Development of a Skin Flap Therapy Device

皮瓣治疗装置的研制

• 批准号: 6550105
• 负责人: Patrick S Cottler
• 金额: $ 38.59万
• 依托单位: COTTLER TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-03-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6550105
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood coagulation; body fluid balance therapy; body fluids; clinical research; clinical trials; consumable /disposable biomedical equipment; electrical property; human subject; human therapy evaluation; patient oriented research; skin; swine

DESCRIPTION (provided by applicant): Research done prior to and including Phase I has led to publications and subsequent data that has proven the feasibility of utilizing a self-contained device as the standard of care in removing stagnated blood and generation of blood flow within congested skin flaps to promote survival. Completion of Phase I was the development of the AspiraideTM, a device that successfully mimicked the beneficial mechanisms of clinically used leeches. The skin flap therapy device was designed to minimize regulatory and manufacturing complexities. Phase II includes developing appropriately fabricated, labeled, and packaged devices for testing and preparing for commercial distribution. Due to the lack of a standard of care involving leeches, a clinical treatment schedule will be developed. Using a venous congested skin flap porcine model, research can lead to a standardized treatment regimen. The pig an optimal model for clinical relevance due to many similarities between human and porcine skin and wound healing properties between. The second portion will be using the AspiraideTM on human patients with venous congestion as part of a pilot clinical study to prove equivalency to leeches in the promotion of survival of venous congested tissues. Success of these tasks will lead to a commercially viable product.

描述（由申请人提供）：在第一阶段之前（包括第一阶段）进行的研究已发表出版物和随后的数据，证明了利用独立设备作为去除停滞血液和在充血内产生血流的护理标准的可行性皮瓣以促进生存。第一阶段的完成是 AspiraideTM 的开发，该设备成功模仿了临床​​使用的水蛭的有益机制。皮瓣治疗装置的设计旨在最大限度地减少监管和制造的复杂性。第二阶段包括开发适当制造、标记和包装的设备，用于测试和准备商业分销。由于缺乏涉及水蛭的护理标准，将制定临床治疗方案。使用静脉充血皮瓣猪模型，研究可以形成标准化的治疗方案。由于人类和猪的皮肤和伤口愈合特性之间有许多相似之处，猪是临床相关的最佳模型。第二部分将在患有静脉充血的人类患者身上使用 AspiraideTM，作为试点临床研究的一部分，以证明与水蛭在促进静脉充血组织存活方面的等效性。这些任务的成功将带来商业上可行的产品。