JP2015039484A - Stent machining jig and manufacturing process of stent - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a stent machining jig, when expanding a tubular base body on which net-like struts are formed, in a manufacturing process of a self-expandable stent, capable of arranging the mesh of the struts into a prescribed pattern in the expansion, and to provide a manufacturing process of the self-expandable stent.SOLUTION: The stent machining jig for a self-expandable stent that is manufactured by expanding a tubular base body on which net-like struts are formed, includes one or more recesses for receiving the struts of the base body after the expansion from an outer peripheral side of the base body, or a plurality of protrusions that enter gaps between the struts of the base body after the expansion from the outer peripheral side of the base body. The recesses or the protrusions are disposed in accordance with a prescribed pattern of the mesh of the struts in the self-expandable stent.

Description

  The present invention relates to a processing jig for shaping a strut mesh pattern of an expanded stent and a method for manufacturing a stent having a strut mesh pattern shaped when the diameter is expanded.

  Stents are widely used to expand a narrowed portion formed in a tube having a lumen such as a blood vessel or a digestive tract in a living body, and secure a path through which blood, digested material, and the like pass. There are two types of known stents. One is a balloon-expandable stent in which a balloon expanded by a pressure fluid using a conventional balloon catheter expands the stent by its expansion force. The other is a self-expandable stent having an expandability formed by a shape memory alloy or the like.

  Of these, most self-expanding stents (hereinafter simply referred to as “stents” unless otherwise specified) are often composed of shape memory alloys, and the shape after diameter expansion is memorized in the manufacturing process. In the sheath of the delivery catheter, it is held in a reduced diameter state. When the delivery catheter is inserted into the body and guided to the desired position, the stent is released from the sheath, expanded to the outer diameter that has memorized the shape due to body temperature, and placed. A stent placed in a lesion site such as a stenosis generated in a living body tube can support the tube from the inside due to a physical property called radial force.

  However, stents placed in this way need to be supported from the inside against the force of stenosis so that the biological tube does not restenect. Because it receives various external forces such as extension and torsion, external force is repeatedly applied to the stent strut from various directions, and the strut breaks due to fatigue due to repeated external force load on the expanded stent. The destruction of stents has become a challenge.

  In order to solve this problem, each stent manufacturer has improved the fatigue resistance by devising a mesh pattern (design) that is resistant to fatigue failure. However, even if the design itself has fatigue resistance, if the design itself cannot be manufactured according to the design, the effect based on the design is greatly reduced.

  By the way, it is the diameter expansion process that disturbs the design most in the manufacturing process. The manufacturing process of the self-expanding stent is various and various, such as manufacturing from a tube, manufacturing from a sheet, and manufacturing from a wire. As an example, a general process in manufacturing from a tube is shown. The tube-shaped substrate is processed as designed by forming a mesh-like strut by laser, electric discharge machining, cutting with a tool, or the like. Thereafter, deburring is performed, and a diameter expansion process for expanding the tube-shaped substrate from the initial diameter to a desired diameter is performed, and shape memory processing such as heat treatment is performed. Thereafter, chemical polishing or blasting is performed as necessary, and the surface is finally finished to a mirror surface by electrolytic polishing.

For example, when the stent is manufactured from a small-diameter tube, a small-diameter tube cut into a desired design in anticipation of the mesh pattern of the stent at the time of expansion is used as the diameter expansion step. A method is known in which a mandrel having a diameter is gradually increased to a desired diameter. And since shape memory processing is performed on the tube in such a diameter-expanded state, it is very important that the struts are arranged in a desired mesh pattern during the diameter expansion. When the shape memory treatment is performed with the strut arrangement different from the desired mesh pattern (design) at the time of expansion, for example, excessive stretching or excessive compression between the struts, microcracks are generated in the strut. It is known that the fatigue resistance characteristics deteriorate due to the concentration of residual stress or the stent placed in the body is easily broken.
Therefore, in the diameter expansion process, it is known that it is very important to arrange the strut meshes in the predetermined pattern at the time of diameter expansion, and it is necessary to pay high attention. In order to place it in a predetermined pattern, the operator visually observes the struts placed on the mandrel with a core material etc. while paying high attention while comparing it with the design drawing on which the desired mesh pattern is described. A method is known in which the arrangement of struts is manually shaped so as to have a predetermined pattern. However, with this method, quality fluctuations due to differences among workers are large, and when the strut mesh pattern is complex, the shaping work itself is difficult and the work efficiency and productivity are reduced. The big issue is.

  As a method for dealing with such a problem, for example, in prior art document 1, in order to make the mesh pattern of the struts at the time of diameter expansion a desired pattern, that is, to make the openings formed by the struts uniform, A method of providing a sacrificial bridge between a pair of struts is disclosed so that excessive stretching and excessive compression do not occur. By providing this sacrificial bridge, it is possible to expand the diameter so that the opening becomes uniform by keeping the distance between the struts constant, but a step of removing the sacrificial bridge in the middle of the manufacturing process is necessary, There is a problem in that man-hours increase. Moreover, as a method for detachment, complicated work such as cutting and chemical polishing is required, and there is a problem in that man-hours are further increased.

  As another method, a method in which the diameter expansion process is not performed has been proposed. For example, in the prior art document 2, a tube having a desired stent diameter suitable for an in-vivo site to be placed is processed to form a mesh-like strut, and then the diameter is reduced when necessary to carry out a diameter expansion process. A method of manufacturing a stent without the need is disclosed. Certainly, the diameter expansion process is not performed in this method, so the strut arrangement is not different from the desired mesh pattern at the time of diameter expansion, but the cost of the tube that is the raw material is increased by increasing the diameter of the tube to be processed. The problem is that it takes too much. Since the material cost is proportional to the tube diameter, it is not particularly suitable when manufacturing a large-diameter stent.

Special table 2008-518643 gazette Japanese Patent No. 3565986

  The problem to be solved by the present invention is to arrange the strut mesh in a predetermined pattern when expanding the diameter of the tube-shaped substrate on which the mesh struts are formed in the manufacturing process of the self-expanding stent. It is an object of the present invention to provide a stent processing jig and a method for manufacturing a self-expanding stent that can be easily performed.

  In view of the above problems, as a result of intensive studies by the present inventors, a self-expanding stent manufactured by expanding the diameter while forming a mesh-like strut by cutting a tube-shaped substrate, The strut mesh pattern on the expanded base is shaped into a predetermined strut mesh pattern on the self-expanding stent by correcting the position of the strut, for example, formed on a tubular substrate. Using a stent processing jig in which one or more recesses for receiving a mesh strut or a plurality of projections entering a gap between mesh struts are arranged in accordance with a predetermined pattern of the strut mesh in a self-expandable stent As a result, the present inventors have found that the above problems can be solved. That is, the gist of the present invention is as follows.

