WO2016107357A1

WO2016107357A1 - Occluder, manufacturing method thereof and woven mesh pipe for manufacturing occluder

Info

Publication number: WO2016107357A1
Application number: PCT/CN2015/095985
Authority: WO
Inventors: 刘香东
Original assignee: 先健科技(深圳)有限公司
Priority date: 2014-12-30
Filing date: 2015-11-30
Publication date: 2016-07-07
Also published as: CN104605909A

Abstract

Disclosed are an occluder (100), a manufacturing method thereof and a woven mesh pipe (520) for manufacturing the occluder (100), wherein the occluder (100) comprises an elastic woven body (110) made of a plurality of weaving filaments (113, 11, 12, 13, 14, 15, 16, 17); and in the extension direction of any weaving filament (11) in the woven body (110), weaving filaments (12, 13, 14, 15, 16, 17) which intersect with the weaving filament (11) comprise a plurality of first weaving sets and a plurality of second weaving sets, the first weaving sets and the second weaving sets being alternately located on two opposite sides of the weaving filament (11), and each first weaving set and each second weaving set respectively comprising at least two weaving filaments (12, 13, 14, 15, 16, 17) extending in the same direction. By means of the weaving structure, the bonding force between the weaving filaments is relatively small, so that sheathing force is reduced, sheathing of the occluder is facilitated, and thus the occluder can adapt to a relatively small sheath pipe. Meanwhile, by means of rationally arranging the number of weaving filaments in the first and the second weaving sets, it can be ensured that the weaving filaments are compactly woven, such that the occluder can have enough elasticity and radial supporting force after being unsheathed, thereby effectively plugging a missing part.

Description

Occluder and manufacturing method thereof, and braided mesh tube for making occluder

[Technical Field]

The present invention relates to a medical device and a method of manufacturing the same, and more particularly to an occluder that can be used to occlude intracardiac or intravascular defects, a method of manufacturing the same, and a braided mesh tube for making the occluder.

【Background technique】

With the development of interventional materials and interventional cardiology, transcatheter interventional occlusion devices for minimally invasive treatment of atrial septal defect (VSD), ventricular septal defect (ASD), patent ductus arteriosus (PDA) and patent foramen ovale Congenital heart disease such as (PFO) has become an important method. Interventional methods for intravascular occlusion are also widely accepted treatments.

At present, the occluder is usually made of metal tube or woven with braided wire. For the woven occluder, on the one hand, the woven wire is required to be compact, so as to ensure a certain binding force between the braided wires. The plug is released from the conveyor and has sufficient elasticity to return to the expanded state, which can effectively block the heart or blood vessel defect; on the other hand, when the knitting is compact, the binding force between the braided wires is increased, resulting in the occluder The force required for deformation increases, thereby increasing the sheathing resistance of the occluder, making it more difficult to accommodate smaller sheaths, increasing the difficulty and risk of surgery. It can be seen that the woven structure of the occluder needs to ensure the sealing effect, and at the same time, it is necessary to minimize the sheathing force to facilitate the delivery of the occluder.

[Summary of the Invention]

The technical problem to be solved by the present invention is to provide an occluder, a method of manufacturing the same, and a braided mesh tube for making the occluder, in view of the deficiencies of the prior art.

The technical solution adopted by the present invention to solve the technical problem thereof is to provide an occluder comprising an elastic braid made of a plurality of braided wires along an extending direction of any one of the braids. The woven wire intersecting the woven wire includes a plurality of first woven sets and a plurality of second woven sets, the first woven set and the second woven set being alternately located on opposite sides of the woven wire, each The first weave set and each of the second weave sets include at least two filaments extending in the same direction.

In the occluder according to an embodiment of the present invention, the number of the braided wires in each of the first knitting groups is equal to the number of the braided wires in each of the second knitting groups.

In an occluder according to an embodiment of the invention, the braid comprises a multi-stage woven mesh; the multi-stage woven mesh comprising at least a distal end closest to the braid and made of a plurality of first-order braided wires a first-stage woven mesh and a second-order woven mesh co-woven by a plurality of first-order woven wires and second-order woven wires, the first-stage woven mesh being compressed toward an axis perpendicular to the elastic braid The minimum cross-sectional area is smaller than the minimum cross-sectional area of any other order woven mesh after compression to the axis.

