WO2024082640A1

WO2024082640A1 - Method for manufacturing biliary tract stent and biliary tract stent

Info

Publication number: WO2024082640A1
Application number: PCT/CN2023/097111
Authority: WO
Inventors: 罗永春; 葛泉波; 冯志辉; 李冬存
Original assignee: 常州乐奥医疗科技股份有限公司
Priority date: 2022-10-19
Filing date: 2023-05-30
Publication date: 2024-04-25
Also published as: CN115553972B; CN115553972A

Abstract

The present invention relates to a method for manufacturing a biliary tract stent and a biliary tract stent. According to the manufacturing method, first wires and second wires can be woven simultaneously, and it is not necessary to wait until weaving of the first wires is completed to start the weaving of the second wires, thereby ensuring the manufacturing efficiency of the biliary tract stent; in addition, in the process of weaving the first wires around a clamp to form first cylindrical mesh structures and weaving the second wires around the clamp to form second cylindrical mesh structures, cross non-self-locking structures can be formed in at least some of regions, and when the biliary tract stent is axially stretched within a certain range, relative movement between different cylindrical mesh structures would occur first, so that deformation of the wires is reduced, thereby reducing the recovery tendency of the biliary tract stent, so as to increase the degree of fitting of the biliary tract stent to the biliary tract structure of a human body, thus reducing the possibility that the biliary tract stent brings an abnormal feeling to a patient at a bent position of a biliary tract.

Description

A method for manufacturing a biliary stent and a biliary stent

Technical Field

The present invention relates to the technical field of interventional medical devices, and in particular to a method for manufacturing a biliary stent and a biliary stent.

Background technique

The biliary system has the functions of secreting, storing, concentrating and transporting bile, and plays an important role in regulating the discharge of bile into the duodenum. Malignant biliary obstruction caused by malignant tumors such as biliary cancer, liver cancer, pancreatic cancer and metastatic cancer has a high incidence rate and is often discovered in the late stage. Implanting a biliary stent into the narrow or blocked area is a good method for treating biliary obstruction. Biliary stents can not only reduce pressure, drain, support, and facilitate the healing of the bile duct, but also facilitate the observation of bile conditions and postoperative cholangiography.

After being implanted into the human bile duct, the biliary stent can expand freely at body temperature, thereby ensuring the patency of the bile duct. Generally, the biliary stent is made of a shape memory alloy (such as nickel-titanium memory alloy) that can maintain expansion force at body temperature.

In the prior art, biliary stents are almost all in a straight line shape, but the actual shape of the bile duct in the human body is not a straight line. Therefore, after the biliary stent is implanted, the shape memory alloy restores its original shape at body temperature, and the biliary stent always tends to become a straight line, reflecting that the biliary stent does not fit the human bile duct well, causing the biliary stent to always exert force on the bend of the human bile duct, giving the patient a foreign body sensation.

In order to solve the problem of poor fit between the biliary stent and the bile duct, some current stent weaving schemes use a cross and self-locking weaving method, so that different cylindrical structures of the stent can be relatively displaced at the self-locking position, so that the stent has the ability to move relative to each other without deformation of the wire. That is, the axial compression of the stent within a certain range causes less deformation of the wire.

When the stent is bent, the inner radius of the bend is in an axial compression state. Therefore, the self-locking design makes the inner radius of the bend mainly undergo relative displacement when the stent is bent, and the wire deformation is small. Therefore, the inner radius recovery tendency is small, and thus the axial recovery tendency is small.

Since there is no space at the self-locking position of different cylindrical structures, when bending, the outer radius of the bending is in an axially stretched state. At this time, the deformation of the outer radius is caused by the deformation of the wire. Therefore, the wire deforms more and its recovery tendency is greater, so the axial recovery tendency of the stent is large, which reduces the fit of the stent.

In summary, the cross self-locking weaving scheme in the prior art does not achieve the expected fitting effect, the stent does not fit well with the bending part of the human cavity, the stent still exerts force on the human cavity, and there is still the possibility of giving the patient a strange feeling.

Summary of the invention

The invention discloses a method for manufacturing a biliary stent and a biliary stent, which are used to solve the problem of poor fit between the biliary stent and the bile duct in the prior art.

The present invention adopts the following technical solutions:

In a first aspect, the present application provides a method for manufacturing a biliary stent, wherein the method is wound around the axis of a fixture as the central axis, and a plurality of pins are arranged in the circumferential direction and the length direction of the fixture; the method comprises:

Using any pin at one end of the fixture as a first starting point, the first wire is moved from the first starting point along the circumferential direction, and is bent and wound in a zigzag shape with the pin as a fulcrum to form a first cylindrical mesh structure;

A plurality of first cylindrical mesh structures are axially arranged in sequence until they extend to the other end of the clamp;

Taking any pin at one end of the fixture and not on the first cylindrical mesh structure as the second starting point, the second wire is moved from the second starting point along the circumferential direction, and is bent and wound in a zigzag shape with the pin not on the first cylindrical mesh structure as a fulcrum to form a second cylindrical mesh structure;

The second cylindrical mesh structure intersects with the first cylindrical mesh structure trajectory and is sequentially arranged along the axial direction of the clamp until it extends to the other end of the clamp;

Between the axially adjacent first cylindrical mesh structures, at least part of the first wires are crossed around the pins but are not self-locking; or,

Between the axially adjacent second cylindrical mesh structures, at least part of the second wires are crossed around the pins but are not self-locking.

In a second aspect, the present application provides a biliary stent, comprising a plurality of first cylindrical mesh structures and a plurality of second cylindrical mesh structures;

The first cylindrical mesh structure includes a first wire material bent and wound in a zigzag shape, and each first cylindrical mesh structure includes a plurality of circumferentially arranged grid structures;

The second cylindrical mesh structure includes a second wire, and the second wire is configured into a plurality of circumferentially arranged grid structures or a circumferentially extending zigzag structure;

A plurality of first cylindrical mesh structures and a plurality of second cylindrical mesh structures are axially arranged in sequence, and the mesh structures or zigzag structures in the second cylindrical mesh structures are arranged crosswise with the mesh structures in the first cylindrical mesh structures;

At least part of the first wires between the axially adjacent first cylindrical mesh structures are in a non-self-locking structure at the intersection; or,

At least part of the second wires between the axially adjacent second cylindrical mesh structures are in a non-self-locking structure at the intersection.

