WO2022007920A1

WO2022007920A1 - Novel film-coating occlusion disk

Info

Publication number: WO2022007920A1
Application number: PCT/CN2021/105384
Authority: WO
Inventors: 李彪; 张丽红; 李刚; 邵烨
Original assignee: 宁波迪创医疗科技有限公司
Priority date: 2020-07-09
Filing date: 2021-07-09
Publication date: 2022-01-13

Abstract

Disclosed is a novel film-coating occlusion disk, comprising a plurality of supporting rods having elasticity and/or shape memory, a first flow-blocking film, and a first deformation compensation structure (4), wherein the plurality of supporting rods sequentially extend out of a first supporting and unfolding surface (1) and a second supporting and unfolding surface (2) from a first central portion (6) to form a cage-shaped structure or a bowl-shaped structure; the first flow-blocking film comprises a coating film (5); the coating film (5) at least coats the inner and outer surfaces of the first supporting and unfolding surface (1), and the local outer annular surface of a connection region of the first supporting and unfolding surface (1) and the second supporting and unfolding surface (2); and the edge of the distal end of the coating film (5) is connected to the second supporting and unfolding surface (2) by means of the first deformation compensation structure (4). By using a novel film-coating method, the occlusion disk achieves three-dimensional occlusion, solves a series of problems in the prior art that residual shunt is extremely easy to occur due to incomplete occlusion, and the like, and also accelerates endothelialization, so that the safety of the occlusion disk is further improved.

Description

A new type of film-coated plugging disc

technical field

The present application relates to the field of medical devices, and in particular, to a novel membrane-covered plugging disc.

Background technique

Atrial fibrillation, one of the most common arrhythmic conditions, is the leading cause of hospital visits and hospitalizations for arrhythmia-related conditions, and is associated with decreased mobility, quality of life, cardiac function, and overall survival. As the population grows older, the social and economic burden of atrial fibrillation will continue to increase. Although atrial fibrillation itself is not a fatal arrhythmia, it can cause stroke due to slow blood flow in the atrium and loss of atrioventricular synchronization. The incidence of complications such as heart failure increases, and even the mortality rate increases.

In atrial fibrillation, the effective contraction of the atrium is lost, causing blood to stay in the left atrial appendage. In addition, the unique anatomical structure of the left atrial appendage and the unevenness of the internal muscle trabeculae cause the retained blood to generate eddy currents and promote the formation of thrombus. The thrombus falls off the left atrial appendage and enters the The arterial system may cause pulmonary embolism, cerebral infarction, myocardial infarction, etc. The most serious outcome of thrombus shedding is cerebral infarction, because the thrombus stays in the blood vessels of the brain, restricting blood flow and causing stroke.

At present, preventive strategies for high-risk patients mainly include anticoagulation therapy, surgical left atrial appendage ligation, and left atrial appendage occlusion, and the application of left atrial appendage occlusion to reduce embolic events caused by atrial fibrillation is becoming a current research focus. The domestic instruments used in left atrial appendage occlusion are mainly disc-type occluders such as LAmbre.

The existing occluder mainly has the following shortcomings:

(1) The LAmbre left atrial appendage occluder with the patent number of: CN201480073126.X and the LACbes occluder with the patent number of: CN201610565731.X, the blocking body on the blocking disc is mainly fixed on the Inside the plugging disc, in this way, the metal wire of the plugging disc is in direct contact with blood for a long time, which will lead to the precipitation of nickel ions, which will increase the risk of teratogenicity and sensitization; and the hardness of the metal wire is relatively high. , With the beating of the heart, the long-term friction between the metal wire and the tissue causes the surrounding tissue to wear and tear, and eventually leads to complications such as bleeding and inflammation.

(2) At present, most of the left atrial appendage occluders on the market, such as the LAmbre left atrial appendage occluder, the LACbes left atrial appendage occluder and the occluder with the patent number of CN201511025291.0, block the flow blocking membrane on the disc. The following designs are adopted: ① The blocking film is an inner plug type and is flat, so that there is a gap between the metal wire on the blocking disk and the blocking film; ② The metal wire on the blocking disk will not exceed 72 Strand wire, connect the blocking film and the metal wire through the suture, and finally realize the connection between the blocking film and the blocking disc, so the suture points will not exceed 72, and finally make the edge of the blocking film and the circumferential edge of the blocking disk. There are also gaps; ③ When the operator chooses the size of the occluder, there will be 10% to 30% of the interference, so when this type of occluder is placed in the left atrial appendage cavity, the blocking membrane will be in a "collapsed" state , so that the gap between the blocking membrane and the edge of the occluding disc is larger, and finally only a local area or local point of the blocking membrane contacts the LAA cavity; ④ Since 70% of the LAA openings are oval, only 5.7% of the LAA The opening is circular, whereas this type of blocking disc is a regular circle. Therefore, when this type of occlusion disc is placed at the mouth of the left atrial appendage or the cavity of the left atrial appendage, the occlusion disc and the blocking membrane cannot completely cover the opening of the left atrial appendage or completely fit the cavity of the left atrial appendage, which eventually leads to postoperative closure. The probability of residual shunts is greatly increased, and even lead to failure of plugging.

(3) Some researchers have proposed a palliative design, that is, an expanded polytetrafluoroethylene film is inserted into the occluder, and its peripheral edge is covered with the inner and outer walls of the braided wire by thermal fusion, bonding, etc. In order to avoid the defects brought by the suture connection in the prior art, however, because 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, so this design It is only applicable to a very small range on the circumferential surface of the occluder, usually not exceeding the length of a braided mesh in the braided design of the conventional occluder (≤4mm), and the sheath used in the interventional operation of the occluder is usually not larger than 14F, so the thickness of the film used should not be too thick (usually no more than 0.2mm), which is essentially the same as the above-mentioned planar blocking film, so the blocking performance brought by this design also exists in the above-mentioned planar shape. Defects of the blocking film.

(4) The left atrial appendage occluder with the patent number of CN201720115376.6 and the occlusion disc of the LAmbre left atrial appendage occluder are thin sheets with sharp edges, which can only be placed on the outer edge of the left atrial appendage orifice. The beating will wear away the tissues around the left atrial appendage, such as the mitral valve and the left upper pulmonary vein, and eventually lead to complications such as myocardial perforation, hemorrhage, and inflammation.

(5) The existing plugging disc is formed by alternately interlacing and braiding up and down nickel-titanium alloy wires, and the wires are restrained from each other, so it is difficult to adapt to the irregular left atrial appendage opening, and it is easy to cause residual shunting.

Therefore, it is an important research direction to provide a new type of membrane-covered occlusion disc, which can solve a series of problems in the prior art, such as complications, incomplete occlusion and poor biocompatibility caused by the worn tissue of the device.

SUMMARY OF THE INVENTION

In view of the above problems in the prior art, the present application provides a novel film-coated plugging disc.

