Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, The Johns Hopkins Hospital, Baltimore Maryland.
Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Oper Neurosurg (Hagerstown). 2018 Jul 1;15(1):39-45. doi: 10.1093/ons/opx210.
Neuromodulation devices have the potential to transform modern day treatments for patients with medicine-resistant neurological disease. For instance, the NeuroPace System (NeuroPace Inc, Mountain View, California) is a Food and Drug Administration (FDA)-approved device developed for closed-loop direct brain neurostimulation in the setting of drug-resistant focal epilepsy. However, current methods require placement either above or below the skull in nonanatomic locations. This type of positioning has several drawbacks including visible deformities and scalp pressure from underneath leading to eventual wound healing difficulties, micromotion of hardware with infection, and extrusion leading to premature explantation.
To introduce complete integration of a neuromodulation device within a customized cranial implant for biocompatibility optimization and prevention of visible deformity.
We report a patient with drug-resistant focal epilepsy despite previous seizure surgery and maximized medical therapy. Preoperative imaging demonstrated severe resorption of previous bone flap causing deformity and risk for injury. She underwent successful responsive neurostimulation device implantation via complete integration within a clear customized cranial implant.
The patient has recovered well without complication and has been followed closely for 180 d. Device interrogation with electrocorticographic data transmission has been successfully performed through the clear implant material for the first time with no evidence of any wireless transmission interference.
Cranial contour irregularities, implant site infection, and bone flap resorption/osteomyelitis are adverse events associated with implantable neurotechnology. This method represents a novel strategy to incorporate all future neuromodulation devices within the confines of a low-profile, computer-designed cranial implant and the newfound potential to eliminate contour irregularities, improve outcomes, and optimize patient satisfaction.
神经调节设备有可能改变目前对药物难治性神经疾病患者的治疗方法。例如，NeuroPace 系统（NeuroPace Inc，加利福尼亚州山景城）是一种经食品和药物管理局（FDA）批准的设备，用于药物难治性局灶性癫痫发作时的闭环直接脑神经刺激。然而，目前的方法需要将设备放置在颅骨上方或下方的非解剖位置。这种定位方式有几个缺点，包括可见的畸形和来自下方的头皮压力，导致最终伤口愈合困难、硬件的微动和感染以及挤出导致过早拔出。
介绍一种将神经调节设备完全集成到定制颅骨植入物中的方法，以优化生物相容性并防止可见畸形。
我们报告了一例药物难治性局灶性癫痫患者，尽管之前进行了癫痫手术和最大限度的药物治疗。术前影像学显示先前骨瓣严重吸收导致畸形和受伤风险。她成功地通过完全集成在透明定制颅骨植入物中进行了响应性神经刺激设备植入。
患者恢复良好，无并发症，已密切随访 180 天。首次通过透明植入物材料成功进行了设备询问和脑电图数据传输，没有任何无线传输干扰的证据。
颅骨轮廓不规则、植入部位感染和骨瓣吸收/骨髓炎是与可植入神经技术相关的不良事件。这种方法代表了一种将所有未来神经调节设备整合到低轮廓、计算机设计的颅骨植入物中的新策略，以及消除轮廓不规则、改善结果和优化患者满意度的新潜力。
