Anorectal Stimulation Device for Urinary Dysfunction
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Solution Overview
Problem
Current treatments for fecal and urinary incontinence, such as sacral nerve stimulation and electrical stimulation, often require invasive procedures and may not effectively address the distinct physiological needs of the internal and external anal sphincters, leading to inefficiencies and discomfort.
Innovation Solution
A device with multiple electrodes is implanted in the anorectal region, allowing for differential electrical stimulation of the internal and external anal sphincters using distinct algorithms to improve muscle tone and continence, reducing the need for multiple implants and invasive procedures.
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 may cause complications such as pain, device malfunction, or infection
Solution Approach 1:
The patent uses the anorectal structures (rectal wall, anal sphincter) as an intermediary target for electrical stimulation. Instead of directly stimulating the sacral nerve through surgical implantation, the invention delivers electrical signals through electrodes placed in the anorectal region, which then indirectly modulate the urinary sphincter function. This intermediary approach avoids the invasiveness of sacral nerve stimulation while achieving similar therapeutic effects through referred stimulation patterns.
Solution Approach 2:
The patent replaces the mechanical surgical implantation system with a less invasive electrical stimulation system. Instead of surgically implanting electrodes near the sacral nerve, the invention uses electrodes that can be placed in the anorectal region and delivers electrical signals that trigger physiological responses in the urinary sphincter through neural reflex pathways, substituting a less invasive mechanical/electrical system for the surgical approach.
2Ease of operation
If electrical stimulation is applied to the anal sphincter using a single probe, then the treatment is inexpensive and non-invasive, but it cannot effectively address the distinct physiological needs of the internal and external anal sphincters
Solution Approach 1:
The patent divides the electrical stimulation system into multiple independent electrodes (first electrode, second electrode, third electrode) that can be placed at different locations within the anorectal region. This segmentation allows each electrode to target specific structures (rectal wall, internal anal sphincter, external anal sphincter) with distinct stimulation parameters, enabling differentiated therapy for each sphincter type while maintaining the non-invasive nature of the treatment.
Solution Approach 2:
The patent applies different electrical stimulation parameters (pulse duration, frequency, amplitude) to different electrodes based on their local anatomical targets. The first electrode targeting the rectal wall receives different stimulation characteristics than the second electrode targeting the internal anal sphincter, which in turn receives different parameters than the third electrode targeting the external anal sphincter. This local customization of stimulation quality addresses the distinct physiological needs of each sphincter while keeping the overall system non-invasive.
3Adaptability or versatility
If multiple electrodes are implanted to stimulate different anorectal structures, then differential stimulation of internal and external sphincters is achieved, but the device complexity and implantation procedure increase
Solution Approach 1:
The patent designs a multi-electrode system where each electrode serves multiple functions: the first electrode can stimulate the rectal wall to trigger rectoanal inhibitory reflex, the second electrode can stimulate the internal anal sphincter for tone modulation, and the third electrode can stimulate the external anal sphincter for voluntary control enhancement. This universal design allows a single implantable device to perform multiple therapeutic functions that would otherwise require separate devices or procedures, reducing overall system complexity while maintaining differential stimulation capability.
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 provides long-term relief for incontinence by maintaining muscle tone and reducing fatigue, improving energy efficiency and patient comfort through targeted stimulation of both sphincter types.
Implementation Method 1
a waveform generator coupled to the first electrode and second electrode, wherein the waveform generator is configured to produce electrical pulses to the first electrode and second electrode and wherein said electrical pulses comprise a pulse width having a range of 10 μsec to 500 msec; a pulse amplitude of 1 μAmp to 100 mAmp; and a pulse frequency of 1cpm to 100 Hz
Data Source
Figure 1
Figure 2~3A
Figure 3B
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.