[1] A stent processing jig for a self-expandable stent manufactured by expanding the diameter of a tube-shaped substrate on which a mesh strut is formed,
One or more recesses for receiving the struts of the base after the diameter expansion from the outer peripheral side of the base, or a plurality of convex parts entering from the outer peripheral side of the base in the gap between the struts of the base after the diameter expansion are included,
The stent processing jig in which the concave portion or the convex portion is arranged in accordance with a predetermined pattern of a strut mesh in the self-expanding stent.
[2] The planar view shape of the portion surrounded by the concave portion or the convex portion has a shape in which the occupation ratio of the gap between the struts in the self-expanding stent with respect to the planar view shape is 10% or more and 90% or less. The stent processing jig according to 1.
[3] The planar view shape of the portion surrounded by the concave portion or the convex portion has a shape corresponding to the planar view shape of the gap between the struts in the self-expanding stent or a shape obtained by reducing the corresponding shape. 2].
[4] The corresponding shape or a shape obtained by reducing the corresponding shape has a shape in which the occupation ratio of the gap between the struts in the self-expandable stent with respect to the planar shape is 50% or more and 90% or less. ] The stent processing jig described in the above.
[5] The stent processing jig according to [2], wherein the convex shape of the convex portion is a small planar shape that occupies only the periphery of a predetermined position of the gap between the struts in the self-expanding stent.
[6] The stent processing jig according to [5], wherein the shape in the small plan view has a shape in which an occupation ratio of the space between the struts in the self-expandable stent with respect to the shape in the plan view is 10% or more and less than 50%. .
[7] The stent processing jig according to any one of [1] to [6], wherein the convex portion is tapered toward a convex tip.
[8] The stent processing jig according to any one of [1] to [4], wherein the recess is tapered toward the bottom of the recess.
[9] The stent processing jig according to any one of [1] to [8], which is made of a material having a lower hardness than a material constituting the substrate.

[10] A method for producing a self-expanding stent produced by expanding the diameter of a tube-shaped substrate on which mesh struts are formed,
A method for producing a self-expanding stent, wherein the strut mesh pattern on the base after diameter expansion is shaped into a predetermined pattern of strut mesh in the self-expandable stent by correcting the position of the strut.
[11] In correcting the strut position,
Using a stent processing jig in which a plurality of recesses for receiving struts are arranged, the struts of the base after diameter expansion are fitted into the recesses from the outer peripheral side of the base,
Or
[10] In which the gap between the struts of the base body after diameter expansion is fitted into the convex part from the outer peripheral side of the base by using a stent processing jig in which a plurality of convex parts entering the gap between the struts are arranged. A method for manufacturing the described self-expanding stent.
[12] By causing the struts of the base body after the diameter expansion or the gap between the struts to be partially fitted into the concave portion or the convex portion of the stent processing jig in order along the circumferential direction from the outer peripheral side of the base body. The method for producing a self-expanding stent according to [11], wherein the strut positions are sequentially corrected.
[13] The method for manufacturing a self-expanding stent according to [12], wherein the strut positions are sequentially corrected in a state where a mandrel is inserted into the base after the diameter expansion.
[14] The self-expanding type according to [13], wherein the position of the strut is sequentially corrected by rotating the mandrel together with the base and relatively moving the mandrel axis and the stent processing jig. A method for manufacturing a stent.
[15] The method for producing a self-expanding stent according to any one of [10] to [14], wherein the shaped substrate is subjected to heat treatment to fix the shaped state as a diameter-expanded posture.

  According to the present invention, when expanding the diameter of a tube-shaped substrate on which a mesh-like strut is formed in the manufacturing process of a self-expanding stent, it is easy to arrange the strut mesh at the time of diameter expansion in a predetermined pattern. Therefore, it is possible to manufacture a self-expanding stent efficiently with little variation in quality by an operator.

(A) It is the side view which showed typically an example of embodiment of the tube-shaped base | substrate which formed the net-like strut before diameter expansion used by this invention. (B) It is the side view which showed typically the state which inserted the mandrel whose diameter is larger than this base | substrate and expanded the diameter to the tubular base body shown to Fig.1 (a). (C) It is the side view which showed typically the state which inserted the mandrel larger in diameter than the mandrel shown in FIG.1 (b) in the tube-shaped base | substrate shown to Fig.1 (a), and expanded the diameter. (D) is a side view schematically showing a self-expanding stent having a predetermined pattern of strut mesh obtained by expanding the tube-shaped substrate shown in FIG. 1 (a). (A) It is the side view which showed typically the state which inserted the small diameter cylindrical part of the mandrel which has a small diameter and a large diameter cylindrical part in the tube-shaped base | substrate shown to Fig.1 (a), and expanded the diameter. (B) It is the side view which showed typically the state which inserted the large diameter cylindrical part of the mandrel which has two cylindrical parts of small diameter and large diameter in the tube-shaped base | substrate shown to Fig.1 (a), and expanded the diameter. . (A) It is the top view which showed the outline of 1st Embodiment of the stent processing jig concerning this invention. (B) It is sectional drawing which showed the outline of the II direction cross section. (C) It is sectional drawing which showed the outline of the modification of a II direction cross section. (A) It is the top view which showed the outline of 2nd Embodiment of the stent processing jig concerning this invention. (B) It is sectional drawing which showed the outline of the II-II direction cross section. (C) It is sectional drawing which showed the outline of the modification of the II-II direction cross section. It is the top view which showed the outline of 3rd Embodiment of the stent processing jig which concerns on this invention. It is the top view which showed the outline of 4th Embodiment of the stent processing jig concerning this invention. It is the top view which showed the outline of 5th Embodiment of the stent processing jig which concerns on this invention. It is the side view which showed the outline of 6th Embodiment of the stent processing jig which concerns on this invention. (A) It is the top view which showed typically the state which inserted the mandrel in the tube-shaped base | substrate shown to Fig.1 (a), and expanded the diameter. (B) It is the top view which showed typically the state in the middle of correcting the position of the strut using the stent processing jig | tool in the state which inserted the mandrel and expanded the diameter. (C) It is the top view which showed typically the state after correcting the position of a strut. (D) It is the figure which showed the III-III direction cross section typically. It is the perspective view which showed typically the outline of the drive device for moving the base | substrate of the state which inserted the mandrel and expanded the diameter with respect to a stent processing jig | tool.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

  A manufacturing method of a self-expanding stent according to the present invention is a manufacturing method of a self-expanding stent manufactured by expanding the diameter of a tube-shaped substrate on which network struts are formed. The strut mesh pattern is shaped into a predetermined strut mesh pattern in the self-expanding stent by correcting the strut position.

