CN106691521B

CN106691521B - Plugging device

Info

Publication number: CN106691521B
Application number: CN201710068551.5A
Authority: CN
Inventors: 李彪; 葛均波; 周达新; 叶金华; 沈雳
Original assignee: Ningbo Diochange Medical Technology Co Ltd
Current assignee: Ningbo Diochange Medical Technology Co Ltd
Priority date: 2017-02-08
Filing date: 2017-02-08
Publication date: 2023-08-04
Anticipated expiration: 2037-02-08
Also published as: CN106691521A

Abstract

The invention relates to an occluder comprising at least one occlusion disc; the plugging disc comprises two central end parts and two plugging surfaces, wherein one plugging surface is formed by a plurality of main rods which are directly diverged from the central end parts to the edge direction of the plugging surfaces, the other plugging surface is connected with the plugging surfaces through connecting rods, each connecting rod is formed by two or more sub rods which are separated from each main rod, the two or more sub rods are respectively combined with the sub rods which are separated from the adjacent main rods to form the main rods of the other plugging surface, the main rods converge towards the central end parts of the other plugging surfaces, the two plugging surfaces have the same structure, and the connecting rods are provided with bending sections, so that the two plugging surfaces can be attached, and at least one plugging surface of the two plugging surfaces is coated with a film. The invention solves a series of problems caused by the fact that the prior art adopts a traditional structure of alternately weaving up and down and can not realize film covering; the membrane is easy to cover, the plugging is complete, the shape of the compressed body is smaller, the anatomical form adaptability is better, and the preparation is convenient.

Description

Plugging device

Technical Field

The invention relates to the field of percutaneous medical equipment, in particular to an occluder which is transmitted into a human body and/or an animal body by a sheath tube conveying technology through an interventional method and is used for occluding defect openings, tissue lacerations, inner cavities, organ channels and the like.

Background

Interventional procedures are emerging therapeutic approaches between surgical and medical treatments, including endovascular interventions and non-vascular interventional procedures. Over 30 years of development, it has now been known as the three major supportive disciplines along with surgery and internal medicine. In simple terms, the interventional therapy is a minimally invasive treatment method for locally treating the focus under the guidance of image equipment (angiography, fluoroscopy, CT, MR, B-ultrasonic and the like) by making a micro-channel with a diameter of a few millimeters on blood vessels and skin or through an original pipeline of a human body under the condition of exposing the focus without opening the operation. The interventional therapy has the advantages of small wound, simplicity, safety, effectiveness, less complications, obvious reduction of hospitalization time and the like.

As an implant for interventional therapy, the occluder may be used to occlude defect openings, or tissue lacerations, lumens, organ passages in the human and/or animal body. For example, congenital heart disease treatments, including atrial septal defects (as shown in fig. 1), ventricular septal defects, patent arterial sheath defects, and the like, have been widely used in clinic, and the main principle thereof is to block "holes" in the left and right atria, between the left and right ventricles, and between the aorta and the pulmonary artery. As another example, in recent years, they have been developed for the treatment of structural heart diseases, including the inner cavities of the left atrial appendage, the mouth or the interior of the organ passages, such as placing occluders in the left atrial appendage to block blood flow into the left atrial appendage, to eliminate the risk of thrombus formation in the left atrial appendage due to atrial fibrillation, and to prevent stroke.

However, the access route through which the occluder is delivered to a defect opening, or tissue breach, lumen, organ passage in the human and/or animal body by interventional procedures, including the human arteriovenous and/or heart, is too tortuous, requires a sheath of very small outer diameter and flexibility, and at the same time requires that the occluder can be easily introduced into and released from the sheath, and therefore should have the property of having a small profile after compression. In addition, the occluder should be capable of accurately reaching the predetermined position and completely and effectively occluding the defect opening, the inner cavity and the organ channel, which requires that the occluder has good mechanical requirements and blood flow force requirements, and the structure of the occluder must be reasonably designed.

