技术领域technical field
本发明涉及医疗器械领域，具体地说是一种手术器械，更具体地说是一种瓣膜夹合装置。The invention relates to the field of medical instruments, in particular to a surgical instrument, more specifically to a valve clamping device.
背景技术Background technique
心脏瓣膜病是一种常见的心脏病。二尖瓣反流、三尖瓣反流、主动脉瓣反流是最常见的心脏瓣膜病，近年来发病率呈明显上升趋势。其病因可分为风湿性，退行性改变，先天性畸形，缺血性坏死，感染或创伤等，影响血液的正常流动，从而造成心脏功能异常，最终导致心力衰竭。随着人口老龄化加重，老年性瓣膜病以及冠心病、心肌梗死后引起的瓣膜病变也越来越常见。Heart valve disease is a common heart disease. Mitral regurgitation, tricuspid regurgitation, and aortic regurgitation are the most common valvular heart diseases, and the incidence has shown a significant upward trend in recent years. Its etiology can be divided into rheumatic, degenerative changes, congenital malformations, ischemic necrosis, infection or trauma, etc., which affect the normal flow of blood, thereby causing abnormal heart function and eventually heart failure. With the aging of the population, senile valvular disease and valvular disease caused by coronary heart disease and myocardial infarction are becoming more and more common.
临床试验显示，药物治疗只能改善心脏瓣膜病患者症状，而不能延长患者寿命。外科手术进行瓣膜修复或置换被认为是该疾病的标准治疗方法，能缓解患者的症状及延长其寿命。然而，外科手术具有创伤大、恢复慢、风险高等缺点，一些高龄、有开胸病史、心功能差或合并多脏器功能不全的患者不适合进行外科手术。因此，通过微创介入方法治疗心脏瓣膜病是未来发展重点方向，治疗心脏瓣膜病的介入器械是近年来研究热点，具有巨大市场需求，将产生巨大社会效益和经济效益。Clinical trials have shown that drug treatment can only improve the symptoms of patients with heart valve disease, but cannot prolong the life of patients. Surgical valve repair or replacement is considered the standard treatment for the disease, relieving symptoms and prolonging life in patients. However, surgery has the disadvantages of large trauma, slow recovery, and high risk. Some patients who are elderly, have a history of chest surgery, have poor heart function, or have multiple organ insufficiency are not suitable for surgery. Therefore, the treatment of valvular heart disease through minimally invasive interventional methods is a key direction for future development. Interventional devices for the treatment of valvular heart disease have been a research hotspot in recent years, have huge market demand, and will generate huge social and economic benefits.
目前，国内外用于微创介入方法治疗二尖瓣疾病的产品较多，也有少量微创介入方法治疗三尖瓣疾病的产品，以及个别二尖瓣和三尖瓣通用产品。但是，上述产品大部分都处于临床前阶段，部分产品进入临床试验后效果不佳，未再跟进。目前获得欧洲CE认证的只有MitraClip、Carrillon、Mitralign、Cardioband及NeoChord。获得美国食品药品管理局(FDA)认证的只有MitraClip。At present, there are many products for minimally invasive interventional treatment of mitral valve diseases at home and abroad, and there are also a small number of products for minimally invasive interventional treatment of tricuspid valve diseases, as well as individual general-purpose products for mitral and tricuspid valves. However, most of the above-mentioned products are in the pre-clinical stage, and some products have not performed well after entering clinical trials, and have not been followed up. At present, only MitraClip, Carrillon, Mitralalign, Cardioband and NeoChord have obtained European CE certification. Only MitraClip has been approved by the US Food and Drug Administration (FDA).
现有瓣膜夹合装置，包括MitraClip在内，均以外科缘对缘缝合技术为原理。基于外科缘对缘缝合技术研发的瓣膜夹合装置，结构复杂，制作成本较高。在心脏瓣膜运动状态下，很难同时抓住不同瓣叶，并将其靠拢实现缘对缘对合，所以很难设置该类装置的位置，手术操作难度极大。另外，因该类装置不利于调整瓣膜夹合部位，对于某些病例，该类装置夹住瓣叶后，瓣叶之间间隙仍较大，手术效果明显低于预期。Existing valve clipping devices, including MitraClip, are all based on the surgical edge-to-edge suturing technique. The valve clamping device developed based on the surgical edge-to-edge suture technique has a complex structure and high manufacturing cost. When the heart valve is in motion, it is difficult to grasp different valve leaflets at the same time and bring them closer to achieve edge-to-edge apposition, so it is difficult to set the position of this type of device, and the surgical operation is extremely difficult. In addition, because this type of device is not conducive to the adjustment of the valve clamping position, in some cases, after the valve leaflets are clamped by this type of device, the gap between the leaflets is still large, and the surgical effect is significantly lower than expected.
另外，外科缘对缘缝合技术主要用于治疗二尖瓣前叶或前后叶脱垂造成的二尖瓣反流。以二尖瓣反流病变部位划分，前叶、前后叶、以及后叶脱垂的发病率分别为6％、16％和78％。因此，在微创介入治疗二尖瓣反流方面，仍有很大改进空间。In addition, the surgical edge-to-edge suture technique is mainly used to treat mitral regurgitation caused by anterior mitral leaflet or anterior and posterior leaflet prolapse. Divided by mitral regurgitant lesion sites, the incidence rates of anterior leaflet, anterior and posterior leaflet prolapse, and posterior leaflet prolapse were 6%, 16% and 78%, respectively. Therefore, there is still much room for improvement in minimally invasive interventional treatment of mitral regurgitation.
近年来，瓣缘对合成形技术在外科手术治疗二尖瓣反流的临床实践中逐渐成熟，并显现出良好的治疗效果。外科瓣缘对合技术通过对脱垂段瓣缘进行对合缝合，使病变部位两侧的正常腱索相互靠近，从而使瓣叶恢复至正常对合水平，达到恢复二尖瓣正常对合的功能。其优点在于：1、直接处理病变部位，治疗确切；2、将瓣缘对合，对合牢固；3、成形有可重复性，能确保最佳的瓣叶对合以及与剩余组织的关系；4、充分保留瓣叶组织，减少张力；5、可有效防止因纵向折叠组织过多，造成后叶前移，引起SAM征。目前，发明人应用该技术已成功完成外科二尖瓣成形术一百余例，收到非常好的治疗效果。In recent years, the edge-to-synthesis technology has gradually matured in the clinical practice of surgical treatment of mitral regurgitation, and has shown good therapeutic effects. Surgical valve edge apposition technique is to make the normal chordae on both sides of the lesion close to each other by suturing the prolapsed valve edge, so as to restore the valve leaflets to the normal apposition level and achieve the goal of restoring the normal apposition of the mitral valve. Function. Its advantages are as follows: 1. Directly treat the diseased part, and the treatment is accurate; 2. The apposition of the valve margin is firm; 3. The forming is repeatable, which can ensure the best apposition of the valve leaflets and the relationship with the remaining tissues; 4. Sufficiently retain leaflet tissue and reduce tension; 5. It can effectively prevent the posterior leaflet from moving forward due to excessive longitudinal folding tissue and causing SAM sign. At present, the inventor has successfully completed more than 100 cases of surgical mitral valvuloplasty by using this technology, and received very good therapeutic effects.
因此，基于外科瓣缘对合技术原理、微创植入、结构简单、易于操作、可拆卸或调整夹合部位、效果理想的通用瓣膜夹合装置更具临床意义。Therefore, a general-purpose valve clamping device based on the principle of surgical valve-margin approximation technology, minimally invasive implantation, simple structure, easy to operate, detachable or adjustable clamping position, and ideal effect has more clinical significance.
