JP2019118810A - Lumen-expanding triplex structure stent and method of manufacturing it - Google Patents

Abstract

To provide a method of manufacturing a lumen-expanding triplex structure stent and the lumen-expanding triplex structure stent manufactured thereby.SOLUTION: A lumen-expanding triplex structure stent comprises: an inner cylindrical net having a mesh shape which is formed by repeating the following process for crossing each other: a wire of a certain length is spirally wound 3 times along a reference circumferential surface from one end part of the reference circumferential surface to another end part, inwardly folded at a determined angle, and spirally wound 3 times along the reference circumferential surface and whose two ends which are not connected each other is finished with V markers respectively; a cover film member surrounding entire outer peripheral edge except for end parts at both sides; an outer cylindrical net having a cylindrical mesh shape entirely, which is formed by the same method as the inner cylindrical net with a wire which is stretchable, has a flexibility and a certain length on outer peripheral edge of the inner cylindrical net including outer peripheral edge of the cover film member and whose two end parts which are not connected each other are finished with V markers respectively on each of the ends so as not to be cut.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a method for manufacturing a lumen-expanding triple-structure stent and a lumen-expanding triple stent manufactured by the method, and more specifically, it is not twisted at wire crossing points and has good flexibility. Is relatively easy, and does not require much production time, so the production cost is reduced, the demagnification is sufficient, there is no fear that the size of the insertion device will be increased, the expansion force is extremely high as a triple structure, the contact area The present invention relates to a method for manufacturing a lumen-expanding triple-layer stent and a lumen-expanding triple-layer stent manufactured by the method, which are difficult to move from the initial point, have high strength, and can be used for a long time.

  In general, a disease that occurs in the human body may cause the lumens in the human body to be constricted, diminished in function, or do nothing if severe. For example, when the lumen is narrowed, the esophagus may cause narrowing of the esophagus due to esophagus cancer, arteriosclerosis may not provide a smooth blood circulation, or narrowing of a track through which bile from the liver flows.

  In such a state where the lumen is narrowed, food, blood, bile and the like can not flow smoothly, so the narrowed lumen must be expanded to maintain the passage, but in this case, the stenosis has been narrowed. As a way to expand and maintain the passageway, for example, a stent is inserted into the lumen.

  Such a stent generally has a cylindrical structure as a whole, and has an elastic force itself, which is contracted by applying an external force, and when this external force is removed, a method of expanding by itself is widely used. ing. The self-expanding stent described above has various properties, ie, an expandable property for expanding the lumen, a flexibility that can be flexibly adapted to the bend of the lumen, and a reduced diameter. If it does not have reducibility etc., it will become impossible to exhibit the function as a stent well.

  Among the properties of the stent described above, poor expandability makes it easy to move from the position where the lumen was initially inserted, and poor flexibility makes the stent not extend to the stenosis site when it expands at the stenosis site. If the phenomenon of shortening occurs and the reducibility is poor, the size of the insertion device for inserting the stent increases.

  Therefore, in order to solve such problems, various stents have been proposed, among which "the cylindrical stent made of wire of unit length and having a longitudinal axis is The stent has at least a first turn and a second turn consisting of a number of straight sections of the same length connected by a number of bending points so as to have a peak and a bary section, said valleys being short straight And the peak of the second turn is twisted with the straight portion of the first turn, and the end of the last straight portion of the first turn is the first straight portion of the first turn Patent Document 1 discloses a cylindrical stent "which is extended to the first straight portion of the second turn after being torsionally connected to the straight bary formed between the straight portion adjacent thereto." There.

  The conventional stent described above is excellent in expandability because the peak and barry are connected by at least two or more twists, but the flexibility and reducibility are remarkably inferior, so that the shortening phenomenon occurs severely. In addition, there is a problem that the insertion device of the stent becomes large.

  In order to solve the above-mentioned problems, “one long filament is equally divided from the start point which is one point on the N equally divided circumference that constitutes one side end of the tube, the other N equally divided At one point on the circumference, it proceeds spirally along the tubular wall, and reciprocates the tube-like ends in a zigzag, and while crossing each other, forming a mesh on the wall Patent Document 2 discloses a stent in which one long filament forms a tubular whole as a spiral filament.

  Such a conventional stent has excellent flexibility and shrinkability as compared with the stent disclosed in the above-mentioned Patent Document 1, but is inferior in expansion force, so it moves from the first implanted point of the lumen. There was a problem that it became easy to do.

