WO2022138384A1

WO2022138384A1 - Embolization system

Info

Publication number: WO2022138384A1
Application number: PCT/JP2021/046330
Authority: WO
Inventors: 篤志小川; 雅之高寺
Original assignee: 株式会社カネカ
Priority date: 2020-12-23
Filing date: 2021-12-15
Publication date: 2022-06-30

Abstract

An embolization system (1) for an aneurysm in a lumen includes: a first cylinder (11) having a distal end and a proximal end; a basket (30) which is disposed in a lumen of the first cylinder (11), has a plurality of wires (20), is capable of expanding when going outside of the first cylinder (11), and is formed by a mesh-like wall surface in which the plurality of wires (20) intersect; a basket plunger (40) disposed on the proximal side of the basket (30); a coil body (100) disposed in the lumen of the first cylinder (11); and a coil plunger (110) disposed on the proximal side of the coil body (100). An opening (22) in the mesh of the basket (30) enables the first cylinder (11) to penetrate. The coil body (100) has a primary shape formed by winding wires, and a secondary shape formed by winding a coil portion of the primary shape. The basket (30) has a mesh in which the long diameter (D1) of the opening (22) in the mesh of the basket (30) is smaller than the diameter of a curve of the secondary shape in the winding of the primary shape.

Description

Embolization system

The present invention relates to an embolic system having an embolic device for forming an embolus in a blood vessel of a vascular diseased part.

Intravascular treatment is one of the treatment methods for vascular lesions such as head and neck aneurysms, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, renal arteries, and abdominal aneurysms. As endovascular treatment, for example, embolization is used in which an embolization device having a coil for embolization is placed at a target site such as the inside of the aneurysm to promote thrombus formation and prevent the aneurysm from rupturing.

If the opening of an aneurysm or the like on the blood vessel wall is large, the embolization coil placed inside the aneurysm may come out of the aneurysm. In embolization, an indwelling tool placed in a blood vessel in the aneurysm or near the opening of the aneurysm may be used to prevent the coil placed in the aneurysm from deviating.

For example, Patent Document 1 includes a bulb-shaped body portion and an anchor sized to be accepted in an aneurysm, and the body portion and the anchor are integrally formed of an elastic cloth, and the occlusion device is folded. Described is an aneurysm occlusion device that can be deployed in and elastically self-expand to occlude an aneurysm. Patent Document 2 describes a mesh that is permeable to blood flow that folds when delivered, expands to hang over the neck of the aneurysm when deployed, and is in contact with the inner wall of the aneurysm. Described is a device for treating an aneurysm having an inflatable frame and allowing the embolic material to be injected through a permeable mesh or valve after being deployed within the aneurysm. .. Patent Document 3 describes at least one embolic member having a first non-expanded shape and a second expanded shape, and a non-expanded shape and a support structure capable of fixing a therapeutic device and passing through an opening of the support structure. A therapeutic tool for angiopathy comprising a fixation member having an expanded state that cannot pass through an opening is described. Pat. Described are implantable retainers that can be delivered via an elongated tubular delivery device for holding a vascular occlusion device in an aneurysm, including multiple external array elements configured to remain outside the aneurysm. .. Patent Document 5 has a first spread state having an outer surface that can contact the aneurysm, and dimensions suitable for insertion through the patient's vasculature and through the neck of the aneurysm. A patient comprising a substantially tubular structure having a second folded state and a control ring having a substantially annular body that prevents the structure from spreading radially. A occlusive device suitable for endovascular treatment of aneurysms of blood vessels in the blood vessels has been described.

International Publication No. 1997/026939 Special Table 2001-518320 Gazette Japanese Patent Publication No. 2005-537092 Japanese Unexamined Patent Publication No. 2008-173497 JP-A-2015-196092 Japanese Unexamined Patent Publication No. 2004-154536 JP-A-2018-69092 Japanese Patent Publication No. 2020-503147

However, in the indwelling tool as in Patent Documents 1 to 5, since the opening through which the coil body can be inserted into the indwelling tool is limited, the coil body is inserted into the indwelling tool depending on the condition of the lesion and the procedure. It is difficult, and as a result, there is a problem that it is difficult to place the coil body in the knob, and a problem that the coil body in the indwelling tool placed in the knob passes through the opening of the indwelling tool and goes out of the knob. There was room for improvement.

Further, in the indwelling tool as in Patent Documents 6 to 8, in order to stably arrange the coil body in the aneurysm, an assist stent may be arranged in the blood vessel facing the aneurysm. When an assist stent is placed in a blood vessel, there is a problem that it is necessary to use a drug such as an antiplatelet agent for a long period of time. The present invention eliminates the need to place an assist stent by realizing a device that places the role of the assist stent placed in the blood vessel in the aneurysm. As a result, the use of drugs such as antiplatelet agents is reduced.

The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an embolic system in which a coil body can be easily placed in a knob and the coil body placed in the knob does not easily go out. It is in.

The first embolization system that was able to solve the above-mentioned problems is an intraluminal aneurysm embolization system in the lumen of the first cylinder having a distal end and a proximal end, and the lumen of the first cylinder. Arranged, it has multiple wires, is expandable when it goes out of the first cylinder, and is arranged on the proximal side of the basket and the basket composed of mesh-like wall surfaces where multiple wires intersect. It has a basket pusher, a coil body arranged in the lumen of the first cylinder, and a coil pusher arranged on the proximal side of the coil body, and the mesh opening of the basket has. The first cylinder can be inserted, and the coil body is formed by winding a wire to form a primary shape, and the coil portion of the primary shape is wound to form a secondary shape. The basket is characterized in that the major axis of the opening of the mesh has a mesh smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape.

The second embolization system that was able to solve the above-mentioned problems is the embolization system of the aneurysm in the lumen, in the first cylinder having a distal end and a proximal end, and in the lumen of the first cylinder. The coil body is arranged, the coil pusher arranged on the proximal side of the coil body, the second cylinder having a distal end and the proximal end, and the second cylinder arranged in the lumen of the second cylinder. A basket that has multiple wires and is expandable when it goes out of the second cylinder, and consists of a mesh-like wall surface where multiple wires intersect, and a basket pusher located on the proximal side of the basket. , And the mesh opening of the basket allows the first cylinder to be inserted, and the coil body is formed by winding a wire to form a primary shape, and the coil portion of the primary shape is wound. The basket has a mesh in which the major axis of the mesh opening of the basket is smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape. It is characterized by.

In the embolic system of the present invention, it is preferable that the first cylinder is arranged in the lumen of the second cylinder.

In the embolic system of the present invention, it is preferable that the short diameter of the mesh opening of the basket is larger than the diameter of the winding of the wire forming the primary shape.

In the embolic system of the present invention, it is preferable that the minor diameter of the mesh opening of the basket is larger than the outer diameter of the distal end of the first cylinder.

In the embolic system of the present invention, it is preferable that the first cylinder has a tapered portion at the distal end portion whose outer diameter decreases toward the distal side.

In the embolic system of the present invention, the ratio of the diameter of the wire to the diameter of the winding of the wire forming the primary shape is preferably 0.01 or more and 0.5 or less.
Ratio of the diameter of the wire to the diameter of the wire winding that forms the primary shape = the diameter of the wire / the diameter of the wire winding that forms the primary shape

In the embolic system of the present invention, it is preferable to have a detachable connecting member located proximal to the basket and distal to the basket pusher.

