JP2015029864A - Mold for manufacturing in-vivo indwelling member, in-vivo indwelling member manufacturing apparatus having the mold and method for manufacturing in-vivo indwelling member using the mold - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a mold for manufacturing an in-vivo indwelling member in which the in-vivo indwelling member capable of being stably arranged in lumps, e.g., such as aneurysm can be simply made.SOLUTION: A mold for manufacturing an in-vivo indwelling member is provided for obtaining the in-vivo indwelling member having a secondary shape of a three-dimensional arrangement by further incorporating a primary coil formed of strands. The mold includes a variable member that can be changed into an assembled state and an expanded state, and the variable member is a mold having a first surface where the primary coil is disposed and a holding part for disposing the primary coil in a predetermined shape on the first surface.

Description

  The present invention relates to a mold for manufacturing an in-vivo indwelling member used when manufacturing an in-vivo indwelling member such as an embolic material, an in-vivo indwelling member manufacturing apparatus having the mold, and an in-vivo indwelling member using the mold It relates to a manufacturing method.

  Examples of a method for treating an aneurysm or the like formed in a blood vessel include a method of inserting an in-vivo indwelling member such as an embolic material into the aneurysm. Such a treatment can reduce the risk of the aneurysm rupturing by forming a thrombus around the embolic material within the aneurysm. In order to insert an embolic material into a desired aneurysm, first, a medical device composed of a small-diameter and long tube called a microcatheter is inserted into a blood vessel and guided to an aneurysm or the like. Then, an embolic material is inserted into the aneurysm via the tube lumen of the microcatheter and placed.

  In general, such an embolic material is composed of a secondary coil obtained by further forming a primary coil obtained by forming a metal wire into a coil shape. And when this embolic material is guided to an aneurysm or other aneurysm, it is straight in the thin tube of the microcatheter, and when released from within the tube in the aneurysm, it returns to the original secondary coil shape, It is possible to stay inside.

  By the way, the shape of the aneurysm includes a spherical shape, an elliptical spherical shape, a bilobal shape, a shape in which another blood vessel branches from the aneurysm, and the like. Among them, for example, in a type of aneurysm called a wide neck aneurysm having a wide boundary with a parent blood vessel with respect to the diameter of the aneurysm, when the secondary coil is placed in the aneurysm, the general coil shape ( For example, when a secondary coil having a simple spiral shape is used, the coil shape is cylindrical and does not sufficiently correspond to the shape of the inner wall surface of the aneurysm, and the neck opening is wide. The pressing force against the inner wall of the aneurysm that remains in the aneurysm even if it is restored to the original coil shape is weak, and the secondary coil jumps out to the parent blood vessel, causing a serious danger when it flows to the periphery as it is there is a possibility.

  For such a wide neck aneurysm, if the shape of the secondary coil has a three-dimensional structure that matches the shape of the inner wall surface of the aneurysm to some extent, the secondary coil changes to the three-dimensional structure in the aneurysm. It is known that by restoring and applying a pressing force to the inner wall surface of the aneurysm, it can be firmly fixed and the possibility of the secondary coil jumping out to the parent vessel can be reduced.

  Various manufacturing techniques have already been disclosed for secondary coils having such a three-dimensional structure. For example, Patent Document 1 discloses a method of manufacturing a secondary coil having a three-dimensional structure by winding a primary coil around a mandrel-shaped (with pins), clover-shaped, or cubic-shaped core material. However, when the primary coil is wound around the core material in this way, it is necessary to pay attention to the winding order in the case of a complicated three-dimensional structure that may damage the primary coil during winding in the manufacturing process. There are problems such as complicated work.

  Patent Document 2 also describes a method of manufacturing a secondary coil having a three-dimensional structure by winding a coil around a mandrel (bar, cube, and groove). In the case of the method described in Patent Document 1, Similarly to the above, there is a problem in terms of damage to the primary coil during winding and workability.

  On the other hand, Patent Document 3 describes a method of manufacturing a secondary coil having a spherical three-dimensional structure by inserting a primary coil into a spherical mold, in addition to a method of winding a primary coil around a mandrel or the like. Yes. In this method using a mold, a spherical inner space is formed by combining molds having a hemispherical inner space to form a pair, and a spherical three-dimensional structure is formed by inserting a primary coil into the inner space. The secondary coil is formed. However, in this method, although it is easy to insert the primary coil into the inner space of the mold, the movement of the primary coil in the inner space of the mold cannot be controlled, and the primary coil is not randomly inserted. It becomes a general spiral shape (see, for example, FIG. 22), and the general spiral shape cannot be the intended arrangement of the primary coil in the interior space, and thus the same is stably molded There is a problem that can not be.

JP-T-2001-513389 JP-T-2004-511293 Japanese Patent No. 3024071

  The present invention has been made in view of the above-described problems of the prior art. For example, a three-dimensional structure that can be stably arranged in an aneurysm such as an aneurysm, that is, a secondary shape in a three-dimensional arrangement. In vivo indwelling member manufacturing mold capable of easily producing an in vivo indwelling member, an in vivo indwelling member manufacturing apparatus having the mold, and an in vivo indwelling member manufacturing method using the mold The purpose is to provide.

  As a result of intensive studies by the inventor, by using a mold that can arrange and hold a primary coil in a predetermined shape on the first surface of a variable member that can be deformed into an assembled state and a deployed state, The inventors have found that the problem can be solved and have completed the present invention. That is, the gist of the present invention is as follows.

[1] A mold for manufacturing an in-vivo indwelling member for obtaining an in-vivo indwelling member having a three-dimensionally arranged secondary shape by further shaping a primary coil formed of a strand, A variable member that can be deformed into an assembled state and a deployed state, the variable member including a first surface on which the primary coil is disposed, and a holding portion for disposing the primary coil in a predetermined shape on the first surface. And mold with.
[2] The mold according to [1], wherein the variable member has the first surface facing the same side in the unfolded state.
[3] The mold according to [1] or [2], wherein the variable member is formed by connecting a plurality of pieces.
[4] The mold according to [3], wherein the plurality of pieces are connected by a connection variable portion.
[5] The mold according to [3] or [4], wherein the piece is a flat material.
[6] The [3] to [5], wherein the holding portion has at least one structure selected from a concave portion provided on the first surface, a pair of convex portions, a through-hole portion, and a hook-shaped portion. The mold according to any one of the above.
[7] The through hole is formed by at least one of a through hole of a cylindrical member provided on the first surface and a through hole of the variable member provided below the first surface. ] The type described.
[8] The mold according to any one of [1] to [7], further including a fixing portion for fixing the primary coil disposed in the holding portion.
[9] The mold according to any one of [1] to [8], wherein the holding portion has a curved portion.
[10] The variable member according to any one of [3] to [9], wherein the variable member includes a plurality of three or more pieces, and at least three pieces are linearly connected in the developed state. The type described in
[11] The mold according to the above [10], further comprising pieces of material connected in a cross shape.
[12] The mold according to any one of [4] to [11], wherein the connection variable portion is at least one selected from a hinge, a ring binder, and a flexible sheet.

[13] An in-vivo indwelling member manufacturing apparatus having the mold according to any one of [1] to [12].
[14] The mold according to any one of [10] to [12], a support surface that supports a part of a plurality of pieces constituting the mold in an unfolded state, and a recess in the support surface A supporting base having a receiving portion for receiving the mold in the assembled state, and pressing the piece material positioned on the receiving portion to fit the die into the receiving portion; The in-vivo indwelling member manufacturing apparatus which has a press part which changes in an assembly state by.

  [15] A method of manufacturing an in-vivo indwelling member having a secondary shape of a three-dimensional arrangement obtained by further shaping a primary coil formed of a strand, which can be deformed into an assembled state and a deployed state Using a mold provided with a member, placing the primary coil in the unfolded mold, and transforming the mold into an assembled state with the primary coil placed, the primary coil into the secondary shape of the three-dimensional arrangement A method for producing an in-vivo indwelling member, comprising a step of deforming.

