CN115869031A - Spring ring for blocking blood flow and release system thereof - Google Patents
Spring ring for blocking blood flow and release system thereof Download PDFInfo
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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,具体而言,涉及一种血流阻断用弹簧圈,以及具有该弹簧圈的血流阻断用弹簧圈释放系统。The invention relates to the technical field of medical devices, in particular to a spring coil for blocking blood flow, and a spring coil release system for blocking blood flow with the spring coil.
背景技术Background technique
在血管阻断疗法的过程中,需要通过血流阻断用弹簧圈释放系统将弹簧圈等植入物植入于人体血管中,为了提高手术治疗效率,现有技术在弹簧圈上绑扎纤维线,进而提高造栓效果。In the process of vascular occlusion therapy, implants such as coils need to be implanted in human blood vessels through a coil release system for blood flow occlusion. In order to improve the efficiency of surgical treatment, fiber threads are bound on the coils in the prior art , thereby improving the thrombus effect.
然而,现有的纤维绑扎方式一般是通过弹簧圈相邻弹簧丝缝隙夹紧纤维线,此种方式固定效果差,容易造成纤维线脱落而引发严重的远端栓塞等不良事件;另外一种方式将纤维线打结固定在弹簧丝上,此种方式操作困难,效率低下,而且搭接点外露增加了弹簧丝的输送的阻力。此外,现有的弹簧圈释放结构也存在操作繁琐,效率低下,甚至容易出现释放失效等问题。However, the existing fiber binding method generally clamps the fiber thread through the gap between the adjacent spring wires of the spring coil. This method has poor fixing effect, and it is easy to cause the fiber thread to fall off and cause serious distal embolism and other adverse events; another method Knotting and fixing the fiber thread on the spring wire is difficult and inefficient, and the exposure of the overlapping points increases the resistance of the spring wire. In addition, the existing spring coil release structure also has problems such as cumbersome operation, low efficiency, and even prone to release failure.
发明内容Contents of the invention
本发明的目的在于提供一种血流阻断用弹簧圈及其释放系统,旨在全部或部分的解决上述技术问题。The object of the present invention is to provide a spring coil for blocking blood flow and its release system, aiming to solve the above technical problems in whole or in part.
为解决上述问题,本发明首先提供了一种血流阻断用弹簧圈,包括弹簧圈本体和纤维线,所述弹簧圈本体由弹簧丝螺旋加工成型后的弹簧体经缠绕而成,所述纤维线至少部分位于所述弹簧圈本体内,并至少一端伸出所述弹簧圈本体的外表面;沿所述弹簧体长度方向,所述弹簧体内穿设有并排贴合设置的第一抗解旋丝和第二抗解旋丝,所述纤维线通过下述方式绑扎于所述第一抗解旋丝和所述第二抗解旋丝:In order to solve the above problems, the present invention firstly provides a spring coil for blocking blood flow, which includes a coil body and a fiber thread. The fiber thread is at least partly located in the spring coil body, and at least one end protrudes from the outer surface of the spring coil body; along the length direction of the spring body, the spring body is pierced with first anti-decomposition joints arranged side by side. spinning and the second anti-untwisting yarn, the fiber thread is bound to the first anti-untwisting yarn and the second anti-untwisting yarn in the following manner:
S1.在所述弹簧体缠绕成型为所述弹簧圈本体前拉直所述弹簧体,并将至少部分所述弹簧体拉伸至形变状态,拉伸后的所述弹簧体的弹簧丝形成多个第一绑扎空间;S1. Before the spring body is wound into the coil body, the spring body is straightened, and at least part of the spring body is stretched to a deformed state, and the spring wire of the stretched spring body is formed into multiple a first binding space;
S2.将长度大于所述弹簧体拉直后长度的第一抗解旋丝和第二抗解旋丝穿设于所述弹簧体形成的通道内,保证第一抗解旋丝和所述第二抗解旋丝处于上下平行且固定状态,此时,所述第一抗解旋丝和所述第二抗解旋丝之间形成第二绑扎空间;S2. The first anti-untwisting wire and the second anti-untwisting wire whose length is longer than the straightened length of the spring body are passed through the channel formed by the spring body to ensure that the first anti-untwisting wire and the second anti-untwisting wire The secondary anti-untwisting filament is in a vertically parallel and fixed state, at this time, a second binding space is formed between the first anti-untwisting filament and the second anti-untwisting filament;
S3.将双股闭环式的纤维线穿过所述第二绑扎空间,并保持所述纤维线的中部位于所述第一抗解旋丝和所述第二抗解旋丝之间,此时所述纤维线具有位于所述第一抗解旋丝和所述第二抗解旋丝一侧的第一部分,以及位于所述第一抗解旋丝和所述第二抗解旋丝另一侧的第二部分;S3. Pass the double-strand closed-loop fiber thread through the second binding space, and keep the middle part of the fiber thread between the first anti-untwisting yarn and the second anti-untwisting yarn, at this time The fiber thread has a first portion located on one side of the first anti-untwisting yarn and the second anti-untwisting yarn, and on the other side of the first anti-untwisting yarn and the second anti-untwisting yarn. the second part of the side;
S4.平移所述第一抗解旋丝或所述第二抗解旋丝,使得所述第一抗解旋丝和所述第二抗解旋丝并排贴合,并夹紧所述纤维线;S4. Translate the first anti-untwisting yarn or the second anti-untwisting yarn so that the first anti-untwisting yarn and the second anti-untwisting yarn fit side by side, and clamp the fiber thread ;
S5.将所述第一抗解旋丝的一端和所述第二抗解旋丝的一端与所述弹簧体的固定端头固定连接;S5. Fixedly connecting one end of the first anti-untwisting wire and one end of the second anti-untwisting wire to the fixed end of the spring body;
S6.将所述第一部分沿第一圆周方向搭设缠绕于所述第一抗解旋丝和/或所述第二抗解旋丝,将所述第二部分沿第二圆周方向搭设缠绕于所述第二抗解旋丝和/或所述第一抗解旋丝,所述第一圆周方向与所述第二圆周方向的相同或相反;S6. Winding the first part on the first anti-untwisting wire and/or the second anti-untwisting wire along the first circumferential direction, and winding the second part on the first anti-untwisting wire along the second circumferential direction The second anti-untwisting thread and/or the first anti-untwisting thread, the first circumferential direction is the same as or opposite to the second circumferential direction;
S7.解除对所述弹簧体的拉伸,相邻的两圈所述弹簧丝夹紧所述第一部分和所述第二部分;S7. Release the stretching of the spring body, and two adjacent coils of the spring wire clamp the first part and the second part;
S8.裁切多余的所述第一抗解旋丝和所述第二抗解旋丝,将所述第一抗解旋丝另一端和所述第二抗解旋丝另一端固定连接。S8. Cutting the redundant first anti-untwisting yarn and the second anti-untwisting yarn, and fixedly connecting the other end of the first anti-untwisting yarn to the other end of the second anti-untwisting yarn.