In the prior art, the basic structure of the plugging device is a self-expanding double-disc or mushroom-shaped structure formed by alternately and densely weaving superelastic nickel-titanium alloy wires from top to bottom so as to form a bracket main body, and the inside of the bracket main body is filled with a film made of polyester or polytetrafluoroethylene and the like for blocking blood from flowing into or flowing out of a defect opening, or a tissue breach, an inner cavity and an organ channel. Such as atrial septal defects-like occluders, left atrial appendage-like occluders, which are positioned in the heart anatomy as shown in fig. 2 and 3. It has the advantage of simple structure, but has a plurality of disadvantages including

(1) The plugging device adopts a traditional vertically alternate weaving structure, which results in:

a. the compression length of the plugging disc of the plugging device after being compressed into the sheath is far longer than the length of the plugging disc in a natural state after being released from the sheath, and the reversible deformation of the membrane is limited, so that the design of a covering membrane (the membranes and the wires in all areas are fixedly connected) cannot be adopted;

b. when the plugging disc is placed in a defect opening, an inner cavity and an organ channel, the wires are mutually involved, so that the plugging disc is difficult to adapt to the rugged shape of the mouth part, as shown in fig. 4a and 4b, a gap area is formed (as shown by a reference numeral 6), a target part cannot be completely plugged, residual shunt exists after operation, as shown in fig. 2 and 3, and the phenomenon is frequently found clinically at present.

(2) The existing plugging device can be connected only by placing a membrane inside the bracket main body and suturing the membrane through simple points, which results in:

a. the relative positions between the membrane and the filaments of the plugging disc are not fixed except the edges of the membrane, after the plugging disc is compressed into the conveying sheath tube, the membrane is arranged in the sheath tube in disorder to cause larger gaps, so that the shape (profile) of the plugging device after compression is larger, and the diameter of the sheath tube is larger, such as a left atrial appendage type plugging device, and the minimum sheath tube which can be adapted at present is 8-10F; the requirements on blood vessels and blood vessel access ways are still high, namely, the current occluder has certain adaptation limitation;

b. although the membrane and the stent main body are connected in a sewing mode, the upper and lower alternate weaving structures can not enable the membrane and the stent to be fixed firmly, the membrane can slide relative to the wire of the stent main body when the sheath tube is in and out, even the suture line is broken to cause the membrane to shrink into a group, the phenomenon of incomplete membrane expansion can occur when the occluder is released, the occlusion is incomplete, and residual flow distribution exists;

c. the positions of the wires of the plugging disc are not relatively fixed, so that after the plugging device is implanted, the wires are easy to rub with each other along with the beating of the heart and continuous impact of blood, and the high risk of long-term fatigue fracture of the wires is caused;

d. the series of operations such as placing the membrane into the inside of the stent body, spreading the membrane into a disc shape in the inside of the stent body, and finally sewing and connecting the membrane in the stent body with the filaments at the circumferential edge of the body are difficult through the very narrow operation channel of the formed stent body with the woven structure alternately inserted up and down (as shown in fig. 4 a);

e. the adopted membrane is basically a non-woven fabric of polyester or polytetrafluoroethylene, and although the non-woven fabric has good biocompatibility and is soft, the non-woven fabric is not suitable for suturing, the membrane is very easy to separate from the plugging device or tear, so that the membrane cannot be plugged effectively, and the previous experiment and use have been verified;

f. the membrane is arranged in the plugging disc, nickel-titanium alloy wires of the plugging disc are in direct contact with blood and the like, so that nickel ions are separated out, and finally the risk of toxicity, sensitization and teratogenicity is caused, and the biocompatibility is poor; complications such as thrombosis on the surface of the occlusion disk are also likely to occur.

(3) The number of filaments used for weaving the plugging disc is high at present, such as 32 pairs and 64 pairs, which results in:

a. the metal coverage rate is high, and the risk of toxicity, sensitization and teratogenicity caused by nickel ion precipitation is high;

b. the overall body shape of the plugging device is larger after the plugging device is compressed, so that the diameter of the sheath tube is larger, namely, the current plugging device still has certain adaptation limitation.

Disclosure of Invention

The invention aims to solve a series of problems caused by the fact that a traditional up-down alternate weaving structure is adopted in the prior art, and provides the plugging device which is easy to be covered, complete in plugging, smaller in shape after compression and better in anatomical form adaptability.

The invention aims at realizing the following technical scheme:

an occluder comprising at least one occlusion disc; the plugging disc comprises two central end parts and two plugging surfaces, wherein one plugging surface is formed by a plurality of main rods which are directly diverged from the central end parts to the edge direction of the plugging surface, the other plugging surface is connected with the plugging surface through a connecting rod, the connecting rod is formed by two or more sub rods which are separated from each main rod, the two or more sub rods are respectively combined with the sub rods which are separated from the adjacent main rods to form the main rod of the other plugging surface, the main rods converge towards the central end parts of the other plugging surface, the two plugging surfaces have the same structure, and a bending section is arranged on the connecting rod, so that the two plugging surfaces can be attached, and at least one plugging surface of the two plugging surfaces is coated with a film.

