KR102692668B1 - Stent and apparatus for fabricating the same - Google Patents

Abstract

The stent has a first crest, a first trough, a second crest, and a second trough sequentially repeated along the circumferential direction, and a plurality of first rings E having a wave shape with an amplitude in the longitudinal direction. It may include _i (i is a natural number from 1 to n, and n is a natural number of 2 or more) and a plurality of first bridges connecting the first ring E _i-1 and the first ring E _i . A plurality of first rings E _i are formed to be spaced apart from each other along the longitudinal direction, and the first ring E _i-1 and the first ring E _i are the first ridge and the first ring E i-1 of the first ring E _i-1 along the longitudinal direction. It can be arranged to have a phase difference along the circumferential direction so that the second ridges of the first ring E _i correspond. In addition, the stent includes a plurality of first rings E _i and a plurality of second rings E _{i 'and a plurality of second bridges that are symmetrical to the plurality of first bridges with respect to the axis of symmetry S4 along the circumferential direction, and an adjacent first ring E i} . It may include a plurality of third bridges connecting the first ring E ₁ and the second ring E ₁ '. Each of the plurality of third bridges may connect the valley of the second ridge of the first ring E ₁ and the valley of the second ridge of the second ring E ₁ '.

Description

Stent and stent manufacturing device {STENT AND APPARATUS FOR FABRICATING THE SAME}

This disclosure relates to a stent and a stent manufacturing device that are inserted into blood vessels of the human body, etc., and in particular, to a stent and a stent manufacturing device designed with an optimal pattern.

A stent is a medical device that is inserted into the human body, especially blood vessels. Coronary artery disease is a disease that occurs when the heart's coronary arteries are narrowed or blocked, preventing sufficient blood supply to the heart muscle. The cause of blood vessel narrowing is atherosclerosis, which is the accumulation of lipids such as cholesterol on the walls of blood vessels, and accompanying blood clots. Because of (Thrombus). Coronary artery disease has long been known as the most common cause of death in the West, and has recently been rapidly increasing in the East, including Korea.

The most typical components of interventional procedure medical devices are metal stents, drug-eluting stents, and biodegradable stents, and the scope of interventional procedures for drug-eluting stents has been further expanded through clinical results. In particular, drug-eluting stents that have undergone changes in the 2nd to 3rd generation are showing superior performance compared to the initial drug-eluting stents, but there is a need for practitioners and industry to solve the problem of delayed vascular recovery that still exists, and there is a need for solutions such as drug release. As a fundamental technology to improve patient survival without additional events (event-free), improving the stent platform itself is still an important area of research and development. In particular, recent technological development is focused on ultra-thin stents with a thickness of 60㎛, which do not require drug release and have good endovascular recovery and re-endothelialization characteristics.

Methods for manufacturing stents include weaving using wire, manufacturing by etching the outer surface of a metal tube, and perforating the surface of the metal tube with a laser. Recently, this method is being considered for adoption to manufacture ultra-thin stents. The most likely method is drilling with a laser.

In order to accurately drill a pattern by irradiating a laser beam onto an ultra-thin base material, the laser beam must not stop at a specific location, resulting in a situation where energy is concentrated. In other words, if the control of the laser beam is not smooth and the energy is concentrated, the pattern at that location will be perforated larger than the desired shape. Therefore, there is no problem in controlling the moving speed of the laser beam or base material, but it is possible to maintain the desired mechanical properties. The development of representing patterns is even more important.

According to one aspect of the present disclosure, the stent has a waveform in which a first crest, a first trough, a second crest, and a second trough sequentially repeat along the circumferential direction and have an amplitude in the longitudinal direction. A plurality of first rings E _i having a shape (i is a natural number from 1 to n, n is a natural number 2 or more), and a plurality of first bridges connecting the first ring E _i-1 and the first ring E _i including those,

The plurality of first rings are formed to be spaced apart from each other along the longitudinal direction,

The first ring E _i-1 and the first ring E _i are such that the first crest of the first ring E _i-1 and the second crest of the first ring E _i correspond to each other along the longitudinal direction. Arranged to have a phase difference along the circumferential direction,

Each of the plurality of first bridges connects a peak of the first crest of the first ring E _i-1 and a valley of the second crest of the first ring E _i ,

Each of the plurality of first bridges includes a first straight section connected to the valley of the second crest of the first ring E _i , a first curved section connected to the first straight section, and the first curved section. It includes a second curved section connected to and a third curved section connected to the second curved section and connected to the peak of the first crest of the first ring E _i-1 ,

The first curved section is curved in a first direction of rotation, with its concave side having a first radius of curvature R1 and its convex side having a second radius of curvature R2, wherein the first direction of rotation is counterclockwise or clockwise,

The second curved section is curved in a second rotation direction opposite to the first rotation direction, the concave side has a third radius of curvature R3 and the convex side has a fourth radius of curvature R4,

The third curved section is curved in the first rotation direction, with its concave side having a fifth radius of curvature R5 and its convex side having a sixth radius of curvature R6,

The connecting portion connecting the convex side of the third curved section and the peak of the first crest of the first ring E _i-1 is curved in the second rotation direction and has a seventh radius of curvature R7,

Each of the plurality of first bridges may have a width w1.

