In-vivo indwelling implement and system for delivering material for in-vivo indwelling implement

Abstract

To provide an in-vivo indwelling implement that can reduce such the risk of unexpectedly occluding a vessel such as peripheral vessels because of leakage or scattering of a material for an in-vivo indwelling implement such as an embolic agent and is facilitated in preventing generation of ischemia, and to provide a system for delivering a material for an in-vivo indwelling implement.SOLUTION: An in-vivo indwelling implement 1 includes: a stent 2 including a radial direction y; and a tubular body 10 fixed to the stent 2 and extending in the radial direction y with the expansion of the stent 2, the tubular body 10 including a side wall 11 and a lumen and further including at least one opening-closing part 20 for communicating between the lumen and the outside of the tubular body 10 in the side wall 11.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an in-vivo indwelling device to be placed in a vascular diseased area, and a delivery system for a material to be placed in the body using the in-vivo indwelling device. [Background technology]

[0002] Endovascular treatment is one of the treatments for vascular lesions such as head and neck aneurysms, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, renal artery aneurysms, thoracic aneurysms, abdominal aneurysms, iliac artery aneurysms, acute aortic dissection, etc. In endovascular treatment, an in-vivo indwelling device such as a stent graft, flow diverter stent, or embolization coil is placed at the target site to promote thrombosis, thereby preventing, for example, the rupture of an aneurysm.

[0003] For example, Patent Documents 1 to 3 disclose stent grafts. The stent graft has a stent and a graft as a tubular body that extends in the radial direction. Patent Document 4 also discloses an occlusion device for treating the left atrial appendage rather than intravascular lesions. Specifically, Patent Document 4 discloses that a left atrial appendage in which a thrombus has formed is treated by using an occlusion device in which a balloon is configured to receive tissue adhesive, and tissue adhesive flows into the balloon from the proximal end of the conduit and flows out through multiple openings. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2018-516735 [Patent Document 2] Special Publication No. 2007-508067 [Patent Document 3] Japanese Patent Publication No. 2022-24124 [Patent Document 4] Special Publication No. 2020-521561 Summary of the Invention [Problem to be solved by the invention]

[0005] The tissue adhesive disclosed in Patent Document 4 can be applied to the left atrial appendage when delivered as a liquid, but when applied to an intravascular lesion, there is a risk that the tissue adhesive may leak or splash into peripheral blood vessels, resulting in occlusion of unintended blood vessels (lacunar infarction, etc.). Furthermore, balloons have traditionally been used to prevent polymeric materials such as embolic agents from leaking into areas not targeted for placement, but there is a risk of ischemia occurring due to balloon expansion.

[0006] In view of the above circumstances, an object of the present invention is to provide an in-vivo indwelling device and a delivery system for a material to be placed in a body that can reduce the risk of occluding unintended blood vessels, such as peripheral blood vessels, due to leakage or scattering of an embolic agent or other material to be placed in a body, and that can easily prevent the occurrence of ischemia. [Means for solving the problem]

[0007] The in-vivo indwelling device according to the embodiment of the present invention that can solve the above problems is as follows. [1] A stent having a radial direction; an in-vivo indwelling device comprising: a tubular body fixed to the stent and extending in the radial direction as the stent expands, the tubular body having a side wall and an inner lumen, and at least one opening / closing portion on the side wall that connects the inner lumen to the outside of the tubular body.

[0008] Furthermore, the in-vivo indwelling device according to the embodiment is preferably any one of the following [2] to [9]. [2] The tubular body has a longitudinal axis direction; The in-vivo indwelling device according to [1], wherein the opening and closing part is disposed in a central region that is located in the middle when the length of the tubular body is divided into three equal parts in the longitudinal axis direction. [3] The tubular body has a longitudinal axis direction and a circumferential direction; The tubular body has a plurality of the opening and closing portions, The in-vivo indwelling device according to [1] or [2], wherein the plurality of opening and closing sections are arranged at different positions in the longitudinal direction or the circumferential direction of the tubular body. [4] The in-vivo indwelling device according to any one of [1] to [3], wherein the opening and closing part is a slit. [5] The tubular body has a longitudinal axis direction; The in-vivo indwelling device according to [4], wherein the slit extends so as to be inclined at an angle of 15 degrees or more and 45 degrees or less with respect to the longitudinal axis of the tubular body. [6] The in-vivo indwelling device according to [4] or [5], wherein the slit has three or more linear portions, and the three or more linear portions have a shape that extends radially in a direction away from a predetermined central position. [7] The in-vivo indwelling device according to any one of [1] to [3], wherein the opening / closing section has an opening arranged in the side wall and a lid that covers the opening. [8] The in-vivo indwelling device according to any one of [1] to [7], further comprising a radiopaque marker arranged around the opening and closing part. [9] The in-vivo indwelling device according to [8], wherein the radiopaque marker is fixed to the tubular body.

[0009] The delivery system for a material to be placed in a living body according to an embodiment of the present invention, which has been able to solve the above problems, is as follows.

[10] A stent having a radial direction; a tubular body having a longitudinal axis direction, fixed to the stent, and extending in the radial direction as the stent expands, the tubular body having a side wall and an inner lumen, and at least one opening / closing portion on the side wall that connects the inner lumen to the outside of the tubular body; a catheter inserted into the lumen of the tubular body and the opening / closing portion, the catheter extending in the longitudinal axis direction and having a lumen for delivering the material to be placed in a body distally.

[0010] Furthermore, the delivery system for a material to be placed in a living body according to the embodiment preferably satisfies the following

[11] .

[11] The catheter has a longitudinal axis and a distal end and a proximal end along the longitudinal axis; The delivery system for a material to be placed in a living body according to

[10] , wherein the distal end of the catheter is exposed to the outside of the tubular body through the opening and closing part when the opening and closing part is in an open state. [Effects of the Invention]

[0011] In the above-described in-vivo indwelling device and delivery system for a material for placement in a body, the in-vivo indwelling device can be placed at a lesion in the body, and the material for placement in a body can be delivered to the lesion through the open / close part. Because the tubular body has an open / close part, when the open / close part is in an open position, the material for placement in a body can be discharged from the open / close part to the lesion located outside the tubular body. Furthermore, when the open / close part is in a closed position, the material for placement in a body can be prevented from leaking out of the tubular body. This reduces the risk of blocking unintended blood vessels, such as peripheral blood vessels, due to leakage or scattering of the material for placement in a body, such as an embolic agent, and also makes it easier to prevent ischemia. [Brief explanation of the drawings]

[0012] [Figure 1] 1 is a side view of an in-vivo indwelling device according to one embodiment of the present invention. [Figure 2] FIG. 2 is a cross-sectional end view taken along line II-II shown in FIG. [Figure 3] FIG. 3 is a cross-sectional end view taken along line III-III shown in FIG. [Figure 4] FIG. 2 is a side view showing a modified example of the in-vivo indwelling device shown in FIG. [Figure 5] 5 is a cross-sectional end view taken along line VV shown in FIG. 4. FIG. [Figure 6] FIG. 6 is a cross-sectional end view showing a modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. 5. [Figure 7] FIG. 2 is a side view showing a modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 8] 1. FIG. 4 is a side view showing another modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 9]FIG. 10 is an enlarged side view of the opening and closing part of yet another modified example of the in-vivo indwelling device shown in FIG. [Figure 10] FIG. 10 is a side view showing a modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 11] FIG. 10 is a side view showing another modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 12] FIG. 10 is a side view showing yet another modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 13] FIG. 10 is a side view showing yet another modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 14] FIG. 10 is a side view showing yet another modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 15] FIG. 10 is a cross-sectional end view showing yet another modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. 2, showing the opening and closing part in a closed state. [Figure 16] FIG. 16 is a cross-sectional end view showing the open state of the opening / closing part of the in-vivo indwelling device shown in FIG. [Figure 17] FIG. 10 is a side view showing yet another modified example of the opening and closing part of the in-vivo indwelling device shown in FIG. [Figure 18] FIG. 18 is an end view of the section perpendicular to the longitudinal axis direction of the in-vivo indwelling device shown in FIG. [Figure 19] FIG. 10 is a side view showing yet another modified example of the in-vivo indwelling device shown in FIG. [Figure 20] 1 is a cross-sectional end view of a delivery system for a material to be placed in a living body according to one embodiment of the present invention, showing the openable / closable part in a closed state. [Figure 21] 21 is a cross-sectional end view showing the open state of the opening / closing part of the delivery system for the implanted material shown in FIG. 20. FIG. [Figure 22] FIG. 21 is a schematic diagram of the delivery system for the implantable material shown in FIG. 20 placed inside the body. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from actual dimensions, as priority is given to helping understand the features of the present invention.