发明内容Contents of the invention
本发明的目的在于提供一种基于外科瓣缘对合技术、通过微创介入方法治疗心脏瓣膜反流的瓣膜夹合装置，它结构简单、使用简便、紧固可靠。在夹合效果不满意的情况下，可以方便地调整夹合部位、再次进行夹合。The object of the present invention is to provide a valve clipping device for treating heart valve regurgitation through minimally invasive intervention based on the surgical valve edge apposition technique, which has a simple structure, is easy to use, and is fastened reliably. In the case of unsatisfactory clamping effect, the clamping position can be conveniently adjusted and clamped again.
本发明与以往基于外科缘对缘缝合技术原理而研发的瓣膜夹合装置的本质区别在于，本发明原理为外科瓣缘对合技术。外科瓣缘对合技术的关键在于，通过对病变瓣叶脱垂段瓣缘进行对合，达到恢复二尖瓣正常对合的功能。目前，发明人应用该技术已成功完成外科二尖瓣成形术一百余例，收到非常好的治疗效果。The essential difference between the present invention and the previous valve clamping devices developed based on the principle of surgical edge-to-edge suture technique is that the principle of the present invention is the technique of surgical valve-edge closure. The key to the surgical valve-margin apposition technique is to restore the normal apposition function of the mitral valve through the apposition of the prolapsed segment of the diseased valve leaflet. At present, the inventor has successfully completed more than 100 cases of surgical mitral valvuloplasty by using this technology, and received very good therapeutic effects.
本发明基于外科瓣缘对合技术原理，创造性地将瓣膜夹合装置应用在病变瓣叶上，通过对合病变瓣叶的游离缘，使病变部位两侧的正常腱索相互靠近，从而使瓣叶恢复至正常对合水平。通过微创植入本发明所述瓣膜夹合装置治疗二尖瓣反流，可以完全替代外科手术方法，同样达到良好的治疗效果。Based on the technical principle of surgical valve margin apposition, the present invention creatively applies the valve clamping device to the diseased valve leaflet, and through the free edge of the diseased valve leaflet by apposition, the normal chordae on both sides of the diseased part are brought close to each other, thereby making the valve Leaves returned to normal apposition levels. Treating mitral valve regurgitation by minimally invasively implanting the valve clipping device of the present invention can completely replace the surgical operation method, and also achieve good therapeutic effect.
为了实现上述目的，解决上述的关键技术问题，本发明采用以下技术方案：In order to achieve the above object and solve the above key technical problems, the present invention adopts the following technical solutions:
一种瓣膜夹合装置，包含以下部件：A valve clamping device comprising the following components:
用于挑起并固定瓣膜瓣叶的瓣叶钩；Leaflet hooks for lifting and securing valve leaflets;
通过靠拢并挤压产生的相互作用力来夹住其中的物体的夹合部件；Clamping parts that clamp objects within them by the interaction forces generated by coming together and squeezing;
设置在夹合部件外，可使夹合部件夹合更紧密且不发生位移的锁定装置；A locking device arranged outside the clamping parts, which can make the clamping parts clamp more tightly without displacement;
以微创介入方式输送各部件至手术位置的输送装置。Delivery device for the minimally invasive interventional delivery of components to the surgical site.
以下就各部件的结构、所起的作用分别进行说明：The structure and function of each component are described below:
所述的瓣叶钩为J型或L型，后端与控制杆连接。瓣叶打开时，瓣叶钩的开口一侧伸入病变瓣叶游离缘中部，挑起并固定病变瓣叶，用于配合设置夹合部件的位置。The leaflet hook is J-shaped or L-shaped, and the rear end is connected with the control rod. When the valve leaflet is opened, the opening side of the leaflet hook extends into the middle of the free edge of the diseased valve leaflet to lift and fix the diseased valve leaflet for matching the position of the clamping part.
所述的夹合部件为两个夹合臂及连接部件组成的一组夹具，其通过两个夹合臂相互靠拢并挤压产生的相互作用力来夹住其中的物体。单个夹合臂呈V形，V形夹角为140-165度。两个夹合臂在连接部件上呈两侧对称布置，在两个夹合臂未夹合时，两个夹合臂之间的平面基本呈菱形。在两个夹合臂相互靠拢并完全夹合后，两个夹合臂外部形状呈圆柱形。The clamping part is a set of clamps composed of two clamping arms and a connecting part, which clamps the object therein through the interaction force generated by the two clamping arms approaching and squeezing each other. The single clamping arm is V-shaped, and the included angle of the V-shape is 140-165 degrees. The two clamping arms are symmetrically arranged on both sides of the connecting part, and when the two clamping arms are not clamped, the plane between the two clamping arms is basically rhombus. After the two clamping arms are close to each other and fully clamped, the outer shape of the two clamping arms is cylindrical.
在本发明的另一种实施方式中，所述两个夹合臂相互靠拢并完全夹合后，两个夹合臂外部形状呈方柱形。In another embodiment of the present invention, after the two clamping arms are close to each other and fully clamped, the outer shape of the two clamping arms is a square column.
在本发明的又一实施方式中，所述两个夹合臂相互靠拢并完全夹合后，两个夹合臂外部形状呈纵切面为菱形的方柱体。In yet another embodiment of the present invention, after the two clamping arms are close to each other and fully clamped, the external shape of the two clamping arms is a square cylinder whose longitudinal section is rhombus.
所述的夹合臂的工作面均有若干锯齿状或波浪状凸起，且夹合臂工作面之间的锯齿状纹或波浪状纹相吻合，从而增强夹合臂与瓣膜组织之间的摩擦力，防止被夹住的瓣膜组织滑脱出来。The working surfaces of the clamping arms have several serrated or wavy protrusions, and the zigzag or wavy lines on the working surfaces of the clamping arms match, thereby enhancing the bond between the clamping arms and the valve tissue. Friction prevents the clamped valve tissue from slipping out.
夹合臂可以与连接部件直接相连，也可以通过其他结构与连接部件相连接。总之，能满足本发明的夹合效果，都可以使用。The clamping arm can be directly connected with the connection part, or can be connected with the connection part through other structures. In a word, whatever can satisfy the clamping effect of the present invention can be used.
所述的锁定装置由连接部件和锁定夹合部件的夹合状态的锁环组成。The locking device is composed of a connecting part and a lock ring for locking the clamped state of the clamping part.
上述的连接部件为方柱形或圆柱形，其上有与锁环配合起到锁定作用的螺纹或弹性插片。The above-mentioned connecting parts are in the shape of a square column or a cylinder, on which there are threads or elastic inserts that cooperate with the lock ring to play a locking role.
所述连接部件为圆柱形，外表面具有外螺纹。所述连接部件也可为方柱形，其上设置有两片弹性插片，弹性插片的开口方向向着夹合臂，弹性插片在受到外力按压时收拢并可完全贴靠在该连接部件上。所述连接部件还可被拉入内部空间与之匹配的锁环中。所述连接部件后端设置有内螺纹连接口，用于连接输送装置。The connecting part is cylindrical, and the outer surface has external threads. The connecting part can also be in the shape of a square column, on which two elastic inserts are arranged. The opening direction of the elastic inserts faces the clamping arm. superior. The connecting part can also be pulled into a locking ring with a matching inner space. The rear end of the connection part is provided with an internal thread connection port for connecting the delivery device.
