Biliary stent and method for making the same

Abstract

The present invention discloses a bile duct stent and a method for manufacturing the same. The bile duct stent with an anti-reflux tool in an embodiment of the present invention comprises: a cylindrical body, which is formed by weaving a metal wire of a shape memory alloy into a zigzag grid structure by a plurality of needles arranged in the circumferential direction (X) and the length direction (Y) of a cylindrical fixture; a membrane portion, a metal wire grid unit (cell) coated on the grid structure; and an anti-reflux pattern film, in which holes are formed in the membrane portion of the grid unit (cell) formed at the outlet end of the cylindrical body, respectively, and a wire (Lasso) passes through any one of the holes (h) and is woven and fixed in a zigzag shape in the metal wire grid unit in the circumferential direction, and the wire crosses the outlet end more than once to form a mesh structure.

Description

Technical Field

[0001] The invention relates to a bile duct stent and a manufacturing method thereof, and more particularly to a bile duct stent for preventing food reflux in the duodenum and a manufacturing method thereof. Background Art

[0002] Normally, the bile duct serves as a channel for the bile produced in the liver and concentrated in the gallbladder to flow into the duodenum. Bile duct stenosis refers to a disease in which the bile duct narrows or blocks the channel due to tumors such as pancreatitis / cancer, cholangitis / cancer, and bile duct cancer.

[0003] Such bile duct strictures can be treated surgically, but recently, they are being treated by endoscopic bile duct stent placement surgery, and stent placement surgery is being widely used, especially in advanced cancer patients who cannot undergo surgery due to malignant bile duct strictures.

[0004] However, existing bile duct stents have been pointed out to have the problem that food passing through the duodenum frequently flows back into the bile duct, affecting the bile flow, thus causing cholangitis, or causing side effects due to stent malfunction.

[0005] In order to solve this problem, bile duct stents with anti-reflux tools have been proposed in the past, but in reality, it is difficult to prove their effectiveness due to various disadvantages.

[0006] For example, Korean Patent No. 0170220 discloses a stent having a backflow prevention means composed of a three-leaf / three-blade valve made of a resin material.

[0007] However, the valve disclosed in the Korean Patent No. 0170220 has the disadvantage that if the stent expansion force is weak or cannot maintain a fully expanded state, the opening portion cannot be fully opened and remains in a closed state, which hinders the bile supply, thereby causing the stagnant bile to coagulate. In addition, the anti-reflux tool is made of a resin material, so like the existing tube-type stent, there is a problem of reduced durability due to membrane damage caused by bile.

[0008] Therefore, an improved solution is required to solve the existing anti-reflux problem and ensure the durability of the expandable bile duct stent opening effect.

[0009] The items recorded in this background technology section are written to facilitate understanding of the background of the invention and may include contents that are not known to persons having ordinary knowledge in the field to which the technology belongs. Summary of the invention

[0010] 1. Technical issues to be resolved

[0011] An embodiment of the present invention provides a bile duct stent and a method for manufacturing the same. A reflux prevention pattern membrane is formed at the duodenal outlet of the stent inserted into the bile duct using a pattern component of a lasso or metal wire to prevent food in the duodenum from flowing back into the bile duct.

[0012] (II) Technical solution

[0013] According to one aspect of the present invention, a bile duct stent with an anti-reflux tool includes: a cylindrical body, which is composed of a mesh structure in which a plurality of needles arranged in the circumferential direction X and the longitudinal direction Y of a cylindrical clamp are used to weave a metal wire of a shape memory alloy into a zigzag shape; a membrane portion, which is coated on a metal wire mesh unit (cell) of the mesh structure; and an anti-reflux pattern membrane, in which holes are formed in the membrane portion of the mesh unit (cell) formed at the outlet end of the cylindrical body, and a wire (Lasso) passes through any one of the holes (h) and is woven and fixed in a zigzag shape in the metal wire mesh unit in the circumferential direction, and the wire crosses the outlet end more than once to form a mesh structure.

[0014] In addition, according to another aspect of the present invention, a bile duct stent with an anti-reflux tool includes: a cylindrical main body, which is composed of a mesh structure made by weaving a metal wire of a shape memory alloy into a zigzag shape with multiple needles arranged in the circumferential direction X and the length direction Y of a cylindrical clamp; and an anti-reflux pattern membrane, in which the metal wire is wound between a needle P and another needle P arranged in the circumferential direction X at the lower end of the clamp, and the outlet end of the cylindrical main body is spanned more than once to form a mesh structure.

[0015] The backflow prevention pattern film may be formed into any one of a cross-shaped anti-backflow pattern film that crosses the outlet end, a straight-line anti-backflow pattern film, a zigzag-shaped anti-backflow pattern film, a polygonal anti-backflow pattern film, and a star-shaped anti-backflow pattern film.

[0016] In addition, the anti-backflow pattern film is a line of metal wire that is continuously wound from the starting point needle P through at least one needle P to the ending point needle P, and then a twisted knot can be tied to complete the weaving.

[0017] In addition, the cross-shaped anti-backflow pattern film is a metal wire of one line starting from the first needle P1 as the starting point, crossing the first line at the center of the outlet end and winding around the second needle, then extending along the circumferential direction and moving 90 degrees to be wound around the third needle, and then starting from the third needle, the second line crossing the outlet end crosses the first line perpendicularly and is wound around the fourth needle as the end point, and then can be twisted more than once to be knotted.

