CN114767179B - A kind of atrial septal defect occluder - Google Patents

Abstract

The invention relates to an atrial septal defect occluder, comprising an elastic braided grid frame and a flow-blocking membrane, wherein the elastic braided grid frame includes a left disk surface, a right disk surface and a waist; film, waist blocking film and waist peripheral blocking film; the left disk blocking film and right disk blocking film are respectively arranged in the left disk surface and the right disk surface; the waist blocking film is arranged in the waist, and the diameter of the waist blocking film is larger than The diameter of the waist is sewed together with the waist peripheral choke film, and the suture of the two choke films can achieve a high-density suture gap; the waist peripheral choke film is arranged around the waist, and the shaft of the waist peripheral choke The lateral length is greater than the wall thickness of the atrial septal defect, so that after the occluder is released at the atrial septal defect, it can effectively prevent the occurrence of residual shunt.

Description

A kind of atrial septal defect occluder

technical field

The invention relates to the field of medical devices for interventional operations, in particular to an atrial septal defect occluder.

Background technique

Atrial septal defect (ASD) is a common congenital heart malformation in clinical practice. It is an abnormality of the original atrial septum during embryonic development, resulting in a gap between the left and right atrium. ASD can occur alone or coexist with other types of cardiovascular malformations. Due to the presence of shunt at the atrial level, it can cause corresponding hemodynamic abnormalities.

For atrial septal defect, the most commonly used clinically at present is the atrial septal defect occluder, which is a medical device specially used to occlude atrial septal defect. The doctor will choose the appropriate occluder for the special atrial septal defect The selected occluder will be implanted into the defect site through the catheter and stay in the defect site permanently.

Since the development of occluders, the design of the Amplatzer series of occluders has become the most mainstream occluder design in clinical application. At present, the designs of various domestic manufacturers are basically based on this design. Taking the design of the Amplatzer atrial septal occluder as an example, it is a self-expanding nickel-titanium alloy wire braided occluder composed of two circular discs and a short waist connecting the two discs, as shown in Figure 1. Its structure includes the left Disk riveting head 1, left disk surface 2, left disk choke film 3, waist 4, waist choke film 5, right disk surface 6, right disk choke film 7, right disk rivet head 8; left disk rivet 1 and right disk The rivet head 8 can be connected with the left disk surface 2 and the right disk surface 6 by means of welding, bonding or physical clamping.

After the occluder is implanted into the human body, the left disc 2 and the right disc 6 are automatically deployed in the left atrium 10 and right atrium 11 respectively, and clamp the edge of the defect together. The waist 4 in the middle of the two discs is located in the defect. Inside the two disks and the waist 4 there are flow blocking membranes adapted to their respective diameters, which are sutured on the two disks and the waist 4 by sutures to block the blood flow through the defect. However, due to the overall mechanical properties of the elastic braided mesh frame and the design of the flow-blocking membrane, after the occluder is implanted, the left and right disks cannot fit the interatrial septum in some cases, and will appear in a dumbbell-like shape, as shown in the figure 2. Blood can easily flow into the occluder from the grid under the choke membrane, while the choke membrane at the waist is sutured inside, and generally speaking, the suture lines are relatively sparse. When there is blood flow loaded on the choke When the membrane is closed, the blood flow can easily flow from the position between the suture points to the right disc surface 6 and then stay into the right atrium 11 from the grid on the right disc surface, or flow directly from the gap between the grid and the defect to the right atrium 11, which can easily cause complications The emergence of residual shunts, and it is not conducive to the endothelialization process of the occluder. This kind of dumbbell-shaped release form is relatively common in clinical practice, mostly due to the oversize selection of the occluder combined with the integrated weaving process of the occluder grid frame.

Based on the above reasons, how to improve the structure of the atrial septal defect occluder so as to effectively prevent the occurrence of residual shunt has become a technical problem that needs to be solved urgently.

Contents of the invention

The invention discloses an atrial septal defect occluder and aims to solve the technical problems in the prior art.