所述锁环为圆柱形，内部设有圆柱形带内螺纹锁孔，正好与连接部件的外螺纹匹配，也与两个夹合臂靠拢并完全夹合后形成的外形匹配。夹合部件完全旋入锁环后不会发生旋转位移或倾斜。锁环后端外表面上有三个凹槽，用于连接输送装置。所述锁环也可为方柱形，内部设有方柱形锁孔，正好与连接部件的外形匹配，也与两个夹合臂靠拢并完全夹合后形成的外形匹配。锁环后端设置有一个内螺纹连接口，用于连接输送装置。所述锁环还可以为圆柱形，内部设有方柱形锁孔，正好与连接部件的外形匹配，也与两个夹合臂靠拢并完全闭合后的下半部分外形匹配。锁环底端外部为外螺纹，用于连接输送装置。The lock ring is cylindrical and has a cylindrical lock hole with an internal thread inside, which just matches the external thread of the connecting part and also matches the shape formed by the two clamping arms approaching and fully clamping. There is no rotational displacement or tilting of the clamping parts when fully screwed into the locking ring. There are three grooves on the outer surface of the rear end of the locking ring, which are used to connect the delivery device. The lock ring can also be in the shape of a square cylinder, with a square cylinder lock hole inside, which just matches the shape of the connecting part, and also matches the shape of the two clamping arms after they are brought together and completely clamped. The rear end of the lock ring is provided with an internal thread connection port for connecting the delivery device. The lock ring can also be cylindrical, with a square column-shaped lock hole inside, which just matches the shape of the connecting part, and also matches the shape of the lower half of the two clamping arms after they are close together and completely closed. The outside of the bottom end of the locking ring is an external thread for connecting the delivery device.
所述锁定装置不仅可以锁定夹合部件和锁环的位置，还可以锁定两个夹合臂之间的夹合状态，从而夹住夹合臂中的瓣膜组织。The locking device can not only lock the positions of the clamping part and the locking ring, but also lock the clamping state between the two clamping arms, so as to clamp the valve tissue in the clamping arms.
这样做的好处在于：锁定装置具有操作可逆性，当夹合效果不满意时可将所述锁环与连接部件分开，便于瓣膜夹合装置的拆除或调整夹合部位。The advantage of this is that the locking device has reversible operation, and the locking ring can be separated from the connecting part when the clamping effect is not satisfactory, so as to facilitate the removal of the valve clamping device or the adjustment of the clamping position.
所述的输送装置包括夹合部件输送杆、锁环输送管、瓣叶钩控制杆和双腔导管。夹合部件输送杆用于连接夹合部件中的连接部件，其前端为外螺纹。锁环输送管用于连接锁环，其前端有三个小凸起。所述锁环输送管的前端也可为内螺纹结构，用于连接锁环。瓣叶钩控制杆与瓣叶钩直接相连。双腔导管为输送提供了轨道。The delivery device includes a clamping component delivery rod, a locking ring delivery tube, a leaflet hook control rod and a double-lumen catheter. The clamping part conveying rod is used for connecting the connecting parts in the clamping part, and its front end is an external thread. The lock ring delivery tube is used to connect the lock ring and has three small protrusions on the front end. The front end of the lock ring delivery pipe can also be an internal thread structure for connecting the lock ring. The leaflet hook lever is directly connected to the leaflet hook. A dual-lumen catheter provides the rails for delivery.
所述的输送装置还包括解锁鞘。也就是说，所述输送装置也可包括夹合部件输送杆、解锁鞘、锁环输送杆、瓣叶钩控制杆和双腔导管。夹合部件输送杆用于连接夹合部件中的连接部件，其前端为外螺纹。解锁鞘为轴向不可压缩的弹性鞘管，在瓣膜夹合装置需要拆除或调整夹合位置时，解锁鞘用于向前推夹合部件上的弹性插片，使弹性插片被按压收拢并完全贴靠在连接部件上。此时向后拉锁环，即可使锁环从前面越过弹性插片，从而松开对夹合部件的锁定。锁环输送杆用于连接锁环，其前端为外螺纹。瓣叶钩控制杆与瓣叶钩直接连接。双腔导管为输送提供了轨道。The delivery device also includes an unlocking sheath. That is, the delivery device may also include a clip member delivery rod, an unlocking sheath, a locking ring delivery rod, a leaflet hook lever, and a dual lumen catheter. The clamping part conveying rod is used for connecting the connecting parts in the clamping part, and its front end is an external thread. The unlocking sheath is an axially incompressible elastic sheath tube. When the valve clamping device needs to be dismantled or the clamping position is adjusted, the unlocking sheath is used to push forward the elastic inserts on the clamping parts, so that the elastic inserts are pressed and closed. It rests completely against the connection part. At this time, pull the locking ring backwards, so that the locking ring can pass over the elastic insert from the front, thereby releasing the locking of the clamping parts. The lock ring delivery rod is used to connect the lock ring, and its front end is external thread. The leaflet hook control rod is directly connected with the leaflet hook. A dual-lumen catheter provides the rails for delivery.
手术操作人员在输送装置的后端通过前推、后拉、旋转夹合部件输送杆、锁环输送管、瓣叶钩控制杆等操作，使夹合部件、锁环和瓣叶钩等在双腔导管内走行，由体外进入心脏内所需位置。At the rear end of the delivery device, the operator pushes forward, pulls back, and rotates the clamping component delivery rod, locking ring delivery tube, leaflet hook control lever, etc. The catheter runs inside the lumen and enters the desired position in the heart from outside the body.
本文所述的“前端”、“前面”均指所述瓣膜夹合装置被输送入人体后远离手术操作者的一端，本文所述的“后端”、“后面”均指所述瓣膜夹合装置被送入人体后靠近手术操作者的一端。本文所述的“前”是指沿着输送轴远离手术操作者的方向，本文所述的“后”是指沿着输送轴指向手术操作者的方向。The "front end" and "front" mentioned herein both refer to the end of the valve clamping device that is away from the operator after being delivered into the human body, and the "rear end" and "rear side" described herein both refer to the valve clamping device. The end of the device that is near the operator after it is inserted into the body. As used herein, "anterior" refers to a direction along the delivery axis away from the operator, and "rear" herein refers to a direction along the delivery axis toward the operator.
上述各组件中，夹合部件采用具有高支撑强度并具有高弹性的高分子材料或弹性金属材料制成，优选地，夹合部件的长度为8.0-15.0mm，夹合臂的长度为6.0-13.0mm，宽度为0.8-1.5mm，厚度为0.8-1.5mm，连接部件的长度为2.0-5.0mm，最宽外边长或最大外径为3.0mm。锁环采用金属材料制成，优选地，锁环的长度为2.0-5.0mm，最宽内边长或最大内径为3.0mm，最宽外边长或最大外径为5.0mm。输送杆、解锁鞘、输送管、控制杆均采用可弯曲、不回弹，且具有轴向支撑力的金属材料。优选地，夹合部件输送杆直径为1.0-2.0mm；解锁鞘内径为3.0-4.0mm，外径为3.2-4.5mm；锁环输送杆直径为1.0-2.0mm；锁环输送管内径为4.0-5.5mm，外径为4.5-6.0mm；瓣叶钩控制杆直径为1.0-2.0mm，双腔导管的单个腔内径为3.0-7.0mm，双腔导管外径为8.0-12.0mm。In each of the above components, the clamping parts are made of polymer materials or elastic metal materials with high supporting strength and high elasticity. Preferably, the length of the clamping parts is 8.0-15.0 mm, and the length of the clamping arms is 6.0-15.0 mm. 13.0mm, the width is 0.8-1.5mm, the thickness is 0.8-1.5mm, the length of the connecting part is 2.0-5.0mm, and the widest outer side length or the largest outer diameter is 3.0mm. The lock ring is made of metal material. Preferably, the length of the lock ring is 2.0-5.0 mm, the widest inner side length or maximum inner diameter is 3.0 mm, and the widest outer side length or maximum outer diameter is 5.0 mm. The delivery rod, unlocking sheath, delivery tube, and control rod are all made of metal materials that are bendable, non-rebound, and have axial support. Preferably, the diameter of the clamping component delivery rod is 1.0-2.0mm; the inner diameter of the unlocking sheath is 3.0-4.0mm, and the outer diameter is 3.2-4.5mm; the diameter of the lock ring delivery rod is 1.0-2.0mm; the inner diameter of the lock ring delivery tube is 4.0mm -5.5mm, the outer diameter is 4.5-6.0mm; the leaflet hook control rod diameter is 1.0-2.0mm, the inner diameter of a single lumen of the double-lumen catheter is 3.0-7.0mm, and the outer diameter of the double-lumen catheter is 8.0-12.0mm.
