Nasal Contour Pack for Epistaxis

鼻出血鼻轮廓包

• 批准号: 6693939
• 负责人: PAUL P BUREK
• 金额: $ 37.71万
• 依托单位: ROSE BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-07-01 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6693939
• 关键词: biomedical equipment development; clinical biomedical equipment; clinical research; computed axial tomography; disease /disorder model; emergency health services; hemorrhage; hemostasis; human subject; human therapy evaluation; human tissue; patient oriented research; physical model; polyurethanes; polyvinyls

DESCRIPTION (provided by applicant): Epistaxis, otherwise known as nosebleed, is a common occurrence that typically responds to home treatment. Some cases, however, do not respond and these patients require emergency room treatment. In severe cases, hospital admittance and intensive care are necessary. Several methods of treatment have evolved: gauze packing, balloon, and desiccated sponge packs. Each strategy has strengths and weaknesses. Gauze packing decreases blood oxygen levels and is extremely painful, requiring administration of narcotics. Nasal balloons resist conformation to the intricacies of the nasal cavity. Desiccated sponges are solid and immalleable during insertion, often damaging the nasal mucosa. RBDC developed and tested the Pillow Pac on an anatomical model in Phase I. The Pillow Pac has a soft PVC tube base for easy insertion and removal with two thin, soft plastic bags mounted on top of the tube. Once inserted the bags are inflated to create sufficient pressure to stop the bleed. The soft bags work into the various crevices, create even pressure, inserts easily, and deflates for easy removal. RBDC proposes to complete technical development based on data obtained in Phase I. If the device proves viable in a model, safety and efficacy studies will be conducted.

描述（由申请人提供）： 鼻衄，也称为鼻出血，是一种常见现象，通常可以通过家庭治疗得到缓解。然而，有些病例没有反应，这些患者需要急诊室治疗。情况严重时，需要入院并接受重症监护。现已发展出几种治疗方法：纱布包裹、气球包裹和干燥海绵包裹。每个策略都有优点和缺点。纱布填塞会降低血氧水平，并且非常痛苦，需要服用麻醉剂。鼻球囊可抵抗鼻腔的复杂结构。干燥的海绵在插入过程中是固体且不可延展的，通常会损坏鼻粘膜。 RBDC 在第一阶段的解剖模型上开发并测试了 Pillow Pac。Pillow Pac 有一个柔软的 PVC 管底座，可以轻松插入和取出，管顶部安装有两个薄的软塑料袋。一旦插入，袋子就会膨胀以产生足够的压力来止血。软袋可插入各种缝隙中，产生均匀的压力，轻松插入，放气后易于取出。 RBDC 提议根据第一阶段获得的数据完成技术开发。如果该设备在模型中证明可行，将进行安全性和有效性研究。