Implantable Nerve Stimulation for Pelvic Dysfunction
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Solution Overview
Problem
Current treatments for urinary and fecal incontinence, such as diet, training, slings, and drug therapies, often fail to effectively manage the condition.
Innovation Solution
An implantable medical device system that delivers nerve-stimulation signals to the pudendal nerve and other pelvic nerves to activate the external urethral and anal sphincters, using an implantable pulse generator and electrodes to provide targeted stimulation based on sensed patient parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional treatments (diet, training, slings, drug therapies) are used for incontinence, then the treatment approach is simple and non-invasive, but the effectiveness is insufficient and leakage events continue to occur
Solution Approach 1:
The patent replaces traditional mechanical/chemical treatment methods (slings, drug therapies) with an electrical stimulation system that uses electrical signals to activate sphincter muscles, providing a more effective treatment mechanism for incontinence
Solution Approach 2:
The implantable device incorporates sensors that automatically detect sphincter activity and bladder pressure, with a controller that autonomously adjusts stimulation parameters based on sensed physiological conditions, reducing the need for manual intervention and improving treatment reliability
2Reliability
If nerve-stimulation signals are delivered to activate sphincters, then sphincter control is enhanced and leakage is reduced, but the device complexity and implantation requirements increase
Solution Approach 1:
The patent combines multiple functions (sensing, signal processing, stimulation delivery) into a single implantable device system, integrating electrodes, sensors, and controllers into one cohesive unit that can be implanted together, simplifying the overall implantation procedure despite the advanced functionality
Solution Approach 2:
The patent uses sensory neurons as intermediaries between the implantable device and the sphincter muscles, where the device stimulates sensory neurons that naturally trigger reflexive sphincter contraction, providing a physiological pathway that enhances control while maintaining biological compatibility
3Adaptability or versatility
If multiple sensors and electrodes are implanted for targeted stimulation, then treatment precision and patient-specific adaptation improve, but the device complexity and surgical requirements increase
Solution Approach 1:
The patent places specific sensors and electrodes at precise anatomical locations (e.g., near the sphincter muscles and bladder) to target specific physiological functions, with each component having a specialized role that contributes to overall treatment effectiveness and patient-specific adaptation
Solution Approach 2:
The patent implements a feedback loop where sensors continuously monitor sphincter activity and bladder pressure, transmitting this information to the controller that adjusts stimulation parameters in real-time based on the sensed physiological state, enabling dynamic adaptation to each patient's needs
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 system effectively treats urinary and fecal incontinence by enhancing sphincter control and reducing leakage events, offering a more reliable solution than traditional methods.
Implementation Method 1
An implantable medical device system that delivers nerve-stimulation signals to the pudendal nerve and other pelvic nerves to activate the external urethral and anal sphincters
Data Source
AI summary
Systems and methods for treating bladder and/or bowel dysfunction of a patient includes a stimulation element implanted to stimulate one or more target sites, and a sensor to sense sensing at least one parameter of the patient indicative of a potential bladder or bowel dysfunction event. In some examples, stimulation energy is applied to an anatomical structure of the patient as a function of the sensed parameter, for example to address the potential bladder or bowel dysfunction event.