CN1777400A - 颅面植入物 - Google Patents

颅面植入物 Download PDF

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CN1777400A
CN1777400A CNA2004800099596A CN200480009959A CN1777400A CN 1777400 A CN1777400 A CN 1777400A CN A2004800099596 A CNA2004800099596 A CN A2004800099596A CN 200480009959 A CN200480009959 A CN 200480009959A CN 1777400 A CN1777400 A CN 1777400A
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格雷格·索兹
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Howmedica Osteonics Corp
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/2875—Skull or cranium
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

一种复合外科植入物，由包括顶面(400)和底面(410)的热塑性树脂平面片材以及包含在其中的手术级金属网(405)制成。该植入物可以手工弯曲。其中当对植入物进行移位时，该植入物大致维持被移位后的形状。

Description

颅面植入物
本发明要求申请号为60/463,036和60/496,684的美国申请的优先权。
技术领域
本发明涉及颅面手术用颅面植入物。
背景技术
颅面特别是眼眶壁和眼眶底面的缺陷可能由创伤、癌症、切除或者先天性缺陷引起。这些缺陷通常采用骨移植物或合成的植入物来进行外科治疗。环绕并支撑人眼的复杂和相对较细的骨结构出现的先天性缺陷或者断裂在内部骨修复和固定上存在困难。在眼睛受到创伤的情况下，眼眶的边缘和周缘可分散冲击力。然而，有时会发生眼眶内容物的压缩并使相对易碎的眼眶底面(orbit floor)和/或外侧和内侧眼眶壁破裂。外侧眼窝周缘的伤害也能导致眼眶中的破裂。当眼眶破裂时，眼眶修复的标准骨移植技术不能导致可预测的眼睛功能及其定位。通常缺陷的矫正不足、过度矫正或者眼眶容积的修复不足导致对眼球的支撑不够。而且，骨移植也可消溶(resorption)，这将导致不能达到最佳支撑。骨眼眶的精确组织修复对保持眼眶损伤后眼睛的正常功能和外表来说是必须的。由于大多数内部眼眶表面的骨骼都很细，如果不使用自体或异体材料，则很难将断裂的骨碎片充分固定。
自体骨移植被认为是眼眶底面和眼眶壁修复的最佳治疗方法。然而，这种材料有时候很难获取，而且也难以将骨移植材料制成与眼眶相符合的合适形状。还有一些与组织供体部位病态有关的问题。如以上所探讨的，颅颌面外科医生频繁使用自体骨移植来修复内眼眶。骨可由颅盖以及其它自体材料，包括髂骨、开裂的肋骨等获取，软骨也可用作骨移植材料。然而，自体骨有时候造成的消溶量是不可接受的。
多种异体材料已被用于眼眶修复，颅面的应用包括硅橡胶、特富龙(Teflon)、聚酰胺纤维(Supramid)、钽网、维塔利姆高钴铬钼耐蚀耐热合金(Vitallium)网、聚乙烯以及甲基丙烯酸甲酯(methyl methacrylate)。带孔的生物相容性金属带以及金属板可用于创伤手术中断片的刚性内部固定，并作为使骨固定并稳定的板材。金属植入物在修复手术中可用作骨移植的支撑材料。
