技术领域technical field
本发明涉及一种可自适应变角度封堵器，用在治疗房间隔缺损房间隔缺损(ASD)、动脉导管未闭(PDA)、室间隔缺损(VSD)或卵圆孔未闭(PFO)中。The invention relates to an adaptive variable angle occluder, which is used for treating atrial septal defect atrial septal defect (ASD), patent ductus arteriosus (PDA), ventricular septal defect (VSD) or patent foramen ovale (PFO) middle.
背景技术Background technique
市场上常用封堵器是由镍钛管状网两端使用结扎钢套结扎，由两个盘状和柱状连接部分组成，常规封堵器的盘状和支撑腰部是一体的网状结构。对于两侧薄厚差异较大的缺损，常规封堵器存在倾斜角度有限从而达不到良好的封堵效果，后续的残余分流现象常常需要额外放置一个封堵器来实现封堵效果。这不仅增加了封堵器的金属植入量和手术操作难度，同时封堵器更容易脱落，另外患者治疗费用大幅增加。Commonly used occluders on the market are made of nickel-titanium tubular mesh with ligature steel sleeves at both ends. It consists of two disc-shaped and column-shaped connecting parts. The disc-shaped and supporting waist of conventional occluders are an integrated mesh structure. For defects with large differences in thickness on both sides, the conventional occluder has a limited inclination angle and cannot achieve a good occlusion effect, and the subsequent residual shunt often requires an additional occluder to achieve the occlusion effect. This not only increases the amount of metal implanted in the occluder and the difficulty of the operation, but also makes the occluder more likely to fall off, and also increases the treatment cost of the patient significantly.
发明内容Contents of the invention
本发明的目的是提供一种可自适应变角度封堵器，其在封堵器与缺损匹配时可以自适应的选择最合适的连接位置，从而达到最优的封堵效果。The purpose of the present invention is to provide an self-adaptive variable-angle occluder, which can adaptively select the most suitable connection position when the occluder matches the defect, so as to achieve the optimal occlusion effect.
为了达到上述目的，本发明提供了一种可自适应变角度封堵器，包括上、下两个封堵盘，其特征在于，所述的上、下两个封堵盘之间通过可旋转的连接结构连接。In order to achieve the above object, the present invention provides an adaptive variable-angle occluder, which includes two upper and lower occlusion disks, and is characterized in that the upper and lower occlusion disks are connected by a rotatable connection structure connection.
优选地，所述的上、下两个封堵盘均为平面，或者，位于上侧的封堵盘的中部向下弯折，或者，位于上侧的封堵盘的外周边向下翻扣。Preferably, both the upper and lower blocking disks are flat, or the middle part of the blocking disk on the upper side is bent downwards, or the outer periphery of the blocking disk on the upper side is turned down .
优选地，所述的可旋转的连接结构包括第一连接件、第二连接件，所述的第一连接件与上封堵盘的下盘面固定连接，第二连接件与下封堵盘的上盘面固定连接，所述的第一连接件具有一个球形的下端，该球形的下端采用可旋转的方式设于第二连接件的顶部中。Preferably, the rotatable connection structure includes a first connecting piece and a second connecting piece, the first connecting piece is fixedly connected with the lower surface of the upper blocking disk, and the second connecting piece is connected with the lower surface of the lower blocking disk. The upper plate is fixedly connected, the first connecting part has a spherical lower end, and the spherical lower end is rotatably arranged in the top of the second connecting part.
更优选地，所述的第一连接件包括第一部件和第二部件，所述的第一部件与上封堵盘的下盘面固定连接，第二部件的上端与第一部件固定连接，第二部件的下端为球形；所述的第二连接件包括圆柱形本体，圆柱形本体的下端与下封堵盘的上盘面固定连接，圆柱形本体的顶端内壁上具有环状凸起，该环状凸起将所述的第二部件的球形的下端限位于圆柱形本体的顶部中，所述的圆柱形本体内设有限位件，限位件的上端具有半球形凹槽，所述的第二部件的球形的下端采用可旋转的方式设于所述的半球形凹槽中。More preferably, the first connecting member includes a first part and a second part, the first part is fixedly connected to the lower surface of the upper blocking disk, the upper end of the second part is fixedly connected to the first part, and the second part The lower end of the second part is spherical; the second connector includes a cylindrical body, the lower end of the cylindrical body is fixedly connected with the upper surface of the lower sealing disc, and the inner wall of the top end of the cylindrical body has a ring-shaped protrusion. The spherical lower end of the second part is limited by the shape protrusion in the top of the cylindrical body, the cylindrical body is provided with a limiter, and the upper end of the limiter has a hemispherical groove. The first The spherical lower ends of the two components are rotatably arranged in the hemispherical groove.
