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费用高达每位患者每年45000美元。穿刺的频率往往会导致并发症，例如透析针头取出后无法控制的出血，每年有70%的患者需要两次或两次以上的矫正外科手术来维持通道。为了解决出血问题，洛基山生物系统公司正在开发一种名为FastSeal的活性粘合剂技术，该技术旨在在针束中产生流体密封。FastSeal使用聚焦的高频交变磁场来影响一种新型生物相容性粘合剂的局部加热，并实现即时密封。FastSeal可以在潮湿、干燥和压力环境中成功使用，并且设计非常经济。通过这项研究开发的技术已经导致了额外的临床应用，在各种程序中有效地管理伤口关闭，包括血管通道关闭，肺体积缩小和肺叶切除术后的组织密封，以及软骨重建和重塑。ii期的重点是将粘合剂和涂抹器开发成临床系统，用于密封针道和静脉通路部位，无论是合成的还是血管的。该临床系统将在体外皮肤穿刺和体内猪模型中进行测试，为人体临床试验和第三期商业化做准备。拟议的组织融合装置可以阻止血液透析后出血，这将为商业和社会带来巨大的好处，因为它可以通过快速密封进入部位来加快透析治疗过程，而这种治疗通常需要10-20分钟。因此，它将使患者更快地恢复正常生活，并大大减少由于人员负担和治疗时间长而造成的透析成本。

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 $45,000 per patient per annum. The frequency of puncture often leads to complications, such as uncontrollable bleeding after dialysis needle removal, with 70% of patients annually requiring two or more corrective surgical procedures 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 alternating magnetic field, to affect localized heating of a novel biocompatible adhesive and achieve an immediate seal. FastSeal can be used successfully in wet, dry and pressurized environments, and is designed to be very economical. The technology developed through this research is already leading to additional clinical applications for effectively managing wound closure in a variety of procedures, including vascular access closure, sealing tissue after lung volume reduction and lobectomy, and in cartilage rebuilding and reshaping. The focus of Phase Il will be to develop the adhesive and applicator into a clinical system for sealing the needle tract and the site of venous access, whether synthetic or vascular. This clinical system will be tested in an in vitro skin puncture and an in vivo porcine model, to prepare for human clinical trials and commercialization in Phase III. The proposed tissue fusion device to stop Post-Hemodialysis bleeding would provide tremendous benefit both commercially and societally, in that, it would expedite the dialysis treatment process by rapidly sealing the access site-a treatment that normally takes 10-20 minutes. Thus, it would allow patients to return to normal routine more quickly, and considerably cut dialysis cost due to staffing burden and lengthy treatment times.