CN101310681B - 抗拉伸医疗器械 - Google Patents

抗拉伸医疗器械 Download PDF

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CN101310681B
CN101310681B CN200810128049XA CN200810128049A CN101310681B CN 101310681 B CN101310681 B CN 101310681B CN 200810128049X A CN200810128049X A CN 200810128049XA CN 200810128049 A CN200810128049 A CN 200810128049A CN 101310681 B CN101310681 B CN 101310681B
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stretch resistant
resistant member
coil
vasoocclusive coil
fiber connector
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CN101310681A (zh
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P·威尔逊
E·列奥波德
R·K·德赛
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Micrus Endovascular LLC
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Abstract

用抗拉伸部件(18)来增强血管阻塞线圈(10)以提高在撤回该线圈的过程中的安全性。抗拉伸部件的一端固定连接到血管阻塞线圈上，而抗拉伸部件的另一端可分离地连接到细长推动器部件(24)上，从而能够将在病人的血管系统内放置和释放血管阻塞线圈。

Description

抗拉伸医疗器械
本申请是2005年1月20日提交的名称为：“抗拉伸医疗器械”的中国专利申请03817338.7的分案申请。
背景技术
本发明一般地涉及用于介入性治疗处理(interventional therapeutictreatment)或血管外科(vascular surgery)的可植入器械，更具体地说，涉及一种抗拉伸医疗器械如栓塞(embolic)线圈或血管阻塞(vasoocclusive)线圈，以及一种用于在病人的血管系统内释放和放置上述抗拉伸医疗器械的装置。
通过利用越来越小的切口或穿过血管系统或人体开口的入口，介入性的治疗和外科的技术及科学在向着治疗内脏缺陷(internal defects)和疾病的方向持续发展，为的是减小对治疗位置周围组织的损伤。这类处理的一个重要的方面便涉及借助于穿过血管系统的入口，来使用导管将医疗器械(therapeutic devices)放置到治疗位置。这种处理的例子包括腔内血管成形(transluminal angioplasty)、放置血管支架(stents)以增强血管壁等、和用血管阻塞装置(vasoocclusive devices)来治疗血管系统内的缺陷。
已经能够有利地利用最新技术发展成果的介入性治疗的一个特定领域就是神经血管缺陷的处理。由于已经开发出更细微和更有效的结构和材料，人脑内的血管缺陷已经成为可以治疗修复的，而以前在传统的外科看来，这些缺陷都是不能治疗的或者意味着不可接受的风险。对于脑血管系统内的缺陷的治疗来说，一种已经变得有利的非外科手术式疗法是：借助于导管而在静脉或动脉的损伤部位放置血管阻塞装置，如栓塞线圈。
