CN102958470B - 用于易于除去植入体的自分离层 - Google Patents

用于易于除去植入体的自分离层 Download PDF

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Publication number
CN102958470B
CN102958470B CN201180031623.XA CN201180031623A CN102958470B CN 102958470 B CN102958470 B CN 102958470B CN 201180031623 A CN201180031623 A CN 201180031623A CN 102958470 B CN102958470 B CN 102958470B
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layer
ground floor
implant
thickness
body fluid
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CN102958470A (zh
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G·索罗沃斯
C·沃依萨德
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Synthes USA LLC
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Synthes USA LLC
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    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

骨植入体，其包括(a)设置在所述骨植入体的第一外表面上的第一层，并且所述第一层由水溶性的或在体液中可降解的第一材料形成，所述第一层具有第一厚度，和(b)设置在所述第一层的外围上的第二层，并且所述第二层由生物相容性材料形成，所述第二层具有小于第一厚度的第二厚度。该排列有利于去除植入体。

Description

用于易于除去植入体的自分离层
优先权要求
本发明要求在2010年7月9日提交的美国临时专利申请序列号为61/362,923，标题为“用于易于除去植入体的自分离层(Self-DetachingLayerforEasyImplantRemoval)”，发明人为GoetzThorwarth和CyrilVoisard的专利申请的优先权。该申请的全部内容以引用到其中的方式并入到本文中。
技术领域
本发明一般涉及用于从骨骼中除去骨植入体的装置。
背景技术
在包括创伤和颅颌面部领域的矫形外科中，在所需的程度的愈合后通常需要除去骨植入体部分。这可能是由于美容的原因和/或使得在植入位点周围的完全再生。对于许多由生物相容性的合金(如，钛-铝-铌“Ti-Al-Nb”)制成的现有的植入体，外科医生通常面临过好地整合到周围组织中的植入体，使得除去比必需的更具有侵害性或损害性。
发明内容
本发明涉及用可溶或生物可降解的层涂布骨植入体的系统和方法，和防止与面对骨植入体的表面的组织直接组织接触的生物相容性层。根据本发明的一个示例性的涂布可以通过多种技术实施，包括浸涂或喷涂和物理或化学气相沉积(PVD/CVD)。这导致在组织接触表面上直接形成“防护物”，其在植入物周围提供有利的愈合，但是在体内在预定的时间之后，其更容易分离，使得从周围组织中释放植入体并允许更低程度侵害性和损害性的除去过程。在所述第一防护物上形成的外部生物相容性层随后在更长的时间尺度上被再吸收，选择它的总体积和材料性能以使得当植入到体内时产生微不足道的副作用。
本发明涉及具有基底材料的植入体，所述基底材料包括用具有厚度D且包含为水溶性的或在体液中可降解的材料的第一层和置于包含生物相容性材料的第一层上的具有厚度d＜D的第二层涂布的金属或金属合金。
该植入物提供了在金属植入物基底上的自分离涂层，防止植入体在骨骼上生长或骨骼内生长，而不妨碍愈合过程。这使得在其已经完成在体内的临时作用后容易地除去植入体。
在所述植入体的一个示例性的实施方案中，所述第二层包含生物可吸收或生物溶解材料。
在所述植入体的另一实施方案中，所述第二层包含不可吸收或不溶解材料。
在所述植入体的再一实施方案中，所述第二层具有1nm、优选10nm的最小厚度d。具有10nm的厚度，所述第二层起到对于细胞通过-生长的有效屏障的作用以降低或阻挡相关的扩散机制。
在所述植入体的再一实施方案中，所述第二层具有100nm最大厚度d。
