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

描述（由申请人提供）：该建议提出了一种创新的和有效的解决方案，以解决由于应用冷疗而导致的皮肤和神经缺血性损伤的问题。冷却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，其好处甚至在外行社区中也被直观地认识到， 令人惊讶的是，对与使用ts有关的风险因素没有明确的了解。每年约有1，500例涉及广泛组织坏死和/或严重神经病变的冷冻治疗损伤病例证明了这些风险是显著的。120多项初步研究表明，即使短暂暴露于循环冰水中，也会导致深度缺血状态，并在冷却后持续数小时。我们的研究也记录了局部可用性的改变和血管活性分子的作用与缺血状态的产生和维持有关。我们发明了一项专有技术，包括特殊设备和应用方法，可提供冷冻治疗的所有好处，同时还大大降低了缺血诱导损伤的风险。该技术的工作原理是在冷冻疗法的应用过程中定期刺激受影响区域的血流。我们还通过固态冷却技术将制冷源直接应用于治疗区域，大大提高了热效率和控制。我们组建了一支优秀的跨学科研究团队，他们在人体热生理学，生物传热工程，设备设计和心血管流量控制机制方面具有专业知识。研究计划将包括三个目标：（a）表征问题：绘制皮肤血液灌注的抑制与冷冻治疗的温度和暴露时间的函数关系图，（B）定义作用机制：应用微透析技术识别和测量控制血管对冷冻治疗反应的候选血管活性剂的作用，以及（c）设计、实施和验证解决方案：建立和测试原型设备，以刺激皮肤在冷冻治疗过程中的血流，并测量对缺血诱导的影响。我们已经证明了多种刺激血流模式与冷冻疗法相结合的疗效。 我们相信，这项技术将对实践产生变革性的好处， 冷冻疗法，并将使其好处，以实现大大降低的风险，在皮肤和神经的附带损伤。

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.