血管阻塞装置就是典型地通过导管而被放置于人体的血管系统内、或放置于在血管上长出的动脉瘤内的医疗器械，用以形成栓塞来阻止血管内的血流从而修补那部分血管系统。血管阻塞装置可以采用各种结构，并由一个或多个部件构成，这些部件在放置后的结构尺寸比在放置之前、位于输送导管内时大。一种广泛应用的血管阻塞装置是螺旋丝状线圈，该线圈具有放置后结构，该放置后结构的尺寸可设计成接合血管壁。在这里特别参考引用的美国专利第5645558号，披露了一种解剖学形状(anatomically shaped)的血管阻塞装置，该装置自身形成像动脉瘤这样的解剖腔形状，并且是以预先成型的柔韧材料股线制成的，这种柔韧性材料可以是镍钛合金。该血管阻塞装置包括一个或多个血管阻塞部件，这些部件是绕制的从而在松弛状态下呈球状或卵球状。这些血管阻塞部件可以是由生物相容的材料制成的螺旋形绕制的线圈或一起编织的编织物(cowoven braid)，并且例如为了处理动脉瘤或瘘管起见，这些装置的尺寸和形状被设计成适于放置在血管腔或囊泡(vesicle)内。可以首先将血管阻塞部件以螺旋方式绕制或以大体线性的方式编织，然后再绕一个形状合适的心轴或线圈架缠绕，并进行热处理以便从加热成型设备中取出后仍能保持原状。通过用填充了粉末状的不透射线的材料的合成纤维或天然纤维来进行编织，就可以使血管阻塞部件具备不透射线性(Radiopacity)，这些粉末状的不透射线的材料例如有粉末状的钽、粉末状的钨、粉末状的氧化铋或粉末状的硫酸钡。
可以使用各种方式实现这些血管阻塞装置的输送，包括使用导管，由推动器推动上述装置通过导管来放置该装置。这些血管阻塞装置可以具有初级形状的丝线圈，然后初级线圈再形成更复杂的第二级形状，可以按这样的方式制造血管阻塞装置：使它们能以线性形状通过导管的空腔，并在被放置到例如动脉瘤之类的感兴趣区之后，能呈现一种复杂的如原来被成形的那种形状。在本技术领域，已经开发出各种各样的、已知的分离机构用来释放血管阻塞装置使其脱离推动器。
当线圈一部分在动脉瘤内、一部分在输送导管内受到拉伸时，由铂、黄金和其他可延展材料制成的血管阻塞线圈将易于在张力作用下改变其线圈形状，造成潜在的危险情况。如果认为线圈放置得不合适，或者线圈太大，就需要取出或替换线圈。然而在这个处理阶段不能再推进线圈，而是必须使其呈线状从导管中缓慢撤出。如果在这个过程中线圈断裂，就必须执行额外的程序以将线圈从动脉瘤中取出。特别在取出线圈以重新放置或进行替换的过程中，希望能够增强这些阻塞线圈以使其具有抗拉性，从而降低线圈断裂的风险，以便在撤出柔软的或换句话说易于延伸的线圈时提供某种安全系数。同样希望的是，在将线圈放置到动脉瘤内的过程中，当线圈被释放之后，使得由于增强线圈所引起的刚度增加降至最小，从而让线圈能够无拘束地变换到所需要的第二级形状并与受到处理的部位的大小相符合。本发明满足了这些要求和其他要求。
发明内容
简而言之，本发明提供了一种抗拉伸医疗器械，用于释放和设置到病人的血管系统内，并提供了一种用于在病人的血管系统内释放和放置所述抗拉伸医疗器械的装置，其中，所述医疗器械是一种由内部抗拉伸部件增强的血管阻塞线圈，该内部抗拉伸部件对线圈提供了拉伸抗力。加入内部抗拉伸部件还可以使下述情形成为可能，即，甚至当线圈是被部分放置时也可以推动该线圈，从而改善了撤出线圈时的安全性。上述血管阻塞线圈可以涂覆一种或多种治疗剂(therapeuticagents)，这些治疗剂可以包括水凝胶。血管阻塞线圈是由内部抗拉伸部件增强的，该抗拉伸部件在血管阻塞线圈的远端或接近远端处固定连接到血管阻塞线圈的一端上，并且在血管阻塞线圈的另一端可分离地安装到细长推动器部件上，以便在病人的血管系统内放置和释放血管阻塞线圈。
在接近于或者就是在血管阻塞线圈的远端处固定内部抗拉伸部件，而不在血管阻塞线圈的另一端连接内部抗拉伸部件，即使得为放置而释放线圈之后，因线圈增强所引起的刚度增加降至最小。一个额外的优点是，线圈可以在近端自由浮置于内部抗拉伸部件上。内部抗拉伸部件可被用来提高射线不透性、帮助形成第二级形状，并可以被设置用来帮助达到所需的线圈刚度，且允许使用更软的线圈而不用拉伸该线圈。
据此，本发明提供了一种用于释放和设置到病人的血管系统内的抗拉伸医疗器械。该医疗器械包括：一个血管阻塞线圈，该线圈确定了一个介于线圈的近端和远端之间的空腔；以及一个抗拉伸部件，该部件延伸穿过血管阻塞线圈的空腔。抗拉伸部件在接近于血管阻塞线圈的远端的第一端是固定连接的，而在第二端则可分离地安装到一个细长推动器部件上，从而能够让血管阻塞线圈放置在病人的血管系统内。抗拉伸部件可以制成带(ribbon)、丝(wire)、编织物(braid)、初级线圈、或多股材料(stranded material)，而且可以用纤维、塑料或其他聚合物(例如乙烯-辛烯共聚物、聚丙烯、或聚乙烯)、或金属或金属合金(例如像镍钛合金)、或不透射线的金属(例如像铂)制成。如果抗拉伸部件是由例如乙烯-辛烯共聚物、聚丙烯、或聚乙烯之类的纤维制成的，就可以借助粘合剂或通过加热纤维的端部，在线圈的远端处或接近远端处，将线圈的一部分固定到抗拉伸部件的一端。另一方面，如果抗拉伸部件是由例如乙烯-辛烯共聚物、聚丙烯、或聚乙烯之类的聚合物制成的，还可以通过在抗拉伸部件上施加热能来分离抗拉伸部件。
