技术领域technical field
本发明涉及阻流膜技术领域，具体涉及一种封堵器阻流膜及其制造方法。The invention relates to the technical field of choke membranes, in particular to a choke membrane of an occluder and a manufacturing method thereof.
背景技术Background technique
阻流膜是封堵器的重要组成部分，当封堵器到达需要封堵的病变部位时，利用封堵器骨架定位，依靠阻流膜隔离病变部位，阻流膜最终完全内皮化，实现封堵的作用。The flow-blocking membrane is an important part of the occluder. When the occluder reaches the lesion that needs to be occluded, the occluder skeleton is used for positioning, and the flow-blocking membrane is used to isolate the lesion. The flow-blocking membrane is finally completely endothelialized to achieve closure. blocking effect.
房颤于1909最初被鉴定为老年心律不齐，随着全球人口日益增长，变得越来越重要。房颤会导致一些不好的影响，其中最严重的就是形成导致中风的血栓。基于植入器械，经皮穿刺封堵住左心耳已被证实为有效治疗方法。左心耳封堵术主要是利用金属骨架固定在左心耳中，依靠骨架外或骨架内的阻流膜封堵住左心耳口，将左心耳与左心房隔离。Originally identified in 1909 as an arrhythmia in the elderly, atrial fibrillation has become increasingly important as the global population grows. Atrial fibrillation can lead to several undesirable effects, the most serious of which is the formation of blood clots that lead to strokes. Based on implantable devices, percutaneous closure of the LAA has proven to be an effective treatment. Left atrial appendage occlusion mainly uses a metal frame to fix it in the left atrial appendage, and relies on the blocking membrane outside the frame or inside the frame to block the opening of the left atrial appendage and isolate the left atrial appendage from the left atrium.
一般采用的阻流膜为致密膜，将左心耳封住后，细胞沿阻流膜的边缘爬满整个阻流膜，这种方法造成阻流膜内皮化的时间较长。内皮化快慢一方面影响着抗凝药的服用周期，进而影响治疗时间，另一方面又影响植入器械的安全性。The blocking membrane generally used is a dense membrane. After the left atrial appendage is sealed, the cells crawl along the edge of the blocking membrane to fill the entire blocking membrane. This method results in a longer time for the endothelialization of the blocking membrane. On the one hand, the speed of endothelialization affects the taking cycle of anticoagulant drugs, which in turn affects the treatment time, and on the other hand, affects the safety of implanted devices.
发明内容Contents of the invention
为解决现有技术中的封堵器阻流膜与封堵器骨架配合使用时，内皮化慢，导致患者服用抗凝药的周期较长，治疗时间较长，提高了治疗费用，加重患者痛苦；同时具有较高的形成器械血栓的风险，导致基于器械植入的封堵术安全性较低的缺陷，本发明提供一种内皮化快速的封堵器阻流膜及其制造方法，进而降低患者抗凝药的服用周期，降低治疗费用，减轻患者的痛苦，并降低器械血栓风险，增加植入封堵手术的安全性。In order to solve the problem of slow endothelialization when the blocking membrane of the occluder in the prior art is used in conjunction with the occluder frame, the period for patients to take anticoagulants is longer, and the treatment time is longer, which increases the cost of treatment and aggravates the suffering of patients At the same time, there is a higher risk of device thrombus formation, which leads to the defect that the safety of occlusion based on device implantation is lower. The present invention provides a fast endothelialized occluder choke membrane and a manufacturing method thereof, thereby reducing The taking cycle of anticoagulant drugs for patients can reduce the cost of treatment, reduce the pain of patients, reduce the risk of device thrombosis, and increase the safety of implant closure surgery.
为实现上述目的，本发明采用的技术方案为：To achieve the above object, the technical solution adopted in the present invention is:
一种封堵器阻流膜，所述封堵器阻流膜上具有多个孔隙，所述孔隙尺寸的最大值R均为15～600μm。A choke film of an occluder, the choke film of the occluder has a plurality of pores, and the maximum value R of the pore size is 15-600 μm.
