A novel film-covered occlusion disc

Abstract

The present invention discloses a novel covered occlusion disc, which comprises a plurality of support rods with elasticity and / or shape memory, a first flow-blocking membrane and a first deformation compensation structure; wherein, the plurality of support rods sequentially extend from a first central part to form a first support expansion surface and a second support expansion surface, so as to form a cage-like structure or a bowl-like structure; the first flow-blocking membrane comprises a covering film, and the covering film covers at least the inner and outer surfaces of the first support expansion surface and a partial outer ring surface of the connection area between the first support expansion surface and the second support expansion surface, and the distal edge of the covering film is connected to the second support expansion surface through the first deformation compensation structure. By adopting a novel covering method, the present invention not only realizes three-dimensional occlusion, solves a series of problems such as incomplete occlusion and easy occurrence of residual shunt in the prior art, but also accelerates endothelialization, further improving the safety of the occlusion disc.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a novel covered occlusion disc. Background Art

[0002] Atrial fibrillation is one of the most common arrhythmia diseases and is the main cause in the diagnosis and hospitalization of arrhythmia-related diseases. It is related to the decline of activity ability, quality of life, cardiac function and overall survival rate. With the increase of the population age, the social and economic burdens brought by atrial fibrillation will continue to increase. Although atrial fibrillation itself is not a fatal arrhythmia, it will increase the incidence probability of complications such as stroke and heart failure due to the slow blood flow velocity in the atrium and the loss of atrioventricular synchronous function, and even increase the mortality rate.

[0003] During atrial fibrillation, the effective contraction of the atrium is lost, causing blood to stagnate in the left atrial appendage. In addition, the unique anatomical structure of the left atrial appendage and the unevenness of the internal trabeculae make the stagnant blood generate eddy currents, promoting the formation of thrombus. The thrombus detaches from the left atrial appendage and enters the arterial system, which may cause pulmonary embolism, cerebral infarction, myocardial infarction, etc. The most serious outcome of thrombus detachment is cerebral infarction. Since the thrombus remains in the blood vessels of the brain, restricting blood flow, it causes stroke.

[0004] Currently, the prevention strategies for high-risk patients mainly include anticoagulant therapy, surgical left atrial appendage ligation, and left atrial appendage occlusion. And the application of left atrial appendage occlusion to reduce embolism events caused by atrial fibrillation is becoming a current research hotspot. Among the domestic devices used for left atrial appendage occlusion, the main one is the disc plug type occluder such as LAmbre.

[0005] The existing occluders mainly have the following deficiencies:

[0006] (1) For the LAmbre left atrial appendage occluder with the patent number: CN201480073126.X and the LACbes occluder with the patent number: CN201610565731.X, the occluding bodies on the occlusion disc are mainly fixed inside the occlusion disc by a simple point suture method. In this way, the metal wires of the occlusion disc are in direct contact with blood for a long time, which will cause the precipitation of nickel ions, thus triggering the risk of increasing teratogenicity and sensitization; and due to the relatively high hardness of the metal wires, with the beating of the heart, the metal wires and tissues rub against each other for a long time, resulting in wear of the surrounding tissues, and finally leading to the occurrence of complications such as bleeding and inflammation.

[0007] (2) Currently, on the market, most of the left atrial appendage occluders, such as the LAmbre left atrial appendage occluder, the LACbes left atrial appendage occluder and the occluder with patent number CN201511025291.0, all have the following designs on the flow-blocking membrane on the occlusion disk: ① The flow-blocking membrane is an inner plug type and is flat, so that there is a gap between the metal wire on the occlusion disk and the flow-blocking membrane; ② The metal wire on the occlusion disk does not exceed 72 strands, and the flow-blocking membrane and the metal wire are connected by sutures to finally achieve the connection between the flow-blocking membrane and the occlusion disk, so The number of suture points will not exceed 72, which will eventually result in a gap between the edge of the flow barrier and the circumferential edge of the occluder disc. ③ When the surgeon selects the specifications of the occluder, there will be a 10% to 30% interference. Therefore, when this type of occluder is placed in the left atrial appendage cavity, the flow barrier will be in a "collapsed" state, resulting in a larger gap between the flow barrier and the edge of the occluder disc. Ultimately, only a local area or point of the flow barrier contacts the left atrial appendage cavity. ④ Because 70% of the left atrial appendage opening is elliptical and only 5.7% of the left atrial appendage opening is circular, while this type of occluder disc is a regular circular shape. Therefore, when this type of occluder disc is placed in the left atrial appendage opening or left atrial appendage cavity, the occluder disc and flow barrier cannot completely cover the left atrial appendage opening or cannot completely fit the left atrial appendage cavity. Ultimately, the probability of residual shunt after occlusion is greatly increased, and even occlusion failure may occur.

[0008] (3) Some researchers have proposed a palliative design, which is to insert an expanded polytetrafluoroethylene film into the occluder, and its circumferential edge is covered on the inner and outer walls of the braided wire by heat fusion, bonding, etc. to avoid the defects caused by suture connection in the existing technology. However, since the occluder needs to be delivered through interventional surgery, the connection between the film and the occluder needs to adapt to the huge deformation of the occluder shape. Therefore, this design is only applicable to a very small range on the circumferential surface of the occluder disk, usually not exceeding the length of a braided grid in the conventional occluder braiding design (≤4mm). Moreover, the sheath used in the interventional surgery of the occluder is usually not larger than 14F, so the thickness of the film used cannot be too thick (usually not more than 0.2mm). In essence, it is also similar to the above-mentioned planar flow-blocking membrane. Therefore, the occluding performance brought by this design also has the defects of the above-mentioned planar flow-blocking membrane.

[0009] (4) The left atrial appendage occluder with patent number CN201720115376.6 and the occluding disc of the LAMbre left atrial appendage occluder are in the form of thin sheets with sharp edges. They can only be placed on the outer edge of the left atrial appendage orifice. As the heart beats, they will wear away the tissues around the left atrial appendage, such as the mitral valve and left superior pulmonary vein, and eventually lead to complications such as myocardial perforation, bleeding, and inflammation.

[0010] (5) The existing occluder disc is formed by weaving nickel-titanium alloy wires alternately up and down. The wires restrain each other and are difficult to adapt to the irregular left atrial appendage opening, which easily causes residual shunt.

[0011] Therefore, providing a new type of covered occlusion disc that can solve a series of problems existing in the prior art, such as complications caused by device wear on tissues, incomplete occlusion, and poor biocompatibility, is an important research direction. Summary of the Invention

[0012] The present invention aims at the above problems in the prior art and provides a new type of covered occlusion disc.

