CN112315523A

CN112315523A - Plugging device

Info

Publication number: CN112315523A
Application number: CN202110006043.0A
Authority: CN
Inventors: 李安宁; 刘建勇; 贾佳; 汤麟
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2021-01-05
Filing date: 2021-01-05
Publication date: 2021-02-05
Anticipated expiration: 2041-01-05
Also published as: CN112315523B; WO2022148135A1

Abstract

The invention relates to a plugging device, which comprises a sealing part and a fixing part connected with the sealing part, wherein the fixing part comprises a supporting net and at least one turnover rod connected with the supporting net, the supporting net is made into a net shape by weaving first woven wires, the turnover rod is made into a rod shape by cutting a tubular piece or is made into a rod shape by winding a plurality of second woven wires, one end of the turnover rod is turned outwards towards the direction of the sealing part after extending towards the distal end in the unfolding process of the fixing part, and at least one part of the supporting net forms at least one part of side wall of the fixing part after the fixing part is unfolded. In the plugging device, the overturning rod enables the fixing part to have higher overturning strength and be overturned more easily and completely, and the situation that a certain part of the fixing part is abutted in a gully between the pectinate muscles to cause abrasion or puncture the left auricle is avoided.

Description

Plugging device

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a plugging device.

Background

In left auricle of the heart plugging device technical field for implant the fixed disk that plays support and fixed action in the left auricle of the heart, all adopt the little weaving silk of silk footpath to make the mesh grid through the mode of weaving at present, or adopt modes such as laser cutting to cut tubular spare and make the skeleton texture who contains a plurality of bracing pieces, promptly, the fixed disk adopts pure weaving mode or pure cutting mode to make. The supporting strength of the fixed disc manufactured by adopting the cutting mode is higher than that of a woven mesh, but the problem of stress concentration is often existed, or the problem that the supporting bar easily punctures weak gullies between adjacent pectinate muscles in the left auricle is also existed. In the case of a net-shaped holding tray made entirely of woven filaments, such as the anchoring net made of pure woven filaments disclosed in WO2017016411a1, the woven filaments of such a holding tray tend to be thin to have good flexibility to allow the holding tray to be turned over. However, such a fixing plate tends to be weaker in turning ability than the anchoring portion disclosed in patent document CN211723305U, which is made in a pure cutting manner. Because the comb-shaped muscles in some left auricles are developed, the resistance given to the fixed disk is larger when the fixed disk is released, or because the reversible space provided for the fixed disk at the deeper position in the left auricle is slightly smaller, the fixed disk with weaker turnover capacity is blocked when the fixed disk is turned over, and is less prone to being completely unfolded, so that the fixed disk is not firmly fixed, and even the plugging device falls off.

Disclosure of Invention

In view of the above, there is a need to provide an improved plugging device for the above-mentioned weak turning ability of the fixing tray of the woven mesh structure.

The utility model provides a plugging device, including sealing and with the fixed part that the sealing is connected, the fixed part include the support net and with at least one upset pole that the support net is connected, the support net is woven the silk by first and is made netted through weaving, the upset pole adopts tubular member to make shaft-like or adopt many seconds to weave the silk through the winding and make shaft-like, the one end of upset pole is in the in-process that the fixed part expandes, towards the distal end orientation again after stretching the outside upset of direction of sealing, at least partly of support net is in constitute after the fixed part expandes at least partly lateral wall of fixed part.

In one embodiment, the turning rod is provided with a plurality of turning rods, the fixing part further comprises a main end part, one end of each of the turning rods is connected with the main end part, and the other end of each of the turning rods is turned outwards from the main end part in the direction of the sealing part after being unfolded outwards in the radial direction.

In one embodiment, one end of the support net is connected to the other end of each of the plurality of turning bars at the distal end or the side wall of the fixing portion, and the other end of the support net extends toward the sealing portion.

In one embodiment, one end of the support net is unfolded radially outwards from the main end portion and turned outwards towards the sealing portion, and then extends towards the sealing portion, and a plurality of turning rods are fixedly connected to the support net respectively.

In one embodiment, the roll strength of the whole of the plurality of roll bars and the main end portion is greater than the roll strength of the support net.

