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45，000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，每年有70%的患者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，Rocky Mountain Biosystems，Inc.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使用聚焦的高频交变磁场来影响新型生物相容性粘合剂的局部加热并实现即时密封。FastSeal可成功用于潮湿、干燥和加压环境，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，用于在各种手术中有效地管理伤口闭合，包括血管通路闭合，肺减容和肺叶切除术后的密封组织，以及软骨重建和重塑。II期的重点是将粘合剂和施源器开发成用于密封针道和静脉通路部位（无论是合成的还是血管的）的临床系统。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III期人体临床试验和商业化做准备。所提出的用于停止血液透析后出血的组织融合装置将在商业上和社会上提供巨大的益处，因为它将通过快速密封进入部位来加速透析治疗过程-通常需要10-20分钟的治疗。因此，它将使患者更快地恢复正常的日常生活，并大大降低由于人员负担和漫长的治疗时间而导致的透析成本。

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.