in the initial clinical trials and initial infant population if infant has umbilical catheter in place.
John Hardy's question for Amnion Life™
How will you maintain the sterile environment in the AmnioBed™ – when the infant is connected to intravenous lines, an umbilical catheter, an endotracheal tube, has a functioning GI tract and is accessed by medical staff and the family? John C. Hardy, D.O., Retired general surgeon.
Amir Fassihi MD answers:
Hi John, Thank you for our very important question. We’ve spent 3 years on R&D on this element and safety mechanisms in our patent application are what makes our IP unique in this field and why we think we will be the leaders in next generation of synthetic amniotic fluid incubators for preterm infants.
In AmnioBed, the infant is safely and securely harnessed in the bath on angled seat with head and neck above fluid line at all times. The infant wears a head cover/device which partly helps to reduce heat and water loss from head and neck area, but also has important sensors such skin temperature monitoring and O2 saturation monitoring. It also has a fluid sensor on the chin area which can detect fluid if levels rise above the chin so that it can automatically lower fluid level and inform nursing.
We are working on either placing the ECG leads partly on the head/scalp monitoring device or possibly on the bath itself and pick on signal in the bath. Our concern at this time is the noise level on the signal and we will have to do some testing to see where is the best place to capture ECG signal for monitoring. On the central lines, we are developing an umbilical catheter anchoring system to help maintain umbilical catheters isolated from bath fluid at all time. How it works is that in current practice the umbilical cord is cut at 5cm from abdominal wall. We are going to ask cord to be cut at 6-10cm from abdominal wall. The distal 1cm tip of the cord will be anchored device above the fluid line.
The catheter is inserted from the distal tip above the fluid line and anchored in place together with the distal tip of the cord. A plastic splash-proof cover is then being developed to cover the catheter from splashes. As far as peripheral lines, that would be in further development down the line and not necessary in the initial clinical trials and initial infant population if infant has umbilical catheter in place.
But if our device proves to be safe for longer than life of umbilical catheters, our current strategy is to float the extremity and cover with splash-proof cover. We are going to add some new 3D rendered images of the infant in the seat with the infant seat, head scalp monitoring and umbilical catheter.
The fluid in the bath is continuously cleaned, monitored, refreshed, filtered, heated and its osmolality adjusted according to medical needs. If stool particles are detected by our sensors, there is automatic flushing of fluid and replacement with clean warm simulated amniotic fluid. We are going to add some new 3D rendered images of our seat, scalp monitoring device and umbilical catheter anchoring system on our updates on our website this week. Thank you for your very important question and interest.
