JP6761741B2 - Mandrel and a method for manufacturing an in vivo indwelling member using the mandrel - Google Patents

Description

The present invention relates to a mandrel for manufacturing an in-vivo indwelling member used for winding a primary coil to form a secondary shape of an in-vivo indwelling member, and a method for manufacturing an in-vivo indwelling member using the mandrel.

In the treatment of an aneurysm formed in a blood vessel, for example, a technique is adopted in which an in-vivo indwelling member made of a metal coil is embedded in the aneurysm to thrombus the aneurysm and prevent rupture. As such a metal coil as an in-vivo indwelling member, a wire such as platinum is processed into a coil shape to form a primary coil, and the primary coil is further bent into a three-dimensional secondary shape and heated to obtain the second coil. A secondary coil shaped into the following shape is used. Such a metal coil (secondary coil) is inserted into the lumen of a catheter for transport in a state of being extended in the shape of a primary coil, transported to a target site together with the catheter, and then pushed out from the catheter by an indwelling operation. It is placed in the aneurysm in a state that follows the secondary shape and the shape of the aneurysm.

When thrombizing an aneurysm, it is advantageous that the metal coil spreads in various directions inside the aneurysm without being collected in one place. Therefore, the secondary shape (shape of the secondary coil) given to the metal coil is a shape that, when the coil is deployed in the aneurysm, is complicatedly curved in various directions along the aneurysm wall and easily spreads in the aneurysm. Is desirable. Therefore, various secondary coils having such a complicated three-dimensional shape and methods for manufacturing the secondary coils have been conventionally proposed.

For example, Patent Document 1 proposes a secondary coil having a secondary shape extending while being curved in various directions substantially on a spherical surface or an elliptical spherical surface, and a method for manufacturing the secondary coil. The secondary coil is given a secondary shape by heating the core in a state in which the primary coil is wound around the outer surface of a core having a substantially spherical or elliptical spherical shape. Further, Patent Document 2 is a method for manufacturing a secondary coil having a secondary shape that also curves and extends along a spherical surface, and is a mandrel in which one or more metal rods are erected on the outer surface of a spherical core. A method has been proposed in which the primary coil is hooked on the metal rod and wound around the outer surface of the core to give a secondary shape.

Further, Patent Document 3 proposes a secondary coil having a three-dimensional orthogonal shape and a method for manufacturing the secondary coil. This secondary coil is given a secondary shape by winding the primary coil around a three-dimensional orthogonal shape mandrel having six cylindrical posts. Further, Patent Document 4 is a method of manufacturing a spherical secondary coil, which is a method of imparting a secondary shape using a spherical mandrel in which a groove for fitting the primary coil is formed along the winding direction on the outer surface. Has been proposed.

Japanese Patent No. 3665133 Japanese Patent No. 3024071 Special Table 2004-500929 Japanese Patent No. 40656665

However, when the outer surface of the core around which the primary coil is wound is a smooth curved surface as in Patent Document 1, the primary coil is slippery on the outer surface when the primary coil is wound, resulting in poor workability. Even after winding, the primary coil shifts on the outer surface and easily loosens, so care must be taken when handling it during management and heat treatment after winding work. Further, the primary coil is wound around the portion already wound on the outer surface of the core while being intersected many times, but the primary coil is locally bent and deformed at the intersection. This flexed deformed part causes damage due to stress concentration and easily interferes with the coil on the distal side that has already been placed in the aneurysm during the indwelling operation, which reduces operability and disturbs the indwelling state. It will cause it to end up.

The method of winding the primary coil while winding it around the metal rod or cylindrical post of the mandrel as in Patent Document 2 and Patent Document 3 stabilizes the position of the primary coil on the mandrel and improves workability, but the metal rod or The primary coils near the base of the cylindrical post tend to be multiple due to crossing, and the above-mentioned local flexion deformation becomes more prominent, the indwelling operability is reduced, and the coil already indwelled in the aneurysm. There is a similar problem such as disturbing.

Further, as in Patent Document 4, fitting the primary coil along a long and complicated groove on the spherical surface makes the primary coil stable after fitting, but the fitting operation is not easy. There is a problem of workability. Further, the primary coil wound while being fitted in the groove intersects at the intersection position in the groove and overlaps vertically, and is locally bent and deformed at the intersection. Therefore, there is also a similar problem that the indwelling operability is lowered and the coil already indwelled in the aneurysm is disturbed.

Therefore, what the present invention attempts to solve in view of the above-mentioned situation is that it is possible to wind a primary coil to give a complicated three-dimensional secondary shape, and at the same time, the workability at the time of winding is good and the winding is performed. The position of the rear coil is also stable, and it is easy to handle when performing subsequent management and heat treatment, and even when the primary coils intersect with each other in a more complicated three-dimensional shape, the coil is locally bent and deformed at the intersection. It is an object of the present invention to provide a mandrel capable of avoiding or alleviating this, and a method for manufacturing an in-vivo indwelling member using the mandrel.

The present invention is a mandrel for manufacturing an in-vivo indwelling member used for winding a primary coil to form a secondary shape of the in-vivo indwelling member in order to solve the above-mentioned problems, and the primary coil is passed by the winding. A mandrel characterized in that a stepped portion is provided at a predetermined position to be formed and a notch groove for receiving the primary coil is provided in the stepped portion.

Here, a plurality of winding portions for winding the primary coil around the outer peripheral surface more than once or less than one circumference are provided, and the stepped portion is a winding portion having a relatively long peripheral surface and a winding portion having a relatively short peripheral surface. It is preferable that is a stepped portion between the winding portions which are coaxially provided. Here, the "perimeter" means a length along the circumferential direction orthogonal to the axis.

In particular, an aggregate composed of two or more winding portions including those having substantially the same peripheral length and different axial directions, and an aggregate composed of the winding portions having a relatively long peripheral length. , The assembly composed of winding portions having a relatively short peripheral length is integrated with each other by coaxially connecting one winding portion of each assembly to each other, and the step portion is connected to each other. It is preferable that it is a stepped portion between the winding portions.

