CN1148953A - 铸造矫形移植体及其制造方法 - Google Patents

铸造矫形移植体及其制造方法 Download PDF

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CN1148953A
CN1148953A CN96111753A CN96111753A CN1148953A CN 1148953 A CN1148953 A CN 1148953A CN 96111753 A CN96111753 A CN 96111753A CN 96111753 A CN96111753 A CN 96111753A CN 1148953 A CN1148953 A CN 1148953A
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R·C·康普顿
L·N·吉尔伯森
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Bristol Myers Squibb Co
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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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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
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    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B22—CASTING; POWDER METALLURGY
    • B22C—FOUNDRY MOULDING
    • B22C9/00—Moulds or cores; Moulding processes
    • B22C9/02—Sand moulds or like moulds for shaped castings
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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    • A61F2/00—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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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A61L2400/00—Materials characterised by their function or physical properties
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Abstract

本发明公开了形成带有多孔表面层的铸造矫形移植体的制备方法。该方法包括将多孔层置于移植体的蜡复型上，使得部分存在的层用蜡材料填充。按照熔模铸造方法用陶瓷材料涂覆蜡复型和多孔表面层，陶瓷材料填充多孔层的剩余部分洞孔。陶瓷材料固化后，熔出蜡材料，在陶瓷材料内留下内腔体。已填充蜡的洞孔被裸露并伸展到内腔体中。将熔融金属倾倒进入内腔内，并且部分熔化裸露的多孔层以便形成与熔融金属熔融结合。金属冷却后，剥离陶瓷材料，露出事先用陶瓷介质填充的多孔层部分。

