技术领域technical field
本发明涉及一种医疗器械，尤其涉及一种通过导管技术利用介入的方法传送到人体选定部位的医疗器械。The invention relates to a medical device, in particular to a medical device which is transmitted to a selected part of a human body by means of an interventional catheter technique.
背景技术Background technique
通过导管技术利用介入的方法进行疾病治疗是目前利用越来越多的治疗方法，导管介入治疗方法放置各种各样的材料、器械和药物到人体的心脏、动静脉血管。Using interventional methods to treat diseases through catheter technology is currently using more and more therapeutic methods. Catheter interventional therapy places various materials, instruments and drugs into the heart, arteriovenous blood vessels of the human body.
比如通过导管介入方法放置封堵器(如房间隔缺损(ASD)封堵器、室间隔缺损(VSD)封堵器、动脉导管未闭(PDA)封堵器、卵圆孔未闭(PFO)封堵器等)到心脏的缺损部位，封堵缺损，以治疗先天性心脏病。这是一种应用比较多的介入式医疗器械，一般是通过器械和推送器之间的螺纹连接，由推送器输送到预定的人体内的部位，然后解脱螺纹以断开器械和推送器的连接。对于这种器械，其螺纹连接可以实现器械和推送器的可靠安全连接，同时可以实现可控释放，即如果器械的尺寸选择不合适，或器械展开不良时，可再次把器械收入输送导管中，换新的合适的器械，重新放置，最后可靠释放。Such as the placement of occluders (such as atrial septal defect (ASD) occluder, ventricular septal defect (VSD) occluder, patent ductus arteriosus (PDA) occluder, patent foramen ovale (PFO) occluder, etc. Occluder, etc.) to the defect site of the heart to block the defect to treat congenital heart disease. This is a widely used interventional medical device, usually through the threaded connection between the device and the pusher, the pusher is delivered to the predetermined part of the human body, and then the thread is released to disconnect the device from the pusher . For this kind of device, its threaded connection can realize reliable and safe connection between the device and the pusher, and can realize controlled release at the same time, that is, if the size of the device is not selected properly, or the device is poorly deployed, the device can be put into the delivery catheter again, Replace with a new suitable instrument, reposition, and finally release reliably.
再比如，通过导管介入方法放置封堵器到左心耳中，预防由于房颤而致左心耳形成血栓，该血栓上行至大脑造成的中风；或预防该血栓通过人体血液循环系统到达身体其他部位，造成的系统性栓塞。置放封堵器到左心耳中，封堵左心耳，阻断进入左心耳的血流，可以消除由于房颤而致使左心耳形成血栓的风险，预防中风。目前该类器械通常都是通过螺纹和推送器连接。Another example is to place an occluder into the left atrial appendage through catheter intervention to prevent the formation of a thrombus in the left atrial appendage due to atrial fibrillation, and the thrombus goes up to the brain to cause a stroke; or prevent the thrombus from reaching other parts of the body through the human blood circulation system, systemic embolism. Place an occluder into the left atrial appendage to block the left atrial appendage and block the blood flow into the left atrial appendage, which can eliminate the risk of thrombosis in the left atrial appendage due to atrial fibrillation and prevent stroke. At present, such devices are usually connected by threads and pushers.
在通过导管介入方法放置这些器械到人体的心脏、动静脉血管、左心耳中时，由于人体的心脏、动静脉血管，尤其是左心耳的解剖结构复杂，要求器械准确到达预定部位，同时要很好的适应预定部位的解剖结构、力学要求及血流动力学要求，必须对器械的结构有一个很好的设计。在只对人体产生微创伤的前提下，首先在靠近血管的皮肤处穿刺，导丝从穿刺口进入血管，导管在导丝的导引下，其一端到达预定部位，另一端留在体外，然后利用导管和推送器将器械送达预定部位。在进行此类手术时，要求非常小的柔性的导管，同时导管和导丝要设计成在X光下有很好的显影。一旦导管到达了预定的部位，移除导丝，利用推送器通过导管建立的通道把器械导向导管的末端，当器械从导管的末端全部露出时，器械要和推送器断开，以实现器械的释放。When placing these devices into the heart, arteriovenous vessels, and left atrial appendage of the human body through catheter intervention, due to the complex anatomical structure of the human heart, arteriovenous vessels, and especially the left atrial appendage, it is required that the instruments accurately reach the predetermined position and at the same time To well adapt to the anatomical structure, mechanical requirements and hemodynamic requirements of the predetermined part, it is necessary to have a good design of the structure of the device. Under the premise of only causing minimal trauma to the human body, the skin near the blood vessel is first punctured, and the guide wire enters the blood vessel from the puncture port. Under the guidance of the guide wire, one end of the catheter reaches the predetermined position, and the other end stays outside the body. The instrument is then delivered to the intended site using a catheter and pusher. When performing this type of operation, a very small flexible catheter is required, and the catheter and guide wire are designed to be well visualized under X-ray. Once the catheter reaches the predetermined position, remove the guide wire, and use the pusher to guide the device to the end of the catheter through the channel established by the catheter. When the device is fully exposed from the end of the catheter, the device should be disconnected from the pusher to achieve the device. freed.