Further, the present invention is a method for manufacturing an in-vivo indwelling member using a mandrel in the present invention described above, and while the primary coil is wound around the mandrel to form a secondary shape, the primary coil is cut at the step portion. It is passed through the notch groove, and then, with respect to the notch groove that received the primary coil, in a direction intersecting the accepted primary coil from above, after the accepted portion of the primary coil. Also provided is a method of manufacturing an in-vivo indwelling member in which a portion on the end side is wound.

Here, the mandrel includes a plurality of winding portions for winding the primary coil around the outer peripheral surface more than once or less than one circumference, and the stepped portion has a winding portion having a relatively long peripheral surface and a relatively long peripheral surface. Is a stepped portion between the winding portions coaxially connected to the short winding portion, and when the primary coil is wound around the mandrel to form a secondary shape, the primary coil has a relatively short circumference. After winding around the winding portion, a portion of the primary coil on the rear end side of the portion wound around the winding portion having a short circumference is passed through the notch groove of the stepped portion, and then the primary coil In winding the portion on the rear end side of the accepted portion around the winding portion having a relatively long circumference, the direction in which the notch groove that receives the primary coil intersects the accepted primary coil. It is preferable to wind it while passing it through. Here, the rear end means the end of both ends of the primary coil on the side to be wound from the rear.

In particular, the mandrel includes two or more aggregates composed of two or more of the winding portions, including those having substantially the same peripheral length and different axial directions, and the winding portion having a relatively long peripheral length. And the aggregate composed of the winding portions having a relatively short peripheral length, one winding portion of each assembly is coaxially connected to each other and integrated with each other. It is a stepped portion between the continuous winding portions, and when the primary coil is wound around the mandrel to form a secondary shape, all the aggregates of the primary coil having the winding portions having a relatively short circumference. After winding around the winding portion, a portion on the rear end side of the portion wound around the winding portion of the aggregate is passed through the notch groove of the step portion, and then the accepted portion of the primary coil is passed. When winding the portion on the rear end side around the winding portion of the aggregate composed of the winding portion having a relatively long peripheral length, the notch groove that receives the primary coil is placed on the accepted primary coil. It is preferable to wind it while passing it in the direction of intersection.

The mandrel for manufacturing an in-vivo indwelling member according to the present invention as described above is used for winding a primary coil to form a secondary shape of the in-vivo indwelling member, and the primary coil passes through the winding. A step portion is provided at a predetermined position, and a notch groove for receiving the primary coil is provided in the step portion. Therefore, by winding the primary coil in the notch groove while engaging the primary coil, the winding is performed as in the conventional case. It is not necessary to fit it in the long groove along the direction, and the primary coil can be wound easily and firmly, improving workability, stabilizing the position of the coil even after winding, and performing subsequent management and heat treatment. The case is also easy to handle.

Further, even when the primary coils further intersect with each other, since the previously wound primary coil is in the notch groove, it is possible to avoid or alleviate the coil from being locally bent and deformed at the intersecting portion. Therefore, damage due to stress concentration and deterioration of operability due to interference between coils during indwelling operation can be prevented, and the indwelling state is not disturbed, and the secondary coil spreads and is in the indwelling state as designed. Can be realized.

Such a combination of the stepped portion and the notch groove shall be configured such that a protrusion is provided on the outer peripheral surface of the mandrel, the portion where the primary coil rides on the protrusion is the stepped portion, and the notch groove is provided at the portion. You can also. In particular, a plurality of winding portions for winding the primary coil around the outer peripheral surface more than once or less than one circumference are provided, and the stepped portion includes a winding portion having a relatively long peripheral surface and a winding portion having a relatively short peripheral surface. By forming a stepped portion between the winding portions coaxially provided with the above, it is possible to impart a complicated three-dimensional secondary shape in which the degree of curvature changes on the way. Further, such a stepped portion usually causes the primary coil to slip easily, which causes the coil to loosen after winding or causes the primary coil to bend locally. However, by accepting the primary coil in the notch groove, the primary coil is accepted. By avoiding such slippage and bending, it is possible to realize excellent workability, operability, and an indwelling state as designed as described above.

An aggregate composed of two or more winding portions including those having substantially the same peripheral length and different axial directions, and an aggregate composed of the winding portions having a relatively long peripheral length, and the above. An aggregate composed of winding portions having a relatively short peripheral length is integrated with each other by coaxially connecting one winding portion of each assembly to each other, and the stepped portion is the connected winding portion. In the case of a stepped portion between parts, such a mandrel can be used to form a secondary shape that is complicated and more stably arranged in the aneurysm, and the stepped portion between aggregates having different peripheral lengths is used. The notch groove can be efficiently provided. Then, by accepting the primary coil in the notch groove, the primary coil can be passed between the aggregates in a stable posture, and the primary coil can be passed through the notch groove side in the winding portion having a relatively long peripheral length. Even if the primary coil is further crossed and wound on the notch groove that has passed through, it is possible to avoid or alleviate the local bending and deformation of the primary coil at the crossing portion, and as described above, excellent workability and operability. The indwelling state as designed can be realized.

Further, according to the method for manufacturing an in-vivo indwelling member according to the present invention, while the primary coil is wound around the mandrel to form a secondary shape, the primary coil is inserted into the notch groove of the step portion and passed through. After that, the portion of the primary coil on the rear end side of the accepted portion is wound around the notch groove in which the primary coil is received in a direction intersecting the accepted primary coil. The winding state of the primary coil is more stable.

Further, the mandrel includes a plurality of winding portions for winding the primary coil around the outer peripheral surface more than once or less than one circumference, and the stepped portion has a winding portion having a relatively long peripheral surface and a relatively long peripheral surface. The short winding portion is coaxially connected to the stepped portion between the winding portions, and when the primary coil is wound around the mandrel to form a secondary shape, the primary coil is wound around the relatively short circumference. After winding around the portion, a portion of the primary coil on the rear end side of the portion wound around the winding portion having a short circumference is passed through the notch groove of the stepped portion, and then the primary coil is described. When winding the portion on the rear end side of the accepted portion around the winding portion having a relatively long circumference, the portion above the notch groove in which the primary coil is received is in a direction intersecting the accepted primary coil. Since it is wound while passing through it, when shifting from a winding part with a relatively short circumference to a winding part with a relatively long circumference, the primary coil tends to loosen slightly even if it passes through the notch groove. Further, by suppressing from above, loosening can be prevented more reliably, and the position of the primary coil can be more stabilized.

