CN215994080U

CN215994080U - Novel plugging instrument

Info

Publication number: CN215994080U
Application number: CN202122082618.5U
Authority: CN
Inventors: 李彪
Original assignee: Ningbo Diochange Medical Technology Co Ltd
Current assignee: Ningbo Diochange Medical Technology Co Ltd
Priority date: 2021-08-31
Filing date: 2021-08-31
Publication date: 2022-03-11
Anticipated expiration: 2031-08-31

Abstract

The utility model relates to the field of medical equipment, in particular to a novel plugging device, which comprises a supporting body, wherein the supporting body comprises a near-end disc, a far-end disc and a waist part connecting the near-end disc and the far-end disc; wherein, the support body is a wavy or latticed structure formed by fixedly connecting a plurality of elastic support rods, and the waist part is provided with a through hole which axially penetrates through; and the barrier body is flexible or elastic and comprises a barrier film, the through hole is covered or blocked by the barrier film, and the periphery of the barrier film is connected with the support body.

Description

Novel plugging instrument

Technical Field

The utility model belongs to the field of medical equipment, concretely relates to novel shutoff apparatus, in particular to intracardiac plugging device.

Background

Atrial septal defects are a common congenital heart disease, and the mainstream treatment method is atrial septal occlusion via femoral vein by using an occluder, wherein the occluder is one of the most important medical devices. The currently used heart defect occluder is an implantation type medical apparatus for treating congenital heart defects, generally comprises a metal mesh framework, a flow-blocking membrane and a suture line, and is in a double-disc and waist I-shaped structure, but because the existing occluder has larger volume and dense grids, the whole atrial septum is almost occupied after being implanted into a human body, and the double discs are generally double-layer dense grids, a sheath tube with the size of at least 14F is needed to be used for being punctured into the left atrium through the atrial septum, after a patient completes a Patent Foramen Ovale (PFO) interventional occlusion operation or an Atrial Septal Defect (ASD) interventional occlusion operation, other heart disease interventional operations such as atrial septal puncture may be required, the adaptive symptoms of the atrial septal puncture operation comprise left atrial ablation, left atrial appendage occlusion, percutaneous mitral valve repair and the like, the surface of the occluder can be endothelialized after being implanted for a period of time, the metal mesh framework is integrated with surrounding tissues, and the metal mesh framework is permanently left on the heart septum, so that a puncture needle or a delivery catheter cannot penetrate through the atrial septum, the intervention channel of atrial septum is lost for a patient, the opportunity of minimally invasive intervention treatment of diseases such as atrial fibrillation and mitral regurgitation is lost, and the operation is affected.

Patent CN212346592U provides an occluder, which comprises a metal framework and a flow-resistant membrane. The metal framework comprises a near-end disk surface, a far-end disk surface and a waist part connecting the near-end disk surface and the far-end disk surface, the near-end disk surface and the far-end disk surface are of net structures formed by weaving metal wires, puncture holes are formed in the near-end disk surface and the far-end disk surface, and the size of the puncture holes is far larger than the size of meshes of the near-end disk surface and the far-end disk surface. The flow-resisting film is arranged in the near-end disc surface and the far-end disc surface, the puncture holes are covered by the flow-resisting film, and the flow-resisting film is made of a high-molecular absorbable material. According to the occluder, puncture holes are formed in the near-end disc surface and the far-end disc surface, and if atrial septal puncture is needed in the future, a puncture needle can penetrate through the puncture holes, so that interference of a metal framework of the occluder can be effectively avoided, and smooth atrial septal puncture operation in the future is facilitated; but the utility model has the disadvantages that: 1. the traditional disc-shaped non-fixed reticular structure woven by metal wires has the defects of high metal content, poor biocompatibility, poor radial supporting force and easy falling-off of the occluder, particularly, when the occluder is filled in a non-regular shape, such as a PFO occluder, the radial supporting force is more insufficient, secondly, the woven reticular structure reduces the endothelialization process, when secondary puncture surgery is carried out in the later period, part of the reticular structure of the occluder main body is highlighted, the surface path of the occluder is unsmooth, when a secondary puncture conveying system slides along the occluder main body, the through hole position is difficult to position, the blocking feeling can be generated, thirdly, the position of the through hole in the waist is wound by connecting wires, the connecting wires generate a collection connection point, a flow blocking film is covered on the occluder main body by a post-connection process of sewing, a suture occupies a certain space and volume, and the diameter of an adaptive conveying sheath tube can be increased, the suture process has the advantages that the suture connection strength is low, the suture connection is easy to loosen or break, or the knotting head is large, so that thrombus aggregation points are easy to cause, and the probability of thrombus formation is increased; 2. the developing points are arranged by winding a developing wire on a metal wire at the edge of the puncture hole and then spirally winding the developing wire on the surface of the re-developing wire through a suture line. And the developing silk is wrapped and finally knotted and fixed, so that the diameter of the conveying sheath pipe is increased.