本发明所述瓣膜夹合装置的手术植入方式可经皮穿刺锁骨下静脉，输送装置从锁骨下静脉进上腔静脉，到达右心房，经房间隔穿刺进入左心房到达二尖瓣附近。The surgical implantation method of the valve clamping device of the present invention can percutaneously puncture the subclavian vein, the delivery device enters the superior vena cava from the subclavian vein, reaches the right atrium, enters the left atrium through the atrial septum, and reaches near the mitral valve.
本发明除了用于治疗二尖瓣反流，还可以用于治疗三尖瓣反流，也可以用于需要夹合几个片状组织的其他微创手术。In addition to treating mitral valve regurgitation, the present invention can also be used for treating tricuspid valve regurgitation, and can also be used for other minimally invasive operations that require clipping of several sheet-like tissues.
本发明具有以下有益技术效果：The present invention has the following beneficial technical effects:
1、微创植入。本发明的瓣膜夹合装置经皮穿刺锁骨下静脉植入，无需开胸，创口小，无需心脏停跳，无需体外循环，属于微创介入手术，可用于外科手术高危或禁忌的患者。1. Minimally invasive implantation. The valve clamping device of the present invention is percutaneously punctured into the subclavian vein, does not require thoracotomy, has small incisions, does not require cardiac arrest, and does not require extracorporeal circulation. It belongs to minimally invasive interventional surgery and can be used for patients with high-risk or contraindicated surgical operations.
2、结构简单，制作方法成熟。本发明的瓣膜夹合装置结构简单，其制造材料与制作方法与目前常用血管支架和输送装置类似，因此制作方法成熟。2. The structure is simple and the production method is mature. The valve clamping device of the present invention has a simple structure, and its manufacturing materials and manufacturing method are similar to those of the current commonly used vascular stents and delivery devices, so the manufacturing method is mature.
3、手术操作难度较低。本发明的瓣膜夹合装置经皮穿刺锁骨下静脉，最终输送至二尖瓣附近，手术入口距瓣膜较近。瓣叶打开时，瓣叶钩伸入病变瓣叶游离缘中部挑起并固定病变瓣叶后，夹合部件在瓣缘对合位置夹住瓣叶。本发明的瓣膜夹合装置易于控制和调整，手术操作较容易。3. The operation is less difficult. The valve clamping device of the present invention percutaneously punctures the subclavian vein and is finally transported to the vicinity of the mitral valve, and the operation entrance is closer to the valve. When the valve leaflet is opened, the valve leaflet hook extends into the middle of the free edge of the diseased valve leaflet to stir up and fix the diseased valve leaflet, and then the clamping part clamps the valve leaflet at the position where the valve edge is aligned. The valve clipping device of the present invention is easy to control and adjust, and the operation operation is relatively easy.
4、操作具有可逆性。本发明的瓣膜夹合装置的锁定装置均可分开，可拆卸或调整夹合部位。在手术中行超声心动检查了解瓣膜成形效果及瓣膜反流情况，据此调整夹合部位。超声心动图证实无反流后，确定夹合部位并锁定瓣膜夹合装置。4. The operation is reversible. The locking device of the valve clamping device of the present invention can be separated, and the clamping position can be detached or adjusted. Echocardiography was performed during the operation to understand the effect of valvuloplasty and valvular regurgitation, and adjust the clipping site accordingly. After no regurgitation was confirmed by echocardiography, the clipping site was determined and the valve clipping device was locked.
5、效果肯定。外科瓣缘对合成形技术对二尖瓣反流的治疗效果已经被明确地证实。本发明的瓣膜夹合装置根据外科瓣缘对合成形技术原理设计而成，瓣膜夹合装置植入后夹合二尖瓣病变瓣叶，起到与外科瓣缘对合成形手术相同的效果。5. The effect is sure. The efficacy of surgical edge-to-synthetic techniques in the treatment of mitral regurgitation has been clearly demonstrated. The valve clipping device of the present invention is designed according to the technical principle of surgical valve edge pairing synthesis. After the valve clipping device is implanted, it clamps the leaflets of mitral valve disease, and has the same effect as the surgical valve edge pairing synthesis operation.
附图说明Description of drawings
图1是本发明的瓣叶钩的结构示意图。Fig. 1 is a schematic diagram of the structure of the leaflet hook of the present invention.
图2是本发明的实施例一夹合部件的结构示意图。Fig. 2 is a schematic structural diagram of a clamping component according to an embodiment of the present invention.
图3是本发明的实施例一锁环的结构示意图。Fig. 3 is a schematic structural diagram of a lock ring according to Embodiment 1 of the present invention.
图4是本发明的实施例一完全夹合并锁定后的瓣膜夹合装置形态示意图。Fig. 4 is a schematic view of the valve clamping device after fully clamped and locked according to Embodiment 1 of the present invention.
图5是本发明的实施例一输送装置的结构示意图。Fig. 5 is a schematic structural diagram of a delivery device according to Embodiment 1 of the present invention.
图6是本发明的实施例二夹合部件的结构示意图。Fig. 6 is a schematic structural view of the clamping part of the second embodiment of the present invention.
图7是本发明的实施例二锁环的结构示意图。Fig. 7 is a schematic structural diagram of a lock ring in Embodiment 2 of the present invention.
图8是本发明的实施例二完全夹合并锁定后的瓣膜夹合装置形态示意图。Fig. 8 is a schematic diagram of the shape of the valve clamping device after the second embodiment of the present invention is fully clamped and locked.
图9是本发明的实施例二输送装置的结构示意图。Fig. 9 is a schematic structural view of the delivery device according to the second embodiment of the present invention.
图10是本发明的实施例三夹合部件的结构示意图。Fig. 10 is a schematic structural view of a clamping part of Embodiment 3 of the present invention.
图11是本发明的实施例三锁环的结构示意图。Fig. 11 is a schematic structural view of the third locking ring of the embodiment of the present invention.
图12是本发明的实施例三完全夹合并锁定后的瓣膜夹合装置形态示意图。Fig. 12 is a schematic diagram of the shape of the valve clamping device after fully clamped and locked according to Embodiment 3 of the present invention.
图13是本发明的实施例三输送装置的结构示意图。Fig. 13 is a schematic structural view of a delivery device according to Embodiment 3 of the present invention.
图14是使用本发明的瓣膜夹合装置时的夹持状态图。Fig. 14 is a clamping state diagram when using the valve clamping device of the present invention.
图15是经本发明的瓣膜夹合装置夹持并锁定后的效果图。Fig. 15 is an effect diagram after being clamped and locked by the valve clamping device of the present invention.
具体实施方式Detailed ways
本发明提供了一种瓣膜夹合装置，包括：瓣叶钩、夹合部件、锁定装置和输送装置。下面将结合附图以具体实施例对本发明做进一步的解释说明，且实施例并不构成对本发明的限定。The present invention provides a valve clamping device, which comprises: a leaflet hook, a clamping part, a locking device and a delivery device. The present invention will be further explained with specific embodiments in conjunction with the accompanying drawings, and the embodiments are not intended to limit the present invention.
