PREVENTION OF COMPARTMENT SYNDROME WITH MICRODIALYSIS

通过微透析预防筋膜室综合征

• 批准号: 2717435
• 负责人: RICK M ODLAND
• 金额: $ 9.91万
• 依托单位: TWIN STAR MEDICAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 1999-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2717435
• 关键词: biomedical equipment development; catheterization; disease /disorder prevention /control; edema; interstitial; limbs; medical complication; method development; microdialysis; necrosis; swine; syndrome; trauma

Microdialysis is an innovative approach to managing compartment syndrome, which will result in reduced healthcare costs and improved patient function and outcomes. Compartment syndrome is a serious potential complication of trauma to the extremities. Prolonged elevated compartment pressure can result in irreversible nerve and muscle damage, amputation and death. The outcome of compartment syndrome is highly dependent on accurate and timely diagnosis. Compartment syndrome is considered a surgical emergency requiring prompt treatment by fasciotomy. Controversy over threshold pressure measurements and subjective clinical indications often render the diagnosis of compartment syndrome difficult and/or untimely. In North America, failure to correctly diagnose and treat compartment syndrome is one of the most common causes of litigation against the medical profession. In this proposal, the applicant's encouraging preliminary studies will be continued in an established animal model, to demonstrate the feasibility of microdialysis technology to manage compartment syndrome. Three Specific Aims separately demonstrate feasibility of microdialysis to (1) monitor, (2) prevent an impending compartment syndrome, and (3) treat a developed compartment syndrome, using this innovative microdialysis methodology. In Phase II, human clinical trials, and further optimization of catheters and manufacturing of microdialysis systems are planned. PROPOSED COMMERCIAL APPLICATIONS: Therapeutic MicroDialysis plans to manufacture and market a microdialysis system for the treatment of compartment syndrome patients. The contemplated product is a self-contained unit with a disposable grouping of microdialysis fibers (with disposable insertion needles), attached to a manifold which optionally attaches to wall suction, and which drains and contains the interstitial edema (with the additional benefit of protecting staff from exposure to body fluids, and aiding in hospital infection control). The market potential is estimated at $80 million.

微透析是治疗筋膜室综合征的一种创新方法， 这将导致降低的医疗保健成本和改善的患者 功能和成果。 昏迷综合征是一种严重的潜在并发症的创伤， 四肢持续升高的室压可能导致 不可逆转的神经和肌肉损伤截肢和死亡成果 骨筋膜室综合征的发生高度依赖于准确及时的 诊断.昏迷综合征被认为是外科急症 需要通过筋膜切开术进行及时治疗。阈值争议 压力测量和主观的临床指征通常使得 筋膜室综合征的诊断困难和/或不及时。在北 在美国，未能正确诊断和治疗筋膜室综合征是 对医疗机构提起诉讼的最常见原因之一 职业 在这份提案中，申请人令人鼓舞的初步研究将 在建立的动物模型中继续，以证明 微透析技术治疗筋膜室综合征的可行性。 三个具体目标分别证明了微透析的可行性 （1）监测，（2）预防即将发生的间隔综合征，以及（3） 治疗发达的筋膜室综合征，使用这种创新的 微透析方法学 在第二阶段，人体临床试验，并进一步优化导管 和微透析系统的制造。 拟议的商业应用： 治疗性微透析计划生产和销售微透析 治疗筋膜室综合征患者的系统。的 预期的产品是具有一次性分组的独立单元 微透析纤维（带有一次性插入针），连接到 歧管，其可选地附接到壁吸，并且其排放 并包含间质性水肿（具有以下额外益处： 保护工作人员不接触体液，并协助医院 感染控制）。市场潜力估计为8 000万美元。