Trauma-Reducing Alginate Cochlear-Implant COating (TRACO)

减少创伤藻酸盐人工耳蜗涂层 (TRACO)

• 批准号: 452405020
• 负责人: Dr. Thomas Stephan Rau
• 金额: --
• 依托单位: Hals-Nasen-Ohrenklinik
• 依托单位国家: 德国
• 项目类别: Research Grants (Transfer Project)
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/452405020?language=en
• 关键词: Trauma; Reducing; Alginate; Cochlear; Implant

The standard therapy for patients suffering from sensorineural hearing loss is cochlear implantation. Within the last decade the indication for a cochlear implant (CI) has expanded to patients with residual hearing in the lower frequencies. Atraumatic electrodes have been designed to preserve the residual hearing in the implanted ear. However, the insertion of the electrode array into the cochlea, with potential mechanical insertion trauma, intraoperative frictional forces and the presence of this foreign body inside the cochlea, may lead to loss of residual hearing. We postulated that by coating the ET with a hydrogel such as alginate, a reduction in post-operative inflammatory processes and intracochlear tissue damage can be achieved and that this enables better residual hearing preservation and improved speech understanding. The main focus of this project is to investigate this working hypothesis in more detail. In cooperation with the industrial partner Advanced Bionics we will develop an alginate-CI- coating-technique at a pre-market level with regard to commercial exploitation. In vitro studies are conducted on insertion force modification and on the biocompatibility and the stability of the coating. Different coating processes are tested and compared. The final, most feasible coating technique with the best results obtained in vitro is tested preclinically in an in vivo study on implanted and chronically stimulated guinea pigs. The testing will be conducted in feedback loop with the competent authorities to implement their suggestions when conducting the experiments to finally have experimental data fitting the regulatory necessities for application of a first in men trial after this translational pre-clinical project.

感音神经性听力损失患者的标准治疗是人工耳蜗植入。在过去的十年中，人工耳蜗植入（CI）的适应症已扩展到低频残留听力的患者。无创电极已被设计用于保留植入耳中的残余听力。然而，将电极阵列插入耳蜗，伴随潜在的机械插入创伤、术中摩擦力和耳蜗内异物的存在，可能导致残余听力丧失。我们假设，通过用诸如藻酸盐的水凝胶涂覆ET，可以实现术后炎症过程和颅内组织损伤的减少，并且这能够更好地保留残余听力并改善言语理解。本项目的主要重点是更详细地研究这一工作假设。在与工业合作伙伴Advanced Bionics的合作中，我们将在商业开发方面开发一种处于上市前水平的藻酸盐CI涂层技术。对插入力修改以及涂层的生物相容性和稳定性进行了体外研究。对不同的涂层工艺进行了测试和比较。在植入和慢性刺激豚鼠的体内研究中，对最终、最可行的涂层技术进行临床前试验，并在体外获得最佳结果。试验将在主管部门的反馈回路中进行，以在进行实验时实施其建议，最终获得符合监管要求的实验数据，以便在该转化临床前项目后应用于首次男性试验。