Method for optimizing percutaneous pulmonary artery valve insertion by using patient-specific model and in vitro simulation circulation through 3D printing

Abstract

The present invention relates to a method for optimizing percutaneous pulmonary artery valve insertion by using a patient-specific model and in vitro simulation circulation through 3D printing, to find an optimal percutaneous pulmonary artery valve size and an optimal insertion position in order to increase a success rate of the percutaneous pulmonary artery valve insertion. In this regard, the present invention includes the steps of: obtaining a computed tomography (CT) image by performing CT on a heart; generating a 3D printing file format after performing 3D modeling by subdividing the heart and blood vessels on the basis of the CT image; and manufacturing an outflow path model (10) corresponding to an outflow path of the right ventricle of a person to be photographed by performing 3D printing using the 3D printing file.

Description

Optimizing Transcatheter Pulmonary Valve Implantation Using Patient-Specific Models and Extracorporeal Simulated Circulation Through 3D Printing

[0001] The present invention relates to a method for optimizing transcatheter pulmonary valve implantation using a patient-specific model and extracorporeal simulated circulation through 3D printing to find the optimal transcatheter pulmonary valve size and insertion location to increase the success rate of transcatheter pulmonary valve implantation.

[0002] Normally, the heart consists of two atria and two ventricles, and there are four valves (aortic valve, pulmonary valve, tricuspid valve, and mitral valve) that help prevent blood from flowing backward between each chamber.

[0003] The pulmonary valve, located between the right ventricle and the pulmonary artery of the heart, prevents the blood pumped out by the right ventricle to return to the right ventricle after it has pumped blood to the lungs. Pulmonary valve disease is a condition in which this valve opens and closes abnormally.

[0004] Meanwhile, in the case of patients who have undergone pulmonary valve replacement surgery due to congenital right ventricular outflow tract malformation, such as tetralogy of Fallot, the risk of developing heart failure is very high as the valve function declines with age, causing regurgitation, enlargement of the right ventricle, or narrowing of the valve, leading to severe stenosis.

[0005] To prevent this, open-heart surgery was performed to open the chest, raise the heart, and replace the pulmonary valve. However, in the case of reoperation, the pain and aftereffects are great, and as the number of reoperations increases, the risk of complications increases, so the development of a treatment method that can replace surgery is urgently needed.

[0006] A treatment for this is percutaneous pulmonary valve implantation, which can improve pulmonary artery stenosis or regurgitation by inserting an artificial pulmonary valve through the femoral vein without making a chest incision and expanding the narrowed valve.

[0007] However, for successful percutaneous pulmonary valve implantation, it was very important to find the optimal size and insertion location of the percutaneous pulmonary stent valve in right ventricular outflow tract disease, which showed various sizes and shapes depending on each patient.

[0008] The present invention is intended to solve the problems of the past, and when performing percutaneous pulmonary artery stent valve implantation, it is possible to perform the procedure by varying the size and insertion location of the pulmonary artery stent valve according to the various sizes and shapes of the right ventricular outflow tract of each patient.

[0009] Accordingly, the purpose of the present invention is to segment the heart and blood vessels based on CT or MR images of patients with complex heart malformations, then create an STL file for 3D printing, and then perform 3D printing using the created file to create a model of an outflow tract that accurately models a complex anatomical structure.

[0010] In addition, the purpose of the present invention is to perform patient-tailored treatment using the manufactured outflow model using in vitro mock circulation.

[0011] To solve this purpose, the present invention;

[0012] (S1) A step of performing cardiac computed tomography (CT) to obtain a CT image;

[0013] (S2) A step of segmenting the heart and blood vessels based on the CT image, performing 3D modeling, and then creating a 3D printing file format;

[0014] (S3) A method for optimizing percutaneous pulmonary valve insertion is provided, characterized in that it comprises a step of producing an outflow tract model corresponding to the right ventricular outflow tract of a subject to be photographed by 3D printing using the above 3D printing file.

[0015] According to the present invention, a patient's right ventricular outflow tract is manufactured to resemble actual tissue using 3D printing, and an in vitro mock circulation is performed to find the optimal transcatheter pulmonary valve size and insertion location, thereby increasing the success rate of future transcatheter pulmonary valve insertion and minimizing side effects.