The technical solution adopted by the present invention can achieve the following beneficial effects:

The present application provides a novel method for manufacturing a biliary stent and a biliary stent produced by the method; on the one hand, the aforementioned manufacturing method enables the first wire and the second wire to be woven simultaneously, without having to wait until the first wire is completely woven before starting, thereby ensuring the efficiency of the biliary stent during production and manufacturing; at the same time, in the process of weaving the first wire around a clamp to form a first cylindrical mesh structure and weaving the second wire around a clamp to form a second cylindrical mesh structure, the first wire can be set as a cross non-self-locking structure in at least part of the area, and when the biliary stent occurs within a certain range, When the biliary stent is axially stretched, relative movement between different cylindrical mesh structures will occur first, reducing the deformation of the wire and thus reducing its recovery tendency; only when the space in the non-self-locking structure disappears will the wire be deformed. Therefore, the setting of this non-self-locking structure can ensure that when the biliary stent is bent, its bending outer radius can be reduced in the stretched state by reducing the structure in the non-self-locking structure space to reduce the tendency of the biliary stent to restore its original shape, so as to improve the fit of the biliary stent to the human biliary structure and reduce the possibility of the biliary stent causing a strange feeling to the patient at the bend of the biliary tract.

In another preferred embodiment, the biliary stent is configured as a self-locking structure at both ends and a non-self-locking structure at the central portion; wherein, since the two ends of the biliary stent are often configured as a trumpet shape for positioning, the self-locking structure can further strengthen the tendency of the biliary stent to restore its original shape, so as to enhance the positioning ability of the biliary stent in the human bile duct, and the bending of the biliary stent often occurs in the middle thereof, so the middle portion is still configured as a non-self-locking structure to improve the structural fit of the stent.

A developing ring is further provided on the biliary stent. The developing ring has a spiral configuration similar to a spring and can be tightly sleeved on certain parts of the first wire and/or the second wire to help doctors position the stent during interventional surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions explain the present invention and do not constitute improper limitations on the present invention. In the drawings:

FIG1 is an expanded view of a biliary stent in the prior art;

FIG2 is a schematic diagram of the structure of a clamp in a preferred embodiment disclosed in Example 1 of the present invention;

FIG3 is a planar distribution diagram of pins on a fixture in a preferred implementation manner disclosed in Example 1 of the present invention;

4a to 4d are diagrams showing the manufacturing process of a first cylindrical mesh structure in a preferred embodiment disclosed in Example 1 of the present invention;

5a to 5d are diagrams showing the manufacturing process of a second cylindrical mesh structure in a preferred embodiment disclosed in Example 1 of the present invention;

FIG6 is a schematic diagram of a partial structure of a biliary stent in a preferred embodiment disclosed in Example 1 of the present invention;

FIG7 is a schematic diagram of a partial structure of a biliary stent in another preferred embodiment disclosed in Example 1 of the present invention;

FIG8 is a partial enlarged view of a non-self-locking structure in a preferred embodiment disclosed in Example 1 of the present invention;

FIG. 9 is a stereoscopic view of a biliary stent in a preferred embodiment disclosed in Example 3 of the present invention.

Description of reference numerals:
A biliary stent 10 , a first wire 11 , a first cylindrical mesh structure 111 , a second wire 12 , a second cylindrical mesh structure 121 , a self-locking structure 13 , a non-self-locking structure 14 ; a clamp 20 , a pin 21 ; and a developing ring 30 .

Detailed ways

In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and/or", unless the content clearly indicates otherwise.

In the description of the present invention, the terms “first”, “second”, etc. are only used for distinguishing the descriptions and cannot be understood as indicating or implying relative importance.

Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

Example 1

Referring to Figure 1, in the prior art, when a biliary stent is manufactured, a first wire is used to manufacture a first cylindrical mesh structure, and a second wire is used to manufacture a second cylindrical mesh structure. Both the first cylindrical mesh structure and the second cylindrical mesh structure include several grid structures arranged in sequence in a circumferential direction. The production process of the entire biliary stent is: after the first wire is wound around a clamp and finally forms a first cylindrical mesh structure, the second wire is moved and woven to form a second cylindrical mesh structure. In the structure of the entire biliary stent, several first cylindrical mesh structures are axially arranged, and several second cylindrical mesh structures are also axially arranged. The first wire or the second wire between axially adjacent mesh structures uses the same clamp pin. When bending and winding around the pin, the wires pass through the same side of the pin and are cross-fixed to form a self-locking structure 13. The self-locking structure 13 can be relatively stable after the biliary stent is heat-set. When the biliary stent is implanted in the human body and bends, relative displacement can occur at the self-locking structure 13, especially at the outer radius of the bend of the biliary stent 10. The bending is caused by the tensile deformation of the wire itself. Due to the large deformation of the wire, the recovery tendency is large and the stent fitting is poor.

In this embodiment, a novel method for manufacturing a biliary stent is provided to overcome the above-mentioned problems existing in the prior art.

Referring to FIG. 2 of the specification, in a preferred embodiment, when the biliary stent 10 is manufactured, the wire is wound around the clamp 20 and finally heat-set to form the biliary stent 10. Preferably, the clamp 20 is roughly in the shape of an elongated cylinder, and a plurality of detachable pins 21 are arranged on the clamp 20. After the biliary stent 10 is woven and shaped, the pins 21 can be removed from the clamp 20 to facilitate the detachment of the biliary stent 10 from the clamp 20; preferably, the two ends of the clamp 20 are roughly in the shape of trumpets that bulge outward, so that the axial ends of the finally shaped biliary stent 10 also have trumpet-shaped structures, which is conducive to the positioning of the biliary stent 10 in the human bile duct to overcome its undesirable sliding.