[0013] To achieve the above object, the present invention adopts the following technical solutions:

[0014] A new type of covered occlusion disc includes a plurality of support rods having elasticity and / or shape memory, a first flow-blocking membrane, and a first deformation compensation structure; wherein, the plurality of support rods sequentially extend from a first central portion to a first support deployment surface and a second support deployment surface, forming a cage-like structure or a bowl-like structure; the first flow-blocking membrane includes a covering film, and the covering film (5) covers at least the inner and outer surfaces of the first support deployment surface and a partial outer ring surface of the connection region between the first support deployment surface (1) and the second support deployment surface (2), and the distal edge of the covering film is connected to the second support deployment surface through the first deformation compensation structure.

[0015] Preferably, it further includes a waist support deployment surface. The first support deployment surface is composed of a plurality of mutually independent support rods radially diverging from the first central portion to the periphery. Each support rod is formed by twisting and braiding a plurality of sub-rods into a twist-like structure. The plurality of sub-rods at the circular edge of the first support deployment surface extend towards the distal direction to form the support rods of the waist support deployment surface. The waist support deployment surface is formed by the plurality of support rods being interwoven up and down to form a grid-like structure, or one or more wave-like structures formed by the plurality of support rods being fixedly connected to each other; the plurality of sub-rods at the distal circular edge of the waist support deployment surface extend towards the center to form the support rods of the second support deployment surface. The plurality of support rods of the second support deployment surface are twisted and braided into a twist-like structure, or interwoven up and down to form a grid-like structure, or fixedly connected to each other to form one or more wave-like structures; one or more strengthening connection structures are provided in the distal region of the covering film to strengthen its connection with the second support deployment surface.

[0016] Preferably, the first deformation compensation structure is composed of a plurality of closed coils, the curve length of the closed coil is 2-20 mm, and each of the closed coils corresponds to each of the support rods on the waist support unfolding surface and / or each of the support rods on the second support unfolding surface one by one; or the first deformation compensation structure is a series wire, and after the series wire sequentially passes through or winds around some or all of the support rods on the waist support unfolding surface and / or some or all of the support rods on the second support unfolding surface and the coating film, the head and the tail are connected; the ratio of the curve length of the series wire to the perimeter of the outer contour of the first support unfolding surface is 0.1-3:1.

[0017] Preferably, the closed coil or the series wire has elasticity, and its elastic deformation amount is 10-500%.

[0018] Preferably, the coating film is made of an elastic material or a shape memory material; the elastic deformation amount of the elastic material is 10-500%; the shape memory material is provided with a fold structure or a corrugated structure that can be stretched and extended.

[0019] Preferably, it further includes a second central part, and a plurality of the support rods on the second support unfolding surface converge towards the second central part and gather at the second central part.

[0020] Preferably, the first blocking film further includes a reinforcement plugging body, the edge of the reinforcement plugging body is connected to the distal edge of the coating film and the waist support unfolding surface through the first deformation compensation structure, and in the natural state, the coating film and the reinforcement plugging body enclose the cage structure; the material of the reinforcement plugging body is a flexible film with a microporous structure; the reinforcement plugging body is provided with a second deformation compensation structure, and the second deformation compensation structure is a single or multiple coils, and the coils are slidably sleeved on the support rods of the second support unfolding surface.

[0021] Preferably, the first central part includes a bolt head, a series wire and an anti-rotation structure; wherein, the bolt head is two-piece and in an I shape; each of the support rods on the first support unfolding surface is provided with a wire-passing hole at the proximal end, and the series wire sequentially passes through all the wire-passing holes to gather the support rods at the waist of the I shape; the anti-rotation structure is fixedly connected to the bolt head and contacts the proximal end of the support rod.

[0022] Preferably, the coating film and the first central part are connected through a reinforcement member, and the reinforcement member is a tubular body or a linear body matching the outer contour of the first central part.

[0023] Preferably, the connection between the waist support deployment surface and the first support deployment surface is in an arc transition, and the arc transition radius is 0.5 - 4 mm. The connection between the waist support deployment surface and the second support deployment surface is in an arc transition, and the arc transition radius is 1 - 4 mm. The first support deployment surface is in an arc connection structure, a central concave structure, a planar structure, or a combination structure of the three.

[0024] Adopting the above technical solution, the present invention has the following technical effects compared with the prior art:

[0025] (1) In the present invention, the distal edge of the covering film is connected to the second support deployment surface through the first deformation compensation structure. When the occlusion disc is loaded into the delivery sheath from the outside, the first deformation compensation structure changes from the free state to the tensile state, and synchronously compresses and expands along with the continuous deformation of the occlusion disc, so that the covering film has self - adaptability for entering and exiting the sheath. And the strengthening connection structure is selectively arranged on the covering film, so that the first deformation compensation structure will not damage or tear the covering film when in the expanded state, and at the same time, the connection between the second support deployment surface and the covering film is made more firm.

[0026] (2) The covering film of the occlusion disc of the present invention covers the first support deployment surface and the waist support deployment surface. The covering film has a "physical barrier" function. This "physical barrier" avoids possible physical contact between the first support deployment surface and the waist support deployment surface and the outside world, thus bringing the following significant benefits: a) During the process of entering and exiting the sheath tube, it avoids direct contact with the inner wall and end face of the delivery sheath tube. Usually, the selected covering film has a lower coefficient of friction, so it reduces the frictional resistance in the delivery sheath tube, improves the operating feel, and helps to achieve the controllability and complete repeatable recovery of the occlusion disc during the release process; b) After being placed at the target position, such as inside the left atrial appendage, since the covering film is softer, it avoids local irritation, tissue inflammation and other complications caused by the circular edge of the first support deployment surface and the entire waist support deployment surface directly, rigidly and permanently pressing against the left atrial appendage cavity tissue; c) The first support deployment surface and the waist support deployment surface are completely covered by the covering film inside, fundamentally isolating the blood in the left atrial cavity from the first support deployment surface and the waist support deployment surface. The selected covering film has better biocompatibility than the first support deployment surface and the waist support deployment surface, and finally reduces the risk of teratogenicity and sensitization; in addition, avoiding direct contact between the first support deployment surface and the waist support deployment surface and the biological cavity reduces the friction force, so that the occlusion disc does not wear the inner wall tissue of the biological cavity; d) Especially importantly, the first support deployment surface and the waist support deployment surface as a whole are in a three-dimensional structure, so that the covering film forms a three-dimensional occlusion such as a bowl-shaped inner plug in the left atrial appendage cavity, greatly reducing or even completely avoiding the residual shunt that usually appears in the prior art, and greatly enhancing the occlusion effectiveness, making the operation have excellent clinical manifestations immediately and during long-term follow-up; e) Usually, it takes 2 to 3 months for the inner plug membrane type occlusion disc to be completely endothelialized. However, the occlusion disc of the present invention has been completely endothelialized half a month after implantation. This is because the covering film has a microporous structure, and the microporous structure is more conducive to tissue growth. Compared with the prior art, it completely avoids the contact between the first support deployment surface, the waist support deployment surface and blood with dense and non-porous structures and the left atrial appendage cavity tissue. Therefore, the endothelialization process is more rapid, enabling the occlusion disc to grow integrally with the cavity tissue in contact with it quickly, and finally enhancing the long-term safety of the occlusion disc, thus significantly reducing the risk of the occlusion disc falling off from the left atrial appendage cavity due to the continuous beating of the heart after implantation. In addition, during the follow-up, a large amount of thrombus was found on the surface of the inner plug type occlusion disc instrument, while new tissue formation was found on the surface of the occlusion disc of the present invention, and there was no thrombus.

