Closure device and design / manufacturing method of closure device

Abstract

To provide a closure device and a closure system capable of properly closing a hole or a duct by a shape adapted to various holes or ducts of individual patients.SOLUTION: A closure device 20 for closing a hole or duct in a tissue in the heart or in a tissue continuous to the heart, the closure device having a coupling part to which a delivery cable 12 is detachably coupled, the closure device being delivered to a treatment site through the inside of a catheter in a state of being coupled to the delivery cable, the closure device being rotatable with rotation of the delivery cable by coupling with the delivery cable. A first plate is formed into a shape adapted to a shape of the hole or duct in the tissue of an individual patient, and the first plate is provided with a marker 38 by which a rotational angle of the closure device can be confirmed with an examination device including ultrasonography.SELECTED DRAWING: Figure 23

Description

[Technical Field]

[0001] The present invention relates to a closure device for closing a congenital hole in the wall separating the atria, a patent ductus arteriosus, or an artificially created hole in the wall or blood vessel separating the atria, and to a method for designing and manufacturing the same. [Background technology]

[0002] In congenital heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, and patent foramen ovale, holes or open ductus arteriosus exist in tissues such as the atrial septum or pulmonary artery. Closure devices are used as instruments for closing holes or open ductus arteriosus. For example, Patent Document 1 discloses a method for closing holes using a mesh structure made by weaving metal wires. When the mesh structure is pushed out from a catheter inserted into the heart, it can expand into a disk shape inside the heart. [Prior art documents] [Patent documents]

[0003] Patent Document 1: Patent No. 6661539 [Non-patent literature]

[0004] Non-patent document 1: Zahid Amin, Echocardiographic Predictors of Cardiac Erosion After Amplatzer Septal Occluder Placement, Catheterization and Cardiovascular Interventions (2014) 83:84-92. Non-patent document 2: Tadaaki Abe; Shinya Tsukano; Yuko Tosaka, Pericardial tamponade due to erosion of a Figulla Flex II device after closure of an atrial septal defect, Catheter Cardiovasc Interv. (2019) 94:1003-1005. Non-patent document 3: Masataka Kitano; Satoshi Yazaki; Hisashi Sugiyama; Shin-ichi Ohtsuki; Hideshi Tomita, Risk Factors and Predictors of Cardiac Erosion Discovered from 12 Japanese Patients Who Developed Erosion After Atrial Septal Defect Closure Using Amplatzer Septal Occluder, Pediatric Cardiology (2020) 41:297-308. Non-patent document 4: Preetham Kumar; James L. Orford; Jonathan M. Tobis, Two cases of pericardial tamponade due to nitinol wire fracture of a gore septal occluder, Catheter Cardiovasc Interv. (2020) 96:219-224. Summary of the Invention [Problem to be solved by the invention]

[0005] When a mesh structure is used, the planar shape of the closure device is limited, so depending on the position and shape of the hole or open ductus arteriosus, it may be difficult to properly close them.

[0006] For example, Non-Patent Documents 1 to 4 present a case in which an Amplatzer septal occluder (hereinafter also referred to as ASO) was used to close a hole in an atrial septal defect. The ASO has a mesh structure formed by weaving metal wires. Non-Patent Documents 1 to 3 report mechanical damage (hereinafter also referred to as erosion) such as cardiac perforation occurring in tissue due to contact with the ASO. Non-Patent Document 4 reports that part of the metal wire in the mesh structure broke, causing erosion due to the broken metal wire. If bleeding or other issues occur due to erosion, there is a risk of cardiac tamponade. Cardiac tamponade is a condition in which the heart is unable to fully expand due to increased intrapericardial pressure caused by an increase in pericardial fluid.

[0007] The presently disclosed embodiments aim to provide a closure device and a method for manufacturing the same that can effectively solve such problems. [Means for solving the problem]

[0008] In order to achieve the above object, the first invention of the present application is 1. A closure device for closing an opening or vessel in the heart or tissue adjacent to the heart, comprising: The closure device comprises: a device having a coupling portion to which a delivery cable is detachably coupled, coupled to the delivery cable and carried to a treatment site through an interior of a catheter, the device being rotatable in accordance with the rotation of the delivery cable due to the coupling with the delivery cable; The garment comprises a resin base layer having elastic restoring force, a first plate including a first central portion and a first extension portion extending around the first central portion, and a first waist portion connected to the first central portion, The first plate is The closure device is characterized by being formed in a shape that matches the shape of the hole or duct in the tissue of an individual patient, and having a marker that allows the rotation angle of the closure device to be confirmed using an inspection device including an echo.

[0009] In one embodiment, the closure device is characterized in that an IC chip including a heart rate sensor and / or a power generation element that generates power using the movement of the heart is embedded inside.

[0010] In one embodiment, the closure device further comprises a second plate connected to the first waist portion, the second plate comprising a resin base layer having elastic resilience, a second central portion connected to the first waist portion, a second expansion portion extending around the second central portion, and a second waist portion connected to the second central portion, and the second plate is formed to a shape that matches the shape of the tissue hole or duct of an individual patient.

[0011] In order to achieve the above object, a second invention of the present application is a closure device operating device for rotating the closure device described above, The closure device operating device is characterized by comprising a delivery cable connected to the closure device and a handle for rotating the delivery cable.

[0012] In order to achieve the above object, a third invention of the present application is a method for designing the above-mentioned closure device, comprising: The shape and position of the holes or tubes in the tissue obtained from individual patients are input into a machine learning model trained using training data in which the shape and position of holes or tubes in the heart or the tissue connected to the heart is used as input information, and design information including the planar shape, thickness, and material of the closure device is used as output information, and the shape and position of the holes or tubes in the tissue obtained from individual patients is output as design information for the closure device to be used for the individual patient.

[0013] In order to further achieve the above object, a fourth invention of the present application is a method for manufacturing the above-mentioned closure device, wherein the design information of the closure device is the design information obtained by the design method according to claim 4, The closure device is characterized in that it is manufactured using the design information and a 3D printer. [Effects of the Invention]