In some examples, the circle of curvature of R1 and the circle of curvature of R2 are concentric and have the relationship R2=R1+w1,

The circle of curvature of R3 and the circle of curvature of R4 are concentric and have the relationship R4=R3+w1,

The circle of curvature of R5 and the circle of curvature of R6 are concentric and have the relationship of R5 = R1 and R6 = R2,

It has the relationship R7=R1,

The circle of curvature of R1 and the circle of curvature of R4 are circumscribed,

The circle of curvature of R2 and the circle of curvature of R3 are circumscribed,

The circle of curvature of R5 and the circle of curvature of R4 are circumscribed,

The circle of curvature of R6 and the circle of curvature of R3 are circumscribed,

The circle of curvature of R7 and the circle of curvature of R6 are circumscribed,

The circle of curvature of R1 may be symmetrical with the circle of curvature of R5, and the circle of curvature of R2 may be symmetrical with the circle of curvature of R6 based on the axis of symmetry S1 passing through the centers of the circles of curvature of R3 and R4 along the circumferential direction. .

The stent of one aspect of the present disclosure may provide the advantage of improving longitudinal compression resistance by allowing compressive force to be distributed rather than concentrated at a local location. It can also provide the advantage of having excellent rigidity. In addition, it can provide the advantage of improving convenience of use by reducing deviation in a specific direction during stent surgery. In addition, by arranging the bridge to have a phase difference, it has the ability to adapt to twisting force, providing the advantage of minimizing damage to the product due to twisting force until it reaches the target lesion.

In some examples, the stent may include a plurality of first rings E _i and a plurality of second rings E _i 'and a plurality of second rings symmetrical to the plurality of first bridges with respect to the axis of symmetry S4 along the circumferential direction. Bridges and a plurality of third bridges connecting the first ring E ₁ and the second ring E ₁ ',

Each of the plurality of third bridges may connect a valley of the second ridge of the first ring E ₁ and a valley of the second ridge of the second ring E ₁ '.

1 is a perspective view of a stent according to an example.
Figure 2 is an exploded view of the stent of Figure 1 cut along the length and then unfolded.
Figure 3 is a diagram showing a pattern of a first bridge of a stent according to an example.
Figure 4 is a diagram showing a pattern of adjacent first rings of a stent and a first bridge between them according to an example.
Figures 5 and 6 are diagrams showing patterns of the first ridge, first valley, second ridge, and second valley of a stent according to an example.
FIG. 7 is a diagram showing a pattern of adjacent first ring E ₁ and second ring E ₁ ′ of a stent according to an example and a third bridge therebetween.
Figure 8 is a configuration diagram of a device for manufacturing a stent according to an example.

The advantages and features of the present disclosure, and how to achieve them, will become clear with reference to the examples described in detail below in conjunction with the accompanying drawings. However, the present disclosure is not limited to the examples disclosed below and will be implemented in various different forms. These examples only serve to ensure that the disclosure of the present disclosure is complete, and that the present disclosure is not limited to the examples disclosed below and will be implemented in various forms. It is provided to fully inform those who have the scope of the invention, and the present invention is only defined by the scope of the claims. Like reference numerals refer to like elements throughout the specification.

The terminology used herein is for the purpose of describing examples and is not intended to limit the disclosure. As used herein, singular forms also include plural forms, unless specifically stated otherwise in the context. As used in the specification, “comprises” and/or “comprising” means that in addition to the mentioned component, step, operation and/or element, one or more other component, step, operation and/or element are included. It does not exclude existing or additions.

Although terms such as first and second are used to describe various components, it goes without saying that these components are not limited by these terms. These terms are merely used to distinguish one component from another. Therefore, of course, the first component mentioned below may also be the second component within the technical spirit of the present disclosure.

Unless otherwise defined, all terms (including technical and scientific terms) used in this specification may be used with meanings that can be commonly understood by those skilled in the art to which this disclosure pertains. Additionally, terms defined in commonly used dictionaries are not interpreted ideally or excessively unless clearly specifically defined.

Hereinafter, examples of the present disclosure will be described with reference to the accompanying drawings.

The stent 100 is a medical device that is inserted into the human body. The stent 100 may be made of a tube with a diameter of several mm or less formed by repeating a net-shaped pattern. The stent 100 may serve to expand the blood vessel by expanding it in the radial direction after inserting it into a narrowed blood vessel. Since the stent 100 is inserted into the human body, it must be harmless to the human body and have strong chemical resistance, and may also need to have strong elasticity to prevent it from shrinking again after expansion. Accordingly, in some examples, the stent 100 may be made of metal, such as stainless steel. In addition, the surface and ends of the stent 100 must be smooth rather than sharp, and the net-shaped pattern may need to be formed uniformly and accurately to maintain uniform expansion force.

FIG. 1 is a perspective view of the stent 100 according to an example, and FIG. 2 is a developed view of the stent 100 of FIG. 1 cut along the longitudinal direction (D _l ) and then unfolded.

As shown, the stent 100 may include a plurality of first rings 10 E _i (i is a natural number from 1 to n, n is a natural number of 2 or more) and a plurality of first bridges 60. . That is, the stent 100 may include first ring 10 E ₁ , first ring 10 E ₂ , first ring 10 E ₃ .

