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

描述（由申请人提供）：支架植入已成为治疗因各种狭窄病变而狭窄的血管或导管的标准医疗实践。虽然支架通常可以缓解收缩的急性症状，但所有支架相关的主要并发症是进行性闭塞，这是可变的和不可预测的，并可导致败血症、梗死或中风。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；而且大多数都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：先发制人和不必要的支架置换，或症状后支架置换联合紧急抗脓毒症治疗。该提案的目的是展示无线、非侵入性、集成系统的能力，该系统可以从支架内部直接测量血管通畅度。测试将使用胆道支架进行，其性能要求对其他支架应用（如TIPS、冠状动脉和输尿管支架）很重要。实现这一目标的研究策略有四个组成部分：(1)进一步开发基于磁弹性谐振传感器与支架集成的传感系统技术，以及相关的无线传感器询问电子设备；(2)利用集成胆道支架植入猪标本，对传感系统进行体内测试和验证；(3)开发一种可观察的、可控的、可重复的体外系统，允许细胞（细菌或内皮细胞）在复制植入情况的环境中在传感器上培养；(4)利用体外系统评价传感器的性能。研究将以完整的系统验证进行，包括：内镜下交付；传感器的生物相容性;亚慢性信号稳定性；传感器分辨率、满量程和可重复性；以及系统的精度、无线范围和可用性。本研究的结果将证明该监测方法适用于各种类型的支架遭受不同的再狭窄病理。该系统的重要性能目标包括全尺寸范围，包括一个完全闭塞的支架，分辨率小于1毫米的专利直径，以及至少7.5厘米的无线范围。该系统的成功演示将导致直接监测支架闭塞的廉价、实时、门诊程序。这将有助于医生进行及时的干预，并将消除不必要的侵入性手术在支架患者植入后的护理过程中。最终，这将导致更低的成本，更少的并发症和更好的结果。此外，无论具体的支架应用是什么，一个具有灵敏度和空间分辨率的无线监测系统可以为临床研究人员提供支架闭塞的进展图。这将导致重要临床研究效率的提高，以及由此获得的知识深度的提高。

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.