Occlusion devices

Abstract

The present application relates to the field of medical devices, in particular to a blocking device, comprising a support body, the support body comprising a proximal end disc, a distal end disc, a waist connecting the proximal end disc and the distal end disc; wherein the support body is a wave-shaped or grid-shaped structure formed by fixing connection of a plurality of elastic support rods; the waist has a through hole penetrating in the axial direction; and a barrier body and a barrier membrane; the barrier body and the barrier membrane have flexibility or elasticity; the barrier membrane and the barrier body are connected by partial or complete non-sewing mode; wherein the barrier body covers the surface of the support rod; the barrier membrane covers or blocks the through hole, and the periphery of the barrier membrane is connected with the support body.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, in particular to occlusion devices, and more particularly to intracardiac occlusion devices. BACKGROUND

[0002] Atrial septal defect is a common congenital heart disease, and the mainstream treatment method at present is to use an occlusion device for transvenous atrial septal occlusion, in which the occlusion device is one of the most important medical devices. The occlusion device for heart defect used at present is an implanted medical device for treating congenital heart defects, which is usually composed of a metal mesh skeleton, a blocking film and a suture, and has a double-disc waist "H" shape structure. However, the existing occlusion device has the following problems: the volume of the occlusion device is large, the grid is dense, the radial support is poor, the metal content of the contact part between the occlusion device and the tissue is high, the occlusion device is easily in direct contact with water and blood after being implanted into the human body, which causes thrombosis, in addition, the occlusion device almost occupies the entire atrial septum after being implanted into the human body, and the double-disc is generally a double-layer dense grid, which requires a sheath tube with a size of at least 14F to be used for transseptal puncture into the left atrium, so that the diameter of the delivery sheath tube is also large, which easily causes some complications, thereby affecting the operation.

[0003] Patent CN212346592U provides an occluder comprising a metal frame and a flow-blocking membrane. The metal frame comprises a proximal disk, a distal disk, and a waist connecting the proximal and distal disks. Both the proximal and distal disks are constructed from a mesh structure woven from warp wire. Both the proximal and distal disks are provided with puncture holes, each significantly larger than the mesh size of the proximal and distal disks. The flow-blocking membrane is disposed within the proximal and distal disks, covering the puncture holes and made of a polymer absorbable material. The above-mentioned occluder has puncture holes on both the proximal and distal disks. If atrial septal puncture is required in the future, the puncture needle can pass through the puncture hole, which can effectively avoid the interference of the metal frame of the occluder, and is conducive to the smooth progress of the future atrial septal puncture operation; However, the disadvantages of this utility model include: 1. The traditional non-fixed mesh structure of the disc woven by metal wire has a high metal content, poor biocompatibility, and weak radial support force. The occluder is easy to fall off, especially for PFO occluders, which need to be filled in irregular shapes. The radial support force is even more insufficient. Secondly, the woven mesh structure reduces the endothelialization process. When a secondary puncture operation is performed later, the mesh of part of the occluder body will fall off. The prominent structure makes the surface path of the occluder uneven. When the secondary puncture delivery system slides along the occluder body, it is difficult to locate it at the through-hole position, which will produce a sense of jamming. Secondly, the waist through-hole position is wrapped with a connecting wire, and the connecting wire creates a convergent connection point. The flow-blocking membrane is covered on the occluder body by a sewing post-connection process. The suture occupies a certain space and volume, and the diameter of the adapted delivery sheath may increase. The suturing process either leads to low suture connection strength, which is easy to loosen or break, or the knot is large, which is easy to cause thrombosis aggregation points, increasing the probability of thrombosis. 2. The setting of the developing point is achieved by wrapping the developing wire around the metal wire at the edge of the puncture hole, and then spirally wrapping the suture around the surface of the developing wire. The developing wire is wrapped and finally tied and fixed, thereby increasing the diameter of the delivery sheath.

