Podoshin L, Nodar R H, Hughes G B, Bauer T, Hayes J D, Fradis M, Boss J, Ramsey L
Department of Otolaryngology, Haifa Medical Center, Rothschild, Israel.
Am J Otol. 1988 Sep;9(5):366-75.
In a variety of structural forms, carbon possesses certain properties that render it suitable for implantation in the human body. This report analyzes biocompatibility of a new carbon-carbon prosthesis following long-term middle ear implantation in a prospective, controlled animal study. The prosthesis was placed in the left ear of 20 healthy guinea pigs and in the dorsal subcutaneous tissues for control. The right ear also served as control. Preoperative and postoperative auditory evoked potentials were recorded and compared. Samples of tissue from all three sites were evaluated at 3 and 6 months by light microscopy. The implants also were evaluated by scanning electron microscopy. Samples of lymph nodes, liver, spleen, and lungs also were examined. Fourteen animals (70%) demonstrated no change in auditory evoked potentials postoperatively. One animal developed unilateral dysfunction and three others developed bilateral dysfunction for unexplained reasons. No significant tissue destruction or inflammation of the tissues and no digestion or erosion of the implants were observed. No passage of carbon particles into the reticuloendothelial system was identified. These preliminary results suggest that this new carbon-carbon prosthesis may be biocompatible at 6 months follow-up in the guinea pig and encourage further investigation.
碳以多种结构形式存在，具有某些特性，使其适合植入人体。本报告在一项前瞻性对照动物研究中，分析了一种新型碳-碳假体长期植入中耳后的生物相容性。将该假体植入20只健康豚鼠的左耳，并置于背部皮下组织作为对照。右耳也作为对照。记录并比较术前和术后的听觉诱发电位。在3个月和6个月时，通过光学显微镜对来自所有三个部位的组织样本进行评估。还通过扫描电子显微镜对植入物进行评估。同时检查淋巴结、肝脏、脾脏和肺的样本。14只动物（70%）术后听觉诱发电位无变化。1只动物出现单侧功能障碍，另外3只因不明原因出现双侧功能障碍。未观察到组织有明显的破坏或炎症，植入物也未出现消解或侵蚀。未发现碳颗粒进入网状内皮系统。这些初步结果表明，在豚鼠6个月的随访中，这种新型碳-碳假体可能具有生物相容性，并鼓励进一步研究。