In one embodiment, at least one of the ends of the turnover rod continues to extend toward the sealing part after being turned.

In one embodiment, the fixing part further comprises a main end part and a leading-out section, the leading-out section is made into a net tube shape by weaving third weaving wires, one end of the leading-out section is closed and fixed by the main end part, and the other end of the leading-out section is connected with the plurality of turnover rods respectively.

In one embodiment, when the number of the supporting nets is one, one end of each supporting net is connected with the plurality of turnover rods, and the other end of each supporting net extends towards the direction of the sealing part; or when the number of the supporting nets is multiple, at least one overturning rod is respectively connected with one end of at least one supporting net.

In one embodiment, the fixing part is further provided with a spreading part connected with the turning rod, and the spreading part pushes the turning rod to turn outwards towards the sealing part in the unfolding process of the fixing part.

In one embodiment, the anchoring portion further comprises a main end portion, one end of the supporting mesh is expanded radially outward from the main end portion and turned outward in the direction of the sealing portion to form a recessed area and a distal end surface connected to the recessed area, and then continues to extend in the direction of the sealing portion, and the turning bar is anchored to at least a portion of the recessed area and a portion of the distal end surface of the supporting mesh.

In one embodiment, the end of the supporting net is open and bent towards the inside of the fixing part, the sealing part comprises a far-end disc surface at the far end of the sealing part, and at least one part of the far-end disc surface of the sealing part is provided with a first thin film body.

In one embodiment, the turning rod is provided with a plurality of turning rods, the fixing part is provided with a second film body, and the second film body connects the turning rods in series along the circumferential direction of the fixing part.

In one embodiment, the support net and/or the turning bar are provided with anchoring barbs, the ends of which are directed towards the sealing part.

In one embodiment, the length of the flip bar from the tip to the apex of the distal-most end of the flip bar ranges from 2 to 15 millimeters.

In the plugging device, the turnover rod is cut into a rod shape by adopting a tubular piece or is wound into a rod shape by adopting a plurality of second braided wires, and the turnover strength of the turnover rod is greater than that of the braided wires with the same axial length and a preset bending shape; and, compared with the sheet-like woven net structure having the same unfolding diameter and the same folding path, the folding bar also has a greater folding strength, and thus, is more easily folded outwardly during the unfolding of the fixing part, thereby ensuring that the fixing part can be completely unfolded after being released. On the other hand, the side wall of the fixing part is formed by a reticular supporting net woven by the first weaving wires, and when the fixing part is abutted against the cavity wall of the left auricle after being released, a larger contact area can be kept between the fixing part and the cavity wall, so that the extrusion force of the fixing part on the cavity wall is uniform and dispersed, and the phenomenon of stress concentration is avoided. In addition, because the first braided wires in the supporting net are mutually crossed and the net holes are usually small in practice, the first braided wires can be in surface contact with the cavity wall, the situation that a part of the fixing part abuts against the weak gully between adjacent pectinate muscles is avoided, and the adverse effect caused by grinding or puncturing the cavity wall of the left auricle is avoided.

The plugging device of this application adopts the great shaft-like structure of upset intensity and soft mesh grid bearing structure to combine together and makes the fixed part, has overcome some problems that the fixed disk that pure cutting mode or pure weaving mode made exists among the prior art, gets the strong point between them, mends the short place between them, has also overcome the technical bias that only pure cutting mode and pure weaving mode preparation fixed disk among the prior art simultaneously, has outstanding characteristics structurally, has apparent progress in the effect.

Drawings

Fig. 1 is a schematic view of the overall structure of the occlusion device of example 1;

FIG. 2 is a schematic illustration of the roll-over strength of the roll-over bar measured by means of a tensile machine;

FIG. 3 is a schematic illustration of the measurement of the turnover strength of a single first braided wire by means of a tensile machine;

FIG. 4 is a schematic view of the anchoring portion of the occluding device of FIG. 1 as viewed from the proximal end to the distal end;

FIG. 5 is a schematic cross-sectional view of the occluding device of example 2;

FIG. 6 is a schematic cross-sectional view of the occluding device of example 3;

fig. 7 is a schematic cross-sectional view of the occlusion device of example 4.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle. The term "connected" in the embodiments includes the case where two components are directly connected and indirectly connected via other components. The following description is directed to the device in its natural state or after deployment for release in vivo, unless otherwise specified.

