技术领域technical field
本实用新型涉属于医疗器械领域，具体涉及一种心房间的压力调节装置。The utility model belongs to the field of medical instruments, in particular to a pressure regulating device for a cardiac chamber.
背景技术Background technique
心力衰竭(heart failure)简称心衰，是指由于心脏的收缩功能和/或舒张功能发生障碍，不能将静脉回心血量充分排出心脏，导致静脉系统血液淤积，动脉系统血液灌注不足，进而引起心脏循环障碍症候群。Heart failure, referred to as heart failure, refers to the failure of the systolic and/or diastolic function of the heart to fully discharge the venous blood back to the heart, resulting in blood stasis in the venous system and insufficient blood perfusion in the arterial system, which in turn causes the heart Circulatory Disorder Syndrome.
心衰是一种发生率和致死率均较高的严重疾病，根据心力衰竭发生的部位可分为左心衰竭、右心衰竭和全心衰竭，根据心力衰竭的临床表现也可以划分为收缩性心力衰竭和舒张性心力衰竭，其中舒张性心衰(diastolic heart failure，DHF)约占全部心衰患者的一半。在中国约有1200万以上的心衰患者，即心衰发病率约为2～3％，其中，舒张性心衰患者约600万，老年人心力衰竭多以舒张性心衰为主，老年人舒张性心衰患者数量占舒张性心衰患者总数量的66.99％。Heart failure is a serious disease with high incidence and mortality. According to the location of heart failure, it can be divided into left heart failure, right heart failure and total heart failure. According to the clinical manifestations of heart failure, it can also be divided into systolic heart failure. Heart failure and diastolic heart failure, of which diastolic heart failure (DHF) accounts for about half of all heart failure patients. There are more than 12 million heart failure patients in China, that is, the incidence of heart failure is about 2 to 3%, of which there are about 6 million patients with diastolic heart failure. The number of patients with diastolic heart failure accounted for 66.99% of the total number of patients with diastolic heart failure.
心衰的病因主要有高血压、冠心病、心肌梗死、心脏瓣膜疾病、房颤、心肌病等。心血管疾病造成左心室损伤，导致左心室病理性重构，进而造成心功能减退，这意味着每成功治疗一位心肌梗死病人，就带来一位潜在的心衰病人。The main causes of heart failure include hypertension, coronary heart disease, myocardial infarction, heart valve disease, atrial fibrillation, and cardiomyopathy. Cardiovascular disease causes damage to the left ventricle, leading to pathological remodeling of the left ventricle, which in turn leads to cardiac dysfunction, which means that for every patient with myocardial infarction successfully treated, there is a potential patient with heart failure.
在治疗心衰时，现有的各种手段都有存在缺陷，具体如下：In the treatment of heart failure, various existing methods have shortcomings, as follows:
a、优化药物治疗，不能从根本上去除病因，仍有反复发作的可能；a. Optimizing drug treatment cannot fundamentally remove the cause, and there is still the possibility of repeated attacks;
b、心脏再同步化治疗(CRT)，对至少20％心衰患者无效；b. Cardiac resynchronization therapy (CRT), which is ineffective in at least 20% of patients with heart failure;
c、左心室辅助装置(LVAD)手术，需进行体外循环，不仅创伤大并发症发生率高，而且价格昂贵难以获得，同时国内也不具备进行手术的条件；c. Left ventricular assist device (LVAD) surgery requires extracorporeal circulation, which not only has a high incidence of major trauma and complications, but also is expensive and difficult to obtain. At the same time, the conditions for surgery are not available in China;
d、心脏移植，能够从根本上解决问题，但是供体来源非常有限，且价格昂贵。d. Heart transplantation can fundamentally solve the problem, but the source of donors is very limited and expensive.
现有技术解决措施之一是在左心房与右心房之间的房间隔植入分流装置，该方法已被临床试验证明有效，但是现有分流装置在结构以及性能上还需进一步改进，这些装置很容易由于内皮爬覆而导致器械开口被封堵，通道关闭失去分流作用。One of the solutions in the prior art is to implant a shunt device in the atrial septum between the left atrium and the right atrium. This method has been proven effective in clinical trials, but the structure and performance of the existing shunt devices still need to be further improved. These devices It is easy to block the opening of the device due to endothelial crawling, and the channel closure loses the shunting effect.
实用新型内容Utility model content
本实用新型要解决的技术问题在于，针对现有技术的缺陷，提供一种通道畅通、内皮不爬覆器械的心房间的压力调节装置，防止由房间隔组织内皮爬覆而导致房间隔通道关闭的问题，避免该压力调节装置丧失分流的功能。The technical problem to be solved by the present utility model is that, aiming at the defects of the prior art, it provides a pressure regulating device for the atrium of the heart with a smooth channel and the endothelium does not climb over the device, so as to prevent the atrial septal channel from being closed due to the endothelium of the atrial septal tissue crawling over. The problem is to avoid the loss of the shunt function of the pressure regulating device.
本实用新型解决其技术问题所采用的技术方案是：The technical scheme adopted by the utility model to solve its technical problems is:
一种心房间的压力调节装置，包括可径向收缩及膨胀并轴向贯通的房间隔通道，所述房间隔通道在轴向上间隔设有分别抵靠在房间隔组织两侧壁面的第一定位部和第二定位部，至少在所述第一定位部和/或第二定位部设置有抵靠房间隔组织并与消融电源电性导通的导电部，所述导电部至少在与房间隔组织接触的表面导电。A pressure regulating device for an atrium, comprising an interatrial septal channel that can be radially contracted and expanded and penetrated in an axial direction; The positioning part and the second positioning part, at least the first positioning part and/or the second positioning part are provided with a conductive part which is abutted against the atrial septum tissue and is electrically connected with the ablation power source, and the conductive part is at least in contact with the atrial septum. The surfaces that the septal tissue contacts conduct electricity.
进一步地，所述的心房间的压力调节装置中，优选所述房间隔通道为波形支架、网状支架、杆状支架或它们组合形成的筒状结构或环状结构。Further, in the atrial pressure regulating device, preferably, the atrial septal channel is a corrugated stent, a mesh stent, a rod-shaped stent, or a cylindrical or annular structure formed by their combination.
进一步地，所述的心房间的压力调节装置中，优选所述第一定位部和第二定位部均由房间隔通道径向向外辐射延伸形成。Further, in the atrial pressure regulating device, preferably, both the first positioning portion and the second positioning portion are formed by radially extending outward from the interatrial septal channel.
进一步地，所述的心房间的压力调节装置中，优选所述第一定位部由房间隔通道远端沿径向向外延伸并逐步朝房间隔通道中部弯曲，且第一定位部的末端向远端方向翻翘；Further, in the atrial pressure regulating device, preferably, the first positioning portion extends radially outward from the distal end of the atrial septal channel and gradually bends toward the middle of the atrial septal channel, and the end of the first positioning portion is directed toward the middle of the atrial septal channel. warping in the distal direction;
或/和所述第二定位部由房间隔通道近端沿径向向外延伸并逐步朝房间隔通道中部弯曲，且第二定位部的末端向近端方向翻翘。Or/and the second positioning portion extends radially outward from the proximal end of the atrial septal channel and gradually bends toward the middle of the atrial septal channel, and the distal end of the second positioning portion is tilted toward the proximal direction.
进一步地，所述的心房间的压力调节装置中，优选所述第一定位部和第二定位部各自独立地为框架结构、网状结构或杆状结构。Further, in the pressure regulating device for the atrium, preferably, the first positioning portion and the second positioning portion are each independently a frame structure, a mesh structure or a rod structure.
进一步地，所述的心房间的压力调节装置中，优选所述第一定位部、第二定位部中的至少一个为框架结构，框架结构包括沿房间隔通道的径向向外辐射延伸的多根分叉的支撑杆，相邻支撑杆通过分叉相互交汇。Further, in the atrial pressure regulating device, preferably at least one of the first positioning portion and the second positioning portion is a frame structure, and the frame structure includes a plurality of radially extending outwards along the radial direction of the interatrial septal channel. The root is bifurcated support rod, and adjacent support rods meet each other through bifurcation.
进一步地，所述的心房间的压力调节装置中，优选所述第一定位部、第二定位部中的至少一个为框架结构，框架结构包括沿房间隔通道的径向向外辐射延伸的多对支撑杆，同属一对的支撑杆相互交汇。Further, in the atrial pressure regulating device, preferably at least one of the first positioning portion and the second positioning portion is a frame structure, and the frame structure includes a plurality of radially extending outwards along the radial direction of the interatrial septal channel. For the support rods, the support rods belonging to the same pair intersect with each other.
进一步地，所述的心房间的压力调节装置中，优选所述第一定位部和第二定位部与相应侧的房间隔之间为点接触、线接触、面接触中的至少一种。Further, in the atrial pressure regulating device, preferably, there is at least one of point contact, line contact, and surface contact between the first positioning portion and the second positioning portion and the interatrial septum on the corresponding side.
进一步地，所述的心房间的压力调节装置中，优选所述导电部为第一定位部或/和第二定位部的表面裸露通电的部分，除与房间隔接触的裸露的导电部表面以外的第一定位部和第二定位部的表面以及房间隔通道的外表面绝缘；Further, in the atrial pressure regulating device, preferably the conductive part is the exposed part of the surface of the first positioning part or/and the second positioning part, except for the exposed surface of the conductive part that is in contact with the interatrial septum. The surfaces of the first positioning part and the second positioning part and the outer surface of the interatrial septal channel are insulated;
或者所述导电部为设置在第一定位部或/和第二定位部上的电极，所述第一定位部或/和第二定位部与电极接触的部分绝缘；或者所述电极与第一定位部或/和第二定位部之间设有避免二者之间通电导通的的绝缘体。Or the conductive part is an electrode arranged on the first positioning part or/and the second positioning part, and the first positioning part or/and the second positioning part are insulated from the part in contact with the electrode; An insulator is provided between the positioning portion or/and the second positioning portion to prevent electrical conduction between the two.
进一步地，所述的心房间的压力调节装置中，优选所述第二定位部或房间隔通道近端设有用于将整个装置回收的回收部。Further, in the atrial pressure regulating device, preferably, the second positioning portion or the proximal end of the interatrial septal channel is provided with a recovery portion for recovering the entire device.
进一步地，所述的心房间的压力调节装置中，优选所述所述回收部设有用于与输送系统连接的连接件，所述导电部通过连接件与消融电源电连接。Further, in the pressure regulating device for the atrial chamber, preferably, the recovery part is provided with a connector for connecting with the delivery system, and the conductive part is electrically connected to the ablation power source through the connector.
进一步地，所述的心房间的压力调节装置中，优选所述连接件为所述第二定位部的末端设有的回收连接头，所述回收连接头上设有连接孔。Further, in the pressure regulating device for the atrium, preferably, the connector is a recovery connector provided at the end of the second positioning portion, and a connection hole is provided on the recovery connector.
进一步地，所述的心房间的压力调节装置中，优选所述回收连接头沿房间隔通道的周向布置。Further, in the atrial pressure regulating device, preferably, the recovery connector is arranged along the circumferential direction of the interatrial septal channel.
进一步地，所述的心房间的压力调节装置中，优选所述房间隔通道近端设有流出道，或者/和所述房间隔通道远端设有流入道。Further, in the atrial pressure regulating device, preferably, the proximal end of the atrial septal channel is provided with an outflow channel, or/and the distal end of the atrial septal channel is provided with an inflow channel.
进一步地，所述的心房间的压力调节装置中，优选所述房间隔通道、流出道和流入道的至少一个内壁设有筒状覆膜，筒状覆膜内形成通道。Further, in the atrial pressure regulating device, preferably, at least one inner wall of the interatrial septal channel, the outflow channel and the inflow channel is provided with a cylindrical coating, and a channel is formed in the cylindrical coating.
进一步地，所述的心房间的压力调节装置中，优选所述流出道的直径大于或等于所述房间隔通道的直径，流出道与房间隔通道的衔接部位的局部或全部贴靠房间隔。Further, in the atrial pressure regulating device, preferably, the diameter of the outflow tract is greater than or equal to the diameter of the interatrial septal channel, and part or all of the joint part of the outflow tract and the interatrial septal channel abuts against the interatrial septum.
进一步地，所述的心房间的压力调节装置中，优选所述流入道朝向房间隔通道逐渐径缩。Further, in the atrial pressure regulating device, preferably, the inflow channel is gradually reduced in diameter toward the atrial septal channel.
进一步地，所述的心房间的压力调节装置中，优选所述流入道自房间隔通道远端起沿房间隔通道的径向向外辐射延伸，且该流入道兼做所述第一定位部。Further, in the atrial pressure regulating device, preferably, the inflow channel extends radially outward from the distal end of the atrial septal channel, and the inflow channel also serves as the first positioning portion. .
进一步地，所述的心房间的压力调节装置中，优选所述第一定位部连接在流入道与房间隔通道的衔接部位或连接在流入道的远端。Further, in the atrial pressure regulating device, preferably, the first positioning portion is connected to the joint between the inflow channel and the interatrial septal channel or is connected to the distal end of the inflow channel.
进一步地，所述的心房间的压力调节装置中，优选所述第二定位部连接在以下部位中的至少一处：Further, in the atrial pressure regulating device, preferably, the second positioning portion is connected to at least one of the following parts:
连接在流出道的近端；或attached to the proximal end of the outflow tract; or
连接在流出道的轴向中部；或connected in the axial middle of the outflow tract; or
连接在流出道上靠近房间隔通道的部位；或Attached to the outflow tract near the atrial septal passage; or
连接在流出道与房间隔通道的衔接部位；或Connected at the junction of the outflow tract and the atrial septal channel; or
连接在房间隔通道上。Connected to the inter-atrial septum channel.
进一步地，所述的心房间的压力调节装置中，优选所述第二定位部由流出道的远端朝房间隔通道一侧弯折直至与房间隔相抵的位置。Further, in the atrial pressure regulating device, preferably, the second positioning portion is bent from the distal end of the outflow tract toward the side of the interatrial septal channel until it is in contact with the interatrial septum.
进一步地，所述的心房间的压力调节装置中，优选所述第二定位部在与房间隔相抵的位置处朝背离流入口的方向翻翘，直至邻近流出道的近端。Further, in the atrial pressure regulating device, preferably, the second positioning portion is tilted in a direction away from the inflow inlet at a position that is in contact with the interatrial septum until it is adjacent to the proximal end of the outflow tract.
进一步地，所述的心房间的压力调节装置中，优选所述流出道内设有单向开放的阀瓣。Further, in the pressure regulating device for the atrium, preferably, the outflow channel is provided with a valve flap that is open in one direction.
进一步地，所述的心房间的压力调节装置中，优选在房间隔通道中与房间隔位置相应的部位至所述阀瓣之间设有覆膜。Further, in the atrial pressure regulating device, preferably, a membrane is provided between the position of the interatrial septum channel corresponding to the position of the interatrial septum and the valve flap.
