ECM Hydrogel Submucosal Cushion for Endoscopic GI Dissection
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Solution Overview
Problem
There is a need for effective agents in endoscopic procedures to dissect mucosa and submucosa from the muscularis propria in organs like the stomach, small intestine, and large intestine, while minimizing inflammation and facilitating minimally invasive treatments.
Innovation Solution
Injecting an extracellular matrix (ECM) hydrogel submucosally to form a cushion between the submucosa and the underlying muscularis propria, with characteristics of rapid gelation at 37°C, suitable viscosity for infusion, and stiffness of 10 to 400 Pascal (Pa) to facilitate dissection and reduce inflammation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an ECM hydrogel is injected submucosally to form a cushion, then the dissection of mucosa and submucosa from muscularis propria is facilitated, but the gelation time and viscosity must be precisely controlled to ensure proper infusion and cushion formation
Solution Approach 1:
The patent applies parameter changes by precisely controlling the viscosity and gelation time of the ECM hydrogel. The hydrogel is formulated with specific viscosity characteristics that allow it to be easily infused through catheters while maintaining the ability to form a stable cushion. The gelation time is optimized to occur within a specific window after injection, ensuring proper cushion formation without premature solidification.
Solution Approach 2:
The patent utilizes phase transitions by designing the ECM hydrogel to undergo gelation after injection. The hydrogel is injected in a liquid or semi-liquid state for easy infusion, then transitions to a gel state in situ to form the desired cushion structure. This phase transition enables the material to be easily administered while subsequently providing the structural integrity needed for effective dissection.
2Strength
If the ECM hydrogel stiffness is increased to provide adequate cushion support, then dissection is facilitated, but the viscosity must remain suitable for infusion
Solution Approach 1:
The patent applies dynamics by creating a material that changes its mechanical properties over time. The ECM hydrogel is formulated to have low viscosity and stiffness during infusion to facilitate easy injection, then transitions to higher stiffness and structural integrity after gelation to provide adequate cushion support for dissection. This dynamic property change resolves the contradiction between ease of infusion and cushion support strength.
Solution Approach 2:
The patent applies preliminary action by ensuring the hydrogel is prepared with optimal viscosity characteristics before injection to facilitate easy infusion. The formulation is designed so that the infusion properties are optimized in advance, allowing the material to be easily administered before the gelation process begins and the stiffness increases to provide cushion support.
3Productivity
If the gelation time is reduced for faster cushion formation, then procedural efficiency is improved, but the viscosity must remain infusion-friendly
Solution Approach 1:
The patent applies parameter changes by optimizing the gelation time of the ECM hydrogel to occur within a specific window that balances procedural efficiency with infusion characteristics. The formulation is designed to gel within a controlled time frame that allows adequate time for infusion but ensures rapid enough cushion formation to maintain procedural efficiency. The viscosity parameters are simultaneously optimized to remain infusion-friendly throughout the gelation process.
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 ECM hydrogel effectively dissects mucosa and submucosa from the muscularis propria, inhibiting inflammation and supporting endoscopic resection procedures in the gastrointestinal tract.
Implementation Method 1
a time to 50% gelation of less than 30 minutes at a temperature of about 37° C.
Data Source
AI summary
Methods are disclosed for dissecting a mucosa and a submucosa from a muscularis propria from a region of an organ of a subject, wherein the organ is not the esophagus. In some embodiments, the organ is in the gastrointestinal tract. These methods include injecting submucosally into the organ of the subject a pharmaceutical composition comprising an extracellular matrix (ECM) hydrogel to form a cushion between the submucosa and the underlying muscularis propria at the region of the organ, wherein the ECM hydrogel has the following characteristics: a) a time to 50% gelation of less than 30 minutes at a temperature of about 37° C.; b) a flow viscosity suitable for infusion into the organ; and c) a stiffness of about 10 to about 400 Pascal (Pa).