Manufacturing Method of a Closure System and a Closure Device

Abstract

A closure system equipped with a catheter having an inner diameter D1 [mm] and a closure device that is moved to a hole or duct in tissue via the catheter. The closure device is equipped with a first plate comprising a first center section and a first expansion section that expands along the periphery of the first center section and includes a resin having elastic recovery properties, and is further equipped with a waist section connected to the first center section. The first expansion section has a thickness A1 [mm]. The waist section has a maximum dimension T1 [mm] when seen in plan view. The inner diameter D1 of the catheter is greater than 2×A1+T1.

Description

Technical Field

[0001] The embodiments of the present disclosure relate to a closure system including a closure device for closing a hole or a tube in the heart or a tissue connected to the heart. The embodiments of the present disclosure also relate to a method for manufacturing the closure device.

Background Art

[0002] In heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, and patent foramen ovale, holes or tubes are formed in tissues such as the atrial septum and pulmonary artery. A closure device is used as an instrument for closing the hole or tube. For example, Patent Document 1 discloses a method for closing a hole using a mesh structure formed by knitting metal wires. When the mesh structure is extruded from a catheter inserted into the heart, it can expand into a disk shape within the heart.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Non-Patent Documents

[0004]

Non-Patent Document 1

Non-Patent Document 2

Non-Patent Document 3

Non-Patent Document 4

Disclosure of the Invention

[0005] When using a mesh structure, the planar shape of the closure device is restricted. Therefore, depending on the position and shape of the hole or tube, it may be difficult to properly close the hole or tube in some cases.

[0006] For example, Non-Patent Documents 1 to 4 introduce cases where the hole of an atrial septal defect was closed using an Amplatzer septal occluder (hereinafter also referred to as ASO). ASO includes 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 tissues due to contact with ASO. Non-Patent Document 4 reports that a part of the metal wire of the mesh structure was damaged, and erosion occurred due to the damaged metal wire. If bleeding or the like occurs due to erosion, there is a risk of causing cardiac tamponade. Cardiac tamponade is a state in which the intracardiac pressure rises due to an increase in the pericardial fluid of the heart, and the heart cannot expand sufficiently.

[0007] An aspect of the present disclosure aims to provide a closure device and a closure system that can effectively solve such problems.

[0008] An aspect of the present disclosure is a closure system for closing a hole or a tube in the heart or a tissue connected to the heart, a catheter having an inner diameter D1 [mm], and a closure device carried to the hole or tube of the tissue through the catheter, and the closure device includes a first plate including a first central portion and a first expansion portion that spreads around the first central portion and includes a resin having elastic restorability, and a waist portion connected to the first central portion, the elastic restorability is a characteristic that the first expansion portion returns from a state in which the first expansion portion is bent so that a part of the surfaces of the first expansion portion face each other to a state in which the first expansion portion spreads around the first central portion, the first expansion portion has a thickness A1 [mm], the waist portion has a maximum dimension T1 [mm] in plan view, and the inner diameter D1 of the catheter is larger than 2×A1 + T1, which is a closure system.

[0009] In the closed system according to the embodiment of the present disclosure, the first extension portion has a maximum dimension B1 [mm] in a plan view, A1 / B1 may be 1 / 50 or more.

[0010] In the closed system according to the embodiment of the present disclosure, the first plate is a base layer that spreads around the first central portion, and may include a base layer containing a fluororesin, a polyester, a polyamide, a urethane, a silicone, or a polyether ketone. The thickness of the base layer may be 50% or more of the thickness A1 of the entire first plate.

[0011] In the closed system according to the embodiment of the present disclosure, the first extension portion may have a tensile strength of 20 MPa or more and 150 MPa or less.

[0012] In the closed system according to the embodiment of the present disclosure, the first extension portion may include, in a plan view, a first portion and a second portion having a shape asymmetric with respect to the first portion with respect to the center of the first central portion.

[0013] The closing device of the closed system according to the embodiment of the present disclosure may include a second plate connected to the waist portion. The second plate may include a second central portion connected to the waist portion and a second extension portion that spreads around the second central portion and contains a resin having elastic resilience.

[0014] In the closed system according to the embodiment of the present disclosure, the second extension portion has a thickness A2 [mm]. The inner diameter D1 of the catheter may be larger than 2×A1 + 2×A2 + T1.

[0015] The closing device of the closed system according to the embodiment of the present disclosure may include an IC chip embedded in a resin.

[0016] In the closed system according to the embodiment of the present disclosure, the IC chip may include a heartbeat sensor.

[0017] In the closed system according to the embodiment of the present disclosure, the IC chip may include a power generation element that generates power by utilizing the operation of the heart.

[0018] In the closed system according to the embodiment of the present disclosure, the first plate may include a surface layer containing a fluororesin.

[0019] In the closed system according to the embodiment of the present disclosure, the first plate may include a plurality of protrusions located on the contact surface facing the tissue.

[0020] In the closed system according to the embodiment of the present disclosure, the first extension portion may include a reinforcing portion extending linearly.

[0021] In the closed system according to the embodiment of the present disclosure, the holes or tubes of the tissue are related to heart diseases, and the heart diseases may be atrial septal defect, ventricular septal defect, patent ductus arteriosus or patent foramen ovale.

[0022] The closed system according to the embodiment of the present disclosure may include a handle for operating the closing device.

[0023] In the closed system according to the embodiment of the present disclosure, the closing device may include a marker provided on the first plate, The handle may include a lever for controlling the rotation angle of the first plate.

[0024] The embodiment of the present disclosure is a method for manufacturing a closing device for closing a hole or a tube in the heart or a tissue connected to the heart, The closing device includes a first plate that covers the hole or the tube, The first plate includes a first central portion and a first extension portion that extends around the first central portion and includes a resin having elastic restorability. The elastic resilience is a characteristic in which the first expansion part returns from a state in which the first expansion part is bent so that a part of the surface of the first expansion part faces each other to a state in which the first expansion part spreads around the first central part. The manufacturing method includes a manufacturing step of manufacturing a closing device based on information regarding the shape and position of the holes or tubes of the tissue. The manufacturing step includes a first plate design step of inputting the shape and position of the holes or tubes of the acquired tissue into a learning model learned using teacher data in which the shape and position of the holes or tubes of the tissue are input and design information including the planar shape, thickness, and material of the first expansion part is output, to output the design information of the first expansion part. It is a manufacturing method of a closing device.