[0016] Figure 1 is an image of various right ventricular outflow tracts in pulmonary valve disease according to one embodiment of the present invention.

[0017] Figure 2 is an image of an artificial valve model according to one embodiment of the present invention.

[0018] Figure 3 is an image obtained by obtaining a CT image of a patient with pulmonary valve disease according to one embodiment of the present invention.

[0019] Figure 4 is a 3D image modeled in three dimensions based on a CT image according to one embodiment of the present invention.

[0020] FIG. 5 is an image of an extracorporeal circulatory device and an artificial valve according to one embodiment of the present invention.

[0021] The features of the method for optimizing percutaneous pulmonary valve implantation using a patient-specific model and extracorporeal simulated circulation through 3D printing according to the present invention can be understood through the following detailed embodiments with reference to the attached drawings.

[0022] Meanwhile, embodiments of the present invention may be implemented in various embodiments within the scope of the technical field to which the invention belongs, and are not particularly limited to the embodiments described herein.

[0023] In addition, in order to clearly explain the present invention, repetitive descriptions of identical or similar components throughout the specification have been omitted, and parts unrelated to the description in relation to the drawings have been omitted, and when describing common components, drawing symbols for them have been omitted.

[0024] Hereinafter, a method for optimizing percutaneous pulmonary valve insertion according to an embodiment of the present invention will be described in detail with reference to FIGS. 1 to 5.

[0025] A method for optimizing percutaneous pulmonary valve implantation according to the present invention comprises the steps of (S1) performing cardiac computed tomography (CT) to obtain a CT image; (S2) performing 3D modeling by segmenting the heart and blood vessels based on the CT image and then generating a 3D printing file format; and (S3) using the 3D printing file to produce an outflow tract model (10) corresponding to the right ventricular outflow tract of a subject to be photographed by 3D printing.

[0026] In addition, after step S3, the method further includes step S4 of connecting the above-mentioned leak model (10) to an extracorporeal simulation circulation device (30) to perform extracorporeal simulation circulation.

[0027] Each of the components described above is described in detail below.

[0028] First, step S1 is to perform computed tomography (CT) of the human heart to obtain CT images.

[0029] This step can obtain individual CT images of different sizes and shapes for patients with complex cardiac malformations by performing cardiac computed tomography as shown in Figure 3. More specifically, computed tomography (CT) is used as the basis, but images for creating a 3D printing file format can optionally be obtained by using magnetic resonance imaging (MRI).

[0030] And the S2 stage is to segment the heart and blood vessels based on the CT images taken in the S1 stage, perform 3D modeling, and then create and provide a 3D printing file format.

[0031] This step, as illustrated in Fig. 4, uses a separate computer program, software capable of performing free 3D modeling in more detail, to segment the heart and blood vessels in the CT image data from the S1 stage, and then accurately 3D model a specific part, i.e., the complex anatomical structure of the right ventricular outflow tract, and then creates a 3D printing file format.

[0032] At this time, the 3D printing file format is a segmented 3D printing file format saved as a stereolithography file, and among them, the STL file format is mainly used in CAD and 3D printing.

[0033] And step S3 is to create an outflow tract model (10) corresponding to the right ventricular outflow tract of the subject of the photograph by 3D printing using a 3D printing file.

[0034] This step uses a 3D printing device to create a 3D model of the 3D printing file generated in step S2 to create a model of the effluent channel (10) similar to an actual tissue, and accordingly, the model of the effluent channel (10) is made of a material similar to an actual tissue.

[0035] Meanwhile, the right ventricular outflow tract is divided into Type 1 Pyramidal, Type 2 Straight, Type 3 Reverse pyramidal, Type 4 Convex, and Type 5 Concave, as shown in Figure 1.

[0036] The pulmonary artery stent valve implanted in these right ventricular outflow tracts is an artificial valve (20), and the Pulsta pulmonary artery stent valve illustrated in Fig. 2 can be applied, which has the characteristic of adapting to various shapes of the right ventricular outflow tract because it is relatively soft and compact.

[0037] Therefore, when performing percutaneous pulmonary artery stent valve implantation using an artificial valve (20), the success rate of the procedure could be improved only by varying the size and insertion location of the pulmonary artery stent valve according to the various sizes and shapes of the right ventricular outflow tract of each patient.

