confirm the information.

[0032] Preferably, the external terminal or server may receive, through a pre-installed spinal surgery-related application service, at least one piece of information from among information on a 3D normal or degenerative spine model, information on a 3D spinal medical device model, information on a virtual spinal surgery process and a 3D spinal surgery model, and evaluation information on the movement of the entire spine and each motion segment of the spine or the pressure inside the intervertebral disc provided between each vertebra, along with preset unique user identification information or device identification information, and based on this, may store and manage, in a separate storage module, information on a 3D normal or degenerative spine model, information on a 3D spinal medical device model, information on a virtual spinal surgery process and a 3D spinal surgery model, and evaluation information on the movement of the entire spine and each motion segment of the spine or the pressure inside the intervertebral disc provided between each vertebra.

[0033] A second aspect of the present invention provides a computer-readable recording medium having recorded thereon a program capable of executing the above-described method for evaluating the performance of a spinal medical device using a computer simulation.

[0034] The method for evaluating the performance of a spinal medical device using computer simulation according to the present invention can be implemented as computer-readable code on a computer-readable recording medium. Computer-readable recording media include all types of recording devices that store data that can be read by a computer system.

[0035] For example, computer-readable storage media include ROM, RAM, CD-ROM, magnetic tape, hard disk, floppy disk, removable storage device, non-volatile memory (flash memory), and optical data storage device.

[0036] According to the method for evaluating the performance of a spinal medical device using a computer simulation of the present invention as described above and the computer-readable recording medium recording the program for executing the same, a three-dimensional spinal model and a spinal medical device model are constructed using a three-dimensional modeling method so as to replace the existing performance verification (evaluation) of a spinal medical device using a cadaver, and a virtual spinal surgery computer simulation process is performed to construct a three-dimensional spinal surgery model by combining them, thereby effectively reducing the time and cost required for conventional cadaver experiments, and contributing to improving the performance of spinal medical devices that have been developed or are under development by predicting them in advance.

[0037] In addition, according to the present invention, there is an advantage in that it can effectively address the problem of conventional cadaver testing that can produce different results under various conditions such as race, gender, age, health status, and temperature and humidity of the experimental space.

[0038] In addition, according to the present invention, there is an advantage in that it can effectively contribute to improving the success rate of surgery and preventing problems that may occur after surgery by analyzing the inherent problem points of spinal medical devices currently in use.

[0039] Figure 1 is a conceptual diagram explaining the development process of a conventional spinal medical device.

[0040] FIG. 2 is an overall flowchart illustrating a method for evaluating the performance of a spinal medical device using computer simulation according to one embodiment of the present invention.

[0041] FIG. 3 is a conceptual diagram showing an example of a spinal medical device modeled through a three-dimensional spinal medical device modeling method applied to one embodiment of the present invention.

[0042] FIG. 4 is a conceptual diagram illustrating an example of a method for connecting ligaments in a virtual spinal surgery process performed through a spinal surgery computer simulation process applied to one embodiment of the present invention.

[0043] Figures 5 and 6 are conceptual diagrams for explaining the mathematical modeling of the ligament connection of Figure 4.

[0044] FIG. 7 is a conceptual diagram illustrating a method of analyzing spine behavior information through a spine medical device performance evaluation process applied to one embodiment of the present invention.

[0045] The aforementioned purposes, features, and advantages are described in detail below with reference to the attached drawings, so that those skilled in the art can readily implement the technical concepts of the present invention. In describing the present invention, detailed descriptions of known technologies related to the present invention will be omitted if they are deemed to unnecessarily obscure the gist of the invention.

[0046] Terms including ordinal numbers, such as "first," "second," etc., may be used to describe various components, but the components are not limited by these terms. These terms are used solely to distinguish one component from another. For example, a first component could be referred to as a "second component," and similarly, a second component could also be referred to as a "first component," without departing from the scope of the present invention. The terminology used in this application is solely for the purpose of describing specific embodiments and is not intended to limit the present invention. The singular expression "a," "an," and "the" include plural expressions unless the context clearly indicates otherwise.

[0047] The terms used in this invention have been selected from widely used, current terms, taking into account the functions of the invention. However, these terms may vary depending on the intentions of those skilled in the art, precedents, the emergence of new technologies, etc. Furthermore, in certain cases, terms may be arbitrarily selected by the applicant, in which case their meanings will be described in detail in the relevant description of the invention. Therefore, the terms used in this invention should not be defined simply as names, but rather based on their inherent meanings and the overall content of the invention.