[0014] The gist of one embodiment of the present invention resides in that it comprises a stent having a radial direction, and a tubular body fixed to the stent and extending in the radial direction as the stent expands, the tubular body having a side wall and an inner lumen, and at least one opening / closing portion on the side wall that connects the inner lumen to the outside of the tubular body.

[0015] Furthermore, a delivery system for a material to be placed in a body in one embodiment of the present invention is characterized by comprising: a stent having a radial direction; a tubular body having a longitudinal direction, fixed to the stent, and extending radially as the stent expands, the tubular body having a side wall and a lumen, and at least one opening / closing portion on the side wall that connects the lumen to the outside of the tubular body; and a catheter to be inserted into the lumen and the opening / closing portion of the tubular body, extending in the longitudinal direction, and having a lumen for delivering the material to be placed in a body distally.

[0016] In the above-mentioned in-vivo indwelling device and delivery system for a material for placement in a body, the material for placement in a body can be delivered to the lesion through the open / close part by placing the in-vivo indwelling device at a lesion inside the body. Because the tubular body has an open / close part, when the open / close part is in an open state, the material for placement in a body can be ejected from the open / close part to the lesion located outside the tubular body, and when the open / close part is in a closed state, the material for placement in a body can be prevented from leaking out of the tubular body. This reduces the risk of blocking unintended blood vessels, such as peripheral blood vessels, due to leakage or scattering of the material for placement in a body, such as an embolic agent, and also makes it easier to prevent ischemia.

[0017] Hereinafter, an in-vivo indwelling device may be referred to as an indwelling device, a material for placement in a body as an indwelling material, and a delivery system for a material for placement in a body as a delivery system. An indwelling device is used in a lumen in the body and is placed, for example, at a lesion in a lumen in the body. Examples of the use of an indwelling device include treatment of vascular lesions such as head and neck aneurysms, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, renal artery aneurysms, thoracic aneurysms, abdominal aneurysms, iliac artery aneurysms, and acute aortic dissection. Of these, it is preferable that the indwelling device be used to treat cerebral aneurysms. Examples of the shape of the aneurysm include fusiform and saccular.

[0018] An in-vivo indwelling device according to one embodiment of the present invention will be described with reference to Figs. 1 to 19. A delivery system for an in-vivo material according to one embodiment of the present invention will be described with reference to Figs. 20 to 22. Fig. 1 is a side view of an in-vivo indwelling device according to one embodiment of the present invention. Fig. 2 is a cross-sectional end view taken along line II-II in Fig. 1. Fig. 3 is a cross-sectional end view taken along line III-III in Fig. 1. Fig. 4 is a side view showing a modified version of the in-vivo indwelling device shown in Fig. 1. Fig. 5 is a cross-sectional end view taken along line VV in Fig. 4. Fig. 6 is a cross-sectional end view showing a modified version of the opening and closing section of the in-vivo indwelling device shown in Fig. 5. Fig. 7 is a side view showing a modified version of the opening and closing section of the in-vivo indwelling device shown in Fig. 1. Fig. 8 is a side view showing another modified version of the opening and closing section of the in-vivo indwelling device shown in Fig. 1. Fig. 9 is an enlarged side view of the opening and closing section showing yet another modified version of the opening and closing section of the in-vivo indwelling device shown in Fig. 1. Figs. 10 to 14 are side views showing modified versions of the opening and closing section of the in-vivo indwelling device shown in Fig. 9. FIG. 15 is a cross-sectional end view showing yet another modified example of the opening and closing portion of the in-vivo indwelling device shown in FIG. 2, showing the closed state of the opening and closing portion. FIG. 16 is a cross-sectional end view showing the open state of the opening and closing portion of the in-vivo indwelling device shown in FIG. 15. FIG. 17 is a side view showing yet another modified example of the opening and closing portion of the in-vivo indwelling device shown in FIG. 9. FIG. 18 is a cross-sectional end view perpendicular to the longitudinal axis of the in-vivo indwelling device shown in FIG. 17. FIG. 19 is a side view showing yet another modified example of the in-vivo indwelling device shown in FIG. 1. FIG. 20 is a cross-sectional end view of a delivery system for a material to be placed in a body according to one embodiment of the present invention, showing the closed state of the opening and closing portion. FIG. 21 is a cross-sectional end view showing the open state of the opening and closing portion of the delivery system for a material to be placed in a body shown in FIG. 20. FIG. 22 is a schematic diagram of the delivery system for a material to be placed in a body shown in FIG. 20. As shown in FIG. 1, the indwelling device 1 has a stent 2 and a tubular body 10, and the tubular body 10 has an opening and closing portion 20. As shown in FIGS. 1 and 20, a delivery system 50 for a material 45 to be placed in a body includes an indwelling device 1 having a stent 2 and a tubular body 10, and a catheter 40.

[0019] As shown in FIG. 1, the stent 2 has a radial direction y. The stent 2 preferably has a longitudinal axis direction x. The stent 2 also preferably has a circumferential direction p. The proximal side of the stent 2 refers to the direction toward the user or surgeon with respect to the longitudinal axis direction x of the stent 2, and the distal side refers to the opposite direction from the proximal side, i.e., the direction toward the treatment target. In FIG. 1, the right side of the drawing is the proximal side, and the left side of the drawing is the distal side. The radial direction y of the stent 2 refers to the radial direction of the stent 2, and the inward direction in the radial direction of the stent 2 refers to the direction toward the center of the longitudinal axis of the stent 2, and the outward direction in the radial direction y refers to the direction extending radially from the center of the longitudinal axis opposite to the inward direction. The circumferential direction p of the stent 2 refers to the direction around the longitudinal axis.

[0020] As shown in FIGS. 1 and 2, the tubular body 10 is fixed to the stent 2 and extends in the radial direction y as the stent 2 expands. The tubular body 10 has a side wall 11 and a lumen 12, and the side wall 11 has at least one open / close part 20 that connects the lumen 12 to the outside of the tubular body 10. With the above-mentioned indwelling device 1, by placing the indwelling device 1 at a lesion in the body, a material for placement in a living body 45 can be delivered to the lesion through the open / close part 20. For example, in a procedure, the indwelling device 1 is first placed at a lesion in the body, and then a catheter 40 is inserted into the indwelling device 1, and the catheter 40 is exposed to the outside of the tubular body 10 through the open / close part 20, allowing the material for placement 45, such as a polymer material, to be delivered to the lesion through the lumen of the catheter 40. Furthermore, when the opening / closing part 20 is in the open state, the placement material 45 can be discharged from the opening / closing part 20 to the lesion located outside the tubular body 10, while when the opening / closing part 20 is in the closed state, the placement material 45 can be prevented from leaking out of the tubular body 10. Therefore, the risk of blocking unintended blood vessels such as peripheral blood vessels due to leakage or scattering of the placement material 45, such as an embolic agent, can be reduced, and the occurrence of ischemia can be more easily prevented.

