Devices, systems, and methods for training pelvic floor muscles
Inventors
Beer, Marc D. • LORIE, Yolanda • Iglesias, Ramon Jose
Assignees
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Publication Number
US-11426626-B2
Publication Date
2022-08-30
Expiration Date
Abstract
The present invention relates to intravaginal devices, systems including the devices, and methods of using the devices to train an individual in the performance of exercises (e.g., pelvic floor lifts (PFLs) and pelvic floor relaxations (PFRs)) that strengthen the individual's pelvic floor muscles in order to treat or prevent pelvic floor disorders (e.g., pelvic organ prolapse and incontinence) and their accompanying symptoms.
Core Innovation
An intravaginal device includes a continuous or non-continuous ring having an outer edge configured to contact a vaginal wall and an internal diameter sized to substantially circumferentially surround a cervix or a vaginal cuff. A cylindrical tether is integrally attached to a point on the circumference of the ring, with accelerometers spaced along a length of the tether. The tether includes a defined width, and the angle between the tether and a transverse plane of the ring is about 90 degrees.
The system is used to assess pelvic floor hypermobility or weakness and to correlate characteristic device curvature during pelvic floor lifts and pelvic floor relaxation with pelvic organ prolapse (POP) stage, including stage IV eversion and extrusion. It supports substantially real-time monitoring and feedback when characteristic measures exceed an established safety score or alter urogenital system or pelvic floor health.
The described system further supports calibration and scoring to establish baselines and to track changes over time in relation to POP stages, enabling predictive assessment and monitoring of health status during use. The intravaginal platform is also described with detachable tether or sleeve modules for pharmaceutical agent delivery to vaginal tissues using locally applied or device-material distributed agents, including sustained or delayed release concepts, reservoir systems, and diffusion-controlled delayed release concepts.
Claims Coverage
The provided claim coverage centers on an intravaginal ring with a cylindrical tether carrying spaced accelerometers and oriented about 90 degrees relative to a transverse plane of the ring. The claim family also includes geometric constraints on tether width and length, along with dependent features for calibration, safety-score-based monitoring, substantially real-time feedback, and pharmaceutical agent distribution.
Intravaginal ring and accelerometer tether arrangement
A continuous or non-continuous intravaginal ring configured to contact a vaginal wall and substantially circumferentially surround a cervix or vaginal cuff, with a cylindrical tether integrally attached to the ring circumference, accelerometers spaced along the tether, and an angle between the tether and a transverse plane of the ring about 90 degrees.
Dimensional tether constraints for intravaginal sensing
The intravaginal ring device with a cylindrical tether having defined width and length, with accelerometers spaced along the tether and the tether-to-ring angle about 90 degrees.
Monitoring with calibration and a safety score
Monitoring the health or safety status of a subject’s urogenital system or pelvic floor by inserting an intravaginal device, calibrating over a calibration period, calculating a safety score, monitoring during daily activities, and providing substantially real-time feedback when performance or characteristics exceed an established safety score or alter health status.
Pharmaceutical agent distributed through device features
The intravaginal device including at least one pharmaceutical agent distributed through device material or applied as a coating, layer, or gel, with detachable tether or sleeve modules and sustained or delayed release concepts, reservoir systems, and diffusion-controlled delayed release concepts.
The claim coverage is primarily directed to an intravaginal ring with a cylindrical accelerometer tether oriented about 90 degrees to the ring plane and defined tether geometry. Additional claim coverage includes calibration and safety-score-based monitoring with substantially real-time feedback, and pharmaceutical agent distribution through device material or coating, layer, gel, tether, or sleeve modules.
Stated Advantages
Provides substantially real-time feedback when performance or characteristics exceed an established safety score or alter urogenital system or pelvic floor health.
Enables assessing POP stage by correlating device-curvature characteristics during pelvic floor lifts and pelvic floor relaxation.
Substantially real-time monitoring and coaching.
Biofeedback based on performance and health metrics including safety scoring.
Optional treatment or inhibition of pelvic floor disorders and related vaginal/female urogenital conditions via drug-delivery modules.
Documented Applications
Assessment or monitoring of pelvic organ prolapse (POP) stages, including stage IV eversion and extrusion, using characteristic device curvature during pelvic floor lifts and relaxation.
Monitoring of urogenital system or pelvic floor health and safety during daily activities that increase abdominal pressure.
Pelvic floor training with biofeedback, including calibration and scoring and correlating sensor scores to POP stages.
Pharmaceutical delivery using detachable tether or sleeve modules for local delivery to vaginal tissues, with sustained or delayed release concepts.
Intravaginal pelvic floor training to teach pelvic floor lifts (PFLs) and pelvic floor relaxations (PFRs).
Treatment or inhibition of pelvic floor disorders and related vaginal/female urogenital conditions, including urinary incontinence, pelvic organ prolapse (POP), and vaginismus.
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