Development of shape memory polymer-based implantable electrode systems.

描述（由申请人提供）：全世界有超过10万名患者在大脑中永久性植入了某种形式的神经接口。虽然有效，但这些接口有一些技术限制，限制了其临床疗效的全面范围。几十年来，硅技术一直被吹捧为创造更先进的神经接口的最有可能的候选人。硅似乎是一种理想的、具有生物相容性的材料，可以用来制造更先进的接口，这些接口可以是微型的、高密度的、批量制造的，并且能够支持有源机载电子设备。然而，硅是一种脆性材料，虽然它的刚度允许很容易植入到柔软的神经组织中，但它在植入设备和植入后的柔软神经组织之间存在严重的机械不匹配。在第一阶段SBIR“从实验室到市场”的提案中，Vulintus LLC将探索开发一种称为形状记忆聚合物（SMP）的新型基板材料的可行性，用于长期神经植入市场。SMP材料的独特之处在于，它们提供了硅的传统技术优势（超微型、批量制造的光刻结构与机载电子设备），但具有更可控的机械和表面化学性能的额外好处。通过操纵聚合物组合物，材料可以被设计成在植入后经历弹性模量的变化。Vulintus将展示一种先进的批量制造的高产量电极界面，其硬度比硅结构低10万倍。Vulintus假设，这种范式转换的“多模量”材料非常适合通过创建一个随大脑运动变形的界面来扩展神经界面的长期功能，从而最大限度地减少组织损伤。提出了以下具体目标：目标1：证明材料刚度的差异导致植入t-e/a SMP神经接口的免疫反应的变化。目的2：表征“优化”的t-e/a SMP皮质电极在大鼠脑中的体内功能：Vulintus及其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，使我们能够迅速利用这一新兴技术，并在商业市场上获得牵引力。在第一阶段，将在大鼠模型中证明t-e/a SMP用于长期功能植入物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，以实现机载电子设备的填充和封装，并演示和测试用于商业动物研究市场的产品线。

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.