[0014] According to the embodiments of the present disclosure, it is possible to provide a closure device that can appropriately close various holes or ducts of individual patients, and a method for designing and manufacturing such a closure device. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 10 is a diagram showing an example in which a vessel formed by the ductus arteriosus is formed between the aorta and the pulmonary artery. [Figure 2] FIG. 2 shows the ductus arteriosus of FIG. 1 being occluded by a closure device. [Figure 3] FIG. 1 illustrates an example of a closure device. [Figure 4] 10A-10C illustrate the elastic recovery of the closure device. [Figure 5] FIG. 3 is a diagram showing the first plate as viewed from the non-contact surface side. [Figure 6] 6 is a cross-sectional view of the first plate of FIG. 5 as viewed from the direction VI-VI. [Figure 7] 10A and 10B are diagrams showing examples of materials constituting the base layer of the first plate. [Figure 8] 10A and 10B are diagrams showing examples of materials constituting the fibers of the first plate. [Figure 9] 10A and 10B are diagrams showing examples of materials constituting the second surface layer of the first plate. [Figure 10] 10A-10C illustrate an example of a method for manufacturing a closure device. [Figure 11A] 1A-1C illustrate an example method for occluding the ductus arteriosus using a closure device. [Figure 11B] 1A-1C illustrate an example method for occluding the ductus arteriosus using a closure device. [Figure 11C] 1A-1C illustrate an example method for occluding the ductus arteriosus using a closure device. [Figure 11D] 1A-1C illustrate an example method for occluding the ductus arteriosus using a closure device. [Figure 12] FIG. 1 illustrates an example of a closed system. [Figure 13] FIG. 1 illustrates an example of a heart including an atrial septum with a hole formed therein. [Figure 14] FIG. 1 illustrates an example of a closure device. [Figure 15] 15 shows the hole in the atrial septum being closed by the closure device of FIG. 14. [Figure 16] FIG. 15 illustrates the dimensions of the closure device of FIG. 14. [Figure 17A] 1A-1C illustrate an example of a method for closing a hole using a closure device. [Figure 17B] 1A-1C illustrate an example of a method for closing a hole using a closure device. [Figure 17C] 1A-1C illustrate an example of a method for closing a hole using a closure device. [Figure 17D] 1A-1C illustrate an example of a method for closing a hole using a closure device. [Figure 18] FIG. 1 illustrates an example of a heart including an atrial septum with a hole formed therein. [Figure 19] 19 shows an example of a closure device for blocking the hole in FIG. 18. [Figure 20] 19 shows the hole in the atrial septum of FIG. 18 being closed by a closure device. [Figure 21] FIG. 10 illustrates the hole in the ventricular septum being closed by a closure device. [Figure 22] FIG. 1 illustrates an example of a closure device. [Figure 23] 10A and 10B show an example of a handle for operating the closure device. [Figure 24A] 10A-10C illustrate an example of how the closure device can be used. [Figure 24B] 10A-10C illustrate an example of how the closure device can be used. [Figure 24C] 10A-10C illustrate an example of how the closure device can be used. [Figure 24D] 10A-10C illustrate an example of how the closure device can be used. [Figure 25] FIG. 10 is a diagram illustrating an example of how to use the device. DETAILED DESCRIPTION OF THE INVENTION

[0016] A closure device according to the presently disclosed embodiment will be described in detail with reference to the drawings. The following embodiments are merely examples, and the presently disclosed embodiment should not be construed as being limited to these embodiments. In the drawings referred to in this embodiment, identical or similar reference numerals are used for identical parts or parts having similar functions, and repeated explanations may be omitted. For convenience of explanation, the dimensional ratios in the drawings may differ from the actual ratios, and some components may be omitted from the drawings.

[0017] (Closed System) Fig. 1 is a diagram showing an example of tissue related to heart disease. In the example shown in Fig. 1, the heart disease is patent ductus arteriosus. Patent ductus arteriosus is a condition in which the ductus arteriosus 73 connecting the aorta 71 and the pulmonary artery 72 is not closed and the ductus arteriosus 73 remains.

[0018] 2 illustrates how the ductus arteriosus 73 of FIG. 1 is treated with a closure system 10. The closure system 10 includes a catheter 11 that is inserted into the body and a closure device 20 that is delivered to the ductus arteriosus 73 via the catheter 11. The closure device 20 is configured to occlude the ductus arteriosus 73.

[0019] 3 is a diagram illustrating an example of a closure system 10. The closure system 10 may include a delivery cable 12 coupled to a closure device 20. By moving the delivery cable 12 inside the catheter 11, the closure device 20 can be moved inside the catheter 11 or pushed out from the catheter 11. After the closure device 20 is attached to the tissue of the heart 1, the delivery cable 12 is detached from the closure device 20.

[0020] The closure device 20 is inserted into the catheter 11 in a folded state and carried to the ductus arteriosus 73. After being carried to the ductus arteriosus 73 or the aorta 71, the closure device 20 is pushed out of the catheter 11 by the delivery cable 12. After being pushed out of the catheter 11, the closure device 20 can elastically restore to the unfolded state as shown in FIG.

[0021] (closing device) The closure device 20 will now be described in detail. The closure device 20 includes at least a first plate 30 that covers the arterial duct 73. The closure device 20 may include a waist portion 50 that is placed on the arterial duct 73. The waist portion 50 may include a coupling portion 51 that couples with the delivery cable 12. The coupling portion 51 includes, for example, a hole through which the delivery cable 12 is inserted. The hole of the coupling portion 51 may be formed with a structure that facilitates coupling with the delivery cable 12 and removal of the delivery cable 12. For example, a screw thread may be formed on the wall surface of the hole of the coupling portion 51.

[0022] (Plate 1) The first plate 30 will be described in detail. As shown in FIG. 3, the first plate 30 includes a contact surface 31 and a non-contact surface 32. The contact surface 31 is a surface that faces and comes into contact with tissue related to heart disease. In this embodiment, the contact surface 31 faces and comes into contact with the wall surface of the aorta 71. The non-contact surface 32 is a surface located opposite the contact surface 31.

[0023] The shape of the first plate 30 in a plan view will be described. "Plan view" means viewing the closure device 20 along the normal direction of the contact surface 31 or the non-contact surface 32. In the example shown in Fig. 3, the first plate 30 has a circular shape in a plan view. In the following description, the shape in a plan view will also be referred to as a planar shape.

[0024] As shown in FIG. 3 , the first plate 30 includes a first central portion 33 and a first extension portion 34 extending around the first central portion 33. The first central portion 33 is connected to the waist portion 50. The first central portion 33 may be integrally formed with the waist portion 50. "Integral" means that there is no interface between the two members. The first extension portion 34 contains a resin with elastic recovery. Elastic recovery refers to the property that the first extension portion 34 returns to a state extending around the first central portion 33 after being folded so that portions of the surfaces of the first extension portion 34 face each other. The first extension portion 34 may be integrally formed with the first central portion 33.

[0025] The elastic recovery property will be described with reference to FIG. First, as shown on the left side of FIG. 4, a force F1 is applied to the first plate 30. This bends the first extension portion 34 so that the contact surface 31 of the first portion 34a of the first extension portion 34 faces the contact surface 31 of the second portion 34b. The second portion 34b is located on the opposite side of the first portion 34a with respect to the center of the first central portion 33. In the example shown in FIGS. 3 and 4, the first portion 34a is located below the first central portion 33, and the second portion 34b is located above the first central portion 33. The symbol S in FIG. 4 represents the distance between the tip of the first portion 34a and the tip of the second portion 34b in the bent state. The distance S is, for example, B1 / 3. B1 is the maximum dimension of the contact surface 31 in a plan view. If the first plate 30 is circular, the maximum dimension B1 is the diameter of the first plate 30 as shown in FIG. 3. Next, the force F1 is removed from the first plate 30. As a result, the first plate 30 elastically returns to its expanded state, as shown on the right side of FIG. 4. In FIG. 4, θ1 represents the angle between the direction in which the first portion 34a expands and the direction in which the second portion 34b expands. In this application, the first expansion portion 34 is said to have elastic recovery when the angle θ1 is 135° or greater and 225° or less. The angle θ1 may be 150° or greater and 210° or less.