In the embolic system of the present invention, the material constituting the connecting member has a property of melting by heat, and it is preferable that the material has a heating mechanism for heating the connecting member.

In the embolic system of the present invention, it is preferable that the basket pusher and the coil pusher can independently slide in the long axis direction of the first cylinder in the lumen of the first cylinder.

In the embolization system of the present invention, the second cylinder has a first lumen and a second lumen, in which the third cylinder in which the basket and the basket pusher are arranged in the lumen is arranged in the first lumen. It is preferable that the first cylinder in which the coil body and the coil pusher are arranged in the lumen is arranged in 2 lumens.

According to the first and second embolization systems of the present invention, the first cylinder can be inserted into the mesh opening of the basket, and the coil body winds a wire to form a primary shape. The secondary shape is formed by winding the coil part of the basket, and the basket has a mesh in which the major axis of the opening of the mesh of the basket is smaller than the diameter of the curve of the secondary shape in the winding of the primary shape. By doing so, it is possible to insert the first cylinder through the opening of the mesh and arrange the coil body in the basket, while the major axis of the opening of the mesh is the secondary in the winding of the primary shape of the coil body. Since it is smaller than the diameter of the curve of the shape, it is difficult for the coil body arranged in the basket to go out of the basket through the opening of the mesh. Therefore, it is possible to make an embolic system that makes it easy to place the coil body in the basket, makes it difficult for the coil body placed in the basket to go out of the basket, and allows the coil body to be stably placed in the knob. can.

FIG. 6 shows a cross-sectional view of the first embolization system according to the embodiment of the present invention parallel to the long axis direction of the first cylinder. The plan view of the basket of the embolic system of this invention is shown. FIG. 6 shows a cross-sectional view of the second embolization system according to the embodiment of the present invention parallel to the long axis direction of the first cylinder. FIG. 6 shows a cross-sectional view of the second embolization system according to the embodiment of the present invention parallel to the long axis direction of the second cylinder. Represents a cross-sectional view of the second embolization system according to another embodiment of the present invention parallel to the major axis of the third cylinder. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic diagram of a basket of an embolic system according to an embodiment of the present invention. FIG. 6 shows a schematic view of a state in which the first embolic system according to the embodiment of the present invention is arranged in a knob at the terminal portion. FIG. 6 shows a schematic view of a state in which a second embolic system according to an embodiment of the present invention is arranged in a knob at the terminal portion.

Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments as well as the present invention, and appropriate changes are made to the extent that it can meet the purposes of the preceding and the following. In addition, it is of course possible to carry out, and all of them are included in the technical scope of the present invention. In each drawing, hatching, member reference numerals, and the like may be omitted for convenience, but in such cases, the specification and other drawings shall be referred to. Further, the dimensions of the various members in the drawings may differ from the actual dimensions because the priority is given to contributing to the understanding of the features of the present invention.

First, the first embolization system 1 of the present invention will be described below. FIG. 1 is a cross-sectional view of the first embolization system 1 according to the embodiment of the present invention parallel to the long axis direction of the first cylinder 11, and FIG. 2 is a plan view of the basket 30 of the embolization system 1.

As shown in FIGS. 1 and 2, the first embolization system 1 of the present invention is an intraluminal aneurysm embolization system 1 with a first cylinder 11 having a distal end and a proximal end. It is arranged in the lumen of the first cylinder 11, has a plurality of wires 20, is expandable when it goes out of the first cylinder 11, and is composed of a mesh-like wall surface where the plurality of wires 20 intersect. The basket 30, the basket pusher 40 arranged on the proximal side of the basket 30, the coil body 100 arranged in the lumen of the first cylinder 11, and the coil arranged on the proximal side of the coil body 100. The pusher 110 and the mesh opening 22 of the basket 30 are capable of inserting the first cylinder 11, and the coil body 100 is formed by winding a wire to form a primary shape. A secondary shape is formed by winding a coil portion of the shape, and in the basket 30, the major axis D1 of the mesh opening 22 of the basket 30 has a curvature of the secondary shape in the winding of the primary shape. It has a mesh smaller than its diameter.

Next, the second embolization system 1 of the present invention will be described. FIG. 3 is a cross-sectional view of the second embolization system 1 according to the embodiment of the present invention parallel to the major axis of the first cylinder 11, and FIG. 4 is a cross-sectional view of the second cylinder 12 of the second embolization system 1. It is a cross-sectional view parallel to the long axis direction, and FIG. 5 is a cross-sectional view parallel to the long axis direction of the third cylinder 13 of the second embolization system 1 in another embodiment of the present invention.

As shown in FIGS. 2 to 4, the second embolization system 1 of the present invention is an intraluminal aneurysm embolization system 1 with a first cylinder 11 having a distal end and a proximal end. A coil body 100 arranged in the lumen of the first cylinder 11, a coil pusher 110 arranged on the proximal side of the coil body 100, and a second cylinder 12 having a distal end and a proximal end. It is arranged in the lumen of the second cylinder 12, has a plurality of wires 20, is expandable when it goes out of the second cylinder 12, and is composed of a mesh-like wall surface where the plurality of wires 20 intersect. It has a basket 30 and a basket pusher 40 arranged on the proximal side of the basket 30, and the mesh opening 22 of the basket 30 is capable of inserting the first cylinder 11 and the coil body 100. , A primary shape is formed by winding a wire, and a secondary shape is formed by winding a coil portion of the primary shape. The basket 30 has a major axis of the mesh opening 22 of the basket 30. D1 has a mesh smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape.

As shown in FIGS. 3 and 4, the second embolic system 1 has a first cylinder 11 having a distal end and a proximal end and a second cylinder 12 having a distal end and a proximal end. Have. As shown in FIG. 3, a coil body 100 and a coil pusher 110 are arranged on the proximal side of the coil body 100 in the lumen of the first cylinder 11. That is, the coil body 100 and the coil pusher 110 are arranged in the lumen of the first cylinder 11. As shown in FIG. 4, a basket 30 and a basket pusher 40 are arranged on the proximal side of the basket 30 in the lumen of the second cylinder 12. That is, the basket 30 and the basket pusher 40 are arranged in the lumen of the second cylinder 12.

The embolic system 1 has a first cylinder 11 in which the coil body 100 and the coil pusher 110 are arranged in the lumen, and a second cylinder 12 in which the basket 30 and the basket pusher 40 are arranged in the lumen. This makes it possible to prevent the coil body 100 and the coil pusher 110 from interfering with the basket 30 and the basket pusher 40 during the use of the embolization system 1. Therefore, it is possible to prevent the coil body 100 from being entangled with the basket 30 or the basket pusher 40 before the basket 30 or the coil body 100 is placed, and to smoothly perform the procedure using the embolization system 1.

The embolization system 1 can be used for embolization that promotes thrombosis of aneurysms in the lumen such as aneurysms of blood vessels and prevents the aneurysms from rupturing. FIG. 15 is a schematic view of a state in which the first embolic system 1 is arranged in the aneurysm at the terminal portion of the in vivo lumen, and FIG. 16 shows the second embolic system 1 in the aneurysm at the terminal portion of the in vivo lumen. It is a schematic diagram of the state in which is arranged. As shown in FIGS. 15 and 16, the embolization system 1 introduces the first cylinder 11 into the lumen and places the basket 30 from the first cylinder 11 in the knob. A coil body 100 is further placed inside the basket 30 placed in the aneurysm to promote thrombus formation in the aneurysm. As shown in FIGS. 15 and 16, according to the embolization system 1 of the present invention, the coil body 100 can be inserted from the mesh portion of the wire 20 of the basket 30 of the embolization system 1 via the first cylinder 11.

