KR102438975B1 - Double structure stent and the manufacturing method thereof - Google Patents

Abstract

The stent of the present invention includes a first structure in which the wire is bent in a zigzag shape and connected to each other by the bent portion 11, and a wire extending parallel to each other in the first spiral direction, the first spiral direction and a second structure in which wires extending parallel to each other in a second spiral direction opposite to each other are braided and connected to each other, and the wire in the first spiral direction of the second structure and the second spiral Each of the directional wires crosses over or under a plurality of radially outward wire segments at a plurality of intersections, and is formed by four bends of the first structure In the rhombic space, the wire in the first spiral direction and the wire in the second spiral direction of the second structure cross and pass.

Description

Double structure stent and the manufacturing method thereof

The present invention relates to a dual structure stent including a first structure and a second structure and a method for manufacturing the same, and the stent according to the present invention has excellent flexibility, and deformation in the longitudinal and radial directions is minimized.

Recently, various methods have been disclosed to conveniently treat a lesion site such as a stenosis of a body or an aneurysm of a blood vessel without performing a surgical operation, and one of them is a procedure using a stent.

The stent is usually composed of a hollow cylindrical body having a number of space parts and a constant length by weaving a shape memory alloy material.

Conventionally, as a structure of a stent, a structure in which a wire is hooked to the V-shaped structure at the top (hereinafter, V-structure), or a structure in which the upper and lower ends do not overlap at the intersection while forming a single line to both ends (hereinafter, Y-structure) has been used a lot, and in recent years, attempts have been made to improve the function of the stent by various structural modifications, not limited to the above-described single structure.

As an example, Patent Documents 1 and 2 discloses a dual structure stent including a first structure having a V-structure and a second structure having a V-structure. The first stent and the second stent are connected by crossing over or under each other.

The stents of Patent Documents 1 and 2 described above, as constituted by two V-structures, have improved flexibility and conformability, and have the advantage that they can be configured in a desired shape. However, when an external force is applied to the stent, at each V-structure itself and/or between two V-structures, the stent cells overlap each node to cause kink, so that even after the external force is removed, the original shape is restored. There is a problem that it does not come back as it is and it shortens in a straight line. Therefore, the stents of Patent Documents 1 and 2 have a limitation that deployment is not easy.

As another example, Patent Document 3 proposes a double-structured stent composed of at least two mesh segments, an inner segment and an outer segment. The inner segment and the outer segment are connected together in one continuous piece, and the outer segment is inverted and folded over the inner segment to form a stent having a dual structure of the outer segment and the inner segment.

The stent of Patent Document 3 may have a double structure formed in an easy manner, but since the inner segment and the outer segment are simply connected by a fold, there is a limitation in that the connection between the segments is unstable. In addition, when the deformation is applied to the stent, there is a problem that precise deformation is difficult because the inner segment and the outer segment are not integrally deformed.

As another example, Patent Document 4 proposes a single structure stent in which a V-structured weave section and a Y-structure cross section are alternately arranged.

However, in the stent of Patent Document 4, there is still a limitation of a single structure stent, and when deployed, kink due to deformation occurs in the weaving section, and in the cross section, the deformation is extended to the periphery of the cell to which the deformation is applied, There is a limit in that it is difficult to use precisely.

Patent Document 1: International Publication WO2017/039389 (published on March 9, 2017)

Patent Document 2: Korean Patent Registration No. 10-2055990 (published on December 18, 2017)

Patent Document 3: US Patent Publication US 8,663,314 B2 (published on June 14, 2012)

Patent Document 4: Korean Patent Registration No. 10-1735702 (published on October 10, 2016)

An object of the present invention is to provide a stent that is excellent in flexibility, and which deformation is minimized during deployment. In addition, the present invention does not generate a kink when a compressive force in the longitudinal direction is applied, and as the deformation is gently extended when a compressive force in the radial direction is applied, a stent that can be deployed in a shape suitable for the diseased site It is a challenge to provide

In one embodiment of the stent according to the present invention for solving the above problems, the stent is a structure in which the wire is bent in a zigzag shape and connected to each other by the bent portion 11, the first structure (1), and the first spiral direction The wire 21 extending parallel to each other and the wire 22 extending parallel to each other in the second spiral direction opposite to the first spiral direction are braided and connected to each other. A second structure (2) is included, and each of the wire (21) in the first helical direction and the wire (22) in the second helical direction of the second structure (2) includes the wire (21) in the first helical direction. And at a plurality of intersection points where the second spiral direction wire 22 meets, cross over the wire segment of the first structure 1 or cross the bottom of the wire segment of the first structure 1 In the rhombic space 12 formed by the four bent portions 11 of the first structure 1 passing through, the wire 21 and the second spiral of the second structure 2 in the first spiral direction Directional wires 22 can cross over.