The aim of the invention is further achieved by the following preferred technical scheme:

preferably, fixed connection structures are respectively arranged between the adjacent main rods.

Preferably, each main rod on the plugging surface is composed of a plurality of sub rods, and the sub rods are respectively combined together through fixing pieces, or the sub rods are respectively woven with each other.

Preferably, each main rod is respectively provided with a wire hole, and the serial wires enable the plurality of main rods to be connected in series into a whole through the wire holes.

Preferably, each main rod on the plugging surface is composed of a plurality of sub rods, a part of the plurality of sub rods is split to form a connecting rod, the connecting rod is combined with sub rods separated from adjacent main rods to form a main rod of the plugging surface, and a bending section is arranged on the connecting rod; and the other parts of the plurality of sub-rods continue to extend and are respectively connected with the plurality of continuously extending sub-rods separated from the adjacent main rods to form the extension parts of the plugging surfaces.

Preferably, the blocking surface is a plane, or a curved surface with a concave middle part, or the edge of the blocking surface is bent towards the other blocking surface.

Preferably, the blocking surface is encapsulated within a membrane.

Preferably, the main rod of the blocking surface is fixed to the membrane in a penetrating manner.

More preferably, the main rod or the sub rod is made of nickel-titanium alloy, cobalt-chromium alloy, stainless steel, metal materials such as titanium, tantalum, platinum, iridium, tungsten, gold, magnesium, zinc and alloys thereof, or polymer materials such as polyamide, polyether block amide, polyimide, polyurethane, polyketone, polyolefin and the like.

More preferably, the membrane is made of polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane, polyamide, silica gel, polyolefin, or degradable material such as polylactic acid, polyvinyl alcohol, or the membrane is selected from animal tissue.

Preferably, the central end is detachably connected with the push rod.

Compared with the prior art, the invention has the beneficial effects that:

1. the plugging surface structure formed by directly diverging the plurality of main rods arranged in the plugging device from the central end part to the edge direction of the plugging surface ensures that the compression length of the plugging surface of the plugging disc of the plugging device after the plugging surface is compressed into the conveying sheath tube is equal to the length of the plugging surface in a natural state after the plugging surface is released from the conveying sheath tube, so that the film coating on the plugging surface is finally realized, the problem that the film coating cannot be realized in the prior art is avoided, and a series of problems caused by connecting the film with a bracket main body by simply stitching a plurality of points are solved by placing the film inside the woven net of the plugging device. In addition, the positions between the main rods on the plugging surface are basically unlimited, and the movement is relatively independent, so that the serial production operations such as film coating and the like can be easily carried out by a producer, and the production is convenient; the shape of the wall of the rugged defect opening area can be adapted, a gap area is avoided from being formed between the plugging disc of the traditional plugging device and the partition wall of the defect opening area, the anatomical form adaptability of the plugging disc is greatly improved, and the plugging effect is enhanced.

2. The sealing surface can be coated in the membrane, or the main rod of the sealing surface is inserted on the membrane, so that the invention has the advantages that: the relative positions of the plurality of main rods and the membrane in the plugging surface are fixed, the membrane is orderly arranged in the sheath tube to realize tight filling after the plugging surface is compressed and enters the delivery sheath tube, the compressed body shape of the plugging surface is reduced, the minimum diameter of the used delivery sheath tube is reduced, the requirement on an operation access is reduced, and the application range of the plugging device is enlarged; after the occluder is placed at a target position, the occluder is in direct contact with blood and other large areas or is in complete contact with a membrane with excellent biocompatibility, so that the risk that nickel ions are separated out and finally toxicity, sensitization and teratogenicity are caused by the direct contact of nickel-titanium alloy wires of the traditional occluder and blood and the like, and thrombus formation on the surface of the occluder is avoided, and the occluding surface is completely wrapped in the membrane, so that the risk can be avoided; the friction coefficient of the film of the high polymer material is lower than that of metal materials such as nickel-titanium alloy, and the friction resistance is reduced in the process of releasing or recovering the occluder from the delivery sheath, so that the operation hand feeling of an operator is better.

