Clinical Validation and Testing of Percutaneous Cochlear Implantation

描述(由申请人提供)：耳蜗术需要接触到内耳，特别是耳蜗，在这种手术中，使用电极阵列来刺激内耳，使聋人能够听到。超过80,000个配置项被放置在世界各地，其中绝大多数在美国执行。预测表明，多达75万患有严重到严重听力损失的美国人可能会受益于CL。此外，药理学的进步为药物输送到耳蜗处可能治疗提供了前景。目前的耳蜗术是基于通过钻取颞骨(内耳所在的骨头)的乳突区进行广泛的手术挖掘。这项手术耗时两小时以上，使用视觉反馈来避免损伤也包裹在颞骨中的重要结构，最明显的是面神经损伤会导致面部下垂。这一建议的假设是，通过使用图像引导手术(IGS)技术可以实现侵入性较小的耳蜗术。使用IGS，我们已经证明了经皮耳蜗术的概念，即外科钻头从侧颅到耳蜗单一次通过，而不会损伤邻近的重要结构。与传统的大范围手术暴露相比，这种微创技术的潜在好处包括(1)节省时间和成本，(2)手术技术标准化，使更多的外科医生能够进行这种手术，以及(3)当天服务(手术植入和在同一天激活)。我们设想这样一种微创技术将成为通过氯和/或药物输送有效恢复听力的LASIK手术。为了验证我们的假设，在这里，我们提出了一项多中心研究，着眼于使用基于术前CT扫描的快速成型建立的针对患者的钻探指南。钻头导向器将从侧颅引导外科钻头到耳蜗处，而不会损伤邻近的重要结构。该设备是FDA批准的，目前用于神经外科应用(顽固性癫痫患者的深部脑刺激器放置)。在第一年和第二年，我们建议进行一项验证性研究，在传统的、广泛暴露的前路手术后，将钻头导向附在患者身上，以确保准确的轨迹。在第三年和第四年，我们建议在临床上使用钻头导向器在CL手术中获得耳蜗术中的通路。在验证阶段(第1年和第2年)的同时，我们建议继续完善技术，包括开发(I)面神经受到钻头威胁时的安全关闭，(Ii)自动手术规划软件，以及(Iii)安装在钻杆上的钻床，以便在第3年和第4年临床使用钻杆。

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.