A method for designing a nasal prosthesis to create a custom-made nasal prosthesis for each patient

Abstract

The present invention provides a nasal prosthesis design method for producing a patient-customized nasal prosthesis, the method comprising the steps of: (a) acquiring a medical image of a patient's nasal region; (b) automatically creating a three-dimensional volume rendering image including the skin, bone, and cartilage of the nasal region from the medical image of the patient's nasal region based on nasal cartilage data learned through artificial intelligence; (c) simulating nasal cartilage in the three-dimensional volume rendering image to suit the patient; (d) placing a nasal prosthesis selected from a virtual nasal prosthesis model database on the simulated nasal cartilage and nasal bone; and (e) simulating the placed nasal prosthesis to suit the patient and designing a custom-made nasal prosthesis.

Description

Detailed Description of the Invention

[0001] [Technical field] The present invention relates to a method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis, and more particularly to a method for designing a nasal prosthesis by cartilage manipulation based on nasal cartilage data learned through artificial intelligence. [Background technology] The nose is a part of the respiratory system and a sensory organ in charge of the sense of smell. Anatomically, the nose protrudes from the face and the nasal cavity constitutes the inside of the nose. FIG. 1 shows the anatomical structure of the nose. Referring to FIG. 1, the nasal bone occupies about 1 / 3 of the entire nose from the space between the eyebrows to the bridge of the nose, and the upper lateral cartridge and the lower lateral cartridge cover about 2 / 3 of the nose from the bridge of the nose to the tip of the nose. The nasal bone and the upper lateral cartridge overlap each other in part.

[0002] Meanwhile, a nasal prosthesis is inserted into the upper part of the nasal cartilage to correct the shape of the nose, and nose surgery has become more common in recent years due to the increasing personal and social interest in appearance. To design a conventional nasal prosthesis, CT data of the patient is used. However, while CT scans can realize the shape of the nasal bone, there is a problem in that the cartilage is not confirmed. In nasal surgery, the shape of the nose tip where the cartilage is located is a very important factor, so many studies are being conducted to create a nasal prosthesis by arbitrarily designing the cartilage based on the structure of the nasal bone and nostrils grasped from existing CT data.

[0003] For example, Korean Patent Publication No. 10-2019-0131796 (Prior Document 1) relates to a method for manufacturing a nose prosthesis, in which the HU (House Field Unit) value is adjusted in a CT image of the nose area, and three-dimensional images of the skin, nasal bone, and nasal cavity around the nose are obtained by a segmentation method, and then the nose cartilage is designed based on the images. This segmentation, or regionalization work, is a work of extracting and correcting triangular data of the skin, bone, and nostrils from the CT raw data, positioning the cartilage data, and designing the prosthesis. However, the triangle extraction method (Marching Cube) may have holes in the triangle mash, long triangles, or incorrectly connected triangles, so a correction or smoothing work is required to fill them in, but in this case, there is a problem that the error may become even larger. In addition, smoothing the extracted mash (Poisson process) is done by averaging the position of the user with the position information of multiple triangles attached to the user, but this creates a problem that there are subtle differences from smoothing the voxel with the average node value in all directions before extracting the triangle, and the error increases depending on the smoothing strength. Moreover, it is necessary to save and load a huge amount of triangular data such as the face, bones, nostrils, etc.

[0004] As another example, Korean Patent No. 10-2041524 (Prior Document 2) is related to a manufacturing method for a 3D custom-made implant, which uses a partial 2D image of a CT image, classifies values ​​according to the degree of contrast of pixels, and converts them into an STL (Stereolithography) file for 3D imaging to manufacture a 3D object including cartilage. However, the STL file format has a problem that not only is the data capacity quite large, but it also takes a lot of time to convert it into other file formats such as an STP file so that workers can operate it.

[0005] In both of the above-mentioned prior art documents 1 and 2, bones and nostrils are regionalized based on general CT data, and the shape of the cartilage shape is arbitrarily designed on the nostrils. However, in the nose surgery process, cartilage manipulation is required to change the shape of the nose tip, and the post-operative result value changes depending on the cartilage manipulation method. However, in both of these prior art documents, there is a limit to predicting the post-operative result due to insufficient consideration of the deformation of the cartilage, making it difficult to design a custom-made nose prosthesis suitable for the patient.

