技术领域technical field
本发明涉及医疗器械技术领域，具体涉及一种减小压缩长度的瓣膜支架及具有该瓣膜支架的瓣膜置换装置。The invention relates to the technical field of medical devices, in particular to a valve support with reduced compressed length and a valve replacement device with the valve support.
背景技术Background technique
法洛四联症是存活婴儿中最常见的发绀型先天性心脏病，发病率占各类先天性心脏病的10～15％。Tetralogy of Fallot is the most common cyanotic congenital heart disease in surviving infants, accounting for 10-15% of all congenital heart diseases.
法洛四联症由以下四种畸形组成：(1)肺动脉狭窄，以漏斗部狭窄多见，其次为漏斗部和瓣膜合并狭窄，狭窄程度可随年龄增加而加重；(2)室间隔缺损，所属高位膜部缺损；(3)主动脉骑跨，主动脉骑跨于左、右心室之上，随着主动脉发育，右跨现象可逐渐加重，约25％病人为右位主动脉弓；(4)右心室肥厚，为肺动脉狭窄后右心室负荷增加导致。以上四种畸形中以肺动脉狭窄对患儿的病理生理影响最大。Tetralogy of Fallot consists of the following four malformations: (1) Pulmonary artery stenosis, infundibulum stenosis is more common, followed by infundibulum and valve combined stenosis, and the degree of stenosis can aggravate with age; (2) Ventricular septal defect, It belongs to the high membrane defect; (3) aortic straddle, the aorta straddles the left and right ventricle, with the development of the aorta, the right straddle phenomenon can gradually increase, and about 25% of the patients have a right aortic arch; (4) ) Right ventricular hypertrophy, which is caused by increased right ventricular load after pulmonary artery stenosis. Among the above four malformations, pulmonary artery stenosis has the greatest impact on the pathophysiology of children.
在法洛四联症外科手术中，医生在修复肺动脉、肺动脉瓣或右心室漏斗部狭窄时，一般是通过在对应位置植入补片，来解决主肺动脉、肺动脉分支狭窄或肺动脉瓣狭窄的问题。但这种外科手术只是一种姑息疗法，往往会导致肺动脉瓣缺失，待患儿长到成年时，仍需继续针对肺动脉瓣缺失进行治疗。In the surgical operation of tetralogy of Fallot, when doctors repair pulmonary artery, pulmonary valve or right ventricular infundibulum stenosis, they generally solve the problem of main pulmonary artery, pulmonary artery branch stenosis or pulmonary valve stenosis by implanting a patch in the corresponding position . However, this surgical procedure is only a palliative treatment and often results in the loss of the pulmonary valve, which needs to be continued when the child grows into an adult.
针对患儿成年后的肺动脉瓣缺失问题，可以采用二次开胸手术植入瓣膜解决，也可以采用介入方法，植入人工肺动脉瓣膜解决。采用介入方法相比外科手术，能够大大降低患者的手术创伤，为不能承受外科手术的患者提供了另一条治疗途径。For the problem of missing pulmonary valve in children as adults, it can be solved by implanting the valve through a second thoracotomy, or by implanting an artificial pulmonary valve through interventional methods. Compared with surgery, interventional methods can greatly reduce the surgical trauma of patients, and provide another treatment for patients who cannot bear surgery.
患儿经过第一次补片手术后，主动脉松软，直径扩大，因此，所需植入的人工肺动脉瓣膜的长度以及直径尺寸都较大。现有技术中的肺动脉瓣膜支架在植入人体之前，是以压缩的状态置于鞘管中，被鞘管输送到人体中后，肺动脉瓣膜支架由鞘管中释放出来，释放后的肺动脉瓣膜支架恢复到自然状态，起到支撑假体瓣膜的作用。After the first patch operation, the aorta was soft and enlarged in diameter. Therefore, the length and diameter of the prosthetic pulmonary valve to be implanted were both large. Before the pulmonary valve stent in the prior art is implanted into the human body, it is placed in the sheath in a compressed state. After being transported into the human body by the sheath, the pulmonary valve stent is released from the sheath, and the released pulmonary valve stent Return to the natural state and play a role in supporting the prosthetic valve.
