JP6279388B2 - Stent manufacturing method and stent manufacturing apparatus - Google Patents

Description

  The present invention relates to a stent manufacturing method and a stent manufacturing apparatus.

  Stents are commonly used to treat various diseases resulting from stenosis or occlusion of in vivo lumens such as blood vessels, to expand the stenosis or occlusion site in the disease and maintain the lumen size of the disease. It is known as a medical device that is indwelled.

  The types of stents from the viewpoint of manufacturing include, for example, a coiled stent formed of a single linear metal or polymer material, a stent formed by cutting a metal tube with a laser, and welding a linear member with a laser. And a stent made by weaving a plurality of linear metals.

  Moreover, as a kind of stent seen from expansion | swelling, two types (types) are mentioned, for example. One is a balloon-expandable type that is expanded by a balloon in a balloon catheter, and the other is a self-expandable type that expands itself by removing a member that holds the stent to be expanded from the outside. .

  This self-expanding stent is generally attached near the distal end of a catheter, and a sheath or the like covering the stent is covered thereon. Then, the catheter is advanced to the treatment site of the patient's in-vivo lumen, the sheath and the like are removed at the treatment site, and the stent is self-expanded along with this, and is placed at the treatment site. In recent years, such stents are often used for ureteral, bile duct, or lower limb arthroplasty.

  And, usually, the self-expanding stent is cut into a metal tube such as a nickel-titanium alloy called a shape memory alloy or a superelastic alloy according to a desired design (this is called a stent design), It is completed by being expanded to a predetermined outer diameter, subjected to heat treatment, and further subjected to electrolytic polishing or the like for surface smoothness.

  In the manufacture of this stent, when a laser is used for cutting into a metal tube, molten metal residue called dross adheres to the inner surface of the cut metal tube, or the laser tube cuts from the metal tube. A portion to be removed may not be completely removed (this portion to be removed is referred to as an unnecessary metal piece). Since such deposits cause deterioration of the quality of the stent, they must be removed. As in Patent Documents 1 and 2, for example, the deposits are removed by etching, cutting, or polishing. The

JP 2003-199833 A JP 2006-305341 A

  By the way, in recent years, it is known that the self-expanding stent after indwelling fractures due to fatigue fracture or the like. Fractured stents are feared to cause intravascular restenosis, and in order to prevent this, improvement in fracture resistance of self-expanding stents is required. From various investigations, it has been found that if the axial flexibility of the self-expanding stent is improved, the fracture resistance is improved.

  In order to improve fracture resistance, the stent design has been complicated, and as a result, has become flexible. On the other hand, due to such a design, there is a concern about a decrease in radial force, which is a force for holding blood vessels, and in recent years, the thickness of metal tubes has been increased in order to prevent this.

  In addition, YAG laser was often used for laser cutting, but recently, high-power, high-efficiency, and high-stability lasers such as Fiber laser or DISK laser, nanosecond laser, picosecond laser, Alternatively, a high-frequency laser such as a femtosecond laser is used. When such a laser is used, the stent design becomes extremely fine, but the cutting width becomes narrow, so that the divergence width between the main body serving as the stent and the unnecessary removal piece becomes narrow. Therefore, when such a laser is used for a thick metal tube, the unnecessary metal piece is very difficult to remove by a process such as etching, cutting, or polishing.

  The present invention has been made to solve the above problems. And the object is to provide a method for manufacturing a stent by simply removing unnecessary metal pieces from a metal tube after laser cutting (cut metal tube), or a stent manufacturing apparatus suitable for this stent manufacturing method. There is.

  A stent manufacturing method for manufacturing a stent based on a metal tube includes a bending step of repeatedly bending a cut metal tube having a cut in the metal tube.

  In this bending step, it is desirable that the bending in two directions of bending in one direction and bending in one other direction be repeated alternately. In such a case, it is desirable that the relationship between one direction and the other direction is a forward / reverse relationship.

  Moreover, in this bending process, it is desirable to bend in order toward three or more multi-directions including one direction and a plurality of other directions. Moreover, in such a case, it is desirable that the direction of bending changes along the circumferential direction of the metal tube.

  Moreover, while including the insertion process which inserts a core material with respect to the lumen | bore of a cut metal tube, a bending process may be performed by bending a core material.

  In addition, the bending process is performed by rotating the cut metal tube while being pressed by a rail base in which a single rail or a plurality of rails having a width shorter than the entire length of the cut metal tube is arranged. Also good.

  In addition, it is desirable to include the fluid supply process of supplying a fluid to the cut metal tube in the bending process.

  By the way, in the stent manufacturing apparatus which manufactures the stent based on a metal tube, the bending provision unit which repeatedly bends the cut metal tube which made the notch in the metal tube is included.

  It is desirable that this bend imparting unit includes a core material inserted into the lumen of the metal tube and a core material variable unit that bends the core material.

  The core material variable unit preferably includes a transport unit that transports the core material inserted into the metal tube while being sandwiched.

  Further, the core material variable unit preferably includes a rotating unit that grips one end of the core material and rotates the core material around an axis of the core material, and a holding unit that rotatably holds the other end of the core material. Furthermore, it is desirable to include a moving unit that changes the position of the holding unit.

  In addition, the flexure imparting unit is not limited to the above-described one. For example, a rail base including one or a plurality of rails and a rail metal base are sandwiched between the rail base and the rail base while rotating the cut metal tube. A transport belt kit for transporting the top.

  In addition, it is desirable that the rail has a tapered shape that tapers toward the contact side of the cut metal tube.

In addition, when the rail base includes a plurality of rails, the rail arrangement interval between the transport start side and the transport end side of the cut metal tube in the rail base is greater on the transport start side than on the transport end side. Narrow is desirable. Further, in such a rail platform, rail width of the rail at the conveyance start side of the pre-cut metal tube and the transport completion side, towards the transport start side and narrower than the conveyance termination side desirable.

In addition, when the rail base includes a plurality of rails, the rail width of the rail on the transport start side and the transport end side of the cut metal tube in the rail base is greater on the transport start side than on the transport end side. Narrow is desirable.

  Moreover, the rail is branched, and it is preferable that the branch side of the cut metal tube is arranged on the conveyance start side and the branch side is arranged on the conveyance end side.

  Further, it is desirable that the distance between the rail on the rail base and the transport belt in the transport belt kit is narrower on the transport end side on the transport start side and transport end side of the cut metal tube than on the transport start side.

  In addition, in the stent manufacturing apparatus, it is preferable that a fluid supply unit that supplies fluid to the metal tube is included.

  According to the stent manufacturing method of the present invention, an unnecessary metal piece is easily removed from a metal tube after laser cutting to manufacture a stent.

