KR101382263B1 - A making method for the stent and the stent thereof - Google Patents

Abstract

The present invention relates to a method for manufacturing a stent and an expansion mechanism for expanding the lumen passage in response to a lesion site by installing in the stenosis progression or stenosis of the body lumen, and more specifically, a single superelastic shape memory alloy Downward movement to form the bent ring portion 12 (12 ') in the longitudinal direction in the circumferential direction of the top end and the bottom end by the wire 10, and to form a repeating single movement pattern 15 downward between the top end and the bottom end. The space portion having a triangular cross-sectional shape in the longitudinal direction in the circumferential direction and the transverse direction in the longitudinal direction is repeated by repeating the upward movement pattern portion 16 'which is formed by repeating the pattern portion 16 and the single movement pattern 15' upward. 70) and an inverted triangle cross-sectional space 70 'is formed so that the peristaltic flexion deforms by repeating partial expansion and contraction by external force, such as esophagus, large intestine and small intestine in the longitudinal direction of the lumen. Minutes, while the same to widen the passage of the cavity cooperating bending deformation according to the linked operation of repeating expansion and contraction there is a feature that provides smooth interoperation of the lumen.

Description

A method of manufacturing a stent capable of interlocking bend deformation and the stent {A MAKING METHOD FOR THE STENT AND THE STENT THEREOF}

The present invention relates to a method of manufacturing a stent, which is an expansion mechanism for widening the passage of the lumen in response to a lesion site by installing in the stenosis progression or stenosis of the body lumen, and in particular, such as the esophagus, the large intestine, and the small intestine. The present invention relates to a method of manufacturing a stent and a stent capable of interlocking flexural deformation in accordance with an interlocking operation of repeating partial expansion and contraction in the longitudinal direction of the lumen.

In general, the medical stent is used as an expansion mechanism for widening the passage of the lumen in response to the lesion site by installing in the stenosis progression or stenosis site of the body lumen.

Conventionally, medical stents having various structures have been disclosed. The superelastic shape memory alloy wires are interlaced as in Patent Registration Nos. 10-424290, 457629, 457630, and 664531, which are previously filed and registered by the present applicant. It was provided with a hollow cylindrical body having a certain length to have a rhombic space, the both ends provided by welding.

Such a medical stent will always have a radial and longitudinal elastic force to return to the initial state unless it is forcibly suppressed by an external force.

Such a medical stent is manufactured using the jig shown in FIGS. 1 and 2, which provides a cylindrical body having a required diameter Φ and a circumference, and distributes the circumferential ratio and length of the cylindrical body at equal intervals. The pins are fixed to the intersections of the set circumferential dividing lines (A1, A2, A3 ... A12) and the length dividing lines (B1, B2, B3 ... B20), respectively. It is to form a hollow cylindrical body of a certain length having a plurality of rhombus-shaped spaces by weaving to cross at different positions in the form bent on the bending.

The medical stent manufactured as described above reduces the volume of the hollow cylindrical body by reducing the number of rhombic spaces, and then inserts it to the lesion site of the lumen through the guide tube, an auxiliary device, and a pusher catheter ( It is pushed into a pusher catheter to push the lesion outwards to expand the passage of the lumen.

In this case, the stent is preferably used by using a diameter larger than about 10-30% and the length of the lesion site of the lumen depending on the use site, that is, the diameter of the body lumen.

However, the stent previously applied and registered by the present applicant was able to be used in the lumen of the form in which the lumen of the body and the lumen of the adsorption site maintain a constant diameter passage, but the lumen such as the esophagus, the large intestine, the small intestine, etc. In the case of the interlocking operation to repeat the partial expansion or contraction for the movement of the contents in the longitudinal direction of the was not suitable for use had a disadvantage of falling.

In other words, each of the stents interweave the wires of the superelastic shape memory alloy to form a rhombus space portion, but each of the stents is formed to cross the wires alternately up and down at each position where the wires cross each other. Since the space portion expands and contracts as a whole, the passage of the lumen widens, so that the linkage operation of repeating partial expansion or contraction is difficult.

