Vaginal Probe for Location-Guided Pelvic Floor Therapy
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Solution Overview
Problem
Current methods for diagnosing and treating female pelvic floor disorders, such as urinary incontinence and overactive bladder, lack standardized, reproducible tools for accurately assessing pelvic floor muscle function and providing guided therapy, with existing devices prone to measurement inaccuracies and invasive procedures associated with adverse events.
Innovation Solution
A vaginal probe equipped with tactile sensors and electromyographic electrodes for simultaneous recording of tactile and EMG responses, allowing for real-time visualization and location-guided therapy, including electrical stimulation, to target damaged or weak muscles based on predetermined response thresholds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical mesh or implanted electrodes are used for pelvic floor treatment, then treatment effectiveness is improved, but patient safety and comfort deteriorate due to adverse events such as vaginal extrusion, erosion, infection, and pain
Solution Approach 1:
The patent replaces mechanical invasive procedures (surgical mesh implantation, electrode insertion) with non-invasive electrical stimulation delivered through a vaginal probe. The system uses electrical fields to stimulate pelvic floor muscles without physical implantation, thereby maintaining treatment effectiveness while eliminating surgical adverse events.
Solution Approach 2:
The vaginal probe acts as an intermediary device that delivers electrical stimulation without requiring permanent implants. It provides temporary, removable access for muscle stimulation, avoiding the need for surgical mesh or implanted electrodes while still enabling effective pelvic floor therapy.
2Adaptability or versatility
If transvaginal electrical stimulation is used for UI and OAB treatment, then treatment feasibility is improved, but measurement accuracy and anatomical specificity deteriorate due to lack of objective functional guidance
Solution Approach 1:
The system incorporates tactile sensors that provide real-time feedback on pelvic floor muscle contraction quality and quantity. This feedback mechanism enables objective assessment of muscle function and allows adjustment of stimulation parameters to achieve anatomically-specific treatment effects, resolving the lack of measurement precision in conventional electrical stimulation.
Solution Approach 2:
The vaginal probe integrates multiple functions including electrical stimulation delivery, tactile sensing for muscle assessment, and real-time feedback. This multi-functional design enables both treatment and objective measurement capabilities in a single device, improving anatomical specificity while maintaining treatment feasibility.
3Ease of operation
If biofeedback with vaginal pressure sensors is used for pelvic floor training, then patient learning about muscle contraction is improved, but measurement reliability deteriorates due to motion artifacts and low measurement accuracy
Solution Approach 1:
The patent replaces mechanical pressure sensors with electrical stimulation and tactile sensing that directly measure muscle contraction properties. This substitution eliminates motion artifacts associated with mechanical sensors while providing more reliable and accurate measurement of pelvic floor muscle function for both patient feedback and clinical assessment.
4Difficulty of detecting and measuring
If conventional EMG probes are used for pelvic floor muscle assessment, then diagnostic capability is improved, but measurement precision deteriorates due to probe geometry issues, electrode misplacement, and motion artifacts
Solution Approach 1:
The system merges electrical stimulation electrodes with tactile sensors in a single integrated vaginal probe. This combination allows simultaneous delivery of stimulation and measurement of muscle response at the same anatomical location, eliminating the need for separate EMG probes and reducing measurement errors related to electrode placement and probe geometry.
Solution Approach 2:
The tactile sensors provide real-time feedback on muscle contraction that occurs during electrical stimulation. This feedback mechanism enables precise measurement of muscle response and allows for adjustment of stimulation parameters to optimize both diagnostic accuracy and treatment effectiveness, resolving the measurement precision issues of conventional EMG probes.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables objective characterization and visualization of pelvic floor muscle conditions, facilitating precise and effective therapy delivery, reducing the need for invasive procedures and improving treatment outcomes for conditions like urinary incontinence and overactive bladder.
Implementation Method 1
a plurality of tactile sensors configured to detect a tactile response of the pelvic floor muscles
Implementation Method 2
a plurality of electrodes configured to record an electromyographic response of the pelvic floor muscles during contraction of the muscles
Implementation Method 3
at least one, some or all of the electrodes may be also configured to provide an electrical pulse stimulation at selected locations suitable for treatment of a pelvic floor dysfunction
Data Source
AI summary
Methods and a probes are disclosed for vaginal tactile and electromyographic imaging, and location-guided female pelvic floor therapy. Methods include the steps of inserting a vaginal probe equipped with tactile sensors and electrodes acting as electromyographic sensors into a vagina along a vaginal canal to separate apart two opposing vaginal walls, recording a tactile response and an electromyographic response from at least one of two opposing vaginal walls during pelvic floor muscle contraction, determining locations along the vaginal canal for delivery of therapy based on presence of tactile response above a predetermined tactile threshold and/or presence of electromyographic response above a predetermined EMG threshold along the vaginal probe, selecting at least one of target locations to be used for location-guided therapy, and applying the therapy such as electrical muscle stimulation to at least one of selected locations using the same electrodes at these locations. The probe comprises a probe housing, a tactile sensors array, a plurality of electrodes which can be used as an electromyography array or as an electric muscle stimulation array, and at least one reference electrode.