Aneurysm neck embolization component and method for manufacturing an aneurysm neck embolization component

Abstract

The present invention provides an aneurysm neck embolization member with flexibility in the neck region, and a method for manufacturing the aneurysm neck embolization member. [Solution] The device has a main body (collectively referred to as a body 52, neck 53, head 54, etc.) made of a tubular mesh material knitted by weft knitting to be flexible, and the main body includes a neck 53 that can fit into the neck of the aneurysm from the inside, and a body 52 knitted continuously with the neck 53 and inserted into the inside of the aneurysm, with the neck 53 interposed between one end in the axial direction and the other end of the neck 53, and the other end of the neck facing the neck N of the aneurysm from the side of the parent artery located outside the aneurysm and locked to the neck N of the aneurysm.

Description

Technical Field

[0001] The present invention relates to an aneurysm neck embolization member and a method for manufacturing an aneurysm neck embolization member.

Background Art

[0002] Numerous techniques have been proposed for treating aneurysms, which are local dilations, expansions, or dissections of arteries caused by, for example, weakened blood vessel walls. For example, open surgery is a technique for confirming and treating the position outside the aneurysm blood vessel. When undergoing open surgery, the patient had to receive general anesthesia, and the doctor had to cut various tissues to reach the aneurysm. Therefore, the patient may suffer significant brain damage (damage) in the aneurysm and other areas. For example, when treating a cerebral aneurysm outside the blood vessel, the doctor has to remove a part of the patient's skull and may damage the brain tissue during the treatment.

[0003] On the other hand, as an intravascular treatment, the mainstream technique is to form an embolism inside the aneurysm. This is because intravascular surgery causes the least damage to the brain. As a technique for forming an embolism, for example, a microcatheter is advanced to the aneurysm, the distal end of the microcatheter is inserted into the aneurysm, and an embolizing material is injected into the aneurysm using the microcatheter.

[0004] However, in the method of forming an embolism inside the aneurysm, generally, a detachable coil is inserted, and the coil inserted inside the aneurysm may move out of the aneurysm and into the parent artery. Or, when a detachable coil is injected, it is difficult to accurately measure how much the aneurysm is filled. Therefore, there is a risk of overfilling the aneurysm, and in that case, the detachable coil may also overflow into the parent artery, or there is a risk of rupturing the aneurysm due to overfilling with coils.

[0005] In recent years, there has also been a medical device called a flow diverter. As described on the following website, for example, a flow diverter deploys a tubular mesh material within the parent blood vessel to shield the aneurysm and restrict blood flow to it. https: / / www.medtronic.com / jp-ja / your-health / conditions / severe-spasticity.html This flow diverter has several drawbacks, including difficulty or inability to guide it into parent vessels that are 1-2 mm in diameter, and the risk of the flow diverter getting stuck in the neck of the aneurysm. Furthermore, if a liquid polymer, which is an embolizing agent, is injected into an aneurysm, the hemodynamics of the vascular system may cause the liquid polymer to migrate out of the aneurysm, potentially leading to irreversible occlusion of the parent artery.

[0006] Therefore, Patent Document 1 discloses a neck clipping device having a first foot inserted into the aneurysm and a second foot inserted outside the aneurysm (i.e., inside the parent artery) at both ends. With the neck clipping device, the first foot inserted into the aneurysm and the second foot inserted outside the aneurysm clamp the aneurysm neck (so-called neck portion) between the parent artery and the aneurysm from both sides, so there is no possibility of the neck clipping device or either foot coming out of the aneurysm or overfilling the aneurysm.

[0007] However, in the neck clipping device disclosed in Patent Document 1, the first foot inserted into the aneurysm and the second foot inserted outside the aneurysm are formed by bundling metal wire feet or polymer feet with polymer tubes turned outward, which may cause excessive pressure to be applied to the blood vessel or aneurysm. The pressure on the aneurysm wall should be as close to 0 grams as possible, as this can trigger aneurysm rupture. If 0 grams cannot be achieved, the pressure must be 6 grams or less, and under no circumstances less than 15 grams.

[0008] Furthermore, the neck clipping device disclosed in Patent Document 1 has four first feet inserted into the aneurysm and four second feet inserted outside the aneurysm, with wide spacing between the first feet or between the second feet. In other words, due to the wide spacing between the feet, the high effect of platelet migration and adhesion to endothelial cells that would normally occur between the feet (so-called intima formation) cannot be expected.

[0009] Furthermore, the neck clipping device disclosed in Patent Document 1 has a configuration that includes a first foot inserted into the aneurysm and a second foot inserted outside the aneurysm on both sides of the main body, and because it involves a large number of parts, it may be difficult to manufacture, or the size of the neck clipping device may become large.

[0010] Therefore, considering the above problems, the inventors proposed an aneurysm neck embolization member and a method for manufacturing the aneurysm neck embolization member that, despite having a simple structure, enables the formation of an embolization in an aneurysm without applying excessive pressure to the blood vessel or aneurysm (Patent Document 2). In the aneurysm neck embolization member disclosed in Patent Document 2, the neck contracts to interpose the neck of the aneurysm between one end and the other end in the axial direction. Furthermore, in the aneurysm neck embolization member of Patent Document 2, the other end of the neck is positioned opposite the neck of the aneurysm from the side of the parent artery located outside the aneurysm and locked to the neck of the aneurysm. In other words, the aneurysm neck embolization member of Patent Document 2 can be positioned in a suitable location for the procedure without applying excessive pressure to the neck of the aneurysm by utilizing the contractility of its neck. [Prior art documents] [Patent Documents]

[0011] [Patent Document 1] Japanese Patent Publication No. 2003-275218 [Patent Document 2] Patent No. 7427202 [Overview of the Initiative] [Problems that the invention aims to solve]

[0012] Incidentally, it is desirable that aneurysm neck embolization members of the type that lock onto the neck of an aneurysm (hereinafter sometimes referred to as "organized embolization members"), such as those disclosed in Patent Document 2, be flexibly applicable to aneurysms of various sizes and shapes. In particular, in the case of relatively large aneurysms, it is necessary to guide a considerable amount of implant into a vessel with a diameter of 1-2 mm and take a considerable amount of time to occlude the aneurysm. The aforementioned flow diverters are also difficult to guide into a vessel with a diameter of 1-2 mm (this difficulty is evident from their low success rate). Furthermore, flow diverters and Terumo's WEB (Woven EndoBridge device) have limitations in the morphology of aneurysms to which they can be applied, and cannot be said to be flexibly applicable to all types of aneurysms. Compared to these conventional technologies, the aneurysm neck embolization member implant according to the present invention has the advantage of only requiring a member that locks onto the neck of the aneurysm. This specification clarifies the configuration, method of guiding, and manufacturing method of an aneurysm neck embolization member that is anchored to the neck of an aneurysm, allowing it to be guided into a blood vessel of approximately 2 mm in diameter.

[0013] The present invention aims to provide an aneurysm neck embolization member that provides flexibility to the neck, and a method for manufacturing an aneurysm neck embolization member. [Means for solving the problem]

[0014] (1) The aneurysm neck embolization member is It has a main body made of a tubular mesh material that is knitted by weft weft to give it flexibility, The main body portion is The neck portion can be fitted from the inside to the neck of the aneurysm, It includes a body that is formed in continuous with the neck and inserted into the aneurysm, The neck of the aneurysm is interposed between one end and the other end in the axial direction. The other end of the neck is positioned opposite the neck of the aneurysm from the side of the parent artery located outside the aneurysm and is locked to the neck of the aneurysm. (2) Method for manufacturing an aneurysm neck embolization member A method for manufacturing an aneurysm neck embolization member for manufacturing the aneurysm neck embolization member of (1) above, using an automatic weft knitting machine, wherein the automatic weft knitting machine feeds out a yarn of a material suitable for the aneurysm neck embolization member for the knitting purpose, and knits the neck and the body part by weft knitting, is characterized.

Effect of the Invention

[0015] According to the present invention, an aneurysm neck embolization member having flexibility in the neck and a method for manufacturing the aneurysm neck embolization member can be provided.

Brief Description of the Drawings

[0016] [Figure 1A] It is a schematic diagram of the first structure of the aneurysm neck embolization member according to the present invention. [Figure 1B] It is a schematic diagram of the first structure of the aneurysm neck embolization member according to the present invention. [Figure 2A] It is a schematic diagram of the cylindrical mesh material of the aneurysm neck embolization member according to the present invention. [Figure 2B] It is a schematic diagram of the second structure of the aneurysm neck embolization member according to the present invention. [Figure 2C] It is a schematic diagram of the second structure of the aneurysm neck embolization member according to the present invention. [Figure 3] It is a cross-sectional view showing an in-vivo detaching tool including the aneurysm neck embolization member according to the present invention. [Figure 4] It is a cross-sectional view showing the states before and after the movement of the aneurysm neck embolization member by a catheter and a guide wire. [Figure 5A] It is a schematic diagram showing the first structure of the aneurysm neck embolization member according to the present invention. [Figure 5B] It is a schematic diagram showing the first structure of the aneurysm neck embolization member according to the present invention. [Figure 6] It is a perspective view showing the first structure of the aneurysm neck embolization member three-dimensionally. [Figure 7] It is a schematic diagram showing the second structure of the aneurysm neck embolization member according to the present invention. [Figure 8]This is a three-dimensional perspective view showing the second structure of the aneurysm neck embolization component. [Figure 9] This is a schematic diagram showing other possible forms of aneurysm neck embolization components. [Figure 10] This is a schematic diagram illustrating a method for manufacturing an aneurysm neck embolization member having the first structure. [Figure 11] This is a schematic diagram illustrating a method for manufacturing an aneurysm neck embolization member having a second structure. [Figure 12A] This is a schematic diagram showing an aneurysm neck embolization member having the first structure placed in an aneurysm. [Figure 12B] This is a three-dimensional perspective view showing an aneurysm neck embolization member having the first structure placed in an aneurysm. [Figure 13A] This is a schematic diagram showing an aneurysm neck embolization member having a second structure placed in an aneurysm. [Figure 13B] This is a three-dimensional perspective view showing an aneurysm neck embolization member having a second structure, placed in an aneurysm. [Figure 14] This is a schematic diagram showing an aneurysm neck embolization member according to Modification 1. [Figure 15] This is a schematic diagram showing an aneurysm neck embolization member according to Modification 1. [Figure 16] This is a schematic diagram showing an aneurysm neck embolization member according to Modification 1. [Figure 17] This is a schematic diagram showing an aneurysm neck embolization member according to modified example 2. [Figure 18] This is a schematic diagram showing an aneurysm neck embolization member according to modified example 2. [Figure 19] This is a schematic diagram showing an aneurysm neck embolization member according to modified example 2. [Figure 20] This is a perspective view showing the structure of the mesh material that forms the aneurysm neck embolization component. [Figure 21] This figure shows an example of an image related to a "wide neck" aneurysm. [Figure 22] (A) is a schematic diagram showing an example of an improved aneurysm neck embolus, and (B) is a schematic diagram showing the aneurysm neck embolus of (A) in a state where it is placed in an aneurysm. [Figure 23] (A) to (C) are photographic images of aneurysm neck embolus members of different shapes. [Figure 24] This figure shows a photographic image of three aneurysm neck embolization components of different shapes lined up. [Figure 25] This is a schematic diagram showing an example of an aneurysm neck embolization member expanded around the axis by a plating portion. [Figure 26] (A) to (C) are schematic diagrams showing aneurysm neck embolus members with different axial lengths. [Figure 27] This is a schematic diagram illustrating a supply system for an aneurysm neck embolization component. [Figure 28] (A) is a schematic diagram showing the weft knitting mechanism of an automatic weft knitting machine, and (B) is a diagram showing three bobbins and their surrounding areas. [Figure 29] This is a flowchart showing the process from receiving an order to placing an order for an aneurysm neck embolization component. [Figure 30] (A) is a schematic diagram showing the external appearance of the release device with the gripping inner cylinder and the retaining inner cylinder connected; (B) is a schematic diagram showing the cross-section of the gripping inner cylinder and the retaining inner cylinder when separated; (C) is a schematic diagram showing the cross-section of the retaining inner cylinder when it is inserted into and connected to the gripping inner cylinder; (D) is a schematic diagram showing the cross-section of the retaining inner cylinder when it is inserted further into the gripping inner cylinder; and (E) is a schematic diagram showing the cross-section of the gripping inner cylinder and the retaining inner cylinder when separated, with protrusions and other parts omitted. [Figure 31] Figures (A) to (C) are schematic diagrams showing, in order, the insertion of a second implant into the aneurysm neck embolization component. [Figure 32] Figures (A) to (C) are photographic images corresponding to the states shown in Figures 31(A) to (C). [Figure 33] (A) to (C) are photographic images of aneurysm neck embolus members of different shapes. [Figure 34](A) is a schematic diagram showing the aneurysm neck embolus member joined to the inner tube, (B) is a magnified view of the aneurysm neck embolus member and its surrounding area in (A), and (C) is a magnified view of the aneurysm neck embolus member and its surrounding area when a guide wire is used. [Figure 35] (A) is a diagram showing an aneurysm neck embolization component that can be applied to a "wide neck" aneurysm, and (B) is a diagram showing an aneurysm neck embolization component that is suitable for a "narrow neck" aneurysm. [Figure 36] (A) is a diagram showing the internal structure of an aneurysm neck embolization member corresponding to a "wide neck" aneurysm, indicated by dashed lines. (B) is a diagram showing the internal structure of an aneurysm neck embolization member corresponding to a "wide neck" aneurysm with increased plating thickness, indicated by dashed lines. (C) is a diagram showing the internal structure of an aneurysm neck embolization member corresponding to a "narrow neck" aneurysm, indicated by dashed lines. [Modes for carrying out the invention]

[0017] (Introduction) The following describes, with reference to the figures, an aneurysm neck embolization member and a method for manufacturing an aneurysm neck embolization member relating to one aspect of this disclosure. However, it should be noted that the technical scope of this disclosure is not limited to those embodiments, but extends to the invention described in the claims and its equivalents.

[0018] Furthermore, the first part of the following explanation provides a common explanation with the aforementioned Patent Document 2 (Japanese Patent No. 7427202) in order to facilitate understanding of the basic technical concept related to the aneurysm neck embolization member (organized embolization member) according to the embodiment of the present invention. In addition, the second part... This document explains the background behind the improvements to the aneurysm neck embolization component, the structure of the improved aneurysm neck embolization component, and the manufacturing method.

[0019] (Overview of the first structure of the aneurysm neck embolization component) Figures 1A and 1B are schematic diagrams of the first structure of the aneurysm neck embolization member 5 according to the present invention. The first structure refers to the structure and manufacturing method created by the first manufacturing method of the aneurysm neck embolization member. Further details will be described later.

[0020] As shown in Figure 1A, the essence of the present invention is an aneurysm neck embolization member 5 that can embolize the neck portion of all aneurysms, from aortic aneurysms to small aneurysms of 5 mm or less (this is called the neck; the neck of the aneurysm is named aneurysm neck N; to avoid confusion between the neck of the aneurysm and the neck of the aneurysm neck embolization member 5, the neck of the aneurysm is named aneurysm neck N). According to the present invention, by locking the appropriate aneurysm neck embolization member 5 at the neck portion of any aneurysm and aligning the aneurysm neck N and the aneurysm neck embolization member 5 snugly, the aneurysm can be cured by endovascular surgery. Furthermore, the present invention also provides a method for easily embolizing the aneurysm and aneurysm neck by locking the neck 53 of the aneurysm neck embolization member 5 with the aneurysm neck N.

[0021] As a definition of terminology, the neck of the aneurysm was referred to as the aneurysm neck N. Next, the names of the embolic components were likened to the human body (see Figure 1A). The component that emboluses the neck of the aneurysm was named the aneurysm neck embolic component 5. The tip portion of this aneurysm neck embolic component 5 (the embolic component that goes deep into the aneurysm) was named as follows, as shown in Figures 1A and 1B: leg 51, body 52, neck 53, head 54, and crown 55. To clearly define these areas, starting from the distal end, which is the innermost part of the embolic member, the parts were designated as follows: the tip of the leg 51A, moving towards the neck of the aneurysm, the posterior end of the leg 51B, the tip of the body 52A (which is in contact with the posterior end of the leg 51B), the posterior end of the body 52B, the tip of the neck 53A (which is in contact with the posterior end of the body 52B), the posterior end of the neck 53B, the tip of the head 54A (which is in contact with the posterior end of the neck 53B), the posterior end of the head 54B, the tip of the crown 55A (which is in contact with the posterior end of the head 54B), and the posterior end of the crown 55B. Furthermore, the point midway between A and B was designated as C. The point midway between the tip of the leg 51A and the posterior end of the leg 51B was designated as the middle of the leg 51C. The point midway between the tip of the body 52A and the posterior end of the body 52B was designated as the middle of the body 52C. The point midway between the tip of the neck 53A and the posterior end of the neck 53B was designated as the middle of the neck 53C. The midpoint between the tip 54A of the head and the posterior end 54B of the head is defined as the midpoint 54C of the head. The midpoint between the tip 55A of the vertex 55B of the vertex is defined as the midpoint 55C of the vertex. Depending on the shape of the aneurysm, the legs 51 and vertex 55 may be omitted or left open. In other words, the neck of the embolic member is more accurately called the "neck 53 of the aneurysm neck embolic member 5," but is abbreviated as "neck 53 of the neck embolic member 5" or "neck 53." The body 52, neck 53, and head 54 are specifically called the main body. It is made of a mesh material that is flexible and has a cylindrical shape with multiple through holes. The legs 51 and vertex 55, which are fixed so that one end of the main body encloses the rod inserted into the main body, are called the fixing part. Furthermore, the neck 53, which extends radially from at least a part of the main body, is called the embolic part.

