主动脉瓣狭窄是老年人常见的一种心脏结构性疾病，其发病率随着年龄的增长而增加。外科开胸手术行主动脉瓣膜置换术是主动脉瓣狭窄的有效治疗手段，但由于高龄、体质虚弱或其他因素等导致约1/3的患者不能接受外科开胸手术。经导管主动脉瓣置换术(Transcatheter Aortic Valve Replacement,TAVR)是一种微创瓣膜置换术，是通过介入导管技术将人工心脏瓣膜输送至主动脉瓣位置，从而完成人工瓣膜植入，恢复瓣膜功能。TAVR目前已经成为外科手术高危症状性重度主动脉瓣狭窄患者的替代治疗以及外科手术禁忌患者的首选治疗。Aortic stenosis is a common structural heart disease in the elderly, and its incidence increases with age. Surgical thoracotomy for aortic valve replacement is an effective treatment for aortic stenosis, but about 1/3 of patients cannot receive surgical thoracotomy due to advanced age, physical weakness or other factors. Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive valve replacement surgery, which uses interventional catheter technology to deliver an artificial heart valve to the position of the aortic valve, thereby completing artificial valve implantation and restoring valve function. . TAVR has become an alternative treatment for patients with symptomatic severe aortic stenosis at high surgical risk and the first choice for patients with surgical contraindications.

在我国，有相当一部分比例的主动脉瓣狭窄患者的原生主动脉瓣严重钙化并出现二叶化畸形病变。在二叶式主动脉瓣病变中，患者的主动脉瓣的瓣叶部分融合，致主动脉瓣由两个瓣叶构成而非正常的三个瓣叶构成，开放的瓣口面积减小。在进行TAVR手术之前，医生可能需要将两个融合的小叶分开，扩大瓣口的有效开放面积，以便于人工瓣膜能够顺利实现跨瓣并放置在原生主动脉瓣的适当位置，从而确保人工瓣膜实现最佳展开。In my country, a considerable proportion of patients with aortic stenosis have severe calcification and bicuspid deformity of the native aortic valve. In bicuspid aortic valve disease, the leaflets of the patient's aortic valve are partially fused, causing the aortic valve to consist of two leaflets instead of the normal three leaflets, and the open valve orifice area is reduced. Before performing TAVR surgery, the doctor may need to separate the two fused leaflets to expand the effective opening area of the valve orifice, so that the artificial valve can successfully cross the valve and be placed in the proper position of the native aortic valve, so as to ensure the realization of the artificial valve. Best unwrapped.

本领域中已报道有通过导管递送切割装置用于对融合的瓣叶进行切割，但上述切割装置要么采用了复杂的定位及切割结构，要么无法对单侧瓣叶进行针对性切割，瓣叶分割效果不理想。It has been reported in the art that a cutting device delivered through a catheter is used to cut the fused leaflet, but the above-mentioned cutting device either adopts a complicated positioning and cutting structure, or cannot perform targeted cutting on the unilateral leaflet, and the leaflet segmentation The effect is not ideal.

发明内容Contents of the invention

本发明公开了一种瓣叶分割装置，用于解决现有技术中，采用了复杂的定位及切割结构，并且不便于对单侧瓣叶进行针对性切割，瓣叶分割效果不理想的问题。The invention discloses a leaflet segmentation device, which is used to solve the problems in the prior art that complex positioning and cutting structures are used, and it is inconvenient to perform targeted cutting on a single leaflet, and the leaflet segmentation effect is not ideal.

为了解决上述问题，本发明采用下述技术方案：In order to solve the above problems, the present invention adopts the following technical solutions:

提供一种瓣叶分割装置，包括：A leaflet segmentation device is provided, comprising:

推送管；push tube;

第一固定件和第二固定件，其近端均固定于所述推送管的远端；所述第一固定件和第二固定件的远端在自然状态下远离所述推送管的延伸方向；The first fixing part and the second fixing part, the proximal ends of which are all fixed to the distal end of the push tube; the far ends of the first fixing part and the second fixing part are away from the extending direction of the pushing tube in a natural state ;

切割导管，可滑动地设置于所述推送管内；所述切割导管的远端具有切割部，所述切割部包括切割电极；所述切割部的远端在自然状态下远离所述切割导管的延伸方向；The cutting catheter is slidably arranged in the push tube; the distal end of the cutting catheter has a cutting portion, and the cutting portion includes a cutting electrode; the distal end of the cutting portion is in a natural state away from the extension of the cutting catheter direction;

内管，可滑动地设置于所述切割导管内；an inner tube slidably disposed within the cutting catheter;

限位端头，设置于所述内管的远端；所述限位端头具有能够容纳所述第二固定件远端的限位孔。The limiting end is arranged at the distal end of the inner tube; the limiting end has a limiting hole capable of accommodating the distal end of the second fixing member.