To achieve the above purpose, the application adopts the following technical solutions:

A novel film-coated plugging disc, comprising a plurality of support rods with elasticity and/or shape memory, a first blocking film and a first deformation compensation structure; wherein, the plurality of support rods are arranged in sequence from the first central portion Extending out the first support unfolding surface and the second supporting unfolding surface to form a cage-like structure or a bowl-like structure; the first blocking film comprises a coating film, and the coating film (5) at least covers the first The inner and outer surfaces of the supporting unfolding surface and the partial outer annular surface of the connection area between the first supporting unfolding surface (1) and the second supporting unfolding surface (2), the distal edge of the covering film and the first supporting unfolding surface (2). The two support unfolding surfaces are connected through the first deformation compensation structure.

Preferably, it also includes a lumbar support development surface, the first support development surface is composed of a plurality of mutually independent support rods radially divergent from the first center portion to the outer circumference, and each support rod is composed of multiple support rods. The root sub-rods are intertwined and woven into a twist-like structure, and a plurality of the sub-rods on the circumferential edge of the first support unwinding surface extend in the distal direction to form the support rods of the waist support unwinding surface, and the waist support unwinding surface A grid structure is formed by interlacing and weaving a plurality of the support rods up and down, or one or more wave-shaped structures formed by a plurality of the support rods being fixedly connected to each other; The sub-rods extend toward the center to form the support rods of the second support and development surface, and the plurality of the support rods of the second support and development surface are intertwined and woven into a twist-like structure, or are interwoven up and down to form a mesh Lattice-like structures, or fixedly connected to each other to form one or more wave-like structures; the distal region of the coating film is provided with one or more reinforcing connecting structures to strengthen its connection with the second support unfolding surface.

Preferably, the first deformation compensation structure is composed of a plurality of closed coils, the length of the curve of the closed coils is 2-20 mm, each of the closed coils and each of the support rods and /or each of the support rods of the second support development surface is in one-to-one correspondence; or the first deformation compensation structure is a series line, and the series line sequentially passes through or wraps around a part of the lumbar support development surface or All the support rods and/or part or all of the support rods and the covering film of the second support development surface are connected end to end; the length of the curve of the series line is outside the first support development surface The ratio of the contour perimeter is 0.1 to 3:1.

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

Preferably, the coating film is an elastic material or a shape memory material; the elastic deformation of the elastic material is 10-500%; the shape memory material is provided with a stretchable corrugated structure or a corrugated structure.

Preferably, it further includes a second center portion, and the plurality of the support rods of the second support unfolding surface converge toward the second center portion and gather at the second center portion.

Preferably, the first flow blocking film further comprises a reinforcing blocking body, and the edge of the reinforcing blocking body is expanded with the distal edge of the covering film and the lumbar support through the first deformation compensation structure In the natural state, the covering film and the reinforcing blocking body close the cage-like structure; the material of the reinforcing blocking body is a flexible film with a microporous structure; the reinforcing blocking body A second deformation compensation structure is provided, and the second deformation compensation structure is a single or multiple coils, and the coils are slidably sleeved on the support rod of the second support development surface.

Preferably, the first central portion includes a bolt head, a series wire and an anti-rotation structure; wherein, the bolt head is two-piece, in an I-shape; each of the supports on the unfolding surface of the first support The proximal end of the rod is provided with a wire threading hole, and the series wire gathers the support rod on the waist of the I-shaped through all the threading holes in turn; the anti-rotation structure is fixedly connected to the bolt head , and is in contact with the proximal end of the support rod.

Preferably, the coating film and the first central portion are connected by a reinforcing member, and the reinforcing member is a tubular body or a linear body matching the outline of the first central portion.

Preferably, the connection between the lumbar support development surface and the first support development surface is an arc transition, the arc transition radius is 0.5-4 mm, and the connection between the waist support development surface and the second support development surface is an arc. The transition, and the arc transition radius is 1-4 mm; the first support unfolding surface is in the form of a circular arc connection structure, a concave center structure, a plane structure or a combination structure of the three.

Preferably, the coating film of the first flow blocking membrane is provided with two types of microporous structures with different pore sizes, and one of the microporous structures has a pore size that allows blood circulation, and the other The pore size allows only air circulation and not blood circulation.

Preferably, the pore size of the one microporous structure is 100-800 μm; the pore size of the other microporous structure is 0.2-100 μm, preferably the average pore size is about 0.45 μm.

Preferably, the two microporous structures with different pore sizes are uniformly distributed on the coating film of the first flow blocking membrane.

In another preferred embodiment, the two microporous structures with different pore sizes can be arranged and combined regularly on the coating film of the first flow blocking membrane.

This application adopts the above-mentioned technical scheme, compared with the prior art, has the following technical effects:

(1) In the present application, the distal edge of the coating film is connected to the second support development 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 free state. It becomes a stretched state, and synchronously compresses and stretches with the continuous deformation of the plugging disc, so that the coating film has self-adaptation in and out of the sheath; and a strengthening connection structure is selectively arranged on the coating film to compensate the first deformation. When the structure is in a stretched state, the covering film will not be damaged or torn, and at the same time, the connection between the second supporting unfolding surface and the covering film is more firm.

(2) The covering film of the blocking disc of the present application covers the first support unfolding surface and the lumbar support unfolding surface, and the covering film has the function of "physical barrier", which prevents the first support from unfolding The possible physical contact between the surface and the lumbar support deployment surface and the outside world, thus bringing the following significant benefits: a) In the process of entering and exiting the sheath, direct contact with the inner wall and end surface of the delivery sheath is avoided, and the usually selected package The coating film has a lower coefficient of friction, thus reducing the frictional resistance in the delivery sheath, improving the operating feel, and helping to achieve the controllability and complete repeatability of the blocking disc during the release process; b) Place it at the target position, For example, after the interior of the left atrial appendage, the covering film is more flexible, so as to avoid the peripheral edge of the first support expansion surface and the entire lumbar support expansion surface directly, rigidly and permanently abutting against the left atrial appendage cavity tissue, which may cause local damage. Occurrence of complications such as irritation and tissue inflammation; c) The first support development surface and the lumbar support development surface are completely covered by the coating film, which fundamentally connects the blood in the left atrial cavity with the first support development surface and the waist The support expansion surface is isolated, and the selected coating film has better biocompatibility than the first support expansion surface and the lumbar support expansion surface, which ultimately reduces the risk of teratogenicity and sensitization; The direct contact between a supporting and developing surface and a lumbar support developing surface and the biological cavity, thereby reducing the frictional force, so that the occlusion disc will not wear the inner wall tissue of the biological cavity; d) It is especially important that the first supporting and unfolding surface and The overall three-dimensional structure of the lumbar support deployment surface enables the covering film to form a three-dimensional block in the left atrial appendage cavity, such as a plugged bowl, which greatly reduces or even completely avoids the residual shunt that usually occurs in the prior art. Enhance the effectiveness of occlusion, so that the immediate operation and long-term follow-up have excellent clinical performance; e) Usually, it takes 2 to 3 months for the occlusion disc of the inner membrane type to complete endothelialization, and the occlusion disc of the present application is implanted It has been completely endothelialized in the second half of the month. This is because the coating film has a microporous structure with a pore size of 0.2 to 100 μm. This microporous structure only allows gas to pass through, but blood cannot pass through, which is more conducive to tissue growth and climbing. Compared with the prior art, it completely avoids the contact between the first support development surface and the lumbar support development surface, blood, etc. with dense structure and non-porous structure material with the left atrial appendage cavity tissue, so the endothelialization process is more efficient. Rapidly, the occluded disc and the cavity tissue in contact with it can grow as a whole, which ultimately enhances the long-term safety of the occluder disc, thus significantly reducing the possibility of the occluder disc being implanted due to the continuous beating of the heart. Risk of detachment within the left atrial appendage cavity. In addition, during the follow-up process, it was found that there were a lot of thrombus on the surface of the plug-type occluding disc device, while new tissue formation was found on the surface of the occluding disc of the present application, but no thrombus; f) Another pore size of the coating film was 100~ The 800μm pore size structure is convenient for liquids such as normal saline and contrast media to enter and exit, which is conducive to preoperative evacuation and intraoperative angiography, and eliminates the hidden danger of postoperative air embolism complications due to failure of evacuation.

