Pediatric Percutaneous Cochlear Implantation Clinical Validation & Implementation

项目摘要/摘要：耳蜗植入术目前需要进入内耳，特别是耳蜗， 植入（CI）手术，其中电极阵列用于刺激听觉神经，并允许聋人 听。在全球范围内已经放置了超过120，000个CI。预测显示， 患有严重听力损失的美国人可能受益于CI（Mohr，Feldman，Dunbar等人，2000年：许多人 都是孩子在我们正在进行的NIH资助的成人项目（R 01 DC 008408）中，我们已经证明了 经皮耳蜗植入术（PCI）经皮冠状动脉介入治疗将CI手术减少为从外侧单次钻孔 从颅底到耳蜗通过图像引导技术规划和执行钻孔路径，以避免 重要的邻近解剖结构并击中目标-耳蜗的鼓阶。在临床试验中我们已经证实 该技术对15名成年患者进行了统计预测，表明99.9%的人避免了重要解剖结构， 特别是面部神经在所附的提交文件中，我们建议将这项技术应用于儿科 人口要做到这一点，我们的技术修改是必要的。我们目前的成人技术包括 以下六个步骤：（i）将三个骨植入的基准标记/锚围绕耳朵放置在 在门诊环境中局部麻醉，（ii）获得临床上适用的CT扫描，（iii）使用CT扫描， 规划从颅骨表面到耳蜗基底圈的手术轨迹，避免重要解剖结构， (iv)构建微立体定向框架以约束钻头沿计划轨迹（对于成人）沿着通过 研究，框架构建需要48小时），（v）将框架固定到骨植入锚钉上，以及（vi） 采用该框架来确定钻孔轨迹。由于儿童和成人在解剖学上不同，我们建议 通过使用儿科CT扫描的大型数据库来修改我们的技术，以产生年龄分层的解剖结构， 地图集，这将使我们能够执行步骤（iii）在一个自动化的方式，因为我们目前正在做的成年人， 一本地图集因为联邦指导方针禁止对儿童进行临床研究， 在没有对儿童有益的前景的情况下，我们对步骤（ii）和（iv）进行了实质性修改， CT扫描的采集以及微立体定向框架的设计和构造发生 与传统的CI手术同时进行，从而将风险降低到指南规定的可接受水平。 为了做到这一点，我们做了大量的工作，将术中CT扫描仪纳入我们的方案， 设计，开发和测试了一种新型的微立体定向框架，可以在30分钟内设计和构建 分钟-远低于我们对2,256例手术的回顾中最短的手术时间。我们招募了两名 其他备受尊敬的CI计划参加研究男孩镇（奥马哈，NE）和最繁忙的CI 世界中心，汉诺威医院（汉诺威，德国），我们与他们有着良好的合作关系 协作我们的希望是，这种技术，经皮耳蜗植入，将使CI手术， 更快，更便宜，更容易执行，让更多的儿童受益于听力康复与CI。

Project Summary/Abstract: Access to the inner ear, specifically the cochlea, is currently required for cochlear implant (CI) surgery, in which an electrode array is used to stimulate the auditory nerve and allow deaf people to hear. More than 120,000 CIs have been placed worldwide. Projections indicate that up to 750,000 Americans with severe hearing loss may benefit from CI (Mohr, Feldman, Dunbar et al., 2000) many of whom are children. In our ongoing, NIH-funded adult project (R01 DC008408), we have demonstrated the feasibility of percutaneous cochlear implantation (PCI). PCI reduces CI surgery to a single pass of a drill from the lateral skull base to the cochlea. The drill path is planned and executed via image-guided technology so as to avoid vital adjacent anatomy and hit the target-the scala tympani of the cochlea. In clinical trials we have validated the technique on 15 adult patients with statistical projections indicating 99.9% avoidance of vital anatomy, specifically the facial nerve. In the attached submission, we propose to translate this technology to the pediatric population. To do this, modifications to our technique are necessary. Our current adult technique consists of the following six steps: (i) placing three bone-implanted fiducial markers/anchors surrounding the ear under local anesthesia in an out-patient setting, (ii) obtaining a clinically applicable CT scan, (iii) using the CT scan to plan a surgical trajectory from the surface of the skull to the basal turn of the cochlea avoiding vital anatomy, (iv) constructing a microstereotactic frame to constrain a drill to pass along the planned trajectory (for the adult study, frame construction requires 48 hours), (v) affixing the frame to the bone-implanted anchors, and (vi) employing the frame to confirm the drill trajectory. Because children and adults differ anatomically, we propose to modify our technique by using a large database of pediatric CT scans to produce age-stratified anatomical atlases that will allow us to perform step (iii) in an automated fashion, as we are currently doing for adults with a single atlas. Because federal guidelines prohibit clinical studies on children entailing greater than minimal risk without the prospect of benefit for children, we have substantially modified steps (ii) and (iv) such that both the acquisition of the CT scan and the design and construction of the microstereotactic frame occur simultaneously with traditional CI surgery, thus reducing the risk to an acceptable level under the guidelines. To do this, we have done extensive work incorporating intraoperative CT scanner into our protocols and designed, developed, and tested a novel microstereotactic frame which can be designed and constructed in 30 minutes-well below the shortest surgical time in our review of 2,256 surgeries. We have recruited two additional well-respected CI programs to participate in the study-Boys Town (Omaha, NE) and the busiest CI center in the world, Medical Hospital of Hannover (Hannover, Germany) with whom we have a standing collaboration. Our hope is that this technique, percutaneous cochlear implantation, will make CI surgery quicker, cheaper, and easier to perform, allowing more children to benefit from aural rehabilitation with CIs.