在上述方案中，所述第一固定件和第二固定件在所述推送管的远端沿所述推送管的轴向大致重叠排列设置，其中，所述第二固定件位于相对远端。In the above solution, the first fixing part and the second fixing part are disposed on the distal end of the pushing tube in a substantially overlapping arrangement along the axial direction of the pushing tube, wherein the second fixing part is located at the opposite distal end.

在上述方案中，所述第一固定件具有第一通槽，和/或，第二固定件具有第二通槽。In the above solution, the first fixing part has a first through slot, and/or, the second fixing part has a second through slot.

在上述方案中，所述第一固定件和第二固定件由弹性材料制成。In the solution above, the first fixing part and the second fixing part are made of elastic material.

在上述方案中，所述第二固定件能够在外力作用下靠近所述内管；在所述第二固定件的远端插入所述限位孔时，所述第二固定件被限制弹起。In the above solution, the second fixing piece can be close to the inner tube under the action of external force; when the distal end of the second fixing piece is inserted into the limiting hole, the second fixing piece is restricted from springing up .

在上述方案中，当所述内管相对于所述推送管向远端滑动，所述第二固定件的远端能够从所述限位孔中脱出并弹起。In the above solution, when the inner tube slides towards the distal end relative to the pushing tube, the distal end of the second fixing member can escape from the limiting hole and spring up.

在上述方案中，所述切割导管的远端具有一条形槽，所述切割部设置于所述条形槽内并固定于条形槽的近端；所述切割部为直线或曲线的条形或柱形，所述切割电极为条形，设置于所述切割部一侧。In the above solution, the distal end of the cutting catheter has a strip-shaped groove, and the cutting part is arranged in the strip-shaped groove and fixed to the proximal end of the strip-shaped groove; the cutting part is a straight line or a curved strip or columnar, the cutting electrode is strip-shaped and arranged on one side of the cutting part.

在上述方案中，所述限位端头远端比近端具有更小的直径；所述限位孔靠近所述内管设置。In the above solution, the distal end of the limiting tip has a smaller diameter than the proximal end; the limiting hole is arranged close to the inner tube.

在上述方案中，所述推送管的远端与所述切割导管远端之间仅能够轴向滑动，而不能相对轴向旋转；In the above solution, the distal end of the push tube and the distal end of the cutting catheter can only slide axially, but cannot rotate relatively axially;

所述切割部的至少部分能够在所述切割导管的带动下，穿过第一通槽和/或第二通槽，对夹持在所述第一固定件和第二固定件之间的天然瓣叶进行切割。Driven by the cutting catheter, at least a part of the cutting part can pass through the first through groove and/or the second through groove, and the natural clamped between the first fixing part and the second fixing part Leaflets are cut.

在上述方案中，还包括电极导线，设置于所述推送管内，连接所述切割电极。In the above solution, it also includes electrode wires, which are arranged in the push tube and connected to the cutting electrodes.

在上述方案中，所述推送管靠近远端的位置处具有可压缩的覆膜支架。In the above solution, a compressible stent graft is provided near the distal end of the push tube.

在上述方案中，所述覆膜支架为套设于所述推送管的伞状结构。In the above solution, the stent-graft is an umbrella-shaped structure sheathed on the push tube.

在上述方案中，所述覆膜支架为设置于所述推送管的漏斗结构，所述漏斗结构设置于所述第一固定件近端一侧附近。In the above solution, the stent graft is a funnel structure arranged on the push tube, and the funnel structure is arranged near the proximal side of the first fixing member.

在上述方案中，所述覆膜支架的开口端边缘与所述第一固定件连接。In the solution above, the edge of the opening end of the stent-graft is connected to the first fixing member.

在上述方案中，还包括外管，套设于所述推送管外；所述第一固定件和所述覆膜支架能够压缩而收容于所述外管中，当向近端回撤外管时，所述第一固定件和所述覆膜支架能够被依次释放。In the above solution, it also includes an outer tube sleeved outside the pushing tube; the first fixing member and the stent-graft can be compressed and accommodated in the outer tube, when the outer tube is withdrawn proximally , the first fixing member and the stent-graft can be released sequentially.

在上述方案中，所述外管具有至少一个调弯段。In the above solution, the outer pipe has at least one bending section.

