Systems and methods for the treatment and prevention of female pelvic dysfunction
Inventors
Assignees
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Publication Number
US-11712547-B2
Publication Date
2023-08-01
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 relates to an expandable vaginal dilation device adapted to expand from a collapsed configuration to an expanded configuration. The device includes a handle portion and a shaft portion extending distally from the handle portion towards a distal tip, and the shaft expands by motor-driven movement between collapsed and expanded configurations, including a central rod coupled to the motor, a first hub fixed relative to the motor, and a second hub configured to move along the central rod when the motor is operated.
Operation of the motor causes the second hub to move along the central rod, which increases an angle of first and second plurality of arms to increase relative to the central rod. This angle increase causes a plurality of spines to extend radially away from the central rod such that the plurality of spines remain substantially parallel to each other. The device defines a non-expanding distal tip region with a constant diameter, a generally tubular spine region that expands in diameter, and a conical distal arm region that provides a gradual ramp between the tip and the spines.
The described device can include optional diameter sensing or diameter gauging to monitor the expanding diameter, and it can include an expansion button enabling incremental user expansion. The described device can further include a vibrating element near the distal tip, an electronic controller, and data logging of expansion history. The device can also include an expandable protective sheath, which operates as a sterile barrier.
Claims Coverage
The independent claim covers a motor-driven vaginal dilation device that expands from a collapsed configuration to an expanded configuration by moving a second hub along a central rod to increase arm angles and extend spines radially while maintaining substantially parallel spines. The coverage is based on the structural relationship among handle portion, central rod, first hub fixed to the motor, second hub movable on the central rod, and arm-and-spine geometry that preserves parallelism during radial extension. Dependent claims refine quantitative diameter ranges, user controllable incremental adjustment, diameter sensing, and a vibrating element near the distal tip.
Motor-driven second hub expansion via central rod
A vaginal dilation device comprising a handle portion, a motor disposed within the handle portion, and a central rod coupled to the motor and extending distally toward a distal tip, where a first hub passes the central rod and is fixed relative to the motor, and a second hub passes the central rod and is configured to move along the central rod when the motor is operated.
Arm angle increase extending radially parallel spines
First and second plurality of arms connecting the first hub and the second hub to a plurality of spines, and a plurality of distal arms connecting the distal tip to the plurality of spines, wherein operation of the motor causes the second hub to move along the central rod to increase an angle of the first and second plurality of arms, causing the plurality of spines to extend radially away from the central rod such that the plurality of the spines remain substantially parallel to each other.
Across the independent claim, the main inventive coverage is the motor-driven translation of a second hub along a central rod that mechanically increases arm angles to radially extend spines while maintaining substantially parallel spines. Dependent claims further narrow the spine diameter in collapsed and expanded states, add user controllable incremental diameter adjustment, add diameter sensing of the spine region, and add a vibrating element near the distal tip.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Vaginal dilation for pelvic pain or vaginismus by dilating vaginal tissue and training pelvic muscles to relax.
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