Interactive Effects of Combined Imaging, BWL, and Ultrasonic Propulsion

组合成像、BWL 和超声波推进的交互效果

• 批准号: 10681343
• 负责人: MICHAEL R BAILEY
• 金额: $ 44.38万
• 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/10681343
• 关键词: 3-Dimensional; Acceleration; Acoustics; Address; Admission activity; Adverse event; Anatomy; Benefits and Risks; Blinded; Bowman' s space; Caring; Clinic; Clutterings; Complex; Computers; Control Groups; Deposition; Detection; Disease; Doppler Ultrasound; Educational workshop; Effectiveness; Emergency department visit; Enrollment; Excision; Family suidae; Feedback; Frequencies; Histology; Human; Image; Implant; Injury; Intervention; Kidney; Kidney Calculi; Lateral; Lithotripsy; Measurement; Measures; Minerals; Modality; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Malignant; Obstruction; Operative Surgical Procedures; Output; Patients; Physiologic pulse; Positioning Attribute; Quality of life; Questionnaires; Randomized, Controlled Trials; Risk; Risk Reduction; Rotation; Safety; Schedule; Sensitivity and Specificity; Serious Adverse Event; Shapes; Signal Transduction; Skin; Specificity; Surface; Symptoms; System; Telephone; Testing; Time; Torque; Transducers; Ultrasonics; Ultrasonography; Ureteroscopy; Urinary Calculi; Urinary tract; Urologic Diseases; Urology; Vision; Visual; Visualization; Wisconsin; arm; compare effectiveness; cost; experience; first-in-human; grasp; imaging probe; improved; in vivo; next generation; preclinical study; programs; response; surgical risk; tissue injury; treatment arm; ultrasound; visual feedback

PROJECT SUMMARY/ABSTRACT - Project 1 Project 1 will investigate the underlying mechanisms and test the benefits of integrating stone-specific (S- mode) ultrasound (US) imaging, burst wave lithotripsy (BWL), and ultrasonic propulsion (UP) and of acoustic tractor beams to image, comminute, and expel urinary stones. Urinary stone disease is the costliest non- malignant urologic disease. The ability to non-invasively break stones and expel the fragments in an office or clinic setting has the potential to reduce risk, reduce cost, and improve care. This Project seeks to answer the major scientific hurdles to this revolutionary vision: find the stone, break the stone, and expel the stone. In Aim 1, Project 1 with Project 3 will conduct the first-in-human test of BWL. We will observe by ureteroscopy the fragmentation of humans stones in vivo. To the first test of BWL alone, we will compare the comminution effectiveness and safety of BWL employed where the output is adapted in response to feedback. At a minimum, in the feedback-based, adaptive control group, UP will be interleaved with BWL, which in preliminary preclinical studies accelerated stone comminution threefold, and also enabled visual feedback on treatment endpoint by dispersing clusters of fragments that otherwise appeared as an intact stone. In Aim 2, we will conduct a randomized controlled trial of the benefits and risks of fragmenting and expelling stones in a urology clinic. We will compare no intervention to expulsion by combined application of BWL and UP to remove stones. Stones will be targeted by S-mode imaging, broken by BWL, and expelled by UP to facilitate natural clearance from the urinary tract. Stone burden, adverse events, and Quality of Life (QOL) will be measured by imaging, telephone and chart reviews, and the Wisconsin Stone QOL questionnaire, respectively. It is important to locate and target small stones not always seen on standard imaging. We have observed that even low amplitude UP or BWL pulses have a synergistic effect with Doppler US stone detection resulting in increased contrast of the stone against the background image. In Aim 3, we will add low frequency pulses from the UP probe in concert with the S-mode pulses and measure the improvement of signal to clutter ratio in the images. Three-dimensional (3D) S-mode imaging will be generated by rotating the imaging probe within the therapy probe. A blinded study to localize small stones implanted in a pig (n=20) will be conducted to measure sensitivity, specificity, and user variability with and without the low frequency enhancement. Lastly in Aim 4 we address how to expel fragments from tight spaces. We will develop and validate in vivo a remote tractor beam to grasp and carry fragments through the complex 3D path of the urinary space and out of the kidney. We will a) visualize with 3D US imaging the path, b) create beams to move the stone, and c) trap and attempt to expel stones from the kidneys of pigs (n=20). We will compare calculations and measurements of the forces for a range of acoustic intensities, beams, and stone sizes, numbers, shapes, and compositions.

项目总结/摘要-项目1 项目1将调查潜在的机制，并测试整合石头特异性（S- 模式）超声（US）成像、爆破波碎石术（BWL）和超声推进（UP），以及声学成像 牵引光束成像、粉碎和排出尿结石。泌尿系结石是最昂贵的非- 恶性泌尿系统疾病能够在办公室内非侵入性地破碎结石并排出碎片， 诊所环境具有降低风险、降低成本和改善护理的潜力。该项目旨在回答 这一革命性愿景的主要科学障碍是：找到石头，打破石头，驱逐石头。 在目标1中，项目1和项目3将进行BWL的首次人体试验。我们将通过输尿管镜观察 人体结石在体内的碎裂。对于单独的BWL的第一个测试，我们将比较 在输出根据反馈进行调整的情况下，采用BWL的有效性和安全性。最低限度， 在基于反馈的自适应控制组中，UP将与BWL交错， 研究加速了三倍的结石粉碎，并通过以下方式实现了治疗终点的视觉反馈： 分散成簇的碎片，否则看起来像是一块完整的石头。 在目标2中，我们将进行一项随机对照试验，以评估碎片化和驱逐的益处和风险。 泌尿科诊所的结石我们将比较不干预和联合应用BWL和UP的驱逐 来移除石头。结石将通过S模式成像定位，通过BWL破碎，并通过UP排出，以促进 从泌尿道自然清除。将评估结石负荷、不良事件和生活质量（QOL） 分别通过影像学、电话和病历回顾以及威斯康星州Stone QOL问卷进行测量。 重要的是定位和靶向在标准成像上不总是可见的小结石。我们观察到 即使是低幅度UP或BWL脉冲也具有与多普勒US结石检测的协同效应， 石头与背景图像的对比度增加。在目标3中，我们将添加低频脉冲 从UP探头与S模式脉冲一致，并测量信号杂波比的改善， 那些画面将通过在成像探头内旋转成像探头来生成三维（3D）S模式成像。 治疗探头将进行一项盲法研究，以定位植入猪（n=20）体内的小结石， 灵敏度、特异性和用户可变性，具有和不具有低频增强。 最后，在目标4中，我们讨论如何从紧密空间中排出碎片。我们将在体内开发和验证 远程牵引光束通过泌尿空间的复杂3D路径抓住并携带碎片， 肾脏我们将a）使用3D US成像可视化路径，B）创建光束以移动石头，以及c）捕获 并尝试从猪的肾脏排出结石（n=20）。我们将比较计算和测量 的力量的范围内的声强度，梁，和石头的大小，数量，形状和成分。