Description

铸造矫形移植体及其制造方法
本发明涉及矫形移植体及制备矫形移植体的方法，本发明和铸造形成的矫形移植体特别相关。
代替一部分人体组织所用的矫形移植体可用各种公知制备方法以各种公知材料形成。例如，移植体可由钛金属块机械加工，或由钴铬合金锻造而成。移值体也可由熔模铸造法形成，其中阳模由蜡形成，然后用陶瓷壳熔模形成阴模。蜡被覆盖并且陶瓷壳硬化之后，将蜡熔化留下阴模，随之用熔融金属填充。在某些移植体中希望提供多孔的外表面以便与骨粘合材料机械连结，或者提供利于骨质长入进而使移植体固定到骨质的表面，这种多孔表面通常采取小金属珠粒层的的形式，或金属网眼层的形式，这在工业上是熟知的。多孔金属表面层通常通过扩散或烧结的手段冶金接合到移植体上。烧结是一种接合工艺，其间至少一种待接合材料的熔点要稍微超过可以形成流动金属的温度，流动金属在待接合部件之间流动形成物理金属结合。扩散结合是一种类似工艺，但无需使温度超过任何待接合材料的熔点。在温度一般稍低于熔化条件下施加压力以压缩待接合界面，这常常会影响物理结合，这是由于仅是固态扩散。将多孔层扩散结合到移植体上是个难于操作的步骤，尤其在移植体表面粗糙或不平坦的情况下，更是如此。这个步骤需要多次扩散结合循环，每次循环都要求严格符合温度和压力工艺参数，为的是确保多孔层合适地结合到移植体上。因此，扩散结合工艺会消耗大量的以工时和基建投资形式的生产者的资源。
本发明的这种移植体和制备方法大大减少了将多孔表层联结到移植体上所需要的时间和物资。本发明利用改良方式的熔模铸造工艺提供一种铸造移植体，其上有冶金接合的多孔表面层。本发明方法中，移植体的蜡质图型形成之后，围绕蜡图型在合适位置上形成多孔表面层。多层表面层优选压延入或者连接到蜡图形上，使得另一部分多孔表面层与蜡图型互相交叉联结并被填充。因此，多孔层的一部分以其洞孔敞开形式保持裸露并且没有蜡。作为另一种方式，蜡或类似的填充材料可被浸渍到多孔层中，在使多孔层接触蜡模型之前封闭或填充部分洞孔。接着，其上连接有多孔表面层的蜡图型用多层陶瓷熔模材料涂覆，以公知方式形成型腔，在涂覆加工期间，事先未用蜡填充的多孔层部分用陶瓷材料填充，使用有生物适应性的陶瓷熔模材料，诸如羟磷灰石或其它磷酸钙类是优选的。所以，蜡模型从陶瓷模中熔化之前，多孔层的一部分用蜡填充。其他部分用陶瓷材料填充，蜡自陶瓷模内部熔化之后，剩下移植体形状的内腔，至于多孔层，事先用蜡填充的部分现在扩展进入内腔中并被裸露，换言之，没有填充蜡材料。在陶瓷模加工成硬化材料之后，倾倒熔融金属进入模具中形成移植体。熔融金属部分地熔化多孔层的裸露部分，从而与多孔层冶金接合，冷却之后，将陶瓷模从移植体和多孔层中清除，使得事先用陶资材料填充的多孔层部分现在被裸露，从这个工艺步骤中可见使用生物适应性的涂料作为熔模的优点，将所有陶瓷熔模从移植体上清除通常是十分重要的。而从多孔表面层去除所有熔模特别困难，但是如果熔模是生物适应性的，则留在多孔表面层洞孔内的剩余熔模对患者的无不利影响。事实上，如果采用已知的骨质生长促进剂羟磷灰石作为熔模，当移植后，残留的封闭多孔层洞孔的熔模可促进骨质在内生长，这样是有益的。
在一个选择的实施方案中，多孔表面层包括在其每一侧面上有多孔材料的薄金属阻挡层，金属阻挡层起到限制蜡材料相互交叉联结的作用。另外，阻挡层还起着防止多孔材料区域内的熔模材料与蜡模型之间的密切接触的作用，以便有助于更完全地清洁最终的移植体。
因此，本发明的一个目的是提供一种带有通过铸造形成的多孔表面层的铸造移植体。
本发明的另一个目的是提供形成带有多孔表面层的铸造移植体的制备方法。
本发明再有一个目的是提供使用熔模铸造工艺制备带有多孔表面层的铸造移植体的方法。
本发明还有一个目的是提供使用熔模铸造工艺制备铸造移植体的方法，其中由陶瓷熔模材料涂覆之前用多孔表面层覆盖移植体的蜡模型。
本发明另个目的是提供使用熔模铸造工艺制备铸造移植体的工艺，其中覆盖材料是生物适应性的。
在参照附图阅读下文说明后，本发明的其它目的将更加清楚可见。
图1是其上附着有多孔表面层的移植体蜡模型的透视图。
图2是图1中划圈区域中切出部分放大图，说明蜡互相交叉联结到多孔表面层中的情况。
图3是用陶瓷材料涂覆的带有多孔表面层蜡模型的切出部分正视图。
图4是图3的正视图，图解说明蜡模型从多孔表面层和陶瓷体中熔出后形成内腔。
图5是图4圆圈部分放大图，说明纤维金属部分裸露并扩散进入内腔体和部分用陶瓷材料填充的情况。
图6图解说明带有多孔表面层的陶瓷模具正用熔融金属填充。
图7是冷却后并脱离陶瓷模具的最终移植体的透视图。
图8是图7圆圈部分部分剖视和放大图，示意说明多孔表面层和移植体之间的接合情况。
图9是一种另一个选择方案的放大图，其中多孔层包括在其每一侧面带有多孔材料的阻挡层。
下面优选实施方案描述不是意味着穷举或限制本发明在所公开的具体公开形式上。而是，这种选择和说明是便于本领域技术人员利用这些提示说明。
现参看附图，图1示意说明矫形髋骨移植体的蜡复型或蜡模型10。应当了解，所示的髋骨移植体仅供说明，绝非限制本发明。图1进而示意出多孔表面层12包裹部分蜡模型10的情况。图示的多孔表面层12由金属丝网制成，同样不应视为对本发明的限制。多孔层可由各种公知材料制成，诸如金属珠粒烧结形成的多孔层，对多孔表面层12加热并压入到蜡模型10外表面到予定程度上，使得在多孔表面层12中形成的洞孔部分被填充，或反之如图2所示用蜡模型材料来封闭。如图所示，多孔表面层的外部不用蜡浸渍，因此仍保留原孔隙度。应再次了解多孔表面层12的确切形状和位置绝非认为是限制本发明，而仅供说明目的。其次，附着多孔表面层12的蜡模型10在陶瓷熔模介质14中重复多次浸渍，并以公知方式硬化形成图3所示的结构。形成陶瓷模型后，陶瓷熔模介质填充多孔表面层的外部洞孔，使得陶瓷模型完全形成之后，一部分多孔表面层用蜡模型材料填充，而另部分多孔表面层用陶瓷材料填充。因此，陶瓷模型完成之后，基本上所有多孔层的洞孔或者用蜡或者用陶瓷介质材料填充。然后，用本领域的普通的熔模铸造1艺。陶瓷模型被加热固化成型并将蜡型10熔掉。如图4所示蜡模型10熔化时，由于陶瓷材料互相交叉联结进入到部分多孔表面层中，使多孔表面层12就地保留。图5说明蜡去除之后，多孔表面层从陶瓷模具扩展进入由于蜡去除形成的内腔体16中。当蜡模型按工业标准的方式去除之后，将熔融金属18倾入如图6所示的陶瓷模型中，以填充蜡模型留下的内腔体16。熔融金属部分地熔化扩散进入内腔体16中的多孔表面层12的裸露部分。因此多孔表面层冶金接合到移植体上，如图7和8所示，这是由于部分多孔层熔融接合到熔融金属上所致。模型及金属冷却之后，以公知方式打碎陶瓷模型，取出移植体。另外，清洗预先用陶瓷材料填充的多孔层中的洞孔，使得不残留陶瓷。如图7和8所得移植体20包括其上带有多孔表面层12的金属体22。
作为常用熔模材料的替代物，可从生物适应性的材料中形成陶瓷熔模材料，例如，羟磷石灰或其它磷酸钙类。其优点是，如果任何生物适应性熔填材料留在多孔表层内，它对患者没有不利影响，再者，生物适应性的熔模材料可刻意留在多孔表面之内以促进骨质在其内生长。
一种供选择的实施方案如图9所示。图9的选择性方案中，形成的多孔层12包括薄金属阻挡层26，它的每个侧面连接有多孔材料28。使用时，阻挡层起两种功能作用。首先，阻挡层限制多孔层互相交叉联结进入蜡型的数量，从而保证最终移植体上多孔层的厚度最小化。其次，阻挡层防止熔模材料和蜡模型之间沿多孔层表面紧密接触。防止这种紧密接触有助于从多孔表面层清除熔模材料。
应当了解，本发明绝非局限于所公开的确切内容，可在所附的权利要求的范围之内改进。