  According to the present invention, for example, an in-vivo indwelling member having a secondary shape of a three-dimensional arrangement that can be stably arranged in an aneurysm such as an aneurysm can be easily produced.

(A) It is the side view which showed the outline of an example of embodiment of the primary coil used by this invention. (B) It is the side view which showed the outline of the other example of embodiment of the primary coil used by this invention. It is the side view which showed the outline of the further another example of embodiment of the primary coil used by this invention. (A) It is the perspective view which showed typically the assembly state of embodiment of the type | mold for in-vivo indwelling member manufacture which concerns on this invention. (B) It is the perspective view which showed typically the unfolded state of embodiment of the type | mold of Fig.3 (a). (C) It is sectional drawing of the II direction of FIG.3 (b). (A) It is the perspective view which showed typically the assembly state of other embodiment of the type | mold for in-vivo indwelling member manufacture which concerns on this invention. (B) It is the perspective view which showed typically the assembly state of further another embodiment of the type | mold for in-vivo indwelling member manufacture based on this invention. (A) It is the perspective view which showed typically the example of the piece of material which has the 2nd example of embodiment of a holding | maintenance part. (B) It is sectional drawing of the II-II direction of Fig.5 (a). (A) It is the perspective view which showed typically the example of the piece of material which has the 3rd example of embodiment of a holding | maintenance part. (B) It is sectional drawing of the III-III direction of Fig.6 (a). (A) It is the perspective view which showed typically the example of the piece of material which has the 4th example of embodiment of a holding | maintenance part. (B) It is sectional drawing of the IV-IV direction of Fig.7 (a). (A) It is the perspective view which showed typically the example of the piece of material which has the 5th example of embodiment of a holding | maintenance part. (B) It is sectional drawing of the VV direction of Fig.8 (a). (A) It is the perspective view which showed typically the example of the piece of material which has the 6th example of embodiment of a holding | maintenance part. (B) It is the perspective view which showed typically the example of the piece of material which has the 7th example of embodiment of a holding | maintenance part. (C) It is the perspective view which showed typically the example of the piece of material which has the 8th example of embodiment of a holding | maintenance part. (A) It is the perspective view which showed typically the example of the single material which has the 9th example of embodiment of a holding | maintenance part. (B) It is the perspective view which showed typically the example of the piece of material which has the 10th example of embodiment of a holding | maintenance part. It is the perspective view which showed typically the 1st example of embodiment of a connection variable part. It is the perspective view which showed typically the 2nd example of embodiment of a connection variable part. It is the perspective view which showed typically the 3rd example of embodiment of a connection variable part. It is the top view which showed typically the planar view seen from the 1st surface side of the type | mold shown in FIG.3 (b). It is the top view which showed typically the state which has arrange | positioned the primary coil to the type | mold shown in FIG.3 (b). (A) It is the perspective view which showed simply the state when the type | mold shown in FIG. 15 which has arrange | positioned the primary coil is made into an assembly state. (B) It is the perspective view which showed typically the in-vivo indwelling member taken out from the type | mold shown to Fig.16 (a) after heat processing. (A) It is the perspective view which showed typically the support stand which is a structure of the in-vivo indwelling member manufacturing apparatus. (B) It is sectional drawing of the VI-VI direction of Fig.17 (a). FIG. 18 is a perspective view schematically showing a state in which the unfolded mold is placed on and supported by the support base shown in FIG. 17. It is the perspective view which showed typically the state which started pressing the type | mold supported by the support stand of the state shown in FIG. 18 by the pressing part. It is the perspective view which showed typically the state in the middle of the type | mold being fitted by the accommodating part of the support stand from the state shown in FIG. It is the perspective view which showed typically the state by which the type | mold was inserted by the accommodating part of the support stand shown in FIG. It is the perspective view which showed typically the conventional metal mold | die used by the comparative example.

  Hereinafter, a mold for producing an in-vivo indwelling member of the present invention (hereinafter sometimes simply referred to as “mold”), an in-vivo indwelling member manufacturing apparatus having the mold, and an in-vivo indwelling member using the mold Embodiments of the manufacturing method will be described with reference to the drawings. In addition, the shape, material, size, length, and the like of each member of the in-vivo indwelling member described as the embodiment shown in the drawings are described as examples and can be appropriately changed.

  In the present invention, the primary coil is used to manufacture an in-vivo indwelling member (hereinafter also referred to as “secondary coil”) having a three-dimensionally arranged secondary shape by further shaping the primary coil. To do. This primary coil is formed of a strand. The material of the strand is not particularly limited, and a metallic strand can be used. Examples of the metal include platinum (platinum), tungsten, gold, tantalum, iridium, titanium, stainless steel, and an alloy containing any material selected from these materials, or a superelastic alloy. . The cross-sectional shape of the strand is not limited to a circle, and various shapes such as an ellipse and a square can be selected. Furthermore, when the cross-sectional shape of the strand is circular, the diameter (wire diameter) can be arbitrarily selected from about φ0.010 mm to 0.200 mm, although it depends on the size of the knob. When the cross-sectional shape of the strand is not circular, the maximum width can be arbitrarily selected from about 0.010 mm to 0.200 mm.

  The primary coil can be formed, for example, by winding a wire as described above around a core wire. The distance (pitch interval) between the strands of the primary coil is not particularly limited. For example, adjacent strands 2 may be in close contact like the primary coil 1 shown in FIG. 1A, or adjacent strands 2 like the primary coil 1a shown in FIG. There may be a predetermined interval between them. This pitch interval may be constant over the entire primary coil or may be different. Moreover, what combined the part which the strands contact | adhered, and the part which the space | interval opened may be combined. The overall shape of the primary coil is preferably formed linearly as shown in FIGS. 1A and 1B, for example, from the viewpoint of ease of insertion into a shaping groove of a mold described later.

  The outer diameter of the primary coil (see, for example, the symbol D in FIG. 1A) is the size of the lumen portion of a microcatheter or the like used to guide the finally obtained in-vivo indwelling member to the aneurysm. It can be appropriately selected according to the above. For example, when the microcatheter is for 0.010 inch (0.254 mm) to 0.018 inch (0.457 mm), it may be set to φ0.200 mm to φ0.450 mm. Further, the outer diameter of the primary coil may be uniform over the entire length (for example, see FIGS. 1A and 1B), or may be arbitrarily changed. For example, when the microcatheter is for 0.010 inch to 0.018 inch, even if the outer diameter is partially changed to φ0.200 mm to φ0.450 mm as in the primary coil 1b shown in FIG. Good. In the example shown in FIG. 2, the portion A having the largest outer diameter when the wire 2 is wound, the portion B smaller than the portion A, and the portion C smaller than the portion B are represented by C, B, A, B, C,.・ Sequentially continuous shape. However, the order of A, B, and C is not limited to this. Moreover, the magnitude | size of an outer diameter is not restricted to 3 types like FIG. 2, 2 types or 4 types or more may be sufficient. In addition, the primary coil as shown in FIG. 2 can be produced using a core wire having a stepped shape or a tapered shape, for example.

In the present invention, an extension preventing wire may be provided inside the primary coil. The extension preventing wire may be either a single wire or a stranded wire, and the material is not particularly limited, and a resin, a metal such as platinum, tungsten, titanium, gold, iridium, palladium, tantalum and alloys thereof, stainless steel, or the like is used. be able to. There are no particular limitations on the connection location and connection method between the primary coil and the extension preventing wire.
In addition, as will be described later, the wire for preventing extension may be performed before being placed in a mold for producing an in-vivo indwelling member or after heat treatment.

