The present invention relates, in general, to a stent, and more particularly, to a method for manufacturing a stent having a superior bending characteristic, in which the stent is flexibly bent and is prevented from being folded even when sharply bent, and a wire constituting the stent provides a superior bending characteristic and is prevented from being twisted after being coated, and the stent manufactured thereby.
To dilate internal organs such as a bile duct which are being narrowed or are narrowed by a tumor formed by growth of cancer cells in the villus or its surroundings of the internal organs, medical stents are used.
Various conventional medical stents having various structures are known. As shown in
To prevent cells growing at a spot where a procedure is to be performed, i.e. cancer cells, from penetrating into the stent, the interior and exterior of the cylindrical body 3 are coated with polytetrafluoroethylene (PTFE) or silicone that is not harmful to a human body.
This stent is manufactured as shown in
The stent manufactured using this basic jig 10 is disclosed in Korean Unexamined Patent Application Publication Nos. 10-2001-18024 and 10-2001-18026, both of which are the prior applications of the applicant of the present invention.
The conventional stent is manufactured such that the wire for forming the cells is bent in a right-angled direction. There is no great difficulty in using the stent in a narrowed, smoothly curved blood vessel of the human body. However, when the blood vessel into which the stent is inserted is sharply curved, the stent has a disadvantage in that it fails to provide a flexible bending characteristic so as to correspond to curvature.
Furthermore, in the case of a coated structure for blocking cell penetrable spaces formed by the weaving of the wire formed of a superelastic shape memory alloy or stainless steel, the bending characteristic is further degraded, and thus the stent exhibits a poor bending characteristic when used in vessels with sharply curved portions.
Accordingly, the present invention has been made keeping in mind the above problems occurring in the related art, and is intended to provide a method for manufacturing a stent having a superior bending characteristic, in which wires are woven by alternating an obtuse angle and an acute angle so as to repetitively form starry cells in left and right portions and upper and lower portions of the stent, and in which the wires intersecting each other in the starry cells are allowed to freely move to provide the superior bending characteristic caused by flexibility in both the diametrical direction and lengthwise direction thereof, and the stent manufactured thereby.
In an aspect, the present invention provides a method of manufacturing a stent having a superior bending characteristic, in which a basic jig is used in which projecting pins are assembled at all transition points at which circumference dividing lines and length dividing lines set by equally dividing a circumference and length of a cylinder having the same diameter and length as the stent to be manufactured cross one another, includes a downward wire bending process of moving a strand of wire, which has a predetermined length and is formed of a superelastic shape memory alloy or stainless steel, from an upper starting point to a transition point (projecting pin) at a four-segment diagonal distance to which an upper head is formed in a downward direction and in lengthwise and circumferential directions, bending and moving the wire three times a one-segment diagonal distance at an acute angle and three times a two-segment diagonal distance at an obtuse angle from the transition point (reference point) to another transition point in a zigzag pattern in the lengthwise and circumferential directions, and repeating this process to move the wire at a predetermined distance in the downward direction;
a lower head forming process of bending and moving the wire from the transition point located in the downward wire bending process five times the one-segment diagonal distance at the acute angle in the lengthwise and circumferential directions again, bending and moving the wire from the transition point to another transition point two times a four-segment diagonal distance in a zigzag pattern in the lengthwise and circumferential directions, bending and moving the wire from the transition point to another transition point six times the four-segment diagonal distance in a zigzag pattern in the lengthwise and circumferential directions, and forming a lower head having sexangular bending finishing ends;
an upward wire bending process of bending and moving the wire from the transition point located in the lower head forming process to another transition point seven times the one-segment diagonal distance in the zigzag pattern in the lengthwise and circumferential directions again, bending and moving the wire from the transition point to another transition point three times the two-segment diagonal distance in the zigzag pattern in the lengthwise and circumferential directions, bending and moving the wire from the transition point to another transition point two times the one-segment diagonal distance in the zigzag pattern in the lengthwise and circumferential directions, bending and moving the wire six times from the transition point to another transition point six times the two-segment diagonal distance in the lengthwise and circumferential directions, bending and moving the wire from the transition point to another transition point seven times the one-segment diagonal distance in the zigzag pattern in the lengthwise and circumferential directions, and repeating this process to bend and move the wire at a predetermined distance in the upward direction, whereby the wires are joined crosswise at the transition points (bending vertexes) overlapped with the transition points of the downward wire bending process, and are bent in the upward direction;
an upper head forming process of bending and moving the wire from the transition point located in the upward wire bending process to another transition point two times the one-segment diagonal distance at the acute angle in the zigzag pattern in the lengthwise and circumferential directions again, bending and moving the wire from the transition point to another transition point six times the four-segment diagonal distance in the zigzag pattern in the lengthwise and circumferential directions, bending and moving the wire from the transition point to another transition point two times the one-segment diagonal distance at the acute angle in the zigzag pattern in the lengthwise and circumferential directions, bending and moving the wire from the transition point to another transition point six times the four-segment diagonal distance in the zigzag pattern in the lengthwise and circumferential directions, and forming an upper head having the sexangular bending finishing ends; and
a finishing connecting process of bending and moving the wire from the transition point located in the upward wire bending process to another transition point (projecting pin) three times the one-segment diagonal distance at the acute angle in the zigzag pattern in the lengthwise and circumferential directions, positioning the wire at the two-segment diagonal distance at the obtuse angle in the lengthwise and circumferential directions once, and connecting the portion overlapped with the wire bent and positioned in the downward wire bending process by welding.
