CN1874739B - 具有增强医疗多股绞合结构的脉管闭塞线圈 - Google Patents

具有增强医疗多股绞合结构的脉管闭塞线圈 Download PDF

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CN1874739B
CN1874739B CN2004800317798A CN200480031779A CN1874739B CN 1874739 B CN1874739 B CN 1874739B CN 2004800317798 A CN2004800317798 A CN 2004800317798A CN 200480031779 A CN200480031779 A CN 200480031779A CN 1874739 B CN1874739 B CN 1874739B
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P·C·威尔逊
E·W·列奥波德
R·K·德赛
D·M-H·唐
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Micrus Endovascular LLC
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Abstract

一种加强抗拉伸元件的脉管闭塞线圈，其增加了在收回线圈过程中的安全性。所述抗拉伸元件固定附着于所述脉管闭塞线圈的一端，所述抗拉伸元件的另一端可分离地安装到一个拉长推动元件，以顾及在患者脉管系统内的放置和释放。所述抗拉伸元件可由医疗和/或生物活性非金属材料制成，其增强了所述脉管闭塞线圈的治疗性能。

Description

具有增强医疗多股绞合结构的脉管闭塞线圈
相关申请 
这是在2002年7月23日提出美国专利申请第10/202,459号的部分延续。 
技术领域
本发明一般涉及可植入器械，其用于介入式(interventional)治疗法或脉管外科手术，更具体地说，涉及一种抗拉伸医疗器械，如栓塞或脉管闭塞线圈，以及用于在患者脉管系统内释放和放置抗拉伸医疗器械的装置。 
背景技术
通过使用穿过脉管系统或身体开口的、越来越小的切口或入口(access)来治疗体内缺损和疾病，从而减少对治疗部位周围组织的损伤，介入式治疗和外科手术的技术和科学已取得了持续的进步。这种治疗的一个重要方面包括使用导管，以通过穿入部位脉管系统的入口，在治疗部位放置医疗器械。这类操作的例子包括血管成形术(transluminal angioplasty)、放置加强血管壁及类似组织的支架、及使用脉管闭塞器械来治疗脉管系统中的缺损。 
已能有利地利用最近技术进展的介入式治疗的一个特定领域即是对神经血管缺损的治疗。由于已经开发出更小且具有更强功能的结构和材料，以前通过传统外科手术所不能治疗的或具有不可接受的危险性的对人脑中脉管缺损的治疗，已经变得可修改从而进行治疗了。对于治疗神经血管系统中的缺损而言，一种非外科式手术疗法已变成有利的，该疗法利用脉管闭塞器械的导管，如栓塞线圈，放置在静脉或动脉的受损部位中。 
脉管闭塞器械是这样的医疗器械：其一般通过导管被放置在人体的脉管系统内，以形成栓塞，从而堵塞穿过脉管(其构成脉管系统的一部分)的血流，或来自脉管的动脉瘤堵塞处内的血流。所述 脉管闭塞器械可具有多种结构，其一般由一个或多个元件组成，所述元件在放置结构下要大于它们在放置之前处于输送导管之内的尺寸。一种被广泛使用的脉管闭塞器械是具有放置结构的螺旋形线圈，其尺寸可接触到脉管壁。由美国专利第5,645,558号可知(在此合并该专利以供参考)，一种具有解剖学形状的脉管闭塞器械，其自身构成诸如动脉瘤的解剖腔(anatomical cavity)的形状，并且是由预成形的柔性材料绞线制成的，该柔性材料可以是镍钛合金。上述脉管闭塞器械包括一个或更多个脉管闭塞元件，其在放松状态下将形成大致球形或卵形的形状。脉管闭塞元件可以是螺旋式绕制的线圈，或者是以生物兼容材料构成的复合编织物(co-woven braid)，所述器械的尺寸和形状适合于放置在脉管腔或囊中，例如用于对动脉瘤或瘘管(fistula)的治疗。所述脉管闭塞元件可以是以大致线性的方式，首先被螺旋形绕制或编织，且随后再围绕一个合适形状的心轴或形状来绕制的，并经过热处理，为的是在从加热形态移出之后保持形状。通过以掺有粉末状不透射线材料的合成或天然纤维进行编织，即可使所述脉管闭塞元件具有不透射线性，上述材料例如为粉末状的钽、粉末状的钨、粉末状的氧化铋或粉末状的硫酸钡。 
