CN101627938A - 带有可渗透和非渗透性组件的避孕用具 - Google Patents

带有可渗透和非渗透性组件的避孕用具 Download PDF

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CN101627938A
CN101627938A CN200910149073A CN200910149073A CN101627938A CN 101627938 A CN101627938 A CN 101627938A CN 200910149073 A CN200910149073 A CN 200910149073A CN 200910149073 A CN200910149073 A CN 200910149073A CN 101627938 A CN101627938 A CN 101627938A
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杰弗里·P·卡利斯特
威廉·S·特雷穆利斯
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Abstract

一种用于阻塞体腔例如生殖腔的装置，包括具有非渗透性阻挡层以提供体腔的最初阻塞的阻塞件以及用于促进提供长期的体腔阻塞的组织向内生长的可渗透体。该装置及使用该装置的方法尤其适用于避孕。

Description

带有可渗透和非渗透性组件的避孕用具
本申请是申请日为2005年1月31日、申请号为200580008232.0、名称为“带有可渗透和非渗透性组件的避孕用具”的专利申请的分案申请。
技术领域
本发明总体上涉及阻塞装置、用于该装置的递送系统以及将该装置和系统用于阻塞体内通道的方法的领域。本发明尤其用于阻塞生殖腔(诸如女性受治疗者的输卵管和男性受治疗者的输精管)以促成避孕。
背景技术
传统的避孕方法大致分为三种：物理阻挡、药物和手术。虽然每一种都具有一些优势，但是它们也具有不同的缺陷。诸如避孕套和子宫帽避孕套的阻挡由于破裂、移位和错放而容易失败。药物方法如药丸和NorplantTM，其依靠人工控制激素水平，长期使用会产生已知和未知的副作用。诸如输卵管结扎和输精管切除术的手术方式非常有效，但具有费用和手术附带危险的问题，而且常常是非逆的。
最近，有人提出微创治疗方法，其将阻塞性的支架状(stent-like)装置置入生殖腔内，例如输卵管或输精管，作为替代输卵管结扎或输精管切除的避孕用品。然而，放置支架或类似阻塞装置可能不会对生殖腔形成充分或永久的阻塞，这取决于阻塞装置的性质。例如，阻塞装置可能太小而不能提供完全的生殖腔阻塞，或装置对细胞移动是可渗透的。例如，置于生殖腔内的阻塞装置可能没有紧靠内腔壁进行密封，或者可能起初能让卵细胞或精细胞穿过装置，直到组织生长完成对生殖腔的阻塞，从而使得怀孕发生。此外，阻塞装置可能一开始就形成阻塞，足以阻止卵细胞的通过，但允许精细胞穿过或绕过该阻塞装置，使得卵细胞在堵塞物的上游受精而导致异位妊娠(宫外孕)。
已经有人提出使用阻塞性避孕或节育装置，特别是带有网或纤维材料以促进组织向内生长的装置(参见例如美国专利第6,096,052号和第6,432,116号)。然而，对于这些装置，在使用之后有一个初始阶段(几周到几个月)，在该阶段内，受治疗者要冒着细胞穿过该装置而造成怀孕的危险。在这种情况下，可能理想的是使用辅助的节育方法，直到组织向内生长有效地阻塞输卵管。当阻塞男性输精管时发现具有同样的初始风险。
甚至在一开始就实现完全阻塞的情况下，体腔可能重新开通。例如，置于输卵管中的堵塞物可能造成起初的堵塞，其阻挡了精子或卵子的通过。然而，一段时间以后，输卵管的壁可能会变形以致在堵塞物周围形成通道，从而有效地重新开通输卵管。
发明内容
本发明涉及用于阻塞体腔、尤其是诸如女性受治疗者的输卵管或男性受治疗者的输精管的生殖体腔的装置和方法，其能从开始并长期地有效阻塞体腔。