[0048] When a part of the specification is said to "include" a component, this does not exclude other components, but rather implies the inclusion of other components, unless otherwise specifically stated. Furthermore, terms such as "part," "module," etc., used throughout the specification refer to a unit that processes at least one function or operation, which may be implemented in hardware, software, or a combination of hardware and software.

[0049] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. However, the embodiments of the present invention exemplified below may be modified in various other forms, and the scope of the present invention is not limited to the embodiments described below. These embodiments of the present invention are provided to more fully explain the present invention to those skilled in the art.

[0050] The combination of each block of the attached block diagram and each step of the flowchart may be performed by computer program instructions (execution engine), and these computer program instructions may be installed in a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing equipment, so that the instructions executed through the processor of the computer or other programmable data processing equipment create a means for performing the functions described in each block of the block diagram or each step of the flowchart. These computer program instructions may also be stored in a computer-available or computer-readable memory that can be directed to a computer or other programmable data processing equipment to implement the functions in a specific manner, so that the instructions stored in the computer-available or computer-readable memory can produce an article of manufacture that includes an instruction means for performing the functions described in each block of the block diagram or each step of the flowchart.

[0051] And, since the computer program instructions can also be installed on a computer or other programmable data processing equipment, a series of operation steps are performed on the computer or other programmable data processing equipment to create a process that is executed by the computer, so that the instructions that execute the computer or other programmable data processing equipment can also provide steps for executing the functions described in each block of the block diagram and each step of the flowchart.

[0052] Additionally, it should be noted that each block or step may represent a module, segment, or portion of code that includes one or more executable instructions for performing specific logical functions, and that in some alternative embodiments, the functions mentioned in the blocks or steps may occur out of order. For example, two blocks or steps depicted in succession may in fact be performed substantially concurrently, or the blocks or steps may be performed in the reverse order of their corresponding functions, as desired.

[0053] FIG. 2 is an overall flowchart for explaining a method for evaluating the performance of a spinal medical device using a computer simulation according to an embodiment of the present invention, FIG. 3 is a conceptual diagram showing an example of a spinal medical device modeled through a three-dimensional modeling method for a spinal medical device applied to an embodiment of the present invention, FIG. 4 is a conceptual diagram showing an example of a method for connecting ligaments in a virtual spinal surgery process performed through a spinal surgery computer simulation process applied to an embodiment of the present invention, FIGS. 5 and 6 are conceptual diagrams for explaining mathematical modeling of the ligament connection of FIG. 4, and FIG. 7 is a conceptual diagram for explaining a method for analyzing behavior information of the spine through a spinal medical device performance evaluation process applied to an embodiment of the present invention.

[0054] Referring to FIGS. 2 to 7, a method for evaluating the performance of a spinal medical device using computer simulation according to one embodiment of the present invention is a method for performing a performance evaluation of a spinal medical device using a computer simulation device operated by at least one processor. That is, each step can be performed by each processor of the computer simulation device.

[0055] Embodiments of the various processes described herein may be implemented in a computer-readable recording medium or similar device, for example, using software, hardware, or a combination thereof.

[0056] In terms of hardware implementation, the embodiments described herein may be implemented using at least one of application specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), processors, controllers, micro-controllers, microprocessors, and electrical units for performing functions. In some cases, such embodiments may be implemented by a separate control module (not shown).

[0057] In a software implementation, embodiments, such as procedures or functions, may be implemented with separate software modules that perform at least one function or operation. The software code may be implemented by a software application written in a suitable programming language. Furthermore, the software code may be stored in a storage module (not shown) and executed by a separate control module (not shown).

[0058] The storage module may include at least one type of storage medium, for example, a flash memory type, a hard disk type, a multimedia card micro type, a card type memory (e.g., SD or XD memory, etc.), a random access memory (RAM), a static random access memory (SRAM), a read-only memory (ROM), an electrically erasable programmable read-only memory (EEPROM), a programmable read-only memory (PROM), a magnetic memory, a magnetic disk, or an optical disk.

