CN101150994A - 用于穿过粘膜或皮肤组织的植入物的生物屏障 - Google Patents

用于穿过粘膜或皮肤组织的植入物的生物屏障 Download PDF

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CN101150994A
CN101150994A CNA2005800493652A CN200580049365A CN101150994A CN 101150994 A CN101150994 A CN 101150994A CN A2005800493652 A CNA2005800493652 A CN A2005800493652A CN 200580049365 A CN200580049365 A CN 200580049365A CN 101150994 A CN101150994 A CN 101150994A
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bone
tissue
mid portion
equipment
metal
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罗恩·佐科
扬·D·迪基
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TERRYMANUS MEDICAL CO Ltd
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Abstract

描述了用于在骨骼骨和设置在身体外部的假体装置之间形成直接机械连接的设备。该设备提供了用于形成有效的生物密封以防止微生物颗粒传播到身体内的方法。

Description

用于穿过粘膜或皮肤组织的植入物的生物屏障
技术领域
本发明一般涉及医学领域，并且更具体地涉及用于在骨骼骨和位于覆盖的软组织外部的结构之间形成直接机械连接的设备，其中，该机械连接穿过覆盖的软组织，并在覆盖组织的内部和外部之间，或者在骨和身体的外部之间形成生物屏障。
背景技术
在某些医学病症的治疗中，希望在外部结构和病人的骨骼骨之间提供机械连接。例子包括诸如假肢或假牙的外部假体，和用于重建矫形术的外部固定销。在这些情况中的每种情况中，希望在身体外部的装置和身体内部的骨之间形成直接机械连接。该连接可表征为具有三个功能部件：锚定至骨的第一部分；穿过身体的粘膜或皮肤表面的第二部分；和与身体外部的假体或其它装置机械连接的第三部分。
在本领域中已知用来固定至骨的各种装置，包括人造关节代替物，用于修复骨的金属板，用于将韧带或腱连接至骨的锚定装置，和牙植入物。这种装置的典型示例是OmniFitTM EON髋关节代替物(StrykerOrthopedics，Mahwah New Jersey)，NexGen膝关节代替物，Statak软组织连接锚定装置，(Zimmer Inc，Warsaw Indiana)，和各种牙植入物(Nobel Biocare AB，Gothenburg Sweden；Institut Straumann AG，Waldenberg Switzerland；Zimmer Dental Inc，Carlsbad CA；DentsplyInternational Inc.，York，PA；Biohorizons，Birmingham Alabama)。
通常使用三种不同的技术将装置固定至骨：粘接剂；利用摩擦(螺钉，卡钉)的机械互连；和促进骨生长至该装置内的材料。Duracon膝关节(Stryker)是利用粘接剂固定至骨的装置的示例，其中，粘接剂与骨的表面结构和植入物的表面结构互锁以提供固定。NaturalHipTM(Zimmer Inc)是具有用于促进骨生长至植入物内，从而在骨和植入物之间形成直接连接的表面的装置的示例。大多数的牙植入物和软组织锚定装置使用用来直接穿至骨内的螺钉的一些变体。
所有这些技术当被正确使用时将在假体装置和骨之间提供可靠的机械连接。
存在许多适于将假体连接至植入物的技术，包括干涉配合，锥形，螺纹，粘接剂或胶粘剂。牙植入物通常使用螺纹或粘接剂，以将陶瓷，或金属和陶瓷连接到固定至骨的植入物部分。
穿过粘膜组织或皮肤组织的植入物(诸如牙植入物，经皮的进入装置或者矫形的外部固定销)给出相当大的感染危险。通常可以以极小的力使与植入物接触的组织破裂，提供感染性微生物进入身体的通道。