[0027] (3) The plugging disc of the present invention includes a waist support deployment surface, and there is a diameter difference between the first support deployment surface and the second support deployment surface. The joints between the waist support deployment surface and the first support deployment surface and the second support deployment surface are in arc transition. It can be naturally placed in the biological cavity and adapt to the anatomical shape of the biological cavity. Generally, the edges of conventional cover-type plugging discs on the market are relatively sharp, and long-term implantation will wear the surrounding tissues of the biological cavity. Therefore, the design of the present invention avoids this type of risk.

[0028] (4) The first support deployment surface is composed of multiple independent twist-shaped support rods radially diverging from the center to the edge. The waist support deployment surface is a grid structure formed by multiple independent sub-rods passing through and weaving up and down to form a movable connection, or a wavy structure formed by multiple independent sub-rods crossing up and down to form a fixed connection. The second support deployment surface is a structure composed of multiple independent main twist-shaped rods, a wavy weaving structure, or a grid or mesh structure formed by passing through or crossing up and down. When the plugging disc is placed in the biological cavity, it has a self-suction effect of concave into the cavity. When the plugging disc is squeezed by the protrusion in the cavity, some of the independent support rods on the first support deployment surface and / or the second support deployment surface can locally adjust their positions without affecting the remaining support rods and / or sub-rods, so that the plugging disc can maintain the best plugging state as the shape of the biological cavity changes and has anatomical shape self-adaptability.

[0029] (5) The present invention is provided with a reinforcement plugging body on the second support deployment surface, which not only brings many benefits brought by the "physical barrier" of the aforementioned coating film, but also makes: a) the plugging disc forms a three-dimensional plugging such as a three-dimensional cage shape. Even if there is a local area that is not plugged tightly, resulting in a small amount of blood entering the left atrial appendage cavity, however, due to the presence of the reinforcement plugging body, the flow rate of the blood entering the left atrial appendage cavity rapidly declines when it encounters the reinforcement plugging body, ultimately significantly enhancing the plugging effectiveness; b) the microporous structure of the reinforcement plugging body is convenient for the entry and exit of liquids such as normal saline, which is beneficial for preoperative evacuation and eliminates the hidden danger of postoperative air embolism complications caused by failed evacuation; c) in the long run, the reinforcement plugging body has a microporous structure, and the microporous structure is more conducive to tissue growth. Therefore, the reinforcement plugging body provided on the plugging disc is also beneficial for accelerating the endothelialization process in the distal region of the plugging disc, so that the reinforcement plugging body in the plugging disc together with the coating film form an integrated growth with the cavity tissue in contact with it in a nearly synchronous and faster manner, as Figure 13 shown in, ultimately further enhancing the long-term safety of the plugging disc, thereby further significantly reducing the risk of the plugging disc falling off from the left atrial appendage cavity due to the continuous beating of the heart after implantation.

[0030] (6) In the present invention, a second deformation compensation structure is provided on the enhanced plugging body. This design has the following two advantages: ① When the plugging disc enters and exits the delivery sheath, the second deformation compensation structure changes from the free state to the stretched state, enabling the enhanced plugging body to be synchronously compressed and stretched as the plugging disc continuously deforms, so that the enhanced plugging body has self - adaptability for entering and exiting the sheath; ② The second deformation compensation structure also avoids the increase in the maximum cross - sectional area of the enhanced plugging body caused by the enhanced plugging body wrinkling together when the plugging disc enters the delivery sheath. Therefore, to a certain extent, it can reduce the diameter of the delivery sheath and expand the applicable population of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 is a schematic structural diagram of the novel film - covered plugging disc in Embodiment 1 of the present invention;

[0032] Figure 2 is Figure 1 a magnified view of the partial view Figure Ⅰ in;

[0033] Figure 3 is a top view of the first implementation manner of the novel film - covered plugging disc in Embodiment 1 of the present invention;

[0034] Figure 4 is a schematic diagram of the endothelialization sequence of the novel film - covered plugging disc in Embodiment 1 found through follow - up anatomy;

[0035] Figure 5 is Figure 3 a magnified view of the partial view Figure Ⅲ in;

[0036] Figure 6 is Figure 1 a magnified view of the partial view Figure Ⅱ in;

[0037] Figure 7 is a partial structural diagram of the novel film - covered plugging disc in the delivery sheath;

[0038] Figure 8 is a top view of the second implementation manner of the novel film - covered plugging disc in Embodiment 1 of the present invention;

[0039] Figure 9 is a top view of the third implementation manner of the novel film - covered plugging disc in Embodiment 1 of the present invention;

[0040] Figure 10 is a schematic structural diagram of the novel film - covered plugging disc in Embodiment 2 of the present invention;

[0041] Figure 11 is Figure 10 a magnified view of the partial test Figure Ⅳ in;

[0042] Figure 12 It is the top view of the novel covered occlusion disc in Embodiment 2 of the present invention;

[0043] Figure 13 It is the schematic diagram of the endothelialization sequence of the novel covered occlusion disc in Embodiment 2 found by follow-up anatomy;

[0044] Figure 14 It is the structural schematic diagram of the novel covered occlusion disc in Embodiment 3 of the present invention;

[0045] Figure 15 It is the top view of the novel covered occlusion disc in Embodiment 3 of the present invention;

[0046] Figure 16 It is the first structural schematic diagram of the novel covered occlusion disc in Embodiment 4 of the present invention;

[0047] Figure 17 It is the top view of the novel covered occlusion disc in Embodiment 4 of the present invention;

[0048] Figure 18 It is the second structural schematic diagram of the novel covered occlusion disc in Embodiment 4 of the present invention;

[0049] Figure 19 It is the first three-dimensional structural schematic diagram of the novel covered occlusion disc in Embodiment 4 of the present invention;

[0050] Figure 20 It is another three-dimensional structural schematic diagram of the novel covered occlusion disc in Embodiment 4 of the present invention;

[0051] Figure 21 It is the schematic diagram of the injection channel of the annular protrusion on the surface of the novel covered occlusion disc in Embodiment 4 of the present invention;

[0052] Figure 22 It is Figure 21 the enlarged view of the local view Figure Ⅴ in;

[0053] Figure 23 It is the third structural schematic diagram of the novel covered occlusion disc in Embodiment 4 of the present invention;

[0054] Figure 24 It is Figure 23 the structural schematic diagram of the novel covered occlusion disc in in vivo;

