Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide, and effective interventions for addressing PPH are urgently needed. Uterine balloon tamponade (UBT) is a technique to control PPH. Commercially available UBT devices are expensive and frequently require imaging technology to ensure placement. Condom-catheter uterine tamponade (C-UBT) is a technique appropriate for low-resource settings. Testing of the C-UBT is needed to better understand and optimize this technique for use in a variety of clinical settings including low-resource contexts. We describe here the design, development, and bench-top validation of a reusable C-UBT device optimized for low-resource settings. The device was tested in three differently sized uterine models using a variety of condom balloon configurations. Intrauterine wall pressure application was measured to evaluate the device capacity to apply pressure of at least 90 mmHg, estimating the mean arterial pressure within the uterine vasculature. Bench-top experimental validation of pressure exerted in uterine models demonstrated the device's capability of reaching hemostatic pressure in uterine volumes ranging from 170 to 1740 mL. Device adaptability and versatility were shown through its ability to reach the target pressure of 90 mmHg in different uterine sizes by varying balloon parameters, including condom thickness and condom configuration. The results of this study show the potential of a low-cost, reusable C-UBT device optimized to treat PPH in a variety of clinical settings, including low-resource contexts.

Gastrostomy tubes (G-tubes) are the gold standard for feeding assistance for children with feeding dysfunction. Current G-tubes pose complications that interrupt the delivery of feed, including tube displacement and difficulty of at-home use. This study details an alternative, spoke-based, double-lumen G-tube design and preliminary validation of its function and usability. Pull force testing was performed on spoke G-tube models across three sizes and two classifications (hard/soft). Preliminary models were evaluated against market standards. Though the pull force of the spoke model was found to be lower than that of both market standards, hard modifications to the spoke model improved retentive force. Ease of use was tested amongst users unfamiliar with G-tube placement. The spoke design required 12.3 ± 4.7 s to deploy, less than half the time required for market standards. However, balloon G-tubes were still perceived to be easiest to use by 70% of participants, with indications that a spoke design may be easier to use if sized similarly to current G-tubes, with auxiliary improvements to factors such as grip. While there is a need for improvements in the material properties and manufacturing of the proposed design, this study provides early validation of the potential to address complications of existing G-tubes.