CN103356257A - 具有加热元件和喷射器的栓塞线圈拆卸机构 - Google Patents
具有加热元件和喷射器的栓塞线圈拆卸机构 Download PDFInfo
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Abstract
本文提供了一种用于从递送管将治疗装置如栓塞线圈递送在患者体内目标部位的系统、方法和设备。将加热元件设置在可远程致动的所述递送管中,并且将一层低温粘合剂施加在所述加热元件处以保持所述治疗装置。将例如压缩弹簧形式的喷射器安装在所述递送管内以便与所述治疗装置接触,用于施加恒定喷射力,所述喷射力被所述低温粘合剂的所述粘合力抵消。当致动所述加热元件时,所述弹簧的喷射力克服所述软化粘合剂的粘合力,从而迫使所述治疗装置离开所述递送管。
Description
背景技术
本发明涉及用于将栓塞线圈放置在人体血管内的预选位置的医疗装置,更具体地讲涉及具有加热元件的柔性递送构件和在所述递送构件远端处的喷射构件,所述喷射构件用于将栓塞线圈递送到预选位置处。
细长柔性导管用于将多种装置放置到人体的血管内。此类装置包括扩张球囊、不透射线流体、液态药物和多种类型的闭塞装置例如球囊和栓塞线圈。包括栓塞线圈在内的闭塞装置可用于治疗动脉瘤或闭塞目标位置处的血管。
放置在血管中的线圈可采用螺旋绕组线圈的形式,或者可以为散绕线圈、盘绕线圈、卷绕在其他线圈内部的线圈或多种其他此类构型,以更好地闭塞血管。栓塞线圈通常由不透射线生物相容性金属材料,例如铂、金、钨或这些金属的合金形成。可用多种材料涂布线圈,以促进其致血栓性。通常,将几个线圈放置在给定位置,以便通过促进特定位置的血栓形成来闭塞血管中的血流。减少的血流降低了施加在动脉瘤上的压力,并降低了动脉瘤破裂的风险。
以前是将栓塞线圈放置在导管的远端内。当将导管的远端正确定位时,可用例如导丝将线圈推出导管的末端以在所需位置处释放线圈。放置栓塞线圈的该工序在荧光镜观察下进行,使得可以监测线圈穿过人体脉管系统的运动并可将线圈放置在所需位置处。使用这些放置系统时,几乎不能控制线圈的准确放置,因为线圈可能被弹出到超出导管末端一段距离的位置。此外,用导丝弹出栓塞线圈可能有问题,因为在沿患者脉管系统运动的过程中线圈和导丝发生偏移。
长有可能危及生命的出血性脑动脉瘤的患者需要用于经导管布置栓塞线圈的安全、可靠且准确的释放机构。已建立了多个工序来使线圈能够更准确地定位在血管内。当前使用的一种商品是Guglielmi可拆卸线圈(GDC)。GDC利用指定导丝接合部的电解溶解来产生释放动作。该工序通常需要10-30分钟并且很难以可靠的方式进行控制。血流中的溶解材料的影响会给患者带来潜在危害。与线圈释放相关联的问题包括使线圈离开递送导管的力导致线圈超越所需部位或驱逐以前部署的线圈。因此,尽管先前付出了许多努力来开发基于导管的治疗应用的微型致动器,仍然需要安全、准确的释放致动器机构以递送栓塞线圈。
依靠延伸穿过导管整个长度的刚性推杆导丝将元件推出导管远端的栓塞线圈递送系统的另一问题是推杆导丝会固有地导致导管具有很大刚性,结果很难引导导管穿过人体脉管系统。因此,需要一种用于从导管远端部署栓塞线圈的机构,所述导管具有柔性主体,其不会阻碍导管远端导航穿过患者脉管系统的曲折路径。
还需要准确的治疗致动器,其能够将治疗元件或装置(如栓塞线圈)部署在人脑血管的较窄界限内,如直径为250-500微米。本发明可满足这些以及其他需要。
发明内容
简而言之并概括地说,本发明提供了释放机构、治疗致动器或用于将治疗元件或装置递送到目标位置的系统。目标位置为人体脉管系统内的部位,例如脑中的血管,以便治疗动脉瘤。
释放机构的最基本形式包括治疗元件,例如栓塞线圈,其具有安装在延伸配件上的栓塞组件,所述延伸配件包括悬挂在栓塞线圈近端的销钉。延伸配件的销钉通过低温粘合剂保持在导管主体的远端,该低温粘合剂将延伸配件附连到圆柱形加热元件。延伸配件的销钉还与压缩弹簧接触,以便对延伸配件和安装于其上的栓塞线圈施加一个远侧定向力。弹簧力足以将延伸配件弹出导管主体,但不足以克服延伸配件与加热元件通过低温粘合剂的粘合。加热元件包括两根电导线,其延伸到导管主体的近端,使得当将导管主体部署在患者脉管系统中时可从患者体外致动加热元件。
