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

使用自固化 NC 水凝胶开发植入式医疗设备。

基本信息

批准号：
22659255
负责人：
MIZUNO Toshihide
金额：
$ 2.07万
依托单位：
National Cardiovascular Center Research Institute
依托单位国家：
日本
项目类别：
Grant-in-Aid for Challenging Exploratory Research
财政年份：
2010
资助国家：
日本
起止时间：
2010 至 2012
项目状态：
已结题

项目摘要

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.

近来，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，我们已经开发出一种新型的纳米复合水凝胶（NC凝胶）具有非凡的机械，光学和溶胀/去溶胀性能的有机/无机NC的概念扩展到软水凝胶。在这项研究中，我们的目的是开发新的NC凝胶材料和设备的生物医学应用，如可植入的材料具有长期的耐久性，通过改善NC凝胶的功能（例如，可伸展性，血浆的吸收，生物安全性，nonconcescence，和无菌性）和制造它在各种形式。我们成功地改善其机械，表面和溶胀/去溶胀性能，通过修改其网络。(2)关于新器械的开发，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持久的植入材料，同时防止形成难治性肉芽肿组织。此外，我们通过植入山羊体内，对活组织与NC凝胶的相互作用进行了体内研究。我们发现NC凝胶周围既没有炎症也没有愈合。(3)关于医疗器械的安全性和产品设计，我们进行了医疗器械的生物学试验，包括致敏试验、刺激试验、皮内试验和体外细胞毒性试验。我们在所有这些试验中证实了NC凝胶的安全性。