合成植入物材料的优点在于没有供体部位病变、易于使用、价格相对低廉并易于获取。合成材料虽然有优点，但其一些特征也被认为是缺点。硅橡胶具有光滑的表面，但是不允许维管向植入物中生长。而且，尽管它有柔性，但当将其制成与特定部位相匹配的形状时，其难以与需要或保持新的形状的区域轮廓相适应。例如，关于眼眶的修复，硅橡胶植入物并不是有吸引力的选择，因为当将其制成需要的外形时，其易于恢复成最初的形状。尽管硅橡胶植入物不能保持其形状，在眼眶软组织受损的情况下，具有极高光滑度的表面在阻止痊愈时组织与植入物的连接方面是理想的。这些组织与植入物壁的连接可造成对眼睛运动的限制，引起复视、头昏眼花以及头痛，同时在向上、向下或侧向凝视时面部异常。
具有预定孔尺寸的多孔聚乙烯等带有多孔结构的植入物允许维管向内生长。在一些情况下维管向内生长是需要的，因为它将植入物整合到组织中，并减少了合成材料被排斥的可能性。此外，在植入物下侧或凹部(sinus)的维管向内生长，使得植入物的表面黏膜化(mucosalization)，并且由于植入物的相对侧可能为屏障，凹部能有效的与眼眶的软组织隔离。这种配置被认为是需要的，因为其增加了植入物防止感染的能力，并将凹部感染通过眼眶进入的几率降到最小。维管向内生长还被认为可将植入物游走或移位的几率降低到最小。多孔聚乙烯稍微有些柔性，适于用作眼眶底面和眼眶壁修复的薄片可弯曲成适当的形状。然而，这种材料易于恢复到其最初的形状。此外，多孔聚乙烯没有光滑度较高的表面，因此当用于眼眶修复时由于纤维的向内生长，可能导致对眼组织的限制。
纯钛是颅面修复手术的一种可选材料，尤其是当植入物倾向于永久植入的时候。作为植入物材料，纯钛是优选的，因为密度和弹性模量比已经用作植入物材料的不锈钢或钴铬合金小。钛抗腐蚀，并且当制成薄片时具有柔韧性。手术时可将钛植入物切割并制成合适的形状。钛网易于原位成型并很容易固定于骨头上，但其表面不光滑，也不能使维管向内生长。因而仍需要一种易于成型的材料，从而使外科医生能制作正确的形状以恰当地修复眼眶壁或眼眶底面。钛网可手工塑成需要的形状，而且由于钛材料的柔韧性和强度，其可保持该形状。
虽然有许多选择可作为眼眶修复植入物材料，但仍需要这样一种材料，其易于手工成型并能在成型后维持其形状，在一侧具有光滑的不渗透表面，在另一侧具有多孔表面，并由具有高度生物兼容性的材料制成。优选地，需要提供一种植入物，其可被修剪并弯曲成与眼眶壁或眼眶底面修复的形状相匹配的形状，而且在眼窝中被放置为：内侧的光滑表面靠着骨膜和软组织，多孔侧朝向凹部区域。而且，需要提供一种材料，其可用手术钉固定于眼眶骨上，或者用缝合线固定于周围组织中。
发明内容
本发明的一个目的在于提供一种用于修复眼眶缺损并固定眼眶断骨的独特的植入物。
本发明的另一个目的在于提供一种独特的复合植入物结构，其可被成形以用于与眼眶修复有关的手术过程，易于切割、重新成型或弯曲成与眼眶壁相符合的形状，并易于固定在眼眶上或眼眶边缘。
本发明的另一个目的在于提供一种植入物结构，其形成眼眶的凹部(sinus)与软组织之间的屏障。
本发明的另一个目的在于提供一种颅面植入物，其可用于需要保持植入物形状的其它应用中。
本发明提供了一种改进的植入物及颅面缺损、特别是眼眶缺损的修复方法。植入物为复合结构，包括手术级的嵌入热塑性树脂中的平面片层形式的金属。在第一实施例中，植入物的一个表面是光滑的，而且是不透水的，以便当植入物放置到体内时可形成屏障。在本发明的一个作为选择的实施例中，植入物的一侧具有光滑表面的同时，植入物的相对侧包括允许纤维组织向内生长的多孔聚乙烯。在一种修复方法中，这里所描述的植入物被切割并随后被成形为与需要治疗的缺损的外形相符合的形状。随后，使用外科螺钉或可供选择的机械紧固件将植入物固定于骨组织上。由于植入物包含网(mesh)，可保持其形状。
附图说明
参照附图，通过下列对本发明的眼眶修复植入物结构的概述和详述，本发明的其它目的和优点将更加清楚。
图1是根据本发明的植入物的第一实施例的顶部平面视图，其中植入物的顶侧为屏障表面。
图2是本发明的第一实施例的侧面图，示出了屏障表面和底部多孔表面。
图3是本发明的第一实施例的底部视图。
图4是本发明的第一实施例的透视图。
图5是植入物的侧面剖面图，其处于装配本发明的模子中。