优选地，所述的可旋转的连接结构包括第一连接件、第二连接件，所述的第一连接件与上封堵盘的下盘面固定连接，第二连接件与下封堵盘的上盘面固定连接，第一连接件的下端通过销轴设于第二连接件的上端内，第一连接件可绕所述的销轴旋转。Preferably, the rotatable connecting structure includes a first connecting piece and a second connecting piece, the first connecting piece is fixedly connected with the lower surface of the upper blocking disk, and the second connecting piece is connected with the lower surface of the lower blocking disk. The upper disk surface is fixedly connected, the lower end of the first connecting part is arranged in the upper end of the second connecting part through a pin shaft, and the first connecting part can rotate around the pin shaft.
优选地，所述的可旋转的连接结构包括第一连接件、第二连接件，所述的第一连接件与上封堵盘的下盘面固定连接，第二连接件与下封堵盘的上盘面固定连接，第一连接件的下端与连接丝连接，所述的连接丝通过销轴设于第二连接件的上端内，第一连接件可经由连接丝绕所述的销轴旋转。Preferably, the rotatable connection structure includes a first connecting piece and a second connecting piece, the first connecting piece is fixedly connected with the lower surface of the upper blocking disk, and the second connecting piece is connected with the lower surface of the lower blocking disk. The upper plate is fixedly connected, the lower end of the first connecting piece is connected with the connecting wire, and the connecting wire is arranged in the upper end of the second connecting piece through a pin shaft, and the first connecting piece can rotate around the pin shaft through the connecting wire.
优选地，所述的可旋转的连接结构包括第一连接件、第二连接件，所述的第一连接件与上封堵盘的下盘面固定连接，第二连接件与下封堵盘的上盘面固定连接，第一连接件的下端与连接丝连接，所述的连接丝连接第二连接件。Preferably, the rotatable connecting structure includes a first connecting piece and a second connecting piece, the first connecting piece is fixedly connected with the lower surface of the upper blocking disk, and the second connecting piece is connected with the lower surface of the lower blocking disk. The upper panel is fixedly connected, the lower end of the first connecting piece is connected with the connecting wire, and the connecting wire is connected with the second connecting piece.
优选地，所述的上、下两个封堵盘皆由镍钛合金丝编织而成。Preferably, the upper and lower occlusion disks are both braided by nickel-titanium alloy wires.
优选地，位于上侧的封堵盘采用镍钛合金丝收口，不设置钢套。Preferably, the sealing disk on the upper side is closed with nickel-titanium alloy wire, and no steel sleeve is provided.
优选地，位于下侧的封堵盘设有可与螺纹推送杆连接的带螺纹的钢套。Preferably, the blocking disc located on the lower side is provided with a threaded steel sleeve which can be connected with the threaded push rod.
优选地，所述的上、下两个封堵盘中的至少一个内部设有起阻断血流作用的高分子阻流膜。Preferably, at least one of the upper and lower occlusion discs is provided with a polymer flow blocking membrane to block blood flow.
与现有技术相比，本发明的有益效果是：Compared with prior art, the beneficial effect of the present invention is:
1、本发明采用上、下两个封堵盘夹角可变的连接方式，在封堵器与缺损匹配时可以自适应的选择最合适的连接位置，更加贴合组织部位，从而达到最优的封堵效果；1. The present invention adopts a connection method with a variable angle between the upper and lower occlusion disks. When the occluder is matched with the defect, the most suitable connection position can be adaptively selected to fit the tissue more closely, thereby achieving optimal blocking effect;
2、本发明通过上封堵盘的翻扣设计，进一步改善了封堵效果；2. The present invention further improves the plugging effect through the flip-up design of the upper plugging disc;
3、本发明的封堵器固定牢靠，不容易脱落，且无需额外放置一个封堵器，来阻断残余分流，减少了手术难度，同时减轻了患者的痛苦。3. The occluder of the present invention is firmly fixed, not easy to fall off, and does not need to place an additional occluder to block the residual shunt, which reduces the difficulty of the operation and relieves the pain of the patient.