That is, the function of the lumen is inferior because the stent does not respond to the interlocking operation of repeating partial expansion or contraction for the movement of the contents in the longitudinal direction of the lumen, such as the esophagus, the large intestine, and the small intestine.

In addition, the stent has a disadvantage in that manufacturing workability and manufacturing productivity are deteriorated since two wires are used as well as the wire is repeatedly manufactured in a plurality of forms of bending patterns.

The present invention was invented to solve all the problems of the prior art, the passage of the lumen by the same peristaltic bending deformation in accordance with the interlocking operation to repeat the partial expansion and contraction in the longitudinal direction of the lumen, such as esophagus, large intestine, small intestine Its purpose is to smoothly provide the interlocking function of the lumen.

The present invention is manufactured by a single superelastic shape memory alloy wire, but because the single pattern shape is repeatedly produced, the object is to provide a simple manufacturing workability and excellent manufacturing productivity.

The present invention has a downwardly moving pattern portion which is formed by a single super-elastic shape memory alloy wire bent ring portion in the longitudinal direction of the top and bottom circumferential direction, and repeating a single movement pattern downward between the top and bottom end; By repeating the upward movement pattern part formed by repeating a single movement pattern upward, the triangular cross-sectional space and the inverse triangular cross-sectional space are formed in the longitudinal direction in the circumferential direction and the transverse direction in the longitudinal direction. It is characterized in that the peristaltic bending deformation to repeat the expansion and contraction.

"와 같이 절곡되고, 상기 상향 이동패턴부의 이동패턴은 "

"와 같이 절곡되게 형성함에 그 특징이 있다.The movement pattern of the downward movement pattern unit is "

Is bent as follows, and the movement pattern of the upward movement pattern portion is "

It is characterized by the formation of the bend as ".

The present invention is manufactured using a single super-elastic shape memory alloy wire, the wire is moved by one space in the diagonal direction from the pin position point of the jig and repeated to manufacture a single pattern shape to move by one space in the horizontal direction again. Therefore, manufacturing workability is simple and manufacturing productivity provides the effect.

First of all, because it has the characteristic of interlocking operation in the longitudinal direction of the stent, in accordance with the interlocking operation that repeats partial expansion and contraction in the longitudinal direction of the lumen, such as the esophagus, large intestine, and small intestine, the peristaltic flexion and deformation to widen the passage of the lumen By providing the lumen interworking function smoothly to ensure the reliability of the product.

1 is a perspective view showing a jig used in the present invention.
2 is a plan view of Fig.
3 is a development view of the pin arrangement configured on the jig used in the present invention.
4 to 8 are exploded views showing a process of constructing a stent by the pin configured in the jig used in the present invention.
9 is a development view showing a stent produced by the jig used in the present invention.
10 and 11 is a schematic view showing a pattern of the present invention.
12 is a front configuration diagram showing the stent of the present invention.
Figure 13 is a front configuration diagram showing an operation relationship of the stent of the present invention.

When described in detail by the accompanying drawings of the present invention.

The stent of the present invention is manufactured by the jig 1 shown in the accompanying drawings, Figs. 1 and 2, which have grooves 3 formed along the longitudinal direction in the cylindrical body 2 and the grooves 3 The pins 4 are coupled to each other at regular intervals.

3 shows how the pin 4 is arranged in the jig 1 in order to manufacture the stent of the present invention, and how the shape memory alloy wire is manufactured by the process of forming the pin as described above. This is a development view of the pin arrangement of the jig.

4 to 7 are exploded views sequentially showing a process of manufacturing the stent of the present invention using the wire 10, Figure 8 shows a complete view of the complete stent by the wire 10 in a developed view.

Therefore, for easy understanding of the present invention, the shape-memory alloy wire of the present invention will be made possible by examining the development process of what is produced with the stent of the present invention.

First, the arrangement of the pin 4 for completing the present invention will be described with reference to FIG. 3.