The present invention adopts following technical scheme:

An atrial septal defect occluder, comprising:

- Elastic braided net frame, the elastic braided net frame includes a left panel and a right panel, the left panel and the right panel are connected through the waist;

- The choke film, the choke film includes the left disk choke film, the right disk choke film, the waist choke film and the waist peripheral choke film;

The left disk choke film and the right disk choke film are respectively arranged in the left disk surface and the right disk surface;

The waist blocking film is arranged in the waist, and the diameter of the waist blocking film is larger than the diameter of the waist;

The peripheral waist blocking film is arranged around the outer periphery of the waist.

As a preferred technical solution, the waist blocking membrane and the peripheral blocking membrane are made of materials that can adapt to the shape of the atrial septal defect.

As a preferred technical solution, the material that can adapt to the shape of the atrial septal defect includes a hydrophilic swelling material, which can absorb liquid and expand after being in contact with blood.

As a preferred technical solution, the hydrophilic swelling material includes medical hyaluronic acid material.

As a preferred technical solution, the thickness of the waist blocking film and the peripheral blocking film is 0.2mm-2mm.

As a preferred technical solution, the waist blocking membrane is circular after planar deployment, and the diameter after deployment is 2-10mm larger than the diameter of the waist.

As a preferred technical solution, the edge of the waist blocking film extends to the left disc surface.

As a preferred technical solution, the lumbar choke film is sutured and connected to the peripheral choke film at the left disc surface.

As a preferred technical solution, the axial length of the peripheral occlusion membrane at the waist is greater than the wall thickness of the atrial septal defect.

As a preferred technical solution, the axial length of the waist peripheral choke film is greater than the axial length of the waist, and the left and right ends of the waist peripheral choke film respectively extend to the left disk surface and the right disk surface.

As a preferred technical solution, the minimum length L of the length L extending from the outer circumference of the waist to the left disk surface is 1mm, and the maximum value is 1/2 the difference between the diameter of the left disk surface and the diameter of the waist;

The minimum value of the length L of the baffle film extending from the periphery of the waist to the right disk surface is 1mm, and the maximum value is 1/2 the difference between the diameter of the right disk surface and the diameter of the waist;

The axial length Ltotal of the peripheral flow blocking film of the waist=L waist+L left+L right, wherein, L waist is the axial length of the waist.

As a preferred technical solution, the left and right ends of the peripheral baffle film of the waist are respectively sutured and fixed to the left disk surface and the right disk surface.

As an optimal technical solution, the peripheral flow blocking membrane of the waist includes mutually independent left section, middle section and right section after being unfolded in a plane; the left section and right section are in the shape of a ring, and the middle section is in the shape of a parallelogram.

As a preferred technical solution, the lumbar peripheral flow blocking membrane is coated with a coating that induces endothelial cell climbing and promotes endothelialization, and the coating includes biological hydrogel.

As a preferred technical solution, the braided warp and weft of the peripheral waist film are at an angle of 45° to the horizontal.

As a preferred technical solution, a riveting head is provided at the ends of the left disc surface and the right disc surface, or only at the end of the right disc surface.

The technical scheme adopted in the present invention can achieve the following beneficial effects:

(1), the present invention provides a kind of atrial septal defect occluder, in the waist periphery of the elastic braided grid frame, a waist peripheral flow blocking film is also fixed around, and the axial length of the waist peripheral flow blocking film is greater than that of the elastic braided The axial length of the waist of the mesh frame extends from the left to the right to the left and right disc surfaces, so that after the occluder is released at the atrial septal defect, it can effectively prevent the occurrence of residual shunt.

(2) In order to adapt to the shape of various atrial septal defects, the lumbar peripheral flow blocking membrane is preferably made of hydrophilic swelling material. After implanting in the defect, as time goes on, the hydrophilic swelling material can absorb liquid after contacting with blood Expansion, to adapt to different shapes of atrial septal defect holes, to ensure the fit of the waist of the occluder and the defect holes, thereby preventing the occurrence of residual shunts.