Moreover, in this invention, you may provide a front-end | tip part in the edge part of a primary coil. The shape of the tip portion is not particularly limited, but from the viewpoint of preventing damage to the blood vessel wall, for example, a shape having a rounded tip shape such as a hemispherical shape or a semi-elliptical spherical shape is preferable. The material constituting the tip is not particularly limited, and materials similar to those for the primary coil and the extension preventing wire can be appropriately selected and used. Moreover, the joining method of the front-end | tip part is not specifically limited, The conventional method can be employ | adopted.
As will be described later, the distal end portion may be performed before being placed on the in-vivo indwelling member manufacturing mold, or may be performed after the heat treatment.

  In the present invention, the in-vivo indwelling member having the secondary shape of the three-dimensional arrangement is formed by further shaping the primary coil as described above. And when shaping | molding into the secondary shape of a three-dimensional arrangement | positioning, a predetermined type | mold is used.

  The mold according to the present invention includes a variable member that can be deformed into an assembled state and a deployed state. The variable member includes a first surface on which the primary coil is disposed and a holding portion for disposing the primary coil in a predetermined shape on the first surface. Thus, with the variable member that can be deformed into the assembled state and the deployed state, the primary coil can be easily disposed on the first surface of the variable member in the deployed state, and the primary coil is disposed on the first surface. After that, it is possible to deform the variable member in the assembled state with the primary coil disposed. Therefore, a secondary shape having a predetermined three-dimensional arrangement can be easily imparted to the primary coil in accordance with the structure of the assembled state of the variable member without being wound around a core member or the like as in the prior art. A three-dimensional arrangement formed by a mold having such a deformable variable member is a three-dimensional arrangement different from a conventional general coil shape. Moreover, it is preferable to form a space surrounded by the first surface in the assembled state. Thus, when forming the space part in which the variable member is surrounded by the first surface in the assembled state, for example, the space part in the aneurysm of the wide neck aneurysm can be secured and the shape of the inner wall surface of the aneurysm can be accommodated. A secondary shape having a predetermined three-dimensional arrangement can be easily imparted to the primary coil. Furthermore, since the primary coil is arranged on the first surface and the mold can be deformed as described above, it is easy to confirm the arrangement of the primary coil in the assembled state or in the middle of the assembly. It is also easy to correct the arrangement of the primary coil by returning to the expanded state from the assembled state or during assembly.

  Embodiments of the mold of the present invention will be described with reference to the drawings.

FIG. 3A is a perspective view schematically showing the assembled state of the mold embodiment of the present invention, and FIG. 3B is a schematic view of the unfolded state of the mold embodiment of FIG. FIG. Thus, the type | mold of this invention is equipped with the variable member which can deform | transform into an assembly state and an unfolded state. The mold 3 shown in FIG. 3 is a variable member in which a plurality of pieces 5a to 5f are connected. The plurality of pieces 5a to 5f are all flat materials and are connected by connection variable portions 6a to 6f. Holding portions 7a to 7f for arranging the primary coils are provided on the first surfaces 4a to 4f constituting the planar portions of the pieces 5a to 5f. Then, as shown in FIG. 3A, in the assembled state, a rectangular space 8 surrounded by the first surfaces 4a to 4f of the pieces 5a to 5f is formed. As shown in FIG. 3B, the first surfaces 4a to 4f face the same side in the unfolded state. Thus, when the 1st surface faces the same side in the deployment state, arrangement of a primary coil becomes easier.
Note that “facing the same side” means, for example, that the first surfaces 4a to 4f of the pieces 5a to 5f face the same direction as shown in FIG. This includes the case where the first surface faces the same side to some extent.

  In the embodiment shown in FIG. 3, the variable member has a structure in which a plurality of pieces 5 a to 5 f are connected by connection variable portions 6 a to 6 f, but in the present invention, the variable member is formed as a single component. Also good. In this case, in order to make the deformable member deformable, it is made of a material that can be bent using the driving force of the shape memory alloy or plastic deformation of a general metal thin plate, or the variable member is thinner than other parts. It is good to provide the concave part which becomes. For example, a shape memory alloy is formed as a single variable member having a shape as shown in FIG. 3 (b), and the shape as shown in FIG. 3 (a) is memorized. A resin sheet or a low hardness metal sheet such as aluminum is used as a variable member that is a single component, and is shaped as shown in FIG. 3 (b). A deformable member that is deformable into a shape as shown in a) or a single component having a shape as shown in FIG. 3B is formed, and a concave portion is formed in a portion corresponding to the connection variable portion. Examples thereof include, but are not limited to, those that can be deformed into a shape as shown in FIG.

In the embodiment shown in FIG. 3, the pieces 5a to 5f constituting the variable member constitute a hexahedron in the assembled state, and each piece constitutes each face of the hexahedron. In the present invention, the structure in the assembled state is not limited to a hexahedron, and may be a regular tetrahedron, a regular hexahedron, a regular octahedron, a regular dodecahedron, a regular dodecahedron, etc. It may be an icosahedron polyhedron or another polyhedron. Therefore, the shape of the single piece may be determined as appropriate according to the assembled polyhedral structure.
Further, in the embodiment shown in FIG. 3A, the single material constituting the variable member is arranged on all the faces of the hexahedron, but in the present invention, the single material is arranged on all the surface portions corresponding to the polyhedron. There is no need to be. For example, one of the polyhedrons on which one piece of material is not disposed may be used, such as a mold 3a shown in FIG. 4A, or two of the polyhedrons may be used like a mold 3b shown in FIG. 4B. It may be one in which no single material is arranged on the surface. That is, the mold 3a shown in FIG. 4A has a structure in which the piece 3d of the mold 3 shown in FIG. 3A is not provided, and the piece 5c is replaced with one piece 5g having no connection variable portion. In the mold 3a shown in FIG. 4 (b), there is no piece material 5d, 5f of the mold 3 shown in FIG. 3 (a), the piece material 5b is replaced with a piece material 5h without some connection variable parts, It has a structure in which the single piece 5c is replaced with a single piece 5g without one variable connecting portion. Further, in the molds 3a and 3b shown in FIGS. 4 (a) and 4 (b), it is assumed that the space portions 8a and 8b surrounded by the first surface of the single piece in the assembled state all form a hexahedron. In FIGS. 4A and 4B, the holding portion is omitted.

  In the embodiment shown in FIG. 3, since the pieces 5 a to 5 f are flat members, the space portion 8 is a square, and the three-dimensional arrangement of the primary coils is also a square. In the case of a flat material, the space portion is a polyhedron depending on the shape. In the present invention, the piece material is not limited to a flat material, and may be a curved material. For example, by using a curved surface material having a concave curved surface for the first surface of each piece, the shape of the space formed in the assembled state can be made spherical or elliptical, and the three-dimensional arrangement of primary coils is also possible It becomes spherical or elliptical. The shape of the single piece can be appropriately determined according to the shape of the inner wall surface of the knob. In addition, although the 1st surface should just have a plane and a curved surface, respectively, a plane material and a curved surface material should just determine the shape of each piece material in consideration of the ease of a deformation | transformation of a variable member, etc.

  The material of the piece material that can be used in the present invention is not particularly limited, and examples thereof include metals, resins, ceramics, and glass. However, as will be described later, since heat treatment is performed on the mold in which the primary coil is arranged and in an assembled state, it is preferable that the mold has heat resistance. The heat resistant temperature varies depending on the heat treatment conditions, but is preferably 700 ° C. or higher, more preferably 1000 ° C. or higher.

  The holding portions 7a to 7f of the mold 3 shown in FIG. 3B have a concave structure (see, for example, FIG. 3C) that opens in the same direction on the first surfaces 4a to 4f, and the first surface 4a. It is formed so that one or several continuous recessed parts may become a predetermined pattern along -4f (1st example). A primary coil is disposed and held along this continuous recess. The width and depth of the recesses constituting the holding portions 7a to 7f (see, for example, the symbols w1 and h1 in FIG. 3C) are not particularly limited as long as the primary coil can be held. From the standpoint of preventing the primary coil from falling off, a portion where the interval w1 (see FIG. 3C) is the same as or slightly smaller than the outer diameter D of the primary coil 1 shown in FIG. You may provide in a part. Thereby, the primary coil 1 can be fixed by preventing the primary coil from falling off by using the frictional force between the side surface of the concave portion constituting the holding portion and the outer peripheral surface of the primary coil. That is, such a recess having a portion that is the same as or slightly smaller than the outer diameter of the primary coil also functions as a fixing portion that fixes the primary coil.