Patent CN112932567A provides an occluder comprising: an occluder body having a through hole extending in an axial direction of the occluder body; and a flow blocking film disposed in the through-hole to partition and block the through-hole. Compared with the prior art, the occluder provided by the invention maintains the structure and working principle of the traditional occluder, ensures the safety and effectiveness of the occluder, and is provided with the totally-enclosed sheet-shaped flow-blocking membrane in the central through hole, so that the blood flow is blocked and the blood flow is easy to puncture and expand by utilizing the characteristics of the flow-blocking membrane, thereby easily puncturing and feeding the sheath from the central through hole of the occluder and reserving a channel for the subsequent atrial septal puncture interventional operation; however, the occluder main body provided by the invention is a disc-shaped traditional non-fixed reticular double-layer structure woven by nickel-titanium alloy, the metal content is high, the biocompatibility is poor, the radial supporting force is poor, the occluder is easy to fall off, especially when PFO occluders and the like need to be filled in a non-regular shape, the requirement on the radial supporting force is higher, even if a stacking structure of encryption weaving is adopted, the radial supporting force is insufficient, the process becomes more complicated, secondly, the endothelialization process is reduced by the woven grid structure, when secondary puncture surgery is carried out in the later period, the reticular structure of part of the occluder main body is highlighted, the surface path of the occluder is not smooth, when a secondary puncture conveying system slides along the occluder main body, the blockage feeling is generated, and thirdly, the position of a waist through hole is provided with connecting wire winding, the connecting wire is collected and connected, the flow-resisting membrane covers the main body of the occluder by a post-connection process of sewing, a suture line occupies a certain space and volume, the diameter of the adaptive conveying sheath tube can be increased, the sewing process either causes low sewing connection strength and easy loosening or breakage, or causes thrombus condensation points easily due to large knotting knots, so that the probability of thrombus formation is increased, and finally, the connecting filament of the invention is easy to block in the middle of the through hole, so that the flow-resisting membrane is difficult to ensure to completely cover the near-end disk surface and the far-end disk surface of the occluder.

Therefore, how to solve the problem of atrial septal defect and reduce postoperative complications in the operation process, avoiding some disadvantages brought by the intervention treatment operation of the traditional occluder, establishing a secondary channel for the later secondary operation and reserving the possibility of future atrial septal puncture becomes the problem to be solved urgently at present.

SUMMERY OF THE UTILITY MODEL

In view of the above and other, it is an object of the present invention to overcome the deficiencies of the prior art.

According to an embodiment in the aspect of the application of atrial septal defect treatment operation, the utility model discloses can provide a novel shutoff apparatus to structural heart disease and the patient that needs intervene the treatment, can solve and adopt some drawbacks that the operation of occluder treatment atrial septal defect brought in the intervention treatment operation process, for example, the good shutoff poor stability that leads to of occluder anchoring effect, even drop, perhaps the metal content of occluder causes damage or atrial isolation about the occluder shutoff back easily to human tissue, lost this important passageway scheduling problem of atrial septal when the secondary operation is carried out again in the later stage.