(3) Since the occluder needs to be pressed and held in a catheter with a small inner diameter for delivery, the entire elastic braided grid will deform in the axial direction, and then be compressed into the catheter in the radial direction, so the weaving warp and weft of the peripheral flow blocking membrane at the waist The wires are designed to form an angle of 45° with the horizontal direction. In this way, the occluded membrane around the waist can be extended with the axial length of the braided grid frame. When the occluder is pushed out of the catheter, according to the superelasticity and shape of the nickel-titanium alloy material With memory properties, it will return to a well-established shape, so the peripheral choke membrane around the waist will also return to its normal state.

(4) The peripheral occluder membrane of the waist is preferably coated with an endothelialization-promoting coating, which can induce the climbing of endothelial cells after release at the defect site, thereby accelerating the fixation and endothelialization process of the occluder.

(5) The size of the waist blocking film is larger than that of the waist, and it is sewn together with the peripheral blocking film of the waist. The suture of the two blocking films can realize a suture gap with a high density, and it will not be sutured on the net like the blocking film On the shelf, a large suture gap will be generated, which will easily cause residual shunt.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings that need to be used in the description of the embodiments will be briefly introduced below, which constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions explain the present invention , does not constitute an improper limitation of the present invention. In the attached picture:

Fig. 1 is the structural representation of atrial septal defect occluder in the prior art;

Fig. 2 is the schematic diagram of the atrial septal defect occluder in the prior art after being implanted into the heart;

Fig. 3 is a schematic structural view of the atrial septal defect occluder disclosed in a preferred embodiment of Example 1 of the present invention;

Fig. 4 is a schematic diagram of the atrial septal defect occluder disclosed in a preferred embodiment of Example 1 of the present invention after being implanted into the heart;

Fig. 5 is a schematic plan view of the middle section of the waist peripheral choke film disclosed in a preferred embodiment of Example 1 of the present invention;

Fig. 6 is a schematic plan view of the left section of the waist peripheral choke film disclosed in a preferred implementation of Example 1 of the present invention;

Fig. 7 is a schematic plan view of the right section of the waist peripheral choke film disclosed in a preferred implementation of Example 1 of the present invention;

Fig. 8 is a schematic diagram of the braided warp and weft structure of the waist peripheral flow blocking film disclosed in a preferred embodiment of Example 1 of the present invention;

Fig. 9 is a schematic structural view of the atrial septal defect occluder disclosed in a preferred implementation of Example 2 of the present invention.

Explanation of reference signs:

Left plate rivet head 1, left plate surface 2, left plate choke film 3, waist 4, waist choke film 5, right plate surface 6, right plate choke film 7, right rivet head 8, waist peripheral choke film 9, Left segment 91, middle segment 92, right segment 93, left atrium 10, right atrium 11.

Detailed ways

In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and/or", unless the content clearly states otherwise.

In the description of the present invention, it should be noted that unless otherwise specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; either directly or indirectly through an intermediary. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations. The structures, proportions, sizes, etc. shown in the drawings attached to this specification are only used to match the content disclosed in the specification for the understanding and reading of those who are familiar with this technology, and are not used to limit the conditions for the implementation of the present invention , so it has no technical substantive meaning, and any modification of structure, change of proportional relationship or adjustment of size shall still fall within the scope of the disclosure of the present invention without affecting the functions and objectives of the present invention. The technical content must be within the scope covered. At the same time, terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit this specification. The scope of the invention can be implemented.

Apparently, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

In order to solve the problems existing in the prior art, the embodiment of the present application provides a new type of atrial septal defect occluder, the occluder includes an elastic braided grid and a flow blocking membrane, wherein the elastic braided grid includes a left disk , the right disk surface and the waist connecting the two; the choke film includes the left disk choke film, the right disk choke film, the waist choke film and the waist peripheral choke film, and the left disk choke film and the right disk choke film are respectively set In the left disc surface and the right disc surface, the waist choke film is arranged in the waist, and the diameter of the waist choke film is larger than the diameter of the waist, and the waist peripheral choke film is arranged around the periphery of the waist, and the waist peripheral choke film The axial length is greater than the wall thickness of the atrial septal defect.

