WO2018110737A1 - Medical stent having resistance-reinforced end parts - Google Patents

Abstract

The present invention relates to a medical stent which is used as a passageway for endoscopic surgery, etc. by penetratingly connecting two adjacent tissues of an organ of the human body, or which is used for a procedure for draining or shunting bile, abscesses, etc. Provided is a medical stent having resistance-reinforced end parts, the stent having washer-type end parts formed by expanding and bending both end sides of a hollow cylindrical body which is formed by braiding hyperelastic shape memory alloy wires so as to intersect and form rhombus-shaped cells, wherein the respective outer circumferences of the washer-type end parts have thereon a resistance-reinforced ring formed by bringing the gaps between the end-side cells forming the stent extremely close together so as to overlap, and thus a penetratingly-connected site may be firmly maintained when performing a procedure on a human body. In order to penetratingly connect two adjacent tissue layers, the medical stent has formed, on both ends of the cylindrical body at the center thereof, a tube-expansion part or a flange having a larger diameter than that of the cylindrical body. According to the present invention, the stent (10) having a uniform diameter, and the washer-type end parts (14) formed by outwardly bending the respective end sides on both sides on the length direction of the cylindrical body (12) of the stent are formed, and the resistance-reinforced ring (16) for providing elasticity by being multiply overlapped is formed on the respective outer circumferences of the expanded washer-type end parts (14).

Description

Medical stent with enhanced resistance at the end

The present invention is a medical stent to be used to pass through two adjacent tissues of the human organs (gallbladder, pancreas, etc.) to use as a passage for endoscopic surgery, or to perform drainage or shunts such as bile and yangyang solution. In more detail, in detail, the two ends of the hollow cylindrical body formed by interweaving a superelastic shape memory alloy wire intersected in the shape of a cell on the rhombus are expanded and bent to form a washer-shaped end, but a stent is formed around the outer periphery of the washer-type end. The gap between the end of the cells forming an extremely close contact with each other to form a superimposed resistance reinforcement ring to the end of the medical reinforcement for strengthening the resistance of the end made to secure the position connected through the procedure.

Widely used for medical purposes, stents are used for the stenosis of the body, when the stenosis is caused by arteriosclerosis, thrombosis, benign and malignant tumors, postoperative sequelae or lesions. It is used as an interventional procedure to recover the pain, and has been implemented as an important procedure since the 1980s.

These stents are largely divided into non-vascular and vascular stents, and are generally known as self-expending type stents, which are metal or polymer network structures that have their own elastic force and contract when they are externally applied and return to their original state when external forces are removed. It is.

The procedure using the stent is divided into vascular stent insertion and non-vascular stent insertion.

The former vascular stent implantation is known as a procedure that opens a 3mm to 4mm hole in the thigh, and then pushes a thin tube called 'catheter' to the lesion site with a femoral artery and then expands the narrowed vessel by placing a stent. .

In the latter non-vascular stent implantation, when the esophagus is blocked or progressed due to narrowing of the esophagus by cancerous tissues, it is impossible to take food into the mouth, and to expand the stenosis to secure food input. It is well known to insert a balloon catheter tube (Balloon Catheter Tube) to inflate the balloon (Balloon).

The stent used in both of the above-described methods has been disclosed to improve the function of the stent with various structures to date.

These stents usually cross superelastic shape memory alloy wires or stainless wires at different positions, or connect hooks and fractures to each other in hook form to connect a plurality of rhombic spaces (cells). And a hollow cylindrical body of a predetermined length.

In addition, recently, a stent for connecting procedure is used to access an endoscope procedure directly to the internal organs of the human body, such as the gallbladder and the longest, or to access a point where it is difficult to drain or shunt such as bile or nocturnal fluid. .

In other words, penetrating the adjacent tissues of the human organs, such as the gallbladder, pancreas to insert through the stent to connect through.

In the prior art shown in Figure 1 as shown in the US Patent 6,620,122 by forming a cross-weave of the hollow cylindrical body (2) formed by interweaving an alloy wire such as superelastic shape memory alloy in the form of a dumbbell 3 in the form of a dumbbell Insert a hole in the adjacent tissue (5) of the human organs, but by the expansion portion (3) to be hooked to the adjacent tissue (5) to prevent the separation process.

