CN101600404B - 微创模块化体内融合装置的方法及设备 - Google Patents

微创模块化体内融合装置的方法及设备 Download PDF

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CN101600404B
CN101600404B CN200780050196.3A CN200780050196A CN101600404B CN 101600404 B CN101600404 B CN 101600404B CN 200780050196 A CN200780050196 A CN 200780050196A CN 101600404 B CN101600404 B CN 101600404B
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modularity
modular
guide rail
interbody fusion
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CN101600404A (zh
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J·弗尔特
B·诺顿
M·赖德
S·克洛斯比
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Vertebral Technologies Inc
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Vertebral Technologies Inc
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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Abstract

本发明提供一种用于融合毗邻的脊椎骨的微创模块化体内融合装置。所述装置包括：第一模块化节段，其具有一宽度并包括沿所述宽度的一侧延伸并超过所述第一模块化节段的本体部的边缘的第一导轨。第二模块化节段在所述宽度的一侧滑动地连接到所述第一导轨，并具有至少部分地沿所述宽度的另一侧延伸并超过所述第二模块化节段的本体部的边缘的第二导轨。第三模块化节段在一侧可滑动地连接到所述第二导轨。所述模块化节段可被延伸并被定位成大致并排的构造，所述并排的构造界定一模仿脊椎骨的平面形状的单一本体，以使所述装置接触并支撑毗邻的脊椎骨。

Description

微创模块化体内融合装置的方法及设备
技术领域
本发明总的涉及一种用于融合病人关节的可植入的整形外科融合装置，例如脊椎体内融合装置。更具体而言，本发明涉及具有预定尺寸和形状的基于导轨的模块化体内融合装置。
背景技术
关节融合或关节固定术是缓解由于关节退化和/或关节炎所造成的疼痛的常见方法。关节融合涉及诱导关节中两个原本可移动的骨头之间的骨头生长，其通过固定和稳定关节来缓解疼痛。通常将关节融合在其最有官能性的位置。踝关节、腕关节、手指关节、脚趾关节和脊椎关节都是可融合以缓解与不稳定的、退化的关节相关的疼痛的实例。
脊柱运动节段由两个毗邻的脊椎体、插入的椎间盘以及相连的韧带、肌肉、骨实和面关节组成。椎间盘由脊柱表面的终板、软内核(称为髓核)以及周向环绕核并将椎骨连接在一起的环状纤维韧带组成。在正常的椎间盘中，髓核对所施加的载荷进行缓冲，从而保护脊柱运动节段的其他部分。正常椎间盘中的髓核通过向外凸起抵靠脊椎终板和纤维环来对压力起反应。纤维环由胶原纤维和较少量的弹性纤维组成，两者均有效地承受张力。然而，纤维环本身不能极有效地耐受压力和剪切力。