进一步地，所述的心房间的压力调节装置中，优选所述第二定位部、流出道近端设有用于将整个装置回收的回收部，所述回收部包括回收连接头，所述回收连接头在轴向上处在邻近流出道近端外侧。Further, in the pressure regulating device for the atrium, preferably the second positioning portion and the proximal end of the outflow channel are provided with a recovery portion for recovering the entire device, the recovery portion includes a recovery connector, and the recovery connection is provided. The head is axially outboard adjacent the proximal end of the outflow tract.
进一步地，所述的心房间的压力调节装置中，优选所述流出道具有单元网格结构，在流出道的近端，所有单元网格的顶点均通过第二定位部顺应连接至其中一个回收连接头。Further, in the pressure regulating device of the atrium, preferably the outflow channel has a unit grid structure, and at the proximal end of the outflow channel, the vertexes of all the unit grids are compliantly connected to one of the recovery channels through the second positioning portion. Connector.
进一步地，所述的心房间的压力调节装置中，优选所述流出道的边缘收敛为在圆周向上间隔分布的至少两个端部，各端部均设有回收连接头。Further, in the interatrial pressure regulating device, preferably, the edge of the outflow channel converges into at least two ends distributed at intervals in the circumferential direction, and each end is provided with a recovery connector.
进一步地，所述的心房间的压力调节装置中，优选所述流出道的边缘的一部分直接收敛至相应的端部，另一部分经由延伸段收敛至相应的端部，在压缩状态下，所述延伸段具有比流出道的边缘更远离流入道的轴向位置。Further, in the atrial pressure regulating device, preferably, a part of the edge of the outflow tract converges directly to the corresponding end, and the other part converges to the corresponding end via the extension section. In the compressed state, the The extension has an axial position further away from the inflow channel than the edge of the outflow channel.
进一步地，所述的心房间的压力调节装置中，优选所述流出道的边缘经由延伸段收敛至相应的端部，在压缩状态下，所述延伸段自流出道的边缘起沿轴向延伸。Further, in the pressure regulating device for the atrium, preferably the edge of the outflow tract converges to the corresponding end through the extension section, and in the compressed state, the extension section extends axially from the edge of the outflow tract. .
进一步地，所述的心房间的压力调节装置中，优选释放状态下，所述延伸段自流出道的边缘起朝远离流入口的方向延伸。Further, in the pressure regulating device for the atrium, preferably in the released state, the extension section extends from the edge of the outflow channel in a direction away from the inflow port.
进一步地，所述的心房间的压力调节装置中，优选释放状态下，所述延伸段自流出道的边缘起具有朝向流入口的第一弯折，以及背向流入口的第二弯折。Further, in the pressure regulating device for the atrium, preferably in the released state, the extension section has a first bend toward the inflow port from the edge of the outflow channel, and a second bend away from the inflow port.
进一步地，所述的心房间的压力调节装置中，优选释放状态下，所述延伸段构成所述第二定位部。Further, in the atrial pressure regulating device, preferably, in the released state, the extension section constitutes the second positioning portion.
进一步地，所述的心房间的压力调节装置中，优选所述延伸段通过第二弯折抵靠房间隔。Further, in the atrial pressure regulating device, preferably, the extending section abuts against the atrial septum through the second bending.
进一步地，所述的心房间的压力调节装置中，优选所述流出道的直径大于所述房间隔通道的直径，所述第一定位部和第二定位部自与房间隔通道的连接部位起均具有径向外扩的趋势。Further, in the atrial pressure regulating device, preferably, the diameter of the outflow tract is larger than the diameter of the interatrial septal channel, and the first positioning portion and the second positioning portion start from the connection portion with the interatrial septal channel. All have a radial outward expansion trend.
进一步地，所述的心房间的压力调节装置中，优选所述流出道以及流入道的直径均大于所述房间隔通道的直径，所述第一定位部和第二定位部自与房间隔通道的连接部位起均具有径向外扩的趋势。Further, in the atrial pressure regulating device, preferably, the diameters of the outflow tract and the inflow tract are both larger than the diameter of the interatrial septal channel, and the first positioning portion and the second positioning portion are separated from the interatrial septal channel. The connection parts have a radial outward expansion trend.
进一步地，所述的心房间的压力调节装置中，优选所述第二定位部自与房间隔通道的连接部位起，具有朝向流入口的第一弯折，以及背向流入口的第二弯折；Further, in the atrial pressure regulating device, preferably, the second positioning portion has a first bend toward the inflow port and a second bend away from the inflow port from the connection portion with the interatrial septal channel. fold;
其中第一弯折与第二弯折之间的部位越靠近流入口越径向扩张；第二弯折之后的部位越远离流入口越径向收敛。The part between the first bending and the second bending is radially expanded as it is closer to the inflow port; the further the part after the second bending is away from the inflow port, the radially converges.
进一步地，所述的心房间的压力调节装置中，优选所述房间隔通道外壁面设有导电部。Further, in the atrial pressure regulating device, preferably, a conductive portion is provided on the outer wall surface of the interatrial septal channel.
本实用新型装置中，至少在所述第一定位部和/或第二定位部设置有抵靠房间隔组织并与消融电源及控制机构电性导通的导电部，导电部通电后可以对其接触的房间隔壁上的组织进行消融，从而防止房间隔组织内皮爬覆，导致房间隔通道关闭，避免该压力调节装置丧失分流的功能。此外，还可以在房间隔通道外壁面设有导电部，则房间隔通道与房间隔接触的表面也可以进行导电消融，进一步扩大消融的范围，缩短因内皮爬覆而导致通道封闭的时间，延长器械的使用寿命。In the device of the present invention, at least the first positioning part and/or the second positioning part is provided with a conductive part that abuts against the atrial septal tissue and is electrically connected to the ablation power source and the control mechanism. The tissue on the contacted atrial septal wall is ablated, thereby preventing the atrial septal tissue from climbing over the endothelium, resulting in the closure of the atrial septal channel and preventing the loss of the shunting function of the pressure regulating device. In addition, a conductive part can also be provided on the outer wall of the atrial septal channel, so that the surface of the atrial septal channel in contact with the atrial septum can also be conductively ablated, which further expands the scope of ablation, shortens the time for the channel to be closed due to endothelial crawling, and prolongs the service life of the device.
附图说明Description of drawings
下面将结合附图及实施例对本实用新型作进一步说明，附图中：The utility model will be further described below in conjunction with the accompanying drawings and embodiments, in the accompanying drawings:
图1是本实用新型实施例1的结构示意图；Fig. 1 is the structural representation of Embodiment 1 of the present utility model;
图2是图1的仰视图；Fig. 2 is the bottom view of Fig. 1;
图3是图1的压力调节装置植入心脏后的结构示意图；Fig. 3 is the structural schematic diagram after the pressure regulating device of Fig. 1 is implanted in the heart;
图4是本实用新型实施例2的结构示意图；Fig. 4 is the structural representation of Embodiment 2 of the present utility model;
图5是本实用新型实施例3的结构示意图；5 is a schematic structural diagram of Embodiment 3 of the present invention;
图6是图5中A-A剖视图；Fig. 6 is A-A sectional view in Fig. 5;
图7为实施例4的结构示意图；Fig. 7 is the structural representation of embodiment 4;
图8为实施例5的结构示意图；Fig. 8 is the structural representation of embodiment 5;
图9为实施例5心房间的压力调节装置立体图；9 is a perspective view of the pressure regulating device in the heart chamber of Example 5;
图10为实施例5心房间的压力调节装置另一实施例的结构示意图；FIG. 10 is a schematic structural diagram of another embodiment of the pressure regulating device in the atrium of Example 5;
图11为实施例6心房间的压力调节装置瓣膜张开的示意图；11 is a schematic diagram of valve opening of the pressure regulating device in the atrium of Example 6;
图12为实施例6心房间的压力调节装置瓣膜关闭的示意图；Figure 12 is a schematic diagram of valve closure of the pressure regulating device in the atrium of Example 6;
图13为实施例7心房间的压力调节装置的主视图；FIG. 13 is a front view of the pressure regulating device in the atrium of Example 7;
图14为实施例7心房间的压力调节装置瓣膜张开的示意图；14 is a schematic diagram of valve opening of the pressure regulating device in the atrium of Example 7;
图15为实施例7心房间的压力调节装置瓣膜关闭的示意图；Figure 15 is a schematic diagram of valve closure of the pressure regulating device in the atrium of Example 7;
图16为实施例8心房间的压力调节装置的主视图；FIG. 16 is a front view of the pressure regulating device of the heart chamber of Example 8;
图17为实施例8心房间的压力调节装置瓣膜张开的示意图；17 is a schematic diagram of valve opening of the pressure regulating device in the atrium of Example 8;
图18为实施例8心房间的压力调节装置瓣膜关闭的示意图；Figure 18 is a schematic diagram of valve closure of the pressure regulating device in the atrium of Example 8;
图19为实施例9心房间的压力调节装置的主视图；FIG. 19 is a front view of the pressure regulating device in the atrium of Example 9;
图20为实施例9心房间的压力调节装置瓣膜张开的示意图；20 is a schematic diagram of valve opening of the pressure regulating device in the atrium of Example 9;
图21为实施例9心房间的压力调节装置瓣膜关闭的示意图；Figure 21 is a schematic diagram of valve closure of the pressure regulating device in the atrium of Example 9;
图22为实施例10心房间的压力调节装置的结构示意图；Figure 22 is a schematic structural diagram of the pressure regulating device in the heart chamber of Example 10;
图23为实施例10心房间的压力调节装置瓣膜张开的示意图；Figure 23 is a schematic diagram of valve opening of the pressure regulating device in the atrium of Example 10;
图24为实施例10心房间的压力调节装置瓣膜关闭的示意图。FIG. 24 is a schematic diagram of valve closure of the pressure regulating device of the atrial chamber of Example 10. FIG.
具体实施方式Detailed ways
为了对本实用新型的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本实用新型的具体实施方式。In order to have a clearer understanding of the technical features, purposes and effects of the present invention, the specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings.
本实用新型中的远端和近端是相对于释放过程中的操作者而言，释放过程中，所述装置中距离操作者更近的一端为近端，相对远离操作者的一端为远端。The distal end and the proximal end in the present invention are relative to the operator during the release process. During the release process, the end of the device that is closer to the operator is the proximal end, and the end that is relatively far away from the operator is the distal end .
在植入后，沿血流方向，朝向患者心脏右心房一侧的位置称为近端，而所述“远端”是指朝向患者心脏左心房一侧的位置。After implantation, in the direction of blood flow, the position toward the right atrium side of the patient's heart is referred to as the proximal end, while the "distal" refers to the position toward the left atrium side of the patient's heart.
实施例1Example 1
本实施例是本实用新型基础实施例。This embodiment is a basic embodiment of the present invention.
如图1-3所示，一种心房间的压力调节装置100，包括可径向收缩及膨胀并轴向贯通的房间隔通道130，所述房间隔通道130在轴向上间隔设有分别抵靠在房间隔组织两侧壁面的第一定位部120和第二定位部150，至少在所述第一定位部120和/或第二定位部150设置有抵靠房间隔组织并与消融电源电性导通的导电部500，所述导电部500至少在与房间隔组织接触的表面导电。As shown in FIGS. 1-3 , an interatrial pressure regulating device 100 includes an interatrial septal channel 130 that can be radially contracted and expanded and axially penetrates. The first positioning part 120 and the second positioning part 150 abutting against the two side walls of the atrial septum tissue, at least the first positioning part 120 and/or the second positioning part 150 are provided with abutting against the atrial septum tissue and are electrically connected to the ablation power source. The conductive portion 500 is electrically conductive, and the conductive portion 500 conducts electricity at least on the surface that is in contact with the interatrial septum tissue.
所述房间隔通道130为筒状结构或环状结构，其中，筒状结构是指房间隔通道130轴向长度比较长，环状结构是指房间隔通道130轴向长度比较短。房间隔通道130可以是波形支架、网状支架、杆状支架或它们组合形成，其中，波形支架是指采用波浪形单元或V形单元首尾相接一圈形成的筒状结构或环形结构。网状支架是指管材切割或编织丝编织成网格形状形成的筒状结构或环形结构。杆状是指采用多根支撑杆排布形成的筒状结构或环形结构。在体内释放后为筒状结构或环状结构后，可以保持房间隔通道内腔的畅通。The atrial septal channel 130 is a cylindrical structure or an annular structure, wherein the cylindrical structure refers to the relatively long axial length of the atrial septal channel 130 , and the annular structure refers to the relatively short axial length of the atrial septal channel 130 . The interatrial septal channel 130 may be formed by a wave-shaped stent, a mesh-shaped stent, a rod-shaped stent or a combination thereof, wherein the waveform-shaped stent refers to a cylindrical or annular structure formed by connecting wave-shaped units or V-shaped units end to end. A mesh stent refers to a tubular or annular structure formed by cutting a tube or braiding a wire into a mesh shape. The rod shape refers to a cylindrical or annular structure formed by arranging a plurality of support rods. After being released in the body into a cylindrical structure or a ring structure, the lumen of the atrial septal channel can be kept unobstructed.
本实施例中房间隔通道130为筒状结构，在筒状结构的轴向上包括中部的房间隔通道130，房间隔通道130远端设有第一定位部120，房间隔通道130近端设有第二定位部150。房间隔通道130的近端和远端直接与第一定位部120和第二定位部150对接。In this embodiment, the interatrial septal channel 130 is a cylindrical structure, and includes a central interatrial septal channel 130 in the axial direction of the cylindrical structure. There is a second positioning portion 150 . The proximal and distal ends of the interatrial septal channel 130 are directly butted with the first positioning portion 120 and the second positioning portion 150 .
本实施例中优选房间隔通道130、第一定位部120和第二定位部150整体上由管材切割而成或/和编织形成的一体结构，即工艺上，除了直接管材切割外，还可以采用编织方式，或局部编织结合局部管材切割的方式加工，不同部位可以焊接或通过连接件相互固定。In this embodiment, it is preferable that the interatrial septal channel 130 , the first positioning portion 120 and the second positioning portion 150 are integrally formed by cutting or/and braiding a pipe. Weaving, or partial braiding combined with partial pipe cutting, different parts can be welded or fixed to each other by connecting pieces.
其中房间隔通道130为波形支架，即房间隔通道130在周向上为波浪形单元或V形单元131首尾相接形成的结构，本实施例的房间隔通道130为多个V形单元131依次排布连接围成，当疏密程度发生变化时也可以是多个X形单元依次排布连接围成，甚至更加复杂的网格结构形成网状支架，总体上要求便于径向的压缩以及保持必要的强度。The interatrial septal channel 130 is a corrugated bracket, that is, the interatrial septal channel 130 is a structure in which wave-shaped units or V-shaped units 131 are connected end to end in the circumferential direction. When the density changes, multiple X-shaped units can be arranged and connected in sequence, or even a more complex grid structure forms a mesh stent, which is generally required to facilitate radial compression and maintain the necessary Strength of.