  In the method for producing a self-expanding stent of the present invention, first, a tube-shaped substrate on which a mesh-like strut is formed is produced. Such a tube-shaped substrate can be obtained by a method usually prepared by those skilled in the art. For example, a tubular substrate can be produced by forming a mesh-like strut by subjecting a tubular tube to a cutting process such as laser cutting. Electropolishing may be performed after laser cutting. Alternatively, the sheet-like member may be cut by laser cutting or the like to form a mesh-like strut, and then rounded into a cylindrical shape and joined by welding or the like to produce a tube-like substrate. Furthermore, a round base, a square line, a flat line, etc. can be arrange | positioned at mesh shape, and a tubular base | substrate can be produced, joining arbitrary places by welding etc. as needed, and forming a mesh-like strut. . In any method, polishing treatment such as buffing and electrolytic polishing, acid cleaning, heat treatment, and the like can be combined. In addition, the tubular base body is formed with a lumen portion that communicates both ends of the base body in the long axis direction for the function of the stent.

  The material constituting the tubular substrate is not particularly limited and may be either an inorganic material or an organic material. Examples of the inorganic material include metal materials such as stainless steel, shape memory alloy, superelastic metal, ceramic, hydroxyapatite, and the like. Examples of the shape memory alloy / superelastic metal include Ni—Ti alloy, Cu—Al—Mn alloy, tantalum, Co—Cr alloy, iridium, iridium oxide, and niobium. Examples of the organic material include polymer compounds such as polyolefin, polyolefin elastomer, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyester, polyester elastomer, polyimide, polyamideimide, and polyetheretherketone.

  The strut mesh pattern formed on the substrate is not particularly limited as long as it can expand in diameter and can have a good radial force when placed in the constriction. An example of an embodiment of a substrate that can be used in the present invention will be described with reference to the drawings. Fig.1 (a) is the side view which showed an example of embodiment of the tube-shaped base | substrate which formed the network-like strut before diameter expansion used by this invention. In the tubular substrate 1 of this example, a plurality of wave-shaped sections 2 traveling in the circumferential direction of the substrate 1 are continuously provided in the long axis direction of the substrate 1 (four in the example of FIG. 1A). The sections 2 that are adjacent to each other are connected to each other by a connecting portion 3 at a crest and a trough adjacent to each section. The connection part 3 may be one place and may be two or more places. Thus, in this example, the section 2 and the connecting portion 3 form a mesh strut. Of course, the present invention is not limited to the embodiment shown in FIG. 1A, and other mesh patterns may be employed.

  After producing a tube-like substrate on which a reticulated strut is formed, the diameter of this substrate is expanded. The method of expanding the diameter is not particularly limited, but a method of expanding the diameter of the base in stages can be adopted. For example, a predetermined outer diameter is formed in the lumen portion formed in the tubular base. There is a method of inserting a mandrel and expanding the diameter stepwise. This example will be described with reference to the drawings. As shown in FIGS. 1A to 1C, first, a tube-shaped substrate 1 as shown in FIG. 1A is prepared, and then a tube-shaped substrate 1 as shown in FIG. A mandrel 4 having a cylindrical portion having a constant outer diameter larger than the inner diameter of the base 1 is inserted into the inner cavity of the base 1 so that the diameter of the base 1 shown in FIG. 1 (a) is larger than the desired diameter. The state is expanded to a small diameter (symbol 1a in FIG. 1B). Next, as shown in FIG. 1 (c), the mandrel 5 having a cylindrical portion having a constant outer diameter larger than the outer diameter of the mandrel 4 shown in FIG. 1 (b) is inserted and expanded to a desired diameter. (Reference numeral 1b in FIG. 1C). In the example of FIG. 1, the mandrel having different diameters is used to increase the diameter to the desired diameter in two stages, but it may be one stage or may be increased stepwise to the desired diameter in two or more stages.

FIG. 2 shows a modification of the diameter expansion method shown in FIG. The example shown in FIG. 2 does not use a plurality of mandrels, as shown in FIGS. 1B and 1C, and is continuously adjacent to the cylindrical portions 7 and 9 and the cylindrical portions 7 and 9 having different outer diameters. This shows a diameter expansion method using one mandrel 6 having a tapered portion 8 that connects the matching cylindrical portions 7 and 9. As shown in FIG. 2A, a cylindrical portion 7 having an outer diameter larger than the inner diameter of the base body 1 is inserted into the lumen of the tubular base body 1 shown in FIG. Is expanded so as to correspond to the outer diameter of the cylindrical portion 7 (reference numeral 1c in FIG. 2A). Then, the base 1c is moved to the cylindrical portion 9 along the tapered portion 8 that gradually increases in diameter from the small-diameter cylindrical portion 7 toward the large-diameter cylindrical portion 9, thereby gradually increasing the internal diameter of the base 1c. 1c is expanded so that its inner diameter corresponds to the outer diameter of the cylindrical portion 9 (reference numeral 1d in FIG. 2B). By setting the outer diameter of the cylindrical portion 9 to a desired outer diameter, a tube-shaped substrate having an expanded diameter can be obtained. In the example shown in FIG. 2, the mandrel 6 having two cylindrical portions 7 and 9 having different outer diameters and the tapered portion 8 connecting the two cylindrical portions is used. However, the cylindrical portions may be provided at two or more locations. . Further, the outer diameter of the cylindrical portion 7 is larger than the inner diameter of the tube-shaped base body 1 before the diameter expansion shown in FIG.
Thus, by using a mandrel having a structure in which a plurality of cylindrical portions having different constant outer diameters are connected at the tapered portion, the base before the diameter expansion can be easily expanded to a desired diameter.

  There is no limitation in particular as a material which comprises a mandrel, An inorganic material and an organic material can be used. Examples of inorganic materials include metals, glass, and ceramics, and examples of organic materials include various polymer compounds. As will be described later, from the viewpoint of performing a heat treatment with a base on which a mandrel is shaped, a material having heat resistance corresponding to the material constituting the base is preferable. Further, the outer surface of the mandrel is preferably smooth from the viewpoint of sliding the substrate.

As described above, for example, when the base 1 on which the mesh-like struts shown in FIG. 1A are formed is expanded to a desired diameter, as shown in FIGS. 1C and 2B, The arrangement of the mesh struts is disturbed, and the mesh pattern is distorted. In the present invention, the mesh pattern distorted in the base after the diameter expansion is shaped into a predetermined pattern of the strut mesh in the self-expanding stent by correcting the position of the strut. Here, the “predetermined pattern of the strut mesh in the self-expanding stent” means a mesh pattern designed as the mesh pattern of the self-expanding stent when not contracted. Hereinafter, unless otherwise specified, the “predetermined pattern of strut mesh in the self-expanding stent” is simply referred to as “predetermined pattern of strut mesh” or “predetermined pattern”.
The predetermined pattern of the mesh is not particularly limited as long as it has a radial force that is good for expanding the constriction and a structure that can be held and contracted within the sheath of the delivery catheter. . FIG.1 (d) is the side view which showed typically the stent which has a predetermined pattern obtained by expanding the base | substrate 1 shown to Fig.1 (a). The stent 1e in FIG. 1D has a section 2a and a connecting portion 3a corresponding to the section 2 and the connecting portion 3 of the base 1, respectively. The section 2a has a wave shape having a smaller amplitude and a longer wavelength than the section 2 by expanding the diameter of the substrate 1.