众所周知，在植入物通过软组织至身体外部的位置，刺激纤维性地向内生长到植入体中可以减少感染。连接的组织(诸如在牙植入物情况下的齿龈组织)的存在显著地改善植入物周围的生物密封，从而阻止微生物进入植入物周围的组织和骨。还认识到的是，增加对植入物附近组织的血液供给将使得白细胞浓度增加以及植入位置周围的感染的相应减少。此外，在牙植入物的情况下，促进纤维性地向内生长到植入物将更加逼真地模仿牙和颚之间的自然连接。
用于促进向内生长至植入物的通过粘膜组织或皮肤组织的那部分内的合适的方法是由促进这种向内生长的材料构成植入物，或者至少该植入物的用来与组织相接触的那部分。本领域已知通过使用生物相容的聚合物材料在经皮的进入装置(例如美国专利4,897,081)的情况下提供这种方法。虽然本方法适合于较短期的应用，但是这种聚合物不提供在骨骼和身体外部的装置之间提供机械连接的植入物的情况下所需的高强度和长寿命。
本领域还已知提供具有软组织可以生长至其内的多孔金属区域的植入物。例如，美国专利No.3,855,638公开了一种多孔区域，该多孔区域包括小的离散金属材料颗粒，在它们的接触点处结合在一起，用于促进这种组织向内生长。在该专利中所述的多孔金属材料的示例包括奥氏体不锈钢，钛，钛合金和钴合金，该钴合金称为VitalliumTM。
仍然需要改善的材料和设备，用于促进与植入装置有关的组织向内生长。
发明内容
本发明提供用来将设置在身体外部的装置连接至骨骼骨的植入物，包括用于促进组织向内生长至植入物的通过粘膜组织或皮肤组织的的那部分内的装置，以便在植入物周围提供生物密封。用于促进向内生长的装置由在用来与粘膜组织或皮肤组织相接触的植入物的表面的那部分处提供诸如钛或钽的骨金属(trabecular metal)区域组成。
在本发明的另一方面中，装置被设置为用来移除和更换布置用来促进组织向内生长的植入物的部分，使得如果该向内生长的部分被感染，则可以移除和更换向内生长的部分，而不需要移除整个植入物。
根据本发明的植入物可采用多种形式。根据本发明的牙植入物提供骨金属的分离的可移除部分，该可移除部分连接至用来连接至骨的第一部分，并且以可移除的方式连接至用来连接至假牙的第二部分。根据本发明的矫形外部固定销提供该销通过皮肤组织处的骨金属区域。根据本发明的用于将假肢连接至人的躯干的植入物提供布置成用来连接至骨的部分，布置成用来连接至假肢的第二部分，和植入物通过皮肤组织处的骨金属区域。
在可选实施例中，根据本发明的牙植入物提供用来连接至齿龈组织和结缔组织的骨金属部分，该部分连接至用来连接至假牙的部分。在该可选实施例中，牙植入物不与骨直接连接，而是通过下方组织的连接而保持在适当位置，从而有利地模仿自然牙的固定。
根据本发明，利用骨金属以促进组织向内生长。骨金属提供大致十二面体的孔隙结构，其具有促进组织通过孔隙很大程度地连接的高度连接(“开孔”)的孔隙度，从而使向内生长的组织与骨金属结构相缠结。这在软组织和金属结构之间提供坚固的连接，并促进向内生长的组织的血管形成。
一种植入物，在其通过齿龈组织，粘膜组织或皮肤组织的区域中布置骨金属材料，促进组织坚固连接的纤维性向内生长，从而减少下方组织和骨被感染的危险。
附图说明
参考优选实施例的以下详细说明以及参考附图，本发明的上述以及其它目的、特征和优点将变得明显，其中：
图1是根据本发明的牙植入物的示意图。
图2是当图1的牙植入物被植入时显现的横截面示意图。
图2A是图1和图2的牙植入物的可选实施例的横截面示意图。
图3是图1和图2的牙植入物的另一可选实施例的横截面示意图。
图3A是图3的牙植入物的可选实施例的示意图。
图4是根据本发明的矫形外部固定销的示意图。
图5是用于将假肢连接至人的骨骼的植入物的示意图。
具体实施方式
参考图1，以牙植入物10的形式示出本发明的实施例。牙植入物10为由金属制成的大致圆柱体物体，该金属诸如不锈钢，钛，钽或者钛和钽的合金，以及相似的金属。植入物10的近端部分12提供促进可靠连接至骨的特征。在图1中，通过螺纹14促进骨连接；然而，在不脱离本发明的情况下，用于将植入物10连接至骨的其它方法是可能的。用于将植入物10连接至骨的其它方法包括提供用于粘接剂连接的卷绕区域，或者提供用于促进骨向内生长的骨金属区域。
提供植入物10的远端部分16用于假牙的连接。这种连接通过利用粘接剂实现，尽管也可使用其它的连接方法，诸如干涉配合，锥度配合，螺纹配合或者其它方法。
