CN1316891A - 植入物以及它的制造方法与应用 - Google Patents

植入物以及它的制造方法与应用 Download PDF

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Publication number
CN1316891A
CN1316891A CN99810766A CN99810766A CN1316891A CN 1316891 A CN1316891 A CN 1316891A CN 99810766 A CN99810766 A CN 99810766A CN 99810766 A CN99810766 A CN 99810766A CN 1316891 A CN1316891 A CN 1316891A
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China
Prior art keywords
implant
tissue
described implant
particulate
batching
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Granted
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CN99810766A
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CN1230134C (zh
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拉尔斯·布鲁斯
英格丽·布鲁斯
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Lanka Ltd
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Lanka Ltd
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Abstract

植入物(假体)，它包括组织匹配型的多孔性细粒/粗粒料与碎裂的组织匹配生物料(最好是自生料如骨粉)的混合物配料。此配料还包括有允许其模制或模塑成形的组份，封装到柔性组织匹配料制成的袋或封套内，且具有尺寸能允许生物材料组织外生长与内生长的孔/眼/通道等。此种植入物适用于许多方面，例如用作髋骨假体的固定剂、整形外科中的填料以及治疗风湿症时的骨生长助进剂。

Description

植入物以及它的制造方法与应用
本发明涉及植入物及其制造方法与应用。
美国专利5217496(Bruce)公开了一种植入物(假体)，它包括组织匹配型的粉料与碎裂的组织匹配料的混合物层，这层混合物通过添加营养液已能生长和可将此混合物的组份相互耦联。上述专利文献还公开了用模具制造这种植入物的方法。
美国专利5015256(Bruce)公开了一种用来在无粘合剂方式下固定关节假体的装置，这种假体包括生物匹配的粒料，基本上是不规则的、有孔的塑料粒，粒度小于5mm。为了固定此关节假体，将此装置插入假体应固定在的腔内，然后在振动上述粒料的过程中将此假体驱入该装置与腔内。这种振动促使假体在腔内联锁与锁合过程中将粒料填充到假体与腔壁之间的腔中。上述粒料的团或床可以包括粒状的内生料。
用上述固定技术进行的试验业已证明能够精确地实现假体的特别快速和稳定的、永久性和无痛苦的固定(愈合)，如果这种粒料包括了由同一类型组织形成的自生料而且植入物则相对于此种粒料分别插入或放入其中时，上述同一类型组织例如当待固定假体是股骨假体时，则是来自股骨腔的骨组织。这种骨组织形成了骨(细胞)，包围上述粒料并从腔壁延伸到假体。此外，这些试验还证明了，耦联起的粒料(外加自生料)愈多，则假体愈能更快地固定。这看来似乎是体细胞的生长趋势缩短了粒料间的距离。
本发明根据上述已知技术和上述试验的学说。因此，本发明的基本认识是这些粒料必须相互耦联且最好是紧致的，同时这种自生的生物材料、组织与营养素应能适用于上述粒料或应能渗入其中。
可以认为美国专利5015256中的体腔构成了美国专利5217496方法中的模具，同时包括了细胞生长的自然营养素溶液，即自生的体液如血液。
美国专利4755184公开了一种香肠形式的植入物，这种植入物的外套是一种软管，两端系紧而包含有羟磷灰石。此外套经牢靠地填实。
根据本发明，这种植入物包括组织匹配型的有孔的细粒/粗粒料和裂碎的组织匹配生物料的混合物配料，所述组织最好是自生组织且最好是来自植入物所在位置的自生组织，而所述配料还包括一或多种能使其模制成形的组份，这种配料封装入组织匹配的柔性片料、箔料、织造织物等形成的袋或封套内，上面有可透过的孔/眼/网目，用来让组织能从此袋/封套内生长到周围同时从外部生长到袋内。此种配料应良好地保持到一起且最好在袋/封套内为紧致的。袋/封套应该封闭，例如缝合，以不使细粒/粗粒料逸出。此袋/封套可以包括例如纱布绷带。