Example 1

Embodiment 1 provides an atrial septal defect occluder, which can better fit the atrial septal defect, so as to effectively improve the situation of residual shunt. Referring to Fig. 3-Fig. 8, the atrial septal defect occluder includes an elastic braided grid frame and a plurality of flow-blocking membranes; the elastic braided grid frame includes a left disk surface 2, a right disk surface 6 and a waist 4 connecting the two; a plurality of flow-blocking membranes The membranes are respectively fixed at different positions of the elastic braided grid frame to block the blood flow at the atrial septal defect.

The elastic braided grid frame is made of multiple elastic metal wires with memory function, preferably nickel-titanium alloy wires. During the production process, multiple nickel-titanium wires are cross-woven in two directions to form a cylindrical network tube , and then shaped into a double-disk structure at a certain temperature; after the elastic braided grid is implanted into the human body and unfolded, the left disc surface 2 is positioned on the left atrium 10, and the right disc surface 6 is positioned on the right atrium 11, and the two together clamp the atrial septal defect At , the waist 4 connecting the left disk surface 2 and the right disk surface 6 is located in the atrial septal defect.

Preferably, the diameter of the left disc surface 2 is greater than the diameter of the right disc surface 6, and the diameter of the waist 4 is smaller than the two; since patients have different ages, genders, heights, weights, atrial septal defect positions and defect shapes, etc., in order to fit Different shapes/sizes of atrial septal defects can play a better role. The size of the left disk surface 2, the right disk surface 6 and the waist 4 can be adjusted or selected adaptively, and will not be repeated here.

Preferably, after the elastic braided mesh frame is unfolded, the left disc surface 2 is shaped into a shape in which the edge is folded toward the right disc surface 6, so as to better fit the contour of the interatrial septum and provide a better clamping effect.

In a preferred embodiment, after the braiding of the elastic braided net frame is completed, the elastic metal wires gather at the center positions of the ends of the left disk surface 2 and the right disk surface 6 respectively, so a left disk riveting head is connected to the end of the left disk surface 2 1. The right disc rivet 8 is connected to the end of the right disc surface 6, and the left disc rivet 1 and the right disc rivet 8 are used to fix the elastic metal wire; in another more preferred embodiment, the left disc rivet is cancelled. 1, and the right disc rivet head 8 is only connected to the end of the right disc surface 6, as shown in Fig. 3-Fig. The disc riveting head 8 is used to fix and constrain the right disc surface 6, and can be connected with the pushing device of the occluder to push the occluder from the delivery catheter to the atrial septal defect and release it.

The choke film includes a left disk choke film 3, a right disk choke film 7, and a waist choke film 5. Preferably, a waist peripheral choke film 9 is arranged around the periphery of the waist 4; optionally, the choke film consists of Polylactic acid, polyglycolic acid, polylactic-co-glycolic acid, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polyamide, polyanhydride, polyphosphate, polyurethane or polycarbonate, or A copolymer composition of at least two of the above-mentioned polymer monomers.

The left disc choke film 3 and the right disc choke film 7 are respectively arranged in the left disc surface 2 and the right disc surface 6, and are respectively cut to match the size of the left disc surface 2 and the right disc surface 6, and are sewn to the left disc surface with sutures 2 and the corresponding position on the right disk surface 6.

The waist blocking film 5 is arranged in the waist 4. Preferably, the diameter of the waist blocking film 5 is greater than the diameter of the waist 4, and it is sewn together with the peripheral blocking film 9 of the waist. The sewing of the two blocking films can achieve a higher density. A high suture gap, unlike the choke film sutured on the grid, will produce a larger suture gap, which will easily cause residual shunts to occur.