Claims (9)

1.一种制备其上带有多孔表面层的移植体的方法，包括步骤如下：
a.提供由第一种材料制成的矫形移植体复型；
b.将第二种材料制成的多孔层连接到复型的至少一部分上，所述多孔层具有许多洞孔；洞孔的第一部分用所述第一种材料填充；
c.用第三种材料涂覆所述复型和多孔层，所述第三种材料填充多孔层的第二部分洞孔；
d.去除所述第一种材料，在所述涂层内形成内腔体，从而裸露所述第一部分洞孔；
e.用第四种材料填充所述内腔体，使所述第四种材料与邻接于所述第一部分洞孔的多孔层结合成整体连接；和，
f.第四种材料固化之后去除第三种材料，从而裸露所述第二部分洞孔。
2.根据权利要求1的方法，其中所述第三种材料是生物适应性的。
3.根据权利要求1的方法，其中所述第一种材料是蜡，所述第二种材料是金属，所述第三种材料是陶瓷熔模材料，所述第四种材料是熔融金属。
4.根据权利要求1的方法，其中所述多孔层由钛纤维金属网形成。
5.根据权利要求1的方法，其中多孔层包括在其上第一和第二侧面结合有多孔金属材料的薄金属阻挡层，其中在金属阻挡层第一侧上的多孔金属材料构成所述第一部分洞孔，金属阻挡层第二侧面上的多孔金属材料构成第二部分洞孔。
6.  一种制备具有金属多孔表面层覆盖一部分移植体的铸造矫形移植体的方法，包括如下步骤：
a.提供一种矫性移植体的蜡模型；
b.提供一种带有许多洞孔的金属表面层；
c.将金属多孔表面层压入蜡复型中，使得第一部分洞孔用蜡填充，
d.用陶瓷熔模材料涂覆其上附有金属多孔表面层的蜡模型，以便形成陶瓷模，使得金属多孔表面层的第二部分洞孔用陶瓷熔模材料填充；
e.从陶瓷模中去除蜡模型并从而裸露多孔材料的第一部分洞孔；
f.用熔融金属填充陶瓷模，其中熔融金属与邻接在多孔金属表面层的第一部分洞孔附近的多孔金属表面层相接合；
g.熔融金属冷却后去除陶瓷模。
7.根据权利要求6的方法，其中陶瓷熔融材料是生物适应性的。
8.根据权利要求7的方法，其中陶瓷模去除之后，陶瓷熔模材料仍残留在多孔金属表面层的第二部分洞孔之内。
9.根据权利要求6的方法，其中多孔金属表面层包括一种带有结合在金属阻挡层的第一和第二侧面上的多孔材料薄金属阻挡层，其中结合在金属阻挡层第一侧面的多孔材料构成所述多孔金属表面的第一部分洞孔，结合在金属阻挡层第二侧面的多孔材料构成所述多孔金属表面层的第二部分洞孔。
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