现有的肺动脉支架为了便于压缩，主体结构为菱形网格，例如，申请公布号为CN 103431931A的中国发明专利文献公开了一种肺动脉支架，包括管状的支撑网架，以及连接在支撑网架轴向两端且径向膨胀呈扩口的流入段和流出段，所述支撑网架邻近流出段部位具有绕周向分布的若干第一单元格，第一单元格采用菱形。In order to facilitate compression, the existing pulmonary artery stent has a main structure of a rhombus grid. For example, the Chinese invention patent document with the application publication number CN 103431931A discloses a pulmonary artery stent, which includes a tubular support grid and a shaft connected to the support grid. The inflow section and the outflow section expand toward both ends and expand radially. The supporting grid has several first cells distributed around the circumference adjacent to the outflow section. The first cells adopt a rhombus shape.
当肺动脉瓣膜支架的主体部分采用菱形结构时，无论是长度方向还是直径方向，压缩前后的尺寸变化较大，而肺动脉瓣膜的植入路径依次通过静脉、右心房、右心室、主肺动脉，该植入路径的弯曲度较大，肺动脉瓣压缩后的长度如果过长，将严重影响器械输送过程中的顺应性，增加输送难度。When the main part of the pulmonary valve stent adopts a rhombic structure, no matter in the direction of length or diameter, the size changes before and after compression are large, and the implantation path of the pulmonary valve sequentially passes through the vein, right atrium, right ventricle, and main pulmonary artery. If the length of the compressed pulmonary valve is too long, it will seriously affect the compliance of the device during delivery and increase the difficulty of delivery.
发明内容Contents of the invention
本发明提供了一种减小压缩长度的瓣膜支架，能够减小瓣膜支架压缩前后的长度变化，提高瓣膜支架的弯曲顺应性，使瓣膜能够在人体内顺利到达植入位置，保证手术过程的顺利进行，降低术后发生血管并发症的风险。The invention provides a valve support with reduced compression length, which can reduce the length change of the valve support before and after compression, improve the bending compliance of the valve support, enable the valve to reach the implantation position smoothly in the human body, and ensure the smooth operation process To reduce the risk of postoperative vascular complications.
一种减小压缩长度的瓣膜支架，包括管状的支撑网架，所述支撑网架的其中一段为过渡段，该过渡段压缩前后的轴向长度之比等于1。A valve support with reduced compressed length, comprising a tubular supporting grid, one section of the supporting grid is a transition section, and the ratio of the axial length before and after compression of the transition section is equal to 1.
现有技术中的心脏瓣膜支架通过输送系统送入人体时，通常是将心脏瓣膜支架压缩后放置在输送系统的器械装载部分，而放置有瓣膜支架的器械装载部分是整个鞘管中最坚硬的部分，为了使该最坚硬部分的长度最小，以满足通过弯曲度较大的植入路径的需求，需要将心脏瓣膜支架压缩后的长度减小。When the heart valve stent in the prior art is sent into the human body through the delivery system, the heart valve stent is usually compressed and placed on the instrument loading part of the delivery system, and the instrument loading part where the valve stent is placed is the hardest in the entire sheath. Partly, in order to minimize the length of the hardest part to meet the requirement of passing through the implantation path with greater curvature, it is necessary to reduce the length of the heart valve stent after compression.
本发明中的支撑网架是指瓣膜支架中除去定位部件之外用于撑开血管的部分，通常为管状，血液在管状内部流动，与管状内部的假体瓣膜相作用。支撑网架并不限于是等径延伸的筒状，支撑网架的端部可以在径向上有膨胀或者收缩。The supporting grid in the present invention refers to the part of the valve stent that is used to expand the blood vessel except for the positioning parts, and is usually tubular, and the blood flows inside the tubular and interacts with the prosthetic valve inside the tubular. The support network frame is not limited to a cylindrical shape extending in an equal diameter, and the ends of the support network frame can expand or contract in the radial direction.
为了减小支撑网架压缩后的长度，本发明在支撑网架上设置一段过渡段，过渡段在压缩前后保持轴向上长度不变，相比现有技术中的菱形网格，能够减小压缩前后在轴向上的长度变化。In order to reduce the compressed length of the supporting grid, the present invention sets a transition section on the supporting grid, and the transition section keeps the axial length unchanged before and after compression, which can reduce the Change in length in the axial direction before and after compression.