  In the embodiment shown in FIG. 3, the holding part has a structure of a continuous concave part, but the present invention is not limited to this, and may have a structure such as a pair of convex parts, a through hole part, and a key-shaped part. In addition, a structure in which two or more kinds of concave portions, a pair of convex portions, a through-hole portion, a key-shaped portion, and the like are combined may be used.

FIG. 5A is a perspective view schematically showing an example of a piece 9 when the holding portion is a pair of convex portions 10 and 11 (second example), and FIG. It is sectional drawing of the II-II direction of 5 (a). As shown in FIG. 5A, in this embodiment, a plurality of pairs of convex portions 10 and 11 are provided on the first surface 12 of the piece 9 and between the convex portions 10 and 11. The primary coil 1 is held by sandwiching the primary coil 1 therebetween. The length along the first surface of the pair of convex portions 10 and 11 is not particularly limited, and may be a length that can be sandwiched at a plurality of locations along the primary coil 1 (for example, FIG. 5A). (Refer to the above.) The length may be continuous from one end of the primary coil 1 to the other end of the portion arranged in one piece. Moreover, what is necessary is just to determine an installation location according to the predetermined shape which arrange | positions the primary coil 1, when providing in multiple places. The height h2 from the first surface of the convex portion 10 and the convex portion 11 and the interval w2 between the convex portion 10 and the convex portion 11 are not particularly limited as long as the primary coil can be held in a predetermined shape.
Note that when the mold is in the assembled state, a portion where the interval w2 is the same as or slightly smaller than the outer diameter D of the primary coil 1 may be provided in part from the viewpoint of suppressing the dropout of the primary coil 1. Accordingly, the primary coil 1 can be fixed by preventing the primary coil from falling off by using the frictional force between the side surfaces of the convex portions 10 and the convex portions 11 and the outer peripheral surface of the primary coil 1. That is, the pair of convex portions having a portion that is the same as or slightly smaller than the outer diameter D of the primary coil 1 also has a function of a fixed portion.

6A is a perspective view schematically showing an example of the piece 13 when the holding portion is a through hole portion (third example), and FIG. 6B is a perspective view of FIG. It is sectional drawing of the III-III direction. As shown in FIG. 6A, in the present embodiment, a plurality of cylindrical portions 16 having through-hole portions 15 on the first surface 14 of the piece 13, that is, on the upper side (outside) with respect to the first surface 14. The primary coil 1 is held by inserting the primary coil 1 through the through hole 15. The length along the first surface of the through-hole portion 15 or the cylindrical portion 16 is not particularly limited, and may be a length that can be inserted at a plurality of locations along the primary coil 1 (for example, FIG. 6A). (Refer to the above.) The length may be continuous from one end of the primary coil 1 to the other end of the portion arranged in one piece. Moreover, what is necessary is just to determine an installation location according to the predetermined shape which arrange | positions the primary coil 1, when providing in multiple places. The interval in the length direction of the primary coil 1 of the cylindrical portion 16 is not particularly limited, but when the mold is deformed to the assembled state, the cylindrical portion 16 or the through hole portion adjacent in the length direction of the primary coil. As long as the primary coil 1 is not extremely bent between 15.
In this example, since the primary coil 1 is inserted through the through hole portion 15 of the cylindrical portion 16, for example, even when the mold is in an assembled state, the primary coil is disposed on the first surface of the single member. It can be held in shape. That is, the cylindrical portion 16 having the through hole portion 15 also has a function of a fixing portion for fixing the primary coil 1. Although not shown, the tubular portion 16 can be inserted into the through-hole portion 15 from the side wall portion of the tubular portion 16 in addition to inserting the primary coil 1 into the through-hole portion 15 from the opening portions at both ends. A cut portion or an opening / closing mechanism may be provided.

FIG. 7A is a perspective view schematically showing an example of the piece 13 when the holding portion is a bowl-shaped portion (fourth example), and FIG. 7B is a perspective view of FIG. It is sectional drawing of IV-IV direction. As shown in FIG. 7A, in the present embodiment, a plurality of hook-shaped portions 19 are provided on the first surface 18 of the piece 17, and the primary coil 1 is hooked on the hook-shaped portion 19. The primary coil 1 is held. The length along the first surface of the bowl-shaped portion 19 is not particularly limited, and may be a length that can be inserted at a plurality of locations along the primary coil 1 (see, for example, FIG. 7A). The length may be continuous from one end of the primary coil 1 to the other end of the portion arranged in one piece. Moreover, what is necessary is just to determine an installation location according to the predetermined shape which arrange | positions the primary coil 1, when providing in multiple places. Further, the distance in the length direction of the primary coil 1 of the saddle-shaped portion 19 is not particularly limited, but when the mold is deformed to the assembled state, the primary coil between the adjacent saddle-shaped portions 19 in the length direction of the primary coil. As long as 1 extreme deflection does not occur.
In this example, the bent portion of the bowl-shaped portion 19 can appropriately surround the primary coil 1 (see, for example, FIG. 7B). For example, even when the mold is in the assembled state, the primary coil is the holding portion. It can be held in a predetermined shape that is disposed on the first surface of the single piece without detaching from a certain bowl-shaped portion 19. That is, the bowl-shaped part 19 also has a function of a fixing part for fixing the primary coil 1.

  FIG. 8A is a perspective view schematically showing an example of the piece 20 when the holding portion is a combination of a concave portion and a through hole portion (fifth example), and FIG. It is sectional drawing of the VV direction of 8 (a). As shown in FIG. 8A, in the present embodiment, the single piece 20 has a main body portion 26 and lid portions 24 and 25, and the first smoother than the upper surfaces of the main body portion 26 and the lid portions 24 and 25. A surface 21 is formed. The main body portion 26 is formed with one continuous concave portion 23 and partly provided with lid portions 24 and 25, so that the lower side (inside) below the first surface 21, that is, with respect to the first surface 21. A through-hole portion 22 surrounded by the lid portions 24 and 25 and the concave portion 23 of the main body portion 26 is formed, and a concave portion 23 is formed on the first surface 21 in a portion where the lid portions 24 and 25 are not provided. The lid parts 24 and 25 may be integrated with the main body part 26, or may be fixed detachably. In the example shown in FIG. 8B, the concave portion is provided on the surface of the lid portion 24 opposite to the first surface, but it may not be provided. Similarly, the presence or absence of a recess can be selected as appropriate for the lid 25 as well. The arrangement, the number, and the like of the through-hole portions 22 can be appropriately determined in consideration of the desired shape of the primary coil arranged on the first surface 21. Moreover, the through-hole part 22 can function also as a fixing | fixed part similarly to the case of the 3rd example shown in FIG.

  In the present invention, the through hole portion is formed by the through hole portion 15 of the cylindrical portion 16 on the first surface shown in FIG. 6 and the lid portions 24 and 25 and the main body portion 26 shown in FIG. It is preferably formed by at least one of the through hole portions 22 below the first surface.

