KR102486166B1 - Stent, Method and Pin-combined Jig for Forming the Same - Google Patents

Abstract

A stent of the present invention includes a first bending part and a second bending part. The first bending part is bent while protruding in a first direction, and includes a 1-1 ring part and a 1-2 ring part integrally extending from the 1-1 ring part in a protruding direction. The second bending part is bent while protruding in a second direction opposite to the first direction, and includes a 2-1 ring part inserted and coupled with the 1-2 ring part. The present invention is to provide the stent, a method for forming the same, and a pin-combined jig, which can increase workability and additionally increase performance of the stent (compression force, expansion force, and the like).

Description

Stent, method of forming it and pin-combined jig {Stent, Method and Pin-combined Jig for Forming the Same}

The present invention relates to a stent, and more particularly, to a hook-inserted stent for inserting and connecting two opposing hooks (or twisted or bent parts), a method for forming the stent, and a pin-coupled jig.

When strictures occur in the lumen of the human body, such as the esophagus, duodenum, bile duct, urethra, airway, etc., due to tumors or other causes, the relevant organs cannot function normally. In this case, the stent may be inserted into the stenosis site to expand the stenosis site. As described above, stents are widely used to secure a passage in a human body lumen.

The stent consists of a cylindrical body having a mesh structure in the form of a plurality of rhombuses by weaving wires of superelastic shape memory alloy crosswise from above and below in a diagonal direction. The mesh-structured cylindrical body expands the stricture area while radially tensioning.

Korean Patent Publication No. 10-2001-0084836 (stent) discloses a stent having a mesh structure in which a plurality of bending parts are formed along a circumferential surface and wires are hooked from bottom to top or from top to bottom to connect the bent parts.

Korean Patent Registration No. 1753206 (stent for connection) is configured to have a plurality of cells by crossing metal wires, but at the intersection, the metal wires are connected by hanging them from bottom to top or from top to bottom.

However, like a conventional stent, when a wire is hooked (hooked) from bottom to top or from top to bottom in a bending part, it is difficult to increase productivity due to limitations in reducing working time.

In addition, like the conventional stent, when the wire is hooked up and down (or back and forth) in the bending part and connected (hooked), the independent movement of the wire in the bending part is restricted, and as a result, the performance of the stent (compression force, expansion force, etc.) is added difficult to improve.

[Prior patent literature]

1. Korean Patent Publication No. 10-2001-0084836 (stent)

2. Korean Patent Registration No. 1753206 (stent for connection)

The present invention is to solve the problems of the prior art,

First, in the process of weaving wires using a jig, the time required to connect (or hook) the wire at the bending part (or intersection) is reduced to increase workability,

Second, to provide a stent, a method for forming the stent, and a pin-coupled jig that can further increase the performance (compressive force, expansion force, etc.) of the stent by maximizing independent movement between the wires coupled (or hooked) in the bending portion. .

A stent according to the present invention for achieving this object may include a first bending part and a second bending part.

The first bending portion may include a 1-1 ring portion that is bent while protruding in a first direction, and a 1-1 ring portion and a 1-2 ring portion integrally extending from the 1-1 ring portion in a protruding direction.

The second bending portion may include a 2-1 ring portion that is bent while protruding in a second direction opposite to the first direction and inserted and coupled with the 1-2 ring portion.

In the stent of the present invention, the 1-2 ring portion is larger than the 2-1 ring portion and may be embedded in the 2-1 ring portion.

In the stent of the present invention, the size of the 1-2nd ring portion may be 1.5 to 3.0 times larger than that of the 2-1st ring portion.

In the stent of the present invention, the 1-1 ring portion and the 1-2 ring portion may have the same size.

In the stent of the present invention, the first direction may be a forward direction (direction from the starting point of weaving the wire to the turning point), and the second direction may be a reverse direction (direction from the turning point to the starting point).

In the stent of the present invention, the first bending portion may include a 1-3 ring portion extending integrally between the 1-1 ring portion and the 1-2 ring portion.

