CN1251510A - 避孕系统及其使用方法 - Google Patents
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Abstract
一种用于避孕或绝育的器件及其使用方法,该器件特别适合可逆的避孕,在所需的时间周期内该器件闭塞生殖腔以阻止生殖细胞通过该生殖腔,直至患者希望能够再次生育并将其生殖腔重新打通为止。闭塞器件优选包括一个形态适合植入生殖腔的由形状记忆材料制成的管形骨架。这个闭塞器件将嵌在体腔内并被固定在生殖腔壁上;然后使生殖腔壁萎陷,从而闭塞生殖腔。另一方面,闭塞器件可以紧裹在一个栓塞上。借助引入气球导管和借助一系列的气球充压使瘪缩的闭塞器件再次膨胀或借助拆除栓塞可以使生殖腔的封闭变成可逆的。闭塞器件和栓塞的整体配合形态将便于内皮化、诱发炎性反应或提供药物。
Description
本发明的技术领域
本发明涉及避孕和绝育器件领域,特别是涉及可逆的避孕器件以及这种器件的使用方法。
本发明的现有技术
常规的避孕方法通常分为三种类型:物理屏障、药物和外科手术。虽然每种方法都有某些优点,但是它们也有各种缺点。诸如阴茎套和子宫帽之类的屏障由于破裂和位移而遭受失败。依靠人为控制激素水平的药物避孕法(诸如避孕药和NorplantTM)由于长期服用将产生某些已知的和未知的副作用。最后,诸如输卵管结扎和输精管切除术之类的外科手术法涉及外科手术的经费以及伴随的风险,而且这种方法往往是不可逆的。因此,需要一种安全有效的避孕方法,特别是非外科手术的可逆方法。
本发明的概述
本发明的目的是一种用于闭塞生殖道或生殖腔以阻止生殖细胞通过该生殖道或生殖腔的避孕或绝育系统。本发明包括一个闭塞器件,该器件在体腔内能够从适于引入体腔的第一种形态膨胀到较大的第二种形态,以便将膨胀的闭塞器件至少固定到定义生殖腔的部分壁面上。为了充分闭塞生殖腔阻止生殖细胞通过,本发明还包括便于将膨胀的闭塞器件固定到该体腔壁上的装置和使膨胀的闭塞器件和固定该闭塞器件的体腔壁部分收缩的装置。
本发明的优选实施例包括用来闭塞女性患者的输卵管及男性患者的输精管或其它生殖道的可逆避孕系统。该避孕系统的主要特征是它的闭塞器件,该器件首先以膨胀状态固定在生殖道壁上,然后在横向上瘪缩用以使其所附着的腔壁闭塞,用来阻塞生殖腔的通路,防止生殖细胞的通过。可以通过几种适当的方式使闭塞器件重新打通。例如,通过将那些有效阻隔生殖通道的栓塞或心轴等闭塞器件移除直到患者希望重新避孕。可通过传统的laparoscopic方法或其它器具将栓塞移除,从而重新打通生殖道。一旦栓塞被移除后,可使用气球膨胀导管进一步扩大生殖通路。其它打通生殖腔的方法包括使得闭塞器件的中央部位打开以便于膨胀器件例如导管的气球可以被插入或膨胀。可通过一系列的扩张和几个步骤的发展,将整个生殖通路打通。
优选地,闭塞器件包括一由形状记忆合金材料制成的管状部件,并且闭塞器件的最初形状横向上相对要小一些,以便于将此器件插入到所需的体腔内。一旦器件入位,闭塞器件就会横向膨胀至第二种形状,与体腔大小相当或稍大一些,以便于闭塞器件可以固定在体腔壁上。具有开口的、格状骨架结构的闭塞部件在体腔内膨胀,通过开口结构,内皮化使闭塞器件固定在体腔壁上。通过加热由形状记忆合金材料制成的闭塞器件至该形状记忆材料的转变温度或该转变温度以上,该器件转变成合拢的即瘪缩的记忆形态,这种形态使固定在闭塞器件上的生殖腔合拢,以至闭塞通过那里的通道。借助适当的装置(诸如类似于输送移植片固定物、主动脉移植片和各种类型假体所用装置的常规的气球导管)可以将该闭塞器件送到体腔内的预定位置。
