Tissue Resection Device With Balloon Cushioning
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Solution Overview
Problem
Current endoscopic techniques face challenges in resecting large or irregularly shaped mucosal lesions in the digestive tract due to limitations in size, visualization, and the risk of muscular layer injury, particularly with needle injection systems that can lead to complications like perforation and incomplete resection.
Innovation Solution
A mucosal layer resection device featuring a tubular shaft with elongated, biased tissue guides and an electrosurgical loop cutter, allowing for precise dissection and removal of mucosal tissue along a defined path, reducing the risk of muscular layer injury and improving visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If conventional snare devices are used to resect mucosal lesions, then small lesions can be removed, but large or irregularly shaped lesions cannot be resected en bloc
Solution Approach 1:
The device segments the cutting function into multiple independent wires (first wire, second wire, third wire) that can be individually positioned and activated. This allows the cutting path to be divided into multiple sections, enabling en bloc resection of large or irregularly shaped lesions that cannot be removed with a single snare loop.
Solution Approach 2:
The invention transitions from a two-dimensional snare loop to a three-dimensional cutting path defined by multiple wires positioned at different locations. The first wire creates an initial incision, the second wire extends the cut, and the third wire completes the resection, creating a volumetric approach to lesion removal.
2Illumination intensity
If needle injection systems are used to elevate lesions, then submucosal elevation is achieved, but risk of muscular layer perforation increases
Solution Approach 1:
The device uses a non-conductive balloon as an intermediary to elevate the mucosal layer and lesion. The balloon is inflated in the submucosal space to create a cushioning effect that lifts the tissue for better visualization and creates a safety buffer between the electrosurgical wires and the muscular layer, reducing perforation risk.
Solution Approach 2:
The non-conductive balloon is inflated beforehand to create a protective cushion in the submucosal space. This cushioning effect provides both visualization enhancement and mechanical protection, preventing direct contact between the electrosurgical wires and the muscular layer before cutting begins.
3Manufacturing precision
If electrosurgical wires are used to cut tissue, then precise cutting is achieved, but risk of damaging underlying muscular layer increases
Solution Approach 1:
The non-conductive balloon serves as an intermediary barrier between the electrosurgical wires and the muscular layer. It allows precise cutting to occur in the submucosal plane while preventing thermal and mechanical damage to the underlying muscular layer through its protective cushioning effect.
Solution Approach 2:
The device applies electrosurgical energy locally and selectively along the defined cutting path created by the three wires. The cutting action is concentrated precisely where needed to separate the lesion from the muscular layer, while the balloon's non-conductive property ensures energy is not applied to the muscular layer itself.
4Manufacturing precision
If multiple wires are used to define cutting path, then resection precision is improved, but device complexity increases
Solution Approach 1:
The three electrosurgical wires serve multiple functions: they define the cutting path, create the incision, and enable en bloc resection of large lesions. This multi-functionality reduces the need for separate devices for different resection tasks, managing complexity through functional integration.
Solution Approach 2:
The device structure nests the three electrosurgical wires and the non-conductive balloon within a single delivery catheter system. The wires are positioned in sequence (first wire, second wire, third wire) within the same delivery mechanism, allowing complex functionality to be delivered through a unified device structure.
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 the safe and effective en bloc resection of large, irregularly shaped mucosal lesions by providing clear visualization and minimizing the risk of muscular layer damage, while allowing for precise control of the electrosurgical cutter to define the resection area.
Implementation Method 1
an electrosurgical loop cutter having an elongate electroconductive member slidably positioned within the lumen of the tubular shaft and a distal wire portion formed into a loop
Implementation Method 2
first and second elongated tubular tissue guides which are formed of a nonconductive material and biased outwardly
Data Source
AI summary
Instruments and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. The instruments include a mucosal resection device, a tissue grasper and a snare. Systems include a combination of one or more of such instruments. Embodiments of various methods for performing the procedures are also provided.