Tissue Fusion to Stop Post-Hemodialysis Bleeding

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惊人的每名患者每年13，500美元。穿刺的频率通常会导致并发症，例如透析针取出后无法控制的出血，导致70%的患者每年需要两次或更多次矫正手术来维持通路。为了解决出血问题，落基山生物系统公司，正在开发一种称为FastSeal的活性粘合剂技术，该技术旨在在针道中产生流体密封。FastSeal使用聚焦高频磁场，对新型生物相容性粘合剂进行局部加热，从而实现即时密封。该粘合剂可在潮湿或干燥环境中使用，可预见地在压力存在下使用，并且非常经济。研究人员建议进一步开发粘合剂和涂抹器，并在体外皮肤穿刺模型中测试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路部位，无论是人造的还是血管的。

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.