[0006] In addition, in the prior art documents 1 and 2, the bottom surface of the prosthesis is designed based on the designed cartilage, but the outer contour of the prosthesis excluding the bottom surface is not considered enough. In general, the shape of the nose after surgery is determined along the outer contour of the prosthesis excluding the bottom surface, so the design of the prosthesis is an important factor that determines the satisfaction of the nose surgery. In particular, since ready-made prosthesis molding products are available in various product groups according to height, length, and outer contour, the conventional custom-made prosthesis made according to the prior art documents 1 and 2 is inferior in competitiveness to the various designs of ready-made prosthesis molding products. In some cases, the prosthesis maker may select the quantified parts of the prosthesis such as the height, length, width, and shape, and design the prosthesis reflecting this, but it is difficult to judge the three-dimensional shape of the entire prosthesis using only numerical values, and it is difficult to reflect the characteristics of each individual patient, so there is a problem that it is difficult to predict the results after surgery.

[0007] Furthermore, the hospital takes a CT scan of the patient and sends it to the relevant company, which then sends the cartilage design data based on the CT data to the hospital, and the nose surgery is carried out in consultation with the patient based on this data. This means that it takes a lot of time for the design, ordering, and consultation of a custom-made nose prosthesis, and the patient has to visit the hospital at least twice, which is inefficient.

[0008] Since the outcome of rhinoplasty depends on the surgeon's surgical technique and aesthetic sense, there is a demand for a nasal prosthesis design method that can combine many elements to create a nasal prosthesis that is custom made for each patient. Summary of the Invention [Problem to be solved by the invention] An object of the present invention is to solve the above-mentioned problems of the conventional technology and to solve the technical problems that have been required in the past.

[0009] Specifically, an object of the present invention is to provide a method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis by cartilage manipulation based on nasal cartilage data learned through artificial intelligence. [Means for solving the problems] The present invention relates to (a) obtaining a medical image of a patient's nasal region; (b) automatically generating a three-dimensional volume rendering image including skin, bone and cartilage of the nasal region from the medical image of the patient's nasal region based on the nasal cartilage data learned by the artificial intelligence; (c) simulating nasal cartilage in said three-dimensional volume rendered image as appropriate for the patient; (d) placing a nasal prosthesis selected from a virtual nasal prosthesis model database onto the simulated nasal cartilage and nasal bone; (e) simulating the placed nasal prosthesis to design a custom-made nasal prosthesis suitable for the patient.

[0010] In step (a), the medical image may be a low-dose CT or low-dose Cone Beam Computed Tomography (CBCT) image.

[0011] The step (b) may include a process of predicting nasal cartilage from a medical image of the patient's nose region based on nasal cartilage data learned by machine learning or deep learning using high-dose medical images in which nasal cartilage is visible.

[0012] In the step (c), the simulation of the nose cartilage comprises: (c-1) selecting a skin thickness from a plurality of options; (c-2) A step of removing a part of the nasal cartilage and nasal bone according to the progress of rasp of the hump part; (c-3) setting the movement of the nasal cartilage according to the progress of the nasal tip surgery; (c-4) correcting the outer contour line of the nose cartilage to make it natural, and the steps (c-1) to (c-3) may be performed in any order.

[0013] In step (c-1), the width of the custom-made nasal prosthesis can be automatically adjusted in step (e) according to the selected skin thickness.

[0014] The steps (c-2) and (c-3) may be progressed or not depending on the doctor's judgment.

[0015] In the step (c-3), the thickness of the skin can be automatically adjusted according to the movement of the nose cartilage.

[0016] The step (c-4) may be performed in a manner to fill in a gap between an upper nasal cartilage and a lower nasal cartilage.

[0017] The step (d) (d-1) displaying a nasal tip reference point and a glabella variable point on a three-dimensional volume rendering image including a simulated nasal cartilage; (d-2) selecting a nasal prosthesis from a database of virtual nasal prosthesis models of various shapes; (d-3) A step of placing the selected nasal prosthesis on the simulated nasal cartilage and nasal bone in accordance with the angle of the connecting line between the nasal tip reference point and the glabella variable point displayed in the three-dimensional volume rendering image.