本发明还提供了一种用于在病人的血管系统内释放和放置所述抗拉伸医疗器械的装置。所述医疗器械包括一个血管阻塞线圈，该线圈确定了介于医疗器械的近端和远端之间的一个空腔。所述医疗器械能够被可分离地安装到推动器部件的远端，而这举例来说要借助于至少一个纤维材料制成的环、在血管阻塞线圈的近端处的移位线圈(displcaced coil)、或者固定在血管阻塞线圈的近端作为套节的环。可通过机械方式或通过注射来安放该医疗器械。
另一个方面，所述抗拉伸部件被可分离地安装到细长推动器部件的远端，而且本发明提供了将抗拉伸部件从细长推动器部件的远端分离开的装置。在一个选择方案中，一个固定在推动器部件上的纤维连接器将医疗器械可分离地安装到推动器部件上，以便将医疗器械放置于血管系统内，而且本发明提供了用于分离纤维连接器的装置，以便当医疗器械到达血管系统内的所需位置时，使纤维连接器从推动器部件释放医疗器械以便安放。如果纤维连接器举例来说是由像聚乙烯之类的热塑性材料制成的，用来分离纤维连接器的装置可以包括电阻加热丝或电阻加热线圈。如果抗拉伸部件是由像乙烯-辛烯共聚物、聚丙烯、或聚乙烯之类的聚合物制成的，也可以按相同方式借助于上述用于分离的装置使抗拉伸部件分离。
在另一个选择方案中，医疗器械的近端包括一个远端治疗部分和一个近端底座部分，而且近端底座部分包括至少一个圆形部件。一个约束材料体被安装到细长推动器部件的远端，其中该约束材料体具有受压形态和恢复形态，在受压形态时，约束材料体接合上述医疗器械的近端底座部分的至少一个圆形部件，而在恢复形态时，约束材料体离开医疗器械的近端底座部分的至少一个圆形部件。在一个选择方案中，约束材料体可以具有管状横截面，构成从其近端到其远端延伸的管式套筒。约束材料体，举例来说，可以用诸如聚氨基甲酸乙酯这样的聚合物或镍钛合金制成。
通过以下以示例方式来阐述本发明的特征的详细说明及相应附图，本发明的这些方面及优点和其他方面及优点便会更加清晰。
附图说明
图1是根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和放置所述抗拉伸医疗器械的装置的截面图。
图2是根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和放置所述抗拉伸医疗器械的装置的第一个可选实施例的截面图。
图3是根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和放置所述抗拉伸医疗器械的装置的第二个可选实施例的截面图。
图4和图5是截面图，表明根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和放置所述抗拉伸医疗器械的装置的第三个可选实施例，还表明了所述抗拉伸医疗器械的释放。
图6是根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和放置所述抗拉伸医疗器械的装置的第四个可选实施例的截面图。
图7是图6的抗拉伸医疗器械和一种用于在病人的血管系统内释放和安置所述抗拉伸医疗器械的装置的截面图，展示了所述抗拉伸医疗器械的释放。
图8是根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和安置所述抗拉伸医疗器械的装置的第五个可选实施例的截面图。
图9是根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和安置所述抗拉伸医疗器械的装置的第六个可选实施例的截面图。
图10是根据本发明的一种抗拉伸医疗器械和一种用于在病人的血管系统内释放和安置所述抗拉伸医疗器械的装置的第七个可选实施例的截面图。
具体实施方式