目前，无论是放置在心脏缺损上的封堵器，还是放置在左心耳中的封堵器，其和推送器连接大部分采用螺纹连接，该螺纹连接是要在封堵器的一端或两端安装一个带螺纹的小螺母，这个小螺母通常是突出在封堵器网盘(或本体)之外。并且，由于现有的封堵器通常都是由很多根细金属丝编织而成，在编织体上需要一个集中固定多根金属丝的部件，故必须先把这些根金属丝的末端收缩固定在一个小套筒里，然后把带有螺纹的小螺母再固定在小套筒之外，如图1和图2所示，编织体包括至少一个固定及连接装置。At present, whether it is an occluder placed on a heart defect or an occluder placed in the left atrial appendage, most of its connection with the pusher is threaded, and the threaded connection is to be at one or both ends of the occluder. Install a small threaded nut, which usually protrudes out of the occluder mesh disc (or body). Moreover, since the existing occluder is usually woven by many thin metal wires, a component for concentrating and fixing multiple metal wires is needed on the braid, so the ends of these metal wires must be shrunk and fixed on the braided body. A small sleeve, then fix the small nut with threads outside the small sleeve, as shown in Figure 1 and Figure 2, the braided body includes at least one fixing and connecting device.
类似地，血管塞、血管支架和血栓过滤器也可由多根金属丝编织而成，也可能需要集中固定这些编织丝，其编织体也包括这样的固定及连接装置。此时，这些医疗器械遇到同样的问题，其固定及连接装置太长，容易突出于心血管组织表面而不利于内皮爬覆并产生较高的血栓源性，或者与心血管组织摩擦较大而导致炎症和损伤。Similarly, vascular plugs, vascular stents and thrombus filters can also be braided by multiple metal wires, and these braided wires may also need to be fixed centrally, and the braided body also includes such fixing and connecting devices. At this time, these medical devices encounter the same problem. Their fixing and connecting devices are too long, and they tend to protrude from the surface of cardiovascular tissue, which is not conducive to endothelial crawling and produces high thrombogenicity, or has greater friction with cardiovascular tissue. leading to inflammation and injury.
现有技术中的植入器械上的螺纹连接装置存在的局限性：Limitations of prior art threaded connections on implanted instruments:
1、现有技术中常用的介入式医疗器械的植入体(如封堵器)的螺纹连接装置的结构，如图1所示。先把编织盘5的很多根金属丝的末端收拢再固定在套筒3的内部，然后再把螺母1的延长部6套在套筒3的外壁上，然后把螺母1的延长部6与套筒3焊接起来。如图2所示，推送器31的末端必须有足够长度的外螺纹32与螺母1咬合，才能保证螺纹连接的安全可靠。但是，如图3所示，按照机械原理和现有的加工技术，推送器31的外螺纹32的末端至少有一段(一般需要0.5～1mm)螺牙不完整的尾部33，螺牙不完整的尾部33不能充分和螺母1咬合，削弱了应有的连接强度。由于推送器31的末端受到编织盘5的集束焊接部2的阻挡，尾部33不能伸出到螺母1的外部，但尾部33却占据了螺母1的一段长度而降低了螺纹连接的牢固性，故要求螺母1适当增加长度，这样螺母1会有较大的部分突出在封堵器编织盘5之外，一般螺母1需要突出2～5毫米。当植入到心脏内的预定部位后，这种突出不会改变，在该突出的部位有较大的血栓形成率。尤其是用在左心耳上的封堵器，因为左心耳封堵器被置放到的房颤病人的左心耳中，根据人体的解剖和生理结构，房颤的病人左心耳附近的血流较慢，极易形成血栓。同时在该突出部位的内皮爬覆较慢，由于金属部件长期暴露在组织或血液中，会导致释放到血液中的有害的金属离子的风险加大。影响器械的安全性的另一个不利因素是，该突出部位会比较大的程度影响人体原有血液的流动方式，同时会触碰影响到周围的组织而造成损害。1. The structure of the screw connection device of the implant (such as the occluder) of the interventional medical device commonly used in the prior art, as shown in FIG. 1 . First gather the ends of many metal wires of the braiding disc 5 and then fix them inside the sleeve 3, then put the extension 6 of the nut 1 on the outer wall of the sleeve 3, and then put the extension 6 of the nut 1 with the sleeve Barrel 3 is welded up. As shown in FIG. 2 , the end of the pusher 31 must have an external thread 32 of sufficient length to engage with the nut 1 to ensure safe and reliable threaded connection. However, as shown in Figure 3, according to the mechanical principle and existing processing technology, the end of the external thread 32 of the pusher 31 has at least one section (generally 0.5-1 mm) of tail 33 with incomplete thread teeth, and incomplete thread threads. The tail part 33 cannot fully engage with the nut 1, which weakens the proper connection strength. Since the end of the pusher 31 is blocked by the bundled welded part 2 of the braided disc 5, the tail part 33 cannot extend to the outside of the nut 1, but the tail part 33 occupies a section of the nut 1 and reduces the firmness of the threaded connection. The length of the nut 1 is required to be appropriately increased, so that a larger part of the nut 1 protrudes outside the braided disc 5 of the occluder, and generally the nut 1 needs to protrude by 2 to 5 mm. After being implanted in a predetermined position in the heart, this protrusion will not change, and there is a greater rate of thrombus formation at the position of the protrusion. Especially the occluder used on the left atrial appendage, because the left atrial appendage occluder is placed in the left atrial appendage of patients with atrial fibrillation, according to the anatomy and physiological structure of the human body, the blood flow near the left atrial appendage of patients with atrial fibrillation is relatively low Slow, prone to thrombosis. At the same time, the endothelium at the protruding part crawls slowly, and the risk of releasing harmful metal ions into the blood will increase due to the long-term exposure of the metal parts to the tissue or blood. Another unfavorable factor that affects the safety of the device is that the protruding part will affect the original blood flow of the human body to a relatively large extent, and at the same time, it will touch and affect the surrounding tissues and cause damage.