[0022] Specifically, the aneurysm neck embolization member 5 is fixed to an inner tube 6 (described later) and is placed in the desired aneurysm neck N using an in vivo detachment device 1 (described later). Furthermore, the aneurysm neck embolization member 5 engages with the aneurysm neck N at its widest radial point, the "neck portion 53 of the aneurysm neck embolization member." By engaging with the aneurysm neck N, the aneurysm neck embolization member 5 is fixed to the aneurysm. The first manufacturing method (first structure) of the aneurysm neck embolization member is suitable for small aneurysms (aneurysms 15 mm or less) and irregularly shaped aneurysms, hence the shape shown in Figure 1A is preferable. That is, it is tapered at the tip and gradually widens as it approaches the aneurysm neck N. When introducing the aneurysm neck embolization member 5 into an aneurysm, it can compress the inner wall of the aneurysm and cause it to rupture. To prevent this, the shape of the aneurysm neck embolization member 5 is such that it is locked and fixed at the aneurysm neck N. Its shape is as shown in Figure 1A. However, aneurysms are often saccular in shape, and the body 52 is larger than the neck 53. In some cases, this may not be the case. Also, the leg portion 51 and the top portion 55 may be absent. Details will be described later. In Figure 1A, the detachment device D is created in contact with the top portion 55. After being locked and fixed in the aneurysm neck N, the aneurysm neck embolization member 5 is detached at the position of this detachment device D. The detachment device is cut as appropriate, such as by electrical detachment or mechanical detachment. After detachment, the guide wire is pulled out, and it is locked and fixed in the aneurysm neck N. In Figure 1B, this detachment device D is absent. When the aneurysm neck embolization member 5 has been placed in the target aneurysm neck N, the aneurysm neck embolization member 5 is cut as appropriate by pulling out the guide wire G, or the inner cannula 6 and the guide wire G. In other words, it is possible to fix it directly to the guide wire G or not. Similarly, it is possible to fix it directly to the inner cannula 6 or not. Note that although the detachment device D is shown in contact with the aneurysm neck embolization member 5 (see Figure 1A), it may also be created between the inner cannula 6 (see Figure 2B). Alternatively, the guidewire may be severed and the embolus created between the guidewires (see Figure 5A). In this case, if the embolus is directly fixed, a detachment device is required for the aneurysm neck embolus member 5. Further details will be described later.

[0023] (Overview of the second structure of the aneurysm neck embolization component) Figures 2A, 2B, and 2C are schematic diagrams of the second structure of the aneurysm neck embolization member 5 according to the present invention. The second structure refers to the structure and manufacturing method created by the second manufacturing method of the aneurysm neck embolization member 5. Details will be described later.

[0024] As shown in Figures 2B and 2C, the essence of the present invention is an aneurysm neck embolization member 5 that can embolize all portions of the aneurysm neck N, from aortic aneurysms to small aneurysms of 5 mm or less. According to the present invention, if the appropriate aneurysm neck embolization member 5 is locked and fitted snugly at all portions of the aneurysm neck N, the aneurysm can be cured by endovascular surgery. As a method of deforming the tubular mesh material, a method of inverting the aneurysm neck embolization member 5 is described. There are also various other methods of deforming the tubular mesh material. The difference from the first structure of the aneurysm neck embolization member 5 described above (the biggest advantage of inversion) is that by inverting one end to the other end (in the figure, the right end to the left end), the aneurysm neck embolization member 5 (especially the head portion 54 and the top portion 55) does not protrude into the parent vessel at the aneurysm neck N. We describe this as the collar of the aneurysm neck embolization member 5 not protruding into the parent vessel (in English, collarless or no collar). This is the most important issue in aneurysm embolization. If the aneurysm neck embolization member 5 protrudes into the parent vessel, it can form a thrombus at that point, occluding the vessel, or it can travel from that point to the periphery, causing a stroke. This can lead to serious complications. Details about this inversion will be explained later. Let's explain the naming due to inversion. Similar to the first structure, the neck of the aneurysm is called the aneurysm neck N. The member that embolizes the neck of the aneurysm is similarly named the aneurysm neck embolization member 5. Next, the names of the embolization members are based on the human body as described above (see Figures 2B and 2C), and are named as shown in Figure 2B, starting from the embolization member that goes deepest into the aneurysm: leg 51, body 52, neck 53, head 54, and vertex 55 (note that because it is inverted, the vertex 55 is formed inside the aneurysm from the aneurysm neck). An origin point was then established to clearly define the position of these parts. Similar to the first structure described above, the embolic member was divided into the following sections starting from the distal end, which is the innermost part of the embolic member: the tip of the leg 51A, the posterior end of the leg 51B towards the neck of the aneurysm, the tip of the body 52A (which is in contact with the posterior end of the leg 51B), the posterior end of the body 52B, the tip of the neck 53A (which is in contact with the posterior end of the body 52B), the posterior end of the neck 53B, the tip of the head 54A (which is in contact with the posterior end of the neck 53B), the posterior end of the head 54B, the tip of the crown 55A (which is in contact with the posterior end of the head 54B), and the posterior end of the crown 55B. Furthermore, the section midway between A and B was designated as C.The point midway between the leg tip 51A and the leg rear end 51B is defined as the leg middle 51C. The point midway between the body tip 52A and the body rear end 52B is defined as the body middle 52C. The point midway between the neck tip 53A and the neck rear end 53B is defined as the neck middle 53C. The point midway between the head tip 54A and the head rear end 54B is defined as the head middle 54C. The point midway between the top of the head tip 55A and the top of the head rear end 55B is defined as the top of the head middle 55C. The body 52, neck 53, and head 54 are specifically referred to as the main body. It is made of a mesh material that is flexible and has a cylindrical shape with multiple through holes. A rod material inserted into the main body is fixed so as to be enclosed by one end of the main body. The leg portion 51 and the top portion 55 are called the fixing portion. Furthermore, the neck portion 53, which extends radially from at least a part of the main body, is called the embolus portion.

[0025] Specifically, the aneurysm neck embolization member 5 is fixed to the inner tube 6, which will be described later, and is placed in the desired aneurysm using the in vivo detachment device 1, which will also be described later. Furthermore, the second manufacturing method (second structure) of the aneurysm neck embolization member 5 is suitable for embolizing large aneurysms (aneurysms between 15 mm and 50 mm). To make it large, the part that is inverted has a distinctive feature; ideally, the widest point in the radial direction of the aneurysm neck embolization member 5 is the neck 53, and the head 54 is as close to 0 mm as possible and engages with the aneurysm neck N. By engaging with the aneurysm neck N, the aneurysm neck embolization member 5 is fixed to the aneurysm. Similar to Figure 1A, when introducing the aneurysm neck embolization member 5 into an aneurysm, it may compress the inner wall of the aneurysm and cause it to rupture. To eliminate this, it is preferable that the shape of the aneurysm neck embolization member 5 be fixed by locking into the neck N of the aneurysm. That shape is as shown in Figures 1A, 2B, and 2C. In other words, it is a shape that is narrow at the end and gradually widens as it approaches the aneurysm neck N. However, aneurysms are often saccular in shape, and the body 52 may be larger than the neck 53. Also, the leg 51 and crown 55 may be absent. Further details will be described later.

[0026] (Configuration of the in vivo detachment device 1) Figures 1B and 3 are cross-sectional views showing an in vivo detachment device 1 including an aneurysm neck embolization member 5 according to the present invention.

[0027] As shown in Figures 1B and 3, the in vivo detachment device 1 comprises a parent catheter 2, a child catheter 3, an aneurysm neck embolization member 5, and a guide wire G. Normally, the guide wire G is made movable inside the aneurysm neck embolization member 5. Movability means that the guide wire G can simply move freely within the inner tube 6 (described later) of the aneurysm neck embolization member 5. During a normal procedure, the guide wire G, child catheter 3, and aneurysm neck embolization member 5 are guided together to the aneurysm neck N of the target aneurysm. It is preferable that the aneurysm neck embolization member 5 be attached from the outset near the distal end 3A of the child catheter 3 (either inside or at the tip of the child catheter 3). This allows for detachment without imposing pressure stress from the aneurysm.

[0028] Furthermore, the in vivo detachment device 1 not only places the aneurysm neck embolization member 5 in the neck N between the parent artery and the aneurysm, but also reliably covers the aneurysm neck N between the parent artery and the aneurysm by appropriately deforming the aneurysm neck embolization member 5 radially within the aneurysm neck N between the parent artery and the aneurysm. In other words, the aneurysm neck embolization member 5 only needs to be engaged with at least a portion of the aneurysm neck N between the parent artery and the aneurysm.

[0029] Figure 4 is a cross-sectional view showing the state of the aneurysm neck embolization member 5 before and after movement by catheters 2 and 3 and guidewire G. In this specification, parent catheter 2 and child catheter 3 may be collectively referred to as catheters 2 and 3.

[0030] As shown in Figure 4(A), the parent catheter 2 has a proximal end (not shown) and a distal end 2A. In this specification, the proximal end is the end to which the operating part (not shown) operated by the practitioner is attached, and the distal end 2A is the end that is open so that the child catheter 3 can extend. The parent catheter 2 is a long tube and holds the child catheter 3 so that it can move along the longitudinal direction inside the tube.

[0031] Furthermore, as shown in Figure 4(A), the child catheter 3, like the parent catheter 2, is a long, tubular shape and has a proximal end (not shown) and a distal end 3A. The distal end 3A is open so that the aneurysm neck embolization member 5 can extend outwards. Of course, the aneurysm neck embolization member 5 can also move within the tube. The guidewire G can also move within the inner tube 6. The proximal end of the sub-catheter 3 is also operable by the operator. Normally, the aneurysm neck embolization member 5 is fixed to the inner cannula 6, which will be described later. However, the aneurysm neck embolization member 5 does not have to be fixed to the inner cannula 6, which will be described later. The case where it is not fixed to the inner cannula 6 will be explained below. In the case of an even smaller aneurysm, the inner cannula 6 and the aneurysm neck embolization member 5 are attached to the tip of the guidewire G (the end opposite the operating end). The aneurysm neck embolization member 5, along with the inner cannula 6 and the guidewire G, is then placed in the target aneurysm. When the inner cannula 6 and the guidewire are withdrawn, only the aneurysm neck embolization member 5 is locked to the neck of the aneurysm, and the aneurysm is embolized. Of course, in this case, only the aneurysm neck embolization member 5 is placed in the target aneurysm. Note that in the explanation of Figure 4(C) below, an example in which the aneurysm neck embolization member 5 is directly fixed to the guidewire G is described, but the present invention is not limited to this configuration.

[0032] Figure 4(C) shows an example in which the aneurysm neck embolization member 5 (the inner cannula 6, described later, is convenient for creating the aneurysm neck embolization member 5, but is not required) is directly fixed to the guidewire G. As mentioned above, the aneurysm neck embolization member 5 is integrated with the tip of the guidewire G and is guided to the aneurysm neck N. The guidewire G has a tip portion of the guidewire that is integrally connected to the aneurysm neck embolization member 5, and a detachment device D (detached by electrical detachment or mechanical detachment device, etc.) is provided to detach it. These can be operated by the practitioner by manipulating the guidewire G. By manipulating the guidewire G, the practitioner can detach the aneurysm neck embolization member 5 and leave it in the aneurysm neck N between the parent artery and the aneurysm. The guidewire G, together with the inner cannula 6 described later, can correspond to the rod material of the present invention. In other words, for even smaller aneurysms, the aneurysm neck embolization member 5 is integrally attached to the tip of the guidewire G (the end opposite the operating end) (the inner cannula 6 may be present). The aneurysm neck embolization member 5 is then integrated with the guidewire G and placed in the target aneurysm. The tip of the guidewire, which is integrally connected to the aneurysm neck embolization member 5, is detached using the detachment device D. When the guidewire G, with its tip detached, is pulled out, the tip of the guidewire that was integrally connected to the aneurysm neck embolization member 5 locks into the neck of the aneurysm, and the aneurysm is embolized. Of course, in this case, only the tip of the guidewire that is integrally connected to the aneurysm neck embolization member 5 is placed in the target aneurysm. Again, the inner cannula 6 may or may not be present. If there is no inner cannula 6, the tip of the guidewire that is integrally connected to the aneurysm neck embolization member 5 is connected with PVA or the like and detached using the detachment device D (electrical or mechanical detachment). Similarly, if there is an inner cylinder 6, the tip of the guide wire, which is integrally connected to the inner cylinder 6, is connected with PVA or the like, and this is detached by a detachment device D (electrical or mechanical detachment).Here, we have described an example in which the aneurysm neck embolization member 5 is directly fixed to the guide wire G, but it is also acceptable to simply place it on the tip of the guide wire G without fixing it; in other words, the guide wire G can be withdrawn when the aneurysm neck embolization member 5 has been placed in the target aneurysm neck N. This is also one type of mechanical detachment device. Thus, there are two methods for detaching the aneurysm neck embolization member 5: electrical detachment and mechanical detachment, but the present invention is not limited to this detachment device. It is acceptable as long as it can be cut as appropriate.

[0033] Then, as shown in Figure 4(B), when the parent catheter 2 reaches the target site (the point from which the child catheter 3 extends), the child catheter 3 moves inside the parent catheter 2 and exits through its distal end 2A. When the child catheter 3 reaches the target site (aneurysm), the guidewire G and the aneurysm neck embolization member 5 move inside the child catheter 3 and exit through its distal end 3A.

[0034] The in vivo detachment device 1 attaches the aneurysm neck embolization member 5 to the distal end 3A of the subcatheter 3, and either pulls the guidewire G towards the operator at the target aneurysm, or pushes the subcatheter 3 toward the distal end 3A. Through this operation by the operator, the in vivo detachment device 1 detaches the aneurysm neck embolization member 5 from the subcatheter 3 and guidewire G, and detaches it from the artery between the parent artery and the aneurysm. To enable implantation in the nodular neck N.

[0035] The shapes of the aneurysm neck embolization member 5 in Figure 4(A) and Figure 4(B) are different. In Figure 4(A), the aneurysm neck embolization member 5 is narrowed to an outer diameter limited by the inner diameter of the sub-catheter 3. As shown in Figure 4(B), the aneurysm neck embolization member 5 extends beyond the sub-catheter 3, eliminating the external force exerted by the inner wall of the sub-catheter 3. As a result, the outer diameter of the aneurysm neck embolization member 5 becomes larger than the inner or outer diameter of the sub-catheter 3.

[0036] The present invention offers two main methods for manufacturing the aneurysm neck embolization member 5. The first manufacturing method is the manufacturing method for the first structure of the aneurysm neck embolization member 5, which will be described later, and has a simple manufacturing method. The first structure of the aneurysm neck embolization member 5 is suitable for small aneurysms (less than 15 mm) or aneurysms with an irregular shape. In other words, the first structure of the aneurysm neck embolization member 5 is characterized by the fact that the aneurysm neck embolization member 5 itself can be manufactured in a small size. On the other hand, the second manufacturing method is the manufacturing method for the second structure of the aneurysm neck embolization member 5, which will be described later. The second structure of the aneurysm neck embolization member 5 is suitable for large aneurysms (approximately 15 mm to 50 mm). In other words, the second structure of the aneurysm neck embolization member 5 is characterized by a manufacturing method that involves inverting the aneurysm neck embolization member 5 itself in order to make it larger. Hereafter, the first structure of the aneurysm neck embolization member 5 and the second structure of the aneurysm neck embolization member 5 will be described individually.

[0037] (First structure of the aneurysm neck embolization member 5) Figures 5A and 5B are schematic diagrams showing the first structure of the aneurysm neck embolization member 5 according to the present invention. Furthermore, Figure 6 is a three-dimensional perspective view showing the first structure of the aneurysm neck embolization member 5.

