Emulsion Submucosal Cushion for Endoscopic Resection
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Solution Overview
Problem
Current endoscopic procedures for gastrointestinal endoscopy lack an ideal solution for submucosal injection that is safe, inexpensive, non-toxic, easy to inject, and capable of providing a high, long-lasting submucosal cushion, particularly for procedures like EMR and ESD, as existing solutions face issues with rapid dispersion, viscosity challenges, and potential contamination risks.
Innovation Solution
A pharmaceutical composition in the form of an emulsion or microemulsion containing an inverse thermosensitive polymer below the critical gelation concentration, which remains in a liquid phase up to 40°C, allowing for a high, long-lasting submucosal cushion without gelling inside the injection needle, facilitating safe and efficient endoscopic procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If an inverse thermosensitive polymer solution is used to provide a long-lasting submucosal cushion, then the duration of action is improved, but the solution may gel inside the injection needle at body temperature
Solution Approach 1:
The patent applies parameter changes by carefully controlling the concentration of the inverse thermosensitive polymer to be below the critical gelation concentration (CGC), and by cooling the solution to temperatures below the critical gelation temperature (CGT) before injection. This allows the solution to remain liquid during injection while still forming a long-lasting gel cushion in the submucosa after injection, thus resolving the contradiction between duration of action and ease of injection.
Solution Approach 2:
The patent applies preliminary action by cooling the polymer solution before injection to prevent premature gelation inside the injection needle. The solution is prepared and stored at temperatures below the CGT, and remains in this cooled state until immediately before injection, ensuring it stays liquid during the procedure while still forming a durable cushion in the target tissue.
2Duration of action of moving object
If a viscous solution is used to provide a long-lasting cushion, then the duration of action is improved, but the solution becomes difficult to inject
Solution Approach 1:
The patent applies dynamics by utilizing the temperature-dependent viscosity changes of the inverse thermosensitive polymer solution. The solution is kept cool (below CGT) during storage and injection to maintain low viscosity and ease of injection. After injection, the solution warms to body temperature, triggering gelation and formation of a durable, long-lasting cushion. This dynamic behavior resolves the contradiction between viscosity for durability and fluidity for injectability.
3Ease of operation
If normal saline solution is used for submucosal injection, then the ease of operation is improved, but the cushion dissipates rapidly
Solution Approach 1:
The patent applies parameter changes by replacing normal saline with an inverse thermosensitive polymer solution at a concentration below the CGC. This polymer solution maintains ease of injection when cool but forms a durable, long-lasting gel cushion in the submucosa after injection, directly addressing the rapid dissipation problem of normal saline while maintaining operational ease.
4Duration of action of moving object
If a gel-forming solution is used to provide a long-lasting cushion, then the duration of action is improved, but the solution cannot be injected through standard needles
Solution Approach 1:
The patent applies preliminary action by cooling the polymer solution before injection to prevent premature gelation. The solution is stored and handled in a cooled state (below CGT) to keep it liquid and injectable through standard needles. Only after injection does the solution warm to body temperature and gel, forming the durable cushion without requiring special injection devices or techniques.
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 composition provides a stable, long-lasting submucosal cushion that supports successful endoscopic resections by maintaining liquidity at body temperature, reducing the need for frequent injections and minimizing risks associated with existing solutions, thus enhancing the safety and efficiency of EMR and ESD procedures.
Implementation Method 1
A pharmaceutical composition in the form of an emulsion or microemulsion containing an inverse thermosensitive polymer below the critical gelation concentration, which remains in a liquid phase up to 40°C
Data Source
AI summary
The present invention relates to a pharmaceutical composition in form of emulsion or microemulsion and the use thereof as aid during endoscopic procedures in which it is injected in a target tissue in order to form a cushion. More in details, the invention relates to a method for performing an endoscopic procedure, which comprises injecting said pharmaceutical composition in form of emulsion or microemulsion in a target tissue of a patient, in order to form a cushion, which cushion is then optionally subjected to an endoscopic surgical procedure, such as a resection.