尽管医疗器械的放置典型地是通过利用推动器部件(举例来说)推动线圈穿过导管来实现的，并且利用了各种分离机构来从推动器上释放该装置，但这些线圈典型地是由有延展性的材料制成的，一旦从输送导管释放或部分释放后便易于从其线圈形状变形，使得线圈不再能被推动，并且通过导管撤回线圈会导致线圈的断裂。本发明为这些医疗器械提供了拉伸抗力，从而在取出线圈以重新放置或更换的过程中降低了线圈断裂的风险。本发明还使得线圈在放置之后由于线圈增强而导致的刚度增加降至最小，从而让线圈能够无拘束地变换到所需的第二级形状并符合目标区域的大小。
如附图所示，本发明的实施例是诸如血管阻塞线圈或栓塞线圈10这样的抗拉伸医疗器械，用于释放和放置到病人的血管系统内。该血管阻塞线圈具有近端12、远端14、和在近端和远端之间延伸的空腔16。血管阻塞线圈可以由各种材料制成，包括但并不限于：一股或多股金属或金属合金丝，如不锈钢或镍钛合金，可包括由铂、钨、或黄金制成的不透射线的丝股以便用作标志器；一股或多股举例来说诸如形状记忆聚合物这样的聚合材料丝；以及涂覆了一种或多种治疗剂以加速愈合进程的线圈，上述治疗剂例如是一种或多种人体生长调整因子(human growth modulating factors)，如白细胞介素、转化生长因子(transformation growth factor)b、血小板衍生的生长因子的同源物(congeners)、和单克隆抗体，用于抑制生长因子、药物、产药细胞(drugproducing cell)、细胞再生因子、与动脉瘤的细胞同类型的祖细胞(progenitor cells)、和组织上与动脉瘤细胞不同的祖细胞。线圈也可以被涂以水凝胶，如选自有机凝胶和无机凝胶的一种或多种水凝胶，而且水凝胶可以和上述的一种或多种治疗剂结合起来。仅供举例而非限定的是，从中选出水凝胶的有机凝胶包括由多糖类和粘多糖类所制成的凝胶，这些糖类包括但不仅限于以下物质：透明质酸、葡聚糖、硫酸肝素、硫酸软骨素、肝素、琼脂、淀粉、和藻酸盐；聚氨基酸；支持细胞生长和愈合的蛋白质，包括但并不限于纤维结合蛋白、明胶、胶原、纤维蛋白、果胶、清蛋白、卵清蛋白、和聚氨基酸；胶原-甲基丙烯酸-羟基乙酯(collagen-hydroxyethyl-methacrylate，HEMA)；聚膦嗪(polyphosphazines)；聚磷酸酯(polyphosphoesters)；聚乙二醇；聚环氧乙烷(polyethylene oxide)；聚乙烯醇(polyvinyl alcohol)；聚乙烯吡咯烷酮(polyvinyl alcohol)；聚乙烷基唑啉(polyethyloxazoline)；聚环氧乙烷-共聚环氧乙烷嵌段共聚物(polyethylene oxide-co-polypropyleneoxide block copolymers)；PGA-PEG-PGA嵌段共聚物；PGA-PEG二嵌段共聚物；丙烯酸盐，包括但并不限于双丙烯酸盐、寡丙烯酸盐、甲基丙烯酸盐、双甲基丙烯酸盐、和寡甲基丙烯酸盐；PEG-寡乙醇酰，如美国专利第5626863号中所描述的，在此通过参考结合该专利；羧基烷基纤维素(carboxy alkyl celluloses)，包括但不限于羧甲基纤维素(carboxymethyl cellulose)；部分氧化的纤维素；生物可降解的聚合物，包括但不限于乙交酯(glycolide)、丙交酯、聚乳酸的聚合物和低聚物、a-羟基酸的聚酯、及DL-丙交酯和乙交酯的三元共聚物，其中a-羟基酸包括乳酸和羟基乙酸，例如聚(a-羟基)酸，其中聚(a-羟基)酸包括聚羟基乙酸、聚-DL-乳、聚-L-乳酸；e-己内酯和与聚酯共聚的e-己内酯；聚内酯和聚己内酯，包括聚(e-己内酯)、聚(d-戊内酯)、和聚(γ-丁内酯)；聚酐类；原酸酯；其他羟基酸；聚对二氧环己酮；和其他可生物降解的聚合物，该聚合物无毒或者以代谢物的形式存在于体内；也包括不能降解的聚合物，例如苯乙烯和丙烯醛。
胶原-甲基丙烯酸-羟基乙酯(HEMA)通常是由胶状交联的亲水单体溶液制成的，以便构成三维的聚合网状粘合高分子。亲水单体溶液的交联可以通过亲水单体如甲基丙烯酸-羟基乙酯(HEMA)的游离自由基聚合反应来实现。由单体的游离自由基聚合反应形成的水凝胶聚合物需要交联以构成三维网，以将水溶液凝成胶体。典型地可以用双甲基丙烯酸将HEMA单体溶液凝成胶体，虽然在聚合反应期间也可以用其他的交联剂，如己二酸乙二醇双甲基丙烯酸盐(ethylene glycoldimethacrylate)或甲基异丁烯酸盐(methylmethacrylate)，来调整水凝胶。也能够有很多种其他合适的亲水单体。