  In order to solve such problems, “it is possible to shrink and expand by itself, and a unit member of a fixed unit length having flexibility is zigzag from one end to the other end of the reference circumferential surface. Are reciprocated like a spiral shape, and are spirally wound along a reference circumferential surface to cross each other to form a mesh structure, and when the unit members and the unit members cross each other, they fly one to three times, Patent Document 3 discloses a lumen-expanding stent in which unit members are connected with each other by twisting at intersections to form an overall cylindrical shape.

  However, such a lumen-expanding stent increases the expansion force, but at the intersection of the unit members and the unit members, there are many processes in which they are torsionally connected with each other, which makes production difficult and requires a lot of time. There was a problem.

  In addition, there is a problem that the unit member and the unit member are connected to each other in a torsional connection with each other, which reduces the contact surface and makes it easy to move from the first transplanted point when attached to the lumen. The

Korean Patent Application 1997-1573 Korean Patent Application 1997-51355 Republic of Korea Patent Registration 10-0320239

  The present invention has been made in view of the above problems, and is not torsionally connected at the crossing points of the wires, has good flexibility, is relatively easy to manufacture, and does not require much manufacturing time, so the manufacturing cost is reduced. There is no fear that the size of the insertion device will be large, the expansion capacity is extremely high as a triple structure, the contact area is large, it is difficult to move from the first point, the strength is high, and it is used for a long time It is an object of the present invention to provide a method for manufacturing a lumen-expanding triple-structure stent and a lumen-expanding triple stent manufactured thereby.

  In order to achieve the above-mentioned object, the method of manufacturing a triple-layered stent for lumen expansion of the present invention is cylindrical which is flexible and can be contracted and expanded by itself and is made of a wire of a fixed length. An inner tube network axial tube maintaining step of maintaining a state in which the diameter of the inner tube network which is a network is contracted by an external force and the diameter of the cover film member which is a cylindrical tube is expanded by an external force In the expanded state, insert the cover film member having the expanded diameter into the outer surface of the inner pipe network whose diameter is reduced at the inner pipe network axial axis step, and remove all external forces after the insertion is completed. The cover film member and the inner pipe network body in a state in which the cover film member is elastically connected to the outer surface, and the cover film member is elastically connected to the outer surface of the cover film member. All the external force An inner tube network maintained in a contracted state by an axial tube maintaining step of an inner tube network body and a cover film member maintaining a state of being contracted further and an axial tube maintaining step of the inner tube network body and the cover film member Insert the outer tube netting body, which is a cylindrical netting of a fixed length wire that can shrink and expand on its own, into the outer surface of the cover film member having the body, and the insertion is completed And an outer tubular network extracorporeal inserting step of resiliently connecting the outer tubular network body to the outer surface of the cover film member having the inner tubular network body by removing the external force. .

After the outer tube network extracorporeal insertion step, the inner tube network body is joined with the suture wire at the distal end portions of the left and right side ends of the outer tube network body having the inner tube network body and the cover film member. The method may further include a suture fixing step of firmly fixing the cover film member and the outer tube network together.
It is characterized by being a lumen-expanding triplex stent manufactured by the above-mentioned manufacturing method.

The triple-layer stent for lumen expansion of the present invention is capable of contracting and expanding by itself, and a wire of a fixed length having flexibility is a reference circumference from one end to the other end of the reference circumferential surface. It is continuously wound three times in a spiral along the surface, bent at an angle further inward from the tip, and further repeatedly wound three times in a spiral along the reference circumferential surface, crossing each other A network is formed, and at each end, two cylindrical ends which are not connected to each other are finished and connected by V markers and cut, and a totally cylindrical inner pipe network and both sides of the inner pipe network A cover film member that surrounds the entire outer periphery excluding the tip, and an inner tube that is capable of contracting and expanding by itself, and a flexible wire of a fixed length includes the outer periphery of the cover film member At the outer edge of the net, An outer tube net body having a generally cylindrical shape without forming a net in the same manner as the tube net, without cutting off two ends which were not connected to each other at each end with a V marker respectively , And.
The wires of the inner tube net and the outer tube net are characterized in that any one of metal, synthetic resin and shape memory alloy is selectively used.
The cover film member is characterized in that any one of silicon and synthetic resin is selectively used.
At both ends of the cover film member, the inner tube network body, the cover film member, and the outer tube network body may be further provided with sutures for firmly fixing by suture.

