






技术领域technical field
本发明涉及一种结扎体内腔体的装置及其使用方法,尤其是涉及一种结扎左心耳的装置及其使用方法。The invention relates to a device for ligating a cavity in the body and a method for using it, in particular to a device for ligating a left atrial appendage and a method for using it.
背景技术Background technique
心房颤动(简称房颤或者AF)是临床上十分常见的心律失常之一。国内外研究显示:人群种房颤的总发病率为0.89%。又16%-21.5%的脑卒中(脑卒中又称中风或脑血管意外,是一组突然起病,以局灶性神经功能缺失为共同特征的急性脑血管疾病。)由房颤导致的血栓脱落引起,非瓣膜病房颤导致的脑卒中占心原性脑卒中病例的50%-67.1%。房颤患者的脑卒中年发病率>4%;而脑卒中引起致死率及致残率可达50%左右。因此预防房颤卒中具有重要的临床意义。Atrial fibrillation (abbreviated as atrial fibrillation or AF) is one of the most common clinical arrhythmias. Studies at home and abroad have shown that the overall incidence of atrial fibrillation in the population is 0.89%. Another 16%-21.5% of stroke (stroke, also known as stroke or cerebrovascular accident, is a group of acute cerebrovascular diseases with sudden onset and common features of focal neurological deficit.) Thrombosis caused by atrial fibrillation Stroke caused by shedding and non-valvular atrial fibrillation accounts for 50%-67.1% of cardiogenic stroke cases. The annual incidence of stroke in patients with atrial fibrillation is more than 4%, and the mortality and disability rate caused by stroke can reach about 50%. Therefore, the prevention of atrial fibrillation stroke has important clinical significance.
抗凝治疗目前是预防房颤卒中并发症的标准方法,但是抗凝治疗存在一定的局限,如部分患者因为存在抗凝禁忌症或相对禁忌症而不能抗凝,又或者抗凝剂容易受到药物和食物的影响而增加检测麻烦,使得一些患者不能长期坚持抗凝治疗。此外,抗凝治疗本身也有出血并发症,这些使得患者长期抗凝坚持率降低,抗凝治疗发挥的作用受限。因此采用更加有效安全的措施预防房颤卒中具有重要意义。Anticoagulant therapy is currently the standard method for preventing stroke complications in atrial fibrillation. However, anticoagulant therapy has certain limitations. For example, some patients cannot be anticoagulated because of anticoagulant contraindications or relative contraindications, or anticoagulants are easily affected by drugs. The influence of food and food increases the trouble of detection, making some patients unable to adhere to anticoagulant therapy for a long time. In addition, anticoagulation therapy itself also has bleeding complications, which reduce the long-term anticoagulation adherence rate of patients and limit the role of anticoagulation therapy. Therefore, it is of great significance to adopt more effective and safe measures to prevent atrial fibrillation stroke.
目前利用内科介入治疗方法闭塞左心耳的方法也得到了很大发展,该种治疗技术对于存在严重出血患者和抗凝禁忌患者来说是一种很好的选择。常用的左心耳封堵术有两种:一种是利用经皮左心耳跨导管堵闭装置(percutaneous left atrial appendage transcatheter occlusion-PLAATO)封堵左心耳,常见的如Appriva Medical公司;另一种是利用Amplazer房间隔封堵伞堵闭左心耳。利用PLAATO装置封堵左心耳的方法因其手术创伤小,成功率高,血栓栓塞发生率低等优点一度备受嘱目,但其手术并发症——心包积血发生率较高,目前发生率约6.9%,因而还需要进一步完善装置的设计结构和积累手术经验。而对于Amplazer封堵伞,很多专家认为其并非是合适的LAA(经皮左心耳封闭)堵闭装置,它不是专门为LAA堵闭所设计,而是为心房缺损所设计,因而认为如果没有合适的设备,还是不要勉强进行左心耳堵闭手术。At present, the method of occluding the left atrial appendage by medical interventional therapy has also been greatly developed. This kind of treatment technology is a good choice for patients with severe bleeding and patients with contraindications to anticoagulation. There are two commonly used left atrial appendage occlusion techniques: one is to use a percutaneous left atrial appendage transcatheter occlusion (PLAATO) to occlude the left atrial appendage, such as Appriva Medical; the other is The left atrial appendage was blocked with the Amplazer atrial septal occlusion umbrella. The method of using the PLAATO device to occlude the left atrial appendage was once highly recommended due to its advantages of small surgical trauma, high success rate, and low incidence of thromboembolism. However, the incidence of surgical complications - hemopericardium is relatively high. 6.9%, so it is necessary to further improve the design structure of the device and accumulate surgical experience. As for the Amplazer occlusion umbrella, many experts believe that it is not a suitable LAA (percutaneous left atrial appendage closure) occlusion device. It is not specially designed for LAA occlusion, but for atrial defects. equipment, or do not reluctantly perform left atrial appendage closure surgery.
