Minimally Invasive Navigated Brain Hematoma Evacuation with Ultrasound Monitoring

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%）和严重残疾相关。对于那些不适合积极治疗的患者，需要手术清除血肿的新选择，以降低这些发病率和死亡率。这些新技术必须(1)最大限度地去除血肿，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。本提案的总体目标是开发一种易于使用且适合ICU的微创脑内血肿引流工具。该工具将一个用于抽吸的螺钉装置和一个超声探头集成在一个护套内，用于实时可视化手术过程，该护套可以携带额外的盐水和药物输送套管。为了减少植入过程中对大脑造成的创伤，它会很小。该工具将容纳一个电磁位置传感器，以便可以使用电磁导航系统引导手术干预。导航将引导探头在目标体积内的放置，并为血栓减少的实时3D评估提供图像定位。一个锁定导向将被用来提供一个稳定的脑探针方向。可以对吸入器进行轻柔的吸入，以促进抽离。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，将开发健壮的图像分割和配准算法，利用入院CT扫描的信息内容。通过在入院CT扫描中注册导航，可以实时重建血肿内获得的超声图像，以确定剩余血块的体积。这种微创脑探针的原型将被制成，其中包括导管超声探头、电磁位置传感器、阿基米德螺旋抽吸器以及用于向血肿部位输送生理盐水和药物的套管。将开发额外的软件，以支持基于超声成像的血肿清除的实时可视化。整个系统将在一系列受控的实验室实验中进行验证。有了诸如此类的改进工具，脑出血死亡率可能会降低，并将重点转移到改善神经预后上。公共卫生相关性：拟议的脑探针将允许在局部麻醉下在重症监护病房以微创方式手术清除颅内血肿（脑内的大血块）。这种手术治疗将导航并利用超声成像来指示手术的进展。用这种脑探针进行早期治疗将降低死亡率并改善功能预后。

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.