在一个优选的实施方案中,闭塞器件具有一个开口的、格状的骨架,以便通过这些格状骨架开口生长的内皮组织将闭塞器件和体腔壁相互连接起来。闭塞器件的表面可以经过处理,以便促进内皮化。
一旦将闭塞器件被移植到体腔内并且借助充分的内皮化将它固定到体壁上(这可能需要一周或一周以上时间),就可以将闭塞器件升温到形状记忆材料的转变温度或该转变温度以上,借此将它激活,于是它回复其收缩的记忆形状。由于内皮化已经将闭塞器件固定在体腔壁上,闭塞器件收缩到它记忆中的瘪缩形状将使定义体腔的壁与闭塞器件一起瘪缩,从而有效地闭塞该通道。此外,在加热激活前可以将一个栓塞定位在闭塞器件的内部,以使闭塞器件紧裹在该栓塞上从而闭塞该体腔。
闭塞器件可以以横截面尺寸较小的第一种形态安装在膨胀气球导管的气球部分的外部,然后将它引入生殖腔并定位在生殖腔的待闭塞区域内。给气球充压,使闭塞器件膨胀,优选的是固定闭塞器件的外径略大于生殖腔的内径。将它加热到使它回复瘪缩状态的转变温度或加热到该温度以上之前,闭塞器件将保持张开的状态,其中所述转变温度指的是它从马氏体转变成奥氏体的转变温度。如果闭塞器件紧裹在栓塞的周围,当患者再次希望能够生育时可以将栓塞取出,以便重新打通该通道。
本发明提供了一种适合男性和女性两者的有效的绝育或避孕方法,重要的是这种方法是容易逆转的。而且,这种闭塞器件的植入与激活以及以后恢复生殖腔原状只需要易于使用的且侵入最小的器件,诸如导管、导丝钩(guidewires)、定向导管等。本发明的这些优点和其它优点结合实例附图通过下面的详细说明将变得更加明显。
附图简要说明
图1表明一个带闭塞器件的导管,它表明了安装在导管远端的可膨胀器件上的本发明的特征。
图2和图3展示闭塞器件的一个实施方案,它们分别表明该闭塞器件处于膨胀形态和收缩(即合拢)时的形态。
图4和图5展示闭塞器件的另一个实施方案,它们分别表明该闭塞器件处于膨胀形态和收缩(即合拢)时的形态。
图6和图7展示闭塞器件的又一个实施方案,它们分别表明该闭塞器件处于膨胀形态和收缩(即合拢)时的形态。
图8描述图1所示的输送导管上的闭塞器件在生殖道或生殖腔内。
图9表明闭塞器件在生殖道或生殖腔内膨胀的状态。
图10表明女性生殖器的解剖模型并且表明闭塞器件在患者的一条输卵管内。
图11表明男性生殖器的解剖模型并且描述在男性患者的一个输精管内的膨胀的闭塞器件。
图12表明借助内皮组织固定在生殖道壁上的闭塞器件。
图13是图12所示的内皮化膨胀的闭塞器件沿13-13线剖开的剖视图。
图14表明在借助温盐水激活之后处于瘪缩状态的闭塞器件。
图15是图14所示的闭塞器件沿15-15线剖开的剖视图。
图16与图14类似,表明闭塞器件紧裹在一个可拆除的长栓塞或轴柄周围。
图17表明闭塞器件在远离其近端的位置被激活,使近端局部保持张开状态,以便于重新打通该通道。
本发明的详细叙述
图1表明在实施本发明时需利用的导管10,该导管包括一个具有充压腔14的长轴12,其中所述充压腔是与安装在导管轴远端和适配器18上的可膨胀器件16流体连通的。为了便于导入所需的体腔内,闭塞器件20(一种形状记忆材料的自承重金属器件)与未充压的可膨胀器件16的直径接近地一致。闭塞器件20的形状使它具有横向尺寸比较小的瘪缩的记忆形态。闭塞器件20可以通过变形安装到可膨胀器件16上,并且可以借助可膨胀器件在体腔内的膨胀使其达到张开的膨胀形态。在加热到转变温度时,它将回复记忆形态。在这个实施方案中,闭塞器件20具有促进内皮化的开口格型结构,其中内皮化的作用是将该闭塞器件固定到定义体腔的体腔壁上。优选的是闭塞器件20可以变形到某个膨胀直径,该直径优选等于或略大于即将配置闭塞器件的体腔尺寸。为了配置在女性患者的输卵管内,膨胀后的横向尺寸应当是大约0.1mm至大约5mm。
