Submucosal Dissection Instrument for Safe Lesion Resection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current endoscopic techniques for accessing and resecting large or irregularly shaped mucosal lesions in the digestive tract face challenges such as size limitations, irregular shape resection, uncertainty in the resected area, and risk of muscular layer injury due to needle perforation and fluid dissipation, making it difficult to perform safe and effective submucosal dissection.
Innovation Solution
A safe access needle injection instrument with a flexible tubular member and a coaxially disposed needle, along with a tissue holding member and injectable dissection materials, is used to create a submucosal bleb and dissect the connective tissue, allowing for precise and controlled access and resection of lesions without damaging the muscular layer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional EMR techniques are used to resect mucosal lesions, then lesions less than 2 cm in diameter can be resected, but larger or irregular shaped lesions cannot be effectively resected
Solution Approach 1:
The instrument divides the resection process into distinct phases: first creating a submucosal bleb to elevate and expose the lesion, then using a cutter to segment and remove the lesion in controlled portions. This allows systematic handling of large and irregular lesions that cannot be removed in a single action with conventional tools.
Solution Approach 2:
The injection of saline solution creates a submucosal bleb before the actual resection begins. This preliminary elevation action separates the lesion from the underlying muscular layer, provides better visualization, and prepares the lesion for safe and complete removal by the cutter.
2Ease of operation
If needle injection is used to elevate the lesion, then the lesion can be raised for resection, but there is risk of puncturing the muscular wall leading to infection or peritonitis
Solution Approach 1:
The catheter acts as an intermediary tool that delivers saline solution into the submucosal space without requiring direct needle penetration through the muscular layer. The catheter can be advanced through the mucosa under visual guidance, and the saline injection elevates the lesion safely without creating perforation wounds that could lead to infection or peritonitis.
Solution Approach 2:
The conventional mechanical needle injection system is replaced with a catheter-based saline injection system. This substitution maintains the lesion elevation function while eliminating the perforation risk associated with needles, as the catheter can be positioned and controlled without creating open wounds in the muscular wall.
3Shape
If saline is injected to elevate the lesion, then the lesion geometry is changed for resection, but the saline dissipates quickly causing damage to the underlying muscular layer
Solution Approach 1:
The patent changes the physical parameters of the elevating agent by using saline solution instead of gas or viscous fluids. Saline provides optimal elevation geometry change while maintaining controlled retention time in the submucosal layer, preventing rapid dissipation that would cause muscular layer damage. The solution can be injected in controlled amounts to achieve the desired elevation without excessive dispersion.
4Productivity
If tissue is suctioned into a cap ligator or aspiration cylinder, then the tissue can be removed, but the tissue obscures the field of view
Solution Approach 1:
The instrument extracts and removes the resected tissue through a controlled cutting mechanism rather than suctioning it into a container that would block the view. The cutter can be positioned to remove the lesion en bloc or in controlled portions, and the tissue is disposed of in a manner that does not interfere with endoscopic visualization, maintaining clear field of view throughout the procedure.
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 solution enables safe and effective access to the submucosal layer for resecting large or irregularly shaped lesions en bloc, reducing the risk of muscular layer injury and improving visualization, while allowing for precise dissection and removal of lesions without perforation.
Implementation Method 1
When a vacuum source connected to the proximal end of the tubular member is activated the vacuum causes the mucosal tissue to be suctioned within the window member of the tissue holding member
Implementation Method 2
The distal end of the needle member is operable from a first position proximal to the window member to a second position within the window member by axially advancing the needle member relative to the tubular member
Data Source
AI summary
Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include safe access needle injection instruments incorporating electrosurgical capability, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.