These are the explanatory drawings which wrote together the perspective view and sectional view (AA 'line arrow sectional view which is a cross section with respect to the axial direction of a core material) which shows the metal tube and the core material inserted in the metal tube, A) shows a state where the core material is bent in one direction, and (B) shows a state where the core material is bent in a direction opposite to the one direction. These are explanatory drawings of a stent manufacturing apparatus provided with a roller kit. These are explanatory drawings of a stent manufacturing apparatus provided with a roller kit. These are explanatory drawings of a stent manufacturing apparatus provided with a rotation motor kit. These are the explanatory views which combined the perspective view and sectional view (BB 'line arrow sectional view which is a cross section with respect to the axial direction of a core material) which show a metal tube and the core material inserted in the metal tube, A) to (D) each show a state where the core material bends in different directions (note that the direction of bending is unchanged). FIG. 5 is a cross-sectional view taken along line BB ′ in the perspective view of FIG. 5, and (A) to (D) correspond to FIGS. 5A to 5D (note that the core material and the metal tube are not rotated). ). These are cross-sectional views with respect to the axial direction of the metal tube and the core material inserted into the metal tube, and (A) to (D) are arranged in this order in chronological order (note that the core material and the metal tube are not rotated) As shown). FIG. 3 is a perspective view of a stent. These are the expanded views of a stent. FIG. 3 is a perspective view showing a metal tube that is the basis of a stent. FIG. 3 is a cross-sectional view of a metal tube. FIG. 3 is a perspective view of a core material. FIG. 3 is a perspective view showing a core material and a metal tube fitted to the core material. These are perspective views which show a rail stand and a press roller. FIG. 15 is a cross-sectional view taken along the line C-C ′ of FIG. 14 (a cross-sectional view along the pressing roller). Is a cross-sectional view of the rail (cross-sectional view with respect to the longitudinal direction of the rail), where (A) is a semicircular rail, (B) is a trapezoidal rail, and (C) is a triangular rail. Show. FIG. 3 is a perspective view of a stent manufacturing apparatus including a transport belt unit. FIG. 18 is a cross-sectional view taken along the line D-D ′ in FIG. 17 (a cross-sectional view taken along the rotating roller). FIG. 18 is a cross-sectional view taken along the line E-E ′ of FIG. 17 (a cross-sectional view along the rail). These are sectional drawings which show the conveyance belt which inclines with respect to a rail. FIG. 21 is a cross-sectional view taken along the line F-F ′ of FIG. FIG. 20 is a cross-sectional view taken along the line G-G ′ of FIG.

These are sectional drawings which show the rail and conveyance belt which the zenith inclined with respect to the bottom face. FIG. 3 is a perspective view of a rail base including branched rails. These are a top view and sectional drawing which show a rail stand containing a branched rail, (A) is a top view, (B) is a HH 'arrow sectional view of (A), and (C) is (A). Is a cross-sectional view taken along the line II ′ of FIG. These are the figure which wrote together the top view which shows the rail stand containing the branched rail, and sectional drawing which shows the conveyance belt which inclines with respect to a rail. FIG. 27 is a cross-sectional view taken along the line J-J ′ of FIG. FIG. 27 is a cross-sectional view taken along the line K-K ′ of FIG. FIG. 3 is a plan view of a rail base including a branched rail. FIG. 3 is a plan view of a rail base including a branched rail. These are sectional drawings which show the stent manufacturing apparatus temperature-controlled with the temperature management system using a chiller.

[Embodiment 1]
The following describes one embodiment with reference to the drawings. For convenience, hatching, member codes, details of members (for example, patterns formed on the stent 20), and the like may be omitted or simplified. In such a case, other drawings are referred to. Conversely, for convenience, hatching may be used even if it is not a sectional view. Moreover, the dimension of the various members in drawing may be adjusted so that it may be easy to see for convenience.

  The stent 20 formed with the void pattern (stent design) as shown in the perspective view of FIG. 8 and the developed view of FIG. 9 is formed of, for example, a metal tube 21 of nickel-titanium alloy as shown in FIG. (It can be said that the design of the stent 20 is a pattern formed by the strands 23 that are the peripheral edges of the voids 22).

  More specifically, for example, the metal tube 21 having an outer diameter of 1 mm to 5 mm is subjected to laser cutting or the like in accordance with the stent design, and the cut metal tube 21 is expanded to an outer diameter of, for example, about 6 mm to 15 mm (expanded diameter). ) Further, the expanded metal tube 21 is heat-treated under a restraint state under a predetermined temperature condition (for example, the time is about 2 minutes to 3 hours, and the temperature is about 400 ° C. to 600 ° C.). The shape is stored, and the stent 20 having the desired design is completed.

  In the stent manufacturing method for manufacturing the stent 20 based on such a metal tube 21, when a laser cut, that is, a cut 24 penetrating the thickness of the metal tube 21 is made, the cut metal tube 21 includes 11, a metal piece 25 corresponding to the gap 22 (essentially, a piece surrounded by the notch 24, which is an unnecessary metal piece 25 that remains on the strand 23 without falling off after engaging with the strand 23. An unnecessary metal piece 25) is likely to adhere.

  Such deposits must be removed because they cause degradation of the quality of the stent 20. Therefore, the unnecessary metal piece 25 is removed by using the core material 11 as shown in FIG.

  More specifically, as shown in FIG. 13, the core material 11 is formed with respect to the inner cavity 21 </ b> L of the cut metal tube 21 (note that the cut metal tube 21 is hatched even in a perspective view). Inserted [this step is referred to as an insertion step]. The core material 11 may be a wire material having high elasticity and flexibility, and examples thereof include a nickel-titanium superelastic alloy wire or a spring stainless wire. In addition, since the residue of the molten metal called dross adheres to the lumen | bore surface of the cut metal tube 21, this is removed with a diamond electrodeposition file etc., and then the core material 11 is cut into the cut metal tube 21. It is good to be inserted into.

  Then, the core material 11 in the cut metal tube 21 is repeatedly bent in one direction and then bent in the other direction [this process is referred to as a bending process]. The bending direction, which is the direction when the core material 11 bends, is the initial linear shape from the top of the bow when the core material 11 whose initial state is linear is bent in a bow shape (parabolic shape). A straight line drawn perpendicular to the core material 11 means a direction from the initial linear core material 11 toward the apex side.

  In this bending step, for example, as shown in FIG. 1A {the perspective view and the cross-sectional view in the axial direction of the core material 11 (the cross-sectional view along the orthogonality etc.)}, the core material 11 Is bent in one direction Df in a curved shape (such as an English letter U), and then in one direction Df as shown in FIG. 1B (an explanatory diagram in which two drawings similar to FIG. 1A are shown). On the other hand, it is bent in a curved direction toward another direction Dr in the opposite direction, which is another direction, and is further repeatedly bent alternately in one direction Df and the other direction Dr.