In an occluder according to an embodiment of the invention, the first-order woven mesh forms an opening adjacent the edge of the distal end.

In the occluder according to the embodiment of the present invention, the opening has a diameter of 2 mm to 5 mm.

In the occluder according to an embodiment of the present invention, the number of each of the braided wires is an even number.

In the occluder according to the embodiment of the present invention, the number of the first-order braided wires is 24, and the number of the second-stage braided wires is 48.

In an occluder according to an embodiment of the present invention, the multi-stage woven mesh further includes a third-order woven mesh on a proximal end side of the second-order woven mesh, the third-order woven mesh being the first The second-order braided yarn, the second-order braided yarn and the third braided yarn are woven together; the number of the first-order braided yarn, the second-order braided yarn and the third-order braided yarn is 24 pieces.

In the occluder according to an embodiment of the present invention, the braid is a single layer structure.

The present invention also provides a braided mesh tube for making an occluder comprising a plurality of braided wires, the braided wire intersecting the braided filaments along a direction of extension of any one of the braided filaments comprising a plurality of first braided groups and a plurality of second knitting groups, the first knitting group and the second knitting group are alternately located on opposite sides of the root knitting wire, and each of the first knitting group and each second knitting group includes at least two The braided wire extending in the same direction has a different compression diameter at both ends of the braided mesh tube.

The invention also provides a method for manufacturing an occluder, comprising weaving a plurality of braided wires into an elastic mesh tube, wherein the plurality of braided wires extending in the same direction along the extending direction of any one of the braided wires The first weave set, and a plurality of second weave sets comprising at least two co-extending braided wires are alternately placed on opposite sides of the braided wire. In a method of fabricating an occluder according to an embodiment of the present invention, the manufacturing method includes polishing the braided wire or plating a nano-film layer on the surface of the braided wire before weaving the mesh tube.

In the occluder of the present invention, the method of manufacturing the same, and the woven mesh tube for making the occluder, the woven wire intersecting the woven wire in the extending direction of any one of the braids includes a plurality of a woven group and a plurality of second woven groups, the first woven group and the second woven group are alternately located on opposite sides of the root woven wire, and each of the first woven group and each of the second woven groups includes at least two The braided wire extending in the same direction, the weaving structure makes the binding force between the braided wires relatively small, and then the force required for the deformation of the braid body becomes small, thereby reducing the sheathing force, facilitating the sheathing of the occluder, and adapting a smaller sheath; at the same time, by properly arranging the number of braided wires in the first and second braiding groups described above, it is also ensured that the knitting between the braided wires is compact, so that the occluder has sufficient elasticity and radial support after being sheathed. Force, thus effectively blocking the defect.

[Description of the Drawings]

The present invention will be further described below in conjunction with the accompanying drawings and embodiments, in which:

1 is a schematic structural view of an occluder according to an embodiment of the present invention;

Figure 2 is a partial schematic view of a braided body of an embodiment of the present invention;

Figure 3 is an exemplary top view of the occluder of Figure 1;

Figure 4 is another exemplary top view of the occluder of Figure 1;

Figure 5a is a schematic view of the occluder when the distal opening is larger than the inner diameter of the sheath;

Figure 5b is a schematic view of the occluder when the distal opening is smaller than the inner diameter of the sheath;

Figure 6 is a schematic view of a mold bar combined with a braided wire according to an embodiment of the present invention;

Figure 7 is a plan view of Figure 7;

Figure 8 is a schematic view of the metal mesh tube produced from Figure 7;

Figure 9 is a schematic view of the metal mesh tube of Figure 9 after the proximal end is closed;

Figure 10 is a schematic view of a plug head;

Figure 11 is a schematic illustration of a tapered metal mesh tube.

【detailed description】

For a better understanding of the technical features, objects and effects of the present invention, the embodiments of the present invention are described in detail with reference to the accompanying drawings. In the field of interventional medicine, the distal end is defined as the end away from the operator during the surgical operation, and the proximal end is defined as the end close to the operator during the surgical operation.