当将导管主体的远端定位在要释放栓塞线圈的所需位置处时,通过电导线致动加热元件,使得栓塞线圈的延伸配件的销钉与加热元件之间的界面上积累热量。该热量积累使低温粘合剂软化,直到削弱加热元件与延伸配件之间的粘结。随着施加更多的热量,弹簧施加到延伸配件的销钉上的力克服了与加热元件的粘合,并且弹簧将延伸配件及其安装的线圈从导管主体的远端弹出到所需位置。
附图说明
图1是用于根据本发明实施例递送治疗装置的系统的侧视图,其中治疗装置安装在附连到导管主体的延伸构件上;并且
图2是用于根据本发明实施例递送治疗装置的系统的侧视图,其中延伸构件已从导管主体释放。
具体实施方式
参见以举例的方式而非以限制的方式提供的附图,本发明提供治疗元件递送系统100(其也可以称为治疗致动器或释放机构),其包括用于将治疗元件140递送到人体目标部位的柔性管102和可通过加热而脱离以从柔性管102拆卸治疗元件140的释放系统。治疗元件140可以为栓塞线圈或用于通过以下方式闭塞动脉瘤的另外的闭塞装置:填充动脉瘤囊,产生物理屏障以减少进入动脉瘤中的血流,以及使其内引起血栓或血小板凝聚。柔性管102(其可为导管主体)沿其整个长度可以为柔性的,或柔性区域可限于管的远端。
治疗元件140可以与延伸构件132一起形成或安装于延伸构件132上,所述延伸构件包括在远端处的支撑治疗元件140的安装部分134,和容纳在管102内的销钉136。延伸构件用于在柔性管的远端处固定治疗元件140,直到其准备好部署到患者体内,如下文更充分示出的。
本发明允许延伸构件132通过加热脱离柔性管102以将治疗元件部署到治疗元件140的更准确位置处。现有技术装置依靠推杆导丝和其他弹出机构,通过对治疗元件施加一个通常不可控制和不可预测的力来对其进行部署,热激活脱离系统可迅速而轻松地脱离,无需将治疗元件推出递送管。这是期望的,因为过早从管释放的不受控制的治疗元件可导致线圈放置不准确或线圈驱逐其他先前放置的线圈。
在柔性管102内,一对电导体从近端(未示出)延伸到远端。例如,可以有带正电的电导体104和带负电的电导体106。电导体通过电触头108、110附接到热响应加热元件112,例如加热线圈等。当通过导体104、106引导电流时,热响应元件112开始升温。导体104、106延伸穿过柔性管102,使得治疗装置140一定位在所需位置它们就可从患者体外致动。
延伸构件132可以与如下元件一起形成或其上安装有如下元件:其远端处的微球126和中间部分处的卡圈138,其中治疗装置140被夹持在微球126与卡圈138之间。微球126的远侧外表面可以基本上为半球形的、弯曲的或倒圆的,以便有利于无创引入治疗元件140。微球126通过相对于柔性管102的远端148或在微球126与卡圈138之间压缩治疗元件140,来保持压缩构型的治疗元件140。在治疗元件140被压缩在微球126与柔性管的远端148之间的情况下,当通过加热元件112的加热切断延伸配件132与柔性管102之间的连接时,治疗元件140可膨胀并占据患者脉管系统中的预期位置。在替代实施例中,还将治疗元件140的至少一部分定位到柔性管102的远端148内。
当设置在柔性管102的远端148内时,延伸配件132具有邻近压缩弹簧150的销钉136。弹簧150的近端154通过附接装置例如粘合剂固定到柔性管状构件102的内表面152,而弹簧150的远端156远离固定的近端向远侧自由延伸。如图1所示,当延伸配件132处于递送位置时,延伸配件132的销钉136靠在弹簧150的远端156上,使得弹簧150在销钉136的近端处对延伸配件132施加力,趋于将延伸配件132推出柔性管102。延伸配件132通过将延伸配件132的销钉136粘结到热响应加热元件112的低温粘合剂160保持在柔性管102中。弹簧150施加到销钉136上的力在标称情况下不足以克服低温粘合剂160的粘结强度。因此,治疗元件140可安全牢固地递送到放置部位,因为其在准备好释放到治疗部位之前都负载于延伸配件132上。
一旦柔性管到达治疗部位并释放治疗元件,便从柔性管102的近端致动导体104、106。当电流通过导体104、106时,热响应加热元件112开始升温,并在升温过程中软化低温粘合剂160。环氧树脂是此类低温粘合剂的例子,并且在优选实施例中粘合剂160具有不低于六十摄氏度的软化温度。当低温粘合剂160软化时,弹簧150的力克服粘合剂160的粘结力,并且弹簧150将延伸配件132和安装的治疗元件140弹出柔性管102的远端148。然后治疗元件140可膨胀并例如填充栓塞部位,从而治疗病症。然后可将柔性管102从患者体内取出,而使治疗元件140连同延伸配件132保持就位。延伸配件132将优选地由生物相容性的可吸收材料制成,该材料会被人体吸收而不会造成血流的任何中断。