Further, the mandrel includes two or more aggregates composed of two or more of the winding portions, including those having substantially the same peripheral length and different axial directions, and the winding portion having a relatively long peripheral length. And the aggregate composed of the winding portions having a relatively short peripheral length, one winding portion of each assembly is coaxially connected to each other and integrated with each other. It is a stepped portion between the continuous winding portions, and when the primary coil is wound around the mandrel to form a secondary shape, all of the aggregate composed of the winding portions having a relatively short circumference of the primary coil. After winding around the winding portion, a portion on the rear end side of the winding portion of the aggregate is passed through the notch groove of the step portion, and then the accepted portion of the primary coil is passed. When winding the portion on the rear end side around the winding portion of the aggregate composed of the winding portion having a relatively long peripheral length, the notch groove that received the primary coil is placed on the accepted primary coil. Since it is wound while passing in the direction of intersection, the state of being wound around an aggregate of winding portions having a relatively short circumference is once stabilized by a primary coil passed over the notch groove so as to further intersect. In this state, the primary coil can be wound around an aggregate of winding parts with a relatively long circumference, and workability is achieved without the primary coil loosening in the middle of giving a complicated three-dimensional secondary shape. You can do it well.

The perspective view which shows the mandrel which concerns on the typical embodiment of this invention. (A) and (b) are side views of the mandrel, and (c) is a front view of the mandrel as seen from one end side (the side forming the anchor portion). (A) is a front view of the mandrel as seen from above, and (b) is a bottom view of the mandrel as seen from below. (A) is a perspective view showing a state in which the primary coil is wound around the mandrel, and (b) is a partially omitted front view showing a state in which the primary coil is also wound. (A) is a perspective view showing a state in which the primary coil is wound around the mandrel, and (b) is a cross-sectional view taken along the line AA in which a part is omitted. Similarly, a perspective view of the state in which the primary coil is wound around the mandrel as viewed from the lower surface side. A perspective view showing the shape of a midway coil also created by a mandrel. (A) is an explanatory view showing how the middle solid and the anchor portion of the intermediate shape coil are arranged inside the large solid, and (b) is a perspective view showing the shape of the secondary coil in which the arrangement is made. (A) to (d) are explanatory views explaining the manufacturing procedure of the primary coil. (A) and (b) are explanatory views explaining the composition of a medium solid and a large solid in an intermediate shape coil and a secondary coil using a virtual tubular body.

Next, an embodiment of the present invention will be described in detail with reference to the accompanying drawings. The shape and intermediate shape of the secondary coil without mandrel shown in the drawing are drawn assuming that the reinforcing core material (core wire) is inserted in the cavity of the primary coil to help understanding. It is a drawing of.

As shown in FIGS. 4 to 6, the mandrel 6 for manufacturing an in-vivo indwelling member according to the present invention has a secondary shape of the in-vivo indwelling member around which a primary coil 11 is wound (in this example, an intermediate shape in front of the secondary shape). ) Is formed, and stepped portions 60a and 60b are provided at predetermined positions through which the primary coil 11 passes by winding, and further, notched grooves 61a for receiving the primary coil 11 are provided in the stepped portions 60a and 60b. , 61b are provided.

In the following description, the side of the mandrel 6 having the winding portion 70 is referred to as the "one end side", the side having the other assembly 7B is referred to as the "other end side", and the side of the primary coil that is wound first around the mandrel 6 is referred to. The "front end side" and the side to be wound afterwards are called the "rear end side", and the primary coil and the aneurysm in the secondary coil used as an in-vivo indwelling member by giving a secondary shape to the primary coil are preceded. The side to be extruded to the distal side is called the "tip side", and the side to be extruded later is called the "base end side".

In the following example, an example in which the anchor portion, the middle solid, and the large solid are wound in order from the front end side of the primary coil and the front end side is extruded into an aneurysm or the like first will be described, but from the front end side. Of course, it is also possible to wind the large solid, the medium solid, and the anchor portion in this order, and configure the front end side as the base end side. Further, in another aspect of the present invention, the anchor portion may not be provided. Further, in another aspect, the size of the solid does not have to be large or small, and instead of being referred to as "medium solid" or "large solid", it may be referred to as "first solid" or "second solid".

As the primary coil 11, those used for conventionally known in-vivo indwelling members can be widely applied. The primary coil 11 of this example is, for example, a mandrel 9 in which the wire 10 which is a single wire or stranded wire as shown in FIG. 9A is a linear rod-shaped member as shown in FIG. 9B. It is a coil to which a spiral primary shape as shown in (c) or (d) in the figure is given by being wound around the coil. The spirally wound loops of the primary coil may be in contact with each other as shown in (c), or may not be in contact with each other as shown in (d). The primary coil may be formed of only (c) or only (d), or may have a shape in which (c) and (d) are combined. Further, the primary coil may include a plurality of portions having the shapes (c) and (d).

The material of the wire 10 is not particularly limited, and examples thereof include simple substances such as platinum, tungsten, iridium, tantalum, gold, and stainless steel, and alloys formed by combining at least these two. These materials are radiation opaque materials.

The diameter of the wire 10 can be appropriately selected depending on the intended use and is not particularly limited, but is preferably 0.010 mm or more and 0.200 mm or less, more preferably 0.200 mm or less when used for the treatment of aneurysm occlusion, for example. , 0.030 mm or more and 0.100 mm or less. The outer diameter or width of the primary coil 11 can be appropriately selected depending on the application and the like, and is not particularly limited. For example, when used for the treatment of aneurysm occlusion, it is 0.100 mm or more and 0.500 mm. The following is preferable. Similarly, the total length of the primary coil 11 can be appropriately selected depending on the application and the like, and is not particularly limited. For example, when used for the treatment of aneurysm occlusion, it is preferably 10 mm or more and 1000 mm or less. ..