As shown in FIG. 1 , an implanted occluder 100 according to an embodiment of the present invention comprises a plurality of braided wires 113 woven to form an elastic braid 110. The braid 110 may be a single-layer woven structure, and all of the proximal ends thereof. The braided wire 113 is tightened and fixed by the plug 130 to close the occluder 100, and the plug 130 can be screwed to the conveyor by providing internal or external threads; the distal end 120 of the braid 110 is a non-head structure That is, the distal end 120 has no other members that bind the braided wire 113, and is also a braided structure in which a plurality of braided wires 113 are woven. A choke film 140 is sutured in the cavity of the braid 110 to further enhance the effect of blocking blood flow.

The braided wire 113 may be a shape memory alloy, such as a nickel-titanium alloy wire, which is superelastic by heat treatment. The braided wire 113 may also be made of a metal material such as stainless steel, a human body absorbable material, or other material suitable for the body to be elastic. The use of nickel-titanium alloy wire ensures that the occluder 100 is housed in the delivery sheath in a compressed state, automatically returns to the original shape after being released from the delivery sheath, and blocks the cardiac septal defect or occludes the blood vessel, and maintains sufficient The radial support force prevents the occluder 100 from shifting.

Referring to Fig. 2, as a whole, the braid 110 is interlaced by two sets of braided wires in opposite directions to form a mesh structure, that is, the braided wire 11 and a braided wire having the same extending direction as a group, and the braided wires 12, 13, 14 , 15, 16, 17 and the same braided wire as the extension direction is another group. The knitting yarn intersecting the braided yarn along the extending direction of any one of the braided filaments in each of the knitting wires includes a plurality of first knitting groups and a plurality of second knitting groups, each of the first knitting groups And each of the second weave sets are alternately located on opposite sides of the root braided wire. Each of the first knitting group and each of the second knitting groups includes at least two knitting yarns extending in the same direction, and the number of knitting threads in the first knitting group may be equal to or equal to the number of knitting threads in the second knitting group Wait. Taking the braided wire 11 as an example, in the illustrated partial weave structure, in the extending direction of the braided wire 11, the braided wire intersecting the braided wire 11 includes the filaments 12 and 13 extending in the same direction below the braided wire 11. a braided set), co-axially extending braided filaments 14 and 15 above the braided wire 11 (second weave set adjacent the first weave set), braided wires 16 and 17 below the braided wire 11 (first weave set) That is, the first weave group and the second weave group are alternately located on opposite sides of the braided wire 11. The woven structure of the other portions of the braid 110 is analogously. Similarly, the other braided yarns in the braid 110 are the same or similar to those of the braided yarns 11 in the drawings, and will not be further described.

In the woven structure provided by the embodiment, the binding force between the braided wires is relatively small, the force required for the deformation of the braided body 110 is reduced, the sheathing force can be reduced, and the occluder 100 is sheathed, thereby being applicable to Small sheath tube; at the same time, by reasonably setting the number of braided wires (two or three) in each braiding group, etc., it is ensured that the knitting between the braided wires is compact, so that the occluder 100 has sufficient elasticity after being sheathed. Radial support force to effectively seal the defect.

In an embodiment of the invention, the braid 110 comprises a multi-stage woven mesh. As shown in FIG. 3, FIG. 3 is an exemplary top view of FIG. 1. The multi-stage woven mesh includes at least a first-order woven mesh 210 that is closest to the distal end of the braid 110 and is made up of a plurality of first-order braided wires 211. And a second-stage woven mesh 220 which is woven by a plurality of first-order braided wires 211 and second-order braided wires 221. The first-order woven mesh 210 comprises a smaller number of woven wires than any other woven mesh; such that in the expanded state, the mesh of the first-order woven mesh 210 is more mesh than any other woven mesh More sparse. The minimum cross-sectional area of the first-order woven mesh 210 after being compressed toward the axis is smaller than the minimum cross-sectional area of any other-stage woven mesh after being compressed toward the axis. The woven mesh can be compressed into the sheath of the conveyor, and the external force can be restored to the preset expanded shape (initial shape).

The number of braids of each order is even, and the ratio of the number of first-stage braids 211 to the number of braids of any other order may be 1:1 or 1:2, or other ratios. For example, the number of the first-order braided wires 211 may be 24, the number of the second-order braided wires 221 may be 48, and the first-order woven mesh 210 includes 24 knitting wires, and the second-order woven mesh 220 includes 72 Braided wire (ie, the sum of the first-order braided wire 211 and the second-order braided wire 221).