This prior art has a problem in that the expansion part slips out of the procedure position frequently when external force of the human body and external force of the internal organs are applied.

In addition, when comparing the size of the stent space portion (cell) of the body 2 and the expansion portion 3 installed on both sides of the body, the space portion of the expansion portion 3 is increased by the expansion pipe as compared to the space portion of the body 2. Since the force supporting the external force is inevitably weakened compared to the body 2 side, the expansion pipe 3 is inevitably weakened, thereby causing problems such as the above-described procedure position deviation.

As another conventional technique, US Pat. No. 8,454,632 shown in FIG. 2 is a technique which slightly improves the above-mentioned problems. Both sides of the hollow cylindrical body 2 formed by interweaving alloy wires such as superelastic shape memory alloys are formed in the holes of the human organs. After inserting it in, a certain portion is pushed inward on both sides to form a double wall flange (4), so as to be hooked to the adjacent tissue (5) to prevent the separation procedure.

This has the disadvantage that the complexity of the stent manufacturing process is inevitable to make the double wall flanges on both sides of the body larger than the cylindrical body.

In other words, stents are made by weaving alloy wires intersectingly, but stretching is possible in the axial direction, but stretching is not possible without restriction.

Therefore, the double wall flanges located on both sides of the cylindrical body have to be woven in large diameters in advance and have a complicated manufacturing process of forming thermoforming for shape memory so as to form a double wall in close contact with each other.

In addition, there is a problem that the procedure is complicated and the procedure can be performed only by a large number of skilled workers because the procedure performed by the operator directly to the elastic bar (rope) to form and maintain the double wall flange.

As a result, according to the prior art, it is difficult to fix and install in a state of close contact with adjacent tissues, and there is a problem that it is difficult to drain or shunt such as bile, lye, and shunt due to the gap generation. Therefore, there is a problem that there is a very high risk of departure from the procedure position to another position.

The present invention has been made to solve the problems of the prior art as described above to solve the following problems.

The present invention provides a medical stent reinforced with resistance at the end portion formed to prevent the stent from falling off from the procedure position by integrally forming a resistance strengthening ring made of the material of the stent at the longitudinal end of the stent connecting through two adjacent tissue layers It is.

The present invention is to provide a medical stent of the end of the cylindrical stent of the same diameter is formed by bending the washer-type end to stand and thus the end of the easy to manufacture by adding to the stent of the mesh form having the same diameter.

The present invention provides a medical stent in which the washer-type end is expanded only by the operator inserting a conventional catheter, and the washer-type end portion substantially provides a rigid locking area in the penetrating tissue layer, thereby increasing the resistance of the end portion, which is easy to perform. To provide.

The present invention is to provide a medical resistant stent of the end portion is made to adjust the degree of overlap of the resistive reinforcement ring by adjusting the cylindrical stent section to be transformed to the washer-type end to enable the production of the stent with the desired resistance .

In order to solve the above problems, the present invention extends in the form of a washer and extends the longitudinal ends of both sides of the central cylindrical body of the stent, which penetrates two adjacent tissue layers and weaves the same diameter. By forming a resistance reinforcement ring that provides a strong elasticity by overlapping multiple layers to form a medical stent of the end of the reinforced resistance.

According to the present invention, the end resistance is variably produced by adjusting the number of turns (number of turns) of the resistance reinforcing ring that provides a strong elasticity by overlapping the outer periphery of the washer-type end.

According to the present invention, both the washer-type end portions of the stent central cylindrical body are fastened to the surgical tissue layer of the human body, and the support and fixation force at the procedure position is improved by the resistance reinforcement ring provided around the washer-type outer periphery.