[0038] As shown in Figure 5A (with detachment device D), Figure 5B (without detachment device D), and Figure 6, the aneurysm neck embolization member 5 is formed by deforming a tubular mesh material. The aneurysm neck embolization member 5 has a tubular shape and multiple through-holes, formed by weaving together multiple long and flexible flexible bodies such as fibers or threads. In this way, the aneurysm neck embolization member 5 can be formed by bundling and integrating multiple flexible bodies. Alternatively, it may be formed by forming multiple through-holes in a continuous body such as a flexible foil, thin plate, or film to form a tubular shape overall. Alternatively, it may be formed by forming a tubular shape overall without forming multiple through-holes in a continuous body such as a flexible foil, thin plate, or film. By forming it in this way, the aneurysm neck embolization member 5 can be integrally formed from a continuous body. In other words, the aneurysm neck embolization member 5 only needs to have a tubular shape (hollow) overall, have multiple through-holes, and be flexible enough to be deformable. Thus, the aneurysm neck embolization member 5 can be formed by bundling and integrating multiple flexible bodies, or by integrally forming it from a continuous body. For simplicity, in this specification, both forms of the aneurysm neck embolization member 5 are collectively referred to as a tubular mesh material. The aneurysm neck embolization member 5 is formed from a leg portion 51, a body portion 52, a neck portion 53, a head portion 54, and a top portion 55.

[0039] Specifically, the leg portion 51, body portion 52, neck portion 53, head portion 54, and crown portion 55 are made of a single mesh material. The aneurysm neck embolization member 5 may remain cylindrical, but it is preferable for it to widen from the tip 51A of the leg portion at one end in the longitudinal direction of the aneurysm neck embolization member 5 toward the posterior end 55B of the crown portion at the other end. The aneurysm neck embolization member 5 may be housed inside the tube of the sub-catheter 3 to make it movable, or it may be movable without being housed inside the tube of the sub-catheter 3. In the latter case, the aneurysm neck embolization member 5 is set on the distal end 3A side of the sub-catheter 3 in an expanded state. In either case, it is sufficient for the aneurysm neck embolization member 5 to be in a movable shape.

[0040] The leg portion 51 and the top portion 55 are formed when the radial peripheral edges of the tip 51A of the leg portion or the posterior end 55B of the top portion of the aneurysm neck embolization member 5 are brought together by the inner cylinder 6 or the guide wire G. It is formed by the following. The leg portion 51 and the top portion 55 are the parts to which the aneurysm neck embolization member 5 is attached to the inner cylinder 6 or the guide wire G. As for the fixing method, a method of tying one end of the leg tip 51A or the leg posterior end 51B or the top tip 55A or the top posterior end 55B with the wire or a method of joining using an adhesive such as Aron Alpha (registered trademark) is preferred. The material of the wire is not particularly limited, and general sutures can be used. In the present invention, as shown in Figures 5 and 6, the leg portion 51 and the top portion 55 indicate the parts in which the mesh material is movable by the guide wire G. Also in Figure 5A, the guide wire is cut and a release device D is connected between the guide wires to enable electrical or mechanical release. In Figure 5B, this release device D is absent. Thus, in Figure 1A, the release device D is shown in contact with the aneurysm neck embolization member 5, but it may also be created between the inner cylinders 6 as in Figure 2B. A detachment device D may be created between the guide wires as shown in Figure 5A. The aneurysm neck embolization member 5 is detached by pulling out the inner tube 6 and the guide wire G. Further details will be described later.

[0041] In this embodiment, (1) an example is presented in which the release device D is directly fixed between the guide wires G (see Figure 5A). In this case, although it is not directly connected to the aneurysm neck embolization member 5, a release device is necessary. (2) An example is presented in which the leg portion 51 and the top portion 55 of the aneurysm neck embolization member 5 are simply resting on the guide wire G (see Figure 5B). In this case, since it is not fixed to the guide wire G, the guide wire G is made movable. (3) An example is presented in which the leg portion 51 and the top portion 55 of the aneurysm neck embolization member 5 are directly fixed to the inner cylinder 6 (see Figure 1A). Since it is directly connected to the aneurysm neck embolization member 5, in this case a release device is necessary between the aneurysm neck embolization member 5 and the inner cylinder 6. (4) An example is presented in which the leg portion 51 and the top portion 55 of the aneurysm neck embolization member 5 are simply resting on and fixed to the inner cylinder 6 (see Figure 1) (see Figure 1B). An example where the device is simply resting on the guide wire G is also presented (see Figure 5B). In this case, since it is not fixed to the guide wire G, the guide wire G is made movable.

[0042] In other words, in cases (2) and (4), once the aneurysm neck embolization member 5 has been placed in the target aneurysm neck N, the guide wire G or the inner cannula 6 and guide wire G can be withdrawn. In other words, it is not necessary to fix it directly to the guide wire G or not. Similarly, it is not necessary to fix it directly to the inner cannula 6 or not. If it is fixed directly, a release device is required for the aneurysm neck embolization member 5. The inner cannula 6 may be made of metal or polymer. If the inner cannula 6 is made entirely of polymer, the aneurysm neck embolization member 5 and the inner cannula 6 can be detached at any position (arbitrary position) by the operator using a release device. The aneurysm neck embolization member 5 to the inner cannula 6 is preferably fixed by joining using an adhesive such as Aron Alpha (registered trademark) or by heat compression. The total length in the longitudinal direction of the inner cannula 6 is preferably less than or equal to the total length in the longitudinal direction of the aneurysm neck embolization member 5, but it may be longer than the total length. Furthermore, the inner diameter of the inner cylinder 6 must be larger than the diameter of the guide wire G, and should be at least 20 μm larger. This is because if there is a gap of 20 μm or more between the inner cylinder 6 and the guide wire G, the guide wire G can move inside the inner cylinder 6. The inner cylinder 6 can also correspond to the rod material of the present invention. As mentioned earlier, the aneurysm neck embolization member 5, the inner cylinder 6, and the guide wire can sometimes be made as a single unit. In that case, a release device is required for the guide wire or the aneurysm neck embolization member 5. In that case, the diameter of the guide wire and the diameter of the inner cylinder 6 may be the same or smaller. In some cases, the inner cylinder 6 may not be necessary.

[0043] The neck 53 is made up of a part of the mesh material and is formed between the body 52 and the head 54. It is preferable that the posterior end 53B of the neck 53 engages with the aneurysm neck N rather than the posterior end 53A of the neck. This means that the aneurysm neck embolization member 5 does not protrude from the parent artery and is tightly engaged with the ideal aneurysm neck N. Figures 5 and 6 disclose a normal configuration, that is, an example in which the neck 53 is formed near the posterior end 54A of the head. The distance between 54 and the crown of the head 55 is very close to 0 mm, and either one end of the neck 53 (tip 53A) or the other end (posterior end 53B) is engaged with the aneurysm neck N.

[0044] As shown in FIG. 5, the diameter D1 at the portion where the leg portion 51 of the aneurysm neck embolization member 5 is formed is the minimum diameter of the aneurysm neck embolization member 5. Also, the diameter D3 at the portion where the neck portion 53 of the aneurysm neck embolization member 5 is formed is the maximum diameter of the aneurysm neck embolization member 5. And the diameter D2 at the portion where the body portion 52 of the aneurysm neck embolization member 5 is formed has a diameter between D1 and D3. That is, the relationship D1 < D2 < D3 holds. That is, the neck portion 53 is the portion that protrudes most in the radial direction in the entire aneurysm neck embolization member 5. When the top portion 55 is formed at the center of the aneurysm neck embolization member 5, the body portion 52 is locked to the aneurysm neck N. In this case, the relationship D1 < D3 < D2 holds. As described above, when introducing the aneurysm neck embolization member 5 into the aneurysm, it may compress the inner wall of the aneurysm and cause the aneurysm to rupture. In order to eliminate this, it is preferable that the shape of the aneurysm neck embolization member 5 is locked and fixed at the aneurysm neck N. The shape is as shown in FIG. 5A. However, the shape of the aneurysm is often sac-like, and the body portion 52 of the aneurysm neck embolization member 5 may be larger than the neck portion 53. In this case as well, the relationship D1 < D3 < D2 holds. Also, there may be cases where the leg portion 51 and the top portion 55 are absent.

[0045] (Second Structure of Aneurysm Neck Embolization Member 5) FIG. 7 is a schematic view showing a second structure of the aneurysm neck embolization member 5 according to the present invention. Further, FIG. 8 is a perspective view showing the second structure of the aneurysm neck embolization member 5 three-dimensionally.

[0046] As shown in FIGS. 7 and 8, the aneurysm neck embolization member 5 is formed by deforming a cylindrical mesh material. The aneurysm neck embolization member 5 includes a leg portion 51, a body portion 52, a neck portion 53, a head portion 54, and a top portion 55.

[0047] Specifically, we describe a method of deforming the tubular mesh material by inverting the aneurysm neck embolization member 5. The second structure of the aneurysm neck embolization member 5 is formed by fixing one end of the tubular mesh material and inverting it by flipping it in the longitudinal direction. After inversion, the embolization member that enters the deepest part of the aneurysm is named as follows, as shown in Figures 2B and 7: leg 51, body 52, neck 53, head 54, and vertex 55. Since one end of the tubular mesh material is fixed and it is inverted by flipping it in the longitudinal direction, the vertex 55 is formed facing the inside of the aneurysm. This is the most obvious difference from the first structure. This difference is very important, and the biggest advantage of inversion is that the aneurysm neck embolization member 5 (especially the head 54 and vertex 55) does not protrude into the parent vessel at the aneurysm neck N. We describe this as the collar of the aneurysm neck embolization member 5 not protruding into the parent vessel (in English, this is called collarless or no collar). This is the most important issue in aneurysm embolization. If the aneurysm neck embolization component 5 protrudes into the parent vessel, it can form a thrombus at that point, blocking the vessel, or it can travel from that point to the periphery, causing a stroke (leading to serious complications).

[0048] In Figure 7, the leg portion 51 and the top portion 55 are formed by the radial peripheral portions of the leg tip 51A, leg posterior end 51B, or top tip 55A or top posterior end 55B of the aneurysm neck embolization member 5 being gathered around the guide wire G. The leg portion 51 and the top portion 55 are the parts to which the aneurysm neck embolization member 5 is attached to the guide wire G. Preferred fixing methods include tying with a wire or joining using an adhesive such as Aron Alpha (registered trademark). The material of the wire is not particularly limited, and general sutures can be used. In the present invention, the leg portion 51 and the top portion 55 indicate the parts in which the mesh material is movable on the guide wire G.

[0049] In this embodiment, the leg portion 51 and the top portion 55 are directly joined to the guide wire G and fixed. The guide wire G may be fixed (if fixed with a wire, etc., the guide wire G is made movable), or it may be fixed to a movable inner cylinder 6 (see Figures 2B and 2C) around the outer circumference of the guide wire G. In this case, the leg portion 51 and the top portion 55 may be securely fixed to the inner cylinder 6. The inner cylinder 6 may be made of metal or polymer. The aneurysm neck embolization member 5 is preferably fixed to the inner cylinder 6 by joining using an adhesive such as Aron Alpha (registered trademark), or by heat compression. The total length of the inner cylinder 6 in the longitudinal direction is preferably less than or equal to the total length of the aneurysm neck embolization member 5 in the longitudinal direction, but it may be longer than the total length. The inner diameter of the inner cylinder 6 must be larger than the diameter of the guide wire G, and should be at least 20 μm larger. This is because if there is a gap of about 20 μm between the inner cylinder 6 and the guide wire G, the guide wire G can move inside the inner cylinder 6. The inner cylinder 6 can also correspond to the rod material of the present invention.

[0050] The greatest advantage of inversion is that the aneurysm neck embolization member 5 does not protrude into the parent vessel. To achieve this, the head 54 must not protrude into the parent vessel as much as possible. In the case of Figure 7, the neck 53 is locked and fixed to the aneurysm neck N. The head 54 is preferably formed near the tip 55A of the top of the head 55 at one end. Figures 7 and 8 disclose an example in which the head 54 is formed near the tip 55A of the top of the head at one end. It is preferable that the head 54 is as close to 0 mm as possible, with one end 53A or the other end 53B of the neck 53 engaged with the aneurysm neck N (or one end 54A of the head 54 engaged with the aneurysm neck N).

[0051] As shown in FIG. 7, the diameter D1 at the portion where the leg portion 51 and the apex portion 55 of the aneurysm neck embolization member 5 are formed is the minimum diameter of the aneurysm neck embolization member 5. Also, the diameter D3 at the portion where the neck portion 53 of the aneurysm neck embolization member 5 is formed is the maximum diameter of the aneurysm neck embolization member 5. And the diameter D2 at the portion where the body portion 52 of the aneurysm neck embolization member 5 is formed has a diameter between D1 and D3. That is, the relationship D1 < D2 < D3 holds. That is, the neck portion 53 is the portion that protrudes most in the radial direction in the whole aneurysm neck embolization member 5. Different from the first structure of the aneurysm neck embolization member 5, in the case of the second structure of the aneurysm neck embolization member 5, even when the apex portion 55 is formed at the center of the aneurysm neck embolization member 5, this relationship holds. That is, the relationship D1 < D2 < D3 holds. When introducing the aneurysm neck embolization member 5 into the aneurysm, it may compress the inner wall of the aneurysm and cause the aneurysm to rupture. To eliminate this, the shape of the aneurysm neck embolization member 5 is preferably locked and fixed at the aneurysm neck N. The shape is as shown in FIGS. 2 and 7. That is, it is a shape that becomes thinner at the tip and gradually becomes thicker as it approaches the aneurysm neck N. However, the shape of the aneurysm is often sac-like, and the body portion 52 may be larger than the neck portion 53. Also, there may be cases where there are no leg portions 51 or apex portions 55.

[0052] (Material of the mesh material) The mesh material composed of the leg portion 51, the body portion 52, the neck portion 53, the head portion 54, and the apex portion 55 is formed of any one of a metal material, a metal alloy, a shape memory alloy, a synthetic resin, and a superconducting material. Specifically, the mesh material is formed by weaving a wire made of any one of a metal material, a metal alloy, a shape memory alloy, a synthetic resin, and a superconducting material, but integral molding may also be used. The mesh material is not particularly limited in terms of material as long as it can be easily deformed in the artery or aneurysm during the treatment.

[0053] The wire diameter of the mesh material varies depending on the material, so it is not specifically limited here. For example, if the metallic material is platinum or gold, a wire diameter of 20 μm or less is preferable, but if possible, around 10 μm is even better. For example, if the shape memory alloy is Ni-Ti alloy, a wire diameter of around 25 μm, preferably around 10 μm, is preferable.

[0054] Furthermore, it is preferable that the mesh material contains an X-ray opaque material. Examples of X-ray opaque materials include barium sulfate, bismuth oxide, and tungsten. The X-ray opacity of the aneurysm neck embolization member 5 makes it convenient when repositioning or retrieving the aneurysm neck embolization member 5.

[0055] The metal material only needs to be able to form a soft mesh, and various materials can be selected. Besides gold, silver, and copper, the metal material may also be a shape memory alloy, synthetic resin, or superconducting material. Examples include stainless steel, platinum, and gold. Furthermore, in the case of platinum, it may contain about 20% iridium. Preferably, it contains 10% or less iridium. Even better, it contains 7-8% iridium. Since the hardness of platinum can be adjusted by iridium, platinum containing iridium as an alloying element is preferred.

[0056] Shape memory alloys only need to be able to be formed into a soft mesh, and various materials can be appropriately selected. Examples of shape memory alloys include Ni-Ti alloys, Ni-Ti-Co alloys, Ni-Ti-Fe alloys, Ni-Ti-Mn alloys, Ni-Ti-Cr alloys, Ni-Ti-V alloys, Ni-Ti-Al alloys, Ni-Ti-Nb alloys, Cu-Zn alloys, Cu-Zn-Be alloys, Cu-Zn-Si alloys, Cu-Zn-Sn alloys, Cu-Zn-Ga alloys, Cu-Al-Ni alloys, and Cu-Al-Zn alloys. The alloy concentration can be changed depending on the application, the degree of shape memory properties, etc. In particular, Ni-Ti alloys with a Ni concentration of 49-58 atomic%, preferably 50-51 atomic%, and more preferably 50.3-50.7 atomic%, are preferred.

[0057] The synthetic resin only needs to be able to be molded into a soft mesh material, and various materials can be selected as appropriate. Examples of synthetic resins include polyvinyl chloride resin, polystyrene resin, ABS resin, acrylic resin, polyethylene resin, polypropylene resin, polyethylene terephthalate resin, nylon resin, fluororesin, polyurethane resin, and silicone resin. Among these, acrylic resins (such as PAMA (methyl polyacrylate), PMMA (polymethyl methacrylate), and PEMA (polyethyl methacrylate)) and silicone resins are preferred in terms of biocompatibility, strength, and moldability. High-performance artificial fibers (such as aramid fibers) and carbon fibers can also be selected.

[0058] Superconducting materials only need to be able to be formed into a flexible mesh, and various materials can be selected as appropriate. Examples of superconducting materials include Nb-Ti, Nb-Zr, Nb3Sn, Nb3Ge, Nb3Ga, Nb3(Al,Ge), V3Ga, V3Si, and NbN.