仅供举例而非限定的是，可从中选择水凝胶的无机凝胶包括硅石、氧化铝、和氧化铁。另外，可以经由导管引入粘合剂以在起始的时候帮助封闭动脉瘤的颈部，且该粘合剂可以选自：氰基丙烯酸酯(cyanoacrylate)、明胶/间苯二酚/甲醛、贝类粘合蛋白质(musseladhesive protein)和自体的纤维蛋白原粘附剂(autologous fibrinogenadhesive)。因此显而易见的是，本发明的水凝胶可以是一种随时间而溶解的水凝胶，或是一种可以保留在血管系统内作为永久阻塞剂的水凝胶。可以将不透射线的材料，作为选定不透射线金属的细微颗粒，加入到水凝胶内，上述不透射线金属例如为金或铂。
抗拉伸部件18延伸穿过血管阻塞线圈的空腔，并具有第一端或称远端20和第二端或称近端22，其中抗拉伸部件的第一端或称远端固定连接到血管阻塞线圈上。抗拉伸部件和/或线圈可分离地在第二端或近端处安装到细长推动器部件24上，以便能够将血管阻塞线圈放置于病人的血管系统内。抗拉伸部件可以制成带、丝、编织物、初级线圈、或多股材料，并且可以由纤维、塑料或其他聚合物、或是金属或金属合金制成，其中上述其他聚合物例如为乙烯-辛烯共聚物、聚丙烯、或聚乙烯，而金属举例来说可以是诸如铂这样的不透射线的金属。当抗拉伸部件是由例如乙烯-辛烯共聚物、聚丙烯、或聚乙烯之类的纤维制成的时，可以通过例如氰基丙烯酸盐之类的粘合剂或通过加热纤维的端部，将线圈在远端处的、或接近远端处的那一部分连接到抗拉伸部件的一端。通过使纤维的成分包括不透射线的金属，如粉末状的钽、钨、氧化铋或硫酸钡，也可以使纤维成为不透射线的。
如图2和图3所示，抗拉伸部件可以在接近于线圈的远端处或者在线圈的远端处是对折的而且固定连接其远端27，形成具有近端29的环28。参考图1，如上所述由纤维材料、金属或金属合金制成的环30，举例来说，可以借助于诸如氰基丙烯酸盐之类的粘合剂，被固定到抗拉伸部件上。环28或30典型地是连接到一个纤维连接器，该纤维连接器固定在细长推动器部件上，从而将抗拉伸部件可分离地连接到细长推动器部件上，下面将进一步解释。线圈自身可以举例来说通过一个或多个环，例如像图1所示由诸如氰基丙烯酸盐粘合剂之类粘合剂固定到线圈上的纤维材料环31，或是通过如图2所示固定于线圈的近端作为套节的环34，或是通过如图3所示位于线圈的近端处的线圈移位端部段36，而可分离地被安装到推动器部件的远端。如图4和图5所示，抗拉伸部件的近端部分37也可以举例来说通过粘合剂、或通过加热粘合，而被粘合到推动器部件上。将线圈和抗拉伸部件都连接到推动器部件上便防止了线圈在抗拉伸部件上滑动，从而出现纠结点。图10所示的另一个可以选择的实施例是图3的实施例的一种变型，其中，线圈可以通过在线圈的近端处的线圈移位端部段36而被可分离地安装到推动器部件的远端，抗拉伸部件在接近于线圈的远端处可以是对折的而且固定连接其远端27，形成具有近端29的环28，其中近端29成环状包围线圈的移位端部段。
本发明还提供了一种装置，用于将例如抗拉伸血管阻塞线圈10之类的抗拉伸医疗器械释放和放置到病人的血管系统内。本发明提供了装置38，用以安装抗拉伸部件而使之可与细长推动器部件的远端分离。如图1～图3所示，在一个方面看，例如通过诸如像氰基丙烯酸盐粘合剂这样的粘合剂，纤维连接器40可以被固定到细长推动器部件上，或者该纤维连接器可以被绑到细长推动器部件上，从而将血管阻塞线圈可分离地安装到推动器部件以便在血管系统内放置血管阻塞线圈，而且本发明提供了用于分离纤维连接器的装置42，其邻近上述纤维连接器设置，当血管阻塞线圈在血管系统内到达所需位置时，该装置使得纤维连接器断裂并释放血管阻塞线圈，从而使血管阻塞线圈线圈与推动器部件分离并得到安置。用于分离纤维连接器的装置，举例来说，当纤维连接器是由例如像聚乙烯之类的热塑性材料制成的时，可以包括通过电线46连接到控制单元48的电阻加热丝或电阻加热线圈44。