[0025] In the manufacturing method according to the embodiment of the present disclosure, the holes or tubes of the tissue are related to heart diseases, and the first plate design step inputs the shape and position of the holes or tubes of the tissue of a patient having a heart disease, and uses teacher data in which design information including the planar shape, thickness, and material of the first expansion part is output. The shape and position of the holes or tubes of the acquired tissue may be input into the learned learning model to output the design information of the first expansion part.

[0026] In the manufacturing method according to the embodiment of the present disclosure, the manufacturing step may include a first plate manufacturing step of manufacturing the first plate by a 3D printer.

[0027] In the manufacturing method according to the embodiment of the present disclosure, the first expansion part may have a thickness A1 [mm] and a maximum dimension B1 [mm] in a plan view. A1 / B1 may be 1 / 50 or more.

[0028] In the manufacturing method according to the embodiment of the present disclosure, the first plate may include a fluororesin, polyester, polyamide, urethane, silicone, or polyether ketone.

[0029] In the manufacturing method according to the embodiment of the present disclosure, the closing device may include a waist portion connected to the first central portion and a second plate connected to the waist portion. The second plate may include a second central portion connected to the waist portion and a second expansion portion that spreads around the second central portion and includes a resin having elastic resilience. The manufacturing process may include a second plate design process in which the shape and position of the hole or tube of the tissue of a patient having heart disease are input into a learning model trained using teacher data that outputs design information including the planar shape, thickness, and material of the second expansion portion, and the shape and position of the hole or tube of the acquired tissue are input to output the design information of the second expansion portion.

[0030] In the manufacturing method according to the embodiment of the present disclosure, the closing device may include an IC chip embedded in a resin.

[0031] In the manufacturing method according to the embodiment of the present disclosure, the IC chip may include a heart rate sensor.

[0032] In the manufacturing method according to the embodiment of the present disclosure, the IC chip may include a power generation element that generates power using the operation of the heart.

[0033] According to the embodiment of the present disclosure, a closing device and a closing system that can appropriately close various holes or tubes can be provided.

Brief Description of Drawings

[0034]

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DETAILED DESCRIPTION OF THE INVENTION

[0035] The closure device according to the embodiment of the present disclosure will be described in detail with reference to the drawings. Note that the following embodiments are examples, and the embodiments of the present disclosure are not construed as being limited to these embodiments. In the drawings referred to in the present embodiment, the same parts or parts having the same function are denoted by the same reference numerals or similar reference numerals, and the repeated description thereof may be omitted. Also, the dimensional ratios in the drawings may be different from the actual ratios for convenience of explanation, and a part of the configuration may be omitted from the drawings.

[0036] (Closure 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 state in which the ductus arteriosus 73 connecting the aorta 71 and the pulmonary artery 72 is not closed and the ductus arteriosus 73 remains.

[0037] FIG. 2 is a diagram showing how the ductus arteriosus 73 in FIG. 1 is treated by the closure system 10. The closure system 10 includes a catheter 11 inserted into the body and a closure device 20 carried to the ductus arteriosus 73 through the catheter 11. The closure device 20 is configured to block the ductus arteriosus 73.

[0038] FIG. 3 is a diagram showing an example of the closure system 10. The closure system 10 may include a delivery cable 12 coupled to the 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 of the catheter 11. After the closure device 20 is attached to the tissue of the heart 1, the delivery cable 12 is removed from the closure device 20.

[0039] The closure device 20 is inserted into the catheter 11 in a folded state and carried to the ductus arteriosus 73. After the closure device 20 is carried to the ductus arteriosus 73 or the aorta 71, it is pushed out of the catheter 11 by the delivery cable 12. After the closure device 20 is pushed out of the catheter 11, it can elastically restore to the expanded state as shown in FIG. 3.

[0040] (Closure Device) The closure device 20 will 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 installed 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 into which the delivery cable 12 is inserted. A structure may be formed in the hole of the coupling portion 51 to facilitate the coupling with the delivery cable 12 and the removal of the delivery cable 12. For example, a thread may be formed on the wall surface of the hole of the coupling portion 51.

[0041] (First Plate) 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 contacts the tissue related to heart disease. In the present embodiment, the contact surface 31 faces and contacts the wall surface of the aorta 71. The non-contact surface 32 is a surface located on the opposite side of the contact surface 31.

[0042] The shape of the first plate 30 in plan view will be described. "Plan view" means looking at 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 plan view. In the following description, the shape in plan view is also referred to as the planar shape.

[0043] As shown in FIG. 3, the first plate 30 includes a first central portion 33 and a first expansion portion 34 that spreads 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. "Integrally" means that there is no interface between the two members. The first expansion portion 34 includes a resin having elastic restorability. Elastic restorability means the property that the first expansion portion 34 returns from a state in which a part of the surface of the first expansion portion 34 is bent so as to face each other to a state in which the first expansion portion 34 spreads around the first central portion 33. The first expansion portion 34 may be integrally formed with the first central portion 33.

[0044] Referring to FIG. 4, the elastic resilience will be described. First, as shown on the left side of FIG. 4, a force F1 is applied to the first plate 30. As a result, the first expansion part 34 is bent so that the contact surfaces 31 of the first part 34a and the second part 34b of the first expansion part 34 face each other. The second part 34b is located on the side opposite to the first part 34a with respect to the center of the first central part 33. In the examples shown in FIGS. 3 and 4, the first part 34a is located below the first central part 33, and the second part 34b is located above the first central part 33. The symbol S in FIG. 4 represents the distance between the tip of the first part 34a and the tip of the second part 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. When the first plate 30 is circular, the maximum dimension B1 is the diameter of the first plate 30 as shown in FIG. 3. Subsequently, the force F1 is removed from the first plate 30. As a result, as shown on the right side of FIG. 4, the first plate 30 elastically restores to the expanded state. In FIG. 4, θ1 represents the angle formed by the direction in which the first part 34a expands and the direction in which the second part 34b expands. In the present application, when the angle θ1 is 135° or more and 225° or less, it is said that the first expansion part 34 has elastic resilience. The angle θ1 may be 150° or more and 210° or less.

[0045] The direction in which the first part 34a expands is defined by the direction in which the first part 34a expands at the boundary between the first central part 33 and the first part 34a, as indicated by the symbol L1 in FIG. 4. Similarly, the direction in which the second part 34b expands is defined by the direction in which the second part 34b expands at the boundary between the first central part 33 and the second part 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.