[0059] Furthermore, the mesh material may be coated with appropriate substances such as hydrophilic polymers such as polyurethane, nylon, or polyolefin that provide antithrombotic properties, thrombotic resistance substances, antithrombotic substances such as hyaluronic acid or paclitaxel, or angiogenic substances or growth factors. In particular, it is preferable to coat the neck 53 with a hydrophilic polymer (maleic anhydride copolymer or polyvinylpyrrolidone) that provides lubricity and slipperiness to allow the surface to slide within the subcatheter 3. Of course, in some cases, the hydrophilic polymer may not be applied in order to prevent the movement of the aneurysm neck embolization member 5 within the aneurysm. On the other hand, it is preferable to coat the leg portion 51 to the top portion 55 with appropriate substances such as angiogenic substances or growth factors. This is preferable because it promotes thrombus formation from the leg portion 51 to the top portion 55 and allows the thrombus to be firmly locked in the aneurysm neck N after formation.

[0060] Examples of growth factors include vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), vascular permeability renewal factor (VPF), basic fibroblast growth factor (BFGF), and converted growth factor β (TGF-β).

[0061] The pore size of the mesh material can be up to about 5000 μm even in the aorta, but it can be 1000 μm or less, and even better if it is 500 μm or less. Considering the size of blood components, it is preferable that the pore size be less than 15 μm for white blood cells, but it is desirable that it be less than 8 μm for red blood cells or less than 2 μm for platelets. However, in reality, when braiding metal wire with a strand diameter of 20 μm, it is preferable that the pore size be between about 20 μm, which is the smallest size that can be manufactured, and about 1000 μm.

[0062] (Variations of the aneurysm neck embolization component 5) Figure 9 is a schematic diagram showing other possible forms of the aneurysm neck embolization member 5.

[0063] First, Figure 9(A) shows an example in which multiple top portions 55 are provided in the first structure of the aneurysm neck embolization member 5 described above. In other words, in the present invention, multiple top portions 55 may be provided. In this case, the neck portion 53 is formed near the approximate center of the tip 51A of the leg portion at one end and the posterior end 55B of the top portion at the other end.

[0064] Figure 9(B) shows an example in which multiple top portions 55 are provided in the second structure of the aneurysm neck embolization member 5 described above. In other words, in the present invention, multiple top portions 55 may be provided. In this case, the neck portion 53 is usually formed at one end on the top portion tip 55A side (the right end side in the figure).

[0065] Furthermore, Figure 9(C) shows an example in which multiple top portions 55 are provided in the second structure of the aneurysm neck embolization member 5 described above, similar to the example in Figure 9(B). In this example, the neck portion 53 is usually formed on the tip 55A side of the top portion at one end (the right end side in the figure). The difference from Figure 9(B) is that at the tip 51A of the leg portion at one end, the leg portion 51 is inverted in the same way as the rear end 55B of the top portion at the other end.

[0066] As is clear from Figures 9(A) to 9(C), the number of legs 51 and top portion 55 of the aneurysm neck embolization member 5 is not particularly limited; one or more are sufficient. They may also be absent. Since an aneurysm neck embolization member 5 is prepared for each target aneurysm, it is preferable that only one neck portion 53 is formed. Depending on the shape of the aneurysm, multiple neck portions 53 may be formed on the aneurysm neck embolization member 5.

[0067] (Method for manufacturing an aneurysm neck embolization member 5 having the first structure) Figure 10 is a schematic diagram illustrating a method for manufacturing an aneurysm neck embolization member 5 having the first structure.

[0068] As shown in Figure 10(A), first prepare a cylindrical mesh material.

[0069] Next, as shown in Figure 10(B), the guide wire G is inserted into the mesh material. The guide wire G may be inserted along the entire length of the mesh material, or it is sufficient that it is inserted only at the points that form the leg portion 51 and the top portion 55.

[0070] Next, as shown in Figure 10(C), the mesh material is gathered together and movably attached to enclose the guide wire G with the mesh material to form the leg portion 51 or the top portion 55. At this time, the positions of the leg portion 51 and the top portion 55 are adjusted so that there is no gap between the aneurysm neck N and the mesh material, thereby forming the neck portion 53, which makes it possible to effectively seal the aneurysm and the aneurysm neck N. The top portion 55 is formed between the tip 55A of the top portion at one end and the posterior end 55B of the top portion at the other end of the aneurysm neck embolization member 5.

[0071] Then, as shown in Figure 10(D), at least a portion of the body 52 is directed toward the head 54. By inflating, the body portion 52 expands and extends radially, forming the neck portion 53. Preferably, the neck portion 53 is formed near the other end of the aneurysm neck embolization member 5, specifically near the posterior end of the neck portion 53B (or the tip of the head portion 54A).

[0072] The order in which the legs 51, the crown 55, and the neck 53 are formed may be reversed. Alternatively, the guide wire G may be inserted after the neck 53 has been formed to form the legs 51 and the crown 55. In other words, as long as there is no inconsistency, the steps can be rearranged as much as possible by those skilled in the art.

[0073] (Method for manufacturing an aneurysm cervical embolization member 5 having a second structure) Figure 11 is a schematic diagram illustrating the manufacturing method of an aneurysm neck embolization member 5 having a second structure.

[0074] As shown in Figure 11(A), first prepare a cylindrical mesh material.

[0075] Next, as shown in Figure 11(B), the guide wire G is inserted into the mesh material. The guide wire G may be inserted along the entire length of the mesh material, or it is sufficient that it is inserted only at the points that form the leg portion 51 and the top portion 55.

[0076] Next, as shown in Figure 11(C), the top portion 55 is formed by gathering the mesh material together and attaching it so that the guide wire G is movably encased in the mesh material.

[0077] Next, as shown in Figures 11(C) and 11(D), the structure is formed by fixing one end of the tubular mesh material, the top 55, and flipping it over in the longitudinal direction. Specifically, the flipping is performed by flipping and moving the aneurysm neck embolus member 5 in the direction of arrow P shown in Figure 11(C). After flipping, the embolus member that enters the deepest part of the aneurysm is named as follows, as shown in Figures 2B and 7: leg 51, body 52, neck 53, head 54, and top 55. This is the most obvious difference from the first structure.

[0078] Similar to the first structure, by adjusting the positions of the leg portion 51 and the top portion 55 so that there is no gap between the aneurysm neck N and the mesh material, and forming the neck portion 53, it becomes possible to effectively block the aneurysm and the aneurysm neck N. Preferably, the neck portion 53 is formed near the other end of the aneurysm neck embolization member 5, near the posterior end portion 53B (near the portion where the mesh material is turned over).

[0079] Then, as shown in Figure 11(E), by inflating at least a portion of the aneurysm neck embolization member 5 toward the head 54, the body 52 bulges and extends radially, forming the neck 53.

[0080] The order in which the legs 51, the crown 55, and the neck 53 are formed may be reversed. Alternatively, the neck 53 may be formed first, and then the guide wire G may be inserted to form the crown 55. Furthermore, the inversion step may be performed at any time before the neck 53 is formed. In other words, as long as there is no contradiction, the steps can be rearranged as much as possible by those skilled in the art.

[0081] (Action of the aneurysm neck embolization member 5 having the first structure) Figure 12 is a schematic diagram showing the state in which the aneurysm neck embolization member 5 having the first structure is placed in the aneurysm.

[0082] As shown in Figures 12A and B, the aneurysm neck embolization member 5 is placed in the aneurysm neck N between the parent artery (PA) and the aneurysm. Specifically, the leg portion 51 and the body portion 52 are inserted into the aneurysm. The neck portion 53 is placed in the aneurysm neck N between the parent artery and the aneurysm. It locks in place. The head 54 and the top 55 protrude slightly into the parent artery. To minimize or eliminate protrusion into the parent artery, the head 54 and the top 55 should be constructed so that they face inward towards the aneurysm, opposite to the parent artery. The neck 53 is designed to be flexible and can be deformed to match the size of the aneurysm neck N. The neck 53 engages with the aneurysm neck N by deforming to the shape of the neck. The size of the aneurysm neck embolus member 5 can be appropriately determined according to the size of the aneurysm.

[0083] As shown in Figures 12A and 12B, the aneurysm neck embolization member 5 having the first structure is suitable for relatively small aneurysms (generally up to about 15 mm). The neck 53 can be made larger than the diameter of the body 52. ​​The neck 53 can be manufactured to a diameter of about 10 times or more the diameter of the mesh material.

[0084] Furthermore, since the aneurysm neck embolization member 5 does not touch the inside of the aneurysm, it does not apply pressure to the aneurysm, thus reducing the possibility of aneurysm rupture. Specifically, the distance L1 from the radial side of the aneurysm neck embolization member 5 to the inner wall of the aneurysm may be approximately the same size as the aneurysm wall, but it is preferable that it be 1 mm or more, as aneurysms usually shrink after embolization. In addition, it is preferable that the distances L2 and L3 (in three-dimensional space, the length, width, and height are referred to as L1, L2, and L3) from the tip of one end leg 51A of the aneurysm neck embolization member 5 to the inner wall of the aneurysm are also 1 mm or more. If the distances L1, L2, and L3 are maximized, there may be cases where the inside of the aneurysm neck embolization member 5 is almost nonexistent inside the aneurysm. In that case, the distance from the neck 53 to L1, L2, and L3 will be approximately 0 mm. Therefore, it can be applied to aneurysms such as dissecting aneurysms. In other words, the axial length of the aneurysm neck embolus member 5 of the present invention is not particularly limited as long as a neck 53 is present.

[0085] (Action of the aneurysm neck embolization member 5 having the second structure) Figure 13 is a schematic diagram showing the aneurysm neck embolization member 5 having the second structure placed in an aneurysm.

[0086] As shown in Figures 13A and B, the aneurysm neck embolus member 5 is placed in the aneurysm neck N between the parent artery and the aneurysm. Specifically, the leg portion 51 and body portion 52 are inserted into the aneurysm. The neck portion 53 locks into the aneurysm neck N between the parent artery and the aneurysm. The head portion 54 protrudes slightly into the parent artery. However, because it is inverted, the vertex portion 55 is inserted into the aneurysm and does not protrude into the parent artery. To minimize the head portion 54, it is preferable to create the head portion 54 and the vertex portion 55 so that they face inward into the aneurysm, opposite to the parent artery. This is a major difference from the first structure, and this difference is very important. The biggest advantage of inversion is that the aneurysm neck embolus member 5 (especially the head portion 54 and the vertex portion 55) does not protrude into the parent artery at the aneurysm neck N. We describe this as the collar of the aneurysm neck embolus member 5 not protruding into the parent artery (collarless or no collar in English). This is the most important issue in aneurysm embolization. If the aneurysm neck embolization component 5 protrudes into the parent vessel, it can form a thrombus at that point, blocking the vessel, or it can travel from that point to the periphery, causing a stroke (leading to serious complications).

[0087] As shown in Figures 13A and 13B, the aneurysm neck embolization member 5 having the second structure is suitable for relatively large aneurysms (generally up to about 15mm to 50mm). Since the neck 53 is inverted at the top tip 55A, it can be manufactured to be more than 10 times larger in diameter than the neck 53 (mesh material) before inversion.

[0088] Furthermore, since the neck portion 53 of the aneurysm neck N does not touch the inside of the aneurysm, it does not apply pressure to the aneurysm, thus reducing the possibility of aneurysm rupture. Specifically, the distance L1 from the radial side of the aneurysm neck embolization member 5 to the inner wall of the aneurysm is 1 mm or more. This is preferable. Furthermore, it is preferable that the distance L2·L3 (where L1·L2·L3 are the length, width, and height in three-dimensional space) between the tip 51A of one end of the aneurysm neck embolization member 5 and the inner wall of the aneurysm is 1 mm or more. If the distances of L1, L2, and L3 are maximized, there may be cases where the aneurysm neck embolization member 5 is almost nonexistent inside the aneurysm. In that case, the distance from the neck 53 to L1·L2·L3 becomes approximately 0 mm. Therefore, it can be applied to aneurysms such as dissecting aneurysms. In other words, the axial length of the aneurysm neck embolization member 5 of this application is not particularly limited as long as the neck 53 is present.

[0089] As described above, the aneurysm neck embolization member 5 and the method for manufacturing the aneurysm neck embolization member 5 according to the present invention allow for easy embolization of the aneurysm and the aneurysm neck N, and promote the formation of the intima on the surface of the aneurysm neck embolization member 5. Specifically, the aneurysm neck embolization member 5 can be easily placed in the aneurysm neck N rather than in the parent artery. Since the aneurysm neck embolization member 5 is made of a soft mesh material, it can be appropriately deformed in the aneurysm neck N, and can be locked and engaged in the aneurysm neck N. That is, the neck 53 is engaged in a way that it bites into the aneurysm neck N by deforming to the shape of the neck. Furthermore, since the aneurysm neck embolization member 5 has a mesh structure with appropriate pores, a high effect of platelet migration to endothelial cells and adhesion (so-called intima formation) can be expected.

[0090] Those skilled in the art should understand that various changes, substitutions, and modifications can be made without departing from the spirit and scope of the present invention.

[0091] (Variation 1) Figures 14 to 16 are schematic diagrams showing the aneurysm neck embolization member 5 according to Modification 1.

[0092] As shown in Figures 14 to 16, the aneurysm neck embolization member 5 according to Modification 1 further has a fastener 7 in addition to the aneurysm neck embolization member 5 having the first structure described above. The fastener 7 is tubular and has a guide wire G inside. The fastener 7 further has multiple longitudinal notches on the parent artery side (the operating end side of the guide wire G). These notches form multiple legs 71 that open radially at the end of the fastener 7. The multiple legs 71 lock and engage the aneurysm neck embolization member 5 with the aneurysm neck N. The length of the fastener 7 (before notch formation) is less than or equal to the total length L0 of the aneurysm neck embolization member 5 in the longitudinal direction, and preferably more than 1 / 4 of L0. The number and length of notches in the fastener 7 are appropriately determined depending on the size and material of the aneurysm neck embolization member 5. The end where the multiple legs 71 are formed does not necessarily have to be the operating end of the guidewire G, but considering mobility within the subcatheter 3, it is preferable that it be formed on the operating end side. That is, the guidewire G passes through the fastener 7, and near the neck 53, it has multiple legs 71 that radiate radially in the direction of the aneurysm neck embolization member 5. This fastener 7, together with the neck 53 of the aneurysm neck embolization member 5, assists in locking or engaging with the aneurysm neck N, and is more securely placed in the aneurysm neck N. In this modified example, the multiple legs 71 bias the neck 53 from the inside to the outside.

[0093] Specifically, the multiple legs 71 bias the neck 53 to the aneurysm neck N from inside the neck 53, as shown in Figure 14. The multiple legs 71 are positioned on the outside (parent artery side) of the aneurysm neck N. However, the position of these multiple legs 71 may also be on the inside (inside the aneurysm) of the aneurysm neck N, as shown in Figure 15. In this case as well, as shown in Figure 14, the multiple legs 71 bias the neck 53 to the aneurysm neck N. Alternatively, as shown in Figure 16, they may be positioned adjacent to the other end of the neck 53 where it is formed, the posterior end of the neck 53B (or the tip of the head 54A). In this case, the multiple legs 71 support engagement with the aneurysm neck N together with the neck 53. In particular, the multiple legs 71 support engagement of the aneurysm neck embolization member 5 to the aneurysm neck N by contacting the parent artery (PA) side of the aneurysm neck N. In Figures 14 to 16, the aneurysm neck N is shown in the diagram to facilitate understanding of the position of the multiple legs 71. It is also shown.

[0094] Furthermore, within the subcatheter 3, the fastener 7 has multiple legs 71 that are closed by the inner wall of the subcatheter 3. The multiple legs 71 are structured to open when pushed out of the subcatheter 3 by the guidewire G due to the radially outward biasing force of the multiple legs 71. This makes it possible to embolize the aneurysm and the aneurysm neck N.

[0095] The material of the fastener 7 is preferably made of synthetic resin, but is not particularly limited as long as it does not affect the human body and has appropriate elasticity. Examples of synthetic resins include polyvinyl chloride resin, polystyrene resin, ABS resin, acrylic resin, polyethylene resin, polypropylene resin, polyethylene terephthalate resin, nylon resin, fluororesin, polyurethane resin, and silicone resin. Among these, acrylic resins (such as PAMA (methyl polyacrylate), PMMA (polymethyl methacrylate), and PEMA (polyethyl methacrylate)) and silicone resins are preferred in terms of biocompatibility, strength, and moldability. Artificial high-performance fibers (such as aramid fibers) or carbon fibers can also be selected.

[0096] Furthermore, the fastener 7 may be made of metal. In this case, the fastener 7 is prepared by bundling multiple metal wires into a roughly tubular shape, and forming the ends of the wires into hook shapes so that they radiate radially in the direction of the aneurysm neck embolization member 5. By bending this, multiple legs 71 are formed. Details are omitted as they are the same as those for the fastener 7 made of the tube described above.

[0097] (Modification 2) Figures 17 to 19 are schematic diagrams showing the aneurysm neck embolization member 5 according to modified example 2.