4、本发明操作简便，与现有封堵器的使用方法相同。4. The operation of the present invention is simple and convenient, and the usage method is the same as that of the existing occluder.
附图说明Description of drawings
图1a为可自适应变角度封堵器结构示意图；Figure 1a is a schematic structural diagram of an adaptive variable-angle occluder;
图1b为实施例2中的连接结构示意图；Fig. 1 b is the connection structure schematic diagram in embodiment 2;
图2a为无钢套设计的上封堵盘结构示意图；Figure 2a is a schematic diagram of the structure of the upper sealing disc designed without a steel sleeve;
图2b为上封堵盘无钢套设计的可自适应变角度封堵器结构示意图；Figure 2b is a schematic structural diagram of an adaptive variable-angle occluder designed without a steel sleeve on the upper occlusion disc;
图3a为可自适应变角度封堵器使用状态图；Figure 3a is a diagram of the state of use of the self-adaptive variable angle occluder;
图3b为实施例1中的连接结构旋转示意图；Figure 3b is a schematic diagram of the rotation of the connection structure in Example 1;
图4为具有外周边向下翻扣的上封堵盘的可自适应变角度封堵器结构示意图；Fig. 4 is a schematic structural diagram of an adaptive variable-angle occluder with an upper occluder that is flipped down on the outer periphery;
图5a为上封堵盘一侧向下翻扣的可自适应变角度封堵器结构示意图；Fig. 5a is a schematic structural diagram of an adaptive variable-angle occluder with one side of the upper occlusion disc flipped downward;
图5b为中部向下弯折的上封堵盘结构示意图；Fig. 5b is a schematic diagram of the structure of the upper sealing disc with the middle part bent downward;
图6为中部向下弯折的可自适应变角度封堵器使用示意图；Fig. 6 is a schematic diagram of the use of the self-adaptive variable-angle occluder bent downward in the middle;
图7a为实施例3中的连接结构示意图；Fig. 7 a is the connection structure schematic diagram in embodiment 3;
图7b为实施例4中的连接结构示意图；Figure 7b is a schematic diagram of the connection structure in Example 4;
图7c为实施例5中的连接结构示意图；Figure 7c is a schematic diagram of the connection structure in Example 5;
图8为连接结构的制作过程图；Fig. 8 is the fabrication process diagram of connection structure;
图9为封堵器定型示意图；Fig. 9 is a schematic diagram of the shaping of the occluder;
图10为定型好的封堵器示意图。Figure 10 is a schematic diagram of the shaped occluder.
具体实施方式detailed description
下面结合具体实施例，进一步阐述本发明。应理解，这些实施例仅用于说明发明而不用于限制本发明的范围。此外应理解，在阅读了本发明讲授的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。Below in conjunction with specific embodiment, further illustrate the present invention. It should be understood that these examples are only for illustrating the invention and are not intended to limit the scope of the invention. In addition, it should be understood that after reading the teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.
实施例1Example 1
如图2b所示，本实施例的可自适应变角度封堵器，包括上、下两个封堵盘1，所述的上、下两个封堵盘1之间可旋转的连接结构2连接。所述的上、下两个封堵盘1皆由镍钛合金丝编织而成，所述的上、下两个封堵盘1均为平面结构。如图2a所示，位于上侧的封堵盘1采用镍钛合金丝收口，不设置钢套。位于下侧的封堵盘1设有可与螺纹推送杆连接的带螺纹的钢套4。As shown in Figure 2b, the self-adaptive variable-angle occluder of this embodiment includes two upper and lower occlusion disks 1, and a rotatable connection structure 2 between the upper and lower two occlusion disks 1 connect. Both the upper and lower sealing discs 1 are braided by nickel-titanium alloy wires, and the upper and lower sealing discs 1 are planar structures. As shown in Fig. 2a, the sealing disk 1 on the upper side is closed with nickel-titanium alloy wire, and no steel sleeve is provided. The plugging disc 1 on the lower side is provided with a threaded steel sleeve 4 that can be connected with the threaded push rod.
