Our Solution: The Smart Diaphragm

Addressing the syndrome of preterm birth early, affordable, and worldwide requires an innovative approach. In response, the UCSF team has developed and is now studying a device called the Smart Diaphragm.

Many of the causes of preterm birth are potentially reversible if microscopic cervical ripening processes can be detected earlier. This would open a new therapeutic window in which clinicians may be able to diagnose the underlying cause (e.g., malaria in developing countries) and reverse the underlying process driving preterm birth (e.g., antibiotics).

diagram showing preterm labor window of intervention

Prototype

Below is a Smart Diaphragm prototype used in clinical studies. The final form of the Smart Diaphragm device will be miniaturized to the size of a contraceptive diaphragm.

  1. Silicone vaginal probe
  2. Impedance measurement system: six electrodes acquiring electrical impedance measurements across multiple electrode pair combinations
  3. Fluorescence measurement system: scans across multiple wavelengths via a fiber-optic bundle that transmits and receives light through an optical window

device prototype

It will be:

  • Miniaturized—the size of a contraceptive diaphragm
  • Wireless & smartphone-enabled
  • Battery-powered
  • Cloud-based and encrypted
  • Usable at home
  • Inexpensively manufactured

With the final iteration, each patient will be able to track the progression of her pregnancy at home without the need for clinical supervision. Data will be relayed daily to a server via a mobile app. If preterm birth risk elevates, an alert will be sent to both patient and clinician. The engineering team is also exploring the addition of pH and temperature sensors to detect infection-initiated preterm birth.

Next: Studies