CN101626801A - 神经学装置 - Google Patents

神经学装置 Download PDF

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CN101626801A
CN101626801A CN200780034915A CN200780034915A CN101626801A CN 101626801 A CN101626801 A CN 101626801A CN 200780034915 A CN200780034915 A CN 200780034915A CN 200780034915 A CN200780034915 A CN 200780034915A CN 101626801 A CN101626801 A CN 101626801A
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史蒂文·斯特里特菲尔德·吉尔
马修·大卫·弗雷德里克·斯特拉顿
雨果·乔治·戴瑞克
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Renishaw Ireland Ltd
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Abstract

一种用于插入脑部来引导可植入器械的导向元件，该导向元件包括细长部件，该细长部件的成分具有至少80％的碳化钨。该导向元件可以具有涂层，例如生物相容性塑料材料，该涂层的弹性比该细长部件的弹性大。

Description

神经学装置
技术领域
本发明涉及用于神经外科的装置，用于定位神经外科装置。特别是，本发明涉及用于插入脑部来引导管状器械例如导管和引管的导向元件。
背景技术
血脑屏障对于向神经系统输送治疗试剂来说是一种相当大的阻碍。术语治疗试剂包括具有治疗效果的物质，例如药物化合物、遗传物质、生物制剂(即，利用活体器官例如干细胞合成的制剂)。绕开该障碍的技术发展能够革命性地治疗帕金森综合症、亨廷顿综合症和阿耳茨海默氏病以及多形性成胶质细胞瘤。已经研制出了有希望抑制或甚至反转这些疾病的基础病理学过程的新型试剂。但是，这些治疗试剂的局限性在于，借助传统方法(例如，口服或静脉内)输送时它们并不能穿过血脑屏障，因此无法到达脑部中有需求的结构。
对流增强输送(CED)允许直接向中枢神经系统输送治疗试剂，而不需要让治疗试剂穿过血脑屏障。CED利用纤细的颅内导管和低的输注速率直接向脑细胞外间隙内注入药物。与直接脑实质内注射、包被细胞和可生物降解聚合物形成对照，CED不依赖于扩散。使用精心设计的、具有精确受控的输注速率的套管会产生压力梯度，治疗试剂沿着压力梯度直接进入细胞外间隙。因此，即便对于相对较大的分子，也能够在较大体积的脑和脊髓上实现受控的均匀分布。
国际专利申请WO03/077764公开了在人或非人脑部植入导管用于脑实质内药物输送。因此，可以通过该导管向希望的脑部目标间歇性地或持续性地泵送药物。
WO03/077764进一步公开了用于向脑部目标纵向引导器械的立体导向件(stereoguide)，该立体导向件限定了轴线，所述器械可以沿着该轴线插入。立体导向件由立体定向框架(stereotactic frame)承载，该立体定向框架牢固连接到病人的颅骨。立体导向件可以在立体定向框架上调节，以便非常精确地定位，从而指导手术器械到达希望位置。导线可以用来加强插入脑部的管状器械的刚性或者用来引导管状器械，所述管状器械例如输送试剂的导管或插入脑部且其他器械可以从中通过的引管。
发明内容
本发明的第一方面提供一种用于插入脑部以引导可植入器械的导向元件，其中该导向元件包括细长部件，该细长部件的成分具有至少80％的碳化钨。
优选该细长部件的直径小于1mm。
更优选该细长部件的直径小于0.6mm。更为优选地，该细长部件的直径小于或等于0.4mm。
该细长部件可以包含5-20％的钴或镍。更优选地，该细长部件包含约5％的钴或镍。
导向元件可以进一步包括包围该细长部件的涂层。该涂层可以包含不同于该细长部件的材料。该涂层可以包含生物相容性材料。该涂层可以包含塑料材料。该涂层可以是聚酰亚胺、聚醚醚酮optima(peek optima)或工业聚氨酯(technical polyurethane)中的一种。优选地，该涂层的材料比导向元件芯部的材料弹性更大。
