CN1114225A - 聚合物复合材料植入物及其制备方法 - Google Patents

聚合物复合材料植入物及其制备方法 Download PDF

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CN1114225A
CN1114225A CN95103347A CN95103347A CN1114225A CN 1114225 A CN1114225 A CN 1114225A CN 95103347 A CN95103347 A CN 95103347A CN 95103347 A CN95103347 A CN 95103347A CN 1114225 A CN1114225 A CN 1114225A
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polymethyl methacrylate
implant
polyethylene
zone
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T·迪旺纳芬
R·S·金
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Bristol Myers Squibb Co
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Abstract

本发明提供髋骨臼和由复合聚合物材料构成的髋骨臼植入物的制备方法，所述植入物的关节联接面为100％超高分子量聚乙烯(UHMWPE)，而该骨臼的骨接合面含显著量的聚甲基丙烯酸甲酯(PMMA)。该骨臼至少由两个带构成。带1形成关节联接面，带2由带1延伸至骨接合面。带1最好由UHMWPE构成并由关节联接面延伸预定厚度。带2最好由模塑前干混的UHMWPE和PMMA的混合物构成。第3带可邻接带2并由PMMA构成。

Description

聚合物复合材料植入物及其制备方法
本发明涉及由聚合物材料制成的植入物并与具有由该聚合物的一种形式制成的关节联接面(articulating surface)和由复合材料形成的基本部分的植入物有特别关联。
用于全髋置换外科手术的假体髋骨臼多年来一直由多种材料制备。骨臼由全金属、全聚合物制成，或由材料的组合来制备，其中外壳由金属制成，而形成关节联接面的衬垫由聚合物形成。各制造厂家选用的聚合物各不相同，但超高分子量聚乙烯(UHMWP E)被广泛使用。
假体骨臼可根据外科医生对具体病人作出的选择而被旋拧、压固或粘合到髋臼上。每种假骨臼及其固定方法均各具优缺点。全UHMWP E骨臼的一个缺点是：由于骨粘固粉不能与UHMWP E充分粘合，因而难于粘合固定。另外，全UHMWP E骨臼在被植入体内时显示蠕变问题，这是由于UHMWP E的玻璃化转变温度低于病人的体温。
本发明提供髋骨臼及髋骨臼植入物的制备方法，所述髋骨臼植入物由复合聚合物材料制成，其关节联接面为100％超高分子量聚乙烯(UHMWP E)，而该骨臼的骨接合面(bone engaging surface)基本上是聚甲基丙烯酸甲酯(P MMA)。该骨臼由至少两个带构成。带1形成关节联接面。带2从带1延伸至骨接合面。带1最好由UHMWP E构成并从并节联接面延伸预定的厚度。带2最好由模塑前干混的UHMWP E和P MMA的混合物构成。第3带基本由P MMA构成。
因此，本发明的一个目的是提供新的聚合物复合材料植入物。
本发明的另一个目的是提供具有由P MMA和UHMWP E的混合物形成的骨臼的基本部分的假体髋骨臼。
本发明的另一个目的是提供具有形成关节联接面的UHMWP E层和由P MMA和UHMWP E的混合物形成的主体的髋骨臼。
本发明的另一个目的是提供制备复合聚合物植入物的新方法。
本发明的其它目的在下面的说明和附图中将是显而易见的。
图1是举例说明本发明的假体髋骨臼的横断面视图。
图2是本发明的另一个实施方案。
下文所描述的优选实施方案不是用来将本发明穷举或限制在所公开的具体形式的范围内。相反，选择并描述这些实施方案是为了最佳地解释本发明以便本领域的其他技术人员可利用其教导。
图1截面所示的本发明的髋骨臼10包括三个层或带。带I即层12由超高分子量聚乙烯制成，它形成用于容纳髋干植入物(hip atem im-plant)(未示出)的股骨头的关节联接面。UHMWP E在矫形工业领域中是众所周知的。骨臼10的带2即层14由UHMWP E和P MMA聚合物混合物形成。可以使用PMMA均聚物或P MMA共聚物。该聚合物混合物形成在负载条件下具有高度完整性的互穿聚合物网络。带3即层16由100％P MMA组成，所述P MMA或者为P MMA均聚物或为P MMA共聚物。由P MMA形成的垫层可通过超声熔接到图1所示的层13上来固定，以帮助外科医生在将该骨臼植入时在其周围形成均匀的粘固粉层。为制备图1的植入物，将P MMA颗粒层或制成的P MMA膜置于压塑模的阴模中。然后将已经干混的P MMA和UHMWP E颗粒层置于该P MMA层上的模中。该混合物最好包括20％-30％(重量)的P MMA。在将所述颗粒置于模中后可能有必要在加下一个相邻层之前通过对所述层施加压力而将其预固结。最后将UHMWP E颗粒层置于混合的P MMA和UHMWP E颗粒层之上。闭模，在一定压力和温度下压塑。在模塑过程中，P MMA熔化并在UHMWP E中形成互透热塑性网络，与全UHMWP E骨臼相比，它能增强骨臼的韧性。此外，本发明的骨臼的压缩蠕变比全UHMWP E骨臼的低，这是因为P MMA的玻璃化转变温度高于UHMWP E的玻璃化转变温度和病人的体温。最后，通过由P MMA形成带3即层16，该骨臼能容易地与置于该髋臼中的P MMA骨粘固粉粘接以将该骨臼粘固就位。
图2说明了本发明的另一个实施方案。图2的骨臼10′包括UHMWP E层12′和混合的UHMWP E和PMMA层14′。骨臼10′的制备方法与上述相似，所不同的是取消了应用P MMA层作带3这一步骤。在使用时，外科医生准备病人的髋臼并将P MMA骨粘固粉施入其中后，将植入物10′置于该骨粘固粉中。置于骨臼中的新鲜骨粘固粉与层14′中的骨粘固粉相互作用而将该植入物粘固就位。
应当理解的是，尽管本发明是以髋臼来描述的，但该方法能应用于多种植入物例如胫骨托(tibial tray)。本方法用于不同植入物部件的改良应被认为是在本发明范围内。
还应理解的是，尽管未讨论各带的具体厚度，但各带即层的厚度可根据制造说明书加以控制以改变植入物的韧性。
此外，还应当理解，本发明不限于所公开的具体形式，而可在所附权利要求的范围内加以改进。

