Devices, systems, and methods for training pelvic floor muscles

Inventors

Beer, Marc D. • Bohorquez, Jose • Pulliam, Samantha J. • McKinney, Jessica L.

Assignees

Axena Health Inc

Abstract

Featured are intravaginal devices and methods of using the devices to observe the state of an individual's pelvic floor muscles in order to diagnose, treat, or prevent pelvic floor disorders (e.g., pelvic organ prolapse and incontinence) and their accompanying symptoms and methods of using the devices to treat or prevent vaginal disorders (e.g., skin laxity) in a subject using an energy transmitter (e.g., a radiofrequency transmitter). Also featured are algorithms to detect pelvic floor movements and physiological indicia from sensor data.

Core Innovation

The invention relates to an intravaginal device for pelvic floor movement detection and training that uses two or more sensors to obtain positional data comprising sensor angle and time. The sensors measure a pelvic floor lift and a pelvic floor relaxation, and the positional data is processed to produce a composite score to determine an occurrence of the pelvic floor movement.

The method determines pelvic floor movement by measuring, for each of the sensors, a change in sensor angle defined as the difference between an angle during a pelvic floor lift and an angle during a pelvic floor relaxation, a change in sensor angle with respect to time, and a derivative of the change in sensor angle with respect to time. Pelvic floor movement is detected when the change in sensor angle with respect to time exceeds a predetermined threshold.

The training method establishes a baseline using processed positional data during performance of one or more pelvic floor movements to identify an occurrence of pelvic floor movement. The processed data is employed to provide an alert presenting physiological data regarding the pelvic floor movement, and additional physiological indicia may be determined using one or more additional sensors.

Claims Coverage

The independent claims include three categories: a method of detecting a pelvic floor movement with two or more intravaginal sensors and providing an alert, a method of training an intravaginal device using baseline establishment during pelvic floor movements, and a peripheral device configured to process intravaginal sensor data to detect pelvic floor movement. Across these independent claims, the inventive features are driven by composite score processing, baseline establishment, and detection based on sensor angle change and a derivative relative to a predetermined threshold.

Across the independent claims, detection and training are based on processing intravaginal sensor positional data into a composite score and baseline, and then detecting pelvic floor movement by evaluating a change in sensor angle with respect to time relative to a predetermined threshold, with the processing including measurement of a derivative of the change in sensor angle with respect to time.

Stated Advantages

Documented Applications