Single balloon ripening device with novel inserter and inflator

Abstract

An improvement on the extra-amniotic balloon and technique of placement is disclosed. It involves a large capacity balloon, modified to efficiently place pressure on the cervix, and markers for ease and of placement. The malleable introducing stylet allows for safe and easy insertion, either manually or visually, through a cervix that is 0.5 cm or more in dilation. The optional traction collar can aid in more efficiently placing pressure on the cervix. The automatic pump for instillation of the fluid has a forward and reverse mode to allow for deflation and repositioning of the balloon if placement is less than optimal. This process can be performed by a physician or a nurse, already certified in the placement of fetal scalp electrodes or intrauterine pressure catheters. Additionally, the procedure can be performed by one person.

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