如图3b所示，所述的可旋转的连接结构2包括第一连接件11、第二连接件12，所述的第一连接件11与上封堵盘1的下盘面固定连接，第二连接件12与下封堵盘2的上盘面固定连接，所述的第一连接件11具有一个球形的下端，该球形的下端采用可旋转的方式设于第二连接件12的顶部中。As shown in Figure 3b, the rotatable connecting structure 2 includes a first connecting piece 11 and a second connecting piece 12, the first connecting piece 11 is fixedly connected with the lower surface of the upper blocking disk 1, and the second The connecting piece 12 is fixedly connected to the upper surface of the lower sealing disk 2 , the first connecting piece 11 has a spherical lower end, and the spherical lower end is rotatably arranged in the top of the second connecting piece 12 .
如图8所示，所述的可旋转的连接结构2的具体结构为：所述的第一连接件11包括第一部件111和第二部件112，所述的第一部件111与上封堵盘1的下盘面固定连接，第二部件112的上端与第一部件111固定连接，第二部件112的下端为球形；所述的第二连接件12包括圆柱形本体121，圆柱形本体121的下端与下封堵盘2的上盘面固定连接，圆柱形本体121的顶端内壁上具有环状凸起123，该环状凸起123将所述的第二部件112的球形的下端限位于圆柱形本体121的顶部中，所述的圆柱形本体121内设有限位件122，限位件122的上端具有半球形凹槽，所述的第二部件112的球形的下端采用可旋转的方式设于所述的半球形凹槽中。制作时，将第二部件112的球形的下端卡入圆柱形本体121中，将限位件122置入圆柱形本体121内对第二部件112的球形的下端进行限位，再将第二部件112与第一部件111连接即可。As shown in Figure 8, the specific structure of the rotatable connecting structure 2 is: the first connecting piece 11 includes a first part 111 and a second part 112, and the first part 111 and the upper block The lower surface of the disc 1 is fixedly connected, the upper end of the second part 112 is fixedly connected with the first part 111, and the lower end of the second part 112 is spherical; the second connecting part 12 includes a cylindrical body 121, the cylindrical body 121 The lower end is fixedly connected to the upper surface of the lower blocking disc 2, and the inner wall of the top end of the cylindrical body 121 has an annular protrusion 123, which limits the spherical lower end of the second part 112 to a cylindrical position. On the top of the body 121, the cylindrical body 121 is provided with a stopper 122, the upper end of the stopper 122 has a hemispherical groove, and the spherical lower end of the second part 112 is rotatably arranged on the In the hemispherical groove. During production, the spherical lower end of the second part 112 is snapped into the cylindrical body 121, the stopper 122 is inserted into the cylindrical body 121 to limit the spherical lower end of the second part 112, and then the second part 112 can be connected with the first component 111.
本实施例的可自适应变角度封堵器的制作过程为，将镍钛合金在模具上进行编织成丝网，热处理定型，将丝网从模具上取下，位于上侧的封堵盘1的上端口采用镍钛合金丝收口，下端口与可旋转的连接结构2的第一连接件11固定连接，将位于下侧的封堵盘1的上端口与第二连接件12固定连接，下端口与带螺纹的钢套4固定连接，并将第一连接件11和第二连接件12连接后，如图9所示，将丝网装入定型模具15中，再次进行热处理，得到如图10所示的可自适应变角度封堵器，在上、下两个封堵盘1中缝合起阻断血流作用的高分子阻流膜。The manufacturing process of the self-adaptive variable-angle occluder in this embodiment is as follows: weave the nickel-titanium alloy into a wire mesh on the mold, heat treatment and shape it, remove the wire mesh from the mold, and place the occlusion disk 1 on the upper side The upper port of the upper port is closed with nickel-titanium alloy wire, the lower port is fixedly connected with the first connecting part 11 of the rotatable connecting structure 2, and the upper port of the sealing disc 1 on the lower side is fixedly connected with the second connecting part 12, and the lower port is fixedly connected with the second connecting part 12. The port is fixedly connected with the threaded steel sleeve 4, and after the first connector 11 and the second connector 12 are connected, as shown in Figure 9, the wire mesh is packed into the shaping die 15, and heat treatment is carried out again to obtain In the self-adaptive variable-angle occluder shown in 10 , a polymer blocking membrane that blocks blood flow is sutured in the upper and lower occlusion discs 1 .