In the stent of the present invention, the 1-3 ring portion is smaller than the 1-1 ring portion and the 1-2 ring portion and may have the same size as the 2-1 ring portion.

The pin-coupled jig according to the present invention may be configured as a cylindrical body having a plurality of pinholes that open at least outward. The plurality of pinholes include a first pinhole, a second pinhole spaced apart from the first pinhole in the longitudinal direction and having the same size, and a size smaller than the first and second pinholes spaced apart in the longitudinal direction between the first pinhole and the second pinhole. A pinhole set in which a third pinhole is arranged may be included. The pinhole sets may be spaced apart in the lengthwise and widthwise directions.

In the pin-coupled jig of the present invention, the pinhole set may be arranged in a lattice form.

In the pin-coupled jig of the present invention, the pinhole set may be arranged in a zigzag shape.

In the pin-coupled jig of the present invention, the first and second pinholes may have a size 1.5 to 3.0 times larger than the third pinhole.

The pin-coupled jig of the present invention may include first, second, and third pins. One side of the first, second, and third pins may be selectively closely inserted into the first, second, and third pin holes, respectively, and the other side may protrude outward.

A method of forming a stent using a pin-coupled jig according to the present invention may include forming a first bending part, forming a second bending part, and combining the bending part.

In the step of forming the first bending portion, the wire is obliquely extended along the forward direction (direction from the starting point of weaving the wire to the turning point), while extending while surrounding 1/2 of the first pin to form 1/2 of the 1-1 loop portion After forming and extending while surrounding the second fin to form the 1-2 ring portion, the remaining 1/2 of the 1-1 ring portion may be formed while surrounding the remaining 1/2 of the first fin.

In the step of forming the second bending portion, the wire may be extended obliquely along the reverse direction (direction from the turning point to the starting point), but extending while surrounding the third pin to form the 2-1st ring portion.

In the coupling of the bending part, the 1-2 ring part may be inserted and coupled to the 2-1 ring part.

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In the stent forming method of the present invention, the step of combining the bent parts may be performed manually.

Another method of forming a stent using the pin-coupled jig according to the present invention may include forming a first bending part, forming a second bending part, and combining a bending part.

In the step of forming the first bending portion, the wire is obliquely extended along the forward direction (direction from the starting point of weaving the wire to the turning point), while extending while surrounding 1/2 of the first pin to form 1/2 of the 1-1 loop portion forming, extending while surrounding 1/2 of the third fin to form 1/2 of the 1-3 ring portion, extending while surrounding the second fin to form the 1-2 ring portion, and then forming the 3rd fin The remaining 1/2 of the 1-3 ring portion may be formed while surrounding the remaining 1/2, and the remaining 1/2 of the 1-1 ring portion may be formed while surrounding the remaining 1/2 of the first pin.

In the step of forming the second bending portion, the wire may be extended obliquely along the reverse direction (direction from the turning point to the starting point), but extending while surrounding the third pin to form the 2-1st ring portion.

In the coupling of the bending part, the 1-2 ring part may be inserted and coupled to the 2-1 ring part.

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In another stent forming method of the present invention, the step of combining the bent part may be performed manually.

According to the stent, its formation method, and jig of the present invention having such a configuration, in the process of weaving the wires using the jig, the wires of the bending part (or intersection) are crossed (that is, walked from bottom to top or top to bottom) to connect By forming a loop (or hook, twist) without (or hooking) and inserting and connecting them, automation is possible, and as a result, productivity can be greatly improved by increasing workability.

In addition, according to the stent, its formation method, and jig of the present invention, a gap is created between the wires hooked (or inserted) in the bending part, so that independent movement between the wires on both sides can be maximized, and as a result, the performance of the stent ( compression force, expansion force, etc.) may be additionally increased.

