技术领域technical field
本发明医疗器械领域，特别是涉及一种可经导管植入的三尖瓣边对边钳夹装置。The invention relates to the field of medical instruments, in particular to an edge-to-edge clamping device for a tricuspid valve that can be implanted through a catheter.
背景技术Background technique
心血管疾病是目前危害人类健康的头号杀手，其中心脏瓣膜疾病占据了非常大的比重。常见的瓣膜疾病包括单个或多个瓣膜结构的功能和结构异常。过去人们对主动脉瓣膜和二尖瓣膜疾病的关注程度比较高，新的治疗方法层出不穷，有效的救治了大量的瓣膜病人。随着人们对瓣膜病认识的不断深入，三尖瓣疾病越来越受到关注，尤其对三尖瓣反流引起的心力衰竭问题，由于治疗手段非常有限，且效果极差，正在成为目前瓣膜病研究领域的热点问题。Cardiovascular disease is currently the number one killer of human health, and heart valve disease accounts for a very large proportion. Common valvular diseases include functional and structural abnormalities of single or multiple valvular structures. In the past, people paid more attention to aortic valve and mitral valve diseases, and new treatment methods emerged one after another, effectively treating a large number of valve patients. With the deepening of people's understanding of valvular disease, more and more attention has been paid to tricuspid valve disease, especially for heart failure caused by tricuspid regurgitation. Hot issues in the research field.
三尖瓣解剖结构包括瓣环、瓣叶、腱索及乳头肌。瓣叶由前瓣、后瓣、隔瓣组成，瓣环是三个瓣叶的附着缘。Minale在1990年发现功能性三尖瓣反流患者的三尖瓣环的扩张是不均匀的、在前、后瓣环的某些部位扩大最明显，而隔瓣环基本不变。后有国内学者统计后瓣环可较正常扩大8O％，前瓣环可扩大40％，隔瓣环因受室间隔的限制仅可扩大lO％[18]。所以说，三尖瓣膜关闭不全主要在前、后瓣环有明显的扩大，实际上只对前、后瓣膜环进行成形，不处理隔瓣环，也是一种策略。Minale提出的选择性三尖瓣环成形术也就是基于这样的考虑，该手术就是在前后瓣叶及前后瓣交界将瓣叶根部切开，选择扩大最显著的瓣环部位进行折叠缝缩，最后将剩余的瓣环与瓣叶连续缝合，完成解剖和功能的重建。因此认为，对三尖瓣前、后瓣叶进行适当的干预，同样也能达到纠正三尖瓣关闭不全的目的。The anatomy of the tricuspid valve includes the annulus, leaflets, chordae and papillary muscles. The valve leaflet is composed of anterior leaflet, posterior leaflet and septal leaflet, and the valve annulus is the attachment edge of the three leaflets. Minale found in 1990 that the expansion of the tricuspid annulus in patients with functional tricuspid regurgitation was uneven, and the expansion was most obvious in some parts of the anterior and posterior annulus, while the septal annulus was basically unchanged. According to statistics by domestic scholars, the posterior annulus can be enlarged by 80%, the anterior annulus can be enlarged by 40%, and the septal annulus can only be enlarged by 10% due to the limitation of the interventricular septum[18] . Therefore, tricuspid regurgitation is mainly caused by the obvious expansion of the anterior and posterior valve annulus. In fact, it is also a strategy to only shape the anterior and posterior valve annulus without dealing with the septal valve annulus. The selective tricuspid annuloplasty proposed by Minale is based on such considerations. This operation is to incise the root of the valve leaflets at the junction of the anterior and posterior valve leaflets, select the most significantly enlarged valve annulus for folding and shrinking, and finally The remaining annulus and leaflets were continuously sutured to complete anatomical and functional reconstruction. Therefore, it is believed that appropriate intervention on the anterior and posterior leaflets of the tricuspid valve can also achieve the purpose of correcting tricuspid regurgitation.