[0046] The elastic resilience of the first expansion part 34 can be realized by various methods. For example, by appropriately setting the relationship between the thickness A1 [mm] of the first expansion part 34 and the maximum dimension B1 [mm] of the first expansion part 34 in a plan view, the elastic resilience can be realized. A1 / B1 is, for example, 1 / 50 or more, may be 1 / 30 or more, and may be 1 / 20 or more. On the other hand, if the thickness A1 is too large, it becomes difficult to bend the first plate 30, and the transportability of the closing device 20 in the catheter 11 decreases. Considering this point, A1 / B1 may be 1 / 3 or less, may be 1 / 5 or less, and may be 1 / 10 or less. As will be described later, the elastic resilience of the first expansion part 34 may be realized based on mechanical properties such as tensile strength.

[0047] As shown in FIG. 4, the waist part 50 has a maximum dimension T1 in a plan view in a state where the first plate 30 is expanded. When the waist part 50 is circular in a plan view, the maximum dimension T1 is the diameter of the waist part 50

[0048] 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. For this reason, it is possible to suppress the first plate 30 from coming off the tissue. The height, shape, distribution density, etc. of the protrusions 31a are set so as to enhance the adhesion of the first plate 30 to the tissue while suppressing the protrusions 31a from damaging the tissue. The height of the protrusions 31a is, for example, 10 μm or more, may be 100 μm or more, and may be 1 mm or more. The height of the protrusions 31a is, for example, 20 mm or less, may be 10 mm or less, and may be 5 mm or less.

[0049] In FIGS. 3 and 4, reference numeral 30e represents the outer edge of the first plate 30. The outer edge 30e preferably does not contain a hard material such as metal. For example, it is preferable that the outer edge 30e is made of a resin such as a biocompatible material described later. Thereby, it is possible to suppress erosion from occurring in the tissue due to contact with the outer edge 30e.

[0050] In FIGS. 3 and 4, reference numeral 50e represents the outer peripheral surface of the waist portion 50. The outer peripheral surface 50e preferably does not contain a hard material such as metal. For example, the outer peripheral surface 50e is preferably composed of a resin such as a biocompatible material described later. Thereby, it is possible to suppress the occurrence of erosion in the tissue due to contact with the outer peripheral surface 50e.

[0051] Next, the structure of the non-contact surface 32 of the first plate 30 will be described. FIG. 5 is a view showing the first plate when 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 resilience of the first expansion portion 34 can be enhanced. Although not shown, the reinforcing portion 35 may be formed on the contact surface 31.

[0052] 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. Further, 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.

[0053] The width W1 of the reinforcing portion 35 is, for example, 1 mm or more, and may be 3 mm or more, or may be 5 mm or more. Also, the width W1 of the reinforcing portion 35 is, for example, 20 mm or less, and may be 15 mm or less, or may be 10 mm or less.

[0054] Next, with reference to FIG. 6, the layer structure of the first plate 30 will be described. The first plate 30 includes at least a base layer 63. The base layer 63 is a layer that occupies most of the first extension portion 34 of the first plate 30. For example, the thickness of the base layer 63 is 50% or more of the total thickness A1 of the first plate 30, and may be 60% or more, or may be 70% or more. The elastic resilience of the first extension portion 34 is mainly determined by the characteristics of the base layer 63.

[0055] The base layer 63 includes a biocompatible material having appropriate elastic properties. For example, the base layer 63 includes a fluororesin, a polyester, a polyamide, a urethane, a silicone, a polyether ketone, or other biocompatible polymers and combinations thereof.

[0056] Examples of fluororesins are polytetrafluoroethylene (PTFE), tetrafluoroethylene - hexafluoropropylene copolymer (FEP), tetrafluoroethylene - ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), etc. Examples of polyesters are polyethylene terephthalate, polyester - based elastomer (TPEE), etc. An elastomer is a material that softens and shows fluidity when heated and returns to a rubbery state when cooled. Examples of polyamides are PC12, polyamide - based elastomer (TPAE), etc. Urethane is a compound having a urethane bond formed by the reaction of an alcohol and an isocyanate. Examples of urethanes are polyurethane - based elastomer (TPU), etc. Silicone is, for example, silicone rubber (SR), etc. Examples of polyether ketones are polyether ether ketone (PEEK), etc. Examples of the materials constituting the base layer 63 and the mechanical properties of each material are shown in FIG. 7.

[0057] As shown in FIG. 6, the first plate 30 may include a first surface layer 64 that constitutes a contact surface 31. The first surface layer 64 may be laminated on the base layer 63. Preferably, the first surface layer 64 is made of a material having biocompatibility or biodegradability. Thereby, the rejection reaction of the living body against the first plate 30 can be suppressed. Preferably, the first surface layer 64 contains a fluororesin. Thereby, the adhesion of the first plate 30 to the tissue can be enhanced.

[0058] Examples of materials having biocompatibility are the following biocompatible polymers. ePTFE (porous body), fluororesins such as PTFE, polyamide, urethane-based polymers, PEEK Examples of materials having biodegradability are the following biodegradable polymers. Lactide-caprolactam copolymer, ePTFE + [collagen - extracellular matrix]

[0059] As shown in FIG. 6, the first plate 30 may include a second surface layer 65 that constitutes a 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 such that the coefficient of friction with the catheter 11 is small. Thereby, the conveyance of the closing device 20 inside the catheter 11 can be performed smoothly.

[0060] For example, the second surface layer 65 contains a fluororesin, polyester, polyamide, urethane, or other biocompatible polymers and combinations thereof.

[0061] Examples of fluororesins are ePTFE, PTFE, FEP, ETFE, etc. Examples of polyamides are PC12, polyamide-based elastomers (TPAE), etc. Examples of the material constituting the second surface layer 65 and the mechanical properties of each material are shown in FIG. 8.

[0062] As shown in FIG. 6, the reinforcing portion 35 may include a bundle of fibers 66. The fibers 66 extend along the direction in which the reinforcing portion 35 extends in a plan view. The fibers 66 are embedded in the base layer 63, for example.

[0063] The fibers 66 preferably have a tensile strength higher than that of the base layer 63. Examples of the fibers 66 include carbon fibers, aramid fibers, polyparaphenylene benzobisoxazole, polyarylate, nylon, ultra-high molecular weight polyethylene fibers, and the like. Examples of the material constituting the fibers 66 and the mechanical properties of each material are shown in FIG. 9.