  According to the present invention, there is no twist connection at the crossing points of the wires, good flexibility, relatively easy fabrication, and no need for much fabrication time, so the fabrication cost is reduced, the reducibility is sufficient, and the insertion There is an effect that the size of the device does not increase, the expansion force is extremely high as a triple structure, the contact area is large, it is difficult to move from the first point, the strength is high, and the device can be used for a long time.

  The present invention is not limited to the specific preferred embodiments described above, but within the scope of the subject matter of the present invention as claimed in the claims, those of ordinary skill in the art to which the present invention belongs However, it goes without saying that various modifications can be made, and such modifications fall within the scope of the claims.

Flow chart sequentially showing a method of manufacturing a triple-layer stent for lumen expansion according to an embodiment of the present invention over time FIG. 6 is a cross-sectional view for explaining an aspect of an inner tube network body axial tube maintenance step in a method of manufacturing a triple-structured stent for lumen expansion according to an embodiment of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-sectional view for explaining an appearance of a cover film member extrapolation stage in a method of manufacturing a triple-layer stent for lumen expansion according to an embodiment of the present invention. FIG. 6 is a cross-sectional view for explaining an aspect of an inner tube network body and a cover film member in an axial tube maintenance step in a method for manufacturing a triple-structure stent for lumen expansion according to an embodiment of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-sectional view for explaining the appearance of an outer tubular network extracorporeal stage in a method of manufacturing a triple-layered stent for lumen expansion according to an embodiment of the present invention. FIG. 5 is a cross-sectional view for explaining an aspect of a suturing step in a method of manufacturing a triple-layer stent for lumen expansion according to an embodiment of the present invention. A front view and a side sectional view showing a state of an inner tube network of a lumen-expanding triple-structure stent manufactured by a method of manufacturing a lumen-expanding triple-structure stent according to an embodiment of the present invention A front view and a side sectional view showing a state of a cover film member of a lumen-expanding triple-layer stent manufactured by a method of manufacturing a lumen-expanding triple-layer stent according to an embodiment of the present invention The front view and side sectional view which show the appearance of the outer tube network body of the triple-structure stent for lumen expansion manufactured by the manufacturing method of the triple-structure stent for lumen expansion by the Example of this invention. Front view and side sectional view showing the appearance of a lumen-expanding triple-structure stent manufactured by the method of manufacturing a lumen-expanding triple-structure stent according to an embodiment of the present invention

  Hereinafter, the present invention will be described in detail with reference to the attached drawings.

For reference, when describing the present invention, when it is determined that the detailed description of related known functions or configurations unnecessarily obscures the gist of the present invention, the detailed description thereof will be omitted.
In addition, the terms described below are terms defined in consideration of the functions in the present invention, and they differ depending on the intention or convention of the user or operator.
Therefore, the definition is determined based on the contents throughout the present specification.

  FIG. 1 is a flowchart sequentially illustrating a method of manufacturing a triple-layer stent for lumen expansion according to an embodiment of the present invention over time, and FIG. 2 is a triple-structure stent for lumen expansion according to an embodiment of the present invention. FIG. 3 is a cross-sectional view for explaining the state of the inner tube network body axial tube maintaining step in the manufacturing method of the present invention, and FIG. 3 is a cover film member outside in the manufacturing method of the triple-layer stent for lumen expansion according to the embodiment of the present invention FIG. 4 is a cross-sectional view for explaining the appearance of the insertion step, and FIG. 4 is a view showing the axial tube maintenance step of the inner tube network body and the cover film member in the manufacturing method of the triple-structure stent for lumen expansion according to the embodiment of the present invention. FIG. 5 is a cross-sectional view for explaining the appearance, and FIG. 5 is a cross-sectional view for explaining the appearance of the outer tubular network extracorporeal stage in the method for manufacturing a triple-layer stent for lumen expansion according to the embodiment of the present invention. FIG. 6 shows an embodiment of the present invention. It is a sectional view for explaining a state of a suturing step in the method of manufacturing the lumen expanding triple structure stents.

  The manufacturing method of the triple-structure stent for lumen expansion according to the present invention comprises the step of maintaining the inner tubular network axial tube 100 in which the diameter of the inner tubular network body 10 is elastically contracted and the outer peripheral surface of the inner tubular network body 10. A cover film member extrapolation step 110 for elastically coupling the cover film member 20 to the inner tube net body and the shaft tube of the cover film member for elastically shrinking the diameter of the inner tube net body 10 and the cover film member 20 combined The loader according to the maintenance step 120, the outer tube network extracorporation step 130 for connecting the outer tube network body 30 to the outer surface of the cover film member 20 having the elastically contracted inner tube network body 10, and the sutures 40, 40a. And a suture fixing step 140 for firmly fixing the protective tube 10, the cover film member 20 and the outer tube network body 30 together.