As a method of correcting the position of the strut as described above, for example, using a stent processing jig in which one or more recesses for receiving the struts are arranged in a predetermined pattern, that is, one or a plurality of the recesses, Using the method of fitting the struts of the base body after diameter expansion from the outer peripheral side of the base body, or a stent processing jig in which a plurality of convex parts entering the gap between the struts are arranged in accordance with a predetermined pattern, For example, a method of fitting the gap between the struts of the base body after the diameter expansion from the outer peripheral side of the base body.
By using such a stent processing jig, it is possible to efficiently manufacture a homogeneous stent with little variation in quality by the operator. Further, since it is not necessary to manufacture from a large diameter tube, even a large diameter stent can be manufactured at low cost.

  As the above-mentioned stent processing jig, there are one or more recesses for receiving the struts of the base after the diameter expansion from the outer peripheral side of the bases, or convex parts that enter the gaps between the struts of the base after the diameter expansion from the outer peripheral side of the base. It is preferable to use a plurality of the concave portions or the convex portions that are arranged in accordance with a predetermined pattern of the strut mesh in the self-expanding stent.

  As described above, the convex portion arranged in conformity with the predetermined pattern of the strut mesh enters the gap between the struts. In other words, struts enter between the plurality of convex portions. In addition, the struts enter the recesses arranged in accordance with the predetermined pattern of the strut mesh. In other words, the portion surrounded by the recess enters the gap between the struts. Therefore, in the case of the concave portion, the portion surrounded by the concave portion, and in the case of the convex portion, the convex portion easily enters the gap between the struts, that is, the arrangement of the concave portion and the convex portion so as to easily correct the arrangement of the struts, The structure is preferably determined. From such a viewpoint, the planar view shape of the portion surrounded by the concave portion or the convex portion has a shape in which the occupation ratio with respect to the planar view shape of the gap between the struts in the self-expandable stent is 10% or more and 90% or less. Is preferred. In calculating the occupancy rate, only the portion that effectively occupies the gap between the struts is considered. In addition, the occupation ratio may be within the above range in either the entire processing jig, a portion surrounded by each concave portion, or each convex portion.

Moreover, it is preferable that the planar view shape of the portion surrounded by the recess has a shape corresponding to the planar view shape of the gap between the struts in the self-expanding stent or a shape obtained by reducing the corresponding shape. Thereby, it becomes easy to make the part enclosed by the recessed part the shape close | similar to the shape of the clearance gap between struts, and it can make it easy to receive the strut which arrangement | positioning disordered in the recessed part.
The planar shape of the convex portion is a shape corresponding to the planar shape of the gap between the struts in the self-expandable stent, or a shape obtained by reducing the corresponding shape, or a predetermined gap between the struts in the self-expandable stent. A small plan view shape occupying only the periphery of the position is preferable. In the case of the former (corresponding shape and a shape obtained by reducing the corresponding shape), it becomes easy to make the convex part a shape close to the shape of the gap between the struts, and it is easy to accept struts that are disordered between the convex parts. can do. The latter shape in small plan view is effective in the case where the gap between the struts is large and the convex portion is provided in a portion where the strut position is likely to fluctuate when the diameter is expanded.
Here, “the shape corresponding to the plan view shape of the gap between the struts in the self-expanding stent” means a shape corresponding to the plan view shape of the gap between the struts (the shape in the development developed on the plane), Means the largest single or multiple polygons, circles, ellipses, or combinations thereof or other shapes that may not fit, but can enter the gap between the struts in a plan view shape. Further, the “polygon” includes a polygon that is substantially polygonal with rounded corners.
In addition, when the corresponding shape matches the planar view shape of the gap between the struts, the self-expansion is performed so that the occupation ratio is 10% or more and 90% or less as the planar view shape of the portion surrounded by the concave portion or the convex portion. It is preferable to adopt a shape obtained by reducing the shape corresponding to the shape in plan view of the gap between the struts in the type stent.

An embodiment of such a stent processing jig will be described with reference to the drawings.
3 to 7 show a predetermined pattern (FIG. 3B) of the base 1b and 1d in which the base 1 shown in FIG. 1 (a) is expanded to a desired diameter shown in FIGS. 1 (c) and 2 (b). 1 (d) shows an embodiment of a stent processing jig that can be used for shaping.

  A stent processing jig 10 (first embodiment) shown in FIG. 3 has a flat support base 12 and the struts of the bases 1b and 1d after diameter expansion shown in FIGS. 1 (c) and 2 (b). One recess 11 to be received from the outer peripheral side of 1b and 1d is arranged in accordance with a predetermined pattern (designed pattern) of the strut mesh. In the first embodiment, since the concave portion 11 is formed on a single plane on the upper surface side of the support base 12, the mesh pattern formed by the concave portion 11 is a development view of a predetermined pattern of the strut mesh in the self-expanding stent. (See reference numeral 21 in FIG. 3.) One transferred on one plane, or two or more developed drawings transferred in parallel so that the circumferential pattern of the stent is smoothly continuous. It almost matches the thing. That is, the planar view shape of the portion surrounded by the concave portion of the present embodiment has a shape that matches the planar view shape of the gap between the struts in the self-expanding stent or a shape obtained by reducing the matching shape.

  The concave portion 11 may have a constant width toward the bottom 13 of the concave portion 11 as shown in FIG. 3B, or taper toward the bottom of the concave portion 11 as in the modification shown in FIG. You may do it. When the recess 11 is tapered toward the bottom of the recess, the opening of the recess can be made larger than the strut width, which is preferable in that the strut can be easily fitted into the recess.