[0064] The height H1 of the reinforcing portion 35 is, for example, 1 mm or more, and may be 3 mm or more, or may be 5 mm or more. Also, the height H1 of the reinforcing portion 35 is, for example, 20 mm or less, and may be 15 mm or less, or may be 10 mm or less.

[0065] The preferable mechanical properties of the first expansion portion 34 will be described. The tensile strength of the first expansion portion 34 is, for example, 20 MPa or more, and may be 25 MPa or more, may be 30 MPa or more, may be 40 MPa or more, or may be 50 MPa or more. Also, the tensile strength of the first expansion portion 34 is, for example, 150 MPa or less, and may be 130 MPa or less, may be 100 MPa or less, or may be 80 MPa or less. The tensile fracture strain of the first expansion portion 34 is, for example, 50% or more, and may be 80% or more, may be 100% or more, or may be 150% or more. Also, the tensile fracture strain of the first expansion portion 34 is, for example, 550% or less, and may be 450% or less, may be 400% or less, or may be 300% or less. The tensile strength and the tensile fracture strain of the first expansion portion 34 are measured in accordance with JIS K 7161. A sample for measurement is obtained, for example, by cutting out a part of the first expansion portion 34 along the direction from the first central portion 33 toward the outer edge of the first plate 30 as indicated by the dashed-dotted line labeled 30S in FIG. 5.

[0066] The layer structure of the waist portion 50 may be entirely the same as, partially the same as, or different from the layer structure of the first plate 30. For example, the waist portion 50 may include a layer integrally formed of the same material as the base layer 63 of the first plate 30.

[0067] As shown in FIG. 6, the closing device 20 may include an IC chip 36 embedded in the resin of the closing device 20. The IC chip 36 includes, for example, MEMS. The IC chip 36 has, for example, a sensor function. For example, the IC chip 36 can function as a heartbeat 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, an object around the closing device 20 can be detected. 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. By embedding the IC chip 36 in the resin, it is possible to prevent the IC chip 36 from coming off the closing device 20. The data acquired by the IC chip 36 is transmitted to an external device by wireless communication or the like.

[0068] The IC chip 36 may include a power generation element 36a. The power generation element 36a generates power by using, for example, the operation of the heart 1. By using the power generation element 36a, the IC chip 36 can operate continuously over a long period of time.

[0069] (Method for manufacturing a closing device) Next, with reference to FIG. 10, a method for manufacturing the closing device 20 will be described. First, a measurement step S1 of measuring the shape and position of the holes or tubes in the tissue related to heart disease is performed. For example, the shape and position of the arterial tube 73 are measured by echocardiography or the like.

[0070] Subsequently, a manufacturing process for manufacturing the closure device 20 is performed based on the information regarding the shape and position of the arterial duct 73. The manufacturing process may include a process of designing and manufacturing a part of the closure device 20 according to the measurement results of the shape and position of the arterial duct 73. For example, as shown in FIG. 10, the manufacturing process may include a first plate design step S2 and a first plate manufacturing step S3. Thereby, a closure device 20 including a first plate 30 suitable for an individual case of a patient can be provided. For parts of the closure device 20 with low dependence on individual cases, predetermined designs or pre-manufactured members may be used.

[0071] In the first plate design step S2, design information of the first extension portion 34 may be generated based on a learning model. For example, 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 of the first extension portion 34 can be obtained. The design information includes at least any one of the planar shape, thickness, or material of the first extension portion 34. The design information may include any two of the planar shape, thickness, or material of the first extension portion 34. The design information may include the planar shape, thickness, and material of the first extension portion 34.

[0072] The first plate 30 learning model can be obtained, for example, by causing a computer to learn using teacher data in which the shape and position of the holes or ducts of the tissue of a patient with heart disease are input and the above-described design information of the first extension portion 34 is output. The 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.

[0073] The input to the computer equipped with the learning model may include the patient's physical characteristics such as height and weight. The input to the computer equipped with the learning model may include information such as the patient's age and gender. The computer may predict changes that will occur in the future in tissues such as the heart and output design information. For example, when it is determined from the input information that the patient is a child, the computer may predict the growth that will occur in tissues such as the heart and output design information. Thereby, the closure device 20 can function properly even after the patient grows.

[0074] In the first plate manufacturing step S3, the first plate 30 may be manufactured by a 3D printer. Thereby, the closure device 20 can be quickly manufactured based on the information obtained in the measurement step S1.

[0075] The manufacturing process may include a waist part design process and a waist part manufacturing process. The waist part design process may generate design information for the waist part 50 based on the 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 an input. The waist part manufacturing process may manufacture the waist part 50 by a 3D printer, similar to the first plate manufacturing step S3.

[0076] In the treatment using a conventional closure device such as ASO, a closure device suitable for the patient is selected according to the shape of the patient's heart disease. For example, assume that the lineup of conventional closure devices prepares a closure device for each 1 mm of diameter. When the diameter of the hole of the heart disease is 19.3 mm, a closure device having a diameter of 20.0 mm is used. That is, an off-the-shelf closure device is used. In this case, erosion may occur due to the excess dimensions of the closure device.

[0077] On the one hand, when manufacturing the closure device 20 by a 3D printer, the closure device 20 can have a shape corresponding to the shape of the patient's heart disease. That is, a customized closure device 20 can be provided. Thereby, it is possible to suppress the closure device 20 from having excessive dimensions. For this reason, it is possible to suppress the occurrence of problems such as erosion. The resolution of the 3D printer is, for example, 500 μm or less. Thereby, the dimensions of the closure device 20 can have an accuracy of 500 μm. The resolution of the 3D printer may be 300 μm or less, may be 100 μm or less, or may be 50 μm or less.

[0078] Manufacturing processes such as the first plate design process may be realized by software operating on a computer. For example, by installing a program in a computer, the computer may execute the first plate design process that utilizes a learning model.

[0079] The program may be pre-installed in the computer at the time of shipment of the computer, or may be installed in the computer by using a non-transitory computer-readable recording medium on which the program is recorded after the shipment of the computer. The type of the recording medium is not particularly limited, and various types such as portable recording media such as magnetic disks and optical disks, and fixed recording media such as hard disk devices and memories can be considered. The program may also be distributed via a communication line such as the Internet. When the program is distributed via a communication line, there is at least temporarily a recording medium storing the program according to the present embodiment in the server for distribution.