[0021] The placement of the indwelling device 1 in the body can be achieved, for example, by the following procedure: First, a guidewire is inserted into a blood vessel. A microcatheter, which serves as a delivery tube for the indwelling device 1, is inserted along the guidewire. Once the microcatheter has been guided to the location of the lesion (e.g., an aneurysm) in the blood vessel, the guidewire is removed, and a delivery device mounted with the indwelling device 1 is inserted to the location of the lesion (e.g., an aneurysm) in the blood vessel. When placed in the delivery device, the indwelling device 1 contracts in the radial direction y of the stent 2 and expands in the longitudinal direction x, resulting in a reduced-diameter state that is more elongated and cylindrical than the expanded state. At this time, the tubular body 10 is positioned to straddle the aneurysm. When the indwelling device 1 is exposed from the delivery device, the stent 2 expands, fixing the indwelling device 1 to the blood vessel, and the tubular body 10 forms an artificial blood vessel. When the indwelling device 1 adheres to the blood vessel wall, blood flows through the indwelling device 1, thereby suppressing the blood inflow rate and blood flow rate into the aneurysm.

[0022] When placed in a delivery device, the indwelling device 1 contracts in the radial direction y of the stent 2 and expands in the longitudinal direction x, thereby assuming a reduced-diameter state in which the indwelling device 1 is cylindrical and longer than the expanded state. The indwelling device 1 is preferably expandable in the radial direction y from a first diameter to a second diameter. The size of the indwelling device 1 in the radial direction y is variable, and the first diameter is, for example, the diameter obtained when a compressive force is applied inward in the radial direction y to the stent 2, causing the diameter to contract, and the second diameter is, for example, the diameter obtained when the compressive force applied inward in the radial direction y to the stent 2 is released, causing the diameter to expand outward in the radial direction y. Note that the delivery device for the indwelling device 1 and the delivery system 50 for the material for placement in a living body 45 are different entities.

[0023] Each element constituting the indwelling device 1 will be further explained below.

[0024] The shape of the indwelling device 1 is not particularly limited, but it is preferably a tubular shape, and more preferably a tubular shape having only one lumen 12 .

[0025] The stent 2 is preferably a self-expanding stent, which allows it to expand to a predetermined size by itself by removing an external member that restricts the expansion of the stent.

[0026] The stent 2 is preferably tubular in shape, more preferably having only one lumen 12 .

[0027] The form of the stent 2 is not particularly limited, and examples thereof include (a) a coiled stent made of a single linear metal and / or polymer material, (b) a stent processed by cutting a metal tube or a tube made of a polymer material with a laser, (c) a stent assembled by welding linear members with a laser, and (d) a stent 2 made by weaving or knitting multiple linear metals, among which form (d) is preferred. The specific structure of the stent 2 will be described later.

[0028] The stent 2 preferably has a mesh structure. The mesh structure preferably has a plurality of meshes 8. The plurality of meshes 8 are preferably aligned in the longitudinal axis direction x. Also, the plurality of meshes 8 are preferably aligned in the circumferential direction p. Although not shown, the stent 2 may have a plurality of cells and links connecting adjacent cells.

[0029] 1, the stent 2 may have a distal stent section 3 extending from a distal end 2D of the stent 2 to a distal end 10D of the tubular body 10 in the longitudinal axis direction x, and a proximal stent section 4 extending from a proximal end 2P of the stent 2 to a proximal end 10P of the tubular body 10. The stent 2 may also have a central stent section 5 located between the distal stent section 3 and the proximal stent section 4 in the longitudinal axis direction x and overlapping with the tubular body 10.

[0030] 1, the stent 2 preferably has a distal end 2D and a proximal end 2P in the longitudinal axis direction x. The tubular body 10 preferably has a distal end 10D and a proximal end 10D in the longitudinal axis direction x.

[0031] In FIG. 1 , the distal end 2D of the stent 2 is located distal to the distal end 10D of the tubular body 10, and the proximal end 2P of the stent 2 is located proximal to the proximal end 10P of the tubular body 10. As such, the tubular body 10 preferably exists only in a portion of the stent 2 in the longitudinal axis direction x, and more preferably the tubular body 10 exists from a position distal to the distal end 2D of the stent 2 to a position proximal to the proximal end 2P of the stent 2. Because the indwelling device 1 has the tubular body 10, it is generally less likely to self-expand than a device consisting only of the stent 2. However, by providing the tubular body 10 partially in the longitudinal axis direction x, the self-expansion of the tubular body 10 can be promoted along with the self-expansion of the portion without the tubular body 10.

[0032] Although not shown, in the longitudinal axis direction x, the distal end 2D of the stent 2 may be positioned to overlap the distal end 10D of the tubular body 10, and the proximal end 2P of the stent 2 may be positioned to overlap the proximal end 10P of the tubular body 10. In other words, the tubular body 10 may be disposed from the distal end 2D of the stent 2 to the proximal end 2P.

[0033] The stent 2 may be made of any material, as long as it can withstand deformations such as diameter expansion and contraction and placement, and is biocompatible. The stent 2 preferably contains a metal. The metal is preferably an elastic metal and / or a shape-memory alloy. Preferred metals for the stent 2 include stainless steels such as SUS304 and SUS316, platinum, gold, silver, nickel, cobalt, chromium, titanium, tungsten, aluminum, magnesium, or alloys thereof. Ni-Ti alloys, Cu-Al-Ni alloys, and magnesium alloys are more preferred, with magnesium alloys being even more preferred. Using magnesium as the material for the stent 2 is expected to provide biodegradable properties, thereby shortening the duration of oral administration of antiplatelet or anticoagulant drugs. Furthermore, because magnesium is highly biodegradable in the bloodstream, the decomposition rate of magnesium can be adjusted by coating the surface of the aforementioned magnesium wire with a resin.

[0034] The stent 2 may contain a resin. The stent 2 may be made of a resin, or the stent 2 may have a stent body made of metal and a coating material made of resin that coats the surface of the stent body. The resin is not particularly limited as long as it is a biocompatible material. In addition to the materials that make up the tubular body described below, at least one of polylactic acid (PLA), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), lactic acid / glycolic acid copolymer (PLGA), polycaprolactone (PCL), polydioxanone (PDS), and polyurea is preferably used, with polyurea being more preferred. By using polyurea as the coating material that coats the surface of the stent body made of metal, endothelial cells will coat the outer periphery of the indwelling device 1 within 1 to 2 months after the indwelling device 1 is placed in the body. Polyurea is preferred to maintain the structural strength of the stent 2 during this period.

[0035] The stent 2 may contain an inorganic material such as ceramic or metal oxide. The stent 2 may have a stent body made of metal and a coating material made of ceramic or metal oxide that coats the surface of the stent body.

[0036] As shown in Figure 1, the stent 2 is preferably made of wires 6 (element wires). The stent 2 is preferably formed by weaving or knitting a plurality of wires 6. The wires 6 may be twisted wires, but are preferably solid wires. Examples of the wires 6 include metal wires, resin wires, and metal wires whose surfaces are coated with resin or inorganic materials such as ceramics or metal oxides.

[0037] The diameter of the wire 6 constituting the stent 2, i.e., the wire diameter, is not particularly limited, but may be, for example, 5.0 μm or more, 6.0 μm or more, 7.0 μm or more, and is also acceptable to be 12 μm or less, 11 μm or less, or 10 μm or less.

