Submucosal Injection Sequence for Stable GI Tissue Elevation
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Solution Overview
Problem
Existing endoscopic procedures face challenges in separating and elevating tissue layers within the gastrointestinal tract for effective resection, as low viscosity fluids dissipate quickly and high viscosity fluids require high injection forces that can damage tissues.
Innovation Solution
A dual injectable composition system is used, where a low viscosity fluid is initially injected to separate tissue layers, followed by a high viscosity fluid to elevate and stabilize them, using a delivery device with a barrier to prevent mixing and minimize tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If low viscosity fluid is injected to separate tissue layers, then tissue layer separation is achieved, but the fluid dissipates quickly and cannot maintain elevation throughout the procedure
Solution Approach 1:
The patent divides the injection process into two distinct stages using two different fluids: first a low viscosity fluid for initial tissue separation, then a high viscosity fluid for sustained elevation. This segmentation allows each fluid to perform its optimal function without the limitations of using a single fluid for both purposes.
Solution Approach 2:
The patent changes the viscosity parameter of the injectable fluid between two different fluids. The first fluid has low viscosity for easy flow and separation, while the second fluid has high viscosity for maintaining elevation. This parameter change resolves the contradiction between ease of separation and duration of elevation.
2Duration of action of moving object
If high viscosity fluid is used to elevate and stabilize tissue layers, then sustained elevation is achieved, but high injection forces are required that can damage or perforate tissue layers
Solution Approach 1:
The patent performs preliminary tissue separation using low viscosity fluid before introducing the high viscosity fluid. This preliminary action creates initial space between tissue layers, reducing the injection force needed when the high viscosity fluid is subsequently introduced, thereby preventing tissue damage while maintaining sustained elevation.
Solution Approach 2:
The low viscosity fluid acts as an intermediary that prepares the tissue layers for subsequent high viscosity fluid injection. By first creating separation space, it mediates between the need for sustained elevation and the risk of tissue damage, allowing the high viscosity fluid to be injected more safely.
3Device complexity
If single fluid is used for both separation and elevation, then device simplicity is maintained, but the fluid cannot simultaneously provide both separation capability and sustained elevation
Solution Approach 1:
The patent makes the injection system multi-functional by incorporating both low viscosity and high viscosity fluids in sequence. The system can perform both tissue separation and sustained elevation functions, achieving versatility without requiring completely separate devices for each function.
Data Source
AI summary
The present disclosure relates to the field of medical devices generally and specifically, to endoscopic systems and methods for resection of malignant and pre-malignant lesions within the gastrointestinal (GI) tract. In particular, the present disclosure relates to systems and methods for delivering injectable compositions between tissue layers (e.g., between the muscularis and submucosa layers) to elevate and stabilize the lesion for fast and efficient resection.