KR20200142910A - Stent and Manufacturing Method thereof - Google Patents

Abstract

The present invention relates to a stent and a manufacturing method thereof. In particular, the present invention provides a method for manufacturing a stent, which uses a jigjag installed with a detachable pin at an intersection between a circumferential dividing line (x1, x2,..., x9, X10) and a length dividing line (y1, y2,...., y21, y22) set by distributing the circumference and length of a cylindrical body having the same diameter and length as the manufactured stent at equal intervals of horizontal and vertical pitches (Ph, Pv), respectively. The method comprises the steps of: repeatedly moving a plurality of patterns for bending a first wire up and down from a first starting point of one end of the jig to form a first stent in which the first cells of the same rhombus shape are repeatedly arranged by the intersection between the first wires; and repeatedly moving a plurality of different patterns for bending a second wire up and down from a second starting point of the other end of the jig to form a second stent in which the second cells of the same rhombus shape are repeatedly arranged by the intersection between the second wires, in which the first cell and the second cell have a rhombus shape of the same size and are provided in an asymmetric shape with different lengths of sides, and the first cell and the second cell are vertically arranged to cross each other by one vertical pitch (Pv) to form the second stent. By forming a double stent pattern in which two cells are overlapped, it is possible to minimize deformation by maximizing resistance to external forces in the radial and longitudinal directions, and to improve shape retention by preventing distortion even against bending.

Description

Stent and manufacturing method thereof TECHNICAL FIELD

The present invention relates to a stent and a method of manufacturing the same, and in particular, by forming a double stent pattern in which two cells are overlapped, the resistance to external forces in the radial direction and the length direction is maximized, thereby minimizing deformation due to this. It relates to a stent and a method of manufacturing the same.

In general, the stent is used for the purpose of expanding the affected part of the lumen of the human body to which the passage is narrowed due to disease, trauma, surgery, or the like.

These stents are known for various structures, and generally include a cylindrical wire structure formed to have a peak portion and a valley portion along the periphery by winding a wire in a specific method, and a cover film formed in a state surrounding the wire structure. Is composed.

Most wire-type stents have a shape-memory alloy wire that has approximately rhombus-shaped cells, and consists of two wires that cross each other to maintain a cylindrical tube shape, and are intersected up and down to form a rhombus cell. Configure.

However, the stent has a problem in that it cannot maintain the curvature of the lumen because it expands unconditionally by a predetermined length in the longitudinal direction, especially in the curved lumen area, because all stent cells are connected. In particular, resistance to external forces in the radial and longitudinal directions There is a problem that the original shape is not well maintained due to weak strength.

KR 457629

Accordingly, the object of the present invention is to maximize the resistance to external forces in the radial and longitudinal directions by forming a double stent pattern in which two cells are overlapped, thereby minimizing deformation due to this, and preventing distortion even against bending. It is to provide a stent that can improve shape retention and a method of manufacturing the same.

In addition, another object of the present invention, it is possible to reduce the profile (diameter) of the stent while maintaining or increasing the strength, when inserting the stent into the insertion device, it is possible to minimize the diameter of the tube into which it is inserted, It is to provide a stent that can be easily operated even in a lumen having a small diameter and a method of manufacturing the same.

The above object is, according to an embodiment of the present invention, a circumferential division set by distributing the circumference and length of a cylindrical body having the same diameter and length as the manufactured stent into equally spaced horizontal and vertical pitches (Ph, Pv), respectively. In the stent manufacturing method using a jig with a detachable pin installed at the intersection of the line (x1, x2,...,x9,X10) and the length division line (y1,y2,....,y21, y22) , By repeatedly moving a plurality of patterns bending the first wire up and down from the first starting point of one end of the jig, the first stent in which the first cells of the same rhombus shape are repeatedly arranged by the intersection between the first wires is formed. And; By repeatedly moving a plurality of different patterns for bending the second wire up and down from the second starting point of the other end of the jig, a second stent in which second cells having the same rhombus shape are repeatedly arranged by the intersection between the second wires Including the step of, wherein the first cell and the second cell have a rhombus shape of the same size, but are provided in an asymmetric shape having different side lengths, and the first cell and the second cell have one vertical pitch It is achieved by the stent manufacturing method of forming the second stent so as to be intersected up and down by (Pv).