1 shows a bent portion of a stent of a first embodiment according to the present invention.
Figure 2 shows a process of combining the bent part in the stent of the first embodiment according to the present invention.
Figure 3 shows a bent portion of the stent of the second embodiment according to the present invention.
Figure 4 shows a process of combining the bent part in the stent of the second embodiment according to the present invention.
Figure 5 shows a pin-coupled jig of the first embodiment according to the present invention.
6 shows a pin-coupled jig of a second embodiment according to the present invention.
7a and 7b illustrate a process of forming a bent portion in the stent of the first embodiment according to the present invention.
8a and 8b illustrate a process of forming a bent portion in a stent of a second embodiment according to the present invention.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

1 shows a bent portion of a stent of a first embodiment according to the present invention.

As shown in FIG. 1, the stent 100 of the first embodiment is configured to have a mesh structure in the form of a rhombus by combining (weaving) a wire (W) at a bending portion (A) while extending in an oblique (or diagonal) direction. And the overall shape can form a cylindrical body.

The bending part (A) is a part for inserting and connecting the hook area of the wire (W), in the first direction (downward in FIG. 1, that is, from the starting point (top) to the turning point (bottom) It includes a first bending part A11 protruding in a direction) and a second bending part A12 protruding in a second direction (upward in FIG. 1, that is, a direction from the turning point (bottom) to the starting point (top)). can do.

The first bending portion A11 is bent while protruding in a first direction (downward in FIG. 1 ), and integrally extends from the 1-1 ring portion R11 and the 1-1 ring portion R11 in the protruding direction. It may include the formed first-second ring part (R12).

The 1-1st ring portion R11 and the 1-2nd ring portion R12 may have a circular shape, an elliptical shape, or a bell shape in plan view while one wire W is stacked on the lower and upper sides.

The 1-1 ring portion R11 and the 1-2 ring portion R12 may have the same shape and size.

In the first bending portion A11, when the stent 100 is stretched (expanded) in the width direction (left and right in FIG. 1), the size (or diameter) of the 1-1 ring portion R11 decreases, The size (or diameter) of the first-second ring portion R12 may increase.

The second bending part A12 is bent while protruding in the second direction (upward in FIG. 1 ), and may include the 2-1st ring part R21 .

The 2-1st ring part (R21) may bind to the 1-2nd ring part (R12). Here, the 2-1st ring part R21 may incorporate (or insert) the 1-2nd ring part R12.

The 2-1 ring portion R21 may have a circular shape, an elliptical shape, a bell shape, or the like in plan view while one wire W is stacked on the lower and upper sides.

The 2-1 ring portion (R21) may be configured to have a smaller size (or diameter) than the 1-1 ring portion (R11) and the 1-2 ring portion (R12) described above, and the 1-1 ring portion (R11) and the 1-2nd ring portion (R12) may have a size (or diameter) 1.5 to 3.0 times larger than that of the 2-1st ring portion (R21). Here, when the difference in size (or diameter) is less than 1.5 times, when the 2-1 ring part (R21) internally couples the 1-2 ring part (R12), the 1-2 ring part (R12) is the first ring part (R12). 2-1 It can be separated from the ring part (R21). On the other hand, when the size (or diameter) difference exceeds 3.0 times, the wire (W) is elastic when the 1-2 ring portion (R12) is internally coupled to the 2-1 ring portion (R21) after heat treatment of the stent Even if it has, it is not easy for the operator to manually insert the 1-2 ring portion (R12) into the 2-1 ring portion (R21), which may reduce workability.

In the second bending portion A12, when the stent 100 is stretched (expanded) in the width direction (left and right in FIG. 1), the size (or diameter) of the 2-1 ring portion R21 may decrease. there is.

The wire W described above may be made of metal, synthetic polymer, natural polymer, or the like.

As for the metal, it may be desirable to use a shape enterprise alloy, for example, a nickel-titanium shape memory alloy or a martensitic nickel-titanium shape memory alloy. etc. can be used. As other metals, stainless steel, tantalum, tungsten (W, tungsten), etc. can be used.

As the synthetic polymer, a degradable polymer or a non-degradable polymer may be used. Degradable polymers include poly(lactic acid) and copolymers thereof, poly(glycolic acid) and copolymers thereof, and the like, and non-degradable polymers include polyamides : nylons), poly(cyano acrylates), and polyphosphazenes.