[0004] Patent CN112932567A provides an occluder, comprising: an occluder body having a through hole, the through hole extending along the axial direction of the occluder body; and a flow-blocking membrane disposed in the through hole to separate and block the through hole. Compared with the prior art, the occluder provided by this invention maintains the structure and working principle of the traditional occluder, ensuring the safety and effectiveness of the occluder, and setting a fully enclosed sheet-like flow-blocking membrane in the central through hole. While blocking the blood flow through the occluder, the thin and brittle characteristics of the flow-blocking membrane are utilized to make it easy to be punctured and expanded, so that the sheath can be easily punctured and inserted from the central through hole of the occluder, thereby reserving a channel for subsequent atrial septal puncture intervention surgery; however, the occluder body provided by this invention is a traditional non-fixed mesh double-layer structure in the shape of a disc woven from nickel-titanium alloy, which has a high metal content, poor biocompatibility, and poor radial support force. The occluder is easy to fall off, especially for PFO occluders, etc., when the occluder needs to be filled in an irregular shape, the radial support force requirement is relatively high. Even if a densely woven stacked structure is adopted, the radial support force is insufficient, which makes the process complicated. The invention is more complicated. Secondly, the woven mesh structure reduces the endothelialization process. When the secondary puncture operation is performed later, the mesh structure of part of the occluder body is prominent, resulting in an uneven surface path of the occluder. It is difficult for the secondary puncture delivery system to locate at the through-hole position when sliding along the occluder body, which will produce a sense of jamming. Thirdly, there is a connecting wire wrapped around the through-hole position at the waist, and the connecting wire produces a gathering connection point. The flow-blocking membrane is covered on the occluder body with a sewn post-connection process. The suture occupies a certain space and volume, and the diameter of the adapted delivery sheath may increase. The suturing process either leads to low suture connection strength, which is easy to loosen or break, or the knot is large, which is easy to cause thrombosis aggregation points, increasing the probability of thrombosis. Finally, the connecting wire of the invention is very easy to be blocked in the middle of the through-hole, and it is difficult to ensure that the flow-blocking membrane completely covers the proximal and distal disks of the occluder.

[0005] Therefore, how to solve the atrial septal defect problem and reduce postoperative complications during the operation, and avoid some disadvantages brought about by traditional occluder interventional treatment, such as weak radial support of the occluder, excessive metal content in the contact part between the occluder and the tissue, direct contact of the occluder with water and blood after implantation, which can easily cause thrombosis, and large diameter of the delivery sheath, has become a problem that needs to be solved urgently. Summary of the Invention

[0006] In view of the above and others, an object of the present invention is to overcome the deficiencies of the prior art.

[0007] According to one embodiment of the application in atrial septal defect treatment surgery, the present invention can provide an occlusion device for patients with structural heart disease who require interventional treatment, and can solve some disadvantages brought about by the use of occluders to treat atrial septal defect during interventional treatment surgery, such as poor anchoring effect of the occluder resulting in poor occlusion stability or even falling off, or high metal content of the occluder that easily causes damage to human tissue, or isolation of the left and right atria after occlusion by the occluder, resulting in loss of the important atrial septum channel during a secondary surgery at a later stage.

[0008] According to one aspect of the present invention, the occlusion device includes a support body, which includes 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 grid-like structure formed by fixedly connecting multiple elastic support rods, and the waist has an axially penetrating through hole; and a barrier body and a barrier membrane; the barrier body and the barrier membrane are flexible or elastic; the barrier membrane, the barrier body and the support body are connected in a partially or completely non-sewing manner; wherein the barrier body covers the surface of the support rod; the barrier membrane covers or blocks the through hole, and the periphery of the barrier membrane is connected to the support body.

[0009] In one embodiment, the occlusion device can be used in surgeries such as foramen ovale occlusion, atrial septal occlusion, patent ductus arteriosus, ventricular septal occlusion, and atrial septal occlusion.

[0010] In one embodiment, the barrier body covers the surface of the support rods and extends to the connecting gaps between the support rods to form a comprehensive three-dimensional coating structure, and the three-dimensional coating structure includes a proximal disc mask, a distal disc mask, and a waist membrane; wherein the proximal disc mask is at least located on the outer surface of the proximal disc; the distal disc mask is at least located on the outer surface of the distal disc, such as Figure 4 shown.