具有本发明特征的阻塞装置通常具有用于放置在受治疗者体腔内例如生殖腔内的可扩展(扩张)阻塞件。该阻塞件具有固定在其上的非渗透性(不可渗透的)部件，该组件对诸如细胞、尤其是诸如卵细胞和精细胞的生殖细胞的生物成分的通过基本上是不可渗透的，以提供立即的阻挡，即，在一开始使用的时候。该阻塞件还具有一个或多个可渗透件，该可渗透件固定在阻塞件上、置于阻塞件中或阻塞件的其它部位，以促进提供长期或永久阻塞的组织生长。组织生长可以在阻塞件内或上，以便至少部分地阻塞生殖腔。组织生长可以包括上皮形成、瘢痕形成、细胞增殖、或其他细胞生长或增殖。
体现本发明特征的一种阻塞装置具有支架状结构形式的阻塞件，该阻塞件具有确保立即阻塞体腔的非渗透性阻挡件和促进用于其长期或永久阻塞的在该阻塞件的支架状结构之内或之上的组织向内生长的可渗透件。
在一个具体实施方式中，非渗透性阻挡件为一个可膨胀和可拆开(可分开)的、由非渗透性材料制成的气囊。支架状结构安装在诸如导管(catheter)的递送装置的非渗透性、可膨胀和可分离的气囊上。将该递送装置的远端引入体腔并向里面推进，直到该可分离气囊位于使用者想要放置阻塞装置的位置。然后使气囊膨胀至期望尺寸，优选膨胀至体腔直径或略大于体腔直径的尺寸。该气囊的膨胀扩展安装在气囊上的支架状结构并贴靠在体腔壁上。膨胀之后，该递送导管的轴从递送导管的可分离气囊部分脱开，然后被抽回，将支架状结构靠着体腔结构的壁留在原位，同时，膨胀的、脱开的气囊置于支架状阻塞件的内腔内。在该阻塞件内设有一个或多个可渗透件，如纤维网、纤维束或多孔聚合体(polymeric mass)或塞，以促进组织向内生长，并且在一段时间后形成有效和永久的体腔阻塞。
上述具体实施方式的一种变化形式是在支架状阻塞件的内腔内或覆盖支架状阻塞件的一端或多端提供非渗透性隔膜或膜，它在该支架状结构扩展而贴靠在体腔结构的壁上时密封支架的内腔。该支架状阻塞件可以是可扩展或自扩展(self-expandable)的气囊。可以在上述支架状结构内设置纤维状或其他多孔物质或物体，例如生物相容性纤维线或束，或开孔生物相容性泡沫，以促进组织向内生长。
自扩展阻塞件可以由诸如NiTi的超弹性金属制成，该金属已经经过处理，使得在体温下具有稳定的奥氏体相和应力诱导的或应力保持的马氏体相。该阻塞件可以为一小直径的形状，用于在适宜的递送导管中递送，并且在从该递送导管中释放后在体腔内扩展成较大尺寸的第二形状。可替换地，该阻塞件可以由形状记忆金属材料如NiTi合金制成，该合金在体温下具有稳定的马氏体相，但是当升温至从马氏体相转变成奥氏体相时，其扩展成记忆性的更大直径的形状。
在阻塞件内部的例如塞的可扩展物质还可以提供阻塞件的扩展或扩大的或其他的扩展。该可扩展物质可以是非渗透性阻挡件或者促进组织向内生长的可渗透件。
体现本发明特征的另一个阻塞装置是包括具有多个节段的可扩展塞的阻塞件，其中至少一个节段是用于一开始就阻塞体腔的非渗透性阻挡件，至少一个节段是配置用来促进组织向内生长(提供长期或永久阻塞)的可渗透件。将该塞形成为可压缩的，以便用于在递送导管(输送鞘，delivery sheath)内递送，而且当从递送导管释放时可以在体腔内扩展。该非渗透性阻挡节段可以是非渗透性膜或闭孔物质或二者的结合。可渗透节段可以是纤维状或多孔物质或二者的结合。本实施方式中的阻塞件可以在阻塞装置的一端或两端具有支架状附着环(attachment ring)，以便将该阻塞件至少部分地固定在体腔内。该阻塞件或附着环可以设有固定件(anchoringelement)如钩子或倒刺，以便将该阻塞件固定在体腔内。扩展的阻塞装置提供立即有效的体腔阻塞，而在一段时间后，组织向内生长提供永久和有效的体腔阻塞。
该阻塞件可以具有在2003年12月24日提出的序列号为10/746,131的临时申请(本申请已转让给本受让人)中所描述的结构，其中披露了具有一个或多个扩展蛛状件(spider-like element)的阻塞件。该非渗透性阻挡件是固定在蛛状件的扩展支柱上的非渗透性膜，以提供最初的体腔阻塞。纤维状或多孔材料可以固定连接在蛛状件的扩展支柱上或连接阻塞件的蛛状件的中心支撑轴或脊柱上。