[0098] As shown in Figures 17 to 19, the aneurysm neck embolization member 5 according to Modification 2 further has a fastener 7 in addition to the aneurysm neck embolization member 5 having the second structure described above. The fastener 7 is tubular or has wires arranged in a substantially tubular shape and has a guide wire G inside. The fastener 7 further has multiple longitudinal notches on the parent artery side (the operating end side of the guide wire G). These notches create multiple legs 71 at the end of the fastener 7 that open radially around the entire circumference. The multiple legs 71 lock and engage the aneurysm neck embolization member 5 with the aneurysm neck N. The length of the fastener 7 (before the notches are formed) should be less than or equal to the total length L0 of the aneurysm neck embolization member 5 in the longitudinal direction, and preferably more than 1 / 4 of L0, so that it can catch on the aneurysm neck N. Alternatively, the length of the fastener 7 is greater than or equal to the diameter D3 at the portion where the neck 53 of the aneurysm neck embolization member 5 is formed to catch on the aneurysm neck N, and may be greater than or equal to 5 / 4 of D3. The number and length of the notches are appropriately determined depending on the size and material of the aneurysm neck embolization member 5. Note that the end where the multiple legs 71 are formed does not have to be the neck side (end) of the aneurysm, i.e., the operating end of the guidewire G, but considering mobility within the subcatheter 3, it is preferable that it be formed on the operating end side. That is, the guidewire G passes through the fastener 7, and the fastener 7 has multiple legs 71 that radiate radially in the direction of the aneurysm neck embolization member 5 near the neck 53. This fastener 7 assists in the locking or engagement of the neck 53 of the aneurysm neck embolization member 5 with the aneurysm neck N, and is more securely placed in the aneurysm neck N. In this modified example, the fastener 7 is positioned to cover the top portion 55 of the aneurysm neck embolization member 5. Furthermore, multiple legs 71 bias the neck 53 from the inside outwards. In addition, the multiple legs 71 are spread out to follow the inverted portion of the body 52 (legs 51).

[0099] Specifically, multiple legs 71, as shown in Figure 17, have the neck 53 of the aneurysm accessible from inside the aneurysm. The multiple legs 71 are positioned to be on the outside (parent artery side) of the aneurysm neck N. However, the position of these multiple legs 71 may also be on the inside (inside the aneurysm) of the aneurysm neck N, as shown in Figure 18. In this case as well, as shown in Figure 17, the multiple legs 71 bias the neck 53 to the aneurysm neck N. Alternatively, as shown in Figure 19, they may be positioned adjacent to the other end of the neck 53 where it is formed, the posterior end of the neck 53B (or the tip of the head 54A). In this case, the multiple legs 71 support the engagement of the aneurysm neck embolus member 5 with the aneurysm neck N together with the neck 53. In particular, the multiple legs 71 support the engagement of the aneurysm neck embolus member 5 with the aneurysm neck N by contacting the artery side of the aneurysm neck N. In Figures 17 to 19, the aneurysm neck N is shown in addition to the figures to facilitate understanding of the position of the multiple legs 71.

[0100] Furthermore, within the subcatheter 3, the fastener 7 has multiple legs 71 that are closed by the inner wall of the subcatheter 3. The multiple legs 71 are structured to open when pushed out of the subcatheter 3 by the guidewire G due to the radially outward biasing force of the multiple legs 71. This makes it possible to embolize the aneurysm and the aneurysm neck N.

[0101] The material of the fastener 7 is preferably made of synthetic resin, as in the modified example 1, but is not particularly limited as long as it does not affect the human body and has appropriate elasticity. Examples of synthetic resins include polyvinyl chloride resin, polystyrene resin, ABS resin, acrylic resin, polyethylene resin, polypropylene resin, polyethylene terephthalate resin, nylon resin, fluororesin, polyurethane resin, and silicone resin. Among these, acrylic resins (such as PAMA (methyl polyacrylate), PMMA (polymethyl methacrylate), and PEMA (polyethyl methacrylate)) and silicone resins are preferred in terms of biocompatibility, strength, and moldability. Artificial high-performance fibers (such as aramid fibers) or carbon fibers can also be selected.

[0102] (Variation 3) Figure 20 is a perspective view showing the structure of the mesh material that forms the aneurysm neck embolization member 5.

[0103] In the above-described embodiment, a case was disclosed in which the mesh material constituting the aneurysm neck embolization member 5 is a single layer. However, in Modification 3, a mesh material consisting of two layers will be described. However, the number of layers of the mesh material is not limited to two layers; as long as it has appropriate softness and elasticity, the number of layers is not particularly limited.

[0104] As shown in Figure 20, the mesh material of Modified Example 3 has an inner layer n1 with a larger wire diameter on the inside (i.e., a harder aneurysm neck embolization member 5 is formed therein) and an outer layer n2, which is the mesh material described above, on the outside. That is, the outer layer n2 has a smaller wire diameter compared to the inner layer n1 (i.e., a softer aneurysm neck embolization member 5 is formed therein). However, in the present invention, the inner layer n1 and the outer layer n2 may be reversed. In other words, the present invention may have at least two or more layers of mesh material with different wire diameters.

[0105] Normally, the wire diameter and mesh size of the material used to create the mesh determine the hardness or softness of the aneurysm neck embolization member 5. A thicker wire diameter results in a harder aneurysm neck embolization member 5, and a smaller mesh size also results in a harder aneurysm neck embolization member 5. When hardness is desired in the mesh material, the wire diameter should be thicker and the mesh size smaller; a wire diameter to mesh size ratio of approximately 40μ:800μ, or 1:20, is preferable. In this invention, in order to minimize pressure on the aneurysm neck N, the wire diameter to mesh size ratio of the inner layer M1 and outer layer M2 should be approximately 1:10 to 1:20. That is, to make the outer layer softer, it is preferable that the wire diameter of the outer layer M2 be somewhat small. This is necessary to obtain appropriate softness and elasticity.

[0106] (Supplementary information regarding aneurysm neck embolus members) As mentioned above, the aneurysm neck embolization member 5 can be formed by bundling multiple flexible bodies together or by integrally forming it from a continuous body. More specifically, this can also include forming a single continuous flexible body from multiple flexible bodies, or vice versa (forming multiple flexible bodies from a single continuous flexible body). For example, in a certain test by the inventors, the aneurysm neck embolization member 5 (or aneurysm neck embolization member 60 after improvements described later) is formed by weaving together (1) sacrificial thread (sacrificial thread section, described later), (2) polyvinyl alcohol (PVA) (2 strands), (3) Tini alloy wire, (4) platinum wire, and (5) thread for plating (plating section, described later) (Macron®). More specifically, the process begins with a single thread (sacrificial thread section, described later), and two strands of PVA are intertwined. Continuing from the sacrificial thread (sacrificial thread section, described later), Tini wire and platinum wire are interwoven and woven for aneurysms approximately 5 mm below the PVA, thus forming the aneurysm neck embolization member 5. Furthermore, a thread (Macron®) for plating (plating section, described later) is interwoven with the platinum wire midway through the process. Notably, when these threads are unraveled, they all unravel into a single thread. Tini alloy wire is used to maintain strength when forming the aneurysm neck embolization member 5 (or aneurysm neck embolization member 60 after improvements described later) for relatively large cerebral aneurysms.

[0107] (Improvement of aneurysm neck embolization component) <Background of the improvements> Next, we will explain the improvements to the aneurysm neck embolization component (organized embolization component) 5 described above. First, the spontaneous rupture rate of aneurysms is 1%. When an aneurysm ruptures, subarachnoid hemorrhage occurs, and 30% of cases result in death or serious complications. As a result, after one year, death and serious complications worsen further. In contrast, regarding the surgical outcomes when an aneurysm is surgically removed, the mortality rate is approximately 1%, and including complications, the incidence rate is 20% to 30%. This means that there is almost no difference between the surgical outcomes and the spontaneous rupture rate.

[0108] The inventors developed a modular aneurysm neck embolization device with the goal of achieving a surgical outcome (clinical trial result) of less than 1%, preferably 0.1%, and more preferably 0.01%, for aneurysms, and enabling clinical application. The inventors concluded that improving surgical outcomes for aneurysms requires preventing complications and improving the surgical training environment. These points are explained in detail below.

[0109] 1. Complications associated with surgery One possible complication associated with endovascular surgery is postoperative changes in the aneurysm. During endovascular surgery, rupture may be induced due to compression (compaction) or movement (movement) of coils or other components within the aneurysm. Furthermore, the aneurysm may expand due to internal pressure (regrowth). In addition, aneurysms can take various forms, such as "wide neck" or "daughter aneurysms."

[0110] It is believed that surgical outcomes would be significantly improved simply by addressing these complications. To improve complications, the inventors focused on resolving problems by more securely fixing the implant (embolizer) at the neck of the aneurysm. The five items mentioned above ("wide neck," "daughter aneurysm," "compaction," "moving," and "regrowth") related to the morphology and changes of the aneurysm are explained below.

[0111] <<wide neck> > For cerebral aneurysms with a wide neck (also called "neck"), the outcomes of endovascular surgery are unfavorable. If it can be easily treated, it is thought that the surgical outcome rate could be improved to less than 0.1%. Figure 21 shows an image of an example of a "wide neck" aneurysm A. Figure 21 shows the external appearance of the blood vessel. In Figure 21, the symbol B indicates the size of the neck portion (diameter and width), and the symbol C indicates the size of the aneurysm in the direction of protrusion (height). In the example in Figure 21, C, including the parent artery, is approximately 2.9 mm.

[0112] <<Daughter aneurysm>> Aneurysms with "daughter aneurysms" that branch off at the buttock (tip) have a rupture rate several times higher than those without daughter aneurysms. If these aneurysms can be easily treated without applying pressure to the daughter aneurysms, it is believed that the surgical outcome rate could be improved to less than 0.1%.

[0113] < <compaction>> Even after successfully performing endovascular surgery on a cerebrovascular system, pressure on the aneurysm can cause the inserted coils to "compact," leading to the recurrence of the aneurysm. Therefore, if it were possible to easily treat the aneurysm without causing this "compaction," the surgical success rate could be improved to less than 0.1%.

[0114] < <moving>> Even after successfully performing endovascular surgery on a cerebrovascular system, the coils used to fill the aneurysm can sometimes "move" and rotate within the aneurysm. This "movement" is dangerous because it can induce rupture of the aneurysm. If it were possible to easily treat the aneurysm without causing this "movement," the surgical success rate could be improved to less than 0.1%.

[0115] < <regrowth>> Even when a brain endovascular surgery is performed successfully, the coils used to fill the aneurysm can push from the inside, causing "regrowth"—a growing aneurysm. If this regrowth could be prevented and the aneurysm could be easily treated, the surgical success rate could be improved to less than 0.1%.

[0116] 2. Improvement of the training environment for surgery Next, I will explain the training environment for surgery and measures to improve it. Currently, in arterial experiments, pigs are used as models for simulated surgeries. Implants are inserted into pig aneurysms, which are far removed from actual cases, and surgical practice is carried out. In contrast, if models that closely resemble actual cases were artificially created, and surgeons could practice using these models dozens or even hundreds of times until they were satisfied, it is believed that the aneurysm rupture rate could be improved from the conventional 1% to 0.1% or even 0.01%.

[0117] The benefits of allowing surgeons to practice dozens or even hundreds of times until they are satisfied are immeasurable, and it perfectly aligns with the saying, "You can't improve your skills without practice."

[0118] Furthermore, practice sessions involving the insertion of implants into artificially created models serve as compensatory trials for animal testing. If we can replace traditional animal testing with experiments using artificially created models, we can significantly change the nonsensical clinical trial methods that result in mortality rates of over 1% and complication rates of over 29% in human trials.

[0119] Thus, since simulated surgeries are performed on pigs before the actual operation, it cannot be said that the practice is necessarily sufficient. Furthermore, as a practical matter, currently, only well-meaning volunteers are performing the surgery. The clinical trials are being conducted at the risk of the lives of the participants. However, it is undesirable to continue a clinical trial system that allows for approval based on current results. The inventors want to improve the clinical trial results as much as possible and reduce the mortality and complication rates to below 0.1%, and ideally to 0%.

[0120] <Improved structure of aneurysm neck embolization component> Next, the structure of the improved aneurysm neck embolization member (woven embolization member) will be described. Figure 22(A) shows one model relating to the improved aneurysm neck embolization member 60. As will be described later, the aneurysm neck embolization member 60 is manufactured by weft knitting (horizontal knitting) and circular knitting of wire material using an automatic weft knitting machine 102 (Figure 27). Weft knitting is also used in the aneurysm neck embolization member 5 shown in Figure 2A, but in Figure 22(A), a part of the mesh is shown in an enlarged view.

[0121] The aneurysm neck embolus member 60 in the example shown in Figure 22(A) is formed by weaving wire into a bag shape, similar to the aneurysm neck embolus member 5 shown in Figures 1A, 2A, etc. The aneurysm neck embolus member 60 has a leg tip 51A at one end and a crown posterior end 55B at the other end, which is the opposite end. Here, for the aneurysm neck embolus member 60 in the example shown in Figure 22(A), the same reference numerals are used for parts that are the same as those for the aneurysm neck embolus member 5 in the example shown in Figure 1A, etc., and their descriptions are omitted as appropriate.

[0122] The aneurysm neck embolus member 60 in the example shown in Figure 22(A) has a leg portion 51, a body portion 52, a neck portion 53, a head portion 54, etc. In the aneurysm neck embolus member 60 in the example shown in Figure 22(A), the leg portion 51 is formed to be relatively smaller compared to the aneurysm neck embolus member 5 in the example shown in Figure 1A, etc. However, as mentioned above regarding the aneurysm neck embolus member 5 in the example shown in Figure 1A, etc., the axial length of the aneurysm neck embolus member 60 in the example shown in Figure 22(A) is not particularly limited as long as the neck portion 53 is present. For this reason, although the details will be described later, it is also possible to omit the leg portion 51 as shown in Figures 26(A) to (D).

[0123] The aneurysm neck embolus member 60 is locked to the neck (neck N, Figure 22(B)) of the aneurysm, similar to the aneurysm neck embolus member 5 in the example shown in Figure 1A. The neck 53 interposes the neck N of the aneurysm between one axial end and the other end, and the other end of the neck 53 is positioned opposite the neck (neck N) of the aneurysm from the side of the parent artery located outside the aneurysm, thereby locking it to the neck (neck N).

[0124] As mentioned above, the aneurysm neck embolization member 60 is manufactured by a circular knitting method in weft knitting. Generally, there are two knitting methods for knitted materials: warp knitting and weft knitting. By forming the aneurysm neck embolization member 60 by weft knitting, high elasticity in the lateral direction can be obtained.

[0125] Lateral stretchability is particularly high in the direction of the "course," which is the lateral mesh. In this embodiment, the direction of the "course" is perpendicular to the axial direction of the aneurysm neck embolization member 60. The direction of the "course" is also the circumferential direction (also called the axial direction, etc.) of the aneurysm neck embolization member 60. Therefore, the aneurysm neck embolization member 60 has high flexibility in the direction perpendicular to the axial direction and in the circumferential direction. The weft knitting method may be plain knit, rubber knit, or pearl knit, but it is desirable to adopt the weft knitting method that best improves surgical outcomes.

[0126] Furthermore, as will be explained in detail later, the aneurysm neck embolization member 60 can be constructed using multiple types of wire. Moreover, it is possible to use different types of wire depending on the location of the aneurysm neck embolization member 60, or to use multiple types of wire in a single location. In the example shown in Figure 22(A), the type of wire used in the construction of the neck 53 is different from that of other parts. A polymer wire (polymer thread, resin wire, resin thread) is placed over (knitted) the neck portion 53 of the metal thread woven from the leg portion 51 to the crown portion 55. This makes the pressure on the neck N from the metal thread softer, while making the metal thread, which converges towards the center, stronger (this could be reconstructed using a technique called plating). Furthermore, plating from the leg portion 51 to the crown portion 55 can also be used to reduce the pressure on the inside of the aneurysm (dome) (however, as an aneurysm neck embolization member 60 (implant), plating causes it to converge inward and become stronger. The aneurysm neck embolization member 60 (implant) tries to move away from the dome inside the aneurysm due to the convergence caused by plating, and as a result it tries to move away from the inside of the aneurysm, thus reducing the pressure. In reality, the area with only metal thread is weaker, and the area with plating is stronger).

[0127] If only metal threads were used to hold down the neck without plating, the stiff metal threads would have to be pressed quite densely against the neck N. The neck N would be pressed in several places by the knitted fabric of stiff metal threads. While the aneurysm neck embolization member 60 knitted with metal threads attempts to hold down the neck N relatively firmly, the addition of plating and the insertion of polymer wires (polymer threads) between the metal threads and the neck adds an additional convergent action. As a result, although it softly envelops the neck N, the converging force (or convergent force) of the plating firmly holds down the neck. In other words, from the perspective of the neck N, compared to when only metal threads are used, the area around the neck is covered with soft polymer wires, and in addition to the converging force of these polymer wires, the metal threads also intertwine with the polymer wires, resulting in a converging force acting from both the metal threads and the polymer wires. As a result, the aneurysm neck embolization member 60, while converging, uses the flexibility of the polymer wire to lock onto the neck N with a relatively strong force. This is something the inventors have actually experienced by plating the aneurysm neck embolization member 60 with polymer wire. Furthermore, the converging force increases in the following order: metal thread only < metal thread + nylon < metal thread + urethane < metal thread + macron thread (a thread made by mixing nylon and urethane). By performing plating, the mesh size can be made smaller compared to when the base material is made only of metal thread, making it easier to obtain the thrombosis effect.