采用上述技术方案,通过双股抗解旋丝起到防止弹簧圈解旋的同时,利用双股抗解旋丝进行纤维线的初步固定,一体多用,然后再将纤维线进行缠绕后通过弹簧丝进行最终固定,无需对纤维线进行打结处理,相比于传统的绑扎方式不仅操作方便、固定效果好,不会出现纤维线脱落和增加弹簧体外径的问题,而且纤维线的两侧均位于弹簧体外并进行打绺处理,也能够进一步提高栓塞效果。Using the above technical scheme, the double-strand anti-untwisting wire is used to prevent the untwisting of the spring coil, and at the same time, the double-strand anti-twisting wire is used to initially fix the fiber thread, which is multi-purpose, and then the fiber thread is wound and passed through the spring wire For final fixation, there is no need to knot the fiber thread. Compared with the traditional binding method, it is not only convenient to operate, but also has a better fixing effect, and there will be no problems of fiber thread falling off and increasing the outer diameter of the spring. The spring outside the body and treated with a beating can also further improve the embolization effect.
进一步的,所述纤维线通绑扎于所述第一抗解旋丝和所述第二抗解旋丝的步骤还包括:S9.对所述第一部分和所述第二部分进行打绺处理,将所述第一部分和所述第二部分均分割为多根纤维丝。Further, the step of binding the fiber thread to the first anti-untwisting yarn and the second anti-untwisting yarn further includes: S9. performing a beating treatment on the first part and the second part, Both the first portion and the second portion are divided into a plurality of filaments.
采用上述技术方案,对纤维线的两侧位于弹簧体外的第一部分和第二部分并进行打绺处理,形成多根纤维丝,进一步提高栓塞效果。By adopting the above technical solution, the first part and the second part located outside the spring body on both sides of the fiber thread are subjected to beating treatment to form a plurality of fiber threads, further improving the embolism effect.
进一步的,所述第一部分的长度大于所述第二部分的长度,在所述弹簧体经缠绕成型弹簧圈后,所述第一部分位于所述弹簧圈外,所述第二部分至少部分位于所述弹簧圈内。Further, the length of the first part is greater than the length of the second part. After the spring body is wound into a coil, the first part is located outside the coil, and the second part is at least partially located on the coil. inside the spring coil.
采用上述技术方案,将第一部分长度设计为大于第二部分长度,避免两者在缠绕时互相干涉,并且将较长的第一部分置于弹簧圈外起到良好的栓塞效果,将较短的第二部分置于弹簧圈内,在辅助栓塞的同时能够降低纤维丝的浪费。Using the above technical solution, the length of the first part is designed to be greater than the length of the second part to avoid mutual interference between the two when winding, and the longer first part is placed outside the spring coil to achieve a good embolism effect, and the shorter part The second part is placed in the spring coil, which can reduce the waste of fiber filaments while assisting embolization.
进一步的,所述第一抗解旋丝面向所述第二抗解旋丝的一侧设有第一夹紧平面,所述第二抗解旋丝面向所述第一抗解旋丝的一侧设有第二夹紧平面,所述纤维线被夹持于所述第一夹紧平面和所述第二夹紧平面之间。Further, the side of the first anti-untwisting wire facing the second anti-untwisting wire is provided with a first clamping plane, and the second anti-untwisting wire faces one side of the first anti-untwisting wire. The side is provided with a second clamping plane, and the fiber thread is clamped between the first clamping plane and the second clamping plane.
采用上述技术方案,通过第一夹紧平面和第二夹紧平面的配合能够提高对纤维线的夹紧力,避免纤维线脱离弹簧圈。By adopting the above technical solution, the clamping force on the fiber thread can be improved through the cooperation of the first clamping plane and the second clamping plane, and the fiber thread can be prevented from detaching from the spring coil.
进一步的,所述第一夹紧平面和/或所述第二夹紧平面设有摩擦颗粒。Further, the first clamping plane and/or the second clamping plane are provided with friction particles.
采用上述技术方案,利用摩擦颗粒提高了第一夹紧平面和第二夹紧平面与纤维线的摩擦力,进一步提高纤维线固定后的稳定性。By adopting the above technical solution, friction particles are used to increase the frictional force between the first clamping plane and the second clamping plane and the fiber thread, further improving the stability of the fiber thread after being fixed.
