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.

抽象的 静脉功能不全 (VI) 是导致每年超过 500,000 例住院的原因 美国每年的医疗费用超过 10 亿美元，占 大约占整个医疗保健预算的 2%。当静脉内的瓣膜关闭时，就会发生 VI 减弱，不再能防止回流和血液汇集。结果，静脉扩张 如果不及时治疗，会导致持续性腹痛、不孕，甚至形成溃疡。 为了缓解 VI 的症状，医生的目标是永久排除患病血管 来自系统流动。目前治疗的金标准是铂植入 栓塞线圈与清洁剂注射相结合，称为硬化疗法，通过化学方法 燃烧血管内皮并导致静脉内形成疤痕。然而，直到 15% 的患者经历了血管再通，或者说之前的血流恢复 处理过的容器。这通常需要患者接受第二次甚至第三次治疗，以 永久闭塞静脉。治疗还可能需要植入多达 16 个线圈， 这给治疗设施带来了高昂的设备成本，并增加了辐射暴露 为了病人。 拟议项目概述了形状记忆聚合物的持续开发 (SMP) 泡沫外周栓塞装置 (PED)，用于治疗与 VI 相关的并发症。这 PED 将快速、完全闭塞回流静脉，同时将装置风险降至最低 脱位、血管破裂和周围组织损伤。可治疗静脉的领域 VI 也将通过 PED 的材料特性以及轻松实现的能力得到扩展 交付给曲折的船只。 将进行台式设备验证研究，以确保拟议的设备 具有足够的机械强度，只需最小的力即可通过 导管，SMP 泡沫牢固地附着在 PED 上，以防止血栓栓塞。这 PED 的生物相容性也将通过 ISO 10993 研究进行广泛评估 通常在此类设备上执行。最后，PED 将交付给 12 名 临床前动物并分析了递送和导航的便利性、设备迁移、时间 闭塞、30 天和 90 天随访时的再通以及局部和系统毒性。在 这项工作的顶峰，向 FDA 提交 510(k) 许可所需的所有研究 将完成。