图1是本发明的一种瓣叶钩的结构示意图，瓣叶钩1为J型，后端与瓣叶钩控制杆连接。瓣叶打开时，J型瓣叶钩的开口一侧伸入瓣叶游离缘内，挑起并固定瓣叶，用于配合设置夹合部件的位置。Fig. 1 is a structural schematic diagram of a leaflet hook of the present invention, the leaflet hook 1 is J-shaped, and the rear end is connected with the leaflet hook control rod. When the leaflet is opened, the opening side of the J-shaped leaflet hook extends into the free edge of the leaflet to lift and fix the leaflet for matching the position of the clamping part.
实施例一Embodiment one
图2至图5为本发明实施例一提供的瓣膜夹合装置的结构示意图。2 to 5 are schematic structural views of the valve clamping device provided by Embodiment 1 of the present invention.
实施例一中的夹合部件如图2，夹合部件为两个夹合臂101及连接部件102组成的一组夹具，其通过两个夹合臂101相互靠拢并挤压产生的相互作用力来夹住其中的物体。单个夹合臂101呈V形，V形夹角为140-165度。两个夹合臂101在连接部件102上呈两侧对称布置，在两个夹合臂101未夹合时，两个夹合臂101之间的平面基本呈菱形。在两个夹合臂101相互靠拢并完全夹合后，两个夹合臂101外部形状呈圆柱形。两个夹合臂101的工作面均有若干凸起103，所述凸起103为锯齿状或波浪状，且两个夹合臂101工作面之间的锯齿状纹或波浪状纹相吻合，从而增强夹合臂与瓣膜组织之间的摩擦力，防止被夹住的瓣膜组织滑脱出来。本实施例中夹合臂101与连接部件102直接相连，在本发明的其他实施例中，夹合臂也可以通过其他结构与连接部件相连接，只要能满足本发明的夹合原理即可。The clamping part in the first embodiment is shown in Figure 2. The clamping part is a set of clamps composed of two clamping arms 101 and a connecting part 102, and the interaction force generated by the two clamping arms 101 approaching each other and squeezing to hold the objects in it. A single clamping arm 101 is V-shaped, and the included angle of the V-shape is 140-165 degrees. The two clamping arms 101 are symmetrically arranged on both sides of the connecting member 102 , and when the two clamping arms 101 are not clamped, the plane between the two clamping arms 101 is basically rhombus. After the two clamping arms 101 are close to each other and fully clamped, the external shape of the two clamping arms 101 is cylindrical. There are several protrusions 103 on the working surfaces of the two clamping arms 101, and the protrusions 103 are serrated or wavy, and the zigzag or wavy lines between the working surfaces of the two clamping arms 101 match, Thereby, the frictional force between the clamping arm and the valve tissue is enhanced, and the clamped valve tissue is prevented from slipping out. In this embodiment, the clamping arm 101 is directly connected to the connecting part 102. In other embodiments of the present invention, the clamping arm can also be connected to the connecting part through other structures, as long as the clamping principle of the present invention can be satisfied.
实施例一中的连接部件102为圆柱形，外表面具有外螺纹，而本实施例中的锁环105具有内螺纹，连接部件102可按需要旋入或旋出锁环105。连接部件102的后端设置有内螺纹连接口104，用于连接输送装置。The connecting part 102 in the first embodiment is cylindrical and has external threads on the outer surface, while the locking ring 105 in this embodiment has internal threads, and the connecting part 102 can be screwed into or out of the locking ring 105 as required. The rear end of the connection part 102 is provided with an internal thread connection port 104 for connecting with a delivery device.
实施例一中的锁环105如图3，为圆柱形，内部设有圆柱形锁孔106，锁孔106内部为螺纹，正好与夹合部件中连接部件102的外螺纹匹配，也与两个夹合臂101靠拢并完全夹合后形成的圆柱形外形匹配。夹合部件完全旋入锁环105后不会发生旋转位移或倾斜。锁环105后端外表面上有三个凹槽107，用于连接输送装置。The lock ring 105 in the first embodiment is cylindrical as shown in Fig. 3, and is provided with a cylindrical lock hole 106 inside. The inside of the lock hole 106 is threaded, which just matches the external thread of the connecting part 102 in the clamping part, and is also compatible with the two The cylindrical shape formed after the clamping arms 101 are brought together and fully clamped matches. There is no rotational displacement or tilting of the clamping parts when fully screwed into the lock ring 105 . There are three grooves 107 on the outer surface of the rear end of the lock ring 105 for connecting the delivery device.
连接部件102和锁环105组成了本实施例中的锁定装置。装配时，将夹合部件从连接部件102所在端开始旋入锁环105中，连接部件102完全旋入锁环105，且不能继续同方向转动时，从而锁定锁环105与夹合部件的相对位置。该位置使锁环105在夹合部件外部，紧固住连接部件102以及夹合臂101靠近连接部件102的部分，使夹合臂101相互靠拢并完全夹合，从而夹住其中的瓣膜组织。完全夹合并锁定后的瓣膜夹合装置形态见图4。The connecting part 102 and the locking ring 105 constitute the locking device in this embodiment. During assembly, the clamping part is screwed into the lock ring 105 from the end where the connecting part 102 is located. When the connecting part 102 is completely screwed into the lock ring 105 and cannot continue to rotate in the same direction, the relative position between the locking ring 105 and the clamping part is locked. Location. This position makes the locking ring 105 outside the clamping part, fasten the connecting part 102 and the part of the clamping arm 101 close to the connecting part 102, so that the clamping arms 101 are close to each other and completely clamped, thereby clamping the valve tissue therein. Figure 4 shows the shape of the valve clamping device after it is fully clamped and locked.
实施例一中的输送装置结构如图5，输送装置包括夹合部件输送杆108、锁环输送管109、瓣叶钩控制杆110和外包双腔导管111。夹合部件输送杆108用于连接夹合部件(如图2所示)中的连接部件102，其前端为外螺纹，用于与连接口104相配合。锁环输送管109用于连接锁环105(如图3所示)，其前端有三个小凸起112，大小与锁环105上的三个凹槽107匹配，可分别插入凹槽107中，用于与凹槽107相配合。瓣叶钩控制杆110与瓣叶钩1直接相连。双腔导管111为输送提供了轨道，其中夹合部件输送杆108、锁环输送管109在一个腔中，夹合部件输送杆108位于最内层，锁环输送管109位于中间层；瓣叶钩控制杆110在另一个腔中。手术操作人员在输送装置的后端通过前推、后拉、旋转夹合部件输送杆108、锁环输送管109、瓣叶钩控制杆110等操作，使夹合部件、锁环和瓣叶钩等在双腔导管111内走行，由体外进入心脏内所需位置。The structure of the delivery device in Embodiment 1 is shown in FIG. 5 . The delivery device includes a clamping component delivery rod 108 , a locking ring delivery tube 109 , a leaflet hook control rod 110 and an outsourcing double-lumen catheter 111 . The clamping component delivery rod 108 is used to connect the connecting component 102 in the clamping component (as shown in FIG. 2 ), and its front end is an external thread for matching with the connecting port 104 . Lock ring delivery pipe 109 is used to connect lock ring 105 (as shown in Figure 3), and its front end has three small protrusions 112, and the size matches with three grooves 107 on the lock ring 105, can be respectively inserted in the groove 107, Used to cooperate with the groove 107. The leaflet hook control rod 110 is directly connected with the leaflet hook 1 . The double-lumen catheter 111 provides a track for delivery, wherein the clamping part delivery rod 108 and the locking ring delivery tube 109 are in one cavity, the clamping part delivery rod 108 is located in the innermost layer, and the locking ring delivery tube 109 is located in the middle layer; The hook lever 110 is in another cavity. The surgical operator pushes forward, pulls back, and rotates the clamping part delivery rod 108, the locking ring delivery tube 109, and the leaflet hook control lever 110 at the rear end of the delivery device to make the clamping part, locking ring and leaflet hook Walk in the double-lumen catheter 111 and enter the required position in the heart from outside the body.