优选的，所述孔隙尺寸的最大值R均为50～300μm。使得所述封堵器阻流膜内皮化速度达到最快，使尽可能多的血流通过所述封堵器阻流膜，又使对人体有不良影响的血栓不能通过。Preferably, the maximum value R of the pore size is 50-300 μm. The speed of endothelialization of the blocking membrane of the occluder is the fastest, so that as much blood as possible passes through the blocking membrane of the occluding device, and the thrombus that has adverse effects on the human body cannot pass through.
优选的，所述封堵器阻流膜具有参数孔隙百分数P，所述孔隙百分数P的计算公式如下：Preferably, the blocking membrane of the occluder has a parameter pore percentage P, and the calculation formula of the pore percentage P is as follows:
所述封堵器阻流膜的孔隙百分数P为10％～60％。The pore percentage P of the blocking membrane of the occluder is 10%-60%.
优选的，所述封堵器阻流膜的孔隙百分数P为15％～50％。Preferably, the pore percentage P of the blocking membrane of the occluder is 15%-50%.
所述封堵器阻流膜的结构可以使封堵器阻流膜快速内皮化，内皮化快一方面可以有效的降低抗凝药的服用周期，缩短治疗时间，降低治疗费用，减轻患者的痛苦，另一方面使形成器械血栓风险降低，提高了基于器械植入的封堵术安全性。The structure of the blocking membrane of the occluder can quickly endothelialize the blocking membrane of the occluder. On the one hand, the fast endothelialization can effectively reduce the taking cycle of anticoagulants, shorten the treatment time, reduce the treatment cost, and reduce the suffering of patients. On the other hand, the risk of device thrombosis is reduced, and the safety of device implantation-based closure is improved.
优选的，所述封堵器阻流膜为筒状结构，其包括膜壁及配套使用的膜盘。Preferably, the blocking membrane of the occluder is a cylindrical structure, which includes a membrane wall and a supporting membrane disc.
优选的，所述膜壁和膜盘为一体式结构。Preferably, the membrane wall and the membrane disc are of an integral structure.
一种上述任一项所述的封堵器阻流膜的制造方法，包括以下步骤：A method of manufacturing the occluder barrier membrane described in any one of the above, comprising the following steps:
预处理：裁剪聚合物膜至合适尺寸，将其贴附模具棒卷绕一圈或多圈，并固定；Pretreatment: Cut the polymer film to a suitable size, attach it to the mold rod, wind it one or more times, and fix it;
热处理：将固定在模具棒上的聚合物膜连同模具棒一起放入加热设备中加热一次或多次，直至聚合物膜的孔隙尺寸及孔隙百分数符合热处理要求；Heat treatment: Put the polymer film fixed on the mold rod together with the mold rod into the heating equipment and heat it once or more times until the pore size and pore percentage of the polymer film meet the heat treatment requirements;
定型：将热处理后的聚合物膜从模具棒上取下，裁剪至合适尺寸，并将裁剪合适的聚合物膜覆盖、固定于定型模具的一端，在定型设备中定型一次或多次，直至聚合物膜的孔隙尺寸及孔隙百分数符合定型要求。Shaping: Remove the heat-treated polymer film from the mold rod, cut it to a suitable size, cover and fix the cut polymer film on one end of the shaping mold, and set it in the shaping equipment for one or more times until polymerized The pore size and pore percentage of the physical film meet the requirements for finalization.
优选的，所述预处理步骤中，所述聚合物膜裁剪后的尺寸为：长20～50cm，宽10～20cm。Preferably, in the pretreatment step, the cut size of the polymer film is: 20-50 cm in length and 10-20 cm in width.
优选的，所述预处理步骤中，通过固定套将所述聚合物膜和所述模具棒固定。Preferably, in the pretreatment step, the polymer film and the mold rod are fixed by a fixing sleeve.
优选的，所述固定套的材料为耐高温材料，具体为聚酰亚胺、聚芳酯、聚对二甲苯或硅胶。Preferably, the material of the fixing sleeve is a high temperature resistant material, specifically polyimide, polyarylate, parylene or silica gel.