上述脉管闭塞器械的输送可通过多种方式来完成，包括由推动器通过导管来推动该器械，从而放置该器械。所述脉管闭塞器械可具有线制的线圈的主要形状，该主要形状随后形成为更复杂的次要形状，可使得所产生的所述脉管闭塞器械以这样的方式工作：其以线性形状通过导管的内腔，并在被放置到诸如动脉瘤的感兴趣区域内之后，呈现复杂形状，如同最初被形成时那样。多种从推动器中释放器械的分离机构已被开发出来，并在本领域内是公知的。 
由铂、金或其它延性材料制成的脉管闭塞线圈，在压力下将会易于从其线圈形状变形，从而当线圈部分处在动脉瘤中而部分被拉长处在输送导管中时，引起潜在的危险情况。如果确定线圈是被不正确放置或是过大了，该线圈就需要被移动或更换。然而，在这一操作阶段，线圈不能再被推动，而必须缓慢地作为线被抽出导管。如果在这一操作中线圈断裂，就必须执行一个额外的的操作以将线圈移除出动脉瘤。希望的是，为了在收回软的或其它容易拉伸线圈的过程中 提供安全系数，加强这类脉管闭塞线圈以便为线圈提供抗拉伸性能，从而特别是在收回线圈以重新放置或更换的过程中，减少线圈断裂的风险。同样希望的是，在动脉瘤内放置线圈的操作中当线圈被释放之后，使得由加强线圈而引起的硬度增加达到最小，因此使线圈可以自由地转变为所需的次要形状，并与所医治位置的尺寸相一致。还希望的是，使脉管闭塞线圈具备额外的治疗性能，以增强治疗的有效性。本发明符合这些以及其它的需求。 
发明内容
简单地且以一般术语来说，本发明提供了一种在患者脉管系统内释放和放置的抗拉伸医疗器械，以及一种在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。其中，所述医疗器械是一种脉管闭塞线圈，该脉管闭塞线圈以内部抗拉伸元件加强，从而为线圈提供了抗拉伸性能。与内部抗拉伸元件结合，还使线圈即使在被部分放置的情况下，仍能被推动，由此提高了收回线圈过程中的安全性。所述脉管闭塞线圈可被涂上一种或多种治疗剂(therapeutic agent)，所述治疗剂可包含水凝胶。所述脉管闭塞线圈是由内部抗拉伸元件加强的，该抗拉伸元件在脉管闭塞线圈的远端处或远端附近，被固定附着于脉管闭塞线圈的一端；并且该抗拉伸元件在脉管闭塞线圈的另一端，被可分离地安装到拉长推动元件，从而能够在患者的脉管系统内放置和释放该脉管闭塞线圈。所述内部抗拉伸元件还可由医疗和/或生物活性非金属材料制成，从而为脉管闭塞线圈提供额外的治疗性能。 
内部抗拉伸元件附着在脉管闭塞线圈的远端附近或附着在该远端处，而内部抗拉伸元件不与脉管闭塞线圈的另一端连接，这使得线圈被释放和放置后因加强线圈而引起的硬度增加达到最小。一个附加的优点在于所述线圈在近端是自由浮动于内部抗拉伸元件上的。内部抗拉伸元件可被用于增强不透射线性、可在次要形状配置中起到帮助作用、可被配置以助改善线圈的所需强度，而且可允许使用更软的线圈而不必拉伸线圈。 
本发明相应地提供了一种抗拉伸医疗器械，用于在患者的脉管系统内释放和放置。所述医疗器械包括脉管闭塞线圈和抗拉伸元 件，该脉管闭塞线圈在其近端和远端之间限定一个内腔，该抗拉伸元件延伸穿过脉管闭塞线圈的内腔。抗拉伸元件在第一端被固定附着于脉管闭塞线圈的远端附近，并且在第二端被可分离地安装到拉长推动元件，从而允许在患者的脉管系统内放置脉管闭塞线圈。