[0018] The glabella variable point can be selected between 20 mm above the nasion.

[0019] In the step (d-3), the nasal prosthesis may be fitted closely onto the simulated nasal cartilage and nasal bone in a manner that the upper and lower portions are curved based on the hump.

[0020] The step (e) (e-1) adjusting the length, width, angle and thickness of the nasal prosthesis; (e-2) The method may include a step of checking whether the nasal prosthesis fits closely onto the simulated nasal cartilage and nasal bone, automatically filling any empty spaces that exist due to the lack of fit, and adjusting only the shape of the prosthesis excluding the nasal cartilage and nasal bone if there is any overlapping area.

[0021] In the step (e-1), the angle of the nasal prosthesis may be adjusted in increments of 0.2 degrees or 0.5 degrees within 5 degrees to the left or right based on a line connecting the nasal tip reference point and the glabella variable point.

[0022] After step (e), (f) cutting and inspecting any surface of the custom nasal prosthesis to ensure complete fit over the simulated nasal cartilage and nasal bone; (e) automatically calculating and indicating a change in skin surface height of the nasal region relative to the custom nasal prosthesis.

[0023] The designed custom nasal prosthesis information can be stored in an encrypted binary file format. [Effects of the Invention] The present invention can automatically perform volume rendering of nasal cartilage from a patient's medical image based on nasal cartilage data learned through artificial intelligence without performing triangulation data processing through segmentation, thereby not only reducing the probability of error and improving accuracy, but also reducing the storage capacity required for the process, making the process simple and economical.

[0024] The present invention can simulate the position and shape of nasal cartilage in a three-dimensional volume rendering image in a manner suitable for each patient, thereby increasing the predictive value of the outcome of nose surgery.

[0025] The present invention can simulate a nasal prosthesis selected from a virtual nasal prosthesis model database to suit the patient, which can not only accurately reflect the patient's needs but also provide aesthetic aesthetics.

[0026] The present invention is highly efficient and time-saving since the process of obtaining medical images of the patient's nasal area and then designing a custom nasal prosthesis through consultation with a physician can be accomplished in at least one visit. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows the anatomy of the nose.

[0027] 2a and 2b are three-dimensional volume rendering images realized from medical images of a patient's nasal region, with FIG. 2a showing the skin surface and FIG. 2b showing the bone, cartilage, and nasal bone.

[0028] FIG. 3a shows the hump portion before rasping.

[0029] FIG. 3b shows the hump portion after rasping.

[0030] Figure 4 shows the lower nasal cartilage elevated.

[0031] Figure 5 shows the lower nasal cartilage lowered.

[0032] Figure 6a shows the skin changes after the lower nasal cartilage was elevated upward.

[0033] Figure 6b shows the skin changes after lowering the lower nasal cartilage downwards.

[0034] FIG. 7a shows the selected nasal prosthesis automatically placed on the previously simulated nasal cartilage and nasal bone.

[0035] Figure 7b shows the nasal prosthesis bent and placed snugly over the simulated nasal cartilage and nasal bone.

[0036] FIG. 8 shows the state where the length, width and thickness of the nasal prosthesis in FIG. 7b have been adjusted to match the cartilage shape.

[0037] FIG. 9 shows a cross-sectional view of the custom-made nasal prosthesis in place.

[0038] FIG. 10 shows a custom nasal prosthesis according to the present invention before insertion (left) and after virtual shaping has been performed after the custom nasal prosthesis has been inserted (right). [Mode for carrying out the invention] Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.

[0039] The present invention relates to (a) acquiring a medical image of a patient's nasal region; (b) automatically generating a three-dimensional volume rendering image including skin, bone and cartilage of the nasal region from a medical image of the patient's nasal region based on the nasal cartilage data learned through artificial intelligence; (c) simulating nasal cartilage in said three-dimensional volume rendered image as appropriate for the patient; (d) placing a nasal prosthesis selected from a virtual nasal prosthesis model database onto the simulated nasal cartilage and nasal bone; (e) simulating the placed nasal prosthesis to design a custom-made nasal prosthesis suitable for the patient.