植入物10的中间部分18由孔隙尺寸在100-800微米范围内、优选地为钛或钽的骨金属制成。在优选实施例中，骨金属利用允许将骨金属沉积在基底(例如HedrocelTM Implex Corporation，Allendale，NJ)所选区域上的化学汽相沉积技术而直接形成在植入物10上，本领域已知的用于形成骨金属的其它技术诸如二氧化碳注射(美国专利6,759,004)，模制(例如美国专利6,221,447或美国专利5,958,314)，或烧结(美国专利6,674,042)。如上所述，诸如在此有利地使用的那些骨金属的骨金属提供近似且大致的十二面体孔隙结构，该孔隙结构具有通过所述孔隙促进高度的组织连接的高度连接的开放单元孔隙度，并使向内生长的组织与骨金属结构相缠结。这提供软组织和金属结构之间的坚固连接，以及促进向内生长的组织的血管形成。
参考图2，植入物10的近端部分12嵌入骨20内，使得中间部分18与齿龈组织22相接触。假牙24(或者其它的牙桥托)连接至植入物10的远端部分16。齿龈组织22生长至构成中间部分18的骨金属内，从而围绕植入物10形成周向的新血管化生物密封。如在此所使用的，术语“生物密封”和“生物屏障”是指以下状态：模仿或接近存在于正常的、未受干扰的相似类型的组织中的对微生物侵入的屏障状态。因此，例如，术语生物密封不意味着表征对横穿外部组织和内部组织之间的微生物有机体的绝对屏障。而是，该术语是指阻止微生物侵入的组织向内生长区域处的状态，但是其不一定限定绝对屏障。
如图2所示，中间部分18与骨20和组织外表面之间的组织相接触，并且组织至中间部分内的向内生长为抑制微生物侵入内部组织内提供有效的生物屏障。换句话说，中间部分18延伸通过内部组织和覆盖组织的外表面之间的分界面。
图2A是图1和图2的牙植入物的可选实施例，它具有模仿自然牙的固定的优点。在本实施例中，植入物10的近端部分12宽松地配合至形成在骨20中的孔穴13内。植入物10通过齿龈组织向内生长至中间部分18内而保持在适当位置上。这提供了允许假牙24响应于外部作用力而相对于骨20稍微移动的固定。这种移动用于将牙24上的机械载荷转移至邻近的自然牙或者假牙，从而减少机械损坏的可能性。
图3表示牙植入物10的可选实施例的纵向剖视图。在本实施例中，植入物10的远端部分12是具有螺纹孔穴30的分离的零件。中间部分18具有与孔穴30相配合的螺栓32。应理解的是，孔穴30和螺栓32可以以其它方式紧固在一起，所述其它方式包括例如通过粘结，机械螺纹互锁或者其它方法。中间部分18的周边由骨金属34制成。中间部分18还包括孔穴36，远端部件16的螺栓38可利用粘接剂，螺纹或其它方法连接至该孔穴36并紧固在适当位置。该可选实施例提供了从中间部件18移除远端部件16的选择方案。这允许部件18以最小的齿龈组织损耗从任何向内生长的齿龈组织分离，中间部件18从近侧部件12移除，以及利用新的部件12或者用于随后的组织处理的临时隔离物更换中间部件18。如果中间部件18变得植有细菌并且受感染，则可能需要上述选择方案。
图3A示出图3的牙植入物的可选实施例的纵向截面图。在本实施例中，植入物由第一部分组成，该第一部分具有被布置用来固定至骨的近端92和被布置用来连接至假牙或桥托的远端部分94。由骨金属制成的环形环90以可移除的方式配合在远端部分94的周围。这允许环90以最小齿龈组织损耗从任何的向内生长的齿龈组织分离、移除环90、以及利用新的部件或者用于随后的组织处理的临时隔离物更换环90。有利地，牙植入物的该可选实施例在假体和牙植入物插入其内的骨之间提供单一的机械连接。
图4表示根据本发明的矫形外部固定销，显示为为了使用可植入该矫形外部固定销。固定销50在近端54锚定至骨52内，使得中间部分56与皮肤组织和皮下组织55以及位于其下方的肌肉组织53相接触。中间部分56由骨金属制成，优选地为钛或钽。固定销50的远端部分58被布置用来利用连接装置62连接至外部固定装置60。
一旦如图所示地植入，皮肤组织和皮下组织53就生长至中间部分56的骨金属内，从而形成生物密封。
图5示出用于将假体连接至截肢的植入物的局部矢状窦旁(para-sagital)截面。植入物70由近端部分72组成，该近端部分72利用上述的粘接剂或其它紧固系统刚性地连接至骨74。植入物70的中间部分76由优选地为钛或钽的骨金属制成。植入物70的远端部分78被布置用来刚性连接至假肢80。
当如图所示地植入时，皮肤组织和皮下组织84以及肌肉组织82生长至中间部分76内，从而形成生物密封。
在不脱离本发明的范围和精神的情况下，可构造在此描述的植入设备的许多不同的构造，因此，本发明应仅由所附权利要求的范围限制。例如，根据本发明的植入物可以是具有用于外部假体的连接装置的完全的骨金属部件。在另一可能的实施例中，根据本发明的牙植入物可大部分由除金属以外的材料构成，而只要穿过齿龈组织的植入物部分由促进齿龈组织向内生长的材料制成。