  When the core material 11 is repeatedly bent in such a way as to bend back and forth, the outer side in the bending direction (before the core material 11 grasped when the core material 11 is seen from the center of curvature of the curved portion of the core material 11). A pressing force P, which is a force directed from the lumen side of the metal tube 21 to the outside, is applied to the strand 23 and the unnecessary metal piece 25 facing the front surface of the core 11 on the back side and the back side. (See black arrow).

  When this pressing force P is applied to the strands 23, as shown in FIGS. 1A and 1B, the distance Wp between the strands 23 to which the pressing force P is applied (for example, the distance W between the strands 23 in the circumferential direction) The interval Wp formed between the strands 23 to which the pressing force P is applied is wider than the interval Wn between the strands 23 to which the pressing force P is not applied.

  Then, the unnecessary metal piece 25 sandwiched between the strands 23 is not engaged with the strand 23 and falls off from the metal tube 21 (the removal of the unnecessary metal piece 25 from the metal tube 21 in this way is also called removal processing). ). Furthermore, when the surface of the core material 11 is in contact with the unnecessary metal piece 25 itself, the unnecessary metal piece 25 fitted in the interval Wp between the strands 23 is directed outward from the lumen side of the metal tube 21. It is pushed out and falls off further.

  As described above, in the method for manufacturing the stent 20, the step of inserting the core material 11 into the lumen 21 </ b> L of the cut metal tube 21 with the cut 24 in the metal tube 21, and the core material in the cut metal tube 21. After bending 11 in one direction, there is a step of bending in another direction different from this one direction. For example, unnecessary metal pieces are removed manually using tweezers or by ultrasonic cleaning. The removal efficiency and removal accuracy are higher than the removal.

  In addition, the stent manufacturing method including both of the above steps does not cause corrosion of the metal as in the case of removal by chemical polishing using an acidic solution. 20 is manufactured.

  Further, in order to improve the fracture resistance performance and radial force of the stent 20, relatively high flexibility and strength are usually required, and for this purpose, a complicated stent design and thickness are required. A meat metal tube 21 is required. However, in such a case, that is, even when the thickness of the unnecessary metal piece 25 is increased and the area is increased, if the stent manufacturing method includes both steps, the unnecessary metal piece 25 can be easily and Remove with high precision.

  1A and 1B, even if the relatively thick and large area unnecessary metal piece 25 becomes wedge-shaped and fits into the gap 22 from the outside of the metal tube 21, it is bent. This is because the pressing force P applied to the metal tube 21 by the core material 11 is directed outward from the inner cavity of the metal tube 21, so that the unnecessary metal piece 25 moves efficiently and falls out of the gap 22.

  In addition, when the core material 11 is bent, the unnecessary metal piece 25 is more reliably removed when the bending in one direction and the bending in the other direction are alternately repeated. In the above description, when the bending in the two directions is repeated alternately, the relationship between the one direction Df and the other direction Dr, which are the directions of bending, is a forward / reverse relationship, but is not limited thereto.

  In the case of the normal / reverse relationship, the direction of the one direction Df and the other direction Dr changes by 180 ° centering on the axial direction of the core material 11. For example, the direction of the other direction Dr with respect to the one direction Df is + 90 ° or You may change into other angles, such as -90 degrees.

  By the way, in the above stent manufacturing method, both processes may be performed manually or using an apparatus. An example of such a device is a device (stent manufacturing device 30) as shown in FIG.

  The stent manufacturing apparatus 30 includes a core material 11 to be inserted into the lumen of the metal tube 21 and a core material variable unit 31 for bending the core material 11 (note that the core material 11 and the core material variable unit 31 are May be referred to as a flexure imparting unit FU). The core material variable unit 31 includes a roller kit [conveyance unit] 31R that conveys the core material 11 inserted into the metal tube 21 while being sandwiched.

The roller kit 31R includes a plurality of transport rollers 32. This roller kit 31R
For example, a plurality of transport rollers 32 are arranged in a line by making the roller shafts 32A parallel to each other at a constant pitch, and a plurality of transport rollers 32 are provided on another plane parallel to the one plane in the same manner as on one plane. Line up. Furthermore, the group U32 of the conveyance rollers 32 on one plane and the group L32 of the conveyance rollers 32 on another plane should be aligned in a line without overlapping the roller shaft 32A when the plane is viewed in plan. The roller shafts 32 </ b> A of the different types of groups U <b> 32 and L <b> 32 are alternately arranged, and the interval between the conveying rollers 32 facing each other in the different types of groups U <b> 32 and L <b> 32 is set to a length that can sandwich the core material 11.

  In this case, when the rotation direction of the conveyance roller 32 of one group U32 is different from the rotation direction of the conveyance roller 32 of the other group L32 (see the solid arrow for the rotation direction), FIG. 2, the core material 11 inserted into the lumen of the metal tube 21 is transported while being sandwiched between the transport rollers 32 and 32 (a mesh hatching arrow indicates the transport direction).

  Then, in this conveyance, when passing over the conveyance roller 32 in the group U32, the core material 11 bends in one direction Df, and when passing over the conveyance roller 32 in the group L32, the core material 11 moves in the other direction Dr. The metal tube 21 on the core 11 is also bent in turn in one direction Df and the other direction Dr. Therefore, if this stent manufacturing apparatus 30 is used, the unnecessary metal piece 25 is easily removed compared with the case where the core material 11 is bent alternately by hand.

  As shown in FIG. 3, when the core material 11 is conveyed by the roller kit 31 </ b> R while being rotated about its own axial direction (see the rotation Q direction indicated by the one-dot chain line arrow), the core material 11. The upper metal tube 21 bends not only in one direction Df and the other direction Dr but also in other directions (Note that the rotation mechanism section [rotation section] 31T having a mechanism for rotating the core 11 is particularly Not limited).

  More specifically, the metal tube 21 is directed in the order of three or more types including one direction Df and the other direction Dr in order {for example, continuously along the circumferential direction of the metal tube 21 in the radial direction (Df, Toward the Dr. etc.). Therefore, the stent manufacturing apparatus 30 uniformly removes all the peripheral surfaces of the metal tube 21.

  Moreover, the stent manufacturing apparatus 30 which bends toward three or more types of multi-directions with respect to the metal tube 21 as described above is, for example, as shown in FIG. This stent manufacturing apparatus 30 also includes a core material 11 that is inserted into the lumen 21L of the metal tube 21 and a core material variable unit 31 that bends the core material 11.

  The core material variable unit 31 holds one end of the core material 11 and rotates it around the axis of the core material 11 and rotates the other end of the core material 11 rotatably. Holding kit [holding part] 31F.

