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

近年来，用于生物相关应用的湿软材料的需求一直在增加。到目前为止，通过将有机/无机纳米复合水凝胶的概念扩展到软凝胶，我们已经开发出了一种新型的纳米复合水凝胶(NC凝胶)，它具有优异的力学、光学和溶胀/脱水性能。在这项研究中，我们旨在通过改善NC凝胶的功能(如延伸性、对血浆的吸收、生物安全性、不愈合和无菌)并以不同的形式制造它，来开发用于生物医学应用的新型NC凝胶材料和装置，例如具有长期耐用性的可植入材料。通过对其网络结构的改进，成功地改善了其力学性能、表面性能和溶胀/脱水性能。(2)在新设备的开发方面，我们使用了NC凝胶医用材料。我们得出结论，NC凝胶能够舒适地用作耐用的植入材料，同时防止难治性肉芽肿组织的形成。此外，我们通过植入山羊体内研究了活体组织与NC凝胶的相互作用。针对医疗器械的安全性和产品设计，我们对医疗器械进行了生物试验，包括致敏试验、刺激性试验、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.