CN101668490B - 使用导管展开治疗器械的设备和方法 - Google Patents

使用导管展开治疗器械的设备和方法 Download PDF

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CN101668490B
CN101668490B CN2008800092504A CN200880009250A CN101668490B CN 101668490 B CN101668490 B CN 101668490B CN 2008800092504 A CN2008800092504 A CN 2008800092504A CN 200880009250 A CN200880009250 A CN 200880009250A CN 101668490 B CN101668490 B CN 101668490B
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D·甘地
K·拉姆齐普尔
N·H·帕迪利亚
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Abstract

用于展开介入治疗器械(44)的设备(40)，其包括细长柔性推动器构件(42)和连接到第一连接器构件(58)的可分离部分的治疗器械，第一连接器构件(58)被安装到具有细长的第二连接器构件(66)的柔性推动器构件，该细长的第二连接器构件(66)被连接到治疗器械。第一连接器构件或第二连接器构件能够通过加热被断开，并且热源(70)被提供用以加热并断开第一连接器构件或第二连接器构件以释放治疗器械。

Description

使用导管展开治疗器械的设备和方法
交叉引用相关申请
此为2004年12月22日提交的序列号为11/020,936申请的部分继续申请，序列号为11/020,936申请为2002年11月7日提交的序列号为10/290,777申请的部分继续申请，序列号为10/290,777申请为2000年2月9日提交的序列号为09/501,466申请的部分继续申请，现在是美国申请No.6,478,773。
技术领域
本发明一般涉及用于血管内介入性治疗处理的器械或用于治疗血管系统内疾病的血管手术，而且更具体地涉及用于传递血管内介入器械的系统和方法，诸如用以治疗动脉瘤。
背景技术
血管介入器械，诸如血管栓塞器械，通过利用导管一般被置于人体血管系统内。血管介入器械，诸如支架，可以被置于封闭血管内以帮助血液流过血管，并且血管栓塞器械一般被置于血管内通过形成栓子以阻塞血液流过血管，或被置于源于血管的动脉瘤内衣在动脉瘤内形成栓子。支架可以具有各种结构，但是一般需要被置于血管内的预定位置并且之后可以被释放。用于这些过程的血管栓塞器械也可以具有各种结构，并且使用外部手术方式的血管夹、可拆卸的血管栓塞充气囊、和血管栓塞器械产生的栓子，诸如一个或多于一个血管栓塞线圈可以治疗动脉瘤。
传递此血管栓塞器械一般可以通过各种装置完成，包括通过导管，在导管中通过推动器推动器械通过导管末端的开口来部署器械。血管栓塞器械可以以下面方式制造：他们以线性形状穿过导管的内腔并且在被部署到被治疗区(诸如动脉瘤)后呈现初始形成的复杂形状。
用来栓塞血管病变的一种传统可释放充气囊导管具有由诸如亲水聚合物材料制成的管部分，该管部分位于导管和充气囊之间，管通过加热可以被融化，或者当被加热时，可以在血液中溶解，并且提供电极来加热此管。将充气囊从充气囊导管分离的另一种传统技术包括：当为加热连接构件的电极供电时，融化和断开充气囊和导管本体之间的连接构件。当连接构件被加热到大约70℃并且施加稍微的拉力，充气囊可以从导管主体上分离。
还知道一种植入传递装置，其用于传递植入体，诸如栓塞线圈，当暴露在本体温度时，利用形状记忆去耦合被激活的机构。冷却溶液在引入和放置植入体期间流过导管以便防止在植入体要被释放之前提前释放植入体。另一种植入传递装置包括电加热系统用以将耦合机构加热到形状记忆材料返回到其初始形状的温度，以展开植入体。
另一种已知的器械，在其上植入的器械可以通过使用高频电流被分开，高频电流融化和分离用来固定被植入器械的树脂直到器械被展开。在另一种已知的器械中，通过激活电连接在电可分离连接的电源来分开被植入的器械来溶解电可分离连接。
在另一种传统技术中，导电导丝传递高频电流穿过导丝来融化和分离接合点以将植入的器械从导丝上分开。在该过程期间患者是接地的，并且电流通过导丝被引入而不是使用两条电流通路。
