Low Cost Negative Pressure Wound Therapy System

低成本负压伤口治疗系统

基本信息

  • 批准号:
    8337525
  • 负责人:
  • 金额:
    $ 3.62万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2014
  • 资助国家:
    美国
  • 起止时间:
    2014-02-01 至 2015-01-31
  • 项目状态:
    已结题

项目摘要

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.
描述(由申请人提供):压力伤口治疗(NPWT)是通过专用敷料系统对伤口施加负压。负压伤口治疗(NPWT)通过以下作用促进伤口愈合:消除伤口水肿、促进血管形成和增加血流量、清除伤口环境中的渗出液,并提供封闭、潮湿的伤口愈合环境。负压伤口治疗(NPWT)在美国医学界已被广泛接受;然而,目前市售的负压伤口治疗(NPWT)系统的每次治疗成本使得低资源环境下的治疗选择成本过高。申报的OsmoHeal系统是一种针对低资源环境的低成本NPWT系统。OsmoHeal系统是一种一次性使用伤口护理系统,通过机械除气和渗透液清除相结合的方式为伤口提供负压。该系统由机械气泵、渗透液泵和专用敷料系统组成。该项目的主要目标是调整Ceramatec的专有技术以用于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,并制定获得许可以在公共商业中使用该系统的监管计划。为了实现低成本目标,Ceramatec建议与印度马哈拉施特拉邦的Reliance Life Sciences合作,扩大制造规模和大规模生产。这一印美合作项目将在两年内完成。第一年将包括设计开发和优化、体外测试以及将设计转移到制造。第二年将包括试生产,体外/体内测试,以及生产计划的制定,监管批准和低成本分销。 公共卫生相关性:负压伤口治疗(NPWT)在美国用于急性伤口、慢性伤口和预期难以愈合的伤口(包括糖尿病相关伤口)的愈合。1,2,3,4,5,6已经证明,“使用NPWT的联合治疗,愈合时间可加快61%,成本降低38%,“6即使目前市售的NPWT系统的每次治疗成本相对较高。本提案的目的是开发和制造低成本NPWT系统,以便为资源不足的个人提供使用NPWT治疗方式的机会,加速伤口愈合过程,并减少其医疗相关费用。

项目成果

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