Inline RF Warmer Using RF Technology

采用射频技术的内联射频加温器

• 批准号: 10583098
• 负责人: Ahmad Khanifar
• 金额: $ 21.66万
• 依托单位: ADVANCED MEDICAL DEVICE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-07 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10583098
• 关键词: Inline; RF; Warmer; Using; Technology

Hypothermia is a common condition encountered in a variety of clinical settings including trauma, critical care, peri/post-operative care and during administration of renal replacement therapy. The causes of hypothermia are vast and include critical illness, induction of anesthesia or iatrogenic administration of sub-body temperature fluids (i.e. fluids or blood products). Effective prevention and treatment of hypothermia is of vital importance given that its presence is associated with poor clinical outcomes including increased mortality. Of the available therapies, methods which increase core body temperature [warm intravenous (IV) fluids], are more effective than external methods (heating blankets). Hence, warming of fluids being administered is a well-accepted and commonly used technique for prevention and treatment of hypothermia. Currently available techniques used to warm medical fluids rely on simple heat-exchange methodologies (convection, induction) which are outdated and have numerous shortcomings. The devices commonly used can be divided into two groups:1) devices which accommodate large fluid volumes at fast rates. These are large, lack portability, consume greater energy, and require extensive set-up. 2) More portable devices which are slower and not suitable for large volume resuscitation. In both groups, the need for disposables which disrupt the native delivery system increases cost and risk of contamination leading to major patient safety issues. Moreover, the set-up process for both groups can be complicated and cumbersome. The proposed research aims to develop an innovative technology to safely warm medical fluids in a real-time inline fashion using radiofrequency (RF) energy. RF (microwave) is more energy efficient and allows for several important advantages including increased portability. Furthermore, in the proposed technology the issue of hotspots, which previously limited the use of this technique, is mitigated via a novel and innovative design thereby allowing for RF energy to be directly applied to the traversing fluid in the delivery tubing. This mode of transfer of energy circumvents the need for disposables, lowering costs, reducing risk of contamination and improving ease-of-use. The proposed project aims to demonstrate the feasibility of design and development of a RF fluid warmer apparatus which avoids hotspot generation by a team of RF engineers using design/quality control processes. This will be done in consultation with clinicians in various specialties who routinely treat hypothermia and specialist in the regulatory aspects of medical device development. Given that hypothermia is a serious and common complication in a variety of medical settings, the potential utility for such a technology is vast and can include emergency response teams, military medical systems, hospitals, outpatient surgery centers and dialysis providers. In addition, the ability to warm medical fluids safely and effectively in an easy to operate manner with improved patient safety can enhance more widespread use of this technology thereby increasing its market share. Finally, once developed this technology can be adapted for use in various other areas affected by hypothermia (i.e. plasmaphoresis, cardiopulmonary bypass).

体温过低是在各种临床环境中遇到的常见情况，包括创伤、重症监护， 肾移植/术后护理和肾脏替代治疗期间。体温过低的原因是 包括危重病、麻醉诱导或低于体温液体的医源性给药 (i.e.液体或血液制品）。有效预防和治疗体温过低是至关重要的，因为它 存在与不良的临床结果相关，包括死亡率增加。在现有的治疗方法中， 增加核心体温的方法[温热的静脉注射液]比外部治疗更有效。 方法（加热毯）。因此，加热所施用的流体是一种被广泛接受和常用的方法。 体温过低的防治技术。目前用于加热医用液体的技术 依靠简单的热交换方法（对流，感应），这些方法已经过时， 缺点通常使用的装置可分为两组：1）容纳大量流体的装置 以快速的速度。这些都是大的，缺乏便携性，消耗更大的能源，并需要广泛的设置。2)更 速度较慢且不适合大容量复苏的便携式设备。在这两组中，对一次性用品的需求 其破坏了天然的输送系统，增加了成本和污染的风险，从而导致严重的患者安全问题。 此外，这两个群体的建立过程可能既复杂又繁琐。 拟议的研究旨在开发一种创新技术，以实时在线安全地加热医用液体。 使用射频（RF）能量的方式。RF（微波）更节能，并允许几个重要的 优点包括增加的便携性。此外，在所提出的技术中， 以前限制了这种技术的使用，通过新颖和创新的设计得到缓解，从而允许 将射频能量直接施加到输送管路中的横向流体。这种能量转移模式 避免了对一次性用品的需求，降低了成本，减少了污染的风险，并提高了易用性。 本项目旨在论证射频液体加温器设计和开发的可行性 一种避免由RF工程师团队使用设计/质量控制过程产生热点的装置。 这将在与常规治疗体温过低的各专科临床医生协商后完成， 医疗器械开发监管方面的专家。 鉴于体温过低是各种医疗环境中严重且常见的并发症，因此 这种技术是广泛的，并且可以包括紧急响应小组、军事医疗系统、医院， 门诊手术中心和透析提供者。此外，安全有效地加热医用液体的能力 以具有改进的患者安全性的易于操作的方式能够促进该技术的更广泛的使用 从而增加其市场份额。最后，一旦开发出这种技术，就可以适用于各种 受低温影响的其他区域（即血浆置换术、心肺转流术）。