The first-order woven mesh 210 begins at the distal end 120 of the occluder 100 and terminates at a circumferential edge 222 of the second-order woven mesh 220. The first-stage woven mesh 210 and the second-order woven mesh 220 pass through the previous one. The braided yarn is continuously woven with the next-stage braided yarn for continuous transition. By analogy, each of the woven meshes terminates at the circumferential edge of the next-stage woven mesh, and the adjacent two-stage woven mesh continuously transitions. The multi-stage woven mesh forms a continuous braid 110, and the last-stage woven mesh is bound at the proximal end by a peg 130. Thus, the edge 212 of the first-order woven mesh 210 is closer to the distal end of the occluder 100 than the edges of the other-order woven mesh. The edges of each woven mesh are interlaced by continuous mesh bends. Preferably, each of the wires at the edges is bent into a thin ring that is deformable as the wire is twisted.

In addition to the first-order woven mesh 210 and the second-order woven mesh 220, the multi-stage woven mesh may further include a third-order woven mesh or a third-order woven mesh, and the third-order woven mesh is composed of a plurality of first-order woven meshes. The braided wire, the second-order braided wire 221 and the third-order braided wire 231 are woven together, and the higher-order woven mesh is similarly pushed. Referring to FIG. 4, FIG. 4 shows another exemplary top view of FIG. 1. The first-stage woven mesh 210 is woven by the first-order woven wire 211; the second-stage woven mesh 220 is composed of the second-order woven wire 221 and the first-order The braided wire 211 is formed by weaving together; the third-stage braided mesh 230 is formed by weaving together the first-order braided wire 211, the second-stage braided wire 221, and the third-order braided wire 231. Here, the ratio of the number of the first-order braided wires 211 to the number of other-order braided wires may be 1:1. For example, the number of the third-order braided wires may each be 24, whereby the first-order braided mesh 210 includes 24 The root braided wire, the second-stage woven mesh 220 includes 48 woven wires, and the third-order woven mesh 230 includes 72 woven wires. With the third-order woven mesh arrangement, the sheathing force of the occluder 100 can be further reduced.

Referring to Figures 3 and 4, the first-stage woven mesh 210 is formed near the distal edge 212 to form an opening 150 having a diameter (diameter) of 2 to 5 mm. The diameter of the opening 150 is set to match the size of the sheath of the conveyor that delivers the occluder 100. Typically, the diameter of the opening 150 is slightly less than the inner diameter of the sheath. The opening diameter of 2mm~5mm corresponds to the inner diameter of the sheath matching 6F~15F. As shown in Figure 5a, when the diameter of the distal circular opening 150 is greater than the inner diameter of the conveyor sheath 300, when the occluder 100 is sheathed, the opening 150 needs to undergo considerable deformation to reduce its open area. When the diameter of the opening 150 is smaller than the inner diameter of the conveyor sheath 300, referring to FIG. 5b, when the occluder 100 is sheathed, the distal circular opening 150 can be received into the sheath 300 without being subjected to large deformation, thereby facilitating The occluder 100 returns to the sheath, which can be applied to a smaller sheath, reducing the risk and difficulty of surgery.

At each edge of the woven mesh, there may be a flexible circumference of a fixed circumference that passes through the braided wire bends at the edges of each of the woven meshes to prevent the braiding of the edges of each of the woven meshes from being discrete. For example, referring to Figures 3 and 4, a flexible ring 151 is provided at the edge of the first-order woven mesh 210. Shrinking the perimeter of the flexible ring 151 reduces the opening 150 and also allows the opening 150 to approach closure.

The above occluder with multi-stage woven mesh can be applied to include various types of cardiac occlusion devices such as atrial septal defect (VSD) occluder, ventricular septal defect (ASD) occluder, patent ductus arteriosus (PDA) occlusion. And patent foramen ovale (PFO) occluder and vascular occlusion devices. In addition, it can also be applied to various medical fields that need to be blocked, for example, it can also be used to repair local blood vessels.