体现本发明特征的其他阻塞件可以包括在轴上的多个可扩展盘体，其中这些盘体中的至少一个是非渗透性阻挡件，并且至少一个是如上所述的可渗透件。
另一种阻塞装置具有这样的支架状阻塞件，其在阻塞件的前端带有增大的子弹形非渗透性阻挡件。在该阻塞件的内部可以设置一个或多个可渗透件。
该阻塞件在扩展后的横向尺寸通常为约1mm至约5mm，优选约2mm至4mm，并且长度通常为约0.5cm至约8cm，优选约1.5cm至约4cm。虽然本文的描述集中在只利用一个阻塞装置上，但是在生殖腔中可以使用两个或多个阻塞装置。
体现本发明特征的阻塞装置及使用这样的阻塞装置的方法既可以在一开始也可以长期地有效阻塞体腔，其足以阻止不希望的生物成分如细胞的通过。该方法和装置尤其适用于用作避孕目的的生殖腔的阻塞。尽管本文详细讨论了受治疗者生殖腔的阻塞，但是可以理解，本文所述的装置、方法和系统可以容易地改成用于阻塞受治疗者的各种情形下的动脉和静脉、动-静脉畸形的病灶、婴儿特有的大管动脉病、以及向癌性肿瘤供血的动脉。
根据本发明的详细描述和所附的示例性附图，本发明的这些和其他特征将更加明显。
附图说明
图1A是体现本发明特征的阻塞装置的前视图，其中，可分离、未扩展的气囊位于支架状阻塞件的内腔内。
图1B是图1A所示的具有膨胀气囊的本发明阻塞装置的前视图。
图1C是处于分离形状的膨胀气囊的前视图。
图2A是体现本发明特征的可选替换的阻塞装置的纵截面图，其中，将非渗透性囊设置在以未扩展形状示出的阻塞件内部。
图2B是图2A所示的阻塞装置的纵截面图，其中，该装置为扩展形状，并且具有围绕阻塞件的组织向内生长。
图3A是体现本发明特征的可选替换的阻塞装置沿纵向中心线的截面图，其中，可分离阻塞件带有可膨胀节段。
图3B是图3A所示的阻塞装置的横截面图。
图4是体现本发明特征的可选替换的阻塞装置的透视图，其具有构成该阻塞件部分的非渗透性和可渗透件。
图5是体现本发明特征的另一可选替换的阻塞装置的透视图，其中，阻塞件具有多个可渗透和非渗透性部件以及在每一端的支架状附着环。
图6A是体现本发明特征的又一可选替换的阻塞装置的前视图，其中，设置在阻塞件内部的多孔塞为未扩展形状。
图6B是图6A所示的阻塞装置为扩展形状的前视图。
图7A为又一可选替换的阻塞装置的前视图，该阻塞装置位于递送管内，并且非渗透性阻挡件和可渗透件为未扩展盘体的形式。
图7B是部分截面的前视图，其中阻塞装置延伸出递送管，并且非渗透性阻挡件和可渗透件为扩展形状。
图8是体现本发明特征的阻塞装置的前视图，其中，阻塞件为支架状结构的形式，非渗透性部件在支架状阻塞件的两端，而纤维体(fibrous mass)形式的可渗透件在支架状阻塞件的内腔中。
图9A是体现本发明特征的又一可选替换的阻塞装置的部分截面的前视图，其中阻塞装置容纳在递送管的腔内。
图9B是图9A所示的阻塞装置的部分截面的前视图，其被置于体腔内呈扩展形状。
图10是具有本发明特征的可选替换的阻塞装置的部分截面的前视图，其中在阻塞件的远端带有增大的非渗透性阻挡件。
图11是将图10所示的阻塞装置置于女性输卵管内的示意图。
图12具体示出适用于本发明中的支架状阻塞件。
具体实施方式
图1A-1C示出了体现本发明特征的阻塞装置10，其包括可扩展、支架状阻塞件11和包含在该支架状阻塞件的内腔13中的可膨胀、可分离(拆卸)的气囊状阻挡件12。可分离的气囊状阻挡件12可释放地固定在递送导管15的远端轴部14，可膨胀的气囊状阻挡件12位于单向阀16(例如，所示出的鸭嘴形阀)的远端，该单向阀允许膨胀流体注入该气囊状阻挡件的内部，但阻止膨胀流体从气囊内流出。在该气囊组件和递送导管15的远端轴部14之间提供螺纹连接17，以在期望位置分离气囊状阻挡件12。邻近螺纹连接17可以设置可选的第二单向阀18，作为递送导管15的膨胀内腔19中的止回阀，以防止在分离气囊状阻挡件12后体液进入膨胀腔。
气囊状阻挡件12由非渗透性的生物相容性聚合材料形成。适宜的聚合材料包括聚对苯二甲酸乙二醇酯(PET)、尼龙和诸如