According to one aspect of the present invention, a novel occlusion device comprises a support body including a proximal disc, a distal disc, and a waist connecting the proximal disc and the distal disc; wherein, the support body is a wavy or latticed structure formed by fixedly connecting a plurality of elastic support rods, and the waist part is provided with a through hole which axially penetrates through; and the barrier body is flexible or elastic and comprises a barrier film, the through hole is covered or blocked by the barrier film, and the periphery of the barrier film is connected with the support body.

In one embodiment, the occlusion device can be used in procedures such as foramen ovale occlusion, atrial defect occlusion, patent ductus arteriosus, ventricular defect occlusion, and the like.

In one embodiment, the support body is at least partially or completely formed by integral laser engraving and heat setting; the barrier membrane is arranged in the through hole area of any one or more of the proximal disc, the distal disc and the waist part; the barrier film and the support body are connected in a partially or wholly non-sewing mode.

In one embodiment, the barrier membrane extends radially along the through-hole to the edge regions of the proximal and distal discs; alternatively, the barrier film extends axially along the through hole to part or all of the waist.

In one embodiment, the barrier membrane in the through hole is a filter membrane with micropores or a thin membrane with a non-porous structure, and the pore size of the micropores is 10-1000 μm; or the barrier membrane on the proximal disc or the distal disc is a filter membrane with micropores, the pore size of the micropores is 10-1000 microns, when the proximal disc, the distal disc and the waist of the plugging device are coated with membranes, the inner part of the plugging device is prevented from being in a completely closed state, and the micropores can assist endothelialization.

In one embodiment, the micropores facilitate the passage of water molecules and blood.

In one embodiment, the through-hole has a certain strength.

In one embodiment, the barrier film in the through hole is two filter films which are arranged at intervals and are parallel to each other, and the included angle α formed by the plane of the filter films and the central axis of the through hole satisfies α e [30 °, 90 ° ], as shown in fig. 5.

In one embodiment, the material of the barrier film comprises degradable material and non-degradable material; wherein, the degradable material comprises sodium alginate, hyaluronic acid, polylactic acid, polyglycolic acid, polyhydroxyalkanoate, polydioxanone and polycaprolactone, so that the barrier membrane is degraded after the endothelial tissue climbs and covers; the non-degradable material comprises polyester, polytetrafluoroethylene, polyurethane, polyamide, polyolefin and silica gel; when the material of the barrier film is a non-degradable material, the barrier film has a non-woven structure, so that the barrier film is easy to puncture.

In one embodiment, the barrier film is made of degradable material, and the degradation time can be adjusted by adjusting the molecular size, distribution amount and the like of the material, so that the barrier film is degraded after the inner skin tissue climbs and covers.

In one embodiment, the barrier film is made of a non-degradable material, which is a non-woven material, without warp and weft.

In one embodiment, the non-sewing means includes one or more of an adhesive coating, a thermal coating, a spray coating, a dip coating; and barrier film and the whole smooth transition structure that is of supporter, the supporter is wrapped up in wherein by the barrier film completely to when guaranteeing to carry out the secondary puncture operation, can prepare to look for the through-hole position, the location is accurate, can not produce the card and feel immediately.

In one embodiment, the barrier further comprises a filler having compression resiliency or swellability such that the through-hole can be filled after the occluding device is placed in the target tissue; the filler is connected with the support, or the filler is wrapped in the barrier film, the barrier film is provided with a plurality of micropores, and the pore size of the micropores is 100-1000 mu m.

In one embodiment, the filler is a hydrogel, and the gel is made of a degradable material.

In one embodiment, the filler can be placed pre-operatively, intra-operatively, post-operatively; when the filler is in a preoperative form, the filler can be a sponge material and can adsorb blood and water in the process of operation and after operation, wherein the sponge material can be a degradable material.