The invention also provides a manufacturing method of the above occluder 100, which comprises weaving a plurality of braided wires into an elastic braid, and the manner in which any one of the braided filaments intersects with other braided wires along the extending direction thereof is: alternately Located below at least two braided wires (first weave group) and above at least two braided wires (second weave group). For example, any one of the braided filaments in the weave is alternately positioned below the two adjacent braided filaments and above the two braided filaments. Specifically, the manufacturing method includes the following steps.

Step one, a plurality of hanging rods are arranged at one end of the mold bar, and the hanging rods are distributed outward from the axis of the mold bar on a plurality of concentric circles, and the hanging rods of the same order are located on the same circle, on each of the hanging rods. Around a braided wire, two branches are drawn outward from each braided wire.

Referring to Fig. 6, a metal mesh tube 500 is first woven on a cylindrical metal mold bar 400 by a braided wire, and a braided collet 410 is disposed at the head of the mold bar 400, and two holes are respectively formed around the axis of the mold bar 400. The two circles are concentric circles. On the first circle, there are 12 holes arranged symmetrically about the axis, and 24 holes of the second ring are arranged at the periphery. Twelve rays are drawn from the center of the circle to the 12 holes, and the outer ring meets at 12 points. The 12 points and the outer 12 small holes are evenly distributed on the outer ring, and there are two small holes between the two adjacent points. This embodiment is a two-stage woven mesh, and two small holes are required to be provided on the woven chuck 410. Similarly, for a multi-stage woven mesh, a plurality of small holes can be provided, and the knitting method is similar.

The holes are used for mounting the threaded rods, so the ones are corresponding to the hanging rods, and the number of holes corresponds to the number of the threaded rods; the number of holes given above is only used as an example and is not a limitation of the present invention. A person of ordinary skill can set the number of specific holes according to the woven structure. For example, it is also possible to provide that the first ring has 12 holes, the second ring has 12 holes, and the third ring further has 12 holes.

Step 2, using a braided wire branch on the mold bar 400 to form a tubular multi-stage woven mesh, first weaving the braided wire on the innermost first-stage hanging screw 420 into the first-order woven mesh 210, and then the innermost The first-stage lanyard 420 and the slightly woven wire on the second-stage lanyard 430 are woven into a second-order woven mesh 220, which is sequentially woven, and then all the woven yarns are woven along the sidewall of the die 400. Tubular, up to the required length of the tube.

The first-stage hanging rods 420 are respectively inserted into the first ring holes, and then the first-stage knitting wires 211 are respectively hung on each of the first-stage hanging rods 420, and are viewed from above the knitting head 410. As shown in Figure 7. Each of the first-order braided wires 211 is bent at the same angle around the respective first-stage threaded rods 420, each forming two branches. The branches of all the first-order braided wires 211 are tensioned, sequentially intersected with the adjacent first-order braided wires 211, and meshed by three-wheel weaving. After the first-stage woven mesh 210 is programmed, the second-stage tangled wire rod 430 is inserted into the hole of the second outer circumference, and then the second-order woven wire 221 is hung on the corresponding second-stage tangled wire 430. The woven fabric is mixed with the first-order braided yarn 211, and is viewed from above the knitting chuck 410. The effect after knitting is as shown in FIG. The first-order woven mesh 210 includes 12 first-order braided wires 211 with a total of 24 branches. The second-stage woven mesh 220 includes 12 first-order braided wires 211 and 24 new second-order braided wires 221, for a total of 72 branches. Therefore, the mesh densities of the first-order woven mesh 210 and the second-order woven mesh 220 are different, the first-order woven mesh 210 is sparse than the second-order woven mesh 220, and the first-order woven mesh 210 has a higher Spatial compression ratio. In the present embodiment, the first-order braided wire 211 and the second-order braided wire 221 are wires made of a nickel-titanium alloy.

Step 3: heat-treating the woven mesh on the mold bar 400 to form a stable mesh structure. The opening 150 formed in the center of the first-stage woven mesh 210 of the woven mesh is smaller than the diameter of the mesh tube, and the opening 150 is located at the occluder 100. remote.

