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，使能技术在NIDDK任务中预防和治疗疾病。优先领域包括，例如：改进医疗器械，如碎石机，以最大限度地减少手术并发症。冲击波碎石术(SWL)是治疗大小约2-20毫米肾结石的最常用方法：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。肾结石的患病率随种族、性别、年龄和地理位置的不同而不同；然而，结石形成者可以是任何年龄，许多人同时发生多种结石。一些结石会自发排出；然而，那些不通过的结石占美国每年门诊治疗的200万多万次，占所有住院人数的1%。在大多数碎石者中，体外产生的冲击波会聚焦到固定的位置。病人通常在麻醉或清醒镇静状态下，将结石放置在这个病灶区域内。在1500至4000之间的冲击波以大约2赫兹(范围1-4赫兹)施加。冲击波通过水进入人体。所有目前的碎石机都将短波源封闭在一个充满水的枕头中，该枕头耦合到患者的皮肤上。治疗结果通过1-3个月后结石排净率和再治疗率来衡量。不同机器的结石排净率从40%到90%不等；较新的机器具有较低的排石率和较高的再治疗率。尽管碎石术仍占结石疾病治疗的一半以上，但它正逐渐被输尿管镜检查和经皮肾镜取石术等微创手术所取代。这些更具侵入性的手术很可能是较新的商业版本碎石机的结果，这些碎石机具有更高的冲击波(SW)幅度和更小的焦点体积。这些较高的振幅和较小的病灶通常会导致较低的结石粉碎效率和更多的组织损伤。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一种出血性损害，这种损害依赖于短波剂量。在猪动物模型中的研究表明，1000次SWS后出血占功能性肾体积的0.3%，2000次SWS标准临床剂量后6.1%，8000次SWS后13.8%。这种反应高度依赖于剂量，但是非线性的，最大的损伤发生在1000到2000 SWS之间。我们的研究表明，碎石机疗效下降的很大一部分原因是靶向性差，以及对治疗进展的反馈有限。特别是，由于更集中的焦点体积和有限的呼吸空间，超过一半的SWS完全错过结石并在这些更强烈的SWS中增加组织损伤并不少见。此外，由于传统碎石机确定结石是否足够碎裂的能力有限，因此通常的标准做法是提供全剂量的SWS，即使结石可能在低得多的剂量下完全碎裂。在这项应用中，我们建议通过开发工程概念和方法来改进碎石机，使其能够更精确地检测和定位结石，以及实时定位和结石粉碎监控方法。通过改进靶向性，并向泌尿科医生提供实时反馈，碎石机很可能实现极大地改善患者的预后。将在这项工作中开发的具体设备和方法将在猪动物模型上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迅速纳入商业碎石机。 与公共卫生相关：冲击波碎石术(SWL)是治疗大小约2-20毫米肾结石的最常见疗法：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疾病治疗的一半以上，但它正逐渐被输尿管镜检查和经皮肾镜取石术等微创手术所取代，这主要是因为新一代碎石机在碎石方面效果不佳，并会造成额外的组织损伤。这项建议的目的是在碎石治疗过程中向泌尿科医生提供即时反馈，以改善结石粉碎并减少肾脏损害。