In a preferred embodiment, the pins 21 are arranged along the circumferential direction and the length direction of the clamp 20, as shown in FIG3; optionally, the pins 21 can be evenly, unevenly or distributed in a certain pattern on the outer surface of the clamp 20. In this embodiment, the pins 21 are arranged at some intersection points of the circumferential dividing line and the length dividing line of the clamp 20, specifically: 7 rows of pins 21 are arranged in the length direction of the clamp 20, respectively x1 to x7, and 10 rows of pins 21 are arranged in the circumferential direction of the clamp 20, respectively y1 to y10; wherein, the pins 21 on x2 to x6 are arranged at intervals, only 5 are arranged, and the pins 21 on x1 and x7 are arranged continuously, both 10 are arranged, which is consistent with the number of rows of pins 21 arranged in the circumferential direction. It should be understood by those skilled in the art that in this embodiment, the arrangement of the pins 21 is only used as an example. In actual arrangement, the specific arrangement mode and number of the pins 21 can be changed according to actual needs.

Preferably, in this embodiment, the wire material used to manufacture the biliary stent 10 is a metal wire, and specifically a metal material with shape memory properties such as nickel-titanium alloy can be selected. After the biliary stent 10 is manufactured, it can be heat-formed and compressed at low temperature. After being implanted in the human body, it automatically expands to a predetermined shape during manufacturing as the temperature rises.

Preferably, in this embodiment, the wires used to manufacture the biliary stent 10 include a first wire 11 and a second wire 12, both of which are made of the same material and diameter to ensure the consistency of strength at all locations of the biliary stent 10. In other preferred embodiments, wires of different materials and diameters may also be selected. Those skilled in the art should understand that when wires of different materials and diameters are selected, the two wires may have the same strength or different strengths.

In a preferred embodiment, Figures 4a-4d show a method for manufacturing a biliary stent 10 according to an embodiment of the present invention using a clamp 20. The solid lines in the figure represent the movement paths of the first wire 11 and/or the second wire 12, and the hollow circles in the figure represent the planar arrangement of the pins 21 on the clamp 20 in a preferred embodiment; in order to distinguish the structures formed by the first wire 11 and the second wire 12 respectively, in Figures 5a-5d, slightly thinner lines are used to represent the structure formed by the second wire 12. Those skilled in the art should understand that the thickness of the solid lines in the figure is only an arbitrarily set part for the convenience of explanation, and the thickness of the solid lines is essentially irrelevant to the properties or dimensions of the wires in this embodiment.

In this embodiment, after the first wire 11 starts to move and weave, the second wire 12 can be moved and weaved, without having to wait until the first wire 11 is completely weaved before starting to weave the second wire 12; alternatively, after the second wire 12 starts to weave, the weaving of the first wire 11 can be started; alternatively, the first wire 11 and the second wire 12 start to weave at the same time; for the convenience of description, the weaving process of the first wire 11 and the second wire 12 is still described separately; it should be noted that "first" and "second" are only artificially set names for the convenience of distinguishing and describing the two wires, and the two do not contain a causal relationship or other necessary logical relationship.

In a preferred embodiment, the method for manufacturing the biliary stent 10 comprises the following steps:

With any pin 21 at one end of the fixture 20 as the first starting point, the first wire 11 is moved from the first starting point along the circumferential direction and is zigzag-bent and wound with the pin 21 as a fulcrum to form a first cylindrical mesh structure 111 .

Preferably, the pin 21 at (x1, y1) is set as the first starting point, and the first wire 11 is woven along the pins 21 on the surface of the clamp 20 according to the bending shape of the peaks and troughs; preferably, when the first wire 11 moves, it is separated by a pin 21 in the length direction, and the adjacent pins 21 are directly connected in the circumferential direction, but because the pins 21 on x2 to x6 are arranged at intervals, the first wire 11 is actually separated by an intersection of a circumferential dividing line and a length dividing line when it moves, that is, when the first wire 11 moves, it is separated by an intersection of a circumferential dividing line and a length dividing line in both the circumferential direction and the length direction.

Preferably, the moving trajectory of the first wire 11 passes through the pins 21 (x1, y1), (x3, y3), (x1, y5), (x3, y7), (x1, y9), (x3, y1). When the first wire 11 completes the movement along the above path, a zigzag structure is formed, and then weaving continues. The moving trajectory passes through the pins 21 (x3, y1), (x1, y3), (x3, y5), (x1, y7), (x3, y9), (x1, y1), (x3, y3). When the first wire 11 moves to the pin 21 (x1, y1) again, the weaving of the first first cylindrical mesh structure 111 of the first wire 11 is completed.

Preferably, the first cylindrical mesh structure 111 includes a plurality of grid structures arranged in sequence in the circumferential direction, the grid structures are substantially diamond-shaped, and the vertices of adjacent grid structures are opposite to each other.

Preferably, after the first cylindrical mesh structure 111 is woven, when the first wire 11 moves from (x1, y1) to (x3, y3) again, in order to fix the first wires 11 that overlap with each other on the moving path, the first wire 11 that passes again is spirally twisted around the first wire 11 that passes for the first time at the pin 21 (x1, y1) to (x3, y3), so as to complete the mutual fixation of the two overlapping moving trajectories of the first wire 11.

Preferably, the first wire 11 moves straight after reaching (x3, y3) again, and continues to bend and wind in a zigzag shape after at least an interval of (x3, y3) to form a second first cylindrical mesh structure 111. Since the starting point of the second first cylindrical mesh structure 111 can be considered to be (x3, y3), and this point also belongs to the end point of the first first cylindrical mesh structure 111, this point is used as the first conversion point, that is, the first conversion point is the first adjacent pin 21 that the first wire 11 passes again from the first starting point along the original moving path.

Preferably, the moving trajectory of the second first cylindrical mesh structure 111 is (x3, y3), (x5, y5), (x3, y7), (x5, y9), (x3, y1), (x5, y3), (x3, y5), (x5, y7), (x3, y9), (x5, y1), (x3, y3), (x5, y5). Similar to the first first cylindrical mesh structure 111, during the weaving process of the second cylindrical mesh structure, the moving trajectory of the first wire 11 is still separated by an intersection of a circumferential dividing line and a length dividing line in both the circumferential direction and the length direction.