(3) The occlusion disc of the present application includes a lumbar support development surface, and the first support development surface and the second support development surface have a diameter difference, and the lumbar support development surface is respectively connected with the first support development surface and the second support development surface. It can be naturally placed in the biocavity and adapt to the anatomical shape of the biocavity, while the edge of the conventional cover-type plugging disc on the market is generally sharp, and long-term implantation will wear the biocavity. the surrounding tissue, so the design of this application avoids this type of risk.

(4) The first support unfolding surface is composed of a plurality of twist-shaped independent support rods radially divergent from the center to the edge, and the waist support unfolding surface is made of a plurality of independent sub-rods that are woven up and down to form an active connection grid structure, or a corrugated structure that is cross-woven up and down by a plurality of independent sub-rods, and the second supporting and unfolding surface is a structure composed of a plurality of twist-shaped independent main rods, a corrugated weave structure, or a mesh that is cross-braided or cross-woven. Lattice or mesh structure, when the blocking disc is placed in the biological cavity, there is a self-priming effect concave in the cavity, and when the blocking disc is squeezed by the protrusions in the cavity, the first supporting expansion surface and/or the second Part of the independent support rods supporting the unfolded surface can be adjusted in position locally without affecting the rest of the support rods and/or sub-rods, so that the occlusion disc can maintain the optimal occlusion state with the change of the biological cavity shape, with anatomical features Morphological adaptability.

(5) The present application is provided with a reinforced plugging body on the second support development surface, which not only brings many benefits brought by the "physical barrier" of the aforementioned coating film, but also makes: a) The plugging disk is formed such as a three-dimensional cage, etc. The three-dimensional occlusion of the left atrial appendage, even if there is a local area that is not tightly sealed, leads to a small amount of blood entering 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 is met with the enhanced occlusion. In the end, the effectiveness of the plugging is significantly enhanced; b) The microporous structure of the plugging body is enhanced to facilitate the entry and exit of liquids such as normal saline, which is conducive to preoperative emptying, and eliminates postoperative air embolism caused by failure of emptying. The hidden danger of complications; c) In the long run, the reinforced plugging body has a microporous structure, and the microporous structure is more conducive to tissue growth, so the reinforced plugging body set in the plugging disc is also conducive to accelerating the distance of the plugging disc. The endothelialization process of the end region makes the reinforced plugging body in the plugging disc together with the coating film to form an encircling cavity tissue growth in contact with it almost simultaneously and more rapidly, as shown in Figure 13, and finally The long-term safety of the occluder disc is further enhanced, thereby further significantly reducing the risk that the occluder disc may fall out of the left atrial appendage cavity due to the continuous beating of the heart after implantation.

(6) In the present application, a second deformation compensation structure is arranged on the reinforced plugging body. This design has the following two advantages: (1) During the process of the plugging disc entering and exiting the delivery sheath, the second deformation compensation structure changes from the free state. It is in a stretched state, so that the reinforced plugging body compresses and stretches synchronously with the continuous deformation of the plugging disc, so that the reinforced plugging body has the self-adaptiveness of entering and exiting the sheath; (2) The second deformation compensation structure also avoids entering and exiting the plugging disc. In the delivery sheath, the maximum cross-sectional area of the reinforced occlusion body is increased due to the crumpling together of the reinforced occlusion bodies, so the diameter of the delivery sheath can be reduced to a certain extent, and the applicable population of the present application can be expanded.

Description of drawings

1 is a schematic structural diagram of a novel film-coated plugging disc in Example 1 of the application;

Fig. 2 is the enlarged view of partial view I in Fig. 1;

3 is a top view of a first implementation manner of the novel film-coated plugging disc in Example 1 of the application;

4 is a schematic diagram of the sequence of endothelialization of the novel membrane-covered occluded disc found in Example 1 after follow-up and dissection;

Fig. 5 is the enlarged view of partial view III in Fig. 3;

Fig. 6 is an enlarged view of partial view II of Fig. 1;

Fig. 7 is a schematic diagram of the partial structure of the novel film-covered occlusion disc in the delivery sheath;

8 is a top view of a second implementation manner of the novel film-coated plugging disc in Example 1 of the application;

9 is a top view of a third implementation manner of the novel film-coated plugging disc in Example 1 of the application;

10 is a schematic structural diagram of a novel film-coated plugging disc in Example 2 of the application;

Figure 11 is an enlarged view of a partial view IV in Figure 10;

12 is a top view of the novel film-coated plugging disc in Example 2 of the application;

Figure 13 is a schematic diagram of the sequence of the endothelialization of the novel membrane-covered occluded disc found in Example 2 after follow-up dissection;

14 is a schematic structural diagram of a novel film-coated plugging disc in Example 3 of the application;

15 is a top view of the novel film-coated plugging disc in Example 3 of the application;

16 is a schematic diagram of the first structure of the novel film-coated plugging disc in Example 4 of the application;

17 is a top view of the novel film-coated plugging disc in Example 4 of the application;

18 is a schematic diagram of the second structure of the novel film-coated plugging disc in Example 4 of the application;

19 is a schematic perspective view of the first structure of the novel film-coated plugging disc in Example 4 of the application;

FIG. 20 is another schematic perspective view of the structure of the novel film-coated plugging disc in Example 4 of the application;

FIG. 21 is a schematic diagram of the injection channel of the annular protrusion on the surface of the novel film-coated blocking disk in Example 4 of the application;

Figure 22 is an enlarged view of the partial view V in Figure 21;

23 is a schematic diagram of the third structure of the novel film-coated plugging disc in Example 4 of the application;

Figure 24 is a schematic diagram of the structure of the novel film-coated plugging disc in Figure 23;

Fig. 25 is an enlarged view of partial view VI in Fig. 24;

FIG. 26 is a schematic structural diagram of the novel film-coated plugging disc in Example 5 of the application.