[0018] In addition, the backflow prevention pattern film can be formed into a radial backflow prevention pattern film by sequentially winding the metal wire around the needles P arranged in the circumferential direction X at the lower end of the clamp and a vertical needle Py arranged at the center of the lower side of the clamp.

[0019] In addition, the radial backflow prevention pattern film is a film in which the metal wires of the plurality of lines woven by the vertical needles Py can be cross-fixed with each other in a bent state.

[0020] In addition, the anti-backflow pattern film can be formed as a conical anti-backflow pattern film, forming a conical inclined peripheral surface under the clamp, and the metal wire is wound in sequence between the vertical needle Py fixed at the vertex of the center of the bottom of the clamp and the needle P arranged in the circumferential direction X at the lower end of the clamp to form a radial shape, and the center protrudes through the conical inclined peripheral surface.

[0021] In addition, the conical backflow prevention pattern film is formed by forming a triangular structure by forming a bent portion through the vertical needle Py when forming the radial metal wire line, and the bent portions cross each other in a state of interfering with each other to form a radial inclined structure.

[0022] In addition, the anti-backflow pattern film is a circular vertical needle array centered on the bottom center of the fixture, which is sequentially wound around the vertical needle Py arrays corresponding to the needles P arranged in the circumferential direction X at the lower end to form a radial anti-backflow pattern film.

[0023] In addition, the anti-backflow pattern film is a truncated cone outer peripheral surface and a truncated cone bottom that are inclined to be wide at the top and narrow at the bottom at the lower end of the fixture, and a circular vertical needle Py array is formed with the truncated cone bottom as the center. The metal wire is sequentially wound around the vertical needle Py array corresponding to the needles P arranged in the circumferential direction to form a truncated cone-shaped anti-backflow pattern film.

[0024] In addition, the truncated cone-shaped backflow prevention pattern film is a film in which each metal wire line is formed with a bending portion through the vertical needle Py, and the bending portion can form an inclined structure that radiates each line without interfering with each other.

[0025] On the other hand, according to one aspect of the present invention, a method for making a bile duct stent using a clamp includes: a) step of weaving metal wires of a shape memory alloy material into a zigzag shape to form a cylindrical body with a grid structure using multiple needles arranged in the circumferential direction X and the length direction Y of the cylindrical clamp; and b) step of using a pattern component of wire or metal wire to cross the channel outlet end of the cylindrical body more than once to form a mesh structure anti-reflux pattern membrane.

[0026] In addition, the b) step may include the following steps: forming a conical anti-backflow pattern film, forming a vertical needle Py fixed to the inclined outer surface and the center vertex of the conical shape under the clamp, arranging the needles P in a circumferential direction X at the lower end of the clamp, and using the metal wire to sequentially wrap around the vertical needles Py and the needles P to form a radial pattern, and the center protrudes through the inclined outer surface of the conical shape.

[0027] In addition, the b) step may include the following steps: the metal wire is wrapped around the vertical needle Py in the center from the first needle as the starting point to form a bending portion, then wrapped around the second needle, and then extended to the third needle in the circumferential direction; the metal wire is wrapped around the vertical needle Py in the center from the third needle to form a bending portion, then wrapped around the fourth needle, and then extended to the fifth needle in the circumferential direction; and the metal wire is wrapped around the vertical needle Py in the center from the fifth needle to form a bending portion, then wrapped around the sixth needle as the ending point, and then twisted more than once to tie a knot.

[0028] (III) Beneficial effects

[0029] According to an embodiment of the present invention, various anti-reflux pattern membranes are formed at the duodenal outlet end of the cylindrical body of the bile duct stent using pattern components of lines or wires, thereby having the effect of preventing food from flowing back into the stent (bile duct).

[0030] In addition, a reflux prevention pattern membrane with various and dense patterns can be easily produced using one line at the outlet end of the bile duct stent, and the reflux prevention pattern membrane is formed using a nylon thread or a metal wire, thereby having the effect of ensuring durability.

[0031] In addition, a radial anti-backflow pattern membrane with a bent portion in the center is formed by using a metal wire with its own expansion force, which has the effect of easily reducing the diameter when mounted on a catheter. Furthermore, it has the effect of maintaining the anti-backflow performance even if any deformation occurs in the cylindrical body of the stent due to the pressure of the lesion. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is a conceptual diagram showing a surgical state of a bile duct stent according to an embodiment of the present invention.

[0033] Figure 2 The figure shows the state of manufacturing a bile duct stent by using a clamp according to the first embodiment of the present invention.

[0034] Figure 3 1 is a development view showing the braided structure of the stent body according to the first embodiment of the present invention.

[0035] Figure 4 An example of manufacturing a cross-shaped backflow prevention pattern film using wires according to the first embodiment of the present invention is shown.

[0036] Figure 5 Examples of implementing various backflow prevention pattern films using wires according to the first embodiment of the present invention are shown.

[0037] Figure 6 The figure shows the state of manufacturing a bile duct stent by using a clamp according to the second embodiment of the present invention.

[0038] Figure 7 An example of implementing various backflow prevention pattern films using metal wires according to the second embodiment of the present invention is shown.

[0039] Figure 8 The diagram shows a state in which a bile duct stent is manufactured using a jig formed with vertical needles according to the third embodiment of the present invention.

[0040] Fig. 9 Various shapes of dense radial backflow prevention pattern films according to the third embodiment of the present invention are shown.

[0041] Fig.10 The fourth embodiment of the present invention shows a state in which a bile duct stent is manufactured using a conical fixture.