In one embodiment, the occlusion device is a smooth integrally covered stent, the stent is made of hard metal and has an unobstructed shape, and a secondary channel is easily established, so that a secondary delivery system can quickly and easily penetrate through a through hole of the pore-forming stent.

In one embodiment, the obstructing membrane can completely cover the proximal and distal faces of the support body.

In one embodiment, the support is a single layer mesh structure; the number of layers of the barrier film is at least one.

In one embodiment, the proximal disc is connected to the delivery system by a detachable connection; the detachable connecting structure comprises a release hole, a release ring and a bolt head which are positioned on the proximal disc, wherein the release ring is sequentially inserted into the release hole to form a closed loop and then is connected with the bolt head; and the detachable connecting structure is connected with the conveying system through the bolt head.

In one embodiment, the barrier film covers the outside of the proximal disc and/or the distal disc, as shown in fig. 2a and 3 a.

In another embodiment, the barrier film covers the outside and inside of the proximal disc and/or the distal disc, the barrier film covering the support.

In one embodiment, the edge area of the through hole is provided with a developing mark for displaying the outline of the through hole; the developing mark comprises a plurality of developing points, and the developing points are of polygonal multi-point structures.

In one embodiment, the material of the support body in the edge area of the through hole is a developing wire, and the developing wire is embedded into the support body and integrally formed with the support body to form a developing point; or the developer is coated or wrapped on the surface of the support body in the edge area of the through hole, so that the diameter of the conveying sheath is reduced.

In one embodiment, the developing wire may be gold, platinum or other materials with good developability under DSA.

Compared with the prior art, the utility model has the advantages of:

1. at present, the traditional occluder generally adopts a woven non-fixed grid structure, the metal content is high, the biocompatibility is poor, the radial supporting force is poor, the occluder is easy to fall off, particularly, when the occluder is required to be filled in a non-regular shape for PFO occluder and the like, the requirement on the radial supporting force is higher, even if a stacking structure of encrypted weaving is adopted, the radial supporting force is insufficient, the process becomes complicated, a barrier film is covered on a support body in a sewing way, sewing threads are easy to loosen or break, and a knotting way adopted by the traditional occluder is easy to generate thrombus condensation points; different from the prior art, in an embodiment of the present invention, the supporting body is a wavy or grid structure formed by fixedly connecting a plurality of elastic supporting rods, which makes the supporting body stable in structure, not only prevents the occluder from falling off from the target tissue region after being implanted, but also has low metal content and good biocompatibility, and prevents risks such as displacement and even falling off of the occluder from the target position region in the whole process of establishing a secondary operation channel in the through hole of the occluder by using puncture and other modes at any time after operation; the barrier has flexibility or elasticity, and the barrier includes the barrier film, and the barrier film covers or plugs up the through-hole, and the periphery and the supporter of barrier film are connected, the material of barrier film includes that the degradable material who is degraded after the endotheca tissue climbs to cover, the non-degradable material that has the non-woven structure for the very easy puncture of barrier film is passed through from the through-hole puncture easily of accessories such as seal wire, pipe that use in the follow-up conventional medical instrument operation of being convenient for, ensures the follow-up establishment of carrying out the operation passageway before the secondary operation.

2. Be different from prior art, the utility model discloses an in the embodiment, the supporter is at least partly or whole through integrative cutting, laser sculpture, heat setting and form, not only makes simple, the high efficiency of technology manufacturing, can also guarantee that the shutoff apparatus has powerful radial holding power, and barrier film and supporter are connected through part or whole non-sewing mode and are formed, reduce the relevant thrombus risk of occluder, have accelerateed endothelial process, have increased the joint strength of barrier film and supporter.