The pins 4 are arranged in the longitudinal direction in the circumferential direction and the transverse direction in the longitudinal direction of the jig. For convenience, the positions of the pins 4 arranged in the longitudinal direction in the circumferential direction are pin position points A1 and pin positions, respectively. Point (A2) ..... pin position point (A9), pin position point (A12), pin position point (B1), pin position point of the pin (4) located in the transverse direction in the longitudinal direction (B2) ..... It is decided as the pin position point (B20).

In this case, the pin position point A1 is further displayed in the longitudinal direction in the circumferential direction in order to help the understanding of the present invention by displaying one more in the circumferential direction in consideration of the fact that the jig is cylindrical.

The arrangement of the pin is just to explain, for example, to perform the stent to be completed in the present invention, can be added or subtracted according to the diameter size and length of the stent of the present invention to be manufactured.

At this time, the number of the pins 4 arranged in the longitudinal direction in the circumferential direction and the transverse direction in the longitudinal direction of the jig should be formed in an even arrangement as shown in the drawing.

The process of manufacturing the stent of the present invention with the superelastic shape memory alloy wire 10 (hereinafter referred to as wire) in the state having the arrangement of the pins as described above will be described with reference to FIG.

First, the wire 10 is bent and positioned so as to pass through the upper end of the pin position point A3B2 from the start point pin position point A1B1 through the lower portion of the pin position point A2B2.

" 형태의 이동패턴(15)을 형성한다.Looking at this process, as shown in the accompanying drawings, Figures 4 and 9, at the pin position point A1B1 and the pin position point A2B2 the wire 10 moves downward by one space in the diagonal direction, the pin position At the point A2B2 and the pin position point A3B2, the wire 10 moves by one space in the horizontal direction,

Form a movement pattern 15.

And again bent to pass through the upper end of the pin position point (A5B3) from the pin position point (A3B2) through the pin position point (A4B3) and passes in the same manner as described above to the same pattern as the movement pattern (15). It can be seen that it only passes through another pin location point.

Then, the pin position point A5B3 is bent to pass through the pin position point A6B4 and the pin position point A7B4 in the same manner as described above to have the same shape as the movement pattern 15, but only another pin position. It can be seen that the point passes.

Then again pin position point (A8B5), pin position point (A9B5), pin position point (A10B6), pin position point (A11B6), pin position point (A11B6) at pin position point (A7B4). Pin position point (A12B7), pin position point (A1B7) at A11B6), pin position point (A2B8) at pin position point (A1B7), pin position point (A3B8), pin position point at pin position point (A3B8) (A4B9), pin position point (A5B9), pin position point (A6B10) at pin position point (A5B9), pin position point (A7B10), pin position point (A8B11) at pin position point (A7B10), pin position Point A9B11, pin position point A9B11 again pin position point A10B12, pin position point A11B12, pin position point A11B12 pin position point A12B13, pin position point A1B13, again Pin position point (A2B14) to pin position point (A1B13), Pin position point (A3B14), Pin position point (A4B15) to Pin position point (A3B14), Pin position point (A5B15), Pin position point (A5B15) Pin position point (A6B16), pin position point (A7B16), pin position point (A8B17), pin position point (A9B17), pin again Bending so that pin point A10B18, pin position A11B18 at pin point A9B17, pin position point A12B19 and pin position point A1B19 at pin position point A11B18 are passed in the same manner as described above. It can be seen that the process of having the same shape as the movement pattern 15 and merely passing the other pin position point.

" 형태의 이동패턴(15)과 동일한 형태를 가지면서 단지 다른 핀위치점을 통과하게 되는 과정을 18번 반복하여 하향 이동패턴부(16)를 형성함을 알 수 있다.In view of the above, the wire 10 starts from the starting point pin position point A1B1 to the pin position point A1B19.

It can be seen that the downward movement pattern part 16 is formed by repeating the process of passing through another pin position point 18 times having the same shape as the movement pattern 15 of the form “.

After this process, the wire 10 is bent from the pin position point (A1B19) to the pin position point (A2B20) to form a lower bending ring portion 12 and then the pin position point (A2B20) It is bent and positioned to pass through the lower end of the pin position point A4B19 through the upper end of A3B19).