The technical solution of the present invention will be described in further detail with reference to specific examples.

Example 1

The occlusion device proposed in example 1 can be used for the occlusion of the left atrial appendage, but also for the occlusion of other body tissues with openings, such as atrial septal defects and the like. The details of the occluding device will be described below by way of example to occlude the left atrial appendage.

Referring to fig. 1, the occluding device 100 includes a sealing portion 110 and a fixing portion 120 connected to the sealing portion 110. The sealing portion 110 and the fixing portion 120 are provided at intervals in the axial direction of the occluding device 100. The sealing portion 110 is located at the proximal end of the occluding device 100 and the securing portion 120 is located at the distal end of the occluding device 100. The occluding device 100 has a collapsed state housed within the sheath for delivery within the body and an expanded state (i.e., a natural state) extending outwardly from the distal end of the sheath and self-expanding as shown in figure 1 after deployment. The configuration of the occluding device 100 after release within the cavity of the left atrial appendage is identical or substantially identical to that of figure 1. In other implementations, the distal end of the sealing portion 110 abuts the proximal end of the fixation portion 120 after the occluding device 100 is released. In other implementations, such as for atrial septal defect occlusion, the sealing portion 110 and the fixation portion 120 may be brought closer together or abutted upon release to secure the occluding device 100 on the septum between the left atrium and the right atrium to effect occlusion.

The fixed portion 120 includes a main end 121 at its proximal end, a plurality of turning rods 122 connected to the main end 121, and a support net 123 connected to each of the turning rods 122. The main end 121 may be hollow and tubular with a distal end connected to the proximal end of each of the turnover rods 122 and a proximal end connected directly or indirectly to the distal end of the sealing portion 110. The support net 123 is formed by weaving one or more first weaving wires 1231 into a net shape, and the turnover bar 122 is formed into a bar shape by cutting using a tubular member. The cut everting rod 122 is generally stiffer and may have a larger cross-section than the braided wires used in the occluding device 100, e.g., the everting rod 122 has a stiffer and a larger cross-section than the first braided wires 1231. In other implementations, the flipping bar 122 may be made of one or more second weaving wires wound in a stacked manner to form a rod shape, and thus, the flipping bar 122 has a hardness greater than that of a single second weaving wire and a cross-section greater than that of a single second weaving wire.

The first braided wire 1231 may be a braided wire made of a material such as nitinol, other alloys, or polymers, the second braided wire may be a braided wire made of a material such as nitinol, other alloys, or polymers, and the diameter of the second braided wire may be larger than or the same as that of the first braided wire 1231. The tubular member for cutting may be a nickel-titanium alloy tube, other alloy tube, polymer tube, or the like. These materials all have superelasticity and good shape memory properties. In the case where the first knitting yarn 1231 and the turning bar 122 are made of the same material, the cross section or the outer diameter of the turning bar 122 is much larger than that of the single first knitting yarn 1231, specifically, the cross section of the turning bar 122 is 1.5 to 5 times of the cross section of the single first knitting yarn 1231, or the outer diameter of the turning bar 122 is 1.5 to 5 times of the outer diameter of the single first knitting yarn 1231. In other implementations, the elasticity of the material used for the flipping bar 122 is greater than the elasticity of the material used for the first knitting yarn 1231, or the elasticity of the material used for the flipping bar 122 is greater than the elasticity of the material used for the first knitting yarn 1231, and the cross section or the outer diameter of the flipping bar 122 is much greater than the cross section or the outer diameter of the single first knitting yarn 1231. These means enable the turning strength of the turning bar 122 to be greater than the turning strength of the single first knitting yarn 1231 and also greater than the turning strength of the sheet-like knitted mesh formed of the first knitting yarns 1231, on the basis of the same axial length and predetermined curved shape.