1- the first support development surface, 2- the second support development surface, 3- waist support development surface, 4- the first deformation compensation structure, 5- coating film, 51- microporous structure, 52- annular protrusion, 53- Micro-thorn, 54- Partial protrusion, 55- One-way valve, 56- Capsule bag, 57- Filler, 6- First central part, 61- Bolt head, 62- Serial wire, 63- Anti-rotation structure, 64-collection piece, 65-reinforcing piece, 7-second central part, 8-reinforced connecting structure, 9-reinforced blocking body, 10-second deformation compensation structure, 11-attachment frame, 12-left atrial appendage.

detailed description

In the present application, the end close to the inner cavity of the left atrial appendage is the distal end, and the end away from the inner cavity of the left atrial appendage is the proximal end.

The present application provides a novel film-coated plugging disc, which includes a plurality of support rods with elasticity and/or shape memory, a first flow blocking film and a first deformation compensation structure; wherein the plurality of support rods extend from the first center The first support development surface and the second support development surface are sequentially extended from the part to form a cage-like structure or a bowl-shaped structure; the first flow blocking film includes a coating film, and the coating film covers at least the inner and outer surfaces of the first supporting development surface and the partial outer annular surface of the connection area between the first support and development surface and the second support and development surface, and the distal edge of the covering film and the second support and development surface are connected by a first deformation compensation structure.

The plugging disc is made of a plurality of support rods with elasticity and/or shape memory, which are woven or laser engraved and then heat-set. The coating film is attached to the blocking disc as a whole in a three-dimensional configuration, and the edge of the coating film and the plurality of support rods on the second supporting and unfolding surface are connected by the first deformation compensation structure, so that the blocking disc enters and exits the delivery sheath. During the tube process, the coating film is synchronously compressed and synchronously stretched along with the continuous deformation of the first supporting and unfolding surface and the second supporting and unfolding surface.

In a specific embodiment, the film-covered occlusion disc includes a lumbar support expansion surface, and the first support expansion surface is composed of a plurality of mutually independent support rods radially divergent from the first central portion to the outer circumference, and each support rod is composed of multiple support rods. The root rods are intertwined and woven into a twist-like structure, and a plurality of sub rods on the circumferential edge of the first support unrolling surface extend to the distal direction to form the support rods of the waist support unrolling surface, and the waist support unrolling surface is a plurality of support rods interspersed and woven up and down to form a grid a plurality of supporting rods, or one or more wave-shaped structures formed by a plurality of supporting rods being fixedly connected to each other; a plurality of supporting rods at the distal circumferential edge of the lumbar support deployment surface extend toward the center to form the supporting rods of the second supporting deployment surface, and the second supporting rods The multiple support rods on the unfolding surface are intertwined and woven into a twist-like structure, or interlaced and woven up and down to form a grid-like structure, or fixedly connected to each other to form one or more wave-like structures; the distal region of the coating film is provided with one or more. The plurality of reinforced connection structures prevent the first deformation compensation structure from breaking or tearing the covering film in the stretched state, and at the same time make the connection between the second supporting and unfolding surface and the covering film more firm.

In a specific implementation method, as shown in FIGS. 8 and 9 , the distal region of the covering film is provided with one or more reinforced connection structures, so that the connection between the second support and unfolding surface and the covering film is more firm. Specifically, as shown in FIG. 8 , the reinforcing connection structure is a reinforcing coil partially or completely embedded or wrapped in the covering film, and the reinforcing coil surrounds the periphery of the distal edge region of the covering film and is completely wrapped by the covering film, so that The cover film is integral with the reinforcement coil. As another preferred example, as shown in FIG. 9 , the proximal part of the reinforcing coil is wrapped in the covering film, and the distal part of the reinforcing coil is bound on the support rod of the second supporting unfolding surface. In this case, the reinforcing coil is Not only can the effect of the first deformation compensation structure be exerted, but also the contact area between the coil and the coating film can be greatly enhanced, so that the connection strength between the reinforced coil or the first deformation compensation structure and the coating film is significantly improved. Through the above-mentioned reinforced connection structures, the second support unrolling surface and the first deformation compensation structure form an enhanced connection, thus making the connection between the second support unrolling surface and the covering film more firm, avoiding the covering film during the process of inserting and exiting the sheath. Cutting by the linear first deformation compensation structure results in tearing or breakage of the cover film.

In another embodiment, the reinforcing connection structure is a patch that is partially or annularly laid on the coating film and is fixedly connected to the coating film. The covering film forms a whole, to a certain extent, the patch can fill the possible gap between the lumbar support expansion surface and the left atrial appendage cavity tissue, and enhance the sealing effectiveness of the occluding disc.

In a specific embodiment, the first deformation compensation structure is composed of a plurality of closed coils, the curve length of the closed coils is 2-20 mm, and each closed coil is connected to each support rod and/or the second Each support rod supporting the unfolded surface corresponds one by one, as shown in Figure 3; or the first deformation compensation structure is a series line, and the serial line passes through or wraps around part or all of the support rods and/or the second support of the lumbar support unfolding surface in turn Part or all of the support rods on the unrolled surface and the coating film are connected end to end, as shown in Figure 12; the ratio of the curve length of the series line to the perimeter of the outer contour of the first support unrolled surface is 0.1 to 3:1. Further, the closed coil or the series wire has elasticity, and its elastic deformation amount is 10-500%.

In a specific embodiment, the coating film is made of elastic material or shape memory material; the elastic deformation of the elastic material is 10-500%; and the shape memory material is provided with a stretchable corrugated structure or a corrugated structure.

In a preferred embodiment, as shown in FIG. 1 , the film-covered occlusion disc further includes a second central portion, and the plurality of support rods supporting the expanded surface of the second converging toward the second central portion and gathered at the second central portion .

The covering film of the present application covers at least the first support unfolding surface and the lumbar support unfolding surface. In a preferred embodiment, a reinforcing blocking body is provided on the second supporting unfolding surface, which not only brings about the "" The many benefits brought by "physical barrier" also make: a) The blocking disc forms a three-dimensional blocking such as a three-dimensional cage, even if there are local areas that are not blocked tightly, resulting in a small amount of blood entering the left atrial appendage cavity, but due to the enhanced The existence of the occluder makes the flow velocity of the blood entering the LAA cavity decline sharply when it encounters the enhanced occlusion body, and finally the amount of blood flowing out of the LAA cavity drops sharply, which ultimately significantly enhances the effectiveness of the occlusion; b) Enhance the microporous structure of the blocking body to facilitate the entry and exit of liquids such as normal saline, facilitate preoperative emptying, and eliminate the hidden danger of postoperative air embolism complications due to emptying failure; c) In the long run, enhanced The plugging body has a microporous structure, and the microporous structure is more conducive to tissue growth. Therefore, the reinforced plugging body provided in the plugging disc is also beneficial to accelerate the endothelialization process in the distal region of the plugging disc, so that the enhancement in the plugging disc is enhanced. The plugging body, together with the covering film, almost synchronously and more rapidly forms a surrounding cavity tissue growth in contact with it, as shown in Figure 13, which ultimately further enhances the long-term safety of the plugging disc, thus further significant Reduces the risk that the occluder disc may be dislodged from the left atrial appendage cavity due to the continuous beating of the heart after implantation.