在上述方案中，所述外管具有第一调弯段和第二调弯段。In the above solution, the outer pipe has a first bend adjustment section and a second bend adjustment section.

在上述方案中，所述第一固定件和/或第二固定件上具有锯齿状凸起，作为所述瓣叶的防滑结构。In the above solution, the first fixing part and/or the second fixing part have saw-toothed protrusions as the anti-skid structure of the leaflets.

在上述方案中，还包括手柄，所述手柄包括切割控制开关；所述切割控制开关电连接所述切割电极。In the above solution, a handle is further included, and the handle includes a cutting control switch; the cutting control switch is electrically connected to the cutting electrodes.

在上述方案中，还包括电气切割主机，所述电气切割主机电连接所述切割控制开关。In the above solution, an electric cutting host is also included, and the electrical cutting host is electrically connected to the cutting control switch.

在上述方案中，所述手柄具有至少一个控弯操作装置，所述控弯操作装置用于控制所述调弯段的弯曲。In the above solution, the handle has at least one bending control operating device, and the bending control operating device is used to control the bending of the bending adjustment section.

本发明采用的技术方案能够达到以下有益效果：The technical scheme adopted in the present invention can achieve the following beneficial effects:

设置切割电极并通过推送管递送到主动脉瓣，能够对瓣叶进行准确快速的切割，实现了对单侧瓣叶进行针对性切割。设置第一固定件和第二固定件，利用第一固定件作为定位件对待切割瓣叶进行定位，且第二固定件的远端能够容纳在限位孔内，在需要固定瓣叶时第二固定件再从限位孔内分离，保证对瓣叶准确定位，且定位结构简单，使切割电极能够精准切割瓣叶。The cutting electrode is set and delivered to the aortic valve through the push tube, so that the valve leaflet can be cut accurately and quickly, and the targeted cutting of the unilateral valve leaflet can be realized. The first fixing piece and the second fixing piece are set, and the first fixing piece is used as a positioning piece to position the leaflet to be cut, and the distal end of the second fixing piece can be accommodated in the limiting hole, and the second fixing piece needs to be fixed when the leaflet needs to be fixed. The fixing part is then separated from the limiting hole to ensure accurate positioning of the leaflet, and the positioning structure is simple, so that the cutting electrode can accurately cut the leaflet.

附图说明Description of drawings

为了更清楚地说明本发明实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，构成本发明的一部分，本发明的示意性实施例及其说明解释本发明，并不构成对本发明的不当限定。在附图中：In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings that need to be used in the description of the embodiments will be briefly introduced below, which constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions explain the present invention , does not constitute an improper limitation of the present invention. In the attached picture:

图1为本发明实施例1公开的瓣叶分割装置的切割电极在近端的状态下的结构示意图；FIG. 1 is a schematic structural view of the cutting electrode in the proximal state of the valve leaflet segmentation device disclosed in Embodiment 1 of the present invention;

图2为本发明实施例1公开的瓣叶分割装置的切割电极在远端的状态下的结构示意图；Fig. 2 is a schematic structural view of the cutting electrode of the leaflet dividing device disclosed in Embodiment 1 of the present invention in the state of the distal end;

图3为本发明实施例2公开的瓣叶分割装置的第二固定件的远端插在限位孔内的结构示意图；Fig. 3 is a structural schematic diagram of the distal end of the second fixing member inserted into the limiting hole of the leaflet dividing device disclosed in Embodiment 2 of the present invention;

图4为本发明实施例2公开的瓣叶分割装置的第二固定件的远端离开限位孔的结构示意图；Fig. 4 is a structural schematic diagram of the distal end of the second fixing member of the leaflet dividing device disclosed in Embodiment 2 of the present invention leaving the limiting hole;

图5为本发明实施例2公开的瓣叶分割装置的第一固定件和第二固定件与推送管连接的结构示意图；Fig. 5 is a schematic diagram of the connection between the first fixing part and the second fixing part of the leaflet dividing device disclosed in Embodiment 2 of the present invention and the push tube;

图6为本发明实施例2公开的瓣叶分割装置的切割导管的结构示意图；Fig. 6 is a schematic structural view of the cutting catheter of the leaflet dividing device disclosed in Embodiment 2 of the present invention;

图7为本发明实施例2公开的另一优选方案中瓣叶分割装置的覆膜支架设置在推送管上的结构示意图；Fig. 7 is a schematic structural view of the stent-graft of the leaflet dividing device in another preferred solution disclosed in Example 2 of the present invention arranged on the push tube;