所述第一定位部120和第二定位部150各自独立地为框架结构、网状结构或杆状结构。框架结构、网状结构或杆状结构易于径向收缩或膨胀。本实用新型可以选择上述结构的任意一种或两种的结合。The first positioning portion 120 and the second positioning portion 150 are each independently a frame structure, a mesh structure or a rod structure. Frame structures, mesh structures or rod structures are prone to radial contraction or expansion. In the present invention, any one of the above structures or a combination of the two can be selected.
所述第一定位部120由房间隔通道130远端沿径向向外延伸并逐步朝房间隔通道130中部弯曲，且第一定位部120的末端向远端方向翻翘；所述第二定位部150由房间隔通道130近端沿径向向外延伸并逐步朝房间隔通道中部弯曲，且第二定位部150的末端向近端方向翻翘。The first positioning portion 120 extends radially outward from the distal end of the interatrial septal channel 130 and gradually bends toward the middle of the interatrial septal channel 130, and the end of the first positioning portion 120 is tilted toward the distal direction; the second positioning portion The portion 150 extends radially outward from the proximal end of the interatrial septal channel 130 and gradually bends toward the middle of the interatrial septal channel, and the distal end of the second positioning portion 150 is tilted toward the proximal direction.
优选第一定位部120、第二定位部150中的至少一个为框架结构，其中，本实施例的第一定位部120为杆状结构，包括沿房间隔通道130的径向向外辐射延伸的多根分叉的支撑杆121，杆状结构是支撑杆121独立径向向外延伸的结构。第二定位部150为框架结构，包括沿房间隔通道130的径向向外辐射延伸的多根分叉的支撑杆151，相邻支撑杆151通过分叉后再相互交汇，多次交汇形成框架结构。框架结构还可以包括沿房间隔通道的径向向外辐射延伸的多对支撑杆151，同属一对的支撑杆151相互交汇。Preferably, at least one of the first positioning portion 120 and the second positioning portion 150 is a frame structure, wherein the first positioning portion 120 in this embodiment is a rod-shaped structure, including radially extending radially outwards along the interatrial septal channel 130 . There are a plurality of bifurcated support rods 121, and the rod-shaped structure is a structure in which the support rods 121 independently extend radially outward. The second positioning portion 150 is a frame structure, including a plurality of bifurcated support rods 151 extending radially outward along the radial direction of the interatrial septal channel 130 . The adjacent support rods 151 cross each other after bifurcation, and form a frame by intersecting multiple times. structure. The frame structure may further include a plurality of pairs of support rods 151 extending radially outward along the interatrial septal channel, and the support rods 151 belonging to the same pair intersect with each other.
在其他实施例中，第一定位部120、第二定位部150中还可以为网状结构。网状结构为带有网孔的网格状。In other embodiments, the first positioning portion 120 and the second positioning portion 150 may also be a mesh structure. The mesh structure is a mesh with mesh holes.
具体地，房间隔通道130远端、近端分别有多个结构端点，例如网格端点或交叉点。如图1-2所示，房间隔通道130远端有多个结构端点133，第一定位部120是由房间隔通道130的每个结构端点133沿径向向外辐射的两个支撑杆121形成，两个支撑杆121分别向不同方向。第一定位部120总体上在向径向上外辐射延伸的同时略朝向房间隔通道130中部倾斜弯曲，在第一定位部120末端122略背向房间隔通道130中部向远端方向翻翘或倾斜弯曲。Specifically, the distal and proximal ends of the interatrial septal channel 130 respectively have a plurality of structural endpoints, such as grid endpoints or intersections. As shown in FIGS. 1-2 , the distal end of the interatrial septal channel 130 has a plurality of structural endpoints 133 , and the first positioning portion 120 is two support rods 121 radiating radially outward from each structural endpoint 133 of the interatrial septal channel 130 . Formed, the two support rods 121 are respectively oriented in different directions. The first positioning portion 120 generally extends radially outward while being slightly inclined and curved toward the middle of the interatrial septal channel 130 , and the distal end 122 of the first positioning portion 120 is slightly turned away from the middle of the interatrial septal channel 130 and is tilted or inclined in the distal direction. bending.
第一定位部120沿轴向的长度较短，当然，第一定位部120也可以采用更加复杂的迂回方式，本实施例在图中仅示意了优选的方式。The length of the first positioning portion 120 in the axial direction is relatively short. Of course, the first positioning portion 120 may also adopt a more complicated circuitous manner. In this embodiment, only a preferred manner is illustrated in the drawings.
第二定位部150由房间隔通道130近端的结构端点132沿径向向外辐射的两个支撑杆151组成，以房间隔通道130的其中一个V形单元131单元为例，包括左右两根支撑杆151，两根支撑杆151在房间隔通道130近端的结构端点132交汇，第二定位部150包括多个端点132延伸的支撑杆151，每个支撑杆151与来自相邻结构端点132的邻近支撑杆交汇为支撑杆153，所有支撑杆153沿周向有若干对，同属一对的支撑杆153再次相互交汇为支撑杆154。The second positioning portion 150 is composed of two support rods 151 radiating radially outward from the structural end point 132 of the proximal end of the interatrial septal channel 130 . Taking one of the V-shaped units 131 of the interatrial septal channel 130 as an example, it includes two left and right Support rods 151, two support rods 151 meet at the structural end points 132 at the proximal end of the interatrial septal channel 130, the second positioning part 150 includes a plurality of support rods 151 extending from the end points 132, each support rod 151 is connected with the adjacent structural end points 132 The adjacent support rods of 1 and 2 meet together to form the support rods 153 , and all the support rods 153 have several pairs along the circumferential direction.
位于更靠近释放过程中操作者的近端的第二定位部150或者房间隔通道130的近端设置有回收部，所述回收部设有用于与输送系统连接的连接件，所述导电部500通过连接件与消融电源电连接，本实施例中，所述连接件为所述第二定位部150的末端设有的回收连接头162，本实施例在支撑杆154末端设有回收连接头162。回收连接头162设有连接孔163。本实施例的回收连接头162由第二定位部150延伸得到，二者一体结构。各个回收连接头162朝向远离近端方向(背向房间隔通道130)以便于回收，各个回收连接头162与房间隔通道130的中轴线大致平行或有较小的夹角，例如小于45°，优选小于30°，具有夹角时，各个回收连接头162既可以朝向房间隔通道130的中轴线聚拢，也可以是背离房间隔通道130的中轴线发散。The second positioning portion 150 located closer to the proximal end of the operator during the release process or the proximal end of the interatrial septal channel 130 is provided with a retraction portion provided with a connector for connection with the delivery system, the conductive portion 500 The connector is electrically connected to the ablation power source. In this embodiment, the connector is a recovery connector 162 provided at the end of the second positioning portion 150 , and a recovery connector 162 is provided at the end of the support rod 154 in this embodiment. . The recovery connector 162 is provided with a connecting hole 163 . The recovery connector 162 in this embodiment is extended from the second positioning portion 150, and the two are integrally formed. Each recovery connector 162 is oriented away from the proximal direction (backward to the interatrial septal channel 130) to facilitate recovery, and each recovery connector 162 is approximately parallel to the central axis of the interatrial septal channel 130 or has a small included angle, for example, less than 45°, It is preferably less than 30°, and when there is an included angle, each recovery connector 162 can either converge toward the central axis of the interatrial septal channel 130 or diverge away from the central axis of the interatrial septal channel 130 .
为了便于设置回收连接头162，第二定位部150由房间隔通道130相应侧每个结构端点132逐级收敛，直至收敛为2～8个支撑杆154，且在每个支撑杆154末端均设置回收连接头162，本实施例中为四个支撑杆154。In order to facilitate the setting of the recovery connector 162 , the second positioning portion 150 is gradually converged from each structural end point 132 on the corresponding side of the interatrial septal channel 130 until it converges to 2-8 support rods 154 , and is provided at the end of each support rod 154 The connecting heads 162 are recovered, which are four support rods 154 in this embodiment.
由支撑杆151交汇为支撑杆153，而同属一对的支撑杆153再次相互交汇形成支撑杆154，可视为两级交汇收敛的框架结构，收敛指网格数量的收敛和减少，与外形没有必然联系，在采用复杂网格结构下可采用更多级的交汇的框架结构。第二定位部150中的支撑杆151延伸至与房间隔相抵的部位，而后相应交汇并以支撑杆153的形式翻翘，在整个翻翘部位可形成圆形或椭圆形的延伸路径。The support rods 151 are merged into the support rods 153, and the support rods 153 belonging to the same pair intersect with each other again to form the support rods 154, which can be regarded as a frame structure with two levels of convergence and convergence. Inevitably, more levels of intersecting frame structures can be used under the use of complex grid structures. The support rods 151 in the second positioning portion 150 extend to the position that is in contact with the interatrial septum, and then meet correspondingly and turn up in the form of the support rods 153 .
回收连接头162的长度约为3～5mm，边缘光滑无尖角，所有的回收连接头162沿筒状结构即房间隔通道130的周向布置，连接孔163为圆孔、椭圆孔或方形圆角结构，利于与释放和控制装置的输送系统配合。The length of the recovery connectors 162 is about 3 to 5 mm, and the edges are smooth without sharp corners. All the recovery connectors 162 are arranged along the cylindrical structure, that is, the circumferential direction of the interatrial septal channel 130, and the connecting holes 163 are round holes, elliptical holes or square circles. Corner construction to facilitate cooperation with the delivery system of the release and control device.
第一定位部120、第二定位部150在沿筒状结构即房间隔通道130的径向向外辐射的同时，朝向房间隔通道130中部弯曲直至与房间隔相抵接触。根据接触位置，所述第一定位部120和第二定位部150与相应侧的房间隔之间为点接触、线接触、面接触中的至少一种。点接触指所述第一定位部120和第二定位部150上有多个点状位置抵靠在房间隔上，线接触指所述第一定位部120和第二定位部150上有线形位置抵靠在房间隔上。面接触指所述第一定位部120和第二定位部150上有一定面积的位置抵靠在房间隔上。如图3所示，所述第一定位部120和第二定位部150分别在房间隔两侧抵靠，形成夹持状态，能将心房间的压力调节装置可靠固定在房间隔上。The first positioning portion 120 and the second positioning portion 150 radiate outward along the radial direction of the cylindrical structure, namely the interatrial septal channel 130 , and bend toward the middle of the interatrial septal channel 130 until they come into contact with the interatrial septum. According to the contact position, the first positioning portion 120 and the second positioning portion 150 are at least one of point contact, line contact, and surface contact with the interatrial septum on the corresponding side. Point contact refers to a plurality of point-like positions on the first positioning portion 120 and the second positioning portion 150 abutting against the interatrial septum, and line contact refers to linear positions on the first positioning portion 120 and the second positioning portion 150 against the room divider. Surface contact means that the first positioning part 120 and the second positioning part 150 have a certain area to abut against the interatrial septum. As shown in FIG. 3 , the first positioning portion 120 and the second positioning portion 150 abut on both sides of the interatrial septum respectively to form a clamping state, which can reliably fix the pressure regulating device of the atrium on the interatrial septum.
如图1-2所示，第一定位部120和第二定位部150中的至少一个与房间隔相抵靠的位置设有导电部500，导电部500有多种结构形式，一种是所述导电部500为裸露的导电金属件，即导电部500与第一定位部120和第二定位部150一体结构或单独设置裸露的导电金属件，即所述导电部500为第一定位部120或/和第二定位部150的表面裸露通电的部分。第一定位部120和第二定位部150为金属或合金制成，本身导电，保留金属或合金部分即形成导电部500。另一种导电部500是附着固定在第一定位部120和第二定位部150外表面的金属电极。As shown in FIGS. 1-2 , at least one of the first positioning portion 120 and the second positioning portion 150 is provided with a conductive portion 500 at a position abutting against the interatrial septum. The conductive portion 500 has various structural forms. The conductive portion 500 is a bare conductive metal piece, that is, the conductive portion 500 is integrally formed with the first positioning portion 120 and the second positioning portion 150 or a bare conductive metal piece is provided separately, that is, the conductive portion 500 is the first positioning portion 120 or the second positioning portion 150. and/and the surface of the second positioning portion 150 is exposed to the energized portion. The first positioning portion 120 and the second positioning portion 150 are made of metal or alloy, and are conductive themselves, and the conductive portion 500 is formed by retaining the metal or alloy portion. Another conductive part 500 is a metal electrode attached and fixed on the outer surfaces of the first positioning part 120 and the second positioning part 150 .
单独设置裸露的导电金属件是金属制成的导电部500镶嵌或粘贴在第一定位部120和第二定位部150上，采用第一定位部120和第二定位部150上的一部分是直接利用第一定位部120和第二定位部150上的金属材质导电的特性，所述导电部500为第一定位部120和第二定位部150上上外表面裸露的金属，直接用作导电部500。导电部500采用裸露的导电金属件是指直接采用金属制成导电部500，导电部500的形状可以是根据第一定位部120和第二定位部150上形状配合的各自独立的片状、网络状、杆状等，围绕第一定位部120和第二定位部150上一周间隔设置多个。导电部500也可以是围绕第一定位部120和第二定位部150上一周设置一圈连续或者间断的环状结构的导电部500。一圈的环状结构是能向中心收缩的结构或软性能弯折的结构。The separately provided exposed conductive metal pieces are the conductive parts 500 made of metal inlaid or pasted on the first positioning part 120 and the second positioning part 150, and a part of the first positioning part 120 and the second positioning part 150 is directly used. The metal material on the first positioning portion 120 and the second positioning portion 150 is conductive, and the conductive portion 500 is the exposed metal on the upper outer surface of the first positioning portion 120 and the second positioning portion 150, which is directly used as the conductive portion 500. . Using bare conductive metal parts for the conductive part 500 means that the conductive part 500 is directly made of metal, and the shape of the conductive part 500 can be independent sheet-like, networked, and shaped according to the shape of the first positioning part 120 and the second positioning part 150 A plurality of the first positioning portion 120 and the second positioning portion 150 are arranged at intervals around the upper circumference of the first positioning portion 120 and the second positioning portion 150 . The conductive portion 500 may also be a conductive portion 500 in which a continuous or discontinuous annular structure is provided around the first positioning portion 120 and the second positioning portion 150 . A ring-shaped structure is a structure that can be contracted toward the center or a structure that can be bent softly.
所述导电部500与所述第一定位部120和第二定位部150上之间设有避免二者之间通电导通的绝缘件，或者除导电部500以外的其余的第一定位部120和第二定位部150上和房间隔通道130至少在与血液接触的外表面绝缘。外表面绝缘的方式有多种，一种是涂覆绝缘涂层，例如聚四氟乙烯绝缘涂层。第二种是套装绝缘套。An insulating member is provided between the conductive portion 500 and the first positioning portion 120 and the second positioning portion 150 to prevent electrical conduction between the two, or the remaining first positioning portions 120 except the conductive portion 500 are provided. And the second positioning part 150 and the interatrial septal channel 130 are insulated at least on the outer surface in contact with blood. There are many ways to insulate the outer surface, one is to apply an insulating coating, such as a polytetrafluoroethylene insulating coating. The second is a set of insulating sleeves.