Figure G2009101490736D00081
的聚酯。其他的中等柔性(moderately-compliant)直至基本上非柔性的生物相容性聚合材料也是适宜的。在一些情况下，生物相容和生物可吸收的材料如聚乳酸、聚乙醇酸、聚己酸内酯及其混合物和共聚物也是适合的。
在支架状阻塞件11内的每一端提供多个纤维状可渗透件20和21，以促进其内的组织向内生长。该可渗透件可以是示出的大量纤维材料，或者成块或成团的多孔聚合材料。
阻塞件10在体腔22(如女性受治疗者的输卵管)内向前移动到期望的位置，支架状阻塞件11安装在非膨胀状态的气囊状阻挡件12上。膨胀流体(在图1B中以箭头23指示)通过导管的膨胀腔19被引入到气囊状阻挡件12的内部，使在支架状阻塞件11内部的阻挡件膨胀，以扩展该阻塞件，直到它与体腔22的壁24接触。膨胀流体可以是盐水、生物相容性气体、或某些其他类似的流体或流体状物质。膨胀流体可以是在膨胀后固化的液体或泡沫，以使气囊在膨胀后是相对坚固的结构。
阻塞件11的气囊可以用足够的压力进行膨胀，以将支架状阻塞件11压靠在体腔22的壁上，并在气囊和体腔壁之间形成紧密的密封，但使用的力量不足以使体腔或气囊破裂或损伤。递送导管15的可分离远端轴部14通过旋转轴柄以将轴部分从气囊部分拧下而可以从气囊组件上分离。在从气囊拆下轴14之后，止回阀18阻止体腔内的流体回流入递送导管15的内腔19。靠近气囊的单向阀16防止膨胀流体的损失，并确保气囊保持膨胀状态。
非渗透性阻挡件12的气囊是由对预选的生物成分非渗透性的材料制成，以便密封体腔并防止这样的生物成分的通过。正如本文使用的，“非渗透性”是指一定程度和适于所需目的的不可渗透性。例如，当横向置于生殖腔时，如果它能阻断精细胞或卵子穿过生殖腔的通道，则在生殖腔(例如输卵管或输精管)中的用于避孕目的的隔离物是非渗透性的。该隔离物不必是气密性、液密性的(实际上，能让一些流体通过可能是理想的)，甚至可允许较小细胞的通过和向内生长。它只需要在足以密封生殖腔的用途上有足够非渗透性足以达到避孕就可以。
支架状阻塞件11通常具有开孔壁的结构，其可渗透到足以允许组织长入其内部。支架状阻塞件11具有至少一个延伸出气囊状阻挡件12远端的端部。延伸出阻挡件12的支架状阻塞件11的近端部25或者远端部26或者两端在它们的内部具有纤维状元件20和21，以促进和支持组织向内生长以便长期或永久阻塞体腔。在支架状阻塞件11上设置了钩子或倒刺27，以便当处于图1B所示的扩张状态时将阻塞装置固定在体腔22内。
图2A和2B示出了可选替换的阻塞装置30，其具有自扩展支架状阻塞件31、设置在阻塞件的内腔35内的非渗透性阻挡件32以及一个或多个纤维状可渗透件33和34。非渗透性阻挡件32是宽松地容置在支架状阻塞件31的内腔35内的非渗透性膜囊36。将阻塞装置30递送到受治疗者体腔37内的期望位置并如前所述进行释放。支架状阻塞件31如图2B所示进行自扩展，例如，如果它由热记忆金属形成，则当其达到体温时就扩展至较大直径外形，或者由于应力释放，从应力诱导或应力维持的马氏体转变成奥氏体的相变，其进行自扩展而导致胀大。阻塞件进行扩展，以使它与体腔37的腔壁接触，同时在体腔37内扩展膜囊36，其形成阻挡件32。膜囊36可以固定在阻塞件31的壁上，并且当阻塞件扩展时进行扩展。可选替换地，膜囊36可以例如通过在膜囊内部的压缩气体的存在而被偏压以扩展，以便当支架状结构从递送导管释放而扩展时，该阻挡件扩展成其较大直径的形状，以提供横跨在阻塞件31的内腔35中的非渗透性阻挡层。在阻塞件31的端部内设置一个或多个纤维体33和34，以促进和增强在其内的组织向内生长。在一段时间内，组织向内生长38和39在包括端部的阻塞件31的周围或穿过其周边进行，形成对于生物成分通过的永久屏障。如果膜囊由产生刺激或别的刺激组织向内生长反应的材料(例如PET)制成，则组织向内生长可以得到增强或加速。