[0040] In step (a), a medical image of the patient's nasal region may be obtained.

[0041] Here, the term "nose region" refers narrowly to the nose region alone, but may broadly refer to the entire face region including the nose.

[0042] The medical image may be, but is not limited to, a CT, CBCT, X-ray, MRI, PET, 3D scanner, etc. In particular, it may be a CT image or a CBCT image.

[0043] Generally, CT images or CBCT images used in orthopedics and the like are low-dose images. Although low-dose medical images have a lower resolution than high-dose medical images, they can minimize the radiation exposure dose, and are widely used in small and medium-sized hospitals such as orthopedics at a low price of 1 / 10 or more. Distinguishing between the radiation exposure dose of low-dose medical images and the radiation exposure dose of high-dose medical images is known in the art, and see Christner JA, Kofler JM, McCollough CH, consequences of adopting International Commission on Radiological Protection publication 103 or dualenergy scanning, AJR Am J Roentgenol. 2010; 194: 881-889, for example, the radiation exposure dose of the low-dose medical images may be 0.1 mGy or more and less than 2.5 mGy, and the radiation exposure dose of the high-dose medical images may be 2.5 mGy or more and less than 1,000 mGy.

[0044] However, while low-dose medical images can capture the skin, nasal bone, and nasal cavity, they cannot see the nasal cartilage, so a process of designing the cartilage is necessary.In contrast, high-dose medical images can capture not only the skin, nasal bone, and nasal cavity, but also the nasal cartilage, so this can be repeatedly learned using machine learning or deep learning methods to obtain nasal cartilage data.

[0045] Therefore, the inventors, after much research and effort, have confirmed that when nasal cartilage data obtained through AI-guided learning is applied to low-dose CT images or low-dose CBCT images in which nasal cartilage is not visible in general orthopedic surgery, the shape, particularly the thickness, of the invisible cartilage can be found. As a result, a 3D volume rendering image including the skin, bone, and cartilage of the nasal region can be automatically realized from the medical image of the patient's nasal region based on the nasal cartilage data learned through AI in the step (b).

[0046] In this regard, Figures 2a and 2b are three-dimensional volume rendering images obtained from medical images of a patient's nasal region, and in particular, Figure 2b shows the upper and lower nasal cartilages.

[0047] That is, the present invention does not extract, correct, and store triangular data of the skin, bones, and nostrils through a segmentation process, but instead maintains the original shape through volume rendering, which projects 3D voxel data from a medical image of the patient's nose area onto a 2D image, to realize a 3D image including nasal cartilage, and designs a prosthesis based on this. Therefore, it is not necessary to create cartilage on the nasal cavity, and it is possible to improve accuracy by reducing the probability of error, and it is simple and economical because it can reduce the storage capacity required for the work.

[0048] Such three-dimensional volume rendering images can be generated automatically, without operator intervention, by uploading medical image data of the patient's nasal region into associated software.

[0049] Since the shape of the nasal tip where the nasal cartilage is located is an important factor that determines the patient's satisfaction with surgery, it is necessary to manipulate the cartilage to reflect the patient's characteristics during the nose surgery. Therefore, the present invention includes a process of simulating the position and shape of the nasal cartilage in the 3D volume rendering image in the step (c) so that the position and shape of the nasal cartilage can be simulated to suit the patient, thereby increasing the predictability of the nose surgery result.

[0050] Specifically, the simulation of the nose cartilage includes: (c-1) selecting a skin thickness from a plurality of options; (c-2) A step of removing a part of the nasal cartilage and nasal bone according to the progress of rasp of the hump part; (c-3) setting the movement of the nasal cartilage according to the progress of the nasal tip surgery; (c-4) A step of correcting the outer contour line of the nasal cartilage to make it natural.

