Device for Promoting Survival of Congested Tissue Flaps

描述（由申请人提供）：显微外科手术的使用正在增加，包括癌症切除后的自由组织转移和/或重建，肢体移植，乳房重建，创伤性截肢，撕脱伤或枪伤。静脉充血是这类手术的严重并发症。移植的组织可能会严重充血，如果不加以纠正，就会导致组织死亡。目前，活的水蛭被用来治疗这种疾病，但对患者来说是心理创伤，而且往往对防止组织死亡无效。在SBIR一期和二期项目中，SpectroCon开发了治疗静脉充血的新技术。AutoFlow是一种全自动医疗设备。在动物模型中，AutoFlow清除了多余的血液，促进了充血组织的血液流动，安全地容纳了清除的血液，并证明了自身输血能力。NHLBI支持SBIR II期拨款的竞争延续奖，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II期延续期的总体目标是：(1)完成美国食品和药物管理局（FDA）的监管合规活动，以获得研究器械豁免（IDE），并通过上市前批准（PMA）申请获得器械批准；(2)在人类患者中完成一项临床试验，将AutoFlow与治疗静脉充血的标准护理（即使用药用水蛭）进行比较。我们的具体目标是：(1)确保符合监管标准，实现FDA批准IDE的目标，并通过PMA机制进一步批准AutoFlow上市；(2)确定人类静脉充血患者使用AutoFlow的安全性；(3)确定人类静脉充血患者使用AutoFlow的有效性。这些目标对于获得FDA对AutoFlow疗法的市场批准以及与药用水蛭相比建立AutoFlow的安全性和有效性至关重要。实现这些目标将在使用AutoFlow和药用水蛭之间创造一个巨大的功能鸿沟，并将AutoFlow建立为市场上治疗静脉充血的普遍首选方法。由于活体水蛭不是治疗静脉充血的最佳方法，因此需要更有效地治疗这种情况的新技术。SpectroCon已经开发了全自动医疗设备AutoFlow，因为它将有利于在乳房重建、头颈癌手术和创伤手术中经历并发症的人恢复功能。有效地挽救被截肢的肢体、手指、乳房或头颈部的关键组织将明显提高身体、职业和职业康复的潜力，以及语言、吞咽、一般外观和生活质量。

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.