优选该导向元件是导线或导杆。
本发明的第二方面提供一种用于插入脑部来引导可植入器械的导向元件，其中该导向元件包括细长部件，该细长部件包括受力时断裂而非弯曲的材料。
本发明的第三方面提供一种用于插入脑部来引导可植入器械的导向元件，其中该导向元件包括细长部件，该细长部件包含非延展性材料。
附图说明
以下将借助实例参照附图描述本发明的实施方式，其中：
图1示出了引管的侧视图；
图2示出了内管的侧视图；
图3示出了导管的侧视图；
图4A示出了组装好的引管、内管和导管的侧视图；
图4B示出了组装好的、插入脑部的引管、内管和导管；和
图5示出了利用立体导向件插入脑部的导线。
具体实施方式
图1-3分别示出了根据本发明的引管、内管和导管。
引管10在图1中示出，包括一端具有接头(hub)14的管12。在该实例中，引管由聚氨酯塑料例如聚碳酸酯基聚氨酯(carbothane)55DB20制成。但是，引管可以使用任何生物相容的且在室温下刚性足够维持其中心孔的材料制成。在该实例中，管12的外径为0.6mm，内径为0.5mm。
引管通过外科医生在颅骨上开设的孔(例如，钻孔)插入脑部。一旦该管12插入脑部，接头可以连接到病人的颅骨，例如利用丙烯酸系胶粘剂粘接到颅骨的孔中。可以使用导线引导引管就位，正如WO03/07784所公开的。在插入之前，将引管切割成尚未到达目标的长度。引管远端通常距离目标几个毫米。
引管的接头优选呈拱形，并具有切开的狭缝16，该狭缝将所述管的中心孔与接头的侧部连接。
内管18在图2中示出，包括两段连接的管，远管20，其在本实例中外径为0.42mm，内径为0.2mm；和近管22，其直径较大。止动元件24连接近管和远管。远端管和近端管部分通常由聚氨酯塑料例如carbothane 85AB20制成，当然也可以使用其他材料制成。止动元件24在本实例中也用聚氨酯塑料例如carbothane 72DB20制成。当然也可以使用其他合适的材料。
止动元件24具有基本上为柱状的中心主体26和一对径向对置的翼部28、30，所述翼部各自包含埋头螺孔32、34，从而止动元件可以拧到病人颅骨的外表面上。带有远端管部分和近端管部分以及止动元件的内管在WO03/077785中描述地更为详细。
止动元件具有两种功能。首先，在将内管插入引管时，止动元件抵靠引管的接头，从而形成止动件并限定远管从引管的管延伸的长度。其次，止动元件的翼部用于将内管固定到病人的颅骨。
将内管固定到病人颅骨的功能可以用替代方式实现。例如，可以在近管上设置成对翼部，例如通过在该管上进行包覆成型(overmould)而设置。所述翼部可以设置有孔，以容纳螺钉，这些螺钉在被拧入颅骨的时候将所述翼部和近管固定就位。这种布置允许一个翼部叠加在另一个翼部上面，以便将单个螺钉穿过所述翼部的两个孔而插入。这种布置的优势在于，导致对近管中的导管产生某种夹持。
导管36在图3中示出，包括纤细的管38，导管36通常用熔融石英制成。可以使用惰性且病毒结合性低的替代材料制造导管36。熔融石英的外径通常为0.2mm，内径为0.1mm。导管在其一端设置有用作止动件的棘突40。该棘突可以直接模制在导管上，并且可以用聚氨酯塑料例如carbothane制成。
棘突40具有阶梯柱状轮廓，并带有中心孔。直径最大的区域41具有平直侧部，形成止挡件，当导管插入内管时，近管的端部抵靠该止挡件。在直径最大的区域的另一侧是柱状部分43，其带有直径减小的收敛部分45。使用中，将管推入该柱状部分，直到其抵靠直径最大的区域41。当管经过收敛部分45时，其变形从而形成密封件。当导管36插入内管18时，推压近管22的端部穿过其中一个柱状部分43。将导管连接到泵的连接管(未示出)可以通过相同的方式连接到棘突的另一个柱状部分。
为了进行神经外科手术，医生首先需要了解病人的神经解剖学结构，从而辨别希望的目标位置。通常将立体定向基准框架固定到病人头部来实现这一点，可以在诊断图像上观察到该框架的元件，并且可以由此进行测量。立体定向框架然后用作平台，可以利用设置在所测量的坐标的立体导向件将器械从该平台导入希望的目标。一旦将器械导入希望的目标，则开始治疗。在WO03/077784中有更为详细的描述。