2、当植入这样的医疗器械后，病人可能需要再施行其他的介入手术，此时，用到的器械(如导丝等)会经过已植入器械旁边时，由于有突出，会钩挂或羁绊到，影响手术的正常进行。2. After implanting such a medical device, the patient may need to perform other interventional operations. At this time, when the used device (such as a guide wire, etc.) passes by the implanted device, it will be hooked due to the protrusion Or fetters to affect the normal operation of the operation.
3、在制作这样的医疗器械时，需要经过两次固定操作，首先把套筒3和编织盘5的金属丝固定，然后把套筒4和螺母1固定，制作流程较多，部件也较多，这样会增加制作的时间，同时会增加制作累计误差，不利于保证质量，提高了实现难度。3. When making such a medical device, two fixing operations are required. First, fix the sleeve 3 and the metal wire of the braided disc 5, and then fix the sleeve 4 and the nut 1. There are many manufacturing processes and many parts. , which will increase the production time and increase the cumulative error of production, which is not conducive to quality assurance and increases the difficulty of implementation.
4、对于套筒3和编织丝固定端的固定，通常使用氩弧焊，但氩弧焊施加在部件上的能量大小不可控，经常会导致编织丝固定端被烧断，工艺质量不稳定，同时氩弧焊的辐射较大，对操作的人员的危害较大。4. For the fixing of the sleeve 3 and the fixed end of the braided wire, argon arc welding is usually used, but the energy applied to the parts by argon arc welding is uncontrollable, which often causes the fixed end of the braided wire to be burnt, and the process quality is unstable. At the same time The radiation of argon arc welding is relatively large, which is very harmful to the operators.
5、现有技术采用的螺母1的结构较复杂，加工难度较大。5. The structure of the nut 1 used in the prior art is relatively complicated and difficult to process.
发明内容Contents of the invention
本发明要解决的技术问题在于提供一种用于介入治疗的带有固定及连接装置的医疗器械，以解决现有技术中的植入医疗器械的编织体的固定及连接装置向外突出或其突出的程度较大等问题，从而使得其固定及连接装置附近的外表面更加平整，同时保留螺纹连接方式的安全简便可控。The technical problem to be solved by the present invention is to provide a medical device with a fixing and connecting device for interventional treatment, so as to solve the problem that the fixing and connecting device of the implanted medical device in the prior art protrudes outward or its The degree of protrusion is relatively large, so that the outer surface near the fixing and connecting device is smoother, while retaining the safety, convenience and controllability of the threaded connection.
解决本发明的技术问题所采用的技术方案是：提供一种用于介入治疗的医疗器械，包括至少一个编织体，所述至少一个编织体由多根编织丝构成，所述多根编织丝之中的至少一根编织丝具有编织丝固定端，还包括一个固定及连接装置，所述固定及连接装置包括一个内套管和一个外套管，所述内套管固定于所述外套管的内部，所述编织丝固定端被固定在所述内套管的外圆周面与所述外套管的内圆周面之间，所述内套管是完全中空的，所述内套管的两端都是开放的；所述编织丝固定端的至少一部分材料熔化并填充在内套管与外套管之间的缝隙中，激光束连续焊接至少一圈，在所述编织丝固定端与所述内套管和外套管之间整体形成环形的焊接部。The technical solution adopted to solve the technical problem of the present invention is to provide a medical device for interventional therapy, including at least one braided body, the at least one braided body is composed of multiple braided wires, and one of the multiple braided wires At least one of the braided wires has a braided wire fixed end, and also includes a fixing and connecting device, the fixing and connecting device includes an inner sleeve and an outer sleeve, and the inner sleeve is fixed inside the outer sleeve , the fixed end of the braided wire is fixed between the outer peripheral surface of the inner casing and the inner peripheral surface of the outer casing, the inner casing is completely hollow, and both ends of the inner casing are It is open; at least a part of the material at the fixed end of the braided wire is melted and filled in the gap between the inner casing and the outer casing, and the laser beam is welded continuously for at least one turn, and the fixed end of the braided wire is connected to the inner casing An annular welding part is integrally formed between the casing and the outer sleeve.
作为本发明的医疗器械的进一步改进，所述内套管的长度与外套管的长度基本相等(两者相差不过10％)。As a further improvement of the medical device of the present invention, the length of the inner sleeve is substantially equal to the length of the outer sleeve (the difference between the two is no more than 10%).
作为本发明的医疗器械的进一步改进，所述外套管的内径与所述内套管的外径之差，基本等于所述编织丝的横截面最大直径的两倍(两者相差不过10％)。As a further improvement of the medical device of the present invention, the difference between the inner diameter of the outer sleeve and the outer diameter of the inner sleeve is substantially equal to twice the maximum diameter of the cross section of the braided wire (the difference between the two is no more than 10%) .
作为本发明的医疗器械的进一步改进，所述内套管具有内螺纹。As a further improvement of the medical device of the present invention, the inner sleeve has internal threads.
作为本发明的医疗器械的进一步改进，所述内套管的长度为1～2毫米，所述内螺纹贯穿整个内套管。As a further improvement of the medical device of the present invention, the length of the inner sleeve is 1-2 mm, and the internal thread runs through the entire inner sleeve.
作为本发明的医疗器械的进一步改进，所述编织丝固定端均匀分布在所述内套管的外圆周面。As a further improvement of the medical device of the present invention, the fixed ends of the braided wire are evenly distributed on the outer circumferential surface of the inner sleeve.
