Management of uterine atony induced post-partum hemorrhage

Abstract

Postpartum hemorrhage (PPH) is one of the greatest and persistent global health burdens in maternal health attributed to high morbidity and mortality, uterine atony is the highest etiology of PPH, other causes include; retained tissue/placenta, trauma, and coagulopathy. Currently, uterine atony induced PPH is being managed using uterotonics, intrauterine balloon tamponade, compression sutures, hysterectomy among others. Team Ultratech developed the intrauterine catheter device for management of uterine atony induced PPH in emergency obstetric care in low- resource settings. The device shall be used to apply pressure on the uterine wall and enhance myometrium contractility by inflating its balloon with air, and coat it with clotting factors to augment hemostasis. The prototype was extracted from the manual sphygmomanometer, stethoscope, y-connectors, and surgical gloves. Three tests were done on the intrauterine catheter prototype which were; pressure-volume, durability & thermostability, these were all preclinical tests. During medical device redesign, both virtual and physical redesign were done. Virtual redesign was done in Autodesk Fusion 360 Computer Aided Design software using the safe maximum volume to derive the diameter of the balloon and confinement volume which were later assembled to form the modified balloon of the intrauterine catheter. During physical redesign the balloon was inflated to the maximum safe volume of 0.0085m3 and its circumference measured, this was used to measure and cut a confinement structure out of bicycle tube tire and wrap around the balloon to form the modified balloon, the balloon was seen to generation its own reaction pressure with increasing volume before and after modification. The only modification on the intrauterine catheter was its balloon to improve safety of a mother by prevent uterine wall tears. During medical device retesting, only the pressure-volume and durability test were done out of the three tests previously done the intrauterine catheter, this was to ascertain the new maximum safe reaction pressure of the uterine wall to the balloon as well as to ascertain if the balloon can hold the safe maximum reaction pressure for at least 24 hours. Results showed the new safe maximum reaction pressure to be 29.5mmHg without uterine wall tears and the critical balloon durability time was 9 hours without any form of deflation. Results clearly showed that modification made intrauterine catheter was safer in terms of not rapturing the uterine wall as well as improved retention of maximum safe volume of air.