In the step of forming the first stent, the first wire starts from the first starting point located at the uppermost end of the jig and descends in a pattern set to the first switching point at the lowest end of the jig, and then back to the first starting point. In the step of forming the second stent, the second wire is extended and connected in a set different pattern, and the second wire starts from the second starting point located at the lowermost end of the jig and rises to a set pattern to a second switching point at the top end of the jig. After that, it may be connected by extending another pattern set to the second starting point again.

Specifically, in the forming of the first stent, starting from the first starting point (x1, y1) located at the uppermost end (y1) of the jig and the first turning point (x7, y22) at the lowermost end (y22) of the jig Whenever the horizontal pitch (Ph) moves 1 to the right, the vertical pitch (Pv) is 2 falling, 1 falling, 2 falling and 2 rising 1-1 pattern (10A), and the first switching point (x7, y22) Whenever the horizontal pitch (Ph) moves to the right by 1, the vertical pitch (Pv) repeats rising and falling by 1, and when the horizontal pitch (Ph) moves by 1 at the intersection with the 1-1 pattern, the vertical pitch (Pv) increases. 2 The rising 1-2 pattern 10B and the vertical pitch Pv repeats falling and rising by 2 each time the horizontal pitch Ph moves to the right at the end point of the 1-2 pattern. Including a 1-3 pattern (10C) in which the vertical pitch (Pv) rises by 1 when the horizontal pitch (Ph) moves by 1 at the intersection point with the pattern, and the 1-2 patterns and the 1-3 patterns are repeated alternately and the first One wire may extend and be fixed to the first starting point (x1, y1).

Specifically, in the forming of the second stent, starting from the second starting point (x10, y22) located at the lowermost end (y22) of the jig and the second turning point (x4, y1) at the uppermost end (y1) of the jig Whenever the horizontal pitch (Ph) moves to the left by 1, the vertical pitch (Pv) rises by 2, rises by 1, rises by 2, and falls at the 2-1 pattern (20A) and the second switching point (x4, y1). Whenever the horizontal pitch (Ph) moves to the left by 1, the vertical pitch (Pv) repeats downward and upward by 1, and when the horizontal pitch (Ph) moves by 1 at the intersection with the 2-1 pattern, the vertical pitch (Pv) increases. 2 Whenever the horizontal pitch (Ph) increases by 1 to the left at the end point of the 2-2 pattern (20B) and the 2-2 pattern is descending, the vertical pitch (Pv) repeats rising and falling by 2, and the 2- When the horizontal pitch (Ph) increases by 1 at the intersection point with the 1 pattern, the vertical pitch (Pv) includes a 2-3 pattern (20C) that falls by 1, and the 2-2 pattern and the 2-3 pattern are repeated alternately. It may be extended and fixed to the second starting point (x10, y22).

In each embodiment, the horizontal pitch Ph and the vertical pitch Pv may have the same length.

Meanwhile, the first cell and the second cell may have a length of 2:1 when they face each other.

Alternatively, the wire may have a diameter in the range of 0.171 to 0.185 mm, the jig may be provided as a cylinder having a diameter of 10 mm, and the number of circumferential dividing lines may be provided in ten.

Therefore, according to the stent and its manufacturing method according to the present invention, a double stent pattern in which two cells are overlapped is formed, thereby maximizing resistance against external forces in the radial and longitudinal directions, thereby minimizing deformation and bending. Also, it is possible to prevent crushing, thereby improving shape retention.

In addition, the present invention can maintain or increase the strength while reducing the profile (diameter) of the stent, so that when inserting the stent into the insertion device, the diameter of the tube into which it is inserted can be minimized, so that the lumen having a small diameter It can also be easily performed.