As shown in Fig. 10, the specific implementation of the above technical means is as follows, the edge of the reinforcing blocking body is connected with the distal edge of the covering film and the lumbar support unfolding surface through the first deformation compensation structure; in the natural state, the covering film is connected to the The reinforcing blocking body forms a closed cage-like structure. During the process of the blocking disc entering and exiting the delivery sheath, the reinforcing blocking body performs synchronous compression and synchronous stretching with the deformation of the lumbar support unfolding surface and the second support unfolding surface. The material of the reinforced plugging body is a flexible film with a microporous structure, and the microporous structure is convenient for liquid to enter and exit; The utility model is sleeved on the supporting rod of the second supporting unfolding surface. The design of the second deformation compensating structure has the following two advantages: a) When the plugging disc moves in and out of the delivery sheath, the second deformation compensating structure changes from a free state to a tensile state, so that the reinforced plugging body follows the plugging process. The continuous deformation of the disc performs synchronous compression and synchronous stretching, so that the reinforced plugging body has the self-adaptiveness of entering and exiting the sheath; b) the second deformation compensation structure also prevents the reinforced plugging body from bunching together when the plugging disc enters the delivery sheath. As a result, the maximum cross-sectional area of the reinforced plugging body is increased, so the diameter of the delivery sheath can be reduced to a certain extent, and the applicable population of the present application can be expanded.

In another preferred embodiment, as shown in FIGS. 16 and 17 , the second support unfolding surface is in an open state.

Further, a reinforced blocking structure or an anchoring structure is provided on the coating film on the outer surface of the lumbar support deployment surface. As shown in Figures 19 and 20, the reinforced blocking structure includes an annular or partial protrusion, and the anchoring structure is formed from the waist. The support rods supporting the unfolded surface or the micro-thorns extending from the coating film, as shown in Figure 18, make the film-coated occlusion disc have an anchoring effect.

In a specific embodiment, as shown in FIG. 2 , the first central part includes a bolt head, a series wire and an anti-rotation structure; wherein, the bolt head is a two-piece type and is in an I-shape; The proximal end of each support rod is provided with a wire threading hole, and the series wire passes through all the threading holes in turn to gather the support rod on the waist of the I-shaped; the anti-rotation structure is fixedly connected to the bolt head and contacts the proximal end of the support rod , 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 detachable connection with the delivery system. Further, the coating film and the first central part are connected by a reinforcing member, and the reinforcing member is a tubular body or a linear body that matches the outline of the first central part to avoid the wrapping of the delivery sheath and the first central part area. Frictional contact of the cover film and enhanced connectivity of the cover film to the first central portion. Further, the concatenated wire is a portion of the support rod on the first support development surface extending toward the proximal end, so that the concatenated wire and the support rod are self-integrated. This design can significantly reduce the risk of thrombus on the device surface, especially at the head of the thrombus, and can reduce the risk of cardiovascular tissue damage and inflammation.

In another specific embodiment, as shown in FIG. 11 , the first central part includes a plug head and a collecting piece, the plug head is integrated, and the proximal ends of the support rods on the first support development surface are all gathered in the collecting piece , the bolt head is connected with the collecting piece, and the bolt head is provided with a detachable connection structure for detachable connection with the conveying system.

In a preferred embodiment, the height of the bolt head protruding from the first support development surface is less than or equal to 1 mm.

In a preferred embodiment, the bolt head is located in the three-dimensional space of the cage-like structure or the bowl-like structure, so as to ensure that the bolt head is not exposed outside the three-dimensional space of the cage-like structure or the bowl-like structure.

In a specific embodiment, the connection between the lumbar support development surface and the first support development surface is an arc transition, the arc transition radius is 0.5-4 mm, and the connection between the lumbar support development surface and the second support development surface is in the shape of an arc transition. The arc transition, and the arc transition radius is 1-4 mm; the design of the arc transition enables the occlusion disc of the present application to be placed in the biological cavity naturally, and adapts to the anatomical shape of the biological cavity, while the conventional one on the market The edge of the cover-type occlusion disc is generally sharp, and long-term implantation will wear the surrounding tissue of the biological cavity, so the design of the present application avoids such risks. Further, as shown in FIGS. 1 , 10 , 14 , 16 and 18 , the first support unfolding surface is in the form of a circular arc connection structure, a concave center structure, a plane structure or a combination structure of the three. When the occlusion disc is placed in the biological cavity, the occlusion disc has a self-suction effect of concave into the cavity, and when the occlusion disc is squeezed by the cavity, the first support development surface and/or the second support development surface has a self-priming effect. Partially independent support rods can be adjusted locally without affecting the rest of the support rods and/or sub-rods, so that the plugging disc can maintain the optimal plugging state with the changes in the shape of the biological cavity, with anatomical shape adaptation sex.

In a preferred embodiment, the material of the first central portion and the second central portion is one or more of pure tantalum, nickel-titanium alloy, 316L stainless steel, cobalt-chromium alloy, and platinum-iridium alloy.

In a specific embodiment, the diameter of the outer contour of the first support development surface is larger than that of the second support development surface by 2-10 mm, so that the plugging disc is in the shape of a plug, as shown in FIG. 1 and FIG. 16 , the sealing The section of the plug is approximately trapezoidal or bowl-shaped.

In a preferred embodiment, as shown in Fig. 26, the distal end of the occluding disc is provided with an attachment bracket, the attachment bracket is fixedly connected with the second central portion, and the attachment bracket is made of elastic and/or shape memory material , capable of anchoring in a biological cavity.

In a preferred embodiment, the wrapping film completely covers the first support unrolled surface and the lumbar support unrolled surface.

Further, the connection mode of the first support unfolding surface and the covering film is one of gluing, pressure lamination, heating and melting, and sewing.

In a preferred embodiment, the materials of the first support development surface, the lumbar support development surface and the second support development surface are titanium, tantalum, platinum, iridium, tungsten, gold, magnesium, zinc and other metal elements and their alloys, For example, nickel-titanium alloy, cobalt-chromium alloy, stainless steel and other metal materials, or polyamide, polyether block amide, polyimide, polyurethane, polyketone, polyolefin and other polymer materials.

