R3: A Smart Attachment for Improving Adherence and Usage of Metered Dose Inhalers

描述(申请人提供)：呼吸系统疾病继续上升1-4，特别是慢性阻塞性肺病影响全球近2.1亿6.计量吸入器(MDI)是最常见的给药机制，患者可用于维持和抢救药物。众所周知，定期使用这种药物可以最大限度地减少对肺部的长期损害，并改善患者的健康状况7。不幸的是，近70%-90%的患者没有表现出正确的技术11-17%，近50%的患者没有定期服药8-10，13正确使用的最大挑战在于使用吸入器的困难。正确的吸入器类似于在夜间向一个小目标射击，即患者必须将吸入器对准喉咙后部，并在吸气过程中的正确时间激活吸入器--事实证明，这一动作对大多数患者来说很难掌握。使问题更加复杂的是，经常使用吸入器仍然是慢性病患者的一个挑战，这主要是因为在使用维持性吸入器时忘记了使用。因此，尽管市场上长期供应吸入器，但正确和定期使用吸入器仍然是大多数COPD患者面临的主要挑战。在这个为期一年的STTR第一阶段项目中，我们将为现成的计量吸入器设计、开发和制作智能附件R3。R3是一种记录、推荐和提醒附件，旨在促进COPD患者正确和定期使用吸入器。R3的核心是一种新的实时记录方法，使用多个传感器实时测量吸入器的使用情况和相关参数，如位置、时间、方位和患者的潮气量。与先进的信号处理算法相结合，R3成为一种教练型吸入器，为患者提供有关吸入器动作的所有步骤的实时建议，从正确摇动吸入器开始，正确地选择激活吸入器的时间，然后在激活后继续吸气。教练既可以使用板载扬声器进行音频训练，也可以使用多色LED进行视觉训练。最后，使用R3上的车载位置和时间传感器，以及患者的智能手机，新的智能附件为用户提供情景提醒，提醒用户外出时记得携带吸入器，在正确的时间服药，并获得所需的补充。该团队由Cognita实验室(赖斯的一个分支)和赖斯的研究人员组成，他们在过去的项目上成功合作了3年多。Cognita实验室将开发硬件原型和关键算法，莱斯研究人员将提供技术专业知识来对原型进行基准测试。过去两年，该团队还一直与贝勒医学院的COPD专家(Guntupalli博士)密切合作，他们将在第一阶段提供设计指导，并在第二阶段提供临床试验合作伙伴。这一高度合作的项目有可能对COPD患者正确和定期使用吸入器产生革命性影响。

DESCRIPTION (provided by applicant): Respiratory illnesses continue to be on the rise1-4, in particular, COPD alone impacts nearly 210 million globally 6. Metered Dose Inhaler (MDI) is the most common mechanism to deliver medicine, and is used by the patients for both maintenance and rescue medications. It is well established that regular use of the medications minimizes long-term damage to the lungs, and results in improved health outcomes for the patients 7. Unfortunately, nearly 70-90% of the patients do not display correct technique11-17 and nearly 50% do not take their medications regularly 8-10,13. The biggest challenge in correct use lies in the difficulty of using the inhaler. Correct inhaler is akin to "shooting at a small target at the ight time" i.e. patients have to point the inhaler towards the back of their throat and activate the inhaler at the correct time during their inhalation - a maneuver which turns out to be difficult fo most patients to master. To compound the problem, regular use of inhaler continues to be a challenge for chronic patients, largely due to forgetfulness in use of maintenance inhalers. Thus, despite the long-term availability of inhalers in the market, correct and regular inhaler use continues to be a major challenge for most COPD patients. In this one-year Phase I STTR project, we will design, develop and prototype a smart attachment, R3, for off-the-shelf MDIs. R3 is a recording, recommending and reminding attachment, with the purpose to promote both correct and regular use of the inhaler for COPD patients. At the heart of R3 is a new real-time recording method using multiple sensors to measure inhaler usage and contextual parameters, like location, time, orientation and patient's tidal volume in real-time. Combined with advanced signal processing algorithms, R3 becomes a coaching inhaler providing patients with real-time recommendations on all steps of inhaler maneuver, starting from proper shaking of the inhaler, correct timing in activating the inhaler and then continuing to inhale after activation. The coaching is both audio-based using the on-board speaker, and visual using the multi-colored LEDs. Finally, using the on-board location and time sensors on R3, and the patient's smartphone, the new smart attachment provides contextual reminders to the users to remember to carry the inhaler when going out, taking medication at the right time and acquiring a needed refill. The team consists of Cognita Labs (a Rice spinoff) and Rice researchers who have successfully collaborated for more than 3 years on past projects. Cognita Labs will develop the hardware prototypes and key algorithms, and Rice researchers will provide technical expertise to benchmark the prototypes. The team has also been working closely with COPD experts (Dr. Guntupalli) at Baylor College of Medicine for last 2 years, who will provide design guidance in Phase I, and partner for clinical trials in Phase II. The highly collaborative project has the potential to have a transformative effect on correct and regular use of inhaler use by COPD patients.