Fister J S, Memoli V A, Galante J O, Rostoker W, Urban R M
J Biomed Mater Res. 1985 May-Jun;19(5):519-33. doi: 10.1002/jbm.820190505.
A thermoplastic polymer, Delrin 150 (polyoxymethylene homopolymer), with creep resistance ten times that of ultrahigh-molecular-weight polyethylene, is used as a material for total joint prostheses. A study was made of the local and systemic host response to this polymer when implanted in three different mammalian species. 316 LC stainless steel was used as a control. The materials were implanted into muscle and bone as solid cylinders. A total of 446 samples were implanted into 74 animals. The duration of implantation ranged from 2 weeks to 2 years. A semi-quantitative evaluation of local tissue reaction was performed. For each implant, 16 histological criteria were graded for severity of host tissue reaction. The liver, spleen, kidneys, pancreas, and lungs from each animal were also studied for evidence of systemic toxicity. The polymer implants exhibited a mild tissue reaction with the same characteristics as the control. Local tumor formation, bone osteolysis, and surrounding muscle necrosis were not seen. No pathological changes compatible with systemic toxicity by Delrin 150 were observed in the study of the organs. Delrin 150 in solid form did not exhibit local or systemic toxicity and is therefore biocompatible by this study. Powder implantation studies should be performed to simulate tissue response to wear particles.
一种热塑性聚合物——聚甲醛均聚物Delrin 150，其抗蠕变性是超高分子量聚乙烯的10倍，被用作全关节假体的材料。对该聚合物植入三种不同哺乳动物物种时的局部和全身宿主反应进行了研究。使用316L不锈钢作为对照。将材料制成实心圆柱体植入肌肉和骨骼中。总共446个样本被植入74只动物体内。植入时间从2周至2年不等。对局部组织反应进行了半定量评估。对于每个植入物，对16个组织学标准的宿主组织反应严重程度进行分级。还研究了每只动物的肝脏、脾脏、肾脏、胰腺和肺，以寻找全身毒性的证据。聚合物植入物表现出与对照相同特征的轻度组织反应。未观察到局部肿瘤形成、骨溶解和周围肌肉坏死。在对器官的研究中未观察到与Delrin 150全身毒性相符的病理变化。固态的Delrin 150未表现出局部或全身毒性，因此根据本研究具有生物相容性。应进行粉末植入研究以模拟组织对磨损颗粒的反应。