The stent manufactured by this manufacturing method is configured so that the cells formed by the crossed wires are formed as repetitive starry cells in which the acute angle bending vertexes bent at the acute angle and the obtuse angle bending vertexes bent at the obtuse angle are joined crosswise and in which the obtuse angle bending vertexes bent at the obtuse angle and the acute angle bending vertexes bent at the acute angle are crossed, and so that the wire bent at the obtuse angle are formed in the starry cell in a simple crossed structure, and provides a flexible bending characteristic by expansion/contraction between the bent vortexes joined crosswise in the event of expansion/contraction or bending in a lengthwise direction and simultaneously by rapid movement of the internal crossed wires.
According to the present invention, a strand of wire is bent from an upper portion to a lower portion at acute and obtuse angles, and from the lower portion to the upper portion at the acute and obtuse angles again. In this process, the bent wire is joined crosswise with another bent wire at bent vortexes, and moves upward. The wires are crossed in opposite directions at the bent vortexes, thereby repetitively forming starry cells. As a result, a stent having a predetermined size is rapidly manufactured.
The cells formed at the wire intersections have a unique starry shape without being folded when expanded/contracted and bent. Thereby, the stent is flexibly bent without being folded after being coated, and thus reliability of a product is ensured.
10: basic jig, 11: projecting pin, 100; stent, 200: wire, 201: acute angle bending vertex, 202: obtuse angle bending vertex, 210, 211: bending finishing end, 300: welding, C1: rhombic cell, C2: starry cell
The present invention provides a stent that has a superior bending characteristic, is flexibly bent, and is prevented from being folded even when sharply bent, and includes a wire that provides a superior bending characteristic and is prevented from being twisted after being coated.
The characteristic primary gist of the present invention can be specified as ensuring a bending characteristic of a stent and providing a flexible bending characteristic after the stent is coated, preventing the stent from folded even when it is bent sharply.
Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.
In
This basic jig 10 is used in which projecting pins 11 are assembled at all transition points at which circumference dividing lines a1, a2, a3, . . . , a13 and length dividing lines b1, b2, b3, . . . , b17, which are set by equally dividing a circumference W and length L of a cylinder having the same diameter Ø and length L of a stent to be manufactured, cross one another.
A detailed configuration of the basic jig is disclosed in Korean Unexamined Patent Application Publication Nos. 10-2001-18024 and 10-2001-18026, both of which are the prior applications of the applicant of the present invention. The basic jig 10 applied to the present invention is different in that the numbers of circumference dividing lines a1, a2, a3, . . . , a13 and length dividing lines b1, b2, b3, . . . , b17, which are set by equally dividing the circumference-to-diameter ratio W and the length L are increased.
A manufacturing method of the present invention using the basic jig 10 will be described.
The manufacturing method of the present invention includes a downward wire bending process, a lower head forming process, an upward wire bending process, an upper head forming process, and a finishing connecting process of connecting a start end and a terminal end of a wire.
Further, the present invention manufactures a stent 100 using a strand of superelastic shape-memory-alloy or stainless wire (hereinafter referred to as a “wire”) having given standards per centimeter.
First, any one of the circumference dividing lines a1, a2, a3, . . . , a13 of the basic jig 10 is set as an arbitrary reference point a1, and a wire 200 extends from the reference point a1 to the projecting pin 11 located at a transition point a5/b2 that is spaced apart from the reference point by a four-segment diagonal distance (4 l) set in the resultant direction of the length L and the diameter Ø.
This process is a basic process of carrying out the upper head forming process.
Here, a one-segment length by which the wire 200 moves along a diagonal line of the length L and the diameter Ø can be defined as a one-segment diagonal distance (1 l). It is appropriate to understand that, in the following description, the transition point is a point at which the wire is bent at each projecting pin 11 assembled into the basic jig 10.