Claims (20)

1.用于在骨骼骨和设置在覆盖在该骨上的组织的外部的假体之间形成直接机械连接的设备，包括：
近端部分，它被构造成用来固定至骨；
远端部分，它构造成用来固定至假体；和
中间部分，它位于所述近端部分和远端部分之间并且构造成以便接触覆盖在所述骨上的组织，所述中间部分至少部分地由骨金属制成，该骨金属由具有大致十二面体几何形状的互连的孔隙形成，并且其中，所述中间部分被构造成用来促进组织向内生长至所述中间部分内，从而促进所述中间部分与所述组织相接触处的有效的生物密封。
2.如权利要求1所述的设备，其中，所述骨金属是钛。
3.如权利要求1所述的设备，其中，所述骨金属是钽。
4.如权利要求1所述的设备，其中，所述骨金属是钛和钽的合金。
5.如权利要求1所述的设备，其中，所述中间部分可从所述近端部分移除。
6.用于将外部假体装置连接至骨骼骨的设备，包括：
外部部分，它构造成用来连接至组织外部的假体装置；
内部部分，它构造成用来连接至骨骼骨；和
中间部分，它构造成用来互连所述内部部分和所述外部部分并穿过所述骨骼骨和覆盖组织之间的组织，所述中间部分至少部分地由金属制成，该金属促进组织向内生长至所述中间部分内，从而在所述中间部分穿过所述组织在外部延伸之处形成有效的生物屏障。
7.如权利要求6所述的设备，其中，所述中间部分包括骨金属。
8.如权利要求7所述的设备，其中，所述中间部分包括限定大致十二面体几何形状的互连孔隙。
9.如权利要求7所述的设备，其中，所述骨金属包括钛。
10.如权利要求7所述的设备，其中，所述骨金属包括钽。
11.如权利要求6所述的设备，其中，所述外部假体装置包括牙植入物。
12.如权利要求11所述的设备，其中，所述牙植入物可从所述外部部分移除，并且所述中间部分可从所述内部部分移除。
13.一种将外部假体连接至骨骼骨的方法，包括以下步骤：
(a)将第一构件连接至骨骼骨；
(b)在一位置将第二构件连接至所述第一构件，使得所述第二构件贯穿覆盖在所述骨骼骨上的组织，以及使得所述第二构件的远端设置在所述组织的外部，使得外部假体可连接至所述远端，所述第二构件至少部分地包括限定互连孔隙的骨金属；
(c)将外部假体连接至所述第二构件的所述远端。
14.如权利要求13所述的方法，包括如下步骤：促进组织向内生长至所述第二构件内，以在所述第二构件周围形成有效的生物密封。
15.如权利要求14所述的方法，包括如下步骤：提供包括钛的所述第二构件。
16.如权利要求13所述的方法，其中，所述外部假体是牙植入物。
17.一种矫形固定销，包括：
近侧构件，它构造成用来固定至骨；
远侧构件，它构造成用来固定至外部框架，以便固定至矫形装置；和
中间构件，它构造成用来贯穿内部组织和外部组织之间的分界面，其中，所述中间构件促进组织向内生长至所述中间构件内。
18.如权利要求17所述的矫形固定销，其中，所述中间构件可从所述近侧构件分离。
19.如权利要求18所述的矫形固定销，其中，所述中间构件至少部分地由骨金属制成。
20.如权利要求19所述的矫形固定销，其中，所述骨金属包括钛。
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