[0128] To make it easier to understand that the entire aneurysm neck embolization member 60 (implant) is covered by plating, the inventors named this "plating 4 / 4" and used a plating technique that strengthens the center of the aneurysm neck embolization member 60 (implant) with metal thread and softens the external pressure with polymer wire (the name "plating 4 / 4" is abbreviated to "4 / 4"). As shown in Figure 26(B), it is also possible to omit the polymer wire (and metal thread) from the leg 51 to the top 55, by not performing plating from the leg 51 to the top 1 / 4. This is named "3 / 4". The advantage of this is that it can eliminate (reduce) the pressure on daughter aneurysms located deep within the aneurysm. As shown in Figure 26(C), it is also possible to omit the polymer wire (and metal thread) from the leg 51 to 2 / 4 (1 / 2). This is named "2 / 4". As shown in Figure 26(D), it is also possible to omit the polymer wire (and metal thread) from the leg 51 to 3 / 4. This was named 1 / 4. A shorter version was also fabricated and named 0 / 4. These ratios are not limited to 4 / 4 to 1 / 4 (and 0 / 4); for example, aneurysm neck embolization members 60 (implants) of lengths such as 3 / 5 or 2 / 5 may also be fabricated.

[0129] The aneurysm neck embolization member 60 is guided to the neck of the aneurysm using a combination of catheters (parent catheter 2, child catheter 3, Figures 1B, 3, and 4), an inner tube 6 (Figure 1A), a guide wire G (Figures 1A, 3, 4, and 5A), etc., as needed, similar to the aneurysm neck embolization member 5 described above. In the following explanation, an example in which the aneurysm neck embolization member 60 is connected to the tip of the guide wire G will be used.

[0130] Guidewire G is integrally connected to the aneurysm neck embolization member 60. The wire has a tip, and a detachment device D (which detaches using an electrical or mechanical detachment device, etc.) is provided to separate it. These can be operated by the practitioner by manipulating the guidewire G. By manipulating the guidewire G, the aneurysm neck embolization member 60 can be detached and placed in the aneurysm neck N between the parent artery and the aneurysm. The inventors have also made improvements to the detachment device D, and the improved detachment device D (Figure 30) will be described later.

[0131] The morphology (shape) of an aneurysm is not uniform; for example, it differs in the size and shape of the neck (N) (circumferential and inner surface irregularities, etc.), the shape of the aneurysm wall (inner wall of the aneurysm), and the depth of the aneurysm. Therefore, the aneurysm neck embolization member 60 (especially the neck 53) needs to be able to flexibly lock onto the neck N of the aneurysm and have a shape that is appropriate for the aneurysm being treated.

[0132] Factors determining the flexibility of the aneurysm neck embolization member 60 (especially the neck 53) include the material of the threads used in the weave, the shape of the mesh, and the size of the mesh. These points are also true for the aneurysm neck embolization member 5 in the example shown in Figure 1A, etc., but in the improved aneurysm neck embolization member 60, the following specific measures have been taken to improve surgical outcomes.

[0133] Figures 23(A) to (C) show photographic images of three aneurysm neck embolization members 60 manufactured in different shapes. The aneurysm neck embolization member 60 may also be manufactured in shapes such as those shown in Figures 23(A) to (C). The reason for manufacturing the aneurysm neck embolization member 60 in these different shapes is to provide an aneurysm neck embolization member 60 that is suitable for the morphology of the aneurysm being treated.

[0134] Figures 23(A) to (C) show the aneurysm neck embolus members 60 immediately after being knitted by the automatic weft knitting machine 102 (Figure 27, described later). Immediately after knitting, the waste yarn portion 80 necessary for knitting is attached. In some cases, excess yarn portion 82 may also be protruding. Figure 24 shows three aneurysm neck embolus members 60a to 60c after the waste yarn portion 80 has been removed. In Figure 24, the three aneurysm neck embolus members 60a to 60c are shown in the upper, middle, and lower sections of the image. In the example in Figure 24, the waste yarn portion 80 has been removed, but some excess yarn portion 82 remains. The method for removing the waste yarn portion 80 and excess yarn portion 82 will be described later.

[0135] In the examples in Figures 23(A) to (C) and Figure 24, there are parts made of metal threads such as titanium nickel (Tini) or platinum, and parts made of resin threads such as nylon, urethane, or artificial blood vessel threads (hereinafter referred to as the "plating part 62"). The plating part 62 may be made of metal threads, or a mixture of metal threads and resin threads. This creates variations in strength in the areas without plating, and the plated areas become stronger due to convergence, making it very easy to converge (shrink) the neck as shown in Figures 31 to 33, 35, and 36, and to change the shape of the aneurysm neck embolization member 60 in various ways.

[0136] In the examples in Figures 23(A)-(C) and Figure 24, the metal wire base material is not always easily distinguishable due to the black and white images. However, the plating portion 62 is made by weaving resin threads into the metal threads and exposing at least a portion of the resin threads to the outside, thereby increasing the flexibility of the surface portion of the aneurysm neck embolization member 60. The flexibility of the plating portion 62 causes convergence towards the center, further reducing the pressure on the aneurysm neck N. Naturally, the aneurysm neck embolization member 60 exerts a force that tries to move away from the aneurysm neck N, thus reducing the pressure on the aneurysm neck N.

[0137] The plating section 62 can be formed using an automatic weft knitting machine 102 (Figure 27, described later). The automatic weft knitting machine 102 can knit by weaving together metal threads and resin threads. In the examples in Figures 23(A) to (C) and Figure 24, the plating section 62 is woven with metal threads.

[0138] Furthermore, the plating portion 62 can also be formed by knitting in multiple layers as described above, based on Figure 20. The following describes the case in which the plating portion 62 is formed by knitting in multiple layers. Using the example in Figure 20, the relatively hard inner layer n1 is formed from metal threads, and the relatively soft outer layer n2 is formed by the plating portion 62 using resin threads.

[0139] As shown in the example in Figure 20, when the inner layer n1 is covered by the outer layer n2, the inner layer n1 is hidden by the outer layer n2. However, in reality, the inner layer n1 may be visible through the mesh of the outer layer n2, or it may protrude from the mesh of the outer layer n2, resulting in the inner layer n1 being exposed.

[0140] Specifically, the aneurysm neck embolus members 60a to 60c in each example of Figure 24 are of the type that have an inner layer n1 and an outer layer n2. In each example of Figure 24, the metal thread portion (inner layer n1) is partially exposed from the plating portion 62, which appears somewhat whitish (hiding the base material made of knitted metal threads). This is because the plating portion 62 is formed by weft knitting to be flexible and easily deformable, and the stitches can easily spread, allowing the inner layer n1 to be partially visible through the stitches.

[0141] The plating portion 62 can be further formed in multiple layers around the axis. By making the plating portion 62 in multiple layers, the thickness of the neck 53 of the aneurysm neck embolization member 60 can be increased, as schematically shown in Figure 25. In Figure 25, the dashed line E indicates the outline of the inner layer n1 hidden within the plating portion 62. In Figure 25, this is represented as "E(n1)".

[0142] In the example shown in Figure 25, the plating section 62 is formed by stacking multiple outer layers (outer layers n2-1 to n2-m, where m is an integer greater than or equal to 1). In the example shown in Figure 25, four outer layers n2-1 to n2-4 are stacked from the inside to the outside.

[0143] Each outer layer n2-1 to n2-m is also formed by weft knitting. In weft knitting, areas where resin yarns overlap occur, such as where the course (horizontal mesh) and wale (vertical mesh) overlap (loop sections). As a result, the thickness of one layer of fabric (knitted fabric) in the outer layers n2-1 to n2-m is, in some parts, about twice the diameter of the resin yarn used.

[0144] For example, if we want to expand the outside of the inner layer n1 by 3.2 mm in diameter (1.6 mm on each side x 2), and the diameter of the resin thread is 200 μm, then theoretically, by knitting the outer layer n2 into 4 layers, we can obtain 200 [μm] x 2 [times] x 4 [layers] x 2 = 3.2 mm, resulting in an outer layer of 1.6 mm on each side (a superposition of outer layers n2-1 to n2-4).

[0145] Here, the term "200 [μm] × 2 [times]" in the above formula corresponds, as mentioned earlier, to the fact that in weft knitting, the thickness of one layer of fabric (knitted fabric) is approximately twice the diameter of the resin yarn used.

[0146] Note that Figure 25 is a schematic representation of the inner layer n1 and outer layer n2. In reality, various irregularities occur due to factors such as the curvature of the wire, its wavy shape (curved shape), the flexibility of the wire, and the flexibility of the knitted fabric provided by the weft knitting.

[0147] Furthermore, since resin threads are not perfectly straight and usually have kinks and twists from being wound on a bobbin, the layering of resin threads also results in an accumulation of irregularities. For this reason, even layering resin threads with a diameter of 200 μm in four or fewer layers can, in some cases, visually expand the diameter by approximately 3.2 mm.

[0148] The automatic weft knitting machine 102 (Figure 27, described later) allows for easy adjustment of the number of layers. Therefore, manufacturers of the aneurysm neck embolization member 60 can easily adjust the number of layers, taking into account factors such as the characteristics of the resin yarn.

[0149] Thus, in the aneurysm neck embolization member 60, the thickness of the neck 53 can be adjusted by the plating portion 62, making it possible to treat aneurysms of various shapes. For example, when treating a "wide neck" aneurysm as described above, the size of the neck N inside the aneurysm A is estimated from an image such as the example shown in Figure 21. Then, an aneurysm neck embolization member 60 is manufactured to match the estimated size of the neck N and used in treatment, thereby preventing the aneurysm neck embolization member 60 from "moving" within the aneurysm.

[0150] Furthermore, since the flexibility of the plating portion 62 is greater than that of the portion knitted with metal threads, providing an outer layer n2 made of the plating portion 62 on the neck portion 53 makes it possible to further reduce the pressure of the aneurysm on the neck N.

[0151] Furthermore, the method is not limited to adding a plating portion 62; for example, the neck 53 of a single-layer (e.g., inner layer n1 only) aneurysm neck embolization member 60 can be made relatively larger to match the shape of a "wide neck" aneurysm.

[0152] Furthermore, in cases where, for example, treatment is performed in which an inner tube 6 (for example, the portion beyond the release device D in Figure 1A, the implanted inner tube) is left inside the aneurysm neck embolization member 60, it is also possible to make the inner tube 6 and the inner circumference (inner diameter) of the neck 53 in the inner layer n1 smaller so as to approach the outer diameter of the inner tube 6, while the outer layer n2 (plating portion 62) is made to match the neck N of the aneurysm, thereby expanding the outer circumference (outer diameter) of the neck 53.

[0153] It should be noted that the weaving of metal or resin threads rarely produces smooth curves, flat straight lines, or sharp angles, as shown in Figure 25. In reality, various irregularities occur, as shown in the photographic images in Figures 23(A) to (C) and Figure 24.

[0154] <Aneurysm neck embolization member 60 with modified axial length> As mentioned above, the aneurysm neck embolus member 60 can have its axial length appropriately changed. In other words, since the aneurysm neck embolus member 60 is formed by weft weaving, the weaving can be stopped at any position. For this reason, for example, as shown in Figures 26(A) to (D), the axial length can be changed to manufacture aneurysm neck embolus members 60A to 60D, etc.

[0155] The aneurysm neck embolus member 60A in the example shown in Figure 26(A) is formed in a bag-like shape, similar to the aneurysm neck embolus member 60 shown in Figure 22(A), and has a shape in which the tip of one end leg 51A is narrowed. In Figure 26(A), an aneurysm neck embolus member with the same shape as that in Figure 22(A) is referred to as "aneurysm neck embolus member 60A" for convenience.

[0156] The aneurysm neck embolization members 60B in the example of Figure 26(B) to the aneurysm neck embolization member 60D in the example of Figure 26(D) have axial lengths that are approximately 3 / 4, approximately 2 / 4 (1 / 2), and approximately 1 / 4 of the axial length of the aneurysm neck embolization member 60A in the example of Figure 26(A), with the axial length of the aneurysm neck embolization member 60A being considered as 1. It is possible to make the axial length shorter than 1 / 4. This is a type of short artery. The aneurysm neck embolization member 60 can be referred to, for example, as a 0 / 4 (aneurysm neck embolization member).

[0157] The aneurysm neck embolus members 60A to 60D in the examples shown in Figures 26(A) to (D) are all formed to include a neck 53. The size of the neck 53 region (axial length, length in the direction perpendicular to the axial direction) should be such that it can be appropriately locked onto the neck N of the aneurysm. Furthermore, in the aneurysm neck embolus members 60A to 60D, the portion from the neck 53 to the posterior end 55B of the other end can be constructed in a similar manner.

[0158] As shown in the examples in Figures 26(A) to (D), the aneurysm neck embolus members 60A to 60D can be selected according to the morphology of the aneurysm wall (the inner wall of the aneurysm). By shortening the overall length in the axial direction, the portion of the aneurysm neck embolus member (here, aneurysm neck embolus members 60B to 60D) that contacts the aneurysm wall can be reduced, thereby reducing the pressure that can act on the aneurysm. In the example of aneurysm neck embolus members 60A to 60D, if all other conditions are the same except for the axial length, the aneurysm neck embolus member 60D, which is assembled into 1 / 4 sections, will reduce the pressure that can act on the aneurysm the most.

[0159] Modified aneurysm neck embolization members with a shorter axial length (for example, modified aneurysm neck embolization members 60B to 60D) are effective in preventing "regrowth" (a growing aneurysm) caused by compressing the inside of the aneurysm. Furthermore, shortening the axial length significantly improves the maneuverability when advancing the aneurysm neck embolization member into the aneurysm.

[0160] <Method for supplying aneurysm neck embolization components, and system for supplying aneurysm neck embolization components> Figure 27 shows an example of an aneurysm neck embolization member supply system (hereinafter referred to as the "embolization member supply system") 100 according to this embodiment. The embolization member supply system 100 includes an automatic weft knitting machine 102, a management computer 104, etc. In this embodiment, an automatic weft knitting machine from Shima Seiki Mfg. Ltd.'s WHOLEGARMENT® series is used as the automatic weft knitting machine 102.

[0161] As shown in Figure 27, the automatic weft knitting machine 102 includes a control unit 112, an input unit 114, a storage unit 116, a communication unit 118, a weft knitting mechanism unit 120, and the like. Based on data input via the input unit 114 or the management computer 104, the automatic weft knitting machine 102 operates the weft knitting mechanism unit 120 to automatically knit the weft of the yarn (fiber, carrier, carriage). The input unit 114 is an input device attached to the automatic weft knitting machine 102. A touch panel display is used as the input unit 114, but it is not limited to this, and may also be a keyboard or a control panel, for example.

[0162] As schematically shown in Figure 28(A), the automatic weft knitting machine 102 can be equipped with multiple bobbins (yarn spools) 122A, 122B, 122C, etc. Each bobbin is wound with yarn of a selected material from among various knitting materials (metal materials, metal alloys, shape memory alloys, synthetic resins, and superconducting materials, etc.). The automatic weft knitting machine 102 draws yarn 123A to 123C from the designated bobbin and produces a knitted fabric. In bobbins 122A, 122B, and 122C, the yarn 123A to 123C is wound in a cylindrical shape, and the axial center is hollow. As shown in an enlarged view in Figure 28(B), support columns 126A to 126C, which are provided on the bobbin mounting base 124 of the automatic weft knitting machine 102, are inserted into the hollow portions of bobbins 122A, 122B, and 122C.

[0163] Here, the number of bobbins 122A to 122C that can be installed is not limited to three; for example, it may be possible to install two or fewer bobbins, or four or more bobbins. Furthermore, it is possible to assemble the aneurysm neck embolization member 60 by installing fewer bobbins than the number that can be installed. Figure 28 In this example, up to six bobbins can be installed.

[0164] The weft knitting mechanism 120 of the automatic weft knitting machine 102, although not shown in the figure, is equipped with, for example, two needle beds, one in the front and one in the back. The weft knitting mechanism 120 moves the yarn back and forth horizontally (left and right) between the needle beds under computer control by the control unit 112 (Figure 27). Furthermore, the weft knitting mechanism 120 creates a knitted fabric by catching the yarn with needles positioned in the front and back to form loops.

[0165] The automatic weft knitting machine 102 can continuously knit not only the inner layer n1 mentioned above, but also the outer layer n2 (n2-1 to n2-m, where m is an integer greater than or equal to 1). When knitting the outer layer n2 is performed in the automatic weft knitting machine 102, the number of layers is specified before knitting begins. Then, as shown by the dashed arrow in Figure 28(A), the knitted aneurysm neck embolus member 60 is discharged from the machine through the knit outlet 125.