Preferably, the waist blocking film 5 is circular after being unfolded, and the diameter after deployment is 2-10 mm larger than the diameter of the waist 4. Optionally, the diameter of the waist 4 is generally 4-40 mm; the waist blocking film 5 is larger than the waist The part with a diameter of 4 preferably extends toward the left disc surface 2. Since the pressure of the left atrium 10 is greater than that of the right atrium 11, when the dumbbell phenomenon occurs, the direction of blood flow tends to flow from the left atrium 10 to the right atrium 11, so this design can effectively block blood from the left atrium 11. Blood flow in atrium 10.

In a preferred embodiment, the waist blocking membrane 5 is made of or coated with a hydrophilic swelling material, so that the waist blocking membrane 5 can absorb liquid and expand after being in contact with blood to adapt to the interatrial septum. The shape of the defect can achieve better closure of the atrial septal defect; optionally, the above-mentioned hydrophilic swelling material is a medical hyaluronic acid material, and preferably, the thickness of the waist blocking membrane 5 is 0.2-2 mm.

Preferably, the axial length of the peripheral waist blocking membrane 9 is greater than the wall thickness of the atrial septal defect, more preferably, the axial length of the peripheral waist blocking membrane 9 is greater than the axial length of the waist 4, and the peripheral waist blocking membrane 9 The left and right ends of the handle extend to the left disc surface 2 and the right disc surface 6 respectively, and are respectively sewed to the left disc surface 2 and the right disc surface 6 through suture threads, so that it is fixed on the waist 4.

Preferably, the _minimum length L of the length L extending from the waist periphery to the left disk surface 2 is 1mm, and the maximum value is 1/2 the difference between the diameter of the left disk surface 2 and the diameter of the waist 4. Referring to FIG. 4 Extending to the maximum diameter of the left disc surface 2 forms a curved surface, and the 1/4 point of the curved surface is the maximum value of the length L _left of the waist peripheral flow blocking film 9 extending to the left disk surface 2; preferably, the waist peripheral flow blocking film 9 The _minimum value of the length L extended to the right disk 6 is 1 mm, and the maximum value is 1/2 the difference between the diameter of the right disk 6 and the diameter of the waist 4. Referring to Figure 4, the elastic woven net extends from the waist 4 to the maximum diameter of the right disk 6 The position also forms a curved surface, and the 1/4 point of the curved surface is the maximum value of the length L _right of the waist peripheral choke film 9 extending to the right disk surface 6; preferably, the axial length L of the waist peripheral choke film 9 _{is total} =L _waist +L _left +L _right , wherein, L _waist is the axial length of the waist 4. Referring to FIG. 4 , by controlling the axial length of the lumbar peripheral choke membrane 9 and suturing the large lumbar choke membrane 5 at the same time, even if the left disk surface 2 and the right disk surface 6 are dumbbell-shaped, the blood from the left atrium 10 cannot flow from the The grid under the left disk choke membrane 3 passes through the waist 4, but is completely blocked by the lengthened waist choke membrane 5, while the blood in the left disk surface 2 and the interatrial septal space is completely blocked by the peripheral choke membrane 9, thereby maximizing To avoid the occurrence of residual shunt disease.

Preferably, the plane of the waist peripheral flow blocking film 9 is sutured from mutually independent left section 91, middle section 92 and right section 93, referring to Fig. 5-Fig. 92 is a parallelogram; preferably, the length of the middle section 92 is L ₁ , that is, the circumference of the waist 4, and the height H of the middle section 92 is _the axial length L of the waist 4, and further, the left section of the circular ring 91 and the diameter _D1 of the small circle of the right section 93 are equal to the length _L1 of the middle section, so as to ensure that there is no gap after sewing, and the diameter D of the large circle of the left section 91 is the length L _left that the peripheral flow blocking film 9 of the waist extends to the left disk surface ₂ , the diameter D of the great circle of the right section 93 is _the length L _that extends from the waist peripheral choke film 9 to the right disc surface 6 .