使用时，将螺纹推送杆连接带螺纹的钢套4，将本封堵器拉入短鞘后将短鞘与长鞘连接，然后将此封堵器送入长鞘，沿长鞘送至缺损部位，释放上侧的封堵盘1后回撤，待下侧的封堵盘1通过缺损后释放下侧的封堵盘1。轻轻拉拽封堵器使封堵器自适应到最佳位置，在遇到两侧薄厚差异较大的缺损时会自适应的变为如图3a所示的形状，连接结构旋转如图3b所示。然后旋转推送杆通过推送杆头端的螺丝将推送杆与封堵器分离。此时封堵器在缺损部位起到阻挡血流的效果，从而起到治疗作用。When in use, connect the threaded push rod to the threaded steel sleeve 4, pull the occluder into the short sheath, connect the short sheath with the long sheath, then send the occluder into the long sheath, and send it to the defect along the long sheath After releasing the upper occluding disk 1, retreat, and release the lower occluding disk 1 after the lower occluding disk 1 passes through the defect. Gently pull the occluder to make the occluder adapt to the best position. When encountering a defect with a large difference in thickness on both sides, it will adapt to the shape shown in Figure 3a, and the connection structure will rotate as shown in Figure 3b shown. Then rotate the push rod to separate the push rod from the occluder through the screw at the head end of the push rod. At this time, the occluder can block the blood flow at the defect site, thus playing a therapeutic role.
实施例2Example 2
如图1a和1b所示，本实施例中的可自适应变角度封堵器类似于实施例1，区别在于，所述的位于上侧的封堵盘1的上端口采用钢套3束缚。As shown in Figures 1a and 1b, the self-adaptive variable-angle occluder in this embodiment is similar to Embodiment 1, except that the upper port of the occlusion disk 1 on the upper side is restrained by a steel sleeve 3 .
实施例3Example 3
如图4所示，本实施例中的可自适应变角度封堵器类似于实施例1，区别在于：位于上侧的封堵盘1的外周边向下翻扣，这种设计能够保证改变封堵的过程中上下封堵盘1都能紧紧贴紧缺损周边组织。As shown in Figure 4, the self-adaptive variable-angle occluder in this embodiment is similar to Embodiment 1, the difference is that the outer periphery of the occlusion disk 1 on the upper side is turned down, and this design can ensure the change of During the occlusion process, the upper and lower occlusion discs 1 can tightly adhere to the surrounding tissue of the defect.
实施例4Example 4
如图5a所示，本实施例中的可自适应变角度封堵器类似于实施例1，区别在于：位于下侧的封堵盘1(受压力较小一侧)为平面设计，位于上侧的封堵盘1的中部向下弯折，形成左右两个部分，左部分与位于下侧的封堵盘1所在平面平行，右部分向下倾斜，该封堵盘1的结构如图5b所示。As shown in Figure 5a, the self-adaptive variable-angle occluder in this embodiment is similar to Embodiment 1, the difference is that the occlusion disc 1 on the lower side (the side with less pressure) is a plane design, and the upper The middle part of the blocking disk 1 on the side is bent downwards to form two parts on the left and right. The left part is parallel to the plane of the blocking disk 1 on the lower side, and the right part is inclined downward. The structure of the blocking disk 1 is shown in Figure 5b shown.
使用时，如图6所示，在遇到两侧薄厚差异较大的缺损时会自适应的变为如图6所示的形状。When in use, as shown in Figure 6, when encountering a defect with a large difference in thickness on both sides, it will adaptively change to the shape shown in Figure 6 .
