Clinical Validation and Testing of Percutaneous Cochlear Implantation

描述（由申请人提供）：人工耳蜗（Cl）手术需要进入内耳，特别是耳蜗，该手术使用电极阵列刺激内耳，使聋人能够听到声音。全球已经有超过8万例ci手术，其中绝大多数在美国进行。预测表明，多达75万患有严重到重度听力损失的美国人可能受益于氯。此外，药理学的进步也为耳蜗给药治疗提供了前景。目前的人工耳蜗通路技术是基于颞骨（内耳所在的骨）乳突区钻孔进行广泛的手术挖掘。这个手术需要两个多小时，使用视觉反馈来避免对颞骨内的重要结构造成损伤最明显的是面神经损伤它会导致面部下垂。本建议的假设是，使用图像引导手术（IGS）技术可以实现较少侵入性的耳蜗通路。利用IGS，我们证明了经皮耳蜗通路的概念，即手术钻从侧颅骨到耳蜗的单一通道，而不会损伤邻近的重要结构。与传统的大范围手术相比，这种微创技术的潜在好处包括：(1)节省时间和成本；(2)手术技术的标准化使更多的外科医生能够执行该手术；(3)当日服务（手术植入和激活在同一天）。我们设想这种微创技术可以成为通过Cl和/或药物输送有效恢复听力的LASIK耳手术。为了验证我们的假设，我们在此提出了一项多中心研究，通过基于术前CT扫描的快速原型构建患者特定钻头导轨的使用。钻头引导器将手术钻头从侧颅骨引导到耳蜗，而不会损伤邻近的重要结构。该设备已获得fda批准，目前用于神经外科应用（在难治性癫痫患者中植入深部脑刺激器）。在第1年和第2年，我们建议进行一项验证研究，在传统的大暴露Cl手术后，将钻头导向附着在患者身上，以确保准确的轨迹。在第3年和第4年，我们建议临床在Cl手术中使用钻导器获得耳蜗通路。在验证阶段（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)面神经受到钻头威胁时的安全关闭，（ii）自动手术计划软件，以及（iii）在第3年和第4年安装在钻头导向上的钻头压力机，以供临床使用。

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.