Improvement of lithotripters by ultrasound imaging and backscatter tecniques

通过超声成像和反向散射技术改进碎石机

• 批准号: 7938072
• 负责人: LAWRENCE A CRUM
• 金额: $ 49.71万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-21 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7938072
• 关键词: Accounting; Acoustics; Acute; Address; Adverse effects; Age; Algorithms; Anesthesia procedures; Animal Model; Area; Calculi; Chronic; Clinical; Color; Computer software; Conscious Sedation; Coupled; Detection; Development; Devices; Disease; Doppler Ultrasound; Dose; Effectiveness; Engineering; Family suidae; Feedback; Fluoroscopy; Frequencies; Generations; Geographic Locations; Goals; Guidelines; Hemorrhage; Hospitalization; Human; Image; Imaging Device; Injury; Injury to Kidney; Kidney; Kidney Calculi; Lead; Lesion; Lithotripsy; Location; Manufacturer Name; Measures; Medical Device; Methodology; Mission; Modeling; Monitor; Morphologic artifacts; Motion; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Outpatients; Particle Size; Patients; Percutaneous Nephrolithotomy; Positioning Attribute; Prevalence; Prevention; Procedures; Race; Research; Respiration; Shock; Skin; Source; System; Techniques; Technology; Testing; Time; Tissues; Training; Travel; Treatment outcome; Ultrasonography; Ureteroscopy; Urologist; Water; Woman; common treatment; computerized data processing; cost; design; effectiveness measure; experience; improved; in vivo; innovation; men; minimally invasive; novel; pressure; public health relevance; research study; response; sex; sound

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (06), Enabling Technologies, Topic 06-DK-104 Enabling technology for the prevention and treatment of diseases within the NIDDK mission. Priority areas include, for example: Improvement of medical devices such as...lithotriptors to minimize complications of procedures. Shock Wave Lithotripsy (SWL) is the most common treatment for kidney stones in the size range from about 2 - 20 mm: Kidney stones afflict 13% of men and 7% of women in the U.S. and these numbers are rising. The prevalence of kidney stones varies dependent on race, sex, age, and geographic location; however, stone formers can be any age, and many develop multiple stones at a time. Some stones pass spontaneously; however, those that don't pass account for over 2 million outpatient treatments and 1% of all hospitalizations annually in the U.S. In most lithotripters, shock waves generated outside the body are focused to a fixed location. The patient, usually under anesthesia or conscious sedation, is positioned with the stone within this focal zone. Between 1500 and 4000 shock waves are applied at about 2 Hz (range 1-4 Hz). The shock waves travel through water into the body. All current lithotripters have the SW source enclosed in a water-filled pillow that is coupled to the patient's skin. Treatment outcome is measured by stone-free rates after 1 to 3 months, and by re-treatment rates. Stone-free rates range from 40-90% with different machines; newer machines have lower stone-free rates and higher re-treatment rates. Although lithotripsy still accounts for more than half of all treatments for stone disease, it is gradually being replaced by minimally-invasive procedures, such as ureteroscopy and percutaneous nephrolithotomy. These more invasive procedures are likely the result of newer commercial versions of lithotripters having higher shock wave (SW) amplitudes and smaller focal volumes. These higher amplitudes and smaller foci often result in less efficient stone comminution and more tissue damage. Lithotripsy causes acute tissue injury that can lead to chronic adverse effects. The acute injury to kidney tissue is primarily a hemorrhagic lesion that is dependent on the SW dose. Studies in a porcine animal model show hemorrhage occupies 0.3% of the functional renal volume following 1000 SWs, 6.1% following a standard clinical dose of 2000 SWs, and 13.8% after 8000 SWs. The response is highly dependent on dose but is nonlinear, with the greatest injury occurring between 1000 and 2000 SWs. Our research has demonstrated that much of this reduced effectiveness of lithotripters is due to poor targeting and to limited feedback on the progress of the treatment. In particular, with more concentrated focal volumes, and limited accommodation for respiration, it is not uncommon for more than half of the SWs delivered to completely miss the stone-and with these more intense SWs-increased tissue damage. Additionally, because there is limited ability of conventional lithotripters to determine when the stone is sufficiently fragmented, it is often standard practice to deliver a full dose of SWs, even though the stone may be fully fragmented at much lower doses. In this application, we propose to improve lithotripters by developing engineering concepts and methodologies that enable more precise detection and localization of the stone, as well as real-time targeting and stone comminution-monitoring approaches. By improving targeting, and providing real-time feedback to the urologist, it is likely that lithotripters can realize greatly improved patient outcomes. The specific devices and methodologies to be developed in this effort will be tested on a porcine animal model as well as in ongoing human treatments. Successful accomplishment of the tasks outlined in this proposal will have potential for rapid incorporation into commercial lithotripters. PUBLIC HEALTH RELEVANCE: Shock Wave Lithotripsy (SWL) is the most common treatment for kidney stones in the size range from about 2 - 20 mm: Kidney stones afflict 13% of men and 7% of women in the U.S. and these numbers are rising. Although lithotripsy still accounts for more than half of all treatments for stone disease, it is gradually being replaced by minimally- invasive procedures, such as ureteroscopy and percutaneous nephrolithotomy, mostly because new generation lithotripters are less effective at stone fragmentation and induce additional tissue damage. The goal of this proposal is to provide immediate feedback to the urologist during lithotripsy treatment that will improve stone break-up and reduce kidney damage.

