Systems and methods for the treatment and prevention of female pelvic dysfunction
Inventors
Assignees
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Publication Number
US-12569657-B2
Publication Date
2026-03-10
Expiration Date
Abstract
Systems for the treatment and prevention of pelvic dysfunction are provided. In one embodiment, a vaginal dilation device includes a handle portion and a shaft portion. The shaft portion is configured to expand from a collapsed configuration to an expanded configuration. The shaft portion can include a distal tip region, a spine region, and a distal arm region connecting the distal tip region to the spine region. The spine region can extend distally from the handle portion to the distal arm region, and can be generally tubular in shape. The distal arm region can be generally conical in shape and be configured to provide a gradual increase in diameter from the distal tip region to the spine region. Methods of use are also provided.
Core Innovation
The invention provides a vaginal dilation device for treating pelvic dysfunction, including vaginismus. The device body includes a distal non-expanding section shaped for entering a vaginal canal by incrementally moving aside a tissue wall during distal travel into the vaginal canal, and an expanding section connected to and proximal to the distal non-expanding section.
In the expanded configuration, the expanding section has a gradually increasing diameter and is conically shaped from the distal non-expanding section to the expanding section. The device includes a motor connected to the expanding section and capable of mechanically expanding the expanding section from a collapsed configuration to an expanded configuration.
The device also includes a cover that extends over the non-expanding section and the expanding section of the body. The cover provides a barrier to biological material over both the non-expanding section and the expanding section.
Claims Coverage
The independent claim is directed to a vaginal dilation device for treating pelvic dysfunction. The main inventive features include a distal non-expanding entry portion for incremental tissue displacement, a proximal conically shaped expanding portion with a gradual diameter ramp, a motor-driven expansion from a collapsed to an expanded configuration, and a barrier cover extending over both portions.
Distal non-expanding section shaped for incremental vaginal canal entry
A distal non-expanding section shaped for entering a vaginal canal of a patient by incrementally moving aside a tissue wall of the vaginal canal during distal travel of the body into the vaginal canal.
Proximal expanding section with gradually increasing conical diameter ramp
An expanding section, connected to the distal non-expanding section and being proximal thereto, and capable of expanding from a collapsed configuration to an expanded configuration, and having a gradually increasing diameter and conically shaped from the distal non-expanding section to the expanding section in the expanded configuration.
Motor for mechanical expansion from collapsed to expanded configuration
A motor connected to the expanding section and capable of mechanically expanding the expanding section from the collapsed configuration to the expanded configuration.
Barrier cover over non-expanding and expanding sections
A cover that provides a barrier to biological material and that extends over the non-expanding section and the expanding section of the body.
Overall, the claim coverage centers on a motor-driven vaginal dilation device with a distal non-expanding insertion portion that incrementally moves aside vaginal tissue, a proximal conically shaped expanding portion with a gradual diameter increase, and a barrier cover extending over the device body.
Stated Advantages
Avoiding a large diameter jump by using a gradually increasing conically shaped expanding section.
Providing incremental tissue displacement during distal travel into the vaginal canal.
Providing a barrier to biological material via a cover over the non-expanding and expanding sections.
Tracking and storing use information such as frequency of use and amount and duration of expansion.
Supporting patient-controlled incremental operation via a handle user control.
Documented Applications
Treatment of pelvic dysfunction, including vaginismus, using a vaginal dilation device.
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