[0011] In one embodiment, the barrier membrane includes at least one of a proximal disc barrier membrane, a distal disc barrier membrane, and an intermediate barrier membrane, and the proximal disc barrier membrane and the distal disc barrier membrane are tangentially connected to the support body; wherein, the occlusion device includes a waist membrane, and when the waist membrane is a filter membrane with micropores, the proximal disc barrier membrane, the distal disc barrier membrane, and the intermediate barrier membrane are filter membranes with micropores or thin films with a non-porous structure; wherein the occlusion device includes a waist membrane, and when the waist membrane is a thin film with a non-porous structure, the proximal disc barrier membrane, the distal disc barrier membrane, and the intermediate barrier membrane are filter membranes with micropores; the pore size of the micropores is 10-1000 μm, and the micropores facilitate the passage of water molecules and blood. The micropores can prevent the inside of the through-hole of the occlusion device from being in a completely closed state, so as to allow water to pass through the micropores, thereby achieving the purpose of exhausting gas before surgery and preventing thrombosis. In addition, the micropores can assist in rapid endothelialization.

[0012] In one embodiment, Figures 3a to 3c As shown, the barrier membrane is a multi-layer filter membrane or thin film, and the barrier membrane is connected to the support body in a spherical or arcuate shape, and the barrier membrane is convex or concave; wherein, along the direction perpendicular to the central axis of the through hole, the intersection a of each layer of the barrier membrane and the central axis, the highest point b where the edge of each layer of the barrier membrane is connected to the support body, and the lowest point c where the edge of each layer of the barrier membrane is connected to the support body, form an angle β that satisfies: β∈[90°, 180°), which can ensure the compliance of the barrier membrane when loaded into the sheath, and the angle β can also avoid thrombosis near the spherical surface.

[0013] In one embodiment, a morphologically stable structure is provided in the through hole; Figures 3a to 3c As shown, the morphologically stable structure does not contact blood, and its free ends are located between the inner surfaces of the barrier membrane; the morphologically stable structure is an elastic support rod or a flexible connecting line; wherein, the morphologically stable structure has an inclination angle, and the morphologically stable structure supports multiple layers of the filter membrane or the film.

[0014] In one embodiment, the flexible connecting line is an elastic connecting line.

[0015] In one embodiment, the barrier film and the barrier body are an integrated structure or a separate structure.

[0016] In one embodiment, when the barrier covers both the inner and outer surfaces of the support body, the support body is fully wrapped by the barrier, which can prevent the support body from direct contact with blood and prevent thrombosis. The barrier membrane, the barrier body and the surface of the support body have a smooth transition structure as a whole, thereby ensuring that when performing a secondary puncture operation, the through-hole position can be prepared and accurately positioned without any jamming.

[0017] In one embodiment, the non-sewing method includes one or more of adhesive coating, heat coating, spray coating, and dip coating.

[0018] In one embodiment, the support body is at least partially or entirely laser engraved and heat-set in one piece to form a fixed connection.

[0019] In one embodiment, a sealing reinforcement structure is provided in the edge area where the barrier film, barrier body and support body are connected; the sealing reinforcement structure may be one of a barrier body thickening structure, a barrier film thickening structure, a sealing ring and a water absorption expansion structure.

[0020] In one embodiment, the water-swellable structure may be a sponge, a gel, or the like.

[0021] In one embodiment, the barrier body and the barrier membrane also include a filler, and the filler has compression resilience or swelling properties, so that the occlusion device can fill the through hole after being placed in the target tissue; the filler is connected to the support body, or the filler is wrapped in the barrier membrane; the barrier membrane and the barrier body have multiple micropores, and the pore size of the micropores is 100-1000μm. The filler has compression resilience or swelling properties, so that the occlusion device can fill the through hole after being placed in the target tissue, and the endothelialization of the occlusion device can be achieved as soon as possible.

[0022] In one embodiment, the filler is a hydrogel made of a degradable material.

[0023] In one embodiment, the micropores facilitate the passage of water molecules and blood.

[0024] In one embodiment, the filler can be placed before, during, or after surgery; when the filler is placed before surgery, it can be a sponge-like material that can absorb blood and water during and after surgery, wherein the sponge-like material can be a degradable material.

[0025] In one embodiment, the support body is at least partially or entirely braided with a plurality of nickel-titanium wires to form the fixed connection.

[0026] In one embodiment, the barrier membrane and the barrier body are an integrated structure, and the barrier membrane extends radially along the through hole to the edge area of ​​the proximal disk and the distal disk; or, the barrier membrane extends axially along the through hole to part or all of the waist, which has good fit and increases biocompatibility. Hypertrophic tissue will not be formed between the double mesh disks of the occlusion device, ensuring the simplicity and feasibility of puncturing the atrial septum occlusion device into the sheath.

[0027] In one embodiment, the through hole has a certain strength.