The shape formed by winding the primary coil 11 around the mandrel 6 of this example is not a final secondary shape, but a shape on the way to the final secondary shape. That is, the mandrel 6 of this example forms the intermediate shape coil 2. The final secondary shape of the in-vivo indwelling member is the shape shown in FIG. 8B obtained by further arranging the middle solid 4A and the anchor portion 40 inside the large solid 4B and heating as described later. There is (in-vivo indwelling member 1 which is a secondary coil 3). In the state of FIG. 8B, the core wire is included inside the primary coil.

However, the mandrel according to the present invention is not limited to the one that gives an intermediate shape as in this example, and of course, the one that gives a final secondary shape is also included. Further, the intermediate shape coil 2 formed by the mandrel 6 of this example may be used as the final secondary coil instead of the “intermediate” coil.

In this example, as the notch groove provided in the mandrel 6, as will be described later, in the step portion 60a between the aggregate 7A for forming the middle solid 4A of the intermediate shape coil and the winding portion 70 for forming the anchor portion 40. The slope-shaped notch groove 61a to be formed and the square notch groove 61b formed in the step portion 60b between the aggregate 7B for forming the large solid 4B and the aggregate 7A for forming the medium solid 4A are formed. Has been done. However, the present invention is not limited to the form of such a combination of the stepped portion and the notch groove. For example, a protruding portion is formed at an appropriate position where the primary coil to be wound is likely to shift, and the stepped portion of the protruding portion is stepped. It also includes a part that is provided with a notch groove.

As shown in FIGS. 1 to 3, the mandrel 6 includes a plurality of winding portions 70 to 78 around which the primary coil 11 is wound around one or more or less than one circumference. Further, between the winding portion having a relatively long peripheral surface and the winding portion having a relatively short peripheral surface coaxially arranged, in this example, the winding portion 71 and the winding portion are connected. Step portions 60a and 60b are formed between the winding portion 70 and the winding portion 75 and the winding portion 74, respectively.

In this example, the winding portions 70 to 78 are formed of rod-shaped portions having a circular cross section when viewed from the axial direction of each winding portion, but are not limited to such a circular shape, and are not limited to such a circular shape, for example, a polygon with rounded corners or the like. An ellipse is also a preferable example. It may be a hollow cylinder instead of a muku (solid) rod. The outer diameter of each winding portion 70 to 78 of the circular cross section is preferably 1 mm or more and 30 mm or less when used for the treatment of aneurysm occlusion. This is because the outer diameter of the wound portion determines the size of the loop-shaped part of the secondary coil and the degree of curvature or curvature of each shape part, and these have a shape that adheres to the inner wall of the aneurysm having an inner diameter of 1 to 30 mm. This is preferable.

More specifically, the mandrel 6 has the same outer circumference as the aggregate 7A composed of winding portions 71 to 74 having substantially the same peripheral length (the outer peripheral length is substantially the same if the cross section is circular as in this example). It includes two aggregates 7B having substantially the same peripheral length and having winding portions 75 to 78. The circumferences of the winding portions 71 to 74 of the assembly 7A are shorter than the circumferences of the winding portions 75 to 78 of the assembly 7B, and the circumferences of the winding portions 75 to 78 of the assembly 7B are the aggregates. It is preferable to set it so that it is 1.05 times or more and 1.5 times or less the peripheral length of each winding portion 71 to 74 of 7A, and further set it so that it is 1.1 times or more and 1.2 times or less. Is preferable. These aggregates 7B and 7A are integrated with each other in a state in which one winding portion 75 and 74 of each aggregate is coaxially connected to each other. A step portion 60b is formed between the continuous winding portions 74 and 75.

Of the four winding portions 71 to 74 constituting the aggregate 7A, the winding portions 71 and 74 are the front and rear portions of the cylindrical portion integrally formed coaxially, and the winding portions 72 and 73 are in the middle of the cylindrical portion. The axis orthogonal to the axis of the cylindrical portion from the position is used as a common axis and is projected to the left and right. As a result, the winding portions 71 to 74 are arranged in an annular shape in four directions in which the axial directions are on the same plane and are offset by 90 degrees. The four winding portions 75 to 78 constituting the aggregate 4B are also arranged in an annular shape.

In this example, the central axes of the winding portions 71 to 74 of the assembly 7A and the central axes of the winding portions 75 to 78 of the assembly 7B are all arranged on the same plane, and the winding portions 72 of the assembly 7A, The common axis of 73 and the common axis of the winding portions 76 and 77 of the assembly 7B are arranged so as to be parallel to each other. Further, on the opposite side of the assembly 7B on the same axis as viewed from the assembly 7A, a winding portion 70 having a circumference shorter than the circumference of the winding portions 71 to 74 of the assembly 7A is coaxial with the winding portion 71. It is provided. A step portion 60a is also formed between these coaxial winding portions 70 and 71.

The stepped portions 60a and 60b are provided with notch grooves 61a and 61b that are received when the primary coil 11 is passed through, respectively. The notch groove 61a is a continuous portion between a portion for forming an anchor portion consisting of only a single winding portion 70 and an aggregate 7A forming the middle solid 4A, and the primary portion between the winding portion 70 and the winding portion 71 is Since the coil 11 extends substantially in the circumferential direction, the coil 11 is formed of notches in a slope shape. Further, the notch groove 61b is a continuous portion between the medium solid 4A and the large solid 4B, and according to the winding method of this example, the primary coil 11 is closer to the axial direction than the circumferential direction of the winding portions 74 and 75. It is composed of square notches because it extends, but it is not limited to these shapes.

Further, the anchor portion 40 of this example is not a three-dimensional portion having four shape portions such as the middle solid 4A and the large solid 4B as described later, but is composed of one shape portion 50 and a spiral portion 53. is there. Therefore, only one winding portion 70 of the mandrel 6 for forming the anchor portion 40 is also provided, and does not form an aggregate composed of two or more winding portions having different axial directions as described above. However, the configuration is not limited to this, and of course, the winding portion of the mandrel forming the anchor portion is formed as an aggregate composed of two or more winding portions, and the anchor portion is configured as a three-dimensional portion. ..

Further, in this example, the two aggregates 7A and 7B are formed by the winding portions 70 to 78, but more aggregates may be continuously provided by increasing the winding portions. In this case, the plurality of aggregates may have substantially the same peripheral length of the winding portion. In this case, a plurality of three-dimensional shapes having the same size are formed.