[0026] The direction in which the first portion 34a extends is determined by the direction in which the first portion 34a extends at the boundary between the first central portion 33 and the first portion 34a, as indicated by the symbol L1 in Fig. 4. Similarly, the direction in which the second portion 34b extends is determined by the direction in which the second portion 34b extends at the boundary between the first central portion 33 and the second portion 34b, as indicated by the symbol L2 in Fig. 4. The direction L1, the direction L2, and the angle θ1 are calculated, for example, by analyzing an image obtained by photographing the first plate 30 from the side.

[0027] The elastic recovery of the first expansion portion 34 can be achieved by various methods. For example, the elastic recovery can be achieved by appropriately setting the relationship between the thickness A1 (mm) of the first expansion portion 34 and the maximum dimension B1 (mm) of the first expansion portion 34 in a planar view. A1 / B1 is, for example, 1 / 50 or more, or may be 1 / 30 or more, or 1 / 20 or more. On the other hand, if the thickness A1 is too large, the first plate 30 becomes difficult to bend, and the transportability of the closure device 20 within the catheter 11 decreases. In consideration of this, A1 / B1 may be 1 / 3 or less, 1 / 5 or less, or 1 / 10 or less. As will be described later, the elastic recovery of the first expansion portion 34 may be achieved based on mechanical properties such as tensile strength.

[0028] As shown in Figure 4, the waist portion 50 has a maximum dimension T1 in a plan view when the first plate 30 is in an unfolded state. If the waist portion 50 is circular in a plan view, the maximum dimension T1 is the diameter of the waist portion 50.

[0029] As shown in FIG. 3, a plurality of protrusions 31a may be formed on the contact surface 31 of the first plate 30. By providing the protrusions 31a, the contact area of the contact surface 31 with the wall surface of the aorta 71 can be increased. This prevents the first plate 30 from coming off the tissue. The height, shape, distribution density, etc. of the protrusions 31a are set to enhance the adhesion of the first plate 30 to the tissue while preventing the protrusions 31a from damaging the tissue. The height of the protrusions 31a is, for example, 10 μm or more, or may be 100 μm or more, or may be 1 mm or more. The height of the protrusions 31a is, for example, 20 mm or less, or may be 10 mm or less, or may be 5 mm or less.

[0030] 3 and 4, the reference numeral 30e denotes the outer edge of the first plate 30. The outer edge 30e preferably does not include a hard material such as metal. For example, the outer edge 30e is preferably made of a resin such as a biocompatible material described below. This can prevent erosion of tissue due to contact with the outer edge 30e.

[0031] 3 and 4, the reference numeral 50e denotes the outer peripheral surface of the waist portion 50. The outer peripheral surface 50e preferably does not include a hard material such as metal. For example, the outer peripheral surface 50e is preferably made of a resin such as a biocompatible material described below. This can prevent erosion of tissue due to contact with the outer peripheral surface 50e.

[0032] Next, the structure of the non-contact surface 32 of the first plate 30 will be described. FIG. 5 is a diagram showing the first plate as viewed from the non-contact surface side. As shown in FIG. 5, a linearly extending reinforcing portion 35 may be formed on the non-contact surface 32. The reinforcing portion 35 protrudes from the non-contact surface 32. By providing the reinforcing portion 35, the elastic recovery of the first extension portion 34 can be improved. Although not shown, the reinforcing portion 35 may also be formed on the contact surface 31.

[0033] As shown in FIG. 5 , the reinforcing portion 35 may extend from the first central portion 33 toward the outer edge of the first plate 30. In other words, the reinforcing portion 35 may extend along the radial direction of the first plate 30. Although not shown, the reinforcing portion 35 may extend along other directions. For example, the reinforcing portion 35 may extend in a direction parallel to the outer edge of the first plate 30. Furthermore, the first plate 30 may include both a reinforcing portion 35 extending from the first central portion 33 toward the outer edge of the first plate 30 and a reinforcing portion 35 extending in a direction parallel to the outer edge of the first plate 30.

[0034] The width W1 of the reinforcing portion 35 is, for example, 1 mm or more, or may be 3 mm or more, or 5 mm or more. The width W1 of the reinforcing portion 35 is, for example, 20 mm or less, or may be 15 mm or less, or may be 10 mm or less.

[0035] Next, the layer structure of the first plate 30 will be described with reference to FIG. 6. The first plate 30 includes at least a base layer 63. The base layer 63 is a layer that occupies most of the first expansion portion 34 of the first plate 30. For example, the thickness of the base layer 63 is 50% or more of the overall thickness A1 of the first plate 30, and may be 60% or more, or even 70% or more. The elastic recovery of the first expansion portion 34 is mainly determined by the characteristics of the base layer 63.

[0036] The base layer 63 may include a biocompatible material with suitable elastic properties, such as fluororesin, polyester, polyamide, urethane, silicone, polyetherketone, or other biocompatible polymers and combinations thereof.

[0037] Examples of fluororesins include polytetrafluoroethylene (PTFE), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), and tetrafluoroethylene-ethylene copolymer (PVDF). Examples of polyesters are polyethylene terephthalate, polyester elastomers (TPEE), etc. Elastomers have the property of softening and becoming fluid when heated, and returning to a rubbery state when cooled. Examples of polyamides include PC12 and polyamide elastomer (TPAE). Urethane is a compound with a urethane bond formed by the reaction of alcohol and isocyanate. An example of a urethane is polyurethane elastomer (TPU). The silicone is, for example, silicone rubber (SR). An example of a polyetherketone is polyetheretherketone (PEEK). FIG. 7 shows examples of materials constituting the base layer 63 and the mechanical properties of each material.

[0038] As shown in FIG. 6, the first plate 30 may include a first surface layer 64 that constitutes the contact surface 31. The first surface layer 64 may be laminated on a base layer 63. Preferably, the first surface layer 64 is made of a biocompatible or biodegradable material. This can suppress the body's elimination reaction against the first plate 30. Preferably, the first surface layer 64 includes a fluororesin. This can increase the adhesion of the first plate 30 to the tissue.

[0039] Examples of biocompatible materials are the following biocompatible polymers: ePTFE (porous), PTFE and other fluororesins, polyamide, urethane polymer, PEEK Examples of biodegradable materials are the following biodegradable polymers: Lactide-co-caprolactone copolymer, ePTFE + [collagen / extracellular matrix]

[0040] 6, the first plate 30 may include a second surface layer 65 that forms the non-contact surface 32. The second surface layer 65 may be laminated on the base layer 63. Preferably, the second surface layer 65 is configured to have a small coefficient of friction with the catheter 11. This allows the closure device 20 to be transported smoothly inside the catheter 11.

[0041] For example, the second surface layer 65 may include fluoroplastics, polyesters, polyamides, urethanes, or other biocompatible polymers and combinations thereof.

