KR101631491B1 - Methods for Manufacturing Stent - Google Patents

Abstract

The present invention relates to a method of manufacturing a stent, which comprises a circumferential dividing line set by equally spacing a circumference (W) and a length (L) of a cylindrical body having the same diameter (R) A jig provided with detachable projecting pins at all of the positional points where the dividing lines intersect is used as the jig for starting and stopping the wire so as to pass through the projecting pin located in the diagonal direction, A method for manufacturing a stent in which a cell is formed by intersection of wires while bending downward, the method comprising: A) bending and moving one wire from a starting point of one end of the jig to a first point of the other end of the jig; (B) repeating a pattern in which the wire is folded in a zigzag from the first point to a point of turning of the other end of the jig to form a lower head; C) bending the wire from the transition point to the second point of the one end of the jig; And a step D of forming an upper head by repeating a pattern in which the wires are staggered from the second point to the starting point in a zigzag manner, wherein the step A comprises, at the starting point, After dividing the line, move it by one diagonal distance). Repeating a zigzag bent pattern formed by shifting a distance from the position point by a diagonal line in a downward direction; And A-2 step of moving the wire by a distance of 2L in a downward diagonal line at a finishing point of step A-1 to separate the position point from the part formed in step A-1, After the wire is moved by the diagonal line of the downward direction at the turning point by?. A C-1 step of repeating a zigzag bent pattern by moving a distance from the position point to a diagonal line of the upper direction by l again; And a C-2 step of moving the wire by a distance of 2 L in a diagonal direction of the upper direction at a finishing point of the step C-1 to separate the position point from the part formed at the step C-1, The step A-1 and the step A-2 alternately, and the step A alternates between the step C-1 and the step C-2.
Therefore, according to the present invention, a stent having structural flexibility can be manufactured by bending a woven wire using a single wire.

Description

[0001] METHOD FOR MANUFACTURING STENT [0002]

The present invention relates to a method for manufacturing a stent.

The stent manufactured to prevent further progression of the stenotic region through the expansion of the diameter of various organs in the body and to smooth the flow of materials in the body exhibits a specific property by crossing the wires formed by the shape memory alloy or the like in a certain manner.

According to the size, nature, and environment of various organs and lumens in which the stent is installed, the stent should be formed in accordance with the use thereof. For this purpose, the stent manufacturing method produced by the crossing of wires can provide various cell shapes and weaving structures have.

In particular, the stent must have a rigid and stable cross-sectional structure of the wire in order to keep the stenosis prevention function through expansion of the lumen, and it should have a supporting force so that the extension shape is not easily deformed. In addition, the stent should have a certain structural flexibility so that it can be closely adhered to the shape of the various bending lumens instead of a simple cylindrical structure to expand the stenosis region.

A prior art document for solving these problems is disclosed in Korean Patent Laid-Open Publication No. 10-1438742 entitled "Stent and Method for Manufacturing the Same" (hereinafter referred to as "Prior Art"). In such a conventional technique, a stent structure having cells of a constant structure is closely attached to the lumen to perform the function of expanding the stenotic region.

However, in the case of the prior art, many wire materials are required for manufacturing the stent, and when the stent thus formed is installed in many variable bending lumens in the body, it can not be attached to the lumen because of lack of flexibility, There was a problem in causing lesion or leaving the installation position.

In addition, in the prior art, when the deformation of the stent contour according to the structure of the lumen, that is, the deformation from the first cylindrical stent expansion shape to the curved shape occurs, the restenosis of the stenosis site is prevented against the external forces applied to the stent There is a problem that the metal fatigue of the wire generated in the process of maintaining the bent shape is increased, and as a result, the wire life is shortened.

SUMMARY OF THE INVENTION The present invention has been made to solve the above problems, and an object of the present invention is to provide a technique for fabricating a stent having structural flexibility by using only one wire to weave in a certain manner.