进一步的,所述固定端头面向所述第一抗解旋丝和所述第二抗解旋丝的一侧设有第一固定孔、第二固定孔和第三固定孔,所述第一固定孔与所述第二固定孔间隔设置,所述第三固定孔位于所述第一固定孔和所述第二固定孔之间,并与所述第一固定孔相邻,所述第三固定孔与所述第二固定孔之间设有卡槽;所述第一抗解旋丝的一端插设于所述第一固定孔内,并与所述第一固定孔紧密配合;沿背离固定端头的方向,所述第二抗解旋丝依次包括第一插接部、折断体、连接带和第二插接部,所述第一插接部的一端被配置为能够与所述第二固定孔插接且紧密配合,所述第一插接部的另一端与所述第二插接部的一端通过所述折断体相连接,所述折断体被配置为在外力作用下能够与所述第一插接部和所述第二插接部解除连接,所述折断体的长度与所述卡槽长度相等并能够卡接于所述卡槽,所述连接带分别与所述第一插接部、所述折断体和所述第二插接部相连接;其中,所述第二抗解旋丝通过以下方式与所述固定端头连接:将所述第二抗解旋丝的一端插设于所述第二固定孔;折断所述折断体,使得所述折断体一端与所述第一插接部解除连接,所述折断体另一端与所述第二插接部,并将所述折断体置于所述卡槽内;将所述第二插接部插设于所述第三固定孔。Further, a first fixing hole, a second fixing hole and a third fixing hole are provided on the side of the fixing end facing the first anti-untwisting wire and the second anti-untwisting wire, the first The fixing hole is spaced apart from the second fixing hole, the third fixing hole is located between the first fixing hole and the second fixing hole, and is adjacent to the first fixing hole, and the third fixing hole There is a card slot between the second fixing hole; one end of the first anti-untwisting wire is inserted into the first fixing hole, and closely fits with the first fixing hole; The direction of the head, the second anti-untwisting wire sequentially includes a first inserting part, a breaking body, a connecting belt and a second inserting part, and one end of the first inserting part is configured to be able to connect with the second The fixing hole is plugged and closely matched, and the other end of the first plug-in part is connected to one end of the second plug-in part through the break body, and the break body is configured to be able to connect with the The first plug-in part and the second plug-in part are disconnected, the length of the snap-off body is equal to the length of the slot and can be snap-fitted into the slot, and the connecting straps are connected to the first slot respectively. The inserting part, the breaking body and the second inserting part are connected; wherein, the second anti-untwisting wire is connected to the fixed end in the following manner: the second anti-untwisting wire One end is inserted into the second fixing hole; the breaking body is broken so that one end of the breaking body is disconnected from the first insertion part, the other end of the breaking body is connected to the second insertion part, and The broken body is placed in the slot; the second insertion part is inserted into the third fixing hole.
采用上述技术方案,利用第一固定孔和第二固定孔便于第一抗解旋丝和第二抗解旋丝的初步固定,进而利于纤维线的穿过,而通过折断体和连接带的设计,便于将第二抗解旋丝平移至第三固定孔进行固定,使得第一抗解旋丝和第二抗解旋丝并排贴合夹持纤维线,结构巧妙,操作简单。By adopting the above technical scheme, the first fixing hole and the second fixing hole are used to facilitate the preliminary fixing of the first anti-untwisting yarn and the second anti-untwisting yarn, thereby facilitating the passing of the fiber thread, and through the design of the breaking body and the connecting belt , it is convenient to translate the second anti-untwisting thread to the third fixing hole for fixing, so that the first anti-untwisting thread and the second anti-untwisting thread fit side by side to clamp the fiber line, the structure is ingenious, and the operation is simple.
进一步的,所述连接带与所述第二抗解旋丝材质相同,并与所述第一插接部、所述折断体和所述第二插接部热熔连接。Further, the connecting belt is made of the same material as the second anti-untwisting thread, and is heat-fused connected with the first insertion part, the breaking body and the second insertion part.
采用上述技术方案,能够进一步提高第二抗解旋丝的结构稳定性。By adopting the above technical solution, the structural stability of the second anti-untwisting wire can be further improved.
本发明还提供了一种血流阻断用弹簧圈释放系统,其包括导管机构、输送机构、释放机构以及如上述技术方案所述的血流阻断用弹簧圈,至少部分所述输送机构、所述释放机构和所述血流阻断用弹簧圈所述位于所述导管机构内,所述输送机构的远端与所述血流阻断用弹簧圈通过所述释放机构相连接;其中,所述释放机构被配置为:操作所述输送机构的近端所述释放机构动作,所述血流阻断用弹簧圈脱离所述输送机构。The present invention also provides a coil release system for blocking blood flow, which includes a catheter mechanism, a delivery mechanism, a release mechanism, and the coil for blocking blood flow as described in the above technical solution, at least part of the delivery mechanism, The release mechanism and the blood flow blocking spring coil are located in the catheter mechanism, and the distal end of the delivery mechanism is connected to the blood flow blocking spring coil through the release mechanism; wherein, The release mechanism is configured to act by operating the proximal end of the delivery mechanism, and the spring coil for blocking blood flow is disengaged from the delivery mechanism.
采用上述技术方案,对弹簧圈上纤维线的绑扎结构做出改进,纤维线通过双股抗解旋丝进行初步固定,然后通过弹簧体的弹性对纤维线的两侧进行夹持固定,无需对纤维线进行打结处理,相比于传统的绑扎方式不仅操作方便、固定效果好,不会出现纤维线脱落和增加弹簧体外径的问题,而且纤维线的两侧均位于弹簧体外并进行打绺处理,也能够进一步提高栓塞效果。Using the above technical scheme, the binding structure of the fiber thread on the spring coil is improved. The fiber thread is initially fixed by the double-strand anti-untwisting wire, and then the two sides of the fiber thread are clamped and fixed by the elasticity of the spring body, without the need for The fiber thread is knotted. Compared with the traditional binding method, it is not only convenient to operate, but also has a better fixing effect, and there will be no problems of fiber thread falling off and increasing the outer diameter of the spring. Moreover, both sides of the fiber thread are located outside the spring body and are locked. Treatment can also further improve the embolism effect.