优选的，所述预处理步骤中，所述模具棒的材料为刚性耐高温材料，具体为不锈钢或聚四氟乙烯。Preferably, in the pretreatment step, the material of the mold rod is a rigid high temperature resistant material, specifically stainless steel or polytetrafluoroethylene.
优选的，所述热处理步骤中，所述加热设备为烘箱或热处理炉。Preferably, in the heat treatment step, the heating equipment is an oven or a heat treatment furnace.
优选的，所述热处理步骤中，加热温度为120～250℃，加热时间为0.5～60min。Preferably, in the heat treatment step, the heating temperature is 120-250° C., and the heating time is 0.5-60 min.
优选的，所述热处理步骤中，加热温度为130～190℃，加热时间为5～40min。Preferably, in the heat treatment step, the heating temperature is 130-190° C., and the heating time is 5-40 minutes.
优选的，所述热处理步骤中，加热至所述聚合物膜的孔隙尺寸的最大值R均为12～480μm，孔隙百分数P为5～50％。Preferably, in the heat treatment step, the polymer membrane is heated until the maximum pore size R is 12-480 μm, and the pore percentage P is 5-50%.
优选的，所述热处理步骤中，加热至所述聚合物膜的孔隙尺寸的最大值R均为40～240μm，孔隙百分数P为10～40％。Preferably, in the heat treatment step, the polymer membrane is heated until the maximum pore size R is 40-240 μm, and the pore percentage P is 10-40%.
优选的，所述定型步骤中，所述聚合物膜(4)裁剪后的尺寸为：长6～15cm，宽6～15cm。Preferably, in the shaping step, the cut size of the polymer film (4) is: 6-15 cm in length and 6-15 cm in width.
优选的，所述定型步骤中，所述定型设备为水浴锅、盐浴锅/炉、烘箱或热处理炉。Preferably, in the shaping step, the shaping equipment is a water bath pot, a salt bath pot/furnace, an oven or a heat treatment furnace.
优选的，所述定型步骤中，定型温度为70～120℃，定型时间为5～2400s。Preferably, in the setting step, the setting temperature is 70-120°C, and the setting time is 5-2400s.
优选的，所述定型步骤中，定型温度为80～115℃，定型时间为5～600s。Preferably, in the setting step, the setting temperature is 80-115°C, and the setting time is 5-600s.
优选的，所述定型步骤中，定型至所述聚合物膜的孔隙尺寸的最大值R均为15～600μm，孔隙百分数P为10～60％。Preferably, in the setting step, the maximum value R of the pore size of the polymer membrane is set to 15-600 μm, and the pore percentage P is 10-60%.
优选的，所述定型步骤中，定型至所述聚合物膜的孔隙尺寸的最大值R均为50～300μm，孔隙百分数P为15～50％。Preferably, in the setting step, the maximum value R of the pore size of the polymer membrane is set to 50-300 μm, and the pore percentage P is 15-50%.
本发明的有益效果为：所述封堵器阻流膜包括膜盘和膜壁，膜材料由聚合物材料制成，孔隙尺寸的最大值为15～600μm，优选为50～300μm，孔隙百分数为10～60％，优选为15～50％。上述设计使所述封堵器阻流膜与封堵器骨架配合使用时，红细胞能够有效通过所述封堵器阻流膜，而血栓不能通过所述封堵器阻流膜，血栓在所述封堵器阻流膜的一侧沉降，经过巨噬细胞和淋巴细胞对沉降血栓吸收的炎症反应，平滑肌细胞浸润和纤维组织生成，封堵器阻流膜能够快速内皮化，缩短了患者治疗、观察时间。The beneficial effect of the present invention is that: the blocking membrane of the occluder includes a membrane disc and a membrane wall, the membrane material is made of a polymer material, the maximum pore size is 15-600 μm, preferably 50-300 μm, and the pore percentage is 10 to 60%, preferably 15 to 50%. The above design makes the occluder blocker membrane and the occluder skeleton used in conjunction, red blood cells can effectively pass through the occluder blocker membrane, and thrombus cannot pass through the occluder blocker membrane, and the thrombus will pass through the occluder blocker. One side of the blocking membrane of the occluder subsides, and through the inflammatory response of macrophages and lymphocytes to the absorption of the settled thrombus, the infiltration of smooth muscle cells and the formation of fibrous tissue, the blocking membrane of the occluding device can be rapidly endothelialized, shortening the treatment and Observe time.