In order to achieve the above object, a stent manufacturing method of the present invention is a stent manufacturing method comprising the steps of: dividing a circumference (W) and a length (L) of a cylindrical body having the same diameter (R) A jig provided with detachable projecting pins at all of the position points where the circumferential dividing line and the length dividing line intersect is used, and after starting from the position point serving as a reference as a starting point, the projecting pin located diagonally A method for manufacturing a stent in which a cell is formed by intersection of wires while bending and moving a wire upwardly and downwardly, the method comprising: A step of folding and moving one wire from a starting point of one end of the jig to a first point of the other end of the jig; (B) repeating a pattern in which the wire is folded in a zigzag from the first point to a point of turning of the other end of the jig to form a lower head; C) bending the wire from the transition point to a second point of the one end of the jig; And a step D of forming an upper head by repeating a pattern in which the wires are staggered from the second point to the starting point in a zigzag manner, wherein the step A comprises, at the starting point, After dividing the line, move it by one diagonal distance). Repeating a zigzag bent pattern formed by shifting a distance from the position point by a diagonal line of the lower direction again; And A-2 step of moving the wire by a distance of 2L in a downward diagonal line at a finishing point of step A-1 to separate the position point from the part formed in step A-1, After the wire is moved by the diagonal line of the downward direction at the turning point by ℓ. A C-1 step of repeating a zigzag bent pattern by moving a distance from the position point to a diagonal line of the upper direction by l again; And a C-2 step of moving the wire by a distance of 2 L in a diagonal direction of the upper direction at a finishing point of the step C-1 to separate the position point from the part formed at the step C-1, Step A-1 and step A-2 alternately, and step C alternates between step C-1 and step C-2.

Here, the number of the circumferential dividing lines is 6 + 4x (x: 0 or a natural number).

Also. The number of length division lines is 8 + 2y (y: 0 or a natural number).

In addition, the first point is located on the same circumferential dividing line as the starting point, and the last finishing point among the plurality of finishing points of the step A-1 formed by alternating the steps A-1 and A- .

Also, the second point is located on the same length dividing line as the first point, and the last finishing point among the plurality of finishing points of the C-1 stage formed by alternating the C-1 and C-2 steps Point.

In the step B-1, the wire is moved by a diagonal line of the downward direction at the first point by a distance L '(a diagonal distance obtained by moving three divisions of the lengthwise dividing line per two circumferential dividing lines). B-2 repeats the zigzag bent pattern formed by moving the wire from the position point moved in the step B-1 by a distance of 2L in a diagonal line in the upward direction, step; And (B-3) moving the wire from the position point moved in the step B-2 by a distance of '1' diagonally in the upward direction and positioning the wire at the turning point.

The step (D) further includes a step D-1 for moving the wire at the second point by a diagonal line of the upper direction by a distance of ℓ '(a diagonal distance obtained by moving three divisions of the length dividing line per two circumferential dividing lines). D-2 repeats a zigzag bent pattern formed by moving the wire by 2 L in a downward diagonal line from the position point moved in the step D-1, step; And a D-3 step of moving the wire by a distance of ℓ 'in a downward diagonal from the position point moved in the step D-2 and positioning the wire at the starting point.

According to the present invention, it is possible to manufacture a stent capable of keeping the deformed structure constant while having structural flexibility, by bending and knitting in a certain manner using one wire.

Furthermore, according to the present invention, the stent with flexibility can be pressed against the lumen wall irrespective of the type of the lumen bent in various forms in the body to push out the stenotic region.

1 to 5 are exploded views for explaining a wire descending step according to the present invention.
6 is a developed view for explaining a bottom head forming step according to the present invention.
7 is an exploded view for explaining a wire rising step according to the present invention.
8 is an exploded view for explaining an upper head forming step according to the present invention.
9 and 10 are exploded views showing the entire crossing and folding state of the wire according to the present invention.
FIG. 11 is a photograph of a real product of a stent manufactured according to the present invention.
12 to 14 are photographs of a bending state of a stent manufactured according to the present invention.
15 is a flowchart showing a stent manufacturing method according to the present invention.