图8为本发明实施例2公开的另一优选方案中瓣叶分割装置的结构示意图；Fig. 8 is a schematic structural view of the valve leaflet dividing device in another preferred solution disclosed in Embodiment 2 of the present invention;

图9为本发明实施例2公开的瓣叶分割装置的外管及第一调弯段和第二调弯段的结构示意图；Fig. 9 is a structural schematic diagram of the outer tube, the first bending adjustment section and the second bending adjustment section of the leaflet dividing device disclosed in Embodiment 2 of the present invention;

图10为本发明实施例2公开的瓣叶分割装置的使用示意图；Fig. 10 is a schematic diagram of the use of the leaflet segmentation device disclosed in Embodiment 2 of the present invention;

图11为本发明实施例3公开的瓣叶分割装置的结构示意图；Fig. 11 is a schematic structural view of the leaflet segmentation device disclosed in Embodiment 3 of the present invention;

图12为本发明实施例3公开的覆膜支架展开的结构示意图；Fig. 12 is a schematic diagram of the unfolded structure of the stent graft disclosed in Example 3 of the present invention;

图13为本发明实施例3公开的瓣叶分割装置的第二固定件的远端离开限位孔的结构示意图；Fig. 13 is a structural schematic diagram of the distal end of the second fixing member of the leaflet dividing device disclosed in Embodiment 3 of the present invention leaving the limiting hole;

图14为本发明实施例4公开的瓣叶分割装置在使用前导引导丝置于瓣叶内的示意图；Fig. 14 is a schematic diagram of the valve leaflet segmentation device disclosed in Embodiment 4 of the present invention placed in the valve leaflet with a guide wire before use;

图15为本发明实施例4公开的瓣叶分割装置跨越主动脉瓣膜的示意图。Fig. 15 is a schematic diagram of the leaflet dividing device disclosed in Embodiment 4 of the present invention across the aortic valve.

附图标记说明：Explanation of reference signs:

推送管-10；切割导管-20；内管-30；电极导线-40；外管-50；手柄-60；电气切割主机-70；瓣叶-80；导引导丝-90；第一固定件-11；第二固定件-12；覆膜支架-13；切割电极-21；条形槽-22；限位端头-31；限位孔-32；第一调弯段-51；第二调弯段-52；切割控制开关-61；第一通槽-111；第二通槽-121。Push tube-10; Cutting catheter-20; Inner tube-30; Electrode lead-40; Outer tube-50; Handle-60; -11; second fixing piece-12; stent graft-13; cutting electrode-21; strip groove-22; limit end-31; limit hole-32; Bending section-52; cutting control switch-61; first through slot-111; second through slot-121.

具体实施方式Detailed ways

为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明具体实施例及相应的附图对本发明技术方案进行清楚、完整地描述。在本发明的描述中，需要说明的是，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and/or", unless the content clearly states otherwise.

在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。In the description of the present invention, it should be noted that unless otherwise specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations.

显然，所描述的实施例仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。Apparently, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

实施例1Example 1

如图1和图2所示，本实施例提供了一种瓣叶分割装置，包括：推送管10；第一固定件11和第二固定件12，其近端均固定于推送管10的远端；第一固定件11和第二固定件12的远端在自然状态下远离推送管10的延伸方向；切割导管20，可滑动地设置于推送管10内；切割导管20的远端具有切割部，切割部包括切割电极21，为了能够通电，切割电极21的金属部分裸露；切割部的远端在自然状态下远离切割导管20的延伸方向；内管30，可滑动地设置于切割导管20内；限位端头31，设置于内管30的远端；限位端头31具有能够容纳第二固定件12远端的限位孔32。As shown in Fig. 1 and Fig. 2, the present embodiment provides a leaflet dividing device, comprising: a push tube 10; end; the distal end of the first fixing member 11 and the second fixing member 12 is away from the extension direction of the push tube 10 in a natural state; the cutting catheter 20 is slidably arranged in the pushing tube 10; the distal end of the cutting catheter 20 has a cutting Part, the cutting part comprises cutting electrode 21, in order to be able to conduct electricity, the metal part of cutting electrode 21 is exposed; The distal end of cutting part is away from the extension direction of cutting catheter 20 under natural state; Inner tube 30, is slidably arranged on cutting catheter 20 Inside; the limiting end 31 is disposed at the distal end of the inner tube 30 ; the limiting end 31 has a limiting hole 32 capable of receiving the distal end of the second fixing member 12 .

