Development of a Next-Generation Shock Wave Lithotripter

下一代冲击波碎石机的开发

• 批准号: 6832531
• 负责人: PEI ZHONG
• 金额: $ 12万
• 依托单位: HEALTHTRONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6832531
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; biophysics; clinical biomedical equipment; lithotripsy; nephrocalcinosis; phantom model; technology /technique development; urinary calculi

DESCRIPTION (provided by applicant): Since the introduction of shock wave lithotripsy (SWL) in the earlier 1980s by Domier Medical System, the technology of SWL has evolved significantly in terms of the means for shock wave generation, focusing, patient coupling, and stone location. However, the fundamental working principle of SWL remains unchanged despite of these technical developments. During this period, extensive basic research in shock wave physics and bio effects has also been carried out, mostly in academic research laboratories. In particular, the research in the past five years has begun to accumulate some critical insights regarding the mechanisms by which SWL works and how collateral tissue injury may be produced. Based on this knowledge, we have developed two novel SWL technologies that can be easily upgraded on a Dornier HM-3 lithotripter. For proof of principle, we have performed a series of in vitro and in vivo experiments that demonstrate the superiority of these technologies to the current gold standard - the Domier HM-3 lithotripter. The objective of this STTR proposal, therefore, is to translate these enabling technologies to the development of a next-generation commercial shock wave lithotripter for improved stone comminution with simultaneously reduced tissue injury. This task will be carried out through a synergistic collaboration between the Therapeutics Research Laboratory at Duke University and the HealthTronics Surgical Services, LLC (HTRN), a leading distributor of shock wave lithotripters. This project represents an unprecedented academic and industrial collaboration in the field of SWL and the proposed product should generate widespread impact and significant benefit to the clinical management of urolithiasis. In Phase I of this STTR proposal, our specific aim is to design and construction of a prototype shock wave generator based on in situ pulse superposition concept. Pressure waveform measurements and in vitro phantom studies will be performed to assess the stone fragmentation efficiency and propensity for vessel rupture produced by the prototype shock wave generator. Once the prototype with performance comparable to a HM-3 generator is constructed, a comprehensive investigation including animal studies with implanted artificial stones in porcine kidney will be performed in phase II to optimize the design of the proposed shock wave lithotripter system.

描述（由申请人提供）：自 20 世纪 80 年代初 Domier Medical System 推出冲击波碎石术 (SWL) 以来，SWL 技术在冲击波产生、聚焦、患者耦合和取石手段方面取得了显着发展地点。然而，尽管有这些技术发展，SWL 的基本工作原理仍然没有改变。在此期间，冲击波物理和生物效应方面也进行了广泛的基础研究，主要是在学术研究实验室。特别是，过去五年的研究已经开始积累一些关于 SWL 作用机制以及如何产生附带组织损伤的重要见解。基于这些知识，我们开发了两种新颖的 SWL 技术，可以在道尼尔 HM-3 碎石机上轻松升级。为了原理证明，我们进行了一系列体外和体内实验，证明这些技术相对于当前黄金标准 - Domier HM-3 碎石机的优越性。因此，该 STTR 提案的目标是将这些使能技术转化为下一代商用冲击波碎石机的开发，以改善结石粉碎，同时减少组织损伤。这项任务将通过杜克大学治疗研究实验室和领先的冲击波碎石机经销商 HealthTronics Surgical Services, LLC (HTRN) 之间的协同合作来完成。该项目代表了 SWL 领域前所未有的学术和工业合作，拟议的产品应该会对尿石症的临床管理产生广泛的影响和显着的益处。在 STTR 提案的第一阶段，我们的具体目标是设计和建造基于原位脉冲叠加概念的原型冲击波发生器。将进行压力波形测量和体外模型研究，以评估原型冲击波发生器产生的结石破碎效率和血管破裂倾向。一旦构建出性能与 HM-3 发生器相当的原型，将在第二阶段进行全面的研究，包括在猪肾中植入人造结石的动物研究，以优化所提出的冲击波碎石机系统的设计。