Novel film-coated plugging disc

Abstract

The invention discloses a novel film-coated plugging disc. The novel film-coated plugging disc comprises a plurality of supporting rods with elasticity and / or shape memory, a first flow blocking filmand a first deformation compensation structure, wherein the plurality of supporting rods sequentially extend out of a first support unfolding face and a second support unfolding face from a first central part to form a cage-shaped structure or bowl-shaped structure, the first flow blocking film comprises a coating film, the coating film at least coats inner and outer surfaces of the first supportunfolding face, and the local outer ring face of a connecting area of the first support unfolding face and the second support unfolding face, and the far-end edge of the coating film is connected withthe second support unfolding face through the first deformation compensation structure. By adopting a novel film coating method, the three-dimensional plugging is realized, a series of problems thatin the prior art, plugging is incomplete, residual shunting is easy to happen, and the like are solved, and the endothelialization is accelerated, so that the safety of the plugging disc is further improved.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a novel membrane-covered occlusion disc. Background technique [0002] Atrial fibrillation is one of the most common cardiac arrhythmia conditions and is the leading cause of hospital visits and hospitalizations for arrhythmia-related conditions, which is associated with decreased mobility, quality of life, cardiac function, and overall survival. As the population grows older, the social and economic burdens brought by atrial fibrillation will continue to increase. Although atrial fibrillation itself is not a fatal arrhythmia, it will cause stroke due to slow blood flow in the atrium and loss of atrioventricular synchronization. , heart failure and other complications increase the incidence rate, and even increase the mortality rate. [0003] Atrial fibrillation loses the effective contraction of the atrium, causing blood to stay in the left atrial appendage. In addition, the uniq...

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Problems solved by technology

Therefore, when this type of occlusion disk is placed at the mouth of the LAA or the cavity of the LAA, the occlusion disk and the blocking membrane cannot completely cover the opening of the LAA or cannot completely fit the cavity of the LAA, which eventually leads to The probability of residual shunt is greatly increased, even leading to the failure of plugging

[0008] (3) Some researchers have proposed a palliative design, that is, the expanded polytetrafluoroethylene film is used to plug the occluder, and its peripheral edge is covered with the inner and outer walls of the braided wire by thermal fusion and bonding. To avoid the defects caused by suture connection in the prior art, however, because the occluder needs to be delivered through interventional surgery, it is required that the connection between the membrane 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 peripheral surface of the occluder disc, and usually does not exceed the length of a braided mesh (≤4mm) in the braided design of the conventional occluder, and the sheath used in the interventional operation of the occluder is usually not larger than 14F, so the thickness of the film used cannot be too thick (usually no more than 0.2mm), which is similar to the above-mentioned planar flow blocking film in essence, so the plugging performance brought by this design also exists in the above-mentioned planar shape barrier film defects

[0009] (4) Patent No.: CN201720115376.6 left atrial appendage occluder and LAmbre left atrial appendage occluder occluder plate is in the shape of a sheet with sharp edges and can only be placed on the outer edge of the mouth of the left atrial appendage. Beating will wear the tissues around the left atrial appendage, such as mitral valve, left upper pulmonary vein, etc., and eventually lead to complications such as myocardial perforation, bleeding, and inflammation

[0010] (5) The existing occlusion disc is formed by alternately weaving nickel-titanium alloy wires up and down, and the wires are restrained by each other. It is difficult to adapt to the irregular opening of the left atrial appendage, and it is easy to cause residual shunt

[0011] Therefore, it is an important research direction to provide a new type of film-coated occlusion disc, which can solve a series of problems in the prior art, such as complications caused by device wear tissue, incomplete occlusion, and poor biocompatibility.

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