Development of shape memory polymer-based implantable electrode systems.

描述(申请人提供)：全世界有超过10万名患者在大脑中永久植入了某种形式的神经接口。虽然有效，但这些接口有几个技术限制，限制了其临床疗效的全部范围。几十年来，硅技术一直被吹捧为创造更先进神经接口的最有可能的候选者。硅似乎是一种理想的生物兼容材料，可以用来创造更先进的接口，这些接口是微型、高密度、批量制造的，能够支持机载有源电子设备。然而，硅是一种脆性材料，虽然它的硬度可以很容易地植入软神经组织，但它在植入装置和植入后的软神经组织之间存在严重的机械失配。在第一阶段SBIR的“实验室到市场”计划中，Vulintus LLC将探索为长期神经植入市场开发一种名为形状记忆聚合物(SMP)的新型基板材料的可行性。SMP材料的独特之处在于，它们提供了硅(带有板载电子设备的超微型、批量制造的光刻结构)的传统技术优势，但具有更可控的机械和表面化学性质的额外好处。通过操纵聚合物组成，可以将材料设计为在植入后经历弹性系数的变化。Vulintus将展示一种先进的批量制造的高产量电极界面，这种界面的硬度比硅结构低10万倍。Vulintus假设，这种改变范式的“多模数”材料非常适合通过创建随大脑运动变形的界面来扩展神经界面的长期功能，从而将组织损伤降至最低。提出了以下具体目标：目标1：证明材料硬度的不同会导致植入的t-e/a SMP神经界面的免疫反应发生变化。目的2：研究优化的t-e/a SMP电极在大鼠大脑中的体内功能：Vulintus和合作伙伴收集的初步体外和体内数据表明，t-e/a SMP材料具有生物相容性，确实适合用于侵入性神经工程应用。Vulintus将与领先的商业电极制造商NeuroNexus建立密切的合作伙伴关系(见支持函)，使我们能够迅速利用这项新兴技术，并在商业市场获得吸引力。在第一阶段，将证明t-e/a SMP在大鼠模型中用于长期功能性植入的安全性和有效性的可行性。在第二阶段，Vulintus将探索表面化学修饰和后处理步骤，以实现机载电子产品的组装和封装，并演示和测试用于商业动物研究市场的产品系列。

DESCRIPTION (provided by applicant): More than 100,000 patients worldwide have some form of permanently implanted neural interface in the brain. Although effective, these interfaces have several technical limitations that limit the full scope of their clinical efficacy. For severa decades, silicon technology has been touted as the most likely candidate for creating more advanced neural interfaces. Silicon seems to be an ideal and biocompatible material from which to create more advanced interfaces that are miniature, high-density, batch-fabricated and capable of supporting active on-board electronics. Silicon, however, is a brittle material, and while its stiffness allows for easy implant into soft neural tissue, it presents a serious mechanicl mismatch between the implanted device and the soft neural tissue after implant. In this Phase I SBIR "Lab to Marketplace" proposal, Vulintus LLC will explore the feasibility of a developing a novel class of substrate materials called Shape Memory Polymers (SMP) for the long-term neural implant market. SMP materials are unique in that they offer the traditional technical advantages of silicon (ultra-miniature, batch-fabricated photolithography structures with on-board electronics), but with the added benefit of having much more controllable mechanical and surface chemistry properties. By manipulating the polymer composition, the material can be engineered to undergo a change in modulus of elasticity following implantation. Vulintus will demonstrate an advanced batch fabricated high-yield electrode interface that is up to 100,000 times less stiff than a silicon structure. Vulintus hypothesizes that this paradigm-shifting 'multile modulus' material is ideally suited for extending the long-term functionality of neural interfaces by creating an interface that deforms with brain motion, minimizing tissue damage. The following specific aims are proposed: Aim 1: Demonstrate that differences in material stiffness lead to variations in the immune response for implanted t-e/a SMP neural interfaces. Aim 2: Characterize in vivo functionality of 'optimized' t-e/a SMP cortical electrodes in the rat brain: Preliminary in vitro and in vivo data collected by Vulintus and partners suggest that t-e/a SMP materials are biocompatible and indeed appropriate for invasive neural engineering applications. Vulintus will establish close partnerships with NeuroNexus, a leading commercial electrode manufacturer (see letters of support) to allow us to rapidly take advantage of this emerging technology and gain traction in the commercial market. In Phase I, the feasibility of t-e/a SMP safety and efficacy for long-term functional implants in a rat model will be demonstrated. In Phase II, Vulintus will explore surface chemistry modifications and post-processing steps to allow population and encapsulation of onboard electronics as well as demonstrate and test a product line for use in the commercial animal research market.