[0080] (Method of using the closure device) Next, with reference to FIGS. 11A to 11D, a method of using the closure device 20 will be described.

[0081] First, the catheter 11 is inserted into the body. Subsequently, as shown in FIG. 11A, the catheter 11 is advanced until the tip of the catheter 11 reaches the aorta 71 beyond the arterial duct 73. Further, the delivery cable 12 is attached to the waist portion 50 of the closure device 20, and the closure device 20 is inserted into the catheter 11. Subsequently, 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 being bent.

[0082] As shown in FIG. 11A, when the closure device 20 is positioned inside the catheter 11, the waist portion 50 may be compressed radially by the force received from the inner wall of the catheter 11. The compressed waist portion 50 has a dimension smaller than the inner diameter of the catheter 11 in the radial direction. The radial direction is the direction from the first central portion 33 toward the outer edge of the first expansion portion 34 in a state where the first expansion portion 34 extends around the first central portion 33. The waist portion 50 after being taken out from the catheter 11 preferably has a dimension larger than the inner diameter of the catheter 11 in the radial direction.

[0083] When the closure device 20 is further advanced, as shown in FIG. 11B, the first plate 30 of the closure device 20 is pushed out from the catheter 11. Then, as shown in FIG. 11C, the first expansion portion 34 elastically restores so as to expand around the first central portion 33. Also, since the waist portion 50 is released from the force received from the catheter 11, it can expand in the radial direction.

[0084] Subsequently, when the delivery cable 12 is pulled back, as shown in FIG. 11D, the contact surface 31 of the first plate 30 contacts the wall surface of the aorta 71. Also, the waist portion 50 contacts the wall surface of the arterial duct 73. Thereby, the arterial duct 73 can be blocked. Thereafter, the delivery cable 12 is removed from the closure device 20. Also, the catheter 11 and the delivery cable 12 are pulled out from the body.

[0085] (Effect of the present embodiment) In this embodiment, the first plate 30 of the closing device 20 includes a first expansion portion 34 containing a resin having elastic resilience. Therefore, the first plate 30 of the closing device 20 conveyed in a bent state can elastically return to a state of expanding inside the body. For this reason, the arterial duct 73 can be blocked by the first plate 30. Further, compared with the case of using a conventional mesh structure, the degree of freedom in the planar shape is high and the production is easy. For example, the first plate 30 having a desired shape can be quickly created using a 3D printer. Therefore, the first plate 30 suitable for various shapes of the arterial duct 73 can be easily provided. Thereby, erosion caused by the excess dimensions of the closing device 20 can be suppressed.

[0086] In this embodiment, without using a mesh structure of a metal wire, a heart disease such as the arterial duct 73 can be blocked. Since the closing device 20 does not include a mesh structure, erosion caused by a broken metal wire can be suppressed.

[0087] By suppressing erosion, a dangerous state such as cardiac tamponade can be suppressed.

[0088] It should be noted that various changes can be made to the above-described embodiment. Hereinafter, modification examples will be described with reference to the drawings as necessary. In the following description and the drawings used in the following description, the same reference numerals as those used for the corresponding parts in the above-described embodiment will be used for the parts that can be configured in the same manner as the above-described embodiment, and the overlapping description will be omitted. Further, when it is clear that the operational effects obtained in the above-described embodiment can also be obtained in the modification example, the description thereof may be omitted.

[0089] (Modification Example of Closing System) FIG. 12 is a diagram showing an example of the closing system 10. The catheter 11 has an inner diameter D1 [mm]. The inner diameter D1 may be larger than 2×A1 + T1. A1 is the thickness of the first extension 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 larger than 2×A1 + T1, it is possible to suppress the waist portion 50 from being compressed in the radial direction of the catheter 11. Thereby, the frictional force between the inner wall of the catheter 11 and the closing device 20 can be reduced, so that the closing device 20 can easily move inside the catheter 11. For this reason, the closing device 20 can be quickly transported to the body tissue.

[0090] (Modified example of heart disease) In the above-described embodiment, an example of treating patent ductus arteriosus using the closing device 20 was shown. However, the heart diseases in which the closing device 20 is used are not limited to patent ductus arteriosus. For example, other heart diseases such as atrial septal defect, ventricular septal defect, and patent foramen ovale may be treated using the closing device 20. FIG. 13 is a diagram showing an example of a heart disease of the heart 1.

[0091] The heart 1 includes a left atrium 2, a right atrium 3, an atrial septum 4, a left ventricle 5, a right ventricle 6, and a ventricular septum 7 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. That is, the heart disease occurring in the heart 1 is atrial septal defect.

[0092] FIG. 14 is a diagram showing an example of the closing device 20. As shown in FIG. 14, the closing 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 disposed inside the heart 1 so as to sandwich the hole 4a of the atrial septum 4 between the second plate 40 and the first plate 30. FIG. 15 is a diagram showing a state in which the hole 4a of the atrial septum 4 is blocked by the closing device 20 of FIG. 14.

[0093] As shown in FIG. 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 a surface located on the opposite side of the contact surface 41.

[0094] As shown in FIG. 14, the second plate 40 includes a second central portion 43 and a second expansion portion 44 that spreads 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 integrally formed with the waist portion 50. The second expansion portion 44 may be integrally formed with the second central portion 43.

[0095] Similar to the first expansion portion 34, the second expansion portion 44 includes a resin having elastic resilience. Therefore, the second expansion portion 44 can return from a state in which the second expansion portion 44 is bent so that a part of the surface of the second expansion portion 44 faces each other to a state in which the second expansion portion 44 spreads around the second central portion 43.

[0096] FIG. 16 is a diagram for explaining the dimensions of the closure device 20 in FIG. 14. The second expansion portion 44 has a thickness A2 [mm]. The second expansion portion 44 has a maximum dimension B2 [mm] in 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, may be 1 / 30 or more, and may be 1 / 20 or more. A2 / B2 may be 1 / 3 or less, may be 1 / 5 or less, and may be 1 / 10 or less.

[0097] It is preferable that the outer edge 40e of the second plate 40 does not contain a hard material such as metal. For example, it is preferable that the outer edge 40e is made of a resin such as the above-described biocompatible material. Thereby, it is possible to suppress erosion of the tissue due to contact with the outer edge 40e.

[0098] The layer structure of the second extension portion 44 may be the same as that 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 constitutes the contact surface 41. Further, the second extension portion 44 may include the above-described second surface layer 65 that constitutes the non-contact surface 42.

