Helical Biliary Stent Placement for Secure Antegrade Retention
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Solution Overview
Problem
Current bile duct surgery methods face challenges such as complex equipment, high complication rates, limited access to specialized endoscopists, and difficulties in placing and retaining stents, particularly when dealing with gallstones or other obstructions.
Innovation Solution
Development of a deformable biliary stent with a polymeric material that transitions from a tensioned linear delivery configuration to an expanded helical deployment configuration, exerting a radially expansive force to securely anchor within the bile duct, allowing for simplified antegrade stent placement and formation of a composite fluid path.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional ERCP or CBDE methods are used for bile duct stone management, then stone extraction can be achieved, but the procedure requires specialist intervention, complex equipment, and has high complication rates
Solution Approach 1:
The patent extracts the essential function of bile duct access and stent placement from complex ERCP/CBDE procedures by using a simplified percutaneous approach through a small abdominal wall incision. The self-expanding helical stent eliminates the need for complex endoscopic equipment and specialist endoscopists, allowing general surgeons to perform the procedure with basic laparoscopic tools.
Solution Approach 2:
The stent is designed to be self-expanding and self-anchoring through its helical geometry that automatically engages with the bile duct wall upon insertion. This eliminates the need for complex deployment mechanisms, specialized endoscopic equipment, and expert operator intervention, enabling the procedure to be performed by general surgeons with minimal training.
2Reliability
If conventional stents are placed in bile ducts, then obstruction can be relieved, but the stents are difficult to place and retain, requiring multiple interventions
Solution Approach 1:
The stent employs a helical (curved) geometry rather than a straight configuration. This curved structure naturally engages with the curved anatomy of the bile duct, providing automatic retention through geometric interlocking. The helical shape allows the stent to be inserted in a compressed state and then expands to conform to the duct's curvature, ensuring secure placement without requiring multiple interventions.
Solution Approach 2:
The stent transitions from a compressed linear configuration during insertion to an expanded helical configuration in the bile duct. This dynamic transformation allows the stent to be easily inserted through a guide wire in a compact form, then automatically expands to its functional helical shape to provide secure retention and maintain patency, eliminating the need for complex deployment mechanisms.
3Ease of operation
If multiple tools and access points are used for antegrade stent placement, then visualization and stent placement can be achieved, but the procedure becomes more complex and time-consuming
Solution Approach 1:
The patent creates a universal access system where a single percutaneous puncture site serves multiple functions: cholangiography, guide wire placement, and stent insertion. The guide wire acts as a universal conduit for delivering the stent, eliminating the need for separate access points and multiple specialized tools. The same puncture site and guide wire configuration used for diagnostic imaging can be directly used for therapeutic stent placement.
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
Facilitates rapid and reliable stent placement with reduced operative time, improved retention, and reduced complications, enabling procedures to be completed percutaneously or with robotic assistance, and allowing for subsequent follow-up treatments without the need for immediate specialist intervention.
Implementation Method 1
a polymeric material having a Young's modulus that is effective to (a) exert a frictional force on an antegrade delivery device in the tensioned linear delivery configuration to so retain the tubular body on the delivery device; and (b) exert a radially expansive force on an inner wall of a bile duct in the expanded helical deployment configuration to radially expand the inner wall of the bile duct so retain the tubular body in the bile duct
Data Source
AI summary
Devices, methods, and kits are presented that allow for simplified stent placement and stent retention in a biological vessel other than a blood vessel, and especially biliary stent placement in an antegrade manner. The devices and methods advantageously allow for shortened imaging and stent placement time, and substantially improve tolerability and/or retention of the stent in the vessel, and in further beneficial aspects, contemplated stents form a composite fluid path to facilitate drainage of the vessel. Still further, the devices and methods presented herein reduce or even entirely eliminate partial deflation of the peritoneal space during imaging and stent placement and so prevent exposure of operating personnel to vented gases carrying harmful agents.