心脏外科手术同时切除或封闭左心耳简单易行,因此许多医生主张对于此类患者需心脏手术治疗的同时切除或封闭左心耳。但是对于仅仅是切除或封闭左心耳来说外科手术创伤面很大,不宜施行外科手术。1996年Odell(奥代尔)等报道了经胸腔镜封闭左心耳预防房颤栓塞的技术,由于大大降低了手术的创伤和风险,使得经胸腔镜封闭左心耳得到了广泛关注。如果能够进一步提高该技术中左心耳封闭的效果,经胸腔镜封闭左心耳预防房颤栓塞有着良好的应用前景。It is simple and easy to remove or seal the left atrial appendage at the same time in cardiac surgery, so many doctors advocate that the simultaneous removal or sealing of the left atrial appendage is required for such patients. However, for only excision or closure of the left atrial appendage, the trauma of the surgical operation is very large, and it is not suitable to perform the surgical operation. In 1996, Odell et al. reported the technique of thoracoscopic LAA closure to prevent atrial fibrillation embolism, which has attracted widespread attention due to the greatly reduced surgical trauma and risk. If the effect of left atrial appendage closure in this technique can be further improved, thoracoscopic closure of the left atrial appendage to prevent atrial fibrillation embolism has a good application prospect.
发明内容Contents of the invention
本发明的目的是提供一种结扎左心耳的装置及其使用方法。能够可以几乎完全封闭左心耳,大大提高阻止血栓脱落的几率。应用于经胸腔镜封闭左心耳手术,防止因房颤而脑卒中。同时避免PLAATO装置封堵术和Amplazer封堵伞的缺陷。The purpose of the present invention is to provide a device for ligating the left atrial appendage and its application method. It can almost completely close the left atrial appendage, greatly improving the chance of preventing thrombus from falling off. It is used in thoracoscopic closure of the left atrial appendage to prevent stroke due to atrial fibrillation. At the same time avoid the defects of PLAATO device occlusion and Amplazer occlusion umbrella.
本发明的目的是这样实现的:一种结扎左心耳的装置,包括结扎线,用于结扎左心耳;输送系统,用于将结扎线预先形成活套;The object of the present invention is achieved in the following way: a device for ligating the left atrial appendage, comprising a ligating thread for ligating the left atrial appendage; a delivery system for pre-forming the ligating thread into a loop;
并且,and,
上述的输送系统用于将结扎线预先形成一活套,包括外鞘管,内有贯通中空结构;内鞘管,内有贯通中空结构,设置长度略长于上述的外鞘管,并可以套接进上述的外鞘管;导丝,设置放置在上述的内鞘管内,其前端设置一圆环,用于引导上述的结扎线;卡帽,设置与上述的内鞘管前端连接,用于固定上述的结扎线形成的活套。The above-mentioned delivery system is used to form a looper for the ligature in advance, including an outer sheath tube with a through hollow structure inside; an inner sheath tube with a through hollow structure inside, which is slightly longer than the above-mentioned outer sheath tube, and can be sleeved into the above-mentioned outer sheath tube; the guide wire is set and placed in the above-mentioned inner sheath tube, and a ring is arranged at the front end to guide the above-mentioned ligature; the clamp cap is set to connect with the front end of the above-mentioned inner sheath tube for fixing The aforementioned ligature forms the looper.
