Ambulatory cryocooling therapy device

门诊冷冻治疗装置

基本信息

批准号：
10603705
负责人：
Steve Michael Savoy
金额：
$ 25.85万
依托单位：
NANOHMICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-23 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10603705
关键词：
Address Adoption Affect Ankle Anti-Inflammatory Agents Area Arthroscopy Articular Range of Motion Bandage Behavior Biomedical Technology Blood Circulation Body Regions Burn injury Caring Chills Climate Controls Cold Therapy Collaborations Consumer Preferences Consumption Data Deep Vein Thrombosis Dependence Development Device Designs Devices Doctor of Medicine Edema Freedom Freezing Gel Hand Heart Arrest Heating Hospitalization Human Subject Research Ice Inflammation Injury Ions Knee Lead Lifting Limb structure Liquid substance Logic Maintenance Manufacturer Name Mattresses Medical Medical Device Medicine Methods Modeling Modernization Operative Surgical Procedures Orthopedics Pain Patient-Focused Outcomes Patients Performance Phase Physicians Postoperative Period Power Sources Production Pump Recovery Refrigeration Regimen Research Risk Site Skin Soft Tissue Injuries Sports Medicine Sprain Surface Surgeon Swelling System Techniques Technology Temperature Texas Therapeutic Thrombosis Time Tissues Trauma Traumatic Brain Injury Tube Universities Validation Vasodilation Water Wrist austin base cold temperature compliance behavior compression therapy cost design flexibility improved interfacial knee replacement arthroplasty melting novel pain score patient mobility postoperative recovery prevent professor programs prototype skin burn skin damage soft tissue solid state square foot stem support network technology development wearable device wireless communication

项目摘要

PI: Savoy Project Summary Tissue protection following injury begins with shutting down vasodilation and limiting subsequent swelling through the application of cold. In many cases, the cold comes in the form of bags of ice or frozen cold packs, or commercial cooling products such ice packs or ice pack holding limb wraps. In others it may be via a chilled water circulator device, for example the Polar Care Kodiak Cold Therapy where ice water is sent from the “holding box” through ¾” tubing into a cooling pad applied to the skin. The drawback with ice and frozen packs is the risk of skin burn and soft tissue damage stemming from skin contact with such a low temperature. With as little as 20-30 minutes of an icepack lying against the skin, damage may occur. However, studies have shown that 20 minutes of cooling one time is not enough to change the course of treatment and decrease the swelling. Longer term cooling is needed to make a difference. However, the patient’s functional mobility and compliance is limited due the bulk of the apparatus, and this discourages longer term use and increases risks associated with deep vein thrombosis which combine decrease patient outcome. Ideally, the device could be worn “hands-free” for extended periods providing a long-term (full day) programmable therapeutic regimen which includes periods of anti-inflammation (T ~ 10 °C) followed by brief periods of elevated temperature (T ~ 20 °C) to prevent skin damage. An alternative electrical-to-thermal cooling device that could be applied directly to the injury site would increase patient adoption and improve patient therapy benefit. Nanohmics’ direct electric-to-thermal approach to address this shortcoming will provide programmable temperature control over the entire contact region in a low-profile, low-power consumption device that will enable the patient full ambulatory freedom during the therapeutic regimen after injury (e.g. ankle/wrist sprain) or surgery (e.g. knee arthroscopy). No ice means there are no issues with melting and replacement, and the temperature can be programmed for cold (anti- inflammatory) and heat (cellular debris clearing, thrombosis) which may lead to benefits in decreased pain medicine consumption, post-injury range of motion, and decreased pain score and risks associated with deep vein thrombosis.

PI：萨沃伊项目概要受伤后的组织保护始于关闭血管舒张和限制在许多情况下，寒冷会以寒冷的形式出现。袋装冰或冷冻冷袋，或商业冷却产品，如冰袋或冰袋在其他情况下，可能通过冷冻水循环装置，例如固定肢体。 Polar Care Kodiak 冷疗法，其中冰水从“保温箱”通过 3/4” 输送将管子插入敷在皮肤上的冷却垫中时，可能会遇到冰块和冷冻袋的危险。皮肤接触如此低的温度而导致的皮肤烧伤和软组织损伤。只要将冰袋贴在皮肤上 20-30 分钟，就可能会造成损害。然而，研究表明，一次20分钟的冷却不足以改变需要更长时间的冷却来减少肿胀。然而，由于体积较大，患者的功能活动性和依从性受到限制。该设备，这阻碍了长期使用并增加了与深度相关的风险静脉血栓会降低患者的治疗效果，理想情况下可以佩戴该装置。长时间“免提”提供长期（全天）可编程治疗治疗方案包括抗炎期（T ~ 10 °C），然后是短暂的升高温度（T~20°C）以防止皮肤损伤。另一种电热冷却装置可直接应用于伤口网站将增加患者的采用并提高 Nanoohmics 的直接治疗效益。解决这一缺点的电热方法将提供可编程以薄型、低功耗的方式对整个接触区域进行温度控制该装置将使患者在治疗后能够完全自由行走受伤（例如脚踝/手腕扭伤）或手术（例如膝关节镜检查）。熔化和更换的问题，并且温度可以编程为冷（反炎症）和热量（细胞碎片清除、血栓形成）可能会带来好处减少止痛药物的消耗、受伤后的活动范围和疼痛评分降低以及与深静脉血栓形成相关的风险。