In one embodiment, each of the first helical wire 21 and the second helical wire 22 of the second structure 2 is above the wire segment of the first structure 1 and the first It is possible to alternately cross under the wire segments of the structure 1 .

In one embodiment, the first helical wire 21 of the second structure 2 comprises the wire segment of the first structure 1 and the second helical wire 22 of the second structure 2 . ) can intersect the segments of

In one embodiment, the first helical wire 21 of the second structure 2 comprises a wire segment of the first structure 1 and the second helical wire 22 of the second structure 2 . may alternately intersect the segments of

In one embodiment, at the center of the space 12 , the wire 21 in the first spiral direction and the wire 22 in the second spiral direction of the second structure 2 may cross each other.

In one embodiment of the method for manufacturing a stent according to the present invention, the wire is bent in a zigzag shape to form a first structure 1, which is a structure connected to each other by a bent portion 11, and a first spiral The wire 21 extending parallel to each other in the direction and the wire 22 extending parallel to each other in the second spiral direction opposite to the first spiral direction are braided and connected. and a second step of forming a second structure (2), wherein each of the wire (21) in the first spiral direction and the wire (22) in the second spiral direction of the second structure (2) comprises the first spiral At a plurality of intersection points where the directional wire 21 and the second helical wire 22 meet, cross over segments of the wire of the first structure 1 or the wire of the first structure 1 The first spiral direction of the second structure 2 in the rhombic space 12 formed by the four bent portions 11 of the first structure 1 and formed to cross the bottom of the segment The wire 21 and the wire 22 in the second spiral direction may cross each other.

In one embodiment, after the first step of forming the first structure 1 , the second step of forming the second structure 2 may be performed.

The stent according to the present invention has a structure that is connected by crossing the first structure of the V-structure and the second structure of the Y-structure from above or below, so that it has excellent flexibility, but also has excellent flexibility, depending on the stent cell structure during deployment It shows the effect that there is no star overlap. In addition, when deformation is applied to the stent, it has the effect of being able to easily deploy the stent to the affected area by gently deforming the shape as it has a slight effect on the surrounding cells while having the expansion force for each cell. see.

By the method for manufacturing a stent according to the present invention, it is possible to manufacture a stent having both the advantages of the independent cell expansion force of the V-structure and the inhibition of kink generation of the Y-structure, and the V-structure and Y- structure having different connection methods Structures can be connected simply and easily.

1 is a stent according to the present invention.
FIG. 2 is an enlarged view of A of FIG. 1 .
3 is an enlarged view of (a) the stent of Comparative Example 1 prepared only with the first structure, and (b) B. FIG.
4 is an enlarged view of (a) the stent of Comparative Example 2 prepared only with the second structure, and (b) C. FIG.
5 is a comparison of the flexibility and conformability of (a) the stent of Example 1 according to the present invention, (b) the stent of Comparative Example 1, and (c) the stent of Comparative Example 2;
Figure 6 compares the kink generation of (a) the stent of Example 1 according to the present invention, (b) the stent of Comparative Example 1, and (c) the stent of Comparative Example 2.
7 is a comparison of the deformation angles of (a) the stent of Example 1 according to the present invention, (b) the stent of Comparative Example 1, and (c) the stent of Comparative Example 2.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Further, the present invention is not limited to the following embodiments, but may be realized in any feasible combination as well as in separate ways that a person skilled in the art will recognize. Moreover, the scope of the present invention is not limited by the preferred embodiments. Furthermore, embodiments are schematically illustrated in the drawings. Herein, like reference numerals in these drawings indicate identical or functionally similar elements.

1 shows the overall structure of the stent of the present invention, in one embodiment according to the present invention, the stent may be a hollow cylindrical having a longitudinal axis (X).

FIG. 2 is an enlarged view of A, which is a part of the stent according to FIG. 1 , wherein the stent may comprise a first structure 1 in a V-configuration and a second structure 2 in a Y-configuration. The number of structures constituting the stent is not limited to two, and may be three or more. In addition, the structure to be added may be a V-structure, a Y-structure, or other structures.

FIG. 3 shows an embodiment of a first structure 1 of a V-structure, and FIG. 4 shows an embodiment of a second structure 2 of a Y-structure.