[0042] Fig.11 1 is a perspective view showing a conical backflow prevention pattern film according to a fourth embodiment of the present invention.

[0043] Fig.12 An example is shown in which the stent according to the fourth embodiment of the present invention is used in a bile duct lesion surgery.

[0044] Fig.13 1 is a perspective view showing a truncated cone-shaped backflow prevention pattern film according to a fourth embodiment of the present invention. DETAILED DESCRIPTION

[0045] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that a person having ordinary knowledge in the technical field to which the present invention belongs can easily implement the present invention. However, the present invention can be implemented in various forms and is not limited to the embodiments described herein. Then, in order to clearly describe the present invention, parts not related to the description are omitted in the accompanying drawings, and similar parts are given similar reference numerals in the entire specification.

[0046] In the entire specification, when a certain part "includes" a certain component, it means that other components may also be included unless there is a special record to the contrary, and other components are not excluded. In addition, the terms "...part", "...device", "...module" and the like recorded in the specification refer to a unit that processes at least one function or action.

[0047] Throughout the specification, terms such as first or second may be used to describe various components, but the components shall not be limited by the terms. The terms are used only to distinguish one component from other components. For example, the first component may be named as the second component without departing from the scope of rights derived from the concept of the present invention, and similarly, the second component may also be named as the first component.

[0048] Now, a bile duct stent and a method for manufacturing the same according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings.

[0049] Figure 1 It is a conceptual diagram showing a surgical state of a bile duct stent according to an embodiment of the present invention.

[0050] Reference Figure 1 , showing a state in which a bile duct stent 10 according to an embodiment of the present invention is inserted into a bile duct connected to the duodenum.

[0051] The bile duct stent 10 is a cylindrical grid structure made of metal wires, which has elasticity itself and contracts when an external force is applied, and expands when the external force is removed.

[0052] The bile duct stent 10 is inserted into the lesioned part of the inner cavity where bile duct stenosis occurs through stent surgery, expands the inner cavity through its own expansion force, and maintains the expansion of the inner cavity to prevent re-narrowing, thereby playing a role in allowing the bile to flow smoothly in the duodenum.

[0053] It has been pointed out in the above description that in the existing stent structure, food passing through the duodenum can flow back into the dilated bile duct. If the food flows back into the stent, the bile flow is blocked, which may cause various problems.

[0054] Accordingly, an embodiment of the present invention aims to provide a bile duct stent and a method for manufacturing the same, wherein a pattern component such as a lasso or a wire is woven at the duodenal side outlet end inserted into the bile duct to form an anti-reflux pattern membrane to prevent food in the duodenum from flowing back into the bile duct.

[0055] Hereinafter, when describing the bile duct stent and the manufacturing method thereof of the present invention, the stent having the anti-reflux pattern film having various patterns according to the types of the pattern parts and the manufacturing method thereof will be described in detail according to the following various embodiments.

[0056] First, a bracket for forming an anti-backflow pattern film using wires and a method for manufacturing the bracket are described by using a first embodiment of the present invention.

[0057] (First embodiment)

[0058] Figure 2 The figure shows the state of manufacturing a bile duct stent by using a clamp according to the first embodiment of the present invention.

[0059] Reference Figure 2 The bile duct stent 10 (hereinafter, named as stent for convenience) of the first embodiment of the present invention is made by weaving a metal wire 11 into a zigzag shape using a plurality of needles P arranged in the circumferential direction X and the longitudinal direction Y of a cylindrical clamp 20.

[0060] The stent 10 can be manufactured with a cylindrical body 12 having a diameter of 8 mm to 10 mm and a length of 5 cm to 7 cm, but is not limited thereto. The length of the clamp 20 can be extended and customized according to the size of the patient's lesion.

[0061] The metal wire 11 may be made of a shape memory alloy such as Nitinol so that a predetermined expansion force can be exerted when the inner cavity of a bile duct is at a predetermined temperature. In addition, other known wires for making stents may also be used.

[0062] A stent 10 is made of a metal wire 11, and the stent 10 has a cylindrical body 12, and the cylindrical body 12 weaves the metal wire 11 in a zigzag pattern in the circumferential direction X with a plurality of needles P arranged at intervals of a predetermined width, and the zigzag patterns formed in the circumferential direction X intersect in a mutually interfering state to form a mesh structure arranged at a predetermined interval W in the length direction Y. The cylindrical mesh structure of the stent 10 presents a shape of a diamond pattern with four sides of the same length arranged in the circumferential direction X and the length direction Y of the stent 10.

[0063] For example, Figure 3 1 is a development view showing the braided structure of the stent body according to the first embodiment of the present invention.

[0064] The metal wire 11 of the embodiment of the present invention includes a first metal wire 11 a and a second metal wire 11 b . The first metal wire 11 a and the second metal wire 11 b can shrink and expand and have flexibility to form unit lengths.

[0065] Reference Figure 3 , showing a diamond pattern in which the first metal wire 11a and the second metal wire 11b are woven into a zigzag pattern by rotating twice respectively and interfering with each other.

[0066] Here, the vertical intersection of the checkerboard pattern indicated by the dotted line is the position of the hole h where the clamp 20 inserts the needle P, and the dot in the intersection refers to the state where the needle P is set in the hole h. In this way, the first metal wire 11a and the second metal wire 11b are woven in the state where the clamp 20 arranges the needle P to produce the cylindrical body 12 of the mesh structure.

[0067] Furthermore, the first metal wire 11a and the second metal wire 11b are configured to cross each other without being knotted when bent by the needle P, thereby ensuring flexibility and ensuring a structure that can be easily reduced when subsequently mounted on a catheter.