[0028] In one embodiment, the barrier membrane is two filter membranes that are spaced apart and parallel to each other, and the angle α formed by the plane where the filter membrane is located and the central axis of the through hole satisfies α∈[30°, 90°]. This can make the film easier to place in the delivery sheath, reduce the diameter of the delivery sheath, and expand the scope of application for patients.

[0029] In one embodiment, the material of the barrier membrane includes degradable materials and non-degradable materials; wherein the degradable materials include sodium alginate, hyaluronic acid, polylactic acid, polyglycolic acid, polyhydroxyalkanoate, polydioxanone, and polycaprolactone, so that the barrier membrane is degraded after being covered by the endothelial tissue; the non-degradable materials include polyester, polytetrafluoroethylene, polyamide, polyolefin, polyurethane, and silicone; when the material of the barrier membrane is non-degradable material, the barrier membrane has a non-woven structure, which makes the barrier membrane easy to be punctured.

[0030] In one embodiment, the material of the barrier film is degradable material, and the degradation time can be adjusted by adjusting the molecular weight and distribution of the material, so that the barrier film is degraded after the endothelial tissue is covered.

[0031] In one embodiment, the material of the barrier film is non-degradable material, which is non-woven fabric material without warp and weft.

[0032] In one embodiment, the occlusion device is a smooth integrated covered stent, the stent is a hard metal, and presents a non-blocking shape, so that a secondary channel is easily established, thereby ensuring that the secondary delivery system quickly and easily passes through the through hole of the pore-forming stent.

[0033] In one embodiment, the support body is a single-layer net structure; and the barrier film and the barrier body have at least one layer.

[0034] In one embodiment, the proximal end of the occlusion device is provided with a delivery system, such as Figure 5c As shown, the delivery system comprises an outer sheath tube, an inner sheath tube and a pushing structure; wherein the outer sheath tube is used to establish a delivery channel; the occlusion device is located at the distal end of the inner sheath tube, and the pushing structure is located at the proximal end of the occlusion device and is used to push the occlusion device.

[0035] In one embodiment, the pushing structure is a pushing rod or a pushing tube.

[0036] In another embodiment, the proximal end disc is connected with the delivery system through a detachable connection structure; wherein the detachable connection structure comprises a release hole, a release ring and a peg head located on the proximal end disc, the release ring is sequentially inserted into the release hole to form a closed loop and is connected with the peg head; and the detachable connection structure is connected with the delivery system through the peg head.

[0037] In one embodiment, the edge region of the through hole is provided with a developing mark for displaying the contour of the through hole; wherein the developing mark comprises a plurality of developing points, and the developing points present a multi-edge multi-point structure.

[0038] In one embodiment, the material of the support body of the edge region of the through hole is developing wire, the developing wire is embedded in the support body and is integrally formed with the support body to form the developing points; or the surface of the support body of the edge region of the through hole is coated or wrapped with developing agent, which is relatively simple and reduces the diameter of the delivery sheath tube.

[0039] In one embodiment, the developing wire can be gold, platinum or other material with good developing property under DSA.

[0040] Compared with the prior art, the advantages of the present application are:

[0041] 1. At present, traditional occluders generally adopt a woven non-fixed grid structure, which has a high metal content, poor biocompatibility, weak radial support force, and the occluder is easy to fall off. Especially for PFO occluders and other devices that need to be filled in irregular shapes, the radial support force requirement is relatively high. Even if a densely woven stacked structure is adopted, the radial support force is insufficient, which makes the process complicated. In addition, the barrier membrane is covered on the support body by sewing, and the suture line is easy to loosen or break. The knotting method used is easy to produce thrombus aggregation points. Different from the prior art, in one embodiment of the present invention, the support body is a wavy or grid-like structure formed by fixedly connecting multiple elastic support rods, which makes the support body structure stable, not only preventing the occluder from falling off from the target tissue area after being implanted, but also the support body has a low metal content and good biocompatibility, and can be inserted into the occluder at any time after surgery by puncture or other methods. During the entire process of establishing a secondary surgical channel in the through-hole of the occluding device, there is no risk of the occluding device shifting from the target position area or even falling off; the barrier body and the barrier membrane are flexible or elastic; the barrier membrane, the barrier body and the support body are connected in a partially or completely non-sewing manner; the barrier body covers the surface of the support rod; the barrier membrane covers or blocks the through-hole, and the periphery of the barrier membrane is connected to the support body, which can reduce the risk of thrombosis related to the occluder, accelerate the endothelialization process, and increase the connection strength of the barrier membrane, the barrier body and the support body; the material of the barrier membrane includes degradable materials that are degraded after being covered by endothelial tissue, and non-degradable materials with a non-woven structure, so that the barrier membrane is easily punctured, which facilitates the guide wire, catheter and other accessories used in subsequent conventional medical device operations to easily puncture through the through-hole, ensuring the establishment of a surgical channel before the subsequent secondary operation.