[0038] The shape of the cross section perpendicular to the longitudinal axis direction of the wire 6 is not particularly limited, and may be circular, elliptical, polygonal, irregular, or a combination of these.

[0039] The outer diameter of the wire 6 may be the same in the longitudinal direction of the wire 6, or may vary depending on the position in the longitudinal direction of the wire 6. When the cross section of the wire 6 is not circular, the outer diameter of the wire refers to the diameter equivalent to a circle.

[0040] An antithrombogenic material may be coated on the surface of the wire 6. As the antithrombogenic material, for example, 2-methacryloyloxyethyl phosphorylcholine or a material in which 2-methoxyethyl acrylate is covalently bonded can be used.

[0041] The diameter of the stent 2, i.e., the length of the stent 2 in the radial direction y, is appropriately selected based on the inner diameter of the blood vessel to be treated. For example, the diameter of the stent 2 for cerebral aneurysms is preferably 2.0 mm to 5.0 mm, and more preferably 2.5 mm to 4.5 mm. The diameter of the stent 2 for aortic aneurysms is preferably 4.5 mm to 15.0 mm, and more preferably 5.0 mm to 13.0 mm.

[0042] The length of the stent 2 in the longitudinal axis direction x is appropriately selected based on the length of the lesion to be treated. For example, the length of the stent 2 for cerebral aneurysms is preferably 10 mm to 50 mm, and more preferably 12 mm to 45 mm. The length of the stent 2 for aortic aneurysms is preferably 20 mm to 120 mm, and more preferably 25 mm to 100 mm.

[0043] The tubular body 10 is preferably a tubular structure arranged along the peripheral wall of the stent 2. The tubular body 10 is preferably a tubular membrane. The tubular body 10 includes what is generally called a graft (artificial blood vessel). The tubular body 10 is preferably a cylindrical body having only one lumen. The longitudinal axis of the stent 2 and the longitudinal axis of the tubular body 10 are preferably coaxial with each other.

[0044] The tubular body 10 may be composed of a single layer or multiple layers. For example, the tubular body 10 may have an inner layer and an outer layer disposed radially outward of the inner layer. The tubular body 10 may also have an intermediate layer between the inner layer and the outer layer in the radial direction y.

[0045] As shown in Figures 1 to 3, a portion of the stent 2, for example, the central stent section 5, may be located further inward in the radial direction y than the tubular body 10. That is, the tubular body 10 may cover the stent 2 from the outer side in the radial direction y. In another embodiment, as shown in Figures 4 and 5, a portion of the stent 2, for example, the central stent section 5, may be located further outward in the radial direction y than the tubular body 10. That is, in a side view of the indwelling device 1, a portion of the stent 2 may be exposed from the tubular body 10.

[0046] 6, a portion of the stent 2, for example, the central stent portion 5, may be contained within the tubular body 10. That is, a portion of the stent 2 may be embedded within the tubular body 10. By arranging the tubular bodies 10 so as to sandwich the stent 2 in the radial direction y, it is possible to obtain the effect of suppressing thrombotic complications associated with thrombus adhesion to the wire 6 of the central stent 5.

[0047] The method for fixing the tubular body 10 to the stent 2 is not particularly limited, and examples thereof include suturing, adhesion, welding, and the like.

[0048] The tubular body 10 is preferably made of a biocompatible material, and is preferably made of a polymeric material. Examples of polymeric materials that can be used to make the tubular body 10 include polyester, polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polyurethane, polyamide, nylon, collagen, and gelatin. The material that makes up the tubular body 10 preferably includes at least one selected from polyester, polyethylene terephthalate, polytetrafluoroethylene, polyurethane, polyacrylonitrile, polyamide, polylactic acid, polyglycolic acid, polyhydroxybutyrate, chitosan, and collagen. The tubular body 10 is preferably made of an elastic material so that it can expand in the radial direction y as the stent 2 expands. In particular, polytetrafluoroethylene is preferably subjected to a stretching process, which creates fine pores through stretching, thereby increasing flexibility and blood vessel compression.

[0049] The tubular body 10 may be formed into a tubular shape by a method such as extrusion molding or blow molding using a polymer material. The tubular body 10 may be a woven fabric, knitted fabric, or nonwoven fabric made of polymer fibers, a protein, or a combination thereof. Among these, the tubular body 10 is preferably a knitted fabric made of collagen fibers. The braided structure of collagen fibers allows the tubular body 10 to function as a scaffold for vascular endothelial cells during aneurysm repair. The tubular body 10 may also be a tubular sheet made of a polymer material. The sheet may be porous. Even if the above-mentioned materials are used for the tubular body 10, rapid endothelialization of the tubular body 10 may be more rapid than expected, potentially causing intimal hyperplasia within the stent 2 or a persistent inflammatory reaction in the vascular wall. Therefore, the tubular body 10 may be a combination of two or more of the above-mentioned structures, and proteins and / or drugs may be immobilized on the fiber surface. For example, by first modifying the surface of a polylactic acid substrate with polydopamine and polyethyleneimine, a tubular body 10 can be obtained in which the surface is coated by hydrophobic interactions with hydrophobic resin materials and by hydrogen bonds or coordinate bonds with metal materials or hydrophilic resin materials. Furthermore, the surface is preferably coated with collagen by electrostatic interactions. Humanized collagen type III is particularly preferred, and the combination of these materials can provide intimal hyperplasia inhibitory and anti-inflammatory properties. Alternatively, the tubular body 10 can be impregnated with antihyperplasia drugs such as rapamycin or sirolimus, or anti-inflammatory drugs such as HMG-CoA reductase inhibitors and COX-2 inhibitors for direct drug action. In this case, the drug to be added to the fiber is preferably processed into a fiber shape by electrospinning. The fiber diameter is not particularly limited, but may be, for example, 10 nm or more, 25 nm or more, or 50 nm or more. The fiber diameter may also be 100 nm or less, 500 nm or less, or 1000 nm or less. The voltage applied during electrospinning is not particularly limited, but for example, fibers can be obtained by producing them from a nozzle at an applied voltage of 15 to 20 kV and a flow rate of 0.12 to 0.20 ml / h. Furthermore, the fiber diameter can be adjusted by controlling the nozzle inner diameter and pressure.For example, if the nozzle diameter is 300 nm and the extrusion pressure is 0.02 MPa, fibers with a diameter of 100 nm to 500 nm can be obtained.

[0050] It is preferable that particles made of a radiopaque material are present inside the tubular body 10. This allows the position of the tubular body 10 within the body cavity to be identified under radioscopy. Hereinafter, particles made of a radiopaque material may be simply referred to as particles.

[0051] Examples of radiopaque materials include lead, barium, iodine, tungsten, gold, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, tantalum, and bismuth.

[0052] The particles may be present within the tubular body 10 in a portion of the longitudinal axis direction x, but are preferably present within the tubular body 10 over the entire longitudinal axis direction x.

[0053] The particles are preferably encapsulated in the tubular body 10, and are preferably dispersed within the tubular body 10. The particles may be exposed on the surface of the tubular body 10. The particles may also cover the surface of the tubular body 10.

[0054] The particle size of the particles is not particularly limited, but may be, for example, 10.0 nm or more, 50.0 nm or more, 100.0 nm or more, or 200 nm or more. The particle size may also be 5.0 μm or less, 4.0 μm or less, 3.0 μm or less, 2.0 μm or less, or 1.0 μm or less. Here, "particle size" refers to the volume average particle size (D50) at the 50% median diameter in the particle size distribution obtained by dynamic light scattering or the like. Commercially available particles may be used, in which case the particle size listed in the catalog can be used.