The turning strength can be measured by means of an existing tensile machine, specifically, taking an overturning rod 122 and a first knitting yarn 1231 as an example, and the axial length of the overturning rod 122 is the same as the axial length of the first knitting yarn 1231, and the two are in the same bending shape by heat setting, that is, the same turning track. The turning bar 122 is naturally bent into a predetermined shape as shown in fig. 2 (a) in a natural state, in which the proximal end of the turning bar 122 is fixed to an immovable fixing device and then the distal end of the turning bar 122 is connected to a tensile machine (not shown). And starting the tensile machine, and resetting the initial force value of the tensile machine. As shown in fig. 2 (b), the turning bar 122 is pulled straight by the pulling machine, and the measured value F1 on the pulling machine is recorded, and the measured value F1 is equal to the turning strength of the turning bar 122 according to the basic knowledge of mechanics. As shown in fig. 3, the turn strength of the single first braided wire 1231, measured in the same manner as the turn bar 122, is equal to the measurement F2 on the tensile machine. As a result of a number of experimental measurements and a comparison of the values of F1 and F2, it can be seen that the eversion strength of the everting bar 122 is greater than the eversion strength of the single first braided wire 1231.

When the fixing portion 120 is received in the sheath tube, the portion located at the relatively proximal end will be described as the proximal end of each component in the fixing portion 120, and the portion located at the relatively distal end will be described as the distal end of each component in the fixing portion 120. As shown in fig. 1, all of the turnover rods 122 are spaced around the main end 121 without any intersection between any of the turnover rods 122 and the other turnover rods 122. The proximal end of each turnover bar 122 is welded to the main end 121, or all the turnover bars 122 and the main end 121 are an integral structure formed by cutting the same tubular member, so that all the turnover bars 122 can be fixedly connected to the main end 121. Each flipping bar 122 is deployed radially outward from the main end 121 while extending a distance distally, and then flipped outward toward the seal 110. The distal end of the flipping bar 122 is disposed on the distal end face 126 of the fixing portion 120, and in other implementations, may be disposed on the side wall 124 of the fixing portion 120 between the proximal end face and the distal end face 126 thereof, preferably on the side wall 124 of the fixing portion 120 near the distal end face 126 thereof. The proximal end of the support mesh 123 is disposed at the distal end of the fixation portion 120 and includes a plurality of necked-in ends 1232 of the necked first braided filaments 1231. All the terminating ends 1232 are connected to all the turning rods 122 in a one-to-one correspondence, and specifically, one terminating end 1232 is fixedly connected to the distal end of one turning rod 122, for example, by welding, sleeving, bonding, or the like. The support mesh 123 extends a distance from each of the necked ends 1232 in a direction towards the sealing portion 110, thereby constituting the side wall 124 of the fixation portion 120. Thereafter, as shown in fig. 4, the distal end of the supporting mesh 123 is bent toward the inside of the fixing part 120, and the distal end of the supporting mesh 123 is opened. The whole body formed by each turning bar 122 and the main end 121 has a greater turning strength (both can be measured and compared by the above-mentioned turning strength measuring method with the aid of a tensile machine) than a tubular woven mesh structure having the same unfolding diameter and turning trajectory, and has a sufficient turning capability in the unfolding process of the fixing part 120, and is more easily turned outwards, thereby ensuring that the fixing part 120 can be completely unfolded after being released. The side wall 124 of the fixing part 120 is formed by a hollow mesh tube woven by the first weaving yarn 1231, and when the fixing part 120 is released and abuts against the cavity wall of the left atrial appendage, a larger contact area can be kept between the side wall and the cavity wall, so that the extrusion force of the fixing part 120 on the cavity wall is uniform and dispersed, and the phenomenon of stress concentration is avoided. In addition, because the first braided wires 1231 in the hollow mesh tube are mutually crossed and the meshes are often smaller, the first braided wires can be in surface contact with the cavity wall, the situation that a part of the fixing part 120 abuts against the weak gully between adjacent pectinate muscles is avoided, and adverse effects caused by abrasion or puncture of the cavity wall of the left auricle are avoided.