  The rotation motor kit 31M includes a fixed chuck 33 that holds one end of the core member 11 and an electric rotation motor 34 that rotates the fixed chuck 33. The fixing chuck 33 grips, for example, the tip of the core material 11 and completely fixes it. For example, there is a fixed chuck 33 having an opening (a lumen; not shown) having an inner diameter slightly larger than the outer diameter of the core material 11 and having a mechanism for narrowing the interval between the lumen walls. The rotation motor 34 has a rotation shaft 35 connected to the fixed chuck 33, and the rotation of the rotation shaft 35 rotates the fixed chuck 33 and eventually the core material 11.

  The holding kit 31F holds the rotating core material 11 held by the rotary motor kit 31M in a bent state and holds the other end of the bent core material 11 rotatably. For example, the holding kit 31F includes, for example, a rotary holding chuck 36 having an opening (not shown) having an inner diameter slightly larger than the outer diameter of the core material 11. The holding kit 31F uses the rotary holding chuck 36 to hold the other end of the core material 11 held by the rotary motor kit 31M without being completely fixed.

  Note that the holding kit 31F makes the core material 11 held by the fixed chuck 33 curved instead of linear, so that the rotation shaft 35 of the rotary motor 34 and the opening shaft (not shown) of the fixed chuck 33 are not. The own opening axis is arranged so as to intersect. For example, in the core material variable unit 31 shown in FIG. 4, the rotation motor kit 31M is disposed with the rotation shaft 35 of the rotation motor 34 and the opening shaft of the fixed chuck 33 being horizontally oriented, and the holding kit 31F is rotated by the rotation motor. Placed below the kit 31M, the opening shaft of the rotary holding chuck 36 is set in the direction of gravity (vertical direction).

  About the bending method of the core material 11 by such a stent manufacturing apparatus 30, the perspective view and sectional drawing of FIG. 5 {The cross-sectional view of the axial direction of the core material 11 (cross-sectional view along orthogonality etc.)} are also described. This will be described with reference to FIGS.

  For convenience, positions at 90 ° intervals around the core material 11 are X1 to X4, and positions around the metal tube 21 corresponding to these X1 to X4 are Y1 to Y4. In addition, the correspondence of the position here is the position of the periphery X1 to X4 of the core material 11 in a state where the core material 11 is inserted into the metal tube 21 before the metal tube 21 and the core material 11 are bent. The overlapping positions are Y1 to Y4. And the unnecessary metal piece 25 shall exist in the position of Y1-Y4 of the metal tube 21. FIG.

  Further, the white arrow indicates the direction in which the metal tube 21 and the core material 11 are bent, the black arrow indicates the direction of the pressing force P directed from the lumen side to the outside of the metal tube 21, and the alternate long and short dash line arrow indicates the direction of the metal tube 21 and the core material 11. Indicates the direction of rotation. Further, FIG. 5 shows the direction of the flexure to change, and shows the change of the rotating core material 11 and the metal tube 21 that rotates together with the rotation of the core material 11, and FIG. 6 shows the rotating core. The material 11 and the metal tube 21 are shown in a non-rotating manner, and a change in the direction of bending and the direction of the pressing force P is shown. 5A to 5D and FIGS. 6A to 6D have a correspondence relationship, and A to D are arranged in chronological order.

  First, as shown in FIG. 5A and FIG. 6A, when the core material 11 and the metal tube 21 rotate while bending so that the position X1 and the position Y1 are at the top, the pressing force P is applied to the strand 23 and the vicinity of the position Y1. It is added to the unnecessary metal piece 25. Then, the space | interval (space | gap 22) between strands 23 spreads, or the core material 11 touches from the inner side of the unnecessary metal piece 25, and the unnecessary metal piece 25 settled in the space | gap 22 falls out of the metal tube 21. .

  Then, as the core material 11 continues to rotate, as shown in FIGS. 5B and 6B, the core material 11 is bent so that the position X2 and the position Y2 that are adjacent to the position X1 and the position Y1 are bent. The material 11 and the metal tube 21 rotate. Then, the pressing force P is applied to the strand 23 and the unnecessary metal piece 25 in the vicinity of the position Y2, and the unnecessary metal piece 25 in the vicinity thereof drops off from the metal tube 21.

  Subsequently, when the core 11 rotates, as shown in FIGS. 5C and 6C, a pressing force P is applied near the position Y3 adjacent to the position Y2 of the metal tube 21, and the unnecessary metal piece 25 near the position Y3 is formed. When the metal tube 21 falls off and continues to rotate, as shown in FIGS. 5D and 6D, a pressing force P is applied near the position Y4 adjacent to the position Y3 of the metal tube 21, and the vicinity of the position Y4. The unnecessary metal piece 25 falls off from the metal tube 21.

  That is, in such a stent manufacturing apparatus 30, as shown in FIG. 6, the metal tube 21 is sequentially bent in three or more multi-directions, and the bending direction of the metal tube 21 is the same as that of the metal tube 21. It changes continuously along the circumferential direction. Therefore, in this stent manufacturing apparatus 30, all the peripheral surfaces of the metal tube 21 are easily removed uniformly compared with the case where the core material 11 bent manually is rotated.

  Note that the stent manufacturing apparatus 30 in FIG. 4 preferably includes a slider [moving part] 37 that moves while fixing the position of the holding kit 31F (the sliding mechanism of the slider 37 is not particularly limited). ).

  If there is such a slider 37, the position of the holding kit 31F relative to the rotary motor kit 31M can be changed, so that the bending of the core 11 supported by the fixed chuck 33 of the rotary motor kit 31M and the rotary holding chuck 36 of the holding kit 31F. The shape can be variously changed. Therefore, such a stent manufacturing apparatus 30 can change the pressing force as appropriate.

  Moreover, in the stent manufacturing apparatus 30 as shown in FIGS. 2 to 4, it is desirable that a supply nozzle [fluid supply unit] 38 for supplying a fluid is included in the metal tube 21 (note that bending is performed). The step of supplying the fluid to the cut metal tube 21 during the step is referred to as a fluid supply step). With such a supply nozzle 38, the fluid touches the unnecessary metal piece 25, so that the unnecessary metal piece 25 is more efficiently removed.

In addition, since the above-mentioned stent manufacturing apparatus 30 fully removes the unnecessary metal piece 25 only by bending the core material 11 inserted in the metal tube 21, for example, for generation | occurrence | production suppression etc. of an unnecessary metal piece. No special device design or laser cutting program is required. Therefore, these stent manufacturing apparatuses 30 reduce the burden of control of a CPU (Central Processing Unit) that performs control, and save labor and automatically.
Manufacturing.

  The present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

  For example, when the core material 11 is bent in order toward three or more kinds of multiple directions, the bending direction is changed along the circumferential direction of the metal tube 21 as shown in FIG. However, the present invention is not limited to this.