Further, in this example, the winding portion 70 forming the anchor portion and the aggregates 7A and 7B are configured in order from one end side, but the arrangement order can be changed as a matter of course. In this case, the form of the stepped portion and the passing position of the primary coil in the stepped portion when winding the primary coil also change, but a notch groove may be appropriately formed at the passing position in the same manner as in this example.

Needless to say, a mandrel having only one aggregate and a mandrel having no aggregate are also the objects of the present invention. The specific peripheral length of the outer peripheral surface of each of the winding portions 70 to 78 can be appropriately selected according to the use of the in-vivo indwelling member, the formed medium solid 4A, large solid 4B, and the shape and structure of the anchor portion 40. ..

As shown in FIG. 7, the intermediate shape formed by winding the primary coil 11 around such a mandrel 6 has shape portions 50, 51a of the primary coil 11 that are continuously curved and extended on substantially the same plane. ~ 51e and 52a to 52f are formed on two or more planes by each winding portion of the mandrel 6, respectively, and form a three-dimensional shape. The core wire 12 is inserted into the lumen of the intermediate shape coil and the secondary coil shown in the drawing. It should be noted that substantially on the same plane means that if the primary coil 11 is substantially along the plane, it may be spirally curved in a loop shape, or these spiral loops may be double or triple overlapped. Includes the case where is slightly deviated from the plane but can be regarded as substantially the same plane. In FIG. 7, 51a and 51c are combined to form an annulus. In this way, a plurality of shape portions that do not form a loop extending less than one circumference are combined to form an annulus. That is. By including such an annular component in the intermediate shape, the bias of the coil in the aneurysm is reduced, and the adhesion of the coil to the inner wall of the aneurysm is improved.

In this example, a three-dimensional portion (middle solid 4A) formed by connecting at least four shape parts 51a to 51e over four planes and at least four shape parts 52a to 52f are connected continuously over four planes. Two three-dimensional parts with the three-dimensional part (large three-dimensional part 4B) are formed by the aggregates 7A and 7B of the mandrel 6. As shown in FIGS. 10A and 10B, the four planes of each three-dimensional part have a relationship in which the normal directions are all orthogonal to the predetermined common axes a1 and a2 directions, and each three-dimensional part (middle solid). The shape portions (51a to 51e, 52a to 52f) constituting 4A, the large solid 4B) are the quadrangular virtual tubular bodies C1 and C2, respectively, when viewed from the common axis surrounded by the four planes. It is formed on any of the planes (F1 to F4, F5 to F8).

In this way, each three-dimensional portion (medium solid 4A / large solid 4B) has the shape portions 51a to 51e / 52a to 52f of the primary coil on the four planes F1 to F4 / F5 to F8 of the virtual tubular body C1 / C2, respectively. Since it is formed and is formed as a three-dimensional part having no shape part on the upper and lower surfaces in the axial direction of the virtual tubular body, the primary coil does not solidify into one when it is extruded into an aneurysm or the like. At the same time as spreading to the three-dimensional shape, it is possible to deform relatively flexibly according to the shape of the inner wall such as an aneurysm without having too strong shape retention, and a frame with high adhesion along the inner wall is formed. In addition, good operability is maintained because it is difficult for the shaped parts to get caught in the operation of pushing out and returning.

These three-dimensional parts are three-dimensional parts in which the area of the quadrangle seen from the common axis of the virtual tubular body is relatively small from the front end side to the rear end side wound around the tip of the primary coil 11, and in this example, the middle three-dimensional part. In order from 4A, a relatively large three-dimensional portion, in this example, the large three-dimensional portion 4B is formed so as to be on the rear end side. In this example, the two three-dimensional portions, the middle solid 4A and the large solid 4B, are formed in this order.

The reason for calling it "middle solid" is not because there is another "small solid" solid part with a smaller area of the square, but the anchor part 40 is not a solid part surrounded by such four planes. Since it has a three-dimensional shape having a loop-shaped portion 50 (loop-shaped portion R01) smaller than the loop-shaped portion R11, which is the shape portion 51b that goes around the three-dimensional 4A in a 360-degree loop shape, the anchor portion. It is called "middle solid" in the sense that it has a three-dimensional shape larger than 40. As described above, a plurality of three-dimensional shapes having the same size may be formed, or a plurality of middle solids may be formed.

Then, the front end side on which the relatively small three-dimensional portion (middle solid 4A) of the primary coil 11 is formed is the tip side, and the relatively large three-dimensional portion (large solid 4B) is the base end side in the aneurysm. When extruded, the larger three-dimensional part (large three-dimensional 4B) that is pushed out later into the aneurysm causes the smaller three-dimensional part (medium three-dimensional 4A) that is pushed out first to form a frame on the aneurysm wall surface toward the inner wall side. It is pressed, the adhesion becomes stronger, it can be prevented from falling off more reliably, and the large three-dimensional part is less likely to get caught in the small three-dimensional part that has already been extruded to form the frame, which is a good operation during the indwelling operation. Sex is obtained.

The quadrangle s1 seen from the common axis a1 of the virtual tubular body C1 of the middle solid 4A is a square, and the quadrangle s2 seen from the common axis a2 of the virtual tubular body C2 of the large solid 4B is also a square. Further, each of the four surfaces F1 to F4 of the virtual tubular body C1 of the middle solid 4A is a square having the same size and shape as the quadrangle s1, and substantially follows the circle inscribed in the square of each surface F1 to F4. The curved shape portions 51a to 51e of the primary coil 11 are formed in the primary coil 11. Further, each of the four surfaces F5 to F8 of the virtual tubular body C2 of the large solid 4B is also a square having the same size and shape as the quadrangle s2, and also substantially follows the circle inscribed in the square of each surface F5 to F8. As described above, the curved shape portions 52a to 52f of the primary coil 11 are formed. According to the general definition, the square here means a quadrangle whose four sides have the same length and the angle between adjacent sides is 90 degrees, but due to the nature of the in-vivo indwelling member formed from the spirally wound primary coil, The shape does not necessarily have to follow the definition of a square, and includes a quadrangular shape in which the lengths and angles of the sides are different or the sides do not intersect.