图6是图5中所示的模子的顶视图，其顶盖被移去。
图7是可用于建立本发明的一种作为选择的模子的顶视图，其顶盖被移去。
图8是图7中所示的模子的侧面剖面图。
图9是可用于本发明的任一实施例的钛网的顶视图。
图10是图9中所示的钛网的一部分的放大图。
图11是具有带中间部分的相对的屏障表面的植入物的侧面剖面图。
图12是图11中所示的植入物的侧面正视图。
图13是图1-3中所示的植入物的侧面剖面图。
图14显示了颅面缺损的剖面图。
图15是图1-3中显示的植入物被植入颅面缺损中的侧面剖面图。
图16是本发明的另一实施例，其中植入物具有相对的屏障表面。
图17是图16中所示的植入物的侧面正视图。
图18是本发明的又一实施例的侧面剖面图，其中具有相对的多孔表面的植入物形成金属网。
图19是具有三层结构的植入物的分解图。
图20是根据本发明的植入物的透视图，显示其在眼眶修复中的应用。
具体实施方式
本发明提供了一种新的颅面手术植入物、制备所述植入物的方法以及采用所述植入物修复眼眶及颅面缺损的方法。如这里所述，植入物的优选应用是由创伤或疾病或者出生缺陷造成的眼眶缺损的修复，也包含了其它颅面应用。
现在参照图1，根据本发明的第一实施例包括钛网片20，其网孔中填充有多孔聚乙烯，并完全覆盖植入物的底面27。固体聚乙烯膜片23覆盖植入物的顶侧。网20提供了强度，用于保持植入物的形状为刚性及固定状态。应当理解，这里所使用的网包括具有穿过片材的孔或通道的任何手术级的金属平面片材。片材中的通道有助于使其在一维以上的方向上成型或弯曲，并随后保持需要的形状。可以设想，网可以以多种方式形成，包括编织筛、由平板蚀刻而成，或者由市售平板切割然后扩展来形成带通道的基板。
在图1中所示的本发明的第一具体实施例中，光滑的屏障材料23位于钛网材料20的上面，多孔聚乙烯25形成于空隙中并位于钛网材料20下面。参照图4可更好地看出，植入物的顶面23具有一定透明度，以便可透过聚乙烯膜层23看到网20。虽然图1中显示了网105延伸到植入物的外周，可以设想，在一些实施例中网也可以不延伸到植入物结构的边缘。在另一些实施例中，网可以从植入物结构延伸。在后一考虑中，网从植入物结构延伸有利于提供在手术过程中用于植入物连接的金属突起。虽然在这里所描述的实施例中，所示的网位于植入结构的中央，可以设想，网也可以定位于邻近于顶部的薄片层或者基于不同应用位于植入物中的其它位置。
现在参照图5，为了制造如图l所示的植入物，网40被选择并定位于从模子部分42底部的侧壁45和48上凸出的凸起50上。接着，将聚乙烯微粒引入模子中，以便将其填充于网40下的空隙中以及钛网40之间的间隙内，并覆盖网40的顶面。最后，将薄片或者固体聚乙烯连续膜55置于合适的模子顶部。固体屏障片55伸到模腔部分的外面，并伸向模子表面63，从而将片材保持在模子的一侧。
图7描绘了一种作为选择的模子装置，其中网可设置于悬挂于模腔上方的支架70上，支架70环绕模腔，并将网片保持在适当的位置。参见图8可更好地看出，伸进模子75的空隙区78中的支架区70支撑网的边缘。聚乙烯片90定位于填充模腔78的聚乙烯微粒92的上方。穿过网的通道以附图标记52表示。应当理解，基于植入物的特定应用，包括从底部模子部分75的顶面85开始的模腔的深度以及模子的长度和宽度等尺寸均是可变的。
如图8所示，微粒92既与光滑聚乙烯片90接触，也与网80接触。一旦模子采用上述方式填满，则将顶部98置于组件的上方，并如本领域公知的那样对材料加热加压以形成多孔聚乙烯材料。热和压力导致微粒烧结在一起并将聚乙烯片和钛网粘贴在一起。形成的结构是：钛网嵌入多孔基体中，固体光滑聚乙烯膜连接到钛网和/或多孔聚乙烯结构。聚乙烯片或膜是不透水的并用作屏障。
在上述本发明的一个优选实施例中，聚乙烯膜的厚度约为0.1mm，钛网的厚度约为0.35mm，包括嵌入的钛网在内，多孔聚乙烯的厚度约为0.9mm，因此材料的总厚度约为lmm。