  The holding portions having various structures as described above are provided on the first surface in order to arrange the primary coils in a predetermined shape. And arrangement | positioning of a holding | maintenance part can be suitably determined according to the secondary shape of the three-dimensional arrangement | positioning of the in-vivo indwelling member finally obtained. The predetermined shape of the primary coil disposed on the first surface is not particularly limited, but from the viewpoint of applying a substantially uniform pressing force to the inner wall surface of the knob, the primary coil is approximately evenly disposed on the first surface in the assembled state. Therefore, it is preferable that the holding portion for arranging the primary coil is also arranged corresponding to such a shape. For example, when the shape of the space surrounded by the first surface in the assembled state is a polyhedron, the holding unit is configured so that each of the first surfaces of the variable members constituting each surface of the polyhedron has a substantially similar structure. It is good to determine the arrangement of. In the embodiment shown in FIG. 3B, the first surfaces 4a to 4f of the plurality of pieces 5a to 5f in the unfolded state are respectively provided with arc or elliptical arc recesses constituting the holding portions 7a to 7f. The single material is provided so as to have substantially the same circle or ellipse as a whole. Further, in adjacent pieces, the ends of the concave portions of the arcs or elliptical arcs constituting the holding portions 7a to 7f are continued by the linear concave portions constituting the holding portions 7a to 7f. Therefore, the recessed portions of the holding portions 7a to 7f of the plurality of pieces 5a to 5f are continuous in a single stroke in the entire variable member. Thus, when the holding parts 7a-7f with which a recessed part continues in a one-stroke form are formed, it is possible to arrange | position a primary coil in the holding parts 7a-7f in a one-stroke form, and use the conventional core material. The primary coil can be easily arranged on the mold 3 without changing the winding order as in the case. Note that the arrangement of the holding portions of the entire variable member is not limited to the overall shape shown in FIG. In addition, when the holding portion has a structure other than the concave portion as described above, the same arrangement as in FIG. Furthermore, although the holding part is continuous in a single stroke in the entire variable member, the above-described effect is obtained. However, a structure other than the single stroke may be used depending on the use of the in-vivo indwelling member.

  The secondary shape of the in-vivo indwelling member is determined according to its use. In the case where the in-vivo indwelling member is an embolic material used for the treatment of aneurysms such as aneurysms, it is preferable that the in-vivo member has a shape generally corresponding to the shape of the aneurysm, and from the viewpoint of preventing the rupture of the aneurysm It is preferable that the primary coil is disposed so as to be able to press the inner wall substantially uniformly and a secondary coil is formed. From such a point of view, the secondary shape is preferably spherical, elliptical, or a shape similar to these, and for that purpose, the primary coil is disposed on the first surface so as to have a bent portion. preferable. Therefore, the holding member for the variable member or the single member preferably has a curved portion. In addition, when a holding part is comprised with a single part that the holding | maintenance part has a curved part, it means that the structure has a curved part, and when it is comprised with multiple parts (for example, FIG. 5). (A) includes those in which a curved portion may be formed in some of the plurality of portions.

As what a holding | maintenance part has such a curve part, what is shown to FIG.3 (b) and FIG.9 (a)-(c) is mentioned, for example. FIG. 9 shows an example of the structure of the holding portion in one piece as a modification, and the primary coil may be used in combination with another piece so that the primary coil can be arranged in a predetermined shape.
In the embodiment (first example) shown in FIG. 3B, the first surfaces 4a, 4e, and 4f of the pieces 5a, 5e, and 5f have a curved portion made up of one approximately 3/4 arc or an elliptical arc and its curved portion. Holding portions 7a, 7e, and 7f that are concave portions having straight portions extending from both ends are formed, and the two straight portions extend so as to be approximately the same width as the chord width of the curved portion. Also, the first surface 4b of the piece 5b is formed with a holding portion 7b composed of a concave portion having a curved portion made up of four circular arcs or elliptical arcs arranged in a circle or an ellipse and straight portions extending from both ends thereof. The straight line portion extends from the curved portion so as to be approximately the same distance as the distance between the adjacent end portions of the other adjacent curved portions. In addition, the first surfaces 4c and 4d of the pieces 5c and 5d have a holding portion formed of a concave portion having a curved portion formed of two circular arcs or elliptical arcs arranged in a circular shape or an elliptic shape, and linear portions extending from both ends thereof. 7c and 7d are formed, and the two most adjacent straight line portions extend from the curved portion so as to be approximately the same distance as the distance between the adjacent end portions of the other adjacent curved portions.
In the embodiment (sixth example) shown in FIG. 9A, the first surface 28 of the piece 27 has a curved portion formed of one approximately ½ arc or elliptical arc and a straight portion extending from both ends thereof. A holding portion 29 formed of a letter-shaped concave portion is formed, and the two straight portions extend so as to be approximately the same width as the chord width of the curved portion.
In the embodiment (seventh example) shown in FIG. 9B, the first surface 31 of the piece 30 has a curved portion formed of one approximately 3/4 arc or an elliptical arc and a linear portion extending from both ends thereof. A holding portion 32 made of a recess is formed. In the seventh example, the straight portion extends so that the straight portion is larger than the width of the portion that becomes the chord of the curved portion, so that the bent portion 33 is formed at the continuous portion of the straight portion and the curved portion.
In the embodiment (eighth example) shown in FIG. 9C, the first surface 35 of the single piece 34 has a curved portion 37 formed of one circle or an ellipse and two straight portions 38 extending in parallel from the curved portion 37. A holding portion 36 is formed which is a concave portion having a. By having the curved portion 37 made of a circle or an ellipse as the concave portion, the primary coil can be wound around this portion.

  By the way, in this invention, you may have the fixing | fixed part for fixing a primary coil as already stated. Moreover, the aspect of this fixing | fixed part can be suitably determined according to the structure of a holding | maintenance part as already stated. Below, the aspect of the fixing portion that is effective when the holding portion includes a recess, particularly when the holding portion includes only the recess will be further described with reference to FIG.

  In the embodiment (ninth example) shown in FIG. 10A, a pressing member 39 that partially covers the recess 29 is provided on the first surface 28 in the embodiment (sixth example) shown in FIG. The fixing part (39) having the above structure is provided. The pressing member 39 may be integrated with the piece material 27, or may be fixed so as to be releasable from being installed in the recess 29. Of these, specific examples of the latter case include, for example, a structure in which the entire pressing member 39 is detachably fixed, and the installation state can be released by a hinge or the like while a part of the pressing member 39 is integrated with the single member 27. And a structure in which the pressing member 39 is rotatably fixed. Further, one or a plurality of pressing members 39 can be provided.

  The embodiment (tenth example) shown in FIG. 10B is provided with a pressing member 40 that entirely covers the recess 29 on the first surface 28 in the embodiment (sixth example) shown in FIG. The fixing portion (39) having the above structure is provided. In the tenth example, the pressing member 40 has a structure that covers the entire recess 29 by covering the entire first surface 28. The pressing member 40 is fixed so that the covering state of the entire recess 29 can be released. The fixing method is not particularly limited, and has a structure in which the entire pressing member 40 is detachably fixed, and a mechanism capable of releasing the covering state of the entire recess 29 by a hinge or the like while a part of the pressing member 40 is integrated with the single member 27. And a structure in which the pressing member 40 is fixed rotatably.

  As already described, when the holding part includes a concave part, it is also possible to provide the fixing part so that the part of the concave part includes the same or slightly smaller width as the outer diameter of the primary coil. However, the fixing portion of the embodiment shown in FIGS. 10A and 10B is more preferable in that the primary coil can be more reliably fixed to the holding portion. In the present invention, if necessary, the fixing portion formed by adjusting the width of the concave portion and the fixing portion formed by providing the pressing members 39 and 40 may be used in combination.

  In the present invention, when the variable member is formed by connecting a plurality of pieces, the pieces are preferably connected by a connection variable portion. The connection variable portion assembles a variable member in which a plurality of pieces are connected by connecting adjacent pieces and relatively changing the facing direction of the first surface of the adjacent pieces. It has a function of deforming into a state and a developed state. The structure of the connection variable part is not particularly limited as long as it has such a function, and examples thereof include a hinge, a ring binder, a flexible sheet, and the like, or a combination thereof. Further, when there are a plurality of connection variable portions, their structures may be the same or different, and for example, at least one selected from a hinge, a ring binder, and a flexible sheet may be used.

