SBIR Phase I: Feasibility of a Novel Minimally Invasive Labor Augmentation System for Stage I Labor

The broader/commercial impact of this Small Business Innovation Research Phase I project is the first medical device intervention for augmenting Stage I active labor. In the US, 3.4 million low-risk childbirths occur in hospitals each year representing the leading cause for admissions, in-hospital bed use, resulting in $50B direct costs. Despite optimal pharmacological administration, one in five (20%) experience significantly prolonged Stage I active labor durations due to ineffective uterine contractions. This results in increased maternal morbidity, health risks to the mother and infant, and is the leading cause of cesarean sections for low-risk delivery in the US. Rates of prolonged labor continue to increase with obesity, sedentary lifestyle and age of mother. This initiative aims to develop the first medical device therapy for use by Obstetricians to directly increase the labor forces while relieving uterine muscle demand during labor to make childbirth safer. This SBIR Phase I project aims to develop a minimally invasive intrauterine labor augmentation system (ILAS) providing direct fluidic mechanical pressure modulation. The trans birth canal system utilizes contemporary Class II medical device catheter-balloon (sac) technology to contain saline which fluidically controls intrauterine pressure synchronized to every labor contraction. In this SBIR Phase I project, the highest risk intrauterine assembly will be developed and mechanically validated through three primary objectives. First, the sac will be further developed for safe prolonged intrauterine use under simulated conditions by refining the biomaterial’s mechanical properties. This will ensure smooth deployment including low coefficient of friction, ease of insertion and withdraw from the uterus, with a suitable external diameter and mechanical handling characteristics. Second, the sac configuration and pleating pattern will be finalized for ensuring a low-profile insertion while maintaining durability and reliability. The system will then be validated through rigorous testing using a mock anatomical test system intrauterine cavity and infant. The results will verify the intrauterine catheter-sac’s ability to deploy properly under simulated use conditions, distribute fluidic pressure evenly to current clinical targets of 50-70mmHg, exhibit durability with a sufficient safety factor. The outcomes are a mechanically validated system using biomaterials suitable for preclinical translation during the next stage of development. 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.