As shown in FIG. 1, the first cylinder 11 has a distal end and a proximal end. In the present invention, the proximal side refers to the user's hand side with respect to the extending direction of the first cylinder 11, and the distal side is the opposite side of the proximal side, that is, the side treated by the embolization system 1 ( Refers to the lesion side). Further, the extending direction of the first cylinder 11 is referred to as a major axis direction. The major axis direction of the first cylinder 11 can be rephrased as the perspective direction of the first cylinder 11. In FIGS. 1 to 5, the right side of the figure is the proximal side, and the left side of the figure is the distal side.

The first cylinder 11 is a tubular member extending in the long axis direction and has at least one lumen. The number of lumens contained in the first cylinder 11 may be a plurality, but is preferably one. Since the number of lumens of the first cylinder 11 is one, the outer diameter of the first cylinder 11 can be reduced, and the embolization system 1 can be made less invasive. .. By providing a partition wall in the lumen of the first cylinder 11, a plurality of lumens can be provided. In the total length of the first cylinder 11, a portion having one lumen and a portion having a plurality of lumens may be mixed. For example, a partition wall may be arranged at least distal to the first cylinder 11 to form a plurality of lumens. As a result, the basket 30 and the coil body 100 can be arranged in different lumens at the distal portion of the first cylinder 11, and the basket 30 and the coil body 100 can be efficiently placed in the knob.

The material constituting the first cylinder 11 is preferably resin or metal. Examples of the resin constituting the first cylinder 11 include polyamide-based resin, polyester-based resin, polyurethane-based resin, polyolefin-based resin, fluorine-based resin, vinyl chloride-based resin, silicone-based resin, and natural rubber. Only one of these may be used, or two or more thereof may be used in combination. Above all, the resin constituting the first cylinder 11 is preferably at least one of a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, and a fluororesin. Since the material constituting the first cylinder 11 is at least one of a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, and a fluororesin, the slipperiness of the surface of the first cylinder 11 is enhanced. It is possible to improve the permeability to a lumen such as a blood vessel. The resin tube constituting the first cylinder 11 is manufactured by a usual method such as extrusion molding or injection molding.

Examples of the metal constituting the first cylinder 11 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni—Ti alloy, Co—Cr alloy, or a combination thereof. Can be mentioned. As the metal tube constituting the first cylinder 11, a metal wire may be spirally wound into a tube, a metal wire may be knitted into a tube, or the like. Further, the first cylinder 11 may be a tube in which a metal and a resin are combined. Further, a cylinder in which a reinforcing material such as a metal wire is arranged on a tubular body made of resin may be used as the first cylinder 11. When a wire rod is arranged on a resin tubular member as the first cylinder 11, the wire rod made of Ni—Ti alloy is preferable because it is excellent in shape memory and high elasticity. In addition to the above-mentioned metals, the wire may be a fiber material such as polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, carbon fiber and the like. The fiber material may be monofilament or multifilament.

The first cylinder 11 may be composed of a single layer or may be composed of a plurality of layers. Further, in the long axis direction, a part of the first cylinder 11 may be composed of a single layer, and the other portion may be composed of a plurality of layers.

The cross-sectional shape of the first cylinder 11 in the cross section perpendicular to the long axis direction may be circular, elliptical, polygonal, or a combination thereof. Further, the cross-sectional shape of the lumen of the first cylinder 11 in the cross section perpendicular to the long axis direction may be circular, elliptical, polygonal, or a combination thereof.

The lumen of the second cylinder 12, the material constituting the second cylinder 12, the layer structure of the second cylinder 12, and the cross-sectional shape of the second cylinder 12 can be configured from the same options as those of the first cylinder 11. The first cylinder 11 and the second cylinder 12 may have the same configuration or may be different. The third cylinder 13, which will be described later, may have the same configuration.

In the embolization system 1 including the first cylinder 11 having the coil body 100 in the lumen and the second cylinder 12 having the basket 30 in the lumen, the lumen of the first cylinder 11 having the coil body 100 in the lumen The second cylinder 12 may be arranged, or the first cylinder 11 may be arranged in the lumen of the second cylinder 12 having the basket 30 in the lumen. Alternatively, as shown in FIG. 5, a third cylinder 13 capable of arranging both the first cylinder 11 and the second cylinder 12 in the lumen is prepared, and the first cylinder 11 is placed in the lumen of the third cylinder 13. And the second cylinder 12 may be arranged and used. As shown in FIG. 5, the third cylinder 13 may have the first cylinder 11 and the second cylinder 12 arranged in different lumens, or may be arranged in the same lumen. In any system, the short diameter D2 of the mesh opening 22 of the basket 30 is preferably larger than the outer diameter of the distal end of the first cylinder 11. Thereby, the distal end of the first cylinder 11 can be arranged inside the basket 30 through the opening 22 of the mesh, and by discharging the coil body 100 from the first cylinder 11 in this state, it is surely entered into the basket 30. The coil body 100 can be arranged in the coil body 100. The first cylinder 11 preferably has a tapered portion at the distal end portion whose outer diameter decreases toward the distal side. Since the distal end of the first cylinder 11 has a tapered portion, the distal end of the first cylinder 11 can easily pass through the mesh opening 22.

Although not shown, it is preferable that the first cylinder 11 is arranged in the lumen of the second cylinder 12. Since the first cylinder 11 is arranged in the lumen of the second cylinder 12, the second cylinder 12 is inserted into the lumen of the living body such as a blood vessel, and at the same time, the first cylinder 11 also becomes the lumen of the living body. Can be inserted. That is, the second cylinder 12 is inserted into the in-vivo lumen in order to indwell the basket 30 in the target site, and then the first cylinder 11 is inserted into the in-vivo lumen in order to indwell the coil body 100 in the basket 30. It is not necessary to insert the first cylinder 11 and the second cylinder 12 into the in-vivo lumen in separate steps so as to insert them, and by inserting the second cylinder 12 into the in-vivo lumen, the second cylinder 12 is inserted. The first cylinder 11 arranged in the lumen of the cylinder 12 is also inserted into the lumen of the living body. Therefore, it is possible to shorten the time required for the procedure.

As shown in FIGS. 1, 4 and 5, the basket 30 is arranged in the lumen of the first cylinder 11 or the second cylinder 12 (hereinafter, may be simply referred to as “cylinder”) and is a wire. It has a plurality of 20s, is expandable when it goes out of the cylinder, and is composed of a mesh-like wall surface on which a plurality of wires 20 intersect. That is, the basket 30 is arranged in the lumen of the cylinder, and as shown in FIG. 2, the basket 30 can be expanded when it is discharged from the cylinder. When the basket 30 is arranged in the lumen of the first cylinder 11 or the second cylinder 12, it is in contact with the inner wall of the cylinder, and is in a state of being deflated by receiving an external force from the cylinder. When the basket 30 is released from the cylinder, it does not receive the external force, and when there is no other external force, the basket 30 is in an expanded state. When the basket 30 is arranged in the knob, the basket 30 comes into contact with the wall portion of the knob and receives an external force from the knob to be deformed.