实施例二Embodiment two
图6至图9为本发明实施例二提供的瓣膜夹合装置的结构示意图。6 to 9 are schematic structural views of the valve clamping device provided by Embodiment 2 of the present invention.
实施例二中的夹合部件如图6，夹合部件为两个夹合臂201及连接部件202组成的一组夹具，其通过两个夹合臂201相互靠拢并挤压产生的相互作用力来夹住其中的物体。单个夹合臂201呈V形，V形夹角为140-165度。两个夹合臂201在连接部件202上呈两侧对称布置，在两个夹合臂201未夹合时，两个夹合臂201之间的平面基本呈菱形。在两个夹合臂201相互靠拢并完全夹合后，两个夹合臂201外部形状呈方柱形。两个夹合臂201的工作面均有若干凸起203，所述凸起203为锯齿状或波浪状，且两个夹合臂201工作面之间的锯齿状纹或波浪状纹相吻合，从而增强夹合臂与瓣膜组织之间的摩擦力，防止被夹住的瓣膜组织滑脱出来。本实施例中夹合臂201与连接部件202直接相连，在本发明的其他实施例中，夹合臂也可以通过其他结构与连接部件相连接，只要能满足本发明的夹合原理即可。The clamping part in the second embodiment is shown in Figure 6. The clamping part is a set of clamps composed of two clamping arms 201 and a connecting part 202. The interaction force generated by the two clamping arms 201 approaching each other and squeezing to hold the objects in it. A single clamping arm 201 is V-shaped, and the included angle of the V-shape is 140-165 degrees. The two clamping arms 201 are symmetrically arranged on both sides of the connecting member 202 , and when the two clamping arms 201 are not clamped, the plane between the two clamping arms 201 is basically rhombus. After the two clamping arms 201 are close to each other and fully clamped, the external shape of the two clamping arms 201 is a square column. There are several protrusions 203 on the working surfaces of the two clamping arms 201, and the protrusions 203 are serrated or wavy, and the zigzag or wavy lines between the working surfaces of the two clamping arms 201 match, Thereby, the frictional force between the clamping arm and the valve tissue is enhanced, and the clamped valve tissue is prevented from slipping out. In this embodiment, the clamping arm 201 is directly connected to the connecting part 202. In other embodiments of the present invention, the clamping arm can also be connected to the connecting part through other structures, as long as the clamping principle of the present invention can be satisfied.
实施例二中的连接部件202为方柱形，其上设置有两片弹性插片204，弹性插片204的开口方向向着夹合臂201，且离夹合臂201在连接部件202上的固定位置的距离小于锁环206的轴向长度。弹性插片204在受到外力按压时收拢并可完全贴靠在连接部件202上。连接部件202的后端设置有内螺纹连接口205，用于连接输送装置。The connecting part 202 in the second embodiment is a square column, and two elastic inserts 204 are arranged on it. The opening direction of the elastic inserts 204 faces the clamping arm 201, and is away from the fixing of the clamping arm 201 on the connecting part 202. The distance of the positions is less than the axial length of the lock ring 206 . The elastic inserting piece 204 is folded when pressed by an external force and can completely lean against the connecting part 202 . The rear end of the connection part 202 is provided with an internal thread connection port 205 for connecting with a delivery device.
实施例二中的锁环206如图7，为方柱形，内部设有方柱形锁孔207，正好与夹合部件中连接部件202的外形匹配，也与两个夹合臂201靠拢并完全夹合后形成的方柱形外形匹配。夹合部件插入锁环206后不会发生旋转位移或倾斜。锁环206后端设置有一个内螺纹连接口208，用于连接输送装置。The lock ring 206 in the second embodiment, as shown in Figure 7, is square column-shaped, with a square column-shaped lock hole 207 inside, which just matches the shape of the connecting part 202 in the clamping part, and is also close to the two clamping arms 201. The shape of the square column formed when fully clamped matches. There is no rotational displacement or tilting of the clamping components after insertion into the locking ring 206 . The rear end of the locking ring 206 is provided with an internal thread connection port 208 for connecting the delivery device.
连接部件202、弹性插片204和锁环206组成了本实施例中的锁定装置。装配时，将夹合部件从连接部件202所在端开始插入锁环206中，锁环206从后面经过弹性插片204时，弹性插片204会收拢，越过弹性插片204后，两片弹性插片204自动弹出并从后端卡住锁环206，从而锁定锁环206与夹合部件的相对位置。该位置使锁环206在夹合部件外部，紧固住连接部件202以及夹合臂201靠近连接部件202的部分，使夹合臂201相互靠拢并完全夹合，从而夹住其中的瓣膜组织。完全夹合并锁定后的瓣膜夹合装置形态见图8。The connecting part 202, the elastic insert 204 and the locking ring 206 constitute the locking device in this embodiment. When assembling, the clamping part is inserted into the lock ring 206 from the end where the connecting part 202 is located. When the lock ring 206 passes through the elastic insert 204 from behind, the elastic insert 204 will be closed, and after crossing the elastic insert 204, the two elastic inserts The piece 204 pops out automatically and clamps the locking ring 206 from the rear end, thereby locking the relative position of the locking ring 206 and the clamping part. This position makes the locking ring 206 outside the clamping part, fasten the connecting part 202 and the part of the clamping arm 201 close to the connecting part 202, so that the clamping arms 201 are close to each other and completely clamped, thereby clamping the valve tissue therein. The shape of the valve clamping device after it is completely clamped and locked is shown in FIG. 8 .
实施例二中的输送装置结构如图9，输送装置包括夹合部件输送杆209、解锁鞘210、锁环输送杆211、瓣叶钩控制杆212和外包双腔导管213。夹合部件输送杆209用于连接夹合部件(如图6所示)中的连接部件202，其前端为外螺纹，用于与连接口205相配合。解锁鞘210为轴向不可压缩的弹性鞘管，在瓣膜夹合装置需要拆除或调整夹合位置时，用于向前推夹合部件上的弹性插片204，使弹性插片204被按压收拢并完全贴靠在连接部件202上。此时向后拉锁环206，即可使锁环206从前面越过弹性插片204，从而松开对夹合部件的锁定。锁环输送杆211用于连接锁环206(如图7所示)，其前端为外螺纹，用于与连接口208相配合。瓣叶钩控制杆212与瓣叶钩1直接连接。双腔导管213为输送提供了轨道，其中夹合部件输送杆209、解锁鞘210和锁环输送杆211在一个腔中，夹合部件输送杆209位于最内层，解锁鞘210套在其外，锁环输送杆211位于解锁鞘210外；瓣叶钩控制杆212在另一个腔中。手术操作人员在输送装置的后端通过前推、后拉、旋转夹合部件输送杆209、解锁鞘210、锁环输送杆211、瓣叶钩控制杆212等操作，使夹合部件、锁环、解锁鞘和瓣叶钩等在双腔导管213内走行，由体外进入心脏内所需位置。The structure of the delivery device in Embodiment 2 is shown in FIG. 9 . The delivery device includes a clipping part delivery rod 209 , an unlocking sheath 210 , a locking ring delivery rod 211 , a leaflet hook control rod 212 and an outsourcing double-lumen catheter 213 . The clamping component delivery rod 209 is used to connect the connecting component 202 in the clamping component (as shown in FIG. 6 ), and its front end is an external thread for matching with the connecting port 205 . The unlocking sheath 210 is an axially incompressible elastic sheath tube, which is used to push forward the elastic insertion piece 204 on the clamping part when the valve clamping device needs to be dismantled or the clamping position is adjusted, so that the elastic insertion piece 204 is pressed and folded And completely abut on the connection part 202 . At this time, pull the locking ring 206 backwards, so that the locking ring 206 can pass over the elastic insert 204 from the front, thereby releasing the locking of the clamping parts. The lock ring delivery rod 211 is used to connect the lock ring 206 (as shown in FIG. 7 ), and its front end is an external thread for matching with the connection port 208 . The leaflet hook control rod 212 is directly connected with the leaflet hook 1 . The dual lumen catheter 213 provides a track for delivery, wherein the clamping component delivery rod 209, unlocking sheath 210 and locking ring delivery rod 211 are in one lumen, the clamping component delivery rod 209 is the innermost layer, and the unlocking sheath 210 is sleeved on the outside , the locking ring delivery rod 211 is located outside the unlocking sheath 210; the leaflet hook control rod 212 is in another cavity. The surgical operator pushes forward, pulls back, and rotates the clamping part delivery rod 209, the unlocking sheath 210, the locking ring delivery rod 211, the leaflet hook control rod 212, etc. at the rear end of the delivery device to make the clamping part, locking ring , the unlocking sheath and the valve leaflet hook run in the double-lumen catheter 213 and enter the desired position in the heart from outside the body.