The preferred embodiments of the present invention will be described in more detail with reference to the accompanying drawings, in which the technical parts already known will be omitted or compressed for the sake of brevity.

<Description of Stent Manufacturing Method>

The process of the stent manufacturing method according to the present invention will be described in detail with reference to the flowchart of FIG. 15 and the developed view of FIG. 1 to FIG. 10 below.

1 to 9 show a method of manufacturing a stent 100 according to an embodiment of the present invention using a jig. Here, the dotted line represents the movement path of the wire being advanced, and the solid line represents the movement path of the wire that is widened at the corresponding step in each drawing.

Here, the jig is formed by dividing the circumference W of the cylindrical body having the same diameter R and length L as the manufactured stent 100 and the circumferential dividing lines a ₁ , b ₂ , b ₃ , ..., b ₂₀ and the lengthwise dividing lines b ₁ , a ₂ , a ₃ , ..., a ₁₄ , By using any of these jigs, one of the position points is set as a starting point, and the wire 10 is bent upward and downward to pass through the projecting pin 20 positioned diagonally therefrom, thereby forming a cell. .

The number of the circumferential dividing lines of the jig is defined as 6 + 4x (x: 0 or a natural number), and the number of the circumferential dividing lines of the jig as a reference in the following description according to an embodiment of the present invention is 14.

The number of lengthwise dividing lines of the jig is defined as 8 + 2y (y: 0 or natural number), and the number of length dividing lines of the jig as a reference in the following description according to an embodiment of the present invention is 20.

1. Wire descending step < S100 >

In this step the fixture once the starting point as shown in Figs. 1 to _{5 (S1, a 2 / b} 4) a first point on the jig the other end from the _{(F15, a 7 / b 17} ) from a single wire (10) Zigzag is bent and moved.

In this process, as shown in FIG. 1, the wire 10 is moved by a diagonal line of the upward direction at a starting point S1 by a distance of 1 (a diagonal distance obtained by moving one division of the length division line per column of the circumferential division line). A first zigzag moving step of repeating a zigzag bent pattern formed by shifting the position point a ₃ / b ₃ by a distance of a diagonal line in a downward direction; And location point from the first portion to the finish point wire 10 from _{(F1, a 7 / b 3} ) of the zigzag movement stage moves 2ℓ in the downward diagonal formed by the zig-zag movement phase, as shown in And a first separation step of separating the first and second electrodes from each other.

A first zigzag movement stage and the first spaced phase alternating progression, and is still in progress, as illustrated in Figures 3-5 a particular first closing point of the zigzag movement phase gamyeo _{(F15, a 7 / b 17} ) the wire falling step in (S100).

As a result, the first point, which is the final position of the wire descending step S100 and is the starting position of the bottom head forming step S200, is formed by a plurality of finish points formed in the course of the first zigzag moving step and the first separating step alternately F1, F2, F3, ..., F15, and the first point F15 is located on the same circumferential dividing line as the starting point S1.

2. Lower head forming step < S200 >

In this step fall through the step S100 and the first point (F15), the wire 10 to the turning point of the jig the other end _{(C1, a 9 / b 17} ) from a position after forming a portion of the stent body 110 in a staggered The lower head 120 is formed by repeating the folding pattern.

6, the wire 10 is moved from the first point F15 by a diagonal line in the lower direction by a distance L '(a diagonal distance obtained by moving the lengthwise division line three spaces per two circumferential division lines) And moves the wire 10 from the position point a ₉ / b ₂₀ by 2 L in a diagonal line in the upward direction.

Thereafter, a zigzag bent pattern formed by shifting by 2 L from the position point a ₁₀ / b _{18 by} a diagonal line in the downward direction is repeated, and as a result, from the shifted position point a ₇ / b ₂₀ , And the wire 10 is moved to the turning point C1 by moving the wire 10 by a distance of?

3. Wire rising step < S300 >

Then the step moves to the bending jig one end of the second branch _{(F'15, a 14 / b 4} ) one wire 10 to the other end of the jig from the turning point (C1) as shown in Figure 7 in a zigzag pattern.