作为本发明的医疗器械的进一步改进，在所述内套管和所述外套管的外端面，所述编织丝固定端与所述内套管和外套管之间整体形成环形的焊接部。As a further improvement of the medical device of the present invention, on the outer end faces of the inner sleeve and the outer sleeve, an annular welding portion is integrally formed between the braided wire fixing end and the inner sleeve and the outer sleeve.
作为本发明的医疗器械的进一步改进，所述焊接部在所述外套管与所述内套管之间的一个环形的台阶上形成，所述台阶的高度为0.2～0.8毫米，所述焊接部通过激光焊接而成。As a further improvement of the medical device of the present invention, the welding part is formed on an annular step between the outer sleeve and the inner sleeve, the height of the step is 0.2-0.8 mm, and the welding part Made by laser welding.
作为本发明的医疗器械的进一步改进，所述固定及连接装置位于所述至少一个编织体的内部。As a further improvement of the medical device of the present invention, the fixing and connecting device is located inside the at least one braided body.
作为本发明的医疗器械的进一步改进，所述固定及连接装置与其中一个编织体的一个外端面相连，所述外端面是平整的。As a further improvement of the medical device of the present invention, the fixing and connecting device is connected to an outer end surface of one of the braided bodies, and the outer end surface is flat.
与现有技术相比，本发明具备以下优点：1、编织体在植入人体后保持为外表面近似平整面或小突出，加快器械表面的内皮的爬覆，最大程度降低血栓形成率，减少有害金属离子向血液中的释放，最大程度地减小医疗器械对人体血液流动的影响，同时避免植入的医疗器械妨碍后续器械的操作。2、产品结构和制作流程简化，减少工艺误差，有利于提高产品合格率。Compared with the prior art, the present invention has the following advantages: 1. After the braid is implanted into the human body, the outer surface remains approximately flat or slightly protruding, which speeds up the climbing of the endothelium on the surface of the device, reduces the thrombosis rate to the greatest extent, and reduces The release of harmful metal ions into the blood minimizes the impact of medical devices on the blood flow of the human body, and at the same time prevents the implanted medical devices from hindering the operation of subsequent devices. 2. Simplify product structure and production process, reduce process errors, and help improve product qualification rate.
附图说明Description of drawings
下面将结合附图及实施例对本发明作进一步说明，附图中：The present invention will be further described below in conjunction with accompanying drawing and embodiment, in the accompanying drawing:
图1为现有技术中的房间隔封堵器的示意图。Fig. 1 is a schematic diagram of an atrial septal occluder in the prior art.
图2为图1中的房间隔封堵器与推送器连接的示意图。Fig. 2 is a schematic diagram of the connection between the atrial septal occluder and the pusher in Fig. 1 .
图3为推送器的末端的放大示意图。Figure 3 is an enlarged schematic view of the end of the pusher.
图4为本发明的医疗器械的第一实施例的侧面局部示意图，其包括至少一个编织体和至少一个固定及连接装置。Fig. 4 is a partial schematic side view of the first embodiment of the medical device of the present invention, which includes at least one braided body and at least one fixing and connecting device.
图5为图4中的固定及连接装置与推送器咬合连接的示意图。Fig. 5 is a schematic diagram of the snap-fit connection between the fixing and connecting device and the pusher in Fig. 4 .
图6为本发明的医疗器械的第二实施例的侧面示意图，该医疗器械为具有一个内向的固定及连接装置的房间隔封堵器。Fig. 6 is a schematic side view of a second embodiment of the medical device of the present invention, which is an atrial septal occluder with an inward fixing and connecting device.
图7为图6中的固定及连接装置的放大图。Fig. 7 is an enlarged view of the fixing and connecting device in Fig. 6 .
图8为本发明的医疗器械的第三实施例的侧面示意图，该医疗器械为具有一个内向的固定及连接装置的左心耳封堵器。Fig. 8 is a schematic side view of a third embodiment of the medical device of the present invention, which is a left atrial appendage occluder with an inward fixing and connecting device.
图9为图8中的固定及连接装置的放大图。Fig. 9 is an enlarged view of the fixing and connecting device in Fig. 8 .
图10为图8中的左心耳封堵器的立体图。Fig. 10 is a perspective view of the left atrial appendage occluder in Fig. 8 .
图11为本发明的医疗器械的固定及连接装置的又一实施例。Fig. 11 is another embodiment of the fixing and connecting device of the medical device of the present invention.
具体实施方式detailed description
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.
本发明提供了一种用于介入治疗的医疗器械，其包括至少一个编织体，所述至少一个编织体由多根编织丝构成，所述多根编织丝之中的至少一部分编织丝具有编织丝固定端，该医疗器械还包括一个固定及连接装置，所述固定及连接装置包括一个内套管和一个外套管，所述内套管固定于所述外套管的内部，所述编织丝固定端被固定在所述内套管的外圆周面与所述外套管的内圆周面之间，所述内套管是完全中空的，所述内套管的两端都是开放的。The present invention provides a medical device for interventional treatment, which includes at least one braided body, the at least one braided body is composed of a plurality of braided wires, and at least a part of the braided wires in the plurality of braided wires has a braided wire The fixed end, the medical device also includes a fixing and connecting device, the fixing and connecting device includes an inner sleeve and an outer sleeve, the inner sleeve is fixed inside the outer sleeve, and the braided wire fixing end It is fixed between the outer peripheral surface of the inner sleeve and the inner peripheral surface of the outer sleeve, the inner sleeve is completely hollow, and both ends of the inner sleeve are open.