根据若干实施例中的一个,本文所述的治疗元件递送系统能够在较小(250-500微米)直径应用中操作,例如在人脑静脉中操作,从而使基于导管的装置能抵达并治疗脑中的动脉瘤。
根据上述内容显而易见,虽然已经图示并描述了本发明的特定形式,但是可在不背离本发明的实质和范围的情况下进行多种修改。例如,可使用除螺旋弹簧之外其他类型的弹出装置来将延伸配件弹出柔性管。相似地,治疗装置可以为预期设置在患者脉管系统内的任何数量的装置。因此,本文无意对本发明加以限制,本发明由所附权利要求书限定。
Claims (29)
1.一种用于将治疗装置递送到患者脉管系统内的系统,包括:
治疗装置,所述治疗装置具有工作组件和悬挂于其上的纵向延伸件;
限定管腔的柔性管材,所述柔性管材具有近端和远端;
设置在所述柔性管材的所述远端处的所述加热元件,所述加热元件能够从其远程致动,并且其中所述加热元件通过粘合剂粘附于所述治疗装置的所述纵向延伸件;和
设置在所述柔性管材内和所述治疗装置近侧的喷射器,所述喷射器能够对所述治疗装置施加纵向力。
2.根据权利要求1所述的系统,其中所述治疗装置为能够治疗动脉瘤的栓塞线圈。
3.根据权利要求1所述的系统,其中所述喷射器为弹簧。
4.根据权利要求3所述的系统,其中所述弹簧的近端被固定到所述柔性管材的内壁。
5.根据权利要求1所述的系统,其中所述治疗装置的所述纵向延伸件为外径小于所述治疗装置的外径的圆柱形构件。
6.根据权利要求1所述的系统,其中所述加热元件为电阻加热线圈。
7.根据权利要求1所述的系统,其中所述粘合剂具有不低于六十摄氏度的软化温度。
8.根据权利要求7所述的系统,其中所述粘合剂为环氧树脂。
9.根据权利要求1所述的系统,其中所述喷射器邻接所述治疗装置的所述纵向延伸件的近端。
10.根据权利要求1所述的系统,其中所述喷射器被弹性地压缩在所述治疗装置和所述柔性管材内的近侧固定位置之间。
11.一种用于递送栓塞组件的导管,包括:
限定管腔的柔性管材,所述柔性管材具有近端和远端;
设置在所述柔性管材的所述远端处的圆柱形加热元件,所述圆柱形加热元件限定穿过其中的通道,所述圆柱形加热元件包括沿所述柔性管材在纵向上延伸的电导体;和
设置在所述柔性管材中且在所述圆柱形加热元件近侧的弹簧,所述弹簧具有近端和远端,所述近端固定在所述柔性管材内并且所述远端能够在所述柔性管材内纵向运动,所述远端延伸穿过由处于未压缩状态的所述圆柱形加热元件限定的所述通道。
12.根据权利要求11所述的导管,其中所述圆柱形加热元件包括内表面上的一层低温粘合剂。
13.根据权利要求12所述的导管,其中所述低温粘合剂具有不低于六十摄氏度的软化温度。
14.根据权利要求11所述的导管,还包括至少部分地设置在所述柔性管材的所述远端内的栓塞线圈装置。
15.根据权利要求13所述的导管,其中所述栓塞线圈包括工作部分和固定部分,所述固定部分包括圆柱形构件,所述圆柱形构件的尺寸被设定成保持在所述圆柱形加热元件的所述通道内。
16.根据权利要求15所述的导管,其中所述固定部分通过所述低温粘合剂保持在所述柔性管材内。
17.根据权利要求15所述的导管,其中所述栓塞线圈的所述工作部分位于所述柔性管材之外。
18.根据权利要求15所述的导管,其中所述圆柱形构件的直径大于所述弹簧的直径。
19.一种部署治疗装置的方法,包括:
将柔性管配置成容纳加热元件和治疗装置;
在所述柔性管内提供弹性构件,并定位所述弹性构件以使其被所述治疗装置压缩;
选择当通过所述加热元件供能时发生软化的低温粘合剂,将所述治疗装置粘附到所述加热元件;
将容纳所述治疗装置的所述柔性管递送到人体中的目标位置;
激活所述加热元件以软化所述低温粘合剂,从而使所述弹性构件施加的力克服所述低温粘合剂施加的粘合力以弹出所述治疗装置。
20.根据权利要求19所述的方法,其中所述弹性构件为弹簧。
21.根据权利要求19所述的方法,其中所述治疗装置为栓塞线圈。
22.根据权利要求19所述的方法,其中所述圆柱形加热元件包括内表面上的一层低温粘合剂。