闭塞器件可以有许多适当的形态,如图2至图7所示。图2说明闭塞器件22处于张开形态,而图3说明适合将它引入并前移到患者体腔内的尺寸较小的形态。闭塞器件22可以由一段形状记忆的皮下管构成。切入管壁的槽24允许闭塞器件膨胀成图2所示的张开形态。同样,在图4和图5中,闭塞器件26是由有形状记忆的丝或带制成的线圈28。图6和图7展示闭塞器件30,该闭塞器件包括由有形状记忆的丝或带32制成的编织管。最后,在图1和图8中闭塞器件20包括许多由有形状记忆的丝或带制成的合拢的波纹环,并且被安装在导管10的可膨胀器件16上。
给可膨胀器件16充压使在生殖道38中的闭塞器件20膨胀到图9所示的尺寸比较大的张开形态。
在每个实施方案中,闭塞器件的形状记忆材料都应当具有充分高于人体正常的体温变化的转变温度,以便防止意外的激活致使过早地使闭塞器件瘪缩。另一方面,转变温度应当足以使闭塞器件的热激活不会对周围组织引起不希望的热损伤。优选的形状记忆材料是有形状记忆的镍钛合金(诸如NITIOL),而且优选具有介于大约43℃至大约70℃之间的转变温度。
在上述的每个实施方案中都可以使用一些常规的精制技术。例如,闭塞器件的骨架表面可以设计成便于内皮生长的。这种改进通常包括提供具有促进内皮朝器件内和周围生长的开放格状骨架的闭塞器件,以促进该器件牢固地附着在体腔壁上。适当的表面技术包括EDM加工、激光打孔、光刻蚀、火花刻蚀(scintering)等。此外,增大闭塞器件的表面积也可以为内皮组织提供更大的粘连。适当的表面处理包括等离子体刻蚀、喷砂、机械加工和其他使表面粗糙的处理。在另一些实施方案中,形状记忆材料可以经过涂敷或播种,以促进内皮化。例如,闭塞器件可以用含有诱发或促进内皮组织生长的药物、酶或蛋白质的聚合物涂敷。在另外一种精制技术中,闭塞器件可以镀铜或将铜引入,以便在定义体腔的壁面组织中产生炎性反应,这种反应对阻塞生殖腔有进一步的贡献。其它诱发炎症的材料可能也是适合的。例如,闭塞器件可以是放射性的,发射α-、β-或γ-粒子。
实施本发明包括下述一般步骤。如图1所示,将一个横向尺寸较小的闭塞器件20安装在导管10的气球16的外部。导管10是在X线透视或内窥镜监视下向前推进的,直至闭塞器件20如图10所示定位在女性患者的一条输卵管34内。将充压流体通过适配器18引入,以便给可膨胀器件16充压。如图9至图10所示,给可膨胀器件16充压使闭塞器件20膨胀到张开形态并使它在体腔38内固定。将导管10取出,使膨胀的闭塞器件20留在体腔38中,如图12所示。以同样的方式将另一个可膨胀器件送到患者的另一条输卵管中并让它在那里膨胀。此外,闭塞器件可以采用同样的方法在男性输精管36中膨胀定位(如图11所示),以便男性避孕。
在一周或更长的时间内,内衬生殖腔的内皮细胞将增殖,围绕着闭塞器件20张开的骨架生长(如图12和图13所示),借此将定义体腔的壁面固定到膨胀的闭塞器件20上。膨胀的闭塞器件20在患者的生殖道38内充分地内皮化之后,将它热激活使它回复记忆中的瘪缩形态。可以借助若干种方式激活闭塞器件,其中包括借助温热的流体、射频能源、激光能源或其它适当的能源。适当的激活系统如图14所示,其中导管40的远端定位在闭塞器件20附近,引入温度略高于转变温度的盐水流体,以便冲刷闭塞器件20,使其温度升高到转变温度或更高,使闭塞器件20瘪缩到直径减小的合拢形态。在闭塞器件的格状结构内形成的内皮组织层有助于闭塞和密封生殖腔,以便阻止生殖细胞(卵细胞或精子细胞)通过。
