EUS Guided Drainage Stylet with Curved Tip and Contrast Channel
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Solution Overview
Problem
Current methods for draining blocked pancreatic or biliary ducts, such as those obstructed by cancer or gallstones, are inadequate in effectively facilitating fluid drainage due to limitations in precision and effectiveness.
Innovation Solution
An endoscopic ultrasound-guided drainage system comprising an access sheath, a stylet with a channel for injecting contrast media, and a dilating sheath with electrosurgical capabilities, which allows for precise puncturing and dilation of obstructed ducts to enable fluid drainage, utilizing a handle assembly for actuating the dilating sheath and facilitating tissue cauterization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a stylet with a curved distal portion is used to puncture obstructed ducts, then the ability to navigate and puncture blocked areas is improved, but the complexity of the device structure increases
Solution Approach 1:
The stylet is designed with a curved distal portion that can assume different configurations (pigtail loop, J-shape, shepherd's crook) to navigate and puncture obstructed ducts effectively. This curvature allows the stylet to adapt to the anatomical geometry of blocked ducts while maintaining a relatively simple overall device structure.
Solution Approach 2:
The stylet's distal portion is made flexible rather than rigid, allowing it to dynamically change its configuration based on the resistance encountered during insertion. The curved portion can flex and adapt its shape to navigate through obstructed areas, providing versatility without requiring multiple separate devices.
2Measurement precision
If contrast media is injected through the stylet channel to verify duct filling, then the precision of duct identification is improved, but the time required for the procedure increases
Solution Approach 1:
The system allows for preliminary injection of contrast media through the stylet channel before final duct access is established. This preliminary action verifies duct filling and identification early in the procedure, preventing unnecessary manipulation and reducing overall procedure time by confirming target accuracy before committing to the full access procedure.
Solution Approach 2:
The stylet serves as an intermediary tool that combines both the puncture function and the contrast media injection function. By integrating the injection capability directly into the puncture instrument, the system eliminates the need for separate injection devices and steps, thereby improving identification precision without significantly increasing procedure time.
3Reliability
If a dilating sheath is advanced over the access sheath to dilate the duct, then the effectiveness of drainage is improved, but the device complexity and ease of operation are worsened
Solution Approach 1:
The dilating sheath is designed to be advanced over the access sheath in a nested configuration, with the access sheath serving as an introduction device for the dilating sheath. This nested arrangement allows the dilating function to be integrated into the existing access system, improving drainage effectiveness while minimizing the addition of separate independent devices.
Solution Approach 2:
The overall drainage system is segmented into distinct functional components: the access sheath for initial puncture and entry, the stylet for duct verification, and the dilating sheath for final duct dilation. Each segment performs a specific function that can be independently controlled and manipulated, allowing complex drainage procedures to be broken down into manageable steps that reduce operational complexity.
4Adaptability or versatility
If the distal portion of the access sheath is biased toward a curved configuration, then the ability to engage obstructed areas is improved, but the ease of insertion through straight pathways is worsened
Solution Approach 1:
The distal portion of the access sheath is designed with dynamic flexibility, allowing it to transition between curved and straight configurations. During insertion through straight pathways, the flexible distal portion naturally follows the straight path. Once the tip engages the obstructed area, the distal portion can curve to conform to the blocked geometry, providing adaptability without sacrificing insertion ease.
Solution Approach 2:
The access sheath incorporates a flexible distal portion made of compliant material that can bend and curve to engage obstructed areas while maintaining a relatively straight overall configuration during insertion. This flexible section acts as a transition zone that adapts to anatomical variations without requiring the entire sheath to be curved, preserving ease of insertion through straight pathways.
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 precise and effective drainage of fluid-filled ducts by allowing for visualization under ultrasound guidance, verification of duct filling, and dilation of obstructed areas, thereby improving the efficiency of fluid removal and potential long-term duct maintenance through stenting.
Implementation Method 1
the stylet extending longitudinally from a proximal end to distal end and including a channel extending therethrough, the channel configured to receive a fluid therethrough
Implementation Method 2
the dilating sheath may include an electrode at a distal end thereof configured to cauterize tissue
Data Source
AI summary
A system for endoscopic ultrasound guided drainage includes an access sheath extending longitudinally from a proximal end to a distal end and including an access lumen extending therethrough from the proximal end to the distal end; a stylet slidably received within the access lumen, the stylet extending longitudinally from a proximal end to distal end and including a channel extending therethrough, the channel configured to receive a fluid therethrough; and a dilating sheath extending longitudinally from a proximal end to a distal end and including a dilating lumen extending therethrough. The dilating lumen is sized and shaped to slidably receive the access sheath.