Collagen Sol for Submucosal Injection Gelation
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Solution Overview
Problem
Current methods for submucosal local injection in endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) face challenges such as quick attenuation of elevation height, contamination risks with blood, insufficient retention of mucosal elevation, and potential histological damage from UV exposure, leading to inadequate lesion removal and safety concerns.
Innovation Solution
A sol containing specific concentrations of collagen, water, sodium chloride, and genipin or its derivatives, which gels upon injection into the submucosa, maintaining a high retention rate of mucosal elevation height and integrating with the submucosal layer for effective lesion removal without the need for special apparatus or UV exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If saline is used for local injection to create submucosal elevation, then the injection is simple and safe, but the elevation height attenuates quickly making it difficult to achieve sufficient lesion removal
Solution Approach 1:
The patent changes the physical and chemical parameters of the injection solution by adding hyaluronic acid to increase viscosity and add genipin to enable gelation. These parameter changes transform the solution from a simple liquid that diffuses quickly into a viscous fluid that gels in situ, thereby extending the duration of elevation retention while maintaining injection simplicity and safety
Solution Approach 2:
The patent creates a composite injection solution combining saline, hyaluronic acid, and genipin. This composite material integrates the safety of saline with the viscosity-enhancing properties of hyaluronic acid and the gelation capability of genipin, achieving both prolonged elevation retention and operational simplicity
2Duration of action of moving object
If whole blood is used for local injection to enhance elevation retention, then the elevation height is retained better, but there is a risk of contamination and limited collection amount
Solution Approach 1:
The patent replaces whole blood with an artificial composite solution containing hyaluronic acid and genipin. This disposable-like approach uses readily available, non-biological materials that can be prepared in sufficient quantities without contamination risks, while achieving the desired elevation retention through controlled gelation rather than relying on blood's natural properties
Solution Approach 2:
The patent introduces hyaluronic acid and genipin as intermediary substances that mediate between the injection process and the desired outcome. These intermediaries provide the necessary viscosity and gelation properties without the contamination risks associated with using whole blood, creating a safe alternative that achieves similar or superior elevation retention
3Stability of the object's composition
If chitosan with photo-reactive group is used and exposed to ultraviolet light to cause gelation, then gelation occurs in submucosa, but there is risk of histological damage and requires special apparatus
Solution Approach 1:
The patent modifies the gelation mechanism to be self-service by using genipin, which automatically gelates the hyaluronic acid solution at physiological conditions without requiring external ultraviolet irradiation. This eliminates the need for complex irradiation apparatus and potential histological damage while achieving reliable gelation in the submucosa through the inherent chemical properties of the composite solution
Solution Approach 2:
The patent extracts the gelation function from the UV-light-dependent chitosan system and transfers it to the genipin-hyaluronic acid system that gelates spontaneously. This extraction removes the requirement for complex UV irradiation equipment and eliminates the associated risks of histological damage while maintaining the essential gelation capability in the submucosa
4Loss of substance
If highly viscous liquid is delivered via catheter to suppress diffusion, then diffusion is reduced, but the liquid does not gel in submucosa causing time-dependent attenuation
Solution Approach 1:
The patent applies preliminary action by incorporating genipin into the hyaluronic acid solution before injection. This pre-prepared composite solution is ready to gel immediately upon injection into the submucosa, preventing both excessive diffusion and time-dependent attenuation. The gelation process is triggered by the physiological environment rather than requiring post-injection intervention
Solution Approach 2:
The patent uses parameter changes by formulating a solution with specific concentrations of hyaluronic acid (0.1-1.0%) and genipin (0.01-1.0%) that transforms from a injectable fluid to a stable gel. This parameter optimization ensures adequate viscosity to prevent diffusion during injection while enabling subsequent gelation to maintain elevation height without time-dependent attenuation
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 sol provides a safe and effective mucosal elevation with a retention rate of over 70% after 60 minutes, reducing the risk of perforation and facilitating complete lesion resection while avoiding contamination and histological damage.
Implementation Method 1
the collagen forms fibrils at a temperature near the body temperature
Implementation Method 2
genipin crosslinking is introduced
Implementation Method 3
adjustment of the concentration of an inorganic salt can increase the gelation rate of a specific aqueous collagen solution
Data Source
AI summary
Object of the present invention is to provide a safe sol for submucosal local injection which gels and creates a mucosal elevation having a high retention rate of mucosal elevation height when locally injected into a digestive submucosa. Provided is a sol for submucosal local injection containing from 0.2 mass % to 1.2 mass % of a collagen, water, a buffer, and from 200 mM to 420 mM sodium chloride.