Natural polymers include collagen, albumin, silk protein, poly(L-lysine), poly(L-glutamic acid), and poly(aspartic acid). acid)) and the like can be used.

The wire W may be made of one material or a combination of two or more materials. In order to uniformly maintain the expansion rate in the longitudinal direction and the compression rate in the width direction, it may be preferable to use one material.

The wire (W) may be made of a material having elasticity, and the surface may be coated so that it can be used in the human body lumen.

Figure 2 shows a process of combining the bent part in the stent of the first embodiment according to the present invention.

As shown in FIG. 2, in the bending part A, the 2-1st ring part R21 of the second bending part A12 is connected to the 1-2nd ring part R12 of the first bending part A11. Can be combined while embedding.

Since both the 1-2 ring part R12 and the 2-1 ring part R21 have elasticity, the operator compresses the 1-2 ring part R12 in one direction to reduce its size (or diameter). After that, it can be inserted into the 2-1 ring part (R21). In addition, since the 1-2 ring portion R12 and the 2-1 ring portion R21 are made of a shape memory alloy, the operator can reduce the size (or diameter) of the 1-2 ring portion R12. After being inserted into the 2-1 ring part R21, when the external force applied to the 1-2 ring part R12 is removed, the 1-2 ring part R12 is restored to its original shape (circular shape, etc.) It can be built (inserted) firmly into the 2-1 ring part (R12) having a small size (or diameter).

In this built-in (insertion) coupling, when the stent 100 is stretched (expanded) in the width direction (left and right in FIG. 2), the size (or diameter) of the first-second ring portion R12 increases and the second While the size (or diameter) of the -1 ring portion R21 decreases, the 1-2 ring portion R12 may be more firmly coupled to the 2-1 ring portion R21.

Figure 3 shows a bent portion of the stent of the second embodiment according to the present invention.

As shown in FIG. 3, the stent of the second embodiment is integrally formed extending between the 1-1 ring portion R11 and the 1-2 ring portion R12 in the first bending portion A21. 1-3 ring parts (R13) may be further provided.

The 1-3 ring part R13 is smaller than the 1-1 ring part R11 and the 1-2 ring part R12, and may have the same size as the 2-1 ring part R12.

The 1-3 ring portion R13 may have a circular shape, an elliptical shape, a bell shape, or the like in plan view while one wire W is stacked on the lower and upper sides.

Even in the stent of the second embodiment, the 2-1st ring part R21 can be coupled while embedding (inserting) the 1-2nd ring part R12 at the bottom of the first bending part A21.

In the stent of the second embodiment, the remaining components are the same as the corresponding components of the stent 100 of the first embodiment described above, so the detailed description of the remaining components is replaced with the description related to the stent of the first embodiment above. .

Figure 4 shows a process of combining the bent part in the stent of the second embodiment according to the present invention.

As shown in FIG. 4 , in the bending part, the 2-1 ring part R21 of the second bending part A12 embeds the 1-2 ring part R12 of the first bending part A21 while can be combined

Also in the stent of the second embodiment, both the 1-2 ring portion R12 and the 2-1 ring portion R21 have elasticity, so that the operator compresses the 1-2 ring portion R12 in one direction. After reducing the size (or diameter), it may be inserted into the 2-1 ring part (R21). In addition, since the 1-2 ring portion R12 and the 2-1 ring portion R21 are made of a shape memory alloy, the operator can reduce the size (or diameter) of the 1-2 ring portion R12. After being inserted into the 2-1 ring part R21, when the external force applied to the 1-2 ring part R12 is removed, the 1-2 ring part R12 is restored to its original shape (circular shape, etc.) It can be built (inserted) firmly into the 2-1 ring part (R12) having a small size (or diameter).

In this built-in (insertion) coupling, when the stent is stretched (expanded) in the width direction (left and right in FIG. 4), the size (or diameter) of the first and second ring portions R12 may decrease slightly, but the first Since the 1-2 ring portion R12 is formed to be 1.5 times or more larger than the 2-1 ring portion R21 and the size (or diameter) of the 2-1 ring portion R21 is reduced, the 1-2 ring portion R21 is reduced in size. The ring part R12 can still be firmly built-in to the 2-1 ring part R21.