进一步的,所述释放机构包括导向套、第一解脱件和第二解脱件;所述导向套安装于所述导管机构内,且所述导向套的外径尺寸小于所述导管机构的内径尺寸,所述导向套的远端的外壁设有第一限位部,所述导管机构的远端的内壁设有能够与所述第一限位部限位配合的第二限位部;所述第一解脱件和所述第二解脱件滑动安装于所述导向套内,所述第一解脱件一端与所述输送机构相连接,所述第一解脱件另一端设有形状记忆合金部,所述第二解脱件一端设有与所述形状记忆合金部插接配合的插槽,所述插槽的侧壁开设有限位槽,所述限位槽内具有供所述形状记忆合金部弯曲变形的空间,所述形状记忆合金部被配置为在第一温度下至少部分伸入所述限位槽内,并在第二温度下脱离所述限位槽,所述第一温度小于所述第二温度。Further, the release mechanism includes a guide sleeve, a first release member and a second release member; the guide sleeve is installed in the catheter mechanism, and the outer diameter of the guide sleeve is smaller than the inner diameter of the catheter mechanism , the outer wall of the distal end of the guide sleeve is provided with a first limiting portion, and the inner wall of the distal end of the catheter mechanism is provided with a second limiting portion that can limitly cooperate with the first limiting portion; The first release part and the second release part are slidably installed in the guide sleeve, one end of the first release part is connected to the conveying mechanism, and the other end of the first release part is provided with a shape memory alloy part, One end of the second release member is provided with a slot for plugging and fitting with the shape memory alloy part, and the side wall of the slot is provided with a limiting groove, and the limiting groove has a space for the bending of the shape memory alloy part. space for deformation, the shape memory alloy part is configured to at least partly protrude into the limiting groove at a first temperature, and escape from the limiting groove at a second temperature, the first temperature being lower than the second temperature.
采用上述技术方案,无需医护人员进行折断、拉线等操作进行解脱处理,直接将弹簧圈置于血液内一定时间即可自动解旋,减轻了医护人员的作业,提高了解脱效率和准确度。With the above-mentioned technical solution, there is no need for medical personnel to perform operations such as breaking and pulling wires for release, and the coil can be automatically untwisted by directly placing the coil in the blood for a certain period of time, which reduces the work of medical personnel and improves the efficiency and accuracy of release.
进一步的,所述输送机构包括与所述释放机构连接的输送管,所述输送管沿其长度方向开设有螺旋槽,由所述输送管的近端至远端,相邻两个螺旋槽之间的间距逐渐减小。Further, the delivery mechanism includes a delivery tube connected to the release mechanism, the delivery tube is provided with a spiral groove along its length, from the proximal end to the distal end of the delivery tube, between two adjacent spiral grooves The distance between them gradually decreases.
采用上述技术方案,利用螺旋槽便于输送管的弯曲输送,并且采用渐变间距的设计,使得输送管由近端至远端逐渐柔软,增强输送性能、降低对导管尖端的影响。With the above technical solution, the spiral groove is used to facilitate the curved delivery of the delivery tube, and the design of the gradual spacing is adopted, so that the delivery tube is gradually soft from the proximal end to the distal end, which enhances the delivery performance and reduces the impact on the catheter tip.
附图说明Description of drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据提供的附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only It is an embodiment of the present invention, and those skilled in the art can also obtain other drawings according to the provided drawings without creative work.
图1为本发明实施例提供的血流阻断用弹簧圈的弹簧体在拉伸后的结构示意图;Fig. 1 is a schematic structural view of the spring body of the spring coil for blocking blood flow provided by the embodiment of the present invention after stretching;
图2为本发明实施例提供的血流阻断用弹簧圈的纤维线被第一抗解旋丝和第二抗解旋丝夹持后的结构示意图;Fig. 2 is a schematic structural view of the fiber thread of the spring coil for blocking blood flow provided by the embodiment of the present invention after being clamped by the first anti-untwisting wire and the second anti-untwisting wire;
图3为本发明实施例提供的血流阻断用弹簧圈的纤维线在缠绕至第一抗解旋丝和第二抗解旋丝的第一状态后的结构示意图;Fig. 3 is a schematic structural view of the fiber thread of the coil for blocking blood flow provided by the embodiment of the present invention after being wound into the first state of the first anti-untwisting wire and the second anti-untwisting wire;
图4为本发明实施例提供的血流阻断用弹簧圈的纤维线在缠绕至第一抗解旋丝和第二抗解旋丝的第二状态后的结构示意图;Fig. 4 is a schematic structural view of the fiber thread of the coil for blocking blood flow provided by the embodiment of the present invention after being wound into the second state of the first anti-untwisting wire and the second anti-untwisting wire;
图5为本发明实施例提供的血流阻断用弹簧圈的纤维线在缠绕至第一抗解旋丝和第二抗解旋丝的第三状态后的结构示意图;Fig. 5 is a schematic diagram of the structure of the fiber thread of the coil for blocking blood flow provided by the embodiment of the present invention after being wound into the third state of the first anti-untwisting wire and the second anti-untwisting wire;
图6为本发明实施例提供的血流阻断用弹簧圈的弹簧体在植入纤维线后的结构示意图;Fig. 6 is a schematic diagram of the structure of the spring body of the spring coil for blocking blood flow provided by the embodiment of the present invention after the fiber line is implanted;
图7为本发明实施例提供的血流阻断用弹簧圈在弹簧体成型弹簧圈后的结构示意图;Fig. 7 is a schematic structural view of the spring coil for blocking blood flow provided by the embodiment of the present invention after the spring body forms the coil;
图8为本发明实施例提供的血流阻断用弹簧圈的固定端头和第二抗解旋丝的结构示意图;Fig. 8 is a schematic structural view of the fixed end of the spring coil for blocking blood flow and the second anti-untwisting wire provided by the embodiment of the present invention;
图9为本发明实施例提供的血流阻断用弹簧圈释放系统的结构示意图;Fig. 9 is a schematic structural diagram of a coil release system for blocking blood flow provided by an embodiment of the present invention;
图10为本发明实施例提供的血流阻断用弹簧圈释放系统在弹簧圈解脱后的结构示意图;Fig. 10 is a schematic structural view of the coil releasing system for blocking blood flow provided by the embodiment of the present invention after the coil is disengaged;
图11为本发明实施例提供的血流阻断用弹簧圈释放系统的输送管的结构示意图。Fig. 11 is a schematic structural view of the delivery tube of the coil release system for blocking blood flow provided by an embodiment of the present invention.