  Further, the width W1 of the opening 43 of the recess 11 shown in FIGS. 3B and 3C is larger than the strut width, and there is no particular limitation as long as the position of the disturbed strut can be corrected and the strut can be received. However, the planar view shape of the portions 44, 45, 46 surrounded by the recess 11 preferably has an occupancy ratio of 50% to 90%, more preferably 60%, of the gap between the struts in the self-expandable stent. It is desirable to determine the width W1 of the opening 43 so as to be 80% or less. Within this range, the disturbed struts tend to be easily received in the recesses, and the position of the disturbed struts tends to be corrected more reliably. Here, the portion surrounded by the recess 11 is a portion indicated by reference numerals 45 and 46 in addition to a portion completely surrounded by the recess 11 and closed, as indicated by reference numeral 44 in FIG. In addition, a portion that is not completely surrounded by the recess 11 is included. In the latter case, the nonoccupied portion is supplemented with a straight line (see the alternate long and short dash lines L1 and L2 in FIG. 3A), and the closed portion is assumed to calculate the occupancy rate. The virtual straight lines L1 and L2 are virtually drawn with reference to the center line of the strut received in the recess 11.

  A stent processing jig 14 (second embodiment) shown in FIG. 4 is placed on a flat support base 15 between the struts of the bases 1b and 1d after diameter expansion shown in FIGS. 1 (c) and 2 (b). A plurality of convex portions 16, 17, and 18 entering the gaps 40, 41, and 42 from the outer peripheral side of the bases 1b and 1d are arranged in accordance with a predetermined pattern (see reference numeral 21 in FIG. 4) of the strut mesh. . The convex portion 16 corresponds to a shape in plan view corresponding to a predetermined pattern (designed pattern) of a gap between adjacent sections 2 and struts constituting the connecting portion 3 in the stent in which the diameter of the base 1 is expanded. , 18 correspond to a planar view shape corresponding to a predetermined pattern (designed pattern) of the gap between the struts constituting the waveform of section 2 in the stent. In the second embodiment, since the convex portions 16, 17, and 18 are formed on one plane on the upper surface side of the support base 15, the mesh pattern formed by the convex portions 16, 17, and 18 is a self-expanding stent. The development of the predetermined pattern of the strut mesh in Fig. 1 is transcribed on one plane, or two or more developments are transferred in parallel so that the circumferential patterns of the stent are smoothly continuous. It almost corresponds to what I did. That is, the plan view shape of the convex portion has a shape that matches the plan view shape of the gap between the struts in the self-expanding stent or a shape obtained by reducing the matching shape. In addition, in this embodiment, although the adjacent convex part 17 and the convex part 18 are each provided with two or more, you may provide so that each convex part 17 may connect each convex part 18, such as A structure shall also correspond to the convex part which enters into the clearance gap between struts. However, the occupancy ratio is calculated using virtual straight lines L1 and L2 (see, for example, a one-dot chain line in FIG. 4A) in the same manner as the portions 45 and 46 in FIG.

  Moreover, the convex part 16 may have a constant width toward the tip 19 of the convex part 16 as shown in FIG. 4B, or the convex part 16 as in the modification shown in FIG. You may taper toward the front-end | tip 19. The same applies to the convex portions 17 and 18. By tapering the convex portion, the tip end side of the convex portion becomes smaller than the gap between the struts, which is preferable in that the convex portion can be easily put into the gap between the struts.

Furthermore, as shown in FIGS. 4B and 4C, the width W2 between the convex portions 16 and between the convex portions 16 and 18 is such that the width between the tips 19 of the convex portions 16 is larger than the strut width. There is no particular limitation as long as the position of the disturbed strut can be corrected and the strut can be received, but the occupation ratio of the gap between the struts in the self-expandable stent with respect to the planar shape is preferably 50% or more and 90% or less, More preferably, the width W2 between the convex portions is determined so as to be 60% or more and 80% or less. In addition, the width | variety between the convex parts 17 and 18 and between the convex part 16 and the convex part 17 is also the same. Within this range, the convex portions tend to easily enter the gaps between the disturbed struts, and the positions of the disturbed struts tend to be corrected more reliably.
Further, the convex portions 16, 17, and 18 may be provided at all locations corresponding to the predetermined pattern, but may be provided at several locations, and the arrangement thereof is appropriately determined in consideration of strut shaping. Can do. The convex portions 17 and 18 may not be provided at all.

FIG. 5 is a plan view schematically showing a stent processing jig 20 according to the third embodiment, which is a modification of the stent processing jig 14 shown in FIG. The third embodiment shown in FIG. 5 is the same except that the projections 22 and 23 having a plan view shape different from the plan view shape of the projections 16, 17 and 18 of the stent processing jig 14 shown in FIG. 4 are provided. It has the composition of. That is, the stent processing jig 20 shown in FIG. 5 is provided on the flat support base 15 with gaps 40, 41 between the struts of the bases 1b, 1d after the diameter expansion shown in FIGS. 1 (c) and 2 (b). 42, a plurality of convex portions 22 and 23 entering from the outer peripheral side of the bases 1b and 1d are arranged in accordance with a predetermined pattern (see reference numeral 21 in FIG. 5) of the strut mesh. Moreover, the planar view shape of the convex parts 22 and 23 has the shape which reduced the shape corresponding to the planar view shape of the clearance gap between struts in the development view of a predetermined pattern, or a corresponding shape. The occupation ratio with respect to the gap between the struts is preferably 50% or more and 90% or less, more preferably 60% or more and 80% or less. Within this range, the convex portions tend to easily enter the gaps between the disturbed struts, and the positions of the disturbed struts tend to be corrected more reliably. However, the occupancy ratio is calculated using virtual straight lines L1 and L2 (see, for example, a one-dot chain line in FIG. 5) in the same manner as the portions 45 and 46 in FIG.
The convex parts 22 and 23 of 3rd Embodiment have a triangular planar view shape corresponding to the clearance gap between the wavy peak part of the section 2a in a predetermined pattern, and trough part struts, as shown in FIG.1 (d). . In the present embodiment, both the planar shapes of the convex portions 22 and 23 are isosceles triangles, and in the circumferential direction of the stent, one of the convex portion 22 and the convex portion 23 is inverted with respect to the base of the isosceles triangle. Thus, the projections 22 and 23 are arranged in a line in the stent axial direction. The size and shape of the triangle may be appropriately determined in consideration of the ease of shaping the struts in accordance with the predetermined pattern of the struts. Further, similarly to the case of the second embodiment in FIG. 4, the arrangement and the number of the convex portions 22 and 23 can be appropriately determined similarly. The distance between the convex portions can be determined in the same manner as in the second embodiment of FIG. Further, the convex portions 22 and 23 may have a constant width toward the tip as in the case of the second embodiment in FIG. 4, or may taper toward the tip.