作为优选，所述过渡段的轴向长度为支撑网架总长度的至少25％。只有在过渡段轴向长度与支撑网架总长度之比达到25％以上时，过渡段的作用才能够得以显现，即基于过渡段的存在，使压缩后的支撑网架的长度能够减小到满足弯曲顺应性的要求，使支撑网架能够顺利地到达人体内部预期部位，保证手术的顺利进行。Preferably, the axial length of the transition section is at least 25% of the total length of the supporting grid. Only when the ratio of the axial length of the transition section to the total length of the supporting grid reaches more than 25%, the effect of the transition section can be manifested, that is, based on the existence of the transition section, the length of the compressed supporting grid can be reduced to It meets the requirements of bending compliance, so that the support grid can smoothly reach the expected part inside the human body, ensuring the smooth progress of the operation.
虽然过渡段能够减小支撑网架压缩前后轴向上的长度变化，但是，过渡段的长度也并非越长越好，因为，菱形网格虽然压缩前后在轴向上的长度变化比较大，但是菱形网格的结构能够保证支撑网架具有足够的强度，能够承受长时间的血液冲刷，且菱形网格的结构使支撑网架能够被压缩，从而放置在鞘管中。Although the transition section can reduce the length change in the axial direction before and after compression of the supporting grid, the length of the transition section is not as long as possible, because although the rhombus grid has a relatively large change in the axial length before and after compression, the The rhombic grid structure can ensure that the supporting grid has sufficient strength to withstand long-term blood flushing, and the rhomboid grid structure enables the supporting grid to be compressed and placed in the sheath.
因此，优选地，所述过渡段的轴向长度为支撑网架总长度的40～90％。进一步优选，所述过渡段的轴向长度为支撑网架总长度的50～80％。Therefore, preferably, the axial length of the transition section is 40-90% of the total length of the supporting grid. Further preferably, the axial length of the transition section is 50-80% of the total length of the supporting grid.
作为最简单的实施方式，所述过渡段由若干沿瓣膜支架轴向延伸的直杆构成，各直杆沿周向均匀排布。As the simplest embodiment, the transition section is composed of several straight rods extending axially along the valve support, and each straight rod is uniformly arranged along the circumferential direction.
直杆沿瓣膜支架的轴向延伸，直杆的长度即过渡段的轴向长度，沿周向均匀排布，可以保证支撑网架整体结构的对称性，在血管中长期经受血流冲刷时，受力均匀，不易发生倾侧，从而对血管壁造成伤害。The straight rods extend along the axial direction of the valve stent, and the length of the straight rods is the axial length of the transition section. They are evenly arranged along the circumference, which can ensure the symmetry of the overall structure of the supporting grid. When the blood vessels are subjected to blood flow for a long time, The force is uniform, and it is not easy to tilt, which will cause damage to the blood vessel wall.
作为优选，所述支撑网架轴向两端连接有流入段和流出段，所述过渡段的两端与流入段、流出段之间通过网格段连接或直接连接。Preferably, the axial ends of the support network frame are connected with an inflow section and an outflow section, and the two ends of the transition section are connected with the inflow section and the outflow section through grid sections or directly.
过渡段通过网格段与流入段或流出段连接时，过渡段和网格段共同构成本发明所述的支撑网架。When the transition section is connected to the inflow section or the outflow section through the mesh section, the transition section and the mesh section together constitute the supporting network frame of the present invention.
所述的流入段和流出段均呈扩口，使瓣膜支架植入人体后，不易随心脏的运动而出现位移。Both the inflow section and the outflow section are flaring, so that after the valve stent is implanted in the human body, it is not easy to be displaced with the movement of the heart.
在人体内释放时，瓣膜支架中的流入段和流出段都有可能是先释放端，处在先释放端的流入段或流出段，称为扩口段。扩口段与支撑网架上对应侧的所有端节点相连。When released in the human body, both the inflow section and the outflow section in the valve stent may be the first release end, and the inflow section or outflow section at the first release end is called the flaring section. The flaring sections are connected to all end nodes on the corresponding sides of the supporting grid.
将所有端节点与扩口段相连接，避免在瓣膜支架非端部的部位出现孤立的顶点，消除了瓣膜支架压缩入鞘管后，出现尖刺的现象。All the end nodes are connected with the flaring section, avoiding the occurrence of isolated vertices at the non-end parts of the valve stent, and eliminating the phenomenon of sharp spikes after the valve stent is compressed into the sheath.
所述扩口段的外边缘由若干弯曲的支撑条围成，支撑网架上与支撑条位置相对应的端节点均与支撑条相连。所述端节点相交在支撑条上或通过接引条交汇连接至支撑条上。The outer edge of the flaring section is surrounded by a number of curved support bars, and the end nodes corresponding to the positions of the support bars on the support grid are all connected with the support bars. The end nodes are intersected on the support bars or are connected to the support bars through connecting bars.