本发明设置切割电极21并通过推送管10递送到主动脉瓣，能够对瓣叶80进行准确快速的切割，实现了对单侧瓣叶进行针对性切割。设置第一固定件11和第二固定件12，利用第一固定件11作为定位件对待切割瓣叶80进行定位，且第二固定件12的远端能够容纳在限位孔32内，在需要固定瓣叶80时第二固定件12再从限位孔32内分离，保证对瓣叶80准确定位，且定位结构简单，使切割电极21能够精准切割瓣叶80。In the present invention, the cutting electrode 21 is set and delivered to the aortic valve through the push tube 10, so that the valve leaflet 80 can be cut accurately and quickly, and the targeted cutting of the valve leaflet on one side is realized. The first fixing part 11 and the second fixing part 12 are provided, and the first fixing part 11 is used as a positioning part to position the leaflet 80 to be cut, and the distal end of the second fixing part 12 can be accommodated in the limiting hole 32, and if necessary When the leaflet 80 is fixed, the second fixing member 12 is separated from the limiting hole 32 to ensure accurate positioning of the leaflet 80 , and the positioning structure is simple, so that the cutting electrode 21 can accurately cut the leaflet 80 .

实施例2Example 2

本实施例为在实施例1基础上的优选方案，如图3和图4所示，第一固定件11和第二固定件12沿推送管10的轴向排列设置，其中，第二固定件12位于相对远端。第一固定件11和第二固定件12由弹性材料制成，例如形状记忆材料制成。并且第二固定件12能够在外力作用下靠近内管30；在第二固定件12的远端插入限位孔32时，第二固定件12被限制弹起。使用时，第一固定件11位于瓣叶80的上部，并调整好位置后，第二固定件12自限位孔32分离后受弹力恢复原状，并位于瓣叶80的下部。This embodiment is a preferred solution based on Embodiment 1. As shown in Figure 3 and Figure 4, the first fixing member 11 and the second fixing member 12 are arranged along the axial direction of the push tube 10, wherein the second fixing member 12 is located relatively far away. The first fixing part 11 and the second fixing part 12 are made of elastic material, such as shape memory material. And the second fixing part 12 can be close to the inner tube 30 under the action of external force; when the distal end of the second fixing part 12 is inserted into the limiting hole 32, the second fixing part 12 is limited to spring up. When in use, the first fixing part 11 is located at the upper part of the leaflet 80 , and after the position is adjusted, the second fixing part 12 is separated from the limiting hole 32 and restored to its original shape by elastic force, and is located at the lower part of the leaflet 80 .

当内管30相对于推送管10向远端滑动，第二固定件12的远端能够从限位孔32中脱出并弹起。当第二固定件12的远端固定在限位孔32内时，第二固定件12与内管30的外壁大致贴合，当内管30相对于推送管10向远端滑动时，由于推送管10的远端部到限位孔32之间的距离超过第二固定件12的长度，因此，第二固定件12的远端从限位孔32中脱出，由于第二固定件12有弹性且在限位孔32时被限制弹起，因此，第二固定件12的远端从限位孔32中脱出后受弹力在作用弹起并恢复原状。When the inner tube 30 slides distally relative to the push tube 10 , the distal end of the second fixing member 12 can escape from the limiting hole 32 and bounce up. When the distal end of the second fixing member 12 is fixed in the limit hole 32, the second fixing member 12 is roughly attached to the outer wall of the inner tube 30, and when the inner tube 30 slides to the distal end relative to the pushing tube 10, due to pushing The distance between the distal end of the tube 10 and the limiting hole 32 exceeds the length of the second fixing member 12, therefore, the distal end of the second fixing member 12 escapes from the limiting hole 32, because the second fixing member 12 is elastic. And it is restricted to spring up when the limiting hole 32 is in place. Therefore, after the distal end of the second fixing member 12 escapes from the limiting hole 32, it bounces up under the action of the elastic force and restores to its original shape.

如图5所示，本实施例优选的，第一固定件11具有第一通槽111和/或第二固定件12具有第二通槽121。第一通槽111和/或第二通槽121用于限定切割路径，避免因操作不当切割失误，保证对瓣叶80精准切割。As shown in FIG. 5 , in this embodiment, preferably, the first fixing part 11 has a first through slot 111 and/or the second fixing part 12 has a second through slot 121 . The first through-slot 111 and/or the second through-slot 121 are used to limit the cutting path, avoid cutting mistakes due to improper operation, and ensure accurate cutting of the leaflet 80 .