实施例三Embodiment three
图10至图13为本发明实施例三提供的瓣膜夹合装置的结构示意图。10 to 13 are schematic structural views of the valve clamping device provided by the third embodiment of the present invention.
实施例三中的夹合部件如图10，夹合部件为两个夹合臂301及连接部件302组成的一组夹具，其通过两个夹合臂301相互靠拢并挤压产生的相互作用力来夹住其中的物体。单个夹合臂301呈V字形，V字夹角为140-165度。两个夹合臂301在连接部件302上呈两侧对称布置，在两个夹合臂301未夹合时，两个夹合臂301之间的平面基本呈菱形。在两个夹合臂301相互靠拢并完全夹合后，两个夹合臂301外部形状呈纵切面为菱形的方柱体。两个夹合臂301的工作面均有若干凸起303，所述凸起303为锯齿状或波浪状，且两个夹合臂301工作面之间的锯齿状纹或波浪状纹相吻合，从而增强夹合臂与瓣膜组织之间的摩擦力，防止被夹住的瓣膜组织滑脱出来。本实施例中夹合臂301与连接部件302直接相连，在本发明的其他实施例中，夹合臂也可以通过其他结构与连接部件相连接，只要能满足本发明的夹合原理即可。The clamping part in the third embodiment is shown in Figure 10. The clamping part is a set of clamps composed of two clamping arms 301 and connecting parts 302, which are generated by the interaction force generated by the two clamping arms 301 approaching and squeezing each other. to hold the objects in it. The single clamping arm 301 is V-shaped, and the included angle of the V is 140-165 degrees. The two clamping arms 301 are symmetrically arranged on both sides of the connecting member 302 , and when the two clamping arms 301 are not clamped, the plane between the two clamping arms 301 is basically rhombus. After the two clamping arms 301 are close to each other and fully clamped, the external shape of the two clamping arms 301 is a square cylinder whose longitudinal section is rhombus. There are several protrusions 303 on the working surfaces of the two clamping arms 301, and the protrusions 303 are serrated or wavy, and the zigzag or wavy lines between the working surfaces of the two clamping arms 301 match, Thereby, the frictional force between the clamping arm and the valve tissue is enhanced, and the clamped valve tissue is prevented from slipping out. In this embodiment, the clamping arm 301 is directly connected to the connecting part 302. In other embodiments of the present invention, the clamping arm can also be connected to the connecting part through other structures, as long as the clamping principle of the present invention can be satisfied.
实施例三中的连接部件302为方柱形，后端设置有内螺纹连接口304，用于连接输送装置。The connection part 302 in the third embodiment is in the shape of a square column, and the rear end is provided with an internal thread connection port 304 for connecting the delivery device.
实施例三中的锁环305如图11，为圆柱形，内部设有方柱形锁孔306，正好与夹合部件中连接部件302的外形匹配，也与两个夹合臂301靠拢并完全闭合后形成的纵切面为菱形的方柱体的下半部分匹配。夹合部件插入锁环305后，除非有强大的外力向前推，否则不会发生旋转位移或倾斜。锁环305底端外部为外螺纹，用于连接输送装置。As shown in Figure 11, the lock ring 305 in the third embodiment is cylindrical, with a square column-shaped lock hole 306 inside, which just matches the shape of the connecting part 302 in the clamping part, and is also close to and completely connected with the two clamping arms 301. The longitudinal section formed after closing is matched with the lower half of the rhombus-shaped square cylinder. After the clamping part is inserted into the locking ring 305, no rotational displacement or inclination will occur unless there is a strong external force pushing forward. The outside of the bottom end of the locking ring 305 is an external thread for connecting the delivery device.
连接部件302和锁环305组成了本实施例中的锁定装置。装配时，将夹合部件从连接部件302所在端开始拉入锁环305中，连接部件302完全进入锁环305，且其后端与锁环305的后端平齐时，由于夹合臂301为高弹性材料，具有向外的张力，从而锁定锁环305与夹合部件的相对位置。该位置使锁环305在夹合部件外部，紧固住连接部件302以及夹合臂301靠近连接部件302的部分，使夹合臂301相互靠拢并完全夹合，从而夹住其中的瓣膜组织。完全夹合并锁定后的瓣膜夹合装置形态见图12。The connecting part 302 and the locking ring 305 constitute the locking device in this embodiment. During assembly, the clamping part is pulled into the lock ring 305 from the end where the connecting part 302 is located. It is a high elastic material with outward tension, so as to lock the relative position of the locking ring 305 and the clamping part. This position makes the locking ring 305 outside the clamping part, fasten the connecting part 302 and the part of the clamping arm 301 close to the connecting part 302, so that the clamping arms 301 are close to each other and completely clamped, thereby clamping the valve tissue therein. Figure 12 shows the shape of the valve clamping device after it is fully clamped and locked.
实施例三中的输送装置结构如图13，输送装置包括夹合部件输送杆307、锁环输送管308、瓣叶钩控制杆309和外包双腔导管310。夹合部件输送杆307用于连接夹合部件(如图10所示)中的连接部件302，其前端为外螺纹，用于与连接口304相配合。锁环输送管308的前端为内螺纹结构，与锁环305(如图11所示)底端外部的外螺纹相配合，用于连接锁环305。瓣叶钩控制杆309与瓣叶钩1直接相连。双腔导管310为输送提供了轨道，其中夹合部件输送杆307、锁环输送管308在一个腔中，夹合部件输送杆307位于最内层，锁环输送管308位于中间层；瓣叶钩控制杆309在另一个腔中。手术操作人员在输送装置的后端通过前推、后拉、旋转夹合部件输送杆307、锁环输送管308、瓣叶钩控制杆309等操作，使夹合部件、锁环和瓣叶钩等在双腔导管310内走行，由体外进入心脏内所需位置。The structure of the delivery device in the third embodiment is shown in FIG. 13 . The delivery device includes a clamping part delivery rod 307 , a locking ring delivery tube 308 , a leaflet hook control rod 309 and an outsourcing double-lumen catheter 310 . The clamping component delivery rod 307 is used to connect the connecting component 302 in the clamping component (as shown in FIG. 10 ), and its front end is an external thread for matching with the connecting port 304 . The front end of the lock ring delivery pipe 308 is an internal thread structure, which is matched with the external thread at the bottom of the lock ring 305 (as shown in FIG. 11 ) for connecting the lock ring 305 . The leaflet hook control rod 309 is directly connected with the leaflet hook 1 . The double-lumen catheter 310 provides a track for delivery, wherein the clamping part delivery rod 307 and the lock ring delivery tube 308 are in one cavity, the clamp part delivery rod 307 is located in the innermost layer, and the lock ring delivery tube 308 is located in the middle layer; The hook lever 309 is in another cavity. The surgical operator pushes forward, pulls back, and rotates the clamping part delivery rod 307, the locking ring delivery tube 308, and the leaflet hook control lever 309 at the rear end of the delivery device to make the clamping part, locking ring and leaflet hook Walk in the double-lumen catheter 310 and enter the desired position in the heart from outside the body.