本实施例中，是直接采用第一定位部120和第二定位部150上位于波形结构中波谷或波峰顶端结构作为导电部500，如图2所示，在第一定位部120和第二定位部150的表面，只在面向房间隔组织的支撑杆153的外表面上设有裸露的金属，作为导电部500，其他的第一定位部120和第二定位部150的外表面全部绝缘。所述外表面绝缘是指在表面涂覆有绝缘涂层或设有绝缘套管，绝缘涂层可采用派瑞林。In the present embodiment, the first positioning portion 120 and the second positioning portion 150 are directly located in the wave trough or peak top structure of the wave structure as the conductive portion 500. As shown in FIG. 2, the first positioning portion 120 and the second positioning portion Only the outer surface of the support rod 153 facing the interatrial septal tissue is provided with bare metal on the surface of the part 150 , as the conductive part 500 , the outer surfaces of the other first positioning parts 120 and the second positioning parts 150 are all insulated. The outer surface insulation means that the surface is coated with an insulating coating or provided with an insulating sleeve, and the insulating coating can be Parylene.
如图1-2所示，由于导电部500需要跟消融电源电性导通，通电导通的方式可以有多种，可以直接采用导线连接，或者同房间隔通道130本身的金属结构导通。本实施例采用房间隔通道130本身的金属结构导通，在房间隔通道130、第一定位部120和第二定位部150上和回收部表面涂覆绝缘层。As shown in FIG. 1-2 , since the conductive portion 500 needs to be electrically connected to the ablation power supply, there are various ways to conduct electricity, such as direct wire connection, or conduction with the metal structure of the interatrial septal channel 130 itself. In this embodiment, the metal structure of the interatrial septal channel 130 itself is used for conduction, and an insulating layer is coated on the interatrial septal channel 130 , the first positioning portion 120 and the second positioning portion 150 and the surface of the recovery portion.
除了与房间隔接触的裸露的导电部500表面以外的第一定位部120和第二定位部150的表面以及房间隔通道130的外表面绝缘；即为了进一步将消融能量集中在导电部500的位置，通电后，只有导电部500与房间隔通电接触，用于消融房间隔组织，从而防止房间隔组织内皮爬覆，导致房间隔通道关闭，避免该压力调节装置丧失分流的功能。The surfaces of the first positioning portion 120 and the second positioning portion 150 and the outer surface of the atrial septal channel 130 are insulated except for the exposed surface of the conductive portion 500 in contact with the interatrial septum; that is, in order to further concentrate the ablation energy at the position of the conductive portion 500 , after electrification, only the conductive part 500 is in electrical contact with the atrial septum for ablating the atrial septal tissue, thereby preventing the atrial septal tissue from creeping over the endothelium, resulting in the closure of the atrial septal channel and preventing the pressure regulating device from losing the shunt function.
此外，房间隔通道130与房间隔接触的外壁面也可以设有导电部500，导电部500对房间隔进行导电消融，进一步扩大消融的范围，缩短因内皮爬覆而导致间隔通道130封闭的时间，延长器械的使用寿命。In addition, the outer wall surface of the interatrial septal channel 130 in contact with the interatrial septum may also be provided with a conductive portion 500, and the conductive portion 500 conducts conductive ablation of the interatrial septum, further expanding the scope of ablation, and shortening the time for the septal channel 130 to be closed due to endothelial creeping , prolong the service life of the device.
本装置可通过回收连接头162与装置输送控制系统连接，进而与消融电源电性导通，再通过装置的导电骨架(例如：房间隔通道130、第二定位部150)传导至导电部500位置，通电后，导电部500可以对其接触的房间隔壁上的组织进行消融，从而防止房间隔组织内皮爬覆导致的房间隔通道130关闭，避免该压力调节装置丧失分流的功能。The device can be connected to the device delivery control system through the recovery connector 162, and then electrically connected to the ablation power source, and then conducted to the conductive portion 500 through the conductive framework of the device (eg, the interatrial septal channel 130, the second positioning portion 150). After electrification, the conductive part 500 can ablate the tissue on the atrial septal wall that it contacts, thereby preventing the atrial septal channel 130 from being closed due to the atrial septal tissue endothelial creeping, and preventing the pressure regulating device from losing the shunt function.
本实施例的心房间隔压力调节装置的操作方法如下：The operation method of the atrial septal pressure regulating device of the present embodiment is as follows:
1.采用穿刺机构对房间隔穿刺，穿刺后，将导丝送入到左上肺静脉内，撤去穿刺套件。将扩张器和鞘管沿导丝推送至左心房内，撤除导丝和扩张器。1. Use the puncture mechanism to puncture the atrial septum. After the puncture, the guide wire is sent into the left upper pulmonary vein, and the puncture kit is removed. The dilator and sheath were advanced along the guide wire into the left atrium, and the guide wire and dilator were removed.
2.将推送器从装载器近端穿过，将心房间隔压力调节装置的回收连接件150与推送件远端电性相连，后撤推送器将心房间隔压力调节装置收入装载器内。2. Pass the pusher through the proximal end of the loader, electrically connect the recovery connector 150 of the atrial septal pressure regulating device to the distal end of the pusher, and withdraw the pusher to receive the atrial septal pressure regulating device into the loader.
3.连接装载器远端至鞘管近端，前推推送器使心房间隔压力调节装置输送至鞘管远端。然后缓慢推送推送器或后撤鞘管，过程中需保证鞘管远端位于左心房中，使心房间隔压力调节装置的第一定位部120和第二定位部150完全张开。然后保持器械间无相对运动并向后拉动鞘管使第一定位部120和第二定位部150紧贴在房间隔上。然后保持心房间隔压力调节装置和推送件位置不动，后撤鞘管，使房间隔通道130和第一定位部120和第二定位部150完全打开且第一定位部120和第二定位部150紧贴在房间隔上。此时可通过DSC观察房间隔与导电部500的位置是否完全贴合。3. Connect the distal end of the loader to the proximal end of the sheath, and advance the pusher to deliver the atrial septal pressure regulating device to the distal end of the sheath. Then slowly push the pusher or withdraw the sheath, during the process, it is necessary to ensure that the distal end of the sheath is located in the left atrium, so that the first positioning part 120 and the second positioning part 150 of the atrial septal pressure regulating device are fully opened. Then, keeping no relative movement between the instruments and pulling the sheath backwards, the first positioning portion 120 and the second positioning portion 150 are tightly attached to the atrial septum. Then keep the position of the atrial septal pressure regulating device and the pusher still, withdraw the sheath, so that the atrial septal channel 130 and the first positioning part 120 and the second positioning part 150 are completely opened and the first positioning part 120 and the second positioning part 150 Fits snugly on the room divider. At this time, it can be observed by DSC whether the position of the interatrial septum and the conductive part 500 is completely fitted.
4.确认房间隔壁的组织与导电部500完全贴合后，连接推送器近端到射频电源，并设置加热参数(如功率40W，持续时间50S)，然后启动加热。4. After confirming that the tissue of the interatrial septum is fully fitted with the conductive part 500, connect the proximal end of the pusher to the RF power supply, and set the heating parameters (eg power 40W, duration 50S), and then start the heating.
加热停止后，解除器械与输送系统的连接，所述装置留置于体内，撤出输送系统。After the heating stops, the device is disconnected from the delivery system, the device is left in the body, and the delivery system is withdrawn.
实施例2，Example 2,
如图4所示，本实施例是在实施例1的基础上的改进。As shown in FIG. 4 , this embodiment is an improvement on the basis of Embodiment 1.
与实施例1的区别为：导电部500除了跟实施例1相同的结构外，还可以是所述导电部500为设置在第一定位部120或/和第二定位部150上的电极561，所述第一定位部120或/和第二定位部150与电极561接触的部分绝缘；或者所述电极561与第一定位部120或/和第二定位部150之间设有避免二者之间通电导通的的绝缘体。电极561可以同时设置在第一定位部120和第二定位部150上，也可以只设置在其中一个上面。The difference from Embodiment 1 is that in addition to the same structure as Embodiment 1, the conductive portion 500 may also be an electrode 561 disposed on the first positioning portion 120 or/and the second positioning portion 150 . The part of the first positioning part 120 or/and the second positioning part 150 in contact with the electrode 561 is insulated; insulators that conduct electricity between them. The electrode 561 may be provided on the first positioning portion 120 and the second positioning portion 150 at the same time, or may be provided only on one of them.
所述电极561可以直接与射频源电连接，即射频源与电极561之间直接通过导线连接，电流不会经过消融装置的其他部分传导；为了将射频能量能够集中在电极561与房间隔壁贴合的面，而不会通过电极561向其他部分传导，所述第一定位部120和第二定位部150上至少与电极561接触的部分绝缘。The electrode 561 can be directly electrically connected to the radio frequency source, that is, the radio frequency source and the electrode 561 are directly connected by wires, and the current will not be conducted through other parts of the ablation device; in order to concentrate the radio frequency energy on the electrode 561 and the interatrial septal wall The surface of the first positioning part 120 and the second positioning part 150 are insulated from at least the part that is in contact with the electrode 561 , and will not conduct to other parts through the electrode 561 .
电极561设置方式有两种：第一种实施方式是围绕房间隔通道130四周一圈连续设置电极561，电极561排布方式为单圈电极或多圈电极。单圈电极是沿第一定位部120和第二定位部150壁面一圈设置一圈电极561。多圈电极是沿第一定位部120和第二定位部150一圈设置至少两圈电极561，相邻两圈电极561之间在第一定位部120和第二定位部150并列排布或间隔排布。连续设置电极561也分为两种实施方式，一种是所述电极561由多个单电极在第一定位部120和第二定位部150周向上连续排布形成的环状结构。另一种是所述电极561为独立围绕第一定位部120和第二定位部150成环的环电极。There are two ways to arrange the electrodes 561: the first embodiment is to continuously arrange the electrodes 561 in a circle around the interatrial septal channel 130, and the electrodes 561 are arranged in a single-circle electrode or a multi-circle electrode. For the single-circle electrode, a circle of electrodes 561 is provided along the walls of the first positioning portion 120 and the second positioning portion 150 in one circle. The multi-circle electrodes are at least two circles of electrodes 561 arranged in one circle along the first positioning portion 120 and the second positioning portion 150, and the first positioning portion 120 and the second positioning portion 150 are arranged side by side or spaced between two adjacent circles of electrodes 561. Arrange. There are also two kinds of implementations for continuously disposing the electrodes 561 . One is that the electrode 561 is a ring-shaped structure formed by a plurality of single electrodes continuously arranged in the circumferential direction of the first positioning portion 120 and the second positioning portion 150 . The other is that the electrode 561 is a ring electrode that independently surrounds the first positioning portion 120 and the second positioning portion 150 and forms a ring.
第二种实施方式是：所述第一定位部120和第二定位部150间断设置有单圈电极或多圈电极，单圈电极或多圈电极中的所述电极561由多个单电极在第一定位部120和第二定位部150周向上间隔排布形成的环状结构。所述电极561中，单电极的形状可选自点状、杆状、片状等，环电极为间断或不间断的环状结构，电极561轴向长度在1mm-12mm之间。所述电极561与第一定位部120和第二定位部150之间通过缝合、或者缠绕的方式连接。The second embodiment is: the first positioning part 120 and the second positioning part 150 are intermittently provided with a single-turn electrode or a multi-turn electrode, and the electrode 561 in the single-turn electrode or the multi-turn electrode is formed by a plurality of single electrodes. The first positioning portion 120 and the second positioning portion 150 are circumferentially spaced to form an annular structure. In the electrode 561, the shape of the single electrode can be selected from point shape, rod shape, sheet shape, etc. The ring electrode is a discontinuous or uninterrupted ring structure, and the axial length of the electrode 561 is between 1mm-12mm. The electrode 561 is connected with the first positioning part 120 and the second positioning part 150 by sewing or winding.
实施例3Example 3
本实施例是在实施例1的基础上的改进。This embodiment is an improvement on the basis of Embodiment 1.
如图5-6所示，与实施例1的区别为：所述房间隔通道130为网状支架，所述第一定位部120和第二定位部150也各自独立地为网状结构。房间隔通道130、第一定位部120和第二定位部150由编织丝编织而成的一体结构。As shown in FIGS. 5-6 , the difference from Embodiment 1 is that the interatrial septal channel 130 is a mesh stent, and the first positioning portion 120 and the second positioning portion 150 are also independently mesh structures. The interatrial septal channel 130 , the first positioning part 120 and the second positioning part 150 are an integrated structure woven from braided silk.
第一定位部120和第二定位部150设有与房间隔壁贴靠的定位面、定位线或定位点，通过定位面、定位线或定位点形成夹持或压紧，则所述第一定位部120和第二定位部150与相应侧的房间隔之间形成点接触、线接触、面接触中的至少一种。其中所述定位面为平面、锥面、弧面或它们的结合形成的面，与房间隔形成面接触。定位线是与房间隔壁形成线形接触，可以是直线、曲线等。定位点是与房间隔形成至少一个点接触。形成定位面、定位线、定位点的第一定位部120和第二定位部150可以不作限定形状和结构只需保证上述结构即可。如图5所示，第一定位部120为一锥形面，锥尖朝向房间隔，形成环状分布的定位点。第二定位部150为带有一平面的锥形瓶结构，平面形成定位面。The first positioning portion 120 and the second positioning portion 150 are provided with a positioning surface, a positioning line or a positioning point that abuts against the inter-room wall. At least one of point contact, line contact, and surface contact is formed between the part 120 and the second positioning part 150 and the interatrial septum on the corresponding side. Wherein, the positioning surface is a surface formed by a plane, a cone surface, an arc surface or a combination thereof, and is in contact with the surface formed by the interatrial septum. The positioning line forms a linear contact with the interatrial septum, and can be a straight line, a curved line, or the like. The anchor point is at least one point contact with the interatrial septum. The shape and structure of the first positioning portion 120 and the second positioning portion 150 that form the positioning surface, positioning line, and positioning point may not be limited, as long as the above structures are ensured. As shown in FIG. 5 , the first positioning portion 120 is a tapered surface, and the tip of the cone faces the interatrial septum, forming a ring-shaped positioning point. The second positioning portion 150 is a conical flask structure with a plane, and the plane forms a positioning surface.
第二定位部150远端连接一个作为回收部的回收连接头162，回收连接头162在锥形瓶结构的锥尖形成回收口620。锥尖形成回收口620设有作为连接件的金属螺钉630。除导电部500外表面和金属螺钉630外螺纹表面640外，其余表面均镀有派瑞林绝缘涂层。金属螺钉630与输送系统的推送器螺接。The distal end of the second positioning portion 150 is connected to a recovery connector 162 serving as a recovery portion, and the recovery connector 162 forms a recovery port 620 at the conical tip of the conical flask structure. The tapered tip forming recovery port 620 is provided with a metal screw 630 as a connecting member. Except for the outer surface of the conductive part 500 and the outer thread surface 640 of the metal screw 630, the other surfaces are plated with parylene insulating coating. The metal screw 630 is screwed with the pusher of the delivery system.
