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: 10192511
• 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/10192511
• 关键词: 3-Dimensional; 3D ultrasound; Acoustics; Address; Admission activity; Adverse event; Anatomy; Benefits and Risks; Blinded; Bowman' s space; Caring; Clinic; 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; Quality of life; Questionnaires; Randomized Controlled Trials; Risk; Safety; Schedule; Sensitivity and Specificity; Serious Adverse Event; Shapes; Signal Transduction; Skin; Surface; Symptoms; System; Telephone; Testing; Time; Torque; Transducers; Ultrasonics; Ultrasonography; Ureteroscopy; Urinary Calculi; Urinary tract; Urologic Diseases; Urology; Vision; Visual; Wisconsin; arm; base; 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; 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.

项目摘要/摘要 - 项目1 项目1将研究基本机制，并测试整合石材特异性的好处（s- 模式）超声（US）成像，爆发波碎屑（BWL）和超声推进（向上）和声学 拖拉机横梁以形象，腐蚀和驱逐尿石。尿石病是最昂贵的非 - 恶性泌尿科疾病。非侵入性折断石头并驱逐办公室中的碎片的能力或 诊所环境有可能降低风险，降低成本并改善护理。该项目试图回答 这一革命性视野的主要科学障碍：找到石头，打破石头并驱逐石头。 在AIM 1中，项目1的项目1将进行BWL的首次人类测试。我们将通过输尿管镜检查观察 人类石头在体内的破碎。仅第一次对BWL进行测试，我们将比较粉刺 在反馈中对输出进行调整的BWL的有效性和安全性。至少 在基于反馈的自适应对照组中，UP将与BWL交织在一起，BWL在初步的临床前将 研究加速了石材的粉刺三倍，还可以通过 分散的碎片簇，否则会显示为完整的石头。 在AIM 2中，我们将对分裂和驱除的好处和风险进行随机对照试验 泌尿外科诊所的石头。我们将通过联合应用BWL和UP进行驱逐与驱逐的措施进行比较 去除石头。石头将由S模式成像瞄准，被BWL打破，并通过促进 尿路的自然清除。石头负担，不利事件和生活质量（QOL）将是 分别通过成像，电话和图表评论和威斯康星州QOL问卷进行衡量。 在标准成像上并不总是能找到和靶向小石头很重要。我们已经观察到 甚至低幅度向上或BWL脉冲都具有与多普勒美国石材检测的协同作用 与背景图像相比，石头的对比度增加。在AIM 3中，我们将添加低频脉冲 从向UP探针与S模式脉冲一起测量信号与混乱比率的改善 图像。三维（3D）S模式成像将通过旋转成像探针而产生 治疗探针。将进行一项盲目的研究，以将植入猪的小石头定位（n = 20）进行测量 有和没有低频增强的敏感性，特异性和用户变异性。 最后，在AIM 4中，我们解决了如何将碎片从狭窄空间中排出。我们将在体内开发和验证 远程拖拉机光束可以掌握并通过尿液空间的复杂3D路径携带碎片 肾脏。我们将a）用3D我们对路径进行成像，b）创建光束以移动石头，c）陷阱 并尝试从猪的肾脏中排出石头（n = 20）。我们将比较计算和测量 各种声音强度，梁和石材尺寸，数字，形状和组成的力。