Preferably, after the second first cylindrical mesh structure 111 is woven, when the first wire 11 moves from (x3, y3) to (x5, y5) again, the first wire 11 that passes for the first time is fixed by spiral twisting. At this time, (x5, y5) serves as the second conversion point, and the second conversion point is the first adjacent pin 21 that the first wire 11 passes again from the first conversion point along the original moving path.

The third first cylindrical mesh structure 111 is woven in the same manner, and its moving trajectory is (x5, y5), (x7, y7), (x5, y9), (x7, y1), (x5, y3), (x7, y5), (x5, y7), (x7, y9), (x5, y1), (x7, y3), (x5, y5), (x7, y7). Similar to the first and second first cylindrical mesh structures 111 mentioned above, during the weaving process of the third cylindrical mesh structure, the moving trajectory of the first wire 11 is still separated by an intersection of a circumferential dividing line and a length dividing line in both the circumferential direction and the length direction.

Preferably, after the third first cylindrical mesh structure 111 is woven, when the first wire 11 moves from (x5, y5) to (x7, y7) again, the first wire 11 that passes for the first time is fixed by spiral twisting. So far, the first cylindrical mesh structure 111 has fully covered the clamp 20 in the axial direction; those skilled in the art should understand that since the number or number of rows of pins 21 on the clamp 20 is not limited to the number provided in this embodiment, when the number of pins 21 increases, the above steps are repeated so that several first cylindrical mesh structures 111 are arranged in sequence in the axial direction until they extend from one end of the clamp 20 to the other end.

Preferably, since each first cylindrical mesh structure 111 includes several mesh structures arranged circumferentially, in a preferred embodiment, the mesh structure in the first cylindrical mesh structure 111 can be defined as the first mesh structure. The vertices of the upper and lower adjacent first cylindrical mesh structures 111 are opposite and share a pin 21, such as (x3, y1), (x3, y3), (x3, y5), (x3, y7), (x3, y9), and (x5, y1), (x5, y3), (x5, y5), (x5, y7), (x5, y9), the first wire 11 will pass through these points twice respectively, and each time it passes is the trajectory of weaving the current first cylindrical mesh structure 111; in a preferred embodiment, with (x3, y1), (x3, y3), (x3, y5), (x3, y7), (x3, y9), the first wire 11 will pass through these points twice respectively, and each time it passes is the trajectory of weaving the current first cylindrical mesh structure 111; 3, y7) as an example, the first wire 11 is the track of weaving the first first cylindrical mesh structure 111 when it passes through for the first time, and is the track of weaving the second first cylindrical mesh structure 111 when it passes through for the second time; preferably, when the first wire 11 passes through the point for the second time, it crosses with the first wire 11 woven for the first time, and is wrapped from the other side of the pin 21 at the point (that is, the opposite side of the first wire 11 wrapped around), and crosses and is fixed with the first wire 11 again, forming a mutually crossed but non-self-locking structure 14 of the first wire 11, as shown in Figure 8. Those skilled in the art should understand that when the first wire 11 passes through the point for the second time and crosses with the first wire 11 woven for the first time, and is wrapped from the same side of the point, abuts against, crosses and is fixed with the first wire 11, this weaving method is a self-locking structure 13.

In a preferred embodiment, the first wires 11 are mutually crossed but non-self-locking structures at the vertices of all upper and lower adjacent first cylindrical mesh structures 111. When the biliary stent 10 is manufactured and the pin 21 is pulled out, the first cylindrical mesh structures 111 have a relatively movable space at these non-self-locking structures 14. When the biliary stent 10 is bent under force, the relative movement between different first cylindrical mesh structures 111 reduces the space in the non-self-locking structure 14 rather than the stretching deformation of the first wires 11 themselves. This makes the tendency of the biliary stent 10 to restore its original shape smaller, and the fit with the biliary structure is high, making the patient more comfortable.

Preferably, after the first wire 11 has completed the weaving of one or more first cylindrical mesh structures 111, a developing ring 30 is also sleeved at the spiral twisted part where the last track overlaps. Preferably, the developing ring 30 is in the shape of a spiral cylinder with a small pitch. When placing the developing ring 30, it can be first moved to the non-spiral twisted part. After the first wire 11 completes the spiral twisting at the track overlap, the developing ring 30 is moved to the spiral twisted part and sleeved outside. On the one hand, it is used for the development of the medical imaging system, and on the other hand, it is used to fix the first wire 11 at the track overlap. Preferably, the developing ring 30 is set at the position where the weaving of the first wire 11 ends to constrain the first wire 11 and prevent its end from curling up.

In a more preferred embodiment, a developing ring 30 is sleeved at each location where the tracks of the first wires 11 overlap, so that each overlapping area of the spirally twisted first wires 11 can be relatively fixed and provide a developing site.

Preferably, after the first wire 11 starts to be weaved, or simultaneously with its weaving, the second wire 12 also starts to move and weave. Since the first wire 11 actually contains an intersection of a circumferential dividing line and a length dividing line in each mesh structure when weaving the first cylindrical mesh structure 111, the gap is relatively large. The second wire 12 is used to reduce the gaps between the several mesh structures formed by the first cylindrical mesh structure 111.

Preferably, the second wire 12 is used to weave a second cylindrical mesh structure 121, and the trajectories of the second cylindrical mesh structure 121 and the first cylindrical mesh structure 111 intersect, and an insertion and pressing design is performed at the intersection to ensure that the final biliary stent 10 forms a stable structure in a single mesh structure.

Those skilled in the art should understand that a first cylindrical mesh structure 111 refers to a cylindrical unit woven by the first wire 11, and a second cylindrical mesh structure refers to a cylindrical unit woven by the second wire 12; there are several first cylindrical mesh structures 111 and second cylindrical mesh structures 121, which are arranged in sequence along the length direction of the clamp 20, and finally cover from one end of the clamp 20 to the other end.

Preferably, any pin 21 at one end of the clamp 20 and not on the first cylindrical mesh structure 111 is used as the second starting point, so that the second wire 12 moves from the second starting point in the circumferential direction, and is bent and wound in a zigzag shape with the pin 21 not on the first cylindrical mesh structure 111 as a fulcrum to form a second cylindrical mesh structure 121; preferably, the second cylindrical mesh structure 121 intersects with the trajectory of the first cylindrical mesh structure 111, and is arranged sequentially along the axial direction of the clamp 20 until it extends to the other end of the clamp 20.