In other implementations, the ends of the support mesh 123 are open, but do not bend toward the inside of the fixing portion 120, i.e., the ends of the support mesh 123 remain in the original direction toward the sealing portion 110. In other implementations, two adjacent turning bars 122 can be connected by one or more struts to keep the adjacent turning bars 122 from crossing or shifting and to enhance the turning strength of the turning bars 122.

The sealing part 110 is formed by weaving a plurality of third weaving wires 111 into a net tube, and both ends of the net tube close and fix the ends of the third weaving wires 111 through a sleeve 112 respectively. The mesh tube is then heat-set to a plug-like shape as shown in the seal 110 in fig. 1, thereby obtaining the seal 110 for sealing the left atrial appendage opening. In other implementations, the sealing portion 110 may also be heat set into a shape such as a disk or column. The sealing portion 110 includes a distal disc surface 113 at its distal end facing the fixation portion 120, and a proximal disc surface 114 opposite the distal disc surface 113. At least one layer of third film (not shown) may be disposed inside the sealing portion 110, wherein an edge of one of the third film is fixed to the woven wire at the edge of the sealing portion 110, and other third film may be fixed at other positions inside the sealing portion 110 as long as the third film can block the blood flow. The third membrane body is used to prevent blood flow from one side of the sealing portion 110 to the other side to prevent blood flow communication between the left atrial appendage and the left atrium. In another embodiment, a first film (not shown) is disposed on at least a portion of the distal disk surface 113 of the sealing portion 110, and the first film is preferably disposed opposite to the distal opening of the supporting mesh 123 to prevent the distal end of the supporting mesh 123 from hooking the third knitting yarn 111 on the distal disk surface 113 of the sealing portion 110 and being unable to be unfolded when the distal end is bent toward the inside of the fixing portion 120, thereby making the plugging device 100 unstable in fixation. The first membrane body may also have a flow-impeding effect.

In another implementation manner, a second film body is further disposed on the fixing portion 120, and the second film body connects the turning rods 122 in series along the circumferential direction of the fixing portion 120. Specifically, the second film body may have a shape similar to a hemisphere, and is attached to the outer surface or the inner surface of the fixing portion 120, and is fixedly connected to each of the turning rods 122 by means of a suture or an adhesive, so that the turning rods 122 are connected in series along the circumferential direction of the fixing portion 120, and the problem of hinge joint between the turning rods 122 during the unfolding process of the fixing portion 120 is prevented. The second membrane body may also have a further flow-impeding effect.

A plurality of anchors 125 are provided on the supporting mesh 123 at intervals along the circumferential direction of the fixing portion 120, one end of the anchor 125 is fixed to one of the first woven wires 1231 or wound around one or more of the first woven wires 1231, and the tip of the anchor 125 faces the sealing portion 110, so that after the fixing portion 120 is deployed, the anchor 125 penetrates into the body tissue to assist in fixing the occluding device 100 more stably. In other implementations, the anchor 125 is provided only on the turnover rod 122, for example, the anchor 125 is provided on at least one turnover rod 122, one end of the anchor 125 is fixed on the turnover rod 122 or is integrally formed with the turnover rod 122, and the end of the anchor 125 faces the sealing part 110. In another embodiment, not only the plurality of anchoring thorns 125 are provided on the support net 123, but also one anchoring thorn 125 is provided on each of the plurality of turning rods 122, and the ends of the anchoring thorns 125 face the sealing portion 110, so that the anchoring thorns 125 provided on the support net 123 and the anchoring thorns 125 provided on the turning rods 122 are distributed in a staggered manner in the axial direction of the fixing portion 120, thereby fixing the plugging device 100 in multiple directions and improving the fixing stability of the plugging device 100. In other implementations, the anchoring thorn 125 may not be provided on the fixation portion 120.

The length from the end of the turning rod 122 to the vertex P of the farthest end of the turning rod 122 ranges from 2 to 15 mm, so that the fixing portion 120 is smooth in the turning process and can ensure sufficient turning strength. The most distal apex point P of the flip bar 122 tends to be the point where the flip bar 122 is most curved.