最好将包/封套内的配料预成形地充填成植入物所需的充填程度。要是此植入物是用于支持身体的某些部分或用在身体的某些部分例如脊椎骨之间保持距离，也即能够具有支承和间隔开的功能时，则充填的程度必须大于对体腔充填的情形，例如用于整形外科目的以及其他涉及到用于风湿症的骨生长促进剂目的的情形。
配料在袋/封套内的致密化最好用振动进行。振动还有另外的优点，即能合适地混匀配料的各组份，同时能有利地使营养素渗入所述细粒/粗粒料中，可以进行较高频率的振动用于混合而另进行较低频率的振动用于密实化。可以采用例如超声振动。
可以将营养素加入玻璃试管内的配料中，例如将载有配料的袋低放到传统的营养液或血液/血袋中并振动此袋，营养液便通过袋壁的孔到达配料提供组织生长。但营养液也可在植入物位置在体内加到配合料中，这时的营养液便含有可掺入袋内的自生流体。
根据应用目的，这种植入物可以缝合、钉合到体内/上的植入物位置处，这在将植入物充填到体腔内时是必需的，同时存在错位的风险。但要是可以指望将植入物通过楔入固定到例如脊椎骨之间，则不需用专门的固定装置。
这种植入物是在密实化后能良好充填到它拟插入的腔、空隙或距离的外形时成型。这一点很重要，不然的话，(体组织与上述袋间的距离)就会有植入物不生长到袋与体组织之上或在袋与体组织之间形成了相连接的组织的危险。
本发明的植入物的形状显然可以是任意的，例如平板形、条带形、柱形或棒形等。
包含有所述混合物的袋在成形时可以把另外的/另外一些组织匹配的组份用到此配料中，以使此配料成为可捏和的而且能保持通过这种捏和而形成的袋/封套形状。这样一种合适的组份是市售的可硬化的双组份纤维朊，例如可以购自IMMUNO(瑞士)股份公司。另一种合适的组份是Focalseal(注册商标)，是美国Focal公司出售的外科用密封剂。但应着重指出，血液(含有纤维朊与凝固剂)本身是合适的另外组份，允许将此混合物于袋/封套内或外模制成腔的形式、待与植入物相配合的形式。作为用于模制或模塑的模型，例如可以利用所涉及的体腔的X射线记录结果。
为方便起见，这种袋/封套可以由能再吸收的材料，例如购自ETHICON LTD的SURGI CEL(TM)制成。
至于组织匹配的细粒/粗粒料，根据本发明首先能选择钛，但也有其他的为内行人熟知的材料，如生物陶瓷、生物玻璃、羟磷灰石、聚合物与合成血液等。多孔的细粒/粗粒料并非天然是多孔的，例如钛，按先有技术是通过将气体或液体吹过这类材料的熔体而形成的。
这种细粒/颗粒料具有基本均匀的粒度分布，最好是塑性的和不规则形状的。理由在于，当通过振动来互联与密实化时，不同的粒度在体腔中将不会成层排列，结果就会有不规则的风险，从而导致有损伤的组织生长。所谓基本均匀的粒度分布是指细粒/粗粒料的粒径可以改变±50％，但最好不超过±25％。这种细粒/粗粒料的绝对粒度可以有较广的变化范围，细粒/粗粒料的粒度小于5mm认为是最方便的，难以确立其下限，但能够采用很小的粒料与生物匹配液结合，形成细小粒子(粉尘)。但通常使用粒度大于0.1mm的细粒/粗粒，粒度的上限可约2mm而下限可约0.5mm。一般地说，选择细粒/粗粒粒度时应考虑完成外科手术后将为此细粒/粗粒料充填的空间，这就是说，与小的体腔相比，较大的体腔要选用较大的细粒/粗粒料，上述名词“细粒/粗粒”、“不规则的”与“粒径”涵盖了(近似)球形以外的其他形式。
要是将本发明的植入物用于置换或修复骨组织，则所述细粒/粗粒料最好包括塑性的或实质上是非弹性的连续性多孔双组份材料，更好是金或金属合金，如钛，且具有下述多孔特性：
这种多孔性是连续的；
坑/凹痕/穴以及与之相连的槽/通道的口，对骨组织而言具有的宽度＞约50μm。这样的孔隙率在为槽、通道互连的粒料中形成了空隙，使得生长到粒料外表面一部分上的骨组织能继续通过各粒料以及通过粒料外表面的其他部分向外继续生长。
根据本发明，能在将配料引入到上述袋或封套起之前对配料的各组份进行混合。此时，将营养配料加到混合物中。或依照本发明，也可在这些配料引入袋内或封套内之前进行混合。
例如在对脊柱进行手术修复脊椎骨间磨损的椎间盘时，常常是将植入物拧入到脊椎骨之间。这种植入物是刚性的，可以包括骨片，参看美国专利4501269与5489308。但这种骨片并无足够量供应，而且具有支承功能的这种的植入物常常造成痛苦且复杂与价昂。
本发明弥补了上述缺陷，提出了上述这种用于稳定脊柱的植入物。
图1概示两个环状柱形袋1，其中有前述的内盛物，用于插入两个脊椎骨K之间。袋1充分地充填有配料(钛制的细粒/粗粒料)，经振动作合适的混合与密实化，以使脊椎骨间的间距保持正确。骨很快地形成并具备支承功能。这种袋是由上述的示例性能再吸收的材料制备。图1a是沿A-A的剖面图。
图2示明了本发明的植入物2，它插入于髋骨腔S内将髋骨植入物3固定于此腔中，植入物3包括传统的以钛5涂层且压配合到依照髋骨腔形成的薄袋1上的塑性杯4，其中含有上述的由钛组成的细粒/粗粒料。袋1也是由前述示例性取织造织物形成的能再吸收料制成。
在本发明的另一实施形式中，此脊柱植入物的内室具有例如美国专利5015247与4501269所述的充填有本发明的植入物的型式。

