Tissue Fusion to Stop Post-Hemodialysis Bleeding

组织融合以阻止血液透析后出血

• 批准号: 6791063
• 负责人: Kevin Marchitto
• 金额: $ 9.94万
• 依托单位: ROCKY MOUNTAIN BIOSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-08 至 2005-03-07
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6791063
• 关键词: adhesions; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; biomaterials; disease /disorder prevention /control; hemodialysis; hemorrhage; hemostasis; iatrogenic disease; infection; laboratory rabbit; magnetic field; medical complication

DESCRIPTION (provided by applicant): Of the 400,000 Americans living with end stage renal disease, nearly 250,000 undergo hemodialysis treatments 2-3 times each week. The cost of establishing and maintaining vascular access in dialysis patients is a staggering $13,500 per patient per annum. The frequency of puncture often leads to complications, such as uncontrollable bleeding after dialysis needle removal, resulting in 70% of patients requiring two or more corrective surgical procedures annually to maintain access. To address the bleeding problem, Rocky Mountain Biosystems, Inc., is developing an activated adhesive technology called FastSeal, which is designed to produce a fluid-tight seal in needle tracts. FastSeal uses a focused, high-frequency magnetic field, to effect localized heating of a novel biocompatible adhesive thus affecting an immediate seal. The adhesive can be used in wet or dry environments, can predictably be used in the presence of pressures, and is very economical. The investigators propose to further develop the adhesive and applicator, and to test the FastSeal process in an in vitro skin puncture model. The focus of Phase II will be developing a clinical system for sealing the needle tract and the site of venous access, whether synthetic or vascular.

描述(由申请人提供)： 在40万患有终末期肾病的美国人中，近25万人每周接受2-3次血液透析治疗。在透析患者中建立和维持血管通路的成本是每个患者每年惊人的13,500美元。频繁的穿刺会导致并发症，如取下透析针后无法控制的出血，导致70%的患者每年需要两次或两次以上的矫正手术才能保持通路。为了解决出血问题，落基山生物系统公司正在开发一种名为FastSeal的激活粘合剂技术，该技术旨在在针道中产生不透液的密封。FastSeal使用聚焦的高频磁场对一种新型生物兼容粘合剂进行局部加热，从而影响即时密封。该粘合剂可以在潮湿或干燥的环境中使用，可以预见地在有压力的情况下使用，并且非常经济。研究人员建议进一步开发粘合剂和涂抹器，并在体外皮肤穿孔模型中测试FastSeal过程。第二阶段的重点将是开发一种临床系统，用于密封针道和静脉通道的位置，无论是人工合成的还是血管的。