In this way, by configuring the three-dimensional part with a shape portion that substantially follows a circle inscribed in each surface of the virtual tubular body C1 / C2 surrounded by squares of the same size, it depends on the shape of the inner wall surface such as an aneurysm. It spreads so as to bulge outward more uniformly, and a stable frame having high adhesion can be formed along the inner wall, and the indwelling density can be further increased. Such a form can be obtained by configuring the four winding portions constituting the aggregate 7A / 7B of the mandrel 6 with the winding portions having the same peripheral length as described above.

The length of the three-dimensional portion excluding the largest three-dimensional portion, in this example, the primary coil constituting the middle solid 4A is preferably set to a length of 25% or more and 50% or less of the total length of the primary coil. As a result, a sufficient amount of the frame is formed by the three-dimensional portion (middle solid 4A) extruded first, and the frame is further pushed toward the inner wall side for the largest three-dimensional portion (large solid 4B) extruded last. Sufficient volume is maintained in which the action of being able to spread and form a frame with excellent adhesion works. For the same reason, the length of the primary coil constituting the largest solid portion, in this example, the large solid 4B, is preferably set to 50% or more and 75% or less of the total length of the primary coil.

The ratio of the length of one side forming the quadrangle to the three-dimensional part having a relatively small area of the quadrangle seen from the common axis of the virtual tubular body and the next largest three-dimensional part, in this example, the virtual tubular shape of the middle solid 4A. The ratio of the length of one side forming the square s1 of the body C1 to the length of one side forming the square s2 of the virtual tubular body C2 of the large solid 4B is the length of the large solid portion (large solid 4B). It is preferable that the length of the small three-dimensional portion (middle solid 4A) is 1.05 times or more and 1.5 times or less, and further 1.1 times or more and 1.2 times or less. It is preferable that it is set. As a result, the frame formed earlier by the relatively small three-dimensional part (middle three-dimensional part 4A) is expanded toward the inner wall by the next largest three-dimensional part (large three-dimensional part 4B), and is firmly formed along the inner wall such as an aneurysm. The frame is surely formed.

An anchor portion 40 composed of at least one loop-shaped shaped portion 50 may be formed in a region extending to the tip of the primary coil on the tip side of the smallest three-dimensional portion (middle solid 4A). In this example, only one loop-shaped portion 50 is formed, and a spiral portion 53 leading to the middle solid 4A is continuously formed.

The spiral portion 53 is formed by winding the primary coil around the slope-shaped notch groove 61a of the mandrel 6. The length of the primary coil constituting the anchor portion 40 is set to be less than 15% of the total length of the primary coil. When the anchor portion 40 is longer than 15%, the holding stability with respect to the inner wall is lowered, and the function as an anchor is lowered. It is particularly preferable that the length of the anchor portion with respect to the total length of the primary coil is 5% or more and 10% or less. The length of the primary coil forming the anchor portion is preferably shorter than the length of the primary coil forming the middle solid.

Hereinafter, a specific procedure will be described based on FIGS. 4 to 8 until the primary coil is wound around the mandrel 6 according to the present embodiment to form the secondary shape.

In this example, the anchor portion on the tip end side is wound and formed in order, but as described above, it is also possible to wind and form in order from the large three-dimensional side on the base end side. First, preferably, a core wire 12 longer than the total length of the primary coil is inserted into the cavity of the primary coil 11. The material of the core wire is not particularly limited, and for example, stainless steel can be used. The diameter of the core wire can be appropriately selected depending on the application, and is not particularly limited.

Then, the protruding end portion on the front end side of the core wire 12 is fixed at a desired position of the winding portion 70 which is the start of winding on one end side of the mandrel 6. In this example, a fixing screw 79 is provided at the end of the winding portion 70, and the screw 79 is fixed by sandwiching the core wire 12 between the head of the screw 79 and the outer surface of the winding portion 70 and tightening the screw 79. Other fixing means such as tapes and clips that can withstand high temperatures may be used. Further, the primary coil may be fixed outside the mandrel 6.

Next, the primary coil 11 is wound around the winding portion 70 of the mandrel 6 while tension is applied as necessary, the primary coil 11 is wound about once (360 degrees), and a step between the winding portion 70 and the winding portion 71. While engaging in the slope-shaped notch groove 61a formed in the portion 60a, the coil is spirally wound about half a circumference toward the winding portion 71. As a result, the primary coil 11 reaches the continuous portion between the winding portion 71 and the winding portion 72 of the assembly 7A on the mandrel 6.

In the steps up to this point, the anchor portion 40 including the loop-shaped portion 50 (loop-shaped portion R01) of the primary coil and the spiral portion 53 is formed. Only one loop-shaped portion (R01) is formed on the anchor portion 40. The loop-shaped portion R01 formed by winding around the winding portion 70 having the shortest circumference is the loop-shaped portion having the shortest loop length, has the highest flexural rigidity as a loop formed by the primary coil, and is used on the inner wall of an aneurysm or the like. Optimal as an anchor that should be held quickly and stably. Here, the flexural rigidity indicates the ease of bending deformation, and the higher the bending rigidity, the less likely it is that the bending will be deformed. Since R01 is formed by the winding portion having the smallest diameter in this example, the flexural rigidity is higher than that of other three-dimensional portions.

Next, as shown in FIG. 6, when the primary coil 11 is wound about half a circumference (180 degrees) along the winding portion 72, it reaches the continuous portion between the winding portion 72 and the winding portion 74 on the mandrel 6, and further. The primary coil 11 is wound around the winding portion 74 about once. Further, when it is wound around the winding portion 72 about half a turn, it returns to the continuous portion between the winding portion 72 and the winding portion 71. Then, it is wound around the winding portion 71 about half a turn.

At this time, the winding portion 70 first intersects the shape portion 51a of the primary coil that is spirally wound along the slope-shaped notch groove 61a and wound around the winding portion 72, and the winding is further performed from above. The primary coil 11 wound around the portion 71 passes through the portion 71, which prevents the spiral portion 53 wound along the notch groove 61a from loosening. Further, when the primary coil 11 is wound around the winding portion 73 about half a turn, it reaches a portion near the continuous portion between the winding portion 73 and the winding portion 74.