Claims (18)

1．植入物(假体)，它包括组织匹配型的多孔性细粒/粗粒料与碎裂的组织匹配生物料(最好是自生料如骨粉)的混合物配料，其特征在于，这种配料另包括一或多种组织-生物匹配组份以允许对此配料进行模制或模塑成形，而此配料是包围在柔性组织匹配材料制的袋或封套内且具有允许此种生物料组织内生长和外生长尺寸的孔/眼/通道或类似装置。
2．权利要求1所述的植入物，其特征在于，所述柔性材料是能再吸收的织造织物，例如再生的纤维素或聚合物中之一。
3．权利要求1或2所述的植入物，其特征在于，所述细粒/粗粒料包括钛或聚合物或人造血液。
4．权利要求1～3中任一项所述的植入物，其特征在于，所述配料包括一种能促进组织匹配生物料在其中生长的营养素/营养素溶液。
5．权利要求1～4中任一项所述的植入物，其特征在于，另一种组份是可硬化的组份和用于其中的增硬剂。
6．权利要求1～5中任一项所述的植入物，其特征在于，此另一种组份是血液。
7．权利要求1～6中任一项所述的植入物，其特征在于，所述细粒/粗粒的粒度为0.1～5mm而最好是0.5～2mm。
8．权利要求1～7中任一项所述的植入物，其特征在于，所述细粒/粗粒料的配合料是在前述袋/封套之内密实化。
9．权利要求1～8中任一项所述的植入物，其特征在于，所述细粒/粗粒料是塑性的或基本上非弹性的，且其多孔性具有下述多孔特性：
这种多孔性是连续的；
坑/凹痕/穴以及与之相连的槽/通道的口，对骨组织而言具有的宽度＞约50μm。
10．将权利要求1～9中任一项所述的植入物用作脊椎骨间假体的固定介质。
11．将权利要求1～9中任一项所述的植入物用作髋骨节假体。
12．将权利要求1～9中任一项所述的植入物用作例如整形外科中的填料。
13．将权利要求1～9中任一项所述的植入物用作治疗风湿症时的骨生长促进剂。
14．将权利要求1～9中任一项所述的植入物用作体腔、坑、凹痕等的充填物或用于身体部分的例如脊椎骨间的支座。
15．将权利要求1～9中任一项所述的植入物用作身体内的隔件。
16．将权利要求1～9中任一项所述的植入物用作有缺陷的/已除去的组织的加强物。
17．将权利要求1～9中任一项所述的植入物用作组织(骨)的替换物。
18．将权利要求1～9中任一项所述的植入物用作常规植入物的互补物。
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