[0042] Examples of fluororesins include ePTFE, PTFE, FEP, and ETFE. Examples of polyamides include PC12 and polyamide elastomer (TPAE). FIG. 8 shows examples of materials constituting the second surface layer 65 and the mechanical properties of each material.

[0043] 6, the reinforcing portion 35 may include bundles of fibers 66. The fibers 66 extend in the same direction as the reinforcing portion 35 in a plan view. The fibers 66 are embedded in the base layer 63, for example.

[0044] The fibers 66 preferably have a higher tensile strength than the base layer 63. Examples of the fibers 66 include carbon fibers, aramid fibers, polyparaphenylene benzobis oxazole, polyarylate, nylon, and ultra-high molecular weight polyethylene fibers. FIG. 9 shows examples of materials constituting the fibers 66 and the mechanical properties of each material.

[0045] The height H1 of the reinforcing portion 35 is, for example, 1 mm or more, or may be 3 mm or more, or 5 mm or more. The height H1 of the reinforcing portion 35 is, for example, 20 mm or less, or may be 15 mm or less, or may be 10 mm or less.

[0046] The preferred mechanical properties of the first extension portion 34 will be described. The tensile strength of the first extension portion 34 is, for example, 20 MPa or more, or may be 25 MPa or more, 30 MPa or more, 40 MPa or more, or 50 MPa or more. The tensile strength of the first extension portion 34 is, for example, 150 MPa or less, or may be 130 MPa or less, 100 MPa or less, or 80 MPa or less. The tensile breaking strain of the first expansion section 34 is, for example, 50% or more, or may be 80% or more, 100% or more, or 150% or more. The tensile breaking strain of the first expansion section 34 is, for example, 550% or less, or may be 450% or less, 400% or less, or may be 300% or less. The tensile strength and tensile breaking strain of the first extension portion 34 are measured in accordance with JIS K 7161. A sample for measurement is obtained by cutting out a portion of the first extension portion 34 along the direction from the first central portion 33 toward the outer edge of the first plate 30, as shown by the dashed line labeled 30S in FIG.

[0047] The layer configuration of the waist portion 50 may be entirely the same as, partially the same as, or different from, the layer configuration of the first plate 30. For example, the waist portion 50 may include a layer that is integrally formed from the same material as the base layer 63 of the first plate 30.

[0048] 6, the closure device 20 may include an IC chip 36 embedded in the resin of the closure device 20. The IC chip 36 may include, for example, a MEMS. The IC chip 36 has, for example, a sensor function. For example, the IC chip 36 can function as a heart rate sensor that electrically measures the movement of the heart 1. The IC chip 36 may have a radar function. For example, the IC chip 36 may include a transceiver that transmits and receives radio waves, thereby enabling the closure device 20 to detect objects around it. The IC chip 36 may have a function of detecting sound. For example, the IC chip 36 may include a sound pickup microphone that detects sound and a converter that converts the detected sound into an electrical signal. Embedding the IC chip 36 in resin can prevent the IC chip 36 from coming off the closure device 20. Data acquired by the IC chip 36 is transmitted to an external device by wireless communication or the like.

[0049] The IC chip 36 may include a power generating element 36a. The power generating element 36a generates power, for example, by utilizing the action of the heart 1. By using the power generating element 36a, the IC chip 36 can operate continuously for a long period of time.

[0050] (Method of manufacturing the closure device) Next, a method for manufacturing the closure device 20 will be described with reference to Fig. 10. First, a measurement step S1 is carried out to measure the shape and position of a hole or duct in tissue related to heart disease. For example, the shape and position of the ductus arteriosus 73 are measured by ultrasound or the like.

[0051] Next, a fabrication step is performed to fabricate the closure device 20 based on the information about the shape and position of the arterial duct 73. The fabrication step may include a step of designing and fabricating a portion of the closure device 20 in accordance with the measurement results of the shape and position of the arterial duct 73. For example, as shown in FIG. 10 , the fabrication step may include a first plate design step S2 and a first plate fabrication step S3. This makes it possible to provide a closure device 20 including a first plate 30 that is more suited to the individual case of a patient. Note that, for portions of the closure device 20 that are less dependent on the individual case, predetermined designs and prefabricated components may be used.

[0052] In the first plate design step S2, design information for the first expansion portion 34 may be generated based on the learning model. For example, the design information for the first expansion portion 34 can be obtained by inputting the shape and position of the arterial duct 73 acquired in the measurement step S1 into a computer equipped with the learning model. The design information includes at least one of the planar shape, thickness, and material of the first expansion portion 34. The design information may include two of the planar shape, thickness, and material of the first expansion portion 34. The design information may include the planar shape, thickness, and material of the first expansion portion 34.

[0053] The learning model of the first plate 30 can be obtained, for example, by training a computer using training data in which the shape and position of holes or vessels in the tissue of a patient with heart disease are input and the above-mentioned design information of the first expansion section 34 is output. Input to the learning model may further include other information such as the inner diameter of the catheter 11 and the friction coefficient of the catheter 11.

[0054] Input to the computer with the learning model may include physical characteristics of the patient, such as height and weight. Input to the computer with the learning model may also include information such as the patient's age and gender. The computer may predict future changes to tissues, such as the heart, and output design information. For example, if the input information determines that the patient is a child, the computer may predict growth that will occur in tissues, such as the heart, and output design information. This allows the closure device 20 to function properly even after the patient grows.

[0055] In the first plate fabrication step S3, the first plate 30 may be fabricated using a 3D printer, which allows the closure device 20 to be quickly fabricated based on the information acquired in the measurement step S1.

[0056] The fabrication process may include a waist portion design process and a waist portion fabrication process. The waist portion design process may generate design information for the waist portion 50 based on a learning model, similar to the first plate design process S2. In this case, the learning model may use information on the thickness of tissues such as the aorta 71 as input. The waist portion fabrication process may fabricate the waist portion 50 using a 3D printer, similar to the first plate fabrication process S3.

[0057] In treatment using conventional closure devices such as ASO, the appropriate closure device is selected for each patient based on the shape of the patient's heart defect. For example, assume that a lineup of conventional closure devices is available in 1mm diameter increments. If the diameter of the hole in the heart defect is 19.3mm, a closure device with a diameter of 20.0mm is used. In this case, erosion may occur due to the excess size of the closure device.

[0058] On the other hand, when the closure device 20 is produced using a 3D printer, the closure device 20 can have a shape that corresponds to the shape of the patient's heart disease. In other words, a custom-made closure device 20 can be provided. This prevents the closure device 20 from having excessive dimensions. This prevents defects such as erosion from occurring. The resolution of the 3D printer is, for example, 500 μm or less. This allows the dimensions of the closure device 20 to have an accuracy of 500 μm. The resolution of the 3D printer may be 300 μm or less, 100 μm or less, or 50 μm or less.

[0059] The manufacturing process, such as the first plate design process, may be realized by software running on a computer. For example, by installing a program on a computer, the computer may execute the first plate design process using a learning model.