The shape of the middle solid 4A is formed by the steps up to this point. In the middle solid 4A, a shape portion 51d having a substantially half circumference is formed on the winding portion 71, and a shape portion 51a having a substantially half circumference and a shape portion 51c having a substantially half circumference are located on the winding portion 72. A circular ring is formed. Further, a shape portion 51e having a substantially half circumference is formed on the winding portion 73, and a loop-shaped shape portion 51b (loop shape portion R11) having a substantially circular circumference is formed on the winding portion 74. As described above, only one loop-shaped portion (R11) is formed in the middle solid 4A.

Next, the connecting portion 54 of the primary coil 11 is arranged from the winding portion 74 toward the winding portion 75 while passing through the notch groove 61b provided in the step portion 60b between them, and the winding portion of the assembly 7B is arranged as it is. Wind around 77 around once. As a result, the primary coil returns to the continuous portion between the winding portion 77 and the winding portion 75, and then is wound around the winding portion 75 by about half a circumference. At this time, as shown in FIGS. 5A and 5B, the primary coil passes over the connecting portion 54 passing through the notch groove 61b, and the shaped portion 52b is formed on the winding portion 75. However, they can pass through without interfering with each other, the formation of the bent portion is prevented, and the shape portion 52b presses the connecting portion 54 to prevent loosening.

When the primary coil 11 reaches the continuous portion between the winding portion 75 and the winding portion 76, the primary coil 11 is then wound around the winding portion 76 by about half a turn, then wound around the winding portion 78 by about one turn, and further wound around the winding portion 76. Wind it up about half a turn, and finally wind it around the winding part 75 about one turn. The length of the primary coil 11 is preset so that the rear end comes at the final winding around the winding portion 75. At the time of winding around the winding portion 75, as shown in FIGS. 5 (a) and 5 (b), the wound portion 54 is further passed over the connecting portion 54 in the notch groove 61b. The loop-shaped portion 52f formed thereby is prevented from forming a bent portion, and the connecting portion 54 is pressed to more reliably prevent loosening of the portion.

Then, the core wire 12 extending from the base end of the primary coil is appropriately wound around the winding portion 75 and the winding portions 77 and 78 so that the primary coil 11 does not loosen, and finally the end portion 78 of the winding portion 78 on the other end side of the mandrel 6. It is fixed to the fixing mounting screw 80 provided in. By the steps up to this point, the shape of the large solid 4B is formed, and the intermediate shape is obtained.

In the large solid 4B, a shape portion 52b having a substantially half circumference and a loop-shaped portion 52f (loop shape portion R23) having a substantially one circumference are formed side by side on the winding portion 75, and a shape portion having a substantially half circumference is formed on the winding portion 76. A shape portion 52e having a substantially half circumference with 52c is located, and both portions are combined to form a ring having a substantially one circumference. Further, a loop-shaped portion 52a (loop-shaped portion R21) having substantially one circumference is formed on the winding portion 77, and a loop-shaped portion 52d (loop-shaped portion R22) having substantially one circumference is formed on the winding portion 78. There is. As described above, three loop-shaped portions (R21, R22, R23) are formed in the large solid 4B.

The number of times the primary coil is wound around the winding portion such as the anchor portion 40, the medium solid 4A, and the large solid 4B, that is, the number of loops formed in the winding portion may be a plurality of loops in addition to one loop. Further, in addition to the loop that extends more than one round to form a loop, a shape portion that does not form a loop that extends less than one round, which is an arc-shaped shape that extends less than one round and does not form a loop, may be included. In addition, a ring component, which is a component in which a plurality of such shape portions are combined to form a ring, may be included. A plurality of the shape portions and the ring constituent portions may be included in one winding portion.

Then, the primary coil 11 wound around the mandrel 6 is heated together with the mandrel 6 with the core wire 12 inside, and the anchor portion 40, the medium solid 4A, and the large solid formed by winding around the mandrel 6 are formed. An intermediate shape consisting of 4B is imparted (heat treatment (firing)). The heating conditions can be appropriately determined depending on the material of the primary coil 11. For example, the heating temperature is preferably 400 ° C. or higher, and the heating time is preferably 15 minutes or longer. After that, when the primary coil 11 with the core wire 12 inside is removed from the mandrel 6, the intermediate shape coil 2 having the intermediate shape shown in FIG. 7 is obtained. In a different aspect of the present invention, this intermediate shape can be the final secondary shape of the in-vivo indwelling member.

The procedure for winding the primary coil around the mandrel 6 described above is an example, and of course, other winding procedures may be used. Further, the mode of winding around one rod-shaped portion by one winding is not limited to this, but may be less than half a turn, 3/4 turn, or more than two turns.

Next, as shown in FIGS. 8A and 8B, a part of the primary coil located between the middle solid and the large solid of the intermediate shape coil removed from the mandrel is bent to form the intermediate shape coil 2. A secondary coil having a secondary shape in which the medium solid 4A and the anchor portion 40 are arranged inside the large solid 4B is created. Specifically, the axis a1 of the medium solid 4A and the axis a2 of the large solid 4B substantially coincide with each other, and the virtual tubular bodies C1 and C2 are rotated relative to each other by a predetermined angle so as not to be parallel to each other. In this example, it is placed in a state where it is rotated by 45 degrees. This is the final secondary shape. In the present invention, the shape coil can be deformed and heated to give the shape. In imparting the shape, another three-dimensional portion can be arranged inside one three-dimensional portion of the coil having an intermediate shape. In order to place another three-dimensional part inside one three-dimensional part, the primary coil located between each three-dimensional part and forming a loop or a part between loops can be bent and placed. .. In particular, it is preferable to arrange the common axis of one three-dimensional portion in which the other three-dimensional portion is arranged so that the common axis of the other three-dimensional portion is parallel to each other. By arranging in this way, it is possible to improve the adhesion to the inner wall of an aneurysm or the like. The arrangement in which the common axes of the solids are parallel includes an arrangement in which the common axes of the solids are coaxial. In this example, the medium solid and the anchor part are arranged inside the large solid in a state of being rotated by 45 degrees, but the large solid is arranged inside the medium solid and the rotation angle is set to 90 degrees. The angle can be selected as appropriate. The mid-shaped coil removed from the mandrel is also flexible and can be bent at any position.