  The inner tube network axial tube maintenance step 100 is a cylindrical network consisting of a wire 11 of a fixed length which can shrink and expand by itself and has a diameter of the inner tube network 10 which is a cylindrical network. This is a process of maintaining the state of contraction and contraction by an external force.

  The cover film member extrapolation step 110 is performed by expanding the diameter of the cover film member 20 which is a cylindrical tube by an external force, and in the expanded state, the diameter is reduced in the inner pipe network body axial tube step 100. The cover film member 20 having an expanded diameter is inserted into the outer surface of the pipe network 10, and in the state where the insertion is completed, the cover film member on the outer surface of the inner pipe network 10 by elasticity by removing all external force. It is a process of joining 20.

  The shaft tube maintaining step 120 of the inner tube net body and the cover film member has all the diameters of the cover film member 20 and the inner tube net body 10 by the external force in a state where the cover film member 20 is elastically coupled to the outer surface. It is a process of maintaining a state of contraction and elastic contraction.

  The outer tube network extracorporation step 130 is performed on the outer surface of the cover film member 20 having the inner tube network body 10 maintained in the contracted state by the axial tube maintenance step 120 of the inner tube network body and the cover film member. The outer tube network body 30, which is a cylindrical net made of a fixed length wire 31 which can shrink and expand on its own, is inserted, and the external force is removed after the insertion is completed. Thus, the outer pipe network body 30 is bonded to the outer surface of the cover film member 20 having the inner pipe network body 10 by elasticity.

  The suturing and fixing step 140 is self-elastically coupled to the tip of the left and right side ends of the outer pipe network body 30 having the inner pipe network body 10 and the cover film member 20 by the suture lines 40 and 40a. In this process, the tube network body 10, the cover film member 20 and the outer tube network body 30 are firmly fixed by suturing.

  FIG. 7 is a front view and a side cross sectional view showing a state of an inner tube network body of a lumen-expanding triple-layer stent manufactured by the method of manufacturing a lumen-expanding triple-layer stent according to an embodiment of the present invention. Fig. 8 is a front view and a side sectional view showing a cover film member of a lumen-expanding triple-structure stent manufactured by the method of manufacturing a lumen-expanding triple-structure stent according to an embodiment of the present invention; FIG. 9 is a front view and a side sectional view showing the appearance of the outer tube network body of the lumen-expanding triple-structure stent manufactured by the method of manufacturing a lumen-expanding triple-structure stent according to the embodiment of the present invention. FIG. 10 is a front view and a side cross-sectional view showing the appearance of a lumen-expanding triple-structure stent manufactured by the method of manufacturing a lumen-expanding triple-structure stent according to an embodiment of the present invention.

  A lumen-expanding triple-layer stent 1 manufactured by the method of manufacturing a lumen-expanding triple-layer stent according to the present invention includes an inner tube network body 10 having a cylindrical network shape, and an inner tube network body. The cover film member 20 surrounding 10 and the outer film network body 30 having a cylindrical shape, the inner pipe network body 10, the cover film member 20 and the outer pipe network body 30 are closely surrounded and closely enclosed with the cover film member 20. And sutures 40, 40a.

  The inner pipe network body 10 is capable of contracting and expanding by itself, and a wire 11 of a fixed length having flexibility is a reference circle from one end to the other end of a reference circumferential surface (not shown) The spiral winding is repeated three times along the circumferential surface, the angle is further bent inwardly from the tip end, and the spiral winding is repeated three times along the reference circumferential surface, and they cross each other. In each tip, two tips which were not connected to each other at each end are finished cylindrically connected with V markers 12 and 12a, respectively, without cutting.

  The cover film member 20 is made of silicon or synthetic resin, and surrounds the entire outer peripheral edge of the inner pipe network body 10 except for the end portions thereof to block the inflow of foreign matter into the inside.

The outer tube network body 30 is capable of contracting and expanding by itself, and the flexible fixed length wire 31 includes the outer edge of the cover film member 20. The outer edge of the inner tube network body 10 , Made in the same manner as the inner tube network 10 to form a network, and at each end, the two tips which were not connected to each other are finished connected by V markers 32, 32a respectively, without cutting off It has a cylindrical shape.
As a matter of course, the wires 11 and 31 of the inner pipe network body 10 and the outer pipe network body 30 may use metal, synthetic resin or shape memory alloy.