附图说明Description of drawings
图1为本发明实施例的封堵器阻流膜的结构示意图；FIG. 1 is a schematic structural view of a flow blocking membrane of an occluder according to an embodiment of the present invention;
图2为本发明实施例的封堵器阻流膜的孔隙尺寸的最大值R的测量示意图；2 is a schematic diagram of measuring the maximum value R of the pore size of the occluder choke membrane of the embodiment of the present invention;
图3为本发明实施例的封堵器阻流膜的孔隙尺寸的最大值R与内皮化速度V的关系曲线；Fig. 3 is the relationship curve between the maximum value R of the pore size R and the endothelialization velocity V of the occluder choke membrane of the embodiment of the present invention;
图4为本发明实施例的封堵器阻流膜的制造方法中的预处理步骤的示意图；4 is a schematic diagram of the pretreatment steps in the manufacturing method of the occluder choke membrane according to the embodiment of the present invention;
图5为本发明实施例的封堵器阻流膜的制造方法中的定型模具的结构示意图；5 is a schematic structural view of a shaping die in a method for manufacturing a occluder flow barrier film according to an embodiment of the present invention;
图6为本发明实施例的封堵器阻流膜的制造方法中的定型步骤的示意图；6 is a schematic diagram of the shaping steps in the manufacturing method of the occluder choke membrane according to the embodiment of the present invention;
图7为本发明实施例的分体结构的封堵器阻流膜的定型步骤示意图；Fig. 7 is a schematic diagram of the shaping steps of the blocking film of the split structure occluder according to the embodiment of the present invention;
图8为本发明实施例的封堵器阻流膜与封堵器骨架组装后的结构示意图。Fig. 8 is a schematic structural view of the assembled occluder frame and the occluder frame according to the embodiment of the present invention.
图中，In the figure,
1-膜壁；2-膜盘；3-孔隙；4-聚合物膜；5-模具棒；6-固定套；7-定型模具；71-固定套槽；8-封堵器骨架。1-membrane wall; 2-membrane disc; 3-pore; 4-polymer film; 5-mold rod;
具体实施方式detailed description
下面结合附图对本发明的结构进行详细解释说明。The structure of the present invention will be explained in detail below in conjunction with the accompanying drawings.
如图1至图2所示，本发明实施例提供的一种封堵器阻流膜，包括膜盘2和膜壁1，其中膜盘2和膜壁1通常为一体式结构，在少数情况下也可以为分体结构。As shown in Figures 1 to 2, an embodiment of the present invention provides a blocking membrane for an occluder, including a membrane disc 2 and a membrane wall 1, wherein the membrane disc 2 and the membrane wall 1 are usually an integral structure, and in a few cases The bottom can also be a split structure.
所述膜盘2不限于圆形或多边形，若膜盘2为圆形时，其直径D为5～80mm，优选15～50mm，若膜盘2为多边形时，其内切圆直径为5～80mm，优选15～50mm。The membrane disc 2 is not limited to a circle or a polygon. If the membrane disc 2 is circular, its diameter D is 5-80 mm, preferably 15-50 mm. If the membrane disc 2 is polygonal, its inscribed circle diameter is 5-80 mm. 80mm, preferably 15-50mm.
膜壁1截面形状不限于圆形或多边形，可以与膜盘2的形状相同，也可以与膜盘2的形状不同。如图1所示，膜壁1长度尺寸L为1～50mm，优选长度L为5～25mm。The cross-sectional shape of the membrane wall 1 is not limited to circular or polygonal, and may be the same as or different from the shape of the membrane disk 2 . As shown in FIG. 1 , the length L of the membrane wall 1 is 1-50 mm, preferably 5-25 mm.