Referring to FIG. 3 , the first structure 1 may have a structure in which a wire is bent in a zigzag shape and connected to each other by a bent portion 11 . The bent portions 11 may be arranged at unequal intervals.

Referring to FIG. 4 , the second structure 2 includes wires 21 extending parallel to each other in a first helical direction, and parallel to each other in a second helical direction opposite to the first helical direction. The extending wires 22 may be braided and connected to each other. The wire 21 in the first spiral direction and the wire 22 in the second spiral direction may be woven to extend in parallel with the same or different intervals, respectively.

The stent according to an embodiment of the present invention includes both a first structure 1 having a V-structure and a second structure 2 having a Y-structure as shown in FIG. 2 . That is, the first structure 1 having a structure in which the wires are bent in a zigzag shape and connected to each other by the bent portion 11, and the wire 21 extending parallel to each other in the first spiral direction, and the first The second structure 2 may include a structure in which wires 22 extending parallel to each other in a second spiral direction opposite to the spiral direction are braided and connected to each other.

In one embodiment, each of the first helical wire 21 and the second helical wire 22 of the second structure 2 intersects above the radially inward wire segments at a plurality of intersection points. It may pass or cross under a plurality of radially outward wire segments.

In the present invention, a 'wire segment' may mean a part of the entire wire. That is, it can mean a part of the wire of the first structure 1, the wire 21 of the first spiral direction of the second structure 2, or the wire 22 of the second spiral direction of the second structure 2 have. If, in addition to the first structure (1) and the second structure (2), other structures are included, the wire of the added structure may also be included.

In addition, in the present invention, 'radially inward' may mean diametrically close to the longitudinal axis (X) of the stent, and 'radially outward' means radially with respect to the longitudinal axis (X) of the stent. It can mean distant.

That is, the wire 21 of the first helical direction of the second structure 2 has a wire 22 segment of the second helical direction of the second structure 2 and/or the wire segment of the first structure 1 . if disposed radially inward, cross over it; The wire 21 in the first helical direction of the second structure 2 has a second helical wire 22 segment of the second structure 2 and/or the wire segment of the first structure 1 radially outward. If placed as a , you can cross and pass under it.

In the same way, the second helical wire 22 of the second structure 2 is a segment of the first helical wire 21 of the second structure 2 and/or the wire of the first structure 1 . If the segment is disposed radially inward, it crosses over it; The wire 22 in the second helical direction of the second structure 2 has a segment of the wire 21 in the first helical direction of the second structure 2 and/or the wire segment of the first structure 1 radially outward. If placed as a , you can cross and pass under it.

In one embodiment, in the rhombic space 12 formed by the four bent portions 11 of the first structure 1, the wire 21 in the first spiral direction of the second structure 2 and The wires 22 in the second helical direction can cross and pass.

In an embodiment, the first helical wire 21 of the second structure 2 can alternately cross over the radially inwardly inward wire segment and under the radially outwardly directed wire segment. Separately or simultaneously, the wire 21 in the first helical direction of the second structure 2 is formed between the segment of the wire 22 in the second helical direction of the second structure 2 and the first structure 1 . It may cross the wire segments, preferably alternately.

In one embodiment, the second helical wire 22 of the second structure 2 may alternately cross over the radially inwardly inward wire segments and under the radially outwardly directed wire segments. Separately or simultaneously, the wire 22 in the second helical direction of the second structure 2 is formed between the segment of the wire 21 in the first helical direction of the second structure 2 and the first structure 1 . It may cross the wire segments, preferably alternately.

In an embodiment, the first helical wire 21 of the second structure 2 is a segment of the second helical wire 22 of the second structure 2 and/or of the first structure 1 . Crossing the wire segments alternately above or below, at the same time the wire 22 of the second helical direction of the second structure 2 , the wire 21 of the first helical direction of the second structure 2 , ) segments and/or wire segments of the first structure 1 alternately intersect above or below.

In one embodiment, in the rhombic space 12 formed by the four bent portions 11 of the first structure 1, the wire 21 in the first spiral direction of the second structure 2 and The wires 22 in the second helical direction can cross and pass. The number of intersection points of the wires in the space 12 may be one or more.

In one embodiment, at the center of the space 12 , the wire 21 in the first helical direction and the wire 22 in the second helical direction of the second structure 2 may cross and pass.

