Safe Flexible Intracerebral Navigation with Steerable Needles

使用可操纵针进行安全灵活的脑内导航

• 批准号: 8114697
• 负责人: Cameron N Riviere
• 金额: $ 18.19万
• 依托单位: CARNEGIE-MELLON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8114697
• 关键词: Animals; Area; Blood Vessels; Brain; Brain Part; Cadaver; Clinical; Collaborations; Computers; Deep Brain Stimulation; Development; Disease; Elements; Ensure; Exhibits; Family suidae; Gelatin; Goals; Hemorrhage; Human; In Vitro; Intervention; Knowledge; Length; Malignant Neoplasms; Modeling; Motion; Needle biopsy procedure; Needles; Operative Surgical Procedures; Parkinson Disease; Process; Research; Research Personnel; Rotation; Safety; Side; Speed; Stress; System; Techniques; Technology; Testing; Tissues; Treatment Efficacy; Treatment outcome; Work; animal tissue; brain tissue; design; flexibility; fundamental research; improved; in vivo; in vivo Model; prevent; response; soft tissue; treatment site; tumor

DESCRIPTION (provided by applicant): Accuracy of needle placement is a matter of fundamental importance in brain interventions such as tumor surgery and deep brain stimulation (DBS), and there is a need for improvements in order to increase efficacy of treatment. In response to this need, we have developed a computer-controlled system designed to steer a flexible needle through brain tissue, with proportional control of steering angle, using an elegantly simple technique of slowly rotating the needle in a "duty-cycled" fashion during insertion. The system can be used to reach targets deep in the brain, and can detour when needed in order to avoid damaging sensitive areas. Preliminary testing of the system has been performed in vitro in a gelatin substrate and in human cadavers. The testing that has been performed to date on this technology has focused solely on efficacy in reaching a particular target. There remain several unanswered needs, especially the development of means for tracking the tip of the flexible probe in vivo. However, before progressing to these questions, research is needed in several areas in order to ensure the safety of the technique. The specific aims of this proposal are as follows: 1. To adapt the tip geometry and the velocity envelope for safety in brain parenchyma. This will require finite element modeling of the needle tip geometry and the process of needle rotation in order to optimize the material, bevel angle, edge sharpness, rotation speed, and insertion speed of the probe in order to avoid damage to tissue. Results of the work will be validated in fresh animal brain tissue in vitro and then in vivo. 2. To adapt the tip geometry and the velocity envelope for safety in contact with blood vessels. This aim will involve testing in vivo in a porcine model, with comparisons to standard straight-sided biopsy needles, in order to validate the needle geometry, rotation speed, and insertion speed of the probe, to avoid damage to blood vessels that are contacted during insertion. The goal will be to limit the amount of bleeding detected via CT to that exhibited by present clinical straight-probe brain needle designs. 3. To optimize the design and the velocity envelope to avoid tissue damage along the length of the curved needle trajectory. Unlike a straight probe, insertion of a flexible needle of course places a certain amount of stress along the outer curvature of the needle path. Therefore, in addition to the above work dealing specifically with the needle tip, it will be necessary to model the interaction between the flexible needle and the tissue all along the shaft, optimizing the design of the needle gauge and the velocity envelope to avoid tissue damage along the trajectory. This work will also serve to prevent the possibility of any "whirling" or "whipping" motion of the tip of the flexible needle as the shaft is rotated. This work will be validated in animal tissue in vitro and then in a porcine model in vivo. These aims are expected to result in a needle tip that looks less like a bevel-tipped needle and more like a round-tipped needle with the high point of the round tip shifted off-center. PUBLIC HEALTH RELEVANCE: This research involves the development of improved techniques for reaching treatment sites deep in the brain, while causing minimal disturbance to surrounding healthy parts of the brain. It has the potential to improve treatment outcomes for cancer, Parkinson's disease, and other disorders.

描述(由申请人提供)：针头放置的准确性在肿瘤手术和脑深部刺激(DBS)等脑部干预中是一个至关重要的问题，需要改进以提高治疗效果。为了满足这一需求，我们开发了一种计算机控制系统，旨在引导灵活的针头穿过脑组织，并按比例控制转向角，使用一种优雅的简单技术，在插入过程中以“循环工作”的方式缓慢旋转针头。该系统可以用来到达大脑深处的目标，并可以在需要时绕道，以避免破坏敏感区域。该系统已在体外明胶基质和人体身体上进行了初步测试。到目前为止，对这项技术进行的测试仅仅集中在实现特定目标的有效性上。仍然有几个未得到满足的需求，特别是在活体内跟踪柔性探头尖端的方法的开发。然而，在解决这些问题之前，需要在几个方面进行研究，以确保该技术的安全性。这一建议的具体目的如下：1.调整尖端几何形状和速度包络，以确保脑实质的安全性。这将需要对针尖几何形状和针旋转过程进行有限元建模，以便优化探头的材料、斜角、边缘锐度、旋转速度和插入速度，以避免对组织的损害。这项工作的结果将在体外和体内的新鲜动物脑组织中得到验证。2.调整针尖的几何形状和速度包络，以确保与血管接触的安全性。这一目标将包括在猪模型上进行活体测试，并与标准直边活检针进行比较，以验证探头的针几何形状、旋转速度和插入速度，以避免在插入过程中接触到的血管受到损害。其目标是将CT检测到的出血量限制在目前临床直探头脑针设计所显示的出血量。3.优化设计和速度包络，避免沿曲针轨迹长度方向的组织损伤。与直探头不同，插入柔性针当然会沿着针路径的外曲率施加一定的应力。因此，除了上述专门针对针尖的工作外，还有必要对柔性针与整个轴上的组织之间的相互作用进行建模，优化针规和速度包络的设计，以避免沿轨迹的组织损伤。这项工作还将有助于防止在轴旋转时柔性针的尖端出现任何“旋转”或“鞭打”运动的可能性。这项工作将在体外的动物组织中得到验证，然后在体内的猪模型中得到验证。这些目标预计将导致针尖看起来不太像斜尖的针，而更像是圆尖的针，圆尖的高点偏离中心。 与公共健康相关：这项研究涉及开发改进的技术，以到达大脑深处的治疗部位，同时对周围健康的大脑部分造成最小的干扰。它有可能改善癌症、帕金森氏病和其他疾病的治疗结果。