Claims (8)

1.无金属矫形植入物，包括：
适于与第二部分滑动接触的第一层，
第二外层，
第一层由聚乙烯类聚合物材料制成，第二层由聚乙烯和聚甲基丙烯酸甲酯的混合物制成。
2.权利要求1的无金属植入物，其中第一层由超高分子量聚乙烯构成。
3.权利要求1的无金属植入物，它还包括模塑到所述第二外层上的第三层，该第三层由聚甲基丙烯酸甲酯构成。
4.权利要求1的植入物，包括由聚甲基丙烯酸甲酯构成的被超声熔接至该植入物的隔离部件。
5.聚合物复合材料植入物，包括基本上由超高分子量聚乙烯构成的第一层和混合的聚甲基丙烯酸甲酯和聚乙烯的第二层。
6.制备聚合物复合材料植入物的方法，该方法包括以下步骤：
a)将聚甲基丙烯酸甲酯第一层置入压塑模中；
b)将混合的聚甲基丙烯酸甲酯和聚乙烯的第二层置于聚甲基丙烯酸甲酯层上；
c)将第三层聚乙烯置于该混合的聚甲基丙烯酸甲酯层之上；和
d)将所述第一、第二和第三层用温度和热压塑在一起，所述温度和热应足以使在所述第二层中的聚甲基丙烯酸甲酯熔化和该超高分子量聚乙烯(UHMWPE)熔融。
7.权利要求6的方法，其中步骤a)和b)包括将该第一和第二层预固结在该模中这一步骤。
8.制备聚合物复合材料植入物的方法，包括以下步骤：
a)将混合的聚甲基丙烯酸甲酯和聚乙烯的第一层置入压塑模中；
b)将聚乙烯第二层置于该混合的聚甲基丙烯酸甲酯层之上；和
c)将所述第一和第二层用足以使在所述第二层中的聚甲基丙烯酸甲酯能在该聚乙烯周围流动的温度和热压塑在一起。
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