In a preferred embodiment, the material of the coating film is polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane, polyamide, silica gel, polyolefin, or polylactic acid, polyvinyl alcohol and other degradable materials, or the coating film is selected from animal tissue.

In a preferred embodiment, the unfolded surface of the lumbar support has a certain height, and the height is 2-8 mm.

The present application will be described in detail and concretely below through specific embodiments, so as to make the present application better understood, but the following embodiments do not limit the scope of the present application.

Example 1

As shown in FIGS. 1-3 , this embodiment provides a novel film-coated plugging disc, which includes a plurality of support rods with elasticity and/or shape memory, a first flow blocking film and a first deformation compensation structure 4; wherein , a plurality of support rods extend from the first central portion 6 to the first supporting unfolding surface 1, the lumbar supporting unfolding surface 3 and the second supporting unfolding surface 2 in turn, and gather in the second central portion 7 to form a cage-like structure; the first The blocking film includes a covering film 5, which is covered on the outer surface of the first central portion 6, the inner and outer surfaces of the first support unfolding surface 1 and the outer surface of the waist support unfolding surface 3, and the outer surface of the covering film 5 is far away. The end edge is connected with the second support development surface 2 through the first deformation compensation structure 4 .

In the prior art, the blocking membrane on the blocking disc is of the inner plug type and is flat, and the metal wire on the blocking disc is directly connected to the blood and the cavity, which is easy to wear tissue and cause inflammation, which makes its endothelialization particularly difficult. Slowly, it usually takes 2 to 3 months, and the coating film 5 in the new film-coated plugging disc of Example 1 of the present application covers the inner and outer surfaces of the first support unfolding surface 1 and the outer surface of the lumbar support unfolding surface 3, so as to avoid the first A support unfolding surface 1 and a lumbar support unfolding surface 3 are in direct contact with blood and the cavity, and the coating film 5 has a microporous structure 51 with a pore size of 0.2-100 μm, which is more conducive to tissue growth and climbing. Therefore, half a month after the implantation of the new membrane-covered occluder disc in Example 1, it was found that the endothelium of the occluder disc was complete, and during the follow-up process, it was found that the sequence of endothelialization was ① lumbar support expansion surface → ② first support The outer surface of the unfolding surface→③the inner surface of the first supporting unfolding surface→④the second supporting unfolding surface, as shown in Figure 4.

In this embodiment, as shown in FIG. 3 , the first support development surface 1 is composed of a plurality of mutually independent support rods radially divergent from the first central portion 6 to the outer circumference, and each support rod is intertwined with a plurality of sub-rods Weaving into a twist-like structure, the plurality of sub-rods on the circumferential edge of the first supporting development surface 1 extend to the distal direction to form the supporting rods of the waist supporting and unfolding surface 3, and the multiple sub-rods on the distal circumferential edge of the waist supporting and unfolding surface 3 extend toward the first. The further extension of the two central portions 7 constitutes the support rods of the second supporting and unfolding surface 2 . The plurality of support rods supporting the unfolding surface 2 are intertwined and woven into a twist-like structure. The lumbar support unfolding surface 3 is made of a plurality of support rods, and the plurality of support rods are interspersed and woven up and down to form a grid-like structure. The plurality of support rods of the second support unrolling surface 2 are fixedly connected to the multiple support rods of the first support unrolling surface 1 through the multiple support rods of the lumbar support unrolling surface 3, so that the multiple support rods of the film-coated plugging disc are surrounded by a plurality of support rods. In the three-dimensional cage-like structure, the plurality of supporting rods of the second supporting unfolding surface 2 converge inward toward the center of the blocking disk and gather in the second central portion 7 . The connection between the lumbar support development surface 3 and the first support development surface 1 is in a circular arc transition, and the arc transition radius is 0.5-4 mm, and the connection between the lumbar support development surface 3 and the second support development surface 2 is in a circular arc transition, And the arc transition radius is 1-4mm. The first support development surface 1 and the second support development surface 2 are in the form of a multi-segment arc connection structure, a central concave structure, a plane structure or a combination structure of the three. The outer contour diameter of the first support development surface 1 is larger than the second support development surface. The diameter of the outer contour is between 2 and 10 mm, so that the plugging disc is in the shape of a plug, and its section is approximately trapezoidal or bowl-shaped.

In this embodiment, as shown in FIG. 2 , the first central portion 6 includes a bolt head 61 and a series wire 62 . The bolt head 61 is two-piece and I-shaped. The end is provided with a threading hole, and the series wire 62 gathers the support rods on the waist of the I-shaped through all the threading holes, so as to realize the connection between the bolt head 61 and all the support rods, and the bolt head 61 is provided with a detachable connection structure for Detachable connection to conveying system. The height of the bolt head 61 protruding from the first support and unfolding surface 1 is ≤ 1 mm. The bolt head 61 is located in the three-dimensional space enclosed by the support rod 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 extending toward the proximal end, so that the series wire 62 and the support rod are self-integrated, and the first central portion 6 also includes an anti-rotation structure 63, which is fixedly connected to the bolt head 61 On the top, the anti-rotation structure 63 can contact the proximal support rod, and the anti-rotation structure 63 is one or more partial protrusions or one or more blocking rods, as shown in FIG. 2 , the anti-rotation structure 63 is a blocking rod; or The I-shaped shape is formed into an irregular structure through mechanical clamping deformation, thereby realizing the limiting or fixing of the bolt head 61 and the proximal support rod in the circumferential direction. In addition, the coating film 5 is connected with the first central portion 1 by a reinforcing member 65 , which is a linear body that matches the outline of the first central portion 6 , and is used to avoid the delivery sheath and the area of the first central portion 6 . The frictional contact of the coating film 5 enhances the connection between the coating film 5 and the first central portion 6 .

In this embodiment, as shown in FIG. 3 , the first deformation compensation structure 4 is a plurality of closed coils, and the length of the curve of the closed coils is between 5 and 20 mm. The plurality of support rods are in one-to-one correspondence, and both the covering film 5 and the closed coil have elasticity, and the elastic deformation amount is between 10% and 500%. The method of connecting the first deformation compensation structure 4 to the covering film 5 and the lumbar support unfolding surface 3 and the second supporting unfolding surface 2 is shown in FIG. One of the supporting rods of the stitching line is passed out, and after the rear suture is wound on the supporting rod of the second supporting and unfolding surface 2, the two ends of the suture are knotted to form a closed loop. When the occluding disc is received into the delivery sheath, the span of the first deformation compensation structure is extended from the original L1 to L2, as shown in FIGS. 6 and 7 . This design has many advantages: the elastic wrapping film 5 and the first deformation compensation structure 4 can be adjusted to the plugging disc in time according to the shape of the plugging disc being squeezed or the length of the stretch, so that the plugging disc has the ability to move in and out. The sheath is self-adaptive, and when the occluder disc is released from the delivery sheath, it will restore its shape in time, making the occluder disc shape-recoverable.

