Non-invasive wireless monitoring of occlusion in biliary stents using arrays of m

使用 m 阵列对胆道支架闭塞进行无创无线监测

• 批准号: 8749394
• 负责人: YOGESH B GIANCHANDANI
• 金额: $ 33.82万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-11 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8749394
• 关键词: Acute; Area; Biliary; Biocompatible Materials; Blood Tests; Caliber; Cardiovascular system; Caring; Cells; Cessation of life; Characteristics; Cholangiography; Cholangitis; Chronic; Clinical; Clinical Research; Complication; Coronary; Coronary artery; Diagnostic Procedure; Duct (organ) structure; Electronics; Emergency Situation; Endothelial Cells; Environment; Family suidae; Goals; Health Care Costs; Implant; In Vitro; Infarction; Intervention; Intubation; Investigation; Knowledge; Lead; Legal patent; Liver; Location; Magnetic Resonance Imaging; Maps; Measurement; Measures; Medical; Metabolic; Metals; Methods; Mind; Monitor; Outcome; Outpatients; Pathology; Patients; Performance; Peripheral; Physicians; Plastics; Procedures; Process; Research; Research Personnel; Resolution; Risk; Sepsis; Series; Shunt Device; Signal Transduction; Specimen; Stents; Stroke; Symptoms; System; Systems Development; Technology; Test Result; Testing; Therapeutic; Time; Ultrasonography; Ureter; Validation; Viscosity; Wireless Technology; Work; X-Ray Computed Tomography; base; bile duct; biomaterial compatibility; constriction; cost; design; follow-up; imaging modality; implantation; improved; in vivo; instrument; public health relevance; response; restenosis; sensor; technology development; usability

DESCRIPTION (provided by applicant): The implantation of stents has become standard medical practice for treatment of vessels or ducts constricted due to various stenotic pathologies. Although stents often relieve acute symptoms of a constriction, a major complication associated with all stents is progressive occlusion, which is variable and unpredictable, and can lead to sepsis, infarctions, or strokes. Unfortunately, the current methods for monitoring stent occlusion are inconclusive, indirect, or invasive; and most require expensive, in-patient diagnostic procedures. These shortcomings often lead to mistimed therapeutic actions: a preemptive and unnecessary stent replacement, or a post-symptomatic stent replacement combined with emergency anti-sepsis therapy. The objective of this proposal is to demonstrate the capabilities of a wireless, non-invasive, integrated system, which provides direct measurement of patency from inside a stent. Testing will be conducted using biliary stents, an application whose performance requirements are important for other stent applications such as TIPS, and coronary and ureteral stents. The research strategy to achieve this objective has four components: (1) further develop the technology for a sensing system based on a magnetoelastic resonant sensor integrated with the stent, and the associated wireless sensor interrogation electronics; (2) conduct in vivo testing and validation of the sensing system using integrated biliary stents implanted in porcine specimens; (3) develop an observable, controllable, and repeatable in vitro system that allows cells (either bacterial or endothelial) to culture on the sensors in an environment that replicates the implanted situation; (4) use the in vitro system to evaluate the performance of the sensors. The research will be conducted with full system verification in mind, including: endoscopic delivery; sensor biocompatibility; sub-chronic signal stability; sensor resolution, full scale range, and repeatability; and system accuracy, wireless range, and usability. The results of this research will demonstrate the applicability of the monitoring method to a wide range of stent types subjected to different restenotic pathologies. Important performance targets for the system include a full-scale range that includes a fully occluded stent, a resolution of less than 1 mm of patent diameter, and a wireless range of at least 7.5 cm. Successful demonstration of this system will lead to an inexpensive, real-time, outpatient procedure for directly monitoring stent occlusion. This will aid physicians in performing timely intervention, and will eliminate unnecessary invasive procedures in the course of post-implant care of stent patients. Ultimately, this will result in lower costs, fewer complications, and better outcomes. Further, regardless of the specific stent application, a wireless monitoring system with the sensitivity and spatial resolution targeted by this proposal can provide clinical researchers with a map of the progression of stent occlusion. This will result in an improvement in the efficiency of important clinical studies, and in the depth of knowledge gained by them.

描述（由申请人提供）：支架植入已成为治疗因各种狭窄病理而狭窄的血管或导管的标准医疗实践。尽管支架通常可以缓解狭窄的急性症状，但与所有支架相关的主要并发症是进行性闭塞，这种闭塞是可变且不可预测的，并可能导致败血症、梗塞或中风。不幸的是，目前监测支架闭塞的方法是不确定的、间接的或侵入性的。大多数需要昂贵的住院诊断程序。这些缺点常常导致不合时宜的治疗行动：先发制人且不必要的支架置换，或症状后支架置换与紧急抗脓毒症治疗相结合。该提案的目的是展示无线、非侵入性集成系统的功能，该系统可以直接测量支架内部的通畅情况。测试将使用胆管支架进行，该应用的性能要求对于 TIPS、冠状动脉和输尿管支架等其他支架应用非常重要。实现这一目标的研究策略有四个组成部分：（1）进一步开发基于与支架集成的磁弹性谐振传感器的传感系统技术，以及相关的无线传感器询问电子设备； (2) 使用植入猪标本的集成胆道支架对传感系统进行体内测试和验证； (3) 开发可观察、可控和可重复的体外系统，允许细胞（细菌或内皮）在复制植入情况的环境中在传感器上培养； (4)利用体外系统评估传感器的性能。该研究将在考虑完整系统验证的情况下进行，包括：内窥镜输送；传感器生物相容性；亚慢性信号稳定性；传感器分辨率、满量程范围和重复性；以及系统精度、无线范围和可用性。这项研究的结果将证明该监测方法对遭受不同再狭窄病理的多种支架类型的适用性。该系统的重要性能目标包括全尺寸范围（包括完全闭塞支架）、专利直径小于 1 毫米的分辨率以及至少 7.5 厘米的无线范围。 该系统的成功演示将带来一种廉价、实时的门诊程序，用于直接监测支架闭塞。这将有助于医生及时进行干预，并消除支架患者植入后护理过程中不必要的侵入性操作。最终，这将带来更低的成本、更少的并发症和更好的结果。此外，无论具体的支架应用如何，具有本提案所针对的灵敏度和空间分辨率的无线监测系统都可以为临床研究人员提供支架闭塞进展图。这将提高重要临床研究的效率以及由此获得的知识的深度。