当人们年老时，椎间盘常自然退变。人们也可能因退变性椎间盘疾病而发生椎间盘的退变。脊柱的退变性椎间盘疾病是一种导致我们人类背痛和残疾的最常见情况。当椎间盘退变时，髓核会脱水。当髓核脱水时，其作为缓冲垫的能力会减小。因为脱水后的髓核不再能够承受载荷，载荷会被传递至纤维环并传递至面关节。纤维环和面关节不能耐受所施加的增大的压力和扭力，且因此它们会自然退变。当纤维环和面关节退化时，会接着发生许多其他效应，包括间隙变窄、形成骨刺、纤维环断裂、软骨终板破裂和退化以及面关节的软骨退化。纤维环和面关节失去它们的结构稳定性且脊柱之间会发生细微的但病理的运动。
当纤维环失去稳定性时，其往往会向外凸出，且可能形成撕裂而使髓核材料突出。椎间盘的破损产物(包括肉眼可见的碎屑、微观的颗粒和有害的生物化学物质)会积聚。所述颗粒和碎屑可能产生坐骨神经痛且有害的生物化学物质可能刺激椎间盘内和其周围的敏感神经末梢并产生腰背痛。受影响的人可发生肌肉痉挛、下背部的柔韧性降低且当试图进行普通的躯干运动时会发生疼痛。
椎间盘退变是不可逆转的。在某些情况下，身体将最终使运动节段的关节得到加强，从而有效地重新稳定椎间盘。即使在发生重新稳定的情况下，该过程可能花费很多年且病人常常继续遭受残疾痛苦。长于三个月的长时间痛苦情节常常导致病人寻求通过手术解决他们的痛苦。
已设计多种方法来试图稳定脊柱运动节段。所述方法中的一些方法包括：在运动节段的侧面使用刚性或半刚性的支撑构件；移除整个椎间盘并用以关节连接的人造装置将其更换；移除并更换髓核；以及脊柱融合，其涉及对毗邻受影响的椎间盘的脊椎进行永久融合。
通常认为脊柱融合是缓解由于椎间盘退变引起的背痛的有效手术治疗。融合过程要求通过刮掉现有脊椎骨的表面以促进出血并释放骨生长因子来准备骨脊椎终板，以及在制备好的表面上设置额外的骨头或合适的骨头替代物。通常将利用刚性材料(例如金属(包括钛和钽)、某些塑料(包括聚醚醚酮(PEEK)或碳纤维填充PEEK))制成的合适尺寸的装置以及同种异体骨(主要来自供体股骨)插入准备好的椎间盘空腔内作为体内融合程序的一部分来帮助分散并稳定椎间盘间隙并在发生骨头生长过程时将脊椎置于正确的位置。体内融合程序也可利用前路、经椎间孔入路和后路手术完成。
体内脊柱融合中所用的大多数装置需要相对很大的开口，所述开口通常大于待插入的刚性单体融合装置或融合器的尺寸，这些装置的实例包括：授予Ray等人的美国专利第5,026,373号；授予Kuslich等人的美国专利第5,458,638号以及Alphatec提供的
Figure GSB00000927288000021
PEEK间隔器。事实上，许多体内融合方法，例如授予Brantigan的美国专利第5,192,327号中所述的方法和装置，需要通过较大的手术开口双向放置单体装置。与任何手术程序一样，所需的手术开口越大，周围组织感染和创伤的风险越高。
存在例如授予Kuslich和美国专利第5,549,679号和授予Manzi等人的美国专利第6,997,929号中所披露的微创脊柱融合装置。第5,549,679号专利中披露的装置是在现场填充的多孔网袋。第6,997,929号专利系关于一系列膜片，该薄片竖直叠放以分散并支撑脊椎终板。授予Baumgartner的美国专利第5,702,454号披露灵活的塑料珠串，其可每次插入一个到椎间隙内。另外，授予Bao的美国专利第5,192,326号披露装入半渗透的薄膜中的水凝胶珠。
尽管上述微创技术能够实现在融合程序中使用通过纤维环(即环形物)的较小入口切口，但所得到的融合装置不具有在传统手术程序中使用的更有刚性的单体融合装置的机械和尺寸特点，且其分散和稳定椎间盘间隙的能力较小。因此，人们需要一种能够更好地仿效刚性单体融合装置的机械和结构特征的微创脊柱融合植入。
发明内容
本发明提供一种用于基于导轨的模块化体内融合装置的方法和装置，所述模块化体内融合装置在现场组装后具有预定的尺寸和形状。在一个实施例中，该模块化体内融合装置通常包括带有导轨的实心模块化节段，该导轨以可操作的方式连接毗邻的模块化节段。该构造使体内间隔器适合通过各种手术入路(包括后路和外侧入路)经由很小的入口切口或环形物植入。在一个实施例中，导轨利用滑动机构动作以连接并联锁毗邻的模块节段。延伸超过假体本体边缘的导轨的杆部分在植入后可移除，以使模块化节段在现场组装后组合形成带有相对平滑的外圆周的单个装置。该模块化融合装置可经构造为提供与被融合的关节的表面几何形状的全接触并精密模仿被融合的关节的表面几何形状，从而更精密地模仿现有最大的刚性单体融合装置的功能。