图3A和3B示出了体现本发明特征的可选替换的阻塞件50，其具有包括可膨胀非渗透性部分52和53的阻塞组件51，以及一个设置在该非渗透性部分之间的中间可渗透件54。阻塞件的可膨胀非渗透性端部52和53可以由非渗透性材料，如聚对苯二甲酸乙二醇酯(PET)、硅酮橡胶和其他非渗透性的生物相容性聚合材料制成。可渗透中间部分54可以由可压缩的开孔泡沫制成。气囊部分52和53可以通过非渗透性分隔壁55和56与泡沫状中间部分54分开。膨胀管57穿过中间部分54并连接两个可膨胀部分52和53，以便当将诸如盐水、其他流体(对比流体，contrast fluid)或生物相容性气体的膨胀流体沿导管内腔58引入时，其将膨胀两个部分52和53。由相对非柔性的聚合材料如PET形成的可膨胀部分52和53，使得可膨胀部分52和53的尺寸和形状可以是预定的，例如与在这两个较大部分之间的中间泡沫部分54一起呈哑铃形。可生物吸收的材料可以用于该可膨胀部分，但是生物吸收的速率应足够慢，以便在通过组织向内生长有效密封体腔之前，形成非渗透性阻挡件的这些部分不被吸收。
阻塞件50以类似于图1A-1B中所示的方式可释放地连接至递送导管(未示出)的轴远端部分。与前面的实施例一样，设置了单向鸭嘴形膨胀阀55，以保持在组件51从递送导管分离时膨胀的阻塞件51的膨胀部分。该可渗透性中间泡沫部分54可以由适宜的生物相容性聚合材料形成，其将形成用于和增强组织向内生长的支撑基质。例如，中间泡沫部分54可以由开孔泡沫形成，组织向内生长可以在泡沫内或穿过泡沫进行。
在应用中，可压缩阻塞装置50将被压缩，以适合递送导管(未示出)的内腔。阻塞装置50可以限制在支架状管形结构(未示出)之内或者可以是自立式装置。当阻塞装置50被推至受治疗者体腔(如输卵管)内的期望位置时，释放的中间泡沫部分54通常会扩展，因为再没有其他限制，并且该部分被偏压扩展。膨胀流体通过管形件57的内腔注入阻塞件51的可膨胀部分52和53的内部。类似地，阻塞件51的可膨胀端部部分53和54通常将膨胀至基本上与体腔直径相同或略大于体腔直径的程度，以使阻塞件部分52和53的外表面紧贴地压靠在限定体腔的腔壁上。如果这些可膨胀端部部分连接至中间泡沫部分54的端部，则端部部分52和53的膨胀可以协助中间泡沫部分54的扩展。
一旦可膨胀端部部分在体腔(未示出)内膨胀，则通过逆时针旋转轴远端部分55而打开其与阻塞装置50之间的螺纹连接59，将递送导管56的轴远端部分55从阻塞装置50分离，然后抽回递送导管56。单向阀55阻止在端部部分52和53内的膨胀流体逸出，并有助于将该膨胀的端部部分保持为膨胀形状。由于非渗透性端部部分52和53紧贴地压靠在体腔壁上，所以体腔的有效阻塞得以发生，该阻塞立即有效，并且持续成为有效的屏障，直到在阻塞件51内或上的组织生长有效阻塞和密封体腔。到体腔组织能够重新生长并重新组织以在阻塞物周围形成通道(即重新开通)的时候，在泡沫部分的组织向内生长已经形成永久的阻塞，并且体腔已经有效和永久地被密封。
例如，如果将该装置置于输卵管内，则气囊部分将形成立即阻塞，以防止卵细胞沿输卵管向下或精细胞沿输卵管向上的通过，通过输卵管中的非渗透性气囊而提供有效的立即避孕。到输卵管能够在气囊结构周围形成新的通道(这一过程可能要花几周乃至几个月的时间)的时候，在非渗透性部分52和53之间的可渗透件54的开孔泡沫内的组织向内生长，将永久地密封输卵管，由此提供永久性避孕。
图4示出了体现本发明特征的另一个阻塞装置70，其中的阻塞件71为细长塞(塞状件)72形状。该阻塞件71具有多个节段72和73，其中的至少一个是可渗透的，而一个是非渗透性的。可渗透节段72由可渗透的开孔聚合物泡沫形成，其促进组织向内生长。非渗透性节段73由非渗透性的闭孔聚合物泡沫形成。优选地，在可渗透和非渗透性节段72和73之间设置有非渗透性膜74。
基本上整个阻塞件71是可压缩的，以有利于在递送导管(未示出，但可参见图7A和9A)内的递送，并且当其被释放以放置在体腔内的适当位置时被偏压扩展。扩展配置的结构优选具有足够的尺寸，以压靠在体腔的壁上，以将塞72固定在体腔中。
