Nanoparticle-Infused Radiopaque Absorbable Medical Device

注入纳米颗粒的不透射线可吸收医疗器械

• 批准号: 9324457
• 负责人: Marites Pasuelo Melancon
• 金额: $ 40.5万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9324457
• 关键词: Adverse effects; Adverse event; Adverse reactions; Affect; American; Animal Model; Anticoagulants; Anticoagulation; Autopsy; Bismuth; Blood Circulation Time; Blood Vessels; Blood coagulation; Calcium; Cardiovascular Diseases; Cardiovascular system; Catheters; Characteristics; Chronic; Coagulation Process; Complex; Contrast Media; Deep Vein Thrombosis; Deposition; Development; Devices; Diagnostic radiologic examination; Disadvantaged; Discrimination; Disease; Dose; Elements; Embolism; Enhancers; Event; Excision; Exhibits; Failure; Family suidae; Fatigue; Film; Filtration; Fluoroscopy; Fracture; Goals; Gold; Health; Hemorrhage; Hospitalization; Human; Hydrolysis; Hypersensitivity; Image; Imagery; Imaging Techniques; Intervention; Iodine; Lead; Life; Lung; Mechanics; Medical Device; Medical Technology; Metals; Monitor; Nail plate; Operative Surgical Procedures; Organ; Orthopedics; Patient risk; Patients; Pharmacologic Substance; Physiological; Plague; Population; Positioning Attribute; Prevention; Procedures; Property; Public Health; Pulmonary Embolism; Reporting; Research; Retrieval; Risk; Stroke; Surgical sutures; System; Tantalum; Therapeutic Embolization; Thromboembolism; Thrombus; Time; Toxic effect; Trauma; Vena Cava Filters; Venous; X-Ray Computed Tomography; Ytterbium; absorption; acute coronary syndrome; base; biodegradable polymer; cost; crystallinity; flexibility; high risk; imaging modality; improved; interest; medical implant; nanoparticle; nephrotoxicity; novel; poly-4-dioxan-2-one; prevent; prophylactic; research study; retinal rods; success; time use

 DESCRIPTION (provided by applicant): Venous thromboembolism (VTE) is the third most common cardiovascular illness after acute coronary syndrome and stroke. The first line of therapy for VTE is blood thinners; however, these agents are temporarily contraindicated for many at-risk VTE patients, such as those with major trauma and those who undergo complex surgeries, for whom bleeding is a concern. Inferior vena cava (IVC) filters are indicated in this population. Most IVC filters (70%) are intended to be retrieved after their indicated use; however, only 19-30% are removed. Unfortunately, complications mount when IVC filters are not removed, which can be very costly ($3-12K for filter retrieval and ~$67K for treatment of complications). Therefore, resorbable IVC filters were developed, which provide critical protection during their required duration and then simply vanish from the body, thereby alleviating costly removal procedures and downstream complications. However, an important limitation of a resorbable IVC filter system is significant clot burden. Monitoring the absorption time and any significant clot burden with use of imaging techniques would greatly improve the efficacy of deep vein thrombosis treatment. In this study, we will develop radiopaque absorbable filters that can be routinely imaged to offer a less expensive alternative for assessing filter integrity. Moreover, visualization of the filter under dual-energy computed tomography (DECT) would facilitate discrimination between two or more materials, such as nanoparticles (made of gold, bismuth, ytterbium, or tantalum), iodine, and calcium deposits, which could provide better image quality and quantification of the materials present in the filter. Specifically, we propose the following aims: Aim 1. Determine the radiopacity, mechanical strength, and crystallinity of nanoparticle-infused PPDO sutures and quantify the amount of nanoparticles (composed of gold, bismuth, ytterbium, and tantalum) infused and released within PPDO sutures in human physiological conditions over a period of 10 weeks. Aim 2. Investigate the ability of DECT to differentiate various radiopaque materials from thrombus and to optimize the parameters for imaging radiopaque PDDO filters using DECT. Aim 3: Determine in swine animal model the radiopacity and mechanical strength of nanoparticle-infused PPDO sutures and identify adverse reactions to the sutures after necropsies. Our long-term goal is to develop a totally absorbable IVC filter, inexpensively deployed and monitored by conventional imaging methods that prevents pulmonary embolism for the recommended prophylactic period and then simply vanishes without intervention. The experiments outlined here will be critical to demonstrating the feasibility of using nanoparticles as radiopaque material for DECT imaging embedded within this medical device. Successful development of imaging enhancers for IVC filters may also lead to widespread use of absorbable devices in other cardiovascular and orthopedic applications in which fixtures (such as plates, screws, nails, and rods) are needed only on a temporary basis.

 描述（由申请人提供）：静脉血栓栓塞 (VTE) 是继急性冠脉综合征和中风之后的第三种最常见的心血管疾病。下腔静脉 (IVC) 过滤器适用于患有严重外伤和接受复杂手术的患者。 (70%) 打算在指定使用后进行回收；然而，只有 19-30% 被移除，不幸的是，如果不移除 IVC 过滤器，就会出现并发症，这可能会非常昂贵（过滤器回收需要 3-12K 美元，约 67 美元）。 K 用于治疗并发症）因此，开发了可吸收的 IVC 过滤器，它在所需的时间内提供关键的保护，然后从体内消失，从而减轻昂贵的去除程序和下游并发症。使用成像技术监测吸收时间和任何显着的血栓负荷将大大提高深静脉血栓形成治疗的效果。在本研究中，我们将开发可常规使用的不透射线的可吸收过滤器。此外，双能计算机断层扫描 (DECT) 下的过滤器可视化将有助于区分两种或多种材料，例如纳米颗粒（由金、铋、镱或钽）、碘和钙沉积物，这可以提供更好的图像质量和过滤器中存在的材料的量化。 目标 1. 具体确定注入纳米颗粒的 PPDO 缝合线的射线不透性、机械强度和结晶度，并量化一段时间内在人体生理条件下注入和释放到 PPDO 缝合线中的纳米颗粒（由金、铋、镱和钽组成）的量10 周 目标 2. 研究 DECT 区分各种不透射线材料的能力。目标 3：在猪动物模型中确定注入纳米粒子的 PPDO 缝合线的射线不透性和机械强度，并确定尸检后缝合线的不良反应。开发一种完全可吸收的 IVC 过滤器，部署成本低廉，并通过传统成像方法进行监测，可在建议的预防期内预防肺栓塞，然后消失这里概述的实验对于证明使用纳米颗粒作为嵌入该医疗设备中的 DECT 成像的可行性至关重要，成功开发 IVC 过滤器的成像增强剂也可能导致可吸收设备在其他心血管和疾病领域的广泛使用。仅临时需要固定装置（例如板、螺钉、钉子和杆）的矫形外科应用。