Since the basket 30 is composed of a mesh-like wall surface on which a plurality of wires 20 intersect, the basket 30 can be made finer than the conventional embolization system. Therefore, in embolization of an aneurysm or the like, it becomes difficult for the coil body 100 arranged inside the basket 30 placed in the aneurysm to jump out of the basket 30 from the opening 22 of the mesh. As a result, the coil body 100 can be stably placed inside the basket 30, that is, inside the knob.

The material constituting the wire 20 is preferably an elastic material, for example, stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, aluminum, gold, silver and Ni—Ti alloy. , A single wire or a stranded metal wire composed of a Co—Cr alloy or the like. Above all, the material constituting the wire 20 is preferably a Ni—Ti alloy metal wire. Since the material constituting the wire 20 is a Ni—Ti alloy metal wire, the elasticity of the wire 20 is increased, and the basket 30 discharged from the first cylinder 11 can be quickly expanded.

The number of wires 20 in the basket 30 may be a plurality, and the number of wires 20 can be selected according to the inner diameter of the lumen in the living body such as a blood vessel. In the drawing, the number of wires 20 in the basket 30 is limited. However, in the embodiment of the present invention, the basket 30 can be, for example, a basket 30 composed of 8 to 48 wires 20. The finer the gap between the meshes of the basket 30, the more the coil body 100 can be prevented from falling off. The wire diameter of the wire 20 can be set according to the size of the basket 30, the number of wires 20, the material, and the like. The number of wires 20 included in the basket 30 is preferably 16 to 32.

As shown in FIGS. 1 and 2, the basket pusher 40 is arranged on the proximal side of the basket 30. The basket pusher 40 moves the basket 30 in the long axis direction of the first cylinder 11 and the second cylinder 12 by moving the basket pusher 40 in the long axis direction of the first cylinder 11, and discharges the basket 30 from the cylinder. be able to. Although not shown, it is preferable that the basket pusher 40 is provided with a handle for controlling the position and rotation in the longitudinal direction on the proximal side of the proximal end of the first cylinder 11.

The material constituting the basket pusher 40 is preferably a metal, and examples thereof include metals such as stainless steel, carbon steel, and nickel-titanium alloy. Above all, the material constituting the basket pusher 40 is preferably stainless steel. Since the material constituting the basket pusher 40 is stainless steel, the rigidity of the basket pusher 40 is increased. As a result, the force applied to the basket pusher 40 can be efficiently transmitted to the basket 30, and the operation of discharging the basket 30 from the first cylinder 11 becomes easy.

As shown in FIGS. 1, 2, 4 and 5, the basket 30 has a first binding portion 51 for bundling and fixing a plurality of wires 20 on its distal side, and a plurality of on its proximal side. It is preferable to have a second binding portion 52 for bundling and fixing the wires 20. The basket 30 is formed by combining a plurality of wires 20 bent between the first binding portion 51 and the second binding portion 52, or by twisting the wires 20 twisted in a right-handed spiral and twisted in a left-handed spiral. By combining with the wire 20 or the like, it is configured in a basket shape having a mesh-like wall surface.

In order to bundle and fix the plurality of wires 20 in the first binding portion 51 and the second binding portion 52, for example, the plurality of wires 20 are welded, crimped using another member such as a binding tool 80, and an adhesive is used. Examples thereof include a method of adhering using and fixing with a brazing material. Above all, it is preferable that at least one of the first binding portion 51 and the second binding portion 52 is bound by the binding tool 80. By binding at least one of the first binding portion 51 and the second binding portion 52 by the binding tool 80, the plurality of wires 20 can be easily and surely bundled and fixed.

Examples of the binding tool 80 include a ring-shaped member, a member having a C-shaped cross section with a notch in the ring, a coil-shaped member in which a wire is wound, a member that is tied and fixed with a string-shaped object, and the like. Above all, the binding tool 80 is preferably a ring-shaped member. The binding tool 80, which is a ring-shaped member, forms the first binding portion 51 or the second binding portion 52 by, for example, passing a plurality of wires 20 through the lumen of the binding tool 80 and crimping the binding tool 80. Can be done. Since the binding tool 80 is a ring-shaped member, the plurality of wires 20 can be firmly fixed by the binding tool 80, and it becomes possible to make it difficult to release the binding of the plurality of wires 20.

As the material constituting the binding tool 80, for example, the wire 20 of the basket 30 or the same material as the basket pusher 40 can be used. Above all, the material constituting the binding tool 80 is preferably stainless steel. Since the material constituting the binding tool 80 is stainless steel, the fixing strength of the plurality of wires 20 can be increased, and the durability of the binding tool 80 can be improved.

It is also preferable that the binding tool 80 contains an X-ray impermeable substance. The X-ray impermeable substance is, for example, at least one selected from the group consisting of lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, and tantalum. Seeds are mentioned. Since the binding tool 80 contains an X-ray impermeable substance, the position of the binding tool 80 can be confirmed under fluoroscopy. As a result, it becomes possible to grasp the position of the basket 30 in the body.

As shown in FIGS. 2 and 16, the mesh opening 22 of the basket 30 is capable of inserting the first cylinder 11. Since the opening 22 of the mesh allows the first cylinder 11 to be inserted, a long medical object is inserted from the mesh-shaped wall surface where the plurality of wires 20 of the basket 30 intersect. A plurality of mesh openings 22 are present on the mesh-shaped wall surface of the basket 30, and an insertion port through which the first cylinder 11 is inserted is appropriately selected according to the condition of the lesion in which the basket 30 is placed. It becomes possible. Therefore, it is possible to deal with various lesion states, and it becomes easy to insert the first cylinder 11 into the basket 30 and place the coil body 100 inside the basket 30.

As shown in FIG. 2, the basket 30 has a mesh in which the major axis D1 of the mesh opening 22 of the basket 30 is smaller than the diameter of the curve of the secondary shape in the winding of the primary shape. When the coil body 100 is discharged from the first cylinder 11 and arranged inside the basket 30, the external force received by the coil body 100 from the inner wall or the like of the first cylinder 11 disappears, and the coil body 100 is 2 in the basket 30. The following shape is given, and it becomes a state curved into a spiral shape or a three-dimensional shape. Therefore, since the basket 30 has a mesh opening 22 having a major axis D1 smaller than the diameter of the curve of the secondary shape of the coil body 100, the coil body 100 arranged inside the basket 30 has a mesh opening 22. It becomes difficult to pass through 22 and go out of the basket 30, and the coil body 100 can be stably placed in the basket 30.

It is preferable that the basket 30 has a mesh in which the major axis D1 of the mesh opening 22 of the basket 30 is smaller than the maximum diameter of the curvature of the secondary shape in the winding of the primary shape. Since the major axis D1 of the mesh opening 22 is smaller than the maximum diameter of the curvature of the secondary shape of the coil body 100, the coil body 100 arranged inside the basket 30 through the mesh opening 22 of the basket 30 is the basket 30. It is possible to make it even more difficult to get out of the outside.

The basket 30 may have a mesh in which the major axis D1 of the mesh opening 22 of the basket 30 is smaller than the diameter of the curve of the secondary shape in the winding of the primary shape, but the openings 22 of all the meshes. It is preferable that the major axis D1 of the coil body 100 is smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape of the coil body 100. Since the major axis D1 of the openings 22 of all the meshes of the basket 30 is smaller than the diameter of the curve of the secondary shape in the winding of the primary shape of the coil body 100, the coil body 100 in the basket 30 is the basket 30. It is possible to further enhance the effect of making it difficult to get out of the basket.