[0055] Figure 25 It is Figure 24 the enlarged view of the local view Figure Ⅵ in;

[0056] Figure 26 It is the structural schematic diagram of the novel covered occlusion disc in Embodiment 5 of the present invention;

[0057] 1 - First support deployment surface, 2 - Second support deployment surface, 3 - Waist support deployment surface, 4 - First deformation compensation structure, 5 - Coating film, 51 - Microporous structure, 52 - Annular protrusion, 53 - Micro-spine, 54 - Local protrusion, 55 - One-way valve, 56 - Pocket, 57 - Filler, 6 - First central part, 61 - Plug head, 62 - Series wire, 63 - Anti-rotation structure, 64 - Collector, 65 - Reinforcement, 7 - Second central part, 8 - Strengthened connection structure, 9 - Enhanced sealing body, 10 - Second deformation compensation structure, 11 - Attachment frame, 12 - Left atrial appendage. Detailed implementation mode

[0058] In the present invention, the end close to the deep part of the left atrial appendage lumen is the distal end, and the end far from the deep part of the left atrial appendage lumen is the proximal end.

[0059] The present invention provides a novel covered occlusion disc, comprising a plurality of support rods with elasticity and / or shape memory, a first flow-blocking membrane and a first deformation compensation structure; wherein, the plurality of support rods extend from the first central part to form a first support deployment surface and a second support deployment surface in sequence, forming a cage-like structure or a bowl-like structure; the first flow-blocking membrane includes a coating film, and the coating film covers at least the inner and outer surfaces of the first support deployment surface and the local outer ring surface of the connection area between the first support deployment surface and the second support deployment surface, and the distal edge of the coating film is connected to the second support deployment surface through the first deformation compensation structure.

[0060] The occlusion disc is made by braiding or laser engraving a plurality of support rods with elasticity and / or shape memory and then thermally shaping. The coating film is integrally in a three-dimensional configuration and is attached to the occlusion disc. The edge of the coating film is connected to the plurality of support rods of the second support deployment surface through the first deformation compensation structure, so that during the process of the occlusion disc entering and exiting the delivery sheath, the coating film is synchronously compressed and synchronously stretched as the first support deployment surface and the second support deployment surface continuously deform.

[0061] In a specific embodiment, the film-covered occlusion disc includes a waist support deployment surface. The first support deployment surface is composed of multiple independent support rods radially diverging from the first central part to the periphery. Each support rod is formed by twisting multiple sub-rods together into a twisted structure. The multiple sub-rods at the circular edge of the first support deployment surface extend towards the distal direction to form the support rods of the waist support deployment surface. The waist support deployment surface is formed by weaving multiple support rods up and down to form a grid-like structure, or one or more wave-like structures formed by fixedly connecting multiple support rods to each other; the multiple support rods at the distal circular edge of the waist support deployment surface extend towards the center to form the support rods of the second support deployment surface. The multiple support rods of the second support deployment surface are woven together by twisting to form a twisted structure, or woven up and down to form a grid-like structure, or fixedly connected to each other to form one or more wave-like structures; one or more strengthening connection structures are provided in the distal region of the coated film, so that the first deformation compensation structure will not break or tear the coated film in the unfolded state, and at the same time, the connection between the second support deployment surface and the coated film is made more firm.

[0062] In a specific implementation method, such as Figure 8 , 9 In, one or more strengthening connection structures are provided in the distal region of the coated film, so that the connection between the second support deployment surface and the coated film is made more firm. Specifically, such as Figure 8 In, the strengthening connection structure is a strengthening coil partially or completely buried or wrapped in the coated film. The strengthening coil surrounds the entire circumference of the distal edge region of the coated film and is completely wrapped by the coated film, so that the coated film and the strengthening coil form an integral body. As another preferred example, such as Figure 9 In, the proximal part of the strengthening coil is wrapped in the coated film, and its distal part is tied to the support rod of the second support deployment surface. In this case, the strengthening coil can not only play the role of the first deformation compensation structure, but also greatly increase the contact area between the coil and the coated film, so that the connection strength between the strengthening coil or the first deformation compensation structure and the coated film is significantly improved. Through the above-mentioned strengthening connection structures, the second support deployment surface and the first deformation compensation structure form an enhanced connection, so that the connection between the second support deployment surface and the coated film is made more firm, and the coated film is prevented from being torn or damaged due to being cut by the linear first deformation compensation structure during the process of the occlusion disc entering and exiting the sheath.

[0063] In another embodiment, the strengthening connection structure is a patch locally or annularly laid on the coated film and fixedly connected to the coated film. As a preference, the patch is taken from the self-material of the coated film, so that the patch and the coated film form an integral body. To a certain extent, the patch can fill the possible gap between the waist support deployment surface and the left atrial appendage cavity tissue, and enhance the sealing effectiveness of the occlusion disc.

[0064] In a specific embodiment, the first deformation compensation structure is composed of a plurality of closed coils. The curved length of the closed coil is 2 to 20 mm. Each closed coil corresponds one by one to each support rod of the waist support deployment surface and / or each support rod of the second support deployment surface, as Figure 3 shown in; or the first deformation compensation structure is a series wire. After the series wire sequentially passes through or winds around some or all of the support rods of the waist support deployment surface and / or some or all of the support rods of the second support deployment surface and the covering film, the head and the tail are connected, as Figure 12 shown in; the ratio of the curved length of the series wire to the perimeter of the outer contour of the first support deployment surface is 0.1 to 3:1. Further, the closed coil or the series wire has elasticity, and its elastic deformation amount is 10 to 500%.

[0065] In a specific embodiment, the covering film is made of an elastic material or a shape memory material; the elastic deformation amount of the elastic material is 10 to 500%; the shape memory material is provided with a wrinkled structure or a corrugated structure that can be stretched and extended.

[0066] In a preferred embodiment, as Figure 1 shown in, the film-covered occlusion disc further includes a second central part, and multiple support rods of the second support deployment surface converge towards the second central part and gather at the second central part.

[0067] The covering film of the present invention covers at least the first support deployment surface and the waist support deployment surface. In a preferred embodiment, an enhanced occlusion body is provided on the second support deployment surface, which not only brings many benefits brought by the "physical barrier" of the aforementioned covering film, but also enables: a) The occlusion disc forms a three-dimensional occlusion such as a three-dimensional cage. Even if there is a local area that is not tightly occluded and a small amount of blood enters the left atrial appendage cavity, however, due to the presence of the enhanced occlusion body, the flow rate of the blood entering the left atrial appendage cavity rapidly declines when it encounters the enhanced occlusion body, and finally the amount of blood flowing out of the left atrial appendage cavity is drastically reduced, ultimately significantly enhancing the occlusion effectiveness; b) The microporous structure of the enhanced occlusion body facilitates the entry and exit of liquids such as normal saline, which is beneficial for preoperative emptying and eliminates the hidden danger of postoperative air embolism complications caused by failed emptying; c) In the long run, the enhanced occlusion body has a microporous structure, and the microporous structure is more conducive to tissue growth. Therefore, the enhanced occlusion body provided on the occlusion disc is also beneficial for accelerating the endothelialization process in the distal region of the occlusion disc, so that the enhanced occlusion body in the occlusion disc together with the covering film form an enclosure and grow into one body with the contacting cavity tissue almost synchronously and more rapidly, as Figure 13 shown in, ultimately further enhancing the long-term safety of the occlusion disc, thus further significantly reducing the risk of the occlusion disc falling off from the left atrial appendage cavity due to the continuous beating of the heart after implantation.

