CN201082203Y - Heart defect occluder device - Google Patents

Abstract

The utility model relates to an intervention medical device, in particular to occlusion device for curing congenital heart disease. The heart defects occlusion device provided by the utility model comprises a network which is made by medical implant material. The expansion shape of the network is predefined. When the network is in predefined shape, the network comprises two umbrella atriums and a waist part which with less diameter at the middle. The end surface of the umbrella atriums are opening hollow. At least one of umbrella atriums are provided with equably distributed bearing wires at the hollow opening. Compared with prior art, the utility model comprises bearing wires at the hollow choking membrane of the far end umbrella atrium end surface, which can help reduce blood stream impact force on the choking membrane and also pressure on the two sides of the occlusion device, in order to avoid damage on the choking membrane and reduce the concave and the metal content inside human body.

Description

Translated fromChinese

心脏缺损封堵器Heart defect occluder

技术领域technical field

本实用新型涉及一种介入医疗器械，特别涉及一种用于治疗先天性心脏病的封堵器。The utility model relates to an interventional medical device, in particular to an occluder for treating congenital heart disease.

背景技术Background technique

先天性心脏病(Congenital Heart Disease；CHD)在正常人群中发病率大约1％(0.6％-1.2％)，按我国10亿人口计算，大约有1000万人患先天性心脏病，先天性心脏病儿童患病率高于成人。先天性心脏病包括动脉导管未闭(PDA)、卵圆孔未闭(PFO)、房间隔缺损(ASD)和室内隔缺损(VSD)等。PDA可能使血液在主动脉和肺动脉之间流动，PFO和ASD可能使血液在左心房和右心房之间流动，VSD可能使血液在左心室和右心室之间流动，流量较多时，一般需要修补。The incidence of congenital heart disease (CHD) in the normal population is about 1% (0.6%-1.2%). According to the calculation of my country's 1 billion population, about 10 million people suffer from congenital heart disease. Children have a higher prevalence than adults. Congenital heart disease includes patent ductus arteriosus (PDA), patent foramen ovale (PFO), atrial septal defect (ASD) and ventricular septal defect (VSD). PDA may flow blood between the aorta and pulmonary artery, PFO and ASD may flow blood between the left atrium and right atrium, and VSD may flow blood between the left ventricle and right ventricle. More flow usually requires repair .

目前已有多种类型的心脏间隔缺损封堵装置用于治疗先天性的心脏病，这些封堵装置通过导管或导线经股静脉或颈静脉送到患者心脏特定的位置。其中广泛使用的金属纤维编制的封堵器，图1所示为该封堵器在心脏内的使用状态，该类封堵器一般包括一个具有收缩性能预设外形的支撑网，该支撑网形成左右两个盘面2、3和连接两个盘面的腰4，盘面上有封头21、32，支撑网内置阻流膜；如图2所示，封堵器的支撑网1被拉长在导管内，经血管送到患者体内的缺损部位，将封堵器从导管内释放出来，但此过程中封堵器左盘2的封头21以突出状态进入左心房可能会触碰或损伤周边的左肺静脉口、冠状窦口及左心室的主动脉瓣以及其他心脏内结构，造成严重伤害。同时在现有的技术条件和操作手段下很难精确确定缺损孔大小和形状，由于腰部尺寸的限制，增加了医生在选择封堵装置型号方面的难度，若选号偏大，封堵器腰部被心脏间隔压缩使左右盘鼓起形成葫芦状，如图3所示，使在金属支撑网外部的封头更加突出，有触碰到周边组织的危险，导致严重后果。At present, various types of cardiac septal defect occlusion devices are used for the treatment of congenital heart diseases. These occlusion devices are sent to specific locations in the patient's heart through catheters or wires through the femoral vein or jugular vein. Among them, the occluder made of metal fiber is widely used. Figure 1 shows the state of use of the occluder in the heart. This type of occluder generally includes a support net with a preset shape of shrinkage performance, and the support net forms The left andright disks 2 and 3 and thewaist 4 connecting the two disks haveheads 21 and 32 on the disks, and the support net has a built-in flow-blocking film; as shown in Figure 2, the support net 1 of the occluder is elongated on the catheter In this process, the occluder is sent to the defective part of the patient's body through the blood vessel, and the occluder is released from the catheter. However, during this process, thehead 21 of theleft disc 2 of the occluder enters the left atrium in a protruding state, which may touch or damage the surrounding area. The ostium of the left pulmonary vein, the ostium of the coronary sinus, and the aortic valve of the left ventricle, as well as other intracardiac structures, caused serious injury. At the same time, it is difficult to accurately determine the size and shape of the defect hole under the existing technical conditions and operating methods. Due to the limitation of the waist size, it is more difficult for doctors to choose the type of occlusion device. If the size is too large, the waist of the occluder will be blocked. Compression of the cardiac septum makes the left and right disks bulge into a gourd shape, as shown in Figure 3, making the sealing head outside the metal support net more prominent, which may touch the surrounding tissues, resulting in serious consequences.