[0060] The program may be pre-installed on the computer when the computer is shipped, or may be installed on the computer after the computer is shipped by using a computer-readable, non-transitory recording medium on which the program is recorded. The type of recording medium is not particularly limited, and various types are possible, such as portable recording media such as magnetic disks and optical disks, and fixed recording media such as hard disk drives and memories. The program may also be distributed via a communication line such as the Internet. When the program is distributed via a communication line, a recording medium on which the program according to this embodiment is stored is present, at least temporarily, on a distribution server.

[0061] (How to use the closure device) Next, a method of using the closure device 20 will be described with reference to FIGS. 11A to 11D.

[0062] First, the catheter 11 is inserted into the body. Next, as shown in FIG. 11A, the catheter 11 is advanced until the tip of the catheter 11 passes through the ductus arteriosus 73 and reaches the aorta 71. Next, the delivery cable 12 is attached to the waist portion 50 of the closure device 20, and the closure device 20 is inserted inside the catheter 11. Next, as shown in FIG. 11A, the closure device 20 is advanced to the vicinity of the tip of the catheter 11. The closure device 20 is positioned inside the catheter 11 with at least the first plate 30 folded.

[0063] 11A , when the closure device 20 is positioned inside the catheter 11, the waist portion 50 may be radially compressed by a force received from the inner wall of the catheter 11. The compressed waist portion 50 has a radial dimension smaller than the inner diameter of the catheter 11. The radial direction is the direction from the first central portion 33 toward the outer edge of the first expansion portion 34 when the first expansion portion 34 is expanded around the first central portion 33. After the closure device 20 is removed from the catheter 11, the waist portion 50 preferably has a radial dimension larger than the inner diameter of the catheter 11.

[0064] As the closure device 20 is further advanced, the first plate 30 of the closure device 20 is pushed out from the catheter 11, as shown in Fig. 11B. Then, as shown in Fig. 11C, the first expansion portion 34 elastically restores its shape so as to expand around the first central portion 33. Furthermore, the waist portion 50 is released from the force applied by the catheter 11, and is therefore able to expand radially.

[0065] Next, when the delivery cable 12 is pulled back, the contact surface 31 of the first plate 30 comes into contact with the wall of the aorta 71, as shown in FIG. 11D. The waist portion 50 also comes into contact with the wall of the ductus arteriosus 73. This allows the ductus arteriosus 73 to be occluded. The delivery cable 12 is then removed from the closure device 20. The catheter 11 and delivery cable 12 are then withdrawn from the body.

[0066] (Effects of this embodiment) In this embodiment, the first plate 30 of the closure device 20 includes a first expansion portion 34 containing a resin with elastic recovery. Therefore, the first plate 30 of the closure device 20, which is transported in a folded state, can elastically recover to its expanded state inside the body. This allows the first plate 30 to occlude the arterial duct 73. Furthermore, compared to conventional mesh structures, the first plate 30 offers greater flexibility in planar shape and is easier to fabricate. For example, a first plate 30 of a desired shape can be quickly created using a 3D printer. Therefore, it is easy to provide a first plate 30 suitable for various shapes of the arterial duct 73. This prevents erosion caused by excess dimensions of the closure device 20.

[0067] In this embodiment, cardiac disease such as the ductus arteriosus 73 can be occluded without using a metal wire mesh structure. Because the occlusion device 20 does not include a mesh structure, erosion caused by broken metal wires can be suppressed.

[0068] By suppressing erosion, the occurrence of dangerous conditions such as cardiac tamponade can be suppressed.

[0069] It should be noted that various modifications can be made to the above-described embodiment. Below, modifications will be described with reference to the drawings as necessary. In the following description and the drawings used in the following description, parts that can be configured similarly to the above-described embodiment will be designated by the same reference numerals as those used for the corresponding parts in the above-described embodiment, and duplicated explanations will be omitted. Furthermore, if it is clear that the effects obtained in the above-described embodiment can also be obtained in the modified embodiment, the explanations thereof may be omitted.

[0070] (Variations of the closed system) FIG. 12 is a diagram showing an example of a closure system 10. The catheter 11 has an inner diameter D1 (mm). The inner diameter D1 may be greater than 2×A1+T1, where A1 is the thickness of the first expansion portion 34 of the first plate 30. T1 is the maximum dimension of the waist portion 50 in a plan view. When the inner diameter D1 is greater than 2×A1+T1, the waist portion 50 is prevented from being compressed in the radial direction of the catheter 11. This reduces the friction between the inner wall of the catheter 11 and the closure device 20, allowing the closure device 20 to move easily inside the catheter 11. This allows the closure device 20 to be quickly delivered to body tissue.

[0071] (Variant of heart disease) In the above-described embodiment, an example has been shown in which the closure device 20 is used to treat patent ductus arteriosus. However, the cardiac disease for which the closure device 20 is used is not limited to patent ductus arteriosus. For example, the closure device 20 may be used to treat other cardiac diseases such as atrial septal defect, ventricular septal defect, and patent foramen ovale. FIG. 13 is a diagram showing an example of cardiac disease of the heart 1.

[0072] The heart 1 includes the left atrium 2, the right atrium 3, the atrial septum 4, the left ventricle 5, the right ventricle 6, and the ventricular septum 7, which are located inside the atrial wall 1a. The atrial septum 4 is located between the left atrium 2 and the right atrium 3. The ventricular septum 7 is located between the left ventricle 5 and the right ventricle 6. In the example shown in FIG. 13, a hole 4a is formed in the atrial septum 4. In other words, the heart disease occurring in the heart 1 is an atrial septal defect.

[0073] Fig. 14 is a diagram showing an example of the closure device 20. As shown in Fig. 14, the closure device 20 may include a second plate 40 connected to the waist portion 50, in addition to the first plate 30 and the waist portion 50. The second plate 40 is placed inside the heart 1 so as to sandwich the hole 4a in the atrial septum 4 between itself and the first plate 30. Fig. 15 is a diagram showing how the hole 4a in the atrial septum 4 is closed by the closure device 20 of Fig. 14.

[0074] 14 , the second plate 40 includes a contact surface 41 and a non-contact surface 42. The contact surface 41 faces the contact surface 31 of the first plate 30. The contact surface 41 may contact the atrial septum 4. The non-contact surface 42 is located on the opposite side of the contact surface 41.

[0075] 14 , the second plate 40 includes a second central portion 43 and a second extension portion 44 extending around the second central portion 43. The second central portion 43 is connected to the waist portion 50. The second central portion 43 may be formed integrally with the waist portion 50. The second extension portion 44 may be formed integrally with the second central portion 43.

[0076] The second expansion portions 44 contain a resin having elastic recovery properties, similar to the first expansion portions 34. Therefore, the second expansion portions 44 can return to a state in which the second expansion portions 44 are spread out around the second central portion 43 from a state in which the second expansion portions 44 are bent so that parts of the surfaces of the second expansion portions 44 face each other.