[0055] A method for making particles present inside the tubular body 10 includes, for example, adding particles when kneading the material (preferably the polymer material described above) that constitutes the tubular body 10 using an extruder or the like.

[0056] The configuration of the open-close part 20 will be described in detail below. As shown in Figures 1 to 3, the tubular body 10 has a side wall 11 and a lumen 12, and has at least one open-close part 20 that connects the lumen 12 to the outside of the tubular body 10. The open-close part 20 can be in an open state in which other members can be exposed or other materials can be discharged from the open-close part 20, and in a closed state in which these members or materials can be prevented from leaking from the tubular body 10.

[0057] The tubular body 10 is required to have at least one open-close section 20, and may have multiple open-close sections 20. For example, the tubular body 10 in Figures 1 to 2 and 4 has only one open-close section 20, while the tubular body 10 in Figures 7 and 8 has multiple open-close sections 20. If there is one open-close section 20, it is possible to pinpoint the lesion, and if there are multiple open-close sections 20, it is possible to expose other members or eject other materials from the open-close section 20 over a wide area of ​​the lesion.

[0058] 1, the opening / closing part 20 may be disposed in a central region 10B that is located in the center when the length of the tubular body 10 is divided into three equal parts in the longitudinal axis direction x of the tubular body 10. By disposing the opening / closing part 20 in the central region 10B, it becomes easier to position the opening / closing part 20 so that it corresponds to the position of the lesion during the procedure.

[0059] Although not shown, when the length of the tubular body 10 is divided into three equal parts in the longitudinal axis direction x of the tubular body 10, a distal region 10A, a central region 10B, and a proximal region 10C, the open-close portion 20 may be disposed in the distal region 10A. Alternatively, the open-close portion 20 may be disposed in the proximal region 10C. The open-close portion 20 may be disposed so as to straddle two of the distal region 10A, the central region 10B, and the proximal region 10C. The open-close portion 20 may be disposed in two or more of the distal region 10A, the central region 10B, and the proximal region 10C.

[0060] The tubular body 10 has a longitudinal axis direction and a circumferential direction. When the tubular body 10 has multiple open-close sections 20, the multiple open-close sections 20 are preferably arranged at different positions in the longitudinal axis direction (FIG. 7) or circumferential direction (FIG. 8) of the tubular body 10. In the embodiment shown in FIG. 7, the ejection position of the in-vivo implantable material 45 can be selected during the procedure in the longitudinal axis direction of the tubular body 10, and in the embodiment shown in FIG. 8, the ejection position of the in-vivo implantable material 45 can be selected in the circumferential direction of the tubular body 10. Therefore, when delivering the indwelling device 1 into the body, there is no need to perform an operation to adjust the position of the open-close section 20 to match the position of the lesion. The multiple open-close sections 20 may be arranged at different positions in the longitudinal axis direction and circumferential direction of the tubular body 10. In FIGS. 7 and 8, the longitudinal axis direction and circumferential direction of the tubular body 10 coincide with the longitudinal axis direction x and circumferential direction p of the stent 2, respectively. This also applies to the subsequent figures.

[0061] As shown in Fig. 7, the multiple open-close sections 20 are preferably arranged at equal intervals in the longitudinal axial direction of the tubular body 10. Furthermore, as shown in Fig. 8, the multiple open-close sections 20 are preferably arranged at equal intervals in the circumferential direction of the tubular body 10. By arranging the open-close sections 20 in a balanced manner in a specific direction in this way, it becomes easier to select the discharge position of the placement material 45.

[0062] The number of opening and closing sections 20 that one tubular body 10 has can be set appropriately depending on the size of the tubular body 10, but may be, for example, 2 or more, 3 or more, 4 or more, 5 or more, or 20 or less, 18 or less, or 15 or less.

[0063] The structure of the open-close part 20 of the tubular body 10 is not particularly limited as long as it can assume the open and closed states described above, but it is preferable that the open-close part 20 penetrates the side wall 11 of the tubular body 10. This allows the open-close part 20 to communicate between the lumen 12 of the tubular body 10 and the outside of the tubular body 10. In order to facilitate communication between the lumen 12 of the tubular body 10 and the outside of the tubular body 10, it is preferable that the open-close part 20 be arranged in a region in the radial direction of the indwelling device 1 where the tubular body 10 is present but where the members constituting the stent 2 are not present.

[0064] The size of the opening / closing part 20 in the side view of the indwelling device 1 is not particularly limited, but may be, for example, 0.60 mm or more, 0.70 mm or more, and is also acceptable to be 1.0 mm or less, 0.90 mm or less.

[0065] For example, as shown in Figures 1 and 2, the opening / closing unit 20 is preferably a slit 21. The slit 21 can be opened by pressing the distal end of the catheter 40 against the slit 21. The slit 21 can be closed by withdrawing the catheter 40 from the slit 21. Since the opening / closing unit 20 is a slit 21, it can be easily switched between the open and closed states, and in the closed state, it is easy to prevent the placement material 45 in the lumen 12 of the tubular body 10 from leaking out of the tubular body 10. Here, the slit 21 refers to a cut or a narrow gap, and for example, the slit 21 has a longitudinal direction and a lateral direction perpendicular to the longitudinal direction, and has a shape in which the slit length in the longitudinal direction is at least five times the slit length in the lateral direction.

[0066] Examples of methods for forming the slits 21 in the tubular body 10 include cutting the side wall 11 of the tubular body 10 with a blade such as a knife or a cutter, or removing part of the tubular wall of the tubular body 10 with a drill, a punch, or an apparatus capable of irradiating laser light or the like to open radial holes in the side wall 11. Forming the slits 21 by cutting the side wall 11 with a blade is preferred because this makes it easy to create the opening and closing portion 20.

[0067] The slit 21 preferably has a linear shape, a curved shape, or a shape that is a combination of these.

[0068] 1 and 2, the slits 21 may extend in the longitudinal direction of the tubular body 10. As shown in Fig. 9, the slits 21 may extend in the circumferential direction of the tubular body 10.

[0069] The slit 21 may have a shape obtained by cutting out a portion of a circle, a polygon, or an irregular shape. Here, circle includes a perfect circle, an ellipse, an oval, an egg, and a rectangle with rounded corners. For example, in FIG. 10, the slit 21 has a shape obtained by cutting out a portion of an ellipse. Such a slit 21 also makes it easier to reduce the gap with the catheter 40 in the open state.

[0070] The tubular body 10 has a longitudinal axis direction, and the slit 21 preferably extends so as to be inclined at an angle of 15 degrees to 45 degrees relative to the longitudinal axis direction of the tubular body 10. In this case, the slit is preferably linear. For example, in FIG. 11 , the slit 21 is inclined at an angle θ relative to the longitudinal axis direction of the tubular body 10. By inclining the slit relative to the longitudinal axis direction of the tubular body 10 in this manner, it becomes easier to prevent the material for placement in a body 45, which is discharged from the catheter 40 into the aneurysm through the opening / closing section 20, from falling into the parent blood vessel lumen 62. The inclination angle θ of the slit relative to the longitudinal axis direction of the tubular body 10 may be 10 degrees or more, 20 degrees or more, or 30 degrees or more, or may be 60 degrees or less, 50 degrees or less, or 45 degrees or less.

[0071] As shown in FIG. 12 , the slit 21 preferably has three or more linear portions 22, each extending radially in a direction away from a predetermined central position 23. Because the slit 21 has a radially extending shape, when the distal end of the catheter 40 is pressed against the slit 21, the slit 21 is bent to fit the outer surface of the catheter 40, allowing the opening area of ​​the slit 21 to be adjusted according to the outer diameter of the catheter 40. For example, if the outer diameter of the catheter 40 is large, the slit 21 opens wider, and if the outer diameter of the catheter 40 is small, the slit 21 opens narrower. Therefore, even when the slit 21 is open, leakage of the placement material 45 from the slit 21 is more easily prevented. Hereinafter, a slit 21 having three or more linear portions 22 extending radially in a direction away from the predetermined central position 23 may be referred to as a radial slit 21.