[0038] And step S4 is to connect the outflow tract model (10) manufactured in step S3 to an extracorporeal simulated circulation device (30) to perform extracorporeal simulated circulation, and to determine the optimal size and insertion position of the artificial valve (20) in the outflow tract model (10) manufactured for each patient.

[0039] In this step, artificial valves (20) of various sizes are inserted into a model of an outflow tract (10) connected to an extracorporeal circulatory device (30) at specific locations, which correspond to the proximal part of the main pulmonary artery, the middle part of the main pulmonary artery, and the distal part of the main pulmonary artery.

[0040] Meanwhile, the extracorporeal simulation circulation device (30) is configured to be able to connect the effluent model (10) through a pipe as shown in FIG. 5, and to create a fluid flow similar to that of a human heart within the effluent model (10) through a pump.

[0041] In this case, after connecting the artificial valve (20) to the extracorporeal simulated circulation device (30), extracorporeal simulated circulation is performed to evaluate side effects such as displacement and movement of the artificial valve (20) within the outflow tract model (10) and insertion failure, and the optimal size and insertion position of the artificial valve (20) are determined in the outflow tract model (10) customized for each patient.

[0042] At this time, the extracorporeal simulation circulation device (30) can determine the potential and movement of the artificial valve (20) through an endoscope (31) that can observe the inside of the effluent model (10), and the status can be checked in real time by connecting a smartphone (32) to the endoscope (31).

[0043] Meanwhile, when the optimal size and insertion position of the artificial valve (20) are determined in the outflow tract model (10) through the extracorporeal simulation circulation as described above, percutaneous pulmonary valve implantation is performed with the determined size and insertion position of the artificial valve (20).

[0044] Accordingly, when performing percutaneous pulmonary artery stent valve implantation, the size and insertion location of the artificial valve (20) are changed according to the various sizes and shapes of the right ventricular outflow tract of each patient.

[0045] For example, the present invention uses 3D printing to create a model (10) of the outflow tract of the patient's right ventricle similar to actual tissue, and performs in vitro mock circulation to find the optimal size and insertion location of the transcatheter pulmonary valve, thereby increasing the success rate of future transcatheter pulmonary valve insertion and minimizing side effects.

[0046] As described above, the present invention has been described through the above description and drawings of preferred embodiments, but is not particularly limited to terms used to describe the present invention, and the present invention can be variously changed or modified in embodiments at the level of a person having ordinary knowledge in the technical field to which the present invention pertains within a scope that does not depart from the technical spirit of the invention, and is not limited to the embodiments in the detailed description and claims of the present invention.

Claims

1. (S1) A step of performing cardiac computed tomography (CT) to obtain a CT image; (S2) A step of segmenting the heart and blood vessels based on the CT image, performing 3D modeling, and then creating a 3D printing file format; (S3) A method for optimizing percutaneous pulmonary valve implantation, characterized in that it comprises a step of producing an outflow tract model corresponding to the right ventricular outflow tract of a subject to be photographed by 3D printing using the above 3D printing file.

2. In paragraph 1, A method for optimizing percutaneous pulmonary valve implantation, further comprising, after step S3, a step S4 of connecting the effluent model to an extracorporeal simulated circulation device to perform extracorporeal simulated circulation.

3. In paragraph 2, A method for optimizing transcatheter pulmonary valve implantation, characterized in that the step S4 above inserts artificial valves of various sizes into specific positions in a model of an outflow tract connected to an extracorporeal circulatory device.

4. In paragraph 3, A method for optimizing transcatheter pulmonary valve implantation, characterized in that the specific locations where the artificial valve is inserted are the proximal part of the main pulmonary artery, the middle part of the main pulmonary artery, and the distal part of the main pulmonary artery.

5. In paragraph 3, A method for optimizing transcatheter pulmonary valve implantation, characterized in that the optimal size and insertion location of the artificial valve are determined by evaluating the displacement and movement of the artificial valve within the outflow tract model.

6. In paragraph 3, A method for optimizing transcatheter pulmonary valve implantation, characterized in that the size and insertion location of the artificial valve are varied according to the various sizes and shapes of the right ventricular outflow tract of each patient.

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