According to the stent according to the present invention, while the coupling of the first structure (1) and the second structure (2) is strong, the first structure (1) and the second structure (2) can be flexibly deformed, so that various It has the advantage that it can be easily deployed to a location. In addition, the stent according to the present invention has an independent cell expansion force, which is an advantage of the V-structure, and at the same time has a characteristic that kink generation, which is an advantage of the Y-structure, is suppressed. Moreover, the stent according to the present invention can return to its original state when the deformation is removed while accommodating the deformation when deformation is applied in the longitudinal and diametric directions.

Next, a method for manufacturing a stent according to the present invention will be described. In the method of manufacturing a stent according to an embodiment of the present invention, the wire is bent in a zigzag shape to form a first structure (1) that is a structure connected to each other by a bent portion (11), and a first spiral The wire 21 extending parallel to each other in the direction and the wire 22 extending parallel to each other in the second spiral direction opposite to the first spiral direction are braided and connected. a second step of forming a second structure (2), wherein each of the wire (21) in the first spiral direction and the wire (22) in the second spiral direction of the second structure (2) is formed at a plurality of intersection points , formed to cross over a segment of a radially inward wire segment or to cross over a segment of a radially outward wire segment, and a rhombus space formed by the four bends 11 of the first structure 1 . In the portion 12 , the wire 21 in the first helical direction and the wire 22 in the second helical direction of the second structure 2 may cross and pass.

In one embodiment, after the first step of forming the first structure 1 , the second step of forming the second structure 2 may be performed.

In one embodiment, forming the first structure 1 , after which the wire 21 in the first helical direction of the second structure 2 is placed above or below the wire segment of the first structure 1 . connecting so as to cross over, and thereafter, the wire 22 of the second helical direction of the second structure 2 is connected to the wire segment of the first structure 1 and/or It may include the step of connecting to cross over or below the wire 21 segment in the second spiral direction.

In one embodiment, the second helical wire 22 of the second structure 2 may comprise alternatingly passing over a radially inwardly inward wire segment and under a radially outwardly directed wire segment. . Separately or simultaneously, the wire 22 in the second helical direction of the second structure 2 is formed between the segment of the wire 21 in the first helical direction of the second structure 2 and the first structure 1 . It may cross the wire segments and may preferably include alternating crossings.

According to the method for manufacturing a stent according to the present invention, the combination of the first structure (1) and the second structure (2) is simple and easy, and the manufactured stent has excellent properties in flexibility, expansion force, elasticity, deformation resistance, etc. There are advantages.

Next, below, a stent according to an embodiment of the present invention shown in FIGS. 1 and 2 (hereinafter, 'Example 1'), a stent consisting only of the V-structure shown in FIG. 3 (hereinafter, 'Comparative Example 1') ), and the properties of the stent consisting only of the Y-structure shown in FIG. 4 (hereinafter, 'Comparative Example 2') are compared. 5 (a) to (c) show the characteristics of flexibility and adaptability according to the modifications of Example 1, Comparative Example 1, and Comparative Example 2, respectively, and FIGS. 6 (a) to (c) are each carried out Example 1, Comparative Example 1, and Comparative Example 2 shows whether kink occurs according to the longitudinal compression, (a) to (c) of Figure 7 are in the radial direction of Example 1, Comparative Example 1 and Comparative Example 2, respectively shows the deformation angle and shape according to the compression of

Figure 3 shows the deformation of the stent after applying the folding deformation so that the length of the stent is half.

Figure 3 (a) shows the example 1, which has excellent flexibility and returns to its original shape when the external force applied temporarily is removed. Therefore, the stent of Example 1 has the advantage that it can be stably deployed to any lesion site.

On the other hand, FIG. 3 (b) is Comparative Example 1, and the conformability is very high, and after deformation is applied to the stent of Comparative Example 1, it is hardly possible to return to the original shape.

Figure 3 (c) is Comparative Example 2, excellent flexibility and almost no conformability, even after applying a deformation to bend the stent is stretched to its original shape.

That is, Example 1 has the advantages of flexibility and deformation resistance similar to those of Comparative Example 2.

Next, Figure 4 shows the deformation of the stent after applying a compressive force in the longitudinal direction to the stent.

Figure 4 (a) is Example 1, when a compressive force is applied to the stent, overlap occurs for each node depending on the cell structure, but after the compressive force is removed, the stent is straightened again and returns to its original shape. . Therefore, since the stent of Example 1 does not have a problem that the length of the stent is shortened during deployment, deployment is easy.

Figure 4 (b) is Comparative Example 1, when a compressive force is applied to the stent, overlap occurs for each node depending on the cell structure, showing the result that the length of the stent is shortened in a straight line even after the compressive force is removed. Therefore, the stent of Comparative Example 1 is highly likely to have a problem of shortening the stent length during deployment.