如图6所示，另外与实施例1不同的结构是：所述导电部500连接有与房间隔组织接触的温度传感器700，用于测量消融温度。所述温度传感器700与消融电源电连接。具体地，在房间隔通道130上，设置有一微型的热敏电阻作为温度传感器700，热敏电阻的两端焊接有两相互绝缘的金属导线711、712，可与消融电源的温度探测系统电性导通。As shown in FIG. 6 , another structure different from Embodiment 1 is that the conductive portion 500 is connected with a temperature sensor 700 in contact with the interatrial septum tissue, for measuring the ablation temperature. The temperature sensor 700 is electrically connected to the ablation power source. Specifically, on the interatrial septal channel 130, a miniature thermistor is provided as the temperature sensor 700, and two mutually insulated metal wires 711 and 712 are welded at both ends of the thermistor, which can be electrically connected to the temperature detection system of the ablation power source. on.
实施例4Example 4
本实施例是在实施例1的基础上的改进。This embodiment is an improvement on the basis of Embodiment 1.
本实施例心房间的压力调节装置中，总体为筒状结构，在筒状结构的轴向上包括中部的房间隔通道130，房间隔通道130朝向左心房一侧设有第一定位部120，房间隔通道130朝向右心房一侧设有第二定位部150(指处在使用环境中)。The pressure regulating device for the atrium of the present embodiment has a cylindrical structure as a whole, and includes a middle atrial septal channel 130 in the axial direction of the cylindrical structure. The atrial septal channel 130 is provided with a first positioning portion 120 on the side facing the left atrium. The side of the interatrial septal channel 130 facing the right atrium is provided with a second positioning portion 150 (in the use environment).
如图7所示，与上述实施例1不同的是：房间隔通道130内设有覆膜170，覆膜170可以是根据需要包覆的一层猪心包，或者生物相容性好的高分子聚合物覆膜，如ePTFE、PET或涤纶等材料的覆膜。覆膜170与房间隔通道130缝合、粘接、热合等工序固定连接在一起。As shown in FIG. 7 , the difference from Embodiment 1 above is that a membrane 170 is provided in the interatrial septal channel 130 , and the membrane 170 may be a layer of porcine pericardium coated as required, or a polymer with good biocompatibility. Polymer laminations such as ePTFE, PET or polyester laminations. The covering film 170 is fixedly connected to the interatrial septal channel 130 by stitching, bonding, heat sealing and other processes.
其余结构同实施例1，在此不再赘述。The rest of the structure is the same as that of Embodiment 1, and will not be repeated here.
实施例5Example 5
本实施例是在实施例1的基础上的改进。This embodiment is an improvement on the basis of Embodiment 1.
与实施例1的区别为：The difference from Example 1 is:
如图8-9所示，一种心房间的压力调节装置，除了筒状结构的房间隔通道130外，在所述房间隔通道130近端设有流出道140，或者/和所述房间隔通道130远端设有流入道110。从轴向上，沿血流方向依次为流入道110、房间隔通道130和流出道140，流出道140和流入道110可以同时设置，也可以只设置一种。所述流出道140和流入道110各自独立地为框架结构、网状结构或杆状结构。流出道140和流入道110的结构可以与房间隔通道130结构相同，都为框架结构、网状结构或杆状结构，也可以不同。框架结构、网状结构或杆状结构结构在实施例1中有详细说明，在此不再赘述。As shown in Figs. 8-9, a pressure regulating device for an atrium, in addition to the atrial septal channel 130 in a cylindrical structure, an outflow channel 140 is provided at the proximal end of the atrial septal channel 130, or/and the atrial septum An inflow channel 110 is provided at the distal end of the channel 130 . From the axial direction, the inflow channel 110, the interatrial septal channel 130 and the outflow channel 140 are sequentially arranged along the blood flow direction. The outflow channel 140 and the inflow channel 110 are each independently a frame structure, a mesh structure or a rod structure. The structure of the outflow channel 140 and the inflow channel 110 may be the same as the structure of the interatrial septal channel 130, and both may be frame structure, mesh structure or rod structure, or may be different. The frame structure, the net-like structure or the rod-like structure are described in detail in Embodiment 1, and will not be repeated here.
所述房间隔通道130、流出道和流入道中的至少一个设有筒状覆膜170，筒状覆膜170内形成通道。轴向上沿血流方向依次为流入道110、房间隔通道130和流出道140，覆膜170的材料可选自ePTFE、PET、涤纶或者猪心包等。At least one of the interatrial septal channel 130 , the outflow channel and the inflow channel is provided with a cylindrical membrane 170 , and a channel is formed in the cylindrical membrane 170 . In the axial direction along the blood flow direction, there are the inflow channel 110, the interatrial septal channel 130 and the outflow channel 140 in sequence. The material of the membrane 170 can be selected from ePTFE, PET, Dacron or pig pericardium.
本实施例中，在流入道110和流出道140上分别设有在相应侧抵靠房间隔壁的第一定位部120和第二定位部150。In this embodiment, the inflow channel 110 and the outflow channel 140 are respectively provided with a first positioning portion 120 and a second positioning portion 150 that abut against the interatrial septum at the corresponding sides.
如图10所示是本实施例的另外一种实施方式，流入道110沿血流方向朝向房间隔通道130逐渐缩径形成圆台状，流入道110的入口端直径为10mm，流入道110的出口端直径为6mm。流入道110由12根支撑杆111构成，各支撑杆111绕流入道110的圆周向分布，相邻两根支撑杆111呈镜面对称结构，相邻两根支撑杆作为一组(即支撑杆111a和支撑杆111b)在流入道110的入口端相交于交点112。10 is another implementation of this embodiment, the inflow channel 110 is gradually reduced in diameter toward the interatrial septal channel 130 along the blood flow direction to form a truncated cone shape, the diameter of the inlet end of the inflow channel 110 is 10 mm, and the outlet of the inflow channel 110 The end diameter is 6mm. The inflow channel 110 is composed of 12 support rods 111, and each support rod 111 is distributed around the circumference of the inflow channel 110. The two adjacent support rods 111 have a mirror-symmetric structure, and the two adjacent support rods are used as a group (ie, the support rods 111a). and support rod 111 b ) intersect at intersection 112 at the inlet end of inflow channel 110 .
两组之间，相邻的两根支撑杆，例如支撑杆111a和支撑杆111c在流入道110的出口端相交于交点113。Between the two groups, two adjacent support rods, such as the support rod 111 a and the support rod 111 c, intersect at the intersection 113 at the outlet end of the inflow channel 110 .
如图8-10所示，第一定位部120连接在流入道110与房间隔通道130的衔接部位，第一定位部120沿筒状的径向向外辐射延伸形成近似平面的圆台形，圆台的顶面直径小于底面直径，圆台的底面直径为18mm，圆台的顶面外缘与流入道的出口端相连接。圆台的底面相对顶面更靠近房间隔。As shown in FIGS. 8-10 , the first positioning portion 120 is connected to the joint portion of the inflow channel 110 and the interatrial septal channel 130 , and the first positioning portion 120 radially extends outward along the cylindrical radial direction to form an approximately flat truncated cone. The diameter of the top surface is smaller than the diameter of the bottom surface, the diameter of the bottom surface of the circular cone is 18mm, and the outer edge of the top surface of the circular cone is connected with the outlet end of the inflow channel. The bottom surface of the frustum is closer to the interatrial septum than the top surface.
如图10所示，第一定位部120由六根分叉的支撑杆构成，分叉后形成12根支撑杆121，各支撑杆121绕第一定位部120的轴线分布，相邻两根支撑杆121呈镜面对称结构，相邻两根支撑杆121在底面处相交于交点122，相邻两根支撑杆121在顶面处相交于交点123，交点123与交点113相连接。支撑杆121的末端124朝背离流出道的方向翻翘，末端124的翻翘为圆滑的弧形，以免刺入房间隔壁，以减小对房间隔的损伤。As shown in FIG. 10 , the first positioning portion 120 is composed of six bifurcated support rods, and 12 support rods 121 are formed after the fork. Each support rod 121 is distributed around the axis of the first positioning portion 120, and two adjacent support rods 121 is a mirror-symmetric structure, two adjacent support rods 121 intersect at intersection 122 at the bottom surface, two adjacent support rods 121 intersect at intersection 123 at the top surface, and intersection 123 and intersection 113 are connected. The end 124 of the support rod 121 is tilted in a direction away from the outflow tract, and the end 124 is tilted in a smooth arc shape, so as to avoid piercing the interatrial septum wall and reduce damage to the interatrial septum.
本实施例中，第一定位部可也视为沿筒状结构的径向向外辐射延伸的多根分叉的支撑杆，例如其中一支撑杆的分叉部位为交点123，支撑杆121a作为其中一分叉，相邻的另一支撑杆中也具有分叉结构，其中一分叉为支撑杆121b，支撑杆121a和支撑杆121b相互交汇在交点122。In this embodiment, the first positioning portion may also be regarded as a plurality of bifurcated support rods extending radially outward along the radial direction of the cylindrical structure. For example, the bifurcation portion of one of the support rods is the intersection 123, and the support rod 121a serves as the One of the bifurcations has a bifurcated structure in another adjacent supporting rod, one of which is a supporting rod 121 b , and the supporting rod 121 a and the supporting rod 121 b meet each other at the intersection 122 .
如图10所示，房间隔通道130近似为圆柱形通道，房间隔通道130的直径为6mm，房间隔通道130由6根支撑杆131构成，6根支撑杆131相互平行且绕圆柱形通道的周向均匀分布，6根支撑杆的一端与交点113连接，另一端连接至流出道140的流入端。As shown in FIG. 10 , the interatrial septal channel 130 is approximately a cylindrical channel, the diameter of the interatrial septal channel 130 is 6 mm, and the interatrial septal channel 130 is composed of 6 support rods 131, and the six support rods 131 are parallel to each other and surround the cylindrical channel. Evenly distributed in the circumferential direction, one end of the six support rods is connected to the intersection point 113 , and the other end is connected to the inflow end of the outflow channel 140 .
如图10所示，流出道140由过渡段141与圆筒段142构成。过渡段141为圆台状，圆台的侧面与母线的夹角为65°。过渡段141由12根支撑杆143构成，相邻两根支撑杆143呈镜面对称，各支撑杆143绕过渡段141的轴线分布，相邻两根支撑杆143在邻近房间隔通道130一侧相交于交点144，相邻两根支撑杆143在远离房间隔通道130一侧相交于交点145。As shown in FIG. 10 , the outflow channel 140 is composed of a transition section 141 and a cylindrical section 142 . The transition section 141 is in the shape of a truncated cone, and the angle between the side surface of the truncated cone and the bus bar is 65°. The transition section 141 is composed of 12 support rods 143, two adjacent support rods 143 are mirror-symmetrical, each support rod 143 is distributed around the axis of the transition section 141, and two adjacent support rods 143 intersect on the side adjacent to the interatrial septal channel 130 At the intersection 144 , two adjacent support rods 143 intersect at the intersection 145 on the side away from the interatrial septal channel 130 .
如图10所示，圆筒段142的直径为12mm，圆筒段142由12根支撑杆146构成，相邻两根支撑杆146呈镜面对称，各支撑杆146绕圆筒段142的轴线分布，相邻两根支撑杆作为一组，例如支撑杆146a和支撑杆146b，在邻近过渡段141一侧相交于交点145；As shown in FIG. 10 , the diameter of the cylindrical section 142 is 12 mm, and the cylindrical section 142 is composed of 12 support rods 146 . The two adjacent support rods 146 are mirror-symmetrical, and each support rod 146 is distributed around the axis of the cylindrical section 142 . , two adjacent support rods as a group, such as support rod 146a and support rod 146b, intersect at the intersection point 145 on the side adjacent to the transition section 141;
相邻两组中，邻近的两根支撑杆例如支撑杆146a和支撑杆146c在远离过渡段141一侧相交于交点147。In the adjacent two groups, two adjacent support rods, such as the support rod 146a and the support rod 146c, intersect at the intersection point 147 on the side away from the transition section 141 .
如图10所示，第二定位部150包括沿筒状结构的径向向外辐射延伸的三对支撑杆，即共6根切割的支撑杆151，各支撑杆151围绕筒状结构的轴线分布，各支撑杆151的一端通过U形圆弧与交点147相连接，另一端在沿筒状结构的径向向外辐射的同时，朝向房间隔通道延伸直至与房间隔相抵。As shown in FIG. 10 , the second positioning portion 150 includes three pairs of support rods radiating outward along the radial direction of the cylindrical structure, that is, a total of six cut support rods 151 , and each support rod 151 is distributed around the axis of the cylindrical structure One end of each support rod 151 is connected to the intersection point 147 through a U-shaped arc, and the other end extends toward the interatrial septum channel until it touches the interatrial septum while radiating outward along the radial direction of the cylindrical structure.
6根支撑杆151分为三对，同属一对的两根支撑杆(支撑杆151a和支撑杆151b)相邻，且在靠近房间隔通道的一端相互交汇，合并为交点152，非同组的支撑杆151不连接，各支撑杆151在交点152处朝背离流入道110的方向翻翘形成翻翘段160，翻翘段160延伸直至邻近流出道140的远端，翻翘段160沿轴向延伸的同时逐步向筒状结构的轴线靠近。The six support rods 151 are divided into three pairs, and the two support rods (support rod 151a and support rod 151b) belonging to the same pair are adjacent to each other, and meet each other at one end close to the interatrial septal channel, and merge into intersection 152, which are not in the same group. The support rods 151 are not connected, and each support rod 151 is warped at the intersection 152 in a direction away from the inflow channel 110 to form a warped section 160 , the warped section 160 extends to the distal end adjacent to the outflow channel 140 , and the warped section 160 is axially While extending, it gradually approaches the axis of the cylindrical structure.
翻翘段160的末端为回收连接头162，回收连接头162的长度约为3～5mm，回收连接头162的边缘光滑无尖角。回收连接头162在轴向上处在邻近流出道140远端的下游，回收连接头162沿筒状结构的周向布置，回收连接头162上设有连接孔163，连接孔163为方形圆角结构，利用连接孔163与输送系统配合。The end of the turned-up section 160 is a recovery connector 162, the length of the recovery connector 162 is about 3-5 mm, and the edge of the recovery connector 162 is smooth without sharp corners. The recovery connector 162 is located downstream of the distal end of the outflow channel 140 in the axial direction. The recovery connector 162 is arranged along the circumferential direction of the cylindrical structure. The recovery connector 162 is provided with a connecting hole 163, and the connecting hole 163 is a square with rounded corners. Structure, using the connecting hole 163 to cooperate with the delivery system.
第二定位部150大致呈圆台形，圆台形的顶面直径小于底面直径，圆台的底面直径为22mm。The second positioning portion 150 is substantially in the shape of a truncated cone, the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
导电部设置同实施例1，在此不再赘述。The configuration of the conductive portion is the same as that in Embodiment 1, and details are not repeated here.
实施例6Example 6
本实施例是在实施例5的基础上的改进。This embodiment is an improvement on the basis of Embodiment 5.
与实施例5的区别为：在流出道140内设有单向开放的阀瓣。The difference from Embodiment 5 is that the outflow channel 140 is provided with a valve flap that is open in one direction.