将所有端节点直接连接或者通过接引条连接至支撑条上，即支撑网架上不存在孤立存在的端节点，每个端节点至少连接有三条线性边，在整个瓣膜支架发生压缩时，端节点不会变形为尖刺。Connect all the end nodes to the support bar directly or through the guide bar, that is, there are no isolated end nodes on the support grid, and each end node is connected with at least three linear edges. When the entire valve stent is compressed, the end nodes Nodes do not deform into spikes.
每根支撑条的两端分别连接支撑网架的一个端节点，支撑条的中部沿支撑网架的轴向延伸，且支撑条邻近端节点的部位向外弯曲以形成扩口。所述接引条由对应端节点至支撑条的延伸路径逐渐背离支撑网架。The two ends of each support bar are respectively connected to an end node of the support grid, the middle part of the support bar extends along the axial direction of the support grid, and the part of the support bar adjacent to the end node is bent outward to form a flare. The extending path of the connecting bar from the corresponding end node to the supporting bar gradually deviates from the supporting grid.
接引条也具有适当的弯曲，且弯曲程度与支撑条的弯曲形状相适应，接引条与支撑条位于同一光滑曲面上。The lead bar also has a proper curvature, and the degree of curvature is adapted to the curved shape of the support bar, and the lead bar and the support bar are located on the same smooth curved surface.
作为优选，延伸路径两端点连线与瓣膜支架轴线的夹角为0～70度。延伸路径与瓣膜支架轴线夹角为0度时，接引条的长度最短，但是，由于接引条以及支撑条均具有弯曲结构，因此，接引条的延伸路径通常不会与瓣膜支架的轴线相平行。接引条需要汇至支撑条上，为了配合支撑条的形状，接引条的延伸路径也不易与瓣膜支架的轴线具有很大的夹角。Preferably, the included angle between the line connecting the two ends of the extension path and the axis of the valve support is 0-70 degrees. When the angle between the extension path and the axis of the valve stent is 0 degrees, the length of the guide strip is the shortest. However, since both the guide strip and the support strip have a curved structure, the extension path of the guide strip is usually not in line with the axis of the valve stent. parallel. The guiding strip needs to be connected to the supporting strip. In order to match the shape of the supporting strip, the extension path of the guiding strip is not easy to have a large angle with the axis of the valve stent.
优选地，延伸路径两端点连线与瓣膜支架轴线的夹角为20～60度。进一步优选，延伸路径两端点连线与瓣膜支架轴线的夹角为30～45度。Preferably, the included angle between the line connecting the two ends of the extension path and the axis of the valve support is 20-60 degrees. Further preferably, the included angle between the line connecting the two ends of the extension path and the axis of the valve support is 30-45 degrees.
接引条与最邻近的支撑条相连接，接引条与支撑条相交部位的夹角为锐角。采用这种结构易于维持原有的力学性能。The lead bar is connected with the nearest support bar, and the angle between the lead bar and the support bar is an acute angle. Adopting this structure is easy to maintain the original mechanical properties.
每相邻的四个端节点作为一组，在一组端节点中，所述支撑条的两端分别与距离最远的两个端节点相连接，位于中部的两个端节点分别由一根接引条连接至对应侧的支撑条上，且两根接引条互不相交，每根接引条与支撑条相交的位置大致位于扩口段轴向上的中部。Every adjacent four end nodes are taken as a group. In a group of end nodes, the two ends of the support bar are respectively connected with the two farthest end nodes, and the two end nodes in the middle are respectively connected by a The leading strips are connected to the supporting strips on the corresponding side, and the two leading strips do not intersect each other, and the position where each leading strip intersects with the supporting strips is roughly located in the middle of the flaring section in the axial direction.
为了最大程度地保留现有的瓣膜支架结构，使瓣膜支架的加工更容易进行，优选地，所述网格段为菱形网格，过渡段各直杆端头与对应的菱形顶点连接。In order to retain the existing valve stent structure to the greatest extent and make the processing of the valve stent easier, preferably, the grid section is a rhombus grid, and the ends of the straight rods in the transition section are connected to the corresponding rhombus vertices.