膜盘2与膜壁1上的孔隙3不限于圆形、多边形。所述孔隙3尺寸的最大值R均为15～600μm，优选为50～300μm，尺寸测量示意图如图2所示。孔隙百分数P为10～60％，优选15～50％，孔隙百分数指二维平面中，孔隙3的总面积占平面面积的百分比，孔隙百分数计算方法如下面公式所示：The pores 3 on the membrane disc 2 and the membrane wall 1 are not limited to circular or polygonal shapes. The maximum value R of the size of the pores 3 is 15-600 μm, preferably 50-300 μm. The schematic diagram of size measurement is shown in FIG. 2 . The pore percentage P is 10-60%, preferably 15-50%. The pore percentage refers to the percentage of the total area of the pores 3 in the plane area in a two-dimensional plane. The calculation method of the pore percentage is as shown in the following formula:
本发明实施例提供的一种封堵器阻流膜，所述孔隙3尺寸的最大值R指：所述孔隙3上距离最远的两点间的距离。In the blocking membrane of an occluder provided by an embodiment of the present invention, the maximum value R of the size of the pore 3 refers to the distance between the two furthest points on the pore 3 .
本发明实施例提供的一种封堵器阻流膜，其材料由聚合物材料制成，所述聚合物材料可以为聚醚指、聚氨酯、聚四氟乙烯、高密度聚乙烯、聚乙烯、聚对笨二甲酸乙二醇酯(PET)、膨体聚四氟乙烯(expanded PTFE)中的一种或多种的混合物材料，优选为聚对笨二甲酸乙二醇酯(PET)或膨体聚四氟乙烯(expanded PTFE)。An embodiment of the present invention provides an occluder blocking membrane, the material of which is made of a polymer material, the polymer material can be polyether finger, polyurethane, polytetrafluoroethylene, high-density polyethylene, polyethylene, One or more mixture materials of polyethylene terephthalate (PET), expanded polytetrafluoroethylene (expanded PTFE), preferably polyethylene terephthalate (PET) or expanded Bulk polytetrafluoroethylene (expanded PTFE).
如图3所示，本发明依据大量模拟实验和动物实验，在病理组织无梗死灶前提下，制得所述封堵器阻流膜孔隙3尺寸的最大值R与内皮化速度V的曲线。由图可知，本发明实施例的封堵器阻流膜的内皮化速度较快。As shown in FIG. 3 , the present invention, based on a large number of simulation experiments and animal experiments, obtains a curve of the maximum value R of the pore 3 size of the blocking membrane of the occluder and the endothelialization velocity V under the premise that the pathological tissue has no infarction. It can be seen from the figure that the endothelialization speed of the blocking membrane of the occluder according to the embodiment of the present invention is relatively fast.
本发明实施例提供的一种封堵器阻流膜的制造方法，包括以下步骤：An embodiment of the present invention provides a method for manufacturing a flow blocking membrane of an occluder, comprising the following steps:
将买回的聚合物纺织/编织成网膜，也可直接买回具有孔隙3的聚合物膜4。The repurchased polymer is spun/woven into a web, or directly repurchased as a polymer membrane 4 with pores 3 .
对聚合物膜4进行预处理，预处理过程为：将聚合物膜4裁剪成合适尺寸，将其贴附模具棒5卷绕两圈，用固定套6将所述聚合物膜4的上下两端固定在模具棒5上，其中，所述固定套6可以为硅胶固定套6，如图4所示，所述模具棒5为刚性耐高温材料，可以为不锈钢或聚四氟乙烯(PTFE)等，所述固定套6为耐高温材料，可以为聚酰亚胺、聚芳酯、聚对二甲苯或硅胶等。The polymer film 4 is pretreated. The pretreatment process is as follows: cutting the polymer film 4 into a suitable size, attaching it to the mold rod 5 and winding it twice, and fixing the upper and lower sides of the polymer film 4 with a fixed sleeve 6. end is fixed on the mold rod 5, wherein, the fixed sleeve 6 can be a silica gel fixed sleeve 6, as shown in Figure 4, the mold rod 5 is a rigid high temperature resistant material, which can be stainless steel or polytetrafluoroethylene (PTFE) etc., the fixed sleeve 6 is made of high temperature resistant material, such as polyimide, polyarylate, parylene or silica gel.