" 형태의 이동패턴(15')을 형성한다.Looking at this process, as shown in the accompanying drawings, Figures 5 and 10, at the pin position point (A2B20) and pin position point (A3B19), the wire 10 moves upward by one space in the diagonal direction, the pin position At point A3B19 and pin position point A4B19, wire 10 moves horizontally by one space to

Form a moving pattern 15 '.

And again bent from the pin position point (A4B19) to pass through the upper end of the pin position point (A5B18) to pass through the lower portion of the pin position point (A6B18) and passes in the same manner as described above to the same as the movement pattern (15 '). It can be seen that it only passes through other pin location points.

Then, the pin position point A6B18 is bent to pass through the pin position point A7B17 and the pin position point A8B17 in the same manner as described above to have the same shape as the movement pattern 15 'and only another pin. It can be seen that it will pass through the location point.

Then again pin position point (A9B16), pin position point (A10B16), pin position point (A11B15), pin position point (A12B15), pin position point (A12B15) at pin position point (A8B17). Pin position point (A1B14), pin position point (A2B14) at A12B15), pin position point (A3B13) at pin position point (A2B14), pin position point (A4B13), pin position point at pin position point (A4B13) (A5B12), pin position point (A6B12), pin position point (A7B11) at pin position point (A6B12), pin position point (A8B11), pin position point (A9B10) at pin position point (A8B11), pin position Point A10B10, again pin position point A11B9 at pin position point A10B10, pin position point A12B9, pin position point A1B8, pin position point A2B8, again at pin position point A12B9 Pin position point (A3B7) to pin position point (A2B8), Pin position point (A4B7), Pin position point (A5B6) to Pin position point (A4B7), Pin position point (A6B6), Pin position point (A6B6) Pin position point (A7B5), pin position point (A8B5), pin position point (A9B4), pin position point (A10B4) Bending so that pin position point A11B3, pin position point A12B3 at position point A10B4, pin position point A1B2 and pin position point A2B2 at pin position point A12B3 are passed in the same manner as the above method It can be seen that the process of having the same shape as the movement pattern 15 'and simply passing through another pin position point.

In view of the above, the wire 10 starts at the pin position point A2B20 to the pin position point A2B2 and has the same shape as the movement pattern 15 ', but passes only another pin position point. It can be seen that the upward movement pattern part 16 ′ repeating the process 18 times is formed.

At this time, the downward movement pattern portion 16 at the pin positions A2B2, A8B5, A2B8, A8B11, A2B14 and A8B17 where the upward movement pattern portion 16 'and the downward movement pattern portion 16 intersect. It can be seen that the wire of the upward movement pattern portion 16 ′ simply passes over the wire.

In other words, the wires are formed so that the wires of the upward movement pattern portion 16 ′ simply pass through the wires of the downward movement pattern portion 16 instead of being interlaced in a staggered form by the hooks as the conventional wires rise and fall. .

After this process, the wire 10 is bent from the pin position point A2B2 to the pin position point A3B1 to form the upper bent ring portion 12 ', and then the pin starts at the pin position point A3B1. The downward movement pattern part 16 is repeated to have the same shape as the movement pattern 15 up to the position point A3B19 but only passes through another pin position point 18 times.

Then, the wire 10 is bent from the pin position point A3B19 to the pin position point A4B20 to form a lower bent ring portion 12, and then starts from the pin position point A4B20 to the pin position point A4B2. The upward movement pattern part 16 ′ having the same shape as the movement pattern 15 ′ and repeating the process of passing only another pin position point 18 times is formed again.

After this process, the wire 10 is again bent from the pin position point A4B2 to the pin position point A5B1 to form the upper bent ring portion 12 ', and then starts at the pin position point A5B1. The downward movement pattern portion 16 having the same shape as the movement pattern 15 to the pin position point A5B19 and merely passing through another pin position point is repeated 18 times, and the wire 10 is formed. Is bent from the pin position point (A5B19) to the pin position point (A6B20) to form the lower bent ring portion 12, and then the movement pattern (15 ') starting from the pin position point (A6B20) to the pin position point (A6B2). In the same shape as), only the upward movement pattern part 16 ′ repeating the process of passing through another pin position point 18 times is formed.

