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.

PI：Savoy 项目摘要 受伤后的组织保护始于关闭血管舒张和限制 随后通过寒冷施加肿胀。在许多情况下，寒冷以形式出现 一袋冰或冷冻的冷包，或商业冷却产品，例如冰袋或冰袋 握住肢体包裹。在其他情况下，它可能是通过冷水电路设备进行的，例如 极地护理Kodiak冷疗法，其中从“举行盒”通过¾发送冰水 将油管变成涂在皮肤上的冷却垫。冰和冷冻包的缺点是风险 皮肤燃烧和软组织损伤的损害是由于皮肤与如此低温接触的。 只需将冰袋躺在皮肤上20-30分钟时，可能会造成伤害。 但是，研究表明20分钟冷却一次不足以改变 治疗过程并减少肿胀。需要长期冷却来制作 不同之处。但是，由于大部分 该设备，并且这种设备不鼓励长期使用，并增加与深层相关的风险 静脉血栓形成可减少患者的结局。理想情况下，该设备可以佩戴 长期提供长期（全天）可编程疗法的“免提” 包括抗炎期（T〜10°C）的方案，然后是短期 温度升高（T〜20°C），以防止皮肤损伤。 可以直接应用于伤害的替代电向冷却装置 现场将增加患者的收养并改善患者治疗益处。 Nanohmics的直接 解决这一缺点的电力到热方法将提供可编程的 低调的低功率消耗中整个接触区域的温度控制 在治疗方案期间，将使患者充分的门诊自由的设备 损伤（例如脚踝/腕部喷雾）或手术（例如膝关节镜检查）。没有冰意味着没有 熔化和替代的问题，并且可以为冷（抗 - 炎症）和热（细胞碎屑清除，血栓形成），这可能会导致有益 减少疼痛药物消耗，伤害后运动范围和疼痛评分降低 和与深静脉血栓形成有关的风险。