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

描述（由申请人提供）：呼吸系统疾病继续呈上升趋势1 -4，特别是，仅COPD就影响全球近2.1亿人6。定量吸入器（MDI）是最常见的药物输送机制，患者使用它进行维持和急救药物治疗。众所周知，定期使用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%的患者没有显示正确的技术11 -17，近50%的患者没有定期服用药物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“在八个时间射击一个小目标”，即患者必须将吸入器指向他们的喉咙后部，并在吸气期间的正确时间激活吸入器-这是一种对大多数患者来说难以掌握的动作。使问题复杂化的是，定期使用吸入器对于慢性患者来说仍然是一个挑战，这主要是由于在使用维持吸入器时的遗忘。因此，尽管吸入器在市场上长期可用，但正确和定期使用吸入器仍然是大多数COPD患者的主要挑战。 在这个为期一年的第一阶段STTR项目中，我们将设计，开发和原型化一个智能附件R3，用于现成的MDI。R3是一个记录、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，使用多个传感器来测量吸入器的使用情况和环境参数，如位置、时间、方向和患者的潮气量。结合先进的信号处理算法，R3成为一个教练吸入器，为患者提供关于吸入器操作所有步骤的实时建议，从适当摇动吸入器开始，正确定时激活吸入器，然后在激活后继续吸入。教练是既基于音频使用板载扬声器，和视觉使用多色LED。最后，使用R3上的机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上下文提醒，提醒用户在外出时记住携带吸入器，在正确的时间服用药物并获得所需的补充。 该团队由Cognita Labs（Rice分拆）和Rice研究人员组成，他们在过去的项目中成功合作了3年多。Cognita Labs将开发硬件原型和关键算法，Rice研究人员将提供技术专长来对原型进行基准测试。在过去的两年里，该团队还与贝勒医学院的COPD专家（Guntupalli博士）密切合作，他们将在I期提供设计指导，并在II期提供临床试验合作伙伴。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变革性影响。

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.