[0068] As Figure 10Among them, the specific implementation of the above technical means is as follows. The edge of the enhanced plugging body is connected to the distal edge of the covering film and the waist support unfolding surface through the first deformation compensation structure. In the natural state, the covering film and the enhanced plugging body form a closed cage-like structure. During the process of the plugging disc entering and exiting the delivery sheath, the enhanced plugging body is synchronously compressed and stretched along with the deformation of the waist support unfolding surface and the second support unfolding surface. The material of the enhanced plugging body is a flexible film with a microporous structure, which is convenient for liquid to enter and exit. The enhanced plugging body is provided with a second deformation compensation structure, and the second deformation compensation structure is a single or multiple coils, and the coils are slidably sleeved on the support rods of the second support unfolding surface. The design of the second deformation compensation structure has the following two advantages: a) When the plugging disc enters and exits the delivery sheath, the second deformation compensation structure changes from the free state to the stretched state, so that the enhanced plugging body is synchronously compressed and stretched along with the continuous deformation of the plugging disc, making the enhanced plugging body have self-adaptability to enter and exit the sheath; b) The second deformation compensation structure also avoids the increase in the maximum cross-sectional area of the enhanced plugging body caused by the enhanced plugging body wrinkling together when the plugging disc enters the delivery sheath. Therefore, to a certain extent, it can reduce the diameter of the delivery sheath and expand the applicable population of the present invention.

[0069] In another preferred embodiment, as Figure 16 , 17 in, the second support unfolding surface is in an open state.

[0070] Furthermore, an enhanced plugging structure or an anchoring structure is provided on the covering film on the outer surface of the waist support unfolding surface, such as Figure 19 , 20 in, the enhanced plugging structure includes a ring-shaped or partial protrusion, and the anchoring structure is microspines extending from the support rods of the waist support unfolding surface or the covering film, such as Figure 18 in, so that the covered plugging disc has an anchoring effect.

[0071] In a specific embodiment, such as Figure 2In the invention, the first central part includes a bolt head, a serial wire and an anti-rotation structure; wherein the bolt head is a two-piece type and is in the shape of an I-beam; the proximal end of each support rod on the first support expansion surface is provided with a wire threading hole, and the serial wire passes through all the wire threading holes in sequence to gather the support rods at the waist of the I-beam; the anti-rotation structure is fixedly connected to the bolt head and contacts the proximal end of the support rod, and is used to limit or fix the bolt head and the proximal end of the support rod in the circumferential direction; the bolt head is provided with a detachable connection structure for detachably connecting to the delivery system. Furthermore, the coating film is connected to the first central part by a reinforcement member, which is a tubular body or a linear body that matches the outer contour of the first central part, and is used to avoid frictional contact between the delivery sheath and the coating film in the first central part area, and to strengthen the connectivity of the coating film and the first central part. Furthermore, the serial wire is the part of the support rod on the first support expansion surface that extends toward the proximal end, so that the serial wire and the support rod are self-contained. This design can significantly reduce the risk of thrombosis on the device surface, especially at the thrombus head, and can reduce the chance of damage and inflammation to cardiovascular tissue.

[0072] In another specific embodiment, Figure 11 In the figure, the first central part includes a bolt head and a collecting piece. The bolt head is integrated. The proximal ends of the support rods on the first support expansion surface are all gathered in the collecting piece. The bolt head is connected to the collecting piece. The bolt head is provided with a detachable connecting structure for detachable connection with the conveying system.

[0073] In a preferred embodiment, the height of the bolt head protruding from the first support extension surface is ≤1 mm.

[0074] In a preferred embodiment, the bolt head is located in the three-dimensional space of the cage-shaped structure or the bowl-shaped structure, ensuring that the bolt head does not protrude outside the three-dimensional space of the cage-shaped structure or the bowl-shaped structure.

[0075] In a specific embodiment, the connection between the lumbar support expansion surface and the first support expansion surface is in an arc transition, and the arc transition radius is 0.5 to 4 mm. The connection between the lumbar support expansion surface and the second support expansion surface is in an arc transition, and the arc transition radius is 1 to 4 mm. The arc transition design allows the occluder disk of the present invention to be naturally placed in the biological cavity and adapt to the anatomical morphology of the biological cavity. Conventional cover-type occluder disks on the market generally have sharp edges, and long-term implantation will wear the surrounding tissues of the biological cavity. Therefore, the design of the present invention avoids this type of risk. Further, as Figure 1 、 10, among 14, 16, and 18, the first support deployment surface is in an arc connection structure, a central concave structure, a flat structure, or a combined structure of the three. When the occlusion disc is placed in the biological cavity, the occlusion disc has a self-suction effect of concaving into the cavity, and when the occlusion disc is squeezed by the cavity, some independent support rods of the first support deployment surface and / or the second support deployment surface can locally adjust their positions without affecting the remaining support rods and / or sub-rods, so that the occlusion disc can maintain the best occlusion state with the change of the biological cavity morphology and has anatomical morphological self-adaptability.

[0076] In a preferred embodiment, the materials of the first central part and the second central part are one or several of pure tantalum, nitinol alloy, 316L stainless steel, cobalt-chromium alloy, and platinum-iridium alloy.

[0077] In a specific embodiment, the outer contour diameter of the first support deployment surface is 2 - 10 mm larger than the outer contour diameter of the second support deployment surface, so that the occlusion disc is in a plug shape, as Figure 1 and Figure 16 In, the cross-section of the occlusion disc is an approximately trapezoidal or bowl-shaped structure.

[0078] In a preferred embodiment, as Figure 26 In, an attachment frame is provided at the distal end of the occlusion disc. The attachment frame is fixedly connected to the second central part and is made of a material with elasticity and / or shape memory, and can be anchored in the biological cavity.

[0079] In a preferred embodiment, the covering film completely covers the first support deployment surface and the waist support deployment surface therein.

[0080] Furthermore, the connection method between the first support deployment surface and the covering film is one of gluing, pressure lamination, heat melting, and sewing.

[0081] In a preferred embodiment, the materials of the first support deployment surface, the waist support deployment surface, and the second support deployment surface are metal elements such as titanium, tantalum, platinum, iridium, tungsten, gold, magnesium, zinc and their alloys, such as nitinol alloy, cobalt-chromium alloy, stainless steel and other metal materials, or polymer materials such as polyamide, polyether block amide, polyimide, polyurethane, polyketone, and polyolefin.