  For example, as shown in FIGS. 7A to 7D, the core material 11 is first bent as shown in FIG. 7A, and then as shown in FIG. 7B, the core material 11 is opposite to the previously bent direction. Will bend. Thereafter, as shown in FIG. 7C, the core material 11 bends in a direction perpendicular to the bending direction in FIGS. 7A and 7B, and then, as shown in FIG. 7D, the bending direction shown in FIG. 7C. However, the core material 11 may be bent in the opposite direction.

  That is, the order of bending of the core material 11, and by extension, the metal tube 21 is based on the axis of the metal tube 21, then bent in one direction, then bent in the opposite direction of the one direction, and then continuously around the axis. After bending in the direction shifted from the previous one direction (forward direction) / reverse direction around the axis line, it may be bent in the reverse direction of the bent direction. And even if it is such a way of bending of the core material 11, all the surrounding surfaces in the metal tube 21 are removed and processed uniformly.

[Embodiment 2]
A second embodiment will be described. In addition, about the member which has the same function as the member used in Embodiment 1, the same code | symbol is attached and various description of the member may be simplified. In addition, even when the same effects as the effects described in the first embodiment are achieved, the description may be simplified.

  Although the bending process has been performed by bending the core material 11 inserted into the cut metal tube 21 as described above, the bending process is not limited to this. That is, the bending step may be performed by bending the cut metal tube 21 without using the core material 11.

  For example, as shown in FIGS. 14 and 15, the metal tube 21 is placed on a rail base 45 in which a plurality of rails 41 are arranged in a line on one plane, and the rail 41 is pressed while being pressed by a pressing roller 47 from above. The bending step is performed by rotating the metal tube 21 in the extending direction (crossing direction with respect to the arrangement direction of the rails 41).

  Such a rail 41 has a semicircular shape in a cross section (orthogonal cross section or the like) with respect to its extending direction. That is, the rail 41 extends linearly while having a portion in which the side (zenith side) in contact with the metal tube 21 is tapered like a semicircle. In addition, the rail 41 is preferably formed of a non-slip material (for example, resin) so that the metal tube 21 is reliably rotated and moved. In addition, a flexible material such as resin can prevent even the metal tube 21 in contact with the material from being damaged.

  In addition, the width 41W of the rail 41 is shorter than the full length of the metal tube 21, and the cross-sectional shape is not limited to the semicircular shape as shown in FIGS. 15 and 16A, but as shown in FIGS. 16B and 16C, It may be a trapezoid or a polygon such as a triangle. Even in the rail 41 having such a shape, since the side (zenith 41P) in contact with the metal tube 21 is tapered, when the metal tube 21 is pressed by the pressing roller 47, the metal tube 21 in contact with the rail 41 is This is because the pressure is efficiently applied and the metal tube 21 is appropriately bent.

  The pressing roller 47 has a total length that can press the entire length of the metal tube 21 simultaneously (at the same time), and has an outer diameter longer than the outer diameter of the metal tube 21 (however, the metal tube 21 is not limited thereto). A plurality of pressing rollers 47 shorter than the total length of 21 may be arranged in a straight line). The pressing roller 47 may be rotated so as to advance from one side to the other side in the longitudinal direction of the rail 41, or from the other side to the one side, or rotate from one side to the other side. May be. Note that, like the rail 41, the pressing roller 47 is preferably made of a non-slip material or a flexible material (for example, resin).

  Then, when the metal tube 21 rotates while being pressed by the pressing roller 47 on the rail base 45 in which a plurality of such rails 41 are arranged with an interval of 41L, that is, an uneven surface, as shown in FIG. In the metal tube 21 compressed by the pressing roller 47, on the side facing the rail base 45, there is a portion 21C that contacts the rail 41 arranged with a space of 41L, and the rails 41 and 41 are not in contact with each other. (Ie, a plurality of bent portions 21F are arranged in the axial direction of the metal tube 21, and a plurality of arcuate portions are arranged in the axial direction of the metal tube 21). A wavy part is generated).

  Then, as shown in the partial enlarged view of FIG. 15, a pressing force P that is a force directed outward from the inner cavity side of the metal tube 21 is applied to the strand 23 and the unnecessary metal piece 25 in the bent portion 21 </ b> F. (See black arrow). When the interval Wp between the strands 23 to which the pressing force P is applied is larger than the interval Wn between the strands 23 to which the pressing force P is not applied (see FIG. 1A and the like), unnecessary metal sandwiched between the strands 23 The piece 25 becomes unengaged with the strand 23 and falls off from the metal tube 21 [removal step]. In particular, the unnecessary metal piece 25 that is shorter than the distance 41L between the rails 41 and 41 is not supported by the rail 41 in the vicinity of both ends, and therefore easily falls off the metal tube 21.

  Further, as shown in FIG. 14, the metal tube 21 moves on the rail base 45 while rotating about its own axial direction (in other words, three or more types including one direction and a plurality of other directions). The direction of bending changes in the circumferential direction of the metal tube 21 when bending in order toward three or more types of multiple directions). .

  Then, the bending portion 21F of the metal tube 21 also moves along the circumferential direction of the metal tube 21 (in short, the metal tube 21 is repeatedly bent as it rolls). That is, as the metal tube 21 rolls on the rail 41, bending occurs in the entire circumferential direction of the metal tube 21, and the direction is radially centered about the axial direction. Therefore, the unnecessary metal piece 25 is efficiently removed around the entire circumference of the metal tube 21.

  Note that the operation of pressing and rotating the metal tube 21 against the rail base 45 with the pressing roller 47 may be performed manually or using an apparatus. An example of such a device is a device (stent manufacturing device 50) as shown in FIG.

  17 is a perspective view of the stent manufacturing apparatus 50, FIG. 18 is a cross-sectional view taken along the line DD ′ of FIG. 17 along the rotation roller 52 described later, and FIG. 19 is along the rail 41, EE of FIG. 'It is a cross-sectional view taken along line (for convenience, the metal tube 21 is omitted in FIG. 17).

  The stent manufacturing apparatus 50 includes a conveyor belt unit 55 in addition to the rail base 45 [The rail base 45 and the conveyor belt unit 55 may be referred to as a bending imparting unit FU]. The conveyor belt unit 55 includes a conveyor belt 51 and a rotating roller kit 54.

  For example, the transport belt 51 is formed in a cylindrical shape by connecting both ends of a strip-shaped resin sheet having a width longer than the entire length of the metal tube 21. Therefore, the total length of the transport belt 51 is less than half the total length of the belt-shaped resin sheet.

  The rotating roller kit 54 is arranged inside the cylindrical conveying belt 51 with a plurality of rotating rollers 52 arranged in a line on a single plane, with the arrangement direction and the entire length direction of the conveying belt 51 being the same direction. . The distance between the rotating rollers 52 corresponding to both ends of the array is set to about the entire length of the conveying belt 51, so that the rotating rollers 52 stretch the conveying belt 51 (in addition, the outer side of the stretched conveying belt 51). The side surface (surface) is a plane (horizontal plane)).