This process moves the wire 10 at a turning point C1 by a diagonal line of a downward direction (a diagonal distance obtained by moving one division of a lengthwise division line per column of the circumferential division line) by a diagonal line as shown in FIG. A second staggering step of repeating a zigzag bent pattern formed by shifting the position point a ₁₀ / b ₁₈ by a distance diagonal to the upper diagonal line again; And the second of the second closing point wire 10 from (F'1, ₁₄ a / ₁₈ b) of the zigzag movement stage is moved by a 2ℓ in the upper diagonal direction away from the location point portion formed in the zigzag movement phase Separation step.

A second zigzag movement step and the second step are alternately spaced in progress and Fig. 7 a continuing specific second finishing point of the zigzag movement step is, as shown in gamyeo _{(F'15, a 14 / b 4} ) wire up-step in ( S300).

As a result, the second point, which is the final position of the wire lifting step (S300) and becomes the starting position of the upper head forming step (S400), is formed by a plurality of finish points formed in the process of alternately moving the second staggering step and the second spacing step (F'15) corresponds to the last finishing point (F'15) among the first division points F'1, F'2, F'3, ..., F'15, Lt; / RTI &gt;

4. Upper Head Forming Step < S400 >

In this step, step S300 is performed to form a part of the stent body 110 to complete the wire 10 crossing structure of the body 110 from the second point F'15, S1, a ₂ / b ₄₎ and to repeat the pattern of bending the wire 10 in a zigzag pattern is made as the process of forming the upper head (130).

Here, as shown in FIG. 8, the wire 10 is moved from the second point (F'15) by a diagonal line in the upper direction by a distance of ℓ '(a diagonal distance obtained by moving three divisional lines per two divisional columns) Then, the wire 10 is moved from the position point a ₂ / b ₁ by a distance of 2 L in a downward diagonal direction.

After that, the upper direction from its position dots (a ₃ / b ₃₎ again moved by 2ℓ in the upper direction diagonally was formed repeatedly zigzag bent pattern, with the result that the movement position points (a ₁₄ / b ₁₎ in the And the wire 10 is moved to the starting point S1 by moving the wire 10 by a distance of?

The wire 10 arriving at the start point S1 is finely connected through welding or the like to form the stent 100 made of one wire 10. [

&Lt; Description of characteristics of the manufactured stent >

In the case of the stent 100 manufactured by the stent manufacturing method of the present invention, as shown in FIG. 9 and FIG. 10, the intersection method of the wire placed on the specific circumferential dividing line a ₁ / b ₈ is a cross And the convex crossing method on the remaining circumferential dividing lines progresses in the form of wrapping both sides of the projecting pin 20 to form the circular ring 20.

Here, the middle by a specific circumferential dividing line (a ₁ / b ₈₎ except for A1 and A2 are that the wires overlap in two layers in the projecting pin 20 the center of the remainder of the steps shown in A of Figure 10 The circular ring 50 is provided with a sufficient space for changing the shape of the cell when the overall structure of the stent 100 is changed and the entire structure of the stent 100 is easily bent The crossed wire form can be deformed to provide a space that can be positioned.

That is, when a hollow cylindrical stent is formed by connecting both ends of the stent 100 of the developed view shown in FIG. 10, only the intersection of the wires 10 on the opposite two circumferential dividing lines forms the intersection 30 , And the intersection of the wires 10 on the other circumferential dividing line forms the circular ring 50 to form the stent 100 as shown in FIG.

Thus, the stent 100 thus fabricated is sufficiently flexible to allow easy structural changes in accordance with the configuration and arrangement of the intersections 30 and the circular rings 50, as shown in Figures 12-14.

The stent 100 is bent so as to be in close contact with the respective lumens in various lumens in the body, which are not formed in a constant cylindrical shape, and the structure of the stent 100 having such flexibility is formed in a constant shape , While expanding while maintaining the structure, to push out the stenosis site and to maintain the constant diameter.