Figure 4 (c) is Comparative Example 2, when a compressive force is applied to the stent, there is no overlap for each node depending on the cell structure.

That is, Example 1, like Comparative Example 2, has an advantage that kink does not occur even after a compressive force in the longitudinal direction is applied.

Next, Figure 5 shows the deformation of the stent in a state in which a compressive force is applied in the radial direction of the stent.

The stent of Comparative Example 1 shown in FIG. 5 (b) has an expansive force for each cell. Accordingly, since the cells in the portion to which the compressive force is applied do not affect the surrounding cells, the deformation angle is steep and the length of the deformed region is the shortest.

In the stent of Comparative Example 2 shown in FIG. 5(c), each cell has an expansive force in association with the surrounding cells. Accordingly, the cells in the portion to which the compressive force is applied also affect the surrounding cells, so that the length of the deformed region is too long.

The stent of Example 1 shown in Figure 5 (a), while having an expansion force for each cell, affects the surrounding cells to some extent.

Accordingly, the deformation angle and the length of the deformed region of Example 1 are most suitable as intermediate between those of Comparative Examples 1 and 2 described above.

5 to 7, the stent according to the present invention, including both the advantages of the V-structure and the advantages of the Y-structure, shows superior properties than the single structure of V or Y, and in a single structure stent Since the problems appearing are suppressed, there is an advantage that easy deployment is possible.

The terms used in the present application are only used to describe specific embodiments, and are not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly dictates otherwise. In the present application, terms such as "comprises" are intended to designate that the described feature, number, step, action, component, or combination thereof exists, but one or more other features or number, step, action, It should be understood that the possibility of the presence or addition of components, or combinations thereof, is not precluded in advance.

1 first structure
11 bend
12 space department
2 second structure
21 wire in the first spiral direction
22 wire in the second helix direction

Claims (7)

As a stent,
A first structure (1) in which the wire is bent in a zigzag shape and connected to each other by a bent portion (11), and
A wire 21 extending parallel to each other in a first helical direction and a wire 22 extending parallel to each other in a second helical direction opposite to the first helical direction are braided with each other, a second structure (2) that is a connected structure,
Each of the wire 21 in the first spiral direction and the wire 22 in the second spiral direction of the second structure 2 is the wire 21 in the first spiral direction and the wire 22 in the second spiral direction. ) crosses over the wire segment of the first structure 1 or crosses under the wire segment of the first structure 1 at a plurality of intersection points where ) meets,
In the rhombic space 12 formed by the four bent portions 11 of the first structure 1, the wire 21 in the first spiral direction of the second structure 2 and the second spiral direction A stent, characterized in that the wires (22) cross over. The method of claim 1,
Each of the first helical wire 21 and the second helical wire 22 of the second structure 2 is above the wire segment of the first structure 1 and of the first structure 1 . A stent that alternately crosses under a wire segment. 3. The method according to claim 1 or 2,
The first helical wire 21 of the second structure 2 intersects the wire segment of the first structure 1 and the segment of the second helical wire 22 of the second structure 2 . By passing, the stent. 4. The method of claim 3,
The wire 21 in the first helical direction of the second structure 2 alternates between the wire segments of the first structure 1 and the segments of the second helical wire 22 of the second structure 2 A stent that crosses and passes by. The method of claim 1,
In the center of the space (12), the wire (21) in the first spiral direction and the wire (22) in the second spiral direction of the second structure (2) cross and pass. A method for manufacturing a stent, comprising:
A first step of forming a first structure (1) in which the wire is bent in a zigzag shape to be connected to each other by the bent portion (11), and
Wires 21 extending parallel to each other in a first spiral direction and wires 22 extending parallel to each other in a second spiral direction opposite to the first spiral direction are braided and connected a second step of forming a second structure (2) which is a structure to be
Each of the wire 21 in the first spiral direction and the wire 22 in the second spiral direction of the second structure 2 is the wire 21 in the first spiral direction and the wire 22 in the second spiral direction. ) is formed so as to cross over the segment of the wire of the first structure (1) or cross over the segment of the wire of the first structure (1) at the plurality of intersection points where they meet,
In the rhombic space 12 formed by the four bent portions 11 of the first structure 1, the wire 21 in the first spiral direction of the second structure 2 and the second spiral direction A method of making a stent, allowing wires (22) to cross over. 7. The method of claim 6,
A method of manufacturing a stent, wherein after the first step of forming the first structure (1), a second step of forming the second structure (2) is performed.

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