In some examples, the stent 100 includes a plurality of first rings 10 E _i and a plurality of first bridges 60 symmetrical about the axis of symmetry S4 along the circumferential direction D _c . It may include two rings 20 E _i 'and a plurality of second bridges 70. That is, the stent 100 may include second ring 20 E ₁ ', second ring 20 E ₂ ', second ring 20 E ₃ '.... In these examples, the second rings 20 and the second bridges 70 are symmetrical to the first rings 10 and the first bridges 60, so hereinafter, except where necessary, the second rings 20 and the second bridges 70 are symmetrical to the first rings 10 and the first bridges 60. The description of (20) and the second bridges 70 is omitted, and the description of the first rings 10 and the first bridges 60 is provided instead. The axis of symmetry S4 is located on the side opposite to the first ring (10) E ₂ among both sides of the first ring (10) E ₁ in the longitudinal direction. In FIGS. 1 and 2 , the number of first rings 10 and the number of second rings 20 are each shown as six, but as described above, the present disclosure is not limited thereto. Furthermore, the symmetry of the first rings 10 and the second rings 20 mentioned in this specification only means the symmetry of the pattern, and the number of the first rings 10 and the number of the second rings 20 is not intended to be limited to being the same. That is, the number of first rings 10 and the number of second rings 20 may be different.

In addition, the present disclosure is not limited to the first rings 10 and the second rings 20 having a symmetrical structure, and the first rings 10 and the second rings 20 may have an asymmetrical structure. . In addition, it is not excluded that the stent 100 is made of only the first rings 10 and the first bridges 60 without the second rings 20, the second bridges 70, and the third bridges 80. .

The plurality of first rings 10 have a first ridge 11, a first valley 13, a second ridge 15, and a second valley 17 sequentially repeated along the circumferential direction D _c and the length It may have a waveform shape with amplitude in the direction (D _l ). That is, the plurality of first rings 10 may have a wave shape that vibrates in the longitudinal direction (D _l ) while moving in the circumferential direction (D _c ). 1 and 2 show first rings 10 having a wave-shaped shape, each having three first ridges 11, first troughs 13, second troughs 15, and second troughs 17. However, the present disclosure is not limited thereto.

Each first bridge 60 may connect the first ring 10 E _i-1 and the first ring 10 E _i . In some examples, each of the plurality of first bridges 60 has a peak of the first crest 11 of the first ring 10 E _i-1 and a second crest of the first ring 10 E _i ( The valleys of 15) can be connected. For example, the first bridge 60 may connect the peak of the first ridge 11 of the first ring 10 E ₁ and the valley of the second ridge 15 of the first ring 10 E ₂ . Therefore, as described above, in examples where each first ring 10 has three first ridges 11 and 3 second ridges 15, the first ring 10 adjacent to E _i-1 Three first bridges 60 may be provided between the first ring 10 E _i , but the present disclosure is not limited to this example.

In some examples, the stent 100 may include a plurality of third bridges 80 connecting the first ring 10 E ₁ and the second ring 20 E ₁ ′. Each of the plurality of third bridges 80 may connect the valley of the second ridge 15 of the first ring 10 E ₁ and the valley of the second ridge 15 of the second ring 20 E ₁ '. Therefore, as described above, in examples where each first ring 10 and the second ring 20 have three second ridges, the second ring 20 adjacent to the first ring 10 E ₁ ) Three third bridges 80 may be provided between E ₁ ', but as described above, the present disclosure is not limited to this example.

The plurality of first rings 10 may be formed to be spaced apart from each other along the longitudinal direction D _l . In some examples, the separation distance between adjacent first rings 10 may be 0.39 to 0.42 mm. The first ring 10 E _i-1 and the first ring 10 E _i are the first crest 11 of the first ring 10 E _i-1 and the first ring along the longitudinal direction D _l . (10) The second ridges 15 of E _i may be arranged to have a phase difference along the circumferential direction (D _c ) so that they correspond to each other. In the illustrated example, the first ring 10 E _i-1 and the first ring 10 E _i are illustrated as having a phase difference of 60° at the center angle of the arc, but the present disclosure is not limited thereto. Through the bridge structure that crosses to have this phase difference, it has the ability to adapt to torsional force, minimizing damage to the product due to torsional force until it reaches the target lesion.

The longitudinal direction (D _l ) refers to a direction perpendicular to the tangent direction and radial direction of the circular arc in the circumferential direction (D _c ), respectively, and specifically, the direction of the central axis of the circle drawn along the circumferential direction (D _c ). While the circumferential direction (D _c ) is expressed as a curve in FIG. 1, it may be expressed as a straight line in FIG. 2 when the stent of FIG. 1 is unfolded. Hereinafter, unless explicitly stated otherwise, the pattern of the stent will be described based on the development diagram of FIG. 2.

FIG. 3 is a diagram showing a pattern of the first bridge 60 of the stent 100 according to an example.

In some examples, each of the plurality of first bridges 60 includes a first straight section 61 connected to the valley of the second ridge 15 of the first ring 10 E _i , and a first straight section A first curved section 63 connected to (61), a second curved section 65 connected to the first curved section 63, and a first ring 10 connected to the second curved section 65. It may include a third curved section 67 connected to the peak of the first crest 11 of E _i-1 .

The first curved section 63 may be curved in the first rotation direction, and its concave side may have a first radius of curvature R1 and its convex side may have a second radius of curvature R2. In Figure 3, an example in which the first rotation direction is counterclockwise is shown, but the present disclosure is not limited thereto, and the first rotation direction may be counterclockwise or clockwise.

The second curved section 65 is curved in a second rotation direction opposite to the first rotation direction, and its concave side may have a third radius of curvature R3 and its convex side may have a fourth radius of curvature R4.