附图标记说明:Explanation of reference signs:
100-弹簧圈本体;110-弹簧体;120-固定端头;121-第一固定孔;122-第二固定孔;123-第三固定孔;124-卡槽;100-spring coil body; 110-spring body; 120-fixed end; 121-first fixing hole; 122-second fixing hole; 123-third fixing hole; 124-card slot;
200-纤维线;210-第一部分;220-第二部分;200-fiber thread; 210-first part; 220-second part;
300-第一抗解旋丝;301-第一夹紧平面;300-the first anti-untwisting wire; 301-the first clamping plane;
400-第二抗解旋丝;401-第二夹紧平面;410-第一插接部;420-折断体;430-连接带;440-第二插接部;400-second anti-untwisting wire; 401-second clamping plane; 410-first socket; 420-broken body; 430-connecting belt; 440-second socket;
500-导管机构;510-第二限位部;500-catheter mechanism; 510-second limiting part;
600-输送机构;610-螺旋槽;600-conveying mechanism; 610-spiral groove;
700-释放机构;710-导向套;711-第一限位部;720-第一解脱件;721-形状记忆合金部;730-第二解脱件;731-插槽。700-release mechanism; 710-guide sleeve; 711-first limiting part; 720-first release part; 721-shape memory alloy part; 730-second release part; 731-slot.
具体实施方式Detailed ways
为使本发明的上述目的、特征和优点能够更为明显易懂,下面结合附图对本发明的具体实施例作详细的说明。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 above objects, features and advantages of the present invention more comprehensible, specific embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.
为了解决现有的纤维固定方法存在的固定效果不佳,容易引发严重的远端栓塞,或者是增加弹簧丝在打结点处的外径,增加输送的阻力的问题,本实施例首先提供了一种血流阻断用弹簧圈,旨在通过对弹簧圈的结构和纤维线的固定方式做出改进,来解决上述技术问题。In order to solve the problem of poor fixation effect existing in the existing fiber fixation method, which is likely to cause serious distal embolism, or increase the outer diameter of the spring wire at the knotting point and increase the resistance of delivery, this embodiment firstly provides A spring coil for blocking blood flow aims to solve the above technical problems by improving the structure of the coil and the fixing method of fiber threads.
结合附图6和附图7所示,本实施例的血流阻断用弹簧圈包括弹簧圈本体100和纤维线200,本实施例的弹簧圈远端的外径设计为近端外径的百分之六十至百分之八十,方便锚定操作,使锚定更牢固,更易在大血液流速的血管内固定、栓塞,具体的,弹簧圈本体100由弹簧丝螺旋加工成型后的弹簧体110经缠绕而成,即区别于传统的弹簧结构形式,本实施例是将弹簧丝螺旋缠绕呈弹簧体110,弹簧体110现有的弹簧结构形式相同,然后再将弹簧体110在通过弯曲等方式缠绕形成弹簧圈,弹簧圈的结构形式可以是图1中的规则的3D弹簧状,也可以是不规则的2D形式(图中未示出此种形式),弹簧体110的结构图可参照图2。需要说明的是,本实施例中所述的“远端”和“近端”中的远近指的是在进行栓塞手术时距离医护操作者的远近。As shown in Figure 6 and Figure 7, the coil for blocking blood flow in this embodiment includes a
本实施例的纤维线200部分位于弹簧圈本体100内,并至少一端伸出弹簧圈本体100的外表面,为了区别于现有的纤维线200固定方式,在沿弹簧体110缠绕成型弹簧圈的方向上,本实施例的弹簧体110内穿设有第一抗解旋丝300和第二抗解旋丝400,第一抗解旋丝300和第二抗解旋丝400的一端均与弹簧圈本体100远端的固定端头120连接,第一抗解旋丝300和第二抗解旋丝400的作用主要是防止弹簧圈意外解旋,并且在医护人员操作时可以对弹簧圈进行回收,避免对弹簧圈进行回收时,弹簧圈远端被卡或阻力变大导致螺距变大而解旋。The
区别于传统的纤维线200绑扎方式,本实施例的纤维线200通过以下步骤固定于第一抗解旋丝300和第二抗解旋丝400:Different from the traditional binding method of the
S1.在弹簧体缠绕成型为弹簧圈本体100前拉直弹簧体,形成附图1中的状态,并将至少部分弹簧体拉伸至形变状态,拉伸后的弹簧体的弹簧丝形成多个第一绑扎空间;该步骤S1中弹簧体的拉伸可以通过拉伸装置(图中未示出)实现,拉伸装置至少具有两个第一夹持机构,两个第一夹持机构能够对弹簧体的两端进行夹持固定,并且两个第一夹持机构能够相互靠近或远离,进而实现对弹簧体的拉伸固定和解除拉伸固定。S1. Straighten the spring body before the spring body is wound into the
S2.将长度大于弹簧体拉直后长度的第一抗解旋丝300和第二抗解旋丝400穿设于弹簧体形成的通道内,保证第一抗解旋丝300和第二抗解旋丝400处于上下平行且固定状态,此时,第一抗解旋丝300和第二抗解旋丝400之间形成第二绑扎空间;此步骤可以通过可动作的夹持装置(图中未示出)实现。S2. The first
S3.将双股闭环式的纤维线200穿过第二绑扎空间,并保持纤维线200的中部位于第一抗解旋丝300和第二抗解旋丝400之间,此时纤维线200具有位于第一抗解旋丝300和第二抗解旋丝400一侧的第一部分210,以及位于第一抗解旋丝300和第二抗解旋丝400另一侧的第二部分220。S3. Pass the double-strand closed-