[0166] The embolus member supply system 100 receives orders for aneurysm neck embolus members 60 and instructs the automatic weft knitting machine 102 to manufacture the aneurysm neck embolus members 60. Order acceptance can be done, for example, via a cloud using an internet communication line. Alternatively, order acceptance may be done, for example, by a management computer 104, or by setting up a separate order server and accepting orders through this server. The order server transmits order information to the management computer 104, and the management computer 104 can transmit manufacturing instruction information to the automatic weft knitting machine 102 based on the order information. Based on the manufacturing instruction information, the automatic weft knitting machine 102 selectively uses the specified yarn to knit the aneurysm neck embolus member 60 according to the specified specifications.

[0167] Figure 29 schematically shows an example of the process from receiving an order to placing an order for an aneurysm neck embolization member 60. When an order for an aneurysm neck embolization member 60 is received (S1), bobbins (bobbins 122A to 122C, etc.) of the material necessary for manufacturing the ordered aneurysm neck embolization member 60 are installed in the automatic weft knitting machine 102 (S2). Multiple size options are displayed on the display unit (not shown) of the management computer 104 (S3), and the operator of the management computer 104 selects the size appropriate for the ordered aneurysm neck embolization member 60 (S4).

[0168] Next, the operator performs an operation to start knitting (start knitting) (S5), and the automatic weft knitting machine 102 automatically knits the aneurysm neck embolus member 60 of the input size (S6). The time required for the automatic weft knitting machine 102 to knit one aneurysm neck embolus member 60 is approximately 3 to 5 minutes.

[0169] The knitted aneurysm neck embolus member 60 is discharged from the knit outlet 125 of the automatic weft knitting machine 102 (S7). As mentioned above, immediately after knitting, the aneurysm neck embolus member 60 also has a waste yarn portion 80 (Figure 23(A)~(C)) knitted into it by the automatic weft knitting machine 102. The waste yarn portion 80 is a necessary part when knitting the aneurysm neck embolus member 60 with the automatic weft knitting machine 102.

[0170] The discarded yarn portion 80 is attached to the aneurysm neck embolization member 60 by, for example, a nylon binding yarn portion (not shown). After knitting by the automatic weft knitting machine 102, a shaping process (S8) is performed and the discarded yarn portion 80 is removed. In removing the discarded yarn portion 80, a binding yarn portion (not shown) made of PVA that dissolves at 40°C to 80°C is interposed between the discarded yarn portion 80 and the aneurysm neck embolization member 60, and this binding yarn portion is dissolved by immersing it in hot water. As the binding yarn portion (not shown) dissolves and disappears, the bond to the discarded yarn portion 80 is released, and the aneurysm neck embolization member 60 is separated from the discarded yarn portion 80.

[0171] Furthermore, the shaping process (S8) involves, for example, the excess thread portion 8 as shown in Figures 23(A) to (C). 2 is cut. The excess yarn portion 82 is an unnecessary part generated when knitting the aneurysm neck embolization member 60 in the automatic weft knitting machine 102. Currently, the excess yarn portion 82 is cut manually. The excess yarn portion 82 is cut using scissors (not shown) to prevent it from protruding as much as possible from the aneurysm neck embolization member 60. However, the process of cutting the excess yarn portion 82 is not limited to this method and may be automated.

[0172] After the shaping process (S8), the display unit (not shown) of the management computer 104 checks whether the ordered parts are ready (S9). If they are not ready (S9: NO), the aneurysm neck embolization member 60 is then manufactured (S2 or S3-S9). If the ordered parts are ready (S9: YES), the aneurysm neck embolization member 60 is packaged (S10) and shipped (S11). The process from checking whether the ordered parts are ready (S9) to shipping the aneurysm neck embolization member 60 (S11) may be performed manually by an operator or automated.

[0173] <Detachment device D> Next, the aforementioned detachment device D will be explained. The "detachment device" is called a mechanical detach. The detachment device D is shown in examples in Figure 1A, Figure 2B, and Figure 5A. As mentioned above, the detachment device D separates the inner cannula 6 and guide wire G when the aneurysm neck embolization members 5 and 60 are placed in the neck N of the aneurysm.

[0174] Regarding such a detachment device D, there is a difficulty in detaching extremely small aneurysm neck embolization members 60 (for example, those applied to aneurysms with a depth of about 1 mm). The inventors have made it possible to more easily detach such extremely small aneurysm neck embolization members 60 (which may be of the type shown in Figures 26(B) to (D) as aneurysm neck embolization members 60B to 60D) at the neck N of the aneurysm.

[0175] Figures 30(A) to (C) schematically show the detachment device D formed in the inner cylinder 6. Figure 30(A) is an enlarged view of the inner cylinder 6 as seen from the outside of the part where the detachment device D is provided, and Figures 30(B) and (C) are enlarged views of the inner cylinder 6 in a cross-section of the part where the detachment device D is provided.

[0176] As shown in Figure 30(A), the detachment device D consists of a grasping-side inner tube 6a that is grasped by the surgeon during surgery and a placement-side inner tube 6b that is placed in the aneurysm. The grasping-side inner tube 6a and the placement-side inner tube 6b are separable from each other by a structure described later. At least a portion of the inner tube 6 constitutes the part that enters the aneurysm neck embolization member 60 (internal neck clipping coil).

[0177] Figure 30(B) shows the gripping inner cylinder 6a and the retaining inner cylinder 6b separated, and Figure 30(C) shows the gripping inner cylinder 6a and the retaining inner cylinder 6b connected. Figure 30(D) shows the retaining inner cylinder 6b inserted further into the gripping inner cylinder 6a and connected.

[0178] The gripping-side inner cylinder 6a and the retaining-side inner cylinder 6b are both cylindrical in shape. For example, the gripping-side inner cylinder 6a has an inner diameter of 500 μm and an outer diameter of 650 μm. Furthermore, the retaining-side inner cylinder 6b has an inner diameter of 690 μm and an outer diameter of 790 μm. Thus, the inner and outer diameters of the gripping-side inner cylinder 6a are somewhat smaller than those of the retaining-side inner cylinder 6b.

[0179] The materials of the grasping-side inner tube 6a and the implantation-side inner tube 6b are, for example, synthetic resins such as urethane or nylon, and have appropriate flexibility. More specifically, the grasping-side inner tube 6a becomes the tip portion of the microcatheter. The grasping-side inner tube 6a, although not shown in the figure, is composed of a combination of a cylindrical inner material and a cylindrical outer material. The material of the inner material is, for example, nylon. The outer casing material is, for example, urethane. The material of the implantation-side inner tube 6b is, for example, urethane. The operator can insert the inner tube 6, which is formed by connecting the grasping-side inner tube 6a and the implantation-side inner tube 6b, into the artery and move it while bending (curving) it.

[0180] As shown in Figures 30(B) to (D), rigid rings 72a and 72b are embedded in the inner circumference of the gripping inner cylinder 6a and the outer circumference of the retaining inner cylinder 6b. For the rigid rings 72a and 72b, metals such as gold or platinum can be used as materials.

[0181] Multiple protrusions 74 (two in Figures 30(B) to (D)) are formed at the end of the gripping inner cylinder 6a that is on the tip side (the gripping inner cylinder 6a side) of the rigid ring 72a. The protrusions 74 are arranged parallel to each other at predetermined intervals in the axial direction of the gripping inner cylinder 6a. Each protrusion 74 extends in the circumferential direction of the gripping inner cylinder 6a and in a direction perpendicular to the axial direction.

[0182] The protrusion 74 can be formed, for example, by winding multiple (in this case, two) nylon threads around the cylindrical base material of the gripping-side inner cylinder 6a. The outer diameter of the portion of the gripping-side inner cylinder 6a where the protrusion 74 is provided (outer diameter of the protrusion 74) is somewhat larger than the inner diameter of the implantation-side inner cylinder 6b (in this case, 690 μm). It is also possible to apply a hydrophilic polymer to the protrusion 74, for example. In this case, the protrusion 74 can be expanded during the procedure, so the outer diameter of the protrusion 74 can be made somewhat smaller than the inner diameter of the implantation-side inner cylinder 6b.

[0183] As shown in Figures 30(A), (C), and (D), when connecting the gripping-side inner cylinder 6a and the retaining-side inner cylinder 6b, the gripping-side inner cylinder 6a is inserted into the inside of the retaining-side inner cylinder 6b and pushed in. Since the outer diameter of the protrusion 74 on the gripping-side inner cylinder 6a is larger than the inner diameter of the retaining-side inner cylinder 6b, the protrusion 74 on the gripping-side inner cylinder 6a is compressed and elastically deformed, as shown in Figures 30(C) and (D). Here, in Figures 30(C) and (D), for the sake of simplicity, the protrusion 74 is shown in a perfectly circular state that has not undergone elastic deformation.

[0184] The protrusion 74 generates a force (resistance force) that pushes against the inner surface of the retaining inner cylinder 6b. As a result, a frictional force is generated between the gripping inner cylinder 6a and the retaining inner cylinder 6b, and the gripping inner cylinder 6a and the retaining inner cylinder 6b are firmly connected. In this case, the amount H1 and H2 that the gripping inner cylinder 6a penetrates into the retaining inner cylinder 6b can be, for example, about 1 mm or more in the state shown in Figures 30(A) and (D), and about 1.0 mm or less in the state shown in Figure 30(C).

[0185] As shown in Figures 30(A), (C), and (D), with the gripping inner tube 6a and the implantation inner tube 6b connected, the practitioner pulls the gripping inner tube 6a with a force exceeding the frictional force, causing the gripping inner tube 6a to detach from the implantation inner tube 6b. An aneurysm neck embolization member 60 is attached to the outside of the implantation inner tube 6b, and the implantation inner tube 6b is implanted in the neck N of the aneurysm together with the aneurysm neck embolization member 60, for example, as shown in Figure 22(B).

[0186] In the state shown in Figure 30(C), the rigid rings 72a and 72b have not reached the same axial position in the gripping-side inner cylinder 6a and the implantation-side inner cylinder 6b. In contrast, in the states shown in Figures 30(A) and (D), the rigid rings 72a and 72b have reached the same axial position in the gripping-side inner cylinder 6a and the implantation-side inner cylinder 6b and are overlapping. Note that in all states, including those shown in Figures 30(A) and (D), and Figure 30(C), the inner cylinder 6 can be used for treatment.

[0187] As mentioned above, there are two methods for detaching the aneurysm neck embolus members (aneurysm neck embolus members 5 and 60): electrical detachment and mechanical detachment. The method shown in Figures 30(A) to (C) is a type of mechanical detachment.

[0188] Furthermore, there are methods of detachment that involve dissolving the synthetic resin using an organic solvent. For example, one method is to dissolve urethane with DMSO (dimethyl sulfoxide) to release the bond. Moreover, the detachment device D according to this embodiment is not limited to those described above, and various methods can be employed as long as appropriate detachment is possible.

[0189] Furthermore, structures like those shown in Figures 30(A) to (C) can also be applied to other implants (for example, guidewire G).

[0190] Here, we will explain in more detail the connection method and connection structure of the detachment device shown in Figures 30(A) to (D), specifically between the gripping inner cylinder 6a and the retaining inner cylinder 6b. Currently, the inventors widen the opening of the retaining inner cylinder 6b with tweezers and push one end of the gripping inner cylinder 6a into the opening. When connecting the gripping inner cylinder 6a and the retaining inner cylinder 6b, the inner cylinder (in this case, the gripping inner cylinder 6a) generates frictional force, pushing and widening the outer cylinder (in this case, the retaining inner cylinder 6b), thereby obtaining a strong connection (joining).

[0191] For example, the allowable amounts H1 and H2 for the amount H1 and H2 that the grasping inner tube 6a penetrates into the implantation inner tube 6b in Figures 30(C) and (D) are affected by the size of the aneurysm being treated (size in the depth direction). For example, if the size of the aneurysm being treated is about 1 to 2 mm from the neck N to the inner wall in the depth direction, it is desirable to limit the allowable amounts H1 and H2 to about 0.5 mm in both cases. Conventionally, there were no detachment devices that could withstand such requirements.

[0192] However, with the detachment device D shown in Figures 30(A) to (D), the inventors' experiments showed that in many cases, the connection could be maintained even when H1 (>H2) = 0.5 mm. Furthermore, when H1 > 0.5 mm, an even greater connection force could be achieved, and in particular, when H1 (or H2) > 1.5 mm, a sufficient connection force at a practical level was obtained.

[0193] Furthermore, as shown in Figure 30(E), for example, it is possible to omit at least one of the rigid rings 72a and 72b, and / or the protrusion 74. Even if the protrusion 74, etc., is omitted, a strong connection can be obtained by utilizing the fine irregularities on the outer surface of the gripping inner cylinder 6a and the inner surface of the retaining inner cylinder 6b.

[0194] Furthermore, as mentioned above, the gripping inner tube 6a (i.e., the tip of the microcatheter) is equipped with a rigid ring 72a (a ring made of gold or platinum). When the gripping inner tube 6a is inserted into the indwelling inner tube 6b, a force (resistance) is generated that pushes against the inner surface from the inside of the indwelling inner tube 6b. As a result, a frictional force is generated between the gripping inner tube 6a and the indwelling inner tube 6b, and the two are firmly connected.

[0195] Furthermore, in this embodiment, the gripping-side inner cylinder 6a is formed with a relatively small diameter, and the retaining-side inner cylinder 6b is formed with a relatively large diameter. However, the embodiment is not limited to this, and the gripping-side inner cylinder 6a may be formed with a large diameter, and the retaining-side inner cylinder 6b may be formed with a small diameter. In this case, the opening of the gripping-side inner cylinder 6a can be widened with tweezers or the like, and the retaining-side inner cylinder 6b can be pushed in with the inside facing inward. However, this may be disadvantageous in the following respects (1) and (2). (1) When inserting or removing the guide wire G (especially when inserting it), the retaining-side inner cylinder 6b protrudes into the inside of the gripping-side inner cylinder 6a, making it easy for the guide wire G to interfere with the retaining-side inner cylinder 6b. (2) When dissolving the urethane with DMSO (dimethyl sulfoxide) to remove it, the inner material of the microcatheter of the grasping inner tube 6a is made of nylon, so the DMSO that flows inside the grasping inner tube 6a dissolves a large amount of the urethane inner tube 6b on the implantation side. It's possible.

[0196] However, as shown in Figures 30(A) to (D) and (E), if the gripping-side inner cylinder 6a is formed with a small diameter and the retaining-side inner cylinder 6b is formed with a large diameter, these disadvantages can be prevented.

[0197] Here, we will provide a supplementary explanation regarding the use of the inner tube 6. As explained with respect to the aneurysm neck embolization member 5 described in Patent Document 2 above, the inner tube 6 can be joined to the aneurysm neck embolization member 5 (implant) using an adhesive such as Aron Alpha (registered trademark). This is also the case for the improved aneurysm neck embolization member 60. In addition, it is also possible to use, for example, Loctite (trade name) AA 3311 from Henkel Japan Ltd. as an adhesive. Furthermore, it is also possible to join (connect) the inner tube 6 (or guide wire G, etc.) to the inner tube 6 in the same manner as the pre-improvement aneurysm neck embolization member 5.

[0198] Figure 34(A) schematically shows the aneurysm neck embolization member 60 joined to the inner cylinder 6, and Figure 34(B) shows a magnified view of the aneurysm neck embolization member 60 and its surrounding area as shown in Figure 34(A). Furthermore, Figure 34(C) shows a magnified view of the aneurysm neck embolization member 60 and its surrounding area when a guide wire G is used.

[0199] <Supplementary information regarding compatibility with various sizes of Neck N> As explained above, the method for manufacturing the aneurysm neck embolization member 60 according to this embodiment makes it possible to easily form aneurysm neck embolization members 60 of various sizes. Therefore, it is possible to supply aneurysm neck embolization members 60 in a form suitable for aneurysms with a "wide neck" that are larger than the intermediate size, and aneurysms with a "narrow neck" that are smaller than the intermediate size, to medical facilities in a timely manner.

[0200] Figure 35(A) shows an aneurysm neck embolus member 60 that can be applied to a "wide neck" aneurysm, similar to the example in Figure 22(A). Compared to this aneurysm neck embolus member 60, as shown by arrow R and in Figure 35(B), it is possible to form an aneurysm neck embolus member 60E that is suitable for a "narrow neck" aneurysm by making the neck 53 smaller (thinner in diameter, reduced in size).

[0201] Figures 36(A) and (B) show the internal structure of the aneurysm neck embolization member 60 corresponding to a "wide neck" aneurysm, indicated by dashed lines (hidden lines). In the example in Figure 36(A), similar to the configuration described above, the neck 53 of the single-layer (for example, inner layer n1 only) aneurysm neck embolization member 60 is made relatively large to match the shape of a "wide neck" aneurysm. In contrast, in the example in Figure 36(B), as also described above, the inner circumference (inner diameter) of the neck 53 in the inner layer n1 is made smaller to approach the outer diameter of the inner cylinder 6, while the outer layer n2 (plating portion 62) is made to match the neck N of the aneurysm, thereby expanding the outer circumference (outer diameter) of the neck 53.