As shown in FIG. 2, it is preferable that the short diameter D2 of the mesh opening 22 of the basket 30 is larger than the winding diameter of the wire forming the primary shape. The diameter of the winding of the wire forming the primary shape indicates the diameter of the primary coil. Since the short diameter D2 of the mesh opening 22 of the basket 30 is larger than the diameter of the winding of the wire forming the primary shape of the coil body 100, the coil body 100 can be easily inserted into the mesh opening 22. .. Therefore, the operation of arranging the coil body 100 inside the basket 30 becomes easy.

It is preferable that the short diameter D2 of the openings 22 of all the meshes of the basket 30 is larger than the winding diameter of the wire forming the primary shape. Since the short diameter D2 of the openings 22 of all the meshes of the basket 30 is larger than the diameter of the winding of the wire forming the primary shape of the coil body 100, the coil body 100 can easily pass through the mesh openings 22. Therefore, it is possible to further enhance the effect of facilitating the placement of the coil body 100 in the basket 30.

It is preferable that the short diameter D2 of the mesh opening 22 of the basket 30 is larger than the outer diameter of the distal end of the first cylinder 11. Since the short diameter D2 of the mesh opening 22 of the basket 30 is larger than the outer diameter of the distal end of the first cylinder 11, the distal end of the first cylinder 11 can be easily inserted into the mesh opening 22. .. Therefore, the distal end of the first cylinder 11 can be arranged inside the basket 30 through the opening 22 of the mesh, and by discharging the coil body 100 from the first cylinder 11 in this state, the coil body 100 can be reliably inserted into the basket 30. The coil body 100 can be arranged.

It is preferable that the short diameter D2 of the openings 22 of all the meshes of the basket 30 is larger than the outer diameter of the distal end of the first cylinder 11. Since the short diameter D2 of the openings 22 of all the meshes of the basket 30 is larger than the outer diameter of the distal end of the first cylinder 11, the mesh through which the first cylinder 11 is inserted according to the condition of the lesion or the like. The opening 22 can be selected, and the coil body 100 can be easily arranged inside the basket 30.

As shown in FIG. 2, the plurality of wires 20 of the basket 30 have an intersection 21. It is preferable that the intersection 21 of the wires 20 is not fixed. That is, it is preferable that each wire 20 is not fixed at the intersection 21. Since the intersection 21 of the wires 20 is not fixed, the wires 20 can move when an external force is applied to the basket 30. As a result, when the coil body 100 is passed through the mesh-like wall surface where the plurality of wires 20 of the basket 30 intersect, the wires 20 move by an external force, and the size of the mesh opening 22 of the basket 30 can be widened. , It becomes easy to arrange the coil body 100 in the basket 30. Further, since the intersection 21 of the wires 20 is not fixed, the basket 30 is easily deformed when the coil body 100 is arranged inside the basket 30. Therefore, it is possible to enhance the effect of preventing the rupture of the aneurysm by deforming the basket 30 according to the shape of the aneurysm and promoting the generation of a thrombus having a size and shape that fills the inside of the aneurysm.

In the basket 30, it is preferable that the position of the intersection 21 of the mesh wires 20 shifts due to an external force and the shape of the mesh opening 22 changes. Specifically, for example, when the coil body 100 is inserted into the wall surface of the basket 30, one of the diamond-shaped openings 22 as shown in FIG. 2 expands into a square shape by an external force. Since the shape of the mesh opening 22 of the basket 30 is changed by an external force, the coil body 100 can be easily inserted through the mesh opening 22, and the operation of placing the coil body 100 in the basket 30 becomes easy.

As shown in FIG. 1, the coil body 100 is arranged in the lumen of the first cylinder 11. The coil body 100 is formed by winding a wire to form a primary shape, and winding a coil portion of the primary shape to form a secondary shape. The primary shape of the coil body 100 is also referred to as a primary coil, and is formed by spirally winding a wire. The secondary shape of the coil body 100 is also referred to as a secondary coil, and the primary coil is further described as an arc shape, a wave shape, a meandering shape, a zigzag shape, a spiral shape (also referred to as a two-dimensional spiral shape or a spiral shape), a ball shape, and the like. It is a habit of a box shape and other random curved shapes without loops. Note that FIGS. 1, 3 and 5 show a state in which the coil body 100 is developed in a straight line, and the state of the primary coil in which the secondary coil is linearly extended is shown.

It is preferable that the material constituting the wire forming the coil body 100 has biocompatibility and flexibility. Examples of the material constituting the wire include platinum, gold, titanium, tungsten and alloys thereof, metals such as stainless steel, or combinations thereof. Above all, the material constituting the wire is preferably a platinum-tungsten alloy. Since the material constituting the wire is a platinum-tungsten alloy, the coil body 100 has excellent flexibility, and the effect of sufficiently filling the inside of the aneurysm to prevent the aneurysm from bursting can be enhanced.

The shape of the cross section of the wire forming the coil body 100 perpendicular to the long axis direction may be a circle, an oval, a polygon, or a combination thereof. The oval shape includes an elliptical shape, an egg shape, and a rectangular shape with rounded corners. The outer diameter of the wire forming the coil body 100 may be, for example, 25 μm or more, 30 μm or more, 35 μm or more, 120 μm or less, or 70 μm or less.

The wire forming the coil body 100 has a distal end and a proximal end. The strands may be composed of a single linear member from the distal end to the proximal end, or may be composed of a plurality of linear members connected to each other in the long axis direction.

The coil body 100 may be a single-layer coil or a multi-layer coil having a plurality of layers. For example, in the coil body 100, a part of the coil body 100 in the long axis direction may be a single layer, and the other part may be a plurality of layers.

The density of the coil body 100, that is, the winding interval of the strands is not particularly limited, and tight winding, pitch winding, or a combination thereof can be used. In the coil body 100, adjacent strands may be in contact with each other in a part of the major axis direction, or adjacent strands may be in contact with each other over the entire major axis direction. The state in which adjacent strands of the coil body 100 are in contact with each other in the major axis direction is referred to as tight winding, and the state in which they are not in contact is referred to as pitch winding. The state in which adjacent strands are not in contact with each other in the direction of the coil body 100 means a state in which adjacent strands are in contact with each other in the major axis direction of the coil body 100.

The shape of the cross section perpendicular to the major axis direction of the coil body 100 may be a circular shape, an oval shape, a polygonal shape, or a combination thereof. The maximum outer diameter and the minimum outer diameter of the coil body 100 can be appropriately selected according to the size of the aneurysm, the procedure, etc., but may be, for example, 150 μm or more, 180 μm or more, 200 μm or more, 500 μm or less, and 380 μm. Hereinafter, it can be 350 μm or less.

As shown in FIG. 1, the coil pusher 110 is arranged on the proximal side of the coil body 100. The coil pusher 110 moves the coil body 100 in the long axis direction of the first cylinder 11 by moving the coil pusher 110 in the long axis direction of the first cylinder 11, and discharges the coil body 100 from the first cylinder 11. be able to.

The material constituting the coil pusher 110 is preferably a metal, and examples thereof include metals such as stainless steel, carbon steel, and nickel-titanium alloy. Above all, the material constituting the coil pusher 110 is preferably stainless steel. Since the material constituting the coil pusher 110 is stainless steel, the rigidity of the coil pusher 110 can be increased, and the force applied to the coil pusher 110 is easily transmitted to the coil body 100. As a result, the operation of discharging the coil body 100 from the first cylinder 11 becomes easy.

