Intrarectal Balloon Stool Drainage Device
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional stool drainage and irrigation systems face issues such as pressure-induced injuries, inadequate sealing, slippage, and contamination due to the use of high-volume-expandable materials like silicone, which lead to fecal incontinence and complex construction, making them unsuitable for long-term use, especially in immobile or uncooperative patients.
Innovation Solution
The system employs a design where the intrarectal and transanal balloon portions are structurally and functionally separated, using polyurethane (PUR) materials with lower volume expandability, allowing for independent pressure and filling volume control, and preshaped balloon structures for enhanced anchoring and sealing, reducing the number of components and improving tissue tolerance and sealing efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If high-volume-expandable materials like silicone are used for balloon portions, then the balloon can be inflated to large volumes for anchoring and sealing, but the material causes pressure-induced injuries, tissue trauma, and slippage due to excessive expansion and poor dimensional stability
Solution Approach 1:
The patent changes the material parameter from high-volume-expandable silicone to low-volume-expandable polyurethane, fundamentally altering the expansion characteristics. This parameter change allows the balloon to achieve adequate anchoring volume without excessive expansion that causes tissue trauma and slippage
Solution Approach 2:
The patent employs composite material construction with multiple layers including an inner layer and outer layer of polyurethane with different properties. This composite structure provides both the necessary mechanical strength for anchoring and the dimensional stability to prevent tissue trauma while maintaining adequate balloon volume
2Reliability
If silicone materials are used for balloon portions, then the balloon can be inflated for sealing function, but the material leads to fecal incontinence and contamination due to slippage and inadequate sealing
Solution Approach 1:
The patent changes the material parameter from silicone to polyurethane with lower volume expandability, which provides more predictable and stable sealing characteristics. This prevents the slippage that leads to fecal incontinence while maintaining adequate sealing pressure
Solution Approach 2:
The composite polyurethane construction with multiple layers provides enhanced sealing reliability through the combination of different material properties, ensuring consistent sealing performance that prevents fecal incontinence and contamination
3Device complexity
If intrarectal and transanal balloon portions are structurally integrated, then the device has simpler construction, but the pressure and filling volume cannot be controlled independently, reducing sealing efficiency
Solution Approach 1:
The patent divides the balloon system into separate intrarectal and transanal balloon portions that can be inflated independently. This segmentation allows each portion to be optimized for its specific function with appropriate pressure and volume control, enhancing overall sealing efficiency despite increased structural complexity
4Duration of action of stationary object
If the device is designed for long-term use in immobile patients, then continuous anchoring is required, but conventional materials cause slippage and require frequent replacement, increasing contamination risk
Solution Approach 1:
The patent changes the material parameter to polyurethane with lower volume expandability and better dimensional stability, which maintains consistent anchoring force over time. This prevents slippage and extends device retention time, reducing the frequency of replacements and associated contamination risks
Solution Approach 2:
The composite polyurethane construction provides enhanced mechanical properties that maintain anchoring effectiveness throughout prolonged use, ensuring device retention without slippage or tissue damage that would necessitate frequent removal and replacement
Data Source
AI summary
A device for sealing a colon, and for removing stool therefrom by irrigation, comprising an expandable intrarectal balloon segment formed from an everted tube with two ends, for insertion into the rectum to anchor the device, and a tapered transanal segment adapted to remain at least partially outside the rectum during use, wherein the balloon segment and the transanal segment have no common compartment, wherein both segments comprise drainage parts with a drainage lumen for irrigation of stool from the patient, wherein one of the two ends of the everted tube is passed through the lumen of the intrarectal balloon segment as an inner layer, the inner layer being in contact with a funnel element, and wherein the transanal segment is adapted to collapse upon resting of the sphincter, and comprises part of the intrarectal balloon segment, or a different balloon element.