如图11所示，本实施例中，在流入道110、流出道140以及房间隔通道的通道表面(支架内部)包覆一层猪心包作为覆膜170，在轴向上，覆膜170由流入道110的入口端延伸至流出道的出口端，形成与支架形状相应的筒状。在流出道140的通道内部缝制三片猪心包瓣膜180，三片猪心包瓣膜180作为单向开放的阀瓣，当左心房较右心房压力差大于4mmHg时，阀瓣开始打开，形成左心房向右心房的单向分流；大于18mmHg时，阀瓣完全打开，如图11所示；当右心房较左心房压力差大于1mm汞柱时，阀瓣完全关闭，如图12所示。As shown in FIG. 11 , in this embodiment, a layer of porcine pericardium is coated on the inflow channel 110 , the outflow channel 140 and the channel surfaces (inside the stent) of the interatrial septal channel as a membrane 170 . In the axial direction, the membrane 170 is composed of The inlet end of the inflow channel 110 extends to the outlet end of the outflow channel, forming a cylindrical shape corresponding to the shape of the stent. Three pieces of porcine pericardial valve 180 are sewn inside the channel of the outflow tract 140. The three pieces of porcine pericardial valve 180 are used as a one-way open valve flap. When the pressure difference between the left atrium and the right atrium is greater than 4 mmHg, the valve flap begins to open to form the left atrium One-way shunt to the right atrium; when it is greater than 18mmHg, the valve flap is fully opened, as shown in Figure 11; when the pressure difference between the right atrium and the left atrium is greater than 1mmHg, the valve flap is completely closed, as shown in Figure 12.
本实施例中，心房间的压力调节装置为一体结构，整体在筒状材料上切割并通过热定型得到各部分结构。第一定位部150和第二定位部120均为框架结构。心房间的压力调节装置中的各支撑杆均具有一定的宽度，在与房间隔等体内组织相接触时，接触面积适当增大，以通过面接触避免应力集中带来的切割作用。In this embodiment, the pressure regulating device of the atrium is an integral structure, and the whole structure is obtained by cutting a cylindrical material and heat-setting to obtain each part of the structure. The first positioning portion 150 and the second positioning portion 120 are both frame structures. Each support rod in the interatrial pressure regulating device has a certain width, and when it comes into contact with internal tissues such as the atrial septum, the contact area is appropriately increased, so as to avoid the cutting effect caused by stress concentration through surface contact.
所述的各交点并非严格交于一点，而是基于支撑杆具有一定区域的扩展，或者通过短距离接引完成交汇，例如交点113处，支撑杆121以及支撑杆131的交汇。The intersection points are not strictly at one point, but are based on the expansion of a certain area of the support rod, or the intersection is completed by short-distance connection, such as the intersection of the support rod 121 and the support rod 131 at the intersection point 113 .
心房间的压力调节装置的各弯折处均为圆滑的弧形弯折，且不存在朝向流出道出口方向的尖刺。房间隔造口瓣膜整体上也不存在尖刺，在孤立的顶点部位的边缘进行圆滑处理，例如，对交点112的边缘进行圆滑处理。Each bend of the pressure regulating device in the atrium is a smooth arc bend, and there is no sharp thorn toward the outlet of the outflow tract. The atrial septostomy valve does not have spikes as a whole, and the edges of the isolated apexes are rounded, for example, the edges of the junction 112 are rounded.
图11-12中所示均为定型之后的状态，在输送过程中，心房间的压力调节装置100以回收连接头162和流入道110入口端为两端进行拉伸，直至处于伸直状态，以搭载在输送系统中。Figures 11-12 show the state after setting. During the delivery process, the pressure regulating device 100 in the atrium is stretched with the recovery connector 162 and the inlet end of the inflow channel 110 as the two ends until it is in a straight state, to be mounted on the conveying system.
如果输送位置不当，通过牵拉回收连接头162可将装置整体收入输送系统中，再次进行释放。If the delivery position is not correct, the device can be integrated into the delivery system by pulling the recovery connector 162 and released again.
导电部设置同实施例1，在此不再赘述。The configuration of the conductive portion is the same as that in Embodiment 1, and details are not repeated here.
实施例7Example 7
本实施例是在实施例6基础上的改进。This embodiment is an improvement on the basis of Embodiment 6.
如图13-15所示，一种心房间的压力调节装置，为筒状结构，在筒状结构的轴向上包括沿血流方向依次设置的流入道110、房间隔通道130和流出道140，在流出道140内设有单向开放的阀瓣，在流入道110和流出道140上分别设有在相应侧抵靠房间隔的第一定位部120和第二定位部150。As shown in FIGS. 13-15 , a pressure regulating device for an atrium is a cylindrical structure, which includes an inflow channel 110 , a septal channel 130 and an outflow channel 140 arranged in sequence along the blood flow direction in the axial direction of the cylindrical structure. , a unidirectional open valve flap is arranged in the outflow channel 140 , and a first positioning portion 120 and a second positioning portion 150 abutting against the interatrial septum on the corresponding sides are respectively provided on the inflow channel 110 and the outflow channel 140 .
如图13所示，流入道110沿血流方向逐渐缩径形成圆台状，流入道110的入口端直径为8mm，流入道110的出口端直径为4mm。流入道110由8根支撑杆111构成，各支撑杆111绕流入道110的圆周向分布，8根支撑杆111分为四组，同属一组的两根支撑杆111呈镜面对称结构，在流入道的出口端相交于交点113。不同组的支撑杆111不连接。As shown in FIG. 13 , the diameter of the inflow channel 110 is gradually reduced along the blood flow direction to form a truncated cone. The diameter of the inlet end of the inflow channel 110 is 8 mm, and the diameter of the outlet end of the inflow channel 110 is 4 mm. The inflow channel 110 is composed of 8 support rods 111, and each support rod 111 is distributed around the circumference of the inflow channel 110. The eight support rods 111 are divided into four groups. The exit end of the track intersects at intersection 113 . Support rods 111 of different groups are not connected.
如图14所示，第一定位部120连接在流入道110与房间隔通道130的衔接部位，第一定位部120沿筒状的径向向外辐射延伸形成近似平面的圆台形，圆台的顶面直径小于底面直径，圆台的底面直径为16mm，圆台的顶面外缘与流入道的出口端相连接。圆台的底面相对顶面更靠近房间隔。As shown in FIG. 14 , the first positioning portion 120 is connected to the connecting portion of the inflow channel 110 and the interatrial septal channel 130 , and the first positioning portion 120 radially extends outward along the cylindrical radial direction to form an approximately flat frustum shape. The diameter of the surface is smaller than the diameter of the bottom surface, the diameter of the bottom surface of the circular cone is 16mm, and the outer edge of the top surface of the circular cone is connected with the outlet end of the inflow channel. The bottom surface of the frustum is closer to the interatrial septum than the top surface.
第一定位部120由8根支撑杆121构成，各支撑杆121绕第一定位部120的轴线分布，相邻两根支撑杆121呈镜面对称结构，相邻两根支撑杆121在底面处相交于交点122，相邻两根支撑杆121在顶面处相交于交点123，交点123与交点113相连接。支撑杆121的末端124朝背离流出道的方向翻翘，末端124的翻翘为圆滑的弧形，以减小对房间隔的损伤。The first positioning portion 120 is composed of eight support rods 121 , each support rod 121 is distributed around the axis of the first positioning portion 120 , two adjacent support rods 121 have a mirror-symmetric structure, and two adjacent support rods 121 intersect at the bottom surface At the intersection point 122 , the two adjacent support rods 121 intersect at the intersection point 123 at the top surface, and the intersection point 123 is connected with the intersection point 113 . The end 124 of the support rod 121 is turned up in the direction away from the outflow tract, and the end 124 is turned up in a smooth arc to reduce damage to the interatrial septum.
如图15所示，房间隔通道130近似为圆柱形通道，房间隔通道130的直径为4mm，房间隔通道130由4根支撑杆131构成，6根支撑杆131相互平行且绕圆柱形通道的周向均匀分布，4根支撑杆的一端与交点113连接，另一端连接至流出道140的流入端。As shown in FIG. 15 , the interatrial septal channel 130 is approximately a cylindrical channel, the diameter of the interatrial septal channel 130 is 4 mm, and the interatrial septal channel 130 is composed of four support rods 131, and the six support rods 131 are parallel to each other and surround the cylindrical channel. Evenly distributed in the circumferential direction, one end of the four support rods is connected to the intersection point 113 , and the other end is connected to the inflow end of the outflow channel 140 .
如图13-15所示，流出道140由过渡段141与圆筒段142构成。过渡段141为圆台状，圆台的侧面与母线的夹角为60°。过渡段141由8根支撑杆143构成，相邻两根支撑杆143呈镜面对称，各支撑杆143绕过渡段141的轴线分布，相邻两根支撑杆143在邻近房间隔通道130一侧相交于交点144，相邻两根支撑杆143在远离房间隔通道130一侧相交于交点145。As shown in FIGS. 13-15 , the outflow channel 140 is composed of a transition section 141 and a cylindrical section 142 . The transition section 141 is in the shape of a truncated cone, and the angle between the side surface of the truncated cone and the bus bar is 60°. The transition section 141 is composed of eight support rods 143, two adjacent support rods 143 are mirror-symmetrical, each support rod 143 is distributed around the axis of the transition section 141, and two adjacent support rods 143 intersect on the side adjacent to the interatrial septal channel 130 At the intersection 144 , two adjacent support rods 143 intersect at the intersection 145 on the side away from the interatrial septal channel 130 .
如图13-15所示，圆筒段142的直径为10mm，圆筒段142由8根支撑杆146构成，相邻两根支撑杆146呈镜面对称，各支撑杆146绕圆筒段142的轴线分布，相邻两根支撑杆146构成一近似菱形的单元格，构成同一单元格的两根支撑杆在邻近房间隔通道130一侧相交于交点144，在远离过渡段141一侧相交于交点147，相邻单元格中，邻近的两根支撑杆146在邻近过渡段141一侧相交于交点145。As shown in FIG. 13-15 , the diameter of the cylindrical section 142 is 10 mm, and the cylindrical section 142 is composed of eight support rods 146 . The two adjacent support rods 146 are mirror-symmetrical, and each support rod 146 surrounds the cylindrical section 142 Axial distribution, two adjacent support rods 146 form an approximate diamond-shaped cell, and the two support rods forming the same cell intersect at the intersection point 144 on the side adjacent to the interatrial septal channel 130, and intersect at the intersection point on the side away from the transition section 141. 147 , in adjacent cells, two adjacent support rods 146 intersect at the intersection 145 on the side adjacent to the transition section 141 .
如图13-15所示，第二定位部150包括8根切割的支撑杆151，各支撑杆151围绕筒状结构的轴线分布，各支撑杆151的一端通过U形圆弧与交点147相连接，另一端在沿筒状结构的径向向外辐射的同时，朝向房间隔通道延伸直至与房间隔相抵。As shown in FIGS. 13-15 , the second positioning portion 150 includes eight cut support rods 151 , each support rod 151 is distributed around the axis of the cylindrical structure, and one end of each support rod 151 is connected to the intersection 147 through a U-shaped arc , and the other end extends toward the interatrial septum channel until it touches the interatrial septum while radiating outward along the radial direction of the cylindrical structure.
8根支撑杆151分为四组，同属一组的两根支撑杆151相邻，且在靠近房间隔通道的一端合并为交点152；在远离房间隔通道的一端，相邻的非同组支撑杆合并为交点153，交点153与交点147连接形成U形圆弧的两端。The eight support rods 151 are divided into four groups, and the two support rods 151 belonging to the same group are adjacent to each other, and merge into the intersection point 152 at one end close to the interatrial septal channel; The rods are merged into the intersection 153, and the intersection 153 and the intersection 147 are connected to form the two ends of the U-shaped arc.
各支撑杆151在交点152处朝背离流入道110的方向翻翘形成翻翘段160，翻翘段160沿第二定位部的轴线延伸8mm，翻翘段160沿轴向延伸的同时逐步向筒状结构的轴线靠近。Each support rod 151 is warped at the intersection 152 in the direction away from the inflow channel 110 to form a warped section 160, the warped section 160 extends 8 mm along the axis of the second positioning portion, and the warped section 160 extends along the axial direction while gradually extending toward the cylinder. The axis of the like structure is close.
翻翘段160的末端为回收连接头162，回收连接头162的长度约为3mm，回收连接头162的边缘光滑无尖角。回收连接头162在轴向上处在邻近流出道140远端的下游，回收连接头162沿筒状结构的周向布置，回收连接头162上设有连接孔163，连接孔163为方形圆角结构，利用连接孔163与输送系统配合。The end of the turned-up section 160 is a recovery connector 162, the length of the recovery connector 162 is about 3 mm, and the edge of the recovery connector 162 is smooth without sharp corners. The recovery connector 162 is located downstream of the distal end of the outflow channel 140 in the axial direction. The recovery connector 162 is arranged along the circumferential direction of the cylindrical structure. The recovery connector 162 is provided with a connecting hole 163, and the connecting hole 163 is a square with rounded corners. Structure, using the connecting hole 163 to cooperate with the delivery system.
第二定位部150大致呈圆台形，圆台形的顶面直径小于底面直径，圆台的底面直径为22mm。The second positioning portion 150 is substantially in the shape of a truncated cone, the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
本实施例中，在流出道140的通道内部缝制两片猪心包瓣膜180，两片猪心包瓣膜作为单向开放的阀瓣，当左心房较右心房压力差大于2mmHg时，阀瓣开始打开，形成左心房向右心房的单向分流；大于15mmHg时，阀瓣完全打开，如图14所示；当右心房较左心房压力差大于3mm汞柱时，阀瓣完全关闭，如图15所示。In this embodiment, two pieces of porcine pericardial valve 180 are sewn inside the channel of the outflow tract 140, and the two pieces of porcine pericardial valve are used as a one-way open valve flap. When the pressure difference between the left atrium and the right atrium is greater than 2 mmHg, the valve flap begins to open , forming a unidirectional shunt from the left atrium to the right atrium; when it is greater than 15mmHg, the valve flap is fully opened, as shown in Figure 14; when the pressure difference between the right atrium and the left atrium is greater than 3mmHg, the valve flap is completely closed, as shown in Figure 15 Show.
如图13-15所示，在流入道、房间隔通道，以及部分流出道的通道表面(支架内部)包覆一层猪心包作为覆膜170。覆膜170在轴向上，由流入道的入口端开始，直至延伸出瓣膜缝合线1～2mm。As shown in FIGS. 13-15 , a layer of porcine pericardium is coated as a membrane 170 on the surface of the inflow tract, the interatrial septal channel, and part of the channel surface (inside the stent) of the outflow tract. In the axial direction, the covering 170 starts from the inlet end of the inflow channel and extends 1-2 mm from the valve suture.
