Methods and apparatus for preventing vaginal lacerations during childbirth

Inventors

Juravic, Mark • Stewart, Michael

Assignees

MATERNA MEDICAL Inc

Abstract

A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. In other embodiments, the vaginal dilation device is configured to apply a constant force to tissue. In other embodiments, the vaginal dilation device is configured to expand at a constant rate. Methods associated with use of the vaginal dilation device are also provided.

Core Innovation

The disclosed invention relates to a vaginal dilation device for mechanically dilating vaginal tissue during labor to prevent childbirth-related vaginal/perineal lacerations. The device includes a handle, a plurality of arms coupled to the handle, and pads disposed on the arms that are shaped and configured to conform to a vagina of a patient. An expansion mechanism moves the arms and the pads radially outwards at a controlled force to dilate the vaginal introitus diameter and associated vaginal tissue while maintaining controlled application to the anatomy.

A key feature is a bump-release disposed on a distal portion of the vaginal dilation device configured to quickly reduce an outer diameter of the vaginal dilation device if the bump-release is engaged by a fetus entering the vagina. The disclosed embodiments further support controlled-force expansion using mechanisms such as a constant-force device and optionally include sensing such as diameter/force sensing to guide dilation behavior. Safety and comfort features include rapid collapse via quick-release/bump-release functionality, and protective/comfort structures such as an expandable protective sheath.

The disclosed methods and embodiments emphasize using the device during the first phase of labor to mechanically dilate, optionally measure force and/or diameter, and dilate according to thresholds and/or constant-force/constant-rate behavior. The disclosure also includes removing the device prior to a second phase of labor, and it describes safety concepts such as clamping/over-expansion prevention and automatic oscillation as mechanisms intended to address pressure-related tissue concerns.

Claims Coverage

The independent claim set includes one independent claim. It defines a vaginal dilation device with an arm-and-pad structure conforming to a patient's vagina, a controlled-force radial expansion mechanism, and a distal bump-release that rapidly reduces outer diameter when engaged by a fetus entering the vagina.

Across the independent claim, the core claimed structure is a handle carrying multiple arms with conforming pads, coupled to a controlled-force radial expansion mechanism, and a distal bump-release that quickly reduces the device’s outer diameter when engaged by a fetus entering the vagina.

Stated Advantages

Documented Applications