The third curved section 67 is curved in the first rotation direction, and its concave side may have a fifth radius of curvature R5 and its convex side may have a sixth radius of curvature R6. In addition, the connecting portion 69 connecting the convex side of the third curved section 67 and the peak of the first crest 11 of the first ring 10 E _i-1 is curved in the second rotation direction and the seventh It can have a radius of curvature R7.

Each of the plurality of first bridges 60 may have a width w1. In some examples, the first straight section 61 of the first bridges 60 has a width of 0.06 to 0.08 mm, and the first curved section 63, the second curved section 65, and the third curved section (67) may have a width of 0.08 to 0.1 mm.

In some examples, the circle of curvature C1 of R1 and the circle of curvature C2 of R2 may be concentric and have a relationship of R2=R1+w1. By applying a constant radius of curvature to the link portion that receives compressive force in the longitudinal direction, the compressive force can be distributed rather than concentrated at a local location, thereby improving longitudinal compression resistance. The circle of curvature (C3) of R3 and the circle of curvature (C4) of R4 are concentric and may have a relationship of R4=R3+w1. The circle of curvature (C5) of R5 and the circle of curvature (C6) of R6 are concentric and may have a relationship of R5=R1 and R6=R2. It can have a relationship of R7=R1.

In some examples, the circle of curvature C1 of R1 and the circle of curvature C4 of R4 may be circumscribed. A load distribution effect can be achieved by creating a link section through a circumscribed circle. The circle of curvature (C2) of R2 and the circle of curvature (C3) of R3 can be circumscribed. The circle of curvature (C5) of R5 and the circle of curvature (C4) of R4 can be circumscribed. The circle of curvature (C6) of R6 and the circle of curvature (C3) of R3 can be circumscribed. The circle of curvature (C7) of R7 and the circle of curvature (C6) of R6 can be circumscribed.

In some examples, the circle of curvature C1 of R1 is symmetrical to the circle of curvature C5 of R5 about the axis of symmetry S1 that passes through the centers of the circle of curvature C3 of R3 and the circle of curvature C4 of R4 along the circumferential direction, and R2 The circle of curvature (C2) of may be symmetrical to the circle of curvature (C6) of R6.

In some examples, the shortest distance L1 between the circle of curvature C2 of R2 and the circle of curvature C6 of R6 measured along the longitudinal direction may have the relationship L1 < 2*R3. Stiffness can be increased by using the curved portion to resist the force generated while the stent 100 moves to position the target lesion.

In some examples, the longest vertical distance A2 between a point on the circle of curvature (C2) of R2 and a point on the circle of curvature (C4) of R4, measured along the circumferential direction, is 0.3*w1 < (A2-2*R4) ≤ 0.5 *Can be w1. A2-2*R4 corresponds to the length indicated by A1. If the gap between A1 is too small, the value of R3 becomes smaller and closer to a straight line, which may lower the longitudinal resistance. Conversely, if the gap between A1 is too wide, interference with the strut may occur during the crimping process. Therefore, the size of A1 can be set to be greater than 0.3*w1 and less than or equal to 0.5*w1.

FIG. 4 is a diagram showing a pattern of adjacent first rings 10 of the stent 100 and a first bridge 60 between them according to an example.

In some examples, the vertical distance from the peak of the second crest 15 of the first ring 10 E _i to the peak of the first valley 13 of the first ring 10 E _i , measured along the longitudinal direction. L2 and the distance (interval) L3 from the peak of the second crest 15 of the first ring 10 E _i measured along the longitudinal direction to the first curved section 63 may have the relationship L2 < L3. there is. In some examples, L2 may have a length between 8.85 and 9.46 mm.

In some examples, L3 and the combined length L4 of the first curved section 63, the second curved section 65, and the third curved section 67 measured along the longitudinal direction may have a relationship of L3 > L4. there is.

In some examples, the relationship may be 0.3*L2 ≤ L4 ≤ 0.35*L2.

In some examples, L2 may have the relationship 0.085*L2 < w1 < 0.115*L2.

In some examples, a waveform extending from the first crest 11 of the plurality of first rings 10 through the first trough 13 to the second trough 15 and a waveform from the second trough 15 to the second trough ( The waveform extending through 17) to the first crest 11 may be symmetrical about the symmetry axis S2 passing through the center of the second crest 15 along the longitudinal direction. Through the symmetrical structure, the user's convenience of use can be increased by reducing the deviation along a specific direction during stent 100 surgery.

Figures 5 and 6 are diagrams showing patterns of the first ridge 11, the first ridge 13, the second ridge 15, and the second ridge 17 of the stent 100 according to an example.

Each of the plurality of first rings 10 connects the first strut 14, which connects the first ridge 13 and the second ridge 15, and the second ridge 15 and the second ridge 17. It may include a second strut 16, and in some examples, the peak of the second ridge 15 is an eighth curve connected to the first strut 14, and a ninth curve connected to the eighth curve. It may have a 10th curve connected to the 9th curve and the second strut 16 as an outline. The eighth curve is curved clockwise and may have an eighth radius of curvature R8. The ninth curve is curved counterclockwise, but may have a ninth radius of curvature R9. The 10th curve is curved clockwise and may have a 10th radius of curvature R10. They can have the relationship R9 > R8 = R10. R9 prevents destruction due to stress concentration during the process of expanding the first strut 14 and the second strut 16 by pressure, and has a radius larger than R8 and R10, thereby allowing the stent 100 to expand. Castle can be secured. The circle of curvature of R8 can be circumscribed with the circle of curvature of R9. The circle of curvature of R10 can be circumscribed with the circle of curvature of R9.