Although not shown, the coil body 100 has a lumen extending in the long axis direction of the coil body 100. It is preferable that an extension resistance member for suppressing the extension of the coil body 100 in the major axis direction during the operation of the embolization system 1 is arranged in the lumen of the coil body 100.

The stretch resistance member suppresses the coil body 100 from stretching in the major axis direction during the operation of the embolization system 1. The extension resistance member is arranged in the lumen of the coil body 100. The stretch resistance member may be a long member made of a single wire or a stranded wire. The stretch resistance member may be a single layer or a multilayer body having a plurality of layers. The stretch resistance member may have an inner layer made of a twisted wire made of a plurality of wires and an outer layer made of a resin composition provided on the outside of the inner layer. One extension resistance member may be arranged in the lumen of the coil body 100, or a plurality of extension resistance members may be arranged.

Examples of the material constituting the stretch resistance member include resin or metal. Examples of the resin constituting the stretch resistance member include polyester resins such as polyethylene terephthalate, polyamide resins such as nylon, and polyolefin resins such as polyethylene and polypropylene. Since the material constituting the stretch resistance member is resin, the flexibility of the stretch resistance member is increased, and the delivery performance of the coil body 100 can be improved. Further, since the material constituting the stretch resistance member is resin, it is possible to eliminate breakage due to metal fatigue during delivery of the coil body 100. By making the length of the extension resistance member longer than the length of the coil body 100 and by using a material that is easy to stretch for the extension resistance member, the length of the extension resistance member becomes longer when the coil body 100 is arranged in the knob. It is possible to alleviate the tension caused by the shortage and the end portion of the coil body 100 extending linearly. Examples of the metal constituting the stretch resistance member include platinum, gold, rhodium, palladium, renium, gold, silver, nickel, titanium, tantalum, tungsten, alloys thereof, and stainless steel.

The stretch resistance member may have a circular, oval, polygonal, or a combination thereof in a cross-sectional shape perpendicular to the long axis direction of the stretch resistance member.

The ratio of the diameter of the wire forming the coil body 100 to the diameter of the winding of the primary wire formed by winding the wire is preferably 0.01 or more and 0.5 or less. .. The ratio between the diameter of the wire and the diameter of the winding of the wire forming the primary shape was calculated by the following formula.
Ratio of the diameter of the wire to the diameter of the wire winding that forms the primary shape = the diameter of the wire / the diameter of the wire winding that forms the primary shape The diameter of the wire and the primary shape are formed. By setting the numerical range of the ratio of the winding diameter of the wire to the above range, the flexibility of the coil body 100 is increased. Therefore, when the coil body 100 is arranged inside the basket 30, the coil body 100 spreads in the basket 30 along the shape of the knob, and the inside of the knob can be sufficiently filled by the coil body 100.

The ratio of the diameter of the wire to the diameter of the winding of the wire forming the primary shape is preferably 0.01 or more, more preferably 0.05 or more, and 0.1 or more. Is even more preferable. By setting the lower limit of the ratio between the diameter of the wire and the diameter of the winding of the wire forming the primary shape within the above range, it is possible to impart appropriate rigidity to the coil body 100. Therefore, the coil body 100 can push the basket 30 outward from the inside of the basket 30 and deploy the basket 30 along the inner wall of the knob. The ratio of the diameter of the wire to the diameter of the winding of the wire forming the primary shape is preferably 0.5 or less, more preferably 0.4 or less, and 0.3 or less. Is more preferable. By setting the upper limit of the ratio between the diameter of the wire and the diameter of the winding of the wire forming the primary shape within the above range, the coil body 100 becomes flexible and becomes the shape of the knob or basket 30. At the same time, the coil body 100 can be deformed, and it becomes possible to promote embolization of the aneurysm.

As shown in FIGS. 1, 2, 4 and 5, the embolic system 1 is located proximal to the basket 30 and distal to the basket pusher 40 and is detachable. It is preferable to have the connecting member 60. The connecting member 60 is a member that connects the basket 30 and the basket pusher 40, and can be separated from each other. Since the embolization system 1 has the connecting member 60, the basket 30 is detached from the basket pusher 40 by disconnecting the connecting member 60 after transporting the basket 30 to the target portion, and the basket 30 can be easily moved to the target portion. It can be detained.

As a method for disconnecting the connecting member 60, various methods such as a mechanical disconnection mechanism, fusing, thermal, electrical, and chemical disconnection can be used. Examples of the connecting member 60 include a rod-shaped object, a string-shaped object, a clip, a member formed by fitting such as unevenness, and the like. As the material constituting the connecting member 60, synthetic resin, metal, or the like can be used. The connecting member 60 may be a member different from the basket 30 or the basket pusher 40, or may be a part of the basket 30 or the basket pusher 40.

The material constituting the connecting member 60 has a property of being melted by heat, and it is preferable that the embolization system 1 has a heating mechanism 70 for heating the connecting member 60. Since the material constituting the connecting member 60 has a property of being melted by heat and the embolization system 1 has a heating mechanism 70, the connecting member 60 is heated by the heating mechanism 70 to melt the connecting member 60. It breaks and the basket 30 can be separated from the basket pusher 40. Therefore, the basket 30 and the basket pusher 40 can be firmly connected by the connecting member 60 until the heating mechanism 70 is operated, and the connecting member 60 can be easily disconnected by operating the heating mechanism 70. The basket 30 can be reliably and easily placed.

The material constituting the connecting member 60, which has a property of melting by heat, is preferably a thermoplastic resin, and more preferably PVA (polyvinyl alcohol). Since the material constituting the connecting member 60 is PVA, the connecting member 60 can be more easily separated, and the embolization system 1 can be easily handled.

The heating mechanism 70 is preferably connected to the basket pusher 40. Since the heating mechanism 70 is connected to the basket pusher 40, the connecting member 60 can be heated via the basket pusher 40. Therefore, it is necessary to separately provide a member for transferring the heat of the heating mechanism 70 to the connecting member 60. The size of the embolization system 1 can be reduced.

In the cross section perpendicular to the long axis direction of the first cylinder 11, the connecting member 60 is arranged inside the second binding portion 52, and the wire 20 is arranged outside the connecting member 60. preferable. That is, the connecting member 60 is arranged at the center of the second binding portion 52 in the cross section perpendicular to the long axis direction of the first cylinder 11, and the plurality of wires 20 are arranged outside the connecting member 60. Is preferable. In the cross section perpendicular to the long axis direction of the first cylinder 11, the connecting member 60 is arranged inside the second binding portion 52, and the wire 20 is arranged outside the connecting member 60, whereby the connection member 60 is connected. The contact area between the member 60 and the wire 20 can be increased. Therefore, the strength of the connection between the connecting member 60 and the basket 30 is increased, and it becomes difficult for the basket 30 to unintentionally disconnect from the connecting member 60 during the transportation of the basket 30.

6 to 14 are schematic views of various baskets 30 of the embolization system 1 according to the embodiment of the present invention. In FIGS. 6 to 14, only a part of the wires 20 is shown so that the positional relationship between the distal end and the proximal end of the first binding portion 51, the second binding portion 52, and the basket 30 can be easily understood. The illustration of the other wires 20 is omitted.

