Submucosal Endoscopy Instruments for Large Lesion Resection
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Solution Overview
Problem
Current endoscopic techniques face challenges in accessing and resecting large or irregularly shaped mucosal lesions, particularly due to limitations in lesion size, visualization, and the risk of perforating the muscular wall during submucosal dissection, which can lead to complications such as infection and damage to underlying tissues.
Innovation Solution
A safe access needle injection instrument with a tissue holding member and a needle member that allows controlled penetration of the mucosal layer and injection into the submucosal layer, combined with injectable dissection materials that dissolve or mechanically separate submucosal connective tissue, and a submucosal tunneling instrument for creating a tunnel beneath the mucosal layer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional needle injection techniques are used to elevate mucosal lesions, then the lesion can be raised for resection, but the risk of puncturing the muscular wall increases
Solution Approach 1:
A cap ligator is introduced as an intermediary device between the needle and the muscular wall. The cap ligator captures the needle tip and provides a barrier that prevents the needle from penetrating through the mucosal layer and damaging the muscular wall, while still allowing fluid injection to elevate the lesion effectively
Solution Approach 2:
The cap ligator is positioned beforehand to cushion and protect the muscular wall from needle penetration. By placing the cap ligator in position before needle injection, it creates a safety barrier that absorbs or deflects potential harmful needle penetration, preventing perforation while allowing the procedure to continue
2Area of stationary object
If large lesions are resected using conventional EMR techniques, then partial removal is possible, but complete en bloc resection cannot be achieved
Solution Approach 1:
The cap ligator is used to preliminarily capture and secure the entire lesion before resection begins. By enclosing the lesion within the cap ligator's capture area, the system prepares the lesion for complete removal in one piece, preventing fragmentation during the resection process
Solution Approach 2:
The cap ligator introduces a new spatial dimension for lesion containment by creating a three-dimensional capture space that encompasses the entire lesion. This dimensional approach allows large, irregular lesions to be contained and removed en bloc, overcoming the limitations of conventional two-dimensional snare resection
3Reliability
If tissue is suctioned into a cap ligator for resection, then the lesion can be captured, but the field of view is obscured
Solution Approach 1:
The system is segmented into distinct functional components: the cap ligator for lesion capture and the endoscope with light source for visualization. This segmentation allows the cap ligator to perform its capture function while the separate endoscopic lighting system maintains field of view visibility, eliminating the trade-off between capture reliability and visualization
4Shape
If saline is injected into the submucosal layer to elevate the lesion, then the lesion geometry changes for resection, but the underlying muscular layer may be damaged
Solution Approach 1:
The cap ligator serves as an intermediary barrier between the injection needle and the muscular layer. It allows controlled fluid injection to change lesion geometry while preventing direct needle contact with and potential damage to the underlying muscular layer
Solution Approach 2:
The cap ligator is positioned beforehand to cushion the muscular layer against needle penetration. This pre-positioned barrier allows safe fluid injection to achieve the desired lesion geometric changes without risking muscular layer injury
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 effective resection of large or irregular lesions en bloc, reduces the risk of perforation, and provides controlled dissection, enhancing the precision and safety of submucosal procedures.
Implementation Method 1
A safe access needle injection instrument with a tissue holding member and a needle member that allows controlled penetration of the mucosal layer and injection into the submucosal layer
Implementation Method 2
combined with injectable dissection materials that dissolve or mechanically separate submucosal connective tissue
Implementation Method 3
a submucosal tunneling instrument for creating a tunnel beneath the mucosal layer
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 a safe access needle injection instrument, 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.