现参照图9，在本发明的一个优选实施例中，钛网由同样由钛制成的桥110相互连接的圆环107组成。最好参见图10，圆环具有可容纳手术螺钉的头部的暗孔115。该结构使植入物中的钛元件具有灵活性，暗孔使得易于使用适当大小的手术螺钉将植入物固定于骨上。在本发明的一个优选实施例中，钛具有与聚乙烯组件(固体片和多孔基体)厚度相关的足够强度，以便外科医生将植入物弯曲后，植入物可保持其形状。由此可以设想，在手术过程中，外科医生可将植入物弯曲，使其与待治疗的缺陷的形状相符合。在一个优选的实施例中，手术过程中外科医生可手工弯曲植入物。上述植入物也可采用常用于切割钛手术板或网的普通平板剪切机切割。
尽管通过图9及图10解释了钛网的优选实施例，可用于本发明的其它钛网产品可从市场上购买，来源包括Stryker Instruments，SynthesMaxillofacial，Leibinger，KLS-Martin，L.P.及Walter-Lorenz Surgical公司。
图11描绘了本发明的另一实施例，其中钛150置于两个相对的聚乙烯屏障片材153与155之间。多孔基体160夹在于屏障片材153于155之间。该植入物的构造形成可弯曲的片，其顶面和底面上都具有光滑的聚乙烯表面。在弯曲成与待处理的缺损的轮廓相符合的形状后，植入物可以保持其形状。植入物具有钛固有的强度特征，并且具有不受连接到植入物的组织影响的无孔屏障表面。可选择聚乙烯片的厚度以产生具有预期厚度的植入物。在作为选择的实施例中，植入物的厚度可通过改变多孔基体层160来进行调整。与前面的实施例相同，植入物可由外科医生弯曲，并可保持其形状。
现参照图13，图1-4中描绘的植入物侧面剖面图显示了沿着多孔层和固体聚乙烯层23之间的界面175形成的网20。如图14所示，颅骨178的缺损具有底面180和侧壁182。为了对该缺损进行处理，将植入物弯曲成与该缺损的轮廓相符合的形状并切成缺损的形状。将植入物放置到缺损中，并将其底部多孔层与缺损的底面和侧壁的骨接触。植入物可由螺钉或缝合线固定到适当位置。由于植入物的底面和侧壁是多孔的，促进了维管向植入物内的生长，而且这种向内生长进一步用于稳固植入物，并将排斥的可能性降到最低。光滑屏障面防止了真皮的连接，从而允许皮肤在植入物区域上滑动。
在本发明的另一种作为选择的实施例中，植入物的结构包括在各侧都具有多孔表面的多孔聚乙烯基体中提供钛网板。图18描绘了其剖面图，其中网300在多孔聚乙烯基体中形成。这种植入物可适用于不需要光滑表面的应用中。例如，具有允许维管从相对侧向内生长的多孔表面的植入物可用于颅面应用以及软组织置换的临时植入物。
在上述本发明的优选实施例中，多孔聚乙烯的孔大小设置为足够大以允许维管向内生长。该孔径大小的范围优选为100-250微米，但可在20-500微米的范围内变化。尽管优选聚乙烯片及高密度多孔聚乙烯基体，还可设想其它合成树脂及其组合物也可用于本发明中。例如PETE、PTFE和/或尼龙也可作为热塑性树脂的选择。还应理解，这里的所绘的附图并不一定是按比例绘制的，例如，图1-4中屏障可形成为比图中建议的宽度更小的片。在如图1-4中所示的本发明的优选实施例的宽度大约为5mm，长度约为10mm，厚度约为1mm。然而，也可采用其它尺寸。
图5是置于模子中的根据本发明的植入物的剖面图。如这里所示，网与模子顶部上的屏障层相邻。屏障层由固体聚乙烯片材制成，并且多孔部分由加热加压下烧结在一起的聚乙烯微粒制成。固体片材可通过将聚乙烯微粒引入具有相对的光滑金属片的压机中，并加热表面以使微粒完全熔合在一起而制成。当植入物冷却后，可将该结构从模子中移去，因为凸起50和植入物材料都具有一定的弹性。
现参照图6，显示了在模子61的下部部分上形成多个凸起的构想设置。钛片将置于围绕模子周边形成的凸起50上或由其提供支撑。凸起与模子的顶面间隔设置，比网的宽度略小，以便当保持屏障片材的模子顶部置于模子底部上方时，薄的屏障片能够与网接触。图7描绘了一种作为选择的设置，其中模子提供了用于保持钛网的支架，位于邻近模子顶部的位置。
