Methods and apparatus for preventing vaginal lacerations during childbirth
Inventors
Juravic, Mark • Stewart, Michael
Assignees
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Publication Number
US-11806047-B2
Publication Date
2023-11-07
Expiration Date
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 document describes a vaginal dilation device including a handle disposed at a proximal portion of the device, a plurality of arms coupled to the handle and extending distally, and an expansion mechanism coupled to the arms. The expansion mechanism is configured to move the arms radially outwards at a controlled force or controlled rate.
A release is disposed distal to the plurality of arms, positioned for delivery into a vaginal canal, and configured to quickly reduce an outer diameter of the vaginal dilation device for quick placement and removal. The device uses pads disposed on the arms so that the arms expand with tissue-conforming pad geometry, and in an expanded configuration the distance between opposing pads is 8–10 cm.
The document also describes staged or incremental dilation, force sensing and/or constant-force mechanisms, including a force sensor and a controller, to maintain a target force, ramp force, pause and resume dilation using force thresholds, and optionally prevent over-expansion. It further describes quick-release and collapse for fast removal, optional protective sterile sheath, optional working/through channels, and alternative cervical dilation device configurations related to the vaginal device.
Claims Coverage
The partial content provides two independent claims for a vaginal dilation device. They share a proximal handle, a plurality of arms extending distally, an expansion mechanism that moves the arms radially outward at a controlled force or controlled rate, and a distal release configured to quickly reduce the outer diameter for delivery into a vaginal canal. Dependent claims add pad-based expansion geometry, quick-release, force sensing, parallel arm configuration, and central rod actuation.
Controlled radial expansion with proximal handle and expansion mechanism
A vaginal dilation device comprising a handle disposed at a proximal portion, a plurality of arms coupled to the handle and extending distally, and an expansion mechanism configured to move the arms radially outwards at a controlled force.
Controlled radial expansion with controlled rate
A vaginal dilation device comprising an expansion mechanism configured to move the arms radially outwards at a controlled rate.
Distal release for quick reduction of outer diameter for delivery
A release disposed distal to the plurality of arms and configured to be at a location for delivery into a vaginal canal of a patient and configured to quickly reduce an outer diameter of the vaginal dilation device.
Axial rod actuation of radial arm movement
A central rod coupled to the expansion mechanism, wherein axial movement of the central rod moves the arms radially outwards from the central rod.
Expanded pad spacing of 8–10 cm
The device is configured such that, in an expanded configuration, the distance between opposing pads is 8–10 cm.
Pads disposed on each arm
The device includes multiple arms, and each arm has a pad disposed on it.
Parallel arm configuration when expanded
The arms are configured so as to be arranged in a parallel configuration when the arms move radially outwards.
Quick-release lever for rapid diameter reduction
The device further includes a quick-release lever configured to quickly reduce the device’s outer diameter.
Force sensor for measuring force against the vaginal canal
The device further includes a force sensor configured to measure a force applied by the vaginal dilation device against the vaginal canal.
Across the independent claims, the inventive focus is a vaginal dilation device with a proximal handle, radially outward-moving arms driven by an expansion mechanism, and a distal release configured to quickly reduce outer diameter for delivery into a vaginal canal. Dependent claim features add pad-based expansion geometry, parallel arm arrangement, quick-release lever, force sensing, and axial actuation via a central rod.
Stated Advantages
Reduces pelvic floor/perineal lacerations by controlled dilation.
Allows quick placement and removal by quickly reducing outer diameter of the vaginal dilation device.
Maintains controlled force during dilation, including pausing and resuming dilation using force thresholds.
Provides staged/incremental dilation with dilation and relaxation cycles.
Provides protection against over-expansion.
Provides protection against pressure necrosis via oscillation.
Documented Applications
Vaginismus treatment.
Pelvic muscle exercise.
Childbirth-related vaginal dilation, including staged dilation from a first labor phase and removal before a second phase (and related cervical dilation device use).
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