参考图4和图5，本发明的另一个实施例提供了一种抗拉伸医疗器械，如血管阻塞线圈10，其具有近端12、远端14、在近端和远端之间延伸的空腔16、和抗拉伸部件18，该抗拉伸部件延伸穿过血管阻塞线圈的空腔，具有固定连接到医疗器械的第一端或称远端20，以及固定连接到细长推动器部件24的第二端或称近端22。如上文所述，举例来说，抗拉伸部件可以制成带、丝、编织物、初级线圈、或多股材料，而且可以由纤维、塑料或其他聚合物、或像铂这样的金属制成，其中其他聚合物例如为乙烯-辛烯共聚物、聚丙烯、或聚乙烯。抗拉伸部件举例来说可以用诸如氰基丙烯酸盐粘合剂之类粘合剂粘合到推动器部件上，但是，如果抗拉伸部件是由例如乙烯-辛烯共聚物、聚丙烯、或聚乙烯之类的纤维制成的，则可以用诸如氰基丙烯酸盐之类的粘合剂粘或通过加热纤维的第二端或称近端，而将抗拉伸部件的第二端或称近端连接到推动器部件上。如图4和图5所示，可以通过举例来说诸如氰基丙烯酸盐粘合剂之类的粘合剂、或通过加热粘合，而将像聚乙烯纤维这样的纤维连接器40连接到细长推动器部件的外部，或者是，例如借助于固定的到线圈或线圈的移位端部段的环34，可以将纤维连接器绑到细长推动器部件上，从而将医疗器械可分离地安装到推动器部件上以便在血管系统内放置医疗器械。如上所述，举例来说，用于分离纤维连接器的装置42可以包括通过电线46连接到控制单元48的电阻加热丝或电阻加热线圈44。
在图6和图7所示的另一个实施例中，医疗器械可以用机械方式释放，医疗器械的近端包括一个远端治疗部分50和一个近端底座部分52，而且该近端底座部分包括至少一个圆形部件54。在细长推动器部件58的远端安装一个约束材料体56，其中该约束材料体具有受压形态和恢复形态，在受压形态时，如图6所示，约束材料体接合血管阻塞线圈的近端底座部分的圆形部件，而在恢复形态时，如图7所示，约束材料体与医疗器械的近端底座部分的圆形部件分离。在细长推动器部件的远端处的端部60可以接触到医疗器械的近端底座部分的圆形部件。在一个选择方案中，约束材料体可以具有管状横截面，而构成从其近端62到远端64延伸的一个管式套筒，并且上述端部位于该管式套筒内，以在管式套筒的形态恢复时，接合医疗器械的近端底座部分的圆形部件，而从管式套筒中推出医疗器械。约束材料体可以举例来说由诸如聚氨基甲酸乙酯之类的聚合物或者镍钛合金制成。
可选择的是，如图8和图9所示，可以通过注射来释放医疗器械。参考图8，医疗器械的近端包括一个远端治疗部分50和一个近端底座部分52，而且该近端底座部分包括至少一个圆形部件54。本发明提供了一种医疗器械输送组件70，包括一个细长的柔韧管状导管72，该导管具有远端74。柔韧管状导管可以由例如聚乙烯、聚对苯二甲酸乙二醇酯(polyethylene terephthalate)、聚氯乙烯、尼龙和离聚物、或者其他类似的合适聚合物、不锈钢或镍钛合金注射管(hypo tube)、及其他类似物制成。在一个实施例中，细长柔韧管状导管的远端呈截头圆锥状。例如，柔韧管状导管72可以包括管状远侧尖端76，该管状远侧尖端具有近端78，近端78例如通过像氰基丙烯酸盐粘合剂之类的粘合剂粘合而安装到柔韧管状导管远端的外表面上。可选择将管状远侧尖端加热粘合到柔韧管状导管的远端，或通过其他合适的方式将其安装到柔韧管状导管的远端。管状远侧尖端具有内腔80和远端82，远端82的表面确定了远端开口84。在一个方面看，管状远侧尖端的远端的直径小于近端，从而医疗器械的近端可以被容纳到管状远侧尖端的内腔内。因此管状远侧尖端通常呈截头圆锥状。另外，导管的远端和管状远侧尖端均呈圆锥管状也是合适的。
管状远侧尖端典型地由易变形的材料制成，该材料的刚度足以将医疗器械的近端保留在管状远侧尖端的内腔内。易变形的材料例如可以是形状记忆聚合物、弹性体、可用商品名是PEBAX、Hytrel、Arnitel、Riteflex的聚合物、诸如聚对苯二甲酸乙二醇酯(polyethyleneterephthalate，PET)或高浓聚乙烯(HDPE)的热缩管(heat shrink tubing)、或形状记忆金属，其中弹性体例如为聚氨基甲酸乙酯、尼龙、PEBAX聚合物、Teloflex、聚丁基对苯二酸酯(polybutyl terephthalate，PBT)，形状记忆金属例如为那类可用商品名NITINOL购到的镍钛合金。
