Anorectal Electrode System for Urinary Dysfunction
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Solution Overview
Problem
Current treatments for fecal and urinary incontinence often require invasive surgeries, have high complication rates, and are not effective for long-term symptom alleviation, while existing electrical stimulation methods fail to differentiate between internal and external anal sphincter stimulation, leading to fatigue and inefficiency.
Innovation Solution
A device with two electrodes is implanted in the anorectal region, using distinct stimulation algorithms to target the internal and external anal sphincters, allowing for simultaneous electrical stimulation of both sphincters with fewer leads and less invasive procedures, improving energy efficiency and reducing fatigue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sacral nerve electrical stimulation is used to treat incontinence, then leakage is eliminated in 40 to 75 percent of patients, but the treatment requires surgical implantation which is invasive and carries complications such as pain, device malfunction, or infection
Solution Approach 1:
The patent uses the anorectal structures (rectum or anal sphincter) as an intermediary target for electrical stimulation. Instead of directly stimulating the sacral nerves through surgical implantation, the invention stimulates the anorectal structures which are more accessible and can indirectly treat urinary dysfunction. This intermediary approach allows transrectal or transanal access without requiring surgical implantation near the sacral nerves.
Solution Approach 2:
The patent replaces the mechanical surgical implantation system with a less invasive electrical stimulation system. Instead of surgically implanting electrodes near sacral nerves, the invention uses transrectal or transanal electrical stimulation to achieve therapeutic effects. This substitution reduces mechanical invasion while maintaining therapeutic effectiveness through electrical field stimulation of accessible anorectal structures.
2Ease of operation
If existing electrical stimulation methods are used to stimulate the anal sphincter, then muscle contraction is achieved, but the method fails to differentiate between internal and external anal sphincter stimulation leading to fatigue and inefficiency
Solution Approach 1:
The patent segments the anal sphincter stimulation into distinct components by differentiating between internal and external anal sphincter stimulation. The invention provides separate stimulation protocols or electrode configurations that can selectively target each sphincter type. This segmentation prevents simultaneous over-stimulation of both sphincters, thereby reducing muscle fatigue and improving the duration of effective action.
Solution Approach 2:
The patent applies different stimulation parameters or electrode placements for different regions of the anal sphincter. By tailoring the stimulation characteristics (such as pulse duration, amplitude, or frequency) to the specific requirements of internal versus external sphincter muscles, the invention optimizes local muscle response and prevents generalized fatigue across the entire sphincter complex.
3Measurement precision
If multiple invasive implants are used to stimulate different sphincters, then precise stimulation control is achieved, but the procedure becomes more invasive and complex
Solution Approach 1:
The patent employs a single multi-functional electrode system that can stimulate both internal and external anal sphincters through different configurations or protocols. Rather than requiring separate implants for each sphincter, the invention designs a universal electrode that can selectively target different sphincter types by adjusting electrical parameters or activation sequences. This reduces the number of implants while maintaining precise stimulation control.
Solution Approach 2:
The patent combines the functionality of multiple separate stimulation devices into a single integrated system. By merging the internal and external sphincter stimulation capabilities into one electrode assembly or control system, the invention simplifies the implantation procedure while preserving the ability to independently control stimulation of each sphincter type through software or parameter adjustments.
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
The device effectively enhances sphincter control, reducing incontinence episodes and maintaining improved function for extended periods without the need for multiple invasive implants, offering a safer and more effective treatment for fecal and urinary incontinence.
Implementation Method 1
a waveform generator coupled to the first electrode and second electrode, wherein the waveform generator is configured to generate electrical pulses to the first electrode and second electrode
Data Source
AI summary
A system and method for treating anorectal and/or genitourinary dysfunction includes implanting, in a minimally invasive manner, an electro-medical device for stimulation of two or more anatomical or histological structures of the anorectal region and/or genitourinary region. Electrodes operably connected to the device are positioned proximate the target anatomical or histological structures. The device provides either the same or different stimulation algorithms to each anatomical or histological structure, which may be the same or different. The varied stimulation parameters, such as pulse width, pulse amplitude, and pulse frequency, are defined such that after an application of the electrical pulses, an abdominal leak pressure, an abdominal leak volume, or a urine volume increases or a number of incontinent episodes or a mean incontinence volume per episode decreases relative to said parameters prior to the application of the electrical pulses.