通过融化或溶解导管尖和植入器械之间的中间部分而释放介入器械的此类器械在分开期间可能热损伤周围组织，这可能在血液中导致栓塞，并且还可能潜在释放不想要的小部分材料到血液中，这也坑在血液中导致栓塞。因此，需要一种展开治疗介入器械的准确方法，而不要让步于植入体的位置，不会引起热损伤周围组织，并且不会释放不想要的小部分材料到血液中，而且没有在血液中形成栓塞的危险。本发明满足这些和其他需要。
发明内容
简要地，并且通常地，本发明提供一种例如使用细长柔性推动构件展开血管内治疗器械的设备，诸如展开血管栓塞器械、微线圈、至少一个电极、支架、或镀膜线圈。治疗器械被连接在安装到柔性推动构件的第一连接器构件，该柔性推动器构件具有连接在第一连接器构件和治疗器械之间的细长第二连接器构件。第一连接器构件和第二连接器构件中的至少一个包括可分离部分，该可分离部分能够被分离，诸如通过融化或降解、通过加热。提供热源用以加热和断开第一连接器构件或第二连接器构件的可分离部分以释放治疗器械。第一连接器构件可以由模塑热塑塑料材料形成，诸如高密度聚乙烯，并且细长的第二连接器构件可以是，例如连接器纤维、或带状物。细长的第二连接器构件也可以由热塑塑料材料形成，诸如高密度聚乙烯。热源优选基本包含在推动器构件内，此推动器提供足够的绝热以在分开治疗器械期间消除潜在的对周围组织的热损伤。因为可分离的第一连接构件在完全包含在推动器构件内的位置被加热和断开，所以潜在的释放不想要小部分材料到血液中并在血液中形成栓塞被充分地消除。
此外，本发明提供一种在患者血管内释放和展开治疗器械的设备，该设备包括细长的柔性推动器，此推动器具有内腔、被安装到细长柔性推动器构件的第一连接器构件。在一方面，第一连接器构件可以具有能够通过在细长柔性推动器构件内通过加热处理而被断开的可分离部分。细长的第二连接器构件被连接到治疗器械并且可分开地连接到第一连接器构件。因而，细长的第二连接器构件将治疗器械连接到推动器构件用以在血管内放置治疗器械，并且在一方面，细长的第二连接器构件可以具有能够通过在细长柔性推动器构件内经加热处理而被断开的可分离部分。
在一方面，热源可以被置于推动器构件的内腔内，其临近第一连接器构件以加热第一连接器构件的可分离部分以使第一连接器构件的可分离部分被断开并且释放细长的第二连接器构件，从而当治疗器械位于血管内的预定位置时，使治疗器械从柔性推动器构件分开并且展开治疗器械。
在另一方面，第一连接器构件可以由模塑热塑塑料材料形成，诸如例如高密度聚乙烯。第一连接器构件可以以延伸穿过推动器构件内腔的内径的杆、柱、环、或其他相似合适结构的形式被模塑。在另一方面，热源可以包括电阻热源线圈。可选地，热源可以包括感应环，并且可以被包括在第一连接器构件内，用以分离细长的第二连接器构件。控制单元一般被连接在热源上以为热源提供电流。柔性推动构件一般包括热绝缘轴，其具有与推动器构件内腔相通的进入接口，并且热源被设置在推动器构件的内腔内临近进入接口。柔性推动器构件具有末梢尖端，并且在一方面，热源可以与柔性推动器构件的末梢尖端间隔。
在其他方面，细长的第二连接器构件可以是连接器纤维，或可以带状物。治疗器械例如可以是血管栓塞器械、微线圈、至少一个电极、支架、或镀膜线圈。
本发明的这些和其他方面和优点根据下面详细描述和附图将变得显而易见，其通过举例本发明特征来说明。
附图说明
图1是用以释放和展开治疗器械的设备的第一实施例的俯视截面图。
图2是图1中的设备的侧视截面图。
图3是用以释放和展开治疗器械的设备的第二实施例的俯视截面图。
图4是用以释放和展开治疗器械的设备的第三实施例的俯视截面图。
图5是图1中的设备的侧视截面图，其图示说明了治疗器械的释放。
图6是图3中的设备的侧视截面图，其图示说明了治疗器械的释放。
图7是图4中的设备的侧视截面图，其图示说明了治疗器械的释放。
图8是用以释放和展开治疗器械的设备的第四实施例的俯视截面图。
图9是图8中的设备的侧视截面图。
图10是图8中的设备的侧视截面图，其图示说明了治疗器械的释放。
具体实施方式
尽管血管栓塞器械传统地通过推动器器械穿过传递导管被传递到待治疗的患者血管的一部分中，但是此类传统的方法可能包括用多种方法将血管栓塞器械从推动器器械上分离，这些方法可能导致损伤血管，诸如通过在分开期间导致热周围组织热损伤，这可能导致血液中的栓塞，或通过释放不想要的材料粒子到血液中，这可以导致血液中的栓塞。
