CN111528987A - 一种血栓取出导管 - Google Patents
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Abstract
本发明公开了一种血栓取出导管，属于血栓清除技术领域。它包括分离器、内管、外管、尾端连接件；所述分离器为纺锤形结构，分离器同轴线固定在内管近端，分离器内部设有与内管连通的导丝孔，分离器远端表面至少设有一个凹槽；所述外管远端与尾端连接件近端密封连接，尾端连接件中部一侧设有与外部连接的抽液口，内管设在外管内。在内管近端设置分离器，通过在纺锤形的分离器远端表面设置凹槽，利用内管来回移动分离器，分离器的凹槽能够将外管近端附近的血栓带入外管内，提高血栓的抽取效率，在推拉件滑动圆柱段与尾端连接件的抽吸作用下，外管近端产生的波动抽吸力也有利于血栓从血管壁分离。
Description
技术领域
本发明涉及一种血栓取出导管，属于血栓清除技术领域。
背景技术
深静脉血栓形成(deep venous thrombosis,DVT)是血液在深静脉内不正常凝结引起的疾病。DVT导致静脉压力增高，血液回流受阻，出现下肢肿胀、疼痛及功能障碍，若在急性期未得到有效治疗，血栓机化，静脉梗阻，瓣膜功能丧失，静脉反流及静脉高压，形成血栓后综合征(post thrombosis syndrome,PTS)，危及肢体生存。同时血栓存在脱落的风险，脱落后的血栓随着血流冲击到达肺动脉，引起肺血栓栓塞(pulmonary thromboembolism,PTE)，肺栓塞具有较高的致死率和致残率，威胁生命安全。PTE和DVT合称为静脉血栓栓塞症(vein thromboembolism,VTE)，两者具有相同易患因素，是VTE在不同部位、不同阶段的两种表现形式。
通过口服或注射阿司匹林、肝素或华法林等，可以使药物进入血液系统，有效溶解静脉血栓，大幅降低深静脉血栓形成和肺栓塞的发生率。与此同时，药物预防治疗也存在显著局限性，对于容易出血性体质，出血性糖尿病，出血性脑卒中，神经手术，严重的创伤，胸腔积血，颅内出血造成的盆骨和下肢骨折，抗凝血障碍等情况可能会造成严重机体出血，危及患者生命。
置管溶栓(catheter-directed thrombolysis，CDT)，可以将溶栓药物(如尿激酶等)定向输送到血栓部位，有效减少血栓负荷量，早期恢复静脉内正向血流，解除或缓解静脉梗阻，保护静脉瓣膜形态和功能，阻断PTS发生的病理过程，降低PTS的发生率。但CDT治疗DVT存在溶栓时间长(平均溶栓时间53.4小时)的问题，会导致长时间留置导管，增加病人的不适感，延长住院时间；反复抽血、需要密切监测和高级别护理；对于肿胀严重甚至危及肢体存活的病例，不利于尽快开通血流；溶栓药物的出血风险；CDT不适用于出血风险高的患者(如严重高血压等)，不适合于分娩和妊娠的患者。
传统外科手术取栓适用于临床症状相当严重的DVT又不能使用溶栓药物的患者。其劣势在于：静脉切开取栓为有创操作，不适于一般情况较差的患者；取栓可能破坏瓣膜功能；有残余血栓，进一步溶栓抗凝易出现伤口并发症。
随着技术的发展，近年来出现了机械血栓清除(percutaneous mechanicalthrombectomy，PMT)装置，它是一组用来清除血管内急性和亚急性血栓形成的器械，采用溶解、粉碎、抽吸方式清除血管内血栓，恢复血运循环和瓣膜功能。PMT是微创伤的腔内血栓清除装置，可以快速清除血栓，恢复血流、挽救瓣膜功能，临床效果得到了专家的认可，成为近年来研究的热点。
