In-Office, Ultrasound-Based Breakage and Removal of Urinary stones

办公室内超声破碎和去除尿路结石

• 批准号: 10452577
• 负责人: MICHAEL R BAILEY
• 金额: $ 155.99万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10452577
• 关键词: 3-Dimensional; Acoustics; Address; Affect; American; Anatomy; Animals; Benefits and Risks; Biostatistics Core; Bowman' s space; Calibration; Clinic; Clinical; Collaborations; Complex; Data Set; Detection; Devices; Diagnostic Imaging; Disease; Effectiveness; Emergency department visit; Engineering; Ensure; Event; Excision; Exposure to; Eye; Family suidae; Feedback; Foundations; Fracture; Future; Health; Human; Image; Ionizing radiation; Kidney; Knowledge; Lithotripsy; Machine Learning; Measures; Methodology; Modality; Modeling; Monitor; Morphology; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Malignant; Operative Surgical Procedures; Outpatients; Output; Pain; Painless; Patients; Procedures; Process; Productivity; Program Research Project Grants; Publications; Radiation exposure; Ramp; Randomized Controlled Trials; Recurrence; Renal Tissue; Reporting; Research; Research Design; Research Personnel; Resources; Retreatment; Safety; Sample Size; Schedule; Signal Transduction; Statistical Methods; Structure; System; Techniques; Technology; Testing; Time; Tissue Model; Tissues; Ultrasonics; Ultrasonography; Urinary Calculi; Urologic Diseases; Wait Time; base; biomechanical model; calcification; complex data; cost; design; experimental study; first-in-human; grasp; improved; in vivo; individualized medicine; next generation; patient safety; porcine model; programs; response; safety study; simulation; success; treatment strategy; ultrasound

OVERALL SUMMARY The main focus of this Program Project Grant is to discover the foundational and translational knowledge needed to create an office-based handheld ultrasound device to target, detach, break, and expel stones and stone fragments from the urinary space to facilitate natural clearance. This system will obviate costly and inefficient emergency department visits that typically include repetitive exposure to ionizing radiation from diagnostic imaging, and will significantly reduce the often lengthy (days to weeks) wait time patients must endure before procedures for stone removal can be scheduled and performed. As the proposed therapy system is entirely noninvasive, patients will be treated on an outpatient basis. Further, as the system is designed to efficiently and painlessly break stones of any size and expel the fragments from the kidney, the treatment of both symptomatic and asymptomatic stones using this technology will reduce the high retreatment and stone event recurrence rates associated with current surgical interventions for stone removal. In this effort, we will combine stone breakage by burst wave lithotripsy (BWL), clearance of fragments by ultrasonic propulsion (UP), and stone-specific ultrasound imaging (S-mode) into an integrated system in which exposure strategies are adapted during treatment in response to real-time acoustic feedback to enhance comminution efficiency and patient safety. We will tailor treatment by investigating numerically and in lab tests the primary mechanisms - cavitation and elastic waves - involved in the comminution process over a broad parameter space. We will develop acoustics-based feedback including model- based, machine learning and passive acoustic mapping (PAM) of the bubble field to signal the need to adjust the energy output. We will investigate the morphological and functional response of the kidney in living animals and in ex vivo perfused porcine kidneys, and pursue tissue protective treatment strategies such as power ramping. These studies will include the first in-human test of BWL in which we will compare the comminution effectiveness and safety of treatment with and without adaptive output control in response to acoustic feedback. In addition, we will conduct a randomized controlled trial of the benefits and risks of fragmenting and expelling symptomatic and asymptomatic stones in the clinic. Toward application of the system for use in humans, we will refine and validate the use of UP and S-mode together to improve stone and fragment detection. With our eye on the future of stone management, we will develop and validate in vivo an extracorporeal acoustic tractor beam to grasp and carry fragments through the complex three- dimensional path of the urinary space and out of the kidney.

总体总结 本计划项目赠款的主要重点是发现基础和翻译 创建基于办公室的手持超声设备以进行靶向、分离、破坏和 排出尿路中的结石和结石碎片，便于自然排出。这个系统将会 避免昂贵和低效的急诊科就诊，通常包括重复接触 来自诊断成像的电离辐射，并将显著减少通常很长的(几天到几周) 在安排和执行取石手术之前，患者必须忍受等待时间。 由于拟议的治疗系统完全是非侵入性的，患者将在门诊的基础上进行治疗。 此外，由于该系统旨在高效和无痛地粉碎任何大小的石头并排出 来自肾脏的碎片，用这种方法治疗有症状和无症状的结石 技术将降低与当前技术相关的高再治疗和结石事件复发率 结石取出的外科干预措施。 在这项工作中，我们将结合冲击波碎石(BWL)碎石，清除碎石碎片 由超声推进(UP)和结石特异性超声成像(S模式)组成一个集成系统 其中在治疗期间响应于实时声反馈而调整暴露策略以 提高粉碎效率和患者安全。我们将通过数字调查来量身定做治疗 在实验室测试中，参与粉碎的主要机制-空化和弹性波- 在一个宽广的参数空间上进行处理。我们将开发基于声学的反馈，包括模型- 基于气泡场的机器学习和被动声映射(PAM)，以发出信号需要 调整能量输出。我们将研究肾脏的形态和功能反应。 活体动物和体外灌流猪肾，并寻求组织保护性治疗策略 例如功率斜坡。 这些研究将包括BWL的首次人体测试，在该测试中，我们将比较粉碎 具有和不具有自适应输出控制的声学响应治疗的有效性和安全性 反馈。此外，我们将对碎片化的好处和风险进行随机对照试验 排出临床上有症状和无症状的结石。该系统在我国的应用 在人类使用时，我们将精炼和验证UP和S模式的使用，共同改善结石和 碎片检测。着眼于结石治疗的未来，我们将在体内开发和验证 一种体外声学牵引束，用来抓住和携带碎片穿过复杂的三个- 空间路径的尿液空间和出肾。