图16描绘了植入物的另一种实施例，其中顶面214和底面126均为聚乙烯片材。网220与上部片214及下部片216的内表面都相邻。该植入物具有顶部屏障表面221和底部屏障表面223，并用于不需要维管向内生长的应用中。
图19显示了根据本发明的实施例的示意分解透视图。顶层400可包括屏障表面或者多孔表面，网405可以是适于手术应用的任何金属材料，并具有柔韧性且能保持其形状。底层410可以是屏障表面或多孔表面。该实施例描绘了位于层400和410之间界面处的网405。
图20描绘了置于眼眶507的眼眶底面中的根据本发明制作的植入物500。除眼眶缺陷的修补和修复外，按照本发明的植入物还可有利地用于其他手术中，如由神经过程引起的骨片缺失的修复、乳突切除术后乳突区域的修复、LeFort过程的固定、滑动颏成形术(sliding genioplasty)中的固定。还可设想将平面片弯曲成管状并用于整形外科手术。弯曲成U形外形的平面片材可用于脊椎固定过程中或者椎间盘突出的修复。
上面参照优选实施例对本发明进行了详细描述，在不背离本发明的广泛方面的情况下，本领域技术人员对其进行变化和修改是显而易见地，因此，如在所附的权利要求书中限定的本发明意图覆盖这些变化和修改，它们均落入本发明的实际范围内。

Claims (21)

1.一种复合手术植入物，包括具有顶面和底面的热塑性树脂平面片材，以及包含于其中的手术级的金属网，所述植入物能够通过手工操作被弯曲或移位，其中，当所述植入物被移位时，所述植入物大致保持其被移位后的形状。
2.权利要求1的植入物，其特征在于所述金属包括钛。
3.权利要求1的植入物，其特征在于所述顶面进一步包括光滑的屏障表面。
4.权利要求3的植入物，其特征在于所述底面包括光滑的屏障表面。
5.权利要求3的植入物，其特征在于所述底面包括多孔表面。
6.权利要求5的植入物，其特征在于所述多孔表面的孔的大小被设定为允许维管向内生长。
7.权利要求1的植入物，其特征在于所述热塑性树脂包括聚乙烯。
8.权利要求5的植入物，其特征在于所述多孔表面包括高密度聚乙烯。
9.权利要求1的植入物，还包括允许维管向内生长的多孔表面。
10.权利要求1的植入物，还包括与骨骼连接的装置。
11.权利要求9的植入物，其特征在于所述装置包括位于所述金属网中的开口，所述开口能容纳并与手术螺钉或手术骨铰钉的头部接合。
12.一种制作手术植入物的方法，包括：
将金属网材料置于模子底部；
将热塑性树脂微粒引入到所述容器中以使所述微粒填充所述模子的底部与所述网的孔隙空间；
将热塑性树脂片置于所述微粒和所述网之上；
将模子顶部置于所述片上，并对包含在所述模子中的组件加热和加压，以使所述微粒部分熔化并彼此熔合，从而构建具有光滑的屏障表面和相对的多孔表面的植入物。
13.如权利要求12所述的制作植入物的方法，其特征在于所述第一步包括将薄片置于所述模子的模腔的底面上，从而制作的植入物包括位于所述网的相对侧面上的屏障。
14.一种修复骨缺损的方法，包括将手术植入物弯曲成与所属缺损的轮廓相符合的形状，并将所述植入物连接到与所述缺损邻近的骨骼上，其中所述手术植入物具有由热塑性树脂构成的顶面和底面以及包含在其中的金属网。
15.根据权利要求14所述的修复方法，其特征在于所述缺损为人体的缺损。
16.根据权利要求14所述的修复方法，其特征在于所述缺损为颅骨缺损。
17.根据权利要求14所述的修复方法，其特征在于所述缺损为眼眶缺损。
18.根据权利要求17所述的修复方法，其特征在于所述植入物还包括顶部的光滑屏障表面和底部的多孔表面，并且所述植入物定位于所述眼眶中，所述顶部光滑屏障表面朝向眼眶空间定位。
19.根据权利要求14所述的修复方法，其特征在于所述固定步骤包括穿过所述植入物的所述网将机械紧固件引入所述骨组织中。
20.根据权利要求19所述的修复方法，其特征在于所述机械紧固件包括手术螺钉。
21.根据权利要求14所述的修复方法，还包括切割所述植入物使其与所述缺损的形状相符合的步骤。
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