本实施例中，心房间的压力调节装置为一体结构，整体在筒状材料上切割并通过热定型得到各部分结构。第一定位部和第二定位部均为框线结构。心房间的压力调节装置中的各支撑杆均具有一定的宽度，在与房间隔等体内组织相接触时，接触面积适当增大，以通过面接触避免应力集中带来的切割作用。In this embodiment, the pressure regulating device of the atrium is an integral structure, and the whole structure is obtained by cutting a cylindrical material and heat-setting to obtain each part of the structure. The first positioning portion and the second positioning portion are both frame-line structures. Each support rod in the interatrial pressure regulating device has a certain width, and when it comes into contact with internal tissues such as the atrial septum, the contact area is appropriately increased, so as to avoid the cutting effect caused by stress concentration through surface contact.
所述的各交点并非严格交于一点，而是基于支撑杆具有一定区域的扩展，或者通过短距离接引完成交汇，例如交点113处，支撑杆121以及支撑杆131的交汇。The intersection points are not strictly at one point, but are based on the expansion of a certain area of the support rod, or the intersection is completed by short-distance connection, such as the intersection of the support rod 121 and the support rod 131 at the intersection point 113 .
心房间的压力调节装置的各弯折处均为圆滑的弧形弯折，且不存在朝向流出道出口方向的尖刺。房间隔造口瓣膜整体上也不存在尖刺，在孤立的顶点部位的边缘进行圆滑处理，例如，对交点112的边缘进行圆滑处理。Each bend of the pressure regulating device in the atrium is a smooth arc bend, and there is no sharp thorn toward the outlet of the outflow tract. The atrial septostomy valve does not have spikes as a whole, and the edges of the isolated apexes are rounded, for example, the edges of the junction 112 are rounded.
图13-15中所示均为定型之后的状态，在输送过程中，心房间的压力调节装置以回收连接头162和流入道110入口端为两端进行拉伸，直至处于伸直状态，以搭载在输送系统中。Figures 13-15 show the state after setting. During the delivery process, the pressure regulating device in the atrium is stretched with the recovery connector 162 and the inlet end of the inflow channel 110 as the two ends until it is in a straight state, so that the installed in the conveying system.
如果输送位置不当，通过牵拉回收连接头162可将装置整体收入输送系统中，再次进行释放。If the delivery position is not correct, the device can be integrated into the delivery system by pulling the recovery connector 162 and released again.
导电部设置同实施例1，在此不再赘述。The configuration of the conductive portion is the same as that in Embodiment 1, and details are not repeated here.
实施例8Example 8
如图16-18所示，一种心房间的压力调节装置，为筒状结构，在筒状结构的轴向上包括沿血流方向依次设置的流入道110、房间隔通道130和流出道140，在流出道140内设有单向开放的阀瓣，在流入道110和流出道140上分别设有在相应侧抵靠房间隔的第一定位部120和第二定位部150。As shown in FIGS. 16-18 , a pressure regulating device for an atrium is a cylindrical structure, and includes an inflow channel 110 , a septal channel 130 and an outflow channel 140 arranged in sequence along the blood flow direction in the axial direction of the cylindrical structure. , a unidirectional open valve flap is arranged in the outflow channel 140 , and a first positioning portion 120 and a second positioning portion 150 abutting against the interatrial septum on the corresponding sides are respectively provided on the inflow channel 110 and the outflow channel 140 .
如图14所示，流入道110沿血流方向逐渐缩径形成圆台状，流入道110的入口端直径为8mm，流入道110的出口端直径为5mm。流入道110由12根支撑杆111构成，各支撑杆111绕流入道110的圆周向分布，相邻两根支撑杆111呈镜面对称结构，构成一组，同一组的两根支撑杆111在流入道110的入口端相交于交点112，不同组的相邻两根支撑杆111在流入道110的出口端相交于交点113。As shown in FIG. 14 , the diameter of the inflow channel 110 is gradually reduced along the blood flow direction to form a truncated cone. The diameter of the inlet end of the inflow channel 110 is 8 mm, and the diameter of the outlet end of the inflow channel 110 is 5 mm. The inflow channel 110 is composed of 12 support rods 111 , each support rod 111 is distributed around the circumference of the inflow channel 110 , and the two adjacent support rods 111 are in a mirror-symmetric structure, forming a group, and the two support rods 111 of the same group are inflow. The inlet end of the channel 110 intersects at the intersection point 112 , and the two adjacent support rods 111 of different groups intersect at the intersection point 113 at the outlet end of the inflow channel 110 .
如图17所示，第一定位120连接在流入道110的入口端，第一定位部120沿筒状的径向向外辐射延伸形成圆台形，圆台的高度与流入道的轴向长度大致相等，圆台的顶面直径大于底面直径，圆台的顶面直径H为24mm，圆台的顶面外缘与流入道的出口端相连接。圆台的底面相对顶面更靠近房间隔。As shown in FIG. 17 , the first positioning portion 120 is connected to the inlet end of the inflow channel 110 . The first positioning portion 120 radially extends outward along the cylindrical shape to form a truncated cone, and the height of the truncated cone is approximately equal to the axial length of the inflow channel. , the diameter of the top surface of the circular table is larger than the diameter of the bottom surface, the diameter H of the top surface of the circular table is 24mm, and the outer edge of the top surface of the circular table is connected with the outlet end of the inflow channel. The bottom surface of the frustum is closer to the interatrial septum than the top surface.
如图16所示，第一定位部120由6根S形支撑杆121构成，各支撑杆121绕第一定位部120的轴线分布，各支撑杆121的一端起始自交点112，支撑杆121的另一端在沿径向向外延伸的同时，朝房间隔通道一侧弯折直至与房间隔相抵，支撑杆121的末端124朝背离流出道的方向翻翘，末端124的翻翘为圆滑的弧形，以减小对房间隔的损伤。As shown in FIG. 16 , the first positioning part 120 is composed of six S-shaped support rods 121 , each support rod 121 is distributed around the axis of the first positioning part 120 , one end of each support rod 121 starts from the intersection 112 , and the support rod 121 The other end of the support rod 121 is bent toward the side of the interatrial septum channel while extending radially outwards until it touches the interatrial septum, the end 124 of the support rod 121 is turned up in the direction away from the outflow tract, and the end 124 is turned up smoothly. Arc to reduce damage to the atrial septum.
如图16所示，房间隔通道130近似为圆柱形通道，房间隔通道130的直径为5mm，房间隔通道130由6根支撑杆131构成，6根支撑杆131相互平行且绕圆柱形通道的周向均匀分布，6根支撑杆的一端与交点113连接，另一端连接至流出道140的流入端。As shown in FIG. 16 , the interatrial septal channel 130 is approximately a cylindrical channel, the diameter of the interatrial septal channel 130 is 5 mm, and the interatrial septal channel 130 is composed of 6 support rods 131, and the six support rods 131 are parallel to each other and surround the cylindrical channel. Evenly distributed in the circumferential direction, one end of the six support rods is connected to the intersection point 113 , and the other end is connected to the inflow end of the outflow channel 140 .
如图16所示，流出道140由过渡段141与圆筒段142构成。过渡段141为圆台状，圆台的侧面与母线的夹角为65°。过渡段141由12根支撑杆143构成，相邻两根支撑杆143呈镜面对称，各支撑杆143绕过渡段141的轴线分布，相邻两根支撑杆143在邻近房间隔通道130一侧与支撑杆131相交于交点144，相邻两根支撑杆143在远离房间隔通道130一侧相交于交点145。As shown in FIG. 16 , the outflow channel 140 is composed of a transition section 141 and a cylindrical section 142 . The transition section 141 is in the shape of a truncated cone, and the angle between the side surface of the truncated cone and the bus bar is 65°. The transition section 141 is composed of 12 support rods 143, two adjacent support rods 143 are mirror-symmetrical, each support rod 143 is distributed around the axis of the transition section 141, and the two adjacent support rods 143 are adjacent to the side of the interatrial septal channel 130 with each other. The support rods 131 intersect at the intersection point 144 , and the two adjacent support rods 143 intersect at the intersection point 145 on the side away from the interatrial septal channel 130 .
如图16所示，圆筒段142的直径为8mm，圆筒段142由6根支撑杆146构成，各支撑杆146绕圆筒段142的轴线分布，6根支撑杆146分为三组，同组中的两根支撑杆146相邻且呈镜面对称，同组的的支撑杆形成倒V字形结构，具体地，同组的两根支撑杆146在远离过渡段141一侧相交于交点147，另一端各自连接至不同的交点145。As shown in FIG. 16 , the diameter of the cylindrical section 142 is 8 mm, and the cylindrical section 142 is composed of six support rods 146 , each of which is distributed around the axis of the cylindrical section 142 , and the six support rods 146 are divided into three groups. The two support rods 146 in the same group are adjacent and mirror-symmetrical, and the support rods in the same group form an inverted V-shaped structure. Specifically, the two support rods 146 in the same group intersect at the intersection 147 on the side away from the transition section 141. , and the other ends are respectively connected to different intersections 145 .
交点147处沿轴向朝背离流出道的方向延伸，形成的延伸段上设有连接孔148，连接孔148用于与输送系统连接。The intersection point 147 extends in the direction away from the outflow channel in the axial direction, and the formed extension is provided with a connecting hole 148, and the connecting hole 148 is used for connecting with the delivery system.
如图16所示，第二定位部150包括6根切割的支撑杆151，各支撑杆151围绕筒状结构的轴线分布，各支撑杆151的一端通过U形圆弧与交点145相连接，另一端在沿筒状结构的径向向外辐射的同时，朝向房间隔通道延伸直至与房间隔相抵。As shown in FIG. 16 , the second positioning portion 150 includes six cut support rods 151 , each support rod 151 is distributed around the axis of the cylindrical structure, one end of each support rod 151 is connected to the intersection 145 through a U-shaped arc, and the other support rods 151 One end extends toward the interatrial septum channel until it abuts against the interatrial septum while radiating outward in the radial direction of the tubular structure.
6根支撑杆151分为三组，同属一组的两根支撑杆151相邻，且在靠近与房间隔相邻处合并为交点152。各支撑杆151在交点152处朝背离流入道110的方向翻翘形成翻翘段160，翻翘段160沿轴向延伸8mm，翻翘段160沿轴向延伸的同时逐步向筒状结构的轴线靠近。The six support rods 151 are divided into three groups, and the two support rods 151 belonging to the same group are adjacent to each other, and merge to form an intersection 152 near the interatrial septum. Each support rod 151 is warped at the intersection 152 in the direction away from the inflow channel 110 to form a warped section 160 , the warped section 160 extends axially by 8 mm, and the warped section 160 extends axially while gradually moving toward the axis of the cylindrical structure. near.
翻翘段160的末端为连接头161，连接头161的长度约为4mm，连接头161的边缘光滑无尖角。连接头161在轴向上处在邻近流出道140远端的下游，连接头161沿筒状结构的周向布置，连接头161上设有连接孔163，连接孔163为方形圆角结构，利用连接孔163与输送系统配合。The end of the turned-up section 160 is a connecting head 161, the length of the connecting head 161 is about 4 mm, and the edge of the connecting head 161 is smooth without sharp corners. The connecting head 161 is located downstream of the distal end of the outflow channel 140 in the axial direction. The connecting head 161 is arranged along the circumference of the cylindrical structure. The connecting head 161 is provided with a connecting hole 163. The connecting hole 163 is a square and rounded structure. The connection holes 163 cooperate with the delivery system.
第二定位部150大致呈圆台形，圆台形的顶面直径小于底面直径，圆台的底面直径为22mm。The second positioning portion 150 is substantially in the shape of a truncated cone, the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
本实施例中，在流入道、流出道以及房间隔通道的通道表面(支架内部)包覆一层猪心包作为覆膜170，在轴向上，覆膜170由流入道的入口端开始，直至延伸出瓣膜缝合线0～1mm。在流出道140的通道内部缝制三片猪心包瓣膜180，三片猪心包瓣膜作为单向开放的阀瓣，当左心房较右心房压力差大于5mmHg时，阀瓣开始打开，形成左心房向右心房的单向分流；大于20mmHg时，阀瓣完全打开，如图17所示；当右心房较左心房压力差大于2mm汞柱时，阀瓣完全关闭，如图18所示。In this embodiment, a layer of porcine pericardium is coated on the channel surface (inside of the stent) of the inflow tract, outflow tract and atrial septal channel as a membrane 170. In the axial direction, the membrane 170 starts from the inlet end of the inflow channel until the Extend the valve suture by 0-1mm. Three pieces of porcine pericardial valve 180 are sewn inside the channel of the outflow tract 140. The three pieces of porcine pericardial valve serve as a one-way open valve flap. When the pressure difference between the left atrium and the right atrium is greater than 5 mmHg, the valve flap begins to open, forming a left atrial One-way shunt of the right atrium; when it is greater than 20mmHg, the valve flap is fully opened, as shown in Figure 17; when the pressure difference between the right atrium and the left atrium is greater than 2mmHg, the valve flap is completely closed, as shown in Figure 18.
本实施例中，心房间的压力调节装置为一体结构，整体在筒状材料上切割并通过热定型得到各部分结构。第一定位部和第二定位部均为框线结构。心房间的压力调节装置中的各支撑杆均具有一定的宽度，在与房间隔等体内组织相接触时，接触面积适当增大，以通过面接触避免应力集中带来的切割作用。In this embodiment, the pressure regulating device of the atrium is an integral structure, and the whole structure is obtained by cutting a cylindrical material and heat-setting to obtain each part of the structure. The first positioning portion and the second positioning portion are both frame-line structures. Each support rod in the interatrial pressure regulating device has a certain width, and when it comes into contact with internal tissues such as the atrial septum, the contact area is appropriately increased, so as to avoid the cutting effect caused by stress concentration through surface contact.
心房间的压力调节装置的各弯折处均为圆滑的弧形弯折，且不存在朝向流出道出口方向的尖刺。房间隔造口瓣膜整体上也不存在尖刺，在孤立的顶点部位的边缘进行圆滑处理，例如，对交点112的边缘进行圆滑处理。Each bend of the pressure regulating device in the atrium is a smooth arc bend, and there is no sharp thorn toward the outlet of the outflow tract. The atrial septostomy valve does not have spikes as a whole, and the edges of the isolated apexes are rounded, for example, the edges of the junction 112 are rounded.
图16-18中所示均为定型之后的状态，在输送过程中，心房间的压力调节装置的各支撑杆均拉伸至处于伸展状态，以搭载在输送系统中，连接孔148、以及连接孔161与输送系统连接。Figures 16-18 show the state after setting. During the delivery process, each support rod of the pressure regulating device in the atrium is stretched to a stretched state so as to be mounted in the delivery system, the connection hole 148, and the connection The holes 161 are connected to the delivery system.
导电部设置同实施例1，在此不再赘述。The configuration of the conductive portion is the same as that in Embodiment 1, and details are not repeated here.