所述抗拉伸元件可以由带、线、编织物、主要绕组、多股绞合材料、多丝材料或绞合多丝材料制成，并且可由医疗和/或生物活性非金属纤维材料构成，例如：丝；胶原；弹性蛋白或其它连接蛋白质；聚羟基乙酸(polyglycolicacid)或聚乙醇酸(polyglycolide，PGA)；聚乳酸(polylactic acid)或聚(D，L-丙交酯)(PLA)；聚(D，L-乳酸-共聚-羟基乙酸)(PGLA)或聚(D，L-丙交酯-共聚-乙交酯)(PLA/PGA)；聚(L-丙交酯)(PLLA)；聚(L-丙交酯-共聚-D，L-丙交酯)(PLLA/PLA)；聚(L-丙交酯-共聚-乙交酯)(PLLA/PGA)；聚(乙交酯-共聚-三亚甲基碳酸酯)(PGA/PTMC)；聚氧化乙烯(PEO)；聚对二氧环己酮(polydioxanone，PDS)；聚己酸内酯(polycaprolactone，PCL)；透明质酸；多羟基丁酸酯(polyhydroxylbutyrate，PHBT)；聚(磷腈(phosphazene))；聚(D，L-丙交酯-共聚-己内酯)(PLA/PCL)；聚(乙交酯-共聚-己内酯)(PGA/PCL)；聚乙烯醇(PVA)；聚酐类(polyanhydrides，PAN)；聚(原酸酯)；聚(磷酸酯(phoshate ester))；聚(氨基酸)；聚(羟基丁酸酯(hydroxy butyrate))；这些材料的共聚物及其复合物和合成物；塑料和其它聚合物，如乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯(polyacrylate)、聚丙烯酰胺(polyacrylamide)、聚(甲基丙乙烯酸羟基荃(hydroxyethyl methacrylate))、聚氨酯、聚硅氧烷(polysiloxane)及它们的共聚物。所述医疗和/或生物活性非金属纤维材料可以是生物可吸收的，例如PGA；或者是不可被吸收的，例如聚丙烯。该医疗和/或生物活性非金属纤维材料还可用于吸收或释放一种或多种治疗剂。所述抗拉伸元件还可由金属或金属合金制成，该金属或金属合金可以是例如像铂这样的不透射线金属。当所述抗拉伸元件是由诸如乙烯-辛烯聚合物、聚丙烯或聚乙烯这样的纤维制成的时候，线圈在远端处或在该远端附近的部分可通过粘合剂或加热纤维的端部，被附着到抗拉伸元件的一端。另一方面，当抗拉伸元件是由诸如乙烯-辛烯共聚物、聚丙烯或聚乙烯的聚合物制成的时候，可通过对抗拉伸元件施加热能来切断该抗拉伸元件。
本发明还提供了一种装置，用于在患者脉管系统内释放和放置抗拉伸医疗器械。所述医疗器械包括脉管闭塞线圈，在该医疗器械的近端和远端之间限定了一个内腔。作为示例，该医疗器械通过至少一个纤维材料环，或位于脉管闭塞线圈近端的可移动线圈，或作为套节被附着于医疗器械近端的环，而被可分离地安装到推动元件的远端。所述医疗器械可用机械方式放置或通过注射来放置。 
另一方面，所述抗拉伸元件被可分离地安装到拉长推动元件的远端，并且提供了从拉长推动元件的远端分离抗拉伸元件的技术手段。在一选择方案中，附着于推动元件的连接纤维，将医疗器械可分离地安装到该推动元件，以在脉管系统内放置医疗器械；并且提供了用于切断所述连接纤维的装置，以使连接纤维从推动元件上释放医疗器械以便对该医疗器械加以放置，从而达到在脉管系统中所需位置放置医疗器械的目的。用于切断连接纤维的装置包括电阻加热丝或电阻加热线圈，而所述连接纤维是由诸如聚乙烯这样的热塑性材料制成的。当所述抗拉伸元件是由诸如乙烯-辛烯共聚物、聚丙烯或聚乙烯这样的聚合物制成的时候，也可用同样的方式，用所述切断装置来切断该抗拉伸元件。 
在另一选择方案中，所述医疗器械的近端包括远侧医疗部分和近侧杆柄部分，且该近侧杆柄部分包括至少一个圆形元件。一约束材料体被安装到拉长推动元件的远端，其中该约束材料体具备这样的承压外形和恢复外形：该承压外形接合所述医疗器械的近侧杆柄部分的至少一个圆形元件，而该恢复外形则从所述医疗器械的近侧杆柄部分的至少一个圆形元件缩回。在一选择方案下，所述约束材料体可具有管状横截面，从而形成从其近端延伸到其远端的管状套箍。作为示例，所述约束材料体可由诸如聚氨酯这样的聚合物构成，或由镍钛合金构成。 
本发明的这些优点和其它优点，将通过下面的以示例形式说明本发明特征的细节描述和附图而变得显而易见。 
附图说明
图1是一剖面图，其显示了根据本发明的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。 
图2是一剖面图，其显示根据本发明第一替换性实施例的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。 