Further heating (heat treatment (firing)) in this state imparts the secondary shape. The heating conditions can be appropriately determined depending on the material of the primary coil 11. For example, the heating temperature is preferably 400 ° C. or higher, but it is desirable that the heating temperature is higher than the heating temperature at the time of imparting the intermediate shape. The heating time is preferably 15 minutes or more. In this heat treatment, for example, a mold having a cavity corresponding to a secondary shape, and in this example, a mold having a cube-shaped lumen can be used.

After the heat treatment, the core wire 12 is removed to obtain the secondary coil 3. When the secondary coil arranged in this way is extruded into an aneurysm or the like, the largest three-dimensional portion more reliably further expands the frame formed by the already extruded small three-dimensional portion toward the inner wall side. It is possible to further improve the adhesion and the indwelling density. For the secondary coil from which the core wire has been removed, an internal wire is inserted in place of the core wire, a tip is formed at one end to form a tip, and a connecting member is interposed at the other end for placement wire. Etc. can be connected to produce an in-vivo indwelling member arranging device.

In the present embodiment, one loop-shaped portion R01 of the anchor portion 40, one loop-shaped portion R11 of the middle solid 4A, and three loop-shaped portions R21 to R23 of the large solid 4B are formed from the tip end side of the secondary shape coil. Since the peripheral length of the winding portion is gradually set to be longer in the order of the anchor portion 40, the medium solid 4A, and the large solid 4B, the loop length of the loop-shaped portion is also gradually lengthened correspondingly. The anchor effect can be ensured by providing only one loop-shaped portion R01 of the anchor portion 40 having the shortest loop length, and the loop-shaped portion of the large solid 4B having the longest loop length can be provided. By providing two or more (R21 to R23), the effect of expanding the portion of the extruded coil and improving the adhesion can be sufficiently obtained.

Although the embodiments of the present invention have been described above, the present invention is not limited to these examples, and it goes without saying that the present invention can be implemented in various forms without departing from the gist of the present invention.

1 In-vivo indwelling member 2 Intermediate coil 3 Secondary coil 4A Medium solid 4B Large solid 6 Mandrel 7A, 7B Assembly 9 Mandrel 10 Wire 11 Primary coil 12 Core wire 40 Anchor 50 Shape part 51a-51e Shape part 52a-52f Shape Part 53 Spiral part 54 Connecting part 60a, 60b Stepped part 61a, 61b Notch groove 70-78 Winding part 79, 80 Mounting screw a1, a2 Common shaft C1, C2 Virtual tubular body F1-F4 surface F5-F8 surface R01 Loop Shape part R11 Loop shape part R21, R22, R23 Loop shape part s1, s2 Square

Claims (5)

A mandrel for manufacturing an in-vivo indwelling member used for winding a primary coil to form a secondary shape of the in-vivo indwelling member.
A step portion is provided at a predetermined position through which the primary coil passes by winding, and a step portion is provided.
A notch groove for receiving the primary coil is provided in the step portion.
It is equipped with a plurality of winding parts for winding the primary coil around the outer peripheral surface more than once or less than once.
And wherein the step portion is a stepped portion between the relatively outer peripheral surface of the circumferential length is long wrappings relatively circumferential length is short winding portion of the outer peripheral surface and the portion wrapped around the provided continuously coaxially mandrel. It is provided with two or more aggregates composed of two or more of the winding portions, including those having substantially the same peripheral length and different axial directions.
The aggregate composed of the winding portions having a relatively long peripheral length and the aggregate composed of the winding portions having a relatively short peripheral length are integrally formed with one winding portion of each aggregate coaxially arranged. Has been transformed into
The step portion is a mandrel of claim 1, wherein a stepped portion between the winding portion, which is the continuously provided. A mandrel for manufacturing an in-vivo indwelling member used for winding a primary coil to form a secondary shape of an in-vivo indwelling member, and providing a stepped portion at a predetermined position through which the primary coil passes by winding. A method for manufacturing an in-vivo indwelling member using a mandrel in which a notch groove for receiving the primary coil is provided in a step portion .
While the primary coil is wound around the mandrel to form the secondary shape, the primary coil is inserted into the notch groove of the step portion and passed through.
After that, a portion of the primary coil on the rear end side of the accepted portion is wound around the notch groove in which the primary coil is received in a direction intersecting the accepted primary coil. ,
A method for manufacturing an in-vivo indwelling member. The mandrel includes a plurality of winding portions for winding the primary coil around the outer peripheral surface more than once or less than one circumference, and the stepped portion is wound with a winding portion having a relatively long peripheral surface and a relatively short peripheral surface. It is a stepped portion between the winding portions that are coaxially connected to the portion.
When the primary coil is wound around the mandrel to form a secondary shape, after the primary coil is wound around the winding portion having a relatively short circumference,
A portion of the primary coil on the rear end side of the winding portion having a short peripheral length is passed through the notched groove of the step portion.
After that, when winding the portion of the primary coil on the rear end side of the accepted portion around the winding portion having a relatively long peripheral length, the portion above the notch groove that received the primary coil was accepted. Wrapped while passing in the direction intersecting the primary coil,
The method for manufacturing an in-vivo indwelling member according to claim 3 . The mandrel includes two or more aggregates composed of the two or more winding portions, including those having substantially the same peripheral length and different axial directions, and the assembly composed of the winding portions having a relatively long peripheral length. The body and the aggregate composed of the winding portions having a relatively short peripheral length are integrated with each other by coaxially connecting one winding portion of each aggregate to each other, and the step portion is the continuous. It is a stepped part between the provided winding parts,
When the primary coil is wound around the mandrel to form a secondary shape,
After winding the primary coil around all the winding portions of the aggregate consisting of the winding portions having a relatively short circumference,
A portion on the rear end side of the portion wound around the winding portion of the aggregate is passed through the notch groove of the step portion.
Then, when the portion of the primary coil on the rear end side of the accepted portion is wound around the winding portion of the aggregate composed of the winding portion having a relatively long peripheral length, the notch groove that receives the primary coil is used. Wrap around the top of the coil while passing it in a direction that intersects the accepted primary coil.
The method for manufacturing an in-vivo indwelling member according to claim 4 .

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