  The extended inner surface of the conveyor belt 51 is in contact with the rotating roller 52, and at least one rotating roller 52 is rotated by a driving source (not shown). As a result, the transport belt 51 rotates (note that the rotation roller 52 can rotate forward and backward, and the rotation of the transport belt 51 also rotates forward and backward in accordance with this rotation).

  The conveyance belt unit 55 is adjusted by the position adjustment unit 58 in the interval (distance) to the rail base 45. More specifically, the position adjustment unit 58 includes a base 56 and a support shaft 57 that can be displaced (can be moved in and out) with respect to the base 56, and the transport that is attached to the support shaft 57 when the support shaft 57 is displaced. The belt unit 55 changes its position with respect to the rail base 45.

  Specifically, the position adjustment unit 58 deviates from the zenith 41P of the rail 41 on the rail base 45 to the surface of the transport belt 51 so that the metal tube 21 is sandwiched between the transport belt 51 and the rail 41 (rail base 45). The position of the conveyor belt unit 55 is adjusted so that the interval L is shorter than the outer diameter of the metal tube 21 (note that the parallel surface of the rotating roller 52 and the parallel surface of the rail 41 in the conveyor belt 51) Are preferably parallel).

  Then, the metal tube 21 placed on the rail base 45 in which the plurality of rails 41 are arranged is sandwiched (compressed) between the rail base 45 and the conveyor belt unit 55 (specifically, the conveyor belt 51). In this state, when the rotation roller 52 rotates forward and backward, the conveyor belt 51 also rotates forward and backward in accordance with the rotation, and the metal tube 21 on the rail base 45 rolls while being compressed. As a result, the bent portion 21 </ b> F of the metal tube 21 moves along the circumferential direction of the metal tube 21, and the unnecessary metal piece 25 in the bent portion 21 </ b> F falls off from the metal tube 21.

  In order to change the degree of compression of the metal tube 21, for example, as shown in FIG. 20, the position adjustment unit 58 (see FIG. 17) inclines the conveyor belt 51 with respect to the longitudinal direction of the rail 41. (In short, the gap L between the conveying belt 51 and the rail 41 facing each other may change gradually, for example, along the longitudinal direction of the rail 41. Note that this change may be a linear change. It can be a regular change other than linear or an irregular change).

  In this case, the horizontal surface of the conveyor belt 51 is inclined with respect to the rail parallel surface of the rail base 45. Then, for example, as shown in FIG. 20, when the conveyance belt 51 advances from the wide (Lw) to the narrow (Ln) between the conveyance belt 51 and the rail 41, the metal tube 21 rolls. As it progresses, it is strongly compressed (in FIG. 20, FIG. 23 and FIG. 26 described later, a plurality of metal tubes 21 are shown to facilitate understanding of the state in which the metal tubes 21 are rolling).

  As described above, if the distance L between the rail 41 in the rail base 45 and the conveyance belt 51 in the conveyance belt unit 55 is gradually changed between the conveyance start side and the conveyance end side of the metal tube 21, If the conveyance end side is gradually narrower than the conveyance start side, the degree of compression of the metal tube 21 changes so as to increase {a cross-sectional view taken along line FF ′ in FIG. FIG. 21 is a cross-sectional view taken along the line GG ′ of FIG. 20 (figure on the conveyance end side)}.

  And when the metal tube 21 bends in various shapes in this way, the unnecessary metal piece 25 is efficiently removed from the metal tube 21. This is because when more unnecessary metal pieces 25 are attached to the metal tube 21 (that is, immediately after the start of conveyance), the unnecessary metal pieces 25 are removed from the metal tube 21 even with a slight deflection, while the rail 41 This is because the remaining unnecessary metal pieces 25 are firmly engaged with the strands 23 in the metal tube 21 that has been rolled to a certain extent, so that it is not removed unless it bends more strongly than the first bend (the rail 41). The metal tube 21 rolled to a certain extent is easily bent because the gap 22 is increased.

  That is, the metal tube 21 is strongly bent at the end of the conveyance in only one direction, so that the unnecessary metal piece 25 that is not removed by the metal tube 21 that is weakly bent just after the start of the conveyance is surely removed. Is done. Further, when the metal tube 21 is compressed and conveyed in this way, the metal tube 21 in a state where it is easily bent due to the increased gap 22 is strongly bent, so that the metal tube 21 is not deformed excessively.

  However, the traveling direction of the metal tube 21 is not limited to this, and during the entire process of removing unnecessary metal pieces from the metal tube 21, the one in which the distance L between the conveyor belt 51 and the rail 41 is wider to the narrower. It is only necessary to have a process in which the metal tube 21 advances toward the direction (that is, the process in which the metal tube 21 advances from the narrower distance L between the transport belt 51 and the rail 41 toward the wider side) May be included).

  In the above, the conveyance belt unit 55 is inclined with respect to the rail base 45 so that the conveyance end side is closer to the distance L between the rail 41 and the conveyance belt 51 on the conveyance start side and conveyance end side of the metal tube 21. It was narrow compared to the conveyance start side. However, it is not limited to this.

  For example, as shown in FIG. 23, the rail 41 in the rail base 45 may be formed in an inclined shape (tapered shape). More specifically, the distance from the bottom surface 41M of the rail 41 to the rail zenith 41P (that is, the height 41H of the rail 41) is short on one side in the longitudinal direction of the rail 41 and long on the other side. The rail 41 may be gradually inclined with respect to the bottom surface 41M. Even in the rail base 45 including such a rail 41, the metal tube 21 becomes soft according to the drop of the unnecessary metal piece 25 and gradually bends strongly, so that the unnecessary metal piece 25 is efficiently removed. .

  By the way, the rail base 45 is not limited to one in which a single linear rail 41 is assembled. For example, as shown in FIG. 24 and FIGS. 25A to 25C (FIG. 25B is a cross-sectional view taken along line HH ′ in FIG. 25A and FIG. 25C is a cross-sectional view taken along line II ′ in FIG. 25A). In addition, it may be a branched rail 41 like an English letter Y (bifurcated) (however, the number of branches is not limited to two).

  In such a rail base 45, the metal tube 21 may be rolled from the branch portion 41B of the rail 41 toward the root portion 41R of the rail 41, or the branch portion 41B of the rail 41 from the root portion 41R of the rail 41. The metal tube 21 may be rolled toward the front or the rail base 45 may be reciprocated.

  In addition, the outer plane of the conveyor belt 51 may be parallel to the parallel surface of the rail 41 of the rail base 45, or may be inclined with respect to the parallel surface of the rail 41 as shown in FIG. May be. When the conveyor belt 51 is inclined with respect to the parallel surface of the rail 41, FIGS. 26 to 28 (FIG. 27 is a cross-sectional view taken along line JJ ′ of FIG. 26, and FIG. When the metal tube 21 is rolled from the branching portion 41B of the rail 41 toward the root portion 41R of the rail 41 as shown in FIG. .