图3是一剖面图，其显示了根据本发明第二替换性实施例的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。 
图4和图5是剖面图，其说明了根据本发明第三替换性实施例的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置，并且说明了抗拉伸医疗器械的释放。 
图6是一剖面图，其显示了根据本发明第四替换性实施例的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。 
图7是图6中的抗拉伸医疗器械以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置的剖面图，显示了抗拉伸医疗器械的释放。 
图8是一剖面图，其显示了根据本发明第五替换性实施例的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。 
图9是一剖面图，其显示了根据本发明第六替换性实施例的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。 
图10是一剖面图，其显示了根据本发明第七替换性实施例的抗拉伸医疗器械，以及用于在患者脉管系统内释放和放置该抗拉伸医疗器械的装置。 
具体实施方式
尽管通过用推动元件来推动线圈从而使其穿过导管，通常已经实现了对医疗器械的放置，并且已使用了许多种从推动器上释放 器械的分离机构，但这类线圈一般是由延性材料制成的，因此当其从输送导管中被释放或被部分释放时，易于从其线圈形状发生变形，从而使线圈就不能再被推动，并且在通过导管收回线圈时可能导致线圈损坏。本发明为这些医疗器械提供了抗拉伸能力，从而减少了重新放置线圈或置换线圈时，其发生损坏的危险。本发明还使得线圈在被放置时，因线圈强化而引起的硬度增加达到最小，所以线圈可以自由地变形为所需次要形状，并且适应目标区域的尺寸。 
如附图所示，本发明是以抗拉伸医疗器械这样的方式来具体实施的，该抗拉伸医疗器械例如为在患者脉管系统内释放和放置的脉管闭塞或栓塞线圈10。该脉管闭塞线圈具有近端12和远端14，以及在近端和远端之间延伸的内腔16。所述脉管闭塞线圈可由多种材料制成，其包括但不限于，一条或多条诸如不锈钢或镍钛合金的金属或金属合金绞线(strand)，例如，所述脉管闭塞线圈可包括由铂、钨或金制成的不透射线绞线(以便作为标记)、诸如形状记忆聚合物这样的聚合材料、及线圈，该线圈被涂上一种或多种治疗剂以加快康复过程，例如一种或多种诸如白介素这样的人类生长调节因子、转化生长因子b、血小板衍生生长因子的同类物、抗增长因子单克隆抗体、药物、药物产生细胞、细胞再生因子、与来自动脉瘤的同型祖细胞，以及与动脉瘤组织形式不相同的祖细胞。所述线圈还可被涂上一种或多种水凝胶，其例如选自有机凝胶或无机凝胶，且可以与上述一种或多种治疗剂相结合。作为示例而非限定，可从中选择水凝胶的有机凝胶包括：由多糖和粘多糖形成的凝胶，其包括但不限于透明脂酸、右旋糖苷、硫酸肝素、硫酸软骨素、肝素、琼脂、淀粉以及藻酸盐；聚氨基酸；支持细胞生长和愈合的蛋白质，其包括但不限于纤连蛋白、明胶、胶原质、纤维蛋白、果胶、清蛋白、卵清蛋白，以及聚氨基酸；胶原-甲基丙烯酸-羟乙酯(HEMA)；聚膦嗪(Polyphosphazines)；聚磷酸酯(polyphosphoesters)；聚乙二醇；聚氧化乙烯；聚乙烯醇(PVA)；聚乙烯吡咯烷酮；聚乙醛唑啉(Polyethyloxazoline)；聚氧化乙烯-共聚-聚环氧丙烷嵌段共聚物；PGA-PEG-PGA嵌段共聚物；PGA-PEG二嵌段共聚物；丙烯酸酯，其包括但不限于二丙烯酸酯、寡丙烯酸酯(oligoacrylates)、甲基丙烯酸酯、二甲基丙烯酸酯(dimethacrylate)， 以及寡甲基丙烯酸酯；PEG-寡乙醇酰丙烯酸酯(PEG-oligoglycolylacrylates)，例如在美国专利第5,626,863号中所描述的，该专利被并入本文中供参考；羧烷基纤维素(carboxy alkylcelluloses)，其包括但不限于羧甲基纤维素；部分氧化的纤维素；生物可降解聚合物，其包括但不限于乙交酯、丙交酯的聚合物和低聚物、聚乳酸、包括乳酸和羟基乙酸的a-羟基酸的聚酯，该a-羟基酸的聚酯包括诸如包含聚羟基乙酸、聚-DL-乳酸、聚-L-乳酸以及DL-乳交酯和乙交酯的三元共聚物的聚(a-羟基)酸；e-己内酯和与聚酯共聚的e-己酯；聚内酯和聚乙酸内酯，其包括聚(e-己内酯)、聚(d-戊内酯)、聚(γ-丁内酯)；聚酐类；聚原酸酯；其它羟酸；聚对二氧环己酮(polydioxanone)；和其它无毒的或作为代谢物存在于体内的生物可降解的聚合物；以及诸如苯乙烯和丙烯醛的不可降解聚合物。 