[0068] The channel of the cylindrical body 12 has directionality according to the bile flow method in the bile duct, and the upper end of the channel formed on the liver or gallbladder side is defined as the inlet end (IN), and the lower end of the channel formed on the duodenum side is defined as the outlet end (OUT).

[0069] At this time, the stent 10 of the first embodiment of the present invention is characterized in that a mesh-structured anti-reflux pattern membrane 13 is formed by using a nylon material line (Lasso) 15 at the duodenal side outlet (OUT) inserted into the bile duct in the cylindrical body 12 to prevent food from the duodenum from flowing back into the bile duct.

[0070] The overall manufacturing process of the bracket 10 of the first embodiment of the present invention is explained, which consists of the following steps: the metal wire 11 is weaved by the clamp 20 and then heat-treated to form an elastic cylindrical body 12; the cylindrical body 12 separated from the clamp 20 is inserted into a clamp (not shown) to be coated with a silicon coating solution and then dried to form a silicon coating portion 14; and then the wire 15 is weaved at the outlet end of the cylindrical body 12 to produce a grid-structured anti-backflow pattern film 13.

[0071] For example, Figure 4 An example of manufacturing a cross-shaped backflow prevention pattern film using wires according to the first embodiment of the present invention is shown.

[0072] Reference Figure 4 , showing that the stent 10 of the first embodiment of the present invention is made larger in diameter (e.g., 10 mm) at the outlet end than in the diameter (e.g., 8 mm) of the central portion of the cylindrical body, and a coating portion 14 is formed on the cylindrical body 12. Here, by enlarging the bottom surface of the outlet end of the cylindrical body 12, it can be seen that the grid cells composed of the metal wires 11 are arranged in a circular shape with the center as the center, like sunflower petals.

[0073] At this time, holes h are formed in the silicon coating portion 14 of each grid cell formed at the outlet end of the cylindrical body 12 .

[0074] For the anti-backflow pattern film 13, the line 15 passes through any hole h at the starting point and is woven and fixed into a zigzag shape in the metal wire 11 grid unit formed in the circumferential direction. The line 15 crosses the outlet end more than once and passes through other holes h. The anti-backflow pattern film 13 can be formed into a mesh structure.

[0075] For example, for Figure 4 The production process of the cross-shaped anti-backflow pattern film 13 is specifically described. The wire 15 passes through the first hole h1 from the starting point (Start) and then passes through the second hole h2 across the outlet end (S1). Then, it passes through the third hole h3 of the metal wire 11 grid unit formed in the circumferential direction and weaves with mutual interference (S2). Then, it passes through the fourth hole h4 and then passes through the fifth hole h5 across the outlet end (S3). Then, it passes through the sixth hole h6 formed in the circumferential direction and is knotted at the end point (End) (S4).

[0076] In this way, the wire 15 passes through the holes h of the membrane portion 14 formed in the grid unit (cell) from the starting point (Start) in sequence through a one-time operation, and is wound like being sewn in the grid unit of the metal wire 11, while forming a cross-shaped anti-backflow pattern film 13 at the outlet end, and can then be knotted at the end point (End) that is the same as the starting point (Start).

[0077] On the other hand, the backflow prevention pattern film 13 of the first embodiment of the present invention is not limited to the cross-shaped backflow prevention pattern film 13 described above, but various shapes of backflow prevention patterns can be applied.

[0078] For example, Figure 5 Examples of implementing various backflow prevention pattern films using wires according to the first embodiment of the present invention are shown.

[0079] Reference Figure 5 , the anti-backflow pattern film 13 of the embodiments of the present invention below can be applicable to the anti-backflow pattern #n of various embodiments, and the reference numerals marking the anti-backflow pattern film 13 are distinguished from the anti-backflow pattern reference numerals #n applicable thereto, such as "13#n".

[0080] That is, in addition to the above-mentioned cross-shaped anti-backflow pattern film 13#1, the anti-backflow pattern film 13 can also form various patterns such as a straight-line anti-backflow pattern film 13#2, a zigzag-shaped anti-backflow pattern film 13#3, a V-shaped anti-backflow pattern film 13#3', a polygonal anti-backflow pattern film 13#4 and a star-shaped anti-backflow pattern film 13#5, etc., in which the wire 15 is wound between the hole h and another hole h and crosses the outlet end.

[0081] In this way, the stent 10 of the embodiment of the present invention can be manufactured to have various anti-reflux pattern films 13 by weaving the wire 15 at the outlet end (OUT) of the cylindrical body 12. When the stent 10 is deployed at the lesion site in the bile duct during surgery, the wire 15 forms a mesh structure of the anti-reflux pattern, thereby having the effect of preventing food from the duodenum from flowing back into the bile duct.

[0082] The backflow prevention pattern film 13 can be produced by sewing while penetrating the thread 15 through the film portion 14 formed around the outlet end using a sewing needle.

[0083] Since the anti-reflux pattern membrane 13 is made of thread, it can be easily mounted on a catheter, and there is no difficulty in reducing the diameter of the stent 10. During surgery, the cylindrical body 12 is unfolded at the diseased site of the bile duct, and in particular, a pattern is formed while unfolding, thereby preventing food from the duodenum from flowing back into the bile duct.

[0084] On the other hand, the pattern component of the anti-backflow pattern film 13 of the stent 10 of the embodiment of the present invention can also be made of metal wires 11 in addition to the wires 15, and the method of making the anti-backflow pattern film 13 using the metal wires 11 is described in detail through the additional embodiments described below.

