SBIR Phase I: Sensor-based bra to measure breast milk output and monitor changes in breast volume before and after breastfeeding or breast pumping

这项小企业创新研究（SBIR）第一阶段项目的广泛影响将对母乳喂养的母亲产生重大影响，这些母亲在每次哺乳期间都难以产奶或不知道泌乳量。虽然在婴儿生命的第一年母乳喂养的好处被医学界广泛接受，但60%的母亲不能成功地持续母乳喂养。母乳喂养的成功或失败取决于婴儿是否获得足够的乳汁，目前还没有客观的方法来确定婴儿接受的乳汁量和乳房中剩余的乳汁量。该装置将收集客观数据，帮助母亲克服母乳喂养的挑战，避免进一步的并发症，如导管堵塞和/或乳腺炎。具体来说，该设备将帮助母亲准确地跟踪她们的产奶量，从而达到哺乳目标，并允许母亲确保婴儿在生命的早期阶段获得茁壮成长所需的营养。从胸罩中收集的非个性化数据将使医学专业人员和研究人员能够深入了解人类产奶量以及影响产奶量和婴儿健康的因素，从而为该领域的进一步研究拓展视野。这个小企业创新研究第一阶段项目将创建一个概念验证原型胸罩，该胸罩利用基于纺织品的传感器来准确测量母乳喂养/吸乳过程中的乳汁量。该项目将为创造首个使用嵌入式织物传感器技术的医疗设备奠定重要基础，以确定三个数据点：乳房空性、每次分泌的乳汁量以及母乳分泌随时间的变化。研究将集中在传感器的设计和胸罩的形状因素，这将有助于捕获准确的数据。将进行相关的数据采集和分析，既展示可衡量的指标数据趋势，为母乳喂养母亲提供信息，也展示汇总队列水平的数据趋势，以便在缺乏实际数据的地区进行高水平的数据分析。在使用时，胸罩将适合哺乳或吸乳的女性，并能够确定乳汁消耗和乳管中的剩余量以及产奶量。在完成额外的研发后，该产品将执行三个不同的功能：1)确定乳房空虚的程度；2)测量每次泌乳量；3)早期发现导管堵塞的危险，避免乳腺炎。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact of this Small Business Innovation Research (SBIR) Phase I project will be significant to breastfeeding mothers who experience difficulties producing milk or knowing the volume of milk expressed during each session. While the benefits of breastfeeding throughout the first year of a baby’s life are widely accepted in the medical community, 60% of mothers do not succeed in sustained breastfeeding. The success or failure of breastfeeding is dependent upon a baby getting enough milk, and currently there is no objective method of determining the amount of milk a baby is receiving and how much residual milk remains in the breasts. The proposed device will collect objective data that will help mothers overcome challenges in breastfeeding and avoid further complications like clogged ducts and/or mastitis. Specifically, the device will help mothers track their milk output accurately, therefore reaching lactation goals, and allow mothers to ensure that babies receive the required nutrition to thrive during the early stages of life. The depersonalized data collected from the bra will enable medical professionals and researchers to gain insights about human milk production volumes and factors influencing milk production and infant health, thereby expanding horizons for further research in this field.This Small Business Innovation Research Phase I project will create a proof-of-concept prototype bra that utilizes textile-based sensors to accurately measure the volume of milk expressed during a breastfeeding/breast pumping session. This project will lay important groundwork to create the first medical device using embedded fabric sensor technology to determine three data points: breast emptiness, milk volume output per session and changes in breast milk production over time. Research will focus on the design of the sensors and the form-factor of the bra that will facilitate capturing accurate data. There will be associated data capture and analysis demonstrating both measurable metric data trends to inform breastfeeding moms and aggregate cohort-level data trends for high level data analysis in an area with a paucity of actual data. When in use, the bra will be fitted to women while breastfeeding or pumping and be able to determine both the milk depletion and residual volume in the milk ducts and the volume of milk produced. After completing additional R&D, the product will perform three different functions: 1) determine the degree of breast emptiness; 2) measure the volume of milk expressed per session; 3) detect early risk of clogged ducts to avoid mastitis.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.