Device for Promoting Survival of Congested Tissue Flaps

描述(申请人提供)：显微外科手术的使用正在增加，包括癌症切除、肢体移植、乳房重建和创伤性截肢、撕脱或枪伤后的自由组织转移和/或重建。静脉充血是此类手术的严重并发症。再移植的组织可能会严重充血，如果不纠正，就会导致组织死亡。目前，活体水蚤被用来治疗这种情况，但对患者来说是心理创伤，在防止组织死亡方面往往无效。在SBIR第一阶段和第二阶段项目中，SpectrCon开发了治疗静脉淤血的新技术。AutoFlow是一种全自动医疗设备。在动物模型中，Autoflow去除了多余的血液，促进了充血组织的血液流动，安全地容纳了取出的血液，并展示了自体输血能力。NHLBI支持SBIR第二阶段拨款的竞争性延续奖，以改进设备并进行临床研究，以获得联邦监管机构的批准。因此，我们第二阶段持续期间的总体目标是：(1)完成与食品和药物管理局(FDA)关于研究设备豁免(IDE)的法规遵从性活动，并通过上市前批准(PMA)申请实现设备批准，以及(2)完成一项针对人类患者的临床试验，在该试验中，Autoflow与静脉充血治疗(即使用药用水蛭)的护理标准进行了比较。我们的具体目标是：(1)确保遵守法规标准，以实现FDA批准IDE并通过PMA机制进一步批准Autoflow上市的目标；(2)确定在人类静脉充血患者中使用Autoflow的安全性；以及(3)确定在人类静脉充血患者中使用Autoflow的疗效。这些目标对于获得FDA对Autoflow疗法的市场批准以及确定Autoflow与药用水蛭相比的安全性和有效性至关重要。实现这些目标将在Autoflow和药用水蛭的使用之间产生巨大的功能鸿沟，并将Autoflow确立为市场上治疗静脉充血的普遍首选方法。项目简介由于活体水蛭不太适合治疗静脉充血，因此需要更有效地治疗这种情况的新技术。SpectrCon开发了一种全自动医疗设备Autoflow，因为它将有助于在乳房重建、头颈部癌症手术和创伤手术中遇到并发症的患者恢复功能。有效地挽救截肢、手指、乳房或头颈部的关键组织将明显提高身体、职业和职业康复潜力，以及言语、吞咽、外观和生活质量。

DESCRIPTION (provided by applicant): The use of microsurgical procedures is increasing, and includes free tissue transfers and/or reconstruction after cancer resection, limb transplantation, breast reconstruction, and traumatic amputation, avulsion, or gunshot injury. Venous congestion is a serious complication of these types of procedures. Replanted tissues can become severely congested, and if uncorrected, tissue death results. Currently, live leeches are used to treat this condition, but are psychologically traumatic to patients, and are often ineffective in preventing tissue death. In SBIR Phase I and II projects, SpectroCon developed new technology for the treatment of venous congestion. AutoFlow is a fully automated medical device. In an animal model, AutoFlow removed excess blood, promoted blood flow in congested tissues, safely contained removed blood, and demonstrated autotransfusion capability. NHLBI supports Competing Continuation Awards of SBIR Phase II grants to improve devices and conduct clinical studies toward approval by a Federal regulatory agency. Accordingly, our overall goals for the Phase II Continuation period are to: (1) Complete regulatory compliance activities with the Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) and toward device approval via a Premarket Approval (PMA) application, and (2) Complete a clinical trial in human patients in which AutoFlow is compared with the standard of care for treatment of venous congestion (i.e. use of medicinal leeches). Our specific aims are: (1) To ensure compliance with regulatory standards toward the goal of achieving FDA approval of an IDE, and further approval to market AutoFlow via the PMA mechanism; (2) To determine the safety of using AutoFlow in human patients with venous congestion, and (3) To determine efficacy of using AutoFlow in human patients with venous congestion. These aims are critical for gaining market approval from the FDA for AutoFlow therapy and in establishing the safety and efficacy of AutoFlow, in comparison with medicinal leeches. Achieving these aims will create a large functional divide between use of AutoFlow and medicinal leeches, and will establish AutoFlow as the universally preferred method for the treatment for venous congestion in the marketplace.Project Narrative Because live leeches are less than optimal for treating venous congestion, new technology is needed that will treat this condition more effectively. SpectroCon has developed AutoFlow, a fully automated medical device, because it will be beneficial in restoring function to persons experiencing complications in breast reconstruction, head and neck cancer surgery, and trauma surgery. Effective salvage of amputated limbs, fingers, breasts, or critical tissues of the head and neck will clearly enhance physical, occupational, and vocational rehabilitative potential, as well as speech, swallowing, general appearance, and quality of life.