As described above, the present invention has an effect of preventing the stent from detaching from the position of the procedure because it forms an integrally strengthening ring made of the material of the stent at the longitudinal end of the stent supported over the pyloric portion of the stomach, and has a cylindrical shape having the same diameter. It is formed by bending the washer-type end on the end of the stent so that it is extremely easy to manufacture and the washer-type end expands simply by inserting it into the usual catheter by the operator in the operating room. It is easy to perform the procedure and at the same time adjusts the degree of overlap of the resistance reinforcement ring by adjusting the cylindrical stent section to be deformed to the washer-type end to create a desired resistance force, the radial force after the procedure (radial force) Strong resistance occurs against stent end deformation So it will prevent inventors have multiple excellent effects such as a stent manufactured to securely support the stent position possible.

1 is a view of the state of the procedure showing a conventional stent.

Figure 2 is an external view of the surgical state showing another conventional stent.

3 is a view of the stent according to the present invention.

Figure 4 is an enlarged view of the main portion "A" resistance ring strengthening of Figure 3 invention.

5 is a development of the stent of the present invention

Figure 6 is an external view showing several embodiments of the present invention stent.

7 is a process chart showing a stent manufacturing process of the present invention.

Figure 8 is a stent surgical state diagram of the present invention.

Hereinafter, a technical configuration as a specific embodiment of the present invention will be described with reference to the accompanying drawings.

As shown in FIGS. 3 to 5, the present invention provides a cylindrical stent in a medical stent formed by forming an extension or flange larger than the cylindrical body diameter at both ends of the central cylindrical body of the stent so as to penetrate two adjacent tissue layers. ) To form a washer-shaped end portion 14 which is bent outwardly at both longitudinal ends, and overlaps the outer circumference of the extended washer-shaped end 14 against radial force applied from the outside of the stent. By forming a resistance-strengthening ring 16 made to be reinforced resistance by the end of the medical stent 100 is reinforced resistance.

The number of times of overlapping the resistance strengthening ring 16 can be varied in accordance with the stent end distance (L) exposed in the longitudinal direction extending to both sides of the cylindrical body 12, thereby making it possible to variably produce end resistance.

In the case where the end distance L is short, the elasticity of the resistance-strengthening ring 16 which provides elasticity by overlapping the outer circumference of the washer-shaped end 14 is provided small, and in the opposite case, the elasticity is large.

In addition, the stent of the present invention is made so that the end diameter is changed in proportion to the diameter of the hollow portion of the stent 10 manufactured to a predetermined diameter.

That is, if the hollow part diameter of the manufactured stent 10 is large, the diameter of the washer-type end 14 is also increased, and in the opposite case, the stent 100 is made smaller.

As shown in FIG. 6, the washer-shaped end portion 14 forms a support surface 14a extending from the cylindrical body 12 to form a structure to be supported by the treatment tissue layer to prevent separation, and to the outer circumference of the support surface 14a. The provided resistance reinforcing ring 16 acts to firmly support the stent 100 by preventing the case from being out of position by the external force in the treated tissue, the stent is a stent made to intersect or bends and fractures Hook to each other in the form of hooks can be applied to any of the stents having a plurality of rhombus-shaped space (cell).

Looking at the stent manufacturing process of the present invention in more detail the understanding of the present invention will become clear.

As shown in FIG. 7, the present invention includes a fixing pin 22 to partition a central portion of the material stent 10 interwoven with a single diameter into a jig 20 having a smaller diameter than the diameter to form a cylindrical body 12. ) And fix it in an annular shape (see Figure 7 (b)).

In the state in which the stent is extended to both ends of the cylindrical body 12, a portion of the cylindrical body 12 is bound and bound by another wire 24 with a margin of an end distance L (see FIG. 7 (c)). .

When binding the cylindrical body 12 at the center of the stent to the jig 20 in close contact with the wire 24, the marginal portions of both ends of the stent are expanded and deformed while taping in the form of a fallopian tube.

Pressing the disk 26, the center hole is formed in both ends of the stent tapered while extending in the fallopian tube form, the end of the stent 10 is pressed until it is blocked by the fixing pin 22 while being compressed from the tapered end As the contraction and movement are limited by the fixing pin 22, the disc 26 compresses the end outwardly and forms the washer-shaped end 14, with the excess stent part extending the washer-shaped end 14 with the extended maximum radius. Laminated to the outer circumferential diameter to form a resistance strengthening ring 16 (see Fig. 7 (d)).