As shown in
That is, as shown in
As shown in
Here, the reason the wire 200 travels five times the one-segment diagonal distance (1 l) from the transition point a11/b14 to the transition point a4/b15 in the zigzag pattern again is to, because a route along which the wire 200 is overlapped in order to form the first triangular bending finishing ends 210 is not formed, form the route along which the triangular wire is overlapped to thereby carry out a bending traveling process.
Further, the reason the wire travels two times the one-segment diagonal distance (1 l) from the transition point a4/b15 to the transition point a6/b15 in the zigzag pattern at the acute angle is to form the route along which the wire 200 is overlapped in order to form the remaining triangular bending finishing ends 210 to thereby carry out the bending traveling process.
As shown in
In detail, as shown in
In the upward wire bending process of sequentially bending the wire 200, the wire is joined crosswise at the transition point (bending vertex) overlapped with the transition point (bending vertex) of the downward wire bending process, and is bent in an upward direction. Thereby, a starry cell C2 is repetitively formed.
As shown in
In the upper head forming process, the reason the wire 200 travels two times the one-segment diagonal distance (1 l) from the transition point a3/b2 to the transition point a5/b2 in the zigzag pattern at the acute angle again is to, because a route along which the wire 200 is overlapped in order to form the first triangular bending finishing ends 211 is not formed, form the route along which the triangular wire is overlapped to thereby carry out a bending traveling process.
Further, the reason the wire travels two times the one-segment diagonal distance (1 l) from the transition point a2/b2 to the transition point a7/b2 in the zigzag pattern at the acute angle is to form the route along which the wire 200 is overlapped in order to form the remaining triangular bending finishing ends 211 to thereby carry out the bending traveling process.
As shown in
Here, the remainders of the start end and the terminal end of the wire 200 excluding the welded portion are cut. In this state, the projecting pins 11 are separated from the basic jig 10, and then a cylindrical body is separated and undergoes heat treatment. Thereby, the stent 100 having a middle body in which the starry cells C2 are formed in the middle thereof as shown in
To perform the heat treatment on the stent 100 manufactured in the manufacturing method of the present invention, a process of forming the hollow cylindrical body and then memorizing its shape at such a temperature as to avoid losing elasticity of the wire 200 is used. This heat treatment technique is disclosed in detail in the prior application of the present applicant, and so detailed description thereof will be omitted.
As shown in
In other words, the wires 200 are woven in such a manner that the acute angle bending vertexes 201 and the obtuse angle bending vertexes 202, which are bent downward at the acute angle of the one-segment diagonal distance (1 l) and at the obtuse angle of the two-segment diagonal distance (2 l) in a predetermined cycle in the downward wire bending process, and the obtuse angle bending vertexes 202 and the acute angle bending vertexes 201 of the wire 200, which are bent upward at the obtuse angle of the two-segment diagonal distance (2 l) and at the acute angle of the one-segment diagonal distance (1 l) in a predetermined cycle in the upward wire bending process, are joined crosswise. Thereby, the starry cells C2 are repetitively formed as shown in
Here, the wires 200 are bent and crossed at an acute angle in the starry cells C2 in a simple crossed structure, and are rapidly displaced when expansion/contraction between the acute angle bending vertexes 201 and the obtuse angle bending vertexes 202 joined crosswise take place in the event of longitudinal expansion or bending. Thus, a flexible bending characteristic is provided.
As shown in
As shown in
In other words, the acute angle bending vertexes 201 at which the crossing of the wires 200 forming the starry cells C2 is bent and formed at an acute angle and the obtuse angle bending vertexes 202 at which the crossing of the wires 200 forming the starry cells C2 is bent and formed at an obtuse angle are joined crosswise, and the wires 200 bent at the obtuse angle are joined crosswise and displaced and supported when the expansion/contraction or the bending takes place. Despite severe bending movement, the wires provide flexible movement without being folded. Thus, after a thin film is coated, the coated thin film is not stripped.
Of course, the upper head and the lower head are formed by the wire 200 in which the rhombic cells C1 are formed in two rows and which is uncomplicatedly crossed, and are not accompanied with great stress, so that they do not exert particular influence on the bending movement or expansion.
An actual stent manufactured by the present invention is shown in
That is, in a state in which an inner and/or outer surface of the stent of the present invention is coated with a coating material such as silicone or polytetrafluoroethylene (PTFE) as in a typical method, the stent is bent in the U shape, and is not folded. Thus, it can be found that the bending characteristic of the stent is very good.
This coating material is used to prevent lesion cells from penetrating into a lumen after the stent is inserted into the lumen.
Number | Date | Country | Kind |
---|---|---|---|
10-2011-0004078 | Jan 2011 | KR | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/KR2012/000238 | 1/10/2012 | WO | 00 | 7/2/2013 |