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High-Performance Transcutaneous Port

高性能经皮端口

基本信息

批准号：
6794299
负责人：
FREDERICK CAHN
金额：
$ 33.57万
依托单位：
BIOMEDICAL STRATEGIES, LLC
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-07-01 至 2007-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6794299
关键词：
artificial limbs artificial skin bioengineering /biomedical engineering biomaterial compatibility biomaterial development /preparation biotechnology guinea pigs medical implant science quality of life tissue engineering wound healing

项目摘要

DESCRIPTION (provided by applicant): The overall objective of our collaborative research program is to develop a clinically useful Lower Extremity Transcutaneous (LET) prosthesis. This structural system that can be attached to an amputee's surviving natural bone to provide a direct, load-bearing path through the skin to an external prosthesis. This device would mitigate a severe and frequent morbidity; in 1996 there were 1,285,000 amputees in the US. The most important clinical advance offered by the LET prosthesis is the elimination of the prosthetic socket and the majority of the common problems of the prosthesis user. Thus the LET will contribute substantially to the quality of life of amputees. This SBIR project is intended to demonstrate the feasibility of the enabling technology for the LET: a high performance transcutaneous port (HPTP) that can provide a long term, efficient infection/ bacterial barrier at the skin/ pylon interface. To overcome the limitations of existing transcutaneous ports, we propose a systems approach to engineering the HPTP, with functional requirements for both dermal and epidermal components. Our approach utilizes the tissue-engineering design principles and technology that led to a clinically and commercially successful artificial skin and our research methodology is based on a well-understood animal model that was used to develop the artificial skin. Another innovation is advanced composite technology that provides the ability to design the port to be integrated into a structural load bearing prosthetic pylon. This approach integrates the patient's skin into the prosthetic unit providing a mechanical barrier to bacteria migration in vivo. We expect our approach to enable the development of a long term, efficient infection/ bacterial barrier at the skin interface that will reduce the rate of superficial and deep infection to clinically acceptable levels. Such a permanent transcutaneous access will have many valuable medical applications in addition to the LET.

描述（由申请人提供）：我们合作研究项目的总体目标是开发一种临床上有用的经皮（LET）假体。这种结构系统可以连接到截肢者幸存的自然骨骼上，通过皮肤提供直接的承重路径，以连接外部假体。该装置将减轻严重和频繁的发病率; 1996年，美国有1，285，000名截肢者。LET假体提供的最重要的临床进步是消除了假肢接受腔和假体使用者的大多数常见问题。因此，LET将大大提高截肢者的生活质量。该SBIR项目旨在证明LET支持技术的可行性：一种高性能经皮输液港（HPTP），可在皮肤/ pylon界面提供长期、有效的感染/细菌屏障。为了克服现有的经皮端口的局限性，我们提出了一个系统的方法来工程HPTP，真皮和表皮组件的功能要求。我们的方法利用组织工程设计原理和技术，导致临床和商业上成功的人工皮肤，我们的研究方法是基于用于开发人工皮肤的良好理解的动物模型。另一个创新是先进的复合材料技术，提供了设计港口的能力，以集成到一个结构承载假肢挂架。这种方法将患者的皮肤整合到假体单元中，为体内细菌迁移提供机械屏障。我们期望我们的方法能够在皮肤界面处形成长期、有效的感染/细菌屏障，这将使浅表和深部感染的发生率降低到临床可接受的水平。除了LET之外，这种永久性经皮通路将具有许多有价值的医学应用。