本发明的替代实施方案如图16所示,其中栓塞42定位在处于膨胀条件下的闭塞器件20的内部,以便于在激活时闭塞器件20紧裹到栓塞42上,从而闭塞生殖腔38。栓塞优选由诸如含氟聚合物(如PTFE)之类的惰性材料制成。其它适当的材料包括高密度聚乙烯和硅橡胶。对栓塞所做的许多改进可能也是适当的。例如,可以将栓塞作为类似于NorplantTM的药物输送器件使用。栓塞还可能如上所述用于诱发炎性反应,以加强生殖腔的闭塞。在这类实施方案中,栓塞42优选具有大约0.25mm至大约4mm的外径。栓塞42还可以有孔、深槽或有助于保护至少一部分生殖道天然衬层的功能。
生殖腔的闭塞可以借助简单地取出栓塞42而得以逆转。如果希望通道大于拆除的栓塞42留下的通道,可以将气球导管在体腔内推进,直至气球进入拆除栓塞留下的体腔为止,然后给导管上的气球充压,使闭塞器件20膨胀,使它变形成张开的形态。为了便于打通该体腔,在将膨胀的闭塞器件激活到瘪缩形态时,为了易于将导管上的膨胀气球引入,保持闭塞器件的近端稍微张开一点即处于膨胀条件下是可行的。如图15所示,用于激活闭塞器件的导管40可以定位在闭塞器件的近端内,以使该近端不能完全回复到它的合拢形态。假如再次希望避孕,借助给闭塞器件20加热使该闭塞器件向瘪缩形态转变,可以将生殖道闭合。
在本发明使用栓塞40的实施方案中,使闭塞逆转的各种其它方法都是适合的。例如,可以简单地拆除栓塞40,使生殖腔38恢复畅通。此外,栓塞40可以是带一个可拆除的芯(未示出)的中空栓塞。为了便于拆除,这个芯可以由较软的材料(如硅树脂)制成或者车上螺纹。类似地,栓塞本身可以车螺纹,拆除栓塞将包括扭转动作,从而使作用在给闭塞器件定位的组织上的应力减至最小。
在另外一些实施方案中,为了将闭塞器件20固定到定义生殖道38的管壁上,可以使用机械装置、粘连装置或其它装置。例如,可以使用在美国专利第4,140,126、4,562,596、4,577,631、4,787,899、5,104,399、5,167,614、5,275,622、5,456,713和5,489,295号中介绍的那些将移植片固定模或修复器件固定到主动脉壁或动脉壁上的装置,而本发明是将生殖道与可膨胀的器件相互连接起来。在此通过引证将这些专利完整地并入。
在不脱离本发明的范围的情况下可以对本发明作出各种各样的修改和改进。例如,为了使可膨胀器件在生殖道内膨胀以便与其壁面咬合,可以使用诸如在美国专利第4,585,000号中介绍的机械式可膨胀器件,在此将该专利引作参考文献。此外,虽然本发明实施方案的独特的特征可能在一些附图中被展示出来,而在另一些附图中没有展示,但是本领域的熟悉技术人员知道可以将本发明的一个实施方案中的特征可以与一个或多个其它实施方案中的任何或全部特征合并。
Claims (43)
1.一种闭塞生殖腔以阻止生殖细胞通过的避孕或绝育系统,该系统包括:
a)一个闭塞器件,该器件至少在生殖腔内可以部分地从第一种形态膨胀到第二种更大的形态,以便于将闭塞器件的膨胀部分固定到至少部分地定义生殖腔的壁面部分上;
b)将闭塞器件的膨胀部分固定到体腔壁部分上的装置;以及
c)使闭塞器件的膨胀部分收缩的装置,该装置使固定在闭塞器件上的体腔壁部分同样地收缩以便充分地闭塞生殖腔阻止生殖细胞通过。
