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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响将是显着的母乳喂养的母亲谁遇到困难，生产牛奶或知道牛奶的体积表达在每个会话。虽然母乳喂养的好处在婴儿生命的第一年被医学界广泛接受，但60%的母亲没有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以及乳房中残留的乳汁量。拟议的设备将收集客观数据，帮助母亲克服母乳喂养的挑战，避免进一步的并发症，如管道堵塞和/或乳腺炎。具体来说，该设备将帮助母亲准确跟踪她们的牛奶产量，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母乳产量以及影响母乳产量和婴儿健康的因素，这一小企业创新研究第一阶段项目将创建一个概念验证的原型胸罩，利用纺织品，基于传感器，可精确测量母乳喂养/吸奶过程中挤出的乳汁量。该项目将为创建第一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：乳房空虚，每次母乳产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形状因素，这将有助于捕捉准确的数据。将有相关的数据采集和分析，展示可测量的指标数据趋势，以告知母乳喂养的妈妈，并在缺乏实际数据的领域进行高级别数据分析的聚集队列级数据趋势。在使用时，胸罩将适合哺乳或吸奶的女性，并且能够确定乳管中的乳汁消耗和剩余量以及所产生的乳汁量。在完成额外的研发后，该产品将执行三种不同的功能：1）确定乳房空虚的程度; 2）测量每次挤奶的量; 3）检测导管堵塞的早期风险，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.