Hybrid retinal prosthesis utilizing bioadhesives for reversible attachment

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三维宽场微电极阵列（3D-WFA）。与目前正在临床试验的设备相比，这些设备可以将视网膜假体的视野扩大一倍。电极阵列与视网膜有一个直径10毫米的接触区域，从而实现宽视野。这项工作是由美国国立卫生研究院的神经疾病和中风研究所（NINDS）资助的。到目前为止，我们的结论是，尽管大面积聚酰亚胺阵列具有与“平均”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，它有时会与视网膜分离，特别是在边缘。此外，使用单一的视网膜钉将假体固定在视网膜上不仅会损害插入部位的视网膜，而且还会导致与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的混合硅/聚酰亚胺宽场阵列，并完全消除粘胶。最近，我们已经证明，硅胶表面可以被修改，以结合一种粘附蛋白，这种粘附蛋白也可以与视网膜的内限制膜紧密结合，更广泛地说，可以与大脑和其他组织结合。用粘接剂代替粘接剂实际上可以消除电极和视网膜之间的距离，从而降低刺激阈值。通过在3D-WFA的设计中加入粘接硅胶技术，我们可以解决两个重要问题：通过减少视网膜损伤的可能性来增加植入物的安全性，通过减少阵列和视网膜之间的距离来提高植入物的功效。

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.