Clinical Validation and Testing of Percutaneous Cochlear Implantation

项目摘要/摘要： 这项建议的目标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(CI)，从而使该方法更接近广泛的临床 领养。这项翻译工作是多年研究的顶峰，如果成功，将从根本上 改变CI手术，让更多的患者接受植入物。 临床意义来自于大量可以从CI受益但尚未接受治疗的患者 其一，部分原因是程序的复杂性和侵入性。尽管它们很有效，但不到10% 的CI候选人已经接受了植入。未充分利用的原因包括高昂的程序成本 接受过CI手术培训的耳鼻咽喉科医生也很缺乏。为了弥合这一差距，技术 有必要改进以降低手术成本并使其更容易进行。我们的方法是 使用图像引导手术和新颖的图像处理来降低侵袭性和简化手术 算法。这种方法用狭窄的钻孔路径取代了手工取出大量的骨骼 使用患者特定的立体定向框架，头骨表面到耳蜗会自动沿路径对齐。这 该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)一种新型外科手术的临床翻译 我们最近从FDA获得了调查设备豁免的方法，(2)多- 基于患者特定模型和术中硬件验证的分层冗余安全检查， (3)测试具有基于患者特定解剖的定制插入深度的插入工具，以及(4)启用 耳蜗骨化患者，脑膜炎的后果，接受这种方法的CI，因为 目前的手术技术导致了这一组中电极放置和性能不佳。 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 使用我们的微创技术比较微创脑梗塞和脑梗塞的几项关键指标 传统CI(电极位置、听力学结果和干预时间)。目标2将进一步改进 通过开发和测试能够插入以下内容的定制CI插入工具，实现最小侵入性CI 在微创隧道的受限工作空间内的直电极和预弯电极阵列 耳蜗管。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，我们将使手术入路适应于耳蜗骨化患者，也就是。迷路炎 骨质疏松症是脑膜炎的结果，耳蜗管因新骨形成而阻塞。 为此，我们将修改微创技术，以钻出听觉周围的多个通道 并使用手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.