以下通过多个实施例来举例说明本发明的医疗器械具体结构和制作等方面。The specific structure and manufacture of the medical device of the present invention are illustrated below through multiple embodiments.
实施例1：Example 1:
如图4所示，本实施例的医疗器械包括至少一个编织体5和与编织体5相连的至少一个固定及连接装置，编织体5由多根编织丝构成，通常用金属丝来编织，例如镍钛合金丝，以使编织体5具有优良的弹性。多根编织丝的末端，即图4中的编织丝固定端7，可以汇集并固定在该固定及连接装置上。在现有技术中，具有此类结构特征的医疗器械包括血管塞、动脉导管未闭(PDA)封堵器、房间隔缺损(ASD)封堵器、卵圆孔未闭(PFO)封堵器、左心耳(LAA)封堵器、血栓过滤器和血管支架等。该医疗器械的其余部分仅与编织体5相连而不与该固定及连接装置相连接，故图中未显示医疗器械的其余部分。例如，血管塞的编织体5一般近似圆柱形，PDA封堵器的编织体5可以是钟形，ASD封堵器的编织体5为双盘形，PFO封堵器可由一个编织盘与若干辐条支撑杆构成，LAA封堵器可由一个编织盘与一个锚部构成。这一类医疗器械都通过编织体5上的固定及连接装置与推送器31建立如图5所示的连接状态，定位于人体组织后再与推送器31分离。As shown in Figure 4, the medical device of this embodiment includes at least one braided body 5 and at least one fixing and connecting device connected with the braided body 5, the braided body 5 is made of a plurality of braided wires, usually braided with metal wires, for example Nitinol wire, so that the braid 5 has excellent elasticity. The ends of a plurality of braided wires, that is, the fixed end 7 of the braided wires in FIG. 4 , can be collected and fixed on the fixing and connecting device. In the prior art, medical devices with such structural features include vascular plugs, patent ductus arteriosus (PDA) occluders, atrial septal defect (ASD) occluders, patent foramen ovale (PFO) occluders , left atrial appendage (LAA) occluder, thrombus filter and vascular stent, etc. The remaining parts of the medical device are only connected to the braided body 5 and not connected to the fixing and connecting device, so the remaining parts of the medical device are not shown in the figure. For example, the braided body 5 of a blood vessel plug is generally approximately cylindrical, the braided body 5 of a PDA occluder can be bell-shaped, the braided body 5 of an ASD occluder is double disc-shaped, and the PFO occluder can be composed of a braided disc and several spokes. The LAA occluder can be composed of a braided disc and an anchor. This type of medical device establishes a connection state with the pusher 31 as shown in FIG. 5 through the fixing and connecting device on the braided body 5 , and is separated from the pusher 31 after being positioned in the human tissue.
该固定及连接装置包括短螺母11(也可称为：内套管)和短套管12(也可称为：外套管)，短套筒12的内径略大于短螺母11的外径，两者之差还应该略大于编织丝的最大直径的两倍(编织丝一般有相同直径)，短螺母11嵌套在短套管12的内部，该编织丝固定端7被固定在短螺母11与短套管12之间的缝隙中。该短螺母11具有内螺纹，并且其两端是完全开放而不受阻挡，在末端设置了外螺纹32的推送器31可以穿过整个短螺母11，推送器的尾部32伸出到短螺母11的外部，如图5所示。The fixing and connecting device includes a short nut 11 (also called: inner sleeve) and a short sleeve 12 (also called: outer sleeve), the inner diameter of the short sleeve 12 is slightly larger than the outer diameter of the short nut 11, two The difference should also be slightly greater than twice the maximum diameter of the braided wire (the braided wire generally has the same diameter), the short nut 11 is nested in the inside of the short sleeve 12, and the braided wire fixed end 7 is fixed between the short nut 11 and the In the gap between the short sleeves 12. The short nut 11 has an internal thread, and its two ends are completely open without being blocked, and a pusher 31 provided with an external thread 32 at the end can pass through the entire short nut 11, and the tail 32 of the pusher stretches out to the short nut 11 outside, as shown in Figure 5.
在现有技术中，如图2所示，螺母1的螺纹并未贯穿全部长度(由于螺母延长部6的存在)，而且其螺纹的内端被套筒3和集束焊接部2堵塞住了，只有螺母1的外端是开放的，推送器31无法穿过整个螺母1，而推送器31的尾部33的螺牙线不完整，如图3所示，故尾部33不能与螺母1的内螺纹紧密咬合，因此，主要依靠推送器31的外螺纹32的中间段(该处的螺牙具有完整的外形)来咬合螺母1，螺母1的螺纹内端有一段“死长度”不能用于牢固连接该推送器31，这就要求增加螺母1的有效长度来补偿其螺纹的“死长度”，而螺母延长部6还会进一步增加螺母1的总长度，螺母1与螺母延长部6的总长度小于2毫米就无法保证牢固连接，其实际的总长度约为3～5毫米。In the prior art, as shown in Figure 2, the thread of the nut 1 does not run through the entire length (due to the existence of the nut extension 6), and the inner end of the thread is blocked by the sleeve 3 and the cluster welding part 2, Only the outer end of the nut 1 is open, the pusher 31 cannot pass through the whole nut 1, and the screw thread of the tail portion 33 of the pusher 31 is incomplete, as shown in Figure 3, so the tail portion 33 cannot be connected with the internal thread of the nut 1 Tightly bite, therefore, mainly rely on the middle section of the external thread 32 of the pusher 31 (where the thread has a complete shape) to engage the nut 1, the inner end of the thread of the nut 1 has a section of "dead length" that cannot be used for a firm connection The pusher 31, which requires increasing the effective length of the nut 1 to compensate for the "dead length" of its thread, and the nut extension 6 will further increase the total length of the nut 1, the total length of the nut 1 and the nut extension 6 is less than 2 mm can not guarantee a firm connection, and its actual total length is about 3 to 5 mm.
