Current techniques for managing potential complications during labor are based on cardiotocographic monitoring and, in some cases, blood sampling from the fetal scalp, which can cause discomfort and potential infections, while providing only sporadic results that are variable and imprecise throughout labor. Based on this limited information, a decision is made on whether an urgent cesarean section is required, although it is not always necessary. In this context, a group of researchers has developed a new microinvasive device that enables, once the amniotic membrane has ruptured and sufficient cervical dilation has been reached, the insertion of a patch that continuously and in real time provides accurate pH and lactate values.
The invention is based on the use of a patch that can adhere to the fetal scalp during labor using microneedles that enable the extraction of interstitial body fluid. The developed system incorporates a tandem biosensor and sensor capable of measuring lactate and pH levels. These parameters are associated with lactic acidosis, which poses a risk to homeostasis and can cause damage to the body. Therefore, measuring these two values using the patch makes it possible to objectively and accurately assess the fetal condition, as well as to detect potential complications during labor. In addition, the system includes an electronic unit capable of acquiring, conditioning, and transmitting the signal, thereby providing the relevant values for clinical assessment. The data obtained can be visualized remotely and stored either temporarily or permanently. Other potential application is biomarker monitoring in sports medicine.
Currently, the device is at a TRL 4 stage of development. The researchers have validated the effectiveness of the device through experiments at a laboratory scale. The technology is protected by a patent application (P202230679) and a subsequent PCT extension (PCT/ES2023/070477).
Benefits:
- Provides a painless and safe application method, avoiding causing injury, pain, or infection, thereby minimizing complications for both the baby and the mother.
- The sensor enables continuous and remote monitoring of the fetal condition during labor.
- Increases significantly the accuracy in identifying when an intervention is truly necessary during labor.
- The device allows measurement across a wide range of lactate concentrations.
- Provides improved diagnostic capability and enhanced clinical monitoring.
The represented institution is looking for a collaboration that leads to commercial exploitation of the presented invention.
Institution: Universidad de Cádiz
TRL: 4
Protection Status: Patent Application
Contacto: Carlos G. Gredilla / c.gredilla@viromii.com