[0072] As shown in Figure 12, it is preferable that each linear portion 22 has a distal end 22A and a proximal end 22B in its extension direction. The extension direction of the linear portion 22 can be rephrased as a direction away from the central position 23. The distal end 22A is located at the position of the linear portion 22 farthest from the central position 23, and the proximal end 22B is located at a position overlapping with the central position 23. The proximal ends 22B of three or more linear portions 22 are connected at the central position 23. In Figure 12, the distal ends 22A of the three or more linear portions 22 do not overlap with one another. Note that the central position 23 is defined when no other components, such as a catheter 40, are placed in the slit 21.

[0073] The linear portion 22 preferably has a linear shape, a curved shape, or a shape that is a combination of these, and more preferably has a linear linear portion 22 as shown in Figure 12. When the linear portion 22 is linear, it becomes easier to form the opening / closing portion 20 in the tubular body 10. In Figure 12, the slit 21 has three linear linear portions 22. In Figure 13, the slit 21 has four linear linear portions 22. As a result, a cross-shaped slit is formed. In Figure 14, the slit 21 has three curved linear portions 22. In each of Figures 12 to 14, the slit 21 is formed in a rotationally symmetrical shape.

[0074] The number of linear portions 22 that the radial slits 21 have may be three or more, may be four or more, may be five or more, may be ten or less, nine or less, or eight or less.

[0075] The lengths of the linear portions 22, that is, the lengths from the base ends 22B to the tips 22A, of the three or more linear portions 22 may be the same or different from one another.

[0076] 15 and 16, the opening / closing unit 20 may have an opening 24 arranged in the side wall 11 and a lid 25 that covers the opening 24. The opening / closing unit 20 can be set to an open state by pressing a member such as a catheter 40 against the lid 25 that covers the opening 24 from the inside of the tubular body 10. In addition, the opening / closing unit 20 can be set to a closed state by moving the catheter 40 proximally and withdrawing the member such as the catheter 40 from the opening 24.

[0077] The opening 24 may be arranged so as to penetrate the side wall 11. The opening 24 may have an outer opening located on the outer surface side of the tubular body 10 and an inner opening located on the inner cavity 12 side of the tubular body 10. The opening 24 can be formed in the same manner as the formation of the slit.

[0078] Hereinafter, the direction in which the cross-sectional center line of the opening extends from the outer opening to the inner opening will be referred to as the extending direction of the opening 24. The extending direction of the opening 24 may be along the radial direction of the tubular body 10, or may be inclined relative to the radial direction of the tubular body 10. Furthermore, part of the extending direction of the opening 24 may be along the radial direction of the tubular body 10, and the remaining part may be inclined relative to the tubular body 10.

[0079] The opening area of ​​the opening 24 may be constant throughout the extension direction of the opening 24. This configuration makes it easier to insert the catheter 40 through the opening 24. Here, the opening area of ​​the opening 24 being constant includes a variation in size within ±5%. Furthermore, the opening area of ​​the opening 24 may vary depending on the position in the extension direction of the opening 24. For example, the opening area of ​​the opening 24 may become smaller from the inner opening toward the outer opening.

[0080] The shape of the opening 24 in a cross section perpendicular to the extension direction of the opening 24 may be, for example, circular, polygonal, irregular, etc. Here, circular includes a perfect circle, an ellipse, an oval, an egg, and a rectangle with rounded corners.

[0081] The lid 25 is preferably fixed to the tubular body 10 in an openable and closable manner. The lid 25 is preferably fixed to an edge portion disposed on the outer periphery of the opening 24. The lid 25 may be fixed to the outer surface of the tubular body 10 or may be fixed to the inner surface of the tubular body 10. Examples of methods for fixing the lid 25 to the tubular body 10 include adhesive bonding, welding, and sewing.

[0082] The lid 25 may be made of any suitable biocompatible material. Preferably, the lid 25 is made of a flexible material. Preferably, the lid 25 is made of an elastic material. The lid 25 may be made of a different material from the tubular body 10, but in order to facilitate bonding to the tubular body 10, it is preferred that the lid 25 and the tubular body 10 be made of the same material.

[0083] The lid 25 can be made up of one or more members. The shape of the lid 25 is not particularly limited as long as it can openably cover the opening 24, and examples of the shape of the lid include a film shape, a membrane shape, a plate shape, and a check valve shape.

[0084] 15 and 16, for example, a single membrane-like lid 25 covers the opening 24. When a single membrane-like lid 25 covers the opening 24 in this manner, it is preferable that the shape of the lid 25 is similar to the shape of the opening 24 in a side view of the indwelling device 1. The length of the lid 25 in the radial direction y is defined as the thickness of the lid 25. The thickness of the lid 25 is not particularly limited, but when a single membrane-like lid 25 covers the opening 24, it is preferable that the thickness of the lid 25 is the same as or smaller than the thickness of the side wall 11 of the tubular body 10.

[0085] 17 and 18 illustrate a lid 25 having multiple flaps arranged along the outer periphery of the opening 24. In FIG. 17, the lid 25 has three flaps 26A, 26B, and 26C. Each flap is curved from the edge of the opening 24 toward the center of the opening 24 as it moves from the inside to the outside in the radial direction of the tubular body 10. Therefore, by pressing the catheter 40 against the flap, the flap can be opened, and the retention material 45 can be discharged through the flap and the catheter 40. On the other hand, when the flap is closed and the catheter 40 is not in contact with the flap, two flaps adjacent to each other in the outer periphery of the opening 24 are in close contact with each other without any gaps, which prevents the retention material 45 from leaking from the lumen 12 of the tubular body 10 to the outside of the tubular body 10.

[0086] 17, each of the three flaps 26A, 26B, and 26C has a generally fan-like shape. Each flap has two radius portions extending in the radial direction of the opening 24 and an arc-shaped portion extending in the circumferential direction of the opening 24 and sandwiched between the two radius portions. The arc-shaped portion of each flap is fixed to an edge on the periphery of the opening 24.

[0087] The indwelling device 1 may have one or more radiopaque markers. This makes it possible to identify the positions of the indwelling device 1, stent 2, tubular body 10, and opening / closing portion 20 within a body cavity under radioscopy. The radiopaque marker is preferably an X-ray opaque marker. Hereinafter, the radiopaque marker may be simply referred to as a marker.

[0088] The marker can be fixed to at least one of the stent 2, the wire 6, the tubular body 10, and other members of the indwelling device 1.

[0089] When the indwelling device 1 has a plurality of markers, the markers may be arranged side by side in the longitudinal axis direction x, or may be arranged side by side in the circumferential direction p.

[0090] The shape of the marker is not particularly limited and may be a circle, an oval, a polygon, a plate, a column, a cone, a frustum, a sphere, an L-shape, a T-shape, a ring, a C-shaped cross section with a notch in the ring, a coil shape with a wound wire, or a combination of these shapes. The shape of the marker is not particularly limited and may be a plate, a column, a cone, a frustum, a sphere, an L-shape, a T-shape, a ring, a C-shaped cross section with a notch in the ring, a coil shape with a wound wire, or a combination of these shapes. Note that FIG. 19 shows an example in which marker 31 is circular and markers 32A, 32B, 33A, and 33B are disk-shaped.

[0091] The marker may contain a radiopaque substance, for which the above description of radiopaque materials can be referred to.