  The suture lines 40 and 40 a firmly and integrally secure the inner tubular network body 10 with the cover film member 20 and the outer tubular network body 30 at both ends of the cover film member 20.

  The inner tube network body 10, the cover film member 20, and the outer tube network body 30 are formed at the tip end portions of the left and right side ends by the suture lines 40 and 40a. It has a triple-layer structure in which the wires 11 and 31 cross each other at the time of production, and the wires 11 and 31 are not torsionally connected at the time of production, and the flexibility is good and the reducibility is sufficient. , There is no fear that the size of the insertion device will increase.

  In addition, since the fabrication is relatively easy and does not require a lot of preparation time, the fabrication cost is reduced, and since the triple-layer structure is used, the expansion force is extremely high and the contact area is large. Because it is difficult to move from the first place of implantation and it has a triple-layer structure, it has high strength and can be used for a long time, thereby greatly reducing maintenance costs.

Reference Signs List 1 triple stent 10 inner tube network body 11 wire 12, 12a V marker 20 cover film member 30 outer tube network body 31 wire 32, 32a V marker 40, 40a suture 100 inner tube network axial tube maintenance stage 110 cover film member Extrapolation stage 120 Axial tube maintenance stage of inner tube network body and cover film member 130 Outer tube network extracorporeal insertion stage 140 Suture fixation stage

Claims (9)

An inner tube network that is itself capable of contracting and expanding, and is a cylindrical network made of a flexible wire having a fixed length, and the inner tube network maintains a state in which the diameter of the inner tube network is contracted by an external force and contracted. Axial tube maintenance phase,
The cover film member which is a cylindrical tube body is expanded in diameter by an external force, and in the expanded state, the cover is expanded in diameter on the outer surface of the inner tube network body whose diameter is reduced at the inner tube network axial tube stage. Inserting the film member and removing all external forces in a state where the insertion is completed, the cover film member extrapolating step of resiliently coupling the cover film member to the outer surface of the inner tubular network;
With the cover film member elastically coupled to the outer surface, the inner tube net body and the cover film member for maintaining the axial diameter of the cover film member and the inner pipe network are contracted by the external force. Stage,
The outer tube surface of the inner tube net body and the cover film member is capable of shrinking and expanding on the outer surface of the cover film member having the inner tube net body maintained in the contracted state, and it is flexible. A cover film member having an inner tube network by elasticity by removing an external force after inserting an outer tube network which is a cylindrical mesh body consisting of a wire having a fixed length and having completed insertion. An outer tube network extracorporeal insertion step of connecting an outer tube network body to an outer surface of the inner tube; After the outer tube network extracorporeal insertion step, the inner tube network body is joined with the suture wire at the distal end portions of the left and right side ends of the outer tube network body having the inner tube network body and the cover film member. The method according to claim 1, further comprising a suture fixing step of securely fixing the cover film member and the outer tube network body. A three-layered stent for lumen expansion, manufactured by the manufacturing method according to claim 1. The method according to claim 1, wherein the wire of the inner tube network body and the outer tube network body selectively uses any one of metal, a synthetic resin, and a shape memory alloy. The method according to claim 1, wherein the cover film member selectively uses any one of silicon and a synthetic resin. A wire of a fixed length, which is capable of shrinking and expanding on its own, has flexibility and is helically wound three times along the reference circumferential surface from one end to the other end of the reference circumferential surface, It continues to be bent at a certain angle further inward from the tip, and is repeatedly wound three times spirally along the reference circumferential surface, and crosses each other to form a mesh, and is not connected to each other at each tip An inner tube net body having a generally cylindrical shape, without cutting and connecting each of the two tips with a V marker.
A cover film member surrounding the whole of the outer peripheral edge excluding the tip ends on both sides of the inner pipe network;
The same method as the inner tube network body in the outer edge of the inner tube network body which can shrink and expand by itself and which has a flexible length of wire including the outer edge of the cover film member And an outer tube net body having a generally cylindrical shape, without cutting and connecting two ends which were not connected to each other with V markers at each end. Lumen-expanding triplex stent. The triple-structure stent for lumen expansion according to claim 6, wherein any one of metal, synthetic resin, and shape memory alloy is selectively used for the wires of the inner tube network body and the outer tube network body. The triple-layer stent for lumen expansion according to claim 6, wherein the cover film member selectively uses any one of silicon and a synthetic resin. The triple-structured stent for lumen expansion according to claim 6, further comprising sutures for firmly fixing the inner tube network body, the cover film member, and the outer tube network body firmly at both ends of the cover film member.

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