目前，三尖瓣关闭不全的处理仍以三尖瓣环成形术为主，三尖瓣瓣膜置换术不仅容易引起传导阻滞，远期效果差，且机械瓣还涉及到术后抗凝等诸多不便，故临床上应用较少。与二尖瓣膜关闭不全的的治疗方法不同是，三尖瓣膜关闭不全治疗方法较多，但是在目前，还没有任何一种方法被公认为最理想的方法。近年来出现的瓣膜病介入治疗技术正在得到人们的普遍关注，能否使用微创的方法治疗三尖瓣膜关闭不全，是个崭新的课题，由于介入治疗创伤小，愈合快，病人容易接受，可以在病变早期进行干预等特点，决定该技术必将是一种革命性的治疗方法。At present, the treatment of tricuspid regurgitation is still dominated by tricuspid annuloplasty. Tricuspid valve replacement is not only likely to cause conduction block, but the long-term effect is poor, and the mechanical valve also involves postoperative anticoagulation and many other Inconvenient, so less clinical application. Different from the treatment of mitral valve insufficiency, there are many treatment methods for tricuspid valve insufficiency, but at present, none of them is recognized as the most ideal method. In recent years, the interventional therapy technology for valvular disease is attracting people's attention. Whether minimally invasive methods can be used to treat tricuspid valve insufficiency is a new topic. Because interventional therapy has less trauma, faster healing, and is easy for patients to accept, it can be used in The characteristics of early intervention of lesions determine that this technology will be a revolutionary treatment method.
进行三尖瓣边对边的微创介入修复，需要植入一种钳夹装置，该装置设计要求一方面需要避免对瓣膜功能的影响，另一方面，需要选择具有良好生物相容性的材料，能在较短的时间内达到内皮化，避免血栓的形成。For minimally invasive interventional repair of the tricuspid valve side-to-side, it is necessary to implant a clamp device. The design of the device requires avoiding the impact on the valve function on the one hand, and on the other hand, it is necessary to select materials with good biocompatibility , can achieve endothelialization in a short period of time and avoid the formation of thrombus.
随着经导管对二尖瓣膜的前叶和后叶进行边对边修复技术的成熟，设计出符合三尖瓣前叶、后叶解剖特点的钳夹装置，进行经导管三尖瓣膜前、后叶修复，使一孔瓣，变成两孔瓣，纠正三尖瓣膜反流，是完成可行，可以想象效果是理想的，更重要的是通过微创技术在病变发生的早期就可以进行干预，控制病变的进展。特别是随着材料的进步，研制出镍钛记忆合金钳夹装置完成可行，使用装置可以明显的减少该技术并发症的发生。With the mature technique of side-to-side repair of the anterior and posterior leaflets of the mitral valve through catheterization, a clamping device that conforms to the anatomical characteristics of the anterior and posterior leaflets of the tricuspid valve has been designed to perform anterior and posterior tricuspid valve repair through catheterization. Leaf repair, changing the one-hole valve into a two-hole valve, correcting tricuspid regurgitation, is feasible, and the effect can be imagined to be ideal. More importantly, minimally invasive techniques can be used to intervene at the early stage of the lesion. Control the progression of the disease. Especially with the advancement of materials, it is feasible to develop a nickel-titanium memory alloy clamp device, and the use of the device can significantly reduce the occurrence of complications of this technique.
发明内容Contents of the invention
本发明所要解决的技术问题是提供一种可经导管植入的三尖瓣边对边钳夹装置，结构简单，生物相容性和示踪性能好，机械支撑力好，有良好的顺应性和形状记忆能力，使用过程对病人造成的创伤较少。The technical problem to be solved by the present invention is to provide a tricuspid valve side-to-side clamping device that can be implanted through a catheter, which has a simple structure, good biocompatibility and tracking performance, good mechanical support, and good compliance And shape memory ability, the use process causes less trauma to the patient.
本发明解决其技术问题所采用的技术方案是：提供一种可经导管植入的三尖瓣边对边钳夹装置，包括旋转推进操作杆、连接推送杆、主体支撑螺纹杆和镍钛合金碟形盘，所述的旋转推进操作杆套在连接推送杆的外侧，所述的连接推送杆通过其下端的圆柱销与下方的主体支撑螺纹杆相连接，所述的主体支撑螺纹杆的外侧均匀布置有螺旋形突起，所述的主体支撑螺纹杆的外侧套接有旋转支撑机构，所述的旋转支撑机构两侧伸出的连接杆分别与两侧对称布置的瓣上针板的中下段相连接，所述的主体支撑螺纹杆的下端通过螺纹连接有球状头部，所述的瓣上针板的下端与球状头部连接，所述的瓣上针板与球状头部的连接处两边对称连接安装有向外伸出的瓣下底板，所述的瓣下底板的中部夹装固定有椭圆形的镍钛合金碟形盘。The technical solution adopted by the present invention to solve the technical problem is to provide a tricuspid valve side-to-side clamping device that can be implanted through a catheter, including a rotating push operation rod, a connecting push rod, a main body supporting threaded rod and a nickel-titanium alloy Disc-shaped disk, the said rotary propulsion operation rod is sleeved on the outside of the connecting push rod, and the said connecting pushing rod is connected with the lower main body supporting threaded rod through the cylindrical pin at the lower end, and the outer side of the said main body supporting threaded rod Spiral protrusions are evenly arranged, and the outer side of the main body supporting threaded rod is sleeved with a rotating support mechanism, and the connecting rods protruding from both sides of the rotating supporting mechanism are respectively connected with the middle and lower sections of the needle plate on the petal that are symmetrically arranged on both sides. connected, the lower end of the main body supporting threaded rod is threadedly connected with a spherical head, the lower end of the needle plate on the petal is connected to the spherical head, and the two sides of the connection between the needle plate on the petal and the spherical head The symmetrical connection is installed with an outwardly protruding sub-petal bottom plate, and an elliptical nickel-titanium alloy dish is clamped and fixed in the middle of the sub-petal bottom plate.