The occluding device 100 may be delivered and controllably released in vivo by means of existing sheaths and delivery rods. The proximal sleeve 112 of the sealing portion 110 is removably attached to the distal end of the delivery rod. In the case of performing the occlusion operation, the sealing portion 110 is connected to the transport rod, and then is accommodated in the sheath tube, and is transported to the target position in the body along with the sheath tube. The delivery rod is then pushed distally to extend the fixation portion 120 from the distal end of the sheath for release and deployment. After the fixing portion 120 is released and fixed at the target position in the body, the delivery rod is continuously pushed distally to extend the sealing portion 110 from the distal end of the sheath tube to be released and deployed to close the opening of the body tissue. Finally, the connection between the delivery rod and the sealing part 110 is released, and the delivery rod and the sheath are recovered to the outside of the body, thereby completing the occlusion operation.

Example 2

The occluding device 200 of example 2 is substantially similar to the occluding device 100 of example 1, and like features are not described in detail herein. The main difference between embodiment 2 and embodiment 1 is that, as shown in fig. 5, the proximal end of the support mesh 223 is closed, and the first knitting yarn 1231 at the proximal end of the support mesh 223 is spread radially outward from the main end 121 and spread a distance toward the distal end, turned outward toward the sealing portion 110, then continues to spread a distance toward the sealing portion 110, and finally, the distal end of the support mesh 223 is bent toward the inside of the fixing portion 120 to prevent the tip of the support mesh 223 from being worn against the cavity wall of the left atrial appendage after the fixing portion 220 is spread. The proximal end of the support mesh 223 may be secured by crimping through the main end 121 or may be secured by crimping through a sleeve. The sleeve may further be received within a cavity of the main end 121, or may be sleeved over the main end 121 to receive the proximal ends of the first braided filaments 1231 within a space between the sleeve and the main end 121. Proximal ends of the plurality of turning bars 122 are connected to the main end portion 121, respectively, and the turning bars 122 are attached to and fixedly connected to the support net 223 at intervals in the circumferential direction of the fixing portion 220. The overall roll strength of all the roll bars 122 and the main end 121 is greater than the roll strength of the support net 223. From this, after fixed part 220 stretches out from the distal end of sheath pipe, each upset pole 122 and supporting net 223 expand and overturn together, and because the upset intensity of upset pole 122 is great, can drive the corresponding part of supporting net 223 rather than laminating fixed together and overturn, thereby make supporting net 223 can still expand completely under the hindrance of the inside pectinate muscle of left atrial appendage or under the less condition in cavity release space, the holistic upset intensity of fixed part 220 has been improved, guarantee that plugging device 100 can be normal fixed in the cavity.

The turning bar 122 may be fixed to the first weaving wire 1231 of the support net 223 by winding it with a suture, or an opening may be provided at one or more positions of the turning bar 122, respectively, and then fixed by passing a suture through the opening and the corresponding portion of the support net 223. In addition, the turnover bar 122 may be fixed in place on the support net 223 by means of an adhesive or a sleeve, or the like. The turning rod 122 may be attached to the inner surface or the outer surface of the supporting net 223, and may be fixedly connected to the first knitting yarn 1231 of the supporting net 223 in an inserting manner.

In other implementations, the distal end of the support mesh 223 may not be bent toward the inside of the fixation part 220, but the tip of the support mesh 223 is woven by the first weaving wire 1231 to be closed in the circumferential direction of the fixation part 220 without having several independent ends in a direction toward the sealing part 110. Further, in order to better avoid the distal end of the support mesh 223 from abrading the body tissue, a plurality of flexible tips may be provided at the distal end of the support mesh 223 in the circumferential direction of the fixing part 220.

In other implementations, on the basis of the structure shown in fig. 5, only the main end portion 121 may be removed, and other features of the fixing portion 220 may be remained, that is, one or more turning rods 122 are separately attached and fixed to the supporting net 223 at intervals along the circumferential direction of the fixing portion 220, and both ends of the turning rod 122 are free ends, so that the overall turning strength of the fixing portion 220 can be enhanced, and the fixing portion 220 can be turned and unfolded completely more easily when being limited.