如图6所示，切割导管20的远端具有一条形槽22，切割部设置于条形槽22内并固定于条形槽22的近端；切割部为直线或曲线的条形或柱形，切割电极21为条形，设置于切割部一侧。As shown in Figure 6, the distal end of cutting catheter 20 has a bar-shaped groove 22, and the cutting portion is arranged in the bar-shaped groove 22 and is fixed on the proximal end of the bar-shaped groove 22; The cutting portion is a straight or curved bar or column , the cutting electrode 21 is strip-shaped, and is arranged on one side of the cutting part.

如图3和图4所示，限位端头31远端比近端具有更小的直径，限位端头31位类圆锥或类棱锥状，远端尺寸小于近端，方便限位端头31在人体内更远的延伸；限位孔32靠近内管30设置，使第二固定件12的远端插入限位孔时能够和内管30大致贴合，尽可能减小内管30的外径，方便内管30在切割导管20内滑动。As shown in Figures 3 and 4, the distal end of the limiting end 31 has a smaller diameter than the proximal end. 31 extends farther in the human body; the limiting hole 32 is set close to the inner tube 30, so that when the distal end of the second fixing member 12 is inserted into the limiting hole, it can be roughly fitted with the inner tube 30, and the inner tube 30 is minimized. The outer diameter facilitates the sliding of the inner tube 30 in the cutting catheter 20 .

再结合图1、图2和图5所示，推送管10的远端与切割导管20远端之间仅能够轴向滑动，而不能相对轴向旋转；且切割部的至少部分能够在切割导管20的带动下，穿过第一通槽111和/或第二通槽121，对夹持在第一固定件11和第二固定件12之间的瓣叶80进行切割。推送管10和切割导管20在生产时进行精准定位，保证切割电极21能够穿过第一通槽111和/或第二通槽121切割瓣叶80，方便手术操作，确保精准切割。As shown in Fig. 1, Fig. 2 and Fig. 5, the distal end of the push tube 10 and the distal end of the cutting catheter 20 can only slide axially, but cannot rotate relative to the axial direction; Driven by 20 , through the first through slot 111 and/or the second through slot 121 , the leaflet 80 clamped between the first fixing part 11 and the second fixing part 12 is cut. The pushing tube 10 and the cutting catheter 20 are precisely positioned during production to ensure that the cutting electrode 21 can pass through the first through-slot 111 and/or the second through-slot 121 to cut the valve leaflet 80, which facilitates surgical operation and ensures precise cutting.

如图10所示，本实施例提供的瓣叶分割装置还包括电极导线40，设置于推送管10内，连接切割电极21。As shown in FIG. 10 , the valve leaflet segmentation device provided in this embodiment further includes an electrode wire 40 disposed in the push tube 10 and connected to the cutting electrode 21 .

如图7所示，本实施例另一个优选的方案中在推送管10靠近远端的位置处具有可压缩的覆膜支架13。覆膜支架13为网状结构，其上覆盖薄膜，覆膜支架13作为过滤保护装置，可以捕获瓣叶80分割过程中产生的脱落颗粒物，同时允许血液通过。As shown in FIG. 7 , another preferred solution of this embodiment has a compressible stent graft 13 near the distal end of the push tube 10 . The stent-graft 13 is a net-like structure covered with a thin film, and the stent-graft 13 serves as a filter protection device, which can capture the exfoliated particles generated during the division of the valve leaflet 80 while allowing blood to pass through.

本实施例优选的，覆膜支架13套设于推送管10上，为伞状结构，展开面积大，能够有效过滤血液，捕获脱落颗粒物。Preferably in this embodiment, the stent graft 13 is sheathed on the push tube 10 and has an umbrella-like structure with a large expansion area, which can effectively filter blood and capture shed particles.

如图3、图4和图8所示，本实施例提供的瓣叶分割装置还包括外管50，套设于推送管10外；第一固定件11和覆膜支架13能够压缩而收容于外管50中，当向近端回撤外管50时，第一固定件11和覆膜支架13能够被依次释放。As shown in Fig. 3, Fig. 4 and Fig. 8, the leaflet dividing device provided in this embodiment also includes an outer tube 50, which is sheathed outside the push tube 10; the first fixing member 11 and the stent graft 13 can be compressed and accommodated in the In the outer tube 50, when the outer tube 50 is retracted proximally, the first fixing member 11 and the stent graft 13 can be released sequentially.