[0085] (Second embodiment)

[0086] Figure 6 The figure shows the state of manufacturing a bile duct stent by using a clamp according to the second embodiment of the present invention.

[0087] Hereinafter, the structures of the clamp 20 and the bracket 10 manufactured by the clamp 20 according to the second embodiment of the present invention are similar to those of the first embodiment described above, so repeated descriptions are omitted and only the differences are mainly described.

[0088] Reference Figure 6 The stent 10 of the second embodiment of the present invention is characterized in that a metal wire 11 is used to form an anti-reflux pattern membrane 13 at the outlet end (OUT) on the duodenal side of the cylindrical body 12 inserted into the bile duct, thereby preventing food in the duodenum from flowing back into the bile duct.

[0089] The overall manufacturing process of the stent 10 of the second embodiment of the present invention is described. The difference is that, after the metal wire 11 is woven by the jig 20 to form the cylindrical body 12, the anti-backflow pattern film 13 is formed at the outlet end (OUT) by the metal wire 11, and then heat treatment is performed to simultaneously manufacture the elastic cylindrical body 12 and the anti-backflow pattern film 13. Then, the cylindrical body 12 of the stent 10 separated from the jig 20 is inserted into a silicon film jig (not shown) and coated with a coating solution, and then dried, thereby completing the manufacturing.

[0090] The backflow prevention pattern film 13 is a cross-shaped backflow prevention pattern film 13#1 formed by winding a metal wire 11 between a needle P and another needle P arranged in a circumferential direction X at one end (i.e., the lower end) of the fixture 20 across the outlet end (OUT). Here, the needles (P1 to P12) arranged in a circumferential direction X at the lower end of the fixture 20 are almost on the same line as the outlet end in the one side section.

[0091] Specifically, the metal wire 11 starts from the starting point (Start) of the first needle P1, crosses the first line 13a of the outlet end, and is wound around the seventh needle P7, then extends and moves 90 degrees to the tenth needle P10 in the circumferential direction X, and then starts from the tenth needle P10, crosses the second line 13b of the outlet end (OUT) and perpendicularly crosses the first line 13a and is wound around the end point (End) of the fourth needle P4, and then twists more than once to form a cross-shaped anti-backflow pattern film 13#1. In this process, when the metal wire 11 is wound around each needle P, the metal wire 11 constituting the outlet end is wound more than once, and can be fixed in a mutually interfering state.

[0092] In this way, the metal wire 11 is continuously wound in one line from the starting point of the first needle P1 to the end point (End) of the fourth needle P4, and then twisted and knotted in other lines to complete the weaving, thereby easily manufacturing the anti-backflow pattern film 13. Furthermore, the cylindrical body 12 is first manufactured from the inlet end (IN) to the outlet end (OUT) by the fixture 20, and then the anti-backflow pattern film 13 can be formed at the outlet end (OUT) without interruption using the metal wire 11, thereby having the advantage of reducing the manufacturing process.

[0093] In this way, if the work of winding the metal wire 11 on the clamp 20 until the anti-backflow pattern film 13 is formed is completed, the stent 10 can be shipped as a finished product after being separated from the clamp 20 and cleaned and sterilized. At this time, the stent 10 can also be shipped as a molded metal stent product after the process of coating the cylindrical body 12 with a coating material to generate a coating portion 14 is performed. The coating portion 14 can be coated by applying a coating solution such as polyurethane to the cylindrical body 12 while the stent 10 is heated at a predetermined temperature.

[0094] On the other hand, the backflow prevention pattern film 13 using the metal wire 11 according to the second embodiment of the present invention is not limited to the cross-shaped backflow prevention pattern film 13 # 1 described above, but various shapes of backflow prevention patterns can be applied.

[0095] For example, Figure 7 An example of implementing various backflow prevention pattern films using metal wires according to the second embodiment of the present invention is shown.

[0096] Reference Figure 7 The anti-backflow pattern film 13 of the second embodiment of the present invention is not limited to the cross-shaped anti-backflow pattern film 13#1, but can be formed into a zigzag-shaped anti-backflow pattern film 13#3 in which the metal wire 11 is wrapped between the needles P and the needles P and spans the outlet end, a polygonal anti-backflow pattern film 13#4, and a star-shaped anti-backflow pattern film 13#5, etc.

[0097] Reference Figure 7The metal wire 11 is wound around the third needle P3 across the outlet end from the starting point (Start) of the eleventh needle P11, and then wound around the ninth needle P9, the fifth needle P5 and the end point (End) of the eleventh needle P11 in sequence across the outlet end, and then knotted to form a zigzag anti-backflow pattern film 13#3. The starting point (Start) is the same as the end point (End).

[0098] Reference Figure 7 (B), the metal wire 11 is wound around the ninth needle P9 across the outlet end from the starting point (Start) of the first needle P1, and then wound around the fifth needle P5 and the end point (End) of the first needle P1 in sequence across the outlet end, and then knotted to form a triangular anti-backflow pattern film. Here, the polygonal anti-backflow pattern film 13#4 can be formed into various polygonal shapes other than a triangular shape, such as a quadrilateral, and the starting point (Start) is the same as the end point (End).

[0099] Reference Figure 7 (C), the metal wire 11 is formed into a star-shaped anti-backflow pattern film 13#5 by winding from the starting point (Start) of the first needle P1 across the outlet end to the eighth needle P8, the third needle P3, the eleventh needle P11, the sixth needle P6 and the end point (End) of the first needle P1 and then knotting.

