Peroral Cholangioscope Guide Sheath Navigation
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Solution Overview
Problem
Conventional endoscopes and duodenoscopes face challenges in navigating deep anatomical regions, requiring multiple skilled operators, increased time and cost due to repeated device insertion and reinsertion, and difficulty incorporating steerability and tissue collection features in small-diameter devices, particularly evident in ERCP procedures.
Innovation Solution
A direct peroral cholangioscopy system comprising a guide sheath and endoscope with enhanced steerability, allowing secondary steering and articulation, enabling easier navigation through the Sphincter of Oddi and increasing the volume of sample material collected with each insertion, reducing the need for multiple device insertions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional endoscopes are used to navigate deep anatomical regions through multiple operators and repeated insertions, then the procedure can be completed, but the time and complexity increase significantly
Solution Approach 1:
The system divides the navigation function into two segments: a guide sheath that performs the complex navigation through the pyloric sphincter and duodenum, and a cholangioscope that is simpler and is inserted through the guide sheath. This segmentation allows the guide sheath to handle the difficult navigation while the cholangioscope focuses on the target area, reducing overall procedural time.
Solution Approach 2:
The guide sheath is inserted and positioned in advance to establish a pathway through the difficult-to-reach anatomical regions before the cholangioscope is inserted. This preliminary navigation action removes the complexity from subsequent operations, allowing faster and simpler insertion of the cholangioscope and tissue retrieval devices.
2Reliability
If multiple skilled operators are required to operate three instruments simultaneously, then the procedure can be performed, but the operational complexity increases
Solution Approach 1:
The system merges the navigation and imaging functions into a single integrated cholangioscope device that is inserted through the guide sheath. This consolidation reduces the number of separate instruments from three (duodenoscope, cholangioscope, tissue retrieval device) to essentially two main components, thereby reducing the number of skilled operators needed.
Solution Approach 2:
The guide sheath acts as an intermediary device that simplifies the insertion and manipulation of the cholangioscope and tissue retrieval devices. By providing a pre-positioned pathway and mechanical support, the guide sheath reduces the operational difficulty and skill requirements for the subsequent instruments.
3Length of moving object
If small-diameter devices are used to access deep anatomical regions, then the devices can be inserted, but the ability to incorporate steerability and tissue collection features is reduced
Solution Approach 1:
The system segments the device functions by placing the steerability and navigation capabilities in the guide sheath (which has larger diameter), while the cholangioscope maintains a smaller diameter for insertion but gains enhanced steerability through the guide sheath's articulation mechanism. This allows tissue collection features to be incorporated without compromising the small-diameter insertion capability.
Data Source
AI summary
A direct peroral cholangioscope system comprises a guide sheath sized to pass through an esophagus of a patient comprising a proximal end portion, a distal end portion, and a lumen extending between the proximal end portion and the distal end portion, an endoscope comprising an elongate body extending from a proximal end to a distal end, an imaging device coupled to the elongate body proximate the distal end, and a passage extending at least partially through the elongate body and exiting at the distal end, the elongate body sized to pass through the lumen, and a tissue retrieval device configured to pass through the passage and retrieve tissue from within the patient. The guide sheath can be used to steer the endoscope through the pyloric sphincter and the sphincter of Oddi to allow the endoscope to be articulated in the common bile duct using native steering capabilities.