Rotatable Side Port Access Needle for Biliary Wire Guidance
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Solution Overview
Problem
Current endoscopic ultrasound-guided biliary access procedures are technically challenging due to the lack of dedicated tools that facilitate easy manipulation and advancement of access needles into bile ducts, often resulting in wire shearing and difficulty in accessing the papilla, especially in cases where ERCP fails.
Innovation Solution
An improved access needle design featuring a needle shaft with a lumen and a rotatable exit port on the sidewall, allowing for easier wire guidance and placement of multiple wires, reducing the risk of wire shearing and facilitating access to complex ductal anatomies, with a flexible material shaft and a tip designed for cutting through tough tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional access needle is used for biliary access, then the procedure can be performed with standard equipment, but the manipulation and advancement of the needle into bile ducts is technically challenging and time-consuming
Solution Approach 1:
The access needle incorporates a rotatable side port that can be dynamically adjusted to different orientations. This dynamic feature allows the operator to rotate the side port to point toward the target bile duct, facilitating easier needle advancement and manipulation compared to fixed-port designs. The rotatable mechanism enables real-time adaptation to different anatomical configurations, reducing procedural difficulty and time.
2Adaptability or versatility
If a conventional access needle with fixed wire exit port is used, then the structure is simple, but wire shearing occurs and placement of multiple wires is difficult
Solution Approach 1:
The side port of the access needle is designed to be rotatable relative to the needle shaft, allowing dynamic repositioning of the wire exit location. This enables the operator to orient the side port toward different target locations within the bile duct, facilitating placement of multiple wires at different angles and positions. The rotatable mechanism increases adaptability for complex ductal anatomies while maintaining a relatively simple overall needle structure.
3Reliability
If standard ERCP techniques are used, then existing equipment can be utilized, but cannulation failure occurs and access to the papilla is difficult
Solution Approach 1:
The access needle is designed as a separate, dedicated device that can be used in conjunction with or替代 standard ERCP equipment. The needle features a distinct rotatable side port mechanism that segments the wire delivery function from the needle body, allowing independent optimization of wire placement capability. This segmented design improves reliability for difficult cannulation cases by providing a specialized tool rather than relying on multipurpose equipment.
Solution Approach 2:
The access needle acts as an intermediary device between the operator and the target bile duct. The rotatable side port serves as a mediator that facilitates smooth wire transition from the needle into the duct, reducing wire shearing and improving successful wire placement. This intermediary mechanism bridges the gap between standard ERCP equipment and successful biliary access in challenging cases.
4Ease of operation
If a rigid needle shaft is used, then structural strength is maintained, but manipulation and navigation into complex ductal anatomies is difficult
Solution Approach 1:
The access needle incorporates a flexible shaft that can bend and navigate complex ductal anatomies while maintaining sufficient structural strength. The flexibility allows the needle to conform to the natural curvature of the bile ducts, facilitating easier advancement to target locations. The shaft is engineered with appropriate flexural properties that balance navigability with the strength needed to support wire placement and resist breaking during the procedure.
Data Source
AI summary
An access needle is provided. The access needle includes a needle housing and a needle shaft having a portion disposed within the needle housing. The access needle also includes a lumen within the needle shaft, an entry port at a proximal end of the needle shaft, and a needle tip at a distal end of the needle shaft. The access needle also includes an exit port on a sidewall of the needle shaft, wherein the exit port is disposed nearer the distal end of the needle shaft than the proximal end, and wherein the lumen extends from the entry port to the exit port. The exit port a reduced diameter from the needle shaft. Guide surfaces in the vicinity of the exit port help to reduce snagging or drag of the guide wire. The access needle tip can be formed from nitinol and the guide surfaces can be formed from UV or AB glue. A system and a method for using the access needle are also provided.