3. Different from the prior art, in an embodiment of the present invention, the barrier film radially extends to the edge regions of the proximal disc and the distal disc along the through hole; or the barrier film axially extends to part or all of the waist along the through hole, the fitness is good, the biocompatibility is increased, a hypertrophic and hyperplastic tissue cannot be formed between the double-net discs of the blocking instrument, and the simplicity and the feasibility of puncturing and feeding the sheath from the atrial septum blocking instrument are guaranteed.

4. Be different from prior art, the utility model discloses an in the embodiment, the through-hole has certain intensity, and the barrier film in the through-hole is one slice or the film that the multi-disc interval set up and be parallel to each other, and the plane at film place satisfies alpha epsilon [30, 90 degrees ] with the contained angle alpha that the axis of through-hole formed, can make the film place more easily when carrying the sheath intraductally, reduces and carries sheath pipe diameter, enlarges sick application scope.

5. Different from the prior art, in one embodiment of the utility model, the non-sewing mode comprises one or more of gluing film coating, hot film coating, spraying film coating and dip coating film coating; the barrier film and the support body are integrally in a smooth transition structure, and the support body is completely wrapped in the barrier film, so that guide instruments such as guide wires and the like can be guided into the through hole quickly and accurately during secondary operations, the phenomenon that a secondary operation conveying system generates blocking and stopping feeling on the surface of the support body is avoided, simplicity and rapidness are realized, the operation time is shortened, complications are avoided, and the establishment of a secondary operation channel in the through hole of the blocking instrument is finally ensured to be accurately and rapidly realized.

6. Different from the prior art, in one embodiment of the utility model, the near-end disc is connected with the conveying system through a detachable connecting structure; the detachable connecting structure comprises a release hole, a release ring and a bolt head which are positioned on the proximal disc, wherein the release ring is sequentially inserted into the release hole to form a closed loop and then is connected with the bolt head; in addition, the detachable connecting structure is connected with the conveying system through the bolt head, so that the safety and reliability of the release of the occluder are improved, the inner diameter of the conveying sheath can be reduced, and the ultrahigh safety of capturing and recovering the occluder after the occluder is released can be ensured.

7. Be different from prior art, the utility model discloses an in the embodiment, through-hole marginal region is equipped with the development mark for show the through-hole profile, when needs carry out the interatrial space secondary puncture operation, can guarantee that the position of accurate searching through-hole punctures, the location is accurate, effectively avoids metal framework, and the development point can be at the embedding supporter or on the supporter surface, has reduced the transport sheath pipe diameter, reduces the damage of going into the way.

8. Different from the prior art, in an embodiment of the utility model, the filler has compression resilience or swelling nature, makes after the plugging device is placed the target tissue, can fill the through-hole can realize the endothelialization of plugging device as early as possible.

Drawings

Fig. 1a to 1b are schematic views illustrating a connection state between a barrier film and a support according to an embodiment of the present invention.

Fig. 2a to 2c are schematic views of a connection state between the barrier film and the support body according to the second embodiment of the present invention.

Fig. 3a to 3c are schematic views of the connection state between the barrier film and the support body in the third embodiment of the present invention.

Fig. 4 is a schematic view of a connection state between the barrier film and the support body in the fourth embodiment of the present invention.

FIG. 5 is a schematic view of the embodiment of the present invention in which the internal resistance diaphragms are arranged in parallel and at intervals

Fig. 6a to 6b are schematic views illustrating a state in which the plugging device is connected to the conveying system through a detachable connection structure according to an embodiment of the present invention.

The names of the parts indicated by the numbers in the drawings are as follows:

11-proximal disc, 12-distal disc, 13-lumbar, 14-through hole, 2-barrier membrane, 3-detachable connection, 31-release hole, 32-release ring, 33-plug head, 4-delivery system.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples.

In the present invention, the term "proximal end" refers to the end close to the operator, and the term "distal end" refers to the end away from the operator.