在一个实施例中，体内模块化融合装置适合植入到准备好的椎间隙，并包括至少三个模块化节段，每一该模块化节段都具有一宽度。第一模块化节段具有第一导轨，其至少部分沿所述宽度的一侧延伸并经过该第一模块化节段的边缘。第二模块化节段以可滑动的方式与该第一导轨在所述宽度的一侧相连并具有第二导轨，该第二导轨至少部分沿所述宽度的另一侧延伸并经过该第二模块化节段的边缘。第三模块化节段以可滑动的方式与该第二导轨在所述宽度的一侧相连。所述体内融合装置具有一扩展位置，在植入之前，模块化节段在该位置沿第一和第二导轨延伸并被导轨间隔开以大致上端部-端部的构造定位。该体内融合装置还具有一植入位置，模块化节段在该位置以大致上并排的构造定位，该并排的构造界定组装好的单个本体，所述本体具有与纤维环的内边界大致对应的大致连续边缘。
在一个实施例中，每一模块化节段都在从上到下方向上具有约0.5-15GPa的压缩模量，以使体内融合装置的压缩模量大致对应于周围皮质骨的压缩模量。
在一个实施例中，提供锁紧功能以确保模块化体内间隔器在插入前和插入后是单体装置。为防止该装置在插入之前被分离，可在刚性导轨上提供锁紧功能以防止模块化节段向后滑离导轨。这确保每一模块化节段都以正确的顺序连接在其正确的位置。另外，可在模块化节段上提供锁紧功能以在插入时将它们锁紧在一起。这防止各节段从组装好的假体上脱位并迁移到纤维环的外侧。另外，所述体内融合装置可在其外表面上包括槽、脊或其他结构以接触周围的骨头并防止该装置迁移到椎间隙的前部界限以外。
本发明的另一方面包括一种用于植入体内间隔器的方法。由于该模块化体内间隔器可每次植入一个节段，在纤维环上所作的用于植入假体的孔可为处于最后组装好的形式的装置的尺寸之一部分。将第一模块化节段通过纤维环内的该小孔插入椎间隙。然后，将第二模块化节段沿第一刚性导轨向上滑动并进入椎间隙，直到第二模块化节段与第一模块化节段联锁。然后，将第一刚性导轨的尾杆从该装置分开。此分开可通过仅仅将导轨从该装置上折断来完成。或者，可通过螺钉、卡口机构、扭转锁紧器或类似部件将所述尾杆附连至该装置上。因此，可通过拧松螺钉或松脱卡口等将导轨从该装置上移除。将后续的模块化节段沿相邻的刚性导轨向上滑动并进入体内空间，且然后与此前以类似方式插入的模块化节段联锁。在已插入所有模块化节段且分开所有尾杆后，模块化体内间隔器完全插入病人的体内空间。
本发明的另一方面提供一种插入工具，其可用于辅助模块化体内间隔器的插入、定位和导轨移除。该工具的近端具有带封闭的棘轮或辊子机构的手柄，所述封闭的棘轮或辊子机构附连至该工具远端处可通过其插入导轨的细长管的内腔并与其排成一行。该细长管可沿该管的长度具有狭缝或其他开口以协助将导轨穿入该管中。该插入工具可提供有切割机构，其用于在模块化节段完全插入后将导轨移除该模块化节段。
附图说明
考虑本发明以下各个实施例的详细说明并结合附图可更全面地了解本发明，附图中：
图1为根据本发明的一个实施例的模块化体内间隔器在其插入构造下的俯视图；
图2为根据本发明的一个实施例的模块化体内间隔器在第一插入阶段的立体图；
图3为根据本发明的一个实施例的模块化体内间隔器在第二插入阶段的立体图；
图4为为根据本发明的一个实施例的模块化体内间隔器在最后插入状态下的立体图；以及
图5为所述装置的一替代实施例的立体图。
具体实施方式
参见图1，可见根据本发明的一个实施例的模块化体内间隔器100配置为插入身体后的俯视图。在本实施例中，模块化椎间盘假体100包括第一模块化节段102、第二模块化节段104、第三模块化节段106和第四模块化节段108。体内间隔器100可由任何合适的生物材料(例如聚合物(例如PEEK)、金属(例如钛、骨小梁金属))、骨头或可作为用于新骨头生长的架子和/或用于干细胞的载体的可再吸收材料组成。