  An embodiment of the connection variable part will be described with reference to FIGS. For simplicity, FIGS. 11 to 13 illustrate an example in which two pieces are connected, but the same configuration can be applied when three or more pieces are connected. That is. Further, the single member is a rectangular flat member, and the holding portion is omitted in the drawing.

  The embodiment (first example) of the variable connecting portion shown in FIG. 11 schematically shows an example in which the variable connecting portion is a hinge. As shown in FIGS. 11A and 11B, the adjacent piece 41 and piece 43 are connected by a hinge 45. The hinge 45 includes a cylindrical female portion 45 a having a hollow portion 46 fixed to the piece material 41, and a male portion 45 b having a convex shaft portion 47 fitted to the hollow portion 46 fixed to the piece material 43. Consists of. The pieces 41 and 43 are connected to each other so as to be rotatable about the center of the long axis direction of the hollow portion 46 and the convex shaft portion 47 as a central axis. 11A, the first surfaces 42, 44 of the piece members 41, 43 are in the unfolded state facing the same side, and in FIG. 11B, the first surfaces 42, 44 of the piece members 41, 43 are It is in an assembled state in which the direction is relatively changed from the expanded state. The hinge is not limited to the structure shown in FIG. 11, and other structures can be used.

  The embodiment (second example) of the variable connecting portion shown in FIG. 12 schematically shows an example in which the variable connecting portion is a ring binder. As shown in FIGS. 12A and 12B, the adjacent piece 48 and piece 50 are connected by a ring binder 52. The ring binder 52 has a cylindrical or annular structure, and is inserted into a through hole 53 provided at the edge of the piece 48 and a through hole 54 provided at the edge of the piece 50. The through holes 53 and 54 open to and communicate with the first surface and the opposite surface. The pieces 48 and 50 are connected so as to be rotatable along the circumferential direction of the cylindrical or annular ring binder 52. 12A, the first surfaces 49, 51 of the pieces 48, 50 are in an unfolded state facing the same side. In FIG. 12B, the first surfaces 49, 51 of the pieces 48, 50 are It is in an assembled state in which the direction is relatively changed from the expanded state. The number of ring binders 52 is not particularly limited, and can be provided at one place or two or more places. Further, the installation position is not particularly limited as long as the directions of adjacent pieces can be made relatively, and the arrangement of the primary coil is not hindered.

  The embodiment (third example) of the connection variable part shown in FIG. 13 schematically shows an example in which the connection variable part is a flexible sheet. As shown in FIGS. 13A and 13B, adjacent piece 55 and piece 57 are connected by a flexible sheet 59. The flexible sheet 59 is fixed to the edge of the surface 60 opposite to the first surface 56 of the piece 55 and the edge of the surface 61 opposite to the first surface 58 of the adjacent piece 57. Yes. The pieces 55 and 57 can be relatively changed in the direction in which the first surfaces 56 and 58 face by bending the flexible sheet 59. In FIG. 13 (a), the first surfaces 56, 58 of the piece members 55, 57 face the same side and are in an unfolded state. In FIG. 13 (b), the flexible sheet 59 is bent, The direction of the first surfaces 56 and 58 of the piece members 55 and 57 is relatively changed from the developed state, and is in an assembled state. The number of the flexible sheets 59 is not particularly limited, and can be provided at one place or two or more places. There is no particular limitation on the installation position as long as the adjacent pieces can be oriented relative to each other, and the arrangement of the primary coil is not hindered, and the installation position is provided on the surface opposite to the first surface as in this example. Alternatively, it may be provided on the first surface side. If the material which comprises a flexible sheet | seat is a material which can be bent, there will be no limitation in particular,

  In the present invention, a deformable piece may be used as a part of the plurality of pieces. In this case, the deformable piece may have the same configuration as the case where the variable member already described is formed as a single component.

  The method of connecting the plurality of pieces is not particularly limited as long as the space surrounded by the first surface is formed in the assembled state, but in particular when the deformable member has three or more pieces, From the viewpoint of ease of deformation from the state to the assembled state, it is preferable that at least three pieces are connected linearly in a developed state, and more preferably linearly connected. The term “linear” means that three or more pieces are connected without branching. For example, the four pieces 5a, 5b, 5c, 5d in FIG. Examples include the connection state of the materials 5e, 5b, and 5f. In addition, these connection states of FIG.3 (b) are linear.

  Further, the piece material may be further connected to the at least three piece material connected in a linear manner in a cross shape. Thereby, the deformation | transformation from an expanded state to an assembly state becomes easier. The crossing means that the piece of material that is branched is connected to the piece of material that is linearly connected in the developed state, so that the piece of material that is branched intersects with the piece of material that is connected linearly. Means that. For example, in FIG.3 (b), the piece materials 5e and 5f are connected so that it may branch from the piece material 5b of the four piece materials 5a, 5b, 5c, and 5d connected linearly, and the piece materials 5e and 5f are wire | line. It intersects with four pieces 5a, 5b, 5c and 5d connected in a shape.

Next, an embodiment of a method for shaping a primary coil to give a secondary shape in a three-dimensional arrangement using a mold having the above-described variable member will be described with reference to the drawings.
FIG. 14 is a plan view schematically showing a plan view of the mold 3 shown in FIG. 3B viewed from the first surfaces 4a to 4f side. In the present invention, the primary coil is disposed when the mold is in the unfolded state. That is, when the primary coil is arranged in the mold, the mold 3 is set in the unfolded state as shown in FIG. And since the 1st surface 4a-4f faces the same side, the type | mold 3 can arrange | position a primary coil from the same side to the holding parts 7a-7f provided in 1st surface 4a-4f. is there. Moreover, as shown in FIG. 3B and FIG. 14, since the pieces 5 a to 5 f are rectangular flat members, the holding portions 7 a to 7 f are the entire first surfaces 4 a to 4 f of the pieces 5 a to 5 f. It is a two-dimensional arrangement. Therefore, it is not necessary to wind a primary coil around a core material or the like as in the prior art, and damage to the primary coil due to a winding process can be reduced.

  After the mold 3 is in the unfolded state, as shown in FIG. 15, the primary coil 1 is disposed in the holding portions 7 a to 7 f that are concave portions. As described above, since the first surfaces 4a to 4f face the same side, the primary coil 1 can be easily arranged from the same side, and workability for arranging the primary coil 1 is improved. . In addition, since the holding portions 7a to 7f of the mold 3 are continuous in a single stroke, the arrangement of the primary coil 1 is not complicated, and the possibility that the winding order is wrong as in the case of using a conventional core or the like is reduced. This improves workability. As a result, the secondary shape to be imparted is stable, the in-vivo indwelling member with stable quality can be easily mass-produced, and is excellent in terms of mass productivity and quality control.

After the primary coil is arranged on the holding parts 7a to 7f of the mold 3, it is fixed by a fixing part (not shown) if necessary, and the directions of the adjacent first surfaces 4a to 4f are relative to each other by the connection variable parts 6a to 6f. The mold 3 is deformed into an assembled state with the primary coil 1 disposed so that a space surrounded by the first surfaces 4a to 4f is formed (see FIG. 16A). FIG. 16A is a perspective view schematically showing a state when the mold 3 shown in FIG. 15 in which the primary coil 1 is arranged is in an assembled state.
In this way, the primary coil 1 is deformed into a three-dimensionally arranged secondary shape by deforming the mold 3 into an assembled state while the primary coil is disposed. Therefore, the secondary shape according to arrangement | positioning of holding | maintenance part 7a-7f provided in the 1st surfaces 4a-4f of the type | mold 3 is provided.