所述的旋转推进操作杆的下端中间布置有一个圆形突起，所述的旋转支撑机构的中间上端开有一个燕尾缺口，所述的燕尾缺口的尺寸与圆形突起相配。A circular protrusion is arranged in the middle of the lower end of the rotating propulsion operating rod, and a dovetail notch is opened in the middle upper end of the rotating support mechanism, and the size of the dovetail notch matches the circular protrusion.
所述的旋转推进操作杆可在连接推送杆的外侧上下滑动，所述的瓣上针板可绕着主体支撑螺纹杆旋转。The said rotary propulsion operating rod can slide up and down on the outer side of the connecting push rod, and the above-mentioned needle plate on the petal can rotate around the main body supporting threaded rod.
所述的瓣上针板上与瓣下底板相对的侧面上均匀布置有若干个圆形卡扣，所述的瓣下底板的内侧面上布置有与瓣上针板上的圆形卡扣相对应的圆孔。There are several circular buckles evenly arranged on the side of the needle plate on the upper flap opposite to the bottom plate under the flap, and there are arranged on the inner side of the bottom plate under the flap corresponding to the circular buckles on the needle plate on the upper flap. corresponding round hole.
所述的旋转推进操作杆、连接推送杆、主体支撑螺纹杆、旋转支撑机构、瓣上针板和瓣下底板采用镍钛合金材料制成。The rotary propulsion operating rod, the connecting push rod, the main body support threaded rod, the rotary support mechanism, the needle plate on the flap and the bottom plate under the flap are made of nickel-titanium alloy.
有益效果Beneficial effect
本发明涉及一种可经导管植入的三尖瓣边对边钳夹装置，其结构简单，具有以下优点：①具有良好的生物相容性，能维持较长时间的有效支撑；②足够的机械支撑力，能在瓣膜夹合的早期克服瓣膜活动导致的部分张力；③具有良好的顺应性和形状记忆能力，可以压缩后经输送鞘管释放；④具有良好的示踪性能，方便通过X线透视或者超声引导下定位。The invention relates to a tricuspid valve side-to-side clamping device which can be implanted through a catheter. It has a simple structure and has the following advantages: ①It has good biocompatibility and can maintain effective support for a long time; ②Sufficient Mechanical support can overcome partial tension caused by valve activity in the early stage of valve clamping; ③ has good compliance and shape memory ability, and can be released through the delivery sheath after compression; ④ has good traceability and is convenient to pass through X Positioning under fluoroscopy or ultrasound guidance.
附图说明Description of drawings
图1为本发明结构的分解示意图；Fig. 1 is the exploded schematic diagram of structure of the present invention;
图2为本发明结构的组装示意图；Fig. 2 is the assembly schematic diagram of structure of the present invention;
图3为本发明所述的镍钛合金碟形盘的安装示意图；Fig. 3 is the installation schematic diagram of the nickel-titanium alloy disc of the present invention;
图4为本发明所配套的输送结构的示意图。Fig. 4 is a schematic diagram of the supporting conveying structure of the present invention.
具体实施方式Detailed ways
下面结合具体实施例，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明讲授的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。Below in conjunction with specific embodiment, further illustrate the present invention. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art may make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.