同时,at the same time,
上述的结扎线设置为可置入人体的生物稳定性材料。The above-mentioned ligature is set as a biostable material that can be placed into the human body.
上述的结扎线设置为聚四氟乙烯或者膨化聚四氟乙烯或者聚酯材料制成。The above-mentioned ligature is set to be made of polytetrafluoroethylene or expanded polytetrafluoroethylene or polyester material.
上述的结扎线前端设置一圆环,靠近上述的圆环的一段长度大于左心耳外周长的结扎线设置若干结点。A ring is arranged at the front end of the above-mentioned ligature, and several nodes are arranged on a section of the ligature near the above-mentioned ring that is longer than the outer circumference of the left atrial appendage.
上述的若干结点中任意两相邻结点之间的距离等于或者稍大于上述的结扎线的直径。The distance between any two adjacent nodes among the above-mentioned several nodes is equal to or slightly larger than the diameter of the above-mentioned ligature.
上述的内鞘管设置一段外螺纹,上述的外鞘管设置一段内螺纹,用于二者螺纹连接。The above-mentioned inner sheath tube is provided with a section of external thread, and the above-mentioned outer sheath tube is provided with a section of internal thread for threaded connection between the two.
上述的内鞘管和外鞘管的前端均设置一段台阶;后端设置为手柄结构,以方便旋转和捏持;上述的外螺纹和内螺纹分别设置在上述的内鞘管和外鞘管的手柄。The front ends of the above-mentioned inner sheath and outer sheath are provided with a step; the rear end is provided with a handle structure to facilitate rotation and pinching; handle.
上述的卡帽设置为具有多个槽的帽状结构,上述的多个槽中至少有一个设置为贯通上述的卡帽;上述的卡帽与上述的内鞘管通过螺纹或者丝扣连接。The above-mentioned clamping cap is configured as a hat-shaped structure with a plurality of grooves, at least one of the above-mentioned multiple grooves is set to pass through the above-mentioned clamping cap; the above-mentioned clamping cap is connected with the above-mentioned inner sheath through threads or threads.
一种结扎左心耳的装置的使用方法,包括如下步骤:A method for using a device for ligating the left atrial appendage, comprising the steps of:
a)将内鞘管旋进外鞘管,旋入后内鞘管有一小段露在外鞘管外;a) Screw the inner sheath into the outer sheath, and after screwing in, a small section of the inner sheath is exposed outside the outer sheath;
b)将结扎线前端的圆环套上内鞘管露在外鞘管外的一小段上;b) Put the ring at the front end of the ligature on the inner sheath exposed to a short section outside the outer sheath;
c)将卡帽与内鞘管连接,同时保持卡帽上的一个贯通槽与结扎线对准;c) connecting the card cap with the inner sheath while keeping a through groove on the card cap aligned with the ligature;
d)利用导丝将没有圆环的结扎线的另一端从内鞘管中穿过,同时也就穿过结扎线前端圆环,形成活套;d) Use the guide wire to pass the other end of the ligature without the ring through the inner sheath, and at the same time pass through the ring at the front end of the ligature to form a looper;
e)利用胸腔镜将结扎线活套套住左心耳根部,再拉紧结扎线另一端以紧束结扎左心耳。e) Use a thoracoscope to loop the ligature thread around the root of the left atrial appendage, and then tighten the other end of the ligature thread to ligate the left atrial appendage tightly.
同时还包括步骤:It also includes steps:
f)拉住结扎线没有圆环的一端并反向旋转内鞘管以退出内鞘管和外鞘管;f) Pull the end of the ligature without the ring and reversely rotate the inner sheath to exit the inner sheath and the outer sheath;
g)剪掉多余的结扎线。g) Cut off excess ligature.
实现了上述的技术方案,就可以实现本发明的目的。能够小创面和低风险的有效结扎左心耳,防止房颤引起血栓脱落而致的脑卒中;同时避免PLAATO装置封堵术和Amplazer封堵伞的缺陷。After realizing the above-mentioned technical solutions, the object of the present invention can be realized. It can effectively ligate the left atrial appendage with minimal trauma and low risk, and prevent stroke caused by thrombus falling off caused by atrial fibrillation; at the same time, it avoids the defects of PLAATO device occlusion and Amplazer occlusion umbrella.