立体导向件用于首先将导向元件朝向目标插入脑部。利用固紧的立体导向件，将引管穿过导向元件，从而将引管插入脑部并固定就位，如上所述。然后去掉导向元件，将引管留在合适位置上。图4A和图4B示出了组装好的引管10、内管18和导管36。图4A是位于颅骨外侧的该组件，而图4B是导管插入脑部42后的该组件。图4B示出了通过骨胶粘剂46在颅骨44的孔中固定就位的引管10的接头14。将远管20插入引管10，直到止动元件24抵靠引管的接头14，从而将内管插入引管。止动元件24因此用作止动件来控制插入脑部的内管的长度。将导管36插入内管并推动导管36，直到其棘突抵靠内管的近管22的端部。
一旦引管、内管和导管全部插入，则包含从引管的接头伸出颅骨的导管的近管弯曲90度，以使止动元件靠着颅骨放平，如图4B所示。然后利用穿过埋头螺孔的螺钉48将其固定就位。引管的接头14上切开的狭缝16允许进行90度弯曲。可以在内管上设置额外的固定装置(例如包覆成型在内管上的翼部)提供额外的夹持，螺钉可以通过该另外的固定装置连接到颅骨。
引管、内管和导管的长度布置成让内管延伸到脑部的长度大于引管(例如，10mm)且导管延伸到脑部的长度大于内管(例如，10mm)。
在引管、内管和导管全部就位的情况下，可以经由连接管将导管连接到泵(未示出)，该连接管连接到导管的棘突。
WO03/077784公开了一种将纤细器械例如导管和电极插入脑部的方法。直径为0.6mm的小直径钨导线插入细管中并固定在其中，让导线从该管的端部伸出。利用立体导向件将细管和导线一起降入脑部的目标处。然后去掉细管并将引管拧在导线上和插入脑部。一旦安装好引管，则去除导线。
实践中，可以在不利用细管的情况下插入导线。
图5示出了利用立体导向件50插入脑部的导线52。立体导向件由立体定向框架(未示出)承载，该立体定向框架牢固连接到病人的颅骨54。图5示出了穿过导向元件54、56和立体导向件的夹子58以及颅骨54上的孔60插入脑部的导线52。示出了引管10拧在导线上，准备插入脑部。在WO03/077784中公开了适合将导线插入脑部的立体导向件。
为了插入非常纤细的导管，需要直径非常小的导线，例如直径为0.2mm。
当导线插入脑部时，其必须穿透软脑膜，软脑膜是脑膜的易损最内层，所述脑膜包围脑部和脊髓。纤薄的、网状的软脑膜紧密包围脑部整个表面，向下进入脑皮层的裂隙。软脑膜与室管膜连接，而室管膜被覆于脑室中从而形成产生脑脊髓液的脉络丛。
钨导线的缺点在于会在这些小直径下弯曲。这种弯曲会导致导向元件末梢到达脑部中的错误目标，导致随后的引管和导管安装错误。
在本发明中，导向元件(例如，导线或导杆)用例如碳化钨的材料制成，该材料是硬质且脆性的材料。
碳化钨与钨具有不同的失效模式。由于钨为非延展性材料，所以受力时将会断裂而非弯曲。这与碳化钨受力时屈服并变形是不同的。因此，由受力时断裂而非弯曲的材料制成的导向元件(例如，导线或导向元件)和/或由包含非延展性材料例如碳化钨的材料制成的导向元件(例如，导线或导向元件)将不会弯曲，并且末梢插入正确的位置。
导向元件包括细长部件，例如由碳化钨制成的细长部件。碳化钨可以包含一定百分比的其他元素，例如钴。添加钴的作用是改善粘合性，并且添加的数量一般介于5-20％(重量)之间。碳化钨导线的适当组成是95％WC和5％Co，当然也可以使用其他组成。替代的添加剂是镍，镍也能改善粘合性。镍还有提高耐腐蚀性和生物相容性的效果。和前述一样，镍的添加范围介于5-20％(重量)之间。
导向元件的碳化钨细长部件的尺寸实例为直径0.36mm。优选地，碳化钨导向元件的细长部件的直径小于1mm，更优选地，直径小于0.6mm，进一步优选地，直径小于或等于0.4mm。
当导向元件插入脑部时，其穿过相对较硬的软脑膜(大约5mm)，然后穿过较软的脑部区域。因此，碳化钨的任何断裂将会发生在最初的5mm，在此期间，可以容易地取出断裂的导向元件。
导向元件的细长部件可以用断裂时可以将其保持在一起的材料涂覆。该涂层包含生物相容性材料，所述材料的弹性比碳化钨芯部的弹性更大。
涂层还可以包含生物相容性塑料材料，例如聚酰亚胺、聚醚醚酮optima或工业聚氨酯。可以通过包覆成型施加适当的涂层。涂层厚度选择为能够将导向元件碎片有效地保持在一起同时限制导向元件的直径增大。涂层厚度通常为0.1-0.25mm的范围。
导向元件例如可以包括导线或导杆。
导向元件可以用除碳化钨之外的受力时断裂而非弯曲的材料和/或非延展性材料制成。