实施例9Example 9
如图19所示，一种心房间的压力调节装置，为筒状结构，在筒状结构的轴向上包括沿血流方向依次设置的流入道110、房间隔通道130和流出道140，在流出道140内设有单向开放的阀瓣，流入道自房间隔通道130入口侧起沿筒状结构的径向向外辐射延伸，形成抵靠房间隔壁的第一定位部120，在流出道140上设有抵靠房间隔的第二定位部150。As shown in FIG. 19 , an atrial pressure regulating device is a cylindrical structure, which includes an inflow channel 110, a septal channel 130 and an outflow channel 140 arranged in sequence along the blood flow direction in the axial direction of the cylindrical structure. The outflow channel 140 is provided with a one-way open valve flap, and the inflow channel radiates outwards from the inlet side of the interatrial septal channel 130 along the radial direction of the cylindrical structure to form a first positioning portion 120 abutting against the interatrial septal wall. 140 is provided with a second positioning portion 150 abutting against the interatrial septum.
如图19所示，第一定位部120由房间隔通道130的入口端起沿筒状的径向向外辐射延伸形成近似平面的圆台形，圆台的顶面直径小于底面直径，圆台的底面直径为18mm，圆台的顶面外缘与房间隔通道130入口端相连接。圆台的底面相对顶面更靠近房间隔。As shown in FIG. 19 , the first positioning portion 120 starts from the inlet end of the interatrial septal channel 130 and extends radially outward along the cylindrical radial direction to form an approximately flat frustum shape. The diameter of the top surface of the frustum is smaller than the diameter of the bottom surface. It is 18mm, and the outer edge of the top surface of the circular frustum is connected with the entrance end of the interatrial septal channel 130 . The bottom surface of the frustum is closer to the interatrial septum than the top surface.
第一定位部120由12根支撑杆121构成，各支撑杆121绕第一定位部120的轴线分布，相邻两根支撑杆121呈镜面对称结构，相邻两根支撑杆121构成一组，同一组的两根支撑杆121在底面处相交于交点122，相邻的非同组的两根支撑杆121在顶面处相交于交点123。支撑杆121的末端124朝背离流出道的方向翻翘，末端124的翻翘为圆滑的弧形，以减小对房间隔的损伤。The first positioning part 120 is composed of 12 support rods 121, each support rod 121 is distributed around the axis of the first positioning part 120, two adjacent support rods 121 are in a mirror-symmetric structure, and two adjacent support rods 121 form a group, The two support rods 121 of the same group intersect at the intersection point 122 at the bottom surface, and the two adjacent support rods 121 of different groups intersect at the intersection point 123 at the top surface. The end 124 of the support rod 121 is turned up in the direction away from the outflow tract, and the end 124 is turned up in a smooth arc to reduce damage to the interatrial septum.
如图19所示，房间隔通道130近似为圆柱形通道，房间隔通道130的直径为6mm，房间隔通道130由6根支撑杆131构成，6根支撑杆131相互平行且绕圆柱形通道的周向均匀分布，6根支撑杆的一端与交点123连接，另一端连接至流出道140的流入端。As shown in FIG. 19 , the interatrial septal channel 130 is approximately a cylindrical channel, the diameter of the interatrial septal channel 130 is 6 mm, and the interatrial septal channel 130 is composed of six support rods 131, which are parallel to each other and surround the cylindrical channel. Evenly distributed in the circumferential direction, one end of the six support rods is connected to the intersection point 123 , and the other end is connected to the inflow end of the outflow channel 140 .
如图19所示，流出道140由过渡段141与圆筒段142构成。过渡段141为圆台状，圆台的侧面与母线的夹角为75°。过渡段141由12根支撑杆143构成，相邻两根支撑杆143呈镜面对称，各支撑杆143绕过渡段141的轴线分布，相邻两根支撑杆143在邻近房间隔通道130一侧相交于交点144，相邻两根支撑杆143在远离房间隔通道130一侧相交于交点145。As shown in FIG. 19 , the outflow channel 140 is composed of a transition section 141 and a cylindrical section 142 . The transition section 141 is in the shape of a truncated cone, and the angle between the side surface of the truncated cone and the bus bar is 75°. The transition section 141 is composed of 12 support rods 143, two adjacent support rods 143 are mirror-symmetrical, each support rod 143 is distributed around the axis of the transition section 141, and two adjacent support rods 143 intersect on the side adjacent to the interatrial septal channel 130 At the intersection 144 , two adjacent support rods 143 intersect at the intersection 145 on the side away from the interatrial septal channel 130 .
如图19所示，圆筒段142的直径为12mm，圆筒段142由12根支撑杆146构成，相邻两根支撑杆146呈镜面对称，各支撑杆146绕圆筒段142的轴线分布，相邻两根支撑杆146在邻近过渡段141一侧相交于交点145，相邻两根支撑杆146在远离过渡段141一侧相交于交点147。As shown in FIG. 19 , the diameter of the cylindrical section 142 is 12 mm, and the cylindrical section 142 is composed of 12 supporting rods 146 . The two adjacent supporting rods 146 are mirror-symmetrical, and each supporting rod 146 is distributed around the axis of the cylindrical section 142 . , the two adjacent support rods 146 intersect at the intersection point 145 on the side adjacent to the transition section 141 , and the two adjacent support rods 146 intersect at the intersection point 147 on the side away from the transition section 141 .
如图19所示，第二定位部150包括6根切割的支撑杆151，各支撑杆151围绕筒状结构的轴线分布，各支撑杆151的一端通过U形圆弧交点147相连接，另一端在沿筒状结构的径向向外辐射的同时，朝向房间隔通道延伸直至与房间隔相抵。As shown in FIG. 19 , the second positioning portion 150 includes 6 cut support rods 151 , each support rod 151 is distributed around the axis of the cylindrical structure, one end of each support rod 151 is connected by a U-shaped arc intersection 147 , and the other end While radiating outward in the radial direction of the tubular structure, it extends toward the interatrial septum channel until it abuts the interatrial septum.
6根支撑杆151分为三组，同属一组的两根支撑杆151相邻，且在靠近房间隔通道的一端合并为交点152，非同组的支撑杆151不连接，各支撑杆151在交点152处朝背离流入道110的方向翻翘形成翻翘段160，翻翘段160延伸直至邻近流出道140的远端，翻翘段160沿轴向延伸的同时逐步向筒状结构的轴线靠近。The six support rods 151 are divided into three groups. The two support rods 151 belonging to the same group are adjacent to each other, and merge into the intersection point 152 at one end close to the interatrial septal channel. The support rods 151 of different groups are not connected. The intersection point 152 is warped in a direction away from the inflow channel 110 to form a warped section 160 , the warped section 160 extends until the distal end of the outflow channel 140 is adjacent, and the warped section 160 is extended in the axial direction while gradually approaching the axis of the cylindrical structure .
翻翘段160的末端为回收连接头162，回收连接头162的长度约为3～5mm，回收连接头162的边缘光滑无尖角。回收连接头162在轴向上处在邻近流出道140远端的下游，回收连接头162沿筒状结构的周向布置，回收连接头162上设有连接孔163，连接孔163为方形圆角结构，利用连接孔163与输送系统配合。The end of the turned-up section 160 is a recovery connector 162, the length of the recovery connector 162 is about 3-5 mm, and the edge of the recovery connector 162 is smooth without sharp corners. The recovery connector 162 is located downstream of the distal end of the outflow channel 140 in the axial direction. The recovery connector 162 is arranged along the circumference of the cylindrical structure. The recovery connector 162 is provided with a connecting hole 163, and the connecting hole 163 is a square with rounded corners. Structure, using the connecting hole 163 to cooperate with the delivery system.
第二定位部150大致呈圆台形，圆台形的顶面直径小于底面直径，圆台的底面直径为22mm。The second positioning portion 150 is substantially in the shape of a truncated cone, the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
本实施例中，在流入道、流出道以及房间隔通道的通道表面(支架内部)包覆一层猪心包作为覆膜170，在轴向上，覆膜170由流入道的入口端延伸至流出道的出口端，形成与支架形状相应的筒状。在流出道140的通道内部缝制三片猪心包瓣膜180，三片猪心包瓣膜作为单向开放的阀瓣，当左心房较右心房压力差大于5mmHg时，阀瓣开始打开，形成左心房向右心房的单向分流；大于15mmHg时，阀瓣完全打开，如图20所示；当右心房较左心房压力差大于1mm汞柱时，阀瓣完全关闭，如图21所示。In this embodiment, a layer of porcine pericardium is coated on the channel surface (inside the stent) of the inflow channel, outflow channel and atrial septal channel as a membrane 170. In the axial direction, the membrane 170 extends from the inlet end of the inflow channel to the outflow channel. The outlet end of the channel is formed into a cylindrical shape corresponding to the shape of the bracket. Three pieces of porcine pericardial valve 180 are sewn inside the channel of the outflow tract 140. The three pieces of porcine pericardial valve serve as a one-way open valve flap. When the pressure difference between the left atrium and the right atrium is greater than 5 mmHg, the valve flap begins to open, forming a left atrial One-way shunt of the right atrium; when the pressure is greater than 15mmHg, the valve flap is fully opened, as shown in Figure 20; when the pressure difference between the right atrium and the left atrium is greater than 1mmHg, the valve flap is completely closed, as shown in Figure 21.
本实施例中，心房间的压力调节装置为一体结构，整体在筒状材料上切割并通过热定型得到各部分结构。第一定位部和第二定位部均为框线结构。心房间的压力调节装置中的各支撑杆均具有一定的宽度，在与房间隔等体内组织相接触时，接触面积适当增大，以通过面接触避免应力集中带来的切割作用。所述的各交点并非严格交于一点，而是基于支撑杆具有一定区域的扩展。In this embodiment, the pressure regulating device of the atrium is an integral structure, and the whole structure is obtained by cutting a cylindrical material and heat-setting to obtain each part of the structure. The first positioning portion and the second positioning portion are both frame-line structures. Each support rod in the interatrial pressure regulating device has a certain width, and when it comes into contact with internal tissues such as the atrial septum, the contact area is appropriately increased, so as to avoid the cutting effect caused by stress concentration through surface contact. Said intersection points are not strictly at one point, but are based on the expansion of a certain area of the support rod.
心房间的压力调节装置的各弯折处均为圆滑的弧形弯折，且不存在朝向流出道出口方向的尖刺。房间隔造口瓣膜整体上也不存在尖刺，在孤立的顶点部位的边缘进行圆滑处理，例如，对支撑杆121的末端边缘进行圆滑处理。Each bend of the pressure regulating device in the atrium is a smooth arc bend, and there is no sharp thorn toward the outlet of the outflow tract. The atrial septostomy valve does not have sharp thorns as a whole, and the edge of the isolated vertex is rounded, for example, the distal edge of the support rod 121 is rounded.
图19-21中所示均为定型之后的状态，在输送过程中，心房间的压力调节装置以回收连接头162和流入道入口端为两端进行拉伸，直至处于伸直状态，以搭载在输送系统中。Figures 19-21 show the state after shaping. During the delivery process, the pressure regulating device in the atrium is stretched with the recovery connector 162 and the inlet end of the inflow channel as the two ends, until it is in a straight state, so as to carry in the delivery system.
如果输送位置不当，通过牵拉回收连接头162可将装置整体收入输送系统中，再次进行释放。If the delivery position is not correct, the device can be integrated into the delivery system by pulling the recovery connector 162 and released again.
导电部设置同实施例1，在此不再赘述。The configuration of the conductive portion is the same as that in Embodiment 1, and details are not repeated here.
实施例10Example 10
如图22-24所示，本实施例一种心房间的压力调节装置为筒状结构，在筒状结构的轴向上包括沿血流方向依次设置的流入道110、房间隔通道130和流出道140，在流出道140内设有单向开放的阀瓣，筒状结构上分别设有在相应侧抵靠房间隔壁的第一定位部120和第二定位部150。As shown in FIGS. 22-24 , an atrial pressure regulating device in this embodiment has a cylindrical structure, and the axial direction of the cylindrical structure includes an inflow channel 110 , an atrial septal channel 130 and an outflow channel arranged in sequence along the blood flow direction. The outflow channel 140 is provided with a unidirectionally open valve flap, and the cylindrical structure is respectively provided with a first positioning portion 120 and a second positioning portion 150 that abut against the interatrial septum on the corresponding side.
第一定位部120连接在筒状结构中流入道110和房间隔通道130的衔接部位。第二定位部150连接在筒状结构中流出道140和房间隔通道130的衔接部位。The first positioning part 120 is connected to the connecting part of the inflow channel 110 and the interatrial septal channel 130 in the cylindrical structure. The second positioning portion 150 is connected to the joint portion of the outflow channel 140 and the interatrial septal channel 130 in the cylindrical structure.
在流入道、流出道以及房间隔通道的通道表面(支架内部)包覆一层猪心包作为覆膜170，在轴向上，覆膜170由流入道的入口端延伸至流出道的出口端，形成与支架形状相应的筒状。在流出道140的通道内部缝制三片猪心包瓣膜180，三片猪心包瓣膜作为单向开放的阀瓣，当左心房较右心房压力差大于2mmHg时，阀瓣开始打开，形成左心房向右心房的单向分流；大于20mmHg时，阀瓣完全打开，如图23所示；当右心房较左心房压力差大于2mm汞柱时，阀瓣完全关闭，如图24所示。A layer of porcine pericardium is coated on the channel surface (inside the stent) of the inflow tract, the outflow tract and the atrial septal channel as the covering membrane 170. In the axial direction, the covering membrane 170 extends from the inlet end of the inflow tract to the outlet end of the outflow tract, A cylindrical shape corresponding to the shape of the holder is formed. Three pieces of porcine pericardial valve 180 are sewn inside the channel of the outflow tract 140. The three pieces of porcine pericardial valve are used as a one-way open valve flap. When the pressure difference between the left atrium and the right atrium is greater than 2 mmHg, the valve flap begins to open, forming a left atrial One-way shunt of the right atrium; when it is greater than 20mmHg, the valve flap is fully opened, as shown in Figure 23; when the pressure difference between the right atrium and the left atrium is greater than 2mmHg, the valve flap is completely closed, as shown in Figure 24.
与实施例5相比，一方面第二定位部150的连接位置更靠近房间隔通道130，另外第二定位部150不再有支撑杆的交汇结构，仅为6根辐射向外分布的支撑杆151，支撑杆151大致沿径向向外延伸，在各支撑杆末端带有回收连接头，且在末端部位朝背离流入道的方向弯折。Compared with Example 5, on the one hand, the connection position of the second positioning portion 150 is closer to the interatrial septal channel 130, and on the other hand, the second positioning portion 150 no longer has the intersection structure of support rods, but only 6 support rods radiating outward. 151, the support rods 151 extend generally radially outwards, each support rod is provided with a recovery connector at the end, and is bent in a direction away from the inflow channel at the end portion.
导电部设置同实施例1，在此不再赘述。The configuration of the conductive portion is the same as that in Embodiment 1, and details are not repeated here.
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| CN201821142800.7UActiveCN209059540U (en) | 2017-07-18 | 2018-07-18 | Atrial pressure regulating device |
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| CN201810792962.3APendingCN109259894A (en) | 2017-07-18 | 2018-07-18 | Interatrial pressure-regulating device |
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| WO2019015617A1 (en) | 2019-01-24 |
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| GR01 | Patent grant | ||
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| PP01 | Preservation of patent right | Effective date of registration:20250620 Granted publication date:20190705 |