2.根据权利要求1的避孕系统包括至少使闭塞器件的一部分膨胀的膨胀装置。
3.根据权利要求2的避孕系统,其中膨胀装置是一根长导管,该长导管有一个从导管的近端内部向远端内部延伸的内腔和一个在其远端部分的可膨胀器件,该器件的内部与所述内腔处于流体连通状态,以便于将充压流体输送到可膨胀器件的内部。
4.根据权利要求1的避孕系统,该系统包括一个形态适合配置在闭塞器件的膨胀部分内芯轴,以便于为了充分地闭塞生殖腔阻止生殖细胞通过,闭塞器件将向该芯轴方向收缩。
5.根据权利要求1的避孕系统,其中闭塞器件具有管状开口壁结构,以便于内皮细胞向内生长,借此将闭塞器件的膨胀部分固定到生殖腔壁部分上。
6.根据权利要求5的避孕系统,其中所述管状结构具有格状的骨架。
7.根据权利要求6的闭塞器件,其中格状骨架包括一个具有切口图案的薄壁金属管,其形态允许闭塞器件膨胀成直径比较大的壁面张开的形态。
8.一种由形状记忆合金制成的避孕器件,该器件在体温下具有稳定的马氏体相,具有便于引入患者生殖系统体腔的小尺寸的第一种形态并且能够膨胀到便于至少将该避孕器件的一部分固定到至少部分地定义患者生殖系统的体腔的体腔壁部分上的较大的第二种形态,具有便于内皮细胞向内生长并借此将避孕器件的膨胀部分固定到体腔壁部分上的张开的格状骨架,以及在高于体温的温度下具有处于奥氏体相的收缩的记忆形状而且这种记忆形态具有比尺寸较大的第二种形态小的横向尺寸。
9.一种安装在患者生殖系统体腔内的避孕系统,该系统包括至少有一部分瘪缩的闭塞器件,该器件固定在至少部分地定义患者生殖系统的体腔壁部分上并且充分地闭塞该体腔以便阻止生殖细胞通过。
10.根据权利要求9安装好的避孕系统,其中闭塞器件具有管状结构。
11.根据权利要求10安装好的避孕系统,其中闭塞器件的管状结构具有格状的骨架。
12.根据权利要求9的避孕系统包括一个配置在瘪缩的闭塞器件内的芯轴。
13.一种由形状记忆合金制成的用于体腔的闭塞器件,该器件在体温下呈现马氏体金相结构而在高于体温的温度下呈现具有减小的直径的记忆形态的奥氏体金相结构,该器件还具有张开的膨胀形态,以便于将其自身固定到定义该体腔的体腔壁部分上。
14.根据权利要求13的闭塞器件,其中所述闭塞器件包括格状的骨架。
15.根据权利要求14的闭塞器件,其中格状骨架包括一个具有切口图案的薄壁金属管,其形态允许闭塞器件膨胀成直径比较大的壁面张开的形态。
16.根据权利要求14的闭塞器件,其中格状骨架包括大量的相互连接的闭合的金属丝环。
17.根据权利要求14的闭塞器件,其中格状骨架包括由金属丝制成的螺旋线圈。
18.根据权利要求14的闭塞器件,其中格状骨架包括由金属丝制成的编织带。
19.根据权利要求13的闭塞器件,其中形状记忆材料包括镍钛合金。
20.根据权利要求13的闭塞器件,其中闭塞器件的表面形态有利于内皮化。
21.根据权利要求13的闭塞器件,该器件进一步包括能够诱发炎性反应的材料。
22.根据权利要求21的闭塞器件,其中诱发炎性反应的材料包括铜和铜合金。
23.一种包括闭塞器件的闭塞组件,该闭塞组件具有一个有内腔在其中延伸的管状金属骨架和一个在该内腔中的栓塞,其中闭塞器件具有在栓塞周围合拢的形态,而该栓塞配置在闭塞器件的内腔中,因此可以借助拆除栓塞将该闭塞器件扩张到直径比较大的张开形态,然后再将它加热到转变温度使闭塞器件回复到直径最小的合拢形态。
24.根据权利要求23的闭塞组件,其中闭塞器件的形态有利于内皮化。
25.根据权利要求23的闭塞组件,其中栓塞是由能够诱发炎性反应的材料制成的。
