Submucosal Injection Sequencing for Stable Tissue Separation
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Solution Overview
Problem
Existing endoscopic procedures face challenges in separating and elevating tissue layers within the gastrointestinal tract for efficient resection, as low viscosity fluids dissipate quickly and high viscosity fluids require high injection forces that can damage tissues.
Innovation Solution
A system and method using a delivery device with two injectable compositions of differing viscosities, where a low viscosity composition separates the tissue layers and a high viscosity composition elevates and stabilizes them, preventing mixing and minimizing tissue trauma through a barrier member.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If low viscosity fluid is injected between tissue layers, then the fluid can flow between layers to separate them, but the fluid dissipates quickly and cannot maintain elevation during the procedure
Solution Approach 1:
The injection system is segmented into two distinct chambers: a first chamber containing low viscosity fluid for initial tissue layer separation and flow, and a second chamber containing high viscosity fluid for sustained elevation. This segmentation allows each fluid type to perform its optimal function at the appropriate stage of the procedure.
Solution Approach 2:
The system changes the viscosity parameter of the injected fluid by transitioning from low viscosity fluid (for initial separation and flow) to high viscosity fluid (for sustained elevation). This parameter change enables the system to overcome the limitation of rapid dissipation while maintaining the ability to flow between tissue layers.
2Duration of action of moving object
If high viscosity fluid is injected to elevate and stabilize tissue layers, then the tissue can be maintained for the procedure duration, but high injection forces are required that can damage or perforate tissue
Solution Approach 1:
The low viscosity fluid is injected first to pre-separate the tissue layers and create a safe pathway. This preliminary action reduces the mechanical resistance that would otherwise be encountered during subsequent high viscosity fluid injection, thereby reducing the risk of tissue damage from high injection forces.
Solution Approach 2:
The low viscosity fluid acts as an intermediary that facilitates the subsequent injection of high viscosity fluid. By first creating separation and reducing tissue adhesion, the low viscosity fluid mediates the transition to high viscosity fluid injection, enabling the benefits of high viscosity (sustained elevation) without the harmful effects (excessive injection force).
3Productivity
If two injectable compositions of different viscosities are used, then both separation and elevation functions are achieved, but the device complexity increases with multiple chambers and barrier members
Solution Approach 1:
The delivery device employs a nested chamber configuration where the first chamber (low viscosity fluid) and second chamber (high viscosity fluid) are positioned adjacent to each other within a single delivery device body. This nesting approach allows two distinct fluid systems to be integrated into one device without requiring separate injection systems, thereby managing complexity while maintaining functional benefits.
Solution Approach 2:
The device utilizes a biodegradable barrier member that is designed to rupture during the procedure. This disposable-like approach within a reusable device simplifies the overall system design by eliminating the need for complex mechanical valves or switches to control fluid delivery sequence.
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
Enables safe and efficient visualization and resection of lesions by maintaining tissue layer separation and elevation, reducing the risk of perforation and improving procedural efficiency.
Implementation Method 1
A viscosity of the first injectable composition may be less than a viscosity of the second injectable composition. For example, a viscosity of the second injectable composition may be at least ten times greater than the viscosity of the first injectable composition.
Implementation Method 2
The barrier member may be configured to rupture above a threshold level of force.
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.