[0059] A method for evaluating the performance of a spinal medical device using a computer simulation according to one embodiment of the present invention first constructs a three-dimensional normal spinal model and / or a degenerative spinal model using human body information of a plurality of normal vertebrae and / or abnormal vertebrae (e.g., degenerative vertebrae, osteopenic vertebrae, osteoporotic vertebrae, etc.) constituting the spine of a human body and soft tissues contributing to the stability of the spine (S100).

[0060] At this time, in the step S100, it is preferable that the human body information of a plurality of normal and / or abnormal vertebrae constituting the human spine includes at least one of, for example, bone shape information of the normal and / or abnormal spine, bone alignment information of the normal and / or abnormal spine, and / or bone property information of the normal and / or abnormal spine.

[0061] In addition, in the above step S100, it is preferable that the human body information of soft tissues contributing to the stability of the spine include at least one of information on the physical properties of ligaments, cartilage, and / or intervertebral discs (e.g., mild intervertebral disc degeneration, moderate intervertebral disc degeneration, severe intervertebral disc degeneration, etc.) so that the same role can be performed mechanically by taking into account anatomical characteristics.

[0062] Here, in the case of the above ligament, it is desirable to assume that the initial length is folded by the length shortened due to intervertebral disc degeneration without any change in the physical properties, and to consider that it can withstand tension from the time when it is restored to its original length when the spine moves.

[0063] In addition, it is preferable that the normal and / or degenerative spine model of the three-dimensional shape constructed in the above step S100 has, for example, cartilage attached to the posterior joints of the vertebrae and an intervertebral disc attached between the upper and lower vertebrae.

[0064] At this time, it is preferable that the intervertebral disc is composed of a cartilaginous endplate, a nucleus pulposus, and a ligament, and the ligament may be provided between each vertebra to connect each consecutive vertebra to each other.

[0065] In addition, the ligament may be further provided between adjacent vertebrae so as to be connected to at least one adjacent vertebra among the N+2-th to N+M-th vertebrae (M is a natural number of 3 or more) adjacent to the N-th vertebrae (N is a natural number of 1 or more), as illustrated in FIG. 4.

[0066] Meanwhile, soft tissues such as intervertebral discs and ligaments that normally connect vertebrae only connect adjacent upper and lower vertebrae, and each movement segment (two consecutive bones and the intervertebral discs and ligaments that connect them are called one movement segment) are independent and do not affect each other's movements.

[0067] For example, when performing a spinal experimental method that describes the movement of the spine by applying a moment to the uppermost bone while fixing the lowest part of the spine specimen, since each motion segment independently does not affect the other motion segments, fixing one motion segment does not affect the movement of the other motion segments.

[0068] That is, when a moment of 10 Nm is applied, and the normal motion segments each rotate 5°, if one motion segment is fixed and only rotates 1°, the other motion segments will still rotate 5°. Therefore, in order to change the rotation angle of the surrounding motion segments after spinal surgery, an experimental method is applied that assumes that the movement after spinal surgery is the same as the normal spine before surgery and rotates the entire spine by 10° so that the movement is the same as after surgery.

[0069] However, testing methods that assume a patient's spinal movement is identical to that of a healthy individual differ from testing methods in actual patients. Therefore, a new modeling method is needed to analyze the mechanisms of occurrence of problems occurring at adjacent segments after spinal fusion surgery, such as Proximal Junctional Kyphosis (PJK), Proximal Junctional Failure (PJF), and Adjacent Segment Disease (ASD), which are among the most critical clinical issues in the field of spine.

[0070] That is, in one embodiment of the present invention, a new modeling method is used that connects the major ligaments of the spine across not only the upper and lower vertebrae but also up to four motion segments according to anatomical information, as illustrated in FIG. 4.

[0071] To elaborate, in experiments / analyses of the spine, the lowest part of the spine is fixed and a load is applied to the highest part. Let's simplify the spine and consider each vertebra as a block. The intervertebral discs, ligaments, and other structures connecting the vertebrae can be thought of as springs, as illustrated on the left side of Figure 5.

[0072] When a load or moment is applied to the top, the movement of each motion segment is calculated by the stiffness and force of each motion segment. That is, in a state such as the left side of Fig. 5, the movement of the B1-B2 segment (d1) and the movement of the B2-B3 segment (d2) are calculated according to the mathematical formulas shown on the right side of Fig. 5. At this time, in a situation where any load is applied, the stiffness of each motion segment does not affect the movement of the adjacent motion segment.

