Tracking kidney stones during shock wave lithotripsy

描述(由申请人提供)：本申请涉及广泛的挑战领域(06)使能技术和具体的挑战主题，06-DK-104使能技术在NIDDK任务中用于预防和治疗疾病。。特别是，它解决了这一挑战主题1/更好的微创工具...泌尿外科手术，最大限度减少并发症2/改进碎石机，最大限度地减少并发症。3/创造新的或改进的机械设计和控制算法冲击波碎石术(SWL)是一种非侵入性的方法，通过这种方法，聚焦的冲击波可以将肾结石粉碎成小到可以自然排出的碎片。在美国，靶向治疗通常是在治疗开始前使用X射线成像完成的。一种典型的治疗方法是在30分钟内发出大约2000个冲击波，在此期间偶尔会检查靶向。然而，由于呼吸(和其他病人的运动)，结石始终不在碎石机的焦点内，因此许多冲击波没有击中结石。这些目标错误的冲击波会对周围组织造成创伤，而没有任何治疗益处。冲击波碎石术造成的创伤既有急慢性并发症，也有慢性并发症。我们建议开发一种实时跟踪系统，该系统可以改装到临床碎石机上，并对碎石机进行门控，以便只有当结石对准目标时才会发射冲击波。如果结石已经永久性地离开了焦点区域，该系统将向泌尿科医生发出信号，表明应该用传统的成像重新评估对齐情况。通过消除误瞄准的冲击波，该系统将在不影响粉碎效率的情况下降低创伤的可能性。目的1：优化追踪算法我们有初步数据表明，我们可以在体外环境(人造结石和人造组织)中追踪肾结石。该算法将被改进以跟踪多个碎片，然后将构建一个原型系统，该原型系统可以重新安装到临床碎石机上并进行测试。目的2：利用活体模型对追踪进行评估该追踪系统将被部署在临床碎石机上，并用于追踪猪模型中肾结石的运动。在第一步中，将评估该系统在受控运动下跟踪石头的准确性。在第二步中，该系统将在两种不同的碎石机上使用，以跟踪治疗过程中结石和门控的短波输送，并评估门控对碎石和组织损伤的影响。该项目的成果将是原型结石跟踪系统，可以改装到临床碎石机上。这种新工具的性能将得到评估，特别是它在减少对肾组织的创伤的同时仍然能够粉碎结石的能力。在为期两年的项目结束时，我们将能够计划临床试验。 公共卫生报道：冲击波碎石术(SWL)是一种常用的无创冲击波碎石技术。在SWL过程中，结石由于呼吸而移动，目前许多冲击波没有击中结石，损害了周围组织。我们的目标是开发一种基于超声波的跟踪系统，该系统将只允许碎石机在结石对准目标时发射冲击波，从而避免周围组织的损伤。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (06) Enabling Technologies and specific Challenge Topic, 06-DK-104 Enabling technology for the prevention and treatment of diseases within the NIDDK mission. . In particular, it addresses the three priority areas mentioned in this challenge topic 1/ better tools for minimally invasive ... urologic surgeries, to minimize complications 2/ improvement of lithotripters to minimize complications. 3/ Creation of new or improved mechanical designs and control algorithms Shock wave lithotripsy (SWL) is a non-invasive procedure by which focused shock waves are used to fragment kidney stones into pieces that are small enough to be passed naturally. In the United States targeting is normally accomplished using X-ray imaging before treatment starts. A typical treatment uses on the order of 2000 shock waves delivered over a 30 minute period and targeting is checked occasionally during this time. However, due to respiration (and other patient movement) the stone is not in the focus of the lithotripter the entire time and therefore many shock waves miss the stone. These mis-targeted shock waves result in trauma to the surrounding tissue without any therapeutic benefit. The trauma induced by shock wave lithotripsy has been associated with both acute and chronic complications. We propose to develop a real-time tracking system that can be retro-fitted onto clinical lithotripters and gate the lithotripter so that it fires a shock wave only when the stone is on target. In the case where a stone has permanently moved from the focal region the system will signal to the urologist that alignment should be reassessed with conventional imaging. By eliminating the mis-targeted shock waves the system will reduce the potential for trauma without affecting the fragmentation efficiency. Aim 1: Optimize tracking algorithm We have preliminary data to show that we can track kidney stones in an in vitro environment (artificial stone and artificial tissue). The algorithm will be improved to track multiple fragments and then a prototype system that can be retro-fitted to a clinical lithotripter will be constructed and tested. Aim 2: Evaluate tracking using an in vivo model The tracking system will be deployed on a clinical lithotripter and used to track the motion of kidney stones in a pig model. In the first step the accuracy of the system to track a stone under controlled motion will be assessed. In the second step the system will be used on two different lithotripters to track a stone and gate SW delivery during treatment and assess the impact of gating on fragmentation and tissue injury. The deliverable from this project will be prototype stone tracking system that can be retro-fitted onto a clinical lithotripter. The performance of this new tool will have been assessed in particular its ability to reduce trauma to kidney tissue while still being able to fragment stones. At the end of the two year project we will be in a position to plan clinical trials. PUBLIC HEALTH REVEVANCE: Shock wave lithotripsy (SWL) is a common non-invasive technique for breaking up kidney stones by shock waves. During SWL the stone moves due to respiration and presently many shock waves miss the stone and damage the surrounding tissue. Our goal is to develop an ultrasound based tracking system which will only allow the lithotripter to fire a shock waves when the stone is on target and therefore spare the surrounding tissue.