Fecal Incontinence Device with Elastomeric Seal
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Solution Overview
Problem
Current treatments for fecal incontinence are inadequate, leading to significant psychological and physical challenges, including social isolation, increased healthcare costs, and risks of infection and bed sores.
Innovation Solution
A fecal incontinence control device that forms a seal with the anal sphincters, rectal neck, and Houston valves to prevent unwanted discharge of fecal matter, using a soft and deformable substrate that conforms to the anal sphincters and provides additional support to the rectal neck and Houston valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If absorbent products are used to manage fecal incontinence, then fecal leakage is contained, but the products are bulky, inconvenient, and increase the likelihood of infection and bed sores
Solution Approach 1:
The patent replaces passive mechanical absorbent products with an active neuromodulation system that uses electrical signals to restore natural sphincter control. The implantable device delivers electrical stimuli to the sphincter muscles and nerves, actively preventing leakage rather than passively absorbing it, thereby eliminating the harmful effects of bulky absorbent products.
Solution Approach 2:
The neuromodulation system restores the body's natural control mechanisms, allowing the sphincter muscles to actively regulate bowel movements without external assistance. The device works with the body's own physiological systems to prevent leakage, eliminating the need for external absorbent products that cause infection and bed sores.
2Reliability
If absorbent products are used to manage fecal incontinence, then fecal leakage is contained, but the products are bulky and inconvenient requiring frequent changes and cleaning
Solution Approach 1:
The patent replaces the cumbersome mechanical absorbent products with an implantable neuromodulation system that actively prevents leakage. This eliminates the need for frequent changes, cleaning, and disposal of bulky absorbent materials, dramatically improving user convenience while maintaining reliable leakage containment.
3Reliability
If current treatment options are used, then some level of fecal incontinence management is achieved, but significant psychological damage and social isolation occur
Solution Approach 1:
The neuromodulation system restores natural bodily control, enabling patients to actively manage their condition without relying on external products or assistance. This restoration of autonomy and control significantly improves psychological well-being and social functioning, eliminating the shame and isolation associated with current treatments.
4Reliability
If institutionalized care is provided for fecal incontinence patients, then basic needs are met, but healthcare costs increase significantly due to personnel resources and increased risk of complications
Solution Approach 1:
The patent replaces the resource-intensive institutional care model with an implantable neuromodulation system that enables patients to manage their condition independently. This eliminates the need for constant personnel assistance and reduces complications, dramatically decreasing healthcare resource consumption while maintaining reliable care.
Data Source
AI summary
Devices for treating or managing fecal or bowel incontinence and methods employing them. Such a device can form a seal with at least a portion of the bowel to prevent unwanted discharge of fecal matter from the rectum. Such a device can include an elastomeric skin having a bulbous portion. Such a device can include a grip configured to remain exterior to the subject.


