Novel Neurosurgical Device for Evacuation of Intracerebral Hematoma - PROJECT SUMMARY Spontaneous supratentorial intracerebral hemorrhage (ICH) affects nearly 67,000 patients every year in the US and is associated with a 35-50% mortality rate within a month of occurrence. In addition to preventive measures and medical management, surgery continues to be an important part of treatment for such patients. Currently, removal of ICH from the brain is accomplished through a craniotomy, or large skull opening. For most large hematomas that come to the surface of the brain, this technique is effective in providing adequate surgical exposure to remove the mass and to obtain hemostasis. A craniotomy, however, is time consuming and retraction of the brain during these operations can result in brain injury. Furthermore, large craniotomies can contribute to postoperative morbidity, such as pain and wound-related complications. Development of less invasive techniques and methodology will minimize these risks and patient discomfort. Moreover, minimally invasive techniques may have socio-economic value by reducing operative and postoperative recovery time, especially for an elderly patient population with multiple medical co-morbidities. Current minimally invasive technologies, however, result in variable ICH evacuation rates and have limited efficacy in removing deeply located basal ganglia hematomas. Thus, neurosurgical devices that enable rapid and consistent hematoma evacuation, irrespective of ICH location, are needed. The goal of this project is to fabricate and determine the feasibility of a novel instrument (termed “ReMiDe”) that can efficiently and consistently remove an ICH using image-guided, minimally invasive techniques. Our initial studies using proof-of-concept prototypes that we designed and fabricated have demonstrated the feasibility of the approach. Our robotic device creates a cavity in the brain through a <1cm skull opening and is capable of automatically detaching, fragmenting, cauterizing, and aspirating tissue through a small channel. We have used live swine models to identify and resolve the mechanical and electrical parameters needed to optimize brain tissue fragmentation, cautery, and aspiration. Based on our initial designs, we are prepared to generate clinical- grade prototypes for testing in ICH models. To accomplish this, we propose the following aims: Aim 1: Design, manufacture, and validate advanced ReMiDe devices. Aim 2: Evaluate the safety and efficacy of ReMiDe procedure in swine. Aim 3: Compare the safety and efficacy of ReMiDe to minimally-invasive surgery in the swine ICH model. The proposed studies are impactful because they will result in the development of a novel instrument that will enable more consistent, efficient, and less invasive removal of ICH.