目前，临床上使用的PMT装置存在血栓取出效率低、大块血栓阻塞导管等缺点，针对这些缺点，本技术提出了一种血栓取出导管，波动式的抽吸力有利于血栓剥离，近端设置有分离器，可将血栓导入导管的同时将其裂解，导管近端带有侧孔，可在血栓转运过程中进一步裂解血栓，并在负压的作用下排至体外。
发明内容
本发明所要解决的技术问题在于：提供一种血栓取出导管，它解决了目前机械血栓清除装置存在大块血栓阻塞导管的问题。
本发明所要解决的技术问题采取以下技术方案来实现：
一种血栓取出导管，它包括分离器、内管、外管、尾端连接件；
所述分离器为纺锤形结构，分离器同轴线固定在内管近端，分离器内部设有与内管连通的导丝孔，分离器远端表面至少设有一个凹槽；
所述外管远端与尾端连接件近端密封连接，尾端连接件中部一侧设有与外部连接的抽液口，内管设在外管内。
作为优选实例，所述内管远端固定有推拉件，推拉件设有滑动圆柱段和手持段，滑动圆柱段密封安装在尾端连接件远端。
作为优选实例，所述外管近端侧面设有至少一个侧孔。
作为优选实例，所述分离器远端表面设有多个凹槽，多个凹槽沿圆周均匀分布。
作为优选实例，所述滑动圆柱段上紧密套设有密封圈，尾端连接件远端固定有将密封圈压紧的锁紧帽，锁紧帽中部设有中空孔，手持段由锁紧帽中空孔穿出。
本发明的有益效果是：
(1)在内管近端设置分离器，通过在纺锤形的分离器远端表面设置凹槽，利用内管来回移动分离器，分离器的凹槽能够将外管近端附近的血栓带入外管内，提高血栓的抽取效率，当抽液口流量固定时，在推拉件滑动圆柱段与尾端连接件的抽吸作用下，外管近端产生的波动抽吸力也有利于血栓从血管壁分离；
(2)此外，对于较大的血栓，分离器的凹槽将大血栓带入外管近端后，通过凹槽的边缘与外管之间的挤压，可将大块血栓裂解、粉碎，防止外管堵塞；
(3)外管近端设有侧孔，当分离器中部堵塞外管口时，在蠕动泵作用下，血管内的血液从侧孔向内喷射，冲击已进入内部的血栓，进一步将血栓粉碎，有利于血栓排出。
附图说明
图1为本发明应用实施例的结构示意图；
图2为本发明的结构示意图；
图3为推拉件推至最远端的结构示意图；
图4为推拉件拉至最近端的结构示意图；
图5为分离器的结构示意图；
图6为设有三个凹槽的分离器结构示意图；
图7为外管近端侧面设置侧孔的结构示意图；
图8为外管上多个构成螺旋形排列的侧孔分布结构示意图。
图中：分离器1，内管2，外管3，尾端连接件4，凹槽5，抽液口6，圆柱腔7，推拉件8，滑动圆柱段9，手持段10，密封圈11，锁紧帽12，蠕动泵13，储液袋14，侧孔15。
具体实施方式
为了对本发明的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体图示，进一步阐述本发明。
文中所说的近端、远端(尾端)是以人体躯干为参照物的。近端就是距离躯干近的一端，相反距离躯干远的一端就是远端(尾端)。
如图1-图8所示，一种血栓取出导管，它包括分离器1、内管2、外管3、尾端连接件4；
分离器1为纺锤形结构，分离器1同轴线固定在内管2近端，分离器1内部设有与内管2连通的导丝孔，分离器1远端表面至少设有一个凹槽5；
分离器1中部最大外径小于等于外管3内径时，可以完全进入外管3中；分离器1外径大于外管3内径时，分离器1可以部分进入外管3内；两种情况都能够不同程度达到将大块血栓裂解、粉碎的效果；
外管3远端与尾端连接件4近端密封连接，尾端连接件4中部一侧设有与外部连接的抽液口6，内管2设在外管3内。
实施例1