节段72和73可以被非渗透性膜74隔开，或者只以交替节段形成。至少一个节段通常是可渗透的，以支持细胞向内生长，并且至少一个节段通常是非渗透性的，以形成对细胞迁移通过体腔的立即有效的屏障，尽管只有该膜可能是非渗透性的但可以形成非渗透性屏障。
图5示出了具有本发明特征的阻塞装置80的另一个可选替换实施例，其包括阻塞件81、多个非渗透性阻挡件82、83和84，以及多个用于促进组织向内生长的可渗透件85和86。优选地，在相邻的可渗透件和非渗透性部件之间设置有非渗透性膜87、88、89和90。非渗透性膜91和92优选设置在阻塞件的远端。可以在阻塞件的端部设置短的支架状附着环93和94，以帮助将该组件固定在它所放置的体腔内，并且抵抗例如由输卵管纤毛的掠过(sweeping)而被逐出。附着环93和94可以具有钩子或倒刺(未示出)，以便更牢固地将装置80固定在体腔内。附着环93和94还可以支持组织向内生长以进一步在体腔内密封阻塞装置80。阻塞装置80可以以类似于上述用于图4所示实施例的方式配置使用。
图6A和6B示出了又一个可选替换实施例。在该实施例中，阻塞装置100包括支架状阻塞件101，在阻塞件101每一端的内腔104内设置有泡沫(状)塞102和103。泡沫塞102和103由适宜的泡沫聚合材料形成，该材料是充分多孔的，以促进组织内生长，但具有足够的长度，以便当放置在受治疗者体腔中时作为阻挡不希望的生物成分通过的非渗透性屏障。可选替换地，一个泡沫塞可以由可渗透开孔泡沫形成，而一个泡沫塞可以由非渗透性闭孔泡沫形成。单个的塞102和103也可以具有一个由可渗透开孔泡沫形成的节段和一个由非渗透性闭孔泡沫形成的节段(如图4所示)。图6A示出了未扩展状态的阻塞装置100，而图6B示出了处于扩展状态的该装置。泡沫塞102和103充分柔性，以便随支架状阻塞件101一起扩展或者随该阻塞件被偏压扩展。支架状阻塞件101可以具有倒刺104，以便将该阻塞件固定在体腔内。
在7A和7B示出了具有本发明特征的另一个可选替换的阻塞装置110，其中装置110具有阻塞件111、立即阻塞体腔的非渗透性阻挡件112和促进用于永久阻塞的如上所述组织向内生长的渗透件113和114。非渗透性阻挡件112为盘体形式并且固定在中心轴115上。它们可以由非渗透性闭孔聚合材料形成。可渗透件113和114固定在轴115上并且为由开孔聚合材料形成的盘体形式。阻塞装置110可以插入到体腔116内，插入时这些盘体在递送导管117的腔内呈压缩形状(图7A)。当这些盘体位于体腔内的期望位置时，轴115保持在原位，而抽回递送导管117。在释放后，盘体112-114扩展成与限定体腔116的壁紧密接触，如图7B所示。
虽然在图7A和7B中未示出，但支撑轴115的近端部分可具有螺纹的可释放连接，如图1A-1B中示出的螺纹连接，以可通过旋转支撑轴115的近端部分能够释放阻塞装置110。这种设置具有另外的优点：使得轴115能够在一开始通过被推入递送导管的内腔(例如通过漏斗)而承载阻塞装置，然后通过将该装置保持在原位同时抽去递送导管117而设置阻塞装置。
非渗透性盘体112对诸如卵子和精细胞的不希望生物成分的通过起到立即阻挡的作用，而可渗透盘体113和114则促进用于永久阻塞的组织向内生长。形成阻塞装置110的盘体应该具有足够的长度与直径的纵横比(aspect ratio)，以形成轻微的圆柱形，以增强定位并确保盘体不会旋转成不能有效密封体腔的平伏状态。
图8示出了具有本发明特征的又一个具体实施例。特别地，阻塞装置120具有类似于图1A-1C所示的支架状阻塞件121，以及在该阻塞件每一端以非渗透性膜形式的非渗透性阻挡件122和123。在阻塞件121的内腔127内设有纤维体(纤维块)形式的可渗透件124、125和126。这些可渗透件如前面实施例所述的那样促进组织向内生长。非渗透性阻挡件122和123可以在整个可扩展支架状结构121的端部延伸，以便当阻塞件121在体腔内扩展时提供对体腔立即有效的密封。可渗透件124-126优选固定在内腔127内，并设置成当被安置在期望位置而扩展时与阻塞件121的壁一起扩展。