[0099] Since the preferred mechanical properties of the second extension portion 44 are the same as those of the first extension portion 34, the description thereof is omitted.

[0100] Next, a method for manufacturing the closure device 20 of FIG. 14 will be described. Also in this modification, first, a measurement step S1 of measuring the shape and position of the holes 4a in the tissue is performed. At this time, the thickness of the tissue, for example, the thickness of the atrial septum 4, may be further measured.

[0101] Subsequently, based on the information regarding the shape and position of the holes 4a, a manufacturing step of manufacturing the closure device 20 is performed. The manufacturing step may include the above-described first plate design step S2 and first plate manufacturing step S3. Further, the manufacturing step may include a second plate design step and a second plate manufacturing step.

[0102] Similar to the first plate design step S2, the second plate design step may generate design information of the second extension portion 44 based on a learning model. For example, 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 of the second extension portion 44 can be obtained. The design information includes at least any one of the planar shape, thickness, or material of the second extension portion 44. The design information may include any two of the planar shape, thickness, or material of the second extension portion 44. The design information may include the planar shape, thickness, and material of the second extension portion 44.

[0103] The learning model of the second plate 40 can be obtained, for example, by training a computer using teacher data that inputs the shape and position of holes or tubes in the tissue of a patient with heart disease and outputs the above-described design information of the second extension portion 44. The 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.

[0104] Similar to the first plate manufacturing step S3, the second plate manufacturing step may manufacture the second plate 40 using a 3D printer.

[0105] The manufacturing process may include a waist portion design process and a waist portion manufacturing process. Similar to the first plate design step S2, the waist portion design process may generate design information of the waist portion 50 based on the learning model. In this case, the learning model may use information on the thickness of tissues such as the atrial septum 4 as an input. Similar to the first plate manufacturing step S3, the waist portion manufacturing process may manufacture the waist portion 50 using a 3D printer.

[0106] Next, with reference to FIGS. 17A to 17D, a method of using the closure device 20 of FIG. 14 will be described.

[0107] First, insert the catheter 11 from a blood vessel at the groin or the like. Subsequently, as shown in FIG. 17A, advance the catheter 11 until the tip of the catheter 11 reaches the left atrium 2 beyond the hole 4a in the atrial septum 4. Also, attach the delivery cable 12 to the waist portion 50 of the closure device 20 and insert the closure device 20 into the catheter 11. Subsequently, as shown in FIG. 17A, advance the closure device 20 to the vicinity of the tip of the catheter 11. The closure device 20 is located inside the catheter 11 with the first plate 30 and the second plate 40 being bent.

[0108] The inner diameter D1 of the catheter 11 may be larger than 2×A1 + 2×A2 + T1. A1 is the thickness of the first extension portion 34 of the first plate 30. A2 is the thickness of the second extension portion 44 of the second plate 40. T1 is the maximum dimension of the waist portion 50 in plan view. When the inner diameter D1 is larger than 2×A1 + 2×A2 + T1, it is possible to suppress the waist portion 50 from being compressed in the radial direction of the catheter 11. Thereby, the frictional force between the inner wall of the catheter 11 and the closing device 20 can be reduced, so that the closing device 20 can easily move inside the catheter 11.

[0109] When the closing device 20 is further advanced, as shown in FIG. 17B, the first plate 30 of the closing device 20 is pushed out from the catheter 11. Then, as shown in FIG. 17B, the first extension portion 34 elastically restores so as to expand around the first central portion 33.

[0110] Subsequently, when the delivery cable 12 is pulled back, as shown in FIG. 17C, the contact surface 31 of the first plate 30 contacts the atrial septum 4. Subsequently, the catheter 11 is pulled back to discharge the second plate 40 from the catheter 11. Then, as shown in FIG. 17D, the second extension portion 44 elastically restores so as to expand around the second central portion 43. Thereby, the atrial septum 4 can be sandwiched between the first plate 30 and the second plate 40. Therefore, the hole 4a of the atrial septum 4 can be more firmly blocked. In addition, it is possible to suppress the closing device 20 from coming off the tissue.

[0111] The closing device 20 of this modification also has a higher degree of freedom in planar shape and is easier to manufacture than in the case of using a conventional mesh structure. For example, the first plate 30 and the second plate 40 having a desired shape can be quickly created using a 3D printer. Therefore, the first plate 30 and the second plate 40 suitable for various shapes of the hole 4a of the atrial septum 4 can be easily provided. Thereby, it is possible to suppress erosion caused by the excess dimensions of the closing device 20. In addition, since the closing device 20 does not include a mesh structure, it is possible to suppress erosion caused by broken metal wires.

[0112] (Modification example of the closed system) Although not shown, the waist portion 50 of the closing device 20 including the first plate 30 and the second plate 40 may be compressed in the radial direction when the closing device 20 is located 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 closing device 20 after being pushed out from the catheter 11 may contact the wall surface of the hole 4a.

[0113] (Modification example of the position of the hole) As shown in FIG. 18, the case where the hole 4a in the atrial septum 4 is close to the atrial wall 1a of the heart 1 will be described. When using a closing device with a conventional mesh structure, a part of the closing device contacts the atrial wall 1a. For this reason, there is a concern that the closing device may not properly block the hole 4a.

[0114] On the other hand, in the present application, since the degree of freedom of the planar shape of the first plate 30 is high, for example, the closing device 20 shown in FIG. 19 can be provided. In the example shown in FIG. 19, the first extension portion 34 of the first plate 30 includes a first portion 34a and a second portion 34b having a shape asymmetric with respect to the first portion 34a with respect to the center of the first central portion 33. For example, the first portion 34a is semicircular, and the second portion 34b has a shape obtained by cutting a part of the arc of the semicircle parallel to the diameter. By processing the second portion 34b in this way, as shown in FIG. 20, it is possible to suppress the first plate 30 from contacting the atrial wall 1a of the heart 1. For this reason, the closing device 20 can properly block the hole 4a. In addition, by suppressing contact with the atrial wall 1a, it is possible to suppress erosion from occurring on the atrial wall 1a.

[0115] In FIG. 19, reference numerals R1 and R2 respectively represent the dimensions of both in the direction in which the first portion 34a and the second portion 34b are arranged. The dimension R2 of the second portion 34b is smaller than the dimension R1 of the first portion 34a. For example, the dimension R2 may be 9 / 10 or less of the dimension R1, may be 8 / 10 or less, or may be 7 / 10 or less.