[0082] In a preferred embodiment, the material of the covering film is polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane, polyamide, silica gel, polyolefin, or degradable materials such as polylactic acid and polyvinyl alcohol, or the covering film is selected from animal tissues.

[0083] In a preferred embodiment, the waist support deployment surface has a certain height, and the height is 2 - 8 mm.

[0084] The present invention will be described in detail and specifically through specific embodiments to facilitate a better understanding of the present invention. However, the following embodiments do not limit the scope of the present invention.

[0085] Embodiment 1

[0086] As Figure 1-3 shown, this embodiment provides a novel film-covered occlusion disc, which includes a plurality of support rods having elasticity and / or shape memory, a first flow-blocking film, and a first deformation compensation structure 4; wherein, the plurality of support rods sequentially extend from a first central part 6 to a first support deployment surface 1, a waist support deployment surface 3, and a second support deployment surface 2, and converge at a second central part 7 to form a cage-like structure; the first flow-blocking film includes a covering film 5, and the covering film 5 covers the outer surface of the first central part 6, the inner and outer surfaces of the first support deployment surface 1, and the outer surface of the waist support deployment surface 3. The distal edge of the covering film 5 is connected to the second support deployment surface 2 through the first deformation compensation structure 4.

[0087] In the prior art, the flow-blocking film on the occlusion disc is of an inner plug type and is planar. The metal wires on the occlusion disc are directly in contact with the blood and the cavity, and are prone to wear the tissue and cause inflammation, resulting in a particularly slow endothelialization, usually taking 2 to 3 months. In the novel film-covered occlusion disc of Embodiment 1 of the present invention, the covering film 5 covers the inner and outer surfaces of the first support deployment surface 1 and the outer surface of the waist support deployment surface 3, avoiding direct contact between the first support deployment surface 1 and the waist support deployment surface 3 and the blood and the cavity. The covering film 5 has a microporous structure 51, which is more conducive to tissue growth. Therefore, it was found that the occlusion disc was completely endothelialized half a month after the implantation of the novel film-covered occlusion disc in this Embodiment 1, and it was found during the follow-up that the order of endothelialization was ① waist support deployment surface → ② outer surface of the first support deployment surface → ③ inner surface of the first support deployment surface → ④ second support deployment surface, as Figure 4 shown.

[0088] In this embodiment, as Figure 3In the figure, the first support expansion surface 1 is composed of multiple independent support rods that radially diverge from the first central part 6 to the periphery. Each support rod is composed of multiple sub-rods that are intertwined and woven into a twist-like structure. The multiple sub-rods at the circumferential edge of the first support expansion surface 1 extend toward the distal end to form the support rods of the waist support expansion surface 3. The multiple sub-rods at the distal circumferential edge of the waist support expansion surface 3 further extend toward the second central part 7 to form the support rods of the second support expansion surface 2. The multiple support rods of the second support expansion surface 2 are intertwined and woven into a twist-like structure. The waist support expansion surface 3 is made of multiple support rods, and the multiple support rods are interwoven and woven up and down to form a grid-like structure. The multiple support rods of the second support expansion surface 2 are fixedly connected to the multiple support rods of the first support expansion surface 1 through the multiple support rods of the waist support expansion surface 3, so that the multiple support rods of the coated occlusion disk form a three-dimensional cage-like structure. The multiple support rods of the second support expansion surface 2 converge inward toward the center of the occlusion disk and gather in the second central part 7. The connection between the lumbar support surface 3 and the first support surface 1 forms an arc transition with a radius of 0.5 to 4 mm. The connection between the lumbar support surface 3 and the second support surface 2 forms an arc transition with a radius of 1 to 4 mm. The first and second support surfaces 1 and 2 have a multi-segment arc connection structure, a central concave structure, a flat structure, or a combination of the three. The outer diameter of the first support surface 1 is larger than that of the second support surface, with a diameter difference between 2 and 10 mm. This gives the occluder disk a plug-like shape, with a cross-section that is approximately trapezoidal or bowl-shaped.

[0089] In this embodiment, Figure 2 In the figure, the first central part 6 includes a bolt head 61 and a series wire 62. The bolt head 61 is a two-piece type and is in the shape of an I. The proximal end of each support rod on the first support expansion surface 1 is provided with a wire threading hole. The series wire 62 collects the support rods on the waist of the I through all the wire threading holes to realize the connection between the bolt head 61 and all the support rods. The bolt head 61 is provided with a detachable connection structure for detachable connection with the conveying system. The height of the bolt head 61 protruding from the first support expansion surface 1 is ≤1mm. The bolt head 61 is located in the three-dimensional space surrounded by the support rods to ensure that the bolt head 61 is not exposed outside the three-dimensional space. The series wire 62 is the part of the support rod on the support rod that extends toward the proximal end, so that the series wire 62 and the support rod are self-contained. The first central part 6 also includes an anti-rotation structure 63. The anti-rotation structure 63 is fixedly connected to the bolt head 61. The anti-rotation structure 63 can contact the proximal support rod. The anti-rotation structure 63 is one or more local protrusions, or one or more blocking rods, such as Figure 2In this case, the anti-rotation structure 63 is a retaining rod; or by mechanical clamping deformation, the I-shaped structure is formed into an irregular structure, thereby realizing the circumferential limitation or fixation of the bolt head 61 and the proximal support rod. In addition, the covering film 5 and the first central part 1 are connected by a reinforcing member 65, and the reinforcing member 65 is a linear body matching the outer contour of the first central part 6, which is used to avoid the frictional contact between the delivery sheath and the covering film 5 in the area of the first central part 6 and enhance the connection between the covering film 5 and the first central part 6.

[0090] In this embodiment, as Figure ③ In this case, the first deformation compensation structure 4 is a plurality of closed coils, the curve length of the closed coils is between 5 and 20 mm, and the plurality of closed coils correspond one by one to the multiple support rods of the second support deployment surface 2 in terms of quantity and position. Both the covering film 5 and the closed coils are elastic, and their elastic deformation amounts are between 10% and 500%. The method of connecting the first deformation compensation structure 4 to the covering film 5 and the waist support deployment surface 3 and the second support deployment surface 2 is as Figure 5 shown. First, the suture passes through the covering film 5, then passes through a support rod of the waist support deployment surface 3 and exits, and then after the suture winds around a support rod of the second support deployment surface 2 for one circle, the two ends of the suture are tied to form a closed coil. When the occlusion disc is received in the delivery sheath, the span of the first deformation compensation structure extends from the original L1 to L2, as Figure 6 、 7 shown. This design has many advantages: the elastic covering film 5 and the first deformation compensation structure 4 can timely adjust to adapt to the occlusion disc according to the shape of the occlusion disc being squeezed or the length of being stretched, so that the occlusion disc has self-adaptability for entering and exiting the sheath, and when the occlusion disc is released from the delivery sheath, it will promptly restore its shape, so that the occlusion disc has shape restorability.