The first embodiment is as follows:

in this embodiment, as shown in fig. 1a to 1b, the support body comprises a proximal disc 11, a distal disc 12, and a waist portion 13 connecting the proximal disc 11 and the distal disc 12; wherein, the support body is a wavy or latticed structure formed by fixedly connecting a plurality of elastic support rods, and the waist part 13 is provided with a through hole 14 which axially penetrates through; and the barrier body is flexible or elastic and comprises a barrier film 2, the through hole 14 is covered or blocked by the barrier film 2, and the periphery of the barrier film 2 is connected with the support body.

In this embodiment, the support body is formed by integral laser engraving and heat setting.

In this embodiment, the barrier film 2 is only provided in the region of the through-hole 14 of the distal disc 12, as shown in fig. 1 b.

In this embodiment, the barrier film 2 and the support are connected to each other partially or entirely without sewing.

In this embodiment, the barrier film 2 in the through hole 14 is a filter film with micropores having a pore size of 10-1000 μm or a thin film with a non-porous structure, and the micropores facilitate the passage of water molecules and blood.

In this embodiment, the number of layers of the barrier film 2 is one.

In this embodiment, the barrier film 2 is made of degradable materials, and the degradable materials include sodium alginate, hyaluronic acid, polylactic acid, polyglycolic acid, polyhydroxyalkanoate, polydioxanone, and polycaprolactone, so that the barrier film 2 is degraded after being covered by the endothelial tissue.

In this embodiment, the non-sewing manner includes one of an adhesive coating film, a hot coating film, a spray coating film, and a dip coating film; and the whole of the barrier film 2 and the support body is in a smooth transition structure.

In this embodiment, the support is completely wrapped by the barrier film 2.

In this embodiment, the barrier further comprises a filler having resilience to compression or swelling such that the blocking device fills the through-hole 14 after being placed in the target tissue; the filler is connected with the support body.

In this embodiment, the proximal disc 11 is connected to the delivery system 4 by a detachable connection 3; the detachable connecting structure 3 comprises a release hole 31, a release ring 32 and a bolt head 33 which are positioned on the proximal disc, wherein the release ring 32 is sequentially inserted into the release hole 31 to form a closed loop and then is connected with the bolt head 33; the detachable connection 3 is also connected to the transport system 4 by means of a plug 33, as shown in fig. 6a to 6 b.

In this embodiment, the edge area of the through hole 14 is provided with a developing mark for displaying the outline of the through hole; the developing mark comprises a plurality of developing points, and the developing points are of polygonal multi-point structures.

In this embodiment, the material of the support body in the edge region of the through hole 14 is a developing wire, and the developing wire is embedded in the support body and integrally formed with the support body to form a developing point.

Example two:

the difference from the first embodiment is that:

in this embodiment, as shown in fig. 2a to 2c, the barrier film 2 is disposed in the region of the through hole 14 of the distal disc 12, extending radially along the through hole 14 to the edge region of the distal disc 12.

In this embodiment, the barrier film 2 in the through hole 14 is a filter film with micropores or a thin film with a non-porous structure, and the pore size of the micropores is 10-1000 μm.

In this embodiment, the barrier membrane 2 on the distal disc 12 is a filter membrane with micropores having a pore size of 10-1000 μm.

In this embodiment, the developing wire may be gold, platinum or other materials with good developing property under DSA.

Example three:

the difference from the first embodiment is that:

in this embodiment, as shown in fig. 3a to 3c, the barrier film 2 is provided in the area of the through-holes 14 of the proximal disc 11 and the distal disc 12.

In this embodiment, the barrier film 2 extends radially along the through hole 14 to the edge area of the proximal disc 11, said distal disc 12.

In this embodiment, the barrier membrane 2 on the proximal disc 11 and the distal disc 12 is a filter membrane with micropores having a pore size of 10-1000 μm.

Example four:

the difference from the third embodiment is that:

in this embodiment, as shown in fig. 4, the barrier film 2 is provided in the area of the through-holes 14 of the proximal disc 11 and the distal disc 12.