Figure 5 shows a pin-coupled jig of the first embodiment according to the present invention.

Figure 5 is a development view showing the outer surface of a pin-coupled jig (ie, a stent manufacturing frame) usually configured in a cylindrical shape by unfolding it. , It may be a division of 32 lines of scale in the length (vertical) direction. The crossing point of the scale may be a bending point at which the wire can be bent.

As shown in FIG. 5, the pin-coupled jig of the first embodiment may include a plurality of pinholes P1 to P3 that open at least outward.

The plurality of pinholes P1 to P3 include a first pinhole P1, a second pinhole P2 spaced apart from the first pinhole P1 in the longitudinal direction and having the same size (or diameter), and the first pinhole P1. and a pinhole set PS in which third pinholes P3 having a smaller size (or diameter) than the first and second pinholes P1 and P2 are spaced apart in the longitudinal direction between the and second pinholes P2. can

The pinhole sets PS formed at the bending point may be spaced apart in the longitudinal and width directions, and may be arranged in a lattice form as shown in FIG. 5 . The number and arrangement of bending points (or sets of pinholes) may vary depending on the diameter, length, shape, etc. of the stent.

The first and second pinholes P1 and P2 may have a size (or diameter) 1.5 to 3.0 times larger than that of the third pinhole P3.

Although not explicitly shown in the drawing, a bending pin may be selectively inserted into the bending point of the pin-coupled jig to support the bent wire. That is, the first to third pins (not shown) may be inserted into the first to third pin holes P1 to P3. One side (inside) of the first to third pins (not shown) may be selectively inserted into the first to third pinholes P1 to P3, respectively, and the other side (outside) may protrude outward (away from the surface of the jig). The first to third pins (not shown) may be closely inserted into and fixed to the first to third pin holes P1 to P3, respectively.

Since it is difficult to distinguish and display the first to third pinholes P1 to P3 and the first to third pins (not shown) in a plan view, the description of FIG. In the description, reference numerals PS and P1 to P3 are used to refer to both a pinhole set/pinhole and a pin set/pin.

6 shows a pin-coupled jig of a second embodiment according to the present invention.

As shown in FIG. 6, the pin-coupled jig of the second embodiment may arrange the pinhole set/pin set (PS: P1 to P3) in a zigzag form.

In the pin-coupled jig of the second embodiment, the remaining components are the same as the corresponding components of the pin-coupled jig of the first embodiment described above, so the detailed description of the remaining components is given in the pin-coupled jig of the first embodiment above. Replaced with the related explanation of

7a and 7b illustrate a process of forming a bent portion in the stent of the first embodiment according to the present invention.

7a and 7b are development views showing a state in which a wire is bent by unfolding the outer surface of a pin-coupled jig (ie, a stent manufacturing frame). (x1, x2, x3, ..., x14) may be divided into 32 scales (y1, y2, y3, ..., y31, y32) in the length (vertical) direction, and the intersection of the scales The point may be a bending point at which the wire can be bent.

In the stent manufacturing method, bending while going from top to bottom (ie, Y1 to Y32) of the wire W is forward bending, and bending while going from bottom to top (ie, Y32 to Y1) of the wire W It can be defined as reverse bending. Further, bending means an act of extending the wire W while bending it at a bending point.

A first method for forming a stent using a pin-coupled jig according to the present invention includes forming a first bending part (FIG. 7A), forming a second bending part (FIG. 7B), and combining a bending part (FIG. 2). can include

As shown in FIG. 7A, the first bending part forming step extends the wire W obliquely along the forward direction (the direction from the starting point of weaving the wire to the turning point), but at the bending points (X9, Y13), first The distal half of the 1-1st ring part R11 may be formed by enclosing and extending the 1/2 of the 1 pin P1 from the far side in the traveling direction.