3. The first plugging surface in the plugging device can be provided with the fixed connection structure, so that all main rods of the first plugging surface are kept rotationally symmetrical on a central shaft at the central end part in the process of recycling or releasing the plugging device and after the plugging device is released to a target position, for example, in the repeated recycling process, after the first plugging surface is compressed into a conveying sheath tube, the films are further orderly arranged in the sheath tube to be further and tightly filled, thereby further reducing the compressed post body shape of the first plugging surface, furthest reducing the diameter of the conveying sheath tube, further reducing the requirement on an operation access way and expanding the application range of the plugging device; and the roundness of the plugging device is improved.

4. The plugging surface can be a plane, or a curved surface with a concave center, or a curved surface with any shape such as the edge of the plugging surface is bent towards the other plugging surface, the anatomical form adaptability of the plugging device to the target position can be adjusted to be optimal, and the plugging effect is further enhanced.

5. The plugging surface can be provided with the extension part, so that the plugging area of the plugging surface is enlarged, and the plugging effect is further enhanced.

Drawings

FIG. 1 is a schematic illustration of the location of atrial septal defects and left atrial appendage in the heart anatomy;

FIG. 2 is a schematic representation of the morphology of a atrial septal defect type occluder of the prior art in the heart;

FIG. 3 is a schematic representation of the morphology of a left atrial appendage occlusion device of the prior art in the heart;

fig. 4a-4b are block diagrams of the sealing surface of a prior art stopper, wherein fig. 4a is a left side view of fig. 4 b; FIG. 4b is a side view of the occlusion disk;

FIGS. 5a-5b are schematic views of an uncoated construction of a first embodiment of an occluder of the present invention, wherein FIG. 5a is a left side view of FIG. 5b and FIG. 5b shows a cross-sectional view along the central-end axis;

FIGS. 6a-6c are block diagrams of a first embodiment of the occluding device of the present invention after a sealing surface is coated, wherein FIG. 6a is a left side view of FIG. 6b, FIG. 6b is a cross-sectional view showing the axial center along the central end, and FIG. 6c is a cross-sectional view A-A of FIG. 6 b;

FIGS. 7a-7b are schematic views of the construction of a second embodiment of the occluding device of the present invention after the occluding surface has been coated, wherein FIG. 7a is a left side view of FIG. 7b and FIG. 7b shows a cross-sectional view taken along the axis of the central end portion;

fig. 8a-8b are schematic structural views of a third embodiment of the occluder of the present invention, wherein fig. 8a is a left-hand view of fig. 8b showing the structure of the occluding surface and a portion of the connecting rod (curved section) without the coating, and fig. 8b is a cross-sectional view of the occluder after coating along the central axis of its central end;

fig. 9a-9d are schematic structural views of a fourth embodiment of the occluder of the present invention, wherein fig. 9a and 9b are left side views of fig. 9c showing only the non-covered occluding surface structure and a portion of the connecting rod (curved section), fig. 9c is a cross-sectional view of the occluder after covering along the center of its central end portion, and fig. 9d is a left side view of fig. 9c showing only the non-covered occluding surface structure, a portion of the connecting rod (curved section), and another fixed connection structure.

Wherein 1 is an occluder, 3 is a defect opening, 4 is a left atrium, 5 is a right atrium, 6 is a void area, 7 is an inner cavity, 10 is an occluding disk, 11 is an anchor frame, 40 is a left atrial inner wall at a left atrial appendage opening area, 41 is a left atrial appendage inner wall, 42 is a left atrial appendage, 50 is a atrial septum wall at a defect opening area, 100 is a central end, 100' is a central end, 101 is an occluding surface, 101' is an occluding surface, 102 is a membrane, 103 is a connecting rod, 104 is an extension, 1001 is a connecting nut, 1010 is a main rod, 1010' is a main rod, 1011 is a sub rod, 1012 is a fixing member, 1013 is a serial line, 1014 is a line hole, 1015 is a fixed connection structure, 1016 is a fixed line, 1031 is a curved section.

Detailed Description

The present invention will be further described in detail with reference to the accompanying drawings, which are incorporated in and constitute a part of this specification, for the purpose of making the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.

Embodiment one:

the occluder of the first embodiment of the present invention can be used for occlusion of defect openings such as atrial septal defects, ventricular septal defects, and tissue lacerations of blood vessels and the like.