US2007/0043391公开了一种封堵器，如图4、5所示，该封堵器远端呈喇叭状，左盘面上已无封头，不仅解决了原有封堵器使用过程中封头触碰其他组织、封头脱落、封头引起的血栓问题，还减少了封堵器的金属含量，也大大降低了封堵器左盘被送入缺损位置时对周边组织伤害的可能性。但是，我们可知道除房间隔缺损两房的压力差交小外，室间隔缺损的左室和右室间的压力约为180毫米汞柱，动脉导管未闭处主动脉和肺动脉的压力差约为70～100毫米汞柱，若远端喇叭状开口处的阻流膜直接受到血流的冲击，承受缺损处血流的压差，会增大阻流膜破裂的可能性，同时在血液的冲击下阻流膜内凹，内凹处仍然会改变该处的血流动力学，使血栓容易形成，并且凹陷部分也会影响体内组织的爬附。US2007/0043391 discloses a occluder, as shown in Figures 4 and 5, the distal end of the occluder is trumpet-shaped, and there is no head on the left disk surface, which not only solves the problem of the original occluder during use. Touching other tissues, head falling off, and thrombus problems caused by the head also reduce the metal content of the occluder, and greatly reduce the possibility of damage to surrounding tissues when the left disc of the occluder is sent to the defect position. However, we know that the pressure difference between the left ventricle and the right ventricle of ventricular septal defect is about 180 mm Hg, and the pressure difference between the aorta and pulmonary artery at the patent ductus arteriosus is about 70-100 mm Hg, if the choke membrane at the distal trumpet-shaped opening is directly impacted by the blood flow and bears the pressure difference of the blood flow at the defect, the possibility of rupture of the choke membrane will be increased, and at the same time in the blood Under the impact, the choke membrane is concave, and the concave part will still change the hemodynamics at the place, making it easy for thrombus to form, and the concave part will also affect the adhesion of tissues in the body.

发明内容Contents of the invention

本实用新型的目的在于进一步提高端面为中空开放形状的封堵器的生物适应性及封堵效果。The purpose of the utility model is to further improve the biocompatibility and sealing effect of the occluder whose end face is hollow and open.

本实用新型的目的是通过如下技术方案来实现的：本实用新型的心脏缺损封堵器，由可医学植入材料制成的网隔组成，具有预先确定的扩展形状，处于扩展形状时包括两伞房和中间较小直径的腰，伞房端面呈开放性中空，其中所述至少一伞房的中空开口处设有均匀分布的承接丝。The purpose of this utility model is achieved through the following technical solutions: the utility model heart defect occluder is composed of mesh partitions made of medically implantable materials, has a predetermined expanded shape, and includes two The canopy and the waist with a smaller diameter in the middle, and the end surface of the canopy are open and hollow, wherein the hollow opening of the at least one canopy is provided with evenly distributed receiving wires.

本实用新型所述均匀分布的承接丝设于第一伞房端阻流膜的内侧。The uniformly distributed receiving wires of the utility model are arranged on the inner side of the flow blocking membrane at the end of the first canopy.

本实用新型所述均匀分布的承接丝穿缝在第一伞房阻流膜上。According to the utility model, the uniformly distributed connecting wires are sewed on the flow-blocking membrane of the first canopy.