胶原-甲基丙烯酸-羟乙酯(HEMA)水凝胶聚合物一般是通过凝胶状和交联的亲水单体溶液制成，以形成三维聚合网状锚定大分子(anchoring macromolecule)。亲水单体溶液的交联可通过亲水单体，例如甲基丙烯酸-2-羟乙酯(HEMA)的自由基聚合来完成。通过单体溶液的自由基聚合而形成的水凝胶聚合物需要交联，以形成使水溶液成为凝胶的三维网。尽管其它交联剂，如乙二醇二甲基丙烯酸酯或甲基丙烯酸甲酯(methylmethacrylate)也可被在聚合时使用以修饰水凝胶，但HEMA单体溶液一般可通过二甲基丙烯酸酯来交联从而形成凝胶。许多其它种亲水单体也可适用。 
作为示例而非限定，可从中选择水凝胶的无机凝胶包括：硅石、氧化铝以及含铁氧化物。此外，可通过导管引入一种粘合剂，以便在开始时帮助密封动脉瘤颈，该粘合剂可选自以下一组物质：氰基丙烯酸酯粘合剂(cyanoacrylate)、明胶/间苯二酚/甲醛、贝类粘合剂蛋白质，以及自体同源纤维蛋白质粘合剂。因而由此可见，本发明的水凝胶可以是这样的类型：其在动脉瘤中随时间而溶解，或是作为永久性的闭塞剂而保留。不透射线材料，可作为选定不透射线金属如金或铂的细小颗粒，被结合到所述水凝胶内。 
抗拉伸元件18穿过脉管闭塞线圈的内腔延伸，且具有第一端或称远端20，以及第二端或称近端22，其中抗拉伸元件的该第一端或称远端固定附着到脉管闭塞线圈。在第二端或称近端处，抗拉伸元件和/或线圈被可分离地安装到拉长推动元件24，从而能够在患者脉管系统内放置脉管闭塞线圈。所述抗拉伸元件可以由带、线、编织物、主要绕组、多股绞合材料、多丝材料或绞合多丝材料制成，并且可由医疗和/或生物活性非金属纤维材料制成，例如：丝；胶原；弹性蛋白或其它连接蛋白质；聚羟基乙酸或聚乙醇酸(PGA)；聚乳酸或聚(D，L-丙交酯)(PLA)；聚(D，L-乳酸-共聚-羟基乙酸)(PGLA)或聚(D，L-丙交酯-共聚-乙交酯)(PLA/PGA)；聚(L-丙交酯)(PLLA)；聚(L-丙交酯-共聚-D，L-丙交酯)(PLLA/PLA)；聚(L-丙交酯-共聚-乙交酯)(PLLA/PGA)；聚(乙交酯-共聚-三亚甲基碳酸酯)(PGA/PTMC)；聚氧化乙烯(PEO)；聚对二氧环己酮(PDS)；聚己酸内酯(PCL)；透明质酸；多羟基丁酸酯(PHBT)；聚(磷腈)；聚(D，L-丙交酯-共聚-己内酯)(PLA/PCL)；聚(乙交酯-共聚-己内酯)(PGA/PCL)；聚乙烯醇(PVA)；聚酐类(PAN)；聚(原酸酯)；聚(磷酸酯)；聚(氨基酸)；聚(羟基丁酸酯)；这些材料的共聚物及其复合物和合成物；塑料和其它聚合物，如乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯、聚丙烯酰胺、聚(甲基丙烯酸羟乙酯)、聚氨酯、聚硅氧烷及它们的共聚物。所述医疗和/或生物活性非金属纤维材料可以是生物可吸收的，例如PGA；或者是不可被吸收的，例如聚丙烯。该医疗和/或生物活性非金属纤维材料还可用于吸收或释放一种或多种治疗剂，例如上述那些治疗剂。所述抗拉伸元件还可由金属或金属合金制成，其可以是不透射线金属，如铂。当所述抗拉伸元件是由诸如乙烯-辛烯聚合物、聚丙烯或聚乙烯这样的纤维制成的时候，所述线圈位于远端处或接近该远端的一部分，可通过粘合剂如氰基丙烯酸酯粘合剂或通过加热纤维的端部，被附着到抗拉伸元件的一端。该纤维也可被制成是不透射线的，这是通过使纤维的组成物中包含不透射线材料来实现的，这些材料例如为粉末状的钽、钨、氧化铋或硫酸钡。