[0077] Figure 16 is a diagram illustrating the dimensions of the closure device 20 of Figure 14. The second extension portion 44 has a thickness A2 (mm). The second extension portion 44 has a maximum dimension B2 (mm) in a plan view. When the second plate 40 is circular, the maximum dimension B2 is the diameter of the second plate 40. A2 / B2 is, for example, 1 / 50 or more, or may be 1 / 30 or more, or 1 / 20 or more. A2 / B2 may be 1 / 3 or less, or 1 / 5 or less, or 1 / 10 or less.

[0078] The outer edge 40e of the second plate 40 preferably does not include a hard material such as metal. For example, the outer edge 40e is preferably made of a resin such as the biocompatible material described above. This can prevent erosion of tissue due to contact with the outer edge 40e.

[0079] The layer configuration of the second extension portion 44 may be the same as the layer configuration of the first extension portion 34. For example, the second extension portion 44 includes at least the above-described base layer 63. The second extension portion 44 may include the above-described first surface layer 64 that forms the contact surface 41. The second extension portion 44 may also include the above-described second surface layer 65 that forms the non-contact surface 42.

[0080] The preferred mechanical properties of the second extension portion 44 are the same as those of the first extension portion 34, and therefore a description thereof will be omitted.

[0081] Next, a method for manufacturing the closure device 20 of Fig. 14 will be described. In this modification, too, first, a measurement step S1 is carried out to measure the shape and position of the hole 4a in the tissue. At this time, the thickness of the tissue, for example, the thickness of the atrial septum 4, may also be measured.

[0082] Next, a manufacturing process is carried out to manufacture the closure device 20 based on the information about the shape and position of the hole 4a. The manufacturing process may include the first plate design process S2 and the first plate manufacturing process S3 described above. The manufacturing process may also include a second plate design process and a second plate manufacturing process.

[0083] In the second plate design step, similar to the first plate design step S2, design information for the second expansion portion 44 may be generated based on a learning model. For example, the design information for the second expansion portion 44 can be obtained by inputting the shape and position of the arterial duct 73 acquired in the measurement step S1 into a computer equipped with a learning model. The design information includes at least one of the planar shape, thickness, and material of the second expansion portion 44. The design information may include two of the planar shape, thickness, and material of the second expansion portion 44. The design information may include the planar shape, thickness, and material of the second expansion portion 44.

[0084] The learning model of the second plate 40 can be obtained, for example, by training a computer using training data in which the shape and position of holes or vessels in the tissue of a patient with heart disease are input and the above-mentioned design information of the second expansion section 44 is output. Input to the learning model may further include other information such as the inner diameter of the catheter 11 and the friction coefficient of the catheter 11.

[0085] In the second plate manufacturing step, the second plate 40 may be manufactured by a 3D printer, similar to the first plate manufacturing step S3.

[0086] The fabrication process may include a waist portion design process and a waist portion fabrication process. In the waist portion design process, design information for the waist portion 50 may be generated based on a learning model, similar to the first plate design process S2. In this case, the learning model may use information on the thickness of tissues such as the atrial septum 4 as input. In the waist portion fabrication process, the waist portion 50 may be fabricated using a 3D printer, similar to the first plate fabrication process S3.

[0087] 17A-17D, a method of using the closure device 20 of FIG. 14 will now be described.

[0088] First, the catheter 11 is inserted through a blood vessel in the groin, for example. Next, as shown in FIG. 17A, the catheter 11 is advanced until the tip of the catheter 11 passes through the hole 4a in the atrial septum 4 and reaches the left atrium 2. Furthermore, the delivery cable 12 is attached to the waist portion 50 of the closure device 20, and the closure device 20 is inserted inside the catheter 11. Next, as shown in FIG. 17A, the closure device 20 is advanced to the vicinity of the tip of the catheter 11. The closure device 20 is positioned inside the catheter 11 with the first plate 30 and the second plate 40 folded.

[0089] The inner diameter D1 of the catheter 11 may be greater than 2×A1+2×A2+T1. A1 is the thickness of the first expansion portion 34 of the first plate 30. A2 is the thickness of the second expansion portion 44 of the second plate 40. T1 is the maximum dimension of the waist portion 50 in a plan view. When the inner diameter D1 is greater than 2×A1+2×A2+T1, compression of the waist portion 50 in the radial direction of the catheter 11 can be suppressed. This reduces the frictional force between the inner wall of the catheter 11 and the closure device 20, allowing the closure device 20 to move easily inside the catheter 11.

[0090] As the closure device 20 is further advanced, the first plate 30 of the closure device 20 is pushed out of the catheter 11, as shown in Fig. 17B. Then, the first expansion portion 34 elastically recovers and expands around the first central portion 33, as shown in Fig. 17B.

[0091] Next, when the delivery cable 12 is pulled back, the contact surface 31 of the first plate 30 comes into contact with the atrial septum 4, as shown in FIG. 17C. Next, the catheter 11 is pulled back, and the second plate 40 is expelled from the catheter 11. Then, as shown in FIG. 17D, the second expansion portion 44 elastically restores its shape so as to expand around the second central portion 43. This allows the first plate 30 and the second plate 40 to sandwich the atrial septum 4. This allows the hole 4a in the atrial septum 4 to be more firmly sealed. Furthermore, the closure device 20 can be prevented from coming off the tissue.

[0092] The closure device 20 of this modification also has a higher degree of freedom in planar shape and is easier to fabricate than devices using conventional mesh structures. For example, the first plate 30 and the second plate 40 of desired shapes can be quickly created using a 3D printer. This makes it easy to provide first plates 30 and second plates 40 that are suitable for various shapes of the hole 4a in the atrial septum 4. This makes it possible to prevent erosion caused by excess dimensions of the closure device 20. Furthermore, because the closure device 20 does not include a mesh structure, it is possible to prevent erosion caused by broken metal wires.

[0093] (Variations of the closed system) Although not shown, the waist portion 50 of the closure device 20 including the first plate 30 and the second plate 40 may be compressed in the radial direction when the closure device 20 is positioned inside the catheter 11. That is, the inner diameter D1 of the catheter 11 may be smaller than 2×A1+2×A2+T1. In this case, similar to the example shown in FIG. 11D , the waist portion 50 of the closure device 20 may come into contact with the wall surface of the hole 4a after being pushed out of the catheter 11.

[0094] (Variations of hole positions) 18, a case will be described in which a hole 4a in the atrial septum 4 is close to the atrial wall 1a of the heart 1. When a conventional mesh structure closure device is used, a portion of the closure device comes into contact with the atrial wall 1a. This raises concerns that the closure device may not be able to properly close the hole 4a.