[0202] Figure 36(C) shows the internal structure of the aneurysm neck embolization member 60 corresponding to a "narrow neck" aneurysm, indicated by dashed lines (hidden lines). In the example in Figure 36(C), the neck 53 is smaller (thinner in diameter, reduced in size) compared to the example in Figure 36(B), and the leg portion 51 and body portion 52 are tapered (narrower towards the tip). In the example in Figure 36(C), the neck 53 is enlarged by the plating portion 62, but the plating portion 62 of the neck 53 may be omitted.

[0203] <Taking images from a radiographic examination> As mentioned above, the radiopaque nature of the aneurysm neck embolization member 5 makes it convenient to reposition or retrieve the aneurysm neck embolization member 5. For example, the same can be said for the aneurysm neck embolization member 60 of this embodiment, as shown in Figures 36(A) to (C). Furthermore, by using a metal wire (a wire made of a material that is radiopaque, such as an X-ray-opaque material) in the inner layer n1, for example, it becomes possible to visualize the aneurysm neck embolization member 60 in radiographic examination images such as X-ray images.

[0204] Since the aneurysm neck embolization member 60 of this embodiment is formed by weft knitting using an automatic weft knitting machine 102, it is easy to form a structure (for example, an inner layer n1) for displaying the aneurysm neck embolization member 60 in a radiographic examination image.

[0205] <Adding reinforcement wires> In the examples shown in Figures 36(A) to (C), in addition to the inner layer n1 and outer layer n2 described above, a reinforcing layer n3, formed by reinforcing wires, is provided. In Figures 36(A) to (C), the reinforcing layer n3 is indicated by a dashed line (hidden line). Furthermore, the reinforcing layer n3 is formed inside the inner layer n1, and the inner layer n1 is formed outside the reinforcing layer n3.

[0206] For example, platinum can be used as the material for the reinforcing wires that make up the reinforcing layer n3. By using a metallic material such as platinum for the wires that make up the reinforcing layer n3, it becomes possible to visualize the aneurysm neck embolization member 60 in radiographic imaging such as X-ray images. Furthermore, even in cases where a clear image cannot be obtained with the inner layer n1 alone, the reinforcing layer n3 makes it possible to obtain an even clearer radiographic image.

[0207] Furthermore, the addition of the reinforcing layer n3 makes it possible to increase the rigidity of the aneurysm neck embolization member 60.

[0208] <Improvement of the training environment for surgery using an aneurysm neck embolization component 60> Next, we will describe the training environment for surgery using the aneurysm neck embolization member 60. For cases in which surgery using the aneurysm neck embolization member 60 is planned, an aneurysm model (case model) is created using image information obtained from the examination device. The case model can be created, for example, by three-dimensional modeling using a 3D printer.

[0209] Although not shown in the diagram, in specific terms, orders for case models are received from hospitals and doctors where surgeries are scheduled, and the system instructs a 3D printer (not shown) to produce the case models. Order acceptance can be done, for example, via a cloud using an internet communication line. Alternatively, orders may be accepted, for example, by a designated management computer, or by setting up a separate order server and accepting orders through this server.

[0210] Order information is transmitted from the order server to the management computer, which can then send manufacturing instructions to the 3D printer based on the order information. The 3D printer then produces a case model based on the manufacturing instructions. The produced case model is then shipped to the customer.

[0211] Upon receiving the case model, the physician can practice (simulate) the procedure as many times as needed before the surgery using the case model and the aneurysm neck embolization component 60. Multiple aneurysm neck embolization components 60 are ordered from the embolization component supply system 100, and in the actual surgery, unused aneurysm neck embolization components 60 that have not been used for practice are used.

[0212] By using such case models, surgical practice can be conducted without excessive reliance on animal experiments or clinical trials involving volunteer patients. As a result, surgical outcomes can be improved. ru.

[0213] <Effects of typical inventions using the aneurysm neck embolization member 60, etc.> Of the various embodiments described above, the aneurysm neck embolization member 60 allows the neck 53 to be flexibly formed by weft weaving. Therefore, it is possible to more flexibly lock (fit) the neck 53 to the neck N of the aneurysm. As a result, it is possible to improve surgical outcomes.

[0214] Furthermore, it is easy to guide the aneurysm neck embolus member 60 (or the aneurysm neck embolus members 60A to 60D shown in Figure 26, and the 0 / 4 aneurysm neck embolus member 60, etc.), which is used for "wide neck" aneurysms, into the parent vessel with a diameter (inner diameter) of about 2 mm.

[0215] Furthermore, improvements have been made to the aneurysm neck embolization member disclosed in the aforementioned Patent Document 2, making it possible to create implants (aneurysm neck embolization members) that can accommodate aneurysm necks N with a narrower neck 53. For wide necks, the aneurysm neck embolization member disclosed in Patent Document 2 can also be used, but it has become possible to create various configurations, as shown in some examples in Figures 23(A)-(C), Figure 24, and Figures 33(A)-(C).

[0216] Furthermore, with respect to the aneurysm neck embolization member 60, the neck 53 is expanded by the outer layer n2 (Figure 25) which is woven in a weft knit, allowing the aneurysm neck embolization member 60 to "inflat." This also allows the neck 53 to be flexibly locked to the neck N of an aneurysm with a "wide neck." This stabilizes the fit of the aneurysm neck embolization member 60 to the neck N of the aneurysm. As a result, "movement" of the aneurysm neck embolization member 60 within the aneurysm can be prevented, improving surgical outcomes.

[0217] Furthermore, since the outer layer is composed of multiple layers (n2-1 to n2-m, where m is an integer greater than or equal to 1), the size of the neck 53 can be easily adjusted.

[0218] Furthermore, since the aneurysm neck embolization member 60 is knitted by weaving together metal threads and resin threads, and a plating portion 62 is formed by the resin threads, appropriate rigidity is obtained from the metal thread portion, and the size of the aneurysm neck embolization member 60 (especially the size in the axial direction) can be expanded by the plating portion 62 (expansion portion). This also stabilizes the fit of the aneurysm neck embolization member 60 to the neck N of the aneurysm.

[0219] Furthermore, in the manufacturing method of the aneurysm neck embolization member 60, an automatic weft knitting machine 102 (Figure 27) is used for weft knitting of the wire material, making it easy to mass-produce or custom-make the aneurysm neck embolization member 60. This makes it possible to supply aneurysm neck embolization members 60 of various sizes to medical facilities in a timely manner.

[0220] Furthermore, as shown in Figures 30(A) to (D), the release device D is provided with a protrusion 74 that elastically deforms to generate frictional force. Therefore, both a strong connection and easy separation can be achieved between the gripping side member (such as the gripping side inner cylinder 6a) and the retaining side member (such as the retaining side inner cylinder 6b).

[0221] Furthermore, in order to securely fit the aneurysm neck embolization member 60 (implant) to the neck closer to the parent artery (the part of the neck N on the parent artery side) and the neck closer to the dome (the part of the aneurysm closer to the protruding side related to the neck N), it is effective to push the inner implant (such as the inner cannula 6b on the implant side) into the outer implant (aneurysm neck embolization member 60), for example, as shown in Figure 22(B) and Figure 30.

[0222] As explained above, by securely fitting the neck 53 to the neck N of the aneurysm, implants such as the inner cannula 6b become less likely to move or become dislodged. As a result, it is possible to prevent the inner implant from protruding into the parent vessel or being pushed back into the aneurysm by blood flow.

[0223] <Insertion of other implants into the aneurysm neck embolization member 60> As an aneurysm neck embolization member 60 into which other implants can be inserted, for example, one can be considered that can be used in the order shown in Figures 31(A) to (C). Figure 31(A) shows that a relatively miniaturized implant 140 is inserted into an aneurysm neck embolization member 60B having approximately 3 / 4 of the total length as shown in Figure 26(B), as indicated by arrow Q.

[0224] The implant 140, like the aneurysm neck embolization member 60B, is formed by weaving a mesh material. For the weaving method, circular knitting in the weft can be used. In this case, a relatively small implant 140 with a similar mesh structure is inserted into the aneurysm neck embolization member 60B. However, it is not limited to this; the implant 140 can be woven using various other methods, as long as it can be delivered into the aneurysm neck embolization member 60B.

[0225] An inner tube 6 is concentrically passed between the aneurysm neck embolization member 60B and the implant 140. The aneurysm neck embolization member 60B is located on the gripping side of the inner tube 6 relative to the implant 140. The implant 140 is located on the tip side of the inner tube 6 relative to the aneurysm neck embolization member 60B. In the state shown in Figure 31(A), the distance between the aneurysm neck embolization member 60B and the implant 140 can be, for example, several millimeters.

[0226] Alternatively, a guide wire G or the like may be used instead of the inner tube 6. Furthermore, the procedure of inserting the implant 140 into the aneurysm neck embolization member 60B may be performed, for example, with the aneurysm neck embolization member 60B locked to the neck N (not shown) of the aneurysm.

[0227] In the state shown in Figure 31(A), the inner cylinder 6 is manipulated to bring the implant 140 closer to the aneurysm neck embolization member 60B. Figure 31(B) shows the state in which the implant 140 has moved and reached the aneurysm neck embolization member 60B. Figure 31(C) shows the state in which the insertion of the implant 140 into the aneurysm neck embolization member 60B is completed, with a portion of the aneurysm neck embolization member 60B cut away.

[0228] In this way, by inserting the implant 140 inside the aneurysm neck embolization member 60B, it becomes possible to reinforce the flexible aneurysm neck embolization member 60B. Figures 32(A) to (C) are photographic images showing the state corresponding to Figures 31(A) to (C). In Figures 32(A) to (C), the same parts as in Figures 31(A) to (C) are denoted by the same reference numerals.

[0229] Furthermore, in Figures 32(A) and 32(B), the distance between the aneurysm neck embolization member 60B and the implant 140 may appear to be approximately the same. This is because Figure 32(B) was photographed at a closer position than Figure 32(A). Also, in Figures 32(A) to (C), a guide wire is passed through the inner tube 6, which has been cut to a short length for experimental purposes. Moreover, in the example of Figure 32(C), the aneurysm neck embolization member 60B and the implant 140 are shifted to one end of the inner tube 6 (the upper side in Figure 32(C)) compared to the examples of Figures 32(A) and (B). In addition, the total axial length of the aneurysm neck embolization member is not limited to 3 / 4, but may be other lengths (1, 2 / 4 (1 / 2), 1 / 4, 0 / 4).

[0230] Furthermore, while implant 140 functions as a relatively small (miniature) stopper, The implant 140 may be formed not as a mass of knitted fabric, but, for example, as a solid polymer made from resin. Alternatively, it may be formed by knitting Tini alloy wire.

[0231] <Inventions that can be extracted from the embodiments> (1) It has a main body (collectively referred to as the body part 52, neck part 53, head part 54, etc.) made of a tubular mesh material knitted by weft knitting to be flexible, The main body portion is The cervical region (such as cervical 53) can be fitted from the inside to the neck of the aneurysm, It includes a body (such as body 52) which is formed in a continuous manner with the neck and inserted into the aneurysm, The neck of the aneurysm is interposed between one end and the other end in the axial direction. An aneurysm neck embolization member characterized in that the other end of the neck portion is positioned opposite the neck (neck N, etc.) of the aneurysm from the side of the parent artery located outside the aneurysm and is locked to the neck of the aneurysm. (2) The aneurysm neck embolus member according to (1) above, characterized in that the neck is expanded by an outer layer (outer layer n2, etc.) made by weft knitting. (3) The aneurysm neck embolization member according to (2) above, characterized in that the outer layer is composed of multiple layers (multiple outer layers n2-1 to n2-m, where m is an integer of 1 or more). (4) It has a main body (collectively referred to as the body part 52, neck part 53, head part 54, etc.) made of a tubular mesh material knitted by weft knitting to be flexible, The main body portion is The cervical region (such as cervical 53) can be fitted from the inside to the neck of the aneurysm, It includes a body (such as body 52) which is formed in a continuous manner with the neck and inserted into the aneurysm, The neck of the aneurysm is interposed between one end and the other end in the axial direction. A method for manufacturing an aneurysm neck embolization member, wherein the other end of the neck portion is positioned opposite the neck (neck N, etc.) of the aneurysm from the side of the parent artery located outside the aneurysm and is locked to the neck of the aneurysm, Using an automatic weft knitting machine (such as automatic weft knitting machine 102), A method for manufacturing an aneurysm neck embolus member, characterized in that the automatic weft knitting machine dispenses yarn of a material matched to the aneurysm neck embolus member to be knitted, and knits the neck and body by weft knitting. (5) The neck is extended by an outer layer (outer layer n2, etc.) which is knitted by weft knitting, The method for manufacturing an aneurysm neck embolization member according to (4) above, wherein the automatic weft knitting machine knits the outer layer. (6) The outer layer is composed of multiple layers (multiple outer layers n2-1 to n2-m, where m is an integer of 1 or more), The method for manufacturing an aneurysm neck embolization member according to (5) above, wherein the automatic weft knitting machine knits the outer layer. (7) A method for manufacturing an aneurysm neck embolus member according to any one of the above items (4) to (6), wherein an aneurysm neck embolus member having a different axial length in the main body (such as aneurysm neck embolus members 60A to 60D shown in Figures 26(A) to (D)) is manufactured using the automatic weft knitting machine. (8) It has a main body (collectively referred to as the body part 52, neck part 53, head part 54, etc.) made of a tubular mesh material knitted by weft knitting to be flexible, The main body portion is a neck (such as neck 53) that can fit internally from the inside to the neck of the aneurysm, and a body part (such as body part 52) that is continuously formed with the neck and inserted into the inside of the aneurysm, and the neck has the neck of the aneurysm interposed between one axial end and the other end, the other end of the neck is locked to the neck of the aneurysm by facing the neck of the aneurysm ( neck N, etc.) from the side of the parent artery outside the aneurysm, and a detachment device (detachment device D, etc.) that enables the aneurysm neck embolization member to be placed in the aneurysm, and a gripping side member (such as gripping side inner cylinder 6a) that can be gripped by an operator, and a placement side member (such as placement side inner cylinder 6b) that is placed in the aneurysm, and the placement side member is detachably connected to the gripping side member, the connection of the placement side member is formed on at least one of the gripping side member and the placement side member, and has a convex part (such as convex part 74) that contacts the other and is compressed and elastically deformed to generate frictional force. A detachment device characterized by this.

Explanation of symbols

[0232] 1: In-vivo detachment tool 2: Parent catheter 3: Child catheter 60, 60a, 60b, 60A - 60D: Aneurysm neck embolization member <^{0000917}>6: Inner cylinder 6a: Gripping side inner cylinder 6b: Placement side inner cylinder 7: Fastener 52: Body part 53: Neck 54: Head 62: Plating part 71: Leg 72a, 72b: Rigid ring 74: Convex part 100: Aneurysm neck embolization member supply system 102: Automatic weft knitting machine 104: Management Computer D: Detachment device G: Guidewire N: Neck of the aneurysm< / regrowth> < / moving> < / compaction>

Claims

1. It has a main body made of a tubular mesh material that is knitted by weft weft to give it flexibility, The main body portion is The neck portion can be fitted from the inside to the neck of the aneurysm, It includes a body that is formed in continuous with the neck and inserted into the aneurysm, The neck of the aneurysm is interposed between one end and the other end in the axial direction. An aneurysm neck embolization member characterized in that the other end of the neck is positioned opposite the neck of the aneurysm from the side of the parent artery located outside the aneurysm and is locked to the neck of the aneurysm.

2. The aneurysm neck embolus member according to claim 1, characterized in that the neck portion is expanded by an outer layer formed by weft knitting.

3. The aneurysm neck embolus member according to claim 2, characterized in that the outer layer is composed of multiple layers.

4. It has a main body made of a tubular mesh material that is knitted by weft weft to give it flexibility, The main body portion is The neck portion can be fitted from the inside to the neck of the aneurysm, It includes a body that is formed in continuous with the neck and inserted into the aneurysm, The neck of the aneurysm is interposed between one end and the other end in the axial direction. A method for manufacturing an aneurysm neck embolus member, wherein the other end of the neck portion is positioned opposite the neck of the aneurysm from the side of the parent artery located outside the aneurysm and is locked to the neck of the aneurysm, Using an automatic weft knitting machine, A method for manufacturing an aneurysm neck embolus member, characterized in that the automatic weft knitting machine dispenses yarn of a material matched to the aneurysm neck embolus member to be knitted, and knits the neck and body by weft knitting.

5. The aforementioned neck is extended by an outer layer knitted by weft knitting. The method for manufacturing an aneurysm neck embolization member according to claim 4, wherein the automatic weft knitting machine knits the outer layer.

6. The aforementioned outer layer is composed of multiple layers, The method for manufacturing an aneurysm neck embolization member according to claim 5, wherein the automatic weft knitting machine knits the outer layer.

7. A method for manufacturing an aneurysm neck embolus member according to any one of claims 4 to 6, wherein the automatic weft knitting machine is used to manufacture an aneurysm neck embolus member in which the axial length of the main body portion differs.

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