Toroidal Balloon Closing System for Stoma Sealing
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Solution Overview
Problem
Current medical management of intestinal stomata and fecal incontinence is hindered by traumatic effects on anatomical structures, insufficient anchoring, and issues with odor and soiling, particularly due to the use of adhesive bags and rectal tubes that cause tissue irritation and are prone to slipping or loosening.
Innovation Solution
An inflatable balloon with a toroidal structure made from low-compliance materials like polyurethane, preformed to its working dimensions, which provides a secure seal against solid and semisolid contents while allowing continuous release of bowel gas and enabling irrigation, minimizing tissue irritation and pressure on exposed tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If adhesive bags are used for extracorporeal storage, then stool collection is achieved, but odor nuisance and risk of loosening occur
Solution Approach 1:
The closing system is divided into distinct functional segments: an intracorporeal closing element (balloon) for sealing, an extracorporeal collection element for stool storage, and a connecting element. This segmentation allows each part to perform its function optimally while isolating the harmful effects - the balloon provides reliable sealing without direct skin contact, and the collection element captures stool without odor nuisance.
Solution Approach 2:
The connecting element acts as an intermediary between the intracorporeal balloon and extracorporeal collection bag. This intermediary structure transfers the sealing function from the skin-contact area to a dedicated intracorporeal location, eliminating the need for adhesive bags to contact the skin while maintaining reliable stool collection.
2Ease of operation
If sealing devices are placed indwelling, then intermittent emptying is enabled, but traumatic effect on anatomical structures occurs
Solution Approach 1:
The closing element is constructed as a flexible, thin-walled balloon that can adapt to the anatomical structures without causing trauma. The flexible material allows the balloon to follow organ movements and conform to the stoma geometry, providing a gentle seal that enables intermittent emptying without damaging surrounding tissues.
Solution Approach 2:
The balloon is designed to be dynamic rather than rigid, allowing it to expand and contract, and adapt its shape according to intra-abdominal pressure changes and organ movements. This dynamic behavior enables the sealing device to maintain contact with anatomical structures without exerting traumatic forces, while still providing reliable sealing for intermittent emptying.
3Reliability
If sealing system is placed indwelling, then closure function is achieved, but insufficient anchoring and tendency to slip out occurs
Solution Approach 1:
The balloon is pre-formed to its final working configuration during manufacturing, creating a structure that is already optimized for anchoring. The pre-formed geometry includes features that facilitate secure positioning within the stoma, ensuring that when inserted, the balloon immediately provides reliable closure function without requiring additional anchoring adjustments.
Solution Approach 2:
The closing system employs a nested structure where the balloon is contained within a protective sleeve during insertion, and the sleeve is positioned within the stoma. This nested arrangement allows the balloon to be guided into place while maintaining secure anchoring, preventing slippage while still enabling the closure function.
4Ease of operation
If rectal tubes are used for stool drainage, then fecal drainage is achieved, but severe traumatic effects on colo-rectal and anal structures occur
Solution Approach 1:
The closing element is constructed as a flexible, thin-walled balloon that replaces the rigid rectal tube. This flexible structure follows the contours of the anal and colo-rectal structures without causing trauma, while still providing effective fecal drainage through the connected collection system.
Solution Approach 2:
The balloon's dynamic flexibility allows it to adapt to the movements and shape changes of the colo-rectal and anal structures, maintaining patent closure while avoiding the severe traumatic effects associated with rigid rectal tubes. The dynamic nature enables the system to follow organ movements without causing ulceration or penetration.
5Reliability
If closure plug is introduced trans-anally, then retention and seal effect are achieved, but tendency to slip out and painful ano-rectal irritations occur
Solution Approach 1:
The balloon is constructed from a flexible, thin-walled material that is gentler on the ano-rectal structures compared to rigid closure plugs. This flexible construction reduces painful irritations while maintaining the retention and seal effect through the connected collection system.
Solution Approach 2:
The balloon's dynamic flexibility allows it to move with and adapt to the ano-rectal structures, reducing the tendency to slip out that is characteristic of rigid closure plugs. The dynamic nature enables the balloon to follow organ movements while maintaining secure retention and sealing.
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 solution effectively anchors the balloon within the body, reduces tissue irritation, and prevents progressive flatulence by maintaining a low pressure load on tissues, allowing for secure and comfortable indwelling placement without causing significant discomfort or soiling.
Implementation Method 1
an inflatable balloon, having an approximately toroidal structure, formed of a hose segment with a two-dimensional surface... made from a thin-walled, soft foil material of low compliance... granting sufficient stability of the preshaped geometry, when the filling pressure inside the balloon structure increases
Implementation Method 2
made from a thin-walled, soft foil material of low compliance, preferably of a polymer with a compliance like polyvinyl chloride or lower, especially of a polymer with a compliance like polyethylene or lower, granting sufficient stability of the preshaped geometry, when the filling pressure inside the balloon structure increases
Data Source
AI summary
The invention relates to a closing system for a natural or an artificial anus, the system comprising an inflatable balloon having a generally toroidal structure, and composed of a plane tubular section folded in on itself, the ends of which extend coaxially within each other and are linked to a sleeve.