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，包括癌症切除术后的游离组织移植和/或重建、肢体移植、乳房重建和创伤性截肢、撕脱或枪伤。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，如果不及时纠正，会导致组织死亡。目前，活水蛭被用来治疗这种情况，但对患者造成心理创伤，并且通常在防止组织死亡方面无效。在SBIR I和II期项目中，SpectroCon开发了治疗静脉充血的新技术。AutoFlow是一种全自动医疗器械。在动物模型中，AutoFlow清除了多余的血液，促进了充血组织中的血流，安全地容纳了清除的血液，并证明了自体输血能力。NHLBI支持SBIR第二阶段赠款的竞争继续奖，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，我们在第二阶段延续期的总体目标是：（1）完成与美国食品药品监督管理局（FDA）的监管合规活动，以获得试验用器械豁免（IDE），并通过上市前批准（PMA）申请获得器械批准，和（2）完成人类患者的临床试验，其中AutoFlow与治疗静脉充血的护理标准进行比较（即使用医用水蛭）。我们的具体目标是：（1）确保符合监管标准，以实现FDA批准IDE的目标，并通过PMA机制进一步批准AutoFlow上市;（2）确定在静脉充血患者中使用AutoFlow的安全性，以及（3）确定在静脉充血患者中使用AutoFlow的有效性。这些目标对于获得FDA对AutoFlow治疗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。这些目标的实现将在AutoFlow和医用水蛭的使用之间产生巨大的功能差异，并将AutoFlow确立为市场上治疗静脉充血的普遍首选方法。项目叙述由于活体水蛭在治疗静脉充血方面并不理想，因此需要新的技术来更有效地治疗这种情况。SpectroCon开发了AutoFlow，一种全自动医疗设备，因为它将有利于恢复乳房重建，头颈癌手术和创伤手术并发症患者的功能。对截肢、手指、乳房或头颈部重要组织的有效挽救将明显提高身体、职业和职业康复潜力，以及言语、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.