[0051] First, even if a prosthesis of the same thickness is inserted, the width of the prosthesis looks different in appearance after surgery depending on the patient's skin thickness, so if the skin is thick, the width of the prosthesis needs to be reduced. Thus, the skin thickness is displayed quantitatively or qualitatively from the multiple options in step (c-1), and the skin thickness can be selected from the multiple options. For example, the multiple options may be displayed to select either "thin skin thickness piece / normal skin thickness piece" or "thick skin thickness piece", but are not limited thereto. Here, if "thick skin piece" is selected, the width of the custom-made prosthesis designed later can be automatically reduced by 0.3 to 0.5 mm, specifically 0.4 mm, from the final result. These values ​​are optimal values ​​obtained by considering aesthetics, function, etc. from numerous studies and treatment data conducted by the applicant.

[0052] If a patient has an aquiline nose and a hump is formed on the outer line of the cartilage, it is necessary to remove a part of the nasal cartilage and nasal bone so that the outer line of the cartilage becomes smooth (the rasping process). Therefore, in step (c-2), the hump can be naturally removed along the curved surface at the beginning and end of the range through the rasping process of the hump part. In this regard, Figure 3a shows the hump part before rasping, and Figure 3b shows it after rasping. In Figure 3a, the part circled in red is the hump.

[0053] However, whether the patient has an aquiline nose or not, the bottom of the nasal prosthesis that contacts the outer edge of the cartilage can be shaved according to the doctor's choice, so whether to proceed with step (c-2) can be decided based on the doctor's judgment.

[0054] The shape of the nasal tip where the cartilage is located is an important factor that determines the patient's satisfaction with the surgery, and in the step (c-3), the shape and position of the highest part of the nose, i.e., the nasal tip, can be adjusted by manipulating the lower nasal cartilage. The lower nasal cartilage consists of two parts, left and right, and it is possible to calculate whether or not to tie the lower nasal cartilage, and if so, the direction and distance of the cartilage to be moved. For example, the lower nasal cartilage can be moved upward by 1 to 12 mm to raise the nasal tip, and can be moved downward to extend a short nose length, and the angle can be changed when moving. In this regard, FIG. 4 shows a state in which the lower nasal cartilage is raised upward and the nasal tip is raised, and FIG. 5 shows a state in which the lower nasal cartilage is lowered downward and the nasal tip is lowered.

[0055] As the lower nasal cartilage moves, the skin also moves and the skin thickness is automatically adjusted. In this regard, Figure 6a shows the change in the skin after the lower nasal cartilage is raised upward, and Figure 6b shows the change in the skin after the lower nasal cartilage is lowered downward. For example, when the cartilage moves upward by about 4 mm, the skin thickness becomes thinner by about 1 mm. This is because the skin is tensioned by the prosthesis that is inserted later.

[0056] Such nasal tip surgery involving the movement of nasal cartilage can be carried out based on the doctor's judgment, taking into account the characteristics of the patient.

[0057] The steps (c-1) to (c-3) may be performed in any order, and thereafter, in step (c-4), the outer contour line of the nasal cartilage can be naturally corrected by filling in the gap between the upper nasal cartilage and the lower nasal cartilage, which constitute the cartilage.

[0058] Thereafter, in step (d), a nasal prosthesis is placed on the nasal cartilage and nasal bone simulated through the above process.

[0059] Specifically, step (d) comprises: (d-1) displaying a nasal tip reference point and a glabella variable point on a three-dimensional volume rendering image including a simulated nasal cartilage; (d-2) selecting a nasal prosthesis from a database of virtual nasal prosthesis models of various shapes; (d-3) A step of placing the selected nasal prosthesis on the simulated nasal cartilage and nasal bone in accordance with the angle of the connecting line between the nasal tip reference point and the glabella variable point displayed in the three-dimensional volume rendering image.

[0060] In step (d-1), the nasal tip reference point may be the highest part of the nose, and the glabella variable point may be selected between 20 mm above the nasion, which is the lowest part of the nose, but may be moved according to the doctor's needs.

[0061] As described above, in the conventional custom-made prosthesis, the bottom surface of the prosthesis is designed based on the cartilage arbitrarily designed above the nostril, but the outer contour of the prosthesis other than the bottom surface is not considered enough, so the competitiveness is lowered compared to the various designs of ready-made prosthesis molding products. In contrast, in the present invention, the nasal prosthesis is selected from the virtual nasal prosthesis model database held by the applicant in the step (d-2), so the competitiveness can be improved.