图9A和9B示出了可选替换的阻塞装置130，其与2004年12月24日提出的序列号为10/746,131的临时申请所描述的阻塞装置相类似。装置130包括阻塞件131，其具有固定于中心轴134的蛛状可扩展件132和133。每个蛛状件132和133具有多个从轴134延伸出的支柱，并且这些支柱具有第一支柱部分135和第二支柱部分136。非渗透性膜137固定在蛛状件132的一侧，如同伞布固定在伞骨上一样，其固定在蛛状件132的支柱上。蛛状可扩展件133设有与图8所示的纤维体相似的纤维体138。在图9A中示出的阻塞装置130在递送导管140内为压缩状态，以有利于在受治疗者体腔141内的推进和放置。在体腔141内的放置位置，当抽回递送导管140以从鞘140释放阻塞装置130时，柱塞142保持在原位。当如图9B所示，被置于受治疗者体腔141内时，阻塞件131的蛛状件132和133扩展以啮合体腔141的内表面。在蛛状件132扩展之后，其扩展的支柱将非渗透性膜137横跨体腔141展开，以提供对体腔立即有效的密封。蛛状件133内的纤维体138起增强阻塞件131内的组织生长和体腔141的永久性阻塞的作用。作为蛛状件133内的可渗透纤维体138的替代，可以将多孔可渗透膜固定在蛛状件133的支柱上，以增强在阻塞件131内的组织生长。可以在蛛状件支柱的一侧上有非渗透性膜，而在该支柱的另一侧有可渗透膜。
图10和图11示出了具有本发明特征的另一具体实施例的有效阻塞装置150。阻塞装置150具有阻塞件151，其包括支架状结构152；以及球茎状、子弹形非渗透性部件153，其固定在支架状结构152的远端154，并通常略大于要阻塞的体腔。在支架状结构152的远端154和近端156内设有多孔聚合物团或束形式的可渗透件155b和155a。如图10所示，阻塞装置150部分处于递送导管157之内，其中扩大的非渗透性部件153伸出导管。柱塞158可滑动地设置在递送导管的内腔159内，最靠近阻塞装置150并被设置成用来在抽回递送导管157以将该阻塞装置放入体腔内时固定阻塞装置150。
图11示出了在阻塞装置从递送导管157释放后置于女性受治疗者的输卵管160中的图10所示的阻塞装置150。扩大的非渗透性阻挡件153的球茎状结构撑开体腔160的直径并立即封闭体腔，以阻止卵细胞或精细胞的通过。还可以在该阻塞件上设置诸如倒刺或钩子(未示出)的其他元件，以进一步将阻塞装置150固定在输卵管160内。阻塞件151的支架状结构可以自扩展，而可渗透件155a和155b可以固定在阻塞件151的端部内，并且可以与阻塞件一起扩展，以延伸横跨内腔通道，起到增强和支持组织向内生长的作用，进而提供内腔160的永久性阻塞。可渗透件以多孔聚合物团示出，但它们可以是纤维网或束状纤维。尽管以置于女性受治疗者输卵管中示出阻塞装置150，但应该清楚，阻塞装置可以用于阻塞诸如男性受治疗者的输精管的生殖腔。
图12示出了适用于本发明的支架状阻塞件171的一部分壁170。阻塞件171具有多个相互连接的环形件172。该环形件172通过一个或多个连接件173相互连接，连接件173在一个环形件的波形峰174和相邻环形件的谷175之间延伸。相邻的环形件被偏置或有相位差(out of phase)，以使一个环形件的峰与相邻环形件的谷对齐。
本文所述的支架状件(stent-like member)可以由包括不锈钢、镍钛合金(形状记忆性和超弹性)、MP35n、耐蚀游丝合金等在内的传统扩张性材料制成。非渗透性材料可以由部分柔性乃至基本上非柔性的生物相容性聚合材料如PET、尼龙、
Figure G2009101490736D00171
等制成。可渗透材料可以是纤维状材料例如聚酯、尼龙等或多孔聚合物泡沫材料，非渗透性闭孔泡沫和可渗透性开孔泡沫可以由扩展的聚四氟乙烯(ePTFE)制成。