模块化节段102、104、106和108可经由小环形物从前路或外侧入路插入。然后，可在体内空间内通过首先将模块化节段102插入体内空间，然后沿一系列导轨滑动模块化节段104、106和108来构造体内间隔器100，其中每一节段都与此前的节段锁紧以产生具有完全接触并支撑脊椎终板的最终、组装好的表面区域的体内间隔器100。
体内间隔器100可包括锁紧倒钩，其防止各单元退出并延伸到该间隔器的前部界限以外。间隔器100可进一步包括啮合周围的骨头或以其他方式防止间隔器100退出椎间隙的槽、脊142或其他结构。
在一较佳实施例中，体内间隔器100可由具有通孔的PEEK制成，能够实现组织向内生长并因此促进骨性融合。孔140的尺寸和形状可变。孔140可在间隔器100上以任何方式间隔开，以使间隔器100的压缩模量大致对应于相邻骨头的压缩模量。间隔器100还可有变化的厚度，以实现期望的支撑和/或特定椎间隙(例如用于L5-S1融合的脊柱前凸构造)的融合。
在一个实施例中，在插入之前，体内间隔器100的孔140可使用例如自体植骨、钙化或脱钙骨衍生物、植骨替代物(例如羟磷灰石)、试剂填塞或填充以促进骨头生长，例如骨形态发生蛋白，或成骨蛋白-1、抗生素、抗癌试剂、干细胞、生物活性细胞因子、细胞因子抑制剂、成纤维细胞生长因子、其他骨诱导和/或骨传导材料或任何其他材料和其结合以促进融合和/或稳定脊柱运动节段。
在另一实施例中，体内间隔器100可包括表面修改以提供药物洗脱。上述药物可包括镇痛剂、抗生素、消炎药、抗凝剂、抗肿瘤药、生物骨骼学药物，例如骨生长剂。在一替代实施例中，间隔器100可由能够从中洗脱所吸取的药物的材料(例如多孔PEEK)组成。在再一个实施例中，间隔器100的内部部分可由一种材料组成，而外部部分由另一种材料组成。例如，该内部部分可由实心PEEK组成，而外部部分由多孔PEEK组成。多孔PEEK的表面可涂有生物活性剂或药物。间隔器100可嵌有射线透不过的材料，例如钽或钛珠，以能够实现植入物的X射线可视化。
在另一实施例中，导轨可用作填充管，以便填充材料可注入或以其他方式插入孔140中。间隔器100还可经制造以包括沟槽或沟道，填充材料可经由导轨插入该沟槽或沟道中。
参见图2，可见根据本发明的较佳实施例的模块化体内间隔器100在插入椎间隙之前的一部分。在替代实施例中，该模块化体内间隔器可包括较大或较小数量的模块化节段和导轨。
在插入之前，模块化体内间隔器100进一步包括第一导轨110、第二导轨112和第三导轨114。第一模块化节段102在第一节段联锁部分116处刚性附连至第一导轨110。如图3所示，第二模块化节段104在第一槽128处以可滑动的方式附连至第一节段联锁部分116，并在第二节段联锁部分118处刚性附连至第二导轨112。如图4所示，第三模块化节段106在第二槽130处以可滑动的方式附连至第二节段联锁部分118，并在第三节段联锁部分120处刚性附连至第三导轨114。第四模块化节段108在第四槽133处以可滑动的方式附连至第三导轨114。
如图2所示，每一导轨110、112和114都包括杆部分，该杆部分分别延伸经过间隔器100的本体的边缘。较佳地，这些杆部分足够长以便能够进入椎间隙，从而一个模块化节段可定位在椎间隙内侧，同时导轨上的下一个模块化节段仍然在本体的外侧。在一示例性实施例中，杆部分的长度介于6厘米至20厘米之间。每一导轨110、112和114都可进一步包括止动部分，以防止装置在插入之前分离。该止动部分经配置以防止相应的模块化节段脱离该导轨。该止动部分可模塑到导轨中，或可为单独的部件或在制造该装置期间增加的导轨变形。当模块化节段102、104、106和108在椎间隙内连接并横向移动时，可将导轨110、112和114从植入物顺序地移除。