S4.平移第一抗解旋丝300或第二抗解旋丝400,使得第一抗解旋丝300和第二抗解旋丝400并排贴合,并夹紧纤维线200,形成附图2中的状态。S4. Translate the first
S5.将第一抗解旋丝300的一端和第二抗解旋丝400的一端与弹簧体的固定端头120固定连接,具体的固定连接方式在下述中给出。S5. Fixedly connect one end of the first
S6.将第一部分210沿第一圆周方向搭设缠绕于第一抗解旋丝300和/或第二抗解旋丝400,将第二部分220沿第二圆周方向搭设缠绕于第二抗解旋丝400和/或第一抗解旋丝300,第一圆周方向与第二圆周方向的相同或相反。缠绕过程可以通过微型机械手臂实现。S6. Winding the
此步骤有多种缠绕方式,例如图3中所示,将第一部分210向上缠绕至半周左右的第一抗解旋丝300,将第二部分220向下缠绕至半周左右的第二抗解旋丝400,当然也可以如图4所示,向下缠绕第一部分210,使得第一部分210缠绕半周左右的第二抗解旋丝400,向上缠绕第二部分220,使得第二部分220缠绕至半周的第一抗解旋丝300。There are many winding ways in this step. For example, as shown in FIG. 3, the
当然为了提高纤维线200缠绕后的稳定性,还可以如图5所示,在第一部分210向上缠绕后再向下缠绕半周左右的第二抗解旋丝400,在第二部分220向下缠绕后再向上缠绕半周左右的第一抗解旋丝300,以此类推。Of course, in order to improve the stability of the
S7.解除对弹簧体的拉伸,相邻的两圈弹簧丝夹紧第一部分210和第二部分220,形成图6中的状态。S7. The tension on the spring body is released, and the two adjacent coils of spring wire clamp the
S8.裁切多余的第一抗解旋丝300和第二抗解旋丝400,将第一抗解旋丝300另一端和第二抗解旋丝400另一端固定连接。S8. Cutting the redundant first
对纤维丝采用上述的处理步骤,通过双股抗解旋丝起到防止弹簧圈解旋的同时,利用双股抗解旋丝进行纤维线200的初步固定,实现了第一抗解旋丝300和第二抗解旋丝400的一体多用,然后再将纤维线200进行缠绕后通过弹簧丝进行最终固定,无需对纤维线200进行打结处理,相比于传统的绑扎方式不仅操作方便、固定效果好,不会出现纤维线200脱落和增加弹簧体外径的问题,而且纤维线200的两侧均位于弹簧体外并进行打绺处理,也能够进一步提高栓塞效果。The above-mentioned processing steps are adopted for the fiber thread, and while the double-strand anti-untwist yarn is used to prevent the untwisting of the spring coil, the
除此之外,为了进一步提高栓塞效果,本实施例的将纤维线200通绑扎于第一抗解旋丝300和第二抗解旋丝400的步骤还包括:S9.对第一部分210和第二部分220进行打绺处理,将第一部分210和第二部分220均分割为多根纤维丝。打绺装置(图中未示出)可以包括多个并排间隙设置的微型刮刀和带动微型刮刀动作的驱动结构,单根纤维线200在打绺后可以形成多根纤维丝,纤维丝的数量根据微型刮刀的数量和动作次数来决定。In addition, in order to further improve the embolization effect, the step of binding the
可选的,可以将本实施例的纤维线200为双股闭环式结构,如此一来,将纤维线200设计为闭环式双股结构,能够进一步增加纤维线200在打绺后的纤维丝的数量,进一步提高栓塞效果。Optionally, the
可选的,本实施例将纤维丝的第一部分210的长度大于第二部分220的长度,在弹簧体经缠绕成型弹簧圈后,第一部分210位于弹簧圈外,第二部分220至少部分位于弹簧圈内。如此一来,使得第一部分210长度设计为大于第二部分220长度,避免两者在通过微型机械手臂等结构进行缠绕时互相干涉,并且将较长的第一部分210置于弹簧圈外起到良好的栓塞效果,将较短的第二部分220置于弹簧圈内,在辅助栓塞的同时能够降低纤维丝的浪费。Optionally, in this embodiment, the length of the
另外,可以在本实施例的第一抗解旋丝300面向第二抗解旋丝400的一侧设有第一夹紧平面301,第二抗解旋丝400面向第一抗解旋丝300的一侧设有第二夹紧平面401,纤维线200被夹持于第一夹紧平面301和第二夹紧平面401之间,通过第一夹紧平面301和第二夹紧平面401的配合能够提高对纤维线200的夹紧力,避免纤维线200脱离弹簧圈。In addition, a
可选的,可以在本实施例的第一夹紧平面301和第二夹紧平面401设有摩擦颗粒(图中未示出),利用摩擦颗粒提高了第一夹紧平面301和第二夹紧平面401与纤维线200的摩擦力,进一步提高纤维线200固定后的稳定性。Optionally, friction particles (not shown in the figure) may be provided on the
结合附图8所示,为了便于第一抗解旋丝300和第二抗解旋丝400在步骤S2中相对固定形成第一绑扎空间,并且能够便于第一抗解旋丝300和第二抗解旋丝400两者中一者移动形成贴合状态,本实施例还对固定端头120的结构做出改进,在固定端头120面向第一抗解旋丝300和第二抗解旋丝400的一侧设有第一固定孔121、第二固定孔122和第三固定孔123,第一固定孔121与第二固定孔122间隔设置,第三固定孔123位于第一固定孔121和第二固定孔122之间,并与第一固定孔121相邻,第三固定孔123与第二固定孔122之间设有卡槽124。As shown in Figure 8, in order to facilitate the first
本实施例的第一抗解旋丝300的一端插设于第一固定孔121内,并与第一固定孔121紧密配合;沿背离固定端头120的方向,第二抗解旋丝400依次包括第一插接部410、折断体420、连接带430和第二插接部440,第一插接部410的一端被配置为能够与第二固定孔122插接且紧密配合,第一插接部410的另一端与第二插接部440的一端通过折断体420相连接,折断体420被配置为在外力作用下能够与第一插接部410和第二插接部440解除连接,折断体420的长度与卡槽124长度相等并能够卡接于卡槽124,连接带430分别与第一插接部410、折断体420和第二插接部440相连接。One end of the first
其中,第二抗解旋丝400通过以下方式与固定端头120连接:在步骤S2中,将第二抗解旋丝400的一端插设于第二固定孔122;在步骤S4中,折断本实施例的折断体420,使得折断体420一端与第一插接部410解除连接,折断体420另一端与第二插接部440,并将折断体420置于卡槽124内;将第二插接部440插设于第三固定孔123。Wherein, the second