再结合图9所示，外管50具有至少一个调弯段。能够使外管50弯折，保证介入人体的进程顺利。本实施例优选的，外管50具有第一调弯段51和第二调弯段52。具体的，在瓣叶分割装置递送到人体主动脉瓣处时，借助控弯操作装置对第一调弯段51和第二调弯段52分别进行弯度调节，使得瓣叶分割装置的远端部准确定位到需要执行瓣叶分割操作的部位。As shown in FIG. 9 again, the outer tube 50 has at least one bending section. The outer tube 50 can be bent to ensure a smooth process of intervening in the human body. Preferably in this embodiment, the outer tube 50 has a first bending section 51 and a second bending section 52 . Specifically, when the leaflet dividing device is delivered to the aortic valve of the human body, the curvature of the first bending section 51 and the second bending section 52 are respectively adjusted by means of the bending control operating device, so that the distal end of the leaflet dividing device Accurately locate the site where the valve leaflet segmentation operation needs to be performed.

本实施例优选的，第一固定件11和/或第二固定件12上具有锯齿状凸起(图中未示出)，作为瓣叶80的防滑结构。能够更好的对瓣叶80定位，瓣叶80在切割时或受外力情况下出现定位偏差。In this embodiment, preferably, the first fixing part 11 and/or the second fixing part 12 have saw-toothed protrusions (not shown in the figure) as the anti-slip structure of the leaflet 80 . The valve leaflet 80 can be better positioned, and the valve leaflet 80 has a positioning deviation during cutting or under external force.

再结合图10所示，本实施例提供的瓣叶分割装置还包括手柄60，手柄60包括切割控制开关61；切割控制开关61通过电极导线40电连接切割电极21。As shown in FIG. 10 , the leaflet segmentation device provided in this embodiment further includes a handle 60 , and the handle 60 includes a cutting control switch 61 ; the cutting control switch 61 is electrically connected to the cutting electrode 21 through the electrode lead 40 .

本实施例提供的瓣叶分割装置还包括电气切割主机70，电极导线40的近端将电气切割主机70与切割控制开关61电连接。The leaflet segmentation device provided in this embodiment further includes an electrical cutting host 70 , and the proximal end of the electrode lead 40 electrically connects the electrical cutting host 70 to the cutting control switch 61 .

本实施例优选的，瓣叶分割装置中除切割电极21以为其余金属元件均进行绝缘处理，避免意外通电对人体造成伤害，金属元件的绝缘方式包括在外层喷涂聚酰亚胺或者包覆高分子材料。In this embodiment, preferably, in the valve leaflet dividing device, except for the cutting electrode 21, the rest of the metal components are insulated to avoid accidental electrification causing harm to the human body. The insulation method of the metal components includes spraying polyimide on the outer layer or coating polymers Material.

手柄60具有至少一个控弯操作装置，控弯操作装置用于控制调弯段的弯曲。The handle 60 has at least one bending control operating device, which is used to control the bending of the bending adjustment section.

实施例3Example 3

如图11～13所示，与实施例2不同的是本实施例优选的，覆膜支架13为设置于推送管10的漏斗结构，且漏斗结构设置于第一固定件11近端一侧附近，将覆膜支架13设置为漏斗结构，在使用时覆膜支架13的撑开面积变小，避免了对血管造成过度支撑。由于瓣叶80在第一固定件11方向分割，因此，覆膜支架13一样具有良好的捕获脱落颗粒物的能力。As shown in Figures 11-13, different from Embodiment 2, this embodiment is preferred. The stent graft 13 is a funnel structure arranged on the push tube 10, and the funnel structure is arranged near the proximal side of the first fixing member 11. The stent-graft 13 is set as a funnel structure, and the stretched area of the stent-graft 13 becomes smaller during use, which avoids excessive support to the blood vessel. Since the valve leaflet 80 is divided in the direction of the first fixing member 11, the stent graft 13 also has a good ability to capture shed particles.

优选的，覆膜支架13的开口端的长度大于第一通槽111的长度，保证了经过第一通槽111的脱落物能够全部被捕获至覆膜支架13。Preferably, the length of the open end of the stent-graft 13 is greater than the length of the first through-slot 111 , so as to ensure that all exfoliated objects passing through the first through-slot 111 can be captured to the stent-graft 13 .

优选的，覆膜支架13的开口端边缘与第一固定件11固定连接，捕获效果更好，避免了颗粒物从第一固定件11与覆膜支架13之间的缝隙流出。Preferably, the edge of the opening end of the stent-graft 13 is fixedly connected with the first fixing part 11 , so that the trapping effect is better, and particles are prevented from flowing out from the gap between the first fixing part 11 and the stent-graft 13 .

