Clinical Validation and Testing of Percutaneous Cochlear Implantation

项目概要/摘要： 本提案的目的是使用我们以前开发的方法进行临床可行性研究 用于微创人工耳蜗植入术（CI），从而使该方法更接近于广泛的临床应用。 领养这项翻译工作是多年研究的成果，如果成功，将从根本上 改变人工耳蜗手术，让更多的患者接受植入。 临床意义来自于大量可以从CI中获益但尚未接受 第一，部分原因是手术的复杂性和侵入性。尽管有效，但不到10% 的线人候选人接受了植入手术使用不足的原因包括程序费用高 以及缺乏接受过CI手术培训的耳鼻喉科医生。为了弥补这一差距，技术 有必要进行改进，以降低手术成本并使其更容易实施。我们的方法来 使用图像引导手术沿着新颖的图像处理， 算法这种方法取代了手动去除大量的骨与狭窄的钻孔路径从 使用患者特定的立体定向框架将颅骨表面与耳蜗自动沿着路径对齐。这 这种方法可以降低手术成本，并使不太专业的外科医生能够进行手术。 该方案的技术和临床创新包括：（1）将一种新的外科手术 我们最近收到了FDA的研究器械豁免，（2）多- 基于患者特定型号和术中硬件验证的分层冗余安全检查， (3)基于患者特定解剖结构测试具有定制插入深度的插入工具，以及（4）使得能够 患有脑膜炎导致的耳蜗僵化的人可以通过这种方法接受CI，因为 目前的手术技术导致在这一组中的电极放置和性能不理想。 我们的方法包括三个具体目标。在目标1中，我们将完成FDA批准的临床可行性研究 研究使用我们的微创技术，比较微创CI和 传统CI（电极放置、听力学结果和干预时间）。目标2将进一步改善 通过开发和测试能够插入的定制CI插入工具， 在微创隧道的受限工作空间内的直的和预弯曲的电极阵列， 耳蜗我们将对该工具进行临床评估，并将插入与传统的插入进行比较。 工具.在目标3中，我们将调整手术入路，以适应耳蜗骨化患者，也就是迷路炎 骨化症，脑膜炎的结果，其中耳蜗管被新骨形成阻塞。 为了做到这一点，我们将修改微创技术，钻出多个通道周围的听觉 神经末梢，并使用术后成像来指定电极如何刺激神经。

Project Summary/Abstract: The objective of this proposal is to perform a clinical feasibility study using our previously developed approach for minimally invasive cochlear implantation (CI), thereby bringing the approach closer to widespread clinical adoption. This translational work is the culmination of years of research and, if successful, will fundamentally change CI surgery and enable more patients to receive an implant. Clinical significance comes from the large number of patients who could benefit from a CI but have not received one, in part due to the complexity and invasiveness of the procedure. Despite their effectiveness, less than 10% of CI candidates have received an implant. The reasons for the underutilization include high procedure costs and a shortage of otolaryngologists trained to perform CI surgery. To bridge this gap, technological improvements to lower the cost of the procedure and make it easier to perform are necessary. Our approach to reduce the invasiveness and simplify the surgery uses image-guided surgery along with novel image processing algorithms. This approach replaces manual removal of a large volume of bone with a narrow drill path from the skull surface to the cochlea automatically aligned along the path using a patient-specific stereotactic frame. This approach may reduce the cost of the procedure and enable less specialized surgeons to perform the surgery. The technical and clinical innovations in this proposal include: (1) clinical translation of a novel surgical approach for which we have recently received an Investigation Device Exemption from the FDA, (2) multi- layered, redundant safety checks based on patient specific models and intra-operative hardware verification, (3) testing of an insertion tool with custom insertion depths based on patient specific anatomy, and (4) enabling individuals with ossified cochleae, a consequence of meningitis, to receive CI with this approach because current surgical techniques result in suboptimal electrode placement and performance in this group. Our approach consists of three Specific Aims. In Aim 1 we will complete an FDA approved clinical feasibility study using our minimally invasive technique comparing several key metrics between minimally invasive CI and traditional CI (electrode placement, audiological outcomes, and time of intervention). Aim 2 will further improve minimally-invasive CI through the development and testing of a custom CI insertion tool capable of inserting straight and pre-curved electrode arrays within the constrained workspace of the minimally invasive tunnel to the cochlea. We will perform a clinical assessment of the tool and compare insertions to those with traditional tools. In Aim 3 we will adapt the surgical approach to patients with ossified cochleae, a.k.a. labyrinthitis ossificans, a consequence of meningitis in which the cochlear duct becomes obstructed by new bone formation. To do this we will modify the minimally invasive technique to drill out multiple channels surrounding the auditory nerve endings and use post-operative imaging to specify how the electrodes stimulate the nerve.