本实用新型第二伞房由一装有连接装置的网隔盘通过导丝与中空开口的伞房连接构成，第二伞房端面可呈开放性中空。所述网隔盘上装有与输送系统连接的栓头。所述第二伞房阻流膜内侧设置均匀分布的承接丝。所述均匀分布的承接丝穿缝于第二伞房阻流膜上。The second umbrella house of the utility model is formed by connecting a mesh partition plate equipped with a connecting device with a hollow open umbrella house through a guide wire, and the end face of the second umbrella house can be open and hollow. A bolt head connected to the conveying system is installed on the mesh separation plate. Evenly distributed receiving wires are arranged on the inner side of the second umbrella house flow blocking membrane. The evenly distributed receiving wires are slit on the second umbrella house flow blocking membrane.

本实用新型与现有技术相比，由于在远端伞面为开放式中空的阻流膜处设有承接丝，帮助阻流膜承受血流冲力和封堵器两侧压力，防止阻流膜破损，减少内凹。丝可以大大减少，减少在人体内的金属含量。Compared with the prior art, the utility model is equipped with a connecting thread at the open and hollow choke membrane on the far-end umbrella surface, which helps the choke membrane to bear the blood flow momentum and the pressure on both sides of the occluder, and prevents the choke membrane from being damaged. breakage, less indentation. Silk can greatly reduce and reduce the metal content in the human body.

附图说明Description of drawings

图1为现有技术中一种封堵器的使用状态图Fig. 1 is the use state diagram of a kind of occluder in the prior art

图2为图1所示封堵器的使用过程示意图Fig. 2 is a schematic diagram of the use process of the occluder shown in Fig. 1

图3为图1所示封堵器的一种状态示意图Fig. 3 is a schematic diagram of a state of the occluder shown in Fig. 1

图4为现有技术中另一种封堵器的示意图Fig. 4 is the schematic diagram of another kind of occluder in the prior art

图5为图3所示封堵器示意图Figure 5 is a schematic diagram of the occluder shown in Figure 3

图6为本实用新型实施例1示意图Fig. 6 is a schematic diagram of theutility model embodiment 1

图7为本实用新型实施例2示意图Fig. 7 is the schematic diagram of theutility model embodiment 2

图8为本实用新型实施例3右盘面放大图Figure 8 is an enlarged view of the right disc surface ofEmbodiment 3 of the present utility model

图9为本实用新型实施例3拆撤网隔盘后的示意图Fig. 9 is a schematic diagram of theutility model embodiment 3 after dismantling the net partition

具体实施方式Detailed ways

下面通过具体实施方式对本实用新型作一详细说明：The utility model is described in detail below by specific embodiment:

如图4为本实用新型一实施例，封堵器1由可医学植入材料制成的网隔组成，具有预先确定的扩展形状，处于扩展形状时封堵器包括左右伞房2、3和中间较小直径的腰4，左伞房端面呈开放性中空，其中空开口22处穿接有均匀分布的承接丝23。使用时，左伞房端面设有阻流膜，该承接丝位于阻流膜内侧，封堵器左端面中空开口处的的阻流膜在封堵缺损口两侧的压差下以及血液的冲击下产生凹陷，穿接在开口处均匀分布的承接丝23设置在阻流膜内侧，承接住凹陷的阻流膜。Figure 4 is an embodiment of the present utility model, theoccluder 1 is made up of mesh partitions made of medically implantable materials, and has a predetermined expanded shape. When in the expanded shape, the occluder includes left andright umbrella chambers 2, 3 and Thewaist 4 with a smaller diameter in the middle, and the end face of the left canopy are open and hollow, and thehollow opening 22 is pierced with evenly distributedreceiving wires 23 . When in use, the end face of the left umbrella house is provided with a flow-blocking film, and the connecting wire is located inside the flow-blocking film. A depression is formed on the bottom, and thereceiving wires 23 evenly distributed at the opening are arranged on the inner side of the flow-stopping film to support the depressed flow-stopping film.

或者如图5所示，承接丝23直接穿接在封堵器左端的阻流膜24上，增加左端面中空开口22处阻流膜的承压性，减少凹陷程度。当然，可以同时采用部分承接丝23设于阻流膜24内侧和部分承接丝23穿接在阻流膜24上的方式。Alternatively, as shown in FIG. 5 , thereceiving wire 23 is directly connected to the flow-blocking membrane 24 at the left end of the occluder to increase the pressure bearing capacity of the flow-blocking membrane at thehollow opening 22 on the left end surface and reduce the degree of depression. Certainly, the method that part of thereceiving wire 23 is arranged inside the flow blocking film 24 and part of thereceiving wire 23 is pierced on the flow blocking film 24 can be adopted at the same time.