[0062] The 100 or more prostheses for rhinoplasty that constitute the virtual nasal prosthesis model database form various product groups according to height, length, and contour line. For example, they can be confirmed from the applicant's Korean Registered Patent No. 0759104, Korean Registered Design No. 0729100, No. 0729098, No. 0398523, No. 0398523 Similar 1, No. 0895587, No. 0895588, No. 0895589, No. 0895590, No. 0895591, No. 0895592, No. 0895593, No. 0895594, No. 0895595, No. 0895596, No. 0895597, No. 0895599, No. 0895600, No. 0895601, No. 0972134, No. 0942611, etc., but are not limited thereto. Such a virtual nasal prosthesis model database may be stored in the library of the software.

[0063] In the step (d-3), according to the angle of the connecting line between the nasal tip reference point and the glabella variable point displayed in the three-dimensional volume rendering image, the selected nasal prosthesis can be placed on the simulated nasal cartilage and nasal bone. In this case, since the upper and lower parts of the nasal prosthesis are closely attached in a manner that automatically bends along the nasal cartilage and nasal bone based on the hump, it is possible to prevent the generation of a space between the nasal prosthesis and the nasal cartilage, and thus prevent side effects such as inflammation. At this time, the angle at which the nasal prosthesis bends can be 1 to 15 degrees based on the angle of the connecting line between the nasal tip reference point and the glabella variable point.

[0064] In connection with this, Fig. 7a shows a state where the selected nasal prosthesis is automatically placed on the previously simulated nasal cartilage and nasal bone, and Fig. 7b shows a state where the nasal prosthesis bends and is placed in close contact with the simulated nasal cartilage and nasal bone.

[0065] The present invention can select a virtual nasal prosthesis from a virtual nasal prosthesis model database, place it on the nasal cartilage, and then simulate such a virtual nasal prosthesis to suit the patient, thereby not only accurately reflecting the patient's needs but also providing an aesthetic feeling.

[0066] Specifically, step (e) comprises: (e-1) adjusting the length, width, angle and thickness of the nasal prosthesis; (e-2) The method can be configured to check whether the nasal prosthesis fits tightly onto the simulated nasal cartilage and nasal bone, and if there is an empty space due to the lack of fit, automatically fill it in, and if there is an overlapping area, adjust only the shape of the prosthesis excluding the nasal cartilage and nasal bone.

[0067] In step (e-1), the length, width, angle and thickness of the nasal prosthesis can be adjusted. Such adjustment can be performed by inputting "numbers" or using a "bar". The length that changes when adjusting using the bar can be displayed in mm. The angle of the nasal prosthesis can be adjusted in units of 0.2 degrees or 0.5 degrees within 5 degrees to the left or right based on the connecting line between the nasal tip reference point and the glabella variable point, but is not limited thereto. When adjusting the length, width, angle and thickness of the nasal prosthesis, the change in the prosthesis can be immediately confirmed with the naked eye.

[0068] Then, in step (e-2), it is checked whether the nasal prosthesis is in close contact with the simulated nasal cartilage and nasal bone, and if there is a vacant space due to lack of close contact, it is automatically filled, and if there is an overlapping portion, only the shape of the prosthesis excluding the nasal cartilage and nasal bone can be adjusted. This process can be performed using 3D reconstruction and Boolean calculation. In this regard, FIG. 8 shows the state where the length, width, and thickness of the nasal prosthesis in FIG. 7b are adjusted to fit the cartilage shape.

[0069] After step (e), (f) cutting and inspecting any surface of the custom nasal prosthesis to ensure complete fit over the simulated nasal cartilage and nasal bone; ( g ) a virtual reshaping step for automatically calculating and indicating a change in the height of the skin surface of the nose area through a custom-made nasal prosthesis.

[0070] In step (f), any cut surface of the custom-made nasal prosthesis can be checked from the line, so that it can be checked whether the nasal prosthesis is completely attached to the cartilage and bone. In this case, the cutting direction may be the direction of the connecting line between the nasal tip reference point and the glabella variable point. In this regard, Figure 9 shows the cross section of the custom-made prosthesis in place.