在所述植入体的又一实施方案中，所述第二层具有小于所述第一层的吸收速率/溶解速率。
在所述植入体的再一实施方案中，吸收/溶解所述第二层需要的时间为2周至3个月。
在所述植入体的另一实施方案中，所述第一层由可吸收材料制备。优选的材料为聚交酯(PLA)和磷酸钙类(CaP)。这种构造允许细胞通过-生长，其可能导致变弱的“细胞-第二层-细胞”结构，该结构在除去大的植入体后容易破裂。在所述第一层已经溶解/已经被再吸收后，所述第二层将在更长的时间尺度上被吸收。
在所述植入体的另一实施方案中，所述第一层的厚度D为至少10μm，优选至少100μm。
在所述植入体的又一实施方案中，所述第一层的厚度D为至多1000μm，优选至多500μm。
在所述植入体的再一实施方案中，D/d的比率为10,000:1至1,000:1。
在所述植入体的另一实施方案中，所述第一层包含聚乙烯醇(PVA)或聚交酯。
在所述植入体的另一实施方案中，所述第二层包含不可吸收的金属，优选钛或钛合金，并且具有100nm的最大厚度d。
在所述植入体的另一实施方案中，所述第二层包含羟磷灰石并且具有10μm的最大厚度d。
在所述植入体的再一实施方案中，包含所述第一层和第二层的材料的混合物的第三层被插入在所述第一层与第二层之间。
在所述植入体的又一实施方案中，在所述第二层上施用其它层，以及在该其它层上施用包含生物相容性的材料的另一层。所述其它层包含水溶性的或在体液中可降解的材料。
在所述植入体的另一实施方案中，包含水溶性的或在体液中可降解的材料和生物相容性的材料的交替层的数量为2x，其中，x为3或更大。
在所述植入体的其它实施方案中，所述第一层的材料不同于第二层的材料。
根据又一方面，提供了用于制备所述植入体的方法，其包括如下步骤：将水溶性的或在体液中可降解的材料施用到包含金属或金属合金的基底上以在所述基底上形成第一层，和在所述第一层上施用生物相容性材料。
在所述方法的另一实施方案中，在实施步骤B之前，将在步骤A和B中使用的材料的混合物施用到所述第一层上。
在所述方法的再一实施方案中，所述层的施用是通过浸涂或喷涂实施的。
附图说明
在下面通过实例的方式和参照附图详细描述本发明的一些实施方案，其中：
图1显示了根据本发明的植入体的第一示例性实施方案的横截面；
图2显示了根据本发明的植入体的另一示例性实施方案的横截面；以及
图3显示了根据本发明的植入体的又一示例性实施方案的横截面。
具体实施方式
本发明涉及一种用于破裂的或损坏的或由于其他原因变弱的骨骼的固定的涂布的骨植入体和制备这种骨植入体的方法。本发明的实施方案可以在需要短期或长期的骨植入体的植入的活生物体内用于整形固定、颅颌面部固定或用于任意的其它骨骼的固定。根据本发明的示例性的实施方案的骨板被一层或多层选择的材料涂布以防止在体内的短期或长期的植入过程中骨板与骨植入体周围的组织变得连成一体。在所述示例性的骨板中的材料的多层中的一层可以由显示所需的特征(例如，吸收速率、生物相容性等)的可吸收性材料形成。应该注意到尽管本发明的实施方案以具体的层厚度和构造来描述，和关于特殊的骨骼的固定来描述，但是在不偏离本发明的实质和范围的情况下，在任意骨骼的固定中可以采用任何其它的厚度或构造。此外，尽管本发明的实施方案描述了仅在骨植入体的一个表面上沉积层，但是在不偏离本发明的实质和范围的情况下，可以用示例性的层涂布所述骨植入体的所有表面。
如在图1中所示，根据本发明的第一实施方案的植入体10包括含有基底材料1的植入体主体12(例如，骨板或骨髓内固定钉(intramedullarynail))。所述植入体主体12的第一表面14被第一层2、包含在所述第一表面2上延伸的第二层3涂布，从而所述第二层3形成植入物10的外表面，当植入时，所述外表面形成与周围组织的接触层。如本领域的技术人员所理解，所述植入物10的基底材料1可以为任何合适的金属、金属合金或聚合物。通常地，用于作为外科植入体的应用，如本领域的技术人员所理解，所述基底材料1为钛(Ti)、Ti合金(例如TiAl6Nb7(“TAN”))、钢或PEEK。
所述第一层2具有厚度D，并且其包含含有聚乙烯醇(PVA)或聚交酯的可吸收材料。所述第一层2的厚度D可以为大约10μm至1000μm，以及在示例性的实施方案中可以为大约100μm至500μm。
所述第二层3具有厚度d，并且其包含可以为生物可吸收或生物溶解性材料和不可吸收或不溶解性材料之一的生物相容性材料。在示例性实施方案中，所述第二层3包含不可吸收的金属，例如，钛或钛合金和/或羟磷灰石。所述第二层3的厚度d小于第一层2的厚度D，并且可以为1nm至100nm，在优选的实施方案中，其具有10μm的最大厚度d。此外，所述第二层3的吸收/溶解时间比第一层2的更长，为2周至3个月。