Preferably, the pin 21 at (x1, y6) is set as the second starting point, and the second wire 12 is woven along the pin 21 on the surface of the clamp 20 according to the bending shape of the crests and troughs; preferably, when weaving the first second cylindrical mesh structure 121, the second wire 12 directly connects adjacent pins 21 without separating them at an intersection of a circumferential dividing line and a length dividing line, in order to reduce the mesh size of the first first cylindrical mesh structure 111.

Preferably, the moving trajectory of the second wire 12 passes through the pins 21 (x1, y6), (x2, y7), (x1, y8), (x2, y9), (x1, y10), (x2, y1), (x1, y2), (x2, y3), (x1, y4), (x2, y5), and (x2, y7). When the second wire 12 completes the movement of the above path, a first second cylindrical mesh structure 121 is formed. The first second cylindrical mesh structure 121 is a circumferentially extending zigzag structure.

Preferably, after the first second cylindrical mesh structure 121 is woven, when the second wire 12 moves from (x1, y6) to (x2, y7) again, in order to fix the second wires 12 that overlap with each other on the moving path, the second wire 12 that passes again is spirally twisted around the second wire 12 that passes for the first time at the pin 21 (x1, y6) to (x2, y7), so as to complete the mutual fixation of the two overlapping moving trajectories of the second wire 12.

Preferably, the moving trajectory of the second second cylindrical mesh structure 121 is (x2, y7), (x4, y9), (x2, y1), (x4, y3), (x2, y5), (x4, y7), (x2, y9), (x4, y1), (x2, y3), (x4, y5), (x2, y7), (x4, y9). Unlike the first second cylindrical mesh structure 121, during the weaving process of the second cylindrical mesh structure, the moving trajectory of the second wire 12 is separated by an intersection of a circumferential dividing line and a length dividing line in both the circumferential direction and the length direction.

Preferably, the second second cylindrical mesh structure 121 includes a plurality of mesh structures arranged in sequence in the circumferential direction, the mesh structures are substantially rhombus-shaped, and the vertices of adjacent mesh structures are opposite. In a preferred embodiment, the mesh structure woven by the second wire 12 can be defined as the second mesh structure.

Similar to the first second cylindrical mesh structure 121 , when the second wire 12 passes through (x2, y7) and (x4, y9) again, it is spirally wound around the second wire 12 that passed for the first time, so as to fix the two overlapping movement trajectories of the second wire 12 to each other.

Preferably, the moving trajectory of the third second cylindrical mesh structure 121 is (x4, y9), (x6, y1), (x4, y3), (x6, y5), (x4, y7), (x6, y9), (x4, y1), (x6, y3), (x4, y5), (x6, y7), (x4, y9), (x6, y1), and the weaving method is the same as the weaving method of the second second cylindrical mesh structure 121, which will not be repeated here; preferably, when the second wire 12 passes through (x4, y9) and (x6, y1) for the second time, it is spirally wound around the second wire 12 that passes for the first time.

When weaving the last second cylindrical mesh structure 121, the movement trajectory of the second wire 12 is (x6, y1), (x7, y2), (x6, y3), (x7, y4), (x6, y5), (x7, y6), (x6, y7), (x7, y8), (x6, y9), (x7, y10), (x6, y1), (x7, y2), and when passing through (x6, y1) and (x7, y2) again, the second wire 12 is spirally wound around the second wire 12 that passed for the first time; preferably, the last second cylindrical mesh structure 121 has the same structure as the first second cylindrical mesh structure 121, and also has a circumferentially extending zigzag structure. At this point, the entire biliary stent 10 is woven, as shown in Figure 6.

Preferably, after the second wire 12 completes the weaving of one or more second cylindrical mesh structures 121, a developing ring 30 is also provided at the spiral twist where the final trajectory overlaps. The setting of the developing ring 30 is the same as the developing ring 30 set in the first cylindrical mesh structure 111, and will not be repeated here.

In a more preferred embodiment, a developing ring 30 is sleeved at each location where the second wire 12 tracks overlap, so that each overlapping area of the spirally twisted second wire 12 can be relatively fixed and provide a developing site.

Preferably, the first and last second cylindrical mesh structures 121 are both circumferentially extending sawtooth structures, and the second and third second cylindrical mesh structures 121 are circumferentially arranged grid structures, and the vertices of the axially adjacent second cylindrical mesh structures 121 are opposite and share a pin 21, such as (x2, y1), (x2, y3), (x2, y5), (x2, y7), (x2, y9), (x4, y1), (x4, y3), (x4, y5), (x4, y7), (x4, y9), (x6, y1), (x6, y3), (x6, y5), (x6, y7), (x6, y9), 6, y9), the second wire 12 will pass through these points twice respectively; in a preferred embodiment, taking (x4, y3) as an example, the second wire 12 will weave the second second cylindrical mesh structure 121 when it passes through for the first time, and will weave the third second cylindrical mesh structure 121 when it passes through for the second time; preferably, when the second wire 12 passes through this point for the second time, it crosses with the second wire 12 woven for the first time, and wraps around from the other side of the pin 21 at this point (that is, the opposite side of the second wire 12 that was first wrapped around), crosses with the second wire 12 again and is fixed, forming a structure 14 in which the second wires 12 cross each other but are not self-locking.

In a preferred embodiment, the second wire 12 has mutually intersecting but non-self-locking structures 14 at the vertices of all upper and lower adjacent second cylindrical mesh structures 121. The non-self-locking structures 14 of the second wire 12 are the same as the non-self-locking structures 14 of the first wire 11, and will not be described in detail here.

Preferably, the size of each non-self-locking structure 14 in each first cylindrical mesh structure 111 can be the same or different; the size of each non-self-locking structure 14 in each second cylindrical mesh structure 121 can be the same or different; the size of the non-self-locking structure 14 in the first cylindrical mesh structure 111 and the non-self-locking structure 14 in the second cylindrical mesh structure 121 can be the same or different.