After the above process, the wire 10 is again bent from the pin position point A6B2 to the pin position point A7B1 to form an upper bent ring portion 12 ', and then at the pin position point A7B1. Starting to form a downward movement pattern portion 16 having the same shape as the movement pattern 15 up to the pin position point A7B19 and only passing through another pin position point 18 times. 10) is bent from the pin position point (A7B19) to the pin position point (A8B20) to form the lower bending ring portion 12, and then starting at the pin position point (A8B20) to the pin position point (A8B2) the movement pattern ( 15 ') has the same shape and forms an upward movement pattern portion 16' that repeats the process of passing only another pin position point 18 times.

After the above process, the wire 10 is again bent from the pin position point A8B2 to the pin position point A9B1 to form an upper bent ring portion 12 ', and then at the pin position point A9B1. Starting to form a downward movement pattern portion 16 having the same shape as the movement pattern 15 up to the pin position point A9B19 and only passing through another pin position point 18 times. 10) is bent from the pin position point (A9B19) to the pin position point (A10B20) to form the lower bending ring portion 12, and then starting at the pin position point (A10B20) to the pin position point (A10B2) the movement pattern ( 15 ') has the same shape and forms an upward movement pattern portion 16' that repeats the process of passing only another pin position point 18 times.

After the above process, the wire 10 is bent again from the pin position point A10B2 to the pin position point A11B1 to form an upper bent ring portion 12 ', and then at the pin position point A11B1. Starting to form a downward movement pattern portion 16 having the same shape as the movement pattern 15 up to the pin position point A11B19 and only passing through another pin position point 18 times. 10) is bent from the pin position point (A11B19) to the pin position point (A12B20) to form the lower bending ring portion (12) and then start at the pin position point (A12B20) to the pin position point (A12B2). 15 ') has the same shape and forms an upward movement pattern portion 16' that repeats the process of passing only another pin position point 18 times.

That is, the wire 10 is a downward movement pattern portion 16 formed by repeating a single movement pattern 15 downward, and an upward movement pattern portion 16 formed by repeating a single movement pattern 15 'upward. ') Is repeatedly manufactured, where the wires of the downward movement pattern portion 16 and the upward movement pattern portion 16' cross each other in the form of a stagger by a hook as the wire rises up and down as in the related art. Instead, the upper part of the wire which has already passed is manufactured as the next wire simply passes.

In addition, the wire 10 has been described centering on forming the downward movement pattern portion 16 and the upward movement pattern portion 16 'while repeating the single movement patterns 15 and 15' up and down 18 times. Depending on the diameter, size and length of the stent, it can be added or subtracted.

After the manufacturing as described above, the end of the wire 10 is bent from the pin position point (A12B2) to the pin position point (A1B1) to meet both ends of the wire (10) in the welding or clip fixing Interconnect by.

In such a state, the stent 100 of the present invention may be removed from the jig 1, and subsequent steps such as heat treatment may be used to suit the purpose.

The stent 100 of the present invention prepared as described above forms a ring portion 12 (12 ') bent in the longitudinal direction of the top and bottom circumferential direction as shown in Figure 9 and 12 to 13, Downward movement pattern portion 16 formed by repeating a single movement pattern 15 downwardly between the upper and lower bent ring portions, and upward movement pattern portion 16 'formed by repeating a single movement pattern 15' upward. Repeatedly, the space portion 70 having a triangular cross-sectional shape and the space portion 70 'having an inverted triangle cross-sectional shape are formed in the longitudinal direction in the circumferential direction and the transverse direction in the longitudinal direction.

The stent 100 of the present invention forms a curved ring portion 12 (12 ') at the top and the bottom of the stent when the stent is subjected to the lumen of the human body, and the lumen is damaged by the bending ring portion. To prevent that.