由于所述第一层2形成在植入体主体12的表面14上，以及所述第二层3形成在第一层2的表面上，防止组织与植入体主体12的表面14之间的接触。通过第一层2和第二层3形成的生物相容性层系统允许在植入体10周围的有利的愈合和用于除去植入体10的更低程度的侵害性和损害性的程序，因为在体内预定的时间后，至少所述第一层2与植入体主体12分离。
在图2中，显示了所述植入体的另一实施方案，所述植入体与图1中的实施方案中的唯一区别在于在植入体10'的第一层2和第二层3之间形成了中间层4。所述第三层4包含第一层2和第二层3的材料的混合物。与图1中的实施方案类似，由基底材料1组成且具有骨板或骨髓内固定钉形式的植入体主体12'被具有厚度D的第一层2涂布。所述中间层4被置于第一层2上，并且，例如，具有厚度δI，其小于第一层2的厚度D且大于与周围组织形成接触层的第二层3的厚度d。
所述植入体的另一实施方案示于图3中，其与图1的实施方案的唯一区别在于第三层21是在所述第二层3上形成的。所述第三层21包含水溶性的或在体液中可降解的材料。在所述第三层21上形成的第四层31包含生物相容性材料。与图1中的实施方案相似，具有形成骨板或骨髓内固定钉的由基底材料1形成的植入体主体12”的植入体10”被具有厚度D的第一层2涂布，以及具有厚度d的第二层3被设置在第一层2上。所述第三层21被置于第二层3上，并且具有厚度δF，例如，其可以具有与所述第一层2的厚度D相同的厚度，而第四和最外层31具有厚度δA，例如，其可以等于所述第二层3的厚度d。所述第四层31形成与周围组织的接触层。
根据用于在根据本发明的植入体上沉积层的示例性的方法，将通常用于破裂固定的骨板与骨螺钉结合使用。这种骨板在体内的使用的通常的持续时间为几周至几个月，之后它们通常被除去。所述骨板通常由TAN合金或钢制备，但是也可以由塑料(例如PEEK)制备。然而，在不偏离本发明的实质和范围的情况下，应该注意到，如果需要，根据本发明的示例性的骨板也可以无限期地植入。
根据第一示例性的步骤，首先通过浸入到50/50的体积百分比的乙醇和丙酮混合物中清洁TAN骨板，接着置入到超声浴中约5分钟。在该步骤之后，在干燥的CO2喷射中清洁所述植入体。接着通过浸涂法在PVA/水溶液中以XXmm/s的除去速率(removalspeed)用聚乙烯醇(PVA)的水溶性第一层2涂布所述植入体，导致在干燥后PVA层XX微米强度，如本领域的技术人员所理解，除去速率与所得的PVA层强度直接相关。在第一示例性实施方案中，所述除去速率可以为1mm/s，导致大约50微米的PVA层。接着，将所述骨板插入到施加小于1e-4mbar的真空系统中。然后，例如，通过反应性磁控溅射(在90％Ar和10％O2的混合物中具有5e-3mbar工作压)将10nm的氧化钛膜沉积在PVA层上。所得的第二层3为生物相容性的，并且可以延缓之前沉积的PVA层的水溶解。然后从真空室中移出涂布的骨植入体10，并在干燥空气或真空中包装。在大约1个月之后，所述第一PVA层2在体内分离，因此释放所述骨植入体，用于在从其中除去骨螺钉之后除去骨植入体。
本领域的技术人员将理解在不偏离所附的权利要求的宽范围的情况下可以作出本发明的多种修改和变化。其中一些已经讨论，而其它的对于本领域的技术人员而言是显而易见的。例如，在不偏离本发明的实质和范围的情况下，根据本发明的示例性的层形成(layering)可以在克氏针(Kirchnerwire)上或骨髓内固定钉上进行。根据本发明的示例性的技术，可以以与上述所讨论的基本相同的方式涂布克氏针,使用浸涂法,接着热蒸发法。如果使用骨髓内固定钉，可以用100μm厚的生物可降解层喷雾涂布所述钉。然后，可以用羟磷灰石层涂布所述生物可降解层。在所述生物可降解性层溶解之后(即，在体内植入预定的时间之后)，在所述骨髓内固定钉与羟磷灰石层之间保留了足够的空间以允许除去骨髓内固定钉，同时防止在其周围的弱组织(weaktissue)的向内生长。
尽管已经详细地描述了本发明及其优点，应该理解在不偏离所附权利要求定义的实质和范围的情况下在此可以作出多种变化、替换或修改。例如，本发明的任何生物可降解层可以被熔融中间层替换，例如，其可以在体内到达预定的温度(例如，休眠体温(restingbodytemperature))之后,溶解至周围组织中。在又一实施例中，可以为仅需要短期植入的骨植入体提供润滑剂以防止或减缓组织在其上生长。此外，本申请的范围并不限于在说明书中描述过程、机器、制备、物质的组合物、装置、方法和步骤的具体的实施方案。作为本领域的普通的技术人员将很容易从本发明的公开中了解：根据本发明可以使用目前已经存在或后来开发的实施作为在此所描述的对应的实施方案的基本相同的功能或实现基本相同的结果的过程、机器、制备、物质的组合物、装置、方法和步骤。

