Device for fetal monitoring during labor
Type: Medical Devices
In the USA and Europe, there are about 9 million births annually. Almost all births are monitored by fetal heart beat recording. The fetus requires an adequate supply of Oxygen during birth. Lack of Oxygen (Hypoxia) could cause long-term neurological damage expressed as cerebral palsy, mental retardation and in some cases, even death.
25% of all fetal death and injury during birth is caused by fetal oxygen deprivation. Out of all medical specialties, obstetrics is considered to hold the highest medicolegal risk and expenses, with fetal Hypoxia as the highest single cause.
Fetal scalp sampling: Is an important test that currently is underused. This method is approved as a standard of care by the FDA. Fetal scalp sampling used nowadays is a cumbersome and longtime (20 min) procedure with technical difficulties to obtain the blood sample from the fetus while in the birth canal. In contrary to fetal heart beat monitoring; blood sampling is considered not as a screening test but a diagnostic test of fetal well-being. This current method requires the woman at birth to lie with her legs stretched, raised and widely spread apart. A conus device is applied to the
fetal’s head, a lancet is positioned on a long rod to be introduced through the long conus device. After the puncture of the fetal’s scalp, a glass capillary is introduced to the fetal’s head for collection of the blood drop. The final step is analysis of the collected blood using a diagnostic stick that is introduced into a mobile biochemical analyzer.
The purpose of “Fetusafe” is to make the fetal’s blood sampling procedure user friendly and fast. Fetusafe is a 5x2 cm, small size device attached to the finger of the Obstetrician/ Midwife. During the standard labor progress evaluation, the device is placed on the fetals’ head that is felt by the Obstetrician /Midwife.
Indications / applications:
- Easy and fast results (up to 2 min.)
- Handheld (finger attached) device
- Fingers will substitute the need of long conus device
- It can be operated by Midwife and not only by a physician
- Developing countries accessibility due to low cost
- No need for a special and uncomfortable position of the woman
- No need for illumination inside the birth canal
- One step procedure