In another embodiment, as shown in FIGS. 8 and 9 , the distal region of the covering film 5 is provided with one or more reinforced connecting structures 8 , so that the connection between the second supporting and unfolding surface 2 and the covering film 5 is more firm. . Specifically, as shown in FIG. 8 , the reinforcing connection structure 8 is a reinforcing coil partially or completely embedded or wrapped in the covering film 5 . It is wrapped so that the wrapping film 5 is integral with the reinforcing coil. As another preferred example, as shown in FIG. 9 , the proximal part of the reinforcing coil is wrapped in the covering film 5, and the distal part of the reinforcing coil is bound on the support rod of the second supporting surface 2. In this case, The reinforcing coil can not only exert the effect of the first deformation compensation structure 4, but also greatly enhance the contact area between the coil and the coating film 5, so that the connection strength of the reinforcing coil or the first deformation compensation structure 4 and the coating film 5 is significantly improved .

Example 2

As shown in Figures 10-12, compared with Example 1, the first difference between Example 2 and Example 1 is that the first flow blocking film further includes a reinforcing blocking body 9, which is arranged on the side of the blocking disk. On the second support unfolding surface 2, the edge of the reinforcing blocking body 9 is connected with the edge of the covering film 5 and the waist support unfolding surface 3 through the first deformation compensation structure 4, so that in the natural state, the covering film 5 and the reinforcing The blocking body 9 is formed into a closed cage shape adapted to the shape of the blocking disc, and the reinforcing blocking body 9 is made of a flexible film, and the flexible film has a microporous structure 51 , which is convenient for liquid to enter and exit. In addition, the microporous structure 51 is more conducive to tissue growth, so the reinforcing blocking body 9 provided in the blocking disk is also beneficial to accelerate the endothelialization process of the distal region of the blocking disk, that is, the second support development surface 2, so that the blocking disk is The inner reinforced plugging body 9 together with the covering film 5 grows as a whole in a near-synchronized, more rapid and encircling manner with the cavity tissue in contact with it, which increases the anchorage and finally further enhances the long-term safety of the plugging disc. . After follow-up and anatomy, it was found that the sequence of endothelialization of the new covered disc in Example 2 was ① lumbar support expansion surface → ② first support expansion surface outer surface → ③ first support expansion surface inner surface, second support expansion surface The inner surface of → ④ the outer surface of the second support development surface, as shown in Figure 13.

The second difference is: as shown in Figure 12, the first deformation compensation structure 4 is a series line surrounding the lumbar support development surface 3, and the ratio of the curve length of the series line to the perimeter of the outer contour of the first support development surface is 0.1 to 3:1, the serial line passes through or wraps around a plurality of support rods and the covering film 5 on the lumbar support unfolding surface 3 in turn, and finally realizes the end-to-end connection of the serial line. Compared with multiple closed coils, this design has the advantage of a simple fabrication process.

The third difference is that: as shown in FIG. 10 , the coating film 5 has a shape memory function and can be stretched and stretched as a corrugated or corrugated structure; this corrugated or corrugated structure improves the static friction between the coating film 5 and the cavity It can further increase the anchoring force, which is helpful for the safety of the anchoring. It can also play a similar effect as the anchoring stab, avoiding the risk of puncturing the left atrial appendage by the traditional anchoring stab, and at the same time, it can play the function of the first deformation compensation structure during the process of entering and exiting the sheath. .

The fourth difference is that: as shown in FIG. 11 , the first central part 6 includes a plug head 61 and a collecting piece 64 , the plug head 61 is integrated, and the proximal ends of all the support rods on the first support development surface 1 are gathered at the In the collecting piece 64, the plug head 61 is connected with the collecting piece 64 by means of welding, mechanical clamping, etc. The plug head 61 is provided with a detachable connection structure for detachable connection with the conveying system. This design has the significant advantages of simple manufacturing process and firm connection.

The fifth difference is that the coating film 5 and the first central portion 6 are connected by a reinforcing member 65, and the reinforcing member 65 is a tubular body that matches the outline of the first central portion 6 to prevent the delivery sheath from colliding with the first central portion 6. The frictional contact of the cladding film 5 in the region of a central portion 6 enhances the connection between the cladding film 5 and the first central portion 6 .

The sixth difference is that: as shown in FIG. 12 , the reinforcing blocking body 9 is provided with a second deformation compensation structure 10 , the compensation structure is a single coil, and the coil is slidably sleeved on the support of the second support development surface 2 On the rod, during the process of the blocking disc entering and exiting the delivery sheath, the reinforcing blocking body 9 synchronously compresses and stretches with the deformation of the lumbar support unfolding surface 3 and the second support unfolding surface 2 .

In another embodiment, the second deformation compensation structure is a plurality of coils.

Example 3

14, 15, the first difference between Embodiment 3 and Embodiment 1 is that the covering film 5 not only covers the lumbar support development surface 3 but also covers the second support development surface 2, and the covering film 5 is provided with There are two kinds of microporous structures 51 with pore sizes, one is a microporous structure with a pore size of 0.2-100 μm, this microporous structure only allows gas to pass through, but blood cannot pass through, which is more conducive to tissue growth and climbing; the other pore size. It has a microporous structure of 100-800 μm, which is convenient for liquids such as normal saline and contrast agents to enter and exit, and is conducive to preoperative emptying and intraoperative imaging.

The second difference is that: as shown in FIG. 15 , the first deformation compensation structure 4 is located at the edge of the coating film 5 , and the first deformation compensation structure 4 is a plurality of independent support rods surrounding the second support development surface 2 . A serial line, the serial line passes through or wraps around a plurality of independent support rods and the covering film 5 on the second support unfolding surface 2 in turn, so that the serial line is connected end to end. The advantage of this design is that the process is simpler, and the three-dimensional sealing performance of the plugging disc is better, and the self-adaptability of the plugging disc in and out of the sheath, shape recovery, etc. are also ensured.

Example 4

As shown in FIGS. 16-20 , compared with Embodiment 1, the first difference of Embodiment 4 is that: as shown in FIG. 16 , the second support unfolding surface 2 is open, and a plurality of support rods are arranged in sequence from the first central portion 6 A first support development surface 1, a lumbar support development surface 3 and a second support development surface 2 are extended to form a bowl-shaped structure.

The second difference is that: as shown in FIG. 17 , the lumbar support unfolding surface 3 is fixedly connected to each other to form a wavy structure by a plurality of support rods, and the covering film 5 of the annular surface of the lumbar support unfolding surface 3 is provided with a reinforcing blocking structure or Anchoring structure, as in Figures 16, 18. The reinforced sealing structure includes annular protrusions 52 or partial protrusions 54, and these protrusions are located on the coating film 5; The occluder disc has an anchoring effect without the need for an additional attachment frame 11 to be attached. The annular protrusions 52 , the partial protrusions 54 and the micro-thorns 53 are realized by filling materials with a sponge-like structure during the manufacturing process of the plugging disc.