1 is a perspective view of a stent according to an embodiment of the present invention,
Figure 2 is a pattern diagram of the stent shown in Figure 1,
3 is a cross-sectional view of the jig,
4 is a pattern diagram of a first stent according to an embodiment of the present invention,
5 is a detailed pattern excerpt of the first stent shown in FIG. 4;
6 is a pattern diagram of a second stent according to an embodiment of the present invention,
7 is a detailed pattern extract of the second stent shown in FIG. 6.

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

In the stent manufacturing method according to an embodiment of the present invention, a plurality of patterns for bending the first wire up and down from the first starting point of one end of the jig 100 are repeatedly moved, and the same diamond is formed by crossing the first wires. Forming a first stent 10 in which the first cells 13 of the shape are repeatedly arranged; By repeatedly moving a plurality of different patterns for bending the second wire up and down from the second starting point of the other end of the jig 100, the second cells 23 of the same rhombus are repeatedly arranged by the intersection between the second wires. And forming the second stent 20.

Here, the first cell 13 and the second cell 23 form a rhombus shape of the same size, but are provided in an asymmetric shape with different lengths of opposite sides, and the first cell 13 and the second cell 23 Is characterized in that the second stent 20 is formed so as to intersect vertically by one of the vertical pitches Pv.

Accordingly, the present invention maximizes the resistance against external forces in the radial direction and the length direction by forming a double stent pattern in which two cells are overlapped, as shown in FIG. 2, thereby minimizing deformation due to this, and also against bending. As it can prevent dents, shape retention can be improved.

In the present invention, "wire" means a strand constituting a stent.

The diameters of the first wire and the second wire may be provided in the range of 0.171 to 0.185 mm, which is relatively thicker than the diameter of the wire used in the conventional stent.

Accordingly, the present invention has the advantage of maintaining or increasing strength while reducing the profile (diameter) of the stent 1. Therefore, when inserting the stent into the insertion device, the diameter of the tube into which the stent is inserted can be minimized, so that the procedure can be easily performed even in a lumen having a small diameter.

The wire may be made of, for example, a shape memory alloy material.

For reference, in FIG. 2, the first stent 10 is indicated by a solid line and the second stent 20 is indicated by a dotted line to distinguish them in the drawing, and is completely independent of the thickness of each wire.

Meanwhile, in the present invention, "cell" refers to an empty space formed by wires. As shown in the enlarged view of FIG. 2, in the present invention, each of the cells 13 and 23 is provided in the same rhombus shape, and specifically, the lengths of the sides l1 and l2 facing each other are provided in an asymmetric shape, The ratio of the length can be provided as 2:1, for example.

Each of the cells 13 and 23 crosses and is arranged by a set pitch, for example, a vertical pitch Pv, to form an overlapping portion 30 at the center, thereby maximizing resistance against external force.

Hereinafter, each step will be described.

3, the jig 100 is set by distributing the circumference and length of a cylindrical body having the same diameter and length as the manufactured stent 1 in equally spaced horizontal pitches (Ph) and vertical pitches (Pv). A detachable pin 103 is installed at a point where one circumferential division line (x1, x2,....x9, x10) and length division lines (y1, y2, ....y21, y22) intersect.

Here, the diameter of the jig 100 and the number of circumferential dividing lines (that is, the number of detachable pins 103) may be provided in various ways, but the circumference is 10 mm and the circumferential dividing line (x1,x2,...) is 10 Can be prepared with dogs. In this case, by setting the diameter of the stent 1 in consideration of the thickness of the wire to be described later, it is not only easy to install when the stent 1 is inserted, but also improves the strength against radial force in the radial direction after installation. The stent 1 can maintain its original shape.

Meanwhile, the horizontal pitch Ph and the vertical pitch Pv may be provided in various ways, may be provided with different lengths, or may be provided with the same length as shown in FIG. 4.

Referring to FIGS. 4 and 5, a step of forming the first stent 10 according to an embodiment of the present invention will be described.

In the forming of the first stent 10, a plurality of patterns for bending the first wire up and down are repeatedly moved from the first starting point of one end of the jig 100 to form the same rhombus by the intersection between the first wires. The first cells 13 of are arranged repeatedly.

Preferably, in the step of forming the first stent 10, the first wire is a pattern set to the first starting point (starting from 0 and the lowest end of the jig 100) located at the top of the jig 100 After descending to the first starting point, it may be extended and connected to another pattern set to the first starting point.