FIG. 6 is a plan view schematically showing a stent processing jig 24 according to the fourth embodiment, which is another modification of the stent processing jig 14 shown in FIG. The fourth embodiment shown in FIG. 6 is the same except that the projections 25 and 26 having a plan view shape different from the plan view shape of the projections 16, 17 and 18 of the stent processing jig 14 shown in FIG. 4 are provided. It has the composition of. That is, the stent processing jig 24 shown in FIG. 6 has gaps 40 and 41 between the struts of the bases 1b and 1d after diameter expansion shown in FIGS. 1 (c) and 2 (b). 42, a plurality of convex portions 25 and 26 entering from the outer peripheral side of the bases 1b and 1d are arranged in accordance with a predetermined pattern of the strut mesh (see reference numeral 21 in FIG. 6). Moreover, the planar view shape of the convex parts 25 and 26 has a small planar view shape which occupies only the periphery of the predetermined position of the clearance gap between struts in the development view of a predetermined pattern. The occupation ratio of the small plan view shape with respect to the gap between the struts is preferably 10% or more and less than 50%, more preferably 20% or more and 40% or less. The occupancy rate is calculated using virtual straight lines L1 and L2 (see, for example, the alternate long and short dash line in FIG. 6) as in the portions 45 and 46 in FIG. Further, in this case, the convex portion can be provided only in a portion where the position of the strut is likely to fluctuate during diameter expansion.
While the convex part 25 of 4th Embodiment passes between the struts of the adjacent peak part and trough part of the adjacent section 2a in a predetermined pattern as shown in FIG.1 (d), it is connected with the peak part and trough part. Have a rectangular plan view shape extending in the valley side and the mountain side, and they are arranged in parallel or on the same straight line. The convex portions 26 are positions corresponding to both ends of the stent in the axial direction, and pass through the vicinity of the struts of the crests or troughs of the section 2a and on one trough side or crest side connected to the crests or troughs. It has an elongated rectangular plan view shape that extends, and is arranged parallel or collinearly with the major axis direction of the convex portion 25. The size and shape of the elongated square may be appropriately determined in consideration of the ease of shaping of the strut according to the predetermined pattern of the strut, but from the viewpoint of correcting the strut position efficiently, It is good to provide in the part which a clearance gap is large and the position of a strut tends to change at the time of diameter expansion. Further, similarly to the case of the second embodiment of FIG. 4, the arrangement and number of the convex portions 25 and 26 can be determined as appropriate. The distance between the convex portions can also be determined in the same manner as in the second embodiment of FIG. Further, the convex portions 25 and 26 may have a constant width toward the tip as in the case of the second embodiment of FIG. 4 or may taper toward the tip.

FIG. 7 is a plan view schematically showing a stent processing jig 27 according to a fifth embodiment, which is still another modification of the stent processing jig 14 shown in FIG. The fifth embodiment shown in FIG. 7 has the same configuration except that a convex portion 28 having a planar view shape different from the planar view shape of the convex portions 16, 17, and 18 of the stent processing jig 14 shown in FIG. 4 is provided. Have That is, the stent processing jig 27 shown in FIG. 7 is provided on the flat support base 15 with gaps 40, 42 between the struts of the bases 1b, 1d after the diameter expansion shown in FIGS. 1 (c) and 2 (b). A plurality of convex portions 28 entering from the outer peripheral side of the bases 1b and 1d are arranged in accordance with a predetermined pattern (see reference numeral 21 in FIG. 7) of the strut mesh. Moreover, the planar view shape of the convex part 28 has the small planar view shape which occupies only the periphery of the predetermined position of the gap between the struts in the development view of the predetermined pattern. The occupation ratio of the small plan view shape with respect to the gap between the struts is preferably 10% or more and less than 50%, more preferably 20% or more and 40% or less. The occupancy rate is calculated using virtual straight lines L1 and L2 (see, for example, a one-dot chain line in FIG. 7) in the same manner as the portions 45 and 46 in FIG. Further, in this case, the convex portion can be provided only in a portion where the position of the strut is likely to fluctuate when the diameter is expanded.
As shown in FIG. 1D, the convex portion 28 of the fifth embodiment has a circular plan view shape that enters a gap between struts in the vicinity of the crests or troughs of adjacent sections 2a in a predetermined pattern. They are arranged in a grid. In this example, the shape is circular, but other shapes such as an elliptical shape may be used in accordance with a predetermined pattern of struts. The size of the struts may be determined appropriately in consideration of the ease of shaping the struts, but from the viewpoint of efficiently correcting the strut positions, the gap between the struts is large, and the strut positions fluctuate when the diameter is expanded. It is good to provide in the part which is easy to do. Further, similarly to the case of the second embodiment in FIG. 4, the arrangement and number of the convex portions 28 can be appropriately determined in the same manner. The distance between the convex portions can also be determined in the same manner as in the second embodiment of FIG. Further, the convex portion 28 may have a constant width toward the tip as in the case of the second embodiment of FIG. 4 or may taper toward the tip.

  In the first to seventh embodiments, a concave portion or a convex portion is provided on one surface of the flat plate-like support base 15, but in the present invention, the concave portion or the concave portion or the gap is formed from the outer peripheral side of the base body. The shape and structure of the support base 15 are not particularly limited as long as the convex portions can be brought close to each other. For example, as shown in a stent processing jig 29 (sixth embodiment) shown in FIG. 8, a projection 31 may be provided on the convex side of a plate-like support base 30 having a semi-elliptical curved surface. Instead of the convex portion, a concave portion (not shown) may be provided. Moreover, although not shown in figure, you may provide a recessed part and a convex part in the outer peripheral surface side of a cylindrical shape or an elliptical cylinder shape, or the outer peripheral surface of a column shape or an elliptical cylinder shape on the inner peripheral surface side. Furthermore, not only a curved surface but a polygonal surface may be sufficient, and a recessed part and a convex part may be provided in the convex surface side or concave surface side of a polygonal surface.

  The material constituting the stent processing jig of the present invention is not particularly limited. From the viewpoint of preventing the strut from being damaged when contacting the strut of the expanded base and correcting its position, the base is formed. It is preferable to use a material having a lower hardness than the material to be used. In the case of using, for example, a Ni—Ti alloy as a material constituting the substrate, metals such as aluminum, copper, brass, etc. having lower hardness, resin, glass and the like can be mentioned. Among these, from the viewpoint of wear resistance and strength, a metal having a lower hardness than the material constituting the substrate is preferable.

  In the following, the tube-shaped substrate 1b whose diameter is expanded by the mandrel 5 shown in FIG. 1C and the arrangement of the mesh-like struts is disturbed is obtained by using the stent processing jig 20 shown in FIG. The process of correcting the position and shaping the strut mesh into a predetermined pattern will be described as an example, but a stent processing jig provided with a predetermined convex portion as shown in FIGS. It is also possible to perform shaping similarly in the case of using a stent processing jig provided with a concave portion or a stent processing jig provided with other convex portions or concave portions arranged in accordance with a predetermined pattern of the mesh.