In another embodiment, in order to reduce the diameter of the delivery sheath used in surgery, an injection channel with a one-way valve 55 is provided on the occlusion disc, as shown in Figures 21 and 22, so as to facilitate injection filling in minimally invasive surgery technique to fill.

In another embodiment, referring to FIGS. 23 , 24 and 25 , the covering film 5 on the lumbar support unfolding surface 3 is designed as a pouch 56 , and the gel material is filled as a filler 57 by injecting filler during the operation for individualization. Filling. The design of this injection filling technique can be used to individually fill the occlusion disc according to different left atrial appendages 12, so that the occlusion disc fits the cavity of the left atrial appendage 12 better, and reduces the incidence of residual shunts, while improving to a certain extent. The anchoring force finally achieves effective sealing.

Example 5

Referring to FIG. 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 blocking disc, and the attachment frame 11 is fixedly connected to the second central portion 7 , The attachment frame 11 is made of elastic and/or shape memory material and can be anchored within the biological cavity.

The second difference is that the coating film 5 not only completely covers the blocking disk, but also covers the connecting piece between the blocking disk and the attachment frame 11, which further reduces the contact area between the blood and the occluder and reduces the metal ions Precipitates and accelerates endothelialization. In addition, the microporous structure of the coating film 5 at the second support unfolding surface 2 is not shown in the figure.

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

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

Claims

A novel film-coated plugging disc, comprising a plurality of support rods with elasticity and/or shape memory, a first flow blocking film and a first deformation compensation structure (4); wherein the plurality of support rods are formed from the first The central portion (6) extends out of the first support development surface (1) and the second support development surface (2) in turn to form a cage-like structure or a bowl-like structure; the first flow blocking film includes a coating film (5) , the coating film (5) at least covers the inner and outer surfaces of the first support development surface (1) and the connection area between the first support development surface (1) and the second support development surface (2). Partial outer annular surface, the distal edge of the covering film (5) is connected with the second support unfolding surface (2) through the first deformation compensation structure (4).
The novel film-covered occlusion disc according to claim 1, further comprising a lumbar support unfolding surface (3); the first supporting unfolding surface (1) is formed by an outer peripheral diameter from the first central portion (6) A plurality of mutually independent supporting rods are formed, each supporting rod is made of a plurality of sub-rods that are intertwined and woven into a twist-like structure, and a plurality of the sub-rods on the circumferential edge of the first supporting development surface (1) are formed. The rod extends in the distal direction to form the support rod of the lumbar support expansion surface (3), and the lumbar support expansion surface (3) is a grid-like structure formed by a plurality of the support rods interspersed and woven up and down, or a plurality of One or more wave-like structures formed by the fixed connection of the support rods; a plurality of the support rods at the distal circumferential edge of the lumbar support development surface (3) extending toward the center to form the second support development surface (2) ) of the support rod, the plurality of the support rods of the second support development surface (2) are intertwined and woven into a twist-like structure, or a grid-like structure is formed by interlacing and weaving up and down, or fixedly connected to each other to form a or multiple corrugated structures; the distal region of the covering film (5) is provided with one or more reinforced connecting structures (8) to reinforce its connection with the second support unfolding surface (2).
The novel film-coated plugging disc according to claim 1, wherein the first deformation compensation structure (4) is composed of a plurality of closed coils, and the curve length of the closed coils is 2-20 mm, and each closed coil has a length of 2-20 mm. The coils are in one-to-one correspondence with each of the support rods of the lumbar support development surface (3) and/or each of the support rods of the second support development surface (2); or the first deformation compensation structure (4) is a series line, which in turn passes through or wraps around part or all of the support rod and/or part or all of the second support development surface (2) of the lumbar support development surface (3) The support rod and the coating film (5) are connected end to end; the ratio of the curve length of the series line to the perimeter of the outer contour of the first support unfolding surface (1) is 0.1-3:1.
The novel film-coated plugging disc according to claim 3, wherein the closed coil or the series wire has elasticity, and the elastic deformation amount thereof is 10-500%.
The novel film-coated plugging disc according to claim 1, wherein the coating film (5) is an elastic material or a shape-memory material; the elastic deformation of the elastic material is 10-500%; the shape The memory material is provided with an extendable corrugated structure or a corrugated structure.
The novel film-coated plugging disc according to claim 1, further comprising a second center portion (7), and the plurality of the support rods of the second support development surface (2) are directed toward the second center The part (7) converges and gathers at said second central part (7).
The novel film-coated plugging disc according to claim 6, wherein the first flow blocking film further comprises a reinforcing plugging body (9), the edge of the reinforcing plugging body (9) passing through the first The deformation compensation structure (4) is connected with the distal edge of the covering film (5) and the lumbar support unfolding surface (3). In a natural state, the covering film (5) is connected to the enhanced sealing The body (9) closes the cage-like structure; the material of the reinforcing blocking body (9) is a flexible film with a microporous structure (51); the reinforcing blocking body is provided with a second deformation compensation structure (10) , the second deformation compensation structure (10) is a single or multiple coils, and the coils are slidably sleeved on the support rod of the second support development surface (2).
The novel film-coated plugging disc according to claim 1, wherein the first central portion (6) comprises a plug head (61), a series wire (62) and an anti-rotation structure (63); wherein the plug The head (61) is a two-piece type, in the shape of an I-shaped; the proximal end of each of the support rods on the first support development surface (1) is provided with a wire threading hole, and the series wire (62) passes through in turn All the threading holes gather the support rod at the waist of the I-shape; the anti-rotation structure (63) is fixedly connected to the bolt head (61), and is connected with the proximal end of the support rod get in touch with.
A new type of film-coated plugging disc according to claim 1, wherein the coating film (5) and the first central portion (6) are connected by a reinforcing member (65), and the reinforcing member (65) ) is a tubular body or a linear body matched with the outline of the first central portion (6).
The novel film-coated occlusion disc according to claims 2 to 9, wherein the connection between the lumbar support unfolding surface (3) and the first support unfolding surface (1) is an arc transition, and the arc transition radius is 0.5 ~4mm, the connection between the lumbar support development surface (3) and the second support development surface (2) is an arc transition, and the arc transition radius is 1 ~ 4mm; the first support development surface (1) is Arc connection structure, concave center structure, plane structure or a combination of the three.
The novel film-coated plugging disc according to claims 1-9, wherein the coating film of the first flow blocking film is provided with two microporous structures with different pore sizes, and one of the microporous structures is The pore size of the microporous structure allows blood circulation, and the pore size of the other microporous structure allows only air circulation and does not allow blood circulation.
The novel film-coated plugging disc according to claim 11, wherein the pore size of the one microporous structure is 100-800 μm; the pore size of the other microporous structure is 0.2-100 μm, preferably the average pore size is about 0.45 μm.
The novel film-coated plugging disc according to claim 11, wherein the microporous structures of the two different pore sizes are uniformly distributed on the coating film of the first flow blocking film.