[0073] However, when ligaments connecting multiple segments are attached (see Figures 4 and 6), changes in the stiffness of each motion segment affect adjacent segments. A detailed mathematical explanation can be provided as follows.

[0074] That is, when the stiffness (k1) of the first motion segment increases significantly due to spinal fixation, the movement (d1) of the first motion segment converges to 0, while the movement (d2) of the second motion segment converges to 0. can be expressed as . Conversely, if the stiffness of the second motion segment increases, it can be calculated in the same way. That is, a change in the stiffness of one motion segment, such as in spinal surgery, affects the movement of other motion segments.

[0075] In other words, when a surgical procedure such as spinal fusion increases the stiffness of one motion segment, the stiffness of other adjacent segments decreases. This is a new modeling method that can explain the cause of clinical problems that occur due to increased motion in adjacent segments after surgery, such as Proximal Junctional Kyphosis (PJK), Proximal Junctional Failure (PJF), and Adjacent Segment Disease (ASD).

[0076] In addition, the human body information of a plurality of normal and / or abnormal vertebrae constituting the human spine applied in the above step S100 may include three-dimensional vertebra shape information obtained using at least one medical image data among X-ray images, computed tomography (CT), and / or magnetic resonance imaging (MRI) data taken of the human spine.

[0077] For example, a three-dimensional shape of a vertebra can be obtained by stacking computed tomography (CT) and / or magnetic resonance imaging (MRI) data. In addition, when using X-ray images, it can be produced using a three-dimensional shape model of a reference bone (template bone model) and X-ray images taken from two or more different directions.

[0078] In addition, when using computed tomography (CT) images, the material properties of each part of the vertebrae can be specified using the density information of the CT images. The vertebrae can be divided into three parts: cortical bone, cancellous bone, and posterior bone, and modeled by assigning material property information to each part. In addition, the model can be modeled without distinction between cortical bone and cancellous bone, and the material properties of the internal bone can be modeled by applying the material properties (e.g., density, elastic modulus, Poisson's ratio, etc.) calculated using the CT number or Houns unit field value (intensity value of the image) of the CT image corresponding to each part. Bones other than the vertebrae can also be generally divided into cortical bone and cancellous bone, and modeled by assigning material properties to each, or they can be modeled without any special distinction and adding material properties using the shading of the CT image.

[0079] Afterwards, a three-dimensional spinal medical device model is constructed based on information on spinal medical devices developed to be inserted into the body during spinal surgery for degenerative spinal diseases of the human body to assist in recovery of the body or to restore and reproduce the function by replacing the role of human joints (S200).

[0080] At this time, it is preferable that the spinal medical device applied in the above step S200 includes, for example, a spinal fixation prosthesis inserted into a damaged and removed intervertebral disc portion in an abnormal degenerative spine model, a pedicle screw inserted and fixed into the vertebra, and a connecting rod fixed between the inserted pedicle screw and the screw, as shown in FIG. 3.

[0081] Next, based on the information about the normal and / or degenerative spine model of the three-dimensional shape constructed in the step S100 and the information about the spinal medical device model of the three-dimensional shape constructed in the step S200, a virtual spinal surgery (e.g., surgery to insert a medical device to be evaluated, surgery to perform a performance evaluation, etc.) simulation process is performed so that the spinal surgical medical device model of the three-dimensional shape is applied to the normal spine model and / or degenerative spine model of the three-dimensional shape according to a preset spinal surgery method (e.g., spinal fusion, etc.) to construct a spinal surgery model of the three-dimensional shape (S300).

[0082] At this time, the virtual spinal surgery in step S300 may include, for example, a first step of removing a damaged intervertebral disc due to degeneration of the intervertebral disc of the spine, as illustrated in FIG. 3, and then inserting a pre-prepared spinal fixation prosthesis at that location, a second step of inserting and fixing a pre-prepared pedicle screw into the vertebrae that contact the upper and lower surfaces of the intervertebral fixation prosthesis inserted in the first step, respectively, and a third step of fixing the pedicle screw inserted in the second step using a pre-prepared connecting rod of a predetermined length between the screws.

[0083] Then, a specific load set in advance is added from the top to the bottom of the spinal surgery model constructed in the above step S300, and the movement of the entire spine and the movement of each spinal motion segment are evaluated under the added specific load (S400).

