Split Overtube Assembly with Textured Balloon for Endoscopy
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Solution Overview
Problem
Conventional endoscopes face challenges in navigating irregular anatomy and small bowel examinations due to the low coefficient of friction between smooth balloons and the mucous-covered walls of the gastrointestinal tract, leading to premature slippage and potential damage during double balloon enteroscopy procedures.
Innovation Solution
The development of an overtube assembly with a flexible tubular body and an inflatable balloon featuring a textured exterior surface with outwardly extending protrusions, which provides increased friction and adhesion with the physiological lumen, allowing for better anchoring and advancement of the endoscope without the need for repeated insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If smooth latex-like balloons are used for DBE procedures, then the balloons are easy to manufacture and insert, but the low coefficient of friction causes the balloons to slip prematurely against the GI tract wall
Solution Approach 1:
The balloon surface is equipped with protrusions that are localized at specific positions rather than uniformly distributed. These protrusions are positioned to engage with the GI tract wall at optimal locations, providing enhanced friction and anchoring reliability without requiring complex manufacturing throughout the entire balloon surface.
Solution Approach 2:
The protrusions on the balloon surface have asymmetric geometries with varying heights, widths, and spacing patterns. This asymmetric design creates differential engagement with the GI tract wall, allowing the balloon to anchor more effectively at certain positions while maintaining manufacturability through standardized asymmetric elements.
2Reliability
If over-inflation of balloons is used to increase friction with the wall, then friction is improved, but damage to the patient's GI tract can occur
Solution Approach 1:
Instead of uniformly increasing balloon inflation pressure, the protrusions are strategically positioned and dimensioned to concentrate engagement forces at specific localized points on the GI tract wall. This localized engagement achieves sufficient anchoring reliability while distributing stress to prevent widespread tissue damage.
Solution Approach 2:
The balloon system incorporates dynamic adjustment capabilities where the inflation pressure and protrusion engagement can be modulated in real-time. This allows the system to maintain optimal anchoring force without exceeding tissue tolerance thresholds, preventing GI tract damage while ensuring reliable anchoring.
3Reliability
If a conventional overtube is used, then the enteroscope can be protected during insertion, but the enteroscope must be fully removed from the patient before attaching the overtube, effectively restarting the procedure
Solution Approach 1:
The overtube is divided into segmented sections with at least one collapsible segment that can be compressed radially. This segmentation allows the overtube to be inserted over the enteroscope in a collapsed state, then expanded within the patient's body to provide protection and anchoring, eliminating the need to remove and reinsert the enteroscope.
Solution Approach 2:
The overtube incorporates dynamic collapsible and expandable sections that can transition between compressed and expanded states. This dynamic behavior allows the overtube to be inserted in a low-profile collapsed state over the enteroscope, then expanded to provide protection and facilitate procedure completion without requiring enteroscope removal, thereby reducing procedure time and improving success rate.
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 textured overtube assembly enhances the reliability of endoscope advancement by maintaining engagement with the lumen wall, reducing slippage and damage risk, and allows for more successful completion of medical procedures, including improved detection of colorectal cancer in early stages.
Implementation Method 1
These materials have a low coefficient of friction, especially with the soft, mucous covered wall of the small bowel, colon, and other portions of the gastrointestinal (GI) tract. The low coefficient of friction can cause the balloon to slip prematurely
Data Source
AI summary
An overtube assembly for use with an elongate medical tool includes an overtube including a flexible tubular body having a proximal end and distal end. The flexible tubular body includes a split extending from the proximal end to the distal end. The overtube assembly further includes an inflatable balloon coupled to a distal portion of the flexible tubular body. The flexible tubular body is disposable over a section of the elongate medical tool by inserting the elongate medical tool through the split.