如图2和3所示，可朝向线圈的远端或在该远端处，使得抗拉伸元件在其远端27被折叠或连接，从而构成一个具有近端29的环28。参考图1，环30如上所述是由纤维材料、金属或金属合金制成的，该环可通过粘合剂，如氰基丙烯酸酯粘合剂，被附着到抗拉伸元件。环28或30通常连接到被附着到被拉长推动元件的连接纤维，从而将抗拉伸元件可分离地连接到被拉长推动元件，如后面进一步的描述。线圈本身可通过一个或多个环，被可分离地安装在推动元件的远端；例如通过如图1所示的纤维材料环31，该环举例来说通过诸如氰基丙烯酸酯粘合剂这样的粘合剂，被附着到线圈；或通过如图2所示的环34，该环作为套节被附着于线圈的近端处；或者通过如图3所示的移位端部分36，该移位端部分位于线圈的近端。如图4和5所示，抗拉伸元件的近侧部分37还可举例来说通过粘合剂或加热粘接，被粘接到推动元件。线圈和抗拉伸元件二者均连接到推动元件，即避免了线圈沿着抗拉伸元件滑动而露出结点。在示于图10的又一替换性实施例中(该实施例是图3所示实施例的一个变化方案)，其中在线圈的近端处，线圈能够通过线圈移位端部分36，被可分离地安装到推动元件的远端；该抗拉伸元件可在其远端27处，朝向线圈的远端被折叠和连接，从而构成一个具有近端29的环28，该近端29环绕着线圈的移位端部分。 
本发明还提供了一种装置，用于在患者脉管系统内释放和放置抗拉伸医疗器械，如抗拉伸脉管闭塞线圈10。提供了装置38，用于从拉长推动元件的远端可分离地安装抗拉伸元件。如图1-3所示，一方面，连接纤维40可举例来说利用诸如氰基丙烯酸酯粘合剂这样的粘合剂，被附着到拉长推动元件；或者，该连接纤维可被绑在拉长推动元件上，从而将脉管闭塞线圈可分离地安装到推动元件，以将脉管闭塞线圈放置脉管系统内；并且提供了装置42，其被设置在连接纤维附近，用于切断所述连接纤维，从而使连接纤维从推动元件上断裂并释放脉管闭塞线圈，以便在脉管闭塞线圈达到脉管系统中的所需位置时，从推动元件上分离和释放脉管闭塞线圈。当所述连接纤维是由热塑性材料，如聚乙烯制成的时候，举例来说，用于切断连接纤维的装置可包括电阻加热丝或电阻加热线圈44，其通过电线46与控制单元48相连。 
参考图4和图5，本发明的另一实施例提供了一种抗拉伸医疗器械，如脉管闭塞线圈10，该线圈具有近端12、远端14、在近端和远端之间延伸的内腔16；且抗拉伸元件18穿过脉管闭塞线圈的内腔 延伸，其中抗拉伸元件的第一端或称远端20固定附着到医疗器械，而抗拉伸元件的第二端或称近端22固定附着到拉长推动元件24。如上所述，抗拉伸元件可以由带、线、编织物、主要绕组、多股绞合材料、多丝材料或绞合多丝材料制成，并且可由医疗和/或生物活性非金属纤维材料制成，例如丝、胶原、弹性蛋白或其它连接蛋白质、聚羟基乙酸或聚乙醇酸(PGA)、聚乳酸或聚(D，L-丙交酯)(PLA)、聚(D，L-乳酸-共聚-羟基乙酸)(PGLA)或聚(D，L-丙交酯-共聚-乙交酯)(PLA/PGA)，聚(L-丙交酯)(PLLA)、聚(L-丙交酯-共聚-D，L-丙交酯)(PLLA/PLA)、聚(L-丙交酯-共聚-乙交酯)(PLLA/PGA)，聚(乙交酯-共聚-三亚甲基碳酸酯)(PGA/PTMC)，聚氧化乙烯(PEO)，聚对二氧环己酮(PDS)、聚己酸内酯(PCL)、透明质酸、多羟基丁酸酯(PHBT)、聚(磷腈)、聚(D，L-丙交酯-共聚-己内酯)(PLA/PCL)、聚(乙交酯-共聚-己内酯)(PGA/PCL)、聚乙烯醇(PVA)、聚酐类(PAN)、聚(原酸酯)、聚(磷酸酯)、聚(氨基酸)、聚(羟基丁酸酯)、和这些材料的共聚物及其复合物和合成物、塑料以及其它聚合物，如乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯、聚丙烯酰胺、聚(甲基丙烯酸羟乙酯)、聚氨酯、聚硅氧烷以及它们的共聚物。医疗和/或生物活性非金属纤维材料可以是生物可吸收的，例如PGA；或者是不可被吸收的，例如聚丙烯。医疗和/或生物活性非金属纤维材料还可用于吸收或释放一种或多种治疗剂，例如像上面所描述的那些治疗剂。抗拉伸元件还可由金属或金属合金制成，所述金属或金属合金可以是不透射线的金属，如铂。抗拉伸元件可通过粘合剂，如氰基丙烯酸酯粘合剂，与推动元件相结合。但是，当抗拉伸元件是由诸如乙烯-辛烯聚合物、聚丙烯或聚乙烯的纤维制成的时候，所述抗拉伸元件的第二端或称近端，即可通过诸如氰基丙烯酸酯粘合剂之类粘合剂或者通过加热纤维的第二端或称近端，被附着到推动元件。如图4和5所示，聚乙烯纤维这样的连接纤维40可通过诸如氰基丙烯酸酯粘合剂的粘合剂或加热连接，被附着于拉长推动元件的外部；或者，所述连接纤维也可被绑在拉长推动元件上，以将所述医疗器械通过诸如附着于线圈或线圈的移位端部分的环34，可分离地安装到推动元件，用于在脉管系统内放置医疗器械。如上所述，作为示例，用于切断连接纤维的装置42可包括电阻加热丝或电阻加热线圈44，电阻加热丝或电阻加热线圈44通过电线46与控制单元48相连的。