[0092] The marker can be fixed to the indwelling device 1 by methods such as welding, fusion bonding, adhesion, suturing, or crimping. When the marker is placed on the stent 2, it is preferably fixed to the stent 2 (preferably to the wire 6) by welding. When the marker is placed on the tubular body 10, it is preferably fixed to the tubular body 10 by adhesion. Examples of adhesives that can be used include acrylic adhesives and urethane adhesives.

[0093] As shown in Figure 19, it is preferable that the indwelling device 1 further has a radiopaque marker 31 arranged around the openable / closable part 20. By arranging the marker 31 around the openable / closable part 20, the position of the openable / closable part 20 in the body can be identified, thereby enabling the procedure to be performed efficiently. It is preferable that the marker 31 be arranged around the entire outer periphery of the openable / closable part 20. It is preferable that the marker 31 be fixed to the tubular body 10.

[0094] It is preferable that a marker 31 is disposed near the opening / closing section 20. For example, the reference length is defined as the longer of the length of one opening / closing section 20 in the longitudinal axis direction x of the tubular body 10 and the length of that one opening / closing section 20 in the circumferential direction of the tubular body 10. It is preferable that at least a part of the marker 31 is located within a region surrounded by an imaginary circle whose center is the centroid of the opening / closing section 20 and whose radius is twice the size of the reference length, and it is preferable that the entire marker 31 is located within that region.

[0095] The indwelling device 1 may further have a radiopaque marker disposed at at least one of the distal end and the proximal end of the tubular body 10. Figure 19 shows an example in which a radiopaque marker 32A is disposed at the distal end of the tubular body 10 and a radiopaque marker 32B is disposed at the proximal end of the tubular body 10. By providing markers at least at the distal end and the proximal end of the tubular body 10 in this way, the position of the tubular body 10 within the body can be identified, thereby enabling the procedure to be performed efficiently.

[0096] When at least one of the markers 31, 32A, and 32B is fixed to the tubular body 10, the marker may be fixed to the radially outer surface of the tubular body 10 or to the radially inner surface of the tubular body 10. The marker may also penetrate the tubular body 10 in the radial direction of the tubular body 10. The marker may also be embedded in the tubular body 10.

[0097] 19, it is preferable that at least one of the markers 31, 32A, and 32B is disposed in the mesh 8 of the mesh structure portion of the stent 2. In other words, it is preferable that the marker 31 is disposed so as not to overlap with the wire rod 6 constituting the stent 2.

[0098] Although not shown, the tubular body 10 has a radial direction, and when the thickness of the tubular body 10 is divided into two equal parts in the radial direction into an inner part and an outer part, the indwelling device 1 may further have a radiopaque marker disposed on the inner part. This makes it easier to identify the position of the tubular body 10 inside the body while preventing the marker from coming into contact with the inner wall of the blood vessel.

[0099] The indwelling device 1 may further have a radiopaque marker arranged on the stent 2. For example, in Fig. 19, a marker 33A is arranged on the distal end 2D of the stent 2, and a marker 33B is arranged on the proximal end 2P of the stent 2. This makes it easier to identify the position of the stent 2.

[0100] 20 to 22, a delivery system 50 for a material for placement in a body 45 will be described. The delivery system 50 for a material for placement in a body 45 according to one embodiment of the present invention is characterized in that it comprises: a stent 2 having a radial direction y; a tubular body 10 having a longitudinal axis direction x, which is fixed to the stent 2 and extends in the radial direction y as the stent 2 expands, the tubular body 10 having a side wall 11 and a lumen 12 and at least one open-close portion 20 in the side wall 11 that connects the lumen 12 to the outside of the tubular body 10; and a catheter 40 that is inserted into the lumen 12 and the open-close portion 20 of the tubular body 10, which extends in the longitudinal axis direction x and has a lumen 41 for delivering the material for placement in a body 45 to the distal side.

[0101] The above description can be referred to for the configuration of the stent 2 and the tubular body 10.

[0102] As can be seen from Figure 20, the catheter 40 has a longitudinal axis direction. The catheter 40 preferably has a radial direction, which is a direction perpendicular to the longitudinal axis direction, and a circumferential direction, which is a direction along the outer periphery. The catheter 40 has a distal end and a proximal end in the longitudinal axis direction. In Figure 20, the longitudinal axis direction, radial direction, and circumferential direction of the catheter 40 coincide with the longitudinal axis direction x, radial direction y, and circumferential direction p of the tubular body 2, respectively.

[0103] As shown in Figures 20 and 21, the catheter 40 has a lumen 41 for delivering the placement material 45 to the distal side. Multiple lumens 41 may be provided, but it is preferable to provide only one lumen. The lumen 41 preferably extends in the longitudinal axis direction of the catheter 40. The catheter 40 is preferably, for example, a tube having a cylindrical shape.

[0104] The catheter 40 preferably has an opening 42 on the side wall of the distal portion or in a portion including the distal end. Figures 20 and 21 show an example in which the opening 42 is provided in a portion including the distal end of the catheter 40. The opening 42 connects the lumen 41 with the outside of the catheter 40. As can be seen from Figure 22, the provision of the opening 42 allows the retention material 45 to be delivered from the proximal side to the distal side through the lumen 41. As a result, the retention material 45 can be expelled from the opening 42 to the outside of the catheter 40.

[0105] As shown in Figure 22, it is preferable that the distal end of the catheter 40 is exposed to the outside of the tubular body 10 from the open-close unit 20 when the open-close unit 20 is in the open state. In Figure 22, by pressing the distal end of the catheter 40 against a slit 21 serving as the open-close unit 20, the distal end of the catheter 40 can be exposed to the outside of the tubular body 10 through the open-close unit 20. As a result, the placement material 45 can be discharged toward the lump 61 outside the tubular body 10.

[0106] The outer surface of the tubular body 10 preferably contacts the blood vessel wall 60. This fixes the position of the tubular body 10 inside the body, preventing the placement material 45 from migrating from within the aneurysm 61 or leaking into the parent blood vessel lumen 62, making efficient occlusion easier.

[0107] The catheter 40 may have one or more lumens 41 and openings 42, but preferably has only one lumen 41 and one opening 42. This makes it easier to eject the placement material 45 toward the lesion, making it easier to place the placement material 45 at the lesion.

[0108] The shape of the opening 42 is not particularly limited, and may be, for example, a circle, an oval, a polygon, a combination of these, or an irregular shape.

[0109] The material constituting the catheter 40 is preferably a resin, a metal, or a combination of a resin and a metal. Using a resin as the material constituting the catheter 40 makes it easier to impart flexibility and elasticity to the catheter 40. Furthermore, using a metal as the material constituting the catheter 40 can improve the insertability of the catheter 40 into the lumen of a blood vessel.

[0110] Examples of resins that can be used to form the catheter 40 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, polystyrene resins, fluorine-based resins, vinyl chloride resins, silicone resins, natural rubber, synthetic rubber, and polyimides. These may be used alone or in combination. When DMSO is used as the solvent for the placement material 45, the resin that forms the catheter 40 is preferably polyethylene, polypropylene, polystyrene, fluorine-based resins, or a mixture thereof. This can reduce damage to the catheter 40 caused by DMSO.

[0111] Examples of metals that can be used to form the catheter 40 include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, nickel-titanium alloys, cobalt-chromium alloys, and combinations thereof. The catheter 40 may be formed by combining a metal with a resin, or may have a configuration in which a cylindrical body made of resin is combined with a reinforcing material such as a wire made of the above metal.