The center point of the circle of curvature of R8 is located in the space between the first strut 14 and the first bridge 60, and the center point of the circle of curvature of R10 is located in the space between the first bridge 60 and the second strut 16. You can.

The struts of the plurality of first rings 10 E _i may have a width w2. In some examples, w2 may have a size between 0.09 and 0.11 mm.

In addition, the concave side where the first strut 14 and the first bridge 60 meet has an 11th radius of curvature R11, and the concave side where the first bridge 60 and the second strut 16 meet has a 12th radius of curvature R12. You can have it. The relationship can be R8 = R10 > R11 + w2 = R12 + w2. The center of R11 may be located eccentrically toward the first strut 14 relative to the center of R8, and the center of R12 may be located eccentrically toward the second strut 16 relative to the center of R10.

C8' in FIG. 6 is a circle of curvature shown for comparison with the circle of curvature (C11) of R11, and P8' represents the center of the circle of curvature of C8'. The circle of curvature of C8' has the same center point as the circle of curvature of R8 (C8) and is a circle of curvature obtained when the radius value is reduced by the width of w2. The radius of the curvature circle of C8' obtained in this way is reduced and its center point is eccentrically located closer to the first strut 14, resulting in the curvature circle of C11. By arranging P11, which is the center of the circle of curvature of C11, closer to the first strut 14 than P8', the overall strut width can be maintained uniformly.

The peak of the first ridge 11 may have a 13th radius of curvature R13, and the valley may have a 14th radius of curvature R14. The peak of the first valley 13 may have a 15th radius of curvature R15, and the valley may have a 16th radius of curvature R16. The peak of the second valley 17 may have a 17th radius of curvature R17, and the valley may have an 18th radius of curvature R18.

The strut between the first ridge (11) and the first trough (13) has a common inscribed line between the circle of curvature (C13) of R13 and the circle of curvature (C16) of R16, and the common circle of curvature (C14) of R14 and the circle of curvature (C15) of R15. You can have an inscribed line as a contour.

The first strut 14 may have a common inscribed line of the circle of curvature C16 of R16 and the circle of curvature C8 of R8, and a common inscribed line of the circle of curvature C15 of R15 and the circle of curvature C11 of R11 as outlines.

The second strut 16 may have a common inscribed line of the circle of curvature C10 of R10 and the circle of curvature C18 of R18 and a common inscribed line of the circle of curvature C12 of R12 and the circle of curvature C17 of R17 as outlines.

The strut between the second valley (17) and the first ridge (11) has a common inscribed line between the circle of curvature (C17) of R17 and the circle of curvature (C14) of R14, and the common circle of curvature (C18) of R18 and the circle of curvature (C13) of R13. You can have tangent lines as outlines.

Figure 7 is a diagram showing the pattern of the adjacent first ring 10 E ₁ and the second ring 20 E ₁ 'of the stent 100 according to an example and the third bridge 80 between them.

Each of the plurality of third bridges 80 has a first 'straight section 81 connected to the valley of the second ridge 15 of the first ring 10 E ₁ , and a first 'straight section 81 A first'curve section (83) connected to, a second'curve section (85) connected to the first'curve section (83), and a first''curve connected to the second'curve section (85). It may include a section 87 and a first''straight section (89) connected to the first''curved section (87) and connected to the valley of the second crest of the second ring (20) E ₁ '. .

The first 'curved section 83 may be curved in the first rotation direction, and its concave side may have a first 'curvature radius R1' and its convex side may have a second 'curvature radius R2'. The second 'curved section 85' is curved in the second rotation direction, and its concave side may have a third 'curvature radius R3' and its convex side may have a fourth 'curvature radius R4'. The first ''curved section 87' is curved in the first rotation direction, and its concave side may have a first ''radius of curvature R1'' and its convex side may have a second ''radius of curvature R2''. The first'straight section 81 and the first'straight section 89 may be symmetrical about the symmetry axis S4. Additionally, the first 'curve section 83' and the first 'curve section 87 may be symmetrical about the symmetry axis S4.

Each of the plurality of third bridges 80 may have a width w1' and have a relationship of w1' = w1.

The circle of curvature of R1' and the circle of curvature of R2' are concentric and may have a relationship of R2'=R1'+w1'=R2=R1+w1. The circle of curvature of R3' and the circle of curvature of R4' are concentric, and may have a relationship of R4'=R3'+w1'=R4=R3+w1. The circle of curvature of R1'' and the circle of curvature of R2'' are concentric and may have the relationships R1''=R1'=R1 and R2''=R2'=R2. The circle of curvature of R1' and the circle of curvature of R4' can be circumscribed. The circle of curvature of R2' and the circle of curvature of R3' can be circumscribed. The circle of curvature of R1'' and the circle of curvature of R4' can be circumscribed. The circle of curvature of R2'' and the circle of curvature of R3' can be circumscribed. The axis of symmetry S4 may pass through the center of the circle of curvature of R3' and the circle of curvature of R4'.

The shortest distance L1' between the circle of curvature of R2' and the circle of curvature of R2'' measured along the longitudinal direction may have the relationship of L1' < 2*R3'.