"형상의 단일 이동패턴(15)을 하부로 반복하면서 형성하는 하향 이동패턴부(16)와 "

"형상의 단일 이동패턴(15')을 상부로 반복하면서 형성하는 상향 이동패턴부(16')가 상하로 지나며 교차하는 것에 의해 상기 삼각형 단면 형상의 공간부(70)와 역삼각형 단면 형상의 공간부(70')를 형성한다.In addition, the stent 100 of the present invention is "

And the downward movement pattern portion 16 formed by repeating the shape of the movement pattern 15 downward.

The space of the triangular cross-sectional shape and the space of the inverted triangular cross-section is formed by the crossover of the upward movement pattern portion 16 'formed by repeating the shape of the single movement pattern 15' upwardly. The part 70 'is formed.

At this time, at the position where the wires of the downward movement pattern portion 16 and the upward movement pattern portion 16 'intersect, the wires are lifted up and down as in the prior art, and the wires that have already gone through are not interlaced in a staggered form by hooks. To form the next wire simply passes.

Therefore, the stent 100 of the present invention partially contracts the diameter of the stent while the space portion formed by the downward movement pattern portion 16 and the upward movement pattern portion 16 'is reduced by the force acting in the circumferential direction. In the case of partial expansion, the diameter of the stent is expanded to allow the interlocking operation of repeating contraction and expansion.

For this reason, the stent 100 of the present invention is installed in the narrowing progression or narrowing of the lumen repeating partial expansion and contraction in the longitudinal direction of the lumen, such as the esophagus, the large intestine, and the small intestine to widen the passage of the lumen in response to the lesion site. In particular, in accordance with the interlocking operation of the lumen stent 100 is to provide a linkage function of the lumen smoothly with the linkage bending deformation to partially expand or contract the same.

100: stent
10: Wire
12,12 ': bend ring
15,15 ': Movement pattern
16: downward movement pattern part
16 ': upward movement pattern portion
70: space part of triangular cross-sectional shape
70 ': space section with inverted triangle cross section

Claims (4)

In the method of manufacturing a stent from a super elastic shape memory alloy wire,
By the single super-elastic shape memory alloy wire 10, the bent ring portions 12, 12 'are formed in the longitudinal direction in the circumferential direction at the top and the bottom, and the single moving pattern 15 is lowered between the top and the bottom. Repeating the downward movement pattern portion 16 formed repeatedly while repeating and the upward movement pattern portion 16 'formed repeatedly repeating a single movement pattern 15' to the upper direction in the circumferential direction and the transverse direction in the longitudinal direction. The interlocking flexural deformation is characterized in that it is configured to form a triangular cross-sectional space portion 70 and an inverted triangular cross-sectional space portion 70 'to form an interlocking bending deformation that repeats partial expansion and contraction by external force. Method of making possible stents. The method of claim 1,
The movement pattern 15 of the downward movement pattern unit 16 is "

Is bent as follows, and the movement pattern 15 'of the upward movement pattern portion 16' is "

"The method of producing a stent capable of interlocking bending deformation, characterized in that the bending. In the stent composed of a super elastic shape memory alloy wire,
A single super elastic shape memory alloy wire 10 forms bent ring portions 12, 12 'in the longitudinal direction of the uppermost and lowermost circumferential direction, and a single moving pattern 15 is lowered between the uppermost and lowermost ends. Repeating the downward movement pattern portion 16 formed repeatedly while repeating and the upward movement pattern portion 16 'formed repeatedly repeating a single movement pattern 15' to the upper direction in the circumferential direction and the transverse direction in the longitudinal direction. Interlocking flexural deformation is possible, characterized in that the triangular cross-sectional space portion 70 and the inverted triangular cross-sectional space portion 70 'is formed to form an interlocking bending deformation that repeats partial expansion and contraction by external force. Stent. The method of claim 3,
The movement pattern 15 of the downward movement pattern unit 16 is "

Is bent to form the movement pattern 15 'of the upward movement pattern portion 16'.

The stent is capable of interlocking bending deformation, characterized in that formed by bending as ".

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