MagSToNE - a magnetic system for kidney stone fragment elimination

MagSToNE - 用于消除肾结石碎片的磁性系统

• 批准号: 10491338
• 负责人: JOSEPH C LIAO
• 金额: $ 23.81万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10491338
• 关键词: Address; Affect; Affinity; Animal Model; Binding; Biodistribution; Buffers; Calcium Binding; Cell Culture Techniques; Clinical; Computer Simulation; Consumption; Disease; Dust; Endoscopic Surgical Procedures; Environment; Excision; Family suidae; Fiber; Goals; Health Care Costs; Health Expenditures; Image; In Vitro; Individual; Intervention; Kidney; Kidney Calculi; Kinetics; Label; Laser Lithotripsy; Lasers; Lead; Left; Magnetic nanoparticles; Magnetism; Mechanics; Medical; Methods; Modality; Modeling; Nanotechnology; Operating Rooms; Operative Surgical Procedures; Outcome; Particle Size; Patients; Performance; Persons; Procedures; Process; Recurrence; Repeat Surgery; Research; Residual state; Retrieval; Side; Symptoms; System; Technology; Time; Toxic effect; United States; Ureteroscopes; Ureteroscopy; Urinary Calculi; Urinary system; Urothelial Cell; Visualization; base; biomaterial compatibility; common treatment; cost; design; feasibility testing; fine particles; flexibility; improved; in vitro testing; in vivo; innovation; iron oxide; magnetic field; novel; novel strategies; particle; performance tests; porcine model; prevent; prototype; simulation; superparamagnetism; uptake; urinary

Project Summary Urinary (kidney) stone disease is common and affects about 1 in 11 people in the United States, costing > $2 billion in healthcare expenditures per year in the United States. Current endoscopic surgical treatment of urinary stone disease is centered around ureteroscopic laser lithotripsy to fragment the stone into smaller parts. The fragments are either actively retrieved from the body one by one with a wire basket or left to pass spontaneously. Depending on the size of the stone fragments, the process can be inefficient, tedious, and time-consuming in the operating room which is expensive. Rendering a patient stone-free is the best way to prevent further complications or repeat interventions due to residual stone fragments, yet current stone-free rates only approach 60-75%. The long-term goal is to improve clinical outcomes by achieving higher stone-free rates in a shorter amount of time. The objective of this R21 application is to develop, characterize, and test the feasibility of a novel magnetic-based technology to improve kidney stone fragment retrieval. We propose MagSToNE (Magnetic System for Total Nephrolith Elimination), a new approach based on magnetic nanotechnology for efficient stone fragment retrieval. MagSToNE consists of a flexible magnetic wire with a biocompatible plastic sheath, and superparamagnetic particles which are functionalized to bind to kidney stones. The magnetic wire is compatible with standard ureteroscopes and is similar in size to the guidewires routinely used in ureteroscopy. It is additionally uniquely designed to generate much stronger magnetic field gradients than a typical magnet. After laser fragmentation of a kidney stone, stone fragments are coated with magnetic nanoparticles which have been functionalized to bind to kidney stones. The stones can then be easily retrieved en masse by the magnetic wire, improving the efficiency of stone clearance compared to the conventional wire basket. This technology will be developed through the following specific aims: (1) to develop and optimize the superparamagnetic particles and magnetic wire to capture and retrieve stone fragments; and (2) to compare the performance of MagSToNE to conventional stone retrieval methods, with in vivo feasibility and biodistribution/toxicity studies in a porcine model. This project is innovative in that it shifts the paradigm of stone clearance from one based purely on mechanical retrieval to one that utilizes attractive magnetic forces and promises better performance. The proposed research is significant because it has the potential to substantially improve clinical outcomes and reduce healthcare costs related to kidney stone surgery.

项目概要 尿路（肾）结石疾病很常见，在美国大约每 11 个人中就有 1 人受到影响，费用 > 2 美元 美国每年的医疗保健支出达数十亿美元。目前泌尿外科内镜手术治疗 结石病以输尿管镜激光碎石术为中心，将结石破碎成更小的部分。这 碎片要么用铁丝篮从体内一一主动取出，要么自行排出。 根据石头碎片的大小，该过程可能效率低下、乏味且耗时 手术室很贵。让患者远离结石是防止进一步结石的最佳方法 由于残留结石碎片而出现并发症或重复干预，但目前的无结石率仅接近 60-75%。长期目标是通过在更短的时间内实现更高的无结石率来改善临床结果 时间量。该 R21 应用程序的目标是开发、表征和测试一种新颖的可行性 基于磁性的技术可改善肾结石碎片的检索。 我们提出了 MagSToNE（用于消除肾结石的磁性系统），这是一种基于 磁性纳米技术可有效检索石块碎片。 MagSToNE 由柔性磁线组成 具有生物相容性塑料护套和经过功能化以与肾脏结合的超顺磁性颗粒 石头。磁力线与标准输尿管镜兼容，尺寸与导丝相似 常规用于输尿管镜检查。它还经过独特设计，可产生更强的磁场 梯度比典型的磁铁。激光破碎肾结石后，结石碎片上会涂上一层 磁性纳米粒子已被功能化以与肾结石结合。然后石头就可以很容易地被 通过磁力线集中回收，相比传统方式提高了结石清除效率 传统的金属丝篮。 该技术的开发将通过以下具体目标：（1）开发和优化 超顺磁颗粒和磁线来捕获和回收石头碎片；和（2）比较 MagSToNE 的性能优于传统取石方法，具有体内可行性和 猪模型中的生物分布/毒性研究。该项目的创新之处在于它改变了石材的范式 从纯粹基于机械检索的间隙到利用吸引力的磁力的间隙，以及 承诺更好的性能。拟议的研究意义重大，因为它有可能实质性地 改善临床结果并降低与肾结石手术相关的医疗费用。