The longest vertical distance A2' between the first point of the circle of curvature of R2' and the first point of the circle of curvature of R4', measured along the circumferential direction, can be 0.3*w1' < (A2'-2*R4') ≤ 0.5*w1'. there is.

L2 and the distance L3' from the peak of the second crest 15 of the first ring 10 E ₁ measured along the longitudinal direction to the first 'curved section' may have a relationship of L2 <L3'.

The total length L4' of the first'curve section 83, the second'curve section 85, and the first'curve section 87 measured along L3' and the longitudinal direction has the relationship of L3' > L4'. You can have it.

L2 and L4' may have a relationship of 0.3*L2 ≤ L4' ≤ 0.35*L2.

The center point of the circle of curvature (C8) of R8 is located in the space between the first strut (14) and the third bridge (80), and the center point of the circle of curvature (C10) of R10 is located between the third bridge (80) and the second strut (16). It can be located in the space between.

In some examples, the concave side of the first ring 10 E ₁ where the first strut 14 and the third bridge 80 meet has an 11th 'radius of curvature R11', and the third bridge 80 and the first bridge 80 have an 11th 'radius of curvature R11'. The concave side of the ring 10 E ₁ where the second strut 16 meets may have a 12th 'radius of curvature R12'. There can be a relationship of R8 = R10 >R11' + w2 = R12' + w12. The center of R11' may be located eccentrically toward the first strut 14 relative to the center of R8, and the center of R12' may be located eccentrically toward the second strut 16 relative to the center of R10.

In some examples, the separation distance between adjacent first ring 10 E ₁ and second ring 20 E ₁ 'may be 0.38 to 0.42 mm.

In some examples, the first 'straight section 81 and the first 'straight section 89 of the third bridges 80 each have a width of 0.06 to 0.08 mm, and the first 'curved section 83 , the second 'curve section 85' and the first 'curve section 87 may each have a width of 0.08 to 0.1 mm.

Hereinafter, we will look at the manufacturing method and manufacturing device for the stent 100.

As a method of manufacturing the stent 100, first, as in U.S. Patent No. 5,855,597 or 5,879,370, it can be manufactured by connecting members such as wire bent into a predetermined shape forming a net-shaped pattern to each other by welding or gluing. there is.

In another method, as in U.S. Patent No. 5,421,955 or 5,776,161, an etching-resistant material such as photoresist is coated on the outer surface of the metal tube, and the photoresist is exposed and developed according to the pattern of the stent 100 to be formed. After forming the pattern, the stent 100 can be manufactured by etching the metal tube using the photoresist pattern as an etching mask.

As another method, as in U.S. Patent No. 5,780,807 or 5,852,277, the stent 100 can be manufactured by rotating the metal tube and irradiating a laser on the surface of the metal tube to cut (perforate) the metal tube into a predetermined pattern.

Figure 8 is a diagram showing the schematic configuration of a device for manufacturing the stent 100 by irradiating a laser in this way.

As shown, the stent 100 manufacturing apparatus includes a support part 200 that supports a hollow circular tube 100', a laser irradiation part 300 that irradiates a laser to the circular tube 100', and a support part ( A driving unit 400 that drives at least one of the support unit 200 and the laser irradiation unit so that the 200) and the laser irradiation unit 300 move relative to each other, and a plurality of rings and a plurality of bridges are patterned on the circular tube 100'. It may include a control unit 500 that controls the driving of the drive unit 400 by control.

In some examples, the support unit 200 may include a fixing chuck for fixing one end of the circular tube 100' and a table on which the fixing chuck is mounted and capable of moving in the horizontal direction. Additionally, the table may be composed of a combination of a table movable in the X direction and a table movable in the Y direction. The driving unit 400 includes a rotation drive for rotating the fixed chuck about the central axis of the circular tube 100', a horizontal movement for horizontally moving the table (e.g., movement in the X-axis direction and movement in the Y-axis direction), and a laser irradiation unit ( 300) may be vertically moved (e.g., moved in the Z-axis direction).

The laser irradiation unit 300 is a device that generates and irradiates a laser beam necessary for perforation of the circular tube 100'. In some examples, the laser irradiation unit 300 may be a pulse-type Nd:YAG laser device.

A circular tube (100') to be processed into a stent (100) is aligned so that one end thereof is fixed by a fixed chuck and the other end thereof is positioned directly below a laser irradiation unit (300). The exact position can be aligned by horizontal movement of the table and vertical movement of the laser irradiation unit (300). The control unit (500) can control horizontal movement of the table, rotational movement of the fixed chuck, and irradiation of a laser beam of the laser irradiation unit (300) according to CAD data of a pre-stored stent pattern.

Although embodiments of the present disclosure have been described above with reference to the attached drawings, those skilled in the art will understand that the present disclosure can be implemented in other specific forms without changing its technical idea or essential features. You will understand that it can be done. Therefore, the examples described above should be understood in all respects as illustrative and not limiting.