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，主题 06-DK-104 在 NIDDK 使命范围内预防和治疗疾病的使能技术。例如，优先领域包括： 改进医疗设备，例如碎石机，以最大限度地减少手术并发症。冲击波碎石术 (SWL) 是治疗直径在 2 - 20 毫米左右的肾结石的最常见方法：在美国，有 13% 的男性和 7% 的女性患有肾结石，而且这一数字还在不断上升。肾结石的患病率因种族、性别、年龄和地理位置而异；然而，结石形成者可以是任何年龄的，并且许多人一次会形成多个结石。有些石头会自行排出；有些则会自行排出。然而，在美国，每年有超过 200 万例门诊治疗和 1% 的住院治疗未通过。在大多数碎石机中，体外产生的冲击波会聚焦到固定位置。患者通常在麻醉或清醒镇静状态下，将结石放置在该焦点区域内。以约 2 Hz（范围 1-4 Hz）施加 1500 至 4000 次冲击波。冲击波通过水传播到体内。目前所有的碎石机都将 SW 源封装在一个充满水的枕头中，该枕头与患者的皮肤相连。治疗结果通过 1 至 3 个月后的无结石率和再治疗率来衡量。不同机器的去石率在 40-90% 之间；较新的机器具有较低的去石率和较高的再处理率。尽管碎石术仍占结石病所有治疗方法的一半以上，但它正在逐渐被微创手术所取代，例如输尿管镜检查和经皮肾镜取石术。这些更具侵入性的手术可能是新型碎石机商业版本的结果，该碎石机具有更高的冲击波（SW）振幅和更小的焦点体积。这些较高的振幅和较小的病灶通常会导致结石粉碎效率较低和组织损伤较多。碎石术会导致急性组织损伤，从而导致慢性不良反应。肾组织的急性损伤主要是出血性病变，具体取决于 SW 剂量。对猪动物模型的研究表明，1000 次 SW 后，出血占功能性肾体积的 0.3%，标准临床剂量 2000 次 SW 后，出血占 6.1%，8000 次 SW 后，出血占功能性肾体积的 13.8%。该反应高度依赖于剂量，但呈非线性，最大伤害发生在 1000 至 2000 个 SW 之间。我们的研究表明，碎石机有效性降低的主要原因是靶向性差以及对治疗进展的反馈有限。特别是，由于焦点体积更集中，呼吸调节有限，超过一半的 SW 完全错过结石的情况并不少见，并且这些更强烈的 SW 增加了组织损伤。此外，由于传统碎石机确定结石何时充分碎裂的能力有限，因此通常的标准做法是输送全剂量的 SW，即使结石可能在低得多的剂量下完全碎裂。在此应用中，我们建议通过开发工程概念和方法来改进碎石机，从而能够更精确地检测和定位结石，以及实时瞄准和结石粉碎监测方法。通过提高靶向性并向泌尿科医生提供实时反馈，碎石机很可能可以大大改善患者的治疗效果。这项工作中开发的具体设备和方法将在猪动物模型以及正在进行的人类治疗中进行测试。成功完成本提案中概述的任务将有可能快速纳入商业碎石机。 公众健康相关性：冲击波碎石术 (SWL) 是治疗尺寸范围为 2 - 20 毫米左右的肾结石的最常见方法：在美国，13% 的男性和 7% 的女性患有肾结石，而且这一数字还在上升。尽管碎石术仍占结石病所有治疗方法的一半以上，但它正逐渐被微创手术所取代，例如输尿管镜检查和经皮肾镜取石术，这主要是因为新一代碎石器在碎石方面效果较差，并会引起额外的组织损伤。该提案的目标是在碎石治疗期间向泌尿科医生提供即时反馈，以改善结石破碎并减少肾脏损伤。