When the washer-shaped end 14 is formed by compressing the disk 26 at both ends, the disks 26 are bound together to bind each other so as not to be separated (see FIG. 7 (e)), and the jig is formed by thermal processing for shape memory. Removing it gives you a finished stent 100.

The washer-shaped end portion 14 has been described as being perpendicular to the cylindrical body 12, but may be formed by compressing the inner angle of the inner angle with the disk 26 to form a shape memory process.

Of course, when the inner angles of the cylindrical body 12 and the washer-shaped end 14 are formed at an obtuse angle or an acute angle, the surface angle of the disk 26 fitted to the jig 20 is formed at opposite angles.

The outer surface of the stent 100 of the present invention made as described above may be made by further forming a synthetic film of PETT or silicon material having affinity with the human body.

Such the present invention is inserted into two tissues punctured and adjacent to the human body by a conventional insertion device as shown in Figure 8, when the procedure is completed, the stent 100, the central cylindrical body 12, both ends of the washer-type end The support and fixation force at the procedure position is greatly improved by the resistance reinforcing ring 16 which 14 is hooked to the surgical tissue layer 30 of the human body and is provided around the outside of the washer-type end 14.

While the stent 100 of the present invention is expanded, the washer-type end 14 having a wide diameter is widely supported by the tissue of the human body, and the washer-type end 14 supporting the washer is formed to have a plurality of overlapping outer periphery. Deformation, such as shrinkage, is regulated by the ring 16 and strongly supports the external force, thereby acting to eliminate the problem of external force acting on the washer-shaped end 14 resulting in deformation.

Of course, when the gripping and removing with the insertion mechanism to remove the stent 100, the multiple overlapping resistance reinforcing ring (16) portion of the fall out of the perforation while spreading in the form of fallopian tubes while the contraction pressure is easily transmitted while preventing damage to the human body It can be removed.

* Description of the sign *

10, 100: stent 12: cylindrical body

14 washer-type end 16 resistance ring

20: jig 22: fixed pin

24: wire 26: disk

L: end distance

Claims (8)

In the medical stent formed by forming an expansion tube or flange larger than the diameter of the cylindrical body on both ends of the central cylindrical body of the stent to connect through two adjacent tissue layers, With stent 10 of a single diameter. Forming a washer-shaped end portion 14 which is bent outwardly at both longitudinal ends of the cylindrical body 12 of the stent, Overlaid on the outer periphery of the extended washer-shaped end 14 to form a strengthening ring 16 having a large resistance against the radial force applied from the outside of the stent, the external force at the site of the procedure Medical stent 100 is reinforced resistance of the end, characterized in that made to prevent the departure. The method according to claim 1, The number of overlap of the resistance-strengthening ring 16 formed in the stent is characterized in that the resistance of the ring is made to be increased or decreased by adjusting the stent end distance L extended in both longitudinal directions of the cylindrical body 12. Medical stent with enhanced resistance. The method according to claim 1, The stent is a medical stent reinforced resistance of the end, characterized in that the end diameter is changed in proportion to the diameter of the hollow portion of the stent (10) produced to a predetermined diameter. The method according to claim 1, The washer-type end portion 14 is a medical stent reinforced with an end portion, characterized in that the support body (14a) extending at right angles from the cylindrical body (12) is formed to be hung on the procedure tissue layer. The method according to claim 1, The washer-shaped end portion 14 is a medical stent strengthening end of the end, characterized in that formed in the cylindrical body (12) to form a support surface (14a) extending at an obtuse angle hanging on the procedure tissue layer. The method according to claim 1, The washer-shaped end portion 14 is a medical stent reinforced with an end portion, characterized in that to form a support surface (14a) extending at an acute angle from the cylindrical body (12) to be hung on the procedure tissue layer. The method according to any one of claims 4 to 6, The stent has a strengthening resistance of the end, characterized in that the stent is formed by further forming any one of the artificial film of PETT or silicon material. The method according to claim 1, The stent 10 is a medical stent strengthening the resistance of the end, characterized in that made of a stent having a plurality of rhombus-shaped space (cell) by connecting the bent portion and the fracture bent to each other in the form of hooks.

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