上述结构设计利用第一固定孔121和第二固定孔122便于第一抗解旋丝300和第二抗解旋丝400的初步固定,进而利于纤维线200的穿过,而通过折断体420和连接带430的设计,便于将第二抗解旋丝400平移至第三固定孔123进行固定,使得第一抗解旋丝300和第二抗解旋丝400并排贴合夹持纤维线200,结构巧妙,操作简单。The above-mentioned structural design utilizes the
可选的,本实施例的连接带430与第二抗解旋丝400材质相同,例如均为合金或高分子材料,并与第一插接部410、折断体420和第二插接部440热熔连接,以进一步提高第二抗解旋丝400的结构稳定性。Optionally, the material of the connecting
结合附图9和附图10所示,基于上述弹簧圈结构,本发明还提供了一种血流阻断用弹簧圈释放系统,其包括导管机构500、输送机构600、释放机构700以及上述的血流阻断用弹簧圈,其中,至少部分输送机构600、释放机构700和血流阻断用弹簧圈位于导管机构500内,输送机构600的远端与血流阻断用弹簧圈通过释放机构700相连接;并且,本实施例的释放机构700被配置为:操作输送机构600的近端释放机构700动作,血流阻断用弹簧圈脱离输送机构600。As shown in FIG. 9 and FIG. 10 , based on the above-mentioned coil structure, the present invention also provides a coil release system for blocking blood flow, which includes a
本实施例的血流阻断用弹簧圈释放系统对弹簧圈上纤维线200的绑扎结构做出改进,纤维线200通过双股抗解旋丝进行初步固定,然后通过弹簧体的弹性对纤维线200的两侧进行夹持固定,无需对纤维线200进行打结处理,相比于传统的绑扎方式不仅操作方便、固定效果好,不会出现纤维线200脱落和增加弹簧体外径的问题,而且纤维线200的两侧均位于弹簧体外并进行打绺处理,也能够进一步提高栓塞效果。The coil release system for blocking blood flow in this embodiment improves the binding structure of the
本实施例的释放机构700的结构形式有多种,例如可以采用现有的双“S”弯机械解脱结构(图中未示出此种结构),一体切割成型后分成植入物S弯和输送系统S弯,植入物S弯与弹簧圈连接,输送系统S弯与输送机构600连接,植入物S弯和输送系统S弯通过在输送机构600中间插入解脱丝连接;需解脱弹簧圈时,掰断输送机构600近端部分,然后从近端拉伸解脱丝,使植入物S弯与输送系统S弯分离,解脱区域长度只有不到2mm,降低输送过程中对导管头端的影响,避免释放后的踢管现象;具体的,将解脱丝的近端与解脱管连接,并将解脱管与输送系统进行点状焊接;需要解脱时,折断点状焊接点,往后拉解脱管,解脱丝相应的往后退,实现解脱;无需任何手柄、电源等附件,简单、快捷。另外S弯本身的材质选择和内外径选择,也降低了该区域内的硬度;短的解脱区域也可以进一步降低解脱失效的概率,提高稳定性。There are various structural forms of the
解脱丝和解脱管的连接,可以为以下几种方式:A.焊接;将解脱丝插入解脱管,并使用芯轴将解脱丝贴壁,在解脱管外表面进行激光焊接,使解脱丝和解脱管连接在一起;激光焊接可以为连续焊接或点状焊接,实现连接强度;B.压握:将解脱丝插入解脱管,使用压握工具或设备对解脱管进行压握,使解脱丝和解脱管连接在一起;压握可以为连续或点状,实现连接强度;C.粘接:将解脱丝插入解脱管,将胶水注入解脱管内实现连接。The connection between the release wire and the release tube can be in the following ways: A. welding; insert the release wire into the release tube, and use the mandrel to stick the release wire to the wall, and perform laser welding on the outer surface of the release tube to make the release wire and release tube The tubes are connected together; laser welding can be continuous welding or spot welding to achieve connection strength; B. Crimping: insert the release wire into the release tube, and use a crimping tool or equipment to press the release tube to make the release wire and release The tubes are connected together; the crimping grip can be continuous or dotted to achieve connection strength; C. Bonding: insert the release wire into the release tube, and inject glue into the release tube to realize the connection.
解脱管和输送系统的连接可以是点状焊接,例如180度间隔(2个点)、120度间隔(3个点)、90度间隔(4个点),实现连接强度和折断力的平衡;即能避免使用前出现意外折断、意外解脱,也能保证折断时需要的折断力不会过大,满足使用要求、降低操作难度和减少操作时间。The connection between the release pipe and the delivery system can be spot welding, such as 180-degree intervals (2 points), 120-degree intervals (3 points), 90-degree intervals (4 points), to achieve a balance between connection strength and breaking force; That is, it can avoid accidental breaking and accidental release before use, and can also ensure that the breaking force required for breaking will not be too large, meeting the use requirements, reducing the difficulty of operation and reducing the operation time.