  That is, the metal tube 21 of FIG. 26 is compressed in contact with the rail 41 having a narrow width and a narrow interval on the conveyance start side (see FIG. 27), and is wide on the conveyance end side (see FIG. 28). (The rail width 41W, the narrower rail width is 41Wn, the wider rail width is 41Ww, and the rail arrangement interval 41L, the narrower rail interval is 41Ln, the wider rail) The rail interval is 41 Lw).

  When the metal tube 21 is compressed and conveyed in this way, the unnecessary metal piece 25 is removed just by a slight deflection of the metal tube 21 immediately after the start of conveyance, and the metal tube is more strongly near the end of conveyance. The unnecessary metal piece 25 is removed because 21 is bent. That is, since the metal tube 21 is more strongly bent, the unnecessary metal piece 25 that has not been removed by the weakly bent metal tube 21 immediately after the start of conveyance is surely removed.

  Note that the metal tube 21 is not limited to the rail 41 (rail base 45) in FIG. 26, and as shown in FIG. 29, the arrangement interval 41Ln is narrow on the conveyance start side and the arrangement interval 41Lw is wide on the conveyance end side. However, it may be compressed in contact with the rail 41 having a uniform width 41W (note that the white arrow in FIG. 29 is the conveying direction of the metal tube 21).

  In the case of such a rail base 45, like the rail base 45 of FIG. 26, the volume of the space in which the bent portion 21F in the metal tube 21 is generated is larger in the transport direction front side of the metal tube 21 than in the transport direction original side. It has increased. Therefore, as the metal tube 21 is transported, the metal tube 21 is gradually strongly bent, so that the unnecessary metal piece 25 is efficiently removed.

  Further, as shown in FIG. 30, the metal tube 21 is compressed in contact with the rail 41 having a uniform arrangement interval 41L, although the rail width 41Wn is narrow on the conveyance start side and the rail width 41Ww is wide on the conveyance end side. (The white arrow in FIG. 30 is the conveying direction of the metal tube 21).

  In the case of such a rail base 45, if the rail 41 has a tapered shape such as a semicircular cross section, even if the rail width 41Ww is wide, the vicinity of both ends of the width 41Ww is inclined so as to fall. The interval 41L becomes larger. Therefore, the volume of the space in which the bent portion 21F in the metal tube 21 is generated increases on the transport direction front side of the metal tube 21 compared to the transport direction original side. Therefore, as the metal tube 21 is transported, the metal tube 21 is gradually strongly bent, so that the unnecessary metal piece 25 is efficiently removed.

  The present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

  For example, as shown in FIG. 31, the stent manufacturing apparatus 50 (30) of the second embodiment (and further embodiment) is arranged in a space 62 temperature-controlled by a chiller 61, and in that space, the stent 20 may be manufactured (note that the space 62 is formed of a heat insulating material 63, and the refrigerant circulation path 64 is disposed therein).

  When the metal tube 21 is a shape memory alloy such as a Ni—Ti alloy, the metal tube 21 is easily deformed flexibly when the temperature of the metal tube 21 is lowered to near the austenite transformation end temperature. Therefore, by using a temperature management system using the chiller 61, the metal tube 21 that is relatively easily deformed is subjected to removal processing. With this configuration, the metal tube 21 is less damaged during the removal of the unnecessary metal piece 25.

  In the stent manufacturing apparatus 50 according to the second embodiment, it is preferable that a supply nozzle [fluid supply unit] 38 for supplying fluid to the metal tube 21 is included.

  Here, the manufacture of the stent 20 and the detailed description thereof will be given of specific examples and evaluation results regarding the removal processing of the unnecessary metal piece 25 of the metal tube 21.

[Evaluation 1]
<Example 1>
After the nickel-titanium metal tube 21 having an outer diameter (diameter) of 3.0 mm is laser-cut, the dross attached to the inner surface of the cut metal tube 21 has a length of 200 mm and a diameter of 2.5 mm. It is removed with a diamond electrodeposition file. The length of the cut metal tube 21 is 44 mm.

  Then, the core material 11 made of nickel-titanium having an outer diameter (diameter) of 2.5 mm is inserted into the cut metal tube 21 from which the dross has been removed, and as shown in FIG. Then, it is bent alternately in the forward and reverse directions several times. Note that the bending is repeated until all the unnecessary metal pieces 25 are removed from the metal tube 21 by visual inspection.

<Example 2>
The nickel-titanium core 11 inserted into the cut metal tube 21 from which dross has been removed is rotated a plurality of times in a curved state by hand as shown in FIG. . In addition, rotation of the core material 11 is repeated until all the unnecessary metal pieces 25 are removed from the metal tube 21 visually.

<Example 3>
The core material 11 made of nickel-titanium inserted into the cut metal tube 21 from which dross is removed as described above is alternately bent a plurality of times in the forward and reverse directions by the stent manufacturing apparatus 30 shown in FIG. It should be noted that the conveyance by the roller kit 31R is repeated until all the unnecessary metal pieces 25 are removed from the metal tube 21 by visual observation (note that the outer diameter of the conveyance roller 32 is 32 mm and the conveyance roller 32 in the group U32). Is 5, the number of transport rollers 32 in the group L32 is 4, and the rotational speed of the transport rollers 32 is 30 rpm).

<Example 4>
The nickel-titanium core 11 inserted into the cut metal tube 21 from which dross has been removed is rotated a plurality of times in a bent state by the stent manufacturing apparatus 30 shown in FIG. The rotation motor 34 (rotation speed 120 rpm) is assumed to rotate for 30 seconds in one removal process, and is rotated several times until all of the unnecessary metal pieces 25 are removed from the metal tube 21 by visual inspection. Repeated.

<Example 5>
The unnecessary metal piece 25 is removed from the cut metal tube 21 from which dross has been removed by the stent manufacturing apparatus 50 shown in FIG. Note that the rail 41 has a semicircular (in detail, semi-elliptical) cross-sectional shape as shown in FIG. 17 and has a rail height 41H of 3 mm, a rail width 41W of 5.5 mm, and a total length of 150 mm. And the rail stand 45 is formed by arranging four of these rails 41 with the space | interval 41L of 9.5 mm. Further, the distance L between the conveyor belt 51 and the rail 41 is 1 mm in the entire region. And the metal tube 21 reciprocated the rail base 45 10 times. The required time is 6 seconds per round trip.

<Comparative example>
The unnecessary metal piece 25 in the cut metal tube 21 from which dross has been removed as in the first to fifth embodiments is removed with tweezers while being enlarged and visually recognized using a stereomicroscope.