Claims (20)

A plurality of first rings E _i (i is a natural number from 1 to n, n is a natural number of 2 or more), and a plurality of first bridges connecting the first ring E _i-1 and the first ring E _i ,
The plurality of first rings E _i are formed to be spaced apart from each other along the longitudinal direction,
The first ring E _i-1 and the first ring E _i are such that the first crest of the first ring E _i-1 and the second crest of the first ring E _i correspond to each other along the longitudinal direction. Arranged to have a phase difference along the circumferential direction,
Each of the plurality of first bridges connects a peak of the first crest of the first ring E _i-1 and a valley of the second crest of the first ring E _i ,
The plurality of first rings include a first strut connecting the first ridge and the second ridge, and a second strut connecting the second ridge and the second ridge,
The peak of the second ridge outlines an eighth curve connected to the first strut, a ninth curve connected to the eighth curve, and a tenth curve connected to the ninth curve and connected to the second strut. Have it,
The eighth curve is curved clockwise and has an eighth radius of curvature R8,
The ninth curve is curved counterclockwise and has a ninth radius of curvature R9,
The tenth curve is curved clockwise and has a tenth radius of curvature R10,
There is a relationship of R9 > R8 = R10,
The circle of curvature of R8 circumscribes the circle of curvature of R9,
The circle of curvature of R10 circumscribes the circle of curvature of R9,
The center of the circle of curvature of R8 is located in the space between the first strut and the first bridge,
The center of the circle of curvature of R10 is located in the space between the first bridge and the second strut,
stent.
According to paragraph 1,
The concave side where the first strut and the first bridge meet has an 11th radius of curvature R11, and the concave side where the first bridge and the second strut meet has a 12th radius of curvature R12,
The first strut and the second strut have a width w2,
It has the relationship R8 = R10 > R11 + w2 = R12 + w2,
The center of R11 is located eccentrically toward the first strut relative to the center of R8, and the center of R12 is located eccentrically toward the second strut relative to the center of R10.
stent.
According to paragraph 1,
Each of the plurality of first bridges includes a first straight section connected to the valley of the second crest of the first ring E _i , a first curved section connected to the first straight section, and the first curved section. It includes a second curved section connected to and a third curved section connected to the second curved section and connected to the peak of the first crest of the first ring E _i-1 ,
The first curved section is curved in a first direction of rotation, with its concave side having a first radius of curvature R1 and its convex side having a second radius of curvature R2, wherein the first direction of rotation is counterclockwise or clockwise,
The second curved section is curved in a second rotation direction opposite to the first rotation direction, the concave side has a third radius of curvature R3 and the convex side has a fourth radius of curvature R4,
The third curved section is curved in the first rotation direction, with its concave side having a fifth radius of curvature R5 and its convex side having a sixth radius of curvature R6,
The connecting portion connecting the convex side of the third curved section and the peak of the first crest of the first ring E _i-1 is curved in the second rotation direction and has a seventh radius of curvature R7,
Each of the plurality of first bridges has a width w1,
According to paragraph 3,
The circle of curvature of R1 and the circle of curvature of R2 are concentric and have the relationship R2=R1+w1,
The circle of curvature of R3 and the circle of curvature of R4 are concentric and have the relationship R4=R3+w1,
The circle of curvature of R5 and the circle of curvature of R6 are concentric and have the relationship of R5 = R1 and R6 = R2,
It has the relationship R7=R1,
The circle of curvature of R1 and the circle of curvature of R4 are circumscribed,
The circle of curvature of R2 and the circle of curvature of R3 are circumscribed,
The circle of curvature of R5 and the circle of curvature of R4 are circumscribed,
The circle of curvature of R6 and the circle of curvature of R3 are circumscribed,
The circle of curvature of R7 and the circle of curvature of R6 are circumscribed,
The circle of curvature of R1 is symmetrical with the circle of curvature of R5, and the circle of curvature of R2 is symmetrical with the circle of curvature of R6, with respect to the axis of symmetry S1 passing through the centers of the circles of curvature of R3 and R4 along the circumferential direction.
stent.
According to paragraph 3,
The shortest distance L1 between the circle of curvature of R2 and the circle of curvature of R6 measured along the longitudinal direction has the relationship of L1 < 2*R3,
stent.
According to paragraph 3,
The longest vertical distance A2 between the first point of the circle of curvature of R2 and the first point of the circle of curvature of R4 measured along the circumferential direction is 0.3*w1 < (A2-2*R4) ≤ 0.5*w1,
stent.
According to paragraph 3,
The vertical distance L2 from the peak of the second ridge of the first ring E _i measured along the longitudinal direction to the peak of the first valley of the first ring E _i and the first ridge measured along the longitudinal direction The distance L3 from the peak of the second ridge of the ring E _i to the first curve section has the relationship L2 < L3,
stent.
According to paragraph 3,
The distance L3 from the peak of the second crest of the first ring E _i measured along the longitudinal direction to the first curved section, the first curved section measured along the longitudinal direction, the second curved section, and The total length L4 of the third curve section has the relationship L3 > L4,
stent.
According to paragraph 3,
The vertical distance L2 from the peak of the second ridge of the first ring E _i measured along the longitudinal direction to the peak of the first valley of the first ring E _i and the first ridge measured along the longitudinal direction The combined length L4 of the curved section, the second curved section, and the third curved section has a relationship of 0.3*L2 ≤ L4 ≤ 0.35*L2,
stent.
According to paragraph 3,
The vertical distance L2 from the peak of the second crest of the first ring E _i to the peak of the first valley of the first ring E _i measured along the longitudinal direction is 0.085*L2 < w1 < 0.115*L2. having a relationship,