Referring to FIG. 4, the forming of the first stent 10 includes starting from the first starting point (x1, y1) located at the uppermost end (y1) of the jig, and starting from the lowermost end of the jig. 1-1 pattern (10A) in which the vertical pitch (Pv) is 2 falling, 1 falling, 2 falling and 2 rising each time the horizontal pitch Ph moves to the right 1 to the first turning point (x7, y22) of (y22) Includes. (See Fig. 5(a)).

As the 1-1 pattern 10A is repeated, the jig 100 rotates and extends from the first starting point (x1, y1) to the first switching point (x7, y22).

When the first wire reaches the first turning point (x7, y22), it repeats in a zigzag between y21 and y22 in a 1-2 pattern 10B as shown in FIG. 5B. That is, every time the horizontal pitch Ph moves to the right from the first turning point (x7, y22) by one, the vertical pitch Pv repeatedly rises and falls by one. And, when the horizontal pitch Ph moves by one at the intersection with the 1-1 pattern ((x6,y21) in FIG. 5(b)), the vertical pitch Pv rises by 2 and extends to the next pattern.

As for the 1-3 pattern 10C, as shown in FIG. 5C, every time the horizontal pitch Ph moves to the right by 1 at the end point of the 1-2 pattern 10B, the vertical pitch Pv is 2 Each descending and rising is repeated, and when the horizontal pitch Ph moves by one at the intersection with the 1-1 pattern, the vertical pitch Pv increases by one.

Thereafter, as the 1-2 patterns and 1-3 patterns are repeated alternately, the first wire extends to the first starting point (x1, y1) so that the ends of the first wires are fixed to each other.

Here, the 1-2 pattern 10B and the 1-3 pattern 10C only have a difference in the length of the repeating up and down, and when the two patterns have the same vertical repetition length, the first pattern is the same regardless of the pattern. It extends to the starting point.

6 and 7, a step of forming the second stent 20 according to an embodiment of the present invention will be described.

The second stent 20 differs from the first stent 10 in a starting point and a traveling direction, but the progress of each specific pattern is the same.

In the step of forming the second stent 20, the second wire starts from a second starting point located at the lowest end of the jig 100, rises in a pattern set to the second switching point at the top of the jig 100, and then again It may be connected by extending another pattern set to the second starting point.

Specifically, in the forming of the second stent, referring to FIGS. 6 and 7, starting from the second starting point (x10, y22) located at the lowest end (y22) of the jig 100, the uppermost end ( Each time the horizontal pitch Ph moves to the left 1 to the second turning point (x4, y1) of y1), the vertical pitch (Pv) increases by 2, increases by 1, increases by 2, and falls by 2 to 1 pattern (20A). Include. (See Fig. 7(a))

In the 2-2 pattern 20B, as shown in (b) of FIG. 7, every time the horizontal pitch Ph moves to the left from the second switching point x4 and y1, the vertical pitch Pv decreases by one and When the horizontal pitch (Ph) moves by one at the crossing point with the pattern 2-1 after repeating the rise, the vertical pitch (Pv) falls by two.

In the 2-3 pattern (20C) pattern, as shown in (c) of FIG. 7, every time the horizontal pitch Ph increases by 1 to the left at the end point of the 2-2 pattern, the vertical pitch Pv increases by 2 and When the descent is repeated and the horizontal pitch Ph increases by 1 at the intersection with the 2-1 pattern, the vertical pitch Pv decreases by 1.

In addition, as in the first stent 10, the 2-2 patterns and the 2-3 patterns are alternately repeated and extended to and fixed to the second starting points x10 and y22.