在图6和图7所示的本发明的又一实施例中，医疗器械能够以机械方式被释放。该医疗器械的近端包括远侧医疗部分50和近侧杆柄部分52，且该近侧杆柄部分包括至少一个圆形元件54。一约束材料体56被安装到拉长推动元件58的远端，该约束材料体具有承压外形和恢复外形；该承压外形接合脉管闭塞线圈的近侧杆柄部分的圆形元件，如图6所示；该恢复外形从医疗器械的近侧杆柄部分的圆形元件中收回，如图7所示。拉长推动元件的末端部分60位于远端处，能够与医疗器械的近侧杆柄部分的圆形元件相接触。在一种选择方案中，所示约束材料体可具有管状横截面，构成一个从其近端62延伸到其远端64的管状套箍，且所述末端部分位于该管状套箍内部，以便在管状套箍的形状恢复，而从管状套箍上移出医疗器械时，接合医疗器械的近侧杆柄部分的圆形元件。作为示例，约束材料体可由诸如聚氨酯的聚合物制成，或由镍钛合金制成。 
作为选择，如图8和9中表明的，所述医疗器械能够通过注射而被释放。参考图8，所述医疗器械的近端包括远侧医疗部分50和近侧杆柄部分52，且该近侧杆柄部分包括至少一个圆形元件54。此器械配备医疗器械输送组件70，包括拉长而柔软的管状导管72，该管状导管具有远端74。作为示例，柔软的管状导管72可由聚乙烯、聚对苯二甲酸乙二酯(polyethylene terephthalate)、聚氯乙烯(polyvinylchloride)、尼龙和离聚物，或者其它类似的适当聚合物、不锈钢或镍钛合金硫化硫酸钠(hypo)管等材料制成。在一个实施例中，所述拉长柔软的管状导管的远端具有截头圆锥体形状。柔软的管状导管72可包括具有近端78的管状远侧尖端76，该近端举例来说通过诸如氰基丙烯酸酯粘合剂之类粘合剂连接，而被安装到柔软管状导管的远端外表面。所述管状远侧尖端可选择被加热连接到柔软管状导管的远端，或者可通过其它适合方式被连接到柔软管状导管的远端。所述管状远侧尖端具有内部腔80及远端82，该远端具有构成远端开口84的表面。在一方案中，所述管状远侧尖端的远端的直径小于近端，从而使得医疗器械的近端能够被捕获于该管状远侧尖端的内部腔内。该管状远侧尖端因 此而具有大致截头圆锥体的形状。作为选择，对于导管的远端和管状远侧尖端来说，圆柱管形状也是合适的。 
所述管状远侧尖端一般是由可屈服(yieldable)材料制成的，该材料的刚性足以使医疗器械的近端保留在管状远侧尖端的内部腔之内。作为示例，所述可屈服材料可以是一种形状记忆聚合物，即弹性材料(elastomer)，例如：聚氨酯、尼龙、PEBAX聚合物、Teloflex、聚对苯二甲酸丁二醇酯(PBT)、可在商标PEBAX、Hytrel、Arnitel、Riteflex下购到的聚合物、热缩管如聚对苯二甲酸乙二酯(PET)或高密度聚乙烯(HDPE)、或者形状记忆金属如镍钛合金，诸如可在商标NITINOL下购到的合金。 
本发明还提供了用于移出医疗器械的近端(其被捕获于管状远侧尖端的内部腔之内)的装置，其在患者脉管系统内为治疗所需的位置处，将所述医疗器械的近端从管状远侧尖端的远端开口移除。如图8所示，用于从管状远侧尖端的内部腔内将医疗器械的近端移出的装置可以是拉长柔软的推动元件86，此元件例如为一根柔软金属线，以共轴方式被放置在拉长柔软管状导管之内。推动元件的近端88从所述拉长柔软管状导管的近端延伸，并且可包括一个位于推动元件近端的凸缘或限位部分90，用于限制推动元件沿输送导管的运动；而推动元件的远端92适合于接触并从管状远侧尖端移出医疗器械的近端。该推动元件的远端也可具有相应的截头圆柱体形状，以使其能够延伸到导管的远端，从可屈服的管状远侧尖端来推动医疗器械的近端，从而移出医疗器械的近端。 