[0042] 2. Different from the prior art, in one embodiment of the present invention, the proximal disc mask is at least located on the outer surface of the proximal disc; the distal disc mask is at least located on the outer surface of the distal disc, which increases biocompatibility, avoids direct contact between the support surface and blood, and prevents thrombosis.

[0043] 3. In an embodiment of the present application, the barrier film comprises at least one of the proximal disc surface barrier film, the distal disc surface barrier film, and the intermediate barrier film, the proximal disc surface barrier film and the distal disc surface barrier film are tangentially connected with the support body; wherein the occlusion device comprises a waist film, when the waist film is a filter film with micropores, the proximal disc surface barrier film, the distal disc surface barrier film, and the intermediate barrier film are filter films with micropores or non-porous thin films; or in another embodiment of the present application, the occlusion device comprises a waist film, when the waist film is a non-porous thin film, the proximal disc surface barrier film, the distal disc surface barrier film, and the intermediate barrier film are filter films with micropores, in both embodiments, the micropores are arranged at different positions of the barrier film and the barrier body, which can avoid the through hole being in a vacuum state, thereby facilitating the loading and releasing process of the occlusion device into the sheath, and providing a passage for the preoperative exhaust process of the occlusion device to prevent thrombosis when the occlusion device contacts blood.

[0044] 4. In an embodiment of the present application, the support body is at least partially or entirely formed by integral cutting, laser engraving, and heat setting, which not only makes the manufacturing process simple and efficient, but also ensures that the occlusion device has strong radial support force.

[0045] 5. In an embodiment of the present application, the non-sewing method comprises one or more of adhesive film coating, heat film coating, spray film coating, and dip coating film; and the barrier film and the support body have a smooth transition structure as a whole, and the support body is completely wrapped in the barrier film, which can ensure that the guide wire and other guide instruments are quickly and accurately introduced into the through hole position during the secondary surgery, avoid the secondary surgery delivery system from producing a jamming feeling on the surface of the support body, and thus simplify and shorten the operation time, avoid complications, and ultimately ensure the accurate and rapid establishment of the secondary surgery channel in the through hole of the occlusion device.

[0046] 6. In an embodiment of the present application, the proximal disc is connected with the delivery system through a detachable connection structure; wherein the detachable connection structure comprises a release hole, a release ring, and a peg head on the proximal disc, the release ring is sequentially inserted into the release hole to form a closed loop and connected with the peg head; and the detachable connection structure is connected with the delivery system through the peg head, which improves the safety and reliability of the occlusion device release, reduces the inner diameter of the delivery sheath, and ensures the ultra-high safety of the occlusion device after release.

[0047] 7. Different from the prior art, in one embodiment of the present invention, a development mark is provided at the edge area of ​​the through hole to display the outline of the through hole. When a second atrial septal puncture operation is required, the position of the through hole can be accurately found for puncture, with precise positioning, effectively avoiding the metal skeleton, and the development point can be embedded in the support body or on the surface of the support body, reducing the diameter of the delivery sheath and reducing access damage.

[0048] 8. Different from the prior art, in one embodiment of the present invention, the sealing enhancement structure can prevent blood from entering the through-hole through the connection gap between the barrier body, barrier membrane and support frame, thereby avoiding thrombosis and playing a sealing role. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figures 1a and 1b Schematic diagram of the connection between the barrier membrane and barrier body of the occlusion device and the support body in the first embodiment of the present invention.

[0050] Figures 2a to 2c Schematic diagram of the connection between the barrier membrane and barrier body of the occlusion device and the support body in the second embodiment of the present invention.

[0051] Figures 3a to 3c This is a schematic diagram of a state in which the barrier membrane of the occlusion device is connected to the support body in an outward convex or inward concave shape in an embodiment of the present invention.