[0084] That is, the step S400 may further include a step (S410) of attaching a virtual wire to the uppermost vertebra while fixing the sacrum, which is the lowest part of the 3D spinal surgery model based on the 3D spinal surgery model in which the virtual spinal surgery has been completed in the step S300, a step (S420) of connecting the virtual wire along each vertebra, a step (S430) of applying a preset specific load from the top to the bottom of the 3D spinal surgery model in a state in which the virtual spinal surgery has been completed, so that a compressive load is applied along the vertebra, and a step (S440) of evaluating the movement of the entire spine and the movement of each spinal motion segment under the specific load applied in the step S430.

[0085] Meanwhile, at least one of the steps S100 to S400 may perform modeling or simulation using a user-friendly graphical user interface (GUI) service.

[0086] Additionally, although not shown in the drawing, a step of evaluating the pressure inside the intervertebral disc provided between each vertebra under the specific load added in step S430 may be further included before or after step S440.

[0087] In addition, before or after the step S440, a step of applying a preset moment value (e.g., about 10 Nm, etc.) to the uppermost spine in at least one of a bending, extension, lateral bending, and / or torsion direction state while the specific load added in the step S430 is applied may be further included, and then analyzing the behavior information of the spine.

[0088] At this time, the behavior information of the spine analyzed above can be used to analyze the performance of the spine and the spinal medical device from a mechanical engineering perspective, for example, changes in the rotation angle of each motion segment of the spine and the risk of damage to the spinal medical device inserted into the spine.

[0089] In addition, before or after the step S440, the step may further include analyzing at least one of information from among changes in the rotation angle of the surgical segment and the adjacent segment, stress applied to the inserted intervertebral fixation prosthesis and the surrounding vertebrae, direction and magnitude of force applied to the pedicle screw, and stress and strain information generated in the pedicle screw and the connecting rod, while the specific load added in the step S430 is applied.

[0090] In addition, based on the results of the analysis of the above information, the method may further include a step of predicting at least one possibility information among the possibility of accelerated degeneration of the intervertebral disc in an adjacent segment after performing spinal surgery, the possibility of damage to the spinal fixation prosthesis and the possibility of damage to the vertebrae in contact with the fixation prosthesis, the possibility of detachment of the pedicle screw, and / or the possibility of damage to the pedicle screw and connecting rod.

[0091] In addition, in the step S440, at least one of a finite element analysis (FEA) model, a multi-body dynamics module, and a computer simulation model in the field of mechanical engineering that is set to the spinal surgery model of the three-dimensional shape may be applied to evaluate the movement of the entire spine and the movement of each spinal motion segment under the specific load.

[0092] In addition, after the step S400, information on the normal and / or degenerative spine model in a three-dimensional shape constructed in the step S100, information on the spinal medical device model in a three-dimensional shape constructed in the step S200, information on the virtual spinal surgery process and the three-dimensional spinal surgery model in a three-dimensional shape performed in the step S300, and / or information on the evaluation information on the movement of the entire spine and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra under a specific load set in advance based on the three-dimensional spinal surgery model in which the virtual spinal surgery is completed in the step S300, information on the normal and / or degenerative spine model in a three-dimensional shape, information on the spinal medical device model in a three-dimensional shape, information on the virtual spinal surgery process and the three-dimensional spinal surgery model in a three-dimensional shape, and / or information on the evaluation information on the movement of the entire spine and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra is stored as separate data for each unique user identification information. It may further include a step of storing the data in a database (DB) in a storage module (not shown).

[0093] In addition, after the step S400, the method may further include transmitting preset unique user identification information and / or device identification information to an external terminal and / or server (not shown) via wired and / or wireless communication, together with at least one of information among information on a normal and / or degenerative spine model of a three-dimensional shape constructed in the step S100, information on a spinal medical device model of a three-dimensional shape constructed in the step S200, information on a virtual spinal surgery process and a three-dimensional spinal surgery model of a three-dimensional shape constructed in the step S300, and / or information on evaluation information on the movement of the entire spine and the movement of each spinal segment or the pressure inside the intervertebral disc provided between each vertebra under a preset specific load based on the three-dimensional spinal surgery model of which the virtual spinal surgery is completed in the step S300.

