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

小型企业创新研究(SBIR)第一阶段项目的更广泛影响将对母乳喂养的母亲产生重大影响，这些母亲在生产牛奶或了解每一次会议期间所表达的奶量方面遇到困难。虽然在婴儿出生后的第一年里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。母乳喂养的成败取决于婴儿是否获得足够的母乳，目前还没有客观的方法来确定婴儿正在接受的母乳数量以及母乳中剩余的母乳数量。拟议中的设备将收集客观数据，帮助母亲克服母乳喂养中的挑战，并避免进一步的并发症，如导管堵塞和/或乳腺炎。具体地说，该设备将帮助母亲准确跟踪她们的乳汁产量，从而达到哺乳目标，并允许母亲确保婴儿在生命早期获得必要的营养以茁壮成长。从胸罩收集的非个性化数据将使医疗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，从而扩大该领域进一步研究的视野。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文胸，它利用基于纺织品的传感器来准确测量母乳喂养/吸奶过程中排出的奶量。该项目将为创造第一个使用嵌入式光纤传感器技术的医疗设备奠定重要基础，以确定三个数据点：乳房排空率、每次产奶量以及母乳产量随时间的变化。研究将集中在传感器的设计和胸罩的外形因素上，以便于捕获准确的数据。将有相关的数据捕获和分析，展示可测量的指标数据趋势，为母乳喂养的母亲提供信息，并在缺乏实际数据的地区聚合队列水平的数据趋势，进行高水平的数据分析。在使用时，胸罩将适合哺乳或抽奶的女性，并能够确定乳管中的乳汁消耗量和残余量以及产奶量。在完成进一步的研发后，该产品将执行三种不同的功能：1)确定乳房排空的程度；2)测量每一阶段排出的奶量；3)检测早期管道堵塞的风险，以避免乳腺炎。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.