  FIG. 9A is a plan view schematically showing a state after the tube-shaped substrate 1 on which the mesh struts shown in FIG. 1A are formed is expanded to a desired diameter using a mandrel 5. In the figure, the expanded base 1b is in a state where the arrangement of struts is disturbed and the mesh pattern is distorted. In the state where the mandrel 5 is inserted into the base 1b after the diameter expansion in this way, the struts of the base 1b are sequentially partially extended from the outer peripheral side of the base along the circumferential direction, and the convex portions 22 of the stent processing jig 20 are partially 23 (see FIGS. 9B and 9D). At this time, since the convex portions 22 and 23 similar to the predetermined pattern on the stent processing jig 20 are arranged on the support base 15, the struts of the portion where the arrangement is disturbed are formed on the convex portions 22 and / or the convex portions 23. It is pushed and moved (see FIG. 9D). Finally, the convex portions 22 and / or the convex portions 23 are fitted into the gaps between the struts, and the strut positions are matched with a predetermined pattern. Is corrected, and a substrate 1e having a predetermined pattern is obtained (see FIG. 9C). The base 1e has the same pattern of strut mesh as in FIG.

There is no particular limitation on the method of fitting the struts of the base body 1b partially into the convex portions 22 and 23 of the stent processing jig 20 sequentially in the circumferential direction from the outer peripheral side of the base body. Examples include a method in which the mandrel 5 is rotated together with the base body 1b in a state where the mandrel 5 is inserted into 1b, and the mandrel axis and the stent processing jig are relatively moved. 9B and 9D, the mandrel 5 is rotated together with the base body 1b, and parallel to the upper surface side where the convex portions 22 and 23 of the flat support 15 of the stent processing jig 20 are provided. FIG. 6 is a diagram schematically showing a state in the middle of relatively moving the axis of the mandrel 5. Although not shown, when the stent processing jig is cylindrical or columnar, the mandrel 5 may be rotated together with the base 1b and the stent processing jig may be rotated so as to circumscribe the base 1b. According to these methods, it is possible to easily and efficiently correct the strut position.
In the case of the flat stent processing jig 20 shown in FIG. 9, for example, the relative movement may be moved once from one end to the other end, or may be moved a plurality of times. You may make it move so that it may reciprocate twice or more. Further, when the stent processing jig is cylindrical or columnar, the stent processing jig may be relatively moved by one rotation or two or more rotations.

The relative movement may be performed manually or using a drive device or the like.
When performing manually, for example, in a state where the mandrel 5 is inserted into the base 1b after diameter expansion, the operator rolls the mandrel 5 while pressing the mandrel lightly toward the stent processing jig 20 by hand. A method of moving the base 1b together with the mandrel 5 while rotating the base 1b can be mentioned.

  When using a driving device, for example, when using the stent processing jig 20 in which the convex portions 22 and 23 are arranged in accordance with the predetermined pattern shown in FIG. 5, the driving device 32 as shown in FIG. 10 is used. it can. The drive device 32 includes a mandrel part 33, a movable part 34, and a rail base 35. The movable portion 34 can advance and retreat along a rail 36 provided on the rail base 35. The rail base 35 and the rail 36 can be arranged in parallel with the circumferential direction of the stent in the predetermined pattern of the stent processing jig 20. The rail base 35 has a fixing portion (not shown) for fixing the stent processing jig 20 as necessary. Further, the mandrel 33 is projected from the movable portion 34 in the direction in which the major axis direction is orthogonal to the direction in which the movable portion 34 advances and retreats (reference numeral 38 in FIG. 10) and the stent processing jig 20 is disposed. The The mandrel part 33 is provided in the movable part 34 so that the mandrel part 33 can be rotated in the circumferential direction (reference numeral 39 in FIG. 10) about the major axis. The movable part 34 may be provided with a rotation driving means (not shown) as required. Further, all or part of the mandrel part 33 may be separable from the movable part 34. Further, the movable part 34 is applied with lifting means for adjusting the distance between the mandrel part 33 and the stent processing jig 20 or a pressing force for pressing the mandrel part 33 and the base body 1b against the stent processing jig 20. And pressure adjusting means for adjusting (none shown). Advancing and retreating along the rail 36 of the movable part 34 can be performed by a driving means (not shown) provided on the rail base 35 or the movable part 34. However, the operator may hold the movable part 34 and drive it manually.

  Then, as shown in FIG. 10, a tube-like base body 1b (represented in a simplified manner in FIG. 10) in which mesh struts are formed is held in a mandrel portion 33 in a state where the diameter is expanded to a desired diameter. By moving the movable part 34 along the rail 36 of the rail base 5, the axis of the mandrel part 33 with respect to the stent processing jig 20 in parallel with the circumferential direction of the stent in the predetermined pattern of the stent processing jig 20 You can move your mind. At this time, by adjusting the distance between the mandrel part 33 and the stent processing jig 20 or by adjusting the pressing force between the mandrel part 33 and the stent processing jig 20, the convex part 22 and / or the convex part 23 is obtained. However, the struts can be moved against the frictional force between the struts of the base 1b and the mandrel surface and the strut tension when contacting the struts of the part whose arrangement has been disturbed. Further, since the enlarged base 1b inserted into the mandrel 33 can be rotated together with the mandrel 33, the struts of the portions where the arrangement of the base 1b is disturbed sequentially along the circumferential direction of the base The protrusions 22 and 23 are in contact with each other, the struts are moved, the gap between the struts is fitted into the protrusions 22 and / or the protrusions 23, and the positions of the struts all around the base 1b are sequentially corrected. it can.

  When the relative movement is performed, the distance between the base 1b and the stent processing jig 20, for example, the distance between the tips of the convex portions 22 and 23 and the outer surface of the mandrel is determined so that the base 1b and the convex portions 22 and 23 are in contact with each other. If it is possible to move the struts in the disordered portion, the thickness can be appropriately determined within a range that is smaller than the strut thickness of the base body 1b and until the base body 1b is in contact with the convex portions 22 and 23 (distance is zero). .

As described above, after the strut mesh pattern of the expanded base 1b is shaped into a predetermined pattern on the stent, heat treatment is performed to fix the shaped state as a diameter-enlarged posture. Here, the “diameter-expanded posture” means a posture having a predetermined pattern of strut meshes in the self-expandable stent after the base is expanded.
The conditions for the heat treatment can be appropriately determined according to the material constituting the substrate. Examples of the heating furnace that performs the heat treatment include an oxidizing atmosphere furnace, an electric furnace, and a salt bath furnace. For example, when the material is a Ni—Ti alloy, the heating conditions can be 450 to 600 ° C. and 5 to 60 minutes.

  As described above, a self-expanding stent having a predetermined pattern of a desired strut network can be manufactured. As described above, the obtained self-expanding stent is held in a reduced diameter in the sheath of the delivery catheter, guided to a desired position in the body, and released from the sheath, depending on the state of the stenosis. However, it expands to the predetermined | prescribed outer diameter memorize | stored by heat processing, and is detained.