各直杆端头与对应的菱形顶点连接，首先，基于菱形网格的对称结构，更易于控制各直杆沿周向均匀排列，使加工更易进行，其次，瓣膜支架上暴露的端点更少，不容易刺破鞘管或者血管，最后，瓣膜支架的受力状态更为简单，便于瓣膜支架的结构设计(例如选择合适的轴向以及径向长度)同时，也有利于瓣膜支架在流动的血液中保持位置稳定。The ends of the straight rods are connected to the corresponding rhombus vertices. Firstly, based on the symmetrical structure of the rhombus grid, it is easier to control the uniform arrangement of the straight rods along the circumferential direction, which makes the processing easier. Secondly, there are fewer exposed ends on the valve stent. It is not easy to puncture the sheath or blood vessels. Finally, the stress state of the valve stent is simpler, which is convenient for the structural design of the valve stent (such as selecting appropriate axial and radial lengths), and it is also conducive to the flow of blood in the valve stent. Keep the position stable.
作为优选，过渡段各直杆端头连接在菱形网格朝向过渡段的菱形顶点。Preferably, the ends of the straight rods in the transition section are connected to the rhombus vertex of the rhombus grid towards the transition section.
直杆的两端分别与一个菱形顶点连接，相邻的两个直杆以及与直杆连接的菱形的相应边构成六边形结构，该六边形的各个内角均为钝角。采用这种结构能够最大程度的减小菱形暴露的顶点数量，使瓣膜支架的使用安全性更好。The two ends of the straight rods are respectively connected with a rhombus vertex, and the two adjacent straight rods and the corresponding sides of the rhombus connected with the straight rods form a hexagonal structure, and each internal angle of the hexagon is an obtuse angle. Adopting this structure can minimize the number of vertices exposed by the rhombus, so that the use safety of the valve stent is better.
本发明中所述的菱形网格，并非是严格意义上的菱形，菱形的各边可以略有弯曲，每个形成相对接近圆形的结构，减少受力时的应力集中点。The rhombus grid described in the present invention is not a rhombus in the strict sense, and each side of the rhombus can be slightly bent, each forming a relatively close to circular structure, which reduces the stress concentration point when the force is applied.
本发明还提供了一种瓣膜置换装置，包括所述的瓣膜支架，以及固定在所述支撑网架内部的假体瓣膜。The present invention also provides a valve replacement device, which includes the valve support and a prosthetic valve fixed inside the support grid.
所述瓣膜支架的支撑网架和流入段均覆膜，假体瓣膜可缝制在瓣膜支架的内壁，也可以采用现有的其他方法进行安装固定。The support grid frame and the inflow section of the valve support are covered with membranes, and the prosthetic valve can be sewn on the inner wall of the valve support, or installed and fixed by other existing methods.
本发明减小压缩长度的瓣膜支架，能够减小瓣膜支架压缩前后的长度变化，提高瓣膜支架的弯曲顺应性，同时保证瓣膜支架保持良好的压缩性能以及强度，使瓣膜能够在人体内顺利到达植入位置，降低术后发生血管并发症的风险。The valve support with reduced compression length of the present invention can reduce the length change of the valve support before and after compression, improve the bending compliance of the valve support, and at the same time ensure that the valve support maintains good compression performance and strength, so that the valve can smoothly reach the implant in the human body. Into the position, reduce the risk of vascular complications after surgery.
附图说明Description of drawings
图1为减小压缩长度的肺动脉支架的第一种实施方式的示意图；1 is a schematic diagram of a first embodiment of a pulmonary artery stent with reduced compressed length;
图2为减小压缩长度的肺动脉支架的第一种实施方式的立体图；2 is a perspective view of a first embodiment of a pulmonary artery stent with reduced compressed length;
图3为减小压缩长度的肺动脉支架的第二种实施方式的示意图(后半侧省略)；Fig. 3 is the schematic diagram of the second embodiment of the pulmonary artery stent with reduced compressed length (the second half is omitted);
图4为减小压缩长度的主动脉支架的示意图。4 is a schematic diagram of an aortic stent with reduced compressed length.
图中：1、流出段；2、网格段；3、过渡段；4、端节点；5、流入段；6、支撑条；7、直杆；8、接引条；9、网格段；10、流入段；11、过渡段；12、直杆；13、网格段；14、网格段；15、流出段。In the figure: 1. Outflow section; 2. Grid section; 3. Transition section; 4. End node; 5. Inflow section; 6. Support bar; 7. Straight bar; , inflow section; 11, transition section; 12, straight bar; 13, mesh section; 14, mesh section; 15, outflow section.