[0094] At this time, the external terminal or server may be provided with at least one piece of information from among information on a normal or degenerative spine model in a three-dimensional shape, information on a spinal medical device model in a three-dimensional shape, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and / or information on evaluation of the movement of the entire spine and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra, together with preset unique user identification information or device identification information, and based on this, the user may display on a display screen or output by voice at least one piece of information from among information on a normal or degenerative spine model in a three-dimensional shape, information on a spinal medical device model in a three-dimensional shape, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and / or information on evaluation of the movement of the entire spine and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra so that the user can visually and / or audibly confirm the information.

[0095] In addition, the external terminal or server may receive, through a pre-installed spinal surgery-related application service, at least one of information on a normal or degenerative spine model in a three-dimensional shape, information on a spinal medical device model in a three-dimensional shape, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and / or evaluation information on the movement of the entire spine and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra, along with preset unique user identification information and / or device identification information, and based on this, may store and manage, by separate storage modules (not shown) in a database (DB), at least one of information on a normal or degenerative spine model in a three-dimensional shape, information on a spinal medical device model in a three-dimensional shape, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and / or evaluation information on the movement of the entire spine and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra.

[0096] Here, the unique user identification information preferably includes at least one of, for example, the user's name, resident registration number, phone number, address, biometric information, PKI (Public Key Infrastructure), OTP (One Time Password), public certificate, and / or member registration number information, but is not limited thereto, and may include all user identification information that can identify the user.

[0097] The above-described unique device identification information preferably includes at least one of, but is not limited to, the name of the device, the password of the device, the serial number of the device, the type of the device, the manufacturer of the device, the MAC (Media Access Control) address of the device, the unique IP (Internet Protocol) address of the device, the model and version of the device, and the authentication information of the device generated by the secret key or PKI-based private key of the device, and may include all device identification information that can identify the device that performs the method for evaluating the performance of a spinal medical device using a computer simulation according to an embodiment of the present invention.

[0098] Meanwhile, the external terminal is preferably composed of at least one mobile terminal system among a smart phone, a smart pad, and / or a smart note that communicates via wireless Internet or portable Internet, and in addition, it may comprehensively mean all wired / wireless home appliance / communication systems having a user interface for connecting to a data communication module (800), such as a Palm PC, a mobile play-station, a DMB (Digital Multimedia Broadcasting) phone with communication function, a tablet PC, an iPad, etc.

[0099] Meanwhile, the method for evaluating the performance of a spinal medical device using computer simulation according to one embodiment of the present invention can also be implemented as computer-readable code on a computer-readable recording medium. A computer-readable recording medium includes any type of recording device that stores data that can be read by a computer system.

[0100] For example, computer-readable recording media include ROM, RAM, CD-ROM, magnetic tape, hard disk, floppy disk, removable storage device, non-volatile memory (flash memory), and optical data storage device.

[0101] Additionally, the computer-readable recording medium can be distributed across computer systems connected to a computer network, and stored and executed as readable code in a distributed manner.

[0102] Although a preferred embodiment of a method for evaluating the performance of a spinal medical device using a computer simulation according to the present invention and a computer-readable recording medium recording a program for executing the same have been described, the present invention is not limited thereto, and various modifications can be made within the scope of the claims, the detailed description of the invention, and the attached drawings, and these also belong to the present invention.

[0103] The present invention can be widely used in the field of performance evaluation methods for spinal medical devices using computer simulation.

Claims

1. A method for evaluating the performance of a spinal medical device using a computer simulation device operated by at least one processor, (a) a step of constructing a three-dimensional normal or degenerative spine model using human body information of a plurality of normal or abnormal vertebrae forming the spine of the human body and soft tissues contributing to the stability of the spine; (b) A step of constructing a three-dimensional spinal medical device model based on information on spinal medical devices developed to be inserted into the body during spinal surgery for degenerative spinal diseases of the human body to assist in recovery of the body or to restore and reproduce the function of joints in place of the body; (c) a step of constructing a three-dimensional spinal surgery model by performing a virtual spinal surgery computer simulation process so that the three-dimensional spinal medical device model is applied to the three-dimensional normal or degenerative spinal model according to a preset spinal surgery method based on information about the three-dimensional normal or degenerative spinal model constructed in the step (a) and information about the three-dimensional spinal medical device model constructed in the step (b); and (d) A method for evaluating the performance of a spinal medical device using a computer simulation, including a step of adding a preset specific load from the top to the bottom of a three-dimensional spinal surgery model constructed in the above step (c), and evaluating the movement of the entire spine and each motion segment of the spine under the added specific load.