如图1-4所示，本发明的实施方式涉及一种可经导管植入的三尖瓣边对边钳夹装置，包括旋转推进操作杆1、连接推送杆2、主体支撑螺纹杆3和镍钛合金碟形盘8，其特征在于，所述的旋转推进操作杆1套在连接推送杆2的外侧，所述的连接推送杆2通过其下端的圆柱销与下方的主体支撑螺纹杆3相连接，所述的主体支撑螺纹杆3的外侧均匀布置有螺旋形突起，所述的主体支撑螺纹杆3的外侧套接有旋转支撑机构4，所述的旋转支撑机构4两侧伸出的连接杆分别与两侧对称布置的瓣上针板9的中下段相连接，所述的主体支撑螺纹杆3的下端通过螺纹连接有球状头部6，所述的瓣上针板9的下端与球状头部6连接，所述的瓣上针板9与球状头部6的连接处两边对称连接安装有向外伸出的瓣下底板7，所述的瓣下底板7的中部夹装固定有椭圆形的镍钛合金碟形盘8。所述的旋转推进操作杆1的下端中间布置有一个圆形突起11，所述的旋转支撑机构4的中间上端开有一个燕尾缺口10，所述的燕尾缺口10的尺寸与圆形突起11相配。所述的瓣上针板9上与瓣下底板7相对的侧面上均匀布置有若干个圆形卡扣5，所述的瓣下底板7的内侧面上布置有与瓣上针板9上的圆形卡扣5相对应的圆孔71，所述的旋转推进操作杆1、连接推送杆2、主体支撑螺纹杆3、旋转支撑机构4、瓣上针板9和瓣下底板7采用镍钛记忆合金材料制成。As shown in Figures 1-4, the embodiment of the present invention relates to a tricuspid valve side-to-side clamping device that can be implanted through a catheter, including a rotating and advancing operating rod 1, a connecting push rod 2, a main body supporting threaded rod 3 and A nickel-titanium alloy disc 8 is characterized in that the rotary propulsion operating rod 1 is set on the outside of the connection push rod 2, and the connection push rod 2 is supported by the cylindrical pin at its lower end and the main body below the threaded rod 3 connected, the outer side of the main body supporting threaded rod 3 is uniformly arranged with spiral protrusions, the outer side of the main body supporting threaded rod 3 is sleeved with a rotating support mechanism 4, and the two sides of the rotating supporting mechanism 4 protrude The connecting rods are respectively connected with the middle and lower sections of the upper needle plate 9 arranged symmetrically on both sides, the lower end of the main body supporting threaded rod 3 is threadedly connected with a spherical head 6, and the lower end of the upper needle plate 9 on the valve is connected with The spherical head 6 is connected, and the two sides of the connection between the needle plate 9 on the petal and the spherical head 6 are symmetrically connected and installed with an outwardly protruding lower petal bottom plate 7, and the middle part of the lower petal bottom plate 7 is clamped and fixed with a An oval nickel-titanium alloy disc 8 . A circular protrusion 11 is arranged in the middle of the lower end of the rotary propulsion operating rod 1 , and a dovetail notch 10 is opened in the middle upper end of the rotary support mechanism 4 , and the size of the dovetail notch 10 matches the circular protrusion 11 . On the side of the needle plate 9 on the flap 9 that is opposite to the bottom plate 7 under the flap, there are evenly arranged several circular buckles 5 , and on the inner side of the bottom plate 7 under the flap, there are buttons 5 on the inner side of the needle plate 9 on the flap. The circular hole 71 corresponding to the circular buckle 5, the described rotary propulsion operating rod 1, the connecting push rod 2, the main body support threaded rod 3, the rotary support mechanism 4, the needle plate 9 on the petal and the bottom plate 7 on the petal are made of nickel titanium. Made of memory alloy material.
实施例1Example 1
(a)先建立三尖瓣膜关闭不全动物模型(a) Establish an animal model of tricuspid regurgitation first
健康实验山羊40kg左右，穿刺股静脉，通过股静脉将输送长鞘送入到达右房，将体外塑型成半月形的冠状动脉指引导管通过输送长鞘送过三尖瓣膜，半月形的指引导管头段勾住三尖瓣腱索，从指引导管中送入泥鳅导丝，穿过腱索，退出指引导管，沿输送长鞘12送入右冠状动脉造影导管，圈套器从造影导管中送到三尖瓣下，拉出已经穿过腱索的泥鳅导丝，稍用力，拉断腱索，退出鞘管。同时右心室安置临时起搏动电极，给予180次/分起搏2周，经胸彩色多普勒、造影、心导管、解剖等检查证实模型建立成功。Healthy experimental goats weighing about 40 kg, puncture the femoral vein, send the long delivery sheath into the right atrium through the femoral vein, and send the half-moon-shaped coronary artery guiding catheter through the delivery long sheath to the tricuspid valve, and the half-moon-shaped guiding catheter The head hooks the tricuspid valve chord, feeds the loach guide wire from the guide catheter, passes through the chord, exits the guide catheter, and sends it into the right coronary angiography catheter along the delivery sheath 12, and the snare is sent from the angiography catheter Under the tricuspid valve, pull out the loach guide wire that has passed through the chordae, with a little force, break the chordae, and withdraw from the sheath. At the same time, a temporary pacing electrode was placed in the right ventricle, and pacing at 180 beats/min was given for 2 weeks. Transthoracic color Doppler, angiography, cardiac catheterization, anatomy and other examinations confirmed that the model was successfully established.