本发明还提供了用于将被容纳于管状远侧尖端的内腔中的医疗器械的近端推出的装置，以便在病人的血管系统内的所需治疗位置将医疗器械的近端从管状远侧尖端的远端开口排出。如图8所示，用于将医疗器械的近端从管状远侧尖端的内腔推出的装置可以是细长柔韧推动器部件86，例如为同轴设置于细长柔韧管状导管内的柔韧金属丝。推动器部件的近端88从细长柔韧管状导管的近端伸出，而且可以在推动器部件的近端包括一个凸缘或限位部分90以限制推动器部件穿过输送导管的运动，而且推动器部件的远端92适于接触医疗器械的近端并将其从管状远侧尖端推出。推动器部件的远端也可以呈相应的截头圆锥状，为的是能够伸出到达导管的远端，从可变形的(yieldable)管状远侧尖端对医疗器械的近端施加力，从而推出医疗器械的近端。
也可以用一种液压释放机构来注射医疗器械。如图9所示，可以将上述管状远侧尖端的尺寸设计成能够在腔内器械(endoluminaldevice)的近端周围形成紧密的液体密封，而且用于推出腔内器械的装置举例来说可以是注射器94，其具有柱塞96，用于对液体腔98内的液体如盐水加压，以通过可以连接到细长柔韧管状导管的近端的柔韧管口100来提供加压的液体，从而在细长柔韧管状导管内提供加压的液体而从管状远侧尖端排出上述腔内装置的近端。
应该认识到，可以利用其他机构，例如转动释放机构，来释放所述抗拉伸医疗器械。由以上所述显而易见的是，虽然阐明和描述了本发明的特别形式，但在不超出本发明的构思和范围的前提下，可以进行各种改动。因此，本发明仅应由所附权利要求来限定。

Claims (42)

1.一种用于在病人的血管系统内释放和放置的抗拉伸医疗器械，包括：
一血管阻塞线圈，其具有一近端和一远端，所述血管阻塞线圈确定了一介于所述近端和远端之间的空腔；
一抗拉伸部件，其延伸穿过所述血管阻塞线圈的所述空腔，所述抗拉伸部件具有一第一端和一第二端，所述抗拉伸部件的所述第一端固定连接到所述血管阻塞线圈的所述远端，所述抗拉伸部件的所述第二端未被连接到所述血管阻塞线圈的所述近端，其中所述抗拉伸部件在所述第二端可分离地安装到细长推动器部件，以便在病人的血管系统内放置所述血管阻塞线圈。
2.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件被制成带。
3.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件被制成丝。
4.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件被制成编织物。
5.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件被制成初级线圈。
6.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件被制成多股材料。
7.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件是由聚合物制成的纤维。
8.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件是由聚合物制成的纤维，该聚合物选自：乙烯-辛烯共聚物、聚丙烯和聚乙烯。
9.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件是由金属制成的。
10.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件由一种材料制成，该材料选自：铂和镍钛合金。
11.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸部件是不透射线的。
12.如权利要求8所述的抗拉伸医疗器械，其中所述血管阻塞线圈是通过加热所述纤维的端部而被连接到所述抗拉伸部件的所述第一端的。
13.如权利要求1所述的抗拉伸医疗器械，进一步包括一细长推动器部件，其中所述抗拉伸部件被可分离地安装到所述细长推动器部件上以将所述血管阻塞线圈放置在病人的血管系统内。
14.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸医疗器械可以通过注射来释放以便放置。
15.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸医疗器械可以通过机械方式来释放以便放置。
16.如权利要求1所述的抗拉伸医疗器械，其中所述抗拉伸医疗器械是通过一可分离纤维连接器而被可分离地安装到一推动器部件上的。