[0100] In addition, the stent 10 of the embodiment of the present invention can also be manufactured to have various anti-reflux pattern films 13 by weaving the metal wire 11 at the outlet end (OUT) of the cylindrical body 12 using the clamp 20. Then, the stent 10 has the effect of preventing the food in the duodenum from flowing back into the bile duct through the anti-reflux pattern film 13 when it is deployed at the lesion site in the bile duct during surgery.

[0101] On the other hand, the more the number of wires 11 connecting the pins P and the pins P across the outlet end (OUT) of the support 10 is, the higher the density of the anti-backflow pattern film 13 can be produced, which will be described in the following third embodiment.

[0102] (Third Embodiment)

[0103] Figure 8 The diagram shows a state in which a bile duct stent is manufactured using a jig formed with vertical needles according to the third embodiment of the present invention.

[0104] Hereinafter, the structures of the clamp 20 and the bracket 10 manufactured by the clamp 20 according to the third embodiment of the present invention are similar to those of the second embodiment described above, and thus repeated descriptions are omitted and only the differences are mainly described.

[0105] Reference Figure 8 The jig 20 of the third embodiment of the present invention includes at least one vertical needle Py formed at a lower surface 21 corresponding to the outlet end (OUT) of the bracket 10 .

[0106] The feature of the bracket 10 is that the metal wire 11 is sequentially wound between the needles P arranged in the circumferential direction X at the lower end of the clamp 20 and the vertical needles Py to form a radial anti-backflow pattern film 13 # 6 at the outlet end of the cylindrical body 12 .

[0107] To give a specific example, the metal wire 11 is wound around the vertical needle Py in the center from the starting point (Start) of the twelfth needle P12 in a clockwise direction, and then is wound around the second needle P2, and then extends to the fourth needle P4 in the circumferential direction X (S1, S2, S3), and then is wound around the vertical needle Py in the center from the fourth needle P4, and then is wound around the sixth needle P6, and then extends to the eighth needle P8 in the circumferential direction X (S4, S5, S6), and then is wound around the vertical needle Py in the center from the eighth needle P8, and then is wound around the tenth needle P10 as the end point (End) to form a radial anti-backflow pattern film 13#6. Here, the steps S3 and S5 for extending and moving can be omitted according to the change of the manufacturing method, and a triangular circuit connecting a pair of needles to the vertical needle Py can be formed separately. At this time, the metal wire 11 of the three round-trip circuits wound by the vertical needle Py can be cross-fixed to each other in a bent state.

[0108] On the other hand, the backflow prevention pattern film 13 can be made to have a greater density with more lines across the outlet end (OUT), and is not limited to the radial backflow prevention pattern film 13#6 described above, but can be made into a dense radial backflow prevention pattern that is deformed into the shape of various embodiments.

[0109] For example, Fig. 9 Various shapes of dense radial backflow prevention pattern films according to the third embodiment of the present invention are shown.

[0110] First, refer to Fig. 9 (A) shows that the bracket 10 is a first radial backflow prevention pattern film 13#7 in which the number of times of winding the vertical pins Py around the jig 20 is increased to be denser than the above-mentioned radial backflow prevention pattern film 13#6.

[0111] At this time, the first radial anti-backflow pattern film 13#7 is to wind the metal wire 11 more densely in sequence between the needles P arranged in the circumferential direction X at the lower end of the clamp 20 and the vertical needles Py to form 6 round trip lines woven by the vertical needles Py. The 6 round trip lines can be fixed in a mutually intertwined state.

[0112] Then, refer to Fig. 9(B) shows the deformed shape of the first radial anti-backflow pattern film 13#7 as a dense one, forming a circular vertical needle Py array centered on the bottom 21 of the clamp 20, and based on this, a dense second radial anti-backflow pattern film 13#8 is woven with a metal wire 11.

[0113] That is, the metal wire 11 is sequentially wound around the six needles P arranged in the circumferential direction X at the lower end of the fixture 20 and the vertical needle Py arrays corresponding to the six needles P, thereby forming a dense second radial anti-backflow pattern film 13#8 at the outlet end of the cylindrical body 12.

[0114] Thus, according to the third embodiment of the present invention, at least one vertical needle Py formed on the bottom surface 21 of the jig 20 can form a more dense and uniformly spaced radial pattern film at the outlet end of the bracket 10 than in the first to second embodiments.

[0115] On the other hand, the optimal conditions for a bile duct stent considering clinically important physical factors should include excellent flexibility, excellent radial expansile force, conformability to maintain the shape of the stent in a curved state according to the tortuosity of the bile duct and low axial force, minimization of the degree of shortening for positioning at the lesion, reduction in the size of the space (cell) between the wires to reduce tumor growth, durability, and ease of loading on a catheter as a stent delivery system.

[0116] Among them, the ease of catheter loading refers to the fact that the stent 10 is loaded on the catheter in a reduced diameter state for surgery. The structure of the stent 10 that is difficult to physically reduce the diameter has the disadvantage of poor ease of loading and causes the catheter diameter to become larger, which makes it difficult to insert the catheter into the bile duct and inconvenient for doctors to operate.

[0117] Here, the bile duct stent 10 of the third embodiment of the present invention has the characteristic that the metal wire 11 spans across the outlet end to form a radial anti-reflux pattern film 13 of various shapes. This characteristic may be disadvantageous for reducing the diameter, so it is preferred to consider the ease of catheter mounting.