2. In paragraph 1, A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that in the step (a) above, the human body information of a plurality of normal or abnormal vertebrae constituting the human spine includes bone shape information of the normal / abnormal spine, bone alignment information of the normal / abnormal spine, and bone property information of the normal / abnormal spine.

3. In paragraph 1, A method for evaluating the performance of a spinal medical device using computer simulation, characterized in that in the above step (a), the human body information of soft tissues contributing to the stability of the spine includes information on the properties of ligaments, cartilage, and intervertebral discs so that the same role can be performed mechanically by taking into account anatomical characteristics.

4. In paragraph 1, A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that the spinal medical device applied in the above step (b) comprises a spinal fixation prosthesis inserted into a damaged and removed intervertebral disc portion in an abnormal degenerative spine model, a pedicle screw inserted and fixed into a vertebra, and a connecting rod fixing between the inserted pedicle screw and the screw.

5. In paragraph 1, The above step (d) is, (d-1) A step of attaching a virtual wire to the uppermost vertebra while fixing the sacrum, which is the lowest part of the three-dimensional spinal surgery model, based on the three-dimensional spinal surgery model in which the virtual spinal surgery has been completed in the above step (c); (d-2) a step of connecting the corresponding virtual wire along each vertebra; (d-3) a step of applying a load so that a compressive load is applied along the vertebrae by applying a preset specific load from the top to the bottom of the three-dimensional spinal surgery model while the virtual wire is connected; and (d-4) A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that it further includes a step of evaluating the movement of the entire spine and the movement of each spinal motion segment under the specific load added in the step (d-3).

6. In paragraph 5, Before or after the above step (d-4), A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that it further includes a step of evaluating the pressure inside an intervertebral disc provided between each vertebra under the specific load added in the above step (d-3).

7. In paragraph 5, Before or after the above step (d-4), A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that it further includes a step of analyzing the behavior information of the spine after applying a preset moment value to the uppermost spine in at least one of the states of bending, extension, lateral bending, and torsion direction while the specific load added in the above step (d-3) is applied.

8. In paragraph 7, A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that the behavior information of the analyzed spine is analyzed from a mechanical engineering perspective of changes in the rotation angle of each motion segment of the spine and the risk of damage to the spinal medical device inserted into the spine.

9. In paragraph 5, In the above step (c), the virtual spinal surgery is performed The first stage is to remove the damaged intervertebral disc due to degeneration of the intervertebral disc in the spine and then insert a pre-prepared spinal fixation prosthesis into that location; A second step of inserting and fixing a pedicle screw prepared in advance into the vertebrae that contact the upper and lower surfaces of the intervertebral fixation prosthesis inserted in the first step; and It includes a third step of fixing the pedicle screw inserted in the second step using a connecting rod of a predetermined length, A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that it further includes a step of analyzing at least one of information from among changes in the rotation angle of the surgical segment and the adjacent segment, stress applied to the inserted spinal intervertebral fixation prosthesis and the surrounding vertebrae, direction and magnitude of force applied to the pedicle screw, and stress and strain information generated in the pedicle screw and the connecting rod, before or after the step (d-4) above, while the specific load added in the step (d-3) is applied.

10. In paragraph 9, A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that it further includes a step of predicting at least one possibility information among the possibility of accelerated degeneration of an intervertebral disc in an adjacent segment after performing spinal surgery, the possibility of damage to the spinal fixation prosthesis and the possibility of damage to the vertebrae in contact with the fixation prosthesis, the possibility of detachment of the pedicle screw, and the possibility of damage to the pedicle screw and the connecting rod based on the results of the analysis of the above information.

11. In paragraph 5, A method for evaluating the performance of a spinal medical device using computer simulation, characterized in that in the step (d-4) above, at least one of a finite element analysis (FEA) model, a multi-body dynamics module, and a computer simulation model in the field of mechanical engineering is applied to a spinal surgery model of the three-dimensional shape to evaluate the movement of the entire spine and the movement of each spinal motion segment under the specific load.