[0071] Then, in the step ( g ) The completed custom-made nose prosthesis is created by volume calculation. The change in skin surface height of the nose area relative to the nose is automatically calculated and displayed, allowing virtual plastic surgery. In this regard, FIG. 10 shows a custom-made nose prosthesis according to the present invention. Before the insertion of the prosthesis (left), and after the custom-made nasal prosthesis is inserted and virtual shaping is performed The result is shown on the right.

[0072] Once the above steps are completed, the information regarding the custom nasal prosthesis may be stored in an encrypted binary file format rather than in a stereolithography (STL) file format.

[0073] Generally, the STL file format is a standard format for storing triangular data, and since anyone can read, copy, modify, or edit the contents, it is highly vulnerable to intellectual property infringement such as illegal duplication, modification, and editing. The present invention improves security by storing the data in a binary file format encrypted at the final stage. There are no limitations on the encryption method, but for example, in the case of encoding, the data can be encrypted by changing the order of the memory using the file storage time and then stored, and in the case of decoding, the encoded file can be encrypted by restoring the information to the memory while restoring the order of the information using the storage time.

[0074] In this manner, the present invention is highly efficient and time-saving since the process of obtaining medical images of the patient's nasal area and then designing a custom nasal prosthesis through consultation with a physician can be accomplished in at least one visit through the associated program. [Brief description of the drawings]

[0075] [Figure 1] Diagram of nasal anatomy. [Figure 2a] A three-dimensional volume rendering image was generated from a medical image of a patient's nose area, where Figure 2a shows the skin surface. [Figure 2b] A three-dimensional volume rendering image was generated from a medical image of a patient's nasal region, showing the bone, cartilage, and nasal bones in FIG. 2b. [Figure 3a] Shown before rasping of the hump area. [Figure 3b] Shows the hump area after rasping. [Figure 4] The lower nasal cartilage is raised upward. [Diagram 5] The lower nasal cartilage is lowered downward. [Figure 6a] Shows the skin changes after the lower nasal cartilage is elevated. [Figure 6b] Shows the skin changes after lowering the lower nasal cartilage. [Figure 7a]The selected nasal prosthesis is automatically placed onto the previously simulated nasal cartilage and nasal bone. [Figure 7b] The nasal prosthesis is bent and placed so that it fits snugly over the simulated nasal cartilage and nasal bone. [Figure 8] The length, width, and thickness of the nasal prosthesis in Figure 7b have been adjusted to fit the cartilage shape. [Figure 9] This is a cross-sectional view of a custom-made nasal prosthesis in place. [Figure 10] Shown is a custom nasal prosthesis according to the present invention before insertion (left) and after virtual shaping with the custom nasal prosthesis inserted (right).

Claims

1. (a) obtaining a medical image of a patient's nasal region where the nasal cartilage is not visible; (b) automatically generating a three-dimensional volume rendering image including skin, bone and cartilage of a nasal region from the medical image of the nasal region of the patient where the nasal cartilage is not visible based on the nasal cartilage data where the nasal cartilage is visible learned through artificial intelligence; (c) displaying the simulated nasal cartilage on the three-dimensional volume rendering image on a visual display device; (d) displaying on the three-dimensional volume rendering image a nasal prosthesis selected from a virtual nasal prosthesis model database and automatically placed on the simulated nasal cartilage and nasal bone; (e) a step in which the image display device displays a custom-made nasal prosthesis designed by simulating the placed nasal prosthesis in the three-dimensional volume rendering image, said method for designing a nasal prosthesis for creating a custom-made nasal prosthesis for a patient, comprising:

2. In the step (a), The method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis according to claim 1 , wherein the medical image is a low-dose CT or low-dose CBCT (Cone Beam Computed Tomography) image.

3. The step (b) 2. A method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis as described in claim 1, characterized in that it includes a process of predicting nasal cartilage from a medical image of the patient's nose area based on nasal cartilage data learned by machine learning or deep learning using high-dose medical images in which nasal cartilage is visible.

