Minimally Invasive Navigated Brain Hematoma Evacuation with Ultrasound Monitoring

超声监测微创导航脑血肿清除术

• 批准号: 7837656
• 负责人: CONSTANTINOS NIKOU
• 金额: $ 13.38万
• 依托单位: BLUE BELT TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-15 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7837656
• 关键词: Admission activity; Age; Algorithms; Aspirate substance; Blood Clot; Blood coagulation; Brain; Cadaver; Caliber; Cannulas; Catheters; Cerebral hemisphere hemorrhage; Coagulation Process; Computer software; Data; Devices; Early treatment; Electromagnetics; Exhibits; Family suidae; Glasgow Coma Scale; Goals; Head; Hematoma; Housing; Image; Imagery; Intensive Care Units; Laboratories; Lead; Local Anesthetics; Medical; Modeling; Monitor; Morbidity - disease rate; Navigation System; Neurological outcome; Neuronavigation; Normal tissue morphology; Operative Surgical Procedures; Patients; Pharmacologic Substance; Phase; Population; Positioning Attribute; Procedures; Resolution; Saline; Series; Simulate; Site; Specimen; Suction; System; Techniques; Testing; Time; Trauma; Ultrasonography; United States; Update; Ventriculostomy; X-Ray Computed Tomography; base; cost effective; cranium; demographics; design; disability; functional outcomes; imaging Segmentation; improved; innovation; intracranial hematoma; minimally invasive; mortality; point of care; prototype; public health relevance; research study; sensor; software development; standard of care; technology/technique; tool

DESCRIPTION (provided by applicant): Primary intracerebral hemorrhage is associated with a high mortality rate (44% at 6 months) and severe disability. For those patients who are not good candidates for aggressive medical management, new options for surgical evacuation of the hematoma are required in order to reduce these morbidity and mortality rates. These new techniques must (1) maximize the amount of hematoma that is removed while (2) minimizing the damage to the surrounding normal tissue, (3) be available at the point of care in the intensive care unit (ICU) and (4) be cost effective. The overall goal of this proposal is to develop a minimally invasive tool for evacuation of intracerebral hematomas that is easy to use and suitable for the ICU. The tool will integrate a screw device for aspiration with an ultrasound probe for real-time visualization of the procedure within a sheath that can carry an additional cannula for saline and pharmaceutical delivery. It will be small in order to minimize the trauma to the brain during placement. The tool will house an electromagnetic position sensor so that the surgical intervention can be guided using an electromagnetic navigation system. Navigation will guide probe placement within the targeted volume and provide the image localization for real-time 3D assessment of clot reduction. A locking guide will be used to provide a stable orientation of the brain probe. Gentle suction can be applied to the aspirator to promote evacuation. With this tool, hematoma evacuation will be no more invasive than ventriculostomy catheter placement and can be performed under local anesthetic. To accomplish these goals, robust image segmentation and registration algorithms will be developed that exploit the information content of admission CT scans. With the navigation registered to the admission CT scans, ultrasound images acquired within the hematoma can be reconstructed in real time to determine the volume of the remaining clot. A prototype of this minimally invasive brain probe will be built containing the catheter ultrasound probe, electromagnetic position sensor, aspirating Archimedes' screw, and cannula for delivering saline and pharmaceuticals to the hematoma site. Additional software will be developed to support real-time visualization of the hematoma evacuation based on ultrasound imaging. The complete system will be validated in a series of controlled laboratory experiments. With improved tools such as this, ICH mortality rates may be reduced and the focus shifted to improving neurological outcome. PUBLIC HEALTH RELEVANCE: The proposed brain probe will permit intracranial hematomas (large blood clots in the brain) to be surgically evacuated in a minimally invasive manner in the Intensive Care Unit under a local anesthetic. This surgical treatment will be navigated and utilize ultrasound imaging to indicate the progress of the procedure. Early treatment with this brain probe will lead to lower mortality rates and improved functional outcomes.

描述(由申请人提供)：原发性脑出血与高死亡率(6个月时为44%)和严重残疾有关。对于那些不适合积极治疗的患者，需要新的手术清除血肿的选择，以降低这些发病率和死亡率。这些新技术必须(1)最大限度地清除血肿量，同时(2)最大限度地减少对周围正常组织的损害，(3)在重症监护病房(ICU)的护理点可用，(4)具有成本效益。这项建议的总体目标是开发一种易于使用并适合ICU的微创脑内血肿清除工具。该工具将用于抽吸的螺旋装置与超声波探头相结合，以实时可视化鞘内的过程，该鞘可以携带额外的插管用于生理盐水和药物输送。它将很小，以最大限度地减少放置过程中对大脑的创伤。该工具将内置一个电磁位置传感器，以便使用电磁导航系统引导手术干预。导航将指导探头在目标体积内的放置，并为实时3D评估凝块减少提供图像定位。将使用锁定导向器来提供大脑探测器的稳定定向。可以对吸入器施加温和的吸力，以促进排空。有了这个工具，血肿清除将不会比脑室造口导管放置更具侵入性，并且可以在局部麻醉下进行。为了实现这些目标，将开发稳健的图像分割和配准算法，以利用入院CT扫描的信息内容。随着导航登记到入院CT扫描，血肿内采集的超声图像可以实时重建，以确定剩余血块的体积。这种微创脑探头的原型将由导管超声探头、电磁位置传感器、吸气阿基米德螺丝和用于将生理盐水和药物输送到血肿部位的插管组成。还将开发其他软件，以支持基于超声成像的血肿清除的实时可视化。完整的系统将在一系列受控实验室实验中得到验证。有了这样的改进工具，脑出血死亡率可能会降低，重点可能会转移到改善神经预后上。与公共卫生相关：拟议的脑探测器将允许在局部麻醉剂的作用下，以微创方式在重症监护病房内通过手术清除颅内血肿(大脑中的大型血块)。这种外科治疗将被导航，并利用超声成像来指示手术的进展。这种大脑探头的早期治疗将导致较低的死亡率和改善的功能结果。