对预处理后聚合物膜4进行热处理，热处理可以为一次，也可为多次，直至孔隙3尺寸的最大值R为12～480μm，优选为40～240μm，孔隙百分数P为5～50％，优选10～40％。Carry out heat treatment to polymer film 4 after pretreatment, heat treatment can be once, also can be multiple times, until the maximum value R of pore 3 size is 12～480 μm, preferably 40～240 μm, the pore percentage P is 5～50%, Preferably 10 to 40%.
所述热处理设备可以为烘箱或热处理炉，热处理温度为120～250℃，优选130～190℃，热处理时间为0.5～60min，优选5～40min。The heat treatment equipment may be an oven or a heat treatment furnace. The heat treatment temperature is 120-250° C., preferably 130-190° C., and the heat treatment time is 0.5-60 minutes, preferably 5-40 minutes.
对热处理后的聚合物膜4定型：裁剪成长10cm，宽10cm的聚合物膜4，定型可以为一次，也可以为多次，直至孔隙3尺寸的最大值R为15～600μm，优选为50～300μm，孔隙百分数P为10～60％，优选15～50％。Shape the polymer film 4 after heat treatment: cut the polymer film 4 with a length of 10 cm and a width of 10 cm, and set the shape once or multiple times until the maximum value R of the size of the pores 3 is 15-600 μm, preferably 50-600 μm. 300 μm, the porosity percentage P is 10-60%, preferably 15-50%.
如图5至图6所示，定型可以在如下设备：水浴锅、盐浴锅/炉、烘箱或热处理炉中进行，定型温度为70～120℃，优选80～115℃，定型时间为5～2400s，优选5～600s。As shown in Figure 5 to Figure 6, the setting can be carried out in the following equipment: water bath pot, salt bath pot/furnace, oven or heat treatment furnace, the setting temperature is 70 ~ 120 ° C, preferably 80 ~ 115 ° C, and the setting time is 5 ~ 2400s, preferably 5-600s.
下面选取具体数值进行验证：Select specific values for verification below:
预处理：将PET原材料样品膜裁剪成长为40cm，宽为15cm的样品膜，卷绕在模具棒5上，使样品膜贴附在模具棒5上，在样品膜的两端套上硅胶固定套6固定。Pretreatment: Cut the PET raw material sample film into a sample film with a width of 40 cm and a width of 15 cm, wind it on the mold rod 5, make the sample film attach to the mold rod 5, and put silicone fixing sleeves on both ends of the sample film 6 fixed.
热处理：将预处理后的样品膜放入烘箱中进行第一次热处理，第一次热处理温度为180℃，热处理时间7min，取出样品膜在空气中冷却至室温，再将样品膜放入烘箱进行第二次热处理，第二次热处理温度150℃，热处理时间15min，取出样品膜在空气中冷却至室温，用工业相机拍摄热处理后的样品膜，测量样品膜孔隙3尺寸并计算孔隙百分数，得到热处理后的样品膜孔隙3尺寸的最大值为120μm，孔隙百分数为16.6％。Heat treatment: Put the pretreated sample film into an oven for the first heat treatment. The temperature of the first heat treatment is 180°C, and the heat treatment time is 7 minutes. Take out the sample film and cool it to room temperature in the air, and then put the sample film in the oven for further treatment. The second heat treatment, the second heat treatment temperature is 150°C, the heat treatment time is 15min, take out the sample film and cool it to room temperature in the air, take pictures of the sample film after heat treatment with an industrial camera, measure the size of the pores 3 of the sample film and calculate the pore percentage, and obtain the heat treatment The maximum size of pores 3 of the final sample membrane was 120 μm, and the percentage of pores was 16.6%.