1: stent
10: first stent 13: first cell
20: second stent 23: second cell
100: jig

Claims (8)

Circumferential dividing lines (x1, x2,...,x9,X10) set by distributing the circumference and length of a cylindrical body having the same diameter and length as the manufactured stent at equally spaced horizontal and vertical pitches (Ph, Pv), respectively. ) And length division lines (y1,y2,....,y21, y22) in the stent manufacturing method using a jig installed with a detachable pin at the intersection,
A first stent in which the first cells of the same rhombus shape are repeatedly arranged by the crossing between the first wires by repeatedly moving a plurality of patterns for bending the first wire up and down from the first starting point of one end of the jig. Step and;
By repeatedly moving a plurality of different patterns for bending the second wire up and down from the second starting point of the other end of the jig, a second stent in which second cells having the same rhombus shape are repeatedly arranged by the intersection between the second wires Including the step of,
The first cell and the second cell have a rhombus shape of the same size, but are provided in an asymmetric shape having different side lengths,
The stent manufacturing method of forming the second stent so that the first cell and the second cell are vertically intersected by one of the vertical pitches Pv. The method of claim 1,
In the step of forming the first stent, the first wire starts from the first starting point located at the uppermost end of the jig and descends in a pattern set to the first switching point at the lowest end of the jig, and then back to the first starting point. It is connected by extending in a different pattern set,
In the forming of the second stent, the second wire starts from the second starting point located at the lowest end of the jig and rises in a pattern set to the second switching point at the top end of the jig, and then is set again to the second starting point. A method of manufacturing a stent that is extended and connected in a different pattern. The method of claim 2,
The step of forming the first stent,
Every time the horizontal pitch (Ph) moves 1 to the right, starting from the first starting point (x1, y1) located at the top end (y1) of the jig to the first turning point (x7, y22) at the bottom end (y22) of the jig The vertical pitch (Pv) is 2 falling, 1 falling, 2 falling and 2 rising 1-1 pattern (10A), and the horizontal pitch (Ph) is vertical every 1 movement to the right from the first switching point (x7, y22) 1-2 patterns 10B in which the vertical pitch Pv rises by 2 when the pitch Pv repeats rising and falling by 1 and the horizontal pitch Ph moves by 1 at the intersection with the 1-1 pattern, and the Whenever the horizontal pitch (Ph) moves 1 to the right at the end of the 1-2 pattern, the vertical pitch (Pv) repeats falling and rising by 2, and the horizontal pitch (Ph) moves by 1 at the intersection with the 1-1 pattern. When the vertical pitch (Pv) includes a 1-3 pattern (10C) that rises by 1, the first wire until the first starting point (x1, y1) as the 1-2 pattern and the 1-3 pattern are repeated alternately. A stent manufacturing method that is extended and fixed. The method of claim 2,
Forming the second stent,
Every time the horizontal pitch (Ph) moves 1 to the left from the second starting point (x10, y22) located at the bottom end (y22) of the jig to the second turning point (x4, y1) at the top end (y1) of the jig A 2-1 pattern (20A) in which the vertical pitch (Pv) rises by 2, rises by 1, rises by 2, and falls by 2, and the horizontal pitch (Ph) moves 1 to the left from the second switching point (x4, y1). 2-2 pattern 20B in which the vertical pitch Pv falls by 2 when the pitch Pv repeats falling and rising by 1 and the horizontal pitch Ph moves by 1 at the intersection with the 2-1 pattern, and the Whenever the horizontal pitch (Ph) increases to the left by 1 at the end of the 2-2 pattern, the vertical pitch (Pv) repeats rising and falling by 2, and the horizontal pitch (Ph) is 1 at the intersection with the 2-1 pattern. Includes 2-3 patterns (20C) in which the vertical pitch (Pv) decreases by 1 when increasing, and the 2-2 patterns and 2-3 patterns are repeated alternately and extended to the second starting point (x10, y22) and fixed The stent manufacturing method. The method according to claim 3 or 4,
The method of manufacturing a stent in which the horizontal pitch (Ph) and the vertical pitch (Pv) are provided with the same length. The method of claim 1,
The first cell and the second cell, the length of the side (l1, l2) facing each other is provided in a 2:1 stent manufacturing method. The method of claim 1,
The wire is provided in the range of 0.171 ~ 0.185mm in diameter, the jig is provided in a cylinder having a diameter of 10 mm, the circumferential dividing line is provided in 10 stent manufacturing method. A stent prepared by the method according to claim 1.

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