实施例4Example 4

本实施例3提供了瓣叶分割装置的使用方法，如下：Embodiment 3 provides the method of using the leaflet segmentation device, as follows:

如图10、图14和图15所示，连接电气切割主机70，在病人大腿根部行股动脉穿刺，进入鞘管，在鞘管中进入泥鳅导丝并跨瓣，沿着泥鳅导丝进入猪尾导管，撤出泥鳅导丝，进入导引导丝90，撤出鞘管。As shown in Figure 10, Figure 14 and Figure 15, connect the electrical cutting host 70, perform femoral artery puncture at the root of the patient's thigh, enter the sheath tube, enter the loach guide wire in the sheath tube and cross the valve, and enter the pigtail along the loach guide wire Catheter, withdraw loach guide wire, enter guide wire 90, withdraw sheath tube.

打开密封包装并取出无菌经导管瓣叶分割装置，电极导线40一头与电气切割主机70相连，使瓣叶分割装置通电，沿着导引导丝90进入瓣叶分割装置，可通过手柄60上的控弯操作装置将瓣叶分割装置的外管50适当调弯直至跨越主动脉瓣膜。Open the sealed package and take out the aseptic transcatheter valve leaflet dividing device. One end of the electrode lead 40 is connected to the electric cutting host 70, so that the valve leaflet dividing device is energized, and enters the valve leaflet dividing device along the guide wire 90. The bending control operation device properly bends the outer tube 50 of the leaflet dividing device until it crosses the aortic valve.

瓣叶分割装置进入人体后具体的操作方法如下：After the leaflet segmentation device enters the human body, the specific operation method is as follows:

往近端移动外管50(相对的可往远端同步移动推送管10与内管30)，依次释放出第一固定件11与覆膜支架13，整体系统定位直至第一固定件11支撑住需要切割的瓣叶80。Move the outer tube 50 to the proximal end (relatively, the pushing tube 10 and the inner tube 30 can be moved synchronously to the far end), release the first fixing part 11 and the stent graft 13 in sequence, and position the whole system until the first fixing part 11 supports it Leaflets 80 need to be cut.

往远端移动内管30，释放第二固定件12。Moving the inner tube 30 distally releases the second fixing member 12 .

按住切割控制开关61并往远端推送，切割导管2、切割电极21同步往远端移动并完成瓣叶80的切割。Press and hold the cutting control switch 61 and push it to the distal end, the cutting catheter 2 and the cutting electrode 21 move to the distal end synchronously to complete the cutting of the leaflet 80 .

将外管50回正，往远端推送外管50，依次收拢覆膜支架13、第一固定件11及第二固定件12，向近端适当回撤推送管10，直外管50与限位端头31合拢。Put the outer tube 50 back upright, push the outer tube 50 to the far end, gather the stent graft 13, the first fixing part 11 and the second fixing part 12 in sequence, retract the pushing tube 10 to the proximal end appropriately, and straighten the outer tube 50 to the limit. Bit end 31 closes up.

在保证无菌的情况下，检查器械无损坏，恢复原状后可再次执行瓣叶80分割操作。Under the condition of ensuring sterility, check that the instrument is not damaged, and then perform the valve leaflet 80 division operation again after returning to its original shape.

完成瓣叶80分割，从体内撤出器械。The leaflet 80 division is completed and the instrument is withdrawn from the body.

本发明设置切割电极并通过推送管递送到主动脉瓣，能够对瓣叶进行准确快速的切割，实现了对单侧瓣叶进行针对性切割。设置第一固定件和第二固定件，利用第一固定件作为定位件对待切割瓣叶进行定位，且第二固定件的远端能够容纳在限位孔内，在需要固定瓣叶时第二固定件再从限位孔内分离，保证对瓣叶准确定位，且定位结构简单，使切割电极能够精准切割瓣叶。The invention sets the cutting electrode and delivers it to the aortic valve through the pusher tube, which can accurately and quickly cut the valve leaflet, and realizes the targeted cutting of the unilateral valve leaflet. The first fixing piece and the second fixing piece are set, and the first fixing piece is used as a positioning piece to position the leaflet to be cut, and the distal end of the second fixing piece can be accommodated in the limiting hole, and the second fixing piece needs to be fixed when the leaflet needs to be fixed. The fixing part is then separated from the limiting hole to ensure accurate positioning of the leaflet, and the positioning structure is simple, so that the cutting electrode can accurately cut the leaflet.

上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，均属于本发明的保护之内。Embodiments of the present invention have been described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementations, and the above-mentioned specific implementations are only illustrative, rather than restrictive, and those of ordinary skill in the art will Under the enlightenment of the present invention, without departing from the gist of the present invention and the protection scope of the claims, many forms can also be made, all of which belong to the protection of the present invention.