[0091] In another embodiment, as Figure 8 、 9 In this case, one or more strengthening connection structures 8 are arranged in the distal region of the covering film 5, so that the connection between the second support deployment surface 2 and the covering film 5 is more firm. Specifically, as Figure 8 In this case, the strengthening connection structure 8 is a strengthening coil partially or completely buried or wrapped in the covering film 5. The strengthening coil surrounds the entire circumference of the distal edge region of the covering film 5 and is completely wrapped by the covering film 5, so that the covering film 5 and the strengthening coil form an integral body. As another preferred example, as Figure 9 In this case, the proximal part of the strengthening coil is wrapped in the covering film 5, and its distal part is tied to the support rod of the second support deployment surface 2. In this case, the strengthening coil can not only play the role of the first deformation compensation structure 4, but also greatly increase the contact area between the coil and the covering film 5, so that the connection strength between the strengthening coil or the first deformation compensation structure 4 and the covering film 5 is significantly improved.

[0092] Example 2

[0093] As Figure 10-12 shown in [reference], compared with Example 1, the first difference between Example 2 and Example 1 is that: the first baffle film further includes a reinforcement plugging body 9, which is arranged on the second support deployment surface 2 of the plugging disc. The edge of the reinforcement plugging body 9 is connected to the edge of the coating film 5 and the waist support deployment surface 3 through the first deformation compensation structure 4, so that in the natural state, the coating film 5 and the reinforcement plugging body 9 form a closed cage shape adapted to the shape of the plugging disc. The reinforcement plugging body 9 is made of a flexible film, and the flexible film has a microporous structure 51, which facilitates the entry and exit of liquid. In addition, the microporous structure 51 is more conducive to tissue growth. Therefore, the reinforcement plugging body 9 provided on the plugging disc is also conducive to accelerating the endothelialization process of the distal region of the plugging disc, that is, the second support deployment surface 2, so that the reinforcement plugging body 9 in the plugging disc together with the coating film 5 grows into one body with the cavity tissue in contact with it almost synchronously, more quickly, and in a surrounding manner, increasing the anchoring property and ultimately further enhancing the long-term safety of the plugging disc. Through follow-up dissection, it is found that the sequence of endothelialization of the novel covered plugging disc in this Example ② is: ① waist support deployment surface → ② outer surface of the first support deployment surface → ③ inner surface of the first support deployment surface, inner surface of the second support deployment surface → ④ outer surface of the second support deployment surface, as Figure 13 shown

[0094] The second difference is that: as Figure 12 shown in [reference], the first deformation compensation structure 4 is a series wire wound around the waist support deployment surface 3. The ratio of the curve length of the series wire to the perimeter of the outer contour of the first support deployment surface is 0.1 - 3:1. The series wire sequentially passes through or winds around multiple support rods on the waist support deployment surface 3 and the coating film 5, and finally realizes the end-to-end connection of the series wire. Compared with multiple closed coils, this design has the advantage of simple manufacturing process.

[0095] The third difference is that: as Figure 10 shown in [reference], the coating film 5 has a shape memory function and a wrinkled structure or corrugated structure that can be stretched and extended; this wrinkled structure or corrugated structure improves the static friction between the coating film 5 and the cavity, further increases the anchoring property, helps the anchoring safety, and can also play a similar role to that of anchor spines, avoiding the risk of traditional anchor spines piercing the left atrial appendage, and at the same time can play the function of the first deformation compensation structure during the process of entering and exiting the sheath.

[0096] The fourth difference is that: as Figure 11Among them, the first central part 6 includes a bolt head 61 and a collecting member 64. The bolt head 61 is integral. The proximal ends of all the support rods on the first support deployment surface 1 converge within the collecting member 64. The bolt head 61 is connected to the collecting member 64 by means such as welding and mechanical clamping. The bolt head 61 is provided with a detachable connection structure for detachably connecting to the conveying system. This design has the significant advantages of simple manufacturing process and firm connection.

[0097] The fifth difference is that: the covering film 5 is connected to the first central part 6 through a reinforcing member 65. The reinforcing member 65 is a tubular body matching the outer contour of the first central part 6, which is used to avoid the frictional contact between the conveying sheath and the covering film 5 in the area of the first central part 6 and strengthen the connection between the covering film 5 and the first central part 6.

[0098] The sixth difference is that: as Figure 12 shown in, the enhanced plugging body 9 is provided with a second deformation compensation structure 10. This compensation structure is a single coil, and the coil is slidably sleeved on the support rods of the second support deployment surface 2, so that during the process of the plugging disc entering and exiting the conveying sheath, the enhanced plugging body 9 is synchronously compressed and synchronously stretched along with the deformation of the waist support deployment surface 3 and the second support deployment surface 2.

[0099] In another embodiment, the second deformation compensation structure is multiple coils.

[0100] Embodiment 3

[0101] Reference Figure 14 、 15 shown in, the first difference between Embodiment 3 and Embodiment 1 is that: the covering film 5 not only covers the waist support deployment surface 3 but also covers the second support deployment surface 2, and a microporous structure 51 is provided on the covering film 5 at the second support deployment surface 2, so that liquid can enter and exit, facilitating the evacuation before the operation.

[0102] The second difference is that: as Figure 15 shown in, the first deformation compensation structure 4 is located at the edge of the covering film 5. The first deformation compensation structure 4 is a series wire wound around multiple independent support rods on the second support deployment surface 2. The series wire sequentially passes through or winds around multiple independent support rods on the second support deployment surface 2 and the covering film 5, so that the series wire is connected end to end. The advantage of this design is that the process is relatively simple, and at the same time, the three-dimensional plugging performance of the plugging disc is better, and it also ensures the self-adaptability of the plugging disc to enter and exit the sheath, shape recovery, etc.

[0103] Embodiment 4

[0104] As Figure 16-20 shown in, compared with Embodiment 1, the first difference in Embodiment 4 is that: as Figure 16In [reference], the second support deployment surface 2 is in an open state, and multiple support rods extend from the first central part 6 to the first support deployment surface 1, the waist support deployment surface 3, and the second support deployment surface 2 in sequence, forming a bowl-shaped structure.

[0105] The second difference is that: as shown in Figure 17 in [reference], the waist support deployment surface 3 is formed by fixing and connecting multiple support rods to form a wave-shaped structure, and an enhanced sealing structure or an anchoring structure is provided on the covering film 5 of the toroidal surface of the waist support deployment surface 3, such as Figure 16 , 18 in [reference]. The enhanced sealing structure includes a ring-shaped protrusion 52 or a local protrusion 54, and these protrusions are located on the covering film 5; the anchoring structure is microspines 53 extending from the support rods or the covering film 5, so that the film-covered occlusion disk has an anchoring effect without the need to connect an additional attachment frame 11. The ring-shaped protrusion 52, the local protrusion 54, and the microspines 53 are realized by filling a material with a sponge-like structure during the manufacturing process of the occlusion disk.