In a preferred embodiment, the size of the non-self-locking structure 14 can be determined by the size of the pin 21. The larger the pin 21, the larger the space in the non-self-locking structure 14. In another preferred embodiment, a plurality of closely arranged pins 21 can be provided at the non-self-locking structure 14. The more pins 21 there are, the larger the size of the non-self-locking structure 14.

In a preferred embodiment, since the first wire 11 and the second wire 12 can be woven simultaneously, in the entire biliary stent 10, it is no longer limited which wire of the first cylindrical mesh structure 111 and the second cylindrical mesh structure 121 is located on top at the intersection of the trajectories.

In this embodiment, non-self-locking structures 14 are provided at the vertices of the adjacent first cylindrical mesh structures 111 and the vertices of the adjacent second cylindrical mesh structures 121, so that when the biliary stent 10 is axially stretched within a certain range, relative movement between different cylindrical mesh structures will first occur, reducing the deformation of the wire, thereby reducing its recovery tendency. Only when the space in the non-self-locking structure 14 is squeezed to completely disappear will the deformation of the wire be completely caused. Such performance enables the biliary stent 10 to bend in the bile duct, and when its outer radius of the bend is stretched, the space in the non-self-locking structure 14 can be reduced, reducing the deformation of the wire, thereby reducing the tendency of the biliary stent 10 to return to its original shape. Improve the fit of the biliary stent 10 to the human cavity and reduce the possibility of the biliary stent 10 causing a strange feeling to the patient at the bend of the cavity.

Example 2

The present embodiment provides a method for manufacturing a biliary stent 10, which differs from the above-mentioned Embodiment 1 mainly in the wire weaving method at the vertices of the axially adjacent first cylindrical mesh structures 111 and the vertices of the adjacent second cylindrical mesh structures 121. Other technical features already included in Embodiment 1 are naturally inherited in the present embodiment.

In a preferred embodiment, the first wire 11 and/or the second wire 12 cross each other at the pin 21 in the middle of the clamp 20 but are not self-locking, and cross each other and self-lock at the pins 21 near the two ends of the clamp 20; referring to FIG7, since the first wire 11 does not have the conditions for forming a self-locking structure 13 at both ends of the clamp 20, the first wire 11 is provided with a non-self-locking structure 14 in its second and third first cylindrical mesh structures 111. When the number of rows of pins 21 in the length direction increases, it can be expected that the positions near the two ends of the clamp 20 are still provided with a self-locking structure 13, and the pins 21 near the middle of the clamp 20 are provided with a non-self-locking structure 14; preferably, since the second wire 12 does not have the conditions for forming a self-locking structure 13 at both ends of the clamp 20, The condition of the self-locking structure 13 is met, and all the pins 21 on the x2 row and the x6 row are close to both ends. Therefore, the non-self-locking structure 14 is not set on all the pins 21 on the x1, x2, x6, and x7 rows of the second wire 12, and the non-self-locking structure 14 is only set on all the pins 21 on the x4 row in the middle of the clamp 20, that is, it is only set at the vertices opposite to the second, third and second cylindrical mesh structures 121. It can be expected that when the number of rows of pins 21 in the length direction increases, the number of rows of non-self-locking structures 14 that can be set in the middle of the clamp 20 will increase accordingly.

Those skilled in the art should understand that the above-mentioned setting method is only for the number of rows of pins 21 in the y direction of the clamp 20 shown in the accompanying drawings. When the number of rows increases, the number of non-self-locking structures 14 and/or self-locking structures 13 can be increased accordingly, but the overall setting idea remains: fewer or no non-self-locking structures 14 are set near the two ends of the biliary stent 10, and all or more self-locking structures 13 are set; more or all non-self-locking structures 14 are set near the middle part of the biliary stent 10, and no or fewer self-locking structures 13 are set.

After the biliary stent 10 is implanted in the human body, its two ends are often set to a trumpet shape for positioning. The self-locking structure 13 can further strengthen the tendency of the biliary stent 10 to restore its original shape, so as to enhance the positioning ability of the biliary stent 10 in the human bile duct. The bending of the biliary stent 10 often occurs in the middle, so the middle is still set to a non-self-locking structure 14 to improve the structural fit of the stent.

In another preferred embodiment, the biliary stent 10 has few or no self-locking structures 13 at both ends thereof, and all or more non-self-locking structures 14 are set; in the middle part of the biliary stent 10, more or all self-locking structures 13 are set, and no or few non-self-locking structures 14 are set; or, in another preferred embodiment, the first wire 11 has non-self-locking structures 14 at opposite vertices of all first cylindrical units, and the second wire 12 has self-locking structures 13 at opposite vertices of all second cylindrical units; or, in another preferred embodiment, the first wire 11 has self-locking structures 13 at opposite vertices of all first cylindrical units, and the second wire 12 has non-self-locking structures 14 at opposite vertices of all second cylindrical units; or, between adjacent rows of pins 21 with opposite vertices, the first wire 11 and/or the second wire 12 are alternately arranged in self-locking and non-self-locking around the pins 21.

The above four designs can all be applied to patients with certain special biliary tract lesions, so that the biliary stent 10 can better fit the special types of lesions.

Example 3

This embodiment provides a biliary stent 10, which is produced by the manufacturing method of the above-mentioned embodiment 1 or 2, so the technical features already included in embodiments 1 and 2 are naturally inherited in this embodiment.

Referring to Figure 9, in a preferred embodiment, a biliary stent 10 is provided, whose structure includes several first cylindrical mesh structures 111 and several second cylindrical mesh structures 121; preferably, the first cylindrical mesh structure 111 is formed by bending and winding the first wire 11 in a zigzag shape, and each first cylindrical mesh structure 111 includes several circumferentially arranged mesh structures; preferably, the second cylindrical mesh structure 121 is formed by bending and winding the second wire 12 in a zigzag shape, and the second cylindrical mesh structure 121 is configured as several circumferentially arranged mesh structures, or a circumferentially extending zigzag structure.