[0095] On the other hand, in the present application, the planar shape of the first plate 30 has a high degree of freedom, making it possible to provide, for example, a closure device 20 as shown in FIG. 19 . In the example shown in FIG. 19 , the first expansion portion 34 of the first plate 30 includes a first portion 34a and a second portion 34b having a shape asymmetrical with respect to the center of the first central portion 33 relative to the first portion 34a. For example, the first portion 34a is semicircular, and the second portion 34b has a shape in which a portion of an arc of the semicircle is cut parallel to the diameter. By processing the second portion 34b in this manner, as shown in FIG. 20 , contact between the first plate 30 and the atrial wall 1a of the heart 1 can be suppressed. This allows the closure device 20 to properly close the hole 4a. Furthermore, suppressing contact with the atrial wall 1a can suppress erosion of the atrial wall 1a.

[0096] 19, the symbols R1 and R2 respectively represent the dimensions of the first portion 34a and the second portion 34b in the direction in which they are aligned. The dimension R2 of the second portion 34b is smaller than the dimension R1 of the first portion 34a. For example, the dimension R2 is 9 / 10 or less of the dimension R1, or may be 8 / 10 or less, or may be 7 / 10 or less.

[0097] Like the first plate 30, the second plate 40 has a high degree of freedom in terms of its planar shape. As shown in FIG. 19, the second extension portion 44 of the second plate 40 may include a third portion 44a and a fourth portion 44b having a shape asymmetrical with respect to the center of the second central portion 43 relative to the third portion 44a. For example, the third portion 44a may be semicircular, and the fourth portion 44b may have a shape in which a portion of an arc of the semicircle is cut parallel to the diameter. By processing the fourth portion 44b in this manner, as shown in FIG. 20, contact between the second plate 40 and the atrial wall 1a of the heart 1 can be suppressed. This allows the closure device 20 to properly close the hole 4a. Furthermore, suppressing contact with the atrial wall 1a can suppress erosion of the atrial wall 1a.

[0098] (Variations of the manufacturing method of the closure device) Although the above embodiment illustrates an example in which the closure device 20 is designed based on a learning model, other methods may be used to design the closure device 20. For example, the closure device 20 may be designed by a person based on experience.

[0099] Although the above-described embodiment shows an example in which the closure device 20 is produced using a 3D printer, other methods may be used to produce the closure device 20. For example, the closure device 20 may be produced using a molding method such as sheet molding.

[0100] (Variant of heart disease) In the above-described embodiment, an example has been shown in which the closure device 20 is used to treat an atrial septal defect. However, the cardiac disease for which the closure device 20 is used is not limited to an atrial septal defect. For example, the closure device 20 may be used to treat other cardiac diseases such as a ventricular septal defect, a patent ductus arteriosus, and a patent foramen ovale. Figure 21 is a diagram showing an example in which the closure device 20 is used to close a hole 7a in the ventricular septum 7.

[0101] (Modifications of Closure Devices) FIG. 22 is a diagram illustrating an example of the closure device 20. The first plate 30 does not have rotational symmetry. For example, the closure device 20 includes a first portion 34a and a second portion 34b having a shape asymmetrical with respect to the center of the first central portion 33, similar to the example in FIG. 19. In this case, controlling the positions of the first portion 34a and the second portion 34b is required to properly seal the hole or vessel caused by the cardiac disease. To properly control the positions, it is necessary to monitor the positions of the first portion 34a and the second portion 34b while the closure device 20 is inserted inside the body.

[0102] In this modification, the first plate 30 includes a first marker 38. The first marker 38 is located, for example, on the first portion 34a. By detecting the first marker 38 using an echo or the like, the position of the first portion 34a can be determined when the closure device 20 is inserted inside the body. This allows, for example, the rotation angle of the first plate 30 to be calculated.

[0103] The first marker 38 may have any configuration as long as the position of the marker 38 can be detected from outside the body by an examination method such as ultrasound. For example, the first marker 38 may have a structure that protrudes from the surface of the first plate 30. Alternatively, the first marker 38 may have a structure that is recessed from the surface of the first plate 30. The first marker 38 may include a material, such as metal, that is different from the surrounding elements.

[0104] 23 is a diagram showing an example of a handle 80 for operating the closure device 20. The handle 80 includes a lever 81 for controlling the rotation angle of the closure device 20. For example, moving the lever 81 in a rotation direction A causes the closure device 20 to rotate in a rotation direction B. The rotation angle of the closure device 20 can be controlled by operating the lever 81 while monitoring the rotation angle of the closure device 20 using the marker 38.

[0105] Any driving mechanism may be used to rotate the closure device 20. For example, the closure device 20 may be rotated by rotating the delivery cable 12 or the catheter 11.

[0106] Although not shown, the closure device 20 may include multiple markers. For example, the first plate 30 may include a first marker 38 located on the first portion 34a and a second marker located on the second portion 34b. The first marker 38 and the second marker may have different shapes, dimensions, materials, etc. Alternatively, the first plate 30 may include twelve markers spaced equally around the circumference, similar to the hour marks on a watch.

[0107] 22 shows an example in which the first marker 38 is located on the contact surface 31 of the first plate 30. However, this is not limiting, and the first marker 38 may be located on the non-contact surface 32 of the first plate 30. The first marker 38 may be located on the contact surface 41 or non-contact surface 42 of the second plate 40.

[0108] Although not shown, an IC chip, a microactuator, a marker, etc. may be provided on a component of the closure system 10 other than the closure device 20. For example, the catheter 11, the delivery cable 12, etc. may include an IC chip, a microactuator, a marker, etc.

[0109] (Variations in the use of the closure device) In the above-described embodiment, an example has been shown in which the closure device 20 is delivered into the heart 1 via the catheter 11. However, the means for delivering the closure device 20 into the heart 1 is not limited to the catheter 11. For example, the heart 1 may be surgically incised, and the closure device 20 may be delivered into the heart 1 through the incision. In this case, the closure device 20 may be sutured to tissue using thread and needles. In this modification, the first expansion portion 34 has elastic recovery, so the closure device 20 can be passed through the incision site with the first expansion portion 34 folded. Furthermore, the elasticity of the first expansion portion 34 makes it easy to bring the first expansion portion 34 into close contact with the tissue. Furthermore, the first expansion portion 34 has a high degree of freedom in its planar shape, so it can appropriately close holes or ducts in tissue related to heart disease.

[0110] (Variations in the use of the closure device) In the above-described embodiment, an example has been shown in which the closure device 20 closes a hole or duct in tissue related to cardiac disease. However, the placement of the closure device 20 is not limited to a hole or duct in tissue related to cardiac disease. For example, the closure device 20 may be placed in a hole intentionally formed by surgery or the like. The hole may be formed in, for example, the heart or tissue connected to the heart. Examples of cardiac tissue include the left atrium, right atrium, atrial septum, left ventricle, right ventricle, and ventricular septum. Examples of tissue connected to the heart include the aorta, pulmonary artery, pulmonary veins, superior vena cava, and inferior vena cava.

[0111] 24A-24D, an example of a method of using the closure device 20 will be described.

[0112] First, catheter 11 is inserted through a blood vessel in the groin, for example. Next, as shown in FIG. 24A, catheter 11 is advanced until the tip of catheter 11 reaches atrial septum 4. Next, delivery cable 12 is attached to needle 13, and needle 13 is inserted into catheter 11. Needle 13 has a sharp tip. Next, as shown in FIG. 24B, needle 13 is advanced until needle 13 passes the tip of catheter 11 and penetrates atrial septum 4. This forms hole 4a in atrial septum 4.

