Shape Memory Polymer Vascular Occlusion Device for the Treatment of Venous Insufficiency Phase II

治疗静脉功能不全的形状记忆聚合物血管闭塞装置第二期

• 批准号: 9255915
• 负责人: Todd Landsman
• 金额: $ 116.27万
• 依托单位: SHAPE MEMORY MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-21 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255915
• 关键词: Abdominal Pain; Ablation; Accounting; Acute; Address; Alloys; American; Animals; Area; Blood; Blood Coagulation Factor; Blood Vessels; Blood flow; Body Regions; Budgets; Burn injury; Catheters; Cicatrix; Collaborations; Collagen; Connective Tissue; Deposition; Detergents; Development; Device Designs; Devices; Dislocations; Effectiveness; Endothelium; Ensure; Fatigue; Fibrin; Foreign-Body Reaction; Gold; Guidelines; Healed; Healthcare; Hemorrhage; Histology; Hospitalization; Hospitals; Imagery; In Vitro; Industry; Infertility; Injection of therapeutic agent; Laboratories; Lead; Left; Location; Mechanics; Medical Device; Memory; Methods; Modality; Morphology; Particulate; Patients; Peripheral; Persistent pain; Phase; Physicians; Plague; Platinum; Polymers; Polyurethanes; Positioning Attribute; Predisposition; Procedures; Property; Radiation; Reflux; Risk; Rupture; Safety; Sclerotherapy; Shapes; Surface; System; Technology; Tensile Strength; Testing; Texas; Therapeutic; Therapeutic Embolization; Thromboembolism; Thrombus; Time; Tissues; Toxic effect; Treatment Cost; Ulcer; Ultrasonography; United States; Universities; Varicosity; Veins; Venous; Venous Insufficiency; Walking; Work; biomaterial compatibility; chronic abdominal pain; cost; experience; follow-up; healing; implantation; in vivo; migration; minimal risk; neurovascular; pre-clinical; prevent; prototype; reduce symptoms; restoration; skills; standard care; tissue support frame

ABSTRACT Venous insufficiency (VI) is the cause of more than 500,000 annual hospitalizations in the U.S. and accounts for more than $1 billion in annual healthcare expenses, accounting for approximately 2% of the entire healthcare budget. VI occurs when the valves within veins are weakened and can no longer prevent backflow and blood pooling. As a result, the vein dilates and if left untreated can cause persistent abdominal pain, infertility, and even ulcer formation. To alleviate the symptoms of VI, physicians aim to permanently exclude the diseased vessel from systemic flow. The current gold standard of treatment is the implantation of platinum embolic coils combined with a detergent injection, known as sclerotherapy, which chemically burns the endothelium of the vessel and causes scar formation within the vein. However, up to 15% of patients experience recanalization, or the restoration of blood flow through a previously treated vessel. This often requires the patient to undergo a second, or even third treatment, to permanently occlude the vein. Treatments can also require the implantation of up to 16 coils, which creates prohibitive device costs for treatment facilities, and increased radiation exposure for the patient. The proposed project outlines the continued development of a shape memory polymer (SMP) foam peripheral embolization device (PED) to treat complications associated with VI. The PED will provide rapid, complete occlusion of the refluxing veins with minimal risk of device dislocation, vessel rupture, and damage to surrounding tissues. The realm of treatable veins with VI will also be extended by the material properties of the PED and the ability to be easily delivered to tortuous vessels. Benchtop device verification studies will be performed to ensure the proposed device has adequate mechanical strength, requires minimal force for advancement through the catheter, and the SMP foam is securely attached to the PED to prevent thromboembolism. The biocompatibility of the PED will also be extensively evaluated through ISO 10993 studies typically performed on this class of devices. Finally, the PED will be delivered to twelve preclinical animals and analyzed for ease of delivery and navigation, device migration, time to occlusion, recanalization at 30 and 90-day follow up, and local and system toxicity. At the culmination of this work, all studies necessary for submission to the FDA for 510(k) clearance will be completed.

摘要 静脉功能不全(VI)是每年超过500,000人住院的原因 美国每年的医疗费用超过10亿美元，占 约占整个医疗保健预算的2%。当静脉内的瓣膜处于 虚弱，不再能防止回流和血液凝结。结果，静脉扩张。 如果不进行治疗，可能会导致持续性腹痛、不孕不育，甚至形成溃疡。 为了缓解VI的症状，医生的目标是永久排除病变的血管 来自全身的血液流动。目前治疗的黄金标准是植入铂 栓塞剂结合洗涤剂注射，被称为硬化疗法，化学上 烧伤血管内皮细胞，在静脉内形成疤痕。然而，最多 15%的患者经历血管再通，或通过以前的 经过处理的容器。这通常需要患者接受第二次，甚至第三次治疗，以 永久性地闭塞静脉。治疗还需要植入多达16个线圈， 这给治疗设施造成了令人望而却步的设备成本，并增加了辐射暴露 对病人来说。 拟议的项目概述了形状记忆聚合物的持续开发 (SMP)泡沫外周栓塞器(PED)治疗VI相关并发症。 PED将以最小的设备风险提供快速、完全的回流静脉闭塞 脱位、血管破裂以及对周围组织的损害。可治疗静脉的领域 与VI还将扩展PED的材料属性和能力，很容易 运送到曲折的船只上。 将执行台式设备验证研究，以确保建议的设备 具有足够的机械强度，只需最小的力即可通过 SMP泡沫牢固地附着在PED上，以防止血栓栓塞症。这个 PED的生物兼容性也将通过国际标准化组织10993研究进行广泛评估 通常在这类设备上执行。最后，PED将被送到12个 临床前动物和分析，以便于交付和导航，设备迁移，时间 闭塞，30天和90天随访时再通，以及局部和系统毒性。在 这项工作的高潮，提交给FDA以获得510(K)批准所需的所有研究 将会完成。