具体实施方式Detailed ways
实施例1Example 1
下面结合附图，以肺动脉支架为例，对本发明做进一步阐释。In the following, the present invention will be further explained by taking the pulmonary artery stent as an example in conjunction with the accompanying drawings.
如图1、图2所示，减小压缩长度的肺动脉支架，包括支撑网架以及分别连接在支撑网架轴向两端的流入段5和流出段1，支撑网架的其中一段为过渡段3。As shown in Figure 1 and Figure 2, the pulmonary artery stent with reduced compression length includes a support grid and an inflow section 5 and an outflow section 1 respectively connected to the axial ends of the support grid, and one section of the support grid is a transition section 3 .
过渡段3的一端通过网格段13与流入段5相连接，过渡段3的另一端通过网格段2与和流出段1相连接，网格段2、网格段13和过渡段3共同构成支撑网架。网格段2由连续的菱形组成，网格段13由连续的半菱形组成，流入段5相比过渡段3，在径向上向外扩张形成扩口，菱形的边并非严格的直线，而是略向外弯曲，流入段5、网格段2以及网格段13在圆周向上的菱形或半菱形数目相同。One end of the transition section 3 is connected to the inflow section 5 through the mesh section 13, and the other end of the transition section 3 is connected to the outflow section 1 through the mesh section 2, and the mesh section 2, the mesh section 13 and the transition section 3 together form a supporting network frame . Grid segment 2 is composed of continuous rhombus, grid segment 13 is composed of continuous semi-rhombic, inflow segment 5 expands radially outward to form flare compared with transition segment 3, and the sides of rhombus are not strictly straight lines, but slightly Outwardly curved, the number of rhombuses or half rhombuses in the circumferential direction of the inflow segment 5 , the grid segment 2 and the grid segment 13 is the same.
过渡段3由若干沿肺动脉支架轴向延伸的直杆7构成，各直杆7沿周向均匀排布，过渡段3的轴向长度为支撑网架总长度的70％。The transition section 3 is composed of several straight rods 7 extending axially along the pulmonary artery stent, each straight rod 7 is evenly arranged along the circumferential direction, and the axial length of the transition section 3 is 70% of the total length of the supporting grid.
过渡段3各直杆7端头与对应的菱形顶点连接，过渡段3各直杆7端头连接在菱形网格朝向过渡段3的菱形顶点。由图1可以看出，过渡段3的各直杆7与相邻的菱形的边构成六边形，六边形的各内角均为钝角。The ends of the straight rods 7 of the transition section 3 are connected to the corresponding rhombus vertices, and the ends of the straight rods 7 of the transition section 3 are connected to the rhombus vertices of the transition section 3 on the rhombus grid. It can be seen from FIG. 1 that each straight bar 7 of the transition section 3 forms a hexagon with adjacent rhombus sides, and each internal angle of the hexagon is an obtuse angle.
实施例2Example 2
除了与实施例1具有相同的过渡段3结构外，本实施例消除了肺动脉支架中孤立存在的端节点。In addition to having the same structure of the transition section 3 as in Embodiment 1, this embodiment eliminates isolated end nodes in the pulmonary artery stent.
如图3所示，流入段5和流出段1的径向膨胀呈扩口，在人体内释放时，肺动脉支架的流出段1为先释放端，流出段1与支撑网架上对应侧的所有端节点4相连。图3中省却了肺动脉支架的后半侧，仅显示肺动脉支架的前半侧。As shown in Figure 3, the radial expansion of the inflow section 5 and the outflow section 1 is flaring. When releasing in the human body, the outflow section 1 of the pulmonary artery stent is the first release end, and the outflow section 1 and all the corresponding sides on the support network frame End node 4 is connected. In Fig. 3, the rear half of the pulmonary artery stent is omitted, and only the front half of the pulmonary artery stent is shown.
流出段1的外边缘由若干弯曲的支撑条6围成，每相邻的四个端节点4作为一组，在一组端节点4中，具有一根支撑条6以及两根接引条8，支撑条6的两端分别与相距最远的两个端节点4相连接，位于中部的两个端节点4分别由一根接引条8连接至对应侧的支撑条6上，这两根接引条8互不相交，每根接引条8与支撑条6相交的位置大致位于流出段1轴向上的中部。The outer edge of the outflow section 1 is surrounded by a number of curved support bars 6, and each adjacent four end nodes 4 are taken as a group, and in a group of end nodes 4, there is one support bar 6 and two connecting bars 8 , the two ends of the support bar 6 are respectively connected to the two end nodes 4 that are farthest apart, and the two end nodes 4 located in the middle are respectively connected to the support bar 6 on the corresponding side by a lead bar 8 . The leading bars 8 do not intersect each other, and the position where each leading bar 8 intersects with the support bar 6 is roughly located in the middle of the outflow section 1 in the axial direction.