[0052] Figure 4 This is a schematic diagram of a state in which the proximal disc mask of the occlusion device is located on the outer surface of the proximal disc and the distal disc mask is located on the outer surface of the distal disc in an embodiment of the present invention.

[0053] Figures 5a to 5e Schematic diagram of the process of releasing the occluding device from the delivery system in various embodiments of the present invention.

[0054] The parts indicated by the numbers in the accompanying drawings are as follows:

[0055] 1-occlusion device, 11-proximal disc, 12-distal disc, 13-waist, 14-through hole, 21-barrier membrane, 211-proximal disc barrier membrane, 212-distal disc barrier membrane, 213-intermediate barrier membrane, 22-barrier body, 221-proximal disc mask, 222-distal disc mask, 223-waist membrane, 23-angle β, 24-morphologically stable structure, 3-detachable connection structure, 31-release hole, 32-release ring, 33-bolt head, 4-delivery system, 41-outer sheath, 42-inner sheath, 43-pushing structure. DETAILED DESCRIPTION

[0056] The present invention is further described in detail below with reference to the accompanying drawings and embodiments.

[0057] In the present invention, the term "proximal end" refers to the end close to the surgical operator, and the term "distal end" refers to the end far from the surgical operator.

[0058] Example 1:

[0059] In this embodiment, Figures 1a and 1b As shown, the occlusion device 1 includes a support body, which includes a proximal disk 11, a distal disk 12 and a waist 13 connecting the proximal disk 11 and the distal disk 12; wherein, the support body is a wavy or grid-like structure formed by fixedly connecting multiple elastic support rods, and the waist 13 has an axially penetrating through-hole 14; and a barrier body 22 and a barrier membrane 21, and the barrier body 22 and the barrier membrane 21 are flexible or elastic; the barrier membrane 21, the barrier body 22 and the support body are connected by a partial or complete non-sewing method; wherein, the barrier body 22 covers the surface of the support rod; the barrier membrane 21 covers or blocks the through-hole 14, and the periphery of the barrier membrane 21 is connected to the support body.

[0060] In this embodiment, the occlusion device 1 is used in atrial septal occlusion surgery.

[0061] In this embodiment, the barrier film 21 includes a proximal disk barrier film 211 and a distal disk barrier film 212 .

[0062] In this embodiment, the proximal disk barrier film 211 and the distal disk barrier film 212 are tangentially connected to the support body.

[0063] In this embodiment, Figure 1b As shown, the occlusion device 1 includes a waist membrane 223, which is a filter membrane with micropores. The proximal disc barrier membrane 211 and the distal disc barrier membrane 212 are thin films with non-porous structures; the pore size of the micropores is 10-1000μm, and the micropores facilitate the passage of water molecules and blood.

[0064] In this embodiment, the barrier film 21 and the barrier body 22 are separate structures.

[0065] In this embodiment, a sealing reinforcement structure is provided in the edge area where the barrier film 21 and the barrier body 22 are connected to the support body; the sealing reinforcement structure can be one of a barrier body thickening structure, a barrier film thickening structure, a sealing ring, and a water absorption expansion structure.

[0066] In this embodiment, the barrier body 22 and the barrier membrane 21 also include a filler, which has compression resilience or swelling properties, so that the occluding device 1 can fill the through hole after being placed in the target tissue; the filler is connected to the support body, or the filler is wrapped in the barrier membrane 21; the barrier membrane 21 and the barrier body 22 have multiple micropores, and the pore size of the micropores is 100-1000μm. The filler has compression resilience or swelling properties, so that the occluding device 1 can fill the through hole 14 after being placed in the target tissue, and the endothelialization of the occluding device 1 can be achieved as soon as possible.

[0067] In this embodiment, the filler is hydrogel, and the gel is made of degradable material.

[0068] In this embodiment, the through hole 14 has a certain strength.

[0069] In this embodiment, the support body is entirely formed by integrated laser engraving and heat setting.

[0070] In this embodiment, the barrier film 21 has only one layer.

[0071] In this embodiment, the barrier film 21 is made of a degradable material, which includes sodium alginate, hyaluronic acid, polylactic acid, polyglycolic acid, polyhydroxy fatty acid esters, polydioxanone, and polycaprolactone, so that the barrier film 21 is degraded after the endothelial tissue covers it. The degradation time can be adjusted by adjusting the molecular weight and distribution of the material, so that the barrier film 21 can be degraded after the endothelial tissue covers it.