[Evaluation results ]
(Appearance evaluation)
Compared to Examples 1 to 5 and the comparative example, the unnecessary metal piece 25 was completely removed from the metal tube 21 at a magnification of 40 times using a Nikon stereo microscope (product name: MM-400 / L). It was confirmed. As a result, the unnecessary metal piece 25 was removed in all the examples and comparative examples.

(Time required)
It is as follows when the time of the removal process required in Examples 1-5 and the comparative example is made into a table | surface. In each example, three samples (S1, S2, S3) are manufactured.

S1 (seconds) S2 (seconds) S3 (seconds) Average processing time (seconds)
Example 1 132 122 192 149
Example 2 104 103 92 100
Example 3 50 95 42 62
-Example 4 30 30 60 40
-Example 5 60 60 60 60
Comparative example 343 442 292 359
As can be seen from the evaluation results, the stent 20 from which the unnecessary metal piece 25 has been removed is manufactured in a short time in the case of the above-described stent manufacturing method (more specifically, a method for removing the unnecessary metal piece 25).

FU Bending unit 11 Core material 20 Stent 21 Metal tube 21F Part of metal tube bent between rails 21C Part of metal tube in contact with rails 22 Void 23 Strand 24 Notch 25 Unnecessary metal piece W Spacing between strands Wp Spacing between strands applied with pressing force Wn Spacing between strands not receiving pressing force Df Direction of bending of core material and metal tube Dr Direction of bending of core material and metal tube P Direction of pressing force 30 Stent manufacturing device 31 Core variable unit 31R Roller kit [Conveying section]
32 Conveying roller 32A Roller shaft 31T Rotating mechanism part [Rotating part]
U32 Group of transport rollers L32 Group of transport rollers 31M Rotation motor kit [Rotating unit]
33 Fixed chuck 34 Rotating motor 35 Rotating shaft 31F Holding kit 36 Rotating holding chuck 37 Slider [moving part]
38 Supply nozzle [fluid supply unit]
41 Rail L Distance between rail zenith and conveyor belt Lw Larger distance between rail zenith and conveyor belt Ln Distance between rail zenith and conveyor belt Narrow distance 41H Rail height 41Hh Rail height Higher rail height 41Hl Lower rail height at lower rail height 41W Rail width 41Ww The wider rail width at the rail width 41Wn The narrower rail width at the rail width 41L The spacing between the rails 41Lw The wider between the rails Rail spacing 41Ln The narrower rail spacing in the rail spacing 41B Rail branch portion 41R Rail root portion 45 Rail base 47 Press roller 50 Stent production device 51 Conveying belt 52 Rotating roller 54 Rotating roller kit 55 Conveyor belt unit 58 Position adjustment unit

Claims (19)

In a stent manufacturing method for manufacturing a stent based on a metal tube,
An insertion step of inserting a core material into the lumen of the cut metal tube into which the metal tube has been cut ,
The core material by bending the, by repeatedly flexing the pre-cut metal tube, bending process, a stent manufacturing method comprising the you remove unnecessary metal pieces surrounded by slits of the pre-cut metal tube. Deflection of the two directions of the deflection of the flexure and one other direction in the first direction are alternately repeated, the stent manufacturing method according to claim 1.   The stent manufacturing method according to claim 2, wherein the relationship between the one direction and the other direction is a normal / reverse relationship. In a stent manufacturing method for manufacturing a stent based on a metal tube,
The pre-cut metal tube notched in the metal tube at rail stand rail having a width shorter than the overall length of the pre-cut metal tube is arranged a single arrangement or plurality, the pre-cut metal tube even press The stent manufacturing method including a bending step of removing unnecessary metal pieces surrounded by the cut of the cut metal tube by being repeatedly bent by being rotated while being rotated. It is deflected in order toward the 3 or more-way including one direction and a plurality of other directions, the stent manufacturing method according to claim 1 or 4. The stent manufacturing method according to claim 5 , wherein the bending direction changes along the circumferential direction of the metal tube. The stent manufacturing method according to any one of claims 1 to 6 , further comprising a fluid supply step of supplying a fluid to the cut metal tube during the bending step. In a stent manufacturing apparatus for manufacturing a stent based on a metal tube,
To deflect repeat the pre-cut metal tube containing a cut in the metal tube, seen including flexing grant unit you remove the unnecessary metal piece which is surrounded by the cut of the pre-cut metal tube,
The bending giving unit is
A core material inserted into the lumen of the metal tube;
A core variable unit that bends the core;
The stent manufacturing apparatus characterized by including . The core variable unit is
The stent manufacturing apparatus according to claim 8 , further comprising a transport unit that transports the core material inserted into the metal tube while being sandwiched. The core variable unit is
A rotating part that grips one end of the core material and rotates it around the axis of the core material;
A holding portion for rotatably holding the other end of the core material;
The stent manufacturing apparatus according to claim 8 , comprising: The stent manufacturing apparatus according to claim 10 , further comprising a moving unit that changes a position of the holding unit. In a stent manufacturing apparatus for manufacturing a stent based on a metal tube,
Including a bending unit for repeatedly bending a cut metal tube having a cut in the metal tube to remove unnecessary metal pieces surrounded by the cut of the cut metal tube;
The bending giving unit is
A rail platform including one or more rails;
A conveyor belt kit that sandwiches the cut metal tube together with the rail base and transports the cut metal tube on the rail base while rotating the cut metal tube.
The stent manufacturing apparatus characterized by including. The rail is in cross section with respect to the extending direction of the rail, toward the contact side of the pre-cut metal tube, stent manufacturing apparatus according to claim 12 that having a tapered portion. When the rail base includes a plurality of rails,
14. The rail stand according to claim 12 or 13 , wherein in the rail stand, the arrangement interval of the rails on the transport start side and the transport end side of the cut metal tube is narrower on the transport start side than on the transport end side. Stent manufacturing equipment. In the rail platform, rail width of the rail at the conveyance start side of the pre-cut metal tube and the transport completion side, more of the transport start side, stent according to the narrow claim 14 in comparison to the conveying finishing side manufacturing device. When the rail base includes a plurality of rails,
In the rail platform, rail width of the rail at the conveyance start side of the pre-cut metal tube and the transport completion side, more of the transport start side, according to the narrow claim 12 or 13 as compared to the conveyance termination side Stent manufacturing equipment. The stent manufacturing method according to any one of claims 12 to 16 , wherein the rail is branched, and the branch side of the cut metal tube is arranged on the conveyance start side, and the branch side is arranged on the conveyance end side. apparatus. The distance between the rail in the rail base and the transport belt in the transport belt kit is such that the transport end side is narrower on the transport start side and transport end side of the cut metal tube than the transport start side. Item 18. The stent manufacturing apparatus according to any one of Items 12 to 17 . The stent manufacturing apparatus according to any one of claims 8 to 18 , wherein a fluid supply unit that supplies a fluid to the metal tube is included.