Colonoscopic Antigen Capsule for Gastrointestinal Allergy Diagnosis
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Solution Overview
Problem
Current diagnostic methods for gastrointestinal allergy, such as skin testing and RAST, often yield false negatives, making it difficult to definitively diagnose gastrointestinal allergies, especially in patients with mild to severe symptoms and negative test results, as they do not accurately reflect antigen-specific IgE levels in the gastrointestinal mucosa.
Innovation Solution
A device that applies antigens locally to the colonic mucosa using a standardized technique, allowing for simultaneous testing of multiple antigens with a capsule-shaped device that penetrates the mucosal surface, minimizing the risk of perforation and ensuring reproducibility by maintaining a fixed depth of penetration and antigen amount.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If skin testing or RAST is used to diagnose gastrointestinal allergy, then the testing procedure is simple and non-invasive, but the diagnostic accuracy is low due to false negative results
Solution Approach 1:
The patent introduces a colonoscopic allergen provocation test as an intermediary diagnostic method between non-invasive skin/RAST testing and direct oral food challenges. This mediator allows direct assessment of gastrointestinal mucosal IgE responses to allergens, resolving the false negative problem by measuring antigen-specific IgE at the actual site of gastrointestinal allergy rather than relying on surrogate markers from skin or blood tests
Solution Approach 2:
The patent replaces the mechanical/skin-based testing system (skin prick tests, RAST blood tests) with a direct gastrointestinal mucosal testing system using colonoscopy. This substitution enables direct measurement of IgE-mediated responses in the gastrointestinal tract, eliminating the indirect nature of skin and blood tests that lead to false negatives
2Measurement precision
If colonoscopic allergen provocation is used to diagnose gastrointestinal allergy, then the diagnostic accuracy is high, but the risk of complications and costs increase
Solution Approach 1:
The patent applies partial action by using a standardized, limited-depth antigen application protocol during colonoscopy. Rather than performing extensive or deep tissue sampling that would increase perforation risk, the method uses controlled, superficial antigen application to the mucosal surface, achieving sufficient diagnostic accuracy while minimizing harmful effects
Solution Approach 2:
The patent changes the parameter of antigen application depth and dosage to optimize the balance between diagnostic accuracy and safety. By standardizing these parameters within safe limits, the method maintains high diagnostic precision while reducing the risk of complications compared to unstandardized approaches
3Productivity
If multiple antigens are tested simultaneously, then the diagnostic efficiency is improved, but the complexity of the testing device increases
Solution Approach 1:
The patent merges multiple antigen testing capabilities into a single colonoscopic device platform. Multiple allergens can be applied simultaneously or sequentially through the same colonoscope, combining what would otherwise require multiple separate procedures into one efficient diagnostic session, thereby improving productivity without proportionally increasing device complexity
Solution Approach 2:
The colonoscopic testing device is designed with multi-functionality to handle various antigens and testing scenarios through a single platform. The device can test multiple allergens, perform control tests, and accommodate different patient needs, achieving universal applicability that improves diagnostic efficiency while avoiding the need for multiple specialized devices
Data Source
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AI summary
A method and device for the diagnosis of gastrointestinal allergy. The method and the device expose a surface to at least one antigen at a fixed depth. The device includes an application point each having an antigen allowing for the application of the antigen to the surface at a fixed depth. The device may include multiple applications points each with an antigen for simultaneously applying the antigens to the surface.