(b)钳夹装置的植入过程(b) Implantation process of clamp device
取成功建立三尖瓣关闭不全模型的实验羊，穿刺股静脉，进行右房造影，确定三尖瓣的位置，送入加硬钢丝到达肺动脉，建立输送轨道，将输送长鞘送到右心室内，先将旋转推进操作杆1与连接推送杆2固定，再与旋转支撑机构4的中间上端开有一个燕尾缺口10连接。将图4所示的输送装置示意图中的钳口14夹住旋转推进操作杆的圆形突起11处，沿输送长鞘12，将整个装置送送到右心室鞘管的末端，推送输送装置，先在三尖瓣下方释放瓣下底板7，回拉使瓣下底板拉住三尖瓣瓣叶，固定后，后撤输送长鞘12，转动手把13使输送装置旋转，使得推进操作杆1与旋转支撑机构燕尾缺口旋转，逐渐释放瓣上针板9，使其与瓣下底板7连接，并钳夹瓣膜，松开钳口11，后撤旋转推进操作杆1，旋转连接推送杆2，可以通过手把13旋转将主体支撑螺纹杆3和球状头部6分开，使得球状头部6留在体内，主体支撑螺纹杆3通过与其固定的连接推送杆2一起退出体外，使其与钳夹装置分离，释放钳夹装置。术后可以通过心脏超声来评估三尖瓣膜的功能。Take the experimental sheep that successfully established the tricuspid regurgitation model, puncture the femoral vein, perform right atrial angiography, determine the position of the tricuspid valve, send a hardened steel wire to reach the pulmonary artery, establish a delivery track, and send the long delivery sheath to the right ventricle Firstly, the rotating propulsion operating rod 1 is fixed with the connecting push rod 2, and then connected with a dovetail notch 10 at the middle upper end of the rotating supporting mechanism 4. Clamp the jaws 14 in the schematic diagram of the delivery device shown in Figure 4 at the circular protrusion 11 of the rotating pusher lever, send the entire device to the end of the right ventricular sheath along the delivery sheath 12, and push the delivery device, First release the subvalvular floor 7 under the tricuspid valve, pull back to make the subvalvular floor hold the tricuspid valve leaflet, after fixing, withdraw the long delivery sheath 12, turn the handle 13 to rotate the delivery device, and push the operating rod 1 Rotate with the dovetail gap of the rotating support mechanism, gradually release the needle plate 9 on the flap, make it connect with the bottom plate 7 under the flap, clamp the valve, loosen the jaw 11, withdraw and rotate the push lever 1, and connect the push lever 2 by rotation, The main body support threaded rod 3 and the spherical head 6 can be separated by the rotation of the handle 13, so that the spherical head 6 stays in the body, and the main body support threaded rod 3 exits the body through the connection push rod 2 fixed thereto, so that it is in contact with the clamp The device disengages, releasing the clamping device. Tricuspid valve function can be assessed postoperatively by echocardiography.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210326431.8ACN102860846B (en) | 2012-09-05 | 2012-09-05 | A kind of Tricuspid valve edge-to-edge jaw device can implanted through conduit |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210326431.8ACN102860846B (en) | 2012-09-05 | 2012-09-05 | A kind of Tricuspid valve edge-to-edge jaw device can implanted through conduit |
| Publication Number | Publication Date |
|---|---|
| CN102860846A CN102860846A (en) | 2013-01-09 |
| CN102860846Btrue CN102860846B (en) | 2015-08-12 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210326431.8AExpired - Fee RelatedCN102860846B (en) | 2012-09-05 | 2012-09-05 | A kind of Tricuspid valve edge-to-edge jaw device can implanted through conduit |
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| CN (1) | CN102860846B (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 | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee | Granted publication date:20150812 |