Example 3

The occluding device 300 of embodiment 3 is substantially similar to the occluding device 100 of embodiment 1 and the occluding device 200 of embodiment 2, and the same features are not repeated herein. The main difference between embodiment 3 and embodiments 1 and 2 is that, as shown in fig. 6, the fixing portion 320 includes a main end 121 at a proximal end thereof and a lead-out section 326 connected to a distal end of the main end 121. The leading-out section 326 is made into a mesh tube shape with a hollow interior and two open ends by a third weaving wire 3261 through weaving, the near end is closed and fixed by the main end part 121, the far end is fixedly connected with the plurality of turnover rods 122 respectively, and the connection mode can be welding, bonding, sleeve sleeving and the like.

The distal end of the lead-out section 326 is open and the distal edge is fixedly connected to the support mesh 323. In this embodiment, the supporting net 323 is plural and independent, and the distal end of each turning bar 122 is fixedly connected to the proximal end of one supporting net 323. The support screen 323 is woven with one or more first weaving threads 1231 as an internally hollow mesh tube and has only one opening which can be closed off by a sleeve 3231 which in turn is fixed to the end of the turning bar 122. The specific connection mode of the fixed connection can be welding, bonding, sleeving through a sleeve and the like. In other implementations, a support screen 323 may be attached to each end of several flip bars 122. In other implementations, the distal end of the support mesh 323 can also be configured to be open, or can be further secured by another sleeve.

In other implementations, the plurality of support webs 323 in fig. 6 may be replaced with one support web 123 as shown in example 1, and the proximal ends of the support web 123 are connected to the distal ends of the plurality of turnover rods 122 in fig. 6, respectively, and the distal ends extend toward the sealing part 110; alternatively, the distal end of the support mesh 123 may be further bent toward the inside of the fixing part 320.

Example 4

The occluding device 400 of example 4 is generally similar to the occluding device 200 of example 2 and like features are not described in detail herein. The main difference is that, as shown in fig. 7, the fixing part 420 is further provided with a spreading part 427 connected with the turning rod 122, and the spreading part 427 pushes the turning rod 122 to turn outwards in the direction of the sealing part 110 in the process of unfolding the fixing part 420. Specifically, the expanding portion 427 includes at least a first support rod 4271 and a second support rod 4272, a proximal end of the first support rod 4271 is fixedly connected to one of the turning rods 122, a proximal end of the second support rod 4272 is fixedly connected to the other turning rod 122, and the two turning rods 122 may be symmetrically arranged or may not be symmetrically arranged. The distal ends of the first and

second struts

4271, 4272 are fixedly connected together, and in other implementations, the distal ends of the first and

second struts

4271, 4272 can be spaced apart from or abut each other. The first stay 4271 extends from the proximal end thereof toward the distal end and toward the direction close to the central axis of the fixing part 420, and the second stay 4272 also extends from the proximal end thereof toward the distal end and toward the direction close to the central axis of the fixing part 420. Preferably, the first and

second struts

4271 and 4272 are symmetrically disposed. The number of struts in the struts 427 may be plural, for example, 3 or more. In other implementations, the ends of the first and

second struts

4271, 4272 proximate the central axis of the fixation portion 420 can be proximally extending.

When the fixing portion 420 is housed in the sheath tube, the first stay 4271 and the second stay 4272 are constrained in a linear shape and surrounded by the respective turn bars 122. When the fixing part 420 is protruded from the distal end of the sheath tube, the first and

second support rods

4271 and 4272 are restored to a predetermined shape due to their own elasticity, so that the inversion rod 122 is pushed to be outwardly inverted toward the sealing part 110 by being pushed by the opposite acting force of the first and

second support rods

4271 and 4272 to each other or by the acting force of the support net 223 during the process of unfolding the first and

second support rods

4271 and 4272, respectively, thereby enhancing the inversion strength of the inversion rod 122 and further improving the overall inversion strength of the fixing part 420.

In other implementations, the distal end of at least one of the everting rods 122 continues to extend in the direction of the seal 110 after everting. That is, the distal end of the turning bar 122 continues to extend proximally at the position shown in fig. 5, for example, the conformable support web 223 extends proximally for a distance, or further extends to a position near the distal end of the support web 223, and at this time, the distal end of the turning bar 122 is also bent toward the inside of the fixing portion 420, so that the turning of the entire support web 223 is facilitated by the turning bar 122.