In this embodiment, the barrier film 2 may extend axially along the through hole 14 to the entire waist portion 13.

In this embodiment, the barrier film 2 is a filter film having micropores with a pore size of 50 to 2000 μm.

The above description is only an exemplary embodiment of the present invention, and for those skilled in the art, there may be variations in the specific embodiments and applications according to the spirit of the present invention, and the content of the description should not be construed as a limitation to the present invention.

Claims

1. A novel occlusion device, comprising:

a support body comprising a proximal disc, a distal disc, a waist connecting the proximal disc and the distal disc; the support body is of a wavy or latticed structure formed by fixedly connecting a plurality of elastic support rods, and the waist part is provided with a through hole which penetrates through the waist part in the axial direction; and

the barrier body, the barrier body has flexibility or elasticity, the barrier body includes the barrier film, the barrier film covers or blocks up the through-hole, the periphery of barrier film with the supporter is connected.

2. The novel occlusion device of claim 1, wherein: the support body is formed by at least partially or completely carrying out integrated laser engraving and heat setting; the barrier membrane is disposed in the through-hole region of any one or more of the proximal disc, the distal disc, the waist; the barrier film and the support body are connected in a partial or whole non-sewing mode.

3. The novel occlusion device of claim 2, wherein: the barrier film can extend along the through hole to the edge areas of the proximal disc and the distal disc in the radial direction; alternatively, the barrier film extends axially along the through hole to part or all of the waist.

4. The novel occlusion device of claim 3, wherein: the barrier film in the through hole is a filter film with micropores or a thin film with a non-porous structure, and the pore size of the micropores is 10-1000 mu m; or the barrier membrane on the proximal disc or the distal disc is a filter membrane with micropores, and the pore size of the micropores is 10-1000 μm.

5. The novel occlusion device of claim 4, wherein: the barrier film in the through hole is one or more films and/or filter films which are arranged at intervals and are parallel to each other, and an included angle alpha formed by the plane where the films and/or filter films are located and the central axis of the through hole satisfies the following conditions: alpha e [30 degrees, 90 degrees ].

6. The novel occlusion device of claim 1, wherein: the material of the barrier film comprises degradable material or non-degradable material; wherein the content of the first and second substances,

when the material of the barrier film is a non-degradable material, the barrier film has a non-woven structure, so that the barrier film is easy to puncture.

7. The novel occlusion device of claim 2, wherein: the non-sewing mode comprises one or more of an adhesive coating film, a hot coating film, a spraying coating film and a dip coating film; and is

The barrier film and the support body are integrally in a smooth transition structure, and the support body is completely wrapped by the barrier film.

8. The novel occlusion device of any of claims 1-7, wherein: the barrier further comprises a filler having compression resilience or swellability such that the obturator instrument can fill the through-hole after placement in a target tissue;

the filler is connected with the support body, or

The filler is wrapped in the barrier film, the barrier film is provided with a plurality of micropores, the pore size of the micropores is 100-1000 mu m, and the micropores are convenient for water molecules and blood to pass through.

9. The novel occlusion device of claim 1, wherein: the proximal disc is connected with the conveying system through a detachable connecting structure; wherein the content of the first and second substances,

the detachable connecting structure comprises a release hole, a release ring and a bolt head which are positioned on the proximal disc, and the release ring is sequentially inserted into the release hole to form a closed loop and then is connected with the bolt head; and the detachable connecting structure is connected with the conveying system through the bolt head.

10. The novel occlusion device of claim 1, wherein: the edge area of the through hole is provided with a developing mark for displaying the outline of the through hole; wherein the development mark comprises a plurality of development points, and the development points are in a polygonal multi-point structure; or the material of the support body in the edge area of the through hole is a developing wire, and the developing wire is embedded into the support body and integrally formed with the support body to form the developing point; alternatively, the surface of the support in the edge region of the through-hole is coated or wrapped with a developer.