[0116] Similar to the first plate 30, the degree of freedom in the planar shape of the second plate 40 is also high. 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 asymmetric with respect to the third portion 44a with respect to the center of the second central portion 43. For example, the third portion 44a is semicircular, and the fourth portion 44b has a shape in which a part of the arc of the semicircle is cut off parallel to the diameter. By processing the fourth portion 44b in this way, as shown in FIG. 20, it is possible to suppress the second plate 40 from contacting the atrial wall 1a of the heart 1. For this reason, the closing device 20 can appropriately close the hole 4a. Further, by suppressing contact with the atrial wall 1a, it is possible to suppress the occurrence of erosion on the atrial wall 1a.

[0117] (Modification example of the manufacturing method of the closing device) In the above-described embodiment, an example of designing the closing device 20 based on the learning model has been shown, but the closing device 20 may be designed using other methods. For example, a person may design the closing device 20 based on experience.

[0118] Further, in the above-described embodiment, an example of manufacturing the closing device 20 by a 3D printer has been shown, but the closing device 20 may be manufactured using other methods. For example, the closing device 20 may be manufactured by a molding method such as sheet molding.

[0119] (Modification example of heart disease) In the above-described embodiment, an example of treating atrial septal defect using the closing device 20 has been shown. However, the heart diseases for which the closing device 20 is used are not limited to atrial septal defect. For example, other heart diseases such as ventricular septal defect, patent ductus arteriosus, and patent foramen ovale may be treated using the closing device 20. FIG. 21 is a diagram showing an example of closing the hole 7a of the ventricular septum 7 using the closing device 20.

[0120] (Modification example of the closing device) FIG. 22 is a diagram showing an example of the closing device 20. The first plate 30 does not have rotational symmetry. For example, similar to the example of FIG. 19, the closing device 20 includes a first portion 34a and a second portion 34b having a shape asymmetric with respect to the first portion 34a about the center of the first central portion 33. In this case, in order to appropriately close the hole or tube of the heart disease, it is required to control the positions of the first portion 34a and the second portion 34b. In order to appropriately perform the control, it is required to monitor the positions of the first portion 34a and the second portion 34b when the closing device 20 is inserted into the body.

[0121] 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 grasped when the closing device 20 is inserted into the body. Thereby, for example, the rotation angle of the first plate 30 can be calculated.

[0122] As long as the position of the marker 38 can be detected from the outside of the body by an inspection method such as an echo, the configuration of the first marker 38 is arbitrary. For example, the first marker 38 may have a structure protruding from the surface of the first plate 30. Alternatively, the first marker 38 may have a structure recessed from the surface of the first plate 30. The first marker 38 may contain a material different from surrounding elements, such as metal.

[0123] FIG. 23 is a diagram showing an example of a handle 80 for operating the closing device 20. The handle 80 includes a lever 81 for controlling the rotation angle of the closing device 20. For example, when the lever 81 is moved in the rotation direction A, the closing device 20 can rotate in the rotation direction B. By operating the lever 81 while monitoring the rotation angle of the closing device 20 using the marker 38, the rotation angle of the closing device 20 can be controlled.

[0124] The drive mechanism for rotating the closure device 20 is optional. For example, the closure device 20 may be rotated by rotating the delivery cable 12 or the catheter 11.

[0125] Although not shown, the closure device 20 may include a plurality of markers. For example, the first plate 30 may include a second marker located in the second portion 34b in addition to the first marker 38 located in the first portion 34a. The first marker 38 and the second marker may include different shapes, dimensions, materials, etc. Alternatively, the first plate 30 may include 12 markers arranged at equal intervals over a full circle, similar to the hour marks of a clock.

[0126] In FIG. 22, an example where the first marker 38 is located on the contact surface 31 of the first plate 30 is shown. However, it is not limited to this, 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 the non-contact surface 42 of the second plate 40.

[0127] Although not shown, an IC chip, a micro actuator, a marker, etc. may be provided on components 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 micro actuator, a marker, etc.

[0128] (Modification of the method of using the closure device) In the above-described embodiment, an example of transporting the closure device 20 into the heart 1 via the catheter 11 is shown. However, the means for transporting the closure device 20 to 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 transported into the heart 1 through the incision site. In this case, the closure device 20 may be sutured to the tissue using a thread and a needle. In this modification example, since the first expansion part 34 has elastic resilience, the closing device 20 can be passed through the incision in the state where the first expansion part 34 is bent. Further, it is easy to make the first expansion part 34 adhere closely to the tissue by utilizing the elasticity of the first expansion part 34. Further, since the degree of freedom of the planar shape of the first expansion part 34 is high, the holes or tubes of the tissue related to heart diseases can be appropriately blocked.

[0129] (Modification example of the method of using the closing device) In the above-described embodiment, an example in which the closing device 20 closes the holes or tubes of the tissue related to heart diseases has been shown. However, the arrangement of the closing device 20 is not limited to the holes or tubes of the tissue related to heart diseases. For example, the closing device 20 may be arranged in a hole intentionally formed by surgery or the like. The hole is formed, for example, in the heart or the tissue connected to the heart. The tissues of the heart are the left atrium, the right atrium, the atrial septum, the left ventricle, the right ventricle, the ventricular septum, and the like. The tissues connected to the heart are the aorta, the pulmonary artery, the pulmonary vein, the superior vena cava, the inferior vena cava, and the like.

[0130] With reference to FIGS. 24A to 24D, an example of the method of using the closing device 20 will be described.

[0131] First, the catheter 11 is inserted from a blood vessel at the groin or the like. Subsequently, as shown in FIG. 24A, the catheter 11 is advanced until the tip of the catheter 11 reaches the atrial septum 4. Further, the delivery cable 12 is attached to the needle 13, and the needle 13 is inserted into the catheter 11. The needle 13 has a sharp tip. Subsequently, as shown in FIG. 24B, the needle 13 is advanced until the needle 13 penetrates the atrial septum 4 beyond the tip of the catheter 11. Thereby, a hole 4a is formed in the atrial septum 4.

[0132] Subsequently, as shown in FIG. 24C, the needle 13 is withdrawn from the atrial septum 4. Also, the tip of the catheter 11 is inserted into the hole 4a of the atrial septum 4. Then, as shown in FIG. 24D, the closing device 20 is advanced to the vicinity of the tip of the catheter 11. Subsequently, in the same manner as in the above-described embodiment, the closing 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 way, the closing device 20 can be disposed in the hole 4a.

