CN103203064B - 神经外科器械 - Google Patents

神经外科器械 Download PDF

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CN103203064B
CN103203064B CN201310092806.3A CN201310092806A CN103203064B CN 103203064 B CN103203064 B CN 103203064B CN 201310092806 A CN201310092806 A CN 201310092806A CN 103203064 B CN103203064 B CN 103203064B
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conduit
inner tube
guide wire
brain
annular gap
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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

一种用于插入脑部的导管组件。所述导管组件包括第一管部分，所述第一管部分由第一材料形成。所述第一管部分由第二材料环绕，所述第二材料的柔性比第一材料的柔性大，所述第二材料的E型洛氏硬度小于50。所述第二材料提供对第一管部分的减振。

Description

神经外科器械
本申请是申请人为“瑞尼斯豪（爱尔兰）有限公司”、申请日为“2007年8月20日”、申请号为“200780035158.0（对应的国际申请号为“PCT/GB2007/003178”）”、发明名称为“神经外科器械”的中国发明专利申请的分案申请。
技术领域
本发明涉及神经外科中使用的装置，具体而言，本发明设计用于将治疗药物输送到中枢神经系统的导管。
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明显的阻碍。术语治疗试剂包括具有治疗效果的物质，诸如药物化合物、遗传物质、生物制剂（即，利用活体器官诸如干细胞合成的制剂）。绕开该障碍的技术发展可以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较低的输注速率直接向脑细胞外间隙注入药物。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，也可以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公开了在人类或非人类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。对于长期药物输送，包含储存器的泵可以皮下植入，并且该储存器可以根据需要通过可触知的端口经皮再填充。
1999年10月出版的Am J Physical Regal Integr Comp Physical vol277Issue4，R1218-R1229中的论文“在直接输注脑部期间的焦点输送：流速、导管直径和组织机械性能的作用”描述了通过直接填隙输注控制药物输送。
该论文披露了流体以低流速通过植入的导管，能够认为所有的输注溶液输送到目标阻止。但是，以高流速，溶液可以回流导管轴，泄漏到表面，减少了对组织的输送。
以这种高流速，注入物在围绕导管的组织上形成压力，并且使得组织移离导管的表面，由此形成沿着导管的一部分长度的环形间隙。如果该环形间隙足够长，其可变成延伸的输注源，并且扭曲输注物分布的球对称。在极端情况下，该环形间隙可以延伸到脑表面，丧失的输注物直接进入脑脊髓液。
CED的主要局限在于，药物通过细胞外间隙的分布是不可预知的。CED影响治疗试剂的药物分配的主要因素在于导管设计、输注流速、导管放置部位、治疗试剂的负荷以及非特定的治疗试剂粘合。尽管已经进行了多种临床试验来使用该技术对具有神经变性疾病的患者给予治疗试剂或者生物活性试剂，但是可获得的证据揭示，使用的导管与成功的CED不相容。
药物分布的不可预知的关键因素之一在于输注的试剂沿着导管的插入轨迹回流。Neurosurg Focus20（3）：E12，2006-06-1-28中的论文“用于脑部疾病的治疗药物的对流增强输送及其优化”中披露了这种回流发生的两个原因之一。首先，如果导管以机械方式破坏组织足以允许围绕其外壁形成间隙，则会发生回流。在这种情况下，输注的试剂简单地沿着间隙回流，由此减小了输注物到达其所需的目标部位的百分比。这种回流会导致头皮坏死或者导致抗体发展。
即使当导管插入期间没有间隙形成或者当在外壁上密封时，也会发生第二种类型的回流。在这种固有的回流过程中，与输注过程有关的压力推靠在组织上并且使得组织从导管微小地分离，直到组织中的剪切力平衡压力长并且倒退的轴向流动停止。
本申请人旨在通过使用如WO03/077785中公开的小直径导管减小回流量。熔融石英有趣其低的病毒粘合特性是用于该导管的优选材料。这些特性是重要的，因为治疗试剂可能是病毒基的，例如会粘合到基材例如导管上的单纯疱疹，导致无效的输送。但是，已经显示，只有小百分比的病毒性输注会粘合到熔融石英上，因此熔融石英是用于输送的优选材料。
当流体在压力下流过导管时，导管经历振动。由刚性材料例如熔融石英制成的导管具有高的固有频率。当流体冲击导管时，其经历高频率小振幅的振动。导管的这种振动使得导管和其环绕的组织之间的间隙增加，由此增加了回流。
发明内容
根据本发明的第一方面，提供一种用于插入脑部的导管组件，所述导管组件包括第一管部分，所述第一管部分由第一材料形成，所述第一管部分由第二材料环绕，所述第二材料的柔性比第一材料的柔性大，所述第二材料的E型洛氏硬度小于50。
在一种优选实施方式中，所述第二材料包括与所述第一管部分同心的第二管部分。可替代的是，所述第二材料是所述第一管部分的部件。
所述组件可包括另一管部分，所述另一管部分与所述第一管部分同心，其中，在所述第二材料和所述另一管部分之间形成有环形间隙。
所述另一管部分可由柔性大于所述第一材料的材料形成。
所述第一管部分可以比所述另一管部分延伸的更长。
根据本发明的第二方面，提供一种用于插入脑部的导管组件，所述组件包括同心的内管部分和外管部分，在所述内管部分和外管部分之间存在环形间隙。