The embodiments disclosed in the present invention are not intended to limit the scope of the present invention but to limit the scope of the technical idea of the present invention. The scope of protection is to be construed in accordance with the following claims, and all technical ideas within the scope of equivalents thereof should be construed as being included in the scope of the present invention.

100: stent
110: Body
120: Lower head
130: upper head
10: Wire
20: projecting pin
30: intersection
50: Circular ring

Claims (7)

A circumferential dividing line and a length dividing line set by dividing the circumference W and the length L of the cylindrical body having the same diameter (R) and length (L) equal to the stent to be manufactured are equally spaced A jig provided with detachable projecting pins is used. After starting from a position point serving as a reference as one of the starting points, the wires are bent upward and downward to pass through the projecting pins positioned diagonally, A method for manufacturing a stent,
A step of folding and moving one wire from the starting point of one end of the jig to the first point of the other end of the jig;
(B) repeating a pattern in which the wire is folded in a zigzag from the first point to a point of turning of the other end of the jig to form a lower head;
C) bending the wire from the transition point to the second point of the one end of the jig; And
And repeating a pattern in which the wire is bent in a zigzag from the second point to the starting point to form an upper head,
The step A
After moving the wire at the starting point by a diagonal line of the upper direction by a distance of ℓ (a diagonal distance obtained by moving one division of the length dividing line per one circumferential dividing line). Repeating a zigzag bent pattern formed by shifting a distance from the position point by a diagonal line of the lower direction again; And
And a step (A-2) of moving the wire by a distance of 2L in a downward diagonal line at a finishing point of the step A-1 to separate the position point from the part formed in the step A-1,
In step C,
And then moves the wire by a distance of 1 in a downward diagonal line at the turning point. A C-1 step of repeating a zigzag bent pattern by moving a distance from the position point to a diagonal line of the upper direction by l again; And
And a C-2 step of moving the wire by a distance of 2 L in a diagonal line of the upper direction at a finishing point of the step C-1 to separate the position point from the part formed at the step C-1,
The step A alternates between step A-1 and step A-2,
And the step C alternates between the step C-1 and the step C-2.
A method for manufacturing a stent.
The method of claim 1,
Wherein the number of the columnar dividing lines is 6 + 4x (x: 0 or a natural number)
A method for manufacturing a stent.
The method of claim 1,
And the number of length division lines is 8 + 2y (y: 0 or a natural number)
A method for manufacturing a stent.
The method according to claim 1,
Wherein the first point is located on the same circumferential dividing line as the starting point, and the first point is located on the same circumferential dividing line as the starting point, and the first point is the second finishing point among the plurality of finishing points of the A- Characterized by
A method for manufacturing a stent.
The method according to claim 1,
The second point is located on the same length dividing line as the first point, and the second finishing point is located on the same length dividing line as the first finishing point among the plurality of finishing points of the C-1step formed by the alternating C-1 and C- Characterized in that
A method for manufacturing a stent.
The method according to claim 1,
In the step B,
(B-1) moving the wire at the first point by a diagonal line of a downward direction by a distance L '(a diagonal distance obtained by moving three divisions of the lengthwise division line per two circumferential dividing lines);
B-2 repeats the zigzag bent pattern formed by moving the wire from the position point moved in the step B-1 by 2L in the diagonal line in the upward direction and moving the wire by 2L in the diagonal line in the downward direction from the position point again step; And
And a B-3 step of moving the wire by a distance of ℓ 'from the position point moved in the step B-2 to a diagonal line of the upper direction and positioning the wire at the turning point.
A method for manufacturing a stent.
The method according to claim 1,
The step (D)
(D-1) moving the wire at the second point by a diagonal line of an upper direction by a distance L '(a diagonal distance obtained by moving three divisions of the lengthwise division line per two circumferential dividing lines);
D-2 repeats a zigzag bent pattern formed by moving the wire by 2 L in a downward diagonal line from the position point moved in the step D-1, step; And
And a D-3 step of shifting the wire by a distance of? 'In a downward diagonal line from the position point moved in the step D-2 and positioning the wire at the starting point.
A method for manufacturing a stent.

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