4. In the step (c), the simulating of the nasal cartilage comprises: (c-1) displaying a plurality of options for selecting a skin thickness by the image display device; (c-2) displaying the partially removed nasal cartilage and nasal bone on the three-dimensional volume rendering image by the image display device according to the progress of rasping of the hump portion; (c-3) displaying, on the three-dimensional volume rendering image, the nasal cartilage that has been moved according to the progress of the nasal tip surgery by the image display device; (c-4) causing the image display device to display the naturally corrected contour line of the nasal cartilage on the three-dimensional volume rendering image; 2. The method of claim 1, wherein steps (c-1) to (c-3) are performed in any order.

5. In the step (c-1), The method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis as described in claim 4, characterized in that in step (e), the width of the custom-made nasal prosthesis is automatically adjusted depending on the selected skin thickness.

6. In the step (c-3), The method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis according to claim 4, characterized in that the thickness of the skin is automatically adjusted according to the movement of the nasal cartilage.

7. The step (c-4) 5. The method of designing a nasal prosthesis for making a custom-made nasal prosthesis for a patient according to claim 4, characterized in that the method is performed in a manner of filling the gap between the upper nasal cartilage and the lower nasal cartilage that constitute the nasal cartilage.

8. The step (d) comprises: (d-1) displaying a nasal tip reference point and a glabella variable point on a three-dimensional volume rendering image including a simulated nasal cartilage on the image display device; (d-2) causing the image display device to display in the three-dimensional volume rendering image a nasal prosthesis selected from a database of virtual nasal prosthesis models; (d-3) a step in which the image display device displays the selected nasal prosthesis, the nasal prosthesis placed on the simulated nasal cartilage and nasal bone, in the three-dimensional volume rendering image in accordance with the angle of the connecting line between the nasal tip reference point and the glabella variable point displayed in the three-dimensional volume rendering image. The method for designing a nasal prosthesis for creating a patient-customized nasal prosthesis as described in claim 1, characterized in that it includes the steps of:

9. The method for designing a nasal prosthesis for making a patient-customized nasal prosthesis according to claim 8, characterized in that the glabella variable point is selected between 20 mm above the nasion.

10. In the step (d-3), The method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis as described in claim 8, characterized in that the image display device displays the nasal prosthesis configured to fit tightly onto the simulated nasal cartilage and nasal bone in a manner in which the upper and lower parts are bent based on a hump in the three-dimensional volume rendering image.

11. The step (e) comprises: (e-1) displaying the simulated nasal prosthesis on the three-dimensional volume rendering image by adjusting the length, width, angle, and thickness of the nasal prosthesis on the image display device; (e-2) a step in which the image display device displays the simulated nasal prosthesis in the three-dimensional volume rendering image so as to automatically fill in any empty space between the nasal prosthesis and the simulated nasal cartilage and nasal bone, and displays the simulated nasal prosthesis in the three-dimensional volume rendering image by adjusting only the shape of the prosthesis excluding the nasal cartilage and nasal bone, if there is an overlapping portion between the nasal prosthesis and the simulated nasal cartilage and nasal bone. The method for designing a nasal prosthesis for producing a patient-customized nasal prosthesis as described in claim 8, characterized in that it includes the steps of:

12. In the step (e-1), The method for designing a nasal prosthesis for creating a patient-customized nasal prosthesis as described in claim 11, characterized in that the angle of the nasal prosthesis can be adjusted in increments of 0.2 degrees or 0.5 degrees within 5 degrees to the left or right based on the connecting line between the nasal tip reference point and the glabella variable point.

13. After step (e), (f) displaying a cross section of an arbitrary plane of the custom-made nasal prosthesis on the three-dimensional volume rendering image to confirm whether the custom-made nasal prosthesis is completely attached to the simulated nasal cartilage and nasal bone; 2. The method of claim 1 for designing a nasal prosthesis for creating a custom-made nasal prosthesis for a patient, further comprising the step of: (g) automatically calculating and indicating the change in skin surface height of the nasal area for the custom-made nasal prosthesis.

14. The method of claim 1, wherein the designed custom-made nasal prosthesis information is stored in an encrypted binary file format.

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