Preferably, the plurality of first cylindrical mesh structures 111 and the plurality of second cylindrical mesh structures 121 are axially arranged in sequence, and the mesh structure or the zigzag structure in the second cylindrical mesh structure 121 is arranged crosswise with the mesh structure in the first cylindrical mesh structure 111 .

In a preferred embodiment, between axially adjacent first cylindrical mesh structures 111 , the first wires 11 are all non-self-locking structures 14 at the intersection of their trajectories; between axially adjacent second cylindrical mesh structures 121 , the second wires 12 are also all non-self-locking structures 14 at the intersection of their trajectories.

In another preferred embodiment, between axially adjacent first cylindrical mesh structures 111, at least part of the first wires 11 are in a non-self-locking structure 14 at the intersection; or, between axially adjacent second cylindrical mesh structures 121, at least part of the second wires 12 are in a non-self-locking structure 14 at the intersection.

Preferably, the first wire 11 and the second wire 12 are in a non-self-locking structure 14 in the middle of the biliary stent 10, and are in a self-locking structure 13 near both ends of the biliary stent 10. The specific configuration may refer to the above-mentioned embodiment 2 and will not be repeated here.

Preferably, the first wire 11 and the second wire 12 are in a self-locking structure 13 in the middle of the biliary stent 10 , and are in a non-self-locking structure 14 near both ends of the biliary stent 10 .

In another preferred embodiment, all intersections of the first cylindrical mesh structures 111 adjacent to each other in the axial direction of the first wires 11 are self-locking structures 13, and all intersections of the second cylindrical mesh structures 121 adjacent to each other in the axial direction of the second wires 12 are self-locking structures 13. or, all intersections of the first wire 11 with the axially adjacent first cylindrical mesh structures 111 are non-self-locking structures 14, and all intersections of the second wires 12 with the axially adjacent second cylindrical mesh structures 121 are self-locking structures 13; or, all intersections of the first wire 11 with the axially adjacent first cylindrical mesh structures 111 and all intersections of the second wire 12 with the axially adjacent second cylindrical mesh structures 121 are non-self-locking structures 14; or, the intersections of the axially adjacent first cylindrical mesh structures 111 and the intersections of the axially adjacent second cylindrical mesh structures 121 are alternatingly arranged with self-locking structures 13 and non-self-locking structures 14.

Preferably, the self-locking structure 13 in the present embodiment refers to: at the intersection of the axially adjacent first cylindrical mesh structures 111, the first wires 11 cross, abut and are fixed; and/or, at the intersection of the axially adjacent second cylindrical mesh structures 121, the second wires 12 cross, abut and are fixed; Preferably, the non-self-locking structure 14 described in the present embodiment refers to: at the intersection of the axially adjacent first cylindrical mesh structures 111, the first wires 11 cross but do not abut each other; and/or, at the intersection of the axially adjacent second cylindrical mesh structures 121, the second wires 12 cross but do not abut each other.

Preferably, the biliary stent 10 also includes a developing ring 30, which is spirally arranged on the first cylindrical mesh structure 111 and/or the second cylindrical mesh structure 121; preferably, the developing ring 30 is arranged at the end of the weaving of the last first cylindrical mesh structure 111 and the second cylindrical mesh structure 121 to constrain the wire and prevent it from warping.

In a more preferred embodiment, a developing ring 30 is provided in the overlapping section of the trajectory where the first wire 11 overlaps and twists together, and a developing ring 30 is also provided in the overlapping section of the trajectory where the second wire 12 overlaps and twists together; on the one hand, the developing ring 30 can provide more developing sites, and on the other hand, the setting of the developing ring 30 can make each wire overlapping area relatively fixed.

The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the enlightenment of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the purpose of the present invention and the claims, all of which are within the protection of the present invention.

Claims

A method for manufacturing a biliary stent, characterized in that the method is to carry out winding arrangement with the axis of the clamp as the central axis, and a plurality of pins are arranged in the circumferential direction and the length direction of the clamp; the method comprises:

Taking any pin at one end of the clamp as a first starting point, the first wire is moved from the first starting point along the circumferential direction, and is bent and wound in a zigzag shape with the pin as a fulcrum to form a first cylindrical mesh structure;

A plurality of the first cylindrical mesh structures are arranged axially in sequence until they extend to the other end of the clamp;

Taking any pin at one end of the clamp and not on the first cylindrical mesh structure as a second starting point, the second wire is moved from the second starting point along the circumferential direction, and is bent and wound in a zigzag shape with the pin not on the first cylindrical mesh structure as a fulcrum to form a second cylindrical mesh structure;

The second cylindrical mesh structure intersects with the first cylindrical mesh structure trajectory and is sequentially arranged along the axial direction of the clamp until it extends to the other end of the clamp;

Between the first cylindrical mesh structures adjacent to each other in the axial direction, at least part of the first wires are crossed around the pins but are not self-locking; or,

Between the axially adjacent second cylindrical mesh structures, at least part of the second wires are crossed around the pins but are not self-locking.
The method for manufacturing a biliary stent according to claim 1, characterized in that the second wire starts to be braided after the first wire starts to move;

Alternatively, the second wire is braided simultaneously with the first wire;

Alternatively, the first wire starts weaving after the second wire starts moving.
The method for manufacturing a biliary stent according to claim 1, characterized in that after the first wire material completes the weaving of the first first cylindrical mesh structure, it passes through the first conversion point along the original moving path from the first starting point and continues to move spirally downward around the clamp, and the first wire material continues to be bent and wound in a zigzag shape after at least the first conversion point is separated to form the next first cylindrical mesh structure;

The first conversion point is the first adjacent pin that the first starting point passes again along the original moving path. After the first wire completes the weaving of the first cylindrical mesh structure, it is spirally twisted from the first starting point to the first conversion point.
The method for manufacturing a biliary stent according to claim 3 is characterized in that after the first wire completes the weaving of the second first cylindrical mesh structure, it passes through the second conversion point along the original path from the first conversion point and continues to move spirally downward around the clamp, and the first wire continues to bend and wind in a zigzag shape after at least the second conversion point is separated to form the next first cylindrical mesh structure;

The second conversion point is the first adjacent pin that the first conversion point passes again along the original moving path, and the first wire is spirally twisted from the first conversion point to the second conversion point after completing the weaving of the second first cylindrical mesh structure;

