Development of a implantable medical device with the self-curable NC-hydrogel.

近年来，生物相关应用对湿软材料的需求不断增加。到目前为止，我们已经开发出一种新型纳米复合水凝胶（NC凝胶），通过将有机/无机纳米复合水凝胶的概念扩展到软水凝胶，具有非凡的机械，光学和膨胀/溶胀性能。在本研究中，我们的目标是通过改进NC凝胶的功能（如延展性、等离子体吸收、生物安全性、非粘性和无菌性），并以各种形式制造NC凝胶，开发新型的NC凝胶材料和生物医学应用设备，如具有长期耐用性的植入式材料。通过改变其网络，我们成功地改善了其机械性能、表面性能和膨胀/溶胀性能。(2)在新器件的开发方面，我们使用了NC凝胶医用材料。我们的结论是，NC凝胶能够舒适地作为持久的植入材料，同时防止顽固性肉芽肿组织的形成。此外，我们在山羊体内植入了活体组织与NC凝胶的相互作用。我们发现NC凝胶周围既没有炎症也没有愈合。(3)在医疗器械的安全性和产品设计方面，我们开展了医疗器械的生物试验，包括致敏试验、刺激试验、皮内试验和体外细胞毒性试验。我们在所有这些测试中都证实了NC凝胶的安全性。

Recently, the demand of wet soft materials for bio-related applications has been increasing. Thus far, we have developed a novel nanocomposite hydrogel (NC gel) with extraordinary mechanical, optical, and swelling/deswelling properties by extending the concept of organic/inorganic NCs to soft hydrogels. In this study, we aimed to develop novel NC gel materials and devices for biomedical applications, such as an implantable material with long-term durability, by improving the functions of the NC gel (e.g. extensibility, absorption of plasma, biological safety, nonconcrescence, and asepsis) and fabricating it in various forms. We succeeded in improving its mechanical, surface, and swelling/deswelling properties by modifying its network.(2) With regard to the development of new devices, we used NC gel-medical materials. We concluded that NC gels comfortably were able to use as the durable implanted material while simultaneously preventing the formation of intractable granulomatous tissues. Further, we carried out an in vivo investigation of the interaction of living tissue with the NC gel by implantation in goats. We found that neither inflammation nor concrescence occurred around the NC gels.(3) With regard to the safety and product design of medical devices, we carried out biological testing of medical devices, which involved a sensitization test, irritation test, intracutaneous test, and in vitro cytotoxicity test. We confirmed the safety of the NC gel in all these tests.