As shown in FIGS. 6 to 11, it is preferable that the first binding portion 51 is located proximal to the distal end of the basket 30 in a state where no external force is applied to the basket 30. Since the first binding portion 51 and the second binding portion 52 are portions in which a plurality of wires 20 are bundled and fixed, the rigidity is higher than that of the other portions of the basket 30. Since the first binding portion 51 is located proximal to the distal end of the basket 30, the distal end of the basket 30 becomes flexible. As a result, even if the distal end of the basket 30 comes into contact with the wall of the in-vivo lumen such as a blood vessel when the basket 30 is transported to the target site or placed in the target site, the in-vivo lumen remains. The wall portion can be made hard to be damaged, and the safety of the embolization system 1 can be enhanced.

When the first binding portion 51 is located proximal to the distal end of the basket 30, the wire 20 is present on the proximal side of the first binding portion 51, as shown in FIGS. 6-8. The basket 30 may have a concave distal end, and as shown in FIGS. 9 to 11, the wire 20 is present on the distal side of the first binding portion 51. The first binding portion 51 may be located inside the basket 30.

As shown in FIGS. 12 to 14, the first binding portion 51 may be located distal to the distal end of the basket 30 in a state where no external force is applied to the basket 30. Since the first binding portion 51 is located distal to the distal end of the basket 30, the first binding portion 51, which is more rigid than the other parts of the basket 30, is located at the most distal portion of the basket 30. It will be located. Therefore, the insertability of the basket 30 is improved, and the basket 30 can be easily sent to the target portion.

As shown in FIGS. 7, 8, 10, 11, 13, and 14, the second binding portion 52 is distal to the proximal end of the basket 30 when no external force is applied to the basket 30. It is preferably located on the side. Since the second binding portion 52 is located distal to the proximal end of the basket 30, the surface of the proximal side of the basket 30 becomes smooth. Therefore, even if the proximal side of the basket 30 comes into contact with the inner wall of the blood vessel or the like during transportation or indwelling of the basket 30, the inner wall of the blood vessel or the like is less likely to be damaged, and the embolization system 1 with high safety can be obtained.

When the second binding portion 52 is located distal to the proximal end of the basket 30, the wire 20 is distal to the second binding portion 52, as shown in FIGS. 7, 10 and 13. It may be present and may have a configuration in which the proximal end of the basket 30 is concave, and as shown in FIGS. 8, 11 and 14, the wire 20 is located on the proximal side of the second binding portion 52. Is present, and the second binding portion 52 may be located inside the basket 30.

As shown in FIGS. 6, 9 and 12, it is preferable that the second binding portion 52 is located proximal to the proximal end of the basket 30 in a state where no external force is applied to the basket 30. .. Since the second binding portion 52 is located proximal to the proximal end of the basket 30 in the lumen of the first cylinder 11, the basket pusher 40 is moved distally in the first cylinder 11. At that time, the force is easily transmitted to the basket 30. Therefore, the basket 30 can be quickly discharged from the first cylinder 11.

The wire 20 of the basket 30 includes the first wire and the second wire, and it is preferable that the material constituting the first wire is different from the material constituting the second wire. Since the wire 20 contains the first wire and the second wire, which are made of different materials, for example, the first wire is made of a highly rigid material and the second wire is made of a highly elastic material. By doing so, it becomes possible to impart physical properties such as rigidity and elasticity, which are difficult to achieve with one kind of material, to the basket 30. Further, for example, the first wire may be made of a material having high elasticity, and the second wire may be made of a material having high X-ray permeability. By constructing the first wire with a highly elastic material and the second wire with a highly opaque material for X-rays, the basket 30 can be visually recognized under X-ray fluoroscopy, and the basket 30 has excellent elasticity. Can be.

The second wire preferably has a structure in which a plurality of wires are twisted together. Since the second wire has a structure in which a plurality of wires are twisted together, for example, even if the material constituting the second wire is inferior in strength and elasticity, the strength and elasticity are improved by making the second wire stranded. It becomes possible.

When the second wire has a structure in which a plurality of wires are twisted together, it is preferable that the first wire is a single wire. That is, it is preferable that the basket 30 has a single wire first wire and a stranded wire second wire. Since the second wire has a structure in which a plurality of wires are twisted together and the first wire is a single wire, for example, the second wire has characteristics that the first wire does not have, but the single wire has strength and elasticity. Various characteristics can be imparted to the basket 30 by using a material lacking in the amount of material and using a material having sufficient strength and elasticity for the first wire as a single wire.

The second wire is, for example, at least one selected from the group consisting of lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-tungsten alloy, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, and tantalum. It is preferable that the second wire contains an X-ray impermeable substance such as a seed, and the second wire preferably has a structure in which a plurality of wires are twisted together. The X-ray impermeable substance usually has low elasticity, high rigidity, and poor plastic deformation. In order to make the basket 30 expandable when it goes out of the cylinder by using the wire rod containing the X-ray impermeable substance, it is necessary to reduce the thickness of the wire rod containing the X-ray impermeable substance. On the other hand, if the wire is made thinner, the visibility under fluoroscopy is lowered. Therefore, since the second wire contains an X-ray impermeable substance and has a stranded wire configuration, it is possible to achieve both the elasticity of the second wire and the visibility under fluoroscopy.

Although not shown, it is also preferable that at least one of the first wire and the second wire has a core portion and an outer layer portion that covers the core portion. Specifically, the first wire may have a single-layer structure having a core portion and an outer layer portion, and the second wire may have a single-layer structure having no core portion and an outer layer portion, and the first wire has a single-layer structure. The second wire may have a core portion and an outer layer portion, or the first wire and the second wire may have a core portion and an outer layer portion, and the first wire and the second wire may have a core portion and an outer layer portion. May have a single layer structure.

Examples of the material constituting the core portion and the outer layer portion of at least one of the first wire and the second wire include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, aluminum, gold and silver. , Lead, barium, iodine, iridium, stainless steel, titanium, Ni—Ti alloy, Co—Cr alloy and other metals. Above all, it is preferable that the first wire and the second wire have a core portion containing an X-ray impermeable substance and an outer layer portion containing a Ni—Ti alloy. At least one of the first wire and the second wire has a core portion containing an X-ray impermeable substance and an outer layer portion containing a Ni—Ti alloy. While the portion enhances the visibility of the basket 30 under X-ray fluoroscopy, the outer layer portion enhances the elasticity so that the basket 30 discharged from the first cylinder 11 can be quickly expanded. Further, the first wire and the second wire may have the same configuration.

In the first embolization system 1, as shown in FIG. 1, in the lumen of the first cylinder 11, the basket pusher 40 and the coil pusher 110 can independently slide in the long axis direction of the first cylinder 11. Is preferable. In the lumen of the first cylinder 11, the basket pusher 40 and the coil pusher 110 can independently slide in the long axis direction of the first cylinder 11, so that the basket pusher 40 and the cage pusher 40 are in the lumen of the first cylinder 11. Even if both of the coil pushers 110 are arranged, the operation of discharging the basket 30 from the first cylinder 11 by the basket pusher 40 and the operation of discharging the coil body 100 from the first cylinder 11 by the coil pusher 110 are performed. Each can be done independently. Therefore, it becomes easy to perform an embolization technique using the first embolization system 1 in which the basket 30 is placed in a target portion such as inside a knob and then the coil body 100 is placed in the basket 30.

