First twin cervical dilation system and method

A method of dilating a cervix of a patient, the method comprising:

• providing a cervical dilation system, the system comprising:
• a sleeve having an inner surface defining a cavity and opposite proximal and distal openings in communication with the cavity, the sleeve being constructed of a low friction material and configured to contain a lubricant between two layers of the sleeve to reduce friction during use;
• a shaft extending along a longitudinal axis between opposite proximal and distal ends, the shaft having an inner surface defining a passageway;
• and
• a balloon having a proximal end coupled to the proximal end of the shaft and a distal end spaced apart from the shaft, the balloon including an inner surface defining a chamber that is in fluid communication with the passageway,
• wherein the shaft is configured to be coupled to an inflation source to introduce an inflation material into the passageway and into the chamber to move the balloon between an uninflated configuration, in which the distal end has a convex orientation, and an inflated configuration, in which the distal end has a concave orientation,
• wherein inflation and movement of the balloon are configured to dilate a cervix, a vagina, and/or a vaginal introitus of a patient to simulate a first twin dilation effect;
• inserting the sleeve and the balloon into a birth canal of the patient with the balloon in the uninflated configuration;
• coupling an inflation source to the shaft and introducing an inflation material comprising saline through the passageway into the chamber to inflate the balloon to a first diameter of about 3 cm to about 7 cm;
• retracting the balloon to confirm seating of the balloon within the cervix;
• further inflating the balloon to a second diameter of about 10 cm to about 12 cm;
• sequentially reinserting, inflating, and removing the balloon to progressively dilate the cervix, the vagina, and the vaginal introitus;
• and
• removing the balloon to permit delivery of a baby through the fully dilated birth canal.

A cervical dilation device, comprising:

• a two-layered sleeve formed of polyethylene, the sleeve having an inner layer and an outer layer defining a channel therebetween, the channel containing a silicone lubricant enclosed within the sleeve;
• a shaft extending along a longitudinal axis between opposite proximal and distal ends, the shaft having a cylindrical passageway and one or more inflation ports;
• and
• a balloon coupled to the distal end of the shaft, the balloon comprising:
• a narrow conical bottom portion configured for initial dilation,
• a wide spherical top portion configured for maintaining and expanding dilation, and
• a disc-shaped distal tip having a thickness greater than a thickness of a body portion of the balloon,
• wherein the balloon is inflatable from approximately 1 cm to approximately 12 cm using the inflation material delivered through the shaft,
• wherein the disc-shaped distal tip is configured to transition from a convex orientation when the balloon is uninflated to a concave orientation when the balloon is inflated, and
• wherein the sleeve and the silicone lubricant are configured to reduce friction during insertion, inflation, and removal of the balloon to simulate a second twin effect during labor.