较佳的实施例是成套、无菌、准备在手术部位植入的体内间隔器。该成套组件可包括任何数量的模块化节段。在一较佳实施例中，该成套组件包括5个单独的模块化节段。也可使用单一模块的成套组件，以便外科医生可使用期望数量的节段。由于该装置作为单一植入物完全起作用并交付，所以该装置处于外科医生的直接控制下，直到彻底形成体内间隔器。该单一设计减小外科医生确定如何配置间隔器的需要，从而能够实现将该间隔器最有效地放置到椎间隙中，并确保组件的插入顺序及实现正确的连接。该模块化体内间隔器的尺寸和形状提供最终的、组装好的表面区域，其完全接触并支撑脊椎终板，从而稳定脊柱单元。在这方面，应理解，可以多个不同的最终组装尺寸提供本发明的模块化体内间隔器100，以适应不同椎间隙的不同尺寸。
在如图5所示的替代实施例中，可使用单独的两个导向杆150和导向机构152来协助插入并对齐模块化节段。可将杆150附连至每一模块化节段的近端。可使用杆150来将第一模块化节段插入到位。第二导向杆可附连至第二模块化节段，并用于将第二模块化节段放置到位，以与第一模块化节段配合并联锁。然后，可将第一杆分离。可通过重复所述过程来插入后续的节段。
在一个实施例中，模块化节段可包括螺纹孔154，以使杆150可拧入到孔154中。杆150不参与模块化节段的联锁机构。在一个实施例中，杆150可使用与模块化节段相同的材料制造，或杆150可由不同的材料组成，包括但不限于塑料(例如PEEK)或金属(例如不锈钢或钛)。根据本发明的一个方面，杆150可与模块化节段形成一体。例如，杆150可利用塑料注射模制，或利用塑料或金属加工。
在本发明的另一个实施例中，杆150可独立于模块化节段形成，且然后通过机械方法(例如配合螺纹、扭转锁紧、卡口锁紧或类似方法)或通过使用粘合剂或其他材料连接方法(例如热或超声波焊接)将其连接到模块化节段。使用机械方法将杆150连接到模块化节段的一个优点是当产生需求时，可重新啮合模块化节段以从椎间盘间隙移除。在将模块化节段植入椎间盘间隙后从模块化节段移除杆150的顺序与联锁导轨的顺序相同。
在一个实施例中，模块化体内间隔器100可通过部分插入椎间隙的入口管引入。入口管至少3英寸长且较佳约6英寸长。应注意，尽管在关于四节段的实施例中描述模块化椎间间隔器100的插入，但具有任何其他数量的节段的实施例可以类似的方式插入。
在插入期间，槽128、130和133沿导杆110、112、114的杆部分滑动到节段联锁部分116、118、120上。可向槽128、130、133和节段联锁部分116、118、120提供锁紧特征，以防止模块化节段102、104、106和108分离。可提供锁紧特征(例如一倒钩、柱销或一系列倒钩或柱销)，以使一旦将槽滑到节段联锁部分上，其不能向后滑脱该节段联锁部分。也可使用棘齿和棘爪将模块化节段锁紧在一起。在将模块化节段锁紧在一起后期望将其分离的情况下，还可提供棘齿释脱工具。
所属领域的技术人员在阅读本说明书后可易于理解对所揭示的装置和方法进行的各种修改。不应将上文中的说明设想为限制本发明的范围，本发明的范围只受到本申请的权利要求书的限制。

Claims (15)

1.一种用于融合毗邻的脊椎骨并适合植入制备好的体内间隙的模块化体内融合装置，所述融合装置在植入之前具有扩展位置并且在植入之后具有植入位置，所述装置包括：
多个模块化节段，其在所述植入位置上从假体的第一端到所述假体的第二端并排排列，所述多个模块化节段被构造成从所述假体的所述第一端向所述第二端按顺序组装并在处于所述植入位置时相互配合以界定单一本体，所述单一本体具有大致对应于所述制备好的体内间隙并模仿脊椎骨的形状的大致连续边缘，从而使所述装置接触所述毗邻的脊椎骨；
所述多个模块化节段中的第一模块化节段，其具有与所述第一模块化节段刚性附连的第一导轨；
所述多个模块化节段中的第二模块化节段，其可滑动地连接到所述第一导轨并具有与所述第二模块化节段刚性附连的第二导轨；及
所述多个模块化节段中的第三模块化节段，其适可滑动地连接所述第二导轨，
所述多个模块化节段中的每一个都包括通过相应厚度隔开的顶面和底面，并包括适合允許组织向内生长的通孔；
所述第一和第二导轨中的每一个都包括杆部分，所述杆部分延伸超出所述植入位置的所述单一本体的所述大致连续边缘，在所述多个模块化节段中的所述第二模块化节段处于所述植入位置时，所述第一导轨的所述杆部分可选择性地从所述多个模块化节段中的所述第一模块化节段移除；及