[0112] The diameter of the lumen 41 is preferably 0.2 mm or more, more preferably 0.5 mm or more, even more preferably 0.7 mm or more, and is preferably 2.2 mm or less, more preferably 2.0 mm or less, and even more preferably 1.8 mm or less. If the lumen 41 has a diameter within the above range, the placement material 45 can be introduced into the lumen 41 and discharged from the opening 42 into the aneurysm 61 without impairing the insertability of the catheter 40 through the blood vessel lumen.

[0113] The outer diameter of the catheter 40 is preferably 0.7 mm or more, more preferably 1.0 mm or more, even more preferably 1.5 mm or more, and is preferably 3.5 mm or less, more preferably 3.0 mm or less, and even more preferably 2.5 mm or less. By having the outer diameter of the catheter 40 within the above range, the catheter 40 can be made to have appropriate rigidity and improved insertability in the blood vessel lumen.

[0114] Although not shown, the catheter 40 may have a handle at its proximal portion to facilitate manipulation of the catheter 40. The handle may be connected to the proximal portion of the catheter 40. The handle may be made up of one or more members.

[0115] Although not shown, the delivery system 50 may include the catheter 40 and a material supply unit connected to the catheter 40 for introducing the placement material 45 into the lumen 41. The material supply unit may be connected to the handle. For example, a syringe or a pressurizer may be used as the material supply unit.

[0116] The placement material 45 passing through the lumen 41 is preferably a biocompatible medical adhesive also known as an embolic agent. The placement material 45 may be in a liquid, sol, or gel form, as long as it can be introduced into the lumen 41 and expelled from the opening 42 of the catheter 40. It is more preferable that the placement material 45 be made of a material, such as a hydrogel, that undergoes a sol-gel transition in response to a combination of at least one initiator selected from temperature, solvent, pH, and ultraviolet light.

[0117] From the viewpoint of preventing leakage or scattering from the target site, the retention material 45 preferably has a viscosity of at least a predetermined level, and the viscosity at 25°C is preferably at least 0.1 Pa·s, more preferably at least 0.5 Pa·s, even more preferably at least 1.0 Pa·s, and preferably at most 200 Pa·s, more preferably at most 150 Pa·s, and even more preferably at most 100 Pa·s. Even if the retention material 45 has a viscosity above a predetermined level, the maximum pressure applied to the lumen 41 can be increased, and therefore the retention material 45 introduced from the proximal side of the lumen 41 can be discharged from the opening 42. Alternatively, in an embodiment in which the retention material 45 is hardened after being discharged from the opening 42 as described below, the retention material 45 before hardening may have a low viscosity (approximately 1 mPa·s) similar to that of water.

[0118] Examples of the placement material 45 include cyanoacrylate adhesives, polyvinyl alcohol adhesives, polyurethane adhesives, fibrin adhesives, and gelatin adhesives. The placement material 45 may contain a metal such as tantalum powder to improve visibility. The placement material 45 may be dissolved in a solvent such as dimethyl sulfoxide (DMSO) before use.

[0119] The placement material 45 is preferably a material that gels at 35° C. or higher, more preferably a material that gels at 36° C. or higher, and even more preferably a material that gels at 37° C. or higher. The placement material 45 is also preferably a material that gels at 40° C. or lower, and more preferably a material that gels at 39° C. or lower. By using a material that can gel at in vivo temperatures in this way, a device for hardening the placement material 45 is not required, and the procedure time can be shortened.

[0120] Poly(N-isopropylacrylamide) (PNIPAM) gel is suitable for the implantation material 45. NIPAM has hydrophilic amide groups and hydrophobic isopropyl groups. Hydrogen bonds form around the amide groups at temperatures below 32°C. At temperatures above 32°C, molecular motion becomes active, breaking the hydrogen bonds. The hydrophobic isopropyl groups gather, forcing water out of the gel, causing the gel to shrink. Preferably, functionality is imparted by substituting carboxylic acid, hydroxyl, ketone, or ether groups to gel at 37°C, the in vivo temperature. Alternatively, pH responsiveness can be imparted to the gel by copolymerizing NIPAM with methacrylic acid. More preferably, both pH and temperature responsiveness can be imparted by using NIPAM with acrylic acid and a diacrylamide crosslinker. Even more preferably, the molecular weight of the polymer to be polymerized is controlled by varying the concentration of a chain transfer agent, thereby adjusting the target gel to suit the application. Alternatively, the implantation material 45 may be composed of a gel containing a reaction product of an ethylenically unsaturated monomer, a crosslinker, and, if necessary, a bifunctional macromer, and a visualization agent. The visualization agent is primarily a positive contrast agent that absorbs X-rays during X-ray imaging in intravascular treatment, such as a water-soluble iodine contrast agent. Alternatively, the implantation material 45 may be a material that gels upon chemical reaction with the components of the visualization agent. [Explanation of symbols]

[0121] 1: Intravital device 2: Stent 6: Wire rod 10: Tubular body 10B: Central area 11: Side wall 12: Lumen 20: Opening and closing section 21: Slit 22: Linear part 23: Center position 24:Aperture 25: Lid 31, 32A, 32B, 33A, 33B: Radiopaque markers 40: Catheter 41: lumen 42:Aperture 45: Materials for placement in vivo 50: Delivery System 60: Blood vessel wall 61: Aneurysm 62: Parent vessel lumen x: longitudinal axis direction y: radial direction p: Circumferential direction

Claims

1. a stent having a radial direction; an in-vivo indwelling device comprising: a tubular body fixed to the stent and extending in the radial direction as the stent expands, the tubular body having a side wall and an inner lumen, and at least one opening / closing portion on the side wall that connects the inner lumen to the outside of the tubular body.

2. the tubular body has a longitudinal axis direction; 2. The in-vivo indwelling device according to claim 1, wherein the opening / closing portion is disposed in a central region that is located in the middle when the length of the tubular body is divided into three equal parts in the longitudinal direction.

3. the tubular body has a longitudinal axis direction and a circumferential direction; The tubular body has a plurality of the opening and closing portions, 3. The in-vivo indwelling device according to claim 1, wherein the plurality of opening and closing portions are arranged at different positions in the longitudinal direction or the circumferential direction of the tubular body.

4. 3. The in-vivo indwelling device according to claim 1, wherein the opening and closing portion is a slit.

5. the tubular body has a longitudinal axis direction; 5. The in-vivo indwelling device according to claim 4, wherein the slit extends so as to be inclined at an angle of 15 degrees to 45 degrees with respect to the longitudinal axis of the tubular body.

6. 5. The in-vivo indwelling device according to claim 4, wherein the slit has three or more linear portions, and the three or more linear portions have a shape extending radially in a direction away from a predetermined center position.

7. 3. The in-vivo indwelling device according to claim 1, wherein the opening / closing section has an opening disposed in the side wall and a lid that covers the opening.

8. 3. The in-vivo indwelling device according to claim 1, further comprising a radiopaque marker disposed around the opening and closing part.

9. The in-vivo indwelling device according to claim 8, wherein the radiopaque marker is fixed to the tubular body.

10. a stent having a radial direction; a tubular body having a longitudinal axis direction, fixed to the stent, and extending in the radial direction as the stent expands, the tubular body having a side wall and an inner lumen, and at least one opening / closing portion on the side wall that connects the inner lumen to the outside of the tubular body; a catheter inserted into the lumen of the tubular body and the opening / closing portion, the catheter extending in the longitudinal axis direction and having a lumen for delivering the material to be placed in a body distally.

11. the catheter has a longitudinal axis and a distal end and a proximal end along the longitudinal axis; 11. The delivery system for a material to be placed in a living body according to claim 10, wherein the distal end of the catheter is exposed to the outside of the tubular body through the opening and closing part when the opening and closing part is in an open state.

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