Low Cost Negative Pressure Wound Therapy System

描述（由申请人提供）：压力伤口疗法（NPWT）是通过专门的敷料系统将亚大气压应用于伤口。NPWT通过以下作用促进伤口愈合：消除伤口水肿，促进血管化和增加血流，清除伤口环境中的渗出物，提供封闭、湿润的伤口愈合环境。NPWT已被美国医学界广泛接受；然而，目前市场上销售的NPWT系统的每次处理成本使得低资源环境下的处理选择成本令人望而却步。所提出的OsmoHeal系统是一种低成本的NPWT系统，适用于低资源环境。OsmoHeal系统是一种一次性使用的伤口护理系统，通过机械空气去除和渗透流体去除相结合，为伤口提供亚大气压。该系统由机械气泵、渗透流体泵和专用敷料系统组成。该项目的主要目标是将Ceramatec的专有技术应用于NPWT环境，优化OsmoHeal系统的功能和可制造性，在动物研究中证明OsmoHeal的功能，制定大规模生产的制造计划，并制定监管计划，以获得在公共商业中使用该系统的许可。为了实现低成本目标，Ceramatec建议与印度马哈拉施特拉邦的Reliance生命科学公司合作，扩大生产规模和大规模生产。这个印美合作项目将在两年的时间内进行。第一年将包括设计开发和优化，体外测试，并将设计转移到制造。第二年将包括试点生产、体外/体内测试、制定生产计划、监管批准和低成本分销。

DESCRIPTION (provided by applicant): Pressure Wound Therapy (NPWT) is the application of sub atmospheric pressure to a wound through a specialized dressing system. The effects of NPWT promote wound healing through the following actions: drawing edema from the wound, promoting vascularization and increased blood flow, removing of exudate from the wound environment, and providing a closed, moist wound healing environment. NPWT has been widely accepted within the US medical community; however, the per-treatment cost of the currently marketed NPWT systems makes the treatment option cost prohibitive for low-resource settings. The proposed OsmoHeal System is a low cost NPWT system targeted for low-resource settings. The OsmoHeal System is a single use, disposable wound care system that functions to provide sub atmospheric pressure to the wound through a combination of mechanical air removal and osmotic fluid removal. The system consists of a mechanical air pump, an osmotic fluid pump and a specialized dressing system. The primary goals of the project are to adapt Ceramatec's proprietary technology for use in a NPWT setting, optimize the function and manufacturability of the OsmoHeal System, prove OsmoHeal functionality in an animal study, develop a manufacturing plan for large scale production, and develop a regulatory plan for gaining clearance to use the system in public commerce. In order to meet the low cost target, Ceramatec proposes to work collaboratively with Reliance Life Sciences of Maharashtra, India for the manufacturing scale-up and large scale production. This collaborative Indo-US project will be performed over a period of two years. The first year will consist of design development and optimization, in vitro testing, and transfer of the design to manufacturing. The second year will consist of pilot production, in vitro/in vivo testing, and the development of plans for manufacturing, regulatory approval, and low-cost distribution. PUBLIC HEALTH RELEVANCE: Negative Pressure Wound Therapy (NPWT) is used in the US for the healing of acute wounds, chronic wounds, and wounds that are expected to present difficulties while healing, including diabetes related wounds.1, 2, 3, 4, 5, 6 It has been shown that "healing time can be as high as 61% faster and 38% less costly with combination treatment utilizing NPWT,"6 even with the relatively high per-treatment cost of the currently marketed NPWT systems. The objective of this proposal is to develop and manufacture a low-cost NPWT system in order to provide individuals with low resources the opportunity to utilize the NPWT treatment modality, accelerate the wound healing process, and reduce their medical related expenses.