Preferably, the lumbar peripheral flow blocking membrane 9 is preferably coated with an endothelialization-promoting coating, which can induce endothelial cell climbing after release at the defect site, thereby accelerating the fixation and endothelialization process of the occluder.

Preferably, the lumbar peripheral choke membrane 9 is also made of or coated with a hydrophilic swelling material, so that the lumbar peripheral choke membrane 9 can absorb liquid and swell after being in contact with blood, so as to adapt to the atrial septal defect. form, to achieve better closure of atrial septal defect; optionally, the above-mentioned hydrophilic swelling material is a medical hyaluronic acid material, and preferably, the thickness of the lumbar peripheral flow blocking membrane 9 is 0.2-2mm.

As shown in Figure 8, in a preferred embodiment, since the occluder needs to be crimped and delivered in a catheter with a small inner diameter, the entire elastic braided grid will deform in the axial direction and be compressed into the catheter in the radial direction, so The braided warp and weft of the waist peripheral flow blocking membrane 9 are designed to form an angle of 45° with the horizontal direction, so that the waist peripheral flow blocking membrane 9 can be stretched with the axial length of the braided grid frame, and when the occluder is pushed out The catheter, according to the superelasticity and shape memory characteristics of the nickel-titanium alloy material, will return to a well-established shape, so the peripheral flow blocking membrane 9 at the waist will also return to a normal state.

In the present embodiment 1, the operation method and workflow of the above-mentioned atrial septal defect occluder are as follows:

When using the atrial septal defect occluder according to the present invention, first connect the push rod to the right disc rivet 8, push the handle to push the push rod forward, so that the atrial septal defect occluder is pushed out from the delivery catheter To the patient's atrial septal defect, at this time the occluder is released from the delivery catheter, the left disk 2 is released and fixed on the left atrium 10, the waist 4 is positioned at the atrial septal defect, and finally the right disk 6 is released and fixed on the Right atrium 11, when the position of the occluder is anchored, the push rod is twisted to separate from the right disc riveting head 8, so that the push rod is separated from the occluder.

For the occluder anchored at the atrial septal defect, the peripheral blocking membrane 9 at the waist absorbs the water in the blood and expands, which can make the waist 4 fit and adapt better to the shape of the defect. When the occluder When the left disk surface 2 and the right disk surface 6 cannot fit well with the interatrial septum and present a dumbbell shape, the blood from the left atrium 10 flows in from the grid under the left disk choke membrane 3 and will be blocked by the lengthened lumbar choke membrane 5, and The blood in the left disc surface 2 and the interatrial septal space is completely blocked by the peripheral flow blocking membrane, so as to prevent the occurrence of residual shunt.

Example 2

Referring to FIG. 9 , this embodiment provides an atrial septal defect occluder. On the basis of the structure of Embodiment 1, this embodiment changes the size of the waist blocking membrane 5 .

Preferably, in this embodiment, the size of the waist choke film 5 is adapted to the diameter of the waist 4, and a large-sized choke film is no longer used. More preferably, the edge of the waist choke film 5 is in line with the flow resistance of the waist periphery. The membrane 9 is still connected by sutures.

Preferably, the waist blocking membrane 5 is made of or coated with a hydrophilic swelling material, which can adapt to the shape of the atrial septal defect through liquid absorption and swelling, so as to achieve better closure of the atrial septal defect; optional , the above-mentioned hydrophilic swelling material is a medical hyaluronic acid material, preferably, the thickness of the waist blocking membrane 5 is 0.2-2mm.

In this embodiment 2, although the size of the waist choke film 5 is the same as that of the waist 4, since its material contains a hydrophilic swelling material and is still sewn together with the waist peripheral choke film 9, the two are still It can realize suture gap with high density and prevent the occurrence of residual shunt.

Embodiments of the present invention have been described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementations, and the above-mentioned specific implementations are only illustrative, rather than restrictive, and those of ordinary skill in the art will Under the enlightenment of the present invention, without departing from the gist of the present invention and the protection scope of the claims, many forms can also be made, all of which belong to the protection of the present invention.