在本实施例中，如图5所示，由于短螺母11的内螺纹可以贯穿其全部长度(没有螺母延长部6)，而推送器可以穿过整个短螺母11，推送器的螺纹起始端可以露在短螺母11之外，只通过推送器的螺纹的中间段来咬合短螺母11，避免了上述的“死长度”，使得整个短螺母11的长度都能有效地固定推送器。因此，本实施例的短螺母11的长度可以短至1～2毫米，而短套筒12的长度与短螺母11的长度最好是基本相等，短套筒12的长度也可短至1～2毫米。In this embodiment, as shown in Figure 5, since the internal thread of the short nut 11 can run through its entire length (no nut extension 6), and the pusher can pass through the whole short nut 11, the thread starting end of the pusher can be Exposed outside the short nut 11, only engage the short nut 11 through the middle section of the thread of the pusher, avoiding the above-mentioned "dead length", so that the entire length of the short nut 11 can effectively fix the pusher. Therefore, the length of the short nut 11 of the present embodiment can be as short as 1 to 2 millimeters, and the length of the short sleeve 12 is preferably substantially equal to the length of the short nut 11, and the length of the short sleeve 12 can also be as short as 1 to 2 millimeters. 2 mm.
在预制出该医疗器械的编织体5之后，可以按以下方法来制作本实施例的固定及连接装置。After the braided body 5 of the medical device is prefabricated, the fixing and connecting device of this embodiment can be manufactured in the following manner.
第一步是装配，将需要固定在一起的多根编织丝固定端7均匀分散压贴于短螺母11的外侧壁上，然后将这些编织丝固定端7连同短螺母11穿入短套筒12之中；或者，先将多根编织丝固定端7穿过短套筒12，再将短螺母11嵌在短套筒12和这些编织丝固定端7的中间，并让编织丝固定端7均匀分散在短螺母11的周边。并且，让短螺母11的外端面基本上与短套筒12的外端面平行，编织丝固定端7略突出于短螺母11和短套筒12的外端面。The first step is assembly, evenly disperse and press the fixed ends 7 of the braided wires that need to be fixed together on the outer wall of the short nut 11, and then insert the fixed ends 7 of the braided wires together with the short nut 11 into the short sleeve 12 Or, first pass a plurality of braided wire fixed ends 7 through the short sleeve 12, then embed the short nut 11 in the middle of the short sleeve 12 and these braided wire fixed ends 7, and let the braided wire fixed ends 7 evenly scattered around the short nut 11. Moreover, the outer end surface of the short nut 11 is basically parallel to the outer end surface of the short sleeve 12 , and the fixed end 7 of the braided wire slightly protrudes from the outer end surfaces of the short nut 11 and the short sleeve 12 .
下一步是焊接，用激光束将编织丝固定端7的至少一部分材料熔化并填充在短螺母11与短套筒12之间的缝隙中，激光束连续焊接至少一圈，在短螺母11与短套筒12的外端面附近形成一个环形的较平整的整体焊接部13，使得编织丝固定端7、短螺母11以及短套筒12通过它们之间的整体焊接部13被焊接在一起。The next step is welding, at least a part of the material of the braided wire fixed end 7 is melted with a laser beam and filled in the gap between the short nut 11 and the short sleeve 12, and the laser beam is welded continuously for at least one turn, between the short nut 11 and the short sleeve 12. An annular relatively flat integral welding portion 13 is formed near the outer end surface of the sleeve 12 , so that the braided wire fixed end 7 , the short nut 11 and the short sleeve 12 are welded together through the integral welding portion 13 between them.
最后利用公知技术，把编织体5放入相应的模具中，通过热处理的方式形成需要的形状。在现有技术中，一般是把很多根编织丝固定端7聚拢穿入套筒3之中，用氩弧焊接，再将套筒3插入螺母1之中，再一次焊接。通过本发明的改进，省去一次装配和一次焊接，不仅简化生产流程提高效率，还有利于降低工艺误差提高产品合格率。而且，现有技术所用的螺母1较长，其螺纹和螺母延长部6的加工都比较复杂，相对而言，本发明的医疗器械采用的短螺母11的结构较为简单。Finally, using known techniques, the braided body 5 is put into a corresponding mold, and the required shape is formed by heat treatment. In the prior art, generally a lot of braided wire fixed ends 7 are gathered and penetrated into the sleeve 3, welded with argon arc, then the sleeve 3 is inserted into the nut 1, and welded again. Through the improvement of the invention, one assembly and one welding are omitted, which not only simplifies the production process and improves the efficiency, but also helps to reduce process errors and improve the qualified rate of products. Moreover, the nut 1 used in the prior art is relatively long, and the processing of its thread and the nut extension 6 is relatively complicated. Relatively speaking, the structure of the short nut 11 used in the medical device of the present invention is relatively simple.