[0133] Note that the method of forming a hole in the heart tissue or the tissue connected to the heart is not limited to the methods shown in FIGS. 24A to 24C. For example, the needle 13 may be moved using components other than the delivery cable 12. For example, the heart 1 may be surgically incised, and a hole may be formed in the heart tissue or the tissue connected to the heart through the incision site.

[0134] Also, the step of forming a hole in the heart tissue or the tissue connected to the heart and the step of disposing the closing device 20 in the hole may or may not be continuous.

[0135] Even when the closing device 20 is disposed in an intentionally formed hole as in this modification example, the design information of the first expansion portion 34 may be generated based on the learning model. For example, the measurement step S1 may measure the shape and position of the intentionally formed hole. In the first plate design step S2, the design information of the first expansion portion 34 can be obtained by inputting the shape and position of the hole acquired in the measurement step S1 into a computer equipped with a learning model. The design information includes at least any one of the planar shape, thickness, or material of the first expansion portion 34. The design information may include any two of the planar shape, thickness, or material of the first expansion portion 34. The design information may include the planar shape, thickness, and material of the first expansion portion 34.

[0136] Although not shown in the drawings, the closing device 20 of FIG. 14 including the first plate 30 and the second plate 40 may be disposed in a hole formed intentionally. In this case, the design information of the second extension portion 44 may be generated based on the learning model. For example, the measurement step S1 may measure the shape and position of the hole formed intentionally. The second plate design step can obtain the design information of the second extension portion 44 by inputting the shape and position of the hole acquired in the measurement step S1 into a computer equipped with a learning model. The design information includes at least any one of the planar shape, thickness, or material of the second extension portion 44. The design information may include any two of the planar shape, thickness, or material of the second extension portion 44. The design information may include the planar shape, thickness, and material of the second extension portion 44.

[0137] The closing device 20 disposed in the tissue of the heart or the tissue continuous with the heart can perform various functions. For example, when the closing device 20 includes the IC chip 36, the closing device 20 can perform the functions of the IC chip 36. For example, when the IC chip 36 includes a sensor such as a heartbeat sensor, the closing device 20 can function as a sensor such as a heartbeat sensor in the tissue of the heart or the tissue continuous with the heart. As described above, the IC chip 36 may have functions such as a radar function and a function of detecting sound. As described above, the IC chip 36 may include the power generation element 36a.

[0138] (Modification of the method of using the closing device) In the above-described embodiment, an example in which the closing device 20 is disposed in a hole or a tube of the heart or the tissue continuous with the heart is shown. However, the arrangement of the closing device 20 is not limited to the hole or the tube. The closing device 20 may be disposed at any position of the heart or the tissue continuous with the heart. For example, as shown in FIG. 25, the closing device 20 may be disposed in the atrial septum 4. In this case, since the closing device 20 does not perform the function of closing the hole or the tube, the closing device 20 may simply be referred to as the device 20.

[0139] A device 20 disposed in the heart or tissue connected to the heart can perform various functions. For example, when the device 20 includes an IC chip 36, the device 20 can perform the functions of the IC chip 36. For example, when the IC chip 36 includes a sensor such as a heartbeat sensor, the device 20 can function as a sensor such as a heartbeat sensor in the heart tissue or tissue connected to the heart. As described above, the IC chip 36 may have functions such as a radar function and a function of detecting sound. As described above, the IC chip 36 may include a power generation element 36a.

[0140] Although some modifications to the above-described embodiments have been described, it is of course possible to appropriately combine and apply a plurality of modifications.

Explanation of Reference Numerals

[0141] 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 Needle 20 Closure device 30 First plate 31 Contact surface 31a Protrusion 32 Non-contact surface 33 First central part 34 First expansion part 34a First part 34b Second part 35 Reinforcement part 36 IC chip 36a Power generation element 38 Marker 40 Second plate 41 Contact surface 42 Non-contact surface 43 Second central part 44 Second expansion part 50 Waist part 51 Coupling part 63 Base layer 64 First surface layer 65 Second surface layer 66 Fiber 71 Aorta 72 Pulmonary artery 73 Ductus arteriosus 80 Handle 81 Lever

Claims

1. A method for manufacturing a closure device for closing a hole or a tube in the heart or a tissue connected to the heart, The closure device includes a first plate that covers the hole or the tube, The first plate includes a first central portion and a first extension portion that extends around the first central portion and includes a resin having elastic resilience, The elastic resilience is a characteristic that the first extension portion returns from a state in which the first extension portion is bent so that a part of the surface of the first extension portion faces each other to a state in which the first extension portion spreads around the first central portion, The manufacturing method includes a manufacturing step of manufacturing a closure device based on information regarding the shape and position of the hole or the tube of the tissue, The manufacturing step includes inputting the shape and position of the hole or the tube of the tissue, and inputting the shape and position of the hole or the tube of the acquired tissue into a learning model learned using teacher data having an output of design information including the planar shape, thickness, and material of the first extension portion, and outputting the design information of the first extension portion. The manufacturing step includes a first plate design step, The closure device includes a waist portion connected to the first central portion and a second plate connected to the waist portion, The second plate includes a second central portion connected to the waist portion and a second extension portion that extends around the second central portion and includes a resin having elastic resilience, The manufacturing step includes inputting the shape and position of the hole or the tube of the tissue, and inputting the shape and position of the hole or the tube of the acquired tissue into a learning model learned using teacher data having an output of design information including the planar shape, thickness, and material of the second extension portion, and outputting the design information of the second extension portion. The manufacturing step includes a second plate design step, A method for manufacturing a closure device, characterized by the above.

2. The hole or the tube of the tissue is related to a heart disease, The first plate design process inputs the shape and position of the holes or tubes in the tissue of a patient with heart disease, and uses training data with the output being design information including the planar shape, thickness, and material of the first expansion part to train a learning model. Then, the shape and position of the holes or tubes in the obtained tissue are input into the learning model to output the design information of the first expansion part. The method for manufacturing a closure device according to claim 1, characterized in that.

3. The manufacturing process includes a first plate manufacturing process for manufacturing the first plate by a 3D printer. The method for manufacturing a closure device according to claim 1, characterized in that.

4. The closure device includes an IC chip embedded in a resin, and the IC chip includes a heartbeat sensor and / or a power generation element that generates electricity using the operation of the heart. The method for manufacturing a closure device according to claim 1, characterized in that.

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