Claims (16)

1. A atrial septal defect occluder, comprising:

-an elastic knitted net frame comprising a left disc face and a right disc face, the left disc face and the right disc face being connected by a waist;

-a blocker film comprising a left disc blocker film, a right disc blocker film, a lumbar blocker film, and an lumbar outer Zhou Zuliu film;

the left disc flow blocking film and the right disc flow blocking film are respectively arranged in the left disc surface and the right disc surface;

the waist choke film is arranged in the waist, and the diameter of the waist choke film is larger than that of the waist;

the outer waist Zhou Zuliu membrane is arranged around the periphery of the waist, and the outer waist Zhou Zuliu membrane is connected with the waist choke membrane in a sewing mode.

2. The atrial septal defect occlusion device of claim 1, wherein said waist and said peripheral flow blocking membranes are made of a material that is adaptable to atrial septal defect morphology.

3. The atrial septal defect occlusion device of claim 2, wherein said adaptable atrial septal defect morphology material comprises a hydrophilic swelling material that swells imbibition upon contact with blood.

4. The atrial septal defect occlusion device of claim 3, wherein said hydrophilic swelling material comprises a medical hyaluronic acid material.

5. The atrial septal defect occlusion device of claim 2, wherein said waist blocking membrane and said outer Zhou Zuliu membrane have a thickness of 0.2mm-2mm.

6. The atrial septal defect occlusion device of claim 2, wherein said waist blocker plane is circular when deployed and has a diameter 2-10mm greater than a diameter of said waist when deployed.

7. The atrial septal defect occlusion device of claim 6, wherein an edge of said lumbar resistive membrane extends toward said left disc surface.

8. The atrial septal defect occlusion device of claim 7, wherein said waist blocker film is sutured to said outer Zhou Zuliu film at said left disc face.

9. The atrial septal defect occlusion device of claim 2, wherein said lumbar outer Zhou Zuliu membrane has an axial length greater than a wall thickness at the atrial septal defect.

10. The atrial septal defect occlusion device of claim 2, wherein said waist outer Zhou Zuliu membrane has an axial length greater than an axial length of said waist, and wherein left and right ends of said waist outer Zhou Zuliu membrane extend to said left and right disc surfaces, respectively.

11. The atrial septal defect occlusion device of claim 2, wherein,

length L of the waist outer Zhou Zuliu film extending to the left disk surface _{Left side} The minimum value is 1mm, and the maximum value is 1/2 of the difference value between the diameter of the left disc surface and the diameter of the waist;

length L of the waist outer Zhou Zuliu film extending to the right disk surface _{Right side} The minimum value is 1mm, and the maximum value is 1/2 of the difference value between the diameter of the right disc surface and the diameter of the waist;

axial length L of the waist outer Zhou Zuliu film _{Total (S)} ＝L _{Waist part} +L _{Left side} +L _{Right side} Wherein L is _{Waist part} To be the instituteThe axial length of the waist.

12. The atrial septal defect occlusion device of claim 2, wherein left and right ends of said lumbar outer Zhou Zuliu membrane are respectively sutured and secured to said left and right disc surfaces.

13. The atrial septal defect occlusion device of claim 2, wherein said waist out-of-plane Zhou Zuliu membrane comprises left, middle and right segments that are independent of each other; the left section and the right section are annular, and the middle section is parallelogram.

14. The atrial septal defect occlusion device of claim 2, wherein said extralumbar portion Zhou Zuliu membrane is coated with a coating that induces endothelial cell climbing and promotes endothelialization, said coating comprising a biologic hydrogel.

15. The atrial septal defect occlusion device of claim 2, wherein said woven warp and weft threads of said lumbar outer Zhou Zuliu membrane are each at an angle of 45 ° to the horizontal.

16. The atrial septal defect occlusion device of any one of claims 1-15, wherein rivets are further provided at ends of said left and right disc surfaces, or only at ends of said right disc surface.

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