优选的是，所述同心的内管部分和外管部分都是刚性的。所述外管部分的弹性模量可以大于30GPa。
所述内管部分可包括熔融石英。所述外管部分可包括熔融石英。所述外管部分可包括不锈钢。
附图说明
以下将借助实例参照附图解释本发明的实施方式，其中：
图1示出了导引管的侧视图；
图2示出了内管的侧视图；
图3示出了导管的侧视图；
图4A示出了组装好的导引管、内管和导管的侧视图；
图4B示出了组装好的、插入脑部的导引管、内管和导管；和
图5示出了插入到脑部的导管、内管、和导引管的端部的剖视图。
具体实施方式
图1-3分别示出了根据本发明的导引管、内管和导管。
导引管10在图1中示出，包括一定长度的管12，一端具有接头（hub）14。在该实例中，导引管由聚氨酯塑料例如聚碳酸酯基聚氨酯（carbothane）55DB20制成。但是，导引管可以使用任何生物相容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。
导引管通过外科医生在颅骨上开设的孔（例如，钻孔）插入脑部。一旦该长度的管插入脑部，则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。可以使用导线将导引管导入就位，正如WO03/077784所公开的。在插入之前，将导引管切割成到不了目标部位。导引管远端通常距离目标几个毫米。
导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carbothane85AB20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carbothane72DB20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外表面。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，在将内管插入导引管时，止动元件抵靠导引管的接头，从而形成止动件并限定远管从导引管的管部延伸的长度。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，包括纤细的管部分38，导管36通常用熔融的石英制成。可以使用惰性且病毒粘附性低的替代材料制造。熔融石英的外径通常为0.2mm，内径为0.1mm。导管在一端设置有棘突40，用作止动件。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，带有直径减小的收敛部分45。使用中，将管推入柱状部分，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，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。立体定向框架然后作为平台，可以利用设置在所测量的坐标的立体导向件将仪器从该平台导入希望的目标。一旦将仪器导入希望的目标，则开始治疗。在WO03/077784中有更为详细的描述。
利用固紧的立体导向件，将导引管插入脑部并固定就位，如上所述。图4A和图4B示出了组装好的导引管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的孔中固定就位的导引管10的接头14。将远管20插入导引管10，直到止动元件24抵靠导引管的接头14，从而将内管插入导引管。止动元件24因此作为止动件，控制插入脑部的内管长度。导管36插入内管并推动导管，直到其棘突抵靠内管的近管22的端部。
一旦导引管、内管和导管全部插入，则包含从导引管的接头延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。导引管的接头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）进行额外的夹持，螺钉通过该另外的固定装置连接到颅骨。
导引管、内管和导管的长度布置成让内管延伸到脑部的长度大于导引管（例如，10mm）且导管延伸到脑部的长度大于内管（例如，10mm）。
在导引管、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。
这种布置的优点在于，其最小化了导管的振动，下面将参照图5对其进行描述，该图示出了插入到脑部的导管、内管和导引管的端部的放大图。
当导引管插入到脑部时，其会充满脑脊髓液（CSF）。导引管中的脑脊髓液的量沿着其长度变化。当内管和导管插入到导引管中时，在导引管的管12和内管的远端管20之间形成环形间隙50，该环形间隙含有脑脊髓液。在该实例中，环形间隙50大致为0.01mm。当治疗试剂泵送到导管的端部并进入脑组织时，可能会沿着导管和内管的外表面发生一些回流，该回流中的一些治疗试剂会通过毛细作用进入内管和外管之间的环形间隙。内管和导引管之间的流体具有减振作用，减小了导管和内管的振动。因此，同心的管和管之间的环形间隙的布置，形成了减振效果。
在该实施方式中，导管由相对刚性的材料形成，例如熔融石英，内管由更柔性的材料（即carbothane85AB20）形成。在内管中比在导管中使用更柔性的材料也提供了减振作用，由此减小或者消除了内管和外管的振动。
在一种替代实施方式中，熔融石英导管可以用更柔性的物质例如聚氨酯包覆成型，以产生相同的效果。
Thermedics CarbothaneTM PC-3572D-B20聚碳酸酯基聚氨酯Biomedical Elaster的D型肖氏硬度为71。E型洛氏硬度小于50的材料提供足够的减振。
另一种合适的材料是PEEK optima（由INVIBIO生产），其M型洛氏硬度为99（在其粒状形态）。
导引管由比导管更柔性的材料形成（即carbothane85AB20），这也形成了减振效果。
内管对于本发明不是必须的，导管可以直接插入到导引管中。导引管的柔性材料和导引管与导管直接的环形间隙两者都提供了对导管的减振。
内管可以由刚性材料制成，例如，其具有大于30GPa的弹性模量。例如熔融石英，其弹性模量为35-40GPa，或者适于外科器械或者植入手术的不锈钢，其弹性模量为190-200GPa。通过刚性内管，导管和内管之间的环形间隙中的流体提供了减振。可替代的是，导管可以直接插入导引管中，而不需要内管，在这种情况下，导引管可以有具有上面描述的性质的刚性材料制成。