参考图1-10，本发明提供一种设备40，其包括细长柔性推动器构件42以释放和展开治疗器械44，诸如血管器械，例如其可以是患者血管内的微线圈，该微线圈穿过传递导管46，仅仅显示一部分。治疗器械例如可选地可以是一个或多于一个电极、支架、镀膜线圈等。推动器构件具有轴47，其提供对内腔48热绝缘的措施，这将在下面进行详细描述。推动器构件的轴的外径一般大约是0.015英寸，内径大约是0.007英寸，并且可以由聚对苯二甲酸乙二酯(PET)管形成。
在图1、2和5中所说明的第一实施例中，推动器构件具有部分50和位于推动器构件的末端56的插头54，所述部分50具有进入接口52，其与内腔相通，插头54一般通过粘合剂，诸如氰基丙烯酸酯粘合剂，固定在推动器构件的末端内。
第一连接器构件58安装到细长柔性推动器构件，并且具有设置在细长柔性推动器构件内的可分离部分60，该可分离部分60能够通过加热被断开。第一连接器构件一般由模塑热塑塑料材料形成，诸如高密度聚乙烯。在第一实施例中，第一连接器构件可以以延伸横过推动器构件内腔的内径的相对两侧并且连接在推动器构件内腔的内径的相对两侧之间的杆61的形式被模塑，如图1和图2所示。
在图3和图6中说明的第二实施例中，与第一实施例所示的元件相同的元件使用相同的参考数字，第一连接器构件可以具有柱构造62，该柱构造62在一端连接到推动器构件，并且柱构造62具有自由端，所述自由端带有比进入接口更大的扩大部分63，并且柱构造62具有可分离部分64，该可分离部分64能够通过加热被断开，其一般由模塑热塑塑料材料形成，诸如高密度聚乙烯，如图3所示。
在图4和图7中说明的第三实施例中，与第一实施例所示的元件相同的元件使用相同的参考数字，第一连接器构件可以具有环构造65，该环构造65被连接到推动器构件，并且具有可分离部分67，该可分离部分67能够通过加热被断开，其一般由模塑热塑塑料材料形成，诸如高密度聚乙烯，例如如图4所示。
在每个实施例中，治疗器械包括细长的第二连接器构件66，该细长的第二连接器构件66被连接到治疗器械，诸如通过被弯曲穿过微线圈治疗器械的端线圈68。细长的第二连接器构件可选地可以被系在或粘结到治疗器械，诸如通过热焊接，或通过粘结剂，诸如，氰基丙烯酸酯粘合剂。当第一连接器构件是杆或柱时，细长的第二连接器构件一般被弯曲包围第一连接器构件，或当第一连接器构件是环时，细长的第二连接器构件被弯曲穿过第一连接器构件。细长的第二连接器构件可以是连接器纤维、或带状物，其可以例如由聚乙烯、或其他合适纤维材料制成。在已知的优选实施例中，细长的第二连接器构件由聚乙烯形成，并且尽管细长的第二连接器构件的直径最薄大约为0.0005英寸，但是其直径一般大约是0.015-0.030英寸，并且其可以由具有高抗拉强度的多种热塑塑料材料形成。细长的第二连接器构件可选地还可以例如由合适的高抗拉强度的材料形成。
在前面实施例中，热源，诸如电阻热源线圈70，被置于推动器构件的内腔内，其临近第一连接器构件的可分离部分以加热第一连接器构件的可分离部分进而使第一连接器构件的可分离部分被断开并且释放细长的第二连接器构件，从而当治疗器械位于血管内的预定位置时，使治疗器械从柔性推动器构件分离并且展开治疗器械。热源可以与推动器构件的末端间隔。热源通过电连接器72被连接到控制单元74，控制单元74为电阻热源线圈提供电流以使可分离连接器构件被断开并且释放治疗器械。可选地，热源可以通过其他方法传递热量到可分离连接器部分，诸如例如热机械能量、电磁能量或射频(RF)能量。推动器构件的内腔优选提供绝缘空间和壁厚以容纳加热的可分离连接器从而避免热损伤周围组织，并且帮助容纳多块可分离连接器构件，多块可分离连接器构件在加热可分离连接器构件期间被形成以展开治疗器械。因此，治疗器械通过细长的第二连接器构件可以可分开地连接在第一连接器构件上，以用于将治疗器械放置在血管内。
在图8-10中说明的第四实施例中，与第一实施例所示的元件相同的元件使用相同的参考数字，第一连接器构件可以具有环76，该环76的结构被安装到细长柔性推动器构件。在第四实施例中，第一连接器构件优选是感应环，该感应环提供置于推动器构件内腔内的热源。并且具有狭窄、薄边部分或叶片78，其可以被加热。叶片被设置成与细长的第二连接器构件66接触，诸如纤维或带状物。如上所述，当被充分加热时，其可以被融化。第二连接器构件被连接在治疗器械上，以便当感应环的叶片被加热时，诸如如上所述，通过来自连接在控制单元74的电连接器72的电流加热，第一连接器构件将分离第二连接器构件以释放治疗器械。
根据以上所述，显而易见的是，尽管已经说明和描述了具体形式的本发明，但是在不偏离本发明的思想和范围的情况下可以进行各种修改。此外，除了所附权利要求外，其他说明和描述不是为了限制本发明。