本实施例制作出的医疗器械(封堵器)的固定及连接装置，在封堵器编织盘之外突出的长度将显著减小，其总长度通常只有现有技术的螺纹连接装置长度的三分之一，所用的金属量也减少到三分之一以下。这样的封堵器植入到人体血管或心脏后，内皮细胞也容易爬覆到所述的固定及连接装置上，会很大程度的降低血栓的发生率，同时有效减小该连接装置对人体血流的影响，有效降低有害金属离子向血液中的释放。The fixing and connecting device of the medical device (occluder) produced in this embodiment will significantly reduce the protruding length outside the braided disc of the occluder, and its total length usually only has three times the length of the threaded connection device in the prior art. One-third, the amount of metal used is also reduced to less than one-third. After such an occluder is implanted into a human blood vessel or heart, endothelial cells will easily climb onto the fixing and connecting device, which will greatly reduce the incidence of thrombus and effectively reduce the impact of the connecting device on the human body. The effect of blood flow can effectively reduce the release of harmful metal ions into the blood.
实施例2：Example 2:
如图6和图7所示，双盘形封堵器的固定及连接装置也由短螺母11、短套管12和两者之间的整体焊接部13固定在一起构成。其与实施例1的主要区别在于：固定及连接装置处于编织体5的内部，整体焊接部13包括一环形的小台阶41，小台阶41的优选高度是0.2～0.8mm。本实施例的制作方法和实施例1中描述的类似，只是在编织体5仍是两端未固定的编织网管状态时，就先制作所述的固定及连接装置，短螺母11的外端面稍稍突出于短套筒12的外端面而形成小台阶41，编织丝固定端7暴露在短套筒12之外的部分则依靠在短螺母11的侧壁上(刚好也在小台阶41上)，当完成整体焊接部13后，然后把编织体5翻过来，使得已初步成型的固定及连接装置被包在编织体5之内，最后利用公知技术，将编织体5的另一端的编织丝也固定，把编织体5放入相应的模具中，通过热处理的方式形成需要的双盘形状，如图6所示。小台阶41使得编织丝固定端7更加充分地暴露在激光束的照射下，激光束能够更加快速均匀地融化编织丝固定端7的暴露部分，这样加工出来的整体焊接部13更规整也更牢固。为了形成小台阶41，短套筒12的长度略小于短螺母11的长度，但是不需减小短螺母11的长度，也不会影响螺纹连接的强度。当然，也可以制作仅需在其一端固定编织丝的编织体5，此时可撑开编织体5的无固定点的一端的网孔，获得足够的操作空间，以便于在编织体5的内部直接装配和焊接所述的固定及连接装置，在装配时需要先将编织丝固定端7折向编织体5的内部，完成了内向的固定及连接装置的制作之后再热处理定型成双盘形封堵器。As shown in FIGS. 6 and 7 , the fixing and connecting device of the double-disc occluder is also composed of a short nut 11 , a short sleeve 12 and an integral welding part 13 between them. The main difference between it and Embodiment 1 is that the fixing and connecting device is inside the braided body 5, and the integral welding part 13 includes an annular small step 41, and the preferred height of the small step 41 is 0.2-0.8 mm. The manufacturing method of this embodiment is similar to that described in Embodiment 1, except that when the braided body 5 is still in the state of a braided mesh pipe with unfixed ends, the fixing and connecting device is first made, and the outer end surface of the short nut 11 is slightly Protrude from the outer end surface of the short sleeve 12 to form a small step 41, and the part of the braided wire fixed end 7 exposed outside the short sleeve 12 leans on the side wall of the short nut 11 (just on the small step 41), After the integral welding part 13 is completed, the braided body 5 is then turned over so that the preliminarily formed fixing and connecting device is wrapped in the braided body 5, and finally the braided wire at the other end of the braided body 5 is also Fix, put the braided body 5 into the corresponding mold, and form the required double disc shape by heat treatment, as shown in Figure 6. The small step 41 allows the fixed end 7 of the braided wire to be more fully exposed to the irradiation of the laser beam, and the laser beam can melt the exposed part of the fixed end 7 of the braided wire more quickly and evenly, so that the overall welded part 13 processed in this way is more regular and firmer . In order to form the small step 41, the length of the short sleeve 12 is slightly shorter than the length of the short nut 11, but it is not necessary to reduce the length of the short nut 11, nor will it affect the strength of the threaded connection. Of course, it is also possible to make the braided body 5 that only needs to be fixed at one end of the braided wire. At this moment, the mesh at the end of the braided body 5 without a fixed point can be stretched out to obtain enough operating space, so that it can be placed inside the braided body 5. To directly assemble and weld the above-mentioned fixing and connecting device, when assembling, it is necessary to fold the fixed end 7 of the braided wire to the inside of the braided body 5, and after completing the inward fixing and connecting device, heat treatment and shape it into a double disc-shaped seal. Blocker.
采用类似于实施例2中的方法，可制作如图8、图9和图10所示的实施例3的左心耳封堵器。在左心耳附近更易于形成血栓，而且此处的血栓有很大的直接危害，因此，降低左心耳封堵器的血栓源性有更大的必要性。Using a method similar to that in Example 2, the left atrial appendage occluder of Example 3 as shown in Fig. 8, Fig. 9 and Fig. 10 can be manufactured. Thrombosis is more likely to form near the left atrial appendage, and the thrombus here has great direct harm. Therefore, it is more necessary to reduce the thrombogenicity of the left atrial appendage occluder.
