Significance: Of the 4 million babies born in the US each year, 120,000 (3%) have a complex birth defect.
Some defects, such as spina bifida, warrant in utero interventions to improve fetal outcomes. Spina bifida is a
condition where there is incomplete closing of the backbone and membranes around the spinal cord. Texas
Children’s Hospital has pioneered a fetoscopic method to address spina bifida. While much of the surgery can
be performed through ports, the uterus currently needs to be exteriorized in order to position the fetus
appropriately and place sutures to anchor the chorioamniotic membranes to the uterine wall. The sutures are
placed to prevent preterm premature rupture of membranes (pPROM) which leads to both maternal and fetal
complications. PPROM is a common complication of fetal surgery, occurring in about 30% of minimally
invasive cases. The risk of pPROM, both maternal and fetal, often offsets the benefits of fetal treatment.
Innovation: The Uterine wall-Membrane Anchor (UMA) is a linear device that facilitates the percutaneous
suturing of chorioamniotic membranes to the uterine wall during fetoscopic surgery. Two cylindrical anchors
are deployed on either side of the uterine wall and connected by a knotted suture that can be tightened to
secure the membranes. This solution facilitates the conversion of existing open fetal procedures to
percutaneous procedures and potentially the development of new fetal interventions. Approach: In this SBIR
Phase I project, Fannin Innovation Studio will optimize the prototype device design and test it in benchtop and
animal models. Aim 1 is focused on refining and optimizing the UMA prototype and developing the surgical
procedure to deploy the device. This will accelerate our progress towards clinical implementation and
commercialization. In Aim 2, the optimized prototype developed in Aim 1 will be tested in pregnant rabbit
chronic studies and pregnant sheep acute studies. We believe that the UMA device will bring value to patients,
doctors, and children’s hospitals by providing a solution that reduces maternal and fetal complications,
expands patient population through the development of a safer percutaneous procedure, and leads to better
outcomes for children with spina bifida.