As shown in fig. 5a-5b and fig. 6a-6c, the stopper comprises two stopper discs 10, wherein any one stopper disc 10 comprises two central end portions 100 and 100', two stopper faces 101 and 101', one stopper face 101 is formed by a plurality of main bars 1010 which diverge directly from the central end portion 100 toward the edge direction of the stopper face, the other stopper face 101 'is connected to the stopper face 101 through a connecting bar 103, the connecting bar 103 is formed by two or more sub-bars 1011 which are branched from each of the main bars 1010, the two or more sub-bars 1011 are respectively combined with sub-bars 1011 which are branched from an adjacent main bar 1010 to form a main bar 1010' of the other stopper face 101', the main bars 1010' converge toward the central end portion 100 'of the other stopper face 101' so that the two stopper faces have the same structure, and a curved section 1031 is provided on the connecting bar 103 so that the two stopper faces can be adhered, at least one of the two stopper faces is covered with a film.

In this configuration, the design of the plurality of stems 1010 and 1010' diverges directly from the central ends 100 and 100' toward the edges of the plugging surface to form plugging surfaces 101 and 101', respectively, has several advantages: 1. the compression length of the sealing surfaces 101 and 101 'of the sealing disc 10 after being compressed into the conveying sheath is just equal to the length of the sealing surfaces in a natural state after the sealing surfaces are released from the conveying sheath, so that the film covering on the whole sealing surfaces 101 and/or 101' is possible, a series of problems caused by the fact that the film covering cannot be realized in the prior art, the film is placed in the woven net of the sealing device, and the film is connected with the bracket main body through simple several-point stitching are avoided; 2. the positions between the main rods 1010 and between the main rods 1010 'on the plugging surfaces 101 and 101' are basically not limited, and the movement is relatively independent, so that the two plugging surfaces 101 and 101 'are not only suitable for the shape of the partition wall of the rugged defect opening area, but also avoid the formation of a gap area 6 (shown in fig. 2) between the plugging disc of the traditional plugging device and the partition wall 50 of the defect opening area, greatly improve the anatomical adaptability of the plugging disc 10, enhance the plugging effect, and facilitate the production and manufacture of a series of laminated films by a producer easily, including placing soft films into the interior of the plugging disc 10 through the huge gaps between the main rods 1010 or between the main rods 1010', spreading the films inside the films, and finally stitching or other connecting the films inside the films and the main rods 1011, etc., so that the manufacture is convenient.

In one embodiment, the curved sections 1031 may be provided on a portion of the connecting rod 103, or the curved sections 1031 may be provided on the entire connecting rod 103. The design of the bending section 1031 enables the whole process of compressing the plugging surface 101 of the plugging disc 10 into the conveying sheath tube or releasing the plugging surface from the conveying sheath tube to be smooth and smooth, and avoids poor operation hand feeling caused by larger operation resistance of operators in the whole process; in addition, by providing different angles of the curved sections (i.e., degree of curvature) the two sealing surfaces 101 and 101 'can be brought into abutment in the free state, reducing the thickness therebetween, so that one sealing surface 101 along with the other sealing surface 101' will be brought into closer abutment with the septum wall 50 in the area of the defect opening after release of the occluding device, further enhancing the sealing effect.

The main shafts 1010, 1010', or the sub-shafts 1011 of the plugging disk 10 are made of a shape memory material selected from a metal material having a shape memory function such as nickel-titanium (NiTi) alloy, cobalt-chromium (CoCr) alloy, or other metal materials such as stainless steel, titanium, tantalum, platinum, tungsten, gold, magnesium, zinc, and alloys thereof, or a polymer material such as polyamide, polyether block amide, polyimide, polyurethane, polyketone, polyolefin, and the like. As shown in fig. 5a, the plugging disc 10 may be formed by combining a plurality of nickel-titanium alloy wires as sub-rods 1011 by preliminary heat treatment in a two-to-two winding and braiding manner to form an intertwined and braiding structure, such that the relative positions of the plurality of sub-rods 1011 are fixed and form a plurality of main rods 1010 of one plugging surface 101, while the plurality of sub-rods 1011 continue to extend in the circumferential direction of the plugging surface 101, are respectively combined with sub-rods 1011 separated from adjacent main rods 1010 and combined by preliminary heat treatment in an intertwined and braiding manner to form an intertwined and braiding structure, to form a main rod 1010 'of the other plugging surface 101', the plurality of main rods 1010 'are converged toward the central end 100', and finally the connecting rod 103 and the plugging surface are shaped into a desired shape by heat treatment with a final shaping mold, such that the two plugging surfaces have the same structure.