In other embodiments, in the occlusion device 100 of embodiment 1, the occlusion device 200 of embodiment 2, and the occlusion device 300 of embodiment 3, the spreading parts 427 as in embodiment 4 may be respectively disposed on at least two of the turning rods 122 of the fixing parts thereof, so as to enhance the turning strength of the turning rods 122, which is not described herein again.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The utility model provides a plugging device, including sealing and with the fixed part that the sealing is connected, its characterized in that, the fixed part include the support net and with at least one upset pole that the support net is connected, the support net is woven the silk by first and is woven the silk process and weave into netted, the upset pole adopts tubular part to make the shaft-like or adopt many second to weave the silk process winding and make shaft-like, the one end of upset pole is in the in-process that the fixed part expandes, towards the outside upset of direction of sealing again after the distal end extends, at least partly of support net is in constitute after the fixed part expandes at least partly lateral wall of fixed part.

2. The occlusion device of claim 1, wherein the plurality of inversion rods, the fixation portion further comprising a main end portion, one end of each of the plurality of inversion rods being connected to the main end portion, and the other end of each of the plurality of inversion rods being outwardly inverted in a direction toward the sealing portion after being radially outwardly deployed from the main end portion.

3. The occlusion device of claim 2, wherein one end of the support mesh is connected to the other end of each of the plurality of inversion bars at a distal end or side wall of the fixation portion, the other end of the support mesh extending in a direction toward the sealing portion.

4. The occlusion device of claim 2, wherein one end of the support mesh is flared radially outward from the main end portion and turned outward toward the sealing portion, and then continues to extend toward the sealing portion, and wherein a plurality of the turning bars are fixedly attached to the support mesh, respectively.

5. The occlusion device of claim 4, wherein the roll-over strength of the plurality of roll-over bars and the main end portion as a whole is greater than the roll-over strength of the support screen.

6. The occlusion device of claim 1 or 4, wherein said one end of at least one of said inversion bars continues to extend in a direction towards said sealing portion after inversion.

7. The occlusion device of claim 1, wherein the fixation portion further comprises a main end portion and a leading-out portion, the leading-out portion is formed by weaving a third woven wire into a net shape, one end of the leading-out portion is closed and fixed by the main end portion, and the other end of the leading-out portion is connected with the plurality of turning rods respectively.

8. The occlusion device of claim 7, wherein when the support net is one, one end of the support net is connected to each of the plurality of inversion rods, and the other end extends in a direction toward the sealing portion; or when the number of the supporting nets is multiple, at least one overturning rod is respectively connected with one end of at least one supporting net.

9. The occlusion device of claim 1, wherein the fixation portion further comprises a spreading portion connected to the flipping bar, and the spreading portion pushes the flipping bar to flip outward toward the sealing portion during the deployment of the fixation portion.

10. The occlusion device of claim 1, wherein the anchoring portion further comprises a main end portion, wherein one end of the support mesh is flared radially outward from the main end portion and turned outward in a direction toward the sealing portion to form a recessed region and a distal end surface connected to the recessed region, and then continues to extend in a direction toward the sealing portion, and wherein the turning bar is anchored to at least a portion of the recessed region and a portion of the distal end surface of the support mesh.

11. The occlusion device of claim 1, wherein the distal end of the support mesh is open and curved inwardly of the anchoring portion, the sealing portion including a distal disc surface at a distal end thereof, at least a portion of the distal disc surface of the sealing portion being provided with the first membrane body.

12. The occlusion device of claim 1, wherein there are a plurality of said flipping bars, and a second membrane body is disposed on said fixation section, said second membrane body connecting said plurality of said flipping bars in series along a circumferential direction of said fixation section.

13. The occlusion device of claim 1, wherein said support mesh and/or said inversion rod are provided with anchoring barbs, the distal ends of said anchoring barbs facing said sealing portion.

14. The occlusion device of claim 1, wherein a length of the everting rod from a distal end thereof to a distal-most apex thereof ranges from 2 to 15 millimeters.