以实施例一为例，本发明提供的瓣膜夹合装置的使用方法是：Taking Embodiment 1 as an example, the method of using the valve clamping device provided by the present invention is:
1、在体外，将瓣叶钩1及瓣叶钩控制杆110输送于双腔导管111的一个腔中；将夹合部件输送杆108从其后端方向插入锁环输送管109的前端，并从锁环输送管109内部穿过，再将锁环输送管109输送于双腔导管111的另一个腔中；将锁环105连接在锁环输送管109上，再将夹合部件连接在夹合部件输送杆108上。此时，瓣叶钩1、夹合部件和锁环105均位于双腔导管111内，夹合部件在锁环105的前方。1. In vitro, the leaflet hook 1 and the leaflet hook control rod 110 are delivered to one lumen of the double-lumen catheter 111; the clamping part delivery rod 108 is inserted into the front end of the locking ring delivery tube 109 from the rear end direction, and Pass through the inside of the lock ring delivery tube 109, and then deliver the lock ring delivery tube 109 to another cavity of the double-lumen catheter 111; connect the lock ring 105 to the lock ring delivery tube 109, and then connect the clamping parts to the clip on the component delivery rod 108. At this time, the leaflet hook 1 , the clamping part and the locking ring 105 are all located in the double-lumen catheter 111 , and the clamping part is in front of the locking ring 105 .
2、经皮穿刺锁骨下静脉，输送装置从锁骨下静脉进上腔静脉，到达右心房，经房间隔穿刺进入左心房到达二尖瓣附近；前推瓣叶钩控制杆110，使瓣叶钩1从二尖瓣开口穿过进入左心室，在左心室内挑起并固定病变瓣叶2。2. Percutaneously puncture the subclavian vein, the delivery device enters the superior vena cava from the subclavian vein, reaches the right atrium, enters the left atrium through the atrial septum, and reaches near the mitral valve; push the leaflet hook lever 110 forward to make the leaflet hook 1 Pass through the opening of the mitral valve into the left ventricle, provoking and fixing the diseased valve leaflet in the left ventricle 2.
3、前推夹合部件输送杆108，使夹合部件的夹合臂101在左心房内打开；用瓣叶钩1拉住病变瓣叶2并送入夹合臂101的开口，使夹合臂101由心房面向心室面方向夹住病变瓣叶2，病变瓣叶瓣缘对合。夹持状态如图14所示。3. Push forward the delivery rod 108 of the clamping part to open the clamping arm 101 of the clamping part in the left atrium; pull the diseased leaflet 2 with the leaflet hook 1 and send it into the opening of the clamping arm 101 to make the clamping part The arm 101 clamps the diseased leaflet 2 from the atrium to the ventricle, and the edge of the diseased leaflet is apposed. The clamping state is shown in Figure 14.
4、确定瓣叶夹合部位并设置好夹合部件后，前推并旋转锁环输送管109，使夹合部件从连接部件102所在端开始旋入锁环105。连接部件102完全旋入锁环105，且不能继续同方向转动时，夹合部件即被锁定。此时，锁环105在夹合部件外部，紧固住连接部件102以及夹合臂101靠近连接部件102的部分，使夹合臂101相互靠拢并完全夹合，牢牢夹住其中的病变瓣叶2。4. After determining the clamping position of the leaflets and setting the clamping parts, push forward and rotate the delivery tube 109 of the locking ring, so that the clamping parts are screwed into the locking ring 105 from the end where the connecting part 102 is located. When the connecting part 102 is fully screwed into the locking ring 105 and cannot continue to rotate in the same direction, the clamping part is locked. At this time, the locking ring 105 is outside the clamping part, fastening the connecting part 102 and the part of the clamping arm 101 close to the connecting part 102, so that the clamping arms 101 are close to each other and completely clamped, and firmly clamp the diseased valve therein. leaf 2.
5、旋出夹合部件输送杆108；撤回瓣叶钩1及瓣叶钩控制杆110、夹合部件输送杆108、锁环输送管109、双腔导管111，完成微创介入手术。此时，瓣膜夹合装置留在体内，夹合二尖瓣病变瓣叶2，使病变部位两侧的腱索3相互靠近，瓣膜恢复至正常对合水平。最终夹持并锁定后的效果如图15所示。5. Unscrew the delivery rod 108 of the clamping part; withdraw the leaflet hook 1 and the control rod 110 of the leaflet hook, the delivery rod 108 of the clamping part, the delivery tube 109 of the locking ring, and the double-lumen catheter 111 to complete the minimally invasive interventional operation. At this time, the valve clamping device stays in the body to clamp the diseased leaflets 2 of the mitral valve so that the chordae 3 on both sides of the diseased part approach each other, and the valve returns to the normal coaptation level. The final clamping and locking effect is shown in Figure 15.
以上对本发明所涉及的瓣膜夹合装置进行了详细介绍，本文中应用了具体个例对本发明的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出，本发明不限于上述的示例性实施例，本领域技术人员可在不偏离本发明的原理、范围或者精神的情况下做出多种改变和变型。同时，对于本领域的一般技术人员，依据本发明的技术思想，在具体实施方式及应用范围上均会有改变之处。因而，综上所述，本说明书内容不应理解为对本发明的限制。The valve clamping device involved in the present invention has been introduced in detail above. In this paper, specific examples are used to illustrate the principle and implementation of the present invention. The description of the above embodiments is only used to help understand the method and its core of the present invention. Thought. It should be noted that the present invention is not limited to the above-mentioned exemplary embodiments, and those skilled in the art may make various changes and modifications without departing from the principle, scope or spirit of the present invention. At the same time, for those skilled in the art, according to the technical idea of the present invention, there will be changes in the specific implementation and application scope. Therefore, in summary, the contents of this specification should not be construed as limiting the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810553962.8ACN108635017A (en) | 2018-06-01 | 2018-06-01 | Valve clamping device |
| PCT/CN2018/104210WO2019227755A1 (en) | 2018-06-01 | 2018-09-05 | Valve clamping device |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810553962.8ACN108635017A (en) | 2018-06-01 | 2018-06-01 | Valve clamping device |
| Publication Number | Publication Date |
|---|---|
| CN108635017Atrue CN108635017A (en) | 2018-10-12 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810553962.8APendingCN108635017A (en) | 2018-06-01 | 2018-06-01 | Valve clamping device |
| Country | Link |
|---|---|
| CN (1) | CN108635017A (en) |
| WO (1) | WO2019227755A1 (en) |
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| Date | Code | Title | Description |
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| PB01 | Publication | ||
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| SE01 | Entry into force of request for substantive examination | ||
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| RJ01 | Rejection of invention patent application after publication | Application publication date:20181012 | |
| RJ01 | Rejection of invention patent application after publication |