In the second embolization system 1, as shown in FIG. 5, the second cylinder 12 has a first lumen 121 and a second lumen 122, in the first lumen 121, a basket 30 and a basket pusher 40 in the lumen. It is preferable that the arranged third cylinder 13 is arranged, and the first cylinder 11 in which the coil body 100 and the coil pusher 110 are arranged in the lumen is arranged in the second lumen 122. That is, the second cylinder 12 has a first lumen 121 in which the third cylinder 13 is arranged and a second lumen 122 in which the first cylinder 11 is arranged, and the lumen of the first cylinder 11 is arranged. A coil body 100 and a coil pusher 110 are arranged in the coil body 100, and a basket 30 and a basket pusher 40 are preferably arranged in the lumen of the third cylinder 13.

The second cylinder 12 has a first lumen 121 and a second lumen 122, and the first lumen 121 is arranged with a third cylinder 13 in which the basket 30 and the basket pusher 40 are arranged in the lumen, and the second lumen is arranged. By arranging the first cylinder 11 in which the coil body 100 and the coil pusher 110 are arranged in the lumen in 122, the rigidity of the second cylinder 12 of the second embolization system 1 is increased, and the pushability is improved. be able to. Further, after arranging the basket 30 and the coil body 100 at the target site using the second embolization system 1, the coil body 100 and the coil pusher 110 are inside while the second cylinder 12 is arranged in the in-vivo lumen. By replacing the first cylinder 11 arranged in the lumen and the third cylinder 13 in which the basket 30 and the basket pusher 40 are arranged in the lumen, the basket 30 and the coil body 100 are added and placed at the target site. You can do that quickly.

As described above, the first embolization system of the present invention is an intraluminal aneurysm embolization system, which is arranged in the lumen of the first cylinder having a distal end and a proximal end and the lumen of the first cylinder. It has multiple wires, is expandable when it goes out of the first cylinder, and is arranged in a basket composed of mesh-like wall surfaces where multiple wires intersect and on the proximal side of the basket. It has a basket pusher, a coil body arranged in the lumen of the first cylinder, and a coil pusher arranged on the proximal side of the coil body, and the mesh opening of the basket is the first. One cylinder can be inserted, and the coil body is formed by winding a wire to form a primary shape, and the coil portion of the primary shape is wound to form a secondary shape. The basket has a mesh in which the major axis of the opening of the mesh is smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape. Further, the second embolization system of the present invention is an embolization system for a knob in a lumen, which is arranged in a first cylinder having a distal end and a proximal end and in the lumen of the first cylinder. It is arranged in the lumen of the coil body, the coil pusher arranged on the proximal side of the coil body, the second cylinder having a distal end and the proximal end, and the lumen of the second cylinder, and has a plurality of wires. It has a basket composed of a mesh-like wall surface where multiple wires intersect, and a basket pusher located on the proximal side of the basket, which is expandable when it goes out of the second cylinder. The mesh opening of the basket allows the first cylinder to be inserted, and the coil body is formed by winding a wire to form a primary shape, and the coil portion of the primary shape is wound to form a secondary shape. The basket has a mesh in which the major axis of the mesh opening of the basket is smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape. Since the embolic system of the present invention has such a configuration, it is possible to insert the first cylinder through the opening of the mesh and arrange the coil body in the basket, while the major axis of the opening of the mesh is the coil body. Since it is smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape, it is difficult for the coil body arranged in the basket to go out of the basket through the opening of the mesh. Therefore, it is easy to arrange the coil body in the basket, and the coil body arranged in the basket does not easily go out of the basket, so that the coil body can be stably placed in the knob.

This application claims the benefit of priority based on Japanese Patent Application No. 2020-23879 filed on December 23, 2020. The entire contents of the specification of Japanese Patent Application No. 2020-23879 filed on December 23, 2020 are incorporated herein by reference.

1: Embolization system 11: 1st cylinder 12: 2nd cylinder 13: 3rd cylinder 20: Wire 21: Intersection 22: Opening 30: Basket 40: Basket pusher 51: 1st binding part 52: 2nd binding part 60: Connection Member 70: Heating mechanism 80: Bundling tool 100: Coil body 110: Coil pusher 121: 1st lumen 122: 2nd lumen D1: Long diameter of mesh opening D2: Short diameter of mesh opening

Claims

An embolic system for aneurysms in the lumen
A first cylinder with a distal end and a proximal end,
A basket that is located in the lumen of the first cylinder, has a plurality of wires, is expandable when it goes out of the first cylinder, and is composed of a mesh-like wall surface on which the plurality of wires intersect. When,
With the basket pusher located on the proximal side of the basket,
The coil body arranged in the lumen of the first cylinder and
It has a coil pusher, which is located on the proximal side of the coil body.
The mesh opening of the basket allows the first cylinder to be inserted through the basket.
The coil body is formed by winding a wire to form a primary shape, and winding a coil portion of the primary shape to form a secondary shape.
The basket is an embolic system in which the major axis of the mesh opening of the basket is smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape.
An embolic system for aneurysms in the lumen
A first cylinder with a distal end and a proximal end,
The coil body arranged in the lumen of the first cylinder and
With the coil pusher arranged on the proximal side of the coil body,
A second cylinder with a distal end and a proximal end,
A basket that is located in the lumen of the second cylinder, has a plurality of wires, is expandable when it goes out of the second cylinder, and is composed of a mesh-like wall surface on which the plurality of wires intersect. When,
It has a basket pusher, which is located on the proximal side of the basket.
The mesh opening of the basket allows the first cylinder to be inserted through the basket.
The coil body is formed by winding a wire to form a primary shape, and winding a coil portion of the primary shape to form a secondary shape.
The basket is an embolic system in which the major axis of the mesh opening of the basket is smaller than the diameter of the curvature of the secondary shape in the winding of the primary shape.
The embolic system according to claim 2, wherein the first cylinder is arranged in the lumen of the second cylinder.
The embolization system according to any one of claims 1 to 3, wherein the short diameter of the mesh opening of the basket is larger than the diameter of the winding of the wire forming the primary shape.
The embolization system according to any one of claims 1 to 4, wherein the short diameter of the mesh opening of the basket is larger than the outer diameter of the distal end of the first cylinder.
The embolic system according to any one of claims 1 to 5, wherein the first cylinder has a tapered portion at the distal end whose outer diameter decreases toward the distal side.
The embolic system according to any one of claims 1 to 6, wherein the ratio of the diameter of the wire to the diameter of the winding of the wire forming the primary shape is 0.01 or more and 0.5 or less. ..
Ratio of the diameter of the wire to the diameter of the winding of the wire forming the primary shape = the diameter of the wire / the diameter of the winding of the wire forming the primary shape
The embolic system according to any one of claims 1 to 7, which has a detachable connecting member located proximal to the basket and distal to the basket pusher. ..
The material constituting the connecting member has the property of melting by heat.
The embolic system according to claim 8, further comprising a heating mechanism for heating the connecting member.
The embolic system according to claim 1, wherein the basket pusher and the coil pusher can independently slide in the lumen of the first cylinder in the long axis direction of the first cylinder.
The second cylinder has a first lumen and a second lumen.
In the first lumen, a third cylinder in which the basket and the basket pusher are arranged in the lumen is arranged.
The embolic system according to claim 2 or 3, wherein the coil body and the first cylinder in which the coil pusher is arranged in a lumen are arranged in the second lumen.