The two sides of the sealing surface 101 of the first embodiment are covered with a membrane 102, and the membrane 102 functions to prevent blood from flowing into or out of the defect opening and the tissue rupture of blood vessels, etc. Suitable materials for the membrane 102 of the occluding surface 101 of the occluding disc 10 include polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane elastomer, polyamide, silicone, polyolefin, degradable materials such as polylactic acid, polyvinyl alcohol, and animal tissue, etc. The membrane 102 completely encloses the stem 1010 or stem 1011 within the plugging surface 101, as shown in fig. 6b, which has a number of advantages: 1. the relative positions of the plurality of main rods 1010 or the plurality of sub rods 1011 and the membrane 102 in the plugging surface 101 are fixed, after the plugging surface 101 is compressed into the conveying sheath, the membrane is orderly arranged in the sheath to realize tight filling, but not the larger gaps caused by disorder of the membrane of the traditional plugging device, so that the size of the plugging surface 101 of the plugging disc 10 of the plugging device after compression is reduced, the diameter of the conveying sheath used is reduced, the requirement on an operation access is reduced, and the application range of the plugging device is enlarged; 2. because the biocompatibility of the membrane is excellent, the membrane is in direct contact with blood and the like after the occluder is placed at a target position, so that the phenomena that nickel ions are separated out and finally cause toxicity, sensitization and teratogenicity due to the direct contact of a nickel-titanium alloy wire of the system occluder with blood and the like and the occurrence of thrombus formation on the surface of the occluder are avoided; 3. the friction coefficient of the film of the high polymer material is lower than that of metal materials such as nickel-titanium alloy, and the friction resistance is reduced in the process of releasing or recovering the occluder from the delivery sheath, so that the operation hand feeling of an operator is better.

The two sides of the connecting rod 103 adjacent to the edge of the sealing surface 101, as shown in the area I of fig. 6b, may also be covered with a membrane 102, where two or more sub-rods 1011 separated from each main rod 1010 of the sealing surface 101 are used as the connecting rod 103, and this design makes each main rod 1010 and two sub-rods 1011 separated from each main rod form a Y shape, so after the membrane is covered, the edge of the membrane 102 is firmly fixed to the sealing surface 101, so that there is no connection force between the membrane made of a polymer material and the sealing surface 101 made of a metal material such as nitinol, friction exists between the membrane and the inner wall of the delivery sheath during the release process of the stopper after repeated recovery, and the continuous impact of blood on the membrane after the stopper is released to the target position causes the membrane to slide towards the central end 100 relative to the main rod 1010 of the sealing surface 101, and the membrane contracts towards the central end 100 along the main rod 1010 of the sealing surface 101, and finally the membrane 102 is not fully sealed.

If a membrane having a microporous structure, such as expanded polytetrafluoroethylene (ePTFE), is selected, the membranes 102 on both sides of the sealing surface 101 or 101' may be fused together by means of sintering by heating, hot melting, or the like, and then covered. The connection between the films may also be accomplished by the addition of adhesives including, but not limited to, polyurethane (TPU) solutions, fluorinated ethylene propylene copolymer (FEP) emulsions, glue loctite3011, 3321, 3493, 3494, 3751, 4011, 4013, EA M-31CL; glue Dymax203a-cth-f, 204-cth-f, 1201-m-sc, 1128a-m; glue NuSil MED-2000P; glue Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE, TYPE a. Of course, the plugging surface 101 or 101' may be coated with polyurethane (TPU) or the like by dip coating or spray coating, or the like, to finally complete the coating. In addition, the membrane and the membrane can be connected together by sewing with a suture, wherein the suture can be non-absorbable suture such as polypropylene, polyamide, polyester, ultra-high molecular weight polyethylene, polytetrafluoroethylene and the like, or absorbable suture such as sheep intestine tissue, polylactic acid, polyglycolic acid and the like.

In one embodiment, the central end 100 may be provided with a connection nut 1001 having an internal thread structure, the connection nut 1001 is detachably connected with a push rod in the delivery system, the push rod is rotated to release the plugging device at the defect opening of the target, and other structures such as a buckle may be provided on the central end 100 to realize the detachable connection with the push rod.