Claims (13)

1.一种用于插入脑部的导管组件，所述组件包括:
外部导引管；以及
内部导管，所述内部导管在其远端具有孔，流体能通过所述孔输送到所述脑部；
内管，其中，所述内部导管和所述外部导引管同心，并且在它们之间具有环形间隙，所述环形间隙延伸至所述导引管的远端中的开口，所述内部导管、所述内管和所述外部导引管同心，所述内部导管布置成延伸到脑部中并超出所述内管的远端。
2.根据权利要求1所述的导管组件，其特征在于，所述导管包括由更加柔性的材料部分地围绕的相对刚性的管部。
3.根据权利要求2所述的导管组件，其特征在于，所述导管是熔融石英导管，所述熔融石英导管用柔性比它更大的物质包覆成型。
4.根据权利要求1至3中任意一项所述的导管组件，其特征在于，在使用中，所述导管延伸到脑部的长度大于所述导引管。
5.根据权利要求1所述的导管组件，其特征在于，所述环形间隙的尺寸设计成使得在使用中脑脊髓液能进入所述环形间隙中。
6.根据权利要求1所述的导管组件，其特征在于，所述内管与所述导管同心并且具有比所述环形间隙更紧密的配合。
7.一种用于插入脑部的导管套件，所述导管套件包括:
导引管；和
导管，所述导管在其远端具有孔，流体能通过所述孔输送到所述脑部，其中所述导管的尺寸设计成使得所述导管能够插入到所述导引管中以便在它们之间提供环形间隙，所述环形间隙延伸至所述导引管的远端中的开口；
内管，其中所述内管的尺寸设计成使得所述内管能插入所述导引管中，并且所述导管的尺寸设计成使得所述导管能插入所述内管中。
8.根据权利要求7所述的导管套件，其特征在于，所述导管包括由更加柔性的材料部分地围绕的相对刚性的管部。
9.根据权利要求8所述的导管套件，其特征在于，所述导管是熔融石英导管，所述熔融石英导管用柔性比它更大的物质包覆成型。
10.根据权利要求7至9中任意一项所述的导管套件，其特征在于，所述导管能插入所述导引管中，以便在使用中延伸到脑部的长度大于所述导引管。
11.根据权利要求7所述的导管套件，其特征在于，所述环形间隙的尺寸设计成使得在使用中脑脊髓液能进入所述环形间隙中。
12.根据权利要求7所述的导管套件，其特征在于，所述导管能插入所述内管中以延伸到脑部中并超出所述内管的远端。
13.根据权利要求7所述的导管套件，其特征在于，所述导管能插入所述内管中并且具有比所述环形间隙更紧密的配合。
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