在所述多个模块化节段中的所述第三模块化节段处于所述植入位置时，所述第二导轨的所述杆部分可选择性地从所述多个模块化节段中的所述第二模块化节段移除；
所述第二模块化节段在处于所述扩展位置时，沿所述第一导轨延伸，在所述第二模块化节段被植入前，所述第一和第二模块化节段被定位成被所述导轨间隔开的大致端对端构造。
2.如权利要求1所述的模块化体内融合装置，其特征在于，所述多个模块化节段中的所述第三模块化节段具有与所述第三模块化节段刚性附连的第三导轨，且所述模块化脊椎盘假体进一步包括所述多个模块化节段中的第四模块化节段，所述第四模块化节段适可滑动地连接所述第三导轨。
3.如权利要求2所述的模块化体内融合装置，其特征在于，所述多个模块化节段中的所述第四模块化节段具有与所述第四模块化节段刚性附连的第四导轨，且所述模块化脊椎盘假体进一步包括所述多个模块化节段中的第五模块化节段，所述第五模块化节段适可滑动地连接所述第四导轨。
4.如权利要求1所述的模块化体内融合装置，其特征在于，每一模块化节段都在从上到下方向上具有介于约0.5-15GPa的压缩模量。
5.如权利要求1所述的模块化融合装置，其特征在于，所述模块化融合装置提供药物洗脱。
6.如权利要求1所述的模块化体内融合装置，其特征在于，所述孔可使用填充材料填塞。
7.如权利要求6所述的模块化体内融合装置，其特征在于，所述填充材料选自由如下各项组成的群组：骨移植物、骨移植物替代物、促进骨生长的试剂、抗生素、抗癌试剂、干细胞、成纤维细胞生长因子、骨衍生物、生物活性细胞因子、细胞因子抑制剂、骨传导材料、骨诱导材料和它们的任何组合。
8.如权利要求1所述的模块化体内融合装置，其特征在于，所述模块化节段进一步包括用于在所述植入位置联锁所述模块化节段中毗邻的模块化节段的装置。
9.如权利要求1所述的模块化体内融合装置，其特征在于，每一导轨都进一步包括用于在所述扩展位置止动所述导轨上的所述可滑动地附连的模块化节段的装置。
10.如权利要求1所述的模块化体内融合装置，其特征在于，所述单一本体具有可变化的厚度。
11.如权利要求1所述的模块化体内融合装置，其特征在于，所述模块化体内融合装置适可用于一外侧手术程序及一后路手术程序其中之一。
12.一种用于融合毗邻的脊椎骨的模块化装置，其适合植入于制备好的体内间隙中，所述装置包括：
第一模块化节段，其具有宽度，并包括至少部分地沿所述宽度的一侧延伸的配合表面；
第二模块化节段，其具有宽度，并包括至少部分地沿所述宽度延伸的配合表面，所述配合表面适合与所述第一节段的所述配合表面联锁；及
第三模块化节段，其具有宽度并包括至少部分地沿所述宽度延伸的配合表面，所述配合表面适合与所述第二节段的所述配合表面联锁，所述第一、第二和第三模块化节段分别包括通过相应厚度隔开的顶面和底面并且包括适合允許组织向内生长的通孔；
第一导向杆，其适合可释脱地附连至所述第一模块化节段；
第二导向杆，其适合可释脱地附连至所述第二模块化节段；
第三导向杆，其适合可释脱地附连至所述第三模块化节段；
导向机构，其适合可滑动地连接至相邻的二导向杆；
所述模块化节段经构造以形成植入位置，在所述植入位置上，所述模块化节段被定位成大致并排的构造，所述并排的构造界定模仿脊椎骨的平面形状的单一本体，以使所述装置接触所述毗邻的脊椎骨。
13.如权利要求12所述的模块化装置，其特征在于，所述孔可使用填充材料填塞。
14.如权利要求13所述的模块化装置，其特征在于，所述填充材料选自由如下各项组成的群组：骨移植物、骨移植物替代物、促进骨生长的试剂、抗生素、抗癌试剂、干细胞、成纤维细胞生长因子、骨衍生物、生物活性细胞因子、细胞因子抑制剂、骨传导材料、骨诱导材料和所述各项的任何组合。
15.如权利要求12所述的模块化装置，其特征在于，所述模块化融合装置提供药物洗脱。
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