[0072] In this embodiment, the non-sewing method includes one of adhesive lamination, thermal lamination, spray coating, and dip coating; and the barrier film 21, the barrier body 22 and the support body are overall in a smooth transition structure.

[0073] In this embodiment, the support body is completely wrapped by the barrier body 22 .

[0074] In this embodiment, the occlusion device 1 is a stent with a smooth integrated coating. The stent is made of hard metal and is unobstructed, making it easy to establish a secondary channel, thereby ensuring that the secondary delivery system 4 can quickly and easily pass through the through hole 14 of the pore-forming stent.

[0075] In this embodiment, the barrier body 22 and the barrier membrane 21 further include a filler having compression resilience or swelling properties, so that the occlusion device 1 can fill the through hole 14 after being placed in the target tissue; the filler is connected to the support body.

[0076] In the embodiment, the occlusion device 1 is provided with a delivery system at the proximal end, and the delivery system 4 comprises a delivery handle, an outer sheath 41, an inner sheath 42, and a pushing structure 43; wherein the outer sheath 41 is used to establish a delivery channel; the occlusion device 1 is located at the distal end of the inner sheath 42, and the pushing structure 43 is located at the proximal end of the occlusion device 1 and used to push the occlusion device 1.

[0077] In the embodiment, the pushing structure 43 is a pushing rod.

[0078] In the embodiment, the edge area of the through hole 14 is provided with a developing mark for displaying the contour of the through hole; wherein the developing mark comprises a plurality of developing points, and the developing points are in a multi-edge multi-point structure.

[0079] In the embodiment, the material of the support body of the edge area of the through hole 14 is a developing wire, which is embedded in the support body and integrally formed with the support body to form the developing points.

[0080] The working process steps of the embodiment are shown as follows (as shown in Figures 5a to 5e ):

[0081] (1) Puncture to establish a femoral vein access, and the outer sheath 41 is sent to the right atrium of the patient along the guide wire, and the outer sheath 41 is reserved to provide a channel;

[0082] (2) The occlusion device 1 is sent into the right atrium of the patient along the channel through the femoral vein access, and is placed at the target position after passing through the atrial septal defect;

[0083] (3) The inner sheath 42 is retracted, and the pushing tube is slowly pushed, the distal end of the occlusion device 1 is slowly pushed out of the inner sheath 42 and gradually expands to recover to the preset shape, the control handle is retracted, and the distal end of the occlusion device 1 is slowly placed and adhered to the target tissue;

[0084] (4) The inner sheath 42 is continuously retracted, the proximal end of the occlusion device 1 gradually expands to recover to the preset shape, the delivery system 4 is retracted, and the surgical process is completed.

[0085] Embodiment two:

[0086] The difference from embodiment one is that:

[0087] In the embodiment, as shown in Figures 2a to 2c , the barrier body 22 covers the surface of the support rod and extends to the connecting gap between the support rods to form a comprehensive three-dimensional covering structure, and the three-dimensional covering structure comprises a proximal disc membrane 221, a distal disc membrane 222, and a waist membrane 223; wherein the proximal disc membrane 221 is located on the outer side surface and the inner side surface of the proximal disc 11; and the distal disc membrane 222 is located on the outer side surface and the inner side surface of the distal disc 12.

[0088] In the embodiment, as shown in Figure 2b As shown, the occlusion device 1 includes a waist membrane 223. When the waist membrane 223 is a thin film with a non-porous structure, the proximal disc barrier membrane 211 and the distal disc barrier membrane 212 are filter membranes with micropores; the pore size of the micropores is 10-1000 μm.

[0089] In this embodiment, Figure 2a As shown, when the barrier 22 covers both the inner and outer surfaces of the support body, the support body is fully wrapped by the barrier 22 .

[0090] In this embodiment, the proximal disk 11 is connected to the delivery system 4 through a detachable connecting structure 3; wherein, the detachable connecting structure 3 includes a release hole 31, a release ring 32, and a bolt head 33 located on the proximal disk, and the release ring 32 is sequentially inserted into the release hole 31 to form a closed loop and then connected to the bolt head 33; and, the detachable connecting structure 3 is connected to the delivery system 4 through the bolt head 33.