Claims (21)

1.骨植入体，其包含：
第一层，其被设置在骨植入体的第一外表面上并且包含为水溶性的或在体液中可降解的第一材料，所述第一层具有第一厚度；和
第二层，其被设置在所述第一层的外表面上，并且由第二生物相容性材料形成，所述第二层具有小于第一厚度的第二厚度。
2.根据权利要求1所述的植入体，其中，所述第二层包含生物可吸收或生物溶解材料。
3.根据权利要求1所述的植入体，其中，所述第二层包含不可吸收或不溶解性材料。
4.根据权利要求3所述的植入体，其中，所述第二厚度为1nm至100nm之间。
5.根据权利要求2所述的植入体，其中，所述第二层的吸收/溶解速率小于所述第一层的吸收/溶解速率。
6.根据权利要求5所述的植入体，其中，在体内植入之后，所述第二层的吸收/溶解速率为两周至三个月之间。
7.根据权利要求1所述的植入体，其中，所述第一层由可吸收性材料制备。
8.根据权利要求1所述的植入体，其中，所述第一层的第一厚度为10μm至1000μm之间，所述第一厚度与第二厚度的比率为10,000:1至1,000:1。
9.根据权利要求1所述的植入体，其中，所述第一层由聚乙烯醇(PVA)或聚交酯形成。
10.根据权利要求9所述的植入体，其中，所述第二层由具有100nm的最大第二厚度的不可吸收的金属形成。
11.根据权利要求9所述的植入体，其中，所述第二层由羟磷灰石形成，并且具有10μm的最大第二厚度。
12.根据权利要求1所述的植入体，其中，所述第一和第二层中的至少一个包含选自镁、铁及其合金中的至少一种生物可降解的金属或金属合金。
13.根据权利要求1所述的植入体，其进一步包括插入在所述第一层和第二层之间的中间层，所述中间层由第一和第二层的材料的混合物形成。
14.根据权利要求1所述的植入体，其进一步包括设置在所述第二层的外表面上的第三层，所述第三层由水溶性的或在体液中可降解的材料形成。
15.根据权利要求14所述的植入体，其进一步包含设置在所述第三层的外表面上的第四层，所述第四层由生物相容性材料形成。
16.根据权利要求15所述的植入体，其中，包含水溶性的或在体液中可降解的材料和生物相容性的材料的交替层的数量为2x；x为3或更大。
17.根据权利要求1所述的植入体，其中，所述第一层的材料不同于第二层的材料。
18.根据权利要求10所述的植入体，其中，所述不可吸收的金属是钛或钛合金。
19.用于制备骨植入体的方法，其包括：
将第一材料的第一层施用在所述骨植入体的第一表面上，所述第一材料为水溶性的或在体液中可降解的，或所述第一材料为水溶性的和在体液中可降解的；和
将第二材料的第二层施用在所述第一层的外表面上，所述第二材料是生物相容的；
其中第二层的厚度小于第一层的厚度。
20.根据权利要求19所述的方法，其进一步包括如下步骤：在涂布所述第二层之前将中间层涂布在所述第一层上，所述中间层由第一材料和第二材料的混合物形成。
21.根据权利要求19所述的方法，其中，通过浸涂法或喷涂法涂布所述第一层和第二层。
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