Repeat the above steps until the first cylindrical mesh structure completely covers the fixture axially.
The method for manufacturing a biliary stent according to claim 4 is characterized in that the second wire is woven using the same weaving method as the first wire until the second cylindrical mesh structure completely covers the clamp axially.
The method for manufacturing a biliary stent according to claim 1 is characterized in that each of the first cylindrical mesh structures includes a plurality of circumferentially arranged mesh structures; the second cylindrical mesh structure includes a plurality of circumferentially arranged mesh structures, or includes a circumferentially extending zigzag structure.
The method for manufacturing a biliary stent according to claim 6, characterized in that:

The vertices of the axially adjacent grid structures are opposite to each other and share the same pin;

The vertices of the axially adjacent grid structures and the sawtooth structures are opposite and share a same pin;

At least some of the first wires and/or the second wires are crossed around the pins at opposite vertices but are not self-locking.
The method for manufacturing a biliary stent according to claim 6 is characterized in that each of the first cylindrical mesh structures includes a plurality of circumferentially arranged first mesh structures; the second cylindrical mesh structure includes a plurality of circumferentially arranged second mesh structures, or includes a circumferentially extending zigzag structure.
The method for manufacturing a biliary stent according to claim 8, characterized in that:

The vertices of the first grid structures adjacent to each other in the axial direction are opposite to each other and share the same pin;

The vertices of the second grid structures adjacent to each other in the axial direction are opposite to each other and share the same pin;

The vertices of the second grid structure and the sawtooth structure adjacent to each other in the axial direction are opposite and share the same pin;

At least part of the first wires and/or the second wires cross each other around the pins at opposite vertices but are not self-locking.
The method for manufacturing a biliary stent according to claim 7, characterized in that:

The first wire and/or the second wire cross each other at the pin in the middle of the clamp but are not self-locking, and cross each other and are self-locking at the pins near the two ends of the clamp;

Alternatively, the first wire and/or the second wire cross each other and are self-locking at the pin in the middle of the clamp, and cross each other and are not self-locking at the pins near the two ends of the clamp;

Alternatively, the first wire and/or the second wire cross each other around the pin at all vertices of the pin that are opposite to each other but are not self-locking.
The method for manufacturing a biliary stent according to claim 7, characterized in that:

The first wires cross each other around the pins at all the opposite vertices but are not self-locking, and all the second wires cross each other around the pins at all the opposite vertices and are self-locking;

Alternatively, the first wires cross each other around the pins at all the opposite vertices and are self-locked, and all the second wires cross each other around the pins at all the opposite vertices but are not self-locked;

Alternatively, between pins with opposite vertices in adjacent rows, the first wire and/or the second wire are arranged alternately in a self-locking and non-self-locking manner around the pins.
The method for manufacturing a biliary stent according to claim 10 or 11, characterized in that:

The self-locking step includes: when the first wire or the second wire passes through the pins at opposite vertices twice in succession, the first wire or the second wire passes through the same side of the pin and is cross-fixed;

The non-self-locking step includes: when the first wire or the second wire passes through the pins at opposite vertices twice in succession, the first wire or the second wire passes through different sides of the pin respectively and is cross-fixed.
A biliary stent, characterized by comprising:

- a plurality of first cylindrical mesh structures; the first cylindrical mesh structures include first wires bent in a zigzag shape, and each of the first cylindrical mesh structures includes a plurality of circumferentially arranged mesh structures;

- a plurality of second cylindrical mesh structures; the second cylindrical mesh structure comprises a second wire, and the second wire is configured as a plurality of circumferentially arranged grid structures, or a circumferentially extending zigzag structure;

A plurality of the first cylindrical mesh structures and a plurality of the second cylindrical mesh structures are axially arranged in sequence, and the mesh structures or zigzag structures in the second cylindrical mesh structures are arranged crosswise with the mesh structures in the first cylindrical mesh structures;

At least part of the first wires between the axially adjacent first cylindrical mesh structures are in a non-self-locking structure at the intersection; or,

At least a portion of the second wires between the axially adjacent second cylindrical mesh structures are in a non-self-locking structure at the intersection.
The biliary stent according to claim 13, characterized in that

The first wire and/or the second wire is in a non-self-locking structure in the middle of the biliary stent, and is in a self-locking structure near both ends of the biliary stent;

Alternatively, the first wire and/or the second wire has a self-locking structure in the middle of the biliary stent and has a non-self-locking structure near both ends of the biliary stent.
The biliary stent according to claim 13, characterized in that

All intersections of the first cylindrical mesh structures adjacent to each other in the axial direction of the first wires are in a self-locking structure, and all intersections of the second cylindrical mesh structures adjacent to each other in the axial direction of the second wires are in a non-self-locking structure;

Alternatively, all intersections of the first cylindrical mesh structures adjacent to the first wires in the axial direction are in a non-self-locking structure, and all intersections of the second cylindrical mesh structures adjacent to the second wires in the axial direction are in a self-locking structure;

Alternatively, all intersections of the first cylindrical mesh structures adjacent to the first wire in the axial direction and all intersections of the second cylindrical mesh structures adjacent to the second wire in the axial direction are in a non-self-locking structure;

Alternatively, the intersections of the first axially adjacent cylindrical mesh structures and the intersections of the second axially adjacent cylindrical mesh structures are alternately arranged with self-locking structures and non-self-locking structures.
The biliary stent according to claim 14 or 15, characterized in that:

The self-locking structure comprises: at the intersection of the first cylindrical mesh structures adjacent to each other in the axial direction, the first wires are cross-abutted and fixed; and/or, at the intersection of the second cylindrical mesh structures adjacent to each other in the axial direction, the second wires are cross-abutted and fixed;

The non-self-locking structure includes: at the intersection of the first axially adjacent cylindrical mesh structures, the first wires cross but do not abut each other; and/or, at the intersection of the second axially adjacent cylindrical mesh structures, the second wires cross but do not abut each other.
The biliary stent according to claim 13 is characterized in that it also includes a developing ring, which is spirally arranged on the first cylindrical mesh structure and/or the second cylindrical mesh structure.