Ambulatory cryocooling therapy device

门诊冷冻治疗装置

• 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
• 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

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.

派：萨沃伊 项目摘要 损伤后的组织保护始于关闭血管扩张和限制 随后通过冷敷肿胀。在许多情况下，感冒的形式是 冰袋或冷冻冷袋，或商业冷却产品，如冰袋或冰袋 抱着四肢包裹。在其他情况下，它可以通过冷水循环器装置，例如 极地关怀科迪亚克冷疗，冰水从储藏箱送到 将管子插入皮肤上的冷却垫。冰和冷冻包装的缺点是风险 皮肤接触如此低的温度造成的皮肤灼伤和软组织损伤。 冰袋贴在皮肤上只需20-30分钟，就可能造成损害。 然而，研究表明，一次20分钟的降温不足以改变 疗程，消肿消肿。需要更长期的冷却才能使 不同。然而，患者的功能活动和依从性受到限制，因为大部分 该设备，这不鼓励长期使用，并增加了与深 静脉血栓形成结合起来会降低患者的预后。理想情况下，该设备可以佩戴 提供长期(全天)可编程治疗的长期免提服务 该疗法包括消炎期(T~10℃)，然后是短暂的 升高温度(T~20°C)以防止皮肤损伤。 一种可直接应用于损伤的替代电-热冷却装置 SITE将增加患者的采用率并改善患者的治疗效益。NanoHmics的直接 解决这一缺点的电到热的方法将提供可编程的 对整个接触区的温度控制采用低调、低功耗 一种装置，将使患者在治疗方案期间能够完全自由行走 受伤(如脚踝/手腕扭伤)或手术(如膝关节镜检查)。没有冰就意味着没有冰 熔化和更换的问题，温度可以编程为冷(防 炎性)和高温(细胞碎片清除、血栓形成)，这可能会导致 减少止痛药消耗，减少受伤后的活动范围，并降低疼痛评分 以及与深静脉血栓形成相关的风险。