The activities in the PLS project were carried out according to the work packages defined. The introductory work package on PLS requirements (WP1) has been closed and led to extensive requirement lists and initial knowledge relevant for the other work packages. The main activities and achievements in the second report period are:
1. Computational models (WP1 and WP5)
The mathematical model of the fetal physiology including fetal circulation and metabolic processes as well as fetal growth has been extended, implemented and verified, a global sensitivity analysis has been carried out and a first wireless connection with the manikin sensor output has been established.
2. The liquid-based environment (WP2)
Two concepts, liquid filled chamber(LFC) and liquid filled lungs (LFL) are explored. The prototype liquid filled chamber has been optimized and tested. The umbilical cord port has been designed. A first version of an umbilical cord cultivation for testing has been established. For the liquid filled lung procedure trachea tubes have been developed.
3. The fetal manikin and transfer devices (WP3)
A number of actuators and sensors for the fetal manikin that can accurately simulate extremely premature infants as well as a maternal manikin have been developed and tested. Different transfer procedures and associated devices have been defined and analysed.
4. The extracorporeal artificial placenta (WP4)
The two-chamber oxygenator with minimal prime volume and low flow resistance is manufactured and ready for testing with whole blood. First concepts of a possible fetal dialyzer for the liquid filled chamber are defined and prototyped.
5. The monitoring system (WP5)
A compact hybrid unobtrusive monitoring device for fetal function measurements that allows for simultaneous Diffudse Corrolation Spectroscopy (DCS) and Time Domain Near Infrared Spectroscopy (TD-NIRS) measurements was built and tested.
In addition to the substantial activities mentioned above, all necessary actions were taken for dissemination of results to stakeholders and promotion of further uptake of results, the creation of a development and exploitation plan and the project has been managed regarding implementation, financial aspects, monitoring, meetings, and reporting. In the second year of the project, we actively involved Advocate Advisory Board (AAB) and the Scientific Advisory Board.
Additional work package activities funded by the Eindhoven Engine (“WP9”) will focus on the development and clinical verification of PLS prototype in simulated environment (Tue) including a clinical protocol (Máxima MC) and a training program (Medsim): and the foundation of spin-off company (Juno).