23.根据权利要求22所述的方法,其中所述低温粘合剂具有不低于六十摄氏度的软化温度。
24.根据权利要求21所述的方法,其中所述栓塞线圈至少部分地设置在所述柔性管材的所述远端内。
25.根据权利要求21所述的方法,其中所述栓塞线圈包括工作部分和固定部分,所述固定部分包括圆柱形构件,所述圆柱形构件的尺寸被设定成保持在加热元件内。
26.根据权利要求25所述的方法,其中所述固定部分通过所述低温粘合剂保持在所述加热元件内。
27.根据权利要求25所述的方法,其中所述栓塞线圈的所述工作部分位于所述柔性管材之外。
28.一种具有工作部分和固定部分的栓塞线圈的递送系统,包括:
能够远程致动的圆柱形加热元件;
一层低温粘合剂,所述一层低温粘合剂施加在所述圆柱形加热元件的内表面和所述栓塞线圈的所述固定部分之间;和
与所述栓塞线圈的所述固定部分接触的压缩弹簧,选择所述弹簧以在致动所述圆柱形加热元件后克服所述低温粘合剂的粘合力。
29.根据权利要求28所述的递送系统,其中所述低温粘合剂具有不低于六十摄氏度的软化温度。
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US13/436289 | 2012-03-30 | ||
US13/436,289 US9155540B2 (en) | 2012-03-30 | 2012-03-30 | Embolic coil detachment mechanism with heating element and kicker |
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CN103356257B CN103356257B (zh) | 2017-03-01 |
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US (2) | US9155540B2 (zh) |
EP (3) | EP2644131B1 (zh) |
JP (1) | JP6271142B2 (zh) |
KR (1) | KR102104226B1 (zh) |
CN (1) | CN103356257B (zh) |
AU (1) | AU2013202096B2 (zh) |
BR (1) | BR102013007653A2 (zh) |
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US20130261657A1 (en) | 2013-10-03 |
ES2578607T3 (es) | 2016-07-28 |
EP3424443A1 (en) | 2019-01-09 |
AU2013202096A1 (en) | 2013-10-17 |
ES2689494T3 (es) | 2018-11-14 |
EP3061412A3 (en) | 2016-11-23 |
JP2013212374A (ja) | 2013-10-17 |
KR20130111426A (ko) | 2013-10-10 |
KR102104226B1 (ko) | 2020-04-24 |
US10426485B2 (en) | 2019-10-01 |
AU2013202096B2 (en) | 2017-11-02 |
EP2644131B1 (en) | 2016-03-30 |
US9155540B2 (en) | 2015-10-13 |
CA2810081A1 (en) | 2013-09-30 |
EP3061412B1 (en) | 2018-08-29 |
CN103356257B (zh) | 2017-03-01 |
EP3061412A2 (en) | 2016-08-31 |
EP2644131A1 (en) | 2013-10-02 |
US20150374382A1 (en) | 2015-12-31 |
JP6271142B2 (ja) | 2018-01-31 |
BR102013007653A2 (pt) | 2015-07-07 |
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