stent.
According to paragraph 3,
A waveform extending from the first crest of the plurality of first rings to the second crest via the first trough and a waveform extending from the second crest to the first crest via the second trough are along the longitudinal direction. Symmetrical about the axis of symmetry S2 passing through the center of the second ridge,
stent.
According to paragraph 3,
A plurality of first rings E _i and a plurality of second rings E _i 'and a plurality of second bridges symmetrical to the plurality of first bridges with respect to the axis of symmetry S4 along the circumferential direction, and the adjacent second rings E i Additionally comprising a plurality of third bridges connecting the first ring E ₁ and the second ring E ₁ ',
Each of the plurality of third bridges connects the valley of the second ridge of the first ring E ₁ and the valley of the second ridge of the second ring E ₁ ',
stent.
According to clause 12,
Each of the plurality of third bridges includes a first 'straight section connected to the valley of the second ridge of the first ring E ₁ , a first' curved section connected to the first 'straight section, and A second'curve section connected to the first'curve section, a first''curve section connected to the second'curve section, and the second ring R1'connected to the first''curve section. It includes a first ''straight section connected to the valley of the second ridge,
The first 'curved section is curved in the first rotation direction, the concave side has a first 'curvature radius R1' and the convex side has a second 'curvature radius R2',
The second 'curved section is curved in the second rotation direction, the concave side has a third 'curvature radius R3' and the convex side has a fourth 'curvature radius R4',
The first ''curved section is curved in the first rotation direction, the concave side has a first ''radius of curvature R1'' and the convex side has a second ''radius of curvature R2'',
Each of the plurality of third bridges has a width w1' and has a relationship of w1' = w1,
The circle of curvature of R1' and the circle of curvature of R2' are concentric and have the relationship R2'=R1'+w1'=R2=R1+w1,
The circle of curvature of R3' and the circle of curvature of R4' are concentric and have the relationship R4'=R3'+w1'=R4=R3+w1,
The circle of curvature of R1'' and the circle of curvature of R2'' are concentric and have the relationships R1''=R1'=R1 and R2''=R2'=R2,
The circle of curvature of R1' and the circle of curvature of R4' are circumscribed,
The circle of curvature of R2' and the circle of curvature of R3' are circumscribed,
The circle of curvature of R1'' and the circle of curvature of R4' are circumscribed,
The circle of curvature of R2'' and the circle of curvature of R3' are circumscribed,
The axis of symmetry S4 passes through the centers of the circles of curvature of R3' and R4',
stent.
According to clause 13,
The shortest distance L1' between the circle of curvature of R2' and the circle of curvature of R2'' measured along the longitudinal direction has the relationship L1'<2*R3',
stent.
According to clause 13,
The longest vertical distance A2' between the first point of the circle of curvature of R2' and the first point of the circle of curvature of R4' measured along the circumferential direction is 0.3*w1'<(A2'-2*R4') ≤ 0.5*w1 'person,
stent.
According to clause 13,
The vertical distance L2 from the peak of the second crest of the first ring E ₁ measured along the longitudinal direction to the peak of the first valley of the first ring E ₁ and the first measured along the longitudinal direction The distance L3' from the peak of the second ridge of ring E ₁ to the first 'curve section has the relationship L2 <L3',
stent.
According to clause 13,
The distance L3' from the peak of the second crest of the first ring E ₁ measured along the longitudinal direction to the first 'curved section', the first' curved section measured along the longitudinal direction, and the second The combined length L4' of the 'curve section and the first''curve section has a relationship of L3'>L4',
stent.
According to clause 13,
The vertical distance L2 from the peak of the second crest of the first ring E ₁ measured along the longitudinal direction to the peak of the first valley of the first ring E ₁ and the first measured along the longitudinal direction The combined length L4' of the 'curve section, the second' curve section and the first ''curve section' has a relationship of 0.3*L2 ≤ L4' ≤ 0.35*L2,
stent.
According to clause 13,
The plurality of first rings include a first strut connecting the first ridge and the second ridge, and a second strut connecting the second ridge and the second ridge,
The peak of the second ridge outlines an eighth curve connected to the first strut, a ninth curve connected to the eighth curve, and a tenth curve connected to the ninth curve and connected to the second strut. Have it,
The eighth curve is curved clockwise and has an eighth radius of curvature R8,
The ninth curve is curved counterclockwise and has a ninth radius of curvature R9,
The tenth curve is curved clockwise and has a tenth radius of curvature R10,
There is a relationship of R9 > R8 = R10,
The circle of curvature of R8 circumscribes the circle of curvature of R9,
The circle of curvature of R10 circumscribes the circle of curvature of R9,
The concave side where the first strut and the third bridge of the first ring E ₁ meet has an 11th 'radius of curvature R11', and the concave side where the third bridge and the second strut of the first ring E ₁ meet has a Has a 12th 'radius of curvature R12',
The first strut and the second strut have a width w2,
It has the relationship R8 = R10 >R11' + w2 = R12' + w2,
The center of the circle of curvature of R8 is located in the space between the first strut and the third bridge,
The center of the circle of curvature of R10 is located in the space between the third bridge and the second strut,
The center of R11' is located eccentrically toward the first strut relative to the center of R8, and the center of R12' is located eccentrically toward the second strut relative to the center of R10.
stent.
A support portion supporting the hollow circular pipe,
A laser irradiation unit that irradiates a laser to the circular tube,
a driving unit that drives at least one of the support unit and the laser irradiation unit so that the support unit and the laser irradiation unit move relative to each other;
Comprising a control unit that controls the driving of the drive unit by computer numerical control according to pre-stored data of the stent pattern of any one of claims 1 to 19,
Stent manufacturing device.

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