Tissue Fusion to Stop Post-Hemodialysis Bleeding

组织融合以阻止血液透析后出血

基本信息

批准号：
7272551
负责人：
Kevin Marchitto
金额：
$ 49.73万
依托单位：
ROCKY MOUNTAIN BIOSYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-11-01 至 2009-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7272551
关键词：
Address Adhesives Admission activity Adverse effects Adverse event Affect American Analysis of Variance Animal Model Animals Anticoagulants Area Arteriovenous fistula Biocompatible Blood Vessels Blood flow Body Fluids Caring Cartilage Cicatrix Clinical Clinical Research Clinical Trials Closure Colorado Computer Systems Development Computers Cost Control Depth Development Devices Dialysis patients Dialysis procedure Doctor of Medicine Doctor of Philosophy Drug Formulations Electrical Engineering Electromagnetic Energy Electromagnetic Fields End stage renal failure Engineering Environment Equipment Evaluation Excision Family suidae Filament Fistula Foundations Frequencies Future Generations Healed Health Care Costs Heating Hemodialysis Hemorrhage Histology Hospitals Hour Human In Vitro Infection Intervention Ischemia Laceration Lead Legal patent Letters Life Life Expectancy Limb structure Liquid substance Lobectomy Localized Location Lung Volume Reductions Manuals Measurable Medical Medical Device Methods Modeling Morbidity - disease rate Needles Neuro-Oncological Ventral Antigen 2 Object Attachment Operative Surgical Procedures Patients Personal Satisfaction Phase Physical Dialysis Polytetrafluoroethylene Positioning Attribute Power Sources Preparation Procedures Process Production Protocols documentation Punch Biopsy Puncture procedure Range Rate Reporting Research Research Personnel Resistance Risk Sampling Scientist Secure Site Skin Skin Tissue Standards of Weights and Measures Stenosis Structure Surface Surgical wound System Technology Temperature Tensile Strength Testing Texas Thrombosis Time Tissues Ultrasonography United States Food and Drug Administration Universities Vascular Graft Vascular blood supply Venous Veterinary Schools Week analog austin base biomaterial compatibility clinical application commercialization cost design experience healing in vivo interest magnetic field microwave electromagnetic radiation mortality novel pre-clinical pressure prevent professor prototype research study response seal success systems research tissue phantom wound

项目摘要

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.

描述（由申请人提供）：在患有末期肾脏疾病的40万美国人中，每周将有近25万次接受血液透析治疗2-3次。在透析患者中建立和维持血管通道的成本是每年每年45,000美元的$ 45,000。穿刺的频率通常会导致并发症，例如透析切针后无法控制的出血，每年有70％的患者需要两种或更高的纠正手术手术以维持入学。为了解决出血问题，落基山生物系统公司（Rocky Mountain Biosystems，Inc。快速使用集中的高频交替磁场，影响新型生物相容性粘合剂的局部加热并获得立即密封。快速封装可以在潮湿，干和加压环境中成功使用，并且设计为非常经济。通过这项研究开发的技术已经导致了其他临床应用，以有效地管理各种程序中的伤口闭合，包括血管通道封闭，减少肺部量减少和肺叶切除术后的密封组织以及软骨的重建和重塑。 IL期的重点将是将粘合剂和涂抹器开发到临床系统中，以密封针刺和静脉输入部位，无论是合成的还是血管。该临床系统将在体外皮肤穿刺和体内猪模型中进行测试，以准备人类III期间的人类临床试验和商业化。提议的组织融合装置以停止静脉透析后出血将在商业和社会上提供巨大的好处，因为这将通过快速密封透析服务站点来加快透析治疗过程，而该治疗通常需要10-20分钟。因此，这将使患者能够更快地恢复正常的常规，并且由于人员负担和冗长的治疗时间而导致的透析成本大大降低。