图4、5所示所示封堵器的右房伞端面3，如图6、图7、图8、图9所示，可由一网隔盘35通过导丝36与右伞房中空开口32连接构成，网隔盘35上装有与输送系统连接的栓头。右伞房中空开口32处设有均匀分布的承接丝33。使用时，承接丝33置于伞房端面的阻流膜内侧，或穿接在阻流膜上，当然，也可以同时采用部分承接丝设于阻流膜内侧和部分承接丝穿接在阻流膜上的方式。当植入封堵器时，通过栓头上的螺纹装置和输送器相连，然后在X光监视设备下借助输送器将封堵器输送至病变位置，调整好角度后，释放封堵器以封堵缺损部位。确定释放封堵器时，首先松开导丝36一端，将导丝撤掉，然后将带螺纹装置的金属盘35回收。The rightumbrella end face 3 of the occluder shown in Figures 4 and 5, as shown in Figures 6, 7, 8, and 9, can be connected to thehollow opening 32 of the right umbrella by amesh partition plate 35 through theguide wire 36 Connection constitutes, and the bolt head that is connected with conveying system is housed on themesh spacer plate 35. Thehollow opening 32 of the right canopy is provided with evenly distributedreceiving wires 33 . During use, thereceiving wire 33 is placed on the inside of the flow-blocking film on the end face of the canopy, or connected on the flow-blocking film. way on the membrane. When the occluder is implanted, it is connected to the conveyor through the screw device on the plug head, and then the occluder is delivered to the lesion with the help of the conveyor under the X-ray monitoring equipment. After the angle is adjusted, the occluder is released to occlude Plug the defect. When it is determined to release the occluder, first loosen one end of theguide wire 36, remove the guide wire, and then recover themetal disc 35 with the threaded device.

封堵器端面中空，减少了封堵器的金属含量，置于中空开口22、32处的承接丝23、33，增强了封堵器端面阻流膜的承压性，一方面，帮助阻流膜承接血流的冲击压力，进一步保证了阻流膜使用的安全性；另一方面，减少封堵器使用时阻流膜的凹陷形变，使内皮细胞更加容易爬附，加快患者的康复速度。The end face of the occluder is hollow, which reduces the metal content of the occluder, and thereceiving wires 23, 33 placed at thehollow openings 22, 32 enhance the pressure bearing performance of the flow-blocking film on the end face of the occluder. On the one hand, it helps to block flow The membrane bears the impact pressure of the blood flow, which further ensures the safety of the blocking membrane; on the other hand, it reduces the concave deformation of the blocking membrane when the occluder is used, making it easier for endothelial cells to attach and speed up the recovery of patients.

Claims (7)

1. heart defect stopper, but the net of being made by the medical science embedded material is every forming, has predetermined expanded configuration, comprise two umbrella rooms and middle waist when being in expanded configuration than minor diameter, umbrella room end face is open hollow, it is characterized in that: the hollow open place in described at least one umbrella room is provided with the equally distributed silk of accepting.

2. heart defect stopper according to claim 1 is characterized in that: the described equally distributed inboard that silk is located at the first umbrella room end choked flow film of accepting.

3. heart defect stopper according to claim 1 and 2 is characterized in that: the described equally distributed silk of accepting is worn and is sewn on the first umbrella room choked flow film.

4. heart defect stopper according to claim 1 is characterized in that: the second umbrella room is connected and composed every the umbrella room of dish by seal wire and hollow open by a net that connecting device is housed, and the second umbrella room end face can be open hollow.

5. heart defect stopper according to claim 4 is characterized in that: described net is equipped with the bolt head that is connected with induction system on dish.

6. heart defect stopper according to claim 5 is characterized in that: the described second umbrella room choked flow film inboard is provided with the equally distributed silk of accepting.

7. heart defect stopper according to claim 6 is characterized in that: the described equally distributed silk of accepting is worn and is sewn on the second umbrella room choked flow film.

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