Postpartum Hemorrhage (PPH) is the leading cause of maternal mortality worldwide, affecting 14 million women and claiming 150,000 lives annually. 99% of deaths occur in low-resource settings, where the majority of women give birth at home. This is largely due to a lack of available resources and training for midwives performing home deliveries, as most current PPH treatment options can only be administered by higher-level health workers in a hospital setting– often hours away from the patient's home. A community-level PPH treatment option is needed, and it must be simple and available enough for midwives and traditional birth attendants to be able to administer effectively.
OUR SOLUTION: TAMPOSTAT
Tampostat™ is a self-regulating, low cost, emergency obstetric device designed specifically for use in low-resource settings by greatly increasing safety, efficacy, and ease-of-use over existing condom tamponades. While other condom tamponades take a volume-based approach, which may not account for varying uterus sizes, Tampostat is pressure-based and uses air to eliminate the need for saline. It features a safety valve to prevent over-inflation through auditory feedback and allows for periodic uterine contractions by constantly monitoring the pressure. A proprietary probe, featuring a groove, which allows a condom to be attached with an airtight seal without occluding air flow, aids in guiding the condom into the uterus without the use of a vaginal speculum. With minimal training, a birth attendant in the field will be able to successfully administer Tampostat for about $1.50 USD.
1. THE PROBE
The probe is specifically designed to accommodate a postpartum uterus. The thin, rounded shape allows for easy insertion into a dilated cervix by breaking through any mucus that may have accumulated within, while the HDPE body acts as a handle and applicator, eschewing the need for outside applicators such as forceps or a speculum.
2. THE CONDOM
A common male condom acts as an inflatable balloon to apply counter-pressure to a bleeding uterus during PPH. Since most cases of PPH are caused by uterine atony, or an inability of the uterus to contract, pressure is used to constrict capillaries to reduce and stop bleeding. Condoms maintain structural integrity of pressures up to 300 mmHg. Since Tampostat traditionally operates at less than 100 mmHg of pressure, a condom is a safe and cost-effective alternative to other medical balloons.
3. THE O-RING
A rubber O-ring slides down the length of the unrolled condom and affixes it to the Probe by resting firmly within a groove built into the body of the Probe.
4. THE TUBE
The device uses two pieces of medical-grade tubing to transfer air from the inflation mechanism to the condom, allowing the patient some mobility, even while it is fully deployed within her uterus to allow for transportation and general body repositioning.
5. THE NERVE CENTER
The Nerve Center allows the pressure of the condom to be self-regulating, alerting the user via auditory or visual signals whenever the ideal pressure has been reached inside of the uterus by releasing excess air or sterile liquid (when inflated with air or sterile liquid, respectively). This allows low-level medical workers to confidently and successfully administer treatment without the need for extra training or devices to determine uterine volume.
6. THE BULB PUMP
In most cases, the condom will be inflated with air using a simple rubber bulb pump, such as that of a sphygmomanometer, with a barb to receive tubing. However, other inflators may be used. In addition, Tampostat's design also allows for the condom to be filled with sterile water or saline should the user choose to do so.