发明人发现,现有的释放机构700一般是两个释放部通过解脱线连接,解脱线需要穿过输送机构600的输送管,并且在输送管上设有折断线,当需要进行弹簧圈的释放时,需要医护人员手动折断输送管的折断线,然后抽拉解脱线解除两个释放部的嵌合连接,此种方式不仅操作繁琐,而且需要对输送机构600的输送管做出较多结构改进,另外,在抽拉解脱线的过程中,容易出现解脱失败、解脱线卡死、断裂的问题,因此,本实施例还提供了一种新的弹簧圈释放机构700。The inventor found that in the existing
区别于现有释放结构,本实施例的释放机构700包括导向套710、第一解脱件720和第二解脱件730;导向套710安装于导管机构500内,且导向套710的外径尺寸小于导管机构500的内径尺寸,导向套710的远端的外壁设有第一限位部711,导管机构500的远端的内壁设有能够与第一限位部711限位配合的第二限位部510;第一解脱件720和第二解脱件730滑动安装于导向套710内,第一解脱件720一端与输送机构600相连接,第一解脱件720另一端设有形状记忆合金部721,第二解脱件730一端设有与形状记忆合金部721插接配合的插槽731,插槽731的侧壁开设有限位槽,限位槽内具有供形状记忆合金部721弯曲变形的空间,结合附图9所示,形状记忆合金部721被配置为在第一温度下至少部分伸入限位槽内,结合附图10所示,形状记忆合金部721在第二温度下脱离限位槽,第一温度小于第二温度,例如第一温度为0-20℃,第二温度为30-40℃。Different from the existing release structure, the
本实施例的释放机构700在释放弹簧圈时,无需医护人员进行折断、拉线等操作进行解脱处理,直接将弹簧圈置于血液内一定时间即可自动解旋,减轻了医护人员的作业,提高了解脱效率和准确度。When the
结合附图11所示,本实施例的输送机构600包括与释放机构700连接的输送管,输送管沿其长度方向开设有螺旋槽610,由输送管的近端至远端,相邻两个螺旋槽610之间的间距逐渐减小,利用螺旋槽610便于输送管的弯曲输送,并且采用渐变间距的设计,使得输送管由近端至远端逐渐柔软,增强输送性能、降低对导管尖端的影响。As shown in Figure 11, the
具体的,本实施例的输送机构600的输送管采用远端“螺旋、间断、逐级渐变”方式切割,切割宽度为0.01mm-2mm,螺旋的螺距为0.1mm-10mm,逐级变化,间断比例为180°(切割区域):45°(未切割区域),并进行渐变(注:间断比例指,按照定义的切割宽度和螺距,切割180°后,停止切割45°,再次切割180°,停止切割45°,以此循环;)。Specifically, the conveying tube of the conveying
上述结构设计有以下优点:A.渐变的切割,实现近端支撑和远端柔顺的完美结合;B.逐级增大的螺距,实现硬度的平稳变化,增强推送力的传递;C.远端柔软的设计,增强输送性能、降低对导管尖端的影响;D.间断切割,增强抗椭圆化性能,避免出现部分区域切割过度后过软,使用时椭圆化挤压解脱丝,增加解脱拉出的阻力,可能导致器械无法解脱等失效情况。The above-mentioned structural design has the following advantages: A. Gradual cutting, realizing the perfect combination of proximal support and distal flexibility; B. Gradually increasing screw pitch, realizing the smooth change of hardness and enhancing the transmission of pushing force; C. The distal end Soft design, enhance the delivery performance, reduce the impact on the catheter tip; D. Intermittent cutting, enhance the anti-ovalization performance, avoid excessive softness after excessive cutting in some areas, ovalize and squeeze the release wire during use, and increase the release and pull-out resistance, which may lead to failures such as inability to release the device.
另外,本实施例的血流阻断用弹簧圈释放系统上还设有标记环(图中未示出),当首个弹簧圈植入后,弹簧圈本身的显影性能会遮挡住导管尖端的显影;因此常规的弹簧圈导管均有2个标记环,间距为3cm;因此产品在据弹簧圈3cm处需有显影标记,当该标记和导管近端标记对齐时,开始解脱;所以标记环的装配精度要求非常高;因此,本实施例对标记环进行了新设计,将标记环安装在解脱丝上,使用焊接、旋锻、粘接等方法将标记环固定在要求的位置上;标记环可以是缠绕丝、管材或C形管;传统设计均是将标记放在输送系统外表面,一方面增加了外径,增加输送阻力;另一方面标记环两端会有台阶,容易卡顿在导管管座处、迂曲血管内等;新设计完全避免了该问题;而且传统设计,为降低外径,需减小标记环壁厚,增加连接时的难度;本实施例新的设计将标记环固定在解脱丝上,工艺简单、易操作,当需要解脱时,近端拉解脱丝,使植入物解脱;此时解脱丝上的标记环会往近端移动一定距离,与导管上的标记环偏离,起到指示作用,表明植入物已经完成解脱,方便医生操作。In addition, the spring coil release system for blocking blood flow in this embodiment is also provided with a marking ring (not shown in the figure). When the first coil is implanted, the imaging performance of the coil itself will block the catheter tip. Development; therefore, the conventional coil catheter has 2 marking rings with a distance of 3cm; therefore, the product needs to have a developing mark at 3cm from the coil, and when the mark is aligned with the proximal mark of the catheter, it will start to be released; so the marking ring The assembly accuracy is very high; therefore, this embodiment has a new design for the marking ring, and the marking ring is installed on the release wire, and the marking ring is fixed at the required position by welding, swaging, bonding and other methods; the marking ring It can be wound wire, pipe or C-shaped tube; the traditional design is to place the mark on the outer surface of the conveying system, on the one hand, it increases the outer diameter and increases the conveying resistance; on the other hand, there are steps at both ends of the marking ring, which is easy to get stuck The new design completely avoids this problem; and in the traditional design, in order to reduce the outer diameter, the wall thickness of the marking ring needs to be reduced, which increases the difficulty of connection; the new design of this embodiment will mark the ring Fixed on the release wire, the process is simple and easy to operate. When it needs to be released, pull the release wire proximally to release the implant; at this time, the marking ring on the release wire will move a certain distance to the proximal end to match the mark on the catheter. The deviation of the ring plays an indicator role, indicating that the implant has been released, which is convenient for doctors to operate.
虽然本发明披露如上,但本发明并非限定于此。任何本领域技术人员,在不脱离本发明的精神和范围内,均可作各种更动与修改,因此本发明的保护范围应当以权利要求所限定的范围为准。本说明书中各个实施例采用递进的方式描述,每个实施例重点说明的都是与其他实施例的不同之处,各个实施例之间相同相似部分互相参见即可。Although the present invention is disclosed above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention, so the protection scope of the present invention should be based on the scope defined in the claims. Each embodiment in this specification is described in a progressive manner, each embodiment focuses on the difference from other embodiments, and the same and similar parts of each embodiment can be referred to each other.
Claims (10)
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