Devices and Methods to Obviate the Risk of Ischemic Injury during Cryotherapy

描述(由申请人提供)：这项建议提出了一种创新和有效的解决方案，以解决由于应用冷疗而导致的皮肤和神经缺血损伤的问题。降温通常用于骨科手术后和运动医学中，以减轻疼痛、肿胀、炎症和新陈代谢。尽管冷冻疗法已经被广泛应用了几个世纪，它的好处甚至在业外人士中也得到了直观的认可， 令人惊讶的是，人们对使用ts相关的风险因素没有明确的了解。这些风险是重大的，每年发生约1500例冷冻损伤，涉及广泛的组织坏死和/或严重的神经病变。120多项初步研究证明，即使是短暂暴露在循环冰水中，也会导致深度缺血状态，并在寒冷消除后持续数小时。我们的研究还记录了在创造和维持缺血状态的同时，局部可获得性和血管活性分子作用的改变。我们发明了一项专利技术，其中包括特殊的设备和应用方法，在提供冷冻治疗的所有好处的同时，还极大地降低了缺血诱导损伤的风险。这项技术的工作原理是在应用冷冻治疗期间定期刺激受影响区域的血液流动。我们还通过固态冷却技术将制冷源直接应用于处理区域，大大提高了热效率和控制性。我们组建了一支卓越的跨学科研究团队，拥有人体热生理学、生物热传递工程、设备设计和心血管血流控制机制方面的专业知识。研究计划将包括三个目标：(A)描述问题的特征：绘制冷冻治疗时皮肤血液灌注量随温度和暴露时间的函数图，(B)确定作用机制：应用微透析技术来识别和测量候选血管活性物质的作用，这些血管活性物质控制着冷冻治疗对血管的反应，以及(C)设计、实施和验证解决方案：建立和测试原型设备，以刺激冷冻治疗期间皮肤的血液流动，并测量对缺血诱导的影响。我们已经证明了与冷冻疗法相结合的多种刺激血流模式的有效性。我们相信，这项技术将对实践 冷冻治疗将使其益处得以实现，同时极大地降低皮肤和神经附带损伤的风险。

DESCRIPTION (provided by applicant): This proposal presents an innovative and effective solution to the problem of ischemia derived injuries to the skin and nerves as a consequence of applied cold therapy. Cooling is commonly used after orthopedic surgery and in sports medicine to reduce pain, swelling, inflammation, and metabolism. Although cryotherapy has been widely practiced for centuries, and its benefits are recognized intuitively even within the lay community, it is rather amazing that there is no definitive understanding of the risk factors associated with ts use. These risks are significant as evidenced by an annual occurrence of some 1,500 cases of cryotherapy injury involving extensive tissue necrosis and/or severe neuropathy. More than 120 preliminary studies have documented that even brief exposures to circulating ice water cause a deep state of ischemia that persists for hours after the removal of cold. Our studies have also documented the alteration of local availability and action of vasoactive molecules in conjunction with creating and sustaining the ischemic state. We have invented a proprietary technology that includes special devices and application methods that deliver cryotherapy with all of its benefits while also greatly lowering the risk of ischemia induced injury. The technology works by periodically stimulating blood flow in affected areas during the application of cryotherapy. We also apply the refrigeration source directly to the treatment area via solid state cooling technology with greatly increased thermal efficiency and control. We have assembled an exceptional interdisciplinary research team with expertise in human thermal physiology, bioheat transfer engineering, device design, and cardiovascular flow control mechanisms. The research plan will consist of three aims to: (a) characterize the problem: map the depression of skin blood perfusion as a function of the temperature and exposure time to cryotherapy, (b) define the mechanism of action: apply microdialysis technology to identify and measure the action of candidate vasoactive agents that govern the vascular response to cryotherapy, and (c) design, implement, and verify the solution: build and test prototype devices to stimulate blood flow in skin during cryotherapy and measure the effect on ischemia induction. We have already demonstrated the efficacy of multiple modes of stimulating blood flow that can be combined with cryotherapy. We believe that this technology will have a transformative benefit to the practice of cryotherapy and will enable its benefits to be realized with a greatly reduced risk of collateral injury in skin and nerves.