在不脱离本发明范围的情况下，可以对本发明作各种变动和改进。例如，虽然主要以阻塞生殖体腔对本发明进行了描述，但是，所述阻塞装置可以用于阻塞各种体腔或通道。此外，虽然在一个或多个实施例中描述了本发明的一些单个特征，而在其他实施例中未进行描述，但是，本领域技术人员将明白，本发明的一个实施例中的单个特征可以与一个或多个其他实施例的任何或所有特征进行组合。
诸如“元件”、“件”、“装置”、“节段”、“部分”、“组件”、“设备”、“步骤”的术语及类似的表达，当用于权利要求时，不应理解为引用35U.S.C.§112(6)的规定，除非权利要求在表达中使用术语“设备”，然后是没有具体结构的特定功能，或者使用术语“步骤”，然后是没有具体行为的特定功能。所提及的所有专利及专利申请的所有披露内容都结合于此作为参考。

Claims (15)

1.一种用于受治疗者体腔的阻塞装置，包括具有第一端和第二端且配置用于放置在受治疗者体腔内的可扩展阻塞件，所述阻塞件具有至少一个由不同组织材料形成的非渗透性阻挡件，所述阻挡件对生物成分的通过基本上是不可渗透的并且能够提供最初堵塞；以及至少一个可渗透件，其促进在所述阻塞件内或上的组织生长。
2.根据权利要求1所述的阻塞装置，其中，所述可扩展阻塞件是具有在所述第一端和所述第二端之间延伸的内腔的细长管状件。
3.根据权利要求1所述的阻塞装置，其中，所述生物成分是生殖细胞。
4.根据权利要求1所述的阻塞装置，其中，所述可渗透件引起所述阻塞件牢固地附着至所述体腔。
5.根据权利要求1所述的阻塞装置，其中，在所述阻塞件中的组织向内生长有助于所述腔体随着时间的堵塞。
6.根据权利要求1所述的阻塞装置，其中，所述阻挡件设置在所述阻塞件内。
7.根据权利要求1所述的阻塞装置，其中，所述阻挡件包括两个阻挡件。
8.根据权利要求7所述的阻塞装置，其中，所述第一阻挡件设置在邻近所述可渗透件的所述阻塞件内，并且所述第二阻挡件固定至所述阻塞件的第一端。
9.根据权利要求1所述的阻塞装置，其中，所述不同组织材料在所述阻塞件的第一端上形成非渗透性膜。
10.根据权利要求2所述的阻塞装置，其中，所述可渗透件包括设置在所述管状件内腔内的纤维体。
11.根据权利要求10所述的阻塞装置，其中，所述纤维体设置在所述管状件的一端。
12.根据权利要求2所述的阻塞装置，其中，所述可渗透件包括在所述管状件内腔内的两个纤维体，在所述腔体内的所述管状件的所述第一端的第一纤维体和在所述腔体内的所述管状件的所述第二端的第二纤维体。
13.根据权利要求12所述的阻塞装置，其中，所述可渗透件具有一个第三纤维体，所述第三纤维体设置在所述第一纤维体和所述第二纤维体之间的中间位置处的支架状件的内腔内。
14.根据权利要求13所述的阻塞装置，其中，所述第一纤维体、所述第二纤维体以及设置在所述支架状件内腔内的所述第三纤维体引起所述腔体随着时间的堵塞。
15.根据权利要求1所述的阻塞装置，进一步包括由不同组织材料形成的第二非渗透性件，设置在所述阻塞件的所述第二端上。
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EP1715826A1 (en) 2006-11-02
CA2555011C (en) 2013-03-26
WO2005074845A1 (en) 2005-08-18
AU2005209871B2 (en) 2010-06-17
CN101627938B (zh) 2011-12-21
CA2555011A1 (en) 2005-08-18
CN1929798A (zh) 2007-03-14
CN1937976B (zh) 2011-12-07
CN1937976A (zh) 2007-03-28
US20050209633A1 (en) 2005-09-22
US20060009798A1 (en) 2006-01-12
AU2005209871A1 (en) 2005-08-18
EP1715826B1 (en) 2013-03-06
CN100518693C (zh) 2009-07-29

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