接引条8由对应端节点4至支撑条6的延伸路径逐渐背离支撑网架，接引条8与支撑条6相交部位的夹角为锐角。The extension path of the lead bar 8 from the corresponding end node 4 to the support bar 6 gradually deviates from the support grid, and the angle between the lead bar 8 and the support bar 6 is an acute angle.
实施例3Example 3
下面结合附图，以主动脉支架为例，对本发明做进一步阐释。In the following, the present invention will be further explained by taking the aortic stent as an example in conjunction with the accompanying drawings.
如图4所示，减小压缩长度的主动脉支架，包括支撑网架以及连接在支撑网架轴向两端的流出段15和流入段10，支撑网架的其中一段为过渡段11。As shown in FIG. 4 , the aortic stent with reduced compressed length includes a support grid and an outflow section 15 and an inflow section 10 connected to both ends of the support grid in the axial direction. One section of the support grid is a transition section 11 .
过渡段的一端通过网格段9与流出段15相连接，过渡段11的另一端通过网格段14与和流出段10相连接，网格段14、网格段9和过渡段11共同构成支撑网架。网格段14、网格段9由连续的半菱形组成，流入段10相比过渡段11在径向上向外扩张形成扩口，菱形的边并非严格的直线，而是略向外弯曲。One end of the transition section is connected to the outflow section 15 through the mesh section 9, and the other end of the transition section 11 is connected to the outflow section 10 through the mesh section 14, and the mesh section 14, the mesh section 9 and the transition section 11 together form a supporting grid. The mesh section 14 and the mesh section 9 are composed of continuous semi-rhombic shapes. Compared with the transition section 11, the inflow section 10 expands radially outward to form a flared opening. The sides of the rhombus are not strictly straight lines, but slightly curved outward.
过渡段11由若干沿主动脉支架轴向延伸的直杆12构成，各直杆12沿周向均匀排布，过渡段11的轴向长度为支撑网架总长度的80％。The transition section 11 is composed of several straight rods 12 extending axially along the aortic stent, each straight rod 12 is evenly arranged along the circumference, and the axial length of the transition section 11 is 80% of the total length of the support network frame.
过渡段11各直杆12两端头与对应的网格段14、网格段9的半菱形顶点连接，由图4可以看出，过渡段11的各直杆12与相邻的半菱形的边构成六边形，六边形的各内角均为钝角。The two ends of each straight bar 12 of the transition section 11 are connected with the semi-rhombic vertices of the corresponding mesh section 14 and the mesh section 9. As can be seen from Fig. 4, each straight bar 12 of the transition section 11 forms a border with the adjacent semi-diamond In a hexagon, all interior angles of a hexagon are obtuse angles.
采用本发明的技术方案能够大大减小瓣膜支架压缩后的长度，假定一个支撑网架过渡段轴向菱形单元有n个，每一个菱形单元压缩后比压缩前的轴向增长量为X，则支撑网架压缩后长度增加变化量值为n*X；对比可得，若将过渡段菱形格改变为直线，过渡段的两端将分别剩余各半个菱形格，则支撑网架压缩前后长度变化为1*X，直线部分压缩前后轴向长度变化量为‘零’。举例说明如下：目前最常见的自膨式肺动脉支架中，支撑网架全部由菱形网格构成，以最常见的30#瓣为例，圆周向分布有12个菱形网格，固定瓣膜的直段长度为30mm，轴向上存在4个菱形格，当瓣膜支架被压缩时，菱形格变为直线，直段长度变化为约43.04mm；采用本发明提供的技术方案后，在过渡段3的两端分别剩余各半个菱形格，压缩后直段长度约为33.26mm，减少了9.78mm的压缩长度，效果显著。Adopting the technical solution of the present invention can greatly reduce the compressed length of the valve stent, assuming that there are n axial diamond-shaped units in the transition section of a support grid, and the axial growth of each diamond-shaped unit after compression is X compared with that before compression, then The length increase and change value of the supporting grid after compression is n*X; by comparison, if the diamond-shaped grid in the transition section is changed to a straight line, half diamond-shaped grids will remain at both ends of the transition section, and the length of the supporting grid before and after compression The change is 1*X, and the change in axial length before and after compression of the straight line is 'zero'. Examples are as follows: In the most common self-expanding pulmonary artery stents at present, the supporting grids are all composed of diamond-shaped grids. Taking the most common 30# valve as an example, there are 12 diamond-shaped grids distributed in the circumferential direction to fix the straight section of the valve. The length is 30mm, and there are 4 diamond-shaped lattices in the axial direction. When the valve support is compressed, the diamond-shaped lattices become straight lines, and the length of the straight section changes to about 43.04mm; There are half diamond-shaped grids left at each end, and the length of the straight section after compression is about 33.26mm, which reduces the compressed length by 9.78mm, and the effect is remarkable.