[0113] Next, as shown in Fig. 24C, the needle 13 is withdrawn from the atrial septum 4. Additionally, the tip of the catheter 11 is inserted into the hole 4a in the atrial septum 4. Thereafter, as shown in Fig. 24D, the closure device 20 is advanced to the vicinity of the tip of the catheter 11. Next, as in the case of the above-described embodiment, the closure device 20 is pushed out from the catheter 11, and the first plate 30 is brought into contact with the atrial septum 4. In this manner, the closure device 20 can be placed in the hole 4a.

[0114] 24A to 24C. For example, needle 13 may be moved using a component other than delivery cable 12. For example, heart 1 may be surgically incised, and a hole may be formed in the cardiac tissue or tissue connected to the heart through the incision.

[0115] Additionally, the steps of forming a hole in the tissue of the heart or tissue connected to the heart and placing the closure device 20 in the hole may or may not be consecutive.

[0116] As in this modification, even when the closure device 20 is placed in an intentionally formed hole, design information for the first extension portion 34 may be generated based on a learning model. For example, the measuring step S1 may measure the shape and position of the intentionally formed hole. The first plate design step S2 obtains design information for the first extension portion 34 by inputting the shape and position of the hole acquired in the measuring step S1 into a computer equipped with a learning model. The design information includes at least one of the planar shape, thickness, and material of the first extension portion 34. The design information may include two of the planar shape, thickness, and material of the first extension portion 34. The design information may include the planar shape, thickness, and material of the first extension portion 34.

[0117] Although not shown, the closure device 20 of FIG. 14 , which includes a first plate 30 and a second plate 40, may be placed in an intentionally formed hole. In this case, design information for the second extension portion 44 may be generated based on a learning model. For example, the measuring step S1 may measure the shape and position of the intentionally formed hole. In the second plate design step, the design information for the second extension portion 44 can be obtained by inputting the shape and position of the hole acquired in the measuring step S1 into a computer equipped with a learning model. The design information includes at least one of the planar shape, thickness, and material of the second extension portion 44. The design information may also include two of the planar shape, thickness, and material of the second extension portion 44. The design information may also include the planar shape, thickness, and material of the second extension portion 44.

[0118] The closure device 20 placed in cardiac tissue or tissue connected to the heart can perform various functions. For example, if the closure device 20 includes an IC chip 36, the closure device 20 can perform the functions of the IC chip 36. For example, if the IC chip 36 includes a sensor such as a heart rate sensor, the closure device 20 can function as a sensor such as a heart rate sensor in the cardiac tissue or tissue connected to the heart. As described above, the IC chip 36 may have a radar function, a sound detection function, or the like. As described above, the IC chip 36 may include a power generation element 36a.

[0119] (Variations in the use of the closure device) In the above-described embodiment, an example has been shown in which the closure device 20 is placed in a hole or a tube in the heart or tissue connected to the heart. However, the placement of the closure device 20 is not limited to a hole or a tube. The closure device 20 may be placed in any position in the heart or tissue connected to the heart. For example, as shown in FIG. 25 , the closure device 20 may be placed in the atrial septum 4. In this case, the closure device 20 does not perform the function of blocking a hole or a tube, and therefore the closure device 20 may be simply referred to as the device 20.

[0120] The device 20 placed in the heart or tissue connected to the heart can perform various functions. For example, if the device 20 includes an IC chip 36, the device 20 can perform the functions of the IC chip 36. For example, if the IC chip 36 includes a sensor such as a heart rate sensor, the device 20 can function as a sensor such as a heart rate sensor in the heart tissue or tissue connected to the heart. As described above, the IC chip 36 may have a radar function, a sound detection function, or the like. As described above, the IC chip 36 may include a power generation element 36a.

[0121] Although several modifications of the above-described embodiment have been described, it is of course possible to combine a plurality of modifications as appropriate. [Explanation of symbols]

[0122] 1. Heart 1a atrial wall 2 left atrium 3 Right atrium 4 Atrial septum 4a hole 5 left ventricle 6 Right ventricle 7 Ventricular septum 7a hole 8. Inferior vena cava 10 Closure System 11 Catheter 12 Delivery cable 13 needles 20 Closure Device 30 Plate 1 31 Contact surface 31a protrusion 32 Non-contact surface 33 1st Central Section 34 First Extension 34a Part 1 34b Part 2 35 Reinforcement 36 IC chip 36a Power generating element 38 Markers 40 Second Plate 41 Contact surface 42 Non-contact surface 43 2nd central part 44 Second Extension 50 Waist 51 Joint 63 Base Layer 64 1st surface layer 65 2nd surface layer 66 Fiber 71 Aorta 72 Pulmonary artery 73 Ductus arteriosus 80 Handle 81 Lever

Claims

1. 1. A closure device for closing an opening or vessel in the heart or tissue adjacent to the heart, comprising: The closure device comprises: a device having a coupling portion to which a delivery cable is detachably coupled, coupled to the delivery cable and carried to a treatment site through an interior of a catheter, the device being rotatable in accordance with the rotation of the delivery cable due to the coupling with the delivery cable; The garment comprises a resin base layer having elastic restoring force, a first plate including a first central portion and a first extension portion extending around the first central portion, and a first waist portion connected to the first central portion, The first plate is a marker formed in a shape that matches the shape of the hole or duct in the tissue of an individual patient, and capable of confirming the rotation angle of the closure device using an inspection device including an echo; A closure device characterized in that:

2. The closing device has an IC chip embedded therein, the IC chip including a heart rate sensor and / or a power generation element that generates power using the movement of the heart. The closure device of claim 1 .

3. The closure device further comprises a second plate connected to the first waist portion, the second plate comprising a resin base layer having elastic restoring force, a second central portion connected to the first waist portion, a second extension portion extending around the second central portion, and a second waist portion connected to the second central portion, the second plate being formed to a shape that matches the shape of the tissue opening or canal of an individual patient. The closure device of claim 1 .

4. A closure device operating device for rotating the closure device according to any one of claims 1 to 3, The closure device operating device includes a delivery cable connected to the closure device and a handle for rotating the delivery cable. A closure device operating apparatus.

5. A method for designing the closure device according to any one of claims 1 to 3, comprising the steps of: The shape and position of the hole or tube in the tissue obtained from an individual patient are input into a machine learning model trained using training data in which the shape and position of the hole or tube in the tissue connected to the heart or the heart is used as input information, and design information including the planar shape, thickness, and material of the closure device is used as output information, and the shape and position of the hole or tube in the tissue obtained from an individual patient are output. A method for designing a closure device.

6. 4. The method for manufacturing the closure device according to claim 1, wherein the design information of the closure device is the design information obtained by the design method according to claim 3. The closure device is manufactured using the design information and a 3D printer.

10. A method for manufacturing an occlusive device, comprising:

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