[0106] In another embodiment, in order to reduce the diameter of the delivery sheath used in the operation, an injection channel with a one-way valve 55 is provided on the occlusion disk, such as Figure 21 , 22 in [reference], so as to facilitate the use of injection filling during minimally invasive surgery for filling.

[0107] In another embodiment, referring to Figure 23 , 24 , the covering film 5 on the waist support deployment surface 3 is designed as a sac 56, and gel material is filled as a filler 57 through injection filling during the operation for personalized filling. This design of injection filling can perform personalized filling of the occlusion disk according to different left atrial appendages 12, making the occlusion disk fit the cavity of the left atrial appendage 12 better, reducing the incidence of residual shunt, and at the same time improving the anchoring force to a certain extent and finally achieving effective occlusion.

[0108] Embodiment 5

[0109] Referring to Figure 26 , this embodiment is based on Embodiment 3, and the first difference from Embodiment 3 is that: an attachment frame 11 is provided at the distal end of the occlusion disk, the attachment frame 11 is fixedly connected to the second central part 7, and the attachment frame 11 is made of a material with elasticity and / or shape memory, and can be anchored in the biological cavity.

[0110] The second difference is that: the covering film 5 not only completely covers the occlusion disk, but also covers the connecting parts of the occlusion disk and the attachment frame 11, further reducing the contact area between the blood and the occluder, reducing the precipitation of metal ions, and accelerating endothelialization. In addition, the microporous structure of the covering film 5 at the second support deployment surface 2 is not shown in the figure.

[0111] In another embodiment, the attachment frame 11 is provided with a second flow-blocking film, which can further enhance the blocking effect and block the existing thrombus in the left atrial appendage cavity.

[0112] The specific embodiments of the present invention have been described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, equivalent transformations and modifications made without departing from the spirit and scope of the present invention should all be covered within the scope of the present invention.

Claims

1. A novel film-covered occlusion disc, characterized in that, It includes multiple support rods with elasticity and / or shape memory, a first flow-blocking film, and a first deformation compensation structure (4); wherein, the multiple support rods extend from a first central part (6) to a first support deployment surface (1), a waist support deployment surface (3), and a second support deployment surface (2) in sequence, forming a cage-like structure or a bowl-like structure; the first flow-blocking film includes a covering film (5), and the covering film (5) covers at least the inner and outer surfaces of the first support deployment surface (1) and the partial outer ring surfaces of the first support deployment surface (1) and the second support deployment surface (2), and the distal edge of the covering film (5) is connected to the second support deployment surface (2) through the first deformation compensation structure (4); the first deformation compensation structure (4) is composed of multiple closed coils or the first deformation compensation structure (4) is a series wire.

2. The novel film-covered occlusion disc according to claim 1, characterized in that: The first support deployment surface (1) is composed of multiple independent support rods radially diverging from the first central part (6) to the periphery. Each support rod is woven into a twisted structure by multiple sub-rods. The multiple sub-rods at the circular edge of the first support deployment surface (1) extend in the distal direction to form the support rods of the waist support deployment surface (3). The waist support deployment surface (3) is formed by multiple support rods interweaving up and down to form a grid-like structure, or one or more wavy structures formed by the multiple support rods being fixedly connected to each other; the multiple support rods at the distal circular edge of the waist support deployment surface (3) extend towards the center to form the support rods of the second support deployment surface (2). The multiple support rods of the second support deployment surface (2) are woven into a twisted structure by interweaving with each other, or are interwoven up and down to form a grid-like structure, or are fixedly connected to each other to form one or more wavy structures; one or more strengthening connection structures (8) are arranged in the distal region of the covering film (5) to strengthen its connection with the second support deployment surface (2).

3. The novel film-covered occlusion disc according to claim 1, wherein: The curve length of the closed coil is 2 - 20 mm, and each closed coil corresponds one by one to each support rod of the waist support deployment surface (3) and / or each support rod of the second support deployment surface (2).

4. The novel film-covered occluding disc according to claim 1, wherein: The series wire passes through or winds around some or all of the support rods of the waist support deployment surface (3) and / or some or all of the support rods of the second support deployment surface (2) and the covering film (5) in sequence, and then is connected end to end; the ratio of the curve length of the series wire to the perimeter of the outer contour of the first support deployment surface (1) is 0.1 - 3:

1.

5. The novel covered plugging disc according to claim 1, characterized in that: The covering film (5) is made of an elastic material or a shape memory material; the elastic deformation amount of the elastic material is 10 - 500%; the shape memory material is provided with a fold structure or a corrugated structure that can be stretched and extended.

6. The novel film-covered occlusion disc according to claim 1, wherein: It further includes a second central part (7), and the multiple support rods of the second support deployment surface (2) converge towards the second central part (7) and gather at the second central part (7).

7. The novel film-covered occlusion disc according to claim 6, wherein: The first flow-blocking film further includes a reinforcement plugging body (9). The edge of the reinforcement plugging body (9) is connected to the distal edge of the covering film (5) and the waist support deployment surface (3) through the first deformation compensation structure (4). In the natural state, the covering film (5) and the reinforcement plugging body (9) enclose the cage structure. The material of the reinforcement plugging body (9) is a flexible film with a microporous structure (51). The reinforcement plugging body is provided with a second deformation compensation structure (10), and the second deformation compensation structure (10) is a single or multiple coils, and the coils are slidably sleeved on the support rods of the second support deployment surface (2).

8. The novel film-covered occlusion disc according to claim 1, wherein: The first central part (6) includes a bolt head (61), a series connection wire (62) and an anti-rotation structure (63). Among them, the bolt head (61) is two-piece and in an I-shaped form. Each support rod on the first support deployment surface (1) is provided with a wire-passing hole at the proximal end. The series connection wire (62) passes through all the wire-passing holes in sequence to gather the support rods at the waist of the I-shaped form. The anti-rotation structure (63) is fixedly connected to the bolt head (61) and contacts the proximal end of the support rod.

9. A novel film-covered occlusion disc according to claim 1, characterized in that: The covering film (5) is connected to the first central part (6) through a reinforcement member (65), and the reinforcement member (65) is a tubular body or a linear body matching the outer contour of the first central part (6).

10. The novel covered plugging disc according to any one of claims 2 to 9, characterized in that: The connection between the waist support deployment surface (3) and the first support deployment surface (1) is in an arc transition, and the arc transition radius is 0.5 - 4 mm. The connection between the waist support deployment surface (3) and the second support deployment surface (2) is in an arc transition, and the arc transition radius is 1 - 4 mm. The first support deployment surface (1) is in an arc connection structure, a central concave structure, a planar structure or a combined structure of the three.

Images