除此之外，本发明可以将瓣膜支架所使用的金属材质(通常为记忆合金，本发明采用镍钛记忆合金)用量减少近一半，既可以降低瓣膜支架压缩后的直径，又能够改善弯曲顺应性，使瓣膜的通过性能得到进一步提升。In addition, the present invention can reduce the amount of the metal material (usually memory alloy, nickel-titanium memory alloy) used in the valve stent by nearly half, which can not only reduce the diameter of the valve stent after compression, but also improve the bending compliance The performance of the valve is further improved.
本发明提供的瓣膜置换装置，包括前述的瓣膜支架，以及固定在支撑网架内部的假体瓣膜。瓣膜支架通过输送系统进入人体预定位置后，瓣膜支架由鞘管中释放并膨胀，瓣膜支架内部固定的假体瓣膜替代人体内原有的瓣膜，实现使血液单向通过的功能。The valve replacement device provided by the present invention includes the aforementioned valve support and a prosthetic valve fixed inside the support grid. After the valve stent enters the predetermined position of the human body through the delivery system, the valve stent is released and expanded from the sheath, and the prosthetic valve fixed inside the valve stent replaces the original valve in the human body to realize the function of allowing blood to pass through in one direction.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710364702.1ACN107252363B (en) | 2015-03-26 | 2015-03-26 | Valve stent with reduced compressed length and valve replacement device with same |
| CN201510136641.4ACN104720937B (en) | 2015-03-26 | 2015-03-26 | Valve support with reduced compressed length and valve replacement device with the valve support |
| PCT/CN2015/078943WO2016149997A1 (en) | 2015-03-26 | 2015-05-14 | Valve scaffold with reduced compressed length and valve replacement device with valve scaffold |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510136641.4ACN104720937B (en) | 2015-03-26 | 2015-03-26 | Valve support with reduced compressed length and valve replacement device with the valve support |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710364702.1ADivisionCN107252363B (en) | 2015-03-26 | 2015-03-26 | Valve stent with reduced compressed length and valve replacement device with same |
| Publication Number | Publication Date |
|---|---|
| CN104720937Atrue CN104720937A (en) | 2015-06-24 |
| CN104720937B CN104720937B (en) | 2017-09-26 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510136641.4AActiveCN104720937B (en) | 2015-03-26 | 2015-03-26 | Valve support with reduced compressed length and valve replacement device with the valve support |
| CN201710364702.1AActiveCN107252363B (en) | 2015-03-26 | 2015-03-26 | Valve stent with reduced compressed length and valve replacement device with same |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710364702.1AActiveCN107252363B (en) | 2015-03-26 | 2015-03-26 | Valve stent with reduced compressed length and valve replacement device with same |
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| CN (2) | CN104720937B (en) |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| CB03 | Change of inventor or designer information | Inventor after:Zeng Min Inventor after:Luo Lali Inventor after:Wang Yunbing Inventor before:Zeng Min Inventor before:Luo Lali | |
| COR | Change of bibliographic data | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP03 | Change of name, title or address | ||
| CP03 | Change of name, title or address | Address after:310051 311, 3 building, 2 building, 88 Jiangling Road, Binjiang District, Hangzhou, Zhejiang. Patentee after:Hangzhou Qiming Medical Devices Co., Ltd. Address before:310051 East Building of Tax Youyou Building, 3738 Nanhuan Road, Binjiang District, Hangzhou City, Zhejiang Province Patentee before:Hangzhou Qiming Medical Device Co., Ltd. |