26.根据权利要求23的闭塞组件,其中栓塞具有螺纹结构。
27.根据权利要求23的闭塞组件,其中栓塞包括一个空心管和一个可拆除的芯。
28.一种避孕方法,该方法包括下述步骤:
a)将闭塞器件插到所需的体腔内;
b)使闭塞器件在该体腔内膨胀;以及
c)将膨胀的闭塞器件固定到至少部分地定义体腔的体腔壁部分上;
d)使闭塞器件和固定其上的体腔壁部分瘪缩,以便闭塞该体腔。
29.根据权利要求28的方法,该方法进一步包括在使闭塞器件瘪缩之前将一个细长的栓塞定位在膨胀的闭塞器件内。
30.根据权利要求28的方法,其中闭塞器件包括由形状记忆材料制成的金属骨架,它在高于体温的温度下具有由马氏体相变成奥氏体相的相转变并且在奥氏体相具有呈瘪缩形态的记忆形状,因此管状的闭塞器件可以变形成张开的形态,然后在加热到转变温度或高于转变温度时回复到合拢形态。
31.根据权利要求28的方法,其中膨胀的闭塞器件配置在体腔内并持续充足的时间,以便使它在体腔内内皮化,借此将它固定到体腔壁部分上。
32.根据权利要求30的方法,其中给闭塞器件加热的步骤包括用温度为转变温度或高于转变温度的流体冲刷闭塞器件。
33.根据权利要求30的方法,其中闭塞器件是借助选自感应加热、射频加热、激光和超声的一种方法加热的。
34.根据权利要求28的方法,其中闭塞器件具有近端和远端,该方法进一步包括使闭塞器件瘪缩的步骤,该步骤致使近端具有比远端大的直径,以便于将导管插入闭塞器件的内腔。
35.一种完成可逆绝育法的全套用具,包括:
a)一根有可膨胀器件的导管;以及
b)一个包括管状金属骨架的闭塞器件,该器件具有直径最小的合拢形态并且是由转变温度高于体温的形状记忆材料制成的,所以该闭塞器件可以膨胀到直径比较大的张开形态,然后被加热到转变温度或高于转变温度,使该闭塞器件在所需的体腔内回复到小直径的合拢形态。
36.根据权利要求35的全套用具,进一步包括形态适合在激活闭塞器件之前定位在闭塞器件内的栓塞。
37.根据权利要求35的全套用具,其中栓塞是放射性的。
38.根据权利要求35的全套用具,其中提供的栓塞有一个或多个凹陷或沟槽,以便使生殖道周围的组织损伤最小。
39.根据权利要求35的全套用具,其中栓塞是由能够在生殖道内诱发炎性反应的材料制成的。
40.根据权利要求39的全套用具,其中栓塞至少是用一部分铜或铜合金制成的。
41.根据权利要求37的全套用具,其中栓塞已经将药物或治疗剂并入或涂敷其上,这些药物或治疗剂脱离栓塞注入生殖道。
42.根据权利要求41的全套用具,其中治疗剂是促进内皮细胞生长的生长激素。
43.根据权利要求36的全套用具,其中栓塞是由选自含氟聚合物、高密度聚乙烯和硅橡胶的聚合物材料制成的。
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CN103156719A (zh) * | 2011-12-16 | 2013-06-19 | 科维蒂恩有限合伙公司 | 闭塞植入体输送装置和相关方法 |
CN110770138A (zh) * | 2017-04-24 | 2020-02-07 | 乔舒亚·D·莱文 | 触变性宾厄姆塑性流体避孕方法 |
CN109528319A (zh) * | 2018-12-29 | 2019-03-29 | 天津美电医疗科技有限公司 | 一种自然腔道保护套管 |
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