也可使用一种水压释放机构来注射所述医疗器械。如图9所示，所述管状远侧尖端的尺寸可以在此腔内(endoluminal)器械的近端周围产生紧密的液体密封，并且用于将腔内器械移出的装置可以是注射器94，该注射器具有活塞96，该活塞例如用于在液体腔98中，对诸如盐溶液之类液体施加压力，以通过柔软的喷嘴100提供被加压液体，所述喷嘴可被连接到拉长柔软管状导管的近端，用于从管状远侧尖端移出所述腔内器械的近端。 
应当认识到，也可利用其它机构，例如像旋转式释放机构之类，来释放所述抗拉伸医疗器械。从前文可以清楚地了解到，尽管所说明和描述的是本发明的特定形式，在不脱离本发明的精神和范围的情况下，尚可进行多种修正。因此，上述说明无意限定本发明，本发明只受限于所附的权利要求。 

Claims (17)

1.一种用于在患者的脉管系统内释放和放置抗拉伸医疗器械的装置，包括：
脉管闭塞线圈，其具有近端和远端，所述脉管闭塞线圈在所述近端和所述远端之间限定一内腔；
拉长推动元件，其具有远端，该远端与所述脉管闭塞线圈的所述近端相邻；
附着于所述拉长推动元件的连接纤维，所述连接纤维通过加热所述连接纤维是可切断的；
所述脉管闭塞线圈通过作为套节而被附着于所述线圈的所述近端的环被可分离地安装到所述拉长推动元件的所述远端；
与所述连接纤维相邻地布置的电阻加热丝，所述电阻加热丝被连接到加热控制单元并因此切断所述连接纤维；以及
抗拉伸元件，其穿过所述脉管闭塞线圈的所述内腔延伸；所述抗拉伸元件具有远端和近端；所述抗拉伸元件由医疗非金属纤维材料制成；以及该抗拉伸元件仅在所述脉管闭塞线圈的所述远端被固定附着到所述脉管闭塞线圈，所述抗拉伸元件在所述抗拉伸元件的远端被折叠以形成具有近端的环，并且所述抗拉伸元件的环通过附着于所述拉长推动元件的所述连接纤维被可分离地安装到所述拉长推动元件的所述远端，以在所述患者的脉管系统内放置所述脉管闭塞线圈。
2.根据权利要求1所述的装置，其中所述抗拉伸元件是以带制成的。
3.根据权利要求1所述的装置，其中所述抗拉伸元件是以编织物制成的。
4.根据权利要求1所述的装置，其中所述抗拉伸元件是以初级绕组制成的。
5.根据权利要求1所述的装置，其中所述抗拉伸元件是以多股绞合材料制成的。
6.根据权利要求1所述的装置，其中所述抗拉伸元件是以多丝材料制成的。
7.根据权利要求1所述的装置，其中所述抗拉伸元件是以绞合多丝材料制成的。
8.根据权利要求1所述的装置，其中所述抗拉伸元件是医疗非金属纤维材料，该医疗非金属纤维材料选自以下的一种或多种：
丝、胶原、弹性蛋白、聚羟基乙酸、聚乳酸、聚(D，L-乳酸-共聚-羟基乙酸)，聚(L-丙交酯)、聚(L-丙交酯-共聚-D，L-丙交酯)、聚(L-丙交酯-共聚-乙交酯)、聚(乙交酯-共聚-三亚甲基碳酸酯)、聚氧化乙烯、聚对二氧环己酮、聚己酸内酯、透明质酸、多羟基丁酸酯、聚(磷腈)、聚(D，L-丙交酯-共聚-己内酯)、聚(乙交酯-共聚-己内酯)、聚乙烯醇、聚酐类、聚(原酸酯)、聚(磷酸酯)、聚(氨基酸)和聚(羟基丁酸酯)。
9.根据权利要求8所述的装置，其中所述医疗非金属纤维材料是生物活性材料。
10.根据权利要求8所述的装置，其中所述医疗非金属纤维材料是生物可吸收的。
11.根据权利要求8所述的装置，其中所述医疗非金属纤维材料是不可吸收的。
12.根据权利要求8所述的装置，其中所述医疗非金属纤维材料吸收治疗剂。
13.根据权利要求1所述的装置，其中所述医疗非金属纤维材料由选自以下的一种或多种聚合物制成：乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯、聚丙烯酰胺、聚(甲基丙烯酸羟乙酯)、聚氨酯和聚硅氧烷。
14.根据权利要求1所述的装置，其中所述抗拉伸元件是不透射线的。
15.根据权利要求8或13所述的装置，其中所述抗拉伸元件具有远端和近端，且所述脉管闭塞线圈通过加热所述抗拉伸元件的所述远端被附着于所述抗拉伸元件的所述远端。
16.根据权利要求1所述的装置，其中所述连接纤维是由热塑性材料制成的。
17.根据权利要求1所述的装置，其中所述连接纤维是由聚乙烯制成的。
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