  Hereinafter, the present invention will be described based on examples.

Example 1
A desired network-like strut was formed from a Ni-Ti alloy tube with a laser and deburred to obtain a tube-like substrate on which the desired mesh-like strut was formed. Thereafter, a mandrel was inserted into the substrate to expand the diameter to φ8 mm. Using the stent processing jig in which the convex portions shown in FIG. 5 are arranged in accordance with a predetermined pattern, while rotating the base body with the mandrel inserted together with the mandrel, the axis of the mandrel is formed into a flat plate shape of the stent processing jig. The sample was manually reciprocated several times in parallel along the support table. The above operation was repeated three times to produce three samples.
After inserting the mandrel and expanding the diameter, the strut arrangement was disturbed and the mesh pattern was distorted. However, using the stent processing jig, the strut position was corrected, and the strut mesh pattern was shaped. It was confirmed visually.
The time required from the insertion of the mandrel into the substrate to the completion of the strut position correction was within 2 minutes. Even if the operator does not grasp the design drawing which is the predetermined pattern of the stent strut mesh, it is easy to place the strut mesh in the predetermined pattern when the diameter is expanded by using the stent processing jig. It was possible to carry out.

(Comparative Example 1)
Except for using tweezers while visually comparing with the design drawing without using a stent processing jig, work was performed until the position of the strut was shaped into a predetermined pattern in the same manner as in Example 1, and three samples were obtained. Produced.
The time required from the insertion of the mandrel into the substrate to the completion of the correction of the strut position was about 5 minutes, which required more than twice as many steps as in Example 1. In addition, it took time to understand the blueprints and understand the strut arrangement.

(result)
According to the results of Example 1 and Comparative Example 1, both were shaped into a predetermined pattern of almost non-defective product level. However, the variation in each sample is smaller in the example, and therefore the variation in quality by the operator is smaller. It could be confirmed. In addition, regarding the man-hours, it was confirmed that the working time in the example was significantly shortened and the efficiency was good. In this way, by using the stent processing jig, it is possible to easily arrange the strut mesh in a predetermined pattern at the time of diameter expansion, and efficiently manufacture a self-expanding stent with stable quality. Was found to be possible.

DESCRIPTION OF SYMBOLS 1 Base body 1a, 1b, 1c, 1d Base after diameter expansion 1e Base after diameter expansion after shaping 2 Section 2a Section after shaping 3 Connection part 3a Connection part after shaping 4, 5, 6 Mandrel 7, 9 Cylindrical part 8 Tapered part 10, 14, 20, 24, 27, 29 Stent processing jig 11 Concave part 12, 15, 30 Support base 13 Bottom 16, 17, 18, 22, 23, 25, 26, 28, 31 Convex part DESCRIPTION OF SYMBOLS 19 Tip 21 Predetermined pattern of strut mesh 32 Drive device 33 Mandrel part 34 Movable part 35 Rail base 36 Rail 38 Direction of movement of movable part 34 39 Circumferential direction of mandrel part 33 40, 41, 42 Gap 43 Opening 44, 45 , 46 The part surrounded by the concave part W1 The width of the concave part W2 The width between the convex part and the convex part L1, L2 Virtual line

Claims (15)

A stent processing jig for a self-expandable stent manufactured by expanding the diameter of a tube-shaped substrate on which a mesh-like strut is formed,
One or more recesses for receiving the struts of the base after the diameter expansion from the outer peripheral side of the base, or a plurality of convex parts entering from the outer peripheral side of the base in the gap between the struts of the base after the diameter expansion are included,
The stent processing jig in which the concave portion or the convex portion is arranged in accordance with a predetermined pattern of a strut mesh in the self-expanding stent.   2. The planar view shape of the portion surrounded by the concave portion or the convex portion has a shape in which an occupation ratio with respect to the planar view shape of the gap between the struts in the self-expanding stent is 10% or more and 90% or less. Stent processing jig.   3. The planar view shape of the portion surrounded by the concave portion or the convex portion has a shape corresponding to the planar view shape of the gap between the struts in the self-expanding stent or a shape obtained by reducing the corresponding shape. Stent processing jig.   4. The shape according to claim 3, wherein the corresponding shape or a shape obtained by reducing the corresponding shape has an occupancy ratio of 50% or more and 90% or less of the gap between the struts in the self-expandable stent in a plan view shape. Stent processing jig.   The stent processing jig according to claim 2, wherein the shape of the convex portion in plan view is a shape in small plan view that occupies only the periphery of a predetermined position of the gap between the struts in the self-expanding stent.   The stent processing jig according to claim 5, wherein the small planar view shape has a shape in which an occupation ratio of the gap between the struts in the self-expandable stent with respect to the planar view shape is 10% or more and less than 50%.   The stent processing jig according to any one of claims 1 to 6, wherein the convex portion is tapered toward a convex tip.   The stent processing jig according to any one of claims 1 to 4, wherein the recess is tapered toward the bottom of the recess.   The stent processing jig according to any one of claims 1 to 8, wherein the stent processing jig is made of a material having a lower hardness than a material constituting the substrate. A method of manufacturing a self-expanding stent manufactured by expanding the diameter of a tube-shaped substrate on which a reticulated strut is formed,
A method for producing a self-expanding stent, wherein the strut mesh pattern on the base after diameter expansion is shaped into a predetermined pattern of strut mesh in the self-expandable stent by correcting the position of the strut. In correcting the strut position,
Using a stent processing jig in which a plurality of recesses for receiving struts are arranged, the struts of the base after diameter expansion are fitted into the recesses from the outer peripheral side of the base,
Or
Using a stent processing jig in which a plurality of convex portions that enter the gap between the struts are arranged, the gap between the struts of the base body after diameter expansion is fitted into the convex portion from the outer peripheral side of the base body.
The method of manufacturing a self-expanding stent according to claim 10.   The struts of the base after the diameter expansion or the gap between the struts are sequentially fitted in the concave portion or the convex portion of the stent processing jig in order along the circumferential direction from the outer peripheral side of the base. The method for manufacturing a self-expanding stent according to claim 11, wherein the positions of the stent are sequentially corrected.   The method for producing a self-expanding stent according to claim 12, wherein the strut positions are sequentially corrected in a state where a mandrel is inserted into the base after the diameter expansion.   The method of manufacturing a self-expanding stent according to claim 13, wherein the position of the struts is sequentially corrected by rotating the mandrel together with the base and relatively moving the mandrel axis and the stent processing jig. .   The manufacturing method of the self-expanding stent according to any one of claims 10 to 14, wherein the shaped substrate is subjected to heat treatment to fix the shaped state as an expanded posture.

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