Endoscopic Mucosal Resection Device With Transverse Cutting Arm
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Solution Overview
Problem
Existing endoscopic mucosal resection (EMR) techniques face challenges in completely removing suspect tissue from the gastrointestinal tract without penetrating the muscularis layer, due to difficulties in removing the entire suspect region and the risk of muscularis penetration during cutting.
Innovation Solution
A surgical device with an elongated shaft and moveable arms that can be manipulated through a dissection plane to bluntly dissect between tissue layers, equipped with a cutting element that deploys from an un-deployed to a transverse configuration, allowing for precise resection of suspect tissue without penetrating the muscularis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a snare and forceps is used to grasp and lift the lesion while cutting around the lesion through the mucosa and submucosa, then the lesion can be removed, but there is a risk of penetrating the muscularis layer and difficulty in removing the entire suspect region
Solution Approach 1:
The resection process is divided into two distinct phases: first, blunt dissection through the dissection plane to separate the mucosa and submucosa from the muscularis without penetration risk, and second, deployment of the cutting element transverse to the dissection plane to complete the resection. This segmentation allows each phase to be optimized independently, reducing the risk of muscularis penetration while ensuring complete removal of suspect tissue.
Solution Approach 2:
The arm performs preliminary blunt dissection through the dissection plane before the cutting element is deployed. This preliminary action creates a safe working plane and separates tissue layers, establishing a buffer zone that prevents accidental penetration of the muscularis layer during subsequent cutting operations.
2Productivity
If traditional EMR techniques are used to remove suspect tissue, then some tissue can be removed, but complete removal of the entire suspect region is difficult
Solution Approach 1:
The cutting element is deployed transverse to the dissection plane, creating a new dimensional approach to resection. This transverse orientation allows the cutting element to engage suspect tissue from a different angle and plane, enabling more complete removal of the entire suspect region including areas that may be difficult to access with traditional longitudinal cutting approaches.
Solution Approach 2:
The arm is configured to be moveable through the dissection plane, allowing dynamic adjustment of the cutting element's position and orientation during the procedure. This mobility enables the physician to adapt the resection path to completely encompass the suspect region, improving the completeness of tissue removal while maintaining control to avoid muscularis penetration.
3Reliability
If cutting is performed through the mucosa and submucosa with caution not to penetrate the muscularis, then cancerous tissue can be removed, but the procedure is time-consuming and complex
Solution Approach 1:
The dissection plane acts as an intermediary layer between the cutting element and the muscularis. By performing blunt dissection through this intermediate plane first, the procedure creates a safety buffer that simplifies subsequent cutting operations, as the risk of muscularis penetration is reduced. This intermediary step, while adding a phase to the procedure, actually simplifies the overall complexity by providing a clearer, safer working plane.
Data Source
AI summary
A surgical device including an elongated shaft having a distal end and a proximal end, an arm pivotally connected to the distal end and moveable through a dissection plane, and a cutting element disposed on the arm and adapted to move from an un-deployed configuration to a deployed configuration, wherein the cutting element is generally aligned with the dissection plane when in the un-deployed configuration and at least partially transverse with respect to the dissection plane when in the deployed configuration.