Clinical Validation and Testing of Percutaneous Cochlear Implantation

描述（由申请人提供）：耳蜗植入（Cl）手术需要进入内耳，特别是耳蜗，其中电极阵列用于刺激内耳，使聋人能够听到。在全球范围内已放置了80，000多个CI，其中绝大多数在美国进行。预测表明，多达750，000名患有重度至极重度听力损失的美国人可能会从Cl中受益。此外，药理学的进步提出了药物递送到耳蜗可以治疗的前景。耳蜗通路的当前技术是基于通过颞骨（容纳内耳的骨）的乳突区域的钻孔的广泛外科挖掘。这种手术需要2个小时以上，使用视觉反馈来避免对颞骨中重要结构的损伤，最明显的是面神经损伤可能导致面部下垂。该建议的假设是，通过使用图像引导手术（IGS）技术可以实现侵入性更小的耳蜗通路。使用IGS，我们已经证明了经皮耳蜗通路的概念，即手术钻从侧颅到耳蜗的单次通过，而不会损伤相邻的重要结构。与传统的广泛手术暴露相比，这种微创技术的潜在受益包括（1）节省时间和成本，（2）手术技术标准化，使更多外科医生能够执行该手术，以及（3）当天服务（当天手术植入和激活）。我们设想这样一种微创技术成为LASIK手术的耳朵有效地恢复听力通过Cl和/或药物输送。为了验证我们的假设，我们在此提出了一项多中心研究，旨在研究通过基于术前CT扫描的快速原型制作构建的患者专用钻导向器的使用。钻导向器将引导手术钻从侧颅骨到耳蜗，而不会损伤相邻的重要结构。该器械经FDA批准，目前用于神经外科应用（顽固性癫痫患者的脑深部刺激器放置）。在第1年和第2年，我们提出了一项确认研究，在传统的广泛暴露的Cl手术后，将钻导向器连接到患者身上，以确保轨迹准确。在第3年和第4年期间，我们建议在临床上使用钻导向器在Cl手术期间获得耳蜗通路。在确认阶段（第1年和第2年）的同时，我们建议继续改进技术，包括开发（i）面神经受到钻威胁时的安全关闭，（ii）自动手术计划软件，以及（iii）在第3年和第4年期间将钻压安装在钻导向器上，用于钻导向器的临床使用。

DESCRIPTION (provided by applicant): Access to the inner ear, specifically the cochlea, is required for cochlear implant (Cl) surgery in which an electrode array is used to stimulate the inner ear allowing deaf people to hear. More than 80,000 CIs have been placed worldwide with the vast majority performed in the United States. Projections indicate that up to 750,000 Americans with severe-to-profound hearing loss may benefit from Cl. Furthermore, advances in pharmacology hold out the prospect that drug delivery to the cochlea may treat. Current techniques of cochlear access are based on wide surgical excavation via drilling of the mastoid region of the temporal bone (the bone which houses the inner ear). This surgery, which takes upwards of 2 hours, uses visual feedback to avoid damage to vital structures also encased in the temporal bone most notably the facial nerve injury of which can cause drooping of the face. The hypothesis of this proposal is that less invasive cochlear access can be achieved by using image guided surgical (IGS) techniques. Using IGS we have demonstrated the concept of percutaneous cochlear access as a single pass of a surgical drill from the lateral skull to the cochlea without injury to adjacent vital structures. Potential benefits of this minimally-invasive technique over the traditional, wide-surgical exposure include (1) time and cost savings, (2) standardization of surgical technique allowing more surgeons the ability to perform this procedure, and (3) same-day service (surgical implantation and activation on the same day). We envision such a minimally-invasive technique to become the LASIK procedure of the ear efficiently restoring hearing via Cl and/or drug delivery. To test our hypothesis, herein we propose a multi-center study looking at the use of patient-specific drill guides built via rapid-prototyping based on pre-operative CT scans. The drill guide will direct a surgical drill from the lateral skull to the cochlea without injury of adjacent vital structures. This device is FDA-approved and currently used in neurosurgical applications (deep brain stimulator placement in patients with intractable seizures). During years 1 and 2, we propose a validation study whereby the drill guide will be attached to patients after traditional, wide-exposure Cl surgery to ensure accurate trajectory. During years 3 and 4, we propose to clinically use the drill guide to obtain cochlear access during Cl surgery. Concurrent with the validation phase (years 1 and 2), we propose continued refinement of technique including development of (i) safety shut-off should the facial nerve be threatened by the drill, (ii) automated surgical planning software, and (iii) drill press to be mounted on the drill guide for clinical use of the drill guide during years 3 and 4.