Inverting Rectal Device for Fecal Incontinence Control
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Solution Overview
Problem
Current treatments for fecal incontinence are either invasive, painful, or unreliable, and often cause damage to the anal canal or rectum, failing to effectively manage incontinence without causing discomfort or complications like bed sores and gangrene.
Innovation Solution
A non-invasive device with a body and withdrawal mechanism that uses a gas or liquid-filled structure with an outer surface featuring bristles or notches to remain above the dentate line, preventing fecal matter from passing while allowing normal blood flow, and a stopper to prevent excessive upward movement, ensuring the device remains in place and can be easily withdrawn without causing pain or damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a device is inserted into the anal canal or rectum to block fecal matter, then fecal incontinence is controlled, but peristaltic movements push the device out of the patient's body, making it ineffective
Solution Approach 1:
The device inverts inside-out during withdrawal, transforming the rough outer surface into the leading surface that contacts the anal canal wall during insertion, while the smooth inner surface becomes the trailing surface. This inversion mechanism allows peristalsis to push the device upward into the rectum rather than expel it, resolving the contradiction between device retention and effectiveness
Solution Approach 2:
The device transitions from a compressed insertion state to an expanded operational state, and can be withdrawn by pulling the tether which triggers inversion. This dynamic transformation allows the device to adapt to different functional requirements (insertion, retention, withdrawal) while maintaining effectiveness throughout the treatment period
2Reliability
If a device is placed in the anal canal below the dentate line to block fecal matter, then incontinence is controlled, but the device causes pain due to high innervation in that area
Solution Approach 1:
The device is designed with a stopper that prevents excessive upward movement into the highly innervated area below the dentate line. By pre-establishing this positional limit, the device ensures it remains in the less sensitive rectal area while still effectively blocking fecal matter, thus controlling incontinence without causing pain
3Reliability
If a tampon-like device is used to manage incontinence, then fecal matter is blocked, but lateral pressure on the rectal wall causes damage and pain
Solution Approach 1:
The device employs a flexible body that can be compressed for insertion and then expands to a controlled degree to block fecal matter. This flexible shell design allows the device to adapt to the rectal anatomy without exerting excessive lateral pressure on the rectal wall, preventing damage and pain while maintaining effective blocking
4Reliability
If invasive surgery is performed to treat fecal incontinence, then incontinence control is improved, but the procedure is dangerous and cannot be used on all patients
Solution Approach 1:
The device serves as a non-invasive intermediary solution that provides effective incontinence control without requiring surgical intervention. By using a mechanically functional device that can be inserted and retained in the rectum, the treatment achieves surgical-level effectiveness while avoiding all associated surgical risks and limitations
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 controls fecal incontinence by blocking fecal matter while allowing normal tissue function, preventing damage and pain, and can be easily removed without causing harm, addressing the limitations of existing treatments.
Implementation Method 1
the peristaltic movements of the intestines tend to push out anything found within the intestines, and, therefore, they are pushed out of the patient's body, thus being ineffective
Data Source
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AI summary
This invention is directed to a device (100) and a method for controlling fecal incontinence. The device of this invention is easily inserted into the anal canal or rectum, and is designed for remaining where required in the anal canal or rectum, above the dentate line and hemorrhoidal vein area, despite the peristaltic movements of the intestine.