[0118] Therefore, the bile duct stent 10 having a structure that improves the ease of mounting a catheter will be described in detail with reference to the fourth embodiment of the present invention.

[0119] (Fourth embodiment)

[0120] Fig.10 The fourth embodiment of the present invention shows a state in which a bile duct stent is manufactured using a conical fixture.

[0121] Fig.11 2 is a perspective view showing a conical backflow prevention pattern film according to a fourth embodiment of the present invention.

[0122] Hereinafter, the structure of the clamp 20 and the stent 10 manufactured by the clamp 20 according to the fourth embodiment of the present invention is similar to that of the third embodiment, so repeated description is omitted and only the structure for improving the ease of mounting of the catheter is mainly described.

[0123] Reference Fig.10 and Fig.11 The jig 20 of the fourth embodiment of the present invention has an inclined outer peripheral surface 22 formed in a conical shape at the outlet end (OUT) of the stent 10, and includes a vertical needle Py fixed at the vertex of the center.

[0124] Then, the stent 10 is characterized in that a conical anti-backflow pattern film 13#9 is formed, wherein the conical anti-backflow pattern film 13#9 is formed by sequentially winding the metal wire 11 between the needles P and the vertical needles Py arranged in the circumferential direction X at the lower end of the fixture 20 in a radial shape, and protruding through the inclined outer peripheral surface 22 of the conical shape. The specific method of weaving the conical anti-backflow pattern film 13#9 can refer to the above Figure 8 The radial anti-backflow pattern film 13#6 manufacturing process. Further, as Fig. 9 As shown in (A), the conical anti-backflow pattern film 13#9 can be made into a denser structure by increasing the number of winding times of the metal wire 11 to improve the density.

[0125] At this time, the metal wire 11 forming the conical backflow prevention pattern film 13#9 forms a bend 11c through the vertical needle Py to form a triangular structure, and the bend 11c crosses and interferes with each other to form a radially inclined structure.

[0126] on the other hand, Fig.12 An example is shown in which the stent according to the fourth embodiment of the present invention is used in a bile duct lesion surgery.

[0127] Reference Fig.12 (A) shows the stent 10 according to the embodiment of the present invention being carried on a catheter in a reduced diameter state and moving through a lesion in a bile duct.

[0128] At this time, when the conical anti-backflow pattern film 13#9 is mounted on the inner diameter of a catheter for stent surgery, the diameter of the cylindrical body 12 is reduced by external pressure and the bent portion 11c is folded without additional physical resistance, thereby facilitating catheter mounting.

[0129] In addition, refer to Fig.12 (B) shows a state where the exposed stent 10 is expanded to dilate the lesion in the bile duct while the catheter is withdrawn.

[0130] At this time, the conical anti-reflux pattern membrane 13#9 prevents the channel on the duodenal side of the bile duct from expanding, prevents food from flowing back into the bile duct, and discharges the bile flowing in the bile duct into the duodenum.

[0131] on the other hand, Fig.13 1 is a perspective view showing a truncated cone-shaped backflow prevention pattern film according to a fourth embodiment of the present invention.

[0132] Reference Fig.13 The fixture 20 of the fourth embodiment of the present invention forms an inclined truncated cone outer peripheral surface 23a and a truncated cone bottom 23b of a truncated cone structure that is wide at the top and narrow at the bottom at the outlet end (OUT) of the bracket 10, and includes a circular vertical needle Py array formed with the center of the truncated cone bottom 23b as the center.

[0133] At this time, the bracket 10 is to wind the metal wire 11 in sequence around the vertical needle Py array arranged in a circular shape 23b below the truncated cone corresponding to the needles P arranged in the circumferential direction X at the lower end of the clamp 20, thereby forming a truncated cone-shaped anti-backflow pattern film 13#10 at the outlet end of the cylindrical body 12.

[0134] At this time, the metal wires 11 constituting the truncated cone-shaped backflow prevention pattern film 13#10 are respectively formed into bending parts 11c through the vertical needles Py, and the bending parts 11c can form a radially inclined structure without mutual interference.

[0135] As described above, according to an embodiment of the present invention, various anti-reflux pattern films are formed at the duodenal side outlet end of the cylindrical body of the bile duct stent using pattern components of wire or metal wire, thereby having the effect of preventing food from flowing back into the stent (bile duct).

[0136] In addition, the following effects are achieved: a dense and diverse anti-reflux pattern membrane can be easily produced at the outlet end of the bile duct stent using one line, and the anti-reflux pattern membrane is formed using a nylon thread or a metal wire, thereby ensuring durability.

[0137] In addition, a radial anti-backflow pattern membrane with a bent portion in the center is formed by using a metal wire with its own expansion force, which has the effect of easily reducing the diameter when mounted on a catheter. Furthermore, it has the effect of maintaining the anti-backflow performance even if any deformation occurs in the cylindrical body of the stent due to the pressure of the lesion.

[0138] The embodiments of the present invention are not only implemented by the devices and / or methods described above, but can also be implemented by programs for implementing functions corresponding to the structures of the embodiments of the present invention, recording media recording the programs, etc. For such implementation, any professional in the technical field to which the present invention belongs can easily implement it from the records of the above-mentioned embodiments.

[0139] The embodiments of the present invention are described in detail above, but the scope of the present invention is not limited thereto. Various modifications and improvements made by technicians in the technical field to which the present invention belongs using the basic concepts of the present invention defined in the claims are also included in the scope of the present invention.