During the weaving process, the wire first encases the braided collet 410 and then covers the side of the die bar 400 to become a round tubular shape. After a certain weaving length is completed, the tubular multi-stage woven mesh is fixed on the die bar 400 and heat-treated to form a stable tubular structure. The metal mesh tube 500 taken out from the die bar 400 is as shown in FIG. The bent portion of the first-order braided wire 211 (the portion surrounding the first-stage threaded rod 420) constitutes the boundary of the circular opening 150 of the first-order woven mesh 210. The bent portion of the second-order braided wire 221 (the portion surrounding the second-stage threaded rod 430) constitutes a boundary of the second-order woven mesh 220, and the diameter of the boundary of the second-order woven mesh 220 is larger than that of the first-order woven mesh 210 The diameter of the opening 150. The free ends of the first order braided wire 211 and the second order braided wire 221 terminate in a tail portion 510 of the metal mesh tube 500, the diameter of the tail portion 510 of the metal mesh tube 500 being greater than the diameter of the boundary of the second order braided wire 221 . The occluder 100 made of such a multi-stage woven mesh has a distal end first-stage woven mesh 210 woven from a small number of wires, and a distal end portion thereof is compressed toward the axis to achieve a smaller cross-section. The area makes it easier for the occluder 100 to be recycled into the small sheath 300.

In step four, the other end of the woven mesh is gathered and fixed to form a proximal end of the occluder 100, and a closed cavity is formed between the distal end and the proximal end of the occluder 100. Referring to Figures 8-10, the tail portion 510 of the metal mesh tube 500 is gathered and all of the braided wire ends 111 are secured using a steel sleeve 131 to close the proximal end of the metal mesh tube 500 while maintaining a stepped braided structure at the other end. The braided wire end 111 is then welded to the steel sleeve 131 and a weld head 112 is formed in the steel sleeve 131 to form the proximal end of the metal mesh tube 500. Further, the connecting device of the occluder 100 is fixed to the proximal end of the occluder 100. The connecting device may be the plug 130 of FIG. 1. The structure of the plug 130 is as shown in FIG. The sleeve 131 is welded to the blind hole 132, and the other end is an internally threaded hole 133, which can be mated with the conveyor.

In step five, the woven mesh is placed in a heat set mold to provide the desired shape of the occluder 100 and sufficient elasticity.

For some specific occluders, the diameters of the two plugging discs are not equal, and the diameter of one disc surface is smaller than the diameter of the other disc surface; for example, some interatrial occluders have a diameter larger than the distal disc surface. See Figure 1 for the diameter of the proximal disc surface. At this time, if the occluder 100 is heat-set by using the cylindrical metal mesh tube 500 in FIG. 8, since the mesh density of the metal mesh tube 500 is uniformly distributed in the axial direction, the mesh of the distal disk surface may be large, and The smaller mesh of the proximal disk surface makes the density of the braided wire of the proximal disk surface higher than the density of the braided wire of the distal disk surface, thereby causing the mechanical strength of the two disk surfaces to be asymmetric, which affects the occluder 100 at the defect site. The radial support force, in turn, affects the plugging performance and its stability.

Thus, in the present invention, a tapered mold rod having a diameter which gradually decreases in the axial direction from the end on which the threaded rod is provided is employed, thereby producing the braided mesh tube 520 shown in Fig. 11. The braided mesh tube 520 is evenly woven, and the diameter of the braid is gradually reduced from the one end in the axial direction. For example, the diameter may gradually decrease from the closed end to the axial direction, and the diameter of the open end is minimized, thereby obtaining different compression diameters at both ends. The braided mesh tube 520, the so-called compression diameter is the diameter corresponding to the circumferential position of the braided mesh tube 520 after being axially compressed, and the braided mesh tube 520 can be used to make the plug of the diameter of the distal disc surface larger than the diameter of the proximal disc surface. Device. At this time, the distal disc surface of the occluder is shaped by the head of the braided mesh tube 520 having a large compression diameter, and the proximal disc surface is formed by the tail of the braided mesh tube 520 having a small diameter. Thus, the density of the braided filament of the distal disc surface of the occluder is not relatively small due to the larger diameter of the disc surface, whereby the braided filament density can be approximately equal to the density of the braided filament of the proximal disc surface, thereby making the mechanical strength of the two disc faces Basic symmetry improves the overall mechanical strength of the occluder, as well as the plugging performance and its stability.

