Rectal Occlusion System With Angled Gas Drainage
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Solution Overview
Problem
Current closure systems for rectal or anal incontinence are difficult to handle, do not effectively drain intestinal gases, and are not reusable due to the inability to clean them properly, leading to high consumption and discomfort for patients.
Innovation Solution
A closure system with a shaft element and a balloon that includes a transversely extending outlet tube with angled outlet openings for gas drainage, an atraumatic end cap for easy insertion, and connectors for syringe cleaning, allowing for reliable sealing and multiple uses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-generated harmful factors
If the shaft element has both ends open to allow gas drainage, then gas drainage is possible, but intestinal contents easily enter the shaft element causing contamination
Solution Approach 1:
The outlet tube is separated from the main shaft element as a distinct component, allowing independent positioning and orientation. This segmentation enables the outlet tube to be angled at 90° relative to the shaft element, creating a spatial separation between the gas drainage path and the rectal cavity, thus preventing fecal contamination while maintaining gas drainage functionality
Solution Approach 2:
The outlet tube extends in a direction perpendicular to the longitudinal axis of the shaft element, utilizing a different spatial dimension for gas drainage. This dimensional change allows gas to escape laterally through the angled outlet openings while the shaft element remains positioned within the rectum, effectively separating the drainage function from the insertion path
2Reliability
If the closure system is designed for reliable sealing, then incontinence is treated effectively, but handling and insertion become more difficult
Solution Approach 1:
The outlet tube serves as an intermediary structure that provides a lateral extension from the shaft element. This intermediary component facilitates easier handling by providing an extended grip point during insertion and removal, while the balloon sealing mechanism maintains reliable closure of the rectal cavity
Solution Approach 2:
The balloon is preformed with a constriction that allows it to deform and adapt to the rectal anatomy when inflated. This curved, flexible design enables the balloon to conform to the rectal walls for effective sealing, while the overall system maintains simplicity for handling through the extended outlet tube
3Reliability
If tamponade bodies are made to swell for sealing, then sealing is achieved, but removal becomes difficult and painful
Solution Approach 1:
The system employs a dynamic sealing mechanism where the balloon can be inflated to create a seal and then deflated for easy removal. Unlike static swellable tamponades, the balloon's volume can be actively changed by controlling the filling medium, allowing the seal to be maintained during use and then released for painless removal without tissue adhesion
4Object-affected harmful factors
If non-reusable tamponades are used to ensure hygiene, then contamination is prevented, but consumption and cost increase significantly
Solution Approach 1:
The shaft element, outlet tube, and balloon assembly are designed as reusable components that can be removed, cleaned, and sterilized for multiple uses. The system replaces disposable tamponades with a durable structure that maintains hygiene through proper cleaning procedures, significantly reducing consumption and associated costs
Data Source
Figure 1~2
Figure 3
AI summary
The invention relates to an occlusion system for management of rectal or anal incontinence, comprising a shaft element (1) with a distal end (10) and a proximal end (11) and with a lumen (13) extending all the way from the distal end (10) to the proximal end (11) of the shaft element (1), and a balloon (2) which is mounted adhesively and sealingly on the shaft element (1) and can be filled with a filling medium via a filling line (3), wherein the balloon (2) is formed from a tube section and is shaped in such a way that, when filled with the filling medium, it forms a first balloon configuration (20) as intrarectal balloon and a second balloon configuration (21) as abutment balloon, which are delimited from each other by a constriction (22), and wherein the distal end (10) of the shaft element (1) is designed with an end cap (100) with a tip (101) and, at a distance from the tip (101), at least one gas inlet opening (102) is provided communicating with the lumen (13) of the shaft element (1), and the proximal end (11) of the shaft element (1) is connected to an outlet tube (110) which extends transverse to the longitudinal axis (L) of the shaft element (1), has outlet openings (110a, b) at its ends and communicates with the lumen (13).