附图说明Description of drawings
图1为左心耳结扎装置示意图;Figure 1 is a schematic diagram of a left atrial appendage ligation device;
图2为结扎线示意图;Figure 2 is a schematic diagram of the ligature;
图3为鞘管剖视图;Figure 3 is a sectional view of the sheath;
图4为鞘管前端局部结构示意图;Fig. 4 is a schematic diagram of the local structure of the front end of the sheath;
图5为卡帽结构示意图;Figure 5 is a schematic diagram of the cap structure;
图6为该装置结扎左心耳的状态示意图;Fig. 6 is a schematic diagram of the state of the device ligation of the left atrial appendage;
图7为使用本发明的装置的方法的步骤图。Fig. 7 is a step-by-step diagram of a method of using the device of the present invention.
具体实施例specific embodiment
下面结合附图详细描述本发明的较佳实施例,通过对本发明较佳实施例的描述,可以更清楚的看出和理解本发明的优点所在。The preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. Through the description of the preferred embodiments of the present invention, the advantages of the present invention can be seen and understood more clearly.
图1示出了本发明所述的左心耳结扎装置,主要由结扎线1、外鞘管2、内鞘管3、导丝4和卡帽5组成,其中结扎线1用来结扎左心耳开口部位,输送系统则可以使结扎线预先形成一个活套。结扎线1上有很多小结点6,丝扣9可以将卡帽5固定连接在外鞘管2上。其中丝扣9的作用也可以由卡帽设置的内螺纹与内鞘管前端的外螺纹进行螺纹连接替代。导丝4的前端具有一圆环,放置在内鞘管3中。Fig. 1 shows the left atrial appendage ligation device according to the present invention, which mainly consists of a ligation thread 1, an
为能够长期放置在人体内,结扎线最好是可植入人体的生物稳定性材料,如聚四氟乙烯、膨化聚四氟乙烯或者聚酯材料等制成。In order to be able to be placed in the human body for a long time, the ligature is preferably made of a biostable material that can be implanted into the human body, such as polytetrafluoroethylene, expanded polytetrafluoroethylene or polyester.
图2为结扎线1的结构示意图,其前端具有一个小圆环7和很多小结点6,圆环7作用是当结扎线1的没有圆环7的一端从圆环7中穿过时,可以形成一个活套,当活套套住要结扎的左心耳根部时,便可以收紧结扎线1以紧束结扎左心耳。由于存在结点6,因而结扎线1套紧后不会松脱。为了避免卡在两个相邻结点6之间的结扎线1滑动,任意两个相邻结点的距离要适中,较好的是等于或者略大于结扎线1的直径,这样就可以避免结扎线1在两个结点6之间滑动,防止结扎不牢靠。同时要保证有结点6的结扎线段长度要等于或者大于左心耳外周长,以便使得结扎线1收紧时圆环7能够卡在结点6处。Figure 2 is a schematic structural view of the ligature 1, which has a
图3为内、外鞘管剖视图,其中内鞘管3和外鞘管2均是前端具有一段台阶,末端具有手柄的结构,两手柄处有配合螺纹,可使内鞘管3旋进或旋出外鞘管2,且内鞘管3要稍长于外鞘管2,保证内鞘管3在旋进时其前端可从外鞘管2前端露出一小部分,用于预先套上结扎线1前端的小圆环7。Fig. 3 is a cross-sectional view of the inner and outer sheaths, wherein both the
如图4所示的内、外鞘管前端局部结构示意图。Figure 4 is a schematic diagram of the local structure of the front end of the inner and outer sheaths.
图5为卡帽的结构示意图。卡帽5是具有多个槽的结构,且其中的一个槽是贯通的。当结扎线1前端的圆环7套住露出的内鞘管部分时,此时将卡帽5扣上,并让结扎线1通过贯通槽8。卡帽5通过螺纹或丝扣9牢固地扣在内鞘管3前端上,一方面可以避免圆环7脱落,另一方面可以防止手术过程中卡帽5掉入人体内。Fig. 5 is a schematic diagram of the structure of the card cap. The
如图6,示出了左心耳结扎后的状态。As shown in Fig. 6, the state after ligation of the left atrial appendage is shown.