[0091] The above contents are merely exemplary embodiments of the present invention. For those skilled in the art, according to the concept of the present invention, there may be changes in the specific implementation methods and application scopes. The contents of this specification should not be understood as limiting the present invention.

Claims

1. An occlusion device, characterized in that: include: A support body, the support body includes a proximal disk, a distal disk, and a waist connecting the proximal disk and the distal disk; wherein the support body is a wavy or grid-like structure formed by fixedly connecting multiple elastic support rods; the waist has an axially extending through hole; and a barrier body, a barrier membrane; the barrier body and the barrier membrane are elastic; the barrier membrane, the barrier body and the support body are connected in a partially or completely non-sewing manner; wherein the barrier body covers the surface of the support rod; the barrier membrane covers the through hole, the periphery of the barrier membrane is connected to the support body, the barrier membrane is a multi-layer filter membrane or a thin film, the barrier membrane is spherical or arc-shaped and connected to the support body, and the barrier membrane is convex or concave; wherein, Along the direction perpendicular to the central axis of the through hole, the angle β formed by the intersection a of each layer of the barrier film and the central axis, the highest point b where the edge of each layer of the barrier film is connected to the support body, and the lowest point c where the edge of each layer of the barrier film is connected to the support body satisfies: β∈[90°, 180°].

2. The occlusion device according to claim 1, characterized in that: The barrier body covers the surface of the support rod and extends to the connecting gap between the support rods to form a comprehensive three-dimensional coating structure, and the three-dimensional coating structure includes a proximal disc mask, a distal disc mask, and a waist membrane; wherein, the proximal disc mask is at least located on the outer surface of the proximal disc; the distal disc mask is at least located on the outer surface of the distal disc.

3. The occlusion device according to claim 2, characterized in that: The barrier membrane includes at least one of a proximal disc barrier membrane, a distal disc barrier membrane, and an intermediate barrier membrane, and the proximal disc barrier membrane and the distal disc barrier membrane are tangentially connected to the support body; wherein, the barrier body includes a waist membrane, and when the waist membrane is a filter membrane with micropores, the proximal disc barrier membrane, the distal disc barrier membrane, and the intermediate barrier membrane are filter membranes with micropores or thin films with non-porous structures; the barrier body includes a waist membrane, and when the waist membrane is a thin film with non-porous structures, the proximal disc barrier membrane, the distal disc barrier membrane, and the intermediate barrier membrane are filter membranes with micropores; the pore size of the micropores is 10-1000μm, and the micropores facilitate the passage of water molecules and blood.

4. The occlusion device according to claim 1, characterized in that: A morphologically stable structure is provided in the through hole; the morphologically stable structure does not contact blood, and its free ends are located between the inner surfaces of the barrier membrane; the morphologically stable structure is an elastic support rod or a flexible connecting line; wherein, the morphologically stable structure has an inclination angle, and the morphologically stable structure supports multiple layers of the filter membrane or the film.

5. The occlusion device according to claim 1, characterized in that: The barrier film and the barrier body are of an integrated structure or a split structure.

6. The occlusion device according to claim 1, characterized in that: When the barrier covers the inner surface and the outer surface of the support body at the same time, the support body is fully wrapped by the barrier.

7. The occlusion device according to claim 1, characterized in that: The material of the barrier membrane includes degradable materials and non-degradable materials; among them, the degradable materials include sodium alginate, hyaluronic acid, polylactic acid, polyglycolic acid, polyhydroxyalkanoate, polydioxanone, and polycaprolactone, so that the barrier membrane is degraded after being covered by endothelial tissue; the non-degradable materials include polyester, polytetrafluoroethylene, polyamide, polyolefin, and silicone; when the material of the barrier membrane is non-degradable material, the barrier membrane has a non-woven structure, which makes the barrier membrane easy to be punctured.

8. The occlusion device according to claim 1, characterized in that: The edge area where the barrier film, the barrier body and the support body are connected is provided with a sealing reinforcement structure; the sealing reinforcement structure can be one of a barrier body thickening structure, a barrier film thickening structure, a sealing ring and a water absorption expansion structure.

9. The occlusion device according to claim 1, characterized in that: The support body is at least partially or entirely braided with multiple nickel-titanium wires to form the fixed connection; or the support body is at least partially or entirely formed by integrally laser engraving and heat-setting a single nickel-titanium tube to form the fixed connection.

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