Claims

1. A bile duct stent, comprising: The cylindrical body is formed into a mesh structure made by weaving metal wires of shape memory alloy into a zigzag shape by a plurality of needles arranged in the circumferential direction (X) and the longitudinal direction (Y) of the cylindrical fixture; and The anti-backflow pattern film is wound between the needle (P) and another needle (P) arranged in a circumferential direction (X) at the lower end of the clamp, and the outlet end of the cylindrical body is crossed more than once to form a mesh structure. The anti-backflow pattern film is formed into a radial anti-backflow pattern film by sequentially winding the metal wire around the needles (P) arranged in a circumferential direction (X) at the lower end of the clamp and at least one vertical needle (Py) arranged at the center below the clamp, A bending portion is formed in the backflow prevention pattern film by the vertical needle (Py).

2. The bile duct stent according to claim 1, characterized in that: The anti-backflow pattern film is a line of metal wires that are continuously wound from a starting point needle (P) through at least one needle (P) to an ending point needle (P) and then twisted to complete the weaving.

3. The bile duct stent according to claim 1, characterized in that: The anti-backflow pattern film is: A circular vertical needle array is formed with the center of the lower side of the fixture as the center, and is sequentially wound around the vertical needle (Py) arrays corresponding to the needles (P) arranged in the circumferential direction (X) at the lower end to form a radial anti-backflow pattern film.

4. The bile duct stent according to claim 1, characterized in that: The radial anti-backflow pattern film is: The metal wires of the plurality of lines woven by the vertical needles (Py) are cross-fixed to each other in a bent state.

5. A bile duct stent, comprising: The cylindrical body is formed into a mesh structure made by weaving metal wires of shape memory alloy into a zigzag shape by a plurality of needles arranged in the circumferential direction (X) and the longitudinal direction (Y) of the cylindrical fixture; and The anti-backflow pattern film is wound between the needle (P) and another needle (P) arranged in a circumferential direction (X) at the lower end of the clamp, and the outlet end of the cylindrical body is crossed more than once to form a mesh structure. The anti-backflow pattern film is formed as a conical anti-backflow pattern film, and a conical inclined outer peripheral surface is formed under the clamp, and the metal wire is sequentially wound between a vertical needle (Py) fixed at the vertex of the center of the bottom of the clamp and a needle (P) arranged in a circumferential direction (X) at the lower end of the clamp to form a radial shape, and the center is protruded through the conical inclined outer peripheral surface, A bending portion is formed in the backflow prevention pattern film by the vertical needle (Py).

6. The bile duct stent according to claim 5, characterized in that: The conical anti-backflow pattern film is: The radial metal wire line is formed by forming a bend through the vertical needle (Py) to form a triangular structure, and the bends are crossed in a state of mutual interference to form a radial inclined structure.

7. A bile duct stent, comprising: The cylindrical body is formed into a mesh structure made by weaving metal wires of shape memory alloy into a zigzag shape by a plurality of needles arranged in the circumferential direction (X) and the longitudinal direction (Y) of the cylindrical fixture; and The anti-backflow pattern film is wound between the needle (P) and another needle (P) arranged in a circumferential direction (X) at the lower end of the clamp, and the outlet end of the cylindrical body is crossed more than once to form a mesh structure. The anti-backflow pattern film is: A truncated cone outer peripheral surface and a truncated cone bottom surface inclined to be wide at the top and narrow at the bottom are formed at the lower end of the fixture, and a circular vertical needle (Py) array is formed with the truncated cone bottom surface as the center, and the metal wire is sequentially wound around the vertical needle (Py) array corresponding to the needles (P) arranged in the circumferential direction to form a truncated cone-shaped anti-backflow pattern film, A bending portion is formed in the backflow prevention pattern film by the vertical needle (Py).

8. The bile duct stent according to claim 7, characterized in that: The truncated cone-shaped anti-backflow pattern film is: A bend is formed in each metal wire line by the vertical needle (Py), and the bend forms an inclined structure that radiates each line without interfering with each other.

9. A method for manufacturing a bile duct stent, using a clamp to manufacture a bile duct stent, comprising: a) step, weaving the metal wires of the shape memory alloy material into a zigzag shape with a plurality of needles arranged in the circumferential direction (X) and the length direction (Y) of the cylindrical fixture to form a cylindrical body of a grid structure; and b) step, using a pattern component of a line or metal wire to cross the channel outlet end of the cylindrical body more than once to form a mesh-like anti-backflow pattern film, The step b) comprises the following steps: A conical anti-backflow pattern film is formed, a vertical needle (Py) fixed to the inclined outer circumference and the central vertex of the conical shape is formed under the fixture, and needles (P) are arranged in a circumferential direction (X) at the lower end of the fixture, and the metal wire is sequentially wound around the bottom of the fixture and the needles (P) to form a radial pattern, and the center is protruded through the inclined outer circumference of the conical shape, A bending portion is formed in the backflow prevention pattern film by the vertical needle (Py).

10. The method for manufacturing a bile duct stent according to claim 9, characterized in that: The step b) comprises the following steps: The metal wire starts from the first needle as the starting point and is wound around the vertical needle (Py) at the center to form a bent portion, then is wound around the second needle, and then extends and moves toward the third needle in the circumferential direction; The third needle is wound around the central vertical needle (Py) to form a bent portion, then wound around the fourth needle, and then extended to the fifth needle in the circumferential direction; and The fifth needle is wound around the central vertical needle (Py) to form a bent portion, and then wound around the sixth needle as the end point, and then twisted once or more to tie a knot.

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