定型：裁剪热处理后的样品膜，沿固定套6位置裁剪多余的样品膜，再将裁剪后的样品膜裁剪成长为10cm，宽为10cm的样品膜，将其按中心对称覆盖在定型模具7上，根据规格选择固定套槽71，套上固定套6，将固定后的样品膜放入烘箱，定型温度为110℃，定型时间为180s，取出样品膜在水中冷却至室温，沿固定套6位置裁剪，得到膜盘2直径为30mm，膜壁1长度为10mm，孔隙3尺寸的最大值为150μm，孔隙百分数为22.2％的封堵器阻流膜。Shaping: Cut the sample film after heat treatment, cut the excess sample film along the position of the fixing sleeve 6, then cut the sample film after cutting into a sample film with a width of 10 cm, and cover it symmetrically on the shaping mold 7 according to the center According to the specifications, select the fixing sleeve groove 71, put on the fixing sleeve 6, put the fixed sample film into the oven, the setting temperature is 110°C, and the setting time is 180s, take out the sample film and cool it to room temperature in water, and place it along the fixing sleeve 6 Cut to obtain a occluder blocking membrane with a diameter of the membrane disc 2 of 30 mm, a length of the membrane wall 1 of 10 mm, a maximum size of the pore 3 of 150 μm, and a pore percentage of 22.2%.
如图7所示，当所述膜盘2与膜壁1为分体结构时，在进行完上述定型步骤后需沿图7所示样品膜上虚线进行裁剪或熔切，在将膜盘2与膜壁1进行匹配时，需保证膜盘2尺寸大于或等于所述膜壁1的截面尺寸。As shown in Figure 7, when the membrane disc 2 and the membrane wall 1 are in a separate structure, after the above-mentioned shaping steps are completed, it is necessary to cut or melt cut along the dotted line on the sample film shown in Figure 7, and the membrane disc 2 When matching with the membrane wall 1 , it is necessary to ensure that the size of the membrane disc 2 is greater than or equal to the cross-sectional size of the membrane wall 1 .
最后将定型得到的封堵器阻流膜与左心耳封堵器骨架8缝合组成封堵器，植入在体重20kg左右的比格犬左心耳中进行验证，1个月得到内皮化封堵器阻流膜样本，经验证得出，1个月样本基本上实现了完全内皮化，用时仅为文献中记载45天完全内皮化的2/3。Finally, the shaped occluder blocking membrane and the left atrial appendage occluder skeleton 8 were sutured to form the occluder, which was implanted in the left atrial appendage of a Beagle dog weighing about 20 kg for verification, and an endothelialized occluder was obtained within one month As for the choke membrane sample, it has been verified that the complete endothelialization is basically achieved in the 1-month sample, which is only 2/3 of the 45-day complete endothelialization recorded in the literature.
在一些左心耳封堵器实例中，封堵器骨架8可以为编织结构或一体加工结构，封堵器阻流膜与骨架8通过缝合、热压、熔接或其他方式组装后配合使用，图8为组装后的一种实施例。In some left atrial appendage occluder examples, the occluder skeleton 8 can be a braided structure or an integrally processed structure, and the occluder blocking membrane and the skeleton 8 are used together after being assembled by suturing, heat pressing, welding or other methods, as shown in Fig. 8 It is an embodiment after assembly.
内皮化通俗而言是，人体自身器官内膜的最表层细胞向封堵器表面生长，形成一层内皮细胞的膜状组织。Generally speaking, endothelialization is that the most superficial cells of the intima of the body's own organs grow to the surface of the occluder to form a membranous tissue of endothelial cells.
以上仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明实质内容上所作的任何修改、等同替换和简单改进等，均应包含在本发明的保护范围之内。The above are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and simple improvements made on the essence of the present invention shall be included within the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710224082.1ACN106955135A (en) | 2017-04-07 | 2017-04-07 | A kind of plugging device choked flow film and its manufacture method |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710224082.1ACN106955135A (en) | 2017-04-07 | 2017-04-07 | A kind of plugging device choked flow film and its manufacture method |
| Publication Number | Publication Date |
|---|---|
| CN106955135Atrue CN106955135A (en) | 2017-07-18 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710224082.1APendingCN106955135A (en) | 2017-04-07 | 2017-04-07 | A kind of plugging device choked flow film and its manufacture method |
| Country | Link |
|---|---|
| CN (1) | CN106955135A (en) |
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