It is worth mentioning that before weaving, the braided wire 113 may be mechanically polished or chemically polished, or the surface of the braided wire 113 may be coated with a nano film layer, such as a titanium oxide film layer, to reduce the intrusion of the occluder 100. Sheath force.

In summary, for a woven occluder, any one of the woven wires is alternately located below the first woven group consisting of at least two woven wires and above the second woven group consisting of at least two woven wires, The woven structure makes the binding force between the braided wires relatively small, and then the force required for the deformation of the braid body becomes small, thereby reducing the sheathing force, facilitating the occluder to return to the sheath, and the sheath can be applied to reduce the sheath. Surgical risk and difficulty; at the same time, by rationally setting the above The number of braided wires in the first and second braiding groups, two or three, etc., also ensures that the knitting between the braided wires is compact, so that the occluder has sufficient elasticity and radial support force after being sheathed, thereby effectively sealing Block the defect.

In addition, the distal end of the occluder is a non-head structure, which is only a braided structure formed by the braided wire, which reduces the amount of metal remaining in the body; and the distal end has an opening, and the diameter of the opening is slightly smaller than the sheath of the conveyor The inner diameter helps the occluder to return to the sheath. The occluder comprises a multi-stage woven mesh, for example, which may comprise a third-order woven mesh, the first-order woven mesh comprises 24 woven wires, the second-order woven mesh comprises 48 woven wires, and the third-order woven mesh comprises 72 woven wires. With the third-order woven mesh arrangement, the sheathing force of the occluder can be further reduced.

Claims

An occluder comprising an elastic braid made of a plurality of braided wires, wherein the braided yarn intersecting the braided yarn comprises a plurality of braided filaments extending along a direction of any one of the braided filaments a first weave set and a plurality of second weave sets, the first weave set and the second weave set are alternately located on opposite sides of the root braided wire, each first weave set and each second weave The set includes at least two braided filaments extending in the same direction.
The occluder according to claim 1, wherein the number of braided wires in each of the first weave sets is equal to the number of braided wires in each of the second weave sets.
The occluder according to claim 1 or 2, wherein said braid comprises a multi-stage woven mesh; said multi-stage woven mesh comprising at least a distal end closest to said braid and consisting of a plurality of first a first-order woven mesh made of a woven wire and a second-order woven mesh co-woven by a plurality of first-order woven wires and a second-order woven wire, the first-order woven mesh being perpendicular to the elastic braid The minimum cross-sectional area after compression in the axial direction is smaller than the minimum cross-sectional area of any other order woven mesh after compression to the axis.
The occluder of claim 3 wherein said first order woven mesh forms an opening adjacent the edge of said distal end.
The occluder according to claim 4, wherein the opening has a diameter of from 2 mm to 5 mm.
The occluder according to claim 3, wherein the number of each of the braided wires is an even number.
The occluder according to claim 6, wherein the number of the first-order braided wires is 24 and the number of the second-order braided wires is 48.
The occluder according to claim 3, wherein said multi-stage woven mesh further comprises a third-order woven mesh on a proximal end side of said second-order woven mesh, said third-order woven mesh The first-order braided yarn, the second-order braided yarn and the third braided yarn are woven together; the number of the first-order braided yarn, the second-order braided yarn and the third-order braided yarn are both 24 root.
The occluder according to claim 3, wherein the braid is of a single layer structure.
A braided mesh tube for making an occluder, comprising a plurality of braided wires, characterized in that the braided wire intersecting the braided wire comprises a plurality of first braided groups and more along the extending direction of any one of the braided filaments a second knitting group, the first knitting group and the second knitting group are alternately located on opposite sides of the root knitting wire, and each of the first knitting group and each second knitting group includes at least two The braided wire extending in the same direction has different compression diameters at both ends of the braided mesh tube.
A method for manufacturing an occluder comprises: weaving a plurality of braided wires into an elastic mesh tube, wherein a plurality of braided wires including at least two filaments extending in the same direction are arranged along the extending direction of any one of the braided wires in the weaving. A first woven set, and a plurality of second woven sets comprising at least two woven filaments extending in the same direction are alternately placed on opposite sides of the woven wire.
The method of manufacturing an occluder according to claim 11, wherein the manufacturing method comprises polishing the braided wire before plating the mesh tube or plating a nano-film layer on the surface of the braided wire.