12. In paragraph 1, A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that the normal or degenerative spinal model of the three-dimensional shape constructed in the above step (a) has cartilage attached to the posterior joints of the vertebrae, and an intervertebral disc attached between the upper and lower vertebrae, wherein the intervertebral disc is composed of a cartilaginous endplate, a nucleus pulposus, and a ligament, and the ligament is provided between each vertebra to connect each consecutive vertebra to each other.

13. In paragraph 12, A method for evaluating the performance of a spinal medical device using a computer simulation, characterized in that the ligament is further provided between adjacent vertebrae so as to be connected to at least one adjacent vertebra among the N+2-th to N+M-th vertebrae (M is a natural number greater than or equal to 3) adjacent to the Nth vertebrae (N is a natural number greater than or equal to 1).

14. In paragraph 1, A method for evaluating the performance of a medical device for the spine using a computer simulation, characterized in that the human body information of a plurality of normal or abnormal vertebrae constituting the human spine applied in the above step (a) includes three-dimensional vertebrae shape information obtained using at least one medical image data among X-ray images (X-ray), computed tomography (CT), and magnetic resonance imaging (MRI) data taken of the human spine.

15. In paragraph 1, A method for evaluating the performance of a spinal medical device using computer simulation, characterized in that at least one of the steps (a) to (d) above performs modeling or simulation using a user-friendly graphical user interface (GUI) service.

16. In paragraph 1, A computer simulation-based spinal medical device, characterized in that it further includes a step of storing in a separate data storage module as a database (DB) at least one of information among information on a normal or degenerative spine model in a three-dimensional shape constructed in the step (a), information on a three-dimensional spinal medical device model in a three-dimensional shape constructed in the step (b), information on a virtual spinal surgery process and a three-dimensional spinal surgery model performed in the step (c), and information on evaluation information on the entire spine movement and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra under a specific load set in advance based on the three-dimensional spinal surgery model in which the virtual spinal surgery performed in the step (c) is completed, by unique user identification information. Performance evaluation method.

17. In paragraph 1, A method for evaluating the performance of a medical device for the spine using a computer simulation, characterized in that it further comprises a step of transmitting, to an external terminal or server by wired or wireless communication, at least one of information among information on a normal or degenerative spine model in a three-dimensional shape constructed in the step (a), information on a spinal medical device model in a three-dimensional shape constructed in the step (b), information on a virtual spinal surgery process and a three-dimensional spinal surgery model in a three-dimensional shape performed in the step (c), and evaluation information on the movement of the entire spine and the movement of each spinal motion segment or the pressure inside the intervertebral disc provided between each vertebra under a specific load set in advance based on the spinal surgery model in a three-dimensional shape in which the virtual spinal surgery performed in the step (c) is completed, along with preset unique user identification information or device identification information.

18. In paragraph 17, The above external terminal or server receives, through a pre-installed spinal surgery-related application service, at least one of information on a three-dimensional normal or degenerative spine model transmitted, information on a three-dimensional spinal medical device model, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and evaluation information on the movement of the entire spine and each motion segment of the spine or the pressure inside the intervertebral disc provided between each vertebra, along with preset unique user identification information or device identification information, and displays, on a display screen or outputs by voice, the information so that the user can visually or audibly confirm, based on the information, at least one of information on a three-dimensional normal or degenerative spine model, information on a three-dimensional spinal medical device model, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and evaluation information on the movement of the entire spine and each motion segment of the spine or the pressure inside the intervertebral disc provided between each vertebra. A method for evaluating the performance of a spinal medical device using a computer simulation.

19. In paragraph 17, The above external terminal or server receives, through a pre-installed spinal surgery-related application service, at least one of information on a three-dimensional normal or degenerative spine model, information on a three-dimensional spinal medical device model, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and evaluation information on the movement of the entire spine and each motion segment of the spine or the pressure inside the intervertebral disc provided between each vertebra, along with preset unique user identification information or device identification information, and based on this, stores and manages, for each user or device, information on a three-dimensional normal or degenerative spine model, information on a three-dimensional spinal medical device model, information on a virtual spinal surgery process and a three-dimensional spinal surgery model, and evaluation information on the movement of the entire spine and each motion segment of the spine or the pressure inside the intervertebral disc provided between each vertebra, in a separate storage module as a database (DB). The method for evaluating the performance of a spinal medical device using a computer simulation provides a service.

20. A computer-readable recording medium having recorded thereon a program capable of executing the method of any one of claims 1 to 19 by a computer.

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