内管2远端固定有推拉件8，推拉件8设有滑动圆柱段9和手持段10，滑动圆柱段9密封安装在尾端连接件4远端。具体地，尾端连接件4内部设有圆柱腔7，圆柱腔7近端与外管3密封连通，圆柱腔7远端设有圆形开口，圆柱腔7内插入配合的推拉件8，推拉件8设有滑动圆柱段9和手持段10，推拉件8内部设有沿轴线贯穿的中空孔，内管2远端插入推拉件8的中空孔内，并密封固定，推拉件8的滑动圆柱段9从圆形开口插入圆柱腔7内，滑动圆柱段9上紧密套设有密封圈11，圆柱腔7远端固定有将密封圈11压紧的锁紧帽12。
尾端连接件4的抽液口6通过泵管连接有蠕动泵13，蠕动泵13出液端通过泵管连接有储液袋14。
内管2远端与推拉件8的中空孔之间通过胶水密封固定。
锁紧帽12中部设有中空孔，中空孔内径不小于推拉件8的滑动圆柱段9外径。
锁紧帽12与尾端连接件4端部通过螺接或胶水固定。
分离器1远端表面设有多个凹槽5，多个凹槽5沿圆周均匀分布。
外管3近端侧面设有至少一个侧孔15。
工作原理：
手术开始前，推送推拉杆8至分离器1完全裸露在外管3外，将外管3近端放置于生理盐水中，启动蠕动泵13，将生理盐水抽吸至储液袋14内，储液袋14内可见生理盐水时，停止抽吸，排空血栓取出外管3内的空气；回撤推拉杆8至分离器1中部外径最大处与外管3近端口对齐。
手术过程中，穿刺血管，导入导丝(图中未画出)至完全穿越病变(血栓)部位；血栓取出导管内管2在导丝导引下输送至分离器1靠近血栓1-2cm处，启动蠕动泵13，向血栓部位缓慢推进外管3，与此同时，前后往复移动推拉杆8；在蠕动泵13和往复运动的分离器1作用下，血栓被吸入外管3并排至体外的储液袋14内。
血栓抽吸完毕后，将所有器件一同撤出人体。
在内管2近端设置分离器1，通过在纺锤形的分离器1远端表面设置凹槽5，利用推拉件8和内管2来回移动分离器1，分离器1的凹槽5能够将外管3近端附近的血栓带入外管3内，提高蠕动泵13的抽取效率，当抽液口流量固定时，在推拉件8滑动圆柱段9与尾端连接件4的抽吸作用下，外管3近端产生的波动抽吸力也有利于血栓从血管壁分离；
此外，对于较大的血栓，分离器1的凹槽5将大血栓带入外管3近端后，通过凹槽5的边缘与外管3之间的挤压，可将大块血栓裂解、粉碎，防止外管3堵塞；
外管3近端设有侧孔15，当分离器1中部堵塞外管3口时，在蠕动泵13作用下，血管内的血液从侧孔15向内喷射，冲击已进入内部的血栓，进一步将血栓粉碎，有利于血栓排出。
以上显示和描述了本发明的基本原理、主要特征和优点。本领域的技术人员应该了解，本发明不受上述实施例的限制，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入本发明要求保护的范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (5)
1.一种血栓取出导管，其特征在于，它包括分离器、内管、外管、尾端连接件；
所述分离器为纺锤形结构，分离器同轴线固定在内管近端，分离器内部设有与内管连通的导丝孔，分离器远端表面至少设有一个凹槽；
所述外管远端与尾端连接件近端密封连接，尾端连接件中部一侧设有与外部连接的抽液口，内管设在外管内。
2.根据权利要求1所述一种血栓取出导管，其特征在于，所述内管远端固定有推拉件，推拉件设有滑动圆柱段和手持段，滑动圆柱段密封安装在尾端连接件远端。
3.根据权利要求1所述一种血栓取出导管，其特征在于，所述外管近端侧面设有至少一个侧孔。
4.根据权利要求1所述一种血栓取出导管，其特征在于，所述分离器远端表面设有多个凹槽，多个凹槽沿圆周均匀分布。
5.根据权利要求2所述一种血栓取出导管，其特征在于，所述滑动圆柱段上紧密套设有密封圈，尾端连接件远端固定有将密封圈压紧的锁紧帽，锁紧帽中部设有中空孔，手持段由锁紧帽中空孔穿出。
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