Embodiment two:

as shown in fig. 7a-7b, the second embodiment differs from the first embodiment in that the plugging surface 101 of any one of the plugging trays 10 has a plurality of sub-stems 1011 of the main stems 1010 substantially parallel to each other, and the main stems 1010 are interposed over the film 102. The design ensures that the relative positions of the membrane 102 and the main rod 1010 are further fixed, after the sealing surface 101 is compressed into the delivery sheath, the membrane is orderly arranged in the sheath to realize tight filling, but the disorder of the membrane of the traditional plugging device leads to larger gaps. The plurality of sub-stems 1011 of each main stem 1010 are brought together at a partial region, such as at the edge of the plugging face 101, by fasteners 1012 such that the relative positions of the plurality of sub-stems 1011 on the first plugging face 101 are fixed. The fixing member 1012 may be made of commonly used medical materials, including nickel-titanium (NiTi) alloy, cobalt-chromium (CoCr) alloy, 316L stainless steel, 304 stainless steel, and high polymer materials such as Polyamide (PA), polyether block amide (Pebax), polyurethane (TPU), and the like, and the effect of development can be enhanced by adding materials with development function, such as metals including titanium, tantalum, platinum, iridium, tungsten, gold, and the like, and alloys thereof, and compounds such as barium sulfate, bismuth oxide, and the like, so as to enhance visualization in the operation process and facilitate observation of the final form of the sealing surface 101 of the sealing disc 10 of the postoperative sealing device 1. At the periphery of the fixing piece 1012, fixing wires 1016 can be introduced to further fix the relative positions of the plurality of sub rods 1011 and the membranes of each main rod 1010, so that friction between the membranes and the inner wall of the delivery sheath in the repeated recovery process of the occluder is avoided, no connection force exists between the membranes of high polymer materials and the blocking surface 101 of metal materials such as nickel-titanium alloy and the like basically, friction exists between the membranes and the inner wall of the delivery sheath in the release process of the occluder after the repeated recovery, and continuous impact of blood on the membranes after the occluder is released to the target position can cause the membranes to slide towards the central end 100 relative to the main rods 1010 of the blocking surface 101, the membranes shrink towards the central end 100 along the main rods 1010 of the blocking surface 101, and finally the membranes 102 are blocked incompletely.

Embodiment III:

the occluder of the third embodiment of the present invention can be used for occluding lumens, organ passages, such as patent arterial ducts, left atrial appendage, etc.

As shown in fig. 8a-8b, the first embodiment is based on a third embodiment, which differs from the first embodiment in that the stopper comprises a stopper disc 10 and an anchor frame 11. The anchoring frame 11 is placed inside the lumen or organ channel and functions as a fixation stopper. The main rod 1010 of the plugging surface 101 is provided with a wire hole 1014, or a gap between the sub rods 1011 with a intertwining braiding structure is utilized to form a wire hole, the serial wire 1013 connects the plurality of main rods 1010 in series through the wire hole 1014 as shown in fig. 8a, and one plugging surface 101 is wrapped in the membrane 102, as shown in fig. 8b, the design ensures that the membranes 102 on both sides of the plugging surface 101 are firmly fixed with the plugging surface 101, so that the membrane 102 is not basically connected with the plugging surface 101 of a metal material such as a nickel-titanium alloy, friction exists between the membrane and the inner wall of the delivery sheath in the release process of the repeatedly recovered plugging device, and the continuous impact of blood on the membrane after the plugging device is released to the target position causes the membrane to slide towards the central end 100 relative to the main rod 1010 of the plugging surface 101, the membrane is contracted towards the central end 100 along the main rod 1010 of the plugging surface 101, and finally the membrane 102 is not fully plugged. Of course, the same anchoring effect can be achieved by sewing the membrane 102 through the thread hole 1014 using a suture thread. The material of the series wire 1013 may use a suture as described in the first embodiment, and may also use a fiber such as carbon fiber, polyarylate, or the like, and animal tendon tissue.

The second difference is that the sealing surface 101 is a curved surface shape with concave center, and the edge of the sealing surface 101 is curved towards the sealing surface 101 'as shown in fig. 8b, instead of the plane as shown in the drawing describing the first embodiment, which allows the sealing surface 101 and the sealing surface 101' and the connecting rod 103 to better adapt to the uneven anatomical shape of the end surface of the lumen or organ channel, and also allows the central end 100 to be embedded towards the lumen, the inside of the organ channel, reducing the risk of thrombosis caused by the protrusion of the central end 100.