实施例5Example 5
本实施例中的可自适应变角度封堵器类似于实施例1，区别在于：如图7a所示，所述的可旋转的连接结构的具体结构不同，本实施例的可旋转的连接结构包括第一连接件11、第二连接件12，所述的第一连接件11与上封堵盘1的下盘面固定连接，第二连接件12与下封堵盘2的上盘面固定连接，第一连接件11的下端通过销轴13设于第二连接件12的上端内，第一连接件11可绕所述的销轴13旋转。The self-adaptive variable-angle occluder in this embodiment is similar to Embodiment 1, the difference is that, as shown in Figure 7a, the specific structure of the rotatable connection structure is different, and the rotatable connection structure of this embodiment It includes a first connecting piece 11 and a second connecting piece 12, the first connecting piece 11 is fixedly connected to the lower surface of the upper blocking disk 1, and the second connecting piece 12 is fixedly connected to the upper surface of the lower blocking disk 2, The lower end of the first connecting member 11 is disposed in the upper end of the second connecting member 12 through a pin shaft 13 , and the first connecting member 11 can rotate around the pin shaft 13 .
实施例6Example 6
本实施例中的可自适应变角度封堵器类似于实施例1，区别在于：如图7b所示，所述的可旋转的连接结构的具体结构不同，本实施例的可旋转的连接结构包括第一连接件11、第二连接件12，所述的第一连接件11与上封堵盘1的下盘面固定连接，第二连接件12与下封堵盘2的上盘面固定连接，第一连接件11的下端与连接丝14连接，所述的连接丝14通过销轴13设于第二连接件12的上端内，第一连接件11可经由连接丝14绕所述的销轴13旋转。The self-adaptive variable-angle occluder in this embodiment is similar to Embodiment 1, the difference is that, as shown in Figure 7b, the specific structure of the rotatable connection structure is different, and the rotatable connection structure of this embodiment It includes a first connecting piece 11 and a second connecting piece 12, the first connecting piece 11 is fixedly connected to the lower surface of the upper blocking disk 1, and the second connecting piece 12 is fixedly connected to the upper surface of the lower blocking disk 2, The lower end of the first connecting member 11 is connected with the connecting wire 14, and the connecting wire 14 is arranged in the upper end of the second connecting member 12 through the pin shaft 13, and the first connecting member 11 can be wound around the pin shaft through the connecting wire 14 13 spins.
本实施例中的可自适应变角度封堵器类似于实施例1，区别在于：如图7b所示，所述的可旋转的连接结构的具体结构不同，本实施例的可旋转的连接结构包括第一连接件11、第二连接件12，所述的第一连接件11与上封堵盘1的下盘面固定连接，第二连接件12与下封堵盘2的上盘面固定连接，第一连接件11的下端与连接丝14连接，所述的连接丝14连接第二连接件12。The self-adaptive variable-angle occluder in this embodiment is similar to Embodiment 1, the difference is that, as shown in Figure 7b, the specific structure of the rotatable connection structure is different, and the rotatable connection structure of this embodiment It includes a first connecting piece 11 and a second connecting piece 12, the first connecting piece 11 is fixedly connected to the lower surface of the upper blocking disk 1, and the second connecting piece 12 is fixedly connected to the upper surface of the lower blocking disk 2, The lower end of the first connecting piece 11 is connected to the connecting wire 14 , and the connecting wire 14 is connected to the second connecting piece 12 .
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510578225.XACN105054980B (en) | 2015-09-11 | 2015-09-11 | Self-adaptive variable angle plugging device |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510578225.XACN105054980B (en) | 2015-09-11 | 2015-09-11 | Self-adaptive variable angle plugging device |
| Publication Number | Publication Date |
|---|---|
| CN105054980A CN105054980A (en) | 2015-11-18 |
| CN105054980Btrue CN105054980B (en) | 2017-05-17 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510578225.XAActiveCN105054980B (en) | 2015-09-11 | 2015-09-11 | Self-adaptive variable angle plugging device |
| Country | Link |
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| CN (1) | CN105054980B (en) |
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