  In the present invention, the deformation of the mold from the expanded state to the assembled state may be performed manually by the operator, but when a specific mold is used, it may be performed by the in-vivo indwelling member manufacturing apparatus having the mold. Good. The mold that can be used for this in-vivo indwelling member manufacturing apparatus is the above-described mold, in which the variable member has a plurality of three or more pieces, and at least three pieces are connected in a linear form in a deployed state. The portion to be included is included. And when using this specific type | mold, this in-vivo indwelling member manufacturing apparatus supports a part of several piece material which comprises the (i) specific type | mold and (ii) the specific type | mold in a deployment state. A support base having a support surface and a receiving portion that receives the mold in an assembled state that is recessed in the support surface; (iii) pressing the piece material located on the storage portion to make a specific die into the storage portion A presser part that fits and deforms the unfolded mold into an assembled state in the housing part is provided as a configuration.

FIGS. 17-21 is the perspective view which showed typically the process in which a type | mold is deform | transformed using an example of embodiment of the in-vivo indwelling member manufacturing apparatus.
FIG. 17A is a perspective view schematically showing a support base that is a configuration of the in-vivo indwelling member manufacturing apparatus, and FIG. 17B is a cross-sectional view in the VI-VI direction of FIG. It is. In the example shown in FIG. 17, the support base 63 has a support surface 64 on the upper surface side, and a receiving portion 65 is recessed in the center of the support surface 64. As shown in FIG. 17B, the accommodating portion 65 is a concave portion that is opened on the support surface 64 side and is constituted by a side wall portion 67 and a bottom portion 66 that continue from there. The side wall portion 67 has an inclined portion 67a that expands toward the support surface 64, and a vertical portion 67b having a size corresponding to the shape of the assembled mold. As will be described later, the accommodating portion 65 only needs to have a structure that can receive the deformed mold while deforming it and surround the assembled mold with the side wall portion 67 and the bottom portion 66.

In the in-vivo indwelling member manufacturing apparatus of the present invention, a specific mold is supported on such a support base.
FIG. 18 is a perspective view schematically showing a state in which the unfolded die 68 is placed and supported on the support surface 64 of the support base 63. In the mold 68, five pieces 69a to 69e are connected by connection variable portions 71a to 71e. Also, the piece materials 69a, 69b, 69c or the piece materials 69d, 69b, 69e are connected in a linear shape, and the piece materials connected in this linear shape are the piece materials 69d, 69e or the piece materials 69a, 69c, respectively. It is connected to the piece 69b in an intersecting manner. The piece 69b is arranged right above the accommodating portion 65 of the support base 63, and the pieces 69a, 69c to 69e are arranged right above the support surface 64. Further, the first surfaces 70a to 70e of the piece members 69a to 69e are arranged on the support surface 64 so as to be opposite to the surface in contact with the support surface 64 of the support base 63. The primary coil may be disposed on the first surfaces 70 a to 70 e before the mold 68 is placed on the support base 63, or may be disposed after being placed on the support base 63. 18 to 21, the holding unit and the primary coil are omitted.

In the in-vivo indwelling member manufacturing apparatus of the present invention, after a specific mold is supported on a support base, a mold piece is pushed by a pressing part and the mold is fitted into the housing part.
FIG. 19 is a perspective view schematically showing a state where the mold 68 supported by the support base 63 in the state shown in FIG. 18 is started to be pressed by the pressing portion 72, and FIG. 20 is a view from the state shown in FIG. FIG. 7 is a perspective view schematically showing a state in which the presser part 72 advances toward the bottom 66 of the accommodating part 65 of the support base 63 while pressing the piece 69b, and the mold 68 is deformed from the expanded state to the assembled state; FIG. 21 schematically shows a state in which the piece 69b pressed by the presser portion 72 comes into contact with the bottom portion 66 and stops, the assembled mold 68 is fitted in the housing portion 65, and the assembled state is maintained. It is a perspective view.
As shown in FIG. 19, the presser portion 72 advances toward the bottom portion 66 of the storage portion 65, and the presser portion 72 presses the first surface 70 b of the piece 69 b that is positioned directly above the storage portion 65 that opens at the support surface 64. start. At this time, although not shown, the pressing portion 72 and the first surface 70b of the piece 69b may be detachably fixed.
Then, as shown in FIG. 20, as the presser portion 72 advances toward the bottom portion 66, the piece 69b is pushed toward the bottom 66, and the first surface 70b of the piece 69b is formed by the coupling variable portions 71a to 71e. As the direction of the first surfaces 70a, 70c to 70e of the pieces 69a and 69c to 69e changes, the pieces 69a and 69c to 69e move along the inclined portion 67a of the side wall portion 67, and the pieces 69a , 69c to 69e reach the vertical portion 67b of the side wall portion 67, space portions surrounded by the first surfaces 70a to 70e are formed, and an assembled state is obtained.
Then, as shown in FIG. 21, the piece 69 b comes into contact with the bottom 66 and the presser 72 is stopped, and the mold 68 is completely accommodated in the accommodating portion 65. The mold 68 fitted in the housing portion 65 in the assembled state is supported by the vertical portion 67b of the side wall portion 67 of the housing portion 65 and holds the assembled state. It is possible to prevent the assembled state from collapsing by being fitted into the accommodating portion 65.

As described above, after the mold is transformed into the assembled state with the primary coil being placed by the operator or the in-vivo indwelling member manufacturing apparatus, the heat treatment is further performed as it is, and the three-dimensional placement is performed on the primary coil placed on the mold. The secondary shape is memorized and fixed. The heat treatment can be performed using a heating furnace such as an atmospheric furnace, a condensing furnace, a vacuum furnace, and the heating temperature may be appropriately determined in consideration of the material used for the primary coil, etc. Is preferably 500 to 900 ° C., more preferably 550 to 750 ° C., from the viewpoint of effectively fixing the secondary shape. In addition, when it exceeds 900 degreeC, intensity | strength may fall. The heating time may be appropriately determined in consideration of the material used for the primary coil and the like. However, when a metal material is used, it is preferably 30 minutes or more from the viewpoint of effectively fixing the secondary shape.
After the heat treatment is performed, when the cooled mold is in a developed state and the primary coil is removed from the mold, an in-vivo indwelling member (secondary coil) having a memorized three-dimensional secondary shape is obtained. For example, the unfolded mold 3 shown in FIG. 14 is used, the primary coil 1 is disposed in the mold 3 as illustrated in FIG. 15, and the mold 3 is disposed as illustrated in FIG. When heat treatment is performed in the assembled state, as shown in FIG. 16 (b), the in-vivo indwelling member having a secondary shape of a three-dimensional arrangement corresponding to the arrangement of the holding portions 7a to 7f of the mold 3 in the assembled state ( Secondary coil) 62 is obtained. Moreover, when a holding part as shown in FIG.3 (b) and FIG. 14 is a one-stroke writing shape, a primary coil can be easily taken out from a type | mold.

  The in-vivo indwelling member obtained as described above can be suitably used as an embolic material used for treating aneurysms such as aneurysms formed in blood vessels, for example. In particular, in the case of an embolic material obtained using a mold having a variable member that forms a space part surrounded by the first surface, even in the case of a wide neck aneurysm, while securing the space part in the aneurysm, Because it has a secondary shape with a three-dimensional arrangement that can correspond to the shape of the inner wall surface of the aneurysm, by applying a pressing force to the inner wall surface of the aneurysm, it is firmly and stably fixed in the aneurysm, A space portion corresponding to the space portion of the variable member is formed. As a result, it is possible to easily insert another coil for filling this space portion. Thus, the embolic material obtained using the mold having the variable member that forms the space portion surrounded by the first surface is useful as an embolic material that serves as a frame for inserting another coil.