该实施例3中描述的固定及连接装置，也完全被包在左心耳封堵器的编织体5的内部，该固定及连接装置与编织体的一个外端面相连，优选地，编织体5的外端面是平整的，很好地符合了临床使用的要求。在现有技术中，多根编织丝固定端7集中固定在编织体5的中心处，即使将这样的连接装置翻转到编织体5的内部，也很难将编织体5外侧面的中心处的拥挤的编织丝压平。相反，本实施例3的编织丝固定端7不会集中于一个中心点，而是均匀分散的短螺纹11的周边，这就减少了编织丝之间的相互阻碍，因此更容易将在短螺纹11附近弯折的所有编织丝压平，实现了编织体5的外端面的平整性。本实施例3的左心耳封堵器械植入人体后，内向的固定及连接装置避免了外突，很好地实现了平整的外端面，加快内皮细胞在器械表面的爬覆，最大程度降低血栓形成率，减少有害金属离子向血液中的释放，最大程度的减小器械对左心房血液流动的影响，同时避免植入后的器械再妨碍后续的器械操作。The fixing and connecting device described in Embodiment 3 is also completely wrapped inside the braided body 5 of the left atrial appendage occluder, and the fixing and connecting device is connected to an outer end surface of the braided body, preferably, the braided body 5 The outer end surface is flat, which well meets the requirements of clinical use. In the prior art, a plurality of braided wire fixed ends 7 are concentrated and fixed at the center of the braided body 5. Even if such a connecting device is turned over to the inside of the braided body 5, it is difficult to connect the fixed ends 7 at the center of the braided body 5 outer surface. Congested braided filaments are flattened. On the contrary, the braided wire fixed end 7 of the present embodiment 3 will not be concentrated on a central point, but the periphery of the short thread 11 that is evenly dispersed, which reduces the mutual obstruction between the braided thread, so it is easier to place the short thread on the short thread. All the braided wires bent near 11 are flattened, so that the smoothness of the outer end surface of the braided body 5 is realized. After the left atrial appendage occlusion device in Example 3 is implanted into the human body, the inward fixing and connecting device avoids protruding, and a smooth outer end surface is well realized, which speeds up the climbing of endothelial cells on the device surface and minimizes thrombus Formation rate, reduce the release of harmful metal ions into the blood, minimize the impact of the device on the blood flow of the left atrium, and prevent the implanted device from hindering subsequent device operations.
在以上多个实施例中，短螺母11可以替换成如图11所示的无螺纹的内套管24，在编织体5上实现无螺纹的固定及连接装置。用一根辅助杆22和一根远端带球头23的连接杆21插入内套管24，形成可脱离的连接。球头23的直径小于内套管24的内径，辅助杆22的直径与球头23的直径之和大于内套管24的内径。在连接杆21与编织体5建立连接之前，先将连接杆21远端的球头23穿过内套管24，再插入辅助杆22，则连接杆21与编织体5被连接在一起。此时，连接杆21和辅助杆22同时被插入内套管24之中，则连接杆21不能向近端解脱。若将辅助杆22抽出内套管24，则连接杆21可以自由解脱。In the above multiple embodiments, the short nut 11 can be replaced by a threadless inner sleeve 24 as shown in FIG. 11 , so as to realize a threadless fixing and connection device on the braided body 5 . An auxiliary rod 22 and a connecting rod 21 with a ball head 23 at the distal end are inserted into the inner sleeve 24 to form a detachable connection. The diameter of the ball head 23 is smaller than the inner diameter of the inner sleeve 24 , and the sum of the diameter of the auxiliary rod 22 and the diameter of the ball head 23 is greater than the inner diameter of the inner sleeve 24 . Before the connection between the connecting rod 21 and the braided body 5 is established, the ball head 23 at the distal end of the connecting rod 21 is passed through the inner sleeve 24, and then the auxiliary rod 22 is inserted, so that the connecting rod 21 and the braided body 5 are connected together. At this time, the connecting rod 21 and the auxiliary rod 22 are inserted into the inner sleeve 24 at the same time, and the connecting rod 21 cannot be disengaged toward the proximal end. If the auxiliary rod 22 is pulled out of the inner sleeve 24, the connecting rod 21 can be released freely.
本发明的医疗器械的优点在于：1、植入器械的编织体之外侧面无突出或减小突出，优选地，实现编织体在植入人体后保持为外表面近似平整面或小突出，加快医疗器械表面的内皮的爬覆，最大程度降低血栓形成率，减少有害金属离子向血液中的释放，最大程度地减小医疗器械对人体血液流动的影响，同时避免植入的医疗器械妨碍后续器械的操作。2、产品结构和制作流程简化，减少工艺误差，有利于提高产品合格率。The advantages of the medical device of the present invention are: 1. There is no or reduced protrusion on the outer side of the braided body of the implanted device. The crawling of the endothelium on the surface of the medical device minimizes the rate of thrombus formation, reduces the release of harmful metal ions into the blood, minimizes the impact of medical devices on the blood flow of the human body, and prevents implanted medical devices from hindering subsequent devices operation. 2. Simplify product structure and production process, reduce process errors, and help improve product qualification rate.
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention should be included in the protection of the present invention. within range.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210389823.9ACN102908174B (en) | 2012-10-15 | 2012-10-15 | Medical instrument for interventional therapy |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210389823.9ACN102908174B (en) | 2012-10-15 | 2012-10-15 | Medical instrument for interventional therapy |
| Publication Number | Publication Date |
|---|---|
| CN102908174A CN102908174A (en) | 2013-02-06 |
| CN102908174Btrue CN102908174B (en) | 2015-03-25 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210389823.9ACeasedCN102908174B (en) | 2012-10-15 | 2012-10-15 | Medical instrument for interventional therapy |
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