Hybrid retinal prosthesis utilizing bioadhesives for reversible attachment

利用生物粘合剂进行可逆附着的混合视网膜假体

• 批准号: 7926879
• 负责人: Helmut Eckhardt
• 金额: $ 230.36万
• 依托单位: PREMITEC, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2013-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7926879
• 关键词: 3-Dimensional; Address; Adhesives; Affinity; Area; Binding; Brain; Caliber; California; Characteristics; Clinical; Clinical Trials; Collaborations; Complex; Development; Devices; Disintegrins; Drug Formulations; Electrodes; Employee Strikes; Eye; Funding; Goals; Health; Hybrids; Implant; Implantation procedure; Individual; Inferior; Inner Limiting Membrane; Institutes; Lasers; Lead; Lifting; Liver; Manufacturer Name; Mechanics; Medical; Medical Device; Methods; Microelectrodes; Microfabrication; Motivation; Names; National Institute of Neurological Disorders and Stroke; Nature; Operative Surgical Procedures; Phase; Polymers; Population; Positioning Attribute; Process; Property; Prosthesis; Proteins; Public Health; Retina; Retinal; Retinal Detachment; Risk; Safety; Screening procedure; Silicone Elastomers; Silicones; Site; Small Business Innovation Research Grant; Spinal Cord; Stimulus; Stroke; Surface; System; Technology; Testing; Tissues; United States National Institutes of Health; Universities; Variant; Vision; Visual; Visual Acuity; Visual Fields; Widespread Disease; Work; biomaterial compatibility; brain tissue; commercialization; contortrostatin; design; flexibility; implantable device; implantation; improved; in vivo; nervous system disorder; neural prosthesis; novel; pressure; prototype; public health relevance; relating to nervous system; research study; retinal damage; retinal prosthesis; sample fixation

DESCRIPTION (provided by applicant): Premitec, Inc., in collaboration with the Doheny Eye Institute at the University of Southern California has developed novel, 3-dimensional wide field microelectrode arrays (3D-WFA) for retinal prosthesis. These devices can double the visual field for retinal prostheses versus the devices currently being tested in clinical trials. The electrode arrays have a 10-mm diameter area of contact with the retina, thus enabling a wide field of vision. This work is funded by the National Institute of Neurological Disorder and Stroke (NINDS) at NIH. A conclusion of our results so far is that the large area polyimide array, although it has a three dimensional curvature to match an "average" eye, nonetheless has the tendency sometimes to separate from the retina, particularly at the edges, due to difficulty of the implant procedure, the nature of the polyimide array edge and variation in eye curvature. In addition use of a single retinal tack to affix the prosthesis to the retina not only damages the retina at the insertion site but also leads to greater non-uniformity in distance to the retina across the array. To address these shortcoming we propose to develop a novel hybrid silicone/polyimide wide-field array and eliminate the tack altogether. Recently we have demonstrated that the silicone surface can be modified to bind an adhesive protein which also binds strongly to the inner limiting membrane of the retina, and more generally to brain and other tissues. Replacing the tack with an adhesive will virtually eliminate the distance between the electrode and the retina, and thus reduces the stimulus threshold. By incorporating adhesive-silicone technology into the design of the 3D-WFA, we can address two important issues: increase implant safety by reducing the likelihood of retina damage and improve implant efficacy by reducing the distance between the array and the retina. PUBLIC HEALTH RELEVANCE: Advancements in microfabrication and materials have made possible the development of flexible neural interfaces. These medical devices are targeted at treating incurable neurological disorders and solve difficult technical problems that are limiting the capability of neural implant devices. Such diseases are widespread in the population as a whole and their impact on individual health is profound. The progress made by us so far with support from NINDS through Phase II SBIR demonstrates that our technology has the potential to lead to a successful commercialization of complex and challenging neural interfaces like the retinal stimulator and make a real impact on public health by increasing the capability of implantable neural prostheses.

描述（由申请人提供）：Premitec, Inc. 与南加州大学 Doheny 眼科研究所合作开发了用于视网膜假体的新型 3 维宽视场微电极阵列 (3D-WFA)。与目前临床试验中测试的设备相比，这些设备可以使视网膜假体的视野扩大一倍。电极阵列与视网膜的接触面积直径为 10 毫米，从而实现宽阔的视野。这项工作由 NIH 国家神经疾病和中风研究所 (NINDS) 资助。 到目前为止，我们的结果得出的结论是，大面积聚酰亚胺阵列虽然具有与“普通”眼睛相匹配的三维曲率，但由于植入过程的困难、聚酰亚胺阵列边缘的性质和眼睛曲率的变化，有时会倾向于与视网膜分离，特别是在边缘处。此外，使用单个视网膜钉将假体固定到视网膜不仅会损坏插入部位的视网膜，而且还会导致阵列上到视网膜的距离更大的不均匀性。 为了解决这些缺点，我们建议开发一种新型混合硅/聚酰亚胺宽场阵列并完全消除粘性。最近我们已经证明，可以对有机硅表面进行修饰以结合粘附蛋白，该粘附蛋白也可以与视网膜的内界膜，更广泛地与大脑和其他组织牢固地结合。用粘合剂代替大头钉实际上会消除电极和视网膜之间的距离，从而降低刺激阈值。通过将硅胶粘合剂技术融入 3D-WFA 的设计中，我们可以解决两个重要问题：通过降低视网膜损伤的可能性来提高植入安全性，并通过减少阵列和视网膜之间的距离来提高植入功效。 公共健康相关性：微加工和材料的进步使得柔性神经接口的开发成为可能。这些医疗设备旨在治疗无法治愈的神经系统疾病，并解决限制神经植入设备能力的技术难题。此类疾病在整个人群中普遍存在，对个人健康影响深远。迄今为止，我们在 NINDS 的支持下通过第二阶段 SBIR 所取得的进展表明，我们的技术有潜力成功实现视网膜刺激器等复杂且具有挑战性的神经接口的商业化，并通过提高植入式神经假体的能力对公共健康产生真正的影响。