Embodiment four:

as shown in fig. 9a-9d, the fourth embodiment is different from the first embodiment in that, based on the third embodiment, a fixed connection structure 1015 composed of sub-rods 1011 is provided between the plurality of main rods 1010 of the plugging surface 101, and this design not only can exert the same effect as the serial line provided in the third embodiment, but also can further limit the relative positions between all the main rods 1010 of the plugging surface 101, so that in any case, including the plugging device during repeated recovery, or during repeated release, or after release to the target position, all the main rods 1010 of the plugging surface 101 remain rotationally symmetrical on the central axis of the central end 100, such as during repeated recovery, after the plugging surface 101 is compressed into the delivery sheath, the membrane is further arranged in order in the sheath to be further tightly packed, thus further reducing the size of the plugging disc 10 of the plugging device 1 after compression, minimizing the diameter of the delivery sheath used, further reducing the requirement on the surgical access, and expanding the applicable range of the plugging device. In another embodiment, the fixing and connecting structure 1015 may be formed by the sub-rod 1011 and bent radially outwards towards the plugging surface 101 into an arc shape or into a folded angle shape, as shown in fig. 9 d.

The second difference is that each main rod 1010 of the plugging surface 101 is composed of a plurality of sub-rods 1011, a part of the plurality of sub-rods 1011 is split to form a connecting rod 103, and the other part continues to extend, and is respectively connected with the plurality of sub-rods 1011 separated from the adjacent main rod 1010 and continuing to extend toward the edge of the plugging surface, to form an extension 104 of the plugging surface 101, as shown in fig. 9 c. The benefit of this design is that the plugging area of the plugging surface 101 is enlarged, as shown in fig. 9b for region II, further enhancing the plugging effect of the plugging device.

Finally, it should be understood that the foregoing description is merely illustrative of the preferred embodiments of the present invention, and that no limitations are intended to the scope of the invention, as defined by the appended claims.

Claims

1. An occluder, characterized in that: the occluder comprises at least one occlusion disc (10); the sealing disc (10) comprises two central end parts (100, 100 '), and two sealing surfaces (101, 101'), wherein one sealing surface (101) is composed of a plurality of main rods (1010) which are directly diverged from the central end parts (100) to the edge direction of the sealing surface, the other sealing surface (101 ') is connected with the sealing surface (101) through a connecting rod (103), the connecting rod (103) is composed of two or more sub-rods (1011) which are separated from each main rod (1010), the two or more sub-rods (1011) are respectively combined with the sub-rods (1011) which are separated from the adjacent main rods (1010) to form the main rod (1010') of the other sealing surface (101 '), the main rods (1010') are converged towards the central end part (100 ') of the other sealing surface (101'), so that the two sealing surfaces have the same structure, a bending section (1031) is arranged on the connecting rod (103), and the two sealing surfaces (101, 101 ') can be jointed with at least one sealing surface (101') of the sealing surfaces; and, each main bar (1010, 1010 ') on the plugging surface (101, 101') is composed of a plurality of sub bars (1011), and the central end (100) is detachably connected with a push bar.

2. The occluder of claim 1, wherein: a fixed connection (1015) is provided between adjacent stems (1010, 1010').

3. The occluder of claim 1, wherein: a plurality of the sub-poles (1011) are combined together by a fixing member (1012), or a plurality of the sub-poles (1011) are woven with each other.

4. The occluder of claim 1, wherein: each main rod (1010, 1010 ') is respectively provided with a wire hole (1014), and a series wire (1013) enables the plurality of main rods (1010, 1010') to be connected in series into a whole through the wire holes (1014).

5. The occluder of claim 1, wherein: each main rod (1010) on the plugging surface (101) is composed of a plurality of sub-rods (1011), a part of the plurality of sub-rods (1011) is split to form a connecting rod (103), and the connecting rod (103) is provided with a bending section (1031) by combining with the sub-rods (1011) separated from the adjacent main rods (1010) to form a main rod (1010 ') of the other plugging surface (101'); the other part of the plurality of sub-rods (1011) continues to extend and is respectively connected with the plurality of sub-rods (1011) which are separated from the adjacent main rod (1010) and continue to extend, so as to form an extension part (104) of the sealing surface (101).

6. The occluder of claim 1, wherein: the blocking surface (101) is a plane or a curved surface with a concave middle part, or the edge of the blocking surface (101) is bent towards the other blocking surface (101').

7. The occluder of claim 1, wherein: the blocking surface is coated in the membrane.

8. The occluder of claim 1, wherein: the main rod of the plugging surface is fixedly penetrated on the membrane.