如图7,使用本发明的装置的方法,首先是步骤s10,将内鞘管旋进外鞘管,由于设置内鞘管长度长于外鞘管,使旋入后内鞘管有一小段伸出露在外鞘管外;其次是步骤s12,将结扎线前端的圆环套上内鞘管露出在外鞘管外的一小段上,结扎线上靠近圆环的一段左心耳外周长的结扎线上设置若干结点,并且任意两个相邻结点之间的距离等于或者略大于结扎线的直径;再次是步骤s14,将卡帽与内鞘管连接,可以是螺纹连接,也可以是通过丝扣等连接,以防止圆环脱落,并且注意让卡帽上的贯通槽与结扎线对准;下一步是步骤s16,利用导丝将结扎线没有圆环的一端从内鞘管中穿过,这样也就穿过了套在内鞘管前端的圆环,形成了活套;在下一步是步骤s18,在胸部开三个孔,一个用于将本发明的装置放入,一个用于镊子进入,一个用于胸腔镜进入以观察,然后借助胸腔镜将结扎线活套套在左心耳的根部,并收紧结扎线以紧束左心耳,由于结扎线会卡在结扎线上的两个小结点中而锁紧,从而结扎了左心耳;然后是步骤s20,收紧结扎线后,反向旋转内鞘管手柄,退出内、外鞘管;最后是步骤s22,剪掉多余的结扎线,完成整个使用本发明的装置的过程。As shown in Fig. 7, the method of using the device of the present invention is first step s10, the inner sheath tube is screwed into the outer sheath tube, and since the length of the inner sheath tube is set to be longer than the outer sheath tube, a small section of the inner sheath tube protrudes after screwing in. Outside the outer sheath; followed by step s12, put the ring at the front end of the ligature on the inner sheath to expose a small section outside the outer sheath, and set some node, and the distance between any two adjacent nodes is equal to or slightly greater than the diameter of the ligature; again, step s14 connects the cap with the inner sheath, which can be threaded or threaded. Connect to prevent the ring from falling off, and pay attention to align the through groove on the cap with the ligature; the next step is step s16, use the guide wire to pass the end of the ligature without the ring through the inner sheath, so that Just passed through the ring at the front end of the inner sheath to form a looper; the next step is step s18, three holes are opened in the chest, one is used to put the device of the present invention into, one is used for tweezers to enter, and one It is used for thoracoscopic access for observation, and then the ligature looper is placed on the root of the left atrial appendage with the help of the thoracoscope, and the ligature is tightened to tighten the left atrial appendage, because the ligature will be stuck in the two small nodes on the ligature Lock it tightly, thereby ligating the left atrial appendage; then step s20, after tightening the ligature thread, reversely rotate the handle of the inner sheath tube, and exit the inner and outer sheath tubes; finally, step s22, cut off the excess ligature thread, and complete the whole use Process of the device of the present invention.
这里需要指出的是:本领域的普通技术人员可以在本发明的基础上,作出各种适当的变形或者替换,但所有这些变形或者替换,都应当属于本发明的保护范围。It should be pointed out here that those skilled in the art can make various appropriate modifications or replacements on the basis of the present invention, but all these modifications or replacements should belong to the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100603381ACN100453053C (en) | 2006-04-21 | 2006-04-21 | Device for ligating left atrial appendage and method of use thereof |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100603381ACN100453053C (en) | 2006-04-21 | 2006-04-21 | Device for ligating left atrial appendage and method of use thereof |
| Publication Number | Publication Date |
|---|---|
| CN101057789A CN101057789A (en) | 2007-10-24 |
| CN100453053Ctrue CN100453053C (en) | 2009-01-21 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100603381AActiveCN100453053C (en) | 2006-04-21 | 2006-04-21 | Device for ligating left atrial appendage and method of use thereof |
| Country | Link |
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| CN (1) | CN100453053C (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 |