17.如权利要求16所述的抗拉伸医疗器械，其中所述可分离纤维连接器可以通过加热所述可分离纤维连接器而被分离。
18.一种用于在病人的血管系统内释放和放置抗拉伸医疗器械的装置，包括：
一血管阻塞线圈，其具有一近端和一远端，所述血管阻塞线圈确定了一介于所述近端和远端之间的空腔；
一细长推动器部件，其具有一邻近所述血管阻塞线圈的所述近端的远端；和
一抗拉伸部件，其延伸穿过所述血管阻塞线圈的所述空腔，所述抗拉伸部件具有一第一端和一第二端，所述抗拉伸部件的所述第一端固定连接到所述血管阻塞线圈的所述远端，所述抗拉伸部件的所述第二端未被连接到所述血管阻塞线圈的所述近端，并且所述抗拉伸部件的所述第二端被可分离地连接到所述细长推动器部件的所述远端上以将所述血管阻塞线圈放置在病人的血管系统内。
19.如权利要求18所述的装置，其中所述抗拉伸部件被制成带。
20.如权利要求18所述的装置，其中所述抗拉伸部件被制成丝。
21.如权利要求18所述的装置，其中所述抗拉伸部件被制成编织物。
22.如权利要求18所述的装置，其中所述抗拉伸部件被制成初级线圈。
23.如权利要求18所述的装置，其中所述抗拉伸部件被制成多股材料。
24.如权利要求18所述的装置，其中所述抗拉伸部件是由聚合物制成的纤维。
25.如权利要求18所述的装置，其中所述抗拉伸部件是由聚合物制成的纤维，该聚合物选自：乙烯-辛烯共聚物、聚丙烯和聚乙烯。
26.如权利要求18所述的装置，其中所述抗拉伸部件是由金属制成的。
27.如权利要求18所述的装置，其中所述抗拉伸部件是由铂制成的。
28.如权利要求18所述的装置，其中所述抗拉伸部件是不透射线的。
29.如权利要求24或25所述的装置，其中所述抗拉伸部件具有第一端和第二端，并且所述血管阻塞线圈是通过加热所述纤维的端部而被连接到所述抗拉伸部件的所述第一端的。
30.如权利要求18所述的装置，其中所述抗拉伸部件通过一连接到所述推动器部件的纤维材料，而被可分离地连接到该推动器部件的所述远端。
31.如权利要求18所述的装置，其中所述血管阻塞线圈通过位于该血管阻塞线圈的所述近端处的所述血管阻塞线圈的一移位部分，而被可分离地安装到所述推动器部件的所述远端。
32.如权利要求18所述的装置，其中所述血管阻塞线圈通过固定在所述线圈的所述近端作为套节的环，而可分离地安装到所述推动器部件的所述远端。
33.如权利要求18所述的装置，其中所述抗拉伸医疗器械可以通过注射来释放以便放置。
34.如权利要求18所述的装置，其中所述抗拉伸部件通过一可分离纤维连接器被连接到所述细长推动器部件，并且所述可分离纤维连接器可通过加热所述可分离纤维连接器而被分离。
35.如权利要求18所述的装置，进一步包括用于将所述抗拉伸部件从所述细长推动器部件的所述远端分离出来的装置，包括：
一纤维连接器，其将所述血管阻塞线圈可分离地安装到所述推动器部件上，以将该血管阻塞线圈放置于血管系统内；和
一用于分离所述纤维连接器的装置，其设置在该纤维连接器附近，当所述血管阻塞线圈到达血管系统内的期望位置时，使所述纤维连接器从所述推动器部件释放所述血管阻塞线圈以便放置该血管阻塞线圈。
36.如权利要求35所述的装置，其中所述用于分离所述纤维连接器的装置包括电阻加热丝。
37.如权利要求35所述的装置，其中所述纤维连接器是由热塑性材料制成。
38.如权利要求35所述的装置，其中所述纤维连接器是由聚乙烯制成的。
39.如权利要求18所述的装置，进一步包括用于将所述抗拉伸部件从所述细长推动器部件的所述远端分离出来的装置，包括：
一纤维连接器，其将所述血管阻塞线圈可分离地安装到所述推动器部件上，以将该血管阻塞线圈放置于血管系统内；和
一用于分离所述纤维连接器和所述抗拉伸部件的装置，其设置在该纤维连接器和所述抗拉伸部件附近，当所述血管阻塞线圈到达血管系统内的期望位置时，使所述纤维连接器从所述推动器部件释放所述血管阻塞线圈以便放置该血管阻塞线圈。
40.如权利要求39所述的装置，其中所述用于分离所述纤维连接器和所述抗拉伸部件的装置包括电阻加热丝。
41.如权利要求39所述的装置，其中所述纤维连接器是由热塑性材料制成的。
42.如权利要求39所述的装置，其中所述纤维连接器是由聚乙烯制成的。
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