Claims (11)

1.一种用于在患者血管内释放和展开治疗器械的设备，其包括：
细长柔性推动器构件，其具有内腔；
第一连接器构件，其被安装到所述细长柔性推动器构件的内径并延伸横过所述细长柔性推动器构件的内径，所述第一连接器构件具有置于所述细长柔性推动器构件内的可分离部分，所述可分离部分能够通过加热被断开，并且所述第一连接器构件：具有杆构造，所述杆构造延伸横过所述推动器构件的内腔的内径的相对两侧并且被连接在所述推动器构件的所述内腔的所述内径的相对两侧之间；或者具有柱构造，所述柱构造在一端连接到所述推动器构件，并且所述柱构造具有带有扩大部分的自由端；或者具有环构造，所述环构造连接到所述推动器构件；
细长的第二连接器构件，其被连接到所述治疗器械并且可分开地连接到所述第一连接器构件，因而，所述细长的第二连接器构件将所述治疗器械连接到所述推动器构件用以在血管内放置所述治疗器械；
热源，其被置于所述推动器构件的内腔内，所述热源临近所述第一连接器构件的所述可分离部分以加热所述第一连接器构件的所述可分离部分，进而使所述第一连接器构件的所述可分离部分断开，并且释放所述细长的第二连接器构件，从而当获得所述治疗器械在血管内的预定位置时，使所述治疗器械从所述柔性推动器构件分开并且展开所述治疗器械。
2.根据权利要求1所述的设备，其中所述热源包括电阻热源线圈。
3.根据权利要求1所述的设备，进一步包括控制单元，并且其中所述热源通过电连接器被连接到所述控制单元，所述控制单元为所述热源线圈提供电流。
4.根据权利要求1所述的设备，其中所述柔性推动器构件包括热绝缘轴。
5.根据权利要求1所述的设备，其中所述热塑塑料是高密度聚乙烯。
6.根据权利要求1所述的设备，其中所述推动器构件包括进入接口，所述进入接口与所述推动器构件的所述内腔相通，并且所述热源被置于所述推动器构件的所述内腔内且临近所述进入接口。
7.根据权利要求1所述的设备，其中所述细长的第二连接器构件是连接器纤维。
8.根据权利要求1所述的设备，其中所述细长的第二连接器构件包括带状物。
9.根据权利要求1所述的设备，其中所述柔性推动器构件具有末梢尖端，并且所述热源与所述柔性推动器构件的所述末梢尖端间隔。
10.根据权利要求1所述的设备，其中所述治疗器械是血管栓塞器械。
11.根据权利要求1所述的设备，其中所述治疗器械包括微线圈。
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US7740637B2 (en) 2010-06-22
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