Thereafter, the 1-2 ring part R12 is formed by extending while surrounding the second pin P2 from the far side, and then the 1-1 ring part R12 is surrounded by the remaining 1/2 of the first pin P1 ( R11) may form the remaining half.

As shown in FIG. 7B, in the step of forming the second bending part, the wire W is obliquely extended along the reverse direction (direction from the turning point to the starting point) at the bending points X9 and Y13 at which the first bending part is formed. , It may surround and extend the third fin P3 to form the 2-1st ring portion R21.

As shown in FIG. 2 , in the coupling of the bending part, the 1-2 ring part R12 may be manually inserted into the 2-1 ring part R21 and combined.

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8a and 8b illustrate a process of forming a bent portion in a stent of a second embodiment according to the present invention.

As shown in FIGS. 8A and 8B, the second method of forming a stent using a pin-coupled jig includes forming a first bending portion (FIG. 8A), forming a second bending portion (FIG. 8B), and combining the bending portion. step (Fig. 4).

As shown in FIG. 8A, the first bending part forming step extends the wire W obliquely along the forward direction (the direction from the starting point of weaving the wire to the turning point), but at the bending points (X9, Y13), first The distal half of the 1-1st ring part R11 may be formed by enclosing and extending the 1/2 of the 1 pin P1 from the far side in the traveling direction.

1/2 of the 1-3 ring portion R13 may be formed by extending the third pin P3 while surrounding 1/2 from the far side.

The first-second ring part R12 may be formed by extending while surrounding the second pin P2 from the far side.

Thereafter, while moving upward, the remaining 1/2 of the 1-3 ring portion R13 may be formed while surrounding the remaining 1/2 of the third fin P3.

Finally, the remaining 1/2 of the 1-1 ring portion R11 may be formed while surrounding the remaining 1/2 of the first fin P1.

As shown in FIG. 8B, in the step of forming the second bending part, the wire W is obliquely extended along the reverse direction (direction from the turning point to the starting point) at the bending points X9 and Y13 at which the first bending part is formed. , It may surround and extend the third fin P3 to form the 2-1st ring portion R21.

As shown in FIG. 4 , in the coupling of the bending part, the 1-2 ring part R12 may be manually inserted into the 2-1 ring part R21 and combined.

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The present invention has been described above as examples, but these are for illustrating the present invention. A person of ordinary skill in the art may change or modify these embodiments in other forms. However, since the scope of the present invention is determined by the claims below, such variations or modifications may be interpreted as being included in the scope of the present invention.

100: stent W: wire
A: bending part A11, A21: first bending part
A12: 2nd bending part R11: 1-1st ring part
R12: 1-2nd ring part R13: 1-3rd ring part
R21: 2-1 ring part PS: pin hole (or pin) set
P1~P3: Pinhole (or pin)

Claims (18)

a first bending portion that is bent while protruding in a first direction, and includes a 1-1 ring portion and a 1-2 ring portion integrally extending from the 1-1 ring portion in a protruding direction;
A stent comprising a second bending portion having a 2-1 ring portion that is bent while protruding in a second direction opposite to the first direction and insert-coupled with the 1-2 ring portion. According to claim 1, wherein the 1-2 ring portion
A stent larger than the 2-1 ring portion and embedded in the 2-1 ring portion. The method of claim 2, wherein the 1-2 ring portion
A stent having a size 1.5 to 3.0 times that of the 2-1 ring portion. According to claim 1, wherein the 1-1 ring portion and the 1-2 ring portion
Stents, having the same size. According to claim 1,
The first direction is the forward direction (the direction from the starting point of weaving the wire to the turning point),
The second direction is a reverse direction (direction from the turning point to the starting point), the stent. The method according to any one of claims 1 to 5, wherein the first bending part
A stent having a 1-3 ring portion extending integrally between the 1-1 ring portion and the 1-2 ring portion. The method of claim 6, wherein the 1-3 ring portion
A stent having the same size as the 2-1 ring portion and smaller than the 1-1 ring portion and the 1-2 ring portion. delete delete delete delete delete delete delete delete delete delete delete

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