Example 1
A platinum wire having an element diameter of 0.045 mm was wound around a straight cored bar having a uniform outer diameter to produce a primary coil having an outer diameter of 0.250 mm. An extension preventing wire of 0.010 mm was inserted inside and the tip was welded.
Six pieces of stainless steel having a square shape of 15 mm and a thickness of 3 mm were prepared, and these were connected using a hinge as shown in FIG. 3B. On the first surface of each piece, a concave portion having a pattern in which the curved portion and the straight portion shown in FIG. Moreover, the fixed part as shown to Fig.10 (a) was attached to each piece so that a primary coil might not remove | deviate from a recessed part. The radius of curvature of the curved portion of the recess formed in each piece was set to 5 mm, and the outer diameter of the secondary coil of the three-dimensionally arranged secondary shape after molding was approximately 10 mm. As described above, a mold having a variable member in which six pieces are connected by a hinge and capable of being deformed into a cube shape in an assembled state was produced.
After disposing the primary coil along the recess of the unfolded mold, the mold was deformed into an assembled state and deformed into a cubic shape so as to form a cubic space surrounded by the first surface. Thereafter, the assembled mold was placed in an atmospheric furnace with the primary coil disposed, and heat treatment was performed at 700 ° C. for 1 hour. After the heat treatment, when the primary coil is removed from the cooled mold, the secondary shape of the three-dimensional arrangement having a cubic shape that roughly corresponds to the arrangement of the recesses in the assembled mold as shown in FIG. Secondary coil was obtained.
As described above, when 10 secondary coils were produced, 9 were non-defective products.
By using the mold of the present invention, it is not necessary to pay attention to the winding order as in the case of winding around the core material, and it is easy to arrange the primary coil on the mold, and after the arrangement, the three-dimensional structure can be obtained by simply deforming the mold. It was found that the secondary shape of the arrangement can be shaped and a secondary coil can be easily obtained. Moreover, the yield was favorable compared with the comparative example 2 mentioned later.

(Comparative Example 1)
The primary coil (1) produced in the same manner as in Example 1 was inserted into a conventional stainless steel mold (74) having a cubic space (73) inside as shown in FIG. The heat treatment was performed under the same conditions. When the primary coil was taken out from the cooled mold, a secondary coil having a general spiral shape was obtained. This indicates that the primary coil was not randomly arranged in the mold. This is the same because when a linear primary coil is inserted into a mold having a space that is considerably wider than its outer diameter, the primary coil does not have directionality and tries to advance in the same direction. This is caused by orbiting the orbit. Moreover, since it was made of metal and the internal situation could not be grasped, it could not be determined whether it was defective or not, and after the primary coil was inserted into the space, the heat treatment had to be performed as it was. On the other hand, in the mold of the present invention, even if it is made of metal, a deformable mold is used, and it is easy to confirm the arrangement of the primary coil in the recess of the single material, and the arrangement of the primary coil in the recess is insufficient. Even in this case, the deficiency can be easily confirmed, the arrangement can be easily corrected, and the yield is further improved.

(Comparative Example 2)
A primary coil produced in the same manner as in Example 1 was wound around a mandrel as shown in FIG. 9A of Patent Document 1, and then heat-treated under the same conditions as in Example 1. When the primary coil was removed from the mandrel after cooling, a secondary-shaped secondary coil having a three-dimensional arrangement shown in FIG.
As described above, when 10 secondary coils were produced, 6 were non-defective products.

(Evaluation)
The secondary coil produced in Example 1 and Comparative Example 1 was inserted into a transparent glass aneurysm model for evaluation. After the microcatheter is inserted into the aneurysm model, the secondary coil is inserted into the aneurysm via the microcatheter. When the secondary coil is released from the distal end of the catheter, the secondary coil of Example 1 Cubic three-dimensionally arranged secondary shapes were formed inside, and it was confirmed that the primary coils constituting each surface were arranged stably by pressing the inner wall surface almost uniformly. On the other hand, in the secondary coil of Comparative Example 1, the inner wall surface of the aneurysm model cannot be evenly pressed because it remains helically placed in the aneurysm model, and is arranged in a biased state. It was confirmed.

1, 1a, 1b Primary coil 2 Wire 3, 3a, 3b, 68 Mold for manufacturing in-vivo indwelling member 4a, 4b, 4c, 4d, 4e, 4f First surface 5a, 5b, 5c, 5d, 5e, 5f Single piece 6a, 6b, 6c, 6d, 6e, 6f Connection variable part 7a, 7b, 7c, 7d, 7e, 7f Holding part 8, 8a, 8b Space part 9, 13, 17, 20, 27, 30, 34, 41, 43, 48, 50 Single material 10, 11 Convex portion 12, 14, 18, 21, 28, 31, 35, 42, 44, 49, 51 First surface 15, 22 Through hole portion 16 Tubular portion 19 鉤Shaped part 23 Recessed part 24, 25 Lid part 26 Main body part 29, 32, 36 Holding part 33 Bending part 37 Curved part 38 Linear part 39, 40 Holding member (fixed part)
45 Hinge 45a Female part 45b Male part 46 Hollow part 47 Convex shaft part 52 Ring binder 53, 54 Through hole 55, 57, 69a, 69b, 69c, 69d, 69e Single material 56, 58, 70a, 70b, 70c, 70d, 70e First surface 59 Flexible sheet 60 Surface on the opposite side of the first surface 56 61 Surface on the opposite side of the first surface 58 62 In-vivo indwelling member (secondary coil)
63 Support base 64 Support surface 65 Housing part 66 Bottom part 67 Side wall part 67a Inclined part 67b Vertical part 71a, 71b, 71c, 71d, 71e Connection variable part 72 Holding part 73 Space part 74 Mold

Claims (15)

A mold for producing an in-vivo indwelling member for obtaining an in-vivo indwelling member having a secondary shape of a three-dimensional arrangement by further shaping a primary coil formed of strands,
The mold includes a variable member that can be deformed into an assembled state and an unfolded state,
The variable member has a first surface on which the primary coil is disposed and a holding portion for disposing the primary coil in a predetermined shape on the first surface.   The mold according to claim 1, wherein the variable member has the first surface facing the same side in the unfolded state.   The mold according to claim 1, wherein the variable member is formed by connecting a plurality of pieces.   The mold according to claim 3, wherein the plurality of pieces are connected by a connection variable portion.   The mold according to claim 3 or 4, wherein the piece material is a flat material.   The said holding | maintenance part has at least 1 sort (s) of structure selected from the recessed part provided in the said 1st surface, a pair of convex part, a through-hole part, and a bowl-shaped part. The type described.   The mold according to claim 6, wherein the through-hole portion is formed by at least one of a through-hole of a cylindrical member provided on the first surface and a through-hole of the variable member provided below the first surface. .   Furthermore, the type | mold of any one of Claims 1-7 which has a fixing | fixed part for fixing the primary coil arrange | positioned at the said holding | maintenance part.   The said holding | maintenance part is a type | mold in any one of Claims 1-8 which has a curve part.   The mold according to any one of claims 3 to 9, wherein the variable member has a plurality of three or more pieces, and at least three pieces are connected in a linear shape in the unfolded state.   Furthermore, the type | mold of Claim 10 which has the piece material connected by cross shape.   The mold according to any one of claims 4 to 11, wherein the connection variable part is at least one selected from a hinge, a ring binder, and a flexible sheet.   The in-vivo indwelling member manufacturing apparatus which has a type | mold in any one of Claims 1-12. The mold according to any one of claims 10 to 12,
A support base having a support surface for supporting a part of the plurality of pieces constituting the mold in the unfolded state, and a receiving portion for receiving the mold in the assembled state recessed in the support surface;
A pressing part that pushes the piece located on the housing part, fits the mold into the housing part, and deforms the unfolded mold into an assembled state in the housing part;
The in-vivo indwelling member manufacturing apparatus which has this. A method for producing an in-vivo indwelling member having a secondary shape of a three-dimensional arrangement obtained by further shaping a primary coil formed of strands,
By using a mold having a deformable member that can be deformed between an assembled state and an unfolded state, a primary coil is disposed on the unfolded mold, and the mold is deformed into an assembled state while the primary coil is disposed. And a step of deforming the coil into the secondary shape of the three-dimensional arrangement.

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