Claims (21)

1.一种用于插入脑部来引导可植入器械的导向元件，其特征在于，所述导向元件包括细长部件，所述细长部件的成分具有至少80％的碳化钨。
2.如权利要求1所述的导向元件，其特征在于，所述细长部件的直径小于1mm。
3.如权利要求2所述的导向元件，其特征在于，所述细长部件的直径小于0.6mm。
4.如权利要求3所述的导向元件，其特征在于，所述细长部件的直径小于或等于0.4mm。
5.如前述权利要求任一项所述的导向元件，其特征在于，所述细长部件包含5-20％的钴或镍。
6.如前述权利要求任一项所述的导向元件，其特征在于，所述细长部件包含约5％的钴或镍。
7.如前述权利要求任一项所述的导向元件，其特征在于，所述导向元件进一步包括包围所述细长部件的涂层。
8.如权利要求7所述的导向元件，其特征在于，所述涂层包含不同于所述细长部件的材料。
9.如权利要求7或8所述的导向元件，其特征在于，所述涂层的材料比所述细长部件的材料弹性更大。
10.如权利要求7-9任一项所述的导向元件，其特征在于，所述涂层包含生物相容性材料。
11.如权利要求7-10任一项所述的导向元件，其特征在于，所述涂层包含塑料材料。
12.如权利要求7-11任一项所述的导向元件，其特征在于，所述涂层包含选自聚酰亚胺、聚醚醚酮optima或工业聚氨酯之一的材料。
13.如前述权利要求任一项所述的导向元件，其特征在于，所述导向元件是导线或导杆。
14.一种用于插入脑部来引导可植入器械的导向元件，其特征在于，所述导向元件包括细长部件，所述细长部件包括受力时断裂而非弯曲的材料。
15.如权利要求14所述的导向元件，其特征在于，所述导向元件进一步包括包围所述细长部件的涂层。
16.如权利要求15所述的导向元件，其特征在于，所述涂层的材料比所述细长部件的材料弹性更大。
17.如权利要求14或16所述的导向元件，其特征在于，所述涂层包含生物相容性材料。
18.一种用于插入脑部来引导可植入器械的导向元件，其特征在于，所述导向元件包括细长部件，所述细长部件包含非延展性材料。
19.如权利要求18所述的导向元件，其特征在于，所述导向元件